Devices, methods and systems for percutaneous treatment of cholelithiasis

Abstract

Systems, devices, and methods for percutaneous removal of gallstones and gallstone fragments to treat cholelithiasis are disclosed. A representative system includes: an access sheath; a suction device, which can be removably coupled to the access sheath; and a catheter that can be removably inserted into the access sheath. Representative systems may also include a comminuting or fracturing control device and / or a comminuting or fracturing instrument. A representative access sheath includes a tubular shaft and a proximal hub having one or more valves. A representative suction device includes: a syringe body; an extended distal tip, which may also have a valve; and a plunger movable within the interior lumen of the syringe body. Representative conduits include; an outer conduit tube; an inner catheter manipulation shaft movable within the lumen of the outer catheter tube; and a basket or cage having a plurality of longitudinal struts.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is a non-provisional application of U.S. Provisional Patent Application No. 63 / 357,406, entitled “Apparatus, Method and System for Percutaneous Treatment of Cholelithiasis” filed by inventors Ben Merritt et al. on June 30, 2022, and claims priority to and the benefits of the U.S. Provisional Patent Application, which is jointly assigned herein, incorporated herein by reference, and has all the same force and effect as set forth herein in its entirety, and claims priority to all commonly disclosed subject matter. Technical Field

[0003] The present invention relates generally to the medical and surgical treatment of cholelithiasis, and more particularly to apparatus, methods and systems for percutaneous removal of gallstones to treat cholelithiasis. Background Art

[0004] The presence of gallstones in the bile duct, called cholelithiasis, involves the presence of one or more gallstones in the gallbladder or common bile duct, and affects approximately 2 to 4 million patients each year. The standard treatment is surgical intervention and removal of the gallbladder, called cholecystectomy, which is usually successful and usually without complications.

[0005] However, approximately 50,000 patients are non-surgical candidates and require alternative treatments. These patients often receive transhepatic drainage to help relieve inflammation and other symptoms of cholelithiasis. Non-surgical patients may need to live with a transhepatic drain for life. This effectively permanent drainage negatively affects the patient's quality of life and may limit their daily function.

[0006] Attempts have been made to treat cholelithiasis using instruments designed for other medical and surgical procedures and treatment methods. This includes, for example but not limited to, endoscopes, lithotripters, and lasers with various grasping and crushing tools, and re-use them to treat cholelithiasis. However, the configuration, size, or shape of such endoscopes and other instruments are not suitable for removing gallstones, which, for example, may be as large as 30 mm and quite hard. In addition, such endoscopes and other instruments are not designed for the specific environment of the gallbladder, which has flexible, compliant walls and changes greatly in shape and size if emptied or flushed.

[0007] Therefore, there is still a need for a device, method and system specifically designed for percutaneous removal of gallstones to treat cholelithiasis. Such a device, method and system should be able to be placed percutaneously and transhepatically into the affected gallbladder, and any gallstones in the gallbladder, common bile duct or other biliary positions can be removed. The cost of such a device, method and system should be relatively low, particularly compared to the cost associated with the surgical treatment and subsequent hospitalization of cholelithiasis. Such a device, method and system should be able to operate in a typical interventional radiology room, rather than in a surgical operating room. Such a device, method and system should further provide treatment options for patients who are non-surgical candidates, and thereby improve the quality of life that such patients would not otherwise have been able to obtain. Summary of the invention

[0008] Exemplary or representative embodiments of the present invention provide numerous advantages. Various representative embodiments provide devices, methods and systems specifically designed for percutaneous removal of gallstones to treat cholelithiasis, also referred to as cholelithotomy. Representative embodiments can be placed directly percutaneously or percutaneously and transhepatically into the affected gallbladder and can remove any gallstones in the gallbladder. The cost of representative devices, methods and systems is relatively low, particularly compared to the costs associated with surgical treatment and subsequent hospitalization for cholelithiasis. Representative devices, methods and systems can be operated in a typical interventional radiology room, rather than in a surgical operating room. Representative embodiments further provide a treatment option for gallstone removal for patients who are not surgical candidates, and further avoid the discomfort of permanent drainage and other associated problems, for example, thereby improving the quality of life that such patients would not otherwise be able to obtain.

[0009] A representative system embodiment for percutaneous removal of gallstones to treat cholelithiasis is disclosed, wherein the representative system includes: an access sheath; a suction device that can be removably coupled to the access sheath; and a catheter that can be removably inserted into the access sheath.

[0010] In a representative embodiment, the access sheath comprises: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen; and a proximal hub coupled to the first end of the tubular shaft. The second end of the tubular shaft can be angled or beveled.

[0011] In a representative embodiment, the tubular shaft includes: an inner shaft wall, which forms the central lumen; an outer shaft wall, which is coaxially arranged with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and an inflation lumen, which is arranged between the inner and outer shaft walls.

[0012] In a representative embodiment, the outer axial wall further includes: a plurality of infusion ports and at least one inflation port, the plurality of infusion ports being radially arranged around the periphery of the outer axial wall and spaced apart from the second distal end, the inflation lumen being spaced apart from the second distal end, and the plurality of infusion ports being fluidically connected to the one or more peripheral lumens.

[0013] In another representative embodiment, the access sheath further includes: an access sheath tip coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and connected to the one or more peripheral lumen fluids, the access sheath tip further including a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

[0014] In a representative embodiment, the access sheath may further include: an inflatable sealing and anchoring balloon spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen. In a representative embodiment, the access sheath may further include: an adjustable plug spaced apart from the inflatable sealing and anchoring balloon at the proximal end and radially coupled around the outer wall.

[0015] In a representative embodiment, the central lumen forms an aspiration channel for aspirating fluid and one or more gallstones or gallstone fragments from the gallbladder of the human or veterinary subject, and the one or more peripheral lumens and multiple infusion ports together form an infusion channel for infusing fluid into the gallbladder of the human or veterinary subject.

[0016] In a representative embodiment, the proximal hub includes: a hub shell having a hub lumen, the hub lumen being arranged to be in fluid communication with the central lumen; a filter assembly that can be removably coupled to the hub shell, the filter assembly being arranged to be in fluid communication with the central lumen; a first port that is integrally formed with or coupled to the hub shell, the first port being arranged to be in fluid communication with the one or more peripheral lumens; and a second port that is integrally formed with or coupled to the hub shell, the second port being arranged to be in fluid communication with the inflation lumen.

[0017] In a representative embodiment, the filter assembly includes: a filter canister that can be removably coupled to the housing, the filter canister having a filter canister lumen; and a filter that is disposed within the filter canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the filter canister. In a representative embodiment, the filter assembly is linearly arranged with or along the longitudinal axis.

[0018] In a representative embodiment, the proximal hub may further include: an infusion path tubing integrally formed with or coupled to the first port, the infusion path tubing being arranged to be in fluid communication with the one or more peripheral lumens; a first valve integrally formed with or coupled to the infusion path tubing; a second valve integrally formed with or coupled to the hub shell and in fluid communication with the filtration tank lumen; a connector coupled to the first valve and the second valve, the connector being removably coupled to a suction device. In a representative embodiment, the proximal hub may further include: a third valve integrally formed with the infusion path tubing and the first port or coupled between the infusion path tubing and the first port. In a representative embodiment, the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a stopcock, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof. In another representative embodiment, the proximal hub may further include: a third port formed integrally with or coupled to the hub housing, the third port being arranged to be in fluid communication with the central lumen for inserting a catheter into the central lumen.

[0019] In another representative embodiment, the proximal hub may further include: an infusion path tubing integrally formed with or coupled to the first port, the infusion path tubing being arranged to be fluidly connected to the one or more peripheral lumens; one or more first valves integrally formed with or coupled to the infusion path tubing; a second valve integrally formed with or coupled to the filter assembly or the hub shell and fluidly connected to the filter tank lumen; a return path tubing integrally formed with or coupled to the second valve; a connecting tubing having a third valve coupled between the infusion path tubing and the return path tubing and fluidly connected to the infusion path tubing and the return path tubing; a first connector coupled to the infusion path tubing; and a second connector coupled to the return path tubing.

[0020] In a representative embodiment, the suction device includes: a first suction device, which can be removably coupled to the first connector, the first suction device includes a first syringe body and a first plunger movable within the first syringe body; and a second suction device, which can be removably coupled to the second connector, the second suction device includes a second syringe body and a second plunger movable within the second syringe body.

[0021] In a representative embodiment, the system may further include: a first rack gear coupled to the first plunger; a second rack gear coupled to the second plunger; a pinion gear adjacent to and movably engaging the first and second rack gears, the pinion gear being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body; and a clamping assembly coupled to the pinion gear and the first and second syringe bodies.

[0022] In another representative embodiment, the system may further include: a pump coupled to the first and second plungers, the pump being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body.

[0023] In another representative embodiment, the proximal hub may include: a hub shell having a hub lumen, the hub lumen being arranged to be in fluid communication with the central lumen; a first port being integrally formed with or coupled to the hub shell, the first port being arranged to be in fluid communication with the one or more peripheral lumens; a second port being integrally formed with or coupled to the hub shell, the second port being arranged to be in fluid communication with the hub lumen; a filter assembly that may be removably coupled to the second port, the filter assembly being arranged to be in fluid communication with the hub lumen; and a third port being integrally formed with or coupled to the hub shell, the third port being arranged to be in fluid communication with the inflation lumen. In a representative embodiment, the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

[0024] In a representative embodiment, the proximal hub may further include: a first valve formed integrally with or coupled to the first port; an infusion path tubing formed integrally with or coupled to the first valve, the infusion path tubing being arranged to be fluidly connected to the one or more peripheral lumens; a second valve coupled to the second port and the filter assembly, the second valve being fluidly connected to the hub lumen; a return path tubing coupled to the filter assembly, the return path tubing being arranged to be fluidly connected to the filter tank lumen; and a connector coupled to the infusion path tubing and the return path tubing, the connector being removably coupled to a suction device.

[0025] In a representative embodiment, the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

[0026] In representative embodiments, the hub lumen is arranged linearly with or along the longitudinal axis and the filter assembly, and the return path tubing and the infusion path tubing are arranged transversely spaced from the hub lumen, the longitudinal axis, and the central lumen.

[0027] In a representative embodiment, the proximal hub may further include: a third valve coupled to the hub housing and arranged linearly with or along the longitudinal axis. In a representative embodiment, the third valve may be a hemostatic valve with a button actuator, and wherein a catheter may be inserted through the hemostatic valve and or along the longitudinal axis and into the hub lumen and the central lumen.

[0028] In another representative embodiment, the tubular shaft includes: an outer shaft wall having a plurality of infusion ports radially arranged around the periphery of the outer shaft wall and spaced from the second distal end; and an inner shaft wall forming the central lumen, the inner shaft wall being coaxial with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls, the inner shaft wall being removably coupled to the outer shaft wall, the inner shaft wall having a flared distal end.

[0029] In another representative embodiment, the access sheath may further include: an inflatable sealing and anchoring balloon, which is arranged at an interval from the second distal end and proximal to the multiple infusion ports, the inflatable sealing and anchoring balloon is radially coupled around the outer wall, and the inflatable sealing and anchoring balloon has a balloon lumen arranged to be connected to the inflation lumen fluid, and the inflation lumen is arranged on the outside of the outer shaft wall.

[0030] In another representative embodiment, the proximal hub includes: a first proximal hub segment, which is coupled to the outer shaft wall; a first port, which is integrally formed with the first proximal hub segment or coupled to the first proximal hub segment, the first port being arranged to communicate with the inflation lumen fluid; a second proximal hub segment, which is coupled to the inner shaft wall and can be removably coupled to the first proximal hub segment; a second port, which is integrally formed with the second proximal hub segment or coupled to the second proximal hub segment, the second port being arranged to communicate with the one or more peripheral lumen fluids; and an in-line or linear arrangement of ports or connectors, which is integrally formed with the second proximal hub segment or coupled to the second proximal hub segment.

[0031] In a representative embodiment, the central lumen has an inner diameter between 8 and 10 mm (24 to 30 Fr), wherein the access sheath has a length between 12 cm and 18 cm. In another representative embodiment, the central lumen has an inner diameter between 8 mm and 12 mm, wherein the access sheath has a length between 5 cm and 40 cm.

[0032] In another representative embodiment, the proximal hub includes: a housing having a hub lumen that is continuous and in fluid communication with the shaft lumen; a first valve disposed in the hub lumen; and a second valve disposed in the hub lumen, the second valve being spaced apart from the first valve to form a hub lumen between the first and second valves. In a representative embodiment, the first valve and the second valve are each a self-sealing valve.

[0033] In a representative embodiment, the proximal hub may further include: one or more access ports formed integrally with the housing and arranged at the distal end of the first valve, the one or more access ports being connected to the hub lumen fluid; and a central in-line access port being connected to the hub lumen fluid.

[0034] In a representative embodiment, the proximal hub may further include: one or more third valves disposed within or coupleable to the one or more access ports. In a representative embodiment, the proximal hub may further include: a first coupling member including a first tab recess and a second tab recess. In a representative embodiment, the proximal hub may further include: a first coupling member including a connector having a flexible ring or a gasket.

[0035] In a representative embodiment, the proximal hub may include: a housing having a hub lumen, the hub lumen being continuous with and in fluid communication with the shaft lumen; and at least one valve disposed in the hub lumen. In a representative embodiment, the proximal hub may further include: one or more access ports integrally formed with the housing and disposed distal to the first valve, the one or more access ports being in fluid communication with the hub lumen; and a center in-line access port in fluid communication with the hub lumen. In a representative embodiment, the proximal hub may further include: a first coupling member including a first tab recess and a second tab recess. In a representative embodiment, the proximal hub may further include: a first coupling member including a connector having a flexible ring or a gasket.

[0036] In representative embodiments, the access sheath may further include: a flexible self-expanding member coupled to the proximal hub. In representative embodiments, the tubular shaft may further include one or more internal longitudinal partitions forming a plurality of separate shaft lumens. In representative embodiments, the access sheath may be curved, tapered, or angled.

[0037] In a representative embodiment, the aspiration device includes: a syringe body having an internal tubular cavity; an extended distal tip coupled to the syringe body or formed integrally with the syringe body; and a plunger movable within the internal tubular cavity of the syringe body.

[0038] In a representative embodiment, the suction device further includes: a first injection valve (or adapter) coupled to the extended distal tip. In another representative embodiment, the suction device further includes: a second injection valve (or adapter) coupled to the syringe body. In a representative embodiment, the first injection valve and the second injection valve each include at least one valve (or adapter) selected from the group consisting of: a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof. In another representative embodiment, the suction device does not include a valve.

[0039] In a representative embodiment, the plunger includes: a plunger body having a plunger lumen extending longitudinally within the plunger body; a plunger handle coupled to the plunger body. In a representative embodiment, the catheter is further removably insertable through the plunger lumen and into the shaft lumen of the access sheath. In this representative embodiment, the plunger may include: a plunger body having a plunger lumen extending longitudinally within the plunger body; a plunger access port linearly arranged with the plunger lumen and in fluid communication with the plunger lumen; and a plunger handle coupled to the plunger body.

[0040] In a representative embodiment, the catheter has a longitudinal dimension and a transverse dimension, wherein the catheter comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft that is longitudinally and rotationally movable within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and a basket or cage coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts. In a representative embodiment, one or more of the plurality of struts are coupled to each other at a first end of the basket or cage, and one or more of the plurality of struts are coupled to the distal end of the inner catheter steering shaft at a second end of the basket or cage. In another representative embodiment, the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter steering shaft at a second end of the basket or cage. In a representative embodiment, the catheter may further comprise: an atraumatic molded end cap coupled to the strut ring.

[0041] In a representative embodiment, the plurality of struts are arranged only longitudinally and do not cross each other. In a representative embodiment, the inner catheter manipulation shaft can be further moved longitudinally to extend out of the outer catheter tube. In a representative embodiment, the basket or cage can be moved both longitudinally and rotationally in the outer catheter lumen together with the inner catheter manipulation shaft in a retracted or compressed state. In a representative embodiment, the basket or cage can be further moved longitudinally to extend out of the distal end of the outer catheter tube, and when the basket or cage is fully extended out of the distal end of the outer catheter tube, the basket or cage has an expanded state. In a representative embodiment, the basket or cage has a diameter of from 20.0 mm to 50.0 mm in the expanded state. In a representative embodiment, the plurality of struts includes eight to twelve struts. In a representative embodiment, each of the plurality of struts has a width or diameter of from 0.25 mm to 0.7 mm and a length of from 55 mm to 104 mm. In a representative embodiment, in the expanded state of the basket or cage, the maximum gap width between each of the plurality of struts is from 10.0 to 15.0 mm. In representative embodiments, the basket or cage comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metals, metal alloys, carbon fiber, polymers, and combinations thereof.

[0042] In a representative embodiment, the system may further include: a pulverizing or fracturing device that is longitudinally and rotatably movable within the catheter. In a representative embodiment, the pulverizing or fracturing device is longitudinally and rotatably movable within the inner catheter lumen. In a representative embodiment, the pulverizing or fracturing device is further longitudinally movable to extend out of the inner catheter lumen and the outer catheter tube.

[0043] In a representative embodiment, the crushing or fracturing device includes: a crushing or fracturing shaft; and a crushing or fracturing tip, which is integrally formed with the crushing or fracturing shaft or coupled to the crushing or fracturing shaft at a first end, and the crushing or fracturing tip has one or more crushing or fracturing spears at a second distal end.

[0044] Also disclosed is a representative method of using the system, comprising: longitudinally moving the inner catheter steering shaft to extend out of the outer catheter lumen of the outer catheter tube; capturing at least one gallstone or gallstone fragment within the interior of the basket or cage using the basket or cage; longitudinally moving the inner catheter steering shaft to at least partially retract the basket or cage; and longitudinally moving the pulverizing or fracturing instrument to extend out of the inner catheter lumen and impact the at least one gallstone or gallstone fragment.

[0045] In a representative embodiment, each of the one or more pulverizing or fracturing spears comprises at least two beveled and chamfered inner edges terminating in a sharp point. In a representative embodiment, each of the one or more pulverizing or fracturing spears may further comprise an opening, a protrusion or a cutout. In another representative embodiment, the pulverizing or fracturing tip may be at least partially hollow. In another representative embodiment, each of the one or more pulverizing or fracturing spears comprises at least two beveled edges.

[0046] In another representative embodiment, the pulverizing or fracturing device includes: a pulverizing or fracturing shaft; and a pulverizing or fracturing tip, which is integrally formed with the pulverizing or fracturing shaft or coupled to the pulverizing or fracturing shaft at a first end, the pulverizing or fracturing tip having at least one configuration selected from the group consisting of: an angled configuration, a pointed configuration, a sharp edge or bevel configuration, a bullet configuration, a ball or "button" configuration, a concave three-pointed configuration, a spear configuration, a concave spear configuration, a drill core configuration, a groove configuration, a hollow configuration, and combinations thereof. In a representative embodiment, the pulverizing or fracturing device includes one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metal, metal alloy, carbon fiber, polymer, and combinations thereof.

[0047] In another representative embodiment, the catheter may include: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft movable within the outer catheter lumen, the inner catheter steering shaft having an inner catheter shaft distal end; and a basket or cage coupled to the distal end of the outer catheter tube and the distal end of the inner catheter steering shaft, the basket or cage comprising a plurality of struts. In a representative embodiment, the catheter may further include: a catheter tip cap coupled to the plurality of struts, the catheter tip cap having a tip opening; wherein the inner catheter steering shaft further includes an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal end flushing port.

[0048] In a representative embodiment, the catheter may further include: a catheter tube collar coupled to a first end of the basket or cage and a distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter tube collar and the outer catheter tube; and a catheter tip cap coupled to a second end of the basket or cage and a distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cap and the inner catheter steering shaft.

[0049] In a representative embodiment, the catheter may further include: a catheter tube collar coupled to the first end of the basket or cage and the distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter collar and the outer catheter tube; and a catheter tip cover coupled to the second end of the basket or cage and the distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cover and the inner catheter steering shaft, the catheter tip cover further including a tip opening; wherein the inner catheter steering shaft further includes an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal end flushing port.

[0050] In another representative embodiment, the catheter may further include: a catheter tube collar coupled to the plurality of struts; and a catheter tip cap coupled to the plurality of struts. In a representative embodiment, the catheter may further include: a catheter tube collar coupled to the plurality of struts; and a catheter tip cap coupled to the plurality of struts, the catheter tip cap having a tip opening; wherein the inner catheter steering shaft further includes an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port. In another representative embodiment, the plurality of struts are arranged in a selected cross pattern to form a grid having a plurality of pores of different pore sizes. In a representative embodiment, the plurality of struts are arranged in a selected cross pattern to form a grid having relatively larger pores or openings at a proximal region of the basket or cage and relatively smaller pores or openings at a distal region of the basket or cage. In a representative embodiment, the outer catheter tube further includes: a proximal flushing port arranged at the distal end of the outer catheter tube. In another representative embodiment, the plurality of struts are arranged to form a plurality of grabs. In another representative embodiment, the basket or cage further comprises: a plurality of sharp teeth, points or wedges, one or more of the plurality of sharp teeth, points or wedges being coupled to or integrally formed with the inner surface of a corresponding one of the plurality of posts. In a representative embodiment, the plurality of sharp teeth, points or wedges have one or more shapes selected from the group consisting of: triangle, square, rectangle, circle, arc, and combinations thereof.

[0051] In another representative embodiment, the system may further include: a pulverizing or fracturing device movable within the outer catheter tube, the pulverizing or fracturing device terminating at a sharp or pointed tip at a distal end. In another representative embodiment, the system may further include: a shaft drive coupled to the pulverizing or fracturing device, the shaft drive selected from the group consisting of: a linear actuator, a compression spring drive action, a tension spring drive, a torsion spring drive, a spring drive, a constant force spring drive, and combinations thereof. In another representative embodiment, the system may further include: a pulverizing or fracturing device movable within the outer catheter tube, the pulverizing or fracturing device terminating at a distal end at a tip having a shape selected from the group consisting of: sharp, pointed, rounded, spearhead, diamond, chamfered, chisel, bullnose, bullet head, hollow, drill, hole saw, pit, screw, spiral, fin, and combinations thereof. In another representative embodiment, the system may further include: a pulverizing or fracturing device insertable into the access sheath.

[0052] In another representative embodiment, the access sheath includes: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally arranged central lumen, the tubular shaft including: an inner shaft wall forming the central lumen; an outer shaft wall coaxially arranged with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and an inflation lumen arranged between the inner and outer shaft walls; and a proximal hub coupled to the first end of the tubular shaft, the proximal hub including: a hub shell having a hub lumen arranged to be fluidically connected to the central lumen; a filter assembly that can be removably coupled to the hub shell, the filter assembly arranged to be fluidically connected to the central lumen; a first port formed integrally with the hub shell or coupled to the hub a hub housing, the first port being arranged to be in fluid communication with the one or more peripheral lumens; and a second port being integrally formed with or coupled to the hub housing, the second port being arranged to be in fluid communication with the inflation lumen; wherein the suction device comprises: a syringe body having an internal lumen; an extended distal tip being coupled to or integrally formed with the syringe body; and a plunger being movable within the internal lumen of the syringe body; and wherein the catheter comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft being longitudinally and rotatably movable within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and a basket or cage being coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

[0053] Also disclosed is a method of using the system, wherein a representative method embodiment includes: percutaneously inserting at least one dilator into a selected location of a patient's gallbladder to form a tract; inserting the access sheath into the tract; attaching the suction device to the proximal hub; aspirating one or more gallstones; and removing the suction device from the proximal hub.

[0054] In representative embodiments, the method may further include: inserting the catheter through the access sheath; expanding the basket or cage; capturing one or more gallstones using the expanded basket or cage; collapsing the basket or cage around the one or more gallstones; and removing the catheter through the access sheath. In representative embodiments, the method may further include: fracturing or crushing the one or more gallstones using a crushing or fracturing instrument inserted into the lumen of the inner catheter. In representative embodiments, the method may further include: flushing the patient's gallbladder using the suction device.

[0055] In another representative embodiment, the system may further include: a pulverizing or fracturing control device; and a pulverizing or fracturing tool coaxially disposed within the conduit.

[0056] In a representative embodiment, the crushing or fracturing control device may include: a housing; a control device shaft coupled to the housing, the control device shaft having a control device shaft lumen configured to hold the catheter and the crushing or fracturing device arranged in the catheter; a catheter control assembly arranged in the housing, the catheter control assembly including: a catheter control actuator; and a crushing or fracturing pin; a first handle pivotally coupled to the housing; a control linkage lever pivotally coupled to the first handle and pivotally coupled to the catheter control actuator; a crushing or fracturing spring coupled around the crushing or fracturing pin; and a second handle coupled to the crushing or fracturing pin.

[0057] In a representative embodiment, the catheter control actuator includes: a tubular catheter handle that is linearly aligned with the control device shaft lumen, the tubular catheter handle being coupleable about an inner catheter steering shaft of the catheter to secure the inner catheter steering shaft and longitudinally move the inner catheter steering shaft within the catheter in response to movement of the first handle and the control linkage lever. In a representative embodiment, the pulverizing or fracturing pin is linearly aligned with the tubular handle within the housing to engage the pulverizing or fracturing device. In a representative embodiment, the pulverizing or fracturing pin is coaxially disposed within the tubular handle within the housing to engage the pulverizing or fracturing device, the pulverizing or fracturing device being coaxially disposed within the inner catheter steering shaft.

[0058] In a representative embodiment, the second handle can be slid proximally with the crushing or fracturing pin in the housing to compress the crushing or fracturing spring. In a representative embodiment, the crushing or fracturing control device further includes: a retaining clip that is removably coupled to the second handle to retain the second handle in a proximal position with the compressed crushing or fracturing spring. In a representative embodiment, the retaining clip is removable to release the compressed crushing or fracturing spring and advance the crushing or fracturing pin to impact the crushing or fracturing device.

[0059] Another method of using the system is also disclosed, wherein a representative method embodiment includes: inserting a catheter and a pulverizing or fracturing instrument into the control device shaft, the pulverizing or fracturing instrument being coaxially disposed within an inner catheter steering shaft of the catheter; securing the proximal end of the catheter in the catheter control actuator; inserting the distal end of the control device shaft into the gallbladder of a human or veterinary subject when the first handle is in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and moving the first handle toward the first position to retract the basket or cage and secure the captured gallstones or gallstone fragments in the basket or cage.

[0060] In a representative embodiment, the method may further include: when the captured gallstone or gallstone fragment is less than a predetermined size, withdrawing the control device shaft from the gallbladder of the human or veterinary subject. In a representative embodiment, when the captured gallstone or gallstone fragment is not less than the predetermined size, pulling or sliding the second handle proximally to compress the crushing or fracturing spring; and releasing the second handle to advance the crushing or fracturing pin to impact the crushing or fracturing instrument and move the crushing or fracturing instrument into the captured gallstone or gallstone fragment to crush or fracture the captured gallstone or gallstone fragment.

[0061] In representative embodiments, the method may further include: aspirating any crushed or crushed gallstone fragments using the suction device. In representative embodiments, the step of inserting the distal end of the control device shaft into the gallbladder of the human or veterinary subject may further include: inserting the access sheath into the gallbladder of the human or veterinary subject; inserting the distal end of the control device shaft into the access sheath.

[0062] In another representative embodiment, the crushing or fracturing control device may include: a shell having a shell slot; a control device shaft coupled to the shell, the control device shaft having a control device shaft lumen configured to hold the catheter and the crushing or fracturing device arranged in the catheter; a catheter control assembly arranged in the shell, the catheter control assembly including: a catheter control link group; and a crushing or fracturing pin; a first handle coupled to the catheter control link group and slidable in the shell slot; a second handle coupled to the crushing or fracturing pin; and a trigger actuator pivotally coupled to the shell and further coupled to engage the catheter control link group.

[0063] In a representative embodiment, the catheter control linkage group is linearly aligned with the control device shaft lumen and can be coupled to the inner catheter steering shaft of the catheter to fix the inner catheter steering shaft and move the inner catheter steering shaft longitudinally within the catheter. In a representative embodiment, the crushing or fracturing pin is linearly aligned with the catheter control linkage group within the housing to engage with the crushing or fracturing device. In a representative embodiment, the crushing or fracturing pin arranged in the lumen of the catheter control linkage group within the housing is coaxial to engage with the crushing or fracturing device, and the crushing or fracturing device is coaxially arranged within the inner catheter steering shaft. In a representative embodiment, the second handle can slide proximally with the crushing or fracturing pin in the housing to impact the crushing or fracturing device. In a representative embodiment, the trigger actuator is arranged to slidably move the catheter control linkage group proximally to retract the basket or cage of the catheter toward the crushing or fracturing device.

[0064] Another method of using the system is also disclosed, wherein a representative method embodiment includes: inserting a catheter and a pulverizing or fracturing instrument into the control device shaft, the pulverizing or fracturing instrument being coaxially disposed within an inner catheter steering shaft of the catheter; securing the proximal end of the catheter in the catheter control linkage assembly; inserting the distal end of the control device shaft into the gallbladder of a human or veterinary subject when the first handle is in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and moving the first handle toward the first position to retract the basket or cage and secure the captured gallstones or gallstone fragments in the basket or cage.

[0065] In a representative embodiment, the method may further include: when the captured gallstone or gallstone fragment is less than a predetermined size, withdrawing the control device shaft from the gallbladder of the human or veterinary subject. In a representative embodiment, the method may further include: when the captured gallstone or gallstone fragment is not less than the predetermined size, sliding the second handle distally to advance the crushing or fracturing pin to impact the crushing or fracturing instrument and move the crushing or fracturing instrument into the captured gallstone or gallstone fragment to crush or fracture the captured gallstone or gallstone fragment. In a representative embodiment, the method may further include: pressing the trigger actuator to slidably move the catheter control linkage group proximally to retract the basket or cage of the catheter toward the crushing or fracturing instrument.

[0066] In another representative embodiment, the access sheath comprises: a tubular shaft having a first end and a second end, the tubular shaft having a shaft lumen; and a proximal hub coupled to the first end of the tubular shaft. In a representative embodiment, the proximal hub comprises a valve or an adapter. In a representative embodiment, the second end of the tubular shaft can be angled or beveled. In a representative embodiment, the shaft lumen has an inner diameter between 5 mm and 12 mm, wherein the access sheath has a length between 5 cm and 40 cm. The access sheath may further comprise: a handle coupled to the proximal hub.

[0067] Representative system embodiments may also include a balloon dilator expandable to progressively larger diameters or multiple dilators having corresponding multiple successively larger diameters, wherein the largest diameter of the successively larger diameters is equal to or less than the inner diameter of the shaft lumen. The representative system embodiments may also include a balloon tip catheter that can over-dilate the access tract to a diameter greater than the outer diameter of the tubular shaft of the access sheath, followed by partially deflation of the balloon tip catheter and insertion of the access sheath over the balloon tip catheter, which is then further deflated and removed from the access sheath.

[0068] In a representative embodiment, the proximal hub may further include: one or more access ports integrally formed with the housing and disposed at or at the distal end of the first valve, the one or more access ports being in fluid communication with the hub lumen; and a central in-line access port being in fluid communication with the hub lumen. The proximal hub may also further include one or more additional (second, third, fourth, etc.) valves disposed within or coupleable to the one or more access ports, wherein the one or more additional valves or adapters include, for example, at least one valve selected from the group consisting of: duckbill valve; cross-slit valve; stopcock, gate, rotary valve; ball valve; Luer valve; Tuohy-Borst adapter; and combinations thereof.

[0069] The representative system embodiment may also include: tubing insertable into the one or more access ports or the central inline access port; and a peristaltic pump coupled to the tubing or the suction device.

[0070] In a representative embodiment, the proximal hub may further include a first coupling, and in this representative embodiment, the suction device may include a second mating coupling that can be removably coupled to the first coupling. For example (but not limited to), in a representative embodiment, the first coupling and the second mating coupling may be mating quick-connect fittings or couplings. For example, the proximal hub may further include a first coupling including a connector having a flexible ring or gasket, and the suction device may further include a second mating coupling removably coupled to the first coupling, the second mating coupling including a recess for inserting the flexible ring or gasket. In another representative embodiment, the proximal hub may further include: a first coupling including a first tab recess and a second tab recess. In this representative embodiment, the suction device may include a second mating coupling removably coupled to the first coupling, the second mating coupling including a first tab or pawl that can be inserted into the first tab recess and a second tab or pawl that can be inserted into the second tab recess.

[0071] Also disclosed is a method of using the system, wherein the method includes: percutaneously inserting at least one dilator into a selected location of a patient's gallbladder to form a tract; inserting the access sheath into the tract; attaching the suction device to the proximal hub; aspirating one or more gallstones; and removing the suction device from the proximal hub. For example (but not limitation), a series of dilators may be percutaneously inserted into a selected location of a patient's gallbladder to form a tract, followed by percutaneously inserting the access sheath into the selected location of the patient's gallbladder. The dilator may then be removed, for example, through the proximal portion of the access sheath. In another representative embodiment, also for example (but not limitation), the method of using the system includes: inserting a dilation balloon such that the distal end of the balloon (or balloon tip) is inside the gallbladder (forming a tract to the gallbladder) and the proximal end of the balloon is outside the patient's body; inflating the balloon to dilate the tract; and inserting or advancing the access sheath around the dilation balloon. Additionally, the dilation balloon may be partially deflated as the access sheath is advanced or inserted. Also for example, but not limitation, the representative system embodiments may also include inserting a balloon tip catheter and dilating the access tract, followed by partially deflation of the balloon tip catheter and insertion of the access sheath over the balloon tip catheter, which is then further deflated and removed from the access sheath. One or more gallstones are then aspirated.

[0072] In a representative embodiment, the method may further include: inserting the catheter through the access sheath; expanding the basket or cage; capturing one or more gallstones using the expanded basket or cage; collapsing the basket or cage around the one or more gallstones; and removing the catheter through the access sheath. In this representative embodiment, the method may further include: fracturing or pulverizing the one or more gallstones using the expanded basket or cage, including by using a second pointed shaft. In this representative embodiment, the method may further include: flushing the patient's gallbladder using the suction device or the catheter.

[0073] Numerous other advantages and features of the present invention will be readily apparent from the following detailed description of the invention and its embodiments, from the claims and from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] Objects, features, and advantages of the present invention will be more readily understood after reference to the following disclosure when considered in conjunction with the accompanying drawings, wherein like reference numerals are used to identify like components in the various figures, and wherein reference numerals with alphabetical characters are used to identify additional types, instantiations, or variations of selected component embodiments in the various figures, wherein:

[0075] FIG. 1 is a side (elevation) and cross-sectional view illustrating a representative first embodiment of an access sheath.

[0076] Figure 2 is a partial cross-sectional view of a tubular shaft illustrating a representative first embodiment of an access sheath inserted around a representative dilator.

[0077] Figure 3 is a partial cross-sectional view (through the Figure 1 C-C' plane).

[0078] Figure 4 is an isometric view illustrating a representative first embodiment of an aspiration device illustrated as having a translucent syringe body.

[0079] Figure 5 is a partial cross-sectional view illustrating a representative first embodiment of a system having a first embodiment of an access sheath and a representative first embodiment of a suction device.

[0080] Figure 6 is a partial isometric view of a representative second embodiment of the system illustrating the second embodiment having an access sheath and a representative first embodiment of the aspiration device also illustrated as having a translucent syringe body.

[0081] Figure 7is a side (elevation) view illustrating a representative second embodiment of the aspiration device also illustrated as having a translucent syringe body.

[0082] Figure 8 is a side (elevation) view illustrating a representative embodiment of a plunger for a suction device.

[0083] Fig. 9 is an isometric view of a representative third embodiment of an aspiration device also illustrated as having a translucent syringe body.

[0084] Fig.10 is an isometric view of a representative fourth embodiment of an aspiration device also illustrated as having a translucent syringe body.

[0085] Fig. 10A is an isometric view of a representative third embodiment of the system illustrating the third embodiment having an access sheath and a representative fifth embodiment of the aspiration device also illustrated as having a translucent syringe body.

[0086] Fig.11 are isometric views illustrating representative first and second embodiments of a catheter apparatus having a representative first embodiment of a basket or cage illustrated in an expanded state.

[0087] Fig.12 are isometric views illustrating representative first and second embodiments of a catheter apparatus having a representative first embodiment of a basket or cage illustrated in an expanded state.

[0088] Fig.13 is a partial cross-sectional view illustrating a representative first embodiment of a catheter apparatus having a representative first embodiment of a basket or cage illustrated in an expanded state.

[0089] Fig.14 is a partial cross-sectional view illustrating a representative second embodiment of a catheter apparatus having a representative first embodiment of a basket or cage illustrated in an expanded state.

[0090] Fig.15 is an isometric view of a representative third embodiment of a catheter apparatus illustrating the representative second embodiment having a basket or cage (and illustrated in an expanded state).

[0091] Fig.16 is an isometric view illustrating a representative fourth embodiment of a catheter apparatus having a representative third embodiment of a basket or cage illustrated in an expanded state.

[0092] Fig.17 is an isometric view illustrating a representative fourth embodiment of a catheter apparatus having a representative third embodiment of a basket or cage illustrated in an expanded state.

[0093] Fig.18 is an isometric view illustrating a representative fourth embodiment of a catheter device having a representative third embodiment of a basket or cage illustrated in a collapsed state.

[0094] Fig.19 is an isometric view illustrating a representative fourth embodiment of a catheter device having a representative third embodiment of a basket or cage illustrated in a collapsed state.

[0095] Fig. 20 is a partial cross-sectional view (through the FIG. 1 ) illustrating a representative fourth embodiment of a system having a first embodiment of an access sheath, additionally having a representative first or second embodiment of a suction device, and having a representative catheter embodiment. Figure 1 C-C' plane).

[0096] Fig.21 is a partial cross-sectional view (through the Figure 1 C-C' plane).

[0097] Fig. 22 It indicates that Figure 1 A partial cross-sectional view (through the first embodiment of the access sheath described in FIG. 1 ) and a representative sixth embodiment of the system having another representative catheter embodiment. Figure 1 C-C' plane).

[0098] Fig.23 is an isometric view illustrating a representative first comminuting or fracturing instrument for use as part of a system having an access sheath.

[0099] Fig.24 Yes Description Fig.23 A cross-sectional view of a representative first crushing or fracturing device illustrated in FIG.

[0100] Fig.25A is an isometric view of a representative fifth embodiment of a catheter apparatus having a representative fourth embodiment of a basket or cage illustrated in an expanded state, the basket or cage having representative sharp teeth, points, or wedges coupled to or integrally formed with one or more interior surfaces of one or more struts.

[0101] Fig.25B is a description of a passage having a basket or cage described as being in an expanded state Fig.25A A cross-sectional view in the BB' plane of a representative fourth embodiment of a basket or cage illustrated in FIG. 4 having representative sharp teeth, points or wedges coupled to or integrally formed with one or more interior surfaces of one or more struts.

[0102] Fig.26 is a cross-sectional view illustrating a representative fourth embodiment of a basket or cage illustrated in a collapsed state, the basket or cage having sharp teeth, points, or wedges coupled to or integrally formed with one or more interior surfaces of one or more struts.

[0103] Fig.27A , 27B , 27C, 27D and 27E are cross-sectional views illustrating representative configurations of sharp teeth, points or wedges coupled to or integrally formed with one or more interior surfaces of any of the struts in a representative basket or cage (illustrated as being in a collapsed state) of any of the various representative catheter embodiments.

[0104] Fig.28A , 28B 28C is an isometric view illustrating a fifth embodiment of a basket or cage having a grapple for use in or with any of the various representative catheter embodiments and illustrated in an expanded state.

[0105] Fig.29 is an isometric view of a representative sixth embodiment of a catheter device having a sixth embodiment of a basket or cage illustrated in an expanded state, wherein the sixth embodiment of the basket or cage has a proximal annular design (wire or laser cut) with an attached woven collection basket.

[0106] Fig. 30A and 30B is to describe the use of Fig. 30A The expansion state and Fig. 30B Isometric and partial cross-sectional views of capture and initial lysis or pulverization of gallstones by a representative seventh embodiment of the catheter device of the seventh embodiment with a basket or cage in a partially collapsed state.

[0107] Fig.31 is an isometric view illustrating a representative second embodiment of a comminution or fracturing apparatus.

[0108] Fig.32 is a side elevation view of a representative fifth embodiment of an access sheath illustrating proximal fixed suction from a flexible self-expanding member.

[0109] Fig.33 is a partial isometric view illustrating a representative third embodiment of a comminution or fracturing apparatus.

[0110] Fig.34 is a partial side elevation view illustrating a third representative embodiment of a comminution or fracturing apparatus.

[0111] Fig.35is a partial isometric view illustrating a representative fourth embodiment of a comminution or fracturing apparatus.

[0112] Fig.36 It is a partial plan view illustrating a fourth representative embodiment of a comminution or fracturing device.

[0113] Fig.37 is a partial isometric view illustrating a representative fifth embodiment of a comminution or fracturing apparatus.

[0114] Fig.38 It is a partial plan view illustrating a fifth representative embodiment of a comminution or fracturing device.

[0115] Fig.39 is a partial isometric view illustrating a representative sixth embodiment of a comminution or fracturing apparatus.

[0116] Fig.40 is a partial isometric view illustrating a representative seventh embodiment of a comminution or fracturing apparatus.

[0117] Fig.41 is a partial isometric view illustrating a representative eighth embodiment of a comminution or fracturing apparatus.

[0118] Fig.42 is a partial isometric view illustrating a representative ninth embodiment of a comminution or fracturing apparatus.

[0119] Fig.43 is a partial isometric view illustrating a representative tenth embodiment of a comminution or fracturing apparatus.

[0120] Fig.44 is a partial isometric view illustrating a representative eleventh embodiment of a comminution or fracturing apparatus.

[0121] Fig.45 is a partial isometric view illustrating a representative twelfth embodiment of a comminution or fracturing apparatus.

[0122] Fig.46 is a partial isometric view illustrating a representative thirteenth embodiment of a comminution or fracturing apparatus.

[0123] Fig.47 is a partial isometric view illustrating a representative fourteenth embodiment of a comminution or fracturing apparatus.

[0124] Fig.48 is a partial isometric view illustrating a representative fifteenth embodiment of a comminution or fracturing apparatus.

[0125] Fig.49 is a partial isometric view illustrating a representative sixteenth embodiment of a comminution or fracturing apparatus.

[0126] Fig.50is a partial isometric view illustrating a representative seventeenth embodiment of a comminution or fracturing apparatus.

[0127] Fig.51 is a partial isometric view illustrating a representative eighteenth embodiment of a comminution or fracturing apparatus.

[0128] Fig.52 is a partial isometric view of a representative eighth embodiment illustrating a catheter apparatus of the eighth embodiment having a basket or cage.

[0129] Fig.53 is a cross-sectional view (through the catheter shaft and the catheter shaft lumen) illustrating a representative eighth embodiment of the catheter device. Fig.52 F-F' plane).

[0130] Fig.54 is a partial isometric view illustrating a representative ninth embodiment of a catheter apparatus having a ninth embodiment of a basket or cage and illustrating a comminuting or fracturing tip of a comminuting or fracturing device.

[0131] Fig.55 is a partial isometric view illustrating a representative ninth embodiment of a catheter apparatus having a partially retracted ninth embodiment of a basket or cage.

[0132] Fig.56 is an isometric view illustrating a representative tenth embodiment of a basket or cage.

[0133] Fig.57 is an isometric view illustrating a representative eleventh embodiment of a basket or cage.

[0134] Fig.58 is an isometric partially exploded view of a representative seventh embodiment of a system illustrating any of the representative fifth and sixth embodiments of a system having an access sheath and a representative embodiment of an aspiration device (also illustrated as having a translucent syringe body).

[0135] Fig.59 are partial isometric and cross-sectional views of a representative seventh embodiment of a system illustrating any of the representative fifth and sixth embodiments of an access sheath and a representative embodiment of a suction device.

[0136] Fig.60 is a first cross-sectional view (through Fig.58 E-E' plane).

[0137] Fig.61 is a second cross-sectional view (through Fig.58 E-E' plane).

[0138] Fig.62 is a partial cross-sectional view (through the proximal hub of the fifth and sixth embodiments of the access sheaths of the seventh and eighth embodiments of the system illustrating the system Fig.58 and 70 D-D' plane).

[0139] Fig.63 is a partial cross-sectional view (through the Fig.58 and 70 D-D' plane).

[0140] Fig.64 is a cross-sectional view illustrating a representative first embodiment of the access sheath tip.

[0141] Fig.65 is a cross-sectional view illustrating a representative second embodiment of the access sheath tip.

[0142] Fig.66 is a cross-sectional view illustrating a third representative embodiment of an access sheath tip.

[0143] Fig.67 is a cross-sectional view illustrating a fourth representative embodiment of an access sheath tip.

[0144] Fig.68 is a partial isometric view of a representative fifth embodiment illustrating an access sheath tip and a sealing and anchoring balloon for any of the various embodiments of the access sheath.

[0145] Fig.69 is a partial isometric cross-sectional view illustrating a representative sixth embodiment of an access sheath tip.

[0146] Fig.70 is an isometric view of a representative eighth embodiment of a system illustrating seventh and eighth embodiments of an access sheath and a first embodiment of a dual aspiration and infusion assembly.

[0147] Fig.71 is a partial isometric view illustrating a representative proximal hub of a representative eighth system embodiment with seventh and eighth access sheath embodiments.

[0148] Fig.72 is a diagram illustrating fluid flow in a representative gallbladder using the seventh and / or eighth system embodiments.

[0149] Fig.73 is an isometric view illustrating a representative second embodiment of a dual aspiration and infusion assembly that may be used as part of a representative eighth system embodiment.

[0150] Fig.74is an isometric view illustrating the operation of the first embodiment of the dual aspiration and infusion assembly.

[0151] Fig.75 is a top plan view illustrating the operation of the first embodiment of the dual aspiration and infusion assembly.

[0152] Fig.76 is a cross-sectional top plan view of a representative gear assembly illustrating the operation of a first embodiment for a dual aspiration and infusion assembly.

[0153] Fig.77 is a cross-sectional top plan view illustrating the operation of a representative gear assembly for operation of a first embodiment of a dual aspiration and infusion assembly.

[0154] Fig.78 is a cross-sectional top plan view illustrating the operation of a representative gear assembly for operation of a first embodiment of a dual aspiration and infusion assembly.

[0155] Fig.79 is an isometric view illustrating a representative ninth embodiment of an access sheath.

[0156] Fig.80 Yes Description Fig.79 A cross-sectional view of a representative ninth embodiment of an access sheath.

[0157] Fig.81 is a partial cross-sectional view (through Fig.79 G-G' plane).

[0158] Fig.82 is an isometric view of a representative ninth embodiment of a system illustrating a ninth embodiment having an access sheath and a first embodiment of a pulverizing or fracturing control device, a ninth embodiment having a catheter device with any of the representative embodiments of a ninth embodiment with a basket or cage and a suction device.

[0159] Fig.83 is an isometric view of a representative tenth embodiment of a system illustrating a ninth embodiment having an access sheath and a second embodiment of a pulverizing or fracturing control device, a ninth embodiment having a catheter device with a basket or cage, and any of the representative embodiments of a suction device.

[0160] Fig.84 is a side elevation and partial cross-sectional view illustrating a representative two-part tenth embodiment of an access sheath.

[0161] Fig.85 is a side elevation and partial cross-sectional view illustrating a representative two-part tenth embodiment of an access sheath.

[0162] Fig.86 is a partial first cross-sectional view (through Fig.84 H-H' plane).

[0163] Fig.87 is a partial second cross-sectional view (through the Fig.84 H-H' plane).

[0164] Fig.88 is a side elevation and partial cross-sectional view illustrating a first removably couplable portion of a representative tenth embodiment of an access sheath.

[0165] Fig.89 is a side elevation and partial cross-sectional view illustrating a second removably couplable portion of a representative tenth embodiment of an access sheath.

[0166] Fig.90 is a first isometric view illustrating a representative first embodiment of a pulverizing or fracturing control device having a representative conduit embodiment.

[0167] Fig.91 is a second isometric view illustrating a representative first embodiment of a pulverizing or fracturing control device.

[0168] Fig.92 It indicates that Fig.90 A partial cross-sectional view of a representative first embodiment of a crushing or fracturing control device of a proximal portion of a representative catheter embodiment.

[0169] Fig.93 is a first isometric view illustrating a representative second embodiment of a pulverizing or fracturing control device having a representative conduit embodiment.

[0170] Fig.94 is a second isometric view illustrating a representative second embodiment of a pulverizing or fracturing control device.

[0171] Fig.95 It indicates that Fig.93 A first partial cross-sectional view of a representative second embodiment of a pulverizing or fracturing control device of a proximal portion of a representative catheter embodiment.

[0172] Fig.96 is a second partial cross-sectional view illustrating a representative second embodiment of a pulverizing or fracturing control device.

[0173] Fig.97 is a third partial cross-sectional view illustrating a representative second embodiment of a pulverizing or fracturing control device.

[0174] Fig.98is a front elevation view illustrating a representative peristaltic pump for use as part of the system.

[0175] Fig.99A and 99B , collectively referred to as Figure 99, is a roadmap illustrating a representative method for percutaneous removal of gallstones to treat cholelithiasis. DETAILED DESCRIPTION

[0176] Although the present invention is susceptible to embodiments in many different forms, it is shown in the figures and will be described in its detailed specific exemplary embodiments herein, it should be understood that the present disclosure should be regarded as an example of the principles of the present invention and it is not desired to limit the present invention to the specific embodiments described. In this regard, before explaining in detail at least one embodiment consistent with the present invention, it should be understood that the present invention is not limited to the construction details described in the figures or examples and the component arrangements stated above and below in its application. The methods and devices consistent with the present invention can have other embodiments and can be practiced and implemented in various ways. In addition, it should be understood that the wording and terms used herein and in the attached abstract are for the purpose of description and should not be considered as restrictive.

[0177] As mentioned above, various representative embodiments provide for percutaneous removal of gallstones to treat cholelithiasis specially designed devices, methods and systems. Representative embodiments can be percutaneously and transhepatically placed into the affected gallbladder, can crush or fracture gallstones and can capture and remove any gallstones and gallstone fragments from the gallbladder. The cost of representative devices, methods and systems is relatively low, particularly compared to the cost associated with surgical treatment and subsequent hospitalization of cholelithiasis. Representative devices, methods and systems can be operated in a typical interventional radiology room, rather than in a surgical operating room. Representative embodiments further provide treatment options for patients who are non-surgical candidates, thereby improving the quality of life that these patients would not otherwise have.

[0178] Figure 1 1 are side (elevation) and cross-sectional views illustrating a first representative embodiment of the access sheath 100 . Figure 2 is a diagram illustrating the insertion of a representative dilator 145 around Figure 1 100, the dilator 145 may be a generally cylindrical dilator with a tapered tip (as illustrated) or may be a balloon dilator or balloon tip catheter, wherein any and all such dilator 145 variations are considered equivalent and within the scope of the present disclosure. It should also be noted that, also for example (but not limitation), the various access sheaths described herein may also be percutaneously inserted into a subject's gallbladder through a pre-existing (or mature) tissue tract. Figure 3 It indicates that Figure 1A partial cross-sectional view of a representative embodiment of the proximal hub 110 of the first embodiment of the valve and port assembly of the access sheath 100 illustrated in FIG. Figure 1 C-C' plane). Figure 4 is an isometric view illustrating a representative first embodiment of the aspiration device 250, which is illustrated as having a translucent syringe body 270, and the plunger 265 movable within the syringe body 270 is also visible. Figure 5 is a partial cross-sectional view illustrating a representative first embodiment of a system 300 having a first embodiment of an access sheath 100 and a representative first embodiment of a suction device 250. Figure 6 is an isometric view of a representative second embodiment of system 300A illustrating a second embodiment having an access sheath 200 and a representative first embodiment of an aspiration device 250 also illustrated as having a translucent syringe body 270. Figure 7 is a side view (elevation) of a representative second embodiment of the suction device 250A, which is also illustrated as having a translucent syringe body 270, and the plunger 265 that can move within the syringe body 270 can also be seen. Figure 8 is a side (elevation) view illustrating a representative embodiment of a plunger 265 of the suction device 250. Fig. 9 is an isometric view illustrating a representative third embodiment of the aspiration device 250B, which is also illustrated as having a translucent syringe body 270, and the plunger 265 movable within the syringe body 270 is also visible. Fig.10 is an isometric view of a representative fourth embodiment of the aspiration device 250C, which is also illustrated as having a translucent syringe body 270, and the plunger 265 movable within the syringe body 270 is also visible. Fig. 10A is an isometric view of a representative third embodiment of system 300E illustrating a third embodiment having an access sheath 200A and a representative fifth embodiment of a suction device 250D, wherein the suction device 250D is also illustrated as having a translucent syringe body 270, and a plunger 265 movable within the syringe body 270 is also visible.

[0179] Numerous systems, access sheaths, suction devices, catheters, catheter baskets or cages, and pulverizing or fracturing devices are described in detail herein. Unless the context clearly indicates otherwise, reference to any system 300 to 300J should be understood to mean and include any of the other systems 300 to 300J. Unless the context clearly indicates otherwise, reference to any access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 should be understood to mean and include any of the other access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. Similarly, reference to any suction device 250, 250A, 250B, 250C, 250D should be understood to mean and include any of the other suction devices 250, 250A, 250B, 250C, 250D, unless the context clearly indicates otherwise. Furthermore, reference to any conduit 400-400H should be understood to mean and include any of the other conduits 400-400H, and reference to any basket or cage 405-405K (equivalently referred to as cage or basket 405-405K, and vice versa) should be understood to mean and include any of the other baskets or cages 405-405K, unless the context clearly indicates otherwise. Furthermore, reference to any comminution or fracturing apparatus 700-700S should be understood to mean and include any of the other comminution or fracturing apparatus 700-700S, unless the context clearly indicates otherwise. In addition, unless the context clearly indicates otherwise, any of the various systems 300 to 300J, access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, suction devices 250, 250A, 250B, 250C, 250D, catheters 400 to 400H, and baskets or cages 405 to 405K and any of their respective components may be used in any and all combinations with each other except as described, and any and all such combinations are within the scope of the present disclosure.

[0180] refer to Figure 1 to 10A , the access sheath 100 includes a cylindrical hollow tubular shaft or member 105 having an internal shaft lumen 165. The tubular shaft or member 105 having an internal shaft lumen 165, as well as other tubular shafts 505, 505A illustrated in the following description and various figures (with reference to access sheaths 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900) are considered to be oriented in a longitudinal dimension 557, i.e., longitudinally, with a transverse (or radial) dimension 558 orthogonal to the longitudinal dimension 557, e.g., spaced or laterally or radially offset.

[0181] In various embodiments, the tubular shaft 105 may have multiple separate internal shaft lumens (separated by one or more lumen walls), as described below with reference to Fig.21 Description and description. Figures 58 to 71 79 to 81 also illustrate and describe other multi-wall tubular shafts 505, 505A having various types of lumens. The proximal hub 110 is coupled to the first proximal end 180 of the tubular shaft 105 and is further coupled to an optional (first) handle 115. The access sheath tubular shaft or member 105 further has a second distal end 140, which can be angled or beveled, such as Figure 1 Optional handle 115 may be utilized by medical personnel or other users to insert, guide, and manipulate access sheath 100 in a human or veterinary subject or patient, such as for inserting and positioning distal end 140 into the gallbladder of such a patient or subject.

[0182] In a representative embodiment, the proximal hub 110 (and 110A) includes: a housing 112 having a hub lumen 195; a first valve 120 disposed in the hub lumen 195; a second valve 125 disposed in the hub lumen and spaced proximally from the first valve 120 to provide a hub lumen (e.g., a vacuum lumen) 170 within the housing 112 between the first and second valves 120, 125; one or more access ports 130, 130A, 135 within the housing 112, wherein the one or more access ports 130, 130A, 135 are in fluid communication with the hub lumen 195; and a first coupling 150 ( Figure 3 150A, 150B), for example, for connecting to one or more second corresponding or mating coupling members 155 (e.g., Figure 4 The first and second coupling mating tabs (or pawls) 155A, 155B or 155C illustrated as being insertable into the corresponding coupling recesses 150A, 150B of the proximal hub 110. Fig. 10A The first coupling member 150 is typically integrally formed, such as by injection molding, as part of the housing 112. Figure 1 The housing 112 may have any suitable shape or form factor other than the shape illustrated in the cross-section in FIG. The one or more access ports 130, 130A, 135 are generally disposed toward the distal portion 182 of the proximal hub 110, as illustrated, but may be disposed anywhere within the proximal hub 110, such as, for example but not limitation, between the first and second valves 120, 125. The hub lumen 195 is generally continuous and in fluid communication with the shaft lumen 165, such as, for example, Figure 5One or more access ports 130, 130A, 135 provide access to the shaft lumen 165 (via the hub lumen 195) and / or the plurality of shaft lumens 165A, 165B for insertion of various medical or surgical devices (e.g., one or more catheters 400), as described below, for example with reference to Figures 11 to 22 Instructions and description for capturing and removing one or more gallstones or gallstone fragments. Figure 3 Not separately described herein, one or more access ports 130, 135 may also include one or more valves, for example, for maintaining a vacuum within the access sheath 100 and / or the suction device 250, for example, as described below with reference to Figure 6 The valve 160 of the access port 130A is illustrated and described.

[0183] refer to Figure 6 , access sheath 200 differs from access sheath 100 in that access sheath 200 includes a proximal hub 110A and does not include a handle 115. Proximal hub 110A differs from proximal hub 110 in that the illustrated access port 130A is provided at a right angle rather than an obtuse angle and proximal hub 110A further includes a valve 160, illustrated as a stopcock, for sealing access port 130A and preventing entry or exit through access port 130A. One or more such valves 160 (or any other type of valve) may also be used with one or more access ports 130, 135. In representative embodiments, proximal hub 110A also includes other components of proximal hub 110, such as Figure 5 , comprising: a first valve 120 and a second valve 125, wherein the second valve 125 is spaced apart from the first valve 120 to provide a hub chamber (eg, a vacuum chamber) 170 between the first and second valves 120, 125; and a first coupling member 150 ( Figure 3 150A, 150B), for example, for connecting to one or more second corresponding or mating coupling members 155 (250 to 250D) of the suction device 250, 250A, 250B, 250C, 250D (250 to 250D). Figure 4 1 and 2 are illustrated as first and second mating tabs (or detents) 155A, 155B that are insertable into corresponding recesses 150A, 150B of the proximal hub 110. Figure 4 The mating tabs (or pawls) 155A, 155B described in Figure 6 150A is shown inserted into the first and second coupling tab recesses 150A, 150B of the proximal hub 110A. Aside from these specific differences, the system 300A otherwise has the same components and functionality as the system 300.

[0184] For example, but not limitation, the aspiration device 250-250D, illustrated as a syringe, includes a hollow syringe body 270 and a plunger 265 movable within an interior aspiration lumen 220 of the syringe body 270. When the plunger 265 is withdrawn through the syringe body 270, a vacuum is created within the interior aspiration lumen 220. As described in more detail below, using various valves or locks 255, 280, and / or 285, the vacuum pressure can be maintained within the interior aspiration lumen 220, and further, the vacuum pressure can be suddenly released to create an impulse or burst vacuum aspiration.

[0185] The aspiration device 250-250D may have an extended distal tip 275 coupled to or integrally formed with the syringe body 270. In a representative embodiment, the distal tip 275 is longer than the tip of a more typical syringe, wherein the distal tip 275 has sufficient length to be inserted or insertable into the proximal hub 110, 110A, wherein the first end 277 of the distal tip 275 is typically disposed between the first and second valves 120, 125 in the system 300-300D. Depending on the selected embodiment, the distal tip 275 of the aspiration device 250-250D may be inserted through both the first and second valves 120, 125 of the proximal hub 110, 110A and into the interior lumen 165 of the tubular shaft 105. The suction device 250 to 250D has a second mating coupling 155, such as a mating tab 155A, 155B or a Luer lock or other coupling, for connecting or coupling to the first coupling 150 (e.g., recess 150A, 150B) of the proximal hub 110, 110A. The plunger 265 includes a plunger body 268 coupled to a (second) plunger handle 260 for controlling and manipulating the plunger 265, such as for creating a vacuum within the suction device 250 to 250D. In a representative embodiment, as an option, the plunger 265 may also include a plunger lumen 290 arranged longitudinally along the plunger body 268 and passing through the plunger handle 260 and the plunger port 262, such as for inserting various medical or surgical devices (e.g., one or more catheters 400) in line or coaxially with the suction device 250 to 250D (and the tubular shaft 105), such as described below with reference to. Fig. 10A and 20 Description and Instructions. In a representative embodiment, as an option, the suction device 250-250D further includes one or more (third) valves 255, 280 and / or 285, which are used to create and release an impulse or burst vacuum, described in more detail below, for example, for aspirating one or more gallstones or gallstone fragments. In addition, in a representative embodiment, as an option, for example (but not limited to), the suction device 250-250D (or access sheath 100) may further include an additional (fourth) valve 295, such as a Luer-activated valve, through which the catheter 400 can be inserted into the lumen 290 of the suction device 250-250D or access sheath 100-900.

[0186] Any of the suction devices 250 to 250D may have any of the various components of any of the other suction devices 250 to 250D in any combination, and are described separately to indicate these various different features that are available and may be included in any selected embodiment. For example (but not limited to), the suction device 250 is described as including mating tabs (or detents) 155A, 155B for insertion into first and second tab recesses 150A, 150B arranged laterally in the proximal hub 110, and the suction device 250A (and / or 250) may include a tab or thread 282 at the distal tip 275A of the syringe body 270 for coaxial insertion into a mating recess, thread or tab 150C centrally arranged in the proximal hub 110, 110A, thereby forming, for example (but not limited to), a Luer lock. Suction device 250B includes valve 280 (described as a stopcock) as part of distal tip 275, while suction device 250C includes a removable gate valve 285 (which has an internal sliding valve for sealing) as part of distal tip 275. As described, various suction devices 250 to 250D are shown with optional valves or locking devices 255, which can be used to lock plunger 265 in a selected position or otherwise maintain vacuum in suction devices 250 to 250D. As described in more detail below, there are many different valves that can be used in suction devices 250 to 250D and proximal hubs 110, 110A (and other proximal hubs described below), any of which and owners are considered equivalent and within the scope of the present disclosure. For example (but not limited to), a variety of valves and locking devices suitable for use herein are commercially available from Inari Medical, Inc. of Irvine, California, US.

[0187] The gallstone removal system 300 includes several components, including an access sheath 100 and a suction device 250. More specifically, in a representative embodiment, the system 300 includes an access sheath 100 coupled to a suction device 250-250D via a proximal hub 110, e.g. Figure 5 In another representative embodiment, system 300A includes an access sheath 200 coupled to suction devices 250 to 250D via a proximal hub 110A, such as Figure 6Any of these various systems may further include a catheter 400 that is coaxially arranged with the access sheath 100 or 200 and the suction device 250, 250A, 250B, or 250C or is arranged through one or more access ports 130, 130A, 135. In another representative embodiment, the system 300B includes an access sheath 100 or 200 coupled to the suction device 250 to 250D, and a catheter 400 that is coaxially (or in a straight line) arranged with the access sheath 100 or 200 and the suction device 250 to 250D, for example. Fig. 20 In another exemplary embodiment, the system 300C includes an access sheath 100 or 200, and a catheter 400 disposed through one or more access ports 130, 130A, 135, such as Fig.21 In another exemplary embodiment, the system 300D includes an access sheath 100 or 200, and a catheter 400 arranged coaxially (or in a straight line) with the access sheath 100 or 200, for example Fig. 22 As described in the specification, the invention may further include suction devices 250 to 250D.

[0188] A representative third embodiment of a system 300E having a third embodiment of an access sheath 200A and a representative fifth embodiment of a suction device 250D is shown in FIG. Fig. 10A Reference Fig. 10A , access sheath 200 differs from access sheath 100 in that access sheath 200A includes a proximal hub 110B and also does not include a handle 115. Proximal hub 110B differs from proximal hub 110 in that: (1) proximal hub 110B includes a (first) valve 120A, illustrated as a large-bore gate valve, and does not include a second valve 125; (2) first access port 130 is illustrated as including a (third) valve 295 for sealing access port 130 and preventing entry or exit through access port 130, such as for sealing insertion of a scope or lithotripter; and (3) second access port 135 is illustrated as a flushing port 135A, having a (fourth) valve 295A, such as a Luer valve, for sealing access port 135A and preventing entry or exit through access port 135A when flushing is not occurring. One or more such valves 295, 295A (or any other type of valve) may also be used with one or more access ports 130, 135. In a representative embodiment, the proximal hub 110A also includes a first coupling 150D as a "quick connect" coupling, such as a second corresponding or mating coupling 155C for connecting to a suction device 250D. Fig. 10A150C. The first coupling member 150D includes a flexible ring or gasket that seats or fits within the illustrated annular recess 158 of the second coupling member 155C. The suction device 250D also includes an in-line port 262, also with a valve 295, for inserting a catheter 400 to 400H or other instrument, coaxial (in-line) with the suction device 250D and the access sheath 200A, and with a gate valve 255. The distal tip 275A of the suction device 250D can also be removably coupled to the syringe body 270, such as by a screw thread or a Luer lock ( Fig. 10A Except for these specific differences, system 300E has the same components and functions as other systems 300 to 300D.

[0189] In representative embodiments, the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 has a relatively large central bore or lumen 165, 555, typically between 5 mm and 12 mm in inner diameter, wherein the length of the access sheath 100 is typically 10 to 20 cm, but can be as short as 5 cm and as long as 40 cm. In some embodiments, the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is hard and rigid. In these embodiments, the tubular shaft 105, 505 can be polymeric or metallic or both, as described in more detail below. In other embodiments, the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is flexible and can be polymer, metal, or both. Regardless of the material used, the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 can be straight, curved, tapered, angled, or deflectable / steerable. The access sheath 100, 100A, 200, 200A includes a proximal hub 110, 110A, respectively, to provide access to additional tools and scopes, and is supplied with a cooperating suction device 250, 250A, 250B, 250C, 250D, such as a syringe for facilitating suction. The distal end 140 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 may be angled (or beveled, as described) to maximize the size of gallstones that it can remove (or ingest). The distal end 140 may embody a fixation mechanism, such as a balloon (560) or a nitinol leaflet, which will expand to create a gallbladder wall attachment to hold the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 in place while working through the lumen 165, 555, such as (for example) Fig.58 , 59, 68, 69, 70, 71 and 79 to 88. The balloon tip can also help guide the access sheath 100 through the tract into the subject's gallbladder. In addition, the system can include one or more tapered dilators 145 to help insert the access sheath 100 into the gallbladder and track it. In operation, a series of dilators, balloon dilators, or balloon-tipped catheters of increasing diameters are inserted into a patient or subject to create a tract, wherein the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is inserted into the tract (where the dilator has been removed) and into the subject's gallbladder (and / or wherein the lumen 165, 555 of the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is inserted around the dilator 145 and into the subject's gallbladder, after which the dilator 145 is removed from the lumen 165). Alternatively, the tubular shaft 105, 505 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 may be inserted into the gallbladder of a subject through a pre-existing (or mature) tissue tract.

[0190] In a representative embodiment, the proximal hub 110, 110A (and other proximal hubs described herein) may contain a single central in-line port 152 for irrigation, aspiration, and introduction of tools and auxiliary devices. Figure 3 and 6 , in another representative embodiment, in addition to or in lieu of the in-line port 152, the proximal hub 110, 110A may contain one or more access ports 130, 130A, 135 for flushing, suction, and introduction of tools / auxiliary devices. In some embodiments, these instruments / auxiliary devices may be delivered through a shared port, and in other embodiments, they have dedicated ports to increase surgical flexibility. In some embodiments, the tubular shaft 105 may have a single lumen 165 to be connected to the proximal hub 110, 110A. As mentioned above, the proximal hub 110, 110A with a single access point or multiple ports can all be fed into a single lumen 165 of the tubular shaft 105. In another embodiment, the tubular shaft 105, 505 may have multiple lumens (two or more) and may have dedicated lumens for suction, tool access, etc., such as described below with reference to Fig.21 Description and explanation. Each of these lumens of the tubular shaft 105 can then be individually accessed by each port in the proximal hub 110, 110A. In another embodiment, an accessory port can be incorporated into the suction device 250 so that suction can be applied simultaneously during the use of a camera or mechanical tool. This would involve a lumen 290 through the plunger 265 of the suction device 250, with a valve (e.g., valve 295) to seal around the insertion tool.

[0191] like Figure 3 , the proximal hub 110, 110A of the access sheath 100, 100A, 200, 200A may contain a two-stage valve, including a first distal valve 120 and a second proximal or backup valve (or seal) 125. The proximal hub 110, 110A may be configured to be removably connected to an aspiration device 250 to 250D (or syringe), such as using the illustrated mating connector 150, 155, 282 (such as, for example but not limited to, a Luer lock). The second proximal valve 125 seals around the distal tip 275 of the aspiration device 250 to 250D, and the first distal valve 120 itself seals, which creates a hub cavity 170 in which a vacuum can be generated, such as an impulse or burst vacuum (a "whoosh") created. As the vacuum is created, the distal tip 275 of the suction device 250-250D (or syringe) remains in the hub (vacuum) cavity 170 defined by the measurable space or distance between the first distal valve 120 and the second proximal valve 125. Creating a vacuum in the hub cavity 170 allows the user to suddenly expose this created or filled vacuum to the target treatment space and create a rapid, sudden, impulsive, high flow rate suction of the gallbladder. Figure 3 In the embodiment illustrated in FIG. 1 , a “cross-slit” style valve is used as the first distal valve 120 ; alternatively, a duckbill valve or any other style valve that will self-seal when exposed to vacuum inflation of the suction device 250 may be equivalently utilized.

[0192] In addition, the suction device 250 to 250D (or syringe) can be simply fully inserted through the first and second valves 120, 125 of the proximal hub 110, and conventional non-burst suction can be performed with the suction device 250 to 250D (or syringe) by slowly or quickly withdrawing 265 the plunger through the lumen 220 of the suction device 250 to 250D (or syringe). In another embodiment, the proximal hub 110, 110A may not have two or more valves (such as the first and second valves 120, 125), and instead, may have only a single valve or no valve at all. The proximal hub 110, 110A may also have three or more valves to properly seal a variety of instruments (or tools) and instrument sizes. In another embodiment, the second proximal valve 125 may not be present, and all tools and aspiration are accomplished directly through the central single lumen 165, 555 of the tubular shaft 105, 505 or the individual lumens of the multi-lumen tubular shaft 105, 505 that has accessed the target area. In another embodiment, the valveless tubular shaft 105 can also be used as an access and up-size dilator. These access dilators or hubless sheath shafts can have an inner diameter to accommodate a standard guidewire, or they can have an inner diameter that is sized to slide sequentially over a previously sized dilator. Medical personnel can continue to use larger and larger "dilators" or hubless sheath shafts or balloon dilators or balloon-tipped catheters until the appropriate and desired size of dilation is achieved. For example (but not limited to), access can be initiated using a needle (e.g., an 18 to 21 gauge needle) followed by the insertion of the dilator. The outer diameter of these shafts may range from a small initial access size of 6 to 12 Fr (or smaller) and continue to increase to 30 to 40 Fr (where 1 Fr = 0.33 mm diameter, or equivalently, 3 Fr = 1 mm diameter or 1 Fr = 3x (diameter in mm)). In systems without a proximal hub 110, 110A, the suction device 250 (or syringe) or the mechanism described below would be attached directly to the tubular shaft 105 and lumen 165 in a fixed manner, temporarily fixed (removable), or passively against the tubular shaft 105 to seal when the medical practitioner places it for suction.

[0193] The proximal hub 110, 110A and the suction device 250 to 250D may also have two or more locking stages. The first locking stage locks the suction device 250 to 250D to the proximal hub 110, 110A to perform an impulse or burst vacuum (a "whoosh"), and a second, higher level locking stage or position advances the distal tip 275 of the suction device 250 to 250D (or syringe), through the first distal valve 120 (e.g., a cross-slit valve) to release the charging vacuum. The medical staff may also bypass the first stage and fully insert the suction device through both the first and second valves 120, 125 to perform manual suction, rather than impulse or burst vacuum suction.

[0194] In a representative embodiment, the suction device 250 to 250D can be implemented as a locking syringe, such as the locking syringe commercially available from Inari Medical, Inc. of Irvine, California, US and disclosed in U.S. Patent Publication No. 2022 / 0039815A1, which is incorporated herein by reference, with the same full force and effect as set forth in its entirety herein. In a representative embodiment and as illustrated in the various figures, the suction device 250 to 250D includes a relatively long, larger caliber tip 275. The inner diameter of the elongated tip 275 will be the same or larger than the inner diameter of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 to provide gallstone removal without clogging points or other restrictions. Additionally, the suction device 250 to 250D (e.g., a syringe) may include a proximal locking feature or valve 255 to perform impulse or burst vacuum aspiration, and further, a two-stage locking mechanism may be incorporated at the tip 275 to removably connect the suction device 250 to 250D directly to the proximal hub 110, the locking mechanisms being illustrated as respectively Fig. 9 and 10 The distal valve (or locking mechanism) 280, 285 in the suction device 250 to 250D can also be a single-stage one if impulse or burst vacuum aspiration is not required or the impulse or burst vacuum aspiration mechanism is built into the suction device 250 to 250D itself. The locking mechanism can be implemented similarly to the Intri24 sheath from Inari Medical, Inc. (U.S. Patent Application No. 63 / 307,766, also incorporated herein by reference, with all the same force and effect as set forth herein in its entirety).

[0195] In another embodiment, the vacuum chamber may be confined to the suction device 250 to 250D itself. In a representative embodiment, this is achieved by adding a flow control mechanism or valve 280, 285 to the tip 275 of the suction device 250, 250B, 250C, such as a stopcock, gate valve, rotary valve, or ball valve, etc. Fig. 9 and 10. In this embodiment, the suction device 250B, 250C, although separated from the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, can be a closed system (valve closure) with the plunger 265 in the forward position. The plunger 265 can then be retracted to create a vacuum within the suction device 250B, 250C. The isolated vacuum-filled suction device 250B, 250C can then be attached to the proximal hub 110. The flow control mechanism or valve 280, 285 can then be activated to create a rapid transition from no flow to high flow suction (impulse or burst vacuum suction) or slowly open to create a slow transient increase in suction flow rate or partially open to maintain a slow flow rate for the duration of suction.

[0196] Separately, a medical professional can utilize the flow control mechanisms or valves 280, 285 in an open position and the plunger 265 forward. With the suction devices 250 to 250D connected to the proximal hub 110 in this position, the user can quickly or slowly retract the plunger 265 depending on whether they need or want to create a high or low flow suction. Finally, a user, such as a medical professional, can also utilize the flow control mechanisms or valves 280, 285 in an open position and the plunger retracted (the suction devices 250B, 250C (e.g., the illustrated syringes) are filled with the medium desired to be infused) and connect the suction devices 250B, 250C to the proximal hub 110. The user can then infuse the contents of the suction devices 250 to 250D to inflate the gallbladder, perform fluoroscopy, or use the infusion to manipulate the position of gallstones. Similarly, one or more access ports 130, 130A, 135 using access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 can also be used to manipulate the position of gallstones within the gallbladder. Whether the medium is injected by syringe or continuously injected using a pressurized saline bag, this injection or infusion can dislodge any gallstones. The direction of infusion into the gallbladder can be designed to push gallstones away from the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and into the basket or cage 400-400K (illustrated and described below), or from the distal side of the gallbladder toward the distal end 140 and internal lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 to bring them closer for aspiration. The infusion may exit the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 straight on, at some desired angle, or even perpendicular to the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. The directionality of the infusion may be used and rotated as appropriate to the needs of the user to dislodge stones around the gallbladder.

[0197] Additionally, a separate instrument may be inserted through the interior lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 or a selected lumen of the multi-lumen embodiment 300C and positioned within the gallbladder. This separate instrument may also be used to infuse and manipulate the position of the stone with respect to the gallbladder and the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. This separate device, like access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, can be designed to have its infusion port / flow direction straight, at any desired angle, vertical, but can also be designed to point backward toward access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 to move stones toward the distal end 140 and internal lumen 165 of access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. Forward or angled injection can be used in the delivery tubes of the gallbladder and biliary system (cystic duct, common bile duct, pancreatic duct, etc.) to dislodge gallstones from the delivery tubes in the direction of moving them further along the delivery tube pathway toward the duodenum or small intestine or dislodge them from the delivery tube back to the gallbladder for removal via access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and capture baskets (described below).

[0198] An important feature to note is that, unlike current large bore suction devices, in the representative embodiment, there is no large bore side port through which material can be removed. Instead, in the representative embodiment, the suction device 250 to 250D is directly connected to the internal lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 in a straight row (linear alignment). This is particularly important in gallstone removal (rather than thrombus removal) due to the incompressible and non-uniform nature of gallstones. Depending on the composition of the gallstones (pigment stones vs. cholesterol stones), they may be very hard and almost rock-like in structure, and therefore, passing through a side port that includes a steep angle would be undesirable. Alternatively, in another representative embodiment, one or more access ports 130, 130A, 135 and / or other side ports may be provided and appropriately sized, e.g., with a relatively large diameter caliber, and used for suction while giving enough room for the gallstone to transition through the side bend from the interior lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 into the tubing of the access port 130, 130A, 135. Additionally, an alternative embodiment may include a proximal suction source that is a flexible, self-expanding container in which gallstones may be collected and stored during removal. This suction source may be directly connected to the shaft 105, and is described below with reference to Fig.32 Describe in more detail.

[0199] As mentioned above, it should be noted that the proximal hub 110, 110A of the access sheath 100, 100A, 200 may not have two valves 120, 125, but it may have one valve, such as the access sheath 200A, which may have 3 valves or more valves or it may not have a valve. If there is no valve, the suction device 250 to 250D may be permanently fixed, temporarily fixed, or passively "pressed" on the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 to create a seal. In any case, the "fixing" of the suction device 250 to 250D to the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 may be rigid or flexible or both aspects, depending on the component. For example, but not limited to, whether the proximal hub 110, 110A has a valve or no valve, the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 shaft may be straight, curved, tapered, twisted or stepped, e.g. Fig.32 The curved access sheath 100B illustrated in FIG.

[0200] There are instances where various instruments in addition to the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and the suction device 250-250D are necessary or desirable to facilitate the removal of gallstones from the bile duct or any location in the body of a subject or patient. For example, but not limited to, when suction alone is not effective enough or the stone is too large to be removed by the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, one or more additional instruments (e.g., catheter devices 400-400H) may be necessary or desirable to capture and / or fracture the gallstone and break it into smaller, more easily removable pieces. Baskets or cages 405-405K (e.g., composed of Nitinol) may be used to help collect gallstones and / or crush them into smaller sizes for extraction, and may be used in addition to or in place of suction devices 250-250D. Fig.11 are isometric views illustrating representative first and second embodiments of catheter apparatus 400, 400A having a basket or cage 405 illustrated in an expanded state. Fig.12 are isometric views illustrating representative first and second embodiments of catheter apparatus 400, 400A having a basket or cage 405 illustrated in an expanded state. Fig.13 is a partial cross-sectional view illustrating a representative first embodiment of a catheter apparatus 400 having a basket or cage 405 illustrated in an expanded state. Fig.14 is a partial cross-sectional view illustrating a representative second embodiment of a catheter apparatus 400A having a basket or cage 405 illustrated in an expanded state. Fig.15 is an isometric view illustrating a representative third embodiment of a catheter apparatus 400B having a basket or cage 405A (and illustrated in an expanded state). Fig.16 is an isometric view illustrating a representative fourth embodiment of a catheter apparatus 400C having a basket or cage 405B illustrated in an expanded state. Fig.17 is an isometric view illustrating a representative fourth embodiment of a catheter apparatus 400C having a basket or cage 405B illustrated in an expanded state. Fig.18 is an isometric view illustrating a representative fourth embodiment of a catheter apparatus 400C having a basket or cage 405B illustrated in a collapsed state. Fig.19 is an isometric view of a representative fourth embodiment of a catheter apparatus 400C having a basket or cage 405B illustrated in a collapsed state. Fig. 30A , 30B and 52 to 57 describe in more detail additional catheter apparatus 400 to 400H embodiments having additional basket or cage embodiments 405 to 405K.

[0201] refer to Figures 11 to 19 , a representative embodiment of a catheter device (or catheter) 400, 400A, 400B, 400C includes an outer catheter tube (or outer catheter member) 415, 415A having an outer catheter lumen 440, 440A. An inner catheter manipulation shaft (or member) 420, 420A is coaxially (or concentrically) disposed within the outer catheter lumen 440, 440A and can be longitudinally (or longitudinally and rotatably) moved (e.g., pushed or pulled with or without rotation) within the outer catheter lumen 440, 440A. The outer catheter tube (or outer catheter member) 415, 415A (and 415B) and the inner catheter manipulation shaft (or member) 420, 420A (and 420B) can have any size (length and diameter) suitable for insertion through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and into the subject's gallbladder or suitable for coaxial insertion within the shaft 835, 935 of the crushing or fracturing control device 850, 950, and then inserted together through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and into the subject's gallbladder. In representative embodiments not separately illustrated, the proximal ends of the catheters 400-400H are not sealed or otherwise finished so that the inner catheter manipulation shafts (or members) 420, 420A (and 420B) can be accessed and manipulated by a user relative to the outer catheter tubes (or outer catheter members) 415, 415A (and 415B), or vice versa, for example to expand or contract the baskets or cages 405-405K.

[0202] As referenced below Fig. 30A and 30BDescribed in more detail, the inner catheter manipulation shaft (or member) 420, 420A is, among other things, the first shaft 420, 420A (and 420B) of various catheter 400-400H embodiments, which may also include a pulverizing or fracturing device 700, such as (but not limited to) a pulverizing or fracturing device 700 having, as an option, a (second) shaft 705 coupled to an angled or pointed pulverizing or fracturing tip 710. In representative catheter 400, 400A, 400C, 400D embodiments, a cage or basket 405, 405A, 405B is coupled to both the outer catheter tube 415, 415A and the inner catheter manipulation shaft 420, 420A. The cage or basket 405, 405A, 405B includes a plurality of struts 410, wherein the plurality of struts 410 are arranged in a selected grid cross pattern in a plurality of grid cross patterns to form the corresponding cage or basket 405, 405A, 405B into a grid or a variable or otherwise non-uniform grid having a plurality of pores of different sizes, as described in more detail below. In various grid cross patterns, the plurality of struts 410 may overlap each other or may simply abut or engage each other, without overlapping or crossing each other. Any and all grid cross patterns or arrangements of struts 410 other than those described are considered equivalent and within the scope of the present disclosure. The plurality of struts 410 of the various cages or baskets 405, 405A, 405B are arranged to form a grid having relatively larger pores or openings 450 at a proximal region 460 of the cages or baskets 405, 405A, 405B and relatively smaller pores or openings 455 at a distal region 465 of the cages or baskets 405, 405A, 405B. Additionally, in other representative embodiments, the plurality of struts 410 extend longitudinally without crossing. As described in more detail below, the plurality of struts 410 of any of the cage or basket 405-405K embodiments may be composed of any suitable material, such as nitinol or other metal or metal alloy, carbon fiber, or any of a variety of suitable polymers, in any suitable configuration to form a cage or basket 405-405K including wires, braids, braided wires, etc.

[0203] More specifically, in representative catheter 400, 400A, 400C, 400D embodiments, a plurality of struts 410 at a first end 425 of a cage or basket 405, 405A, 405B are coupled to a distal end 427 of an outer catheter tube (or member) 415, 415A, typically or typically coupled between the outer catheter tube (or member) 415, 415A and a relatively thin, generally cylindrical catheter tube collar (or cover) 495, such that any potentially worn or sharp ends of the struts 410 (at the first end 425) are covered by the catheter tube collar or cover 495. A plurality of struts 410 at a second end 445 of the cage or basket 405, 405A, 405B are coupled to a distal end 480 of an inner catheter steering shaft 420, 420A (which forms a catheter tip), usually or typically coupled between the inner catheter steering shaft 420, 420A and a catheter tip cover 430, 430A, also such that any potentially worn or sharp ends of the struts 410 (at the second end 445) are covered by the catheter tip cover 430, 430A.

[0204] Fig.15 and 16 410. Fig.15 4, the cage or basket 405A has relatively few struts 410, thereby providing larger apertures or openings 450 and smaller apertures or openings 455, and no catheter tip caps 430, 430A at the distal end 480. For this catheter apparatus 400B embodiment, it should be noted that the inner catheter steering shaft (or member) 420 does not extend all the way to the distal end 480 or may be omitted altogether. Fig.16 4, cage or basket 405B is illustrated as having more struts 410 than cage or basket 405A and relatively fewer struts 410 than cage or basket 405. Cage or basket 405B has struts 410 of three blades 412 (in a cloverleaf pattern), providing three corresponding groups of smaller pores or openings 455A as illustrated and providing three corresponding and relatively larger pores 450A. In the expanded state, the surface area of ​​each of the large pores 450A is about the same as or even larger than the surface area of ​​each of the blades 412, providing relatively larger pores 450A to capture stones, which can then be more tightly netted by the blades 412. Cage or basket 405B also has a catheter tip cap 430, 430A at the distal end 480, and can use a hollow or solid inner catheter manipulation shaft (or member) 420 or 420A.

[0205] As illustrated, the cage or basket 405, 405A, 405B can be expanded or contracted by longitudinally moving the inner catheter steering shaft (or member) 420, 420A within the outer catheter lumen 440, 440A relative to the outer catheter tube or member 415, 415A. For example, when the distal end 480 is moved to a position farthest or most distal from the outer catheter tube or member 415, 415A, the shape of the cage or basket 405, 405A, 405B becomes more fusiform or elongated (spindle-shaped), and the diameter of the cage or basket 405, 405A, 405B narrows or contracts. When the distal end 480 is moved to a position closer to the outer catheter tube or member 415, 415A, for example Figures 11 to 16 , the length of the cage or basket 405, 405A, 405B is reduced, while the diameter of the cage or basket 405, 405A, 405B is expanded, resulting in the cage or basket 405, 405A, 405B having a more pear-shaped (pear or fig) shape. When the catheter tip 480 moves closer to the outer catheter tube or member 415, 415A, for example Figures 17 to 19 4. As illustrated in FIG. 4, the length of the cage or basket 405, 405A, 405B is reduced more, while the diameter of the cage or basket 405, 405A, 405B is further expanded, resulting in the cage or basket 405, 405A, 405B having a more disc shape.

[0206] Inner catheter manipulation shafts (or members) 420, 420A differ from one another in that inner catheter manipulation shaft (or member) 420 is hollow and has an inner catheter shaft lumen 435, useful, for example (but not limited to), for flushing and moving gallstones, while inner catheter manipulation shaft (or member) 420A is solid and does not have any such lumen. Additionally, outer catheter tubes 415, 415A may differ from one another in that outer catheter tube 415 may have a relatively smaller diameter outer catheter lumen 440, adjacent to or only slightly spaced from inner catheter manipulation shaft (or member) 420, while outer catheter tube 415A may have a relatively larger diameter outer catheter lumen 440A, spaced from inner catheter manipulation shaft (or member) 420 and providing space for flushing and moving gallstones using outer catheter lumen 440A. In other words, using the inner catheter steering shaft (or member) 420, an infusion (e.g., a saline infusion) can be provided through the inner catheter shaft lumen 435 of the inner catheter steering shaft (or member) 420 and flow out through a corresponding opening (referred to as the distal catheter flush port 470) of the distal catheter (catheter tip) (and the catheter tip cover 430), and using the inner catheter steering shaft (or member) 420A, an infusion (e.g., a saline infusion) can be provided through the outer catheter lumen 440A of the outer catheter tube (or member) 415A and flow out through a corresponding outer catheter tube opening (referred to as the proximal catheter flush port 475 of the outer catheter tube (or member) 415A), in Fig.14 and 15In this manner, infusion or flushing may be provided at different locations of the catheter apparatus 400, 400A, 400B, 400C.

[0207] Although not described separately, it should be noted that these various embodiments may be provided in any combination, and all such combinations are within the scope of the present disclosure. For example (but not limitation), a catheter 400, 400A, 400B, 400C may be provided having both an inner catheter shaft lumen 435 of an inner catheter steering shaft (or member) 420 and an outer catheter lumen 440A of an outer catheter tube (or member) 415A to provide optional infusion or flushing at either or both locations of a catheter distal flush port 470 and / or a catheter proximal flush port 475. In addition to having these structural features and combinations of structural features, it should be noted that the catheter device 400, 400A, 400B, 400C is also different from other prior art catheters in that the cage or basket 405, 405A, 405B does not need to have a fully compressed state within the outer catheter tube (or member) 415, 415A, can be provided externally to the outer catheter tube (or member) 415, 415A and does not need to be withdrawn into the outer catheter tube (or member) 415, 415A to capture and remove gallstones. Alternatively, not separately illustrated, the cage or basket 405, 405A, 405B can be collapsed into a small delivery catheter and deployed inside the gallbladder via the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900.

[0208] This catheter device 400, 400A, 400B, 400C can be inserted through the access port 130, 130A, 135, the plunger tube lumen 290 of the suction device 250, 250A, 250B, 250C, 250D or directly through the proximal hub 110, 110A of the access sheath 100, 100A, 200, 200A. For gallstone removal, it is more desirable to insert the catheter device 400, 400A, 400B, 400C through the plunger lumen 290 of the suction device 250, 250A, 250B, 250C, 250D or the hub lumen 195 of the proximal hub 110, 110A of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 so that the catheter device 400, 400A, 400B, 400C remains in the continuous relatively larger diameter internal lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. Once the cage or basket 405, 405A, 405B is inflated inside the gallbladder, the cage or basket 405, 405A, 405B may be manipulated (rotated, advanced, retracted, expanded, etc.) to capture the gallstone within the plurality of struts 410 of the cage or basket 405, 405A, 405B. The user may then recapture the cage or basket 405, 405A, 405B in the delivery catheter and / or otherwise tighten the cage or basket 405, 405A, 405B around the stone to be removed or pulverized. Continued tightening of the cage or basket 405B Figures 16 to 20 4. The cage or basket 405B is illustrated as continuously contracting from an expanded state. When the cage or basket 405, 405A, 405B contracts, and as described in more detail below, the captured gallstones may also be crushed or pulverized, thereby reducing the size of the gallstone mass for easier removal.

[0209] The cage or basket 405, 405A, 405B has a variable pore size: relatively more open on the proximal end and relatively more closed on the distal end, as mentioned above. This variable pore size can help capture and retain stones, using the larger pores or openings 450 to capture gallstones within the cage or basket 405, 405A, 405B, for example Fig. 30A 4, then shrink the cage or basket 405, 405A, 405B around the captured gallstone so that the gallstone is larger than the smaller pores or openings 455 and is held thereby, e.g. Fig. 30B405A, 405B. In other embodiments, the cage or basket 405, 405A, 405B may have a uniform pore size that is smaller or larger than the illustrated example. The catheter device 400 also has a catheter distal end flushing port 470 at the catheter tip 430, which can help push gallstones toward the suction device 250, 250A, 250B, 250C, 250D instead of being pushed away with prior art flushing systems. Alternatively, flushing can be performed at the proximal end of the cage or basket 405, 405A, 405B using the catheter proximal end flushing port 475 of the outer catheter tube (or member) 415A, which will allow more space for larger stones to be trapped in the nitinol cage or basket 405, 405A, 405B.

[0210] In one embodiment, the catheter distal flush port 470 at the catheter tip 430 has a flush lumen. This will allow the user to inject saline and push the gallstones back toward the distal end 140 of the access sheath 100, 100A, 200, 200A for extraction. When flushing from the catheter proximal flush port 475 of the outer catheter tube (or member) 415, the gallstones can be pushed further into the cage or basket 405, 405A, 405B, which can be useful for manipulating the position of the gallstones. When flushing from the catheter distal flush port 470, the gallstones can be pushed further, which can also be useful for manipulating the position of the gallstones. In addition, the expansion cage or basket 405, 405A, 405B can help to hold the gallbladder open during the use of a suction device (impulse or burst vacuum suction or manual). Due to the small size of the gallbladder, it may collapse during aspiration, thereby inhibiting extraction of gallstones, so the use of a cage or basket 405, 405A, 405B to additionally help prevent such collapse may provide additional utility.

[0211] Another alternative version of the cage or basket 405, 405A, 405B is to use the irrigation wire as a pull wire to connect the distal end of the catheter device 400, 400A, 400B, 400C to the user controllable handle. This allows the user to customize the shape and diameter during surgery to better control the accumulation of stones. This also allows the stone to be crushed by pulling the distal end of the cage or basket 405, 405A, 405B, compressing the stone between the struts.

[0212] 25-28, one or more sharp points and / or hooks may be coupled within the cage or basket 405, 405A, 405B, either or both coupled to selected struts 410 or other components of the catheter 400, 400A, 400B, 400C, such as within the cage or basket 405, 405A, 405B to the distal cap 430. This will aid in rupturing gallstones when the cage or basket 405, 405A, 405B contracts, as all inward compressive forces will be concentrated at the sharp contact points.

[0213] Fig. 201 is a partial cross-sectional view (through the lateral view) of a representative fourth embodiment of a system 300B having a first embodiment of an access sheath 100, further having a representative first or second embodiment of a suction device 250, 250A (or other suction devices 250 to 250D), and having a representative catheter device 400 to 400D embodiment. Figure 1 C-C' plane). Fig. 20 A system 300B arrangement is illustrated having catheters 400-400D arranged coaxially (or in-line) with the access sheath 100 (or 200) and the suction devices 250-250D.

[0214] Fig.21 is a partial cross-sectional view (through the 4th embodiment of the system 300C) illustrating a representative fifth embodiment of the system 300C having an access sheath 100A and representative catheter device embodiments 400 to 400D. Figure 1 The access sheath 100A differs from the access sheath 100 in that the access sheath 100A has a plurality of internal lumens 165A, 165B separated by one or more internal longitudinal partitions or walls 168 to form a plurality of individual internal lumens 164A, 165B to illustrate the multi-lumen embodiments described above. Fig.21 A system 300C is described having catheters 400-400D arranged through one or more access ports 130, 130A, 135, and may further include suction devices 250-250D (not separately illustrated). In addition, the system 300C includes a valve 295, such as a Luer valve, within or coupled to the access port 130 and surrounding and sealing the catheters 400-400D. In this embodiment, the access sheath 100A has additional lumens 165A, 165B, which can be used to flush the gallbladder or introduce various tools or medications required to complete the procedure. This embodiment and other embodiments may also utilize a beveled distal end 140 on the access sheath 100A, which can assist in surgical procedures, including (but not limited to) flushing, insertion, and angled suction.

[0215] Fig. 22 It indicates that Figure 1 A partial cross-sectional view (through the first embodiment of the access sheath 100 illustrated in FIG. 1 ) of a representative sixth embodiment of a system 300D having additional representative catheter device embodiments 400 to 400D. Figure 1 The diagram shows a C-C' plane) and is used to illustrate catheters 400 to 400D that are coaxially (or in a straight line) arranged with the access sheath 100 or 200, pass through the proximal hub 110, 110A and the first and second valves 120, 125, and may optionally further include suction devices 250 to 250D (not illustrated separately).

[0216] It should be noted that although Figures 20 to 22Representative catheter apparatus 400-400D having representative cages or baskets 400-400D are used for illustration, but one skilled in the art will recognize that any of catheters 400-400H having any of cages or baskets 400-400K may be equivalently utilized, and any and all such variations are within the scope of the present disclosure.

[0217] Fig.23 is an isometric view illustrating a first embodiment of a representative comminuting or fracturing apparatus 700 for use as part of any of the various systems 300 - 300J. Fig.24 7 is a cross-sectional view illustrating a representative first crushing or fracturing device 700, illustrating a second crushing or fracturing spring 722. A representative second embodiment of a crushing or fracturing device 795 is shown in FIG. Fig.31 , and additional embodiments of the crushing or fracturing apparatus are described below with reference to Figures 33 to 51 Instructions and description.

[0218] refer to Fig.23 , a first embodiment of a crushing or fracturing device 700 includes a flexible, hollow, partially hollow or solid generally cylindrical crushing or fracturing shaft (or tube) 705 integrally formed with or coupled to a first angled or pointed crushing or fracturing tip 710, wherein the crushing or fracturing shaft 705 is disposed in a first crushing or fracturing device lumen 725 of a first crushing or fracturing handle 715; and further includes a first crushing or fracturing spring 720, a second crushing or fracturing spring 722, and a first crushing or fracturing retraction actuator 730. The crushing or fracturing shaft 705 and crushing or fracturing tip 710 can be manufactured with any diameter and length suitable for use with any of the catheter 400 to 400H and access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 embodiments. When the mechanical comminution technique using only the basket or cage 405 to 405K is insufficient, then another mechanical tool (e.g., a comminution or fracturing device 700, 795) can be introduced through the lumen 165 of the access sheath 100, 100A, 200, 200A or the central lumen 555 of the access sheath 500, 500A, 600, 600A, 800, 900 described below. Other embodiments of comminution or fracturing devices 700A to 700S designed for use with other catheters 400 to 400H embodiments having an inner catheter lumen 435 are described below with reference to Fig. 30A , 30B 33 to 51 are described in more detail. The crushing or fracturing device 700, 795 having a first angled or pointed crushing or fracturing tip 710 or a second sharp edge or beveled crushing or fracturing tip 710T, respectively, can be used to lyse, fracture or crush gallstones, and in addition to the illustrated examples and Figures 33 to 51and are referred to below Figures 33 to 51 In addition to the described crushing or fracturing tips, any suitable or appropriate crushing or fracturing tip 710, 710T geometry may be provided. The first angled or pointed crushing or fracturing tip 710 or the second sharp edge or beveled crushing or fracturing tip 710T will be mounted on or as part of a flexible, hollow, partially hollow or solid generally cylindrical shaft (or tube) 705, 705A for transmitting force directly from the proximal end to the gallstone through the first angled or pointed crushing or fracturing tip 710 or the second sharp edge or beveled crushing or fracturing tip 710T.

[0219] Alternatively, energy may be stored by spring loading the first comminution or fracturing device 700, such as Figures 23 to 24 , by using the first crushing or fracturing retraction actuator 730 to retract the crushing or fracturing shaft 705 of the first crushing or fracturing device 700 into the first crushing or fracturing device lumen 725 (relative to the first crushing or fracturing handle 715) and compress the second crushing or fracturing spring 722. For example, Fig.24 It is described that when the first crushing or fracturing device 700 is inserted through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and positioned at a selected or desired position in the gallbladder of the subject, wherein the second crushing or fracturing spring 722 is in a compressed state, the second crushing or fracturing spring 722 can be released (for example, by releasing the first crushing or fracturing retraction actuator 730), and the first angled or pointed crushing or fracturing tip 710 of the first crushing or fracturing shaft 705 is driven by the movement of the first crushing or fracturing spring 720 to impact the gallstones captured in the catheter 400 to 400H to fracture the gallstones. This may be performed multiple times to fracture the gallstones into small enough fragments for removal, i.e., by repeated efforts to capture and then fracture the stones to a diameter smaller than the inner diameter of the lumen 165, 165A, or 165B of the access sheath 100, 100A, 200, 200A or the central lumen 555 of the access sheath 500, 500A, 600, 600A, 800, 900, all of the stones may be removed through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 with the aid of the pulverizing or fracturing instrument 700, 795 (or other pulverizing instruments described in more detail below) and a collection device (e.g., cage or basket 405-405K or other collection devices also described in more detail below). The pulverizing or fracturing instrument 700A-700S functions similarly to impacting and fracturing gallstones and gallstone fragments. The first and second comminuting or fracturing apparatuses 700, 795 and other comminuting or fracturing apparatuses 700A-700S may be composed of any suitable material, such as, for example but not limited to, titanium, stainless steel, polymers.

[0220] Fig.25A is an isometric view of a representative fifth embodiment of a catheter apparatus 400D illustrating a representative fourth embodiment having a basket or cage 405C illustrated as being in an expanded state, the basket or cage 405C having representative sharp teeth, points or wedges 490 coupled to or integrally formed with one or more interior surfaces 492 of one or more struts 410. Fig.25B is a diagram illustrating a basket or cage 405C which is illustrated as being in an expanded state. Fig.25A 4 , a cross-sectional view of the BB′ plane of a basket or cage 405C illustrated in FIG. 4 having representative sharp teeth, points or wedges 490 coupled to or integrally formed with one or more interior surfaces 492 of one or more struts 410. Fig.26 is a cross-sectional view illustrating a basket or cage 405C illustrated as being in a collapsed state, the basket or cage 405C having sharp teeth, points or wedges 490 coupled to or integrally formed with one or more interior surfaces 492 of one or more struts 410. Fig.27A , 27B, 27C, 27D and 27E are cross-sectional views illustrating representative configurations of one or more interior surfaces 492 of a strut 410 or sharp teeth, points or wedges 490 integrally formed with the one or more interior surfaces 492 of any of a representative basket or cage 405, 405A, 405B, 405C (illustrated as being in a collapsed state) coupled to any of the various representative catheter 400, 400A, 400B, 400C, 400D embodiments. As mentioned above, one or more sharp teeth, points or wedges 490 may be coupled to or integrally formed with the interior surface 492 of one or more struts 410 of any of the various baskets or cages 405, 405A, 405B to form a basket or cage 405C, either or both coupled to or formed by one or more selected struts 410 or other components of the basket or cage 405, 405A, 405B of the catheter 400, 400A, 400B, 400C to form a basket or cage 405C, and / or, for example, coupled to or integrally formed with the distal cover 430 and / or one or more struts 410 of the basket or cage 405, 405A, 405B to form a basket or cage 405C. This will help to rupture gallstones when the basket or cage 405C contracts, as all inward compressive forces will be concentrated at the sharp contact points. As mentioned above, the basket or cage 405C may be used to replace or otherwise substitute any of the representative baskets or cages 405, 405A, 405B of any of the catheter 400, 400A, 400B, 400C embodiments, and all such combinations and variations are considered equivalent and within the scope of the present disclosure. Additionally, any of the various baskets or cages 405 to 405K may further include one or more sharp teeth, points or wedges 490 coupled to or integrally formed with one or more interior surfaces 492 of one or more struts 410 of any of the various catheter 400 to 400H embodiments.

[0221] In order to reduce the overall force required to lyse the gallstone, the force can be concentrated on fewer individual sharp teeth, points or wedges 490. In order to achieve this by compression followed by a basket capture device, the inner (or interior) surface 492 of the struts 410 may further include sharp teeth, points or wedges 490 to form a basket or cage 405C. These sharp teeth, points or wedges 490 concentrate the pressure / lysing force by applying the force to smaller and potentially fewer contact points. One way to make this basket or cage 405C is similar to the coring elements of the ClotTriever and FT2 commercially available from Inari Medical, Inc. However, instead of cutting from a tube (which is hollow inside), a large mandrel / wire can be utilized. This will give the struts of the basket or cage 405C a cross-sectional profile similar to a pizza slice or dagger, such as Fig.25A, 25B and as described in 26. Fig.26 The "cut profile" of the basket or cage 405C is illustrated. These cut pieces forming the lines of sharp teeth, points or wedges 490 can be heat set into the expanded shape of any of the various baskets or cages 405, 405A, 405B to form the basket or cage 405C and will have a series of dagger struts (not necessarily uniform and not necessarily non-uniform) around the circumference, as shown in the "expanded shape" of the basket or cage 405C. Fig.25A and 25B 405B. For example, but not limited to, there may be as few as two and as many as 24 struts 410 with sharp teeth, points, or wedges 490, and as previously mentioned, the basket or cage 405C may be designed with a reduced number of struts 410 on the proximal side and an increased number of struts 410 on the distal side to create a less dense / open porous side and a more dense / less porous side. Wires with triangular cross-sections may also be used directly to form some or all of the multiple struts 410 of any of the various baskets or cages 405, 405A, 405B to form the basket or cage 405C or to form the sharp teeth, points, or wedges 490, including grinding away portions of such triangular wire to leave the sharp teeth, points, or wedges 490. As additional alternatives, the entire basket or cage 405C structure may have the same number of struts 410 or may have fewer struts on the distal side and more struts on the proximal side. Additionally, the proximal and distal ends of the basket or cage 405C may have a dense structure or a less dense strut structure than the middle, and vice versa. Nevertheless, having fewer struts is generally beneficial because it reduces the overall force that needs to be provided by the user or user control system in order to achieve the same pressure / lysis force applied to the gallstone per strut 410. Individually, fewer struts 410 generally provide less overall strength of the system to retract the stone through the sheath, and also provide less structure to capture the stone in the basket device.

[0222] In another embodiment, the pillar profile may not be triangular or dagger / pizza shaped, and it may not have sharp points on the inner contact surface of the pillar 410. The pillar profile may also be simply square, rectangular, circular or designed with an arc-like shape, such as Figures 27A to 27E In the description.

[0223] Fig.28A , 28B 28C is an isometric view of a fifth embodiment illustrating a basket or cage 405D illustrated in an expanded state having a grapple 494 for use with any of the various representative catheters 400 to 400D. The basket or cage 405D can collect gallstones in a rotational manner, scoop up gallstones, and can also be retracted or collapsed to pulverize gallstones, and is used to illustrate the various available shapes and functionality of any of the various baskets or cages disclosed herein.

[0224] Fig.29 is an isometric view of a representative sixth embodiment of a catheter 400E device illustrating a sixth embodiment having a basket or cage 405E illustrated in an expanded state, wherein the basket or cage 405E has a proximal annular design (wire or laser cut) with an attached braided collection basket.

[0225] In any of the various embodiments, the basket or cage 405-405K or other capture device may be designed and manufactured from materials other than Nitinol, and it may or may not be laser cut or wire electro-discharge machined (EDM) as a single body basket. The basket or cage 405-405K or other capture device may also be designed and constructed from a braided structure, individual wires extending longitudinally, or an asymmetrical large scooping device (e.g., similar to an ice cream scoop). Outside of the cross-sectional profile of the strut 410, the overall basket or cage 405-405K or other capture device may be any number of shapes, such as cylindrical, spherical, square, rectangular, trapezoidal, diamond, hexagonal, octagonal, etc. The basket or cage 405-405K or other capture device may be a circular pattern that is symmetrical front to back, or it may be asymmetrical, with one large side opening and one closed side. The structure may also be generally unique in each distinct area, with little uniformity.

[0226] In some embodiments, the basket or cage 405-405K or other capture device is connected to a rigid shaft or rod that extends through the outer catheter lumen 440, 440A and can be moved longitudinally or both longitudinally and rotationally within the outer catheter lumen 440, 440A and can be controlled by the user. In other embodiments, the basket or cage 405-405K or other capture device is attached to an inner catheter steering shaft (or member) 420, 420A within a flexible outer catheter tube (or member) 415, 415A, wherein the inner catheter steering shaft (or member) 420, 420A can be moved longitudinally or both longitudinally and rotationally within the outer catheter lumen 440, 440A. In both embodiments, the inner catheter steering shaft or member 420, 420A can be a wire, a tube, a concentric telescopic system, and these inner catheter steering shafts or members can be polymers with metal support structures, polymers without metal support structures, and metal only. The proximal portion of the basket or cage 405-405F or other capture device may simply terminate in the end of a wire or tube or it may terminate in a handle that the user can manipulate to guide, size, open, close, extend, retract or otherwise manipulate the basket or cage 405-405K or other capture device. The basket or cage 405-405K or other capture device may be provided with the capture elements in a normally collapsed position, allowing the user to "expand" it once inside the gallbladder. Alternatively, the basket or cage 405-405K or other capture device may be in an open / expanded position and the user may collapse it prior to inserting it into the gallbladder through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. Alternatively, the basket or cage 405-405K or other capture device may be packaged within a delivery system and the user should deploy the elements from the delivery system to capture gallstones. In this embodiment, once deployed from the delivery system, the device may collapse normally or open normally. The user may then manipulate the basket or cage 405-405K or other capture device appropriately to engulf the stone.

[0227] In some embodiments, the distal and proximal ends of the basket or cage 405-405K or other capture device may be connected to an inner catheter steering shaft or member 420, 420A that extends through the interior 414 of the basket or cage 405-405K or other capture device to the distal end 480 (enabling a user to control the opening / expansion and closing / contraction of the basket or cage 405-405K or other capture device), for example Figures 11 to 14 , 16 to 19 and 30A, 30B. In some embodiments, the inner catheter manipulation shaft (or member) 420, 420A may also have an inner catheter shaft lumen 435. In some embodiments, for example Fig.15 4. It is illustrated that the interior of the basket or cage 405A does not include an inner catheter steering shaft (or member) 420, 420A, and instead has a large open space in the middle of the basket or cage 405A that can capture gallstones.

[0228] Fig. 30A and 30B 400H or any of the other various conduits 400 to 400H or baskets or cages 405 to 405K, wherein the basket or cage 405F captures the gallstone 411 ( Fig. 30A ) and then retract around the gallstone 411 ( Fig. 30B ) (wherein the basket or cage 405F is illustrated using an isometric view and the remainder of the catheter 400F is simplified and illustrated in (partial) cross-section to illustrate the capture and pulverization / fracturing concepts). The catheter 400F includes an outer catheter tube (or outer catheter member) 415C having: an outer catheter lumen 440, 440A; an inner catheter steering shaft (or member) 420, 420A that is longitudinally and rotationally movable within the outer catheter lumen 440, 440A; and a basket or cage 405F that is coupled to the inner catheter steering shaft (or member) 420, 420A both proximally and distally as illustrated. In various embodiments, the basket or cage 405-405K or other capture device may not rely solely on struts or braids to break up captured gallstones. Additional stone fracturing methods may be included with or within the catheters 400-400H. One of these methods includes using a catheter that can be located within the inner catheter lumen 435 (of the inner catheter steering shaft 420B) or within the outer catheter lumens 440, 440A (e.g. Fig. 30A and 30B ) longitudinally or both longitudinally and rotationally movable crushing or fracturing device 700 to 700S, providing a "jack hammer" or "spear" (e.g., pointed or pointed) crushing or fracturing device 700 to 700S that can be used to forcibly engage and rupture gallstones. This can be used in conjunction with any of the types and shapes of support 410 and baskets or cages 405 to 405K or other capture devices disclosed herein. The crushing or fracturing tip 710 to 710T can be round, pointed, spearhead, diamond-shaped, chamfered, chiseled, bullnose, bullet-shaped, hollow, drill bit, hole saw, pitted, screw / spiral, and fin-shaped, etc., and in addition to Fig. 30A , 30BIn addition to the spear-shaped crushing or fracturing tip 710A described in the figure, many are also described and described below. The action of this crushing or fracturing device 700 to 700S is to forcibly engage with the gallstone and fracture the gallstone into smaller pieces, and this action can be achieved using one or more of the following crushing or fracturing device 700 to 700S drive mechanisms: linear actuator, compression spring drive, tension spring drive, torsion spring drive, spring drive, constant force spring drive, user drive and control, ratchet, rotation, and it can also be a lead screw drive mode of spiral rotation. The crushing or fracturing device 700 to 700S can move quickly and have rapid impacts, such as a single rapid impact like a hammer or repeated impacts like a jack hammer. Once the crushing or fracturing tip 710 to 710T is embedded in the gallstone, it can be withdrawn to cause additional fracturing within the gallstone. The crushing or fracturing tip 710 to 710T may also be in a linear or rotational manner to engage the gallstone slowly, similar to a drill bit. Again, this may be forward and / or backward engagement or both. In another embodiment, the crushing or fracturing device 700 to 700S may also be a slow or fast moving, forward or backward motion, which is a spiral or screw-like drive. Such a drive motion will rotate and move linearly. The rotational motion may then also drive forward motion (coupled) like a gear or spiral track, or the rotational motion and forward motion may be decoupled. The rotational motion may impose a drill-like engagement with the gallstone, and the linear motion may be forcibly added by the user or a spring-like or actual spring design system. The screw-like tip or hole saw tip may be embedded in the gallstone and then forcibly retracted to fracture the stone. Several devices and methods for achieving this are described below with reference to Figures 91 to 97 More detailed explanation and description.

[0229] Once the gallstone is captured by the basket or cage 405 to 405K or other capture device, the inner catheter steering shaft (or member) 420, 420A, 420B or pull wire of the capture element can be locked in place to maintain the captured gallstone. In additional embodiments, the inner catheter steering shaft (or member) 420, 420A, 420B or pull wire can be retracted to apply tension and compression of the support 410 of the basket or cage 405 to 405K or other capture device to the gallstone. The inner catheter steering shaft (or member) 420, 420A, 420B or pull wire can continue to be retracted into the delivery system (if applicable) to continue to apply increasing compression force. The entire basket or cage 405 to 405K or other capture device can also be pulled into the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 independently or simultaneously to apply another compression or fracturing force. This may be done independently or in conjunction with the action of the inner catheter manipulation shaft (or member) 420, 420A, 420B or pull wire. Alternatively, both providing contraction and / or retraction of the basket or cage 405 to 405K or other capture device to the inner catheter manipulation shaft (or member) 420, 420A, 420B or pull wire in the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 may be performed, and the crushing or fracturing device 700 to 700S may be actuated to create a third method of forcibly fracturing the target gallstone or obstruction. In other embodiments, the inner catheter manipulation shaft (or member) 420, 420A, 420B or pull wire may be connected to the proximal end of the basket or cage 405 to 405K or other capture device, or it may be individually connected to the support 410 of the basket or cage 405 to 405K or other capture device. In other embodiments, the inner catheter steering shaft (or member) 420, 420A, 420B or pull wire on the proximal end may be the same integrated structure with the basket or cage 405-405K or other capture device of the catheter 400-400H, where the basket or cage 405-405K or other capture device of the catheter 400-400H is cut and expanded from a wire or tubular cavity extending to the proximal end.

[0230] In some embodiments, in addition to or separately from the applied force from the pulverizing or fracturing apparatus 700-700S mentioned above, the proximal end of the inner catheter steering shaft (or member) 420, 420A, 420B or the pull wire or strut 410 of the basket or cage 405-405K or other capture device can be connected to a retraction mechanism. This retraction mechanism can be pulled by using linear actuation, spring driven actuation, linear ratchet, rotary ratchet, lead screw, electric drive or manual and any other form of applying tension to a single wire or a group of wires to pull the inner catheter steering shaft (or member) 420, 420A, 420B or the pull wire or strut 410, which applies compression on the gallstone. Thus, the basket or cage 405-405K itself can compress, fracture and / or pulverize one or more gallstones. Additionally, the basket or cage 405-405K may be retracted into the outer catheter lumen 440, 440A, thereby also providing a contraction to compress, fracture and / or pulverize one or more gallstones.

[0231] In other embodiments, the inner catheter steering shaft (or member) 420, 420A or the pull wire or strut 410 may be constrained on a guide on the distal end of the catheter 400 to 400E or the distal end of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 to prevent the strut 410 from sliding to the side of the gallstone when compression is applied to the gallstone after it is captured. The strut 410 may be accommodated with a toothed / crown distal tip or a multi-lumen disc-like structure fixed to the catheter 400 to 400H.

[0232] In another embodiment, the distal portion of the basket or cage 405-405K or other capture device can be slightly opened to release the fractured gallstones. This single opening or multiple openings / apertures can be sized to be the same size or smaller than the aspiration lumen 165 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900.

[0233] Fig.321 is a side elevation view of a representative fifth embodiment of an access sheath 100B illustrating proximal fixed suction from a flexible self-expanding member 522. In some embodiments, the proximal hub 110, 110A may utilize a proximal hemostasis valve from the FlowTriever and ClotTriever product lines commercially available from Inari Medical, Inc. In other embodiments, the proximal hub 110, 110A may utilize a series of valves 120, 125. In other embodiments, the proximal hub 110, 110A may also provide a source or suction / vacuum for suction, such as through access ports 130, 130A, 135 or direct exhaust port 152. A vacuum source (e.g., a spherical flexible self-expanding member 522) may be coupled to the proximal hub 110, 110A, and the flexible self-expanding member 522 may be compressed by a user to reduce the internal volume of the flexible self-expanding member 522 and then released by the user to allow the flexible self-expanding member 522 to expand and create a vacuum with a suction / evacuation flow rate. This action can pull the gallstone out of the gallbladder. In addition, the flexible self-expanding member 522 and / or the proximal hub 110, 110A can contain a series of valves, such as first and second valves 120, 125. One valve can be located at the distal end of the flexible self-expanding member 522, within or near the shaft 105 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, and can restrict the fluid from being directed to flow outward and restrict the fluid from flowing inward unless a tool is passed through the valve to bypass it. In addition, a second valve can be included on the proximal side of the flexible self-expanding member 522, which allows the fluid to travel farther outward but restricts the inward flow. These two valve series will keep the fluid and stones from moving outward and unable to flow inward toward the gallbladder.

[0234] As described above with reference to FIGS. 30 and 30B and described in more detail below, various embodiments of catheters 400 to 400H (e.g., catheters 400F, 400G, 400H) include an outer catheter tube (or outer catheter member) 415B having an outer catheter lumen 440B. An inner catheter manipulation shaft (or member) 420B is coaxially (concentrically) disposed within the outer catheter lumen 440B and can be moved longitudinally (or longitudinally and rotatably) within the outer catheter lumen 440B (e.g., push-pull with or without rotation). The inner catheter manipulation shaft (or member) 420B has an inner catheter shaft lumen 435, as an option, for example (but not limited to), configured and sized for insertion of a crushing or fracturing device 700 to 700S. For example, when a gallstone is captured and secured within a basket or cage 405-405K (e.g., by retracting struts 410 around the gallstone and into the outer catheter lumen 440B), a pulverizing or fracturing instrument 700-700S may be inserted through the inner catheter shaft lumen 435 and used to fracture the gallstone. As described in more detail below, when the catheter 400F, 400G, 400H is inserted through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and positioned at a selected or desired location within the subject's gallbladder, after capturing the gallstone, the basket or cage 405 to 405K can be retracted around the gallstone, the pulverizing or fracturing instrument 700 to 700S can be inserted through the inner catheter shaft lumen 435 and positioned near or adjacent to the captured gallstone, and the pulverizing or fracturing instrument 700 to 700S can be actuated, causing the angled or pointed pulverizing or fracturing tip 710 to 710S to impact the gallstone captured in the catheter 400F, 400G, 400H to fracture the gallstone. This is particularly useful for gallstones or gallstone fragments that are larger than the inner lumen 165 of the access sheath 100, 100A, 200, 200A or the central lumen 555 of the access sheath 500, 500A, 600, 600A, 800, 900 (e.g., larger than about 8 mm). For example, but not limitation, the crushed gallstone or gallstone fragment can then be removed from the subject's gallbladder using the catheter 400F, 400G, 400H or by suction.

[0235] A variety of crushing or fracturing tools 700B to 700S with a variety of crushing or fracturing tip 710B to 710S geometries are provided. Figures 33 to 51 In the description. Fig.33 is a partial isometric view illustrating a representative third embodiment of a comminution or fracturing apparatus 700B. Fig.34is a partial side elevation view illustrating a representative third embodiment of a pulverizing or fracturing device 700B. The pulverizing or fracturing device 700B includes a pulverizing or fracturing tip 710B coupled to or integrally formed with a pulverizing or fracturing shaft 705. The pulverizing or fracturing shaft 705 may be partially or completely solid or hollow (e.g., a generally cylindrical tube), such as (but not limited to), for example, hollow at a distal end near a pulverizing or fracturing tip lumen 760 (and solid at a proximal end). The pulverizing or fracturing tip 710B includes a plurality of sharp points 735 having beveled and chamfered inner edges 740 (chamfered toward the pulverizing or fracturing tip lumen 760) to achieve significant sharpness and cutting or fracturing capabilities, wherein each sharp point 735 and at least two beveled and chamfered inner edges 740 form a pulverizing or fracturing spear 755, wherein Fig.33 and 34 The crushing or fracturing spears 755 illustrated in FIG. 7 are generally triangular in shape. The crushing or fracturing apparatus 700 to 700S may be configured to have any number or type of crushing or fracturing spears 755. Fig.34 In addition to the 60° illustrated in FIG. 7 , the angle (“α”) 750 between each of the crushing or fracturing spears 755 may vary, such as, for example but not limited to, 30° or 45°. Also by way of example but not limitation, in addition to Fig.33 and 34 The crushing or fracturing tip 710B may have any number of points 735 with beveled and chamfered inner edges 740 in addition to or less than the four points 735 and eight beveled and chamfered inner edges 740 illustrated in the drawings. Not separately illustrated, in addition to the crushing or fracturing tip lumen 760, the crushing or fracturing spears 755 of the crushing or fracturing device 700B may each have an opening, protrusion or notch 745 ( Fig.35 and 35 ), providing an aperture to clear any debris or debris accumulation, such as for suction. The pulverizing or fracturing device 700A-700S may be of any size (length and diameter) suitable for insertion through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and into the gallbladder of a subject or suitable for coaxial insertion within the shaft 835, 935 of the pulverizing or fracturing control device 850, 950 and then inserted together through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and into the gallbladder of a subject.

[0236] Fig.35 is a partial isometric view illustrating a representative fourth embodiment of a comminution or fracturing apparatus 700C. Fig.36is a partial plan view illustrating a representative fourth embodiment of a pulverizing or fracturing device 700C. The pulverizing or fracturing device 700C includes a pulverizing or fracturing tip 710C coupled to or integrally formed with a pulverizing or fracturing shaft 705. The pulverizing or fracturing shaft 705 may also be partially or completely solid or hollow (e.g., a generally cylindrical tube), such as (but not limited to), for example, hollow at the distal end near the pulverizing or fracturing tip lumen 760 (and solid at the proximal end). The pulverizing or fracturing tip 710C includes a plurality of sharp points 735A having beveled edges 740A, also for achieving significant sharpness and cutting or fracturing capabilities, wherein each sharp point 735A and at least two beveled edges 740A form a pulverizing or fracturing spear 755A, wherein Fig.35 and 36 The pulverizing or fracturing spear 755 illustrated in FIG. 700C is also generally triangular in shape. Optionally, the bevel edge 740A may also be chamfered. In addition to the pulverizing or fracturing tip lumen 760, the pulverizing or fracturing spear 755A of the pulverizing or fracturing device 700C further each have an opening, protrusion or cutout 745, providing an aperture to clear any debris or debris accumulation, such as for suction.

[0237] Fig.37 is a partial isometric view illustrating a representative fifth embodiment of a comminution or fracturing apparatus 700D. Fig.38 is a partial plan view illustrating a representative fifth embodiment of a pulverizing or fracturing device 700D. The pulverizing or fracturing device 700D includes a pulverizing or fracturing tip 710D coupled to or integrally formed with a pulverizing or fracturing shaft 705. The pulverizing or fracturing shaft 705 may also be partially or completely solid or hollow (e.g., a generally cylindrical tube), such as (but not limited to), for example, hollow at the distal end near the pulverizing or fracturing tip lumen 760 (and solid at the proximal end). The pulverizing or fracturing tip 710D includes a plurality of sharp points 735B having curved bevels and chamfered edges 740B, also for achieving significant sharpness and cutting or fracturing capabilities, wherein Fig.37 and 38 The pulverizing or fracturing spears 755B illustrated in FIG. 700D are generally semicircular in shape. Not separately illustrated, in addition to the pulverizing or fracturing tip lumen 760, the pulverizing or fracturing spears 755B of the pulverizing or fracturing device 700D may each have an opening, protrusion or cutout 745 providing an aperture to clear any debris or debris accumulation, such as for suction.

[0238] The additional crushing or fracturing tips 710E to 710S have geometric shapes that are different from those of the corresponding sixth to eighteenth embodiments for crushing or fracturing devices 700E to 700S. Figures 39 to 51. Each of the crushing or fracturing devices 700E to 700S also includes a corresponding crushing or fracturing tip 710E to 710S coupled to or integrally formed with the crushing or fracturing shaft 705. The crushing or fracturing device 700E includes a corresponding crushing or fracturing tip 710E having a first narrow bullet configuration (e.g., a 50° tip angle), the crushing or fracturing device 700F includes a corresponding crushing or fracturing tip 710F having a second wide bullet configuration (e.g., a 60° tip angle), and the crushing or fracturing device 700G includes a corresponding crushing or fracturing tip 710G having a third wider bullet configuration (e.g., a 90° tip angle). The crushing or fracturing device 700H includes a corresponding crushing or fracturing tip 710H having a spherical or "button" configuration. The crushing or fracturing device 700J includes a corresponding crushing or fracturing tip 710J having a concave three-tip configuration. The pulverizing or fracturing device 700K includes a corresponding pulverizing or fracturing tip 710K having a concave spear configuration. The pulverizing or fracturing device 700L includes a corresponding pulverizing or fracturing tip 710L having a drill core configuration. The pulverizing or fracturing device 700M includes a corresponding pulverizing or fracturing tip 710M having a slot configuration. The pulverizing or fracturing device 700N includes a corresponding pulverizing or fracturing tip 710N having a hollow configuration. The crushing or fracturing device 700P includes a corresponding crushing or fracturing tip 710P having a first narrow spear configuration (e.g., a 30° tip angle), the crushing or fracturing device 700Q includes a corresponding crushing or fracturing tip 710Q having a second slightly wider spear configuration (e.g., a 45° tip angle), and the crushing or fracturing device 700R includes a corresponding crushing or fracturing tip 710R having a third wider spear configuration (e.g., a 60° tip angle), and at the same time the crushing or fracturing device 700S includes a corresponding crushing or fracturing tip 710S having a fourth wider spear configuration (e.g., a 90° tip angle).

[0239] Fig.52 is a partial isometric view of a representative eighth embodiment of a catheter 400G apparatus illustrating the eighth embodiment having a basket or cage 405G. Fig.53 is a cross-sectional view (through the catheter shaft 415B and the catheter shaft lumens 400B, 435) illustrating a representative eighth embodiment of the catheter 400G device. Fig.52 F-F' plane). Fig.54 is a partial isometric view illustrating a representative ninth embodiment of a catheter apparatus 400H having a ninth embodiment of a basket or cage 405H and illustrating a comminuting or fracturing tip 710D of a comminuting or fracturing device 700D. Fig.54 Also described is a capture and fracturing system 402 (for capturing and fracturing or pulverizing gallstones) comprising a catheter apparatus 400G, 400H and a pulverizing or fracturing device 700 to 700S that is longitudinally and rotationally movable within the catheter 400G, 400H. Fig.55is a partial isometric view of a representative ninth embodiment illustrating a partially retracted ninth embodiment catheter apparatus 400H having a basket or cage 405H. Fig.56 is an isometric view illustrating a representative tenth embodiment of a basket or cage 405J. Fig.57 is an isometric view illustrating a representative eleventh embodiment of a basket or cage 405K. The catheter apparatus (or catheter) 400G, 400H are functionally identical to one another and differ only in the shape (or configuration) of the cage or basket 405G, 405H, 405J, 405K used with the catheter 400G, 400H. Additionally, the cage or basket 405G, 405H, 405J, 405K are functionally identical to one another and differ only in the shape or configuration and number of struts 410 of the cage or basket 405G, 405H, 405J, 405K and also utilize an end cap 485 at the distal end 480 such that any of the cage or basket 405G, 405H, 405J, 405K may be used interchangeably within or as a portion of the catheter 400G, 400H. Reference Fig.52 , the cage or basket 405G has a generally elliptical or oval shape (or configuration). Fig.55 , the cage or basket 405G has a generally cylindrical shape (or configuration) in the center and has a conical shape at the distal and proximal ends. Fig.56 , the cage or basket 405J has a generally pumpkin shape (or configuration) at the center, a generally cylindrical shape (or configuration), and wherein the struts 410 bend into an S-shape at the distal and proximal ends. In addition, the cage or basket 405J has an atraumatic molded end cap 485 coupled to the strut ring 482 at the distal end 480. Reference Fig.57 , the cage or basket 405K has a generally spherical shape (or configuration), being wider at the distal end and narrower at the proximal end.

[0240] refer to Figures 52 to 57, a representative embodiment of the catheter device (or catheter) 400G, 400H includes an outer catheter tube (or outer catheter member) 415B having an outer catheter lumen 440B. An inner catheter steering shaft (or member) 420B is coaxially (concentrically) arranged within the outer catheter lumen 440B and can be longitudinally (or longitudinally and rotatably) moved (e.g., pushed and pulled with or without rotation) within the outer catheter lumen 440B. The inner catheter steering shaft (or member) 420B has an inner catheter shaft lumen 435, as an option, for example (but not limited to), configured and sized for insertion of a crushing or fracturing device 700A to 700S. The support 410 of the cage or basket 405G, 405H, 405J, 405K is coupled (e.g. (for example (but not limited to) by an adhesive, glue or cement) to the outer periphery 484 of the inner catheter steering shaft 420B and is not coupled to the outer catheter tube (or outer catheter member) 415B. When the catheter 400G, 400H is inserted through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, the cage or basket 405G, 405H, 405J, 405K is retracted and compressed within the outer catheter lumen 440B. When the catheter 400G, 400H is positioned at a selected or desired location within the gallbladder of a subject, the inner catheter steering shaft (or member) 420B is extended (distal moved) relative to the outer catheter tube (or outer catheter member) 415B (or equivalently, the outer catheter tube (or outer catheter member) 415B is retracted), thereby causing the inner catheter steering shaft (or member) 420B to extend through the outer catheter lumen 440B and the cage or basket 405G, 405H, 405J, 405K to be unsheathed, exposed from the outer catheter tube (or outer catheter member) 415B and expanded, as shown. Fig.52 , 54 Please refer to 57 for details.

[0241] The cage or basket 405G, 405H, 405J, 405K includes a plurality of struts 410, wherein the plurality of struts 410 are arranged longitudinally and in a non-grid cross pattern. The plurality of struts 410 of the cage or basket 405G, 405H, 405J, 405K have relatively large pores or openings 450 along the length (longitudinally oriented) of the cage or basket 405G, 405H, 405J, 405K. The plurality of struts 410 of the cage or basket 405G, 405H, 405J, 405K are coupled to or integrally formed with a strut ring 482 at a distal end 480 and are coupled to an outer periphery 484 of the inner catheter steering shaft 420B at a proximal end 486 of the struts 410 (at a distal end 488 of the inner catheter steering shaft 420B, as illustrated). As described above, the plurality of struts 410 of the cages or baskets 405G, 405H, 405J, 405K may be composed of any suitable material, such as Nitinol or other metal or metal alloy, carbon fiber, or any of a variety of suitable polymers.

[0242] The cages or baskets 405G, 405H, 405J, 405K can be manufactured as known or become known in the catheter art. In a representative embodiment, not separately illustrated, the cages or baskets 405G, 405H, 405J, 405K are laser cut from Nitinol tubing having an outer diameter in a range from 3.0 mm to 8 mm (and more particularly from 5.0 mm to 7.0 mm, and more particularly having an outer diameter of 6.0 mm), wherein the tubing has a wall thickness in a range from 0.22 mm to 0.5 mm, and more particularly from 0.22 mm to 0.4 mm, and more particularly having a tubing wall thickness of 0.22 mm. In representative embodiments, for example, but not limitation, the number of struts 410 of the laser cut baskets or cages 405G, 405H, 405J, 405K can range from eight to sixteen struts 410, and more particularly from eight to twelve struts 410, and more particularly ten struts 410. In representative embodiments, the length of the laser cut struts (before shaping) ranges from 2.2 inches to 4.1 inches (55 mm to 104 mm) for use with 25 mm to 50 mm heat set mandrels, respectively. In representative embodiments, for example, but not limitation, the width (or diameter) of each strut 410 of the cages or baskets 405G, 405H, 405J, 405K can range from 0.25 mm to 1.0 mm, and more particularly from 0.25 mm to 0.7 mm, and more particularly have a strut 410 width or diameter of 0.5 mm. The laser cut tube is then shaped and / or stretched using a heat set mandrel and electropolishing as is known in the art. In representative embodiments, for example and without limitation, the shape setting diameter of the cage or basket 405G, 405H, 405J, 405K can range from 10.0 mm to 60.0 mm, and more particularly from 20.0 mm to 50.0 mm, and more particularly from 25.0 mm to 40.0 mm, and more particularly having a diameter of the cage or basket 405G, 405H, 405J, 405K of 25.0 mm. In representative embodiments, for example and without limitation, the resulting cage or basket 405G, 405H, 405J, 405K has gaps 450 between struts 410, with a gap width 478 of from 10.0 to 15.0 mm when fully expanded (unconstrained). In a representative embodiment, also for example (but not limitation), the resulting cage or basket 405G, 405H, 405J, 405K has an overall length with a gap width 478 of from 10.0 to 15.0 mm when fully expanded (unconstrained).

[0243] As illustrated, the cages or baskets 405G, 405H, 405J, 405K can be expanded or contracted by longitudinally moving the inner catheter steering shaft (or member) 420B within the outer catheter lumen 440B relative to the outer catheter tube or member 415B (or vice versa). For example, when the inner catheter steering shaft 420B is extended (moved distally), the distal end 480 of the cage or basket 405G, 405H, 405J, 405K moves to a position farthest or most distal from the outer catheter tube or member 415B, the shape of the cage or basket 405G becomes more elongated (e.g., fusiform or spindle-shaped) and the diameter of the cage or basket 405G is enlarged or expanded for capturing any gallstones or gallstone fragments, and the diameter of the cage or basket 405H, 405J, 405K is similarly expanded when the inner catheter steering shaft 420B is extended (moved distally relative to the outer catheter tube or member 415B). When the basket or cage 405G, 405H, 405J, 405K is pressed against a gallstone, the struts 410 deflect to allow the stone to squeeze through the strut gaps 450 and then return to their original configuration, thereby capturing the stone within the basket or cage 405G, 405H, 405J, 405K. As the outer catheter tube or member 415B is advanced or equivalently the inner catheter steering shaft 420B is retracted into the outer catheter tube or member 415B, the distal ends 480 of the cages or baskets 405G, 405H, 405J, 405K move to a position closer to the outer catheter tube or member 415B, the struts 410 of the cages or baskets 405G, 405H, 405J, 405K are retracted along with the inner catheter steering shaft 420B into the outer catheter lumen 440B of the outer catheter tube or member 415B, the remaining length 476 of the cages or baskets 405G, 405H, 405J, 405K is shortened and the baskets or cages 405G, 405H, 405J, 405K are contracted around any captured gallstones or gallstone fragments, such as Fig. 30B In the description.

[0244] Fig. 30A and 30B The operation and function of the catheter device 400F described in is similar to the catheter devices 400G, 400H. As described, the gallstone 411 can be captured through the gap in the cage or basket 405F. The inner catheter steering shaft 420, 420A is retracted into the outer catheter tube or member 415B, the distal end of the cage or basket 405F is moved to a position closer to the outer catheter tube or member 415B, the support 410 of the cage or basket 405F is retracted along with the inner catheter steering shaft 420, 420A into the outer catheter lumen 440, 440A of the outer catheter tube or member 415B, and the basket or cage 405F is contracted around any captured gallstone 411 or gallstone fragments. The pulverizing or fracturing instrument 700 to 700S can then be advanced into the gallstone 411 or gallstone fragment to create fracturing or pulverization, such as Fig. 30BThe catheter device 400F is different in that the crushing or fracturing device 700 to 700S can be inserted into the outer catheter lumen 440, 440A of the outer catheter tube or member 415B parallel to (rather than coaxially or concentrically with) the inner catheter operating shaft 420, 420A, such as Fig. 30A , 30B In the description.

[0245] Depending on whether the catheter device 400F, 400G, 400H is implemented as flexible or rigid (hard), the catheter device 400F, 400G, 400H can be inserted through the access port 130, 130A, 135, 620 of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 or inserted in a straight row directly through the lumen 165, 555 of the tubular shaft 105, 505, 505A of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, for example, in a straight row directly through the tubular shaft 505, 505A ( Fig.81 405J, 405K). Once the cage or basket 405F, 405G, 405H, 405J, 405K is inflated inside the gallbladder, the cage or basket 405F, 405G, 405H, 405J, 405K may be manipulated (rotated, advanced, retracted, expanded, etc.) to capture gallstones within the plurality of struts 410 of the cage or basket 405G, 405H, 405J, 405K. The user may then tighten (contract) the cage or basket 405F, 405G, 405H, 405J, 405K around the gallstone for removal, fracturing, or comminution. For gallstones or gallstone fragments having a size that is smaller than the inner diameter of the lumen 165 of the access sheath 100, 100A, 200, 200A or the central lumen 555 of the access sheath 500, 500A, 600, 600A, 800, 900, the catheter device 400F, 400G, 400H with the captured gallstone or gallstone fragment can be removed from the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. When the cage or basket 405F, 405G, 405H, 405J, 405K is collapsed, as described above and as described in more detail below, the captured gallstones can also be fractured or pulverized, thereby reducing the size of the gallstone mass to facilitate removal.

[0246] In a representative embodiment, for example (but not limited to), the inner catheter manipulation shaft 420B is hollow and has an inner catheter shaft lumen 435, which is useful for inserting any of the various crushing or fracturing instruments 700 to 700S, particularly the crushing or fracturing instruments 700A to 700S. For example, when a gallstone is captured, the crushing or fracturing instrument 700 to 700S can be inserted through the inner catheter shaft lumen 435 and used to fracture the gallstone. Also for example, as described above, when the catheter 400G, 400H is inserted through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and positioned at a selected or desired location within the subject's gallbladder, after capturing the gallstone, the basket or cage 405G, 405H, 405J, 405K can be retracted around the gallstone, the crushing or fracturing instrument 700 to 700S can be inserted through the inner catheter shaft lumen 435 and positioned near or adjacent to the captured gallstone, and the crushing or fracturing instrument 700 to 700S can be actuated, causing the angled or pointed crushing or fracturing tip 710 to 710S to impact the gallstone captured in the cage or basket 405G, 405H, 405J, 405K to fracture the gallstone. For example, but not limited to, the crushed gallstones or gallstone fragments may then be removed from the subject's gallbladder using catheters 400G, 400H or by suction. The pulverizing or crushing devices 700-700S may also be used with other catheters 400-400F having other cages or baskets 405-405F, including cages or baskets without an inner catheter shaft lumen 435, as described above for catheter device 400F.

[0247] In a representative embodiment, for example (but not limited to), the basket or cage 405G, 405H, 405J, 405K has an outer diameter in the range of 25 to 50 mm in the unsheathed expanded state. In addition, in a representative embodiment, for example (but not limited to), the outer catheter tube (or outer catheter member) 415B has a length in the range of 30 cm, an outer diameter in the range of 8.5 mm, and an inner diameter in the range of 6.2 mm. In addition, in a representative embodiment, for example (but not limited to), the inner catheter steering shaft 420B has a length in the range of 41 cm. When used in conjunction with the catheter 400G, 400H, the crushing or fracturing device 700 to 700S is configured and sized accordingly. In a representative embodiment, for example (but not limited to), the crushing or fracturing device 700 to 700S has a shaft 705 with an outer diameter in the range of 5.6 mm and a length in the range of 55.9 cm, wherein the crushing or fracturing device 700 to 700S has an overall length in the range of 73.2 cm. In another representative embodiment, for example (but not limited to), the crushing or fracturing device 700 to 700S has an outer diameter in the range of from 0.156 inches to 0.167 inches (mm to 5.6 mm) and if hollow then an inner diameter in the range of 0.097 inches to 0.116 inches (3.96 mm to 4.24 mm) and if partially hollow (at the distal end) then extending 0.3 inches (7.62 mm) from the distal end of the shaft 705, wherein the crushing or fracturing device 700 to 700S has an overall length in the range of 21 inches (53.4 cm).

[0248] Fig.58 is an isometric partially exploded view of a representative seventh embodiment of a system 300F illustrating any of the representative fifth and sixth embodiments of an access sheath 500, 500A and the representative embodiments of aspiration devices 250 to 250D. Fig.59 are partial isometric and cross-sectional views illustrating a representative seventh embodiment of a system 300F having any of the representative fifth and sixth embodiments of an access sheath 500, 500A and representative embodiments of aspiration devices 250-250D. Fig.60 is a first cross-sectional view (through the first tubular shaft 505 of the fifth embodiment of the access sheath 500 of the representative seventh embodiment of the system 300F) Fig.58 E-E' plane). Fig.61 is a second cross-sectional view (through the second tubular shaft 505A of the representative sixth embodiment of the access sheath 500A) illustrating the representative seventh embodiment of the system. Fig.58 E-E' plane). Fig.62 is a partial cross-sectional view (through the proximal hub 510, 610 of the corresponding access sheath 500, 500A, 600, 600A of the representative system 300F, 300G) Fig.58 and 70D-D' plane). Fig.63 is a partial cross-sectional view (through the lateral view) of representative access sheaths 500, 500A, 600, 600A of representative systems 300F, 300G of additional representative catheter embodiments 400 to 400H. Fig.58 and 70 D-D' plane).

[0249] Fig.64 is a side elevation view illustrating a representative first embodiment of an access sheath tip 530A. Fig.65 is a side elevation view illustrating a representative second embodiment of an access sheath tip 530B. Fig.66 is an isometric cross-sectional view illustrating a representative third embodiment of an access sheath tip 530C. Fig.67 is an isometric cross-sectional view illustrating a representative fourth embodiment of an access sheath tip 530D. Fig.68 is an isometric view illustrating a representative fifth embodiment of an access sheath tip 530E and an inflatable sealing and anchoring balloon 560 of any of the various embodiments of an access sheath 500 , 500A, 600 , 600A, 800 , 900 . Fig.69 is an isometric cross-sectional view illustrating a representative sixth embodiment of the access sheath tip 530F of the second tubular shaft 505A of the representative access sheath 500A, 600A, 800.

[0250] Fig.70 is an isometric view illustrating a representative eighth embodiment of the system 300G having seventh and eighth embodiments of the access sheaths 600 , 600A and a first embodiment of the dual aspiration and infusion assembly 650 . Fig.71 is a partial isometric view illustrating a representative proximal hub 610 of a representative eighth system 300G embodiment of the seventh and eighth embodiments having access sheaths 600, 600A. Fig.72 is a diagram illustrating fluid flow in a representative gallbladder 590 using the seventh and / or eighth system 300F, 300G embodiments. Fig.73 is an isometric view illustrating a representative second embodiment of a dual aspiration and infusion assembly 675 that may be used as part of a representative eighth system 300G embodiment.

[0251] refer to Figures 58 to 73, the gallstone removal system 300F includes several components, including an access sheath 500, 500A and any suction device 250 to 250D, and the gallstone removal system 300G includes several components, including an access sheath 600, 600A and a dual suction and infusion assembly 650, 675. Each of the systems 300F, 300G may further include a catheter 400 to 400H. More specifically, in a representative embodiment, the system 300F includes an access sheath 500, 500A coupled to the suction device 250 to 250D via a proximal hub 510, such as Fig.58 and 59 Also more specifically, in a representative embodiment, the system 300G includes an access sheath 600, 600A coupled to a dual aspiration and infusion assembly 650, 675 via a proximal hub 610, such as Fig.70 , 71 As with the various systems described above, the systems 300F, 300G may further include catheters 400 to 400H, such as Fig.63 , arranged through one or more access ports 130A. Except for the differences described in more detail below, the functions of systems 300F, 300G are similar to the other systems 300-300E described above. The notable differences of systems 300F, 300G are the inclusion of a plurality of separate infusion and aspiration channels 540, 574, respectively, the inclusion of a filter assembly 515 as part of the aspiration channel 574 in the proximal hub 510, 610, and the optional inclusion of a sealing and anchoring balloon 560, which further utilizes a separate inflation lumen 565. The sealing and anchoring balloon 560 can be composed of any suitable expandable material, such as, for example but not limited to, medical / surgical grade Pebax or nylon.

[0252] Access sheath 500 differs from access sheath 500A only in that access sheath 500 includes tubular shaft 505, while access sheath 500A includes tubular shaft 505A instead. Access sheath 600 differs from access sheath 600A only in that access sheath 600 includes tubular shaft 505, while access sheath 600A includes tubular shaft 505A instead. Tubular shafts 505, 505A differ from each other in configuration with respect to peripheral lumen 550 and inflation lumen 565, and function the same as each other in other respects. Unless the context indicates otherwise, reference to any access sheath 500, 500A, 600, 600A will be understood to mean and include any of access sheaths 500, 500A, 600, 600A.

[0253] The access sheath 500 (or 500A) includes a cylindrical hollow tubular shaft or member 505 (or 505A) coupled to a proximal hub 510. The access sheath 600 (or 600A) includes a cylindrical hollow tubular shaft or member 505 (or 505A) coupled to a proximal hub 610. The tubular shaft 505, 505A is composed of a first outer shaft wall 562 and a second inner shaft wall 564, which together form a plurality of separate internal lumens: a central lumen 555, which is arranged inside or at the center of the second inner shaft wall 564, as illustrated; and one or more peripheral lumens 550, which are arranged between the first outer shaft wall 562 and the second inner shaft wall 564 (and arranged at the periphery of the central lumen 555, and may also be further spaced around the periphery of the tubular shaft 505, as illustrated); Fig.60 562 and the second inner axial wall 564 and is further disposed at the periphery of the central lumen 555. The central lumen 555 extends from the proximal hub 510 and passes through the sheath tip 530A to 530F at the distal end 140A of the access sheath 500, 500A, 600, 600A. Each peripheral lumen 550 extends from the proximal hub 510 to a corresponding infusion port 535, wherein the corresponding one or more infusion ports 535 are spaced apart in the sheath tip 530A to 530F and are further spaced proximally from the distal end 140A of the access sheath 500, 500A, 600, 600A. Due to this novel structure, the infusion fluid exits the tubular shaft 505, 505A of the access sheath 500, 500A, 600, 600A (via the peripheral lumen 550 and the infusion port 535) radially (504) from the outer periphery of the access sheath 500, 500A, 600, 600A, i.e., generally normal or perpendicular to the longitudinal dimension (502) of the access sheath 500, 500A, 600, 600A. In a representative embodiment, for example (but not limitation), the access sheath 500, 500A, 600, 600A may be 15 cm (150 mm) in length, wherein the central lumen 555 has an inner diameter of 8 to 10 mm (24 to 30 Fr), wherein the tubular shaft 505 comprises stainless steel.

[0254] like Fig.60 , the tubular shaft 505 includes a gas filling lumen 565 between a first outer shaft wall 562 and a second inner shaft wall 564 and a plurality of peripheral lumens 550, wherein each peripheral lumen 550 extends to a separate corresponding infusion port 535. The access sheaths 500A, 600A are different from the access sheaths 500, 500A, 600, 600A because the tubular shaft 505A includes a gas filling lumen 565 between a first outer shaft wall 562 and a second inner shaft wall 564 and a single large peripheral lumen 550, as shown in FIG. Fig.61 , wherein a single peripheral lumen 550 extends to multiple infusion ports 535. Fig.69 , the access sheath tip 530F includes a plurality of tabs 538 extending between a first outer axial wall 562 and a second inner axial wall 564, wherein a plurality of infusion ports 535 are peripherally spaced between the plurality of tabs 538, also providing for infusion fluid to radially (504) exit the tubular shaft 505A of the access sheath 500A, 600A from the peripheral edge of the access sheath 500A, 600A (via the peripheral lumen 550 and the infusion ports 535). Aside from these specific structural differences, the tubular shafts 505, 505A function identically to one another for infusion, inflation, and aspiration.

[0255] As previously described, the distal portion of the tubular shaft 505 of the access sheath 500, 500A, 600, 600A can be inserted into the gallbladder 590 ( Fig.72 ) for removing one or more gallstones and gallstone fragments. Central lumen 555 forms part of aspiration passage 574, as described in more detail below, for aspirating fluid, gallstones, and gallstone fragments from the subject's gallbladder through central lumen 555 and into filter assembly 515 of proximal hub 510. Peripheral lumen 550 forms part of infusion passage 540, also described in more detail below, for radially (504) infusing fluid into the subject's gallbladder (590).

[0256] In a representative embodiment, the proximal hub 510 includes: a shell 576 having multiple hub tube cavities 570, 575, 585, and a first port 577; a filter assembly 515 having a filter cavity 578; multiple valves 120B, 120C, 125A, 125B, which are coupled within the shell 576 and coupled to the shell 576; an infusion tube 545 (coupled to the first port 577 and connected to the fluid of the peripheral tube cavity 550) and multiple mating couplings 150E and 155E, 150F and 155F and a coupling 150D, and the coupling 150D is used to cooperate with the coupling 155D of the suction device 250, 250A, 250B, 250C or 250D. The mating couplings 150D and 155D removably couple the (first) suction device 250, 250A, 250B, 250C or 250D to the proximal hub 510. The mating couplings 150E and 155E connect the infusion tubing 545 to the hub lumen 570 via the first port 577, which in turn is in fluid communication with the peripheral lumen 550. The mating couplings 150F and 155F connect the tubular shaft 505 to the proximal hub 510. The valves 120B, 120C, 125A, 125B are typically each a one-way valve, such as a stopcock or a pressure lysis valve ( Fig.71610), each of which may be implemented as previously described. In addition, the mating couplings 150D and 155D, 150E and 155E, 150F and 155F may each be implemented as previously described, such as quick-connect fittings, screw threads, snap-on fittings, etc. It should also be noted that the coupling 150E may be incorporated into the first port 577 or be a part of the first port 577.

[0257] The filter assembly 515 includes a filter 520 that forms a filter cavity 578 and a filter tank 525 that can be removably coupled to the housing 576, for example by mating screw threads 579A, 579B, wherein the filter tank 525 surrounds the filter 520 and forms a filter tank lumen 580 around the outside of the filter 520, that is, the filter tank lumen 580 is on the side of the filter opposite to the filter cavity 578.

[0258] The hub lumen 570 is disposed between the infusion tubing 545 and the peripheral lumen 550. The valve 120C is disposed between the central lumen 555 of the tubular shaft 505 and the hub lumen 575. The hub lumen 575 is disposed between the valve 120C and the filter 520 as part of the filter assembly 515. The filter lumen 578 is an internal portion of the filter 520 and is in fluid communication with the hub lumen 575, thereby forming a space within the filter 520 for filtering out and capturing any aspirated gallstones or gallstone fragments. The canister lumen 580 is within the canister 525, on the side of the filter 520 opposite the filter lumen 578. The one-way valve 125A separates the canister lumen 580 from the hub lumen 585 and is used to prevent the injected infusion fluid from entering the canister lumen 580 and the rest of the aspiration channel 574.

[0259] The proximal hub 610 includes the components and structures of the proximal hub 510 described above, and further includes: additional couplings, such as a first suction device 2501, 250A1, 250B1, 250C1 or 250D1 for connecting to the dual suction and infusion assembly 650, 675 and also connected to a second suction device 2502, 250A2, 250B2, 250C2 or 250D2; additional valves for directing fluid flow within the proximal hub 610; and additional tubing, as described in more detail below.

[0260] In various embodiments, the proximal hub 510, 610 may also include an access port 130A having a valve 295, 295A, for example, for inserting a catheter 400-400H, as described in more detail below. Additionally, in various embodiments, when the optional sealing and anchoring balloon 560 is included in the system 300F, 300G, the proximal hub 510 (610) may also include an inflation access port 620 in fluid communication with a separate inflation lumen 565 to infuse or aspirate fluid (e.g., saline) to inflate and deflate the sealing and anchoring balloon 560, respectively.

[0261] When the system 300F, 300G is in operation, fluid is typically infused into the subject's gallbladder to create some turbulence to agitate any gallstones or gallstone fragments for aspiration, as described in more detail below. To infuse fluid in the infusion channel 540, fluid from the aspiration device 250, 250A, 250B, 250C, 250D of the system 300F or the first aspiration device 2501, 250A1, 250B1, 250C1, or 250D1 of the system 300G is injected through the hub lumen 585 (using the plunger 265 of the aspiration device 250, 250A, 250B, 250C, 250D or the first aspiration device 2501, 250A1, 250B1, 250C1, or 250D1) and through the one-way valve 125B and into the infusion tubing 545, 545A. The fluid from the infusion tubing 545 in turn flows through the valve 120B (e.g., the pressure rupture valve 610) and into the hub lumen 570, which is in fluid communication with each of the peripheral lumens 550. The infusion fluid then flows through each of the peripheral lumens 550 and radially outward through each of the corresponding infusion ports 535, as mentioned above.

[0262] The filter assembly 515 of the proximal hub 510, 610 forms part of the suction channel 574. The filter assembly 515 includes a filter 520 disposed within a filter canister 525. The filter 520 can be composed of any suitable material and typically has a sufficiently fine mesh to prevent gallstones or gallstone fragments from passing through the filter 520. Both the filter 520 and the filter canister 525 can typically be removably coupled to the housing 576, for example, for emptying any gallstones or gallstone fragments from the filter assembly 515. Any fluid, gallstones, and gallstone fragments aspirated from the subject's gallbladder through the central lumen 555 pass through the valve 120C, typically implemented as a pressure lysis valve 610, and enter the hub lumen 575 and the filter cavity 578 formed by the filter 520. Any aspirated gallstones or gallstone fragments remain in the filter cavity 578 and do not pass through the filter 520, and are further prevented from returning to the central lumen 555 by the valve 120C. Any remaining fluid flows through the filter 520 and into the filter tank lumen 580, then through the (one-way) valve 125A into the hub lumen 585 and into the suction device 250, 250A, 250B, 250C, 250D of system 300F or the second suction device 2502, 250A2, 250B2, 250C2 or 250D2 of system 300G.

[0263] like Fig.63, any of the various catheters 400-400H and / or pulverizing or fracturing devices 700-700S may also be used with the access sheaths 500, 500A, 600, 600A of the system 300F. The catheters 400-400H may be inserted through the valves 295, 295A and into the catheter access port 130A, through the central lumen 555 and into the subject's gallbladder from the distal end 140A of the access sheath 500. Alternatively, the catheters 400-400H or pulverizing or fracturing devices 700-700S may be inserted through the hub lumens 585, 575 and through the central lumen 555 in a straight row (linear alignment) (e.g. Fig.81 ). Any gallstone capture, pulverization, and removal may then be performed using catheters 400 to 400H and / or pulverization or fracturing devices 700 to 700S, including in combination with infusion and aspiration described above and further described below. In the event that gallstones and / or gallstone fragments may be larger than the inner diameter of central lumen 555, using catheters 400 to 400H and / or pulverization or fracturing devices 700 to 700S, gallstones and / or gallstone fragments may be captured and pulverized prior to aspiration, and then the resulting relatively smaller gallstones and / or gallstone fragments may then be aspirated through central lumen 555 and aspiration channel 574, as described above.

[0264] Any of the various catheters 400-400H and / or pulverizing or fracturing devices 700-700S may be used with the systems 300F, 300G. In a representative embodiment, the pulverizing or fracturing devices 700-700S are used with the catheters 400G, 400H. Additionally, as an option, the catheters 400-400E used may also have appropriate proximal fluid connections that are also compatible with the systems 300F, 300G to perform aspiration through the catheters 400-400E (when the catheters 400-400E are implemented with a hollow shaft, as described above), while still infusing or flushing through the peripheral lumen 550, as described above.

[0265] Targeting and positioning the device in order to successfully perform a gallstone removal procedure can be difficult. The systems 300F, 300G address this problem by turbulently infusing the gallbladder, which tends to move any gallstones or gallstone fragments toward the distal end 140A of the access sheath 500, 500A, 600, 600A for aspiration into the central lumen 555. Additionally, given the ductility of the gallbladder as a structure, this fluid infusion also serves to help prevent its collapse, which is also a distinct advantage of the systems 300F, 300G.

[0266] remove Fig.58 and 59In addition to the single suction device 250, 250A, 250B, 250C, 250D described in the description, the infusion source can also be a dual syringe (for example, the first suction device 2501, 250A1, 250B1, 250C1 or 250D1 and the second suction device 2502, 250A2, 250B2, 250C2 or 250D2 of the system 300G, which will be referred to below) Fig.70 and 71 The infusion source and filter assembly 515 may be disconnected from the access sheath 500, 500A, 600, 600A during portions of the procedure when stone removal is not being performed (e.g., initial access or stone crushing sequences). Additionally, the in-line filter 520 may have a removable filter canister 525 so that stones may be extracted from the system 300F, 300G and then the filter assembly 515 reassembled for additional use. The check valves 125A, 125B direct flow so that aspiration is performed through the larger central lumen 555 and infusion is performed through the smaller peripheral lumen 550.

[0267] One aspect of the mechanism for removing gallstones or gallstone fragments is driven by the multi-lumen access sheath tips 530A to 530F. Figures 64 to 69 , illustrating various access sheath tips 530A to 530F, any of which may be used in any of the various systems 300F, 300G and any and all of which are considered equivalent and within the scope of the present disclosure. Fig.64 In the access sheath tip 530A illustrated in FIG. 5 , the inner wall 564 has a convex taper (i.e., a convex inner diameter) toward the distal end 140A of the access sheath 500. Fig.65 The access sheath tip 530B illustrated in FIG. 5 is tapered or beveled toward the distal end 140A of the access sheath 500 , having a double bevel while maintaining a substantially constant inner diameter of the central lumen 555 . Fig.66 , the access sheath tip 530C is also tapered or beveled toward the distal end 140A of the access sheath 500 while maintaining a substantially constant inner diameter of the central lumen 555 and a constant outer diameter of the tubular shaft 505 (and additionally having the removable inner wall 564). Fig.67 The access sheath tip 530D illustrated in FIG. 5 is also tapered or beveled toward the distal end 140A of the access sheath 500 while maintaining a substantially constant inner diameter of the central lumen 555 and a constant outer diameter of the tubular shaft 505. Fig.68 , the access sheath tip 530E is also tapered or beveled toward the distal end 140A of the access sheath 500, but is shown as having a square or rectangular configuration rather than a circular or cylindrical shape. Fig.69500, as described above, the access sheath tip 530F includes a plurality of tabs 538 extending between the first outer axial wall 562 and the second inner axial wall 564, wherein the plurality of infusion ports 535 are peripherally spaced between the plurality of tabs 538. The access sheath tip 530F is also tapered or beveled at an angle toward the distal end 140A of the access sheath 500, with a concave radial curvature, while maintaining a substantially constant inner diameter of the central lumen 555 and a constant outer diameter of the tubular shaft 505.

[0268] Also refer to Fig.68 In another embodiment, the tubular shaft 505 may also include an inflatable sealing and anchoring balloon 560 or other expandable structure, typically disposed proximally to the distal end 140A of the access sheath 500, 500A, 600, 600A, as illustrated. The distal end 140A of the tubular shaft 505, 505A of the access sheath 500, 500A, 600, 600A with the inflatable sealing and anchoring balloon 560 or expandable structure is inserted into the gallbladder of the subject and the inflatable sealing and anchoring balloon 560 is inflated via the inflation lumen 565 and the inflation port 572, typically by infusing saline or another liquid (or air) into the interior 568 of the inflatable sealing and anchoring balloon 560, such as (but not limited to), such as through the inflation access port 620. This allows the distal end 140A of the tubular shaft 505 of the access sheath 500 to be anchored inside the gallbladder, and the inflatable sealing and anchoring balloon 560 helps create a fluid seal against the gallbladder wall. This creates a closed system, making irrigation and aspiration more effective. For example, without an adequate seal, fluid may leak out of the access site in the gallbladder, which can adversely affect the effectiveness of aspiration, and potentially also allow bile to seep through the access site (around the shaft) during an infusion. Potential problems are avoided by including and using the inflatable sealing and anchoring balloon 560 during the various infusion and aspiration procedures described herein.

[0269] As mentioned above, fluid is infused using one or more peripheral lumens 550 disposed between the inner and outer walls 564, 562 of the tubular shaft 505, and the infusion port 535 directs the fluid flow radially outward from the access sheath tip 530A to 530F. Fig.61One way to make the peripheral lumen 550 is to use a small tube to form a gas-filled lumen 565 between the first outer shaft wall 562 and the second inner shaft wall 564, wherein the rest of the space between the first outer shaft wall 562 and the second inner shaft wall 564 forms the peripheral lumen 550. Another way to make the peripheral lumen 550 can be achieved by creating grooves on the outer surface of the hollow cylinder forming the inner wall 564. These grooves can then be covered with another cylindrical hollow shaft forming the outer wall 562 (rigid, flexible, heat shrink; FEP or PET, etc.) to cover the grooves and create the peripheral lumen 550 between the inner and outer walls 564, 562.

[0270] refer to Fig.72 These outward radial fluid streams (504) from the access sheath tips 530A to 530E can be one, two, three, or any number of fluid streams as desired, or they can also be one continuous radial stream. These outward streams (504) are used to Fig.72 590) described in the figure. This turbulent flow agitates the gallstones and prevents them from settling in a position in the gallbladder that is too far away from the access sheath tips 530A to 530E. By mobilizing the gallstones with this radial fluid flow, it is easier to immediately aspirate when the flow path (506) brings the gallstones to the access sheath tips 530A to 530E. This flow path can be continuous and cyclic or it can be intermittent and cyclic, or it can be randomized to simply move only the gallstones or gallstone fragments and eventually they will cross paths with the aspiration fluid path 506 and be swept into the aspiration channel 574. Due to the novel design of the system 300F, a single syringe as the aspiration device 250, 250A, 250B, 250C, 250D can be used to facilitate cyclic flushing and aspiration to successfully move the gallstones or gallstone fragments out of the gallbladder and into the straight-line filter chamber 578. Simply advancing and retracting the syringe plunger 265 in rapid succession will remove the gallstones or gallstone fragments. Typically, approximately equal amounts of fluid (e.g., saline or another biologically inert fluid) are infused and then aspirated, such as (for example but not limitation) 60 ml of saline is infused and 60 ml of fluid (with any gallstones and / or gallstone fragments) is subsequently or concomitantly aspirated. Alternatively, not separately illustrated, two rigid hollow shafts may be used to provide this infusion / irrigation and aspiration.

[0271] In another embodiment, the suction devices 250, 250A, 250B, 250C, 250D may be replaced by an electric pump 595 ( Fig.72). One potential problem with using a suction device 250, 250A, 250B, 250C, 250D that is manually controlled by the user may be variability in the speed or force with which the user retracts and expel the plunger 265 of the suction device 250, 250A, 250B, 250C, 250D, which may result in a certain amount or level of variation in the suction / infusion flow rate. The pump 595 may be implemented to be simple for the user, with user-independent settings to obtain consistent results.

[0272] refer to Fig.70 , 71 and 73. In other embodiments, the single suction device 250, 250A, 250B, 250C, 250D of the system 300F may be replaced by a dual suction and infusion assembly 650, 675 of the system 300G having two suction devices: a first suction device 2501, 250A1, 250B1, 250C1, or 250D1 (2501 to 250D1) and a second suction device 2502, 250A2, 250B2, 250C2, or 250D2 (2502 to 250D2). Fig.70 A representative system 300G of a first embodiment including an access sheath 600 and a dual aspiration and infusion assembly 650 is illustrated. Fig.71 A representative proximal hub 610 of the access sheath 600 of the system 300G is illustrated. Fig.73 A representative second embodiment of a dual aspiration and infusion assembly 675 is illustrated that may be used in place of the dual aspiration and infusion assembly 650 as part of the representative eighth system 300G embodiment. Figures 74 to 78 The operation of the dual aspiration and infusion assembly 650 and the rack and pinion drive assembly 630 used to synchronize the operation of the first aspiration device 2501-250D1 and the second aspiration device 2502-250D2 is illustrated.

[0273] The advantage of using dual suction and infusion assemblies 650, 675 is that infusion (flushing) and suction can be performed synchronously or cyclically to improve the efficiency of gallstone and / or gallstone fragment removal, such that a first suction device 2501-250D1 is infusing while another second suction device 2502-250D2 is suctioning simultaneously or concurrently. This can be achieved using various mechanisms to mechanically link the two syringe plungers 265, for example, so that their movements can be in phase or out of phase to any selected degree. For example, Fig.73 , 7478 shows two suction devices 250, 250A, 250B, 250C, 250D being 180 degrees out of phase, allowing a second suction device 2502 to 250D2 to suction and another first suction device 2501 to 250D1 to infuse or flush simultaneously. In addition to providing simultaneous or concurrent infusion and suction, and with the inclusion of some additional valves described in more detail below, system 300G otherwise has the same structure and operation as system 300F.

[0274] refer to Figures 70 to 78 , gallstone removal system 300G includes several components, including an access sheath 600 and a dual suction and infusion assembly 650 (or dual suction and infusion assembly 675). More specifically, in a representative embodiment, system 300G includes an access sheath 600 coupled to a dual suction and infusion assembly 650 or 675 via a proximal hub 610, such as Fig.70 , 71 and 73. As with the various systems described above, system 300G may further include catheters 400 to 400H, such as Fig.63 , arranged through one or more access ports 130A. System 300G functions similarly to the other systems 300-300F described above, except for the differences described in more detail below. As with system 300F, notable differences of system 300G are the inclusion of multiple separate infusion and aspiration channels 540, 574, respectively, the inclusion of a filter assembly 515 in the proximal hub 610 as part of the aspiration channel 574, and the optional inclusion of a sealing and anchoring balloon 560, which further utilizes a separate inflation lumen 565. Additional differences are described in more detail below.

[0275] The access sheath 600 includes a cylindrical hollow tubular shaft or member 505 coupled to a proximal hub 610. The tubular shaft 505 of system 300G has the same structure and function as previously described for system 300F. As mentioned above, the proximal hub 610 includes additional valves, tubing, and coupling components, as described in more detail below.

[0276] In a representative embodiment, the proximal hub 610 also includes: a housing 576 having a plurality of hub lumens 570, 575, 580, 585; a filter assembly 515 having a filter cavity 578; infusion tubing 545A, 545B; a plurality of valves 120B, 120C, 125A, 125B, 125C, 125D coupled within the housing 576 and tubing 545A, 545B and return path tubing 625; and a plurality of mating couplings 150E and 155E, 150F and 155F and couplings 150G and 150H. The mating couplings 150G and 155G removably couple the first suction device 2501 to 250D1 to the proximal hub 610. The mating couplings 150H and 155H removably couple the second suction device 2502 to 250D2 to the proximal hub 610. Mating couplings 150E and 155E connect the infusion tubing 545A to the hub lumen 570, which in turn is in fluid communication with the peripheral lumen 550. Mating couplings 150F and 155F connect the tubular shaft 505 to the proximal hub 610. Valves 120B, 120C, 125A, 125B, 125C, and 125D are each typically a one-way valve, such as a stopcock or a pressure rupture valve ( Fig.71 The pressure cracking valve 610 illustrated as valves 120B and 120C in the figure can be implemented as previously described. In addition, the mating couplings 150E and 155E, 150F and 155F, 150G and 155G, and 150H and 155H can be implemented as previously described, such as quick-connect fittings, screw threads, snap-on fittings, etc.

[0277] For the proximal hub 610, as with the proximal hub 510, the hub lumen 570 is also disposed between the infusion tubing 545A and the peripheral lumen 550. The valve 120C is also disposed between the central lumen 555 of the tubular shaft 505 and the hub lumen 575. The hub lumen 575 is also disposed between the valve 120C and the filter 520 as part of the filter assembly 515. The filter lumen 578 is also an internal portion of the filter 520 and is in fluid communication with the hub lumen 575, thereby forming a space within the filter 520 for filtering out and capturing any aspirated gallstones or gallstone fragments. The canister lumen 580 is also within the canister 525, on the side of the filter 520 opposite the filter lumen 578. The one-way valve 125A separates the canister lumen 580 from the hub lumen 585 and is used to prevent the injected infusion fluid from entering the canister lumen 580 and the rest of the aspiration channel 574.

[0278] The proximal hub 610 further includes a return path tubing 625 having a one-way valve 125C coupled between the hub lumen 585 and the infusion tubing 545B, wherein the infusion tubing 545B extends between the coupling 150G and the one-way valve 125B.

[0279] Reference again Figures 58 to 63 70-71, it will be appreciated by those skilled in the art that the various tubing structures of the proximal hub 510, 610 (e.g., the infusion tubing 545, the infusion tubing 545A, the return path tubing 625, and other various components forming the infusion channel 540 and the aspiration channel 574) may all be integrated into a single housing, not separately described, and any and all such embodiments and variations are considered equivalent and within the scope of the present disclosure. This singular housing has the additional advantage of eliminating any requirements for various connectors (e.g., for example but not limited to, mating couplings 150F and 155F and / or couplings 150E and 155E). It will also be appreciated by those skilled in the art that the tubular shaft 505 may also be integrated with the proximal hub 510, 610, and any and all such embodiments and variations are considered equivalent and within the scope of the present disclosure. Those skilled in the art will also recognize that the various tubes, tubular shafts, and proximal hubs may have a wide variety of shapes, sizes, and configurations, and that any and all such embodiments and variations are considered equivalent and within the scope of the present disclosure.

[0280] When the system 300G is in operation, fluid is typically infused into the subject's gallbladder to create some turbulence to agitate any gallstones or gallstone fragments for aspiration, as described in more detail below. To infuse fluid in the infusion channel 540, fluid from the first suction device 2501-250D1 is injected through the infusion tubing 545B (using the plunger 265 of the suction device 250, 250A, 250B, 250C, 250D) and through the one-way valve 125B (and valve 125D) into the infusion tubing 545A. The fluid from the infusion tubing 545A in turn flows through the valve 120B (e.g., the pressure rupture valve 610) and into the hub lumen 570, which is in fluid communication with each of the peripheral lumens 550. The infusion fluid then flows through each of the peripheral lumens 550 and radially outward through each of the corresponding infusion ports 535, as mentioned above.

[0281] The filter assembly 515 of the proximal hub 610 also forms part of the suction channel 574 and has the structure and function described above for the proximal hub 510. Aspiration of fluid, gallstones or gallstone fragments is different using the proximal hub 610 because the filtered fluid (and particles not captured in the filter 520) is aspirated through the valve 125A and the hub lumen 585 and into the second suction device 2502 to 250D2. Any aspirated gallstones or gallstone fragments are also retained in the filter cavity 578 and do not pass through the filter 520, and are further prevented by the valve 120C from returning to the central lumen 555. In the first infusion and aspiration phase, any remaining fluid flows through the filter 520 and into the canister lumen 580, then through the (one-way) valve 125A into the hub lumen 585 and into the second suction device 2502 to 250D2. As described in more detail below, in a second infusion and aspiration phase, using the proximal hub 610, the fluid is returned to the first aspiration device 2501 to 250D1, and another infusion and aspiration sequence can be repeated.

[0282] It should be noted that an additional valve 125D is provided as an option in the infusion tubing 545A of the proximal hub 610. Fig.45 During infusion, stopcock 125D may be opened and closed, allowing and stopping fluid flow, respectively, which may be used to advantageously increase turbulence in and disrupt the fluid flow within the gallbladder of the subject.

[0283] The control and operation of the first suction device 2501-250D1 and the second suction device 2502-250D2 can be performed manually or mechanically, for example by implementing and using the dual suction and infusion assembly 650 (or 675). Fig.73 As illustrated in FIG. 6 , the pump 680 having the illustrated linkage assembly 685 may be implemented to operate the first pumping device 2501-250D1 and the second pumping device 2502-250D2 out of phase (eg, 180 degrees out of phase). Fig.79 , 7174 to 78, for example (but not limited to), a rack and pinion transmission assembly 630 may be utilized, having a first rack gear 635 coupled to the plunger 265 of the first suction device 2501 to 250D1, a second rack gear 640 coupled to the second suction device 2502 to 250D2, wherein the first and second rack gears 635, 640 are engaged with a pinion gear 645 and are coupled and held in place to the first suction device 2501 to 250D1 and the second suction device 2502 to 250D2 using a clamping assembly 655. Retracting one syringe plunger 265 coupled to the first rack gear 635 will rotate the pinion gear 645, which will be coupled to the second rack gear 640, which is coupled to the second syringe plunger 265, thereby advancing it, and vice versa.

[0284] Figures 74 to 78 The structure and operation of the dual aspiration and infusion assembly 650 with the rack and pinion drive assembly 630 are illustrated. The most obvious difference in using the dual aspiration and infusion assembly 650 or 675 is that during the first infusion and aspiration phase, the first aspiration device 2501-250D1 begins with fluid (e.g., saline) in the first aspiration device 2502-250D2 and an empty second aspiration device 2502-250D3. Fig.74 ), while the first suction device 2501-250D1 is infusing fluid (advancing its syringe plunger 265) through the peripheral lumen 550 of the tubular shaft 505 of the access sheath 600 and infusing the fluid into the subject's gallbladder, the second suction device 2502-250D2 is simultaneously aspirating fluid (retracting its syringe plunger 265) through the central lumen 555 of the tubular shaft 505, through the filter assembly 515, through the valve 125A, the hub lumen 585 and aspirating the fluid into the second suction device 2502-250D2 ( Fig.75 and 76 ). At the end of this first infusion and aspiration phase, the first aspiration device 2501-250D1 is now empty and the infused fluid has been aspirated into the now effectively full second aspiration device 2502-250D2 ( Fig.77 ).

[0285] In the second infusion and aspiration phase, the filtered aspirated fluid held by the second aspiration device 2502-250D2 is returned to the now empty first aspiration device 2501-250D1. The filtered aspirated fluid is injected (advancing its syringe plunger 265) into the hub lumen 585 by the second aspiration device 2502-250D2, and this filtered aspirated fluid flow is directed into the infusion tubing 545B using the one-way valve 125C in the return path tubing 625. As the filtered aspirated fluid is injected by the second aspiration device 2502-250D2, the filtered aspirated fluid is simultaneously aspirated (retracting its syringe plunger 265) by the first aspiration device 2501-250D1, wherein the pressure differential caused by withdrawing the plunger 265 in the first aspiration device 2501-250D1 causes the fluid to flow into the first aspiration device 2501-250D1, rather than through the valve 125B. At the end of this second infusion and aspiration phase, the second aspiration device 2502-250D2 is now empty and fluid has been aspirated into the now effectively full first aspiration device 2501-250D1 ( Fig.78 ) and the next first infusion and aspiration phase can begin.

[0286] Fig.79 is an isometric view illustrating a representative eighth embodiment of an access sheath 800 . Fig.80 Yes Description Fig.79 A cross-sectional view of a representative eighth embodiment of an access sheath 800 is shown. Fig.81 is a partial cross-sectional view (through the eighth embodiment) of an exemplary embodiment of an access sheath 800 of another exemplary catheter embodiment. Fig.79 G-G' plane). Fig.82 is an isometric view illustrating a representative ninth embodiment of the system 300H of the first embodiment having an access sheath 800 and a pulverization or frac control device 850 . Fig.83 is an isometric view illustrating a representative tenth embodiment of the system 300J having an access sheath 800 and a second embodiment of a pulverization or frac control device 950 .

[0287] refer to Figures 79 to 83, the access sheath 800 includes a proximal hub 810 having a housing 582 and coupled to the tubular shaft 505A (or 505) at a first end and also coupled to the valve 125E at a second end. The proximal hub 810 includes a filter assembly 515 as part of the suction channel 574 and also includes an infusion channel 540, as previously described. As in other access sheaths 500, 500A, 600, 600A, in a single configuration (as illustrated) or in the dual configuration described above, the access sheath 800 can also be coupled (via a connector 150D) to a suction device 250, 250A, 250B, 250C, 250D. The proximal hub 810 also includes: a first port 577, which is fluidically connected to the peripheral lumen 550 and coupled to the infusion tubes 545A, 545B through the valve 120B, a second port 581, which is fluidically connected to the hub lumen 575 of the proximal hub 810 and coupled to the filter assembly 515 through the valve 120C (or the return path tube 625); and a third port 620, which is fluidically connected to the inflation lumen 555.

[0288] Access sheath 800 differs from access sheaths 500, 500A, 600, 600A in several ways. First, filter assembly 515 is no longer in-line (linearly aligned) with tubular shaft 505A, and is instead off-axis, i.e., spaced or laterally offset from central lumen 555. In other words, infusion and aspiration channels 540, 574 are not in-line (in-line) with tubular shaft 505A and access tubular shaft 505A through proximal hub 810, with infusion channel 540 coupled to hub lumen 575 of proximal hub 810 for fluid communication with peripheral lumen 550, and with aspiration channel 574 coupled to hub lumen 575 of proximal hub 810 for fluid communication and aspiration through central lumen 555 of tubular shaft 505A.

[0289] This provides for straight insertion of catheters 400-400H in a straight line through valve 125E into the central lumen 555 of the proximal hub 810 and tubular shafts 505, 505A, for example Fig.81, i.e., there is no need for any bends in the catheter 400-400H that would otherwise be required if the catheter 400-400H were inserted through the access port 130, 130A, 135. This off-line configuration of the filter assembly 515 along with the in-line configuration of the valve 125E into the proximal hub 810 and into the central lumen 555 of the tubular shaft 505, 505A also allows this catheter 400-400H to have a rigid or stiff configuration. In addition, this off-line configuration of the filter assembly 515 together with the in-line configuration of the valve 125E into the proximal hub 810 and into the central lumen 555 of the tubular shaft 505, 505A also allows for in-line use of pulverizing or fracturing control equipment 850, 950, which can be inserted straight and in-line (typically with catheters 400F to 400H and pulverizing or fracturing equipment 700 to 700S) into the proximal hub 810 and the central lumen 555 of the tubular shaft 505, 505A through the valve 125E, for example Fig.82 and 83 In a representative embodiment, valve 125E is implemented as a hemostatic valve, such as that commercially available from Inari Medical, Inc., with a button actuator 806 that opens a passage in valve 125 for inserting crushing or fracturing control devices 850, 950, catheters 400F to 400H, and / or crushing or fracturing instruments 700 to 700S.

[0290] Second, the access sheath 800 also includes an adjustable plug 566 (with an adjustment ring 567) between the proximal hub 810 and the sealing and anchoring balloon 560. The adjustable plug 566 can slide along the tubular shaft 505, 505A and can be fixed at any selected position along the tubular shaft 505, 505A by tightening the adjustment ring 567. In use, when the access sheath 800 is inserted into the gallbladder of a patient or subject, the sealing and anchoring balloon 560 is inflated and the adjustable plug 566 is slid and fixed to be close to the skin of the patient or subject, so that the access sheath 800 is stable and will not move or be further inserted into the patient or subject.

[0291] Aside from these differences, access sheath 800 operates as previously described for access sheaths 500, 500A, 600, 600A, with infusion provided through infusion channel 540 and aspiration provided through aspiration channel 574 having filter assembly 515. One skilled in the art will also recognize that access sheath 800 may also be configured to use the dual aspiration and infusion assemblies 650, 675 described above, not separately illustrated.

[0292] refer to Fig.82 and 83, the system 300H includes: an access sheath 800; catheters 400F to 400H, which are arranged in a crushing or fracturing control device 850; a crushing or fracturing control device 850 (having a crushing or fracturing shaft 835 and catheters 400F to 400H), which are coupled or inserted through a proximal hub 810 and enter the tubular shaft 505A of the access sheath 800; and a suction device 250, 250A, 250B, 250C, 250D, which is coupled to the access sheath 800 for infusion and suction. Reference Fig.83 , the system 300J includes: an access sheath 800; catheters 400F to 400H, which are arranged in a crushing or fracturing control device 950; a crushing or fracturing control device 950 (having a crushing or fracturing shaft 935 and catheters 400F to 400H), which are coupled or inserted into the tubular shaft 505A of the access sheath 800 through a proximal hub 810; and suction devices 250, 250A, 250B, 250C, 250D, which are coupled to the access sheath 800 for infusion and suction. Fig.82 and 83 Also illustrated are systems 300H and 300J having conduits 400F-400H having cages or baskets 405H (as examples of baskets or cages 405-405K) extending from tubular shaft 505A, as described below with reference to Figures 90 to 97 Described in more detail, cage or basket 405H is controlled using pulverizing or fracturing control devices 850, 950 arranged as described for systems 300H and 300J.

[0293] Fig.84 is an isometric view illustrating a representative two-part ninth embodiment of an access sheath 900 . Fig.85 is a cross-sectional view illustrating a representative two-part ninth embodiment of access sheath 900 . Fig.86 is a first cross-sectional view (through Fig.84 H-H' plane). Fig.87 is a second cross-sectional view (through Fig.84 H-H' plane). Fig.88 is an isometric view illustrating a first removably couplable portion 905A of a representative ninth embodiment of an access sheath 900 . Fig.89 is an isometric view illustrating a second removably couplable portion 905B of the representative ninth embodiment of the access sheath 900 .

[0294] refer to Figures 84 to 89, the access sheath 900 includes a proximal hub 910 coupled to the tubular shaft 505B. The access sheath 900 is separable into two parts: a first removably couplable portion 905A and a second removably couplable portion 905B. The tubular shaft 505B is also removably separable into two component parts: a first outer shaft wall 562A and a second inner shaft wall 564A. The proximal hub 910 is separable into two parts: a first proximal hub segment 915 (coupled to the first outer shaft wall 562A) and a second proximal hub segment 920 (coupled to the second inner shaft wall 564A), respectively using corresponding mating screw threaded connectors 925A, 925B. The first proximal hub segment 915 coupled to the first outer axial wall 562A forms a first removably couplable portion 905A of the access sheath 900, and the second proximal hub segment 920 coupled to the second inner axial wall 564A forms a second removably couplable portion 905B of the access sheath 900. Although not separately illustrated, any of the other various access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800 may also be modified to have this or a similar two-part configuration.

[0295] For this access sheath 900 embodiment, the tubular shaft 505B has a different configuration, with an inflation lumen 565A disposed as an outer groove on the exterior of the first outer shaft wall 562A and covered with a flexible material (e.g., used to form a seal and anchor the balloon 560), such as Fig.86 The inflation lumen 565A extends into the first proximal hub segment 915 (eg, Fig.87 564A) to receive fluid or air, for example, for inflating the sealing and anchoring balloon 560. In addition, the second inner shaft wall 564A of the tubular shaft 505B has a curvature (or slope) 930 at the distal end of the second inner shaft wall 564A to fit closely on the inner surface of the first outer shaft wall 562A, such as Fig.86 , wherein the infusion lumen 550B is provided by the space between the first outer axial wall 562A and the second inner axial wall 564A, as described above. It should also be recognized by those skilled in the art that the access sheath 900 can also be configured to use any suction device 250, 250A, 250B, 250C, 250D, dual suction and infusion assembly 650, 675, infusion channel 540 and / or suction channel 574 with filter assembly 515, as described above, not separately described.

[0296] Fig.90 is a first isometric view illustrating a representative first embodiment of a pulverizing or frac control device 850 having a representative conduit 400F-400H embodiment illustrated as having a cage or basket 405H. Fig.91 is a second isometric view illustrating a representative first embodiment of a pulverizing or fracturing control device 850 . Fig.92It indicates that Fig.90 FIG. 8 is a partial cross-sectional view of a representative first embodiment of a pulverizing or fracturing control device 850 of a representative catheter 400F to 400H embodiment of FIG. 8. The pulverizing or fracturing control device 850 includes a housing 815, a control device shaft 835 coupled to the housing 815, a catheter control assembly 892, a first handle 820, a control linkage lever 825, a pulverizing or fracturing spring 855, and a second handle 830. The catheter control assembly 892 includes a catheter control actuator 870 and a pulverizing or fracturing pin 875. The control device shaft 835 has a lumen 832 for inserting the catheter 400F to 400H and a pulverizing or fracturing device 700 to 700S coaxially arranged in the inner catheter lumen 435 of the inner catheter steering shaft 420, 420A of the catheter 400F to 400H.

[0297] The first handle 820 is pivotally coupled to the housing 815 and is also movably (pivotally) coupled to a first end 826 of a control linkage lever 825. The catheter control actuator 870 is movably (pivotably) coupled to a second end 828 of the control linkage lever 825, and both the catheter control actuator 870 and the control linkage lever 825 are slidable in a slot 834 of the housing 815. The catheter control actuator 870 includes a tubular catheter grip 894 that is linearly aligned with the control device shaft lumen 832 and can be coupled around the inner catheter steering shaft 420, 420A of the catheters 400F to 400H to fix the inner catheter steering shaft 420, 420A and longitudinally move the inner catheter steering shaft 420, 420A within the catheters 400F to 400H (and the lumen 832 of the control device shaft 835) in response to movement of the first handle 820 and the control linkage lever 825. The crushing or fracturing pin is linearly aligned with the tubular catheter grip 894 within the housing 815 (coaxial within the tubular catheter grip 894) to engage with the crushing or fracturing device 700 to 700S, wherein the crushing or fracturing device 700 to 700S is coaxially disposed within the inner catheter lumen 435 of the inner catheter steering shaft 420, 420A of the catheters 400F to 400H. A second handle 830 (with a removable retaining clip 860) is coupled to the crushing or fracturing pin 875, i.e., is arranged to control the crushing or fracturing coil spring 855 and move the crushing or fracturing pin 875. For example (but not limitation), a control device shaft 835 may also be inserted into the access sheath 800, such as Fig.82 820, 830 and the optional thumb grip 840. The various components of the crushing or fracturing control device 850 can be composed of a variety of materials, such as, for example but not limited to, stainless steel, titanium, medical / surgical grade polymers, etc.

[0298] In operation, a catheter 400F to 400H having a crushing or fracturing instrument 700 to 700S coaxially arranged in the inner catheter lumen 435 of the catheter 400F to 400H is inserted into the lumen 832 of the control device shaft 835. The inner catheter manipulation shaft (or member) 420, 420A of the catheter 400F to 400H is arranged to engage with the catheter control actuator 870, and the crushing or fracturing instrument 700 to 700S is arranged to engage with the crushing or fracturing pin 875. With the first handle 820 in the first position 865 ( Fig.91 400F to 400H), the cage or basket 405G, 405H, 405J, 405K of the catheter 400F to 400H is retained within the outer catheter tube or member 415B, 415C of the catheter 400F to 400H. In this arrangement, the pulverizing or fracturing device 700 to 700S is coaxially arranged in the inner catheter lumen 435 of the inner catheter steering shaft 420B within the catheter 400F to 400H, which is in turn coaxially arranged in the lumen of the control device shaft 835. For example (but not limitation), the control device shaft 835 (with the catheter 400F to 400H and the pulverizing or fracturing device 700 to 700S) is then inserted into the access sheath 800 disposed in the gallbladder of the patient or subject.

[0299] As the first handle 820 is then moved into the second position 845 ( Fig.90 825, the catheter control actuator 870 engages with the inner catheter steering shaft 420B and pushes the inner catheter steering shaft 420B, thereby advancing the cage or basket 405G, 405H, 405J, 405K from the inner catheter lumen 435 of the inner catheter steering shaft 420, 420A of the catheter 400F to the pulverizing or fracturing shaft 835, as shown in FIG. Fig.90405J, 405K. The expansion cage or basket 405G, 405H, 405J, 405K can then be used to capture the gallstone 411, as previously described. When the gallstone is then within the interior of the cage or basket 405G, 405H, 405J, 405K, the first handle 820 is then moved toward the first position 865, which retracts or pulls the inner catheter steering shaft 420B back into the outer catheter tube or member 415B, 415C (and the control device shaft 835), thereby retracting the support 410 and contracting the cage or basket 405G, 405H, 405J, 405K around the gallstone. With the cage or basket 405G, 405H, 405J, 405K around the gallstone, the first handle 820 is typically in a position intermediate or between the first and second positions 865, 845. Depending on the size of the captured gallstone, the captured gallstone may then be removed from the patient or subject by withdrawing the control device shaft 835 of the pulverizing or fracturing control device 850 from the access sheath 800. For gallstones that are larger than the inner diameter of the central lumen 555 of the access sheath 800, the captured gallstone may be pulverized or fractured using one of the pulverizing or fracturing instruments 700-700S within the inner catheter shaft lumen 435.

[0300] In the event that a gallstone is to be pulverized or fractured, the pulverizing or fracturing device 700-700S may be advanced through the inner catheter shaft lumen 435 (e.g., Fig.54 ) to impact the gallstone once or repeatedly as needed to crush or fracture the gallstone using the second handle 830 and the force supplied by the crushing or fracturing coil spring 855 through the crushing or fracturing pin 875, which engages the proximal end 877 of the shaft 705 of the crushing or fracturing instrument 700 to 700S. In a first step, the second handle 830 is or has been pulled back (away from the housing 815) to compress the crushing or fracturing coil spring 855, and the second handle 830 is locked in the compressed spring position using the removable retaining clip 860. To impact the gallstone with the pulverizing or fracturing instrument 700-700S, in a second step, the removable retaining clip 860 is removed, thereby releasing the second handle 830 and the compressed pulverizing or fracturing coil spring 855, which advances (distal movement) the pulverizing or fracturing pin 875, which in turn advances (distal movement) the pulverizing or fracturing instrument 700-700S, thereby driving the pulverizing or fracturing tip 710-710S into the gallstone and thereby pulverizing or fracturing the gallstone, for example (but not limited to) typically using an impact force of 15 to 20 lbf (66.7 to 90 N). These first and second steps can be repeated as needed or recommended.

[0301] As another option, not separately illustrated, the pulverizing or fracturing control device 850 may include a release button (in the housing 815) for the second handle 830. The second handle 830 may be pulled and locked into an extended position, thereby storing energy in the pulverizing or fracturing coil spring 855. When actuated using this release button, the pulverizing or fracturing coil spring 855 is released and the pulverizing or fracturing instrument 700 to 700S is advanced to impact the gallstone.

[0302] The crushed or pulverized gallstone pieces may be small enough to be expelled from the cage or basket 405G, 405H, 405J, 405K and aspirated (or removed using the cage or basket 405G, 405H, 405J, 405K), as described above. Feedback may also be provided to the medical staff as the gallstones are crushed or pulverized, as the cage or basket 405G, 405H, 405J, 405K may further retract around the crushed or pulverized gallstone pieces, thereby allowing the first handle 820 to move back closer to the first position 865. Typically, the first crushing or pulverizing control device 850 is removed from the access sheath 800, and the gallstone fragments are aspirated using the aspiration channel 574 with the filter assembly 515, as described above.

[0303] Fig.93 400F through 400H (and illustrated as having a cage or basket 405H). Fig.94 is a second isometric view illustrating a representative second embodiment of a pulverizing or fracturing control device 950 . Fig.95 is a diagram illustrating the proximal end portion of a representative embodiment of a catheter 400F to 400H. Fig.93 A first partial cross-sectional view of a representative second embodiment of a pulverizing or fracturing control device 950. Fig.96 Yes Description Fig.93 A second partial cross-sectional view of a representative second embodiment of a pulverizing or fracturing control device. Fig.97 Yes Description Fig.93 A third partial cross-sectional view of a representative second embodiment of a pulverizing or fracturing control device.

[0304] The crushing or fracturing control device 950 includes a housing 975, a control device shaft 935 having a control device shaft lumen 937, a catheter control assembly 992, a first handle 960, a second handle 955, a trigger actuator 940, and a trigger control tab 994. The catheter control assembly 992 includes a catheter control linkage 965 and a crushing or fracturing pin 990. The crushing or fracturing pin 990 is coaxially arranged in a lumen (not separately illustrated) of the catheter control linkage 965 and is longitudinally movable (slidable) in the lumen. The first handle 960 is slidable in the slot 958 and is coupled to and controls the catheter control linkage 965 to longitudinally move the catheter control linkage 965 both distally and proximally. The second handle 955 is coupled to and controls the crushing or fracturing pin 990. The crushing or fracturing control device 950 may also include a third (trigger) handle 945 and a control tab 970. The control device shaft 935 has a control device shaft lumen 937 for inserting the catheter 400F to 400H and the crushing or fracturing instrument 700 to 700S coaxially arranged in the inner catheter lumen 435 of the inner catheter steering shaft 420, 420A of the catheter 400F to 400H. Also for example (but not limited to), the control device shaft 935 can also be inserted into the access sheath 800. The crushing or fracturing control device 950 is generally used and operated by medical personnel, holding the housing 950 and using the first, second and third handles 960, 955, 945, the control tab 970 and the trigger actuator 940. The various components of the crushing or fracturing control device 950 can be composed of a variety of materials, such as (for example but not limited to) stainless steel, titanium, medical / surgical grade polymers, etc.

[0305] In operation, the catheter 400F to 400H having the crushing or fracturing device 700 to 700S coaxially arranged in the inner catheter lumen 435 of the catheter 400F to 400H is inserted into the control device shaft lumen 937 of the control device shaft 935. The inner catheter manipulation shaft (or member) 420, 420A of the catheter 400F to 400H is arranged to engage with the catheter control linkage group 965, and the crushing or fracturing device 700 to 700S is arranged to engage with the crushing or fracturing pin 990. With the first handle 960 in the first position 962 ( Fig.94400F to 400H), the cage or basket 405G, 405H, 405J, 405K of the catheter 400F to 400H is retained within the outer catheter tube or member 415B, 415C of the catheter 400F to 400H. In this arrangement, the pulverizing or fracturing device 700 to 700S is coaxially arranged in the inner catheter lumen 435 of the inner catheter steering shaft 420B within the catheter 400F to 400H, which in turn is coaxially arranged within the control device shaft lumen 937 of the control device shaft 935. For example (but not limitation), the control device shaft 935 (with the catheter 400F to 400H and the pulverizing or fracturing device 700 to 700S) is then inserted into the access sheath 800 disposed in the gallbladder of the patient or subject.

[0306] When the control tab 970 is engaged, the first handle 960 is moved within the slot 958 of the housing 975 into the second position 964, the catheter control linkage 965 engages with the inner catheter steering shaft 420B and pushes the inner catheter steering shaft 420B distally and longitudinally, thereby advancing the cage or basket 405G, 405H, 405J, 405K from the control device shaft 935, as shown. Fig.93 . The expansion cage or basket 405G, 405H, 405J, 405K may then be used to capture gallstones, as previously described. When the gallstone is then within the interior of the cage or basket 405G, 405H, 405J, 405K, the trigger actuator 940 is depressed, thereby engaging the trigger control tab 994 and moving the first handle 960 back toward the first position 962 (resulting in the first handle 960 being in a third position intermediate the first and second positions 962, 964, not separately illustrated), which retracts or pulls the inner catheter steering shaft 420B back into the outer catheter tube or member 415B, 415C (and the control device shaft 935), thereby retracting the strut 410 and contracting the cage or basket 405G, 405H, 405J, 405K around the gallstone. Depending on the size of the captured gallstone, the captured gallstone may then be removed from the patient or subject by withdrawing the pulverizing or fracturing shaft 935 of the pulverizing or fracturing control device 950 from the access sheath 800. For gallstones that are larger than the inner diameter of the central lumen 555 of the access sheath 800, the captured gallstone may also be pulverized or fractured using one of the pulverizing or fracturing instruments 700-700S within the inner catheter shaft lumen 435.

[0307] In the event that a gallstone is to be pulverized or fractured, the pulverizing or fracturing device 700-700S may be advanced through the inner catheter shaft lumen 435 (e.g., Fig.54The second handle 955 is typically maintained in the first locked position 966 using a biasing spring 980, such as Fig.96 The user unlocks the second handle 955 by rotating it 90° to the second position 968, as shown in FIG. Fig.97 As the user then pushes the second handle 955, the crushing or fracturing pin 990 (coaxially arranged within the catheter linkage assembly 965) is advanced (moved longitudinally at the distal end), which engages with the proximal end of the crushing or fracturing instrument 700 to 700S, which in turn pushes the crushing or fracturing instrument 700 to 700S (moves longitudinally at the distal end) into the gallstone, thereby crushing or fracturing the gallstone. This causes force to be transmitted from the user through the crushing or fracturing pin 990 to the crushing or fracturing tip 710 to 710S and into the gallstone. When the second handle 955 is fully advanced into the second position 968, it can be locked into the appropriate position with a locking pin 995 seated in a corresponding recess 985 in the housing 975, as shown in FIG. Fig.97 Concurrently or sequentially, the trigger actuator 940 is pressed one or more times by the user, resulting in the inner catheter steering shaft 420B being further pulled back into the outer catheter tube or member 415B (and the control device shaft 935), thereby further retracting the support 410, resulting in the gallstone being gradually pulled toward the crushing or fracturing tip 710 to 710S of the crushing or fracturing device 700 to 700S, wherein the crushing or fracturing tip 710 to 710S digs into the gallstone and further helps crush or fractur the gallstone. These operations using the second handle 955 and the trigger actuator 940 can be repeated as needed or recommended.

[0308] The crushed or pulverized gallstone pieces may also be small enough to be expelled from the cage or basket 405G, 405H, 405J, 405K and aspirated (or removed using the cage or basket 405G, 405H, 405J, 405K), as described above. Typically, the second pulverization or fracturing control device 950 is removed from the access sheath 800, and the gallstone fragments are aspirated using the aspiration channel 574 with the filter assembly 515, as described above.

[0309] In addition to the various sizes described above, the catheters 400F to 400H may be sized to accommodate the first or second pulverization or fracturing control devices 850, 950. In a representative embodiment, for example (but not limitation), the two control device shafts 835, 935 may have an outer diameter of 0.310 inches (7.878 mm), an inner diameter of 0.272 inches (6.91 mm), and a length of 11.6 inches (29.46 cm). For the first pulverization or fracturing control device 850, also for example (but not limitation), the inner catheter steering shaft 420B may have an outer diameter of 0.197 inches (5.00 mm), an inner lumen (435) diameter of 0.177 inches (4.50 mm), and a length of 12.9 inches (29.46 cm). For the second pulverizing or fracturing control device 850, 950, also for example (but not limitation), the inner catheter handling shaft 420B may have an outer diameter of 0.22 inches (5.59 mm), an inner lumen (435) diameter of 0.177 inches (4.50 mm), and a length of 15.25 inches (29.46 cm). The pulverizing or fracturing device 700-700S may be sized as described above to accommodate the inner diameter of the lumen 435 of the inner catheter handling shaft 420B.

[0310] Fig.98 300J. 300J is a front elevation diagram illustrating a representative peristaltic pump 980 for use as part of any of the various systems 300 to 300J. In any of these embodiments, an access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 (without a valve or with a valve that only restricts inward flow) can be connected to a length of tubing 985, which can then be connected to a peristaltic pump 980 to create a vacuum source. For example, the tubing can be coupled to or inserted into any of one or more access ports 130, 130A, 135 or the center inline port 152. Separately, this long tubing 985 can be connected to a filter and a collection container. In addition, at the proximal end of the filter and collection chamber can be a vacuum source. When the filter and collection container are in place, the vacuum source may look like a syringe or a peristaltic pump or a vacuum pump. The aspirated contents can then be dispensed into a dump bag or waste container or sorting.

[0311] In other embodiments of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, an infusion or injection port (e.g., one or more access ports 130, 130A, 135 or the central inline port 152) of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900) can be connected to a pressurized saline bag or infusion / syringe pump to keep the gallbladder open and pressurized. In current procedures, this fluid is then allowed to exit the gallbladder around the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 through the access site or through the central lumen of the tubing used for access. This creates a very messy procedure where fluid is dumped onto the table and floor. Alternatively, the design of our access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 may have a dedicated "fluid outlet" lumen (e.g., 165A or 165B) that may or may not be separate from the suction lumen. This "fluid outlet" lumen may then be connected to a waste bin or dump bag.

[0312] FIG. 99 is a flow chart illustrating a representative method 1000 for percutaneously removing gallstones to treat cholelithiasis, and provides useful conclusions, wherein a first method for gallstone aspiration includes steps 1010 to 1035, a second method for capturing and crushing or fracturing gallstones includes steps 1010, 1015, and 1040 to 1075, and a third method for simultaneously aspirating, capturing, and crushing or fracturing gallstones includes steps 1010 to 1075. The method begins with a start step 1005, where a medical professional percutaneously inserts at least one dilator into a selected location of a patient or subject's gallbladder to form a tract (step 1010). For example, but not limitation, this step 1005 may include inserting a series or sequence of dilators 145 with increasing diameters or inserting a balloon dilator or balloon tip catheter, followed by inflating the balloon, thereby forming a tract. Also for example, this step 1005 may include inserting one or more guidewires through an existing gallbladder drainage tube in the patient and removing the drainage tube. The tubular shaft (e.g., 105, 505) of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is preloaded onto a portion of a balloon dilatation catheter (in an uninflated state). The balloon dilatation catheter is then inserted over a guidewire so that the distal tip of the balloon is inside the gallbladder and the proximal end is protruding outward, and the balloon dilatation catheter is inflated to dilate the tissue tract.

[0313] The tubular shaft (e.g., 105, 505, 505A) of the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 is then inserted into the tract (step 1015), either directly into the tract or over a dilator. For example, the tubular shaft (e.g., 105, 505, 505A) can be advanced over a balloon dilatation catheter and positioned inside the gallbladder with the distal end 140, 140, followed by deflation of the balloon dilatation catheter and removal of the balloon dilatation catheter from the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, and inflating the sealing and anchoring balloon 560. After inserting the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, the method may continue separately, sequentially, or concurrently with one or both of the two parallel paths, where steps 1020 to 1035 are the first path and steps 1040 to 1075 are the second path, or vice versa. For example, but not limitation, steps 1020 to 1035 involving aspiration may continue first, and if aspiration alone is not sufficient, the method may further continue with steps 1040 to 1075 to assist in removing gallstones using the catheter 400 to 400H.

[0314] After inserting the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 in step 1015, the medical staff can attach the suction device 250, 250A, 250B, 250C, 250D or the dual suction and infusion assembly 650, 675 to the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, for example, to the proximal hub 110, 110A, 510, 610 (step 1020). Using the suction device 250, 250A, 250B, 250C, 250D or the dual suction and infusion assembly 650, 675, in step 1025, the medical personnel then aspirates (and / or flushes or infuses) one or more gallstones or gallstone fragments into the filter 520 and / or the suction device 250, 250A, 250B, 250C, 250D and / or the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900. The filter 520 or suction device 250, 250A, 250B, 250C, 250D is then removed from the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 (step 1030), e.g., to empty any aspirated gallstones or debris from the filter 520 or suction device 250, 250A, 250B, 250C, 250D. When there are additional gallstones to be removed by suction (step 1035), the method returns to step 1020 and iterates. It should also be noted that other instruments (e.g., endoscopes, cameras, lithotripters) may also be inserted into the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 and used as part of the treatment procedure before, after, or during the performance of any of these steps.

[0315] Prior to, concurrently with, or subsequent to performing steps 1020 through 1035, after inserting access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 in step 1015, medical personnel determines in step 1040 whether catheter 400 through 400H should be utilized, and if so, then in step 1045 medical personnel may then insert catheter 400 through access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 into the catheter 400 through 400H. 00A, 200, 200A, 500, 500A, 600, 600A, 800, 900 (e.g., through one or more access ports 130, 130A, 135 or central inline port 152) inserts the catheter 400-400H and positions the basket or cage 405-405K or other capture device at a desired or selected location within the gallbladder of the patient or subject, for example, by using the pulverization or fracturing control device 850, 950. The basket or cage 405-405K or other capture device is then expanded (step 1050) and the expanded basket or cage 405-405K or other capture device is used to capture one or more gallstones (and optionally, the gallbladder may also be flushed or infused) (step 1055). The basket or cage 405-405K or other capture device is then collapsed around the one or more gallstones and the one or more gallstones are optionally pulverized or fractured into gallstone fragments (step 1060). The catheter 400-400H with one or more gallstones and / or gallstone fragments is then removed through the access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900 (step 1065). The medical staff then determines whether additional infusions or flushes should be performed (step 1070), and if so, the method also returns to step 1020. When there are additional gallstones to be removed using the catheter 400-400E (step 1075), the method returns to step 1045 and iterates. When there are no additional gallstones to be removed in both steps 1035 and 1075, the method for percutaneous removal of gallstones to treat cholelithiasis can end, returning to step 1080. As part of step 1080, another drainage catheter is typically inserted over one of the guidewires and the drainage catheter is secured within the subject's gallbladder.

[0316] As mentioned above, in addition to the sizes (height, width, depth), shapes or form factors illustrated and described above, representative embodiments of any of systems 300 to 300J and their various components (e.g., access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, suction devices 250, 250A, 250B, 250C, 250D and catheters 400 to 400H, etc.) may have any size (height, width, depth), shape or form factor suitable for use with percutaneous removal of gallstones to treat cholelithiasis, and all such variations are deemed equivalent and within the scope of the present disclosure. In addition, representative embodiments of access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, suction devices 250, 250A, 250B, 250C, 250D and catheters 400 to 400E illustrate different combinations of features and elements, wherein any and all mixes and matches of any and all combinations of any and all features and elements are within the scope thereof.

[0317] The access sheath 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, the suction device 250, 250A, 250B, 250C, 250D and the catheters 400 to 400E and other components may be manufactured in a variety of ways, including integrally formed from separate components (e.g., injection molding, 3D printing) or assembled (e.g., using any suitable fasteners or adhesives, not separately described), and all such variations are considered equivalent and within the scope of the present disclosure. The access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, the suction devices 250, 250A, 250B, 250C, 250D and the catheters 400 to 400E and other components may be implemented using any suitable material and may be opaque or translucent, wherein suitable materials include any rigid (or semi-flexible) polymer or plastic, such as (for example but not limited to) polyvinyl chloride (PVC), polystyrene, polyacrylate, polytetrafluoroethylene (PTFE or Teflon), nylon, polycarbonate, polyester, carbon fiber, glass, silicone, silicone rubber, metal, alloy, etc., and all such variations are considered equivalent and within the scope of the present disclosure. The access sheaths 100, 100A, 200, 200A, 500, 500A, 600, 600A, 800, 900, the suction devices 250, 250A, 250B, 250C, 250D and the catheters 400 to 400E and other components may also have one or more coatings (not separately described), such as (for example but not limited to) antibiotic or antimicrobial coatings.

[0318] Representative examples of suitable polymers include, but are not limited to, fluorinated polymers or copolymers such as polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropylene, polytetrafluoroethylene, and expanded polytetrafluoroethane; polysulfones; poly(N-vinyl pyrrolidone); polyaminocarbonates; polyiminocarbonates; polyanhydride-co-imide, polyhydroxyvalerate; poly-L-lactic acid; poly-L-lactide; polycaprolactone; poly(lactide-co-glycolide); polyhydroxybutyrate; polyhydroxybutyrate-co-valerate; polydioxanone; poly(orthoesters); polyanhydrides; polyglycolic acid; poly(glycolide); poly(D,L-lactic acid); poly(D,L-lactide); poly(glycolic acid-propylene carbonate); polyphosphates; polyphosphate ester polyurethanes; polypropylene carbonate; polyiminocarbonates; polyethylene; and any derivatives, analogs, homologs, congeners, salts, copolymers, and combinations thereof.

[0319] Polymers may also include, but are not limited to, poly(propylene) copolyetheresters, such as, for example, poly(dioxanone) and poly(ethylene oxide) / poly(lactic acid); poly(anhydrides), poly(alkylene oxalates); polyphosphazenes; polyurethanes; silicones; silicone rubbers; polyesters; poly(olefins); polyisobutylene copolymers; ethylene-α-olefin copolymers; halogenated vinyl polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as, for example, polyvinyl methyl ether; polyvinylidene halides, such as, for example, polyvinylidene chloride; polyacrylonitrile; poly(vinyl ketones); poly(vinyl aromatics), such as poly(styrene); poly(vinyl esters), such as poly(vinyl acetate); copolymers of vinyl monomers and olefins, such as polyethylene-copolyvinyl alcohol (EVAL), acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; and any derivatives, analogs, homologs, homologues, salts, copolymers, and combinations thereof.

[0320] The polymer may also include, but is not limited to, polyamides such as nylon 66 and polycaprolactam; alkyd resins; polycarbonates; poly(oxymethylene); polyimides; polyesteramides; polyethers, including poly(alkylene glycols) such as, for example, poly(ethylene glycol) and poly(propylene glycol); epoxies; polyurethanes; rayon; rayon triacetate; biomolecules such as, for example, fibrin, fibrinogen, starch, polyamino acids; peptides, proteins, gelatin, chondroitin sulfate, sulfate Dermatan (copolymer of D-glucuronic acid or L-iduronic acid and N-acetyl-D-galactosamine), collagen, hyaluronic acid, and glycosaminoglycans; other polysaccharides such as, for example, poly(N-acetylglucosamine), chitin, chitosan, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, nitrocellulose, cellulose propionate, cellulose ethers, and carboxymethyl cellulose; and any derivatives, analogs, homologs, congeners, salts, copolymers, and combinations thereof.

[0321] The present disclosure is to be viewed as an example of the principles of the present invention and is not intended to limit the present invention to the specific embodiments described. In this regard, it should be understood that the present invention is not limited in its application to the details of construction described in the drawings or examples and the arrangement of components set forth above and below. Systems, methods, and devices consistent with the present invention can have other embodiments and can be practiced and implemented in various ways.

[0322] Although the present invention has been described with respect to specific embodiments of the present invention, these embodiments are only illustrative and do not limit the present invention. In the description herein, numerous specific details are provided, such as examples of electronic components, electronic and structural connections, materials and structural variations, to provide a detailed understanding of embodiments of the present invention. However, those skilled in the relevant art will recognize that embodiments of the present invention may be practiced without using one or more of the specific details or using other equipment, systems, assemblies, components, materials, parts, etc. In other examples, well-known structures, materials or operations are not clearly shown or described in detail to avoid blurring the aspects of embodiments of the present invention. In addition, each figure is not drawn to scale and should not be considered as restrictive.

[0323] References throughout this specification to "one embodiment," "an embodiment," or a specific "embodiment" mean that a particular feature, structure, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the invention and is not necessary in all embodiments, and further, does not necessarily refer to the same embodiment. Furthermore, the particular features, structures, or characteristics of any particular embodiment of the invention may be combined in any suitable manner and in any suitable combination with one or more other embodiments, including the use of selected features without the corresponding use of other features. In addition, many modifications may be made to adapt specific applications, situations, or materials to the basic scope and spirit of the invention. It should be understood that various variations and modifications of the embodiments of the invention described and illustrated herein may be in light of the teachings herein and should be considered part of the spirit and scope of the invention.

[0324] It should also be understood that one or more of the elements depicted in the figure may also be implemented in a more separate or integrated manner, or in some cases, even removed or rendered inoperable, which may be useful depending on the specific application. Combinations of components formed integrally are also within the scope of the present invention, especially for embodiments in which the separation or combination of discrete components is unclear or difficult to distinguish. In addition, the term "coupled" is used herein, including in its various forms such as "coupled" or "couplable", meaning and including any direct or indirect electrical or structural coupling, connection or attachment or the adaptability or ability for such direct or indirect electrical or structural coupling, connection or attachment, including integrally formed components and components coupled via or through another component.

[0325] For the statement of numerical ranges herein, each intervening number having the same precision therebetween is expressly contemplated. For example, for the range of 6 to 9, in addition to 6 and 9, the numbers 7 and 8 are also contemplated, and for the range of 6.0 to 7.0, the numbers 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are expressly contemplated. In addition, each intervening subrange within the range is contemplated, in any combination, and is within the scope of the present disclosure. For example, for the range of 5 to 10, the subranges 5 to 6, 5 to 7, 5 to 8, 5 to 9, 6 to 7, 6 to 8, 6 to 9, 6 to 10, 7 to 8, 7 to 9, 7 to 10, 8 to 9, 8 to 10, and 9 to 10 are contemplated and are within the scope of the disclosed range.

[0326] In addition, any signal arrows in the drawings / Figures should be considered only as exemplary and non-limiting, unless otherwise expressly mentioned. The combination of components of the steps is also considered to be within the scope of the present invention, especially when the ability to separate or combine is unclear or unforeseeable. As used herein and throughout the following claims, the disjunctive term "or" is generally intended to mean "and / or", with a combination and separation meaning (and not limited to the "mutually exclusive or" meaning), unless otherwise indicated. As used in the description herein and throughout the following claims, "a / an" and "the" include plural references, unless the context clearly indicates otherwise. Moreover, as used in the description herein and throughout the following claims, the meaning of "in..." includes "in..." and "on...", unless the context clearly indicates otherwise.

[0327] The foregoing description of the illustrated embodiments of the present invention (including that described in the Summary of the Invention and the Abstract) is not intended to be exhaustive or to limit the present invention to the precise form disclosed herein. It should be observed from the foregoing that numerous variations, modifications, and substitutions are contemplated and can be achieved without departing from the spirit and scope of the novel concepts of the present invention. It should be understood that no limitation to the particular methods and apparatus described herein is intended or should be inferred. Of course, it is intended that all such modifications falling within the scope of the claims be covered by the appended claims.

Claims

1. A system for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the system comprising: Access sheath; a suction device removably couplable to the access sheath; and A catheter is removably insertable into the access sheath.

2. The system of claim 1, wherein the access sheath comprises: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen; and A proximal hub is coupled to the first end of the tubular shaft.

3. The system of claim 2, wherein the second end of the tubular shaft is angled or beveled.

4. The system of claim 2, wherein the tubular shaft comprises: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and A gas-filled lumen is disposed between the inner and outer shaft walls.

5. The system of claim 4, wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

6. The system of claim 4, wherein the access sheath further comprises: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

7. The system of claim 5 or 6, wherein the access sheath further comprises: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

8. The system of claim 7, wherein the access sheath further comprises: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

9. A system according to claim 5 or 6, wherein the central tubular lumen forms an aspiration channel for aspirating fluid and one or more gallstones or gallstone fragments from the gallbladder of the human or veterinary subject, and the one or more peripheral tubular lumens and multiple infusion ports together form an infusion channel for infusing fluid into the gallbladder of the human or veterinary subject.

10. The system of claim 5 or 6, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a filter assembly removably coupleable to the hub housing, the filter assembly disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; and A second port is integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the inflation lumen.

11. The system of claim 10, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

12. The system of claim 11, wherein the filter assembly is arranged linearly with or along the longitudinal axis.

13. The system of claim 11, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a first valve integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the hub housing and in fluid communication with the canister lumen; and A connector is coupled to the first valve and the second valve, and the connector is removably coupleable to a suction device.

14. The system of claim 13, wherein the proximal hub further comprises: A third valve is formed integrally with the infusion pathway tubing and the first port or is coupled between the infusion pathway tubing and the first port.

15. The system of claim 13, wherein the first valve and the second valve each comprise at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

16. The system of claim 13, wherein the proximal hub further comprises: A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the central lumen for inserting a catheter into the central lumen.

17. The system of claim 11, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; one or more first valves integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the filter assembly or the hub housing and in fluid communication with the canister lumen; a return path tubing integrally formed with or coupled to the second valve; a connecting tubing having a third valve coupled between the infusion path tubing and the return path tubing and in fluid communication with the infusion path tubing and the return path tubing; a first connector coupled to the infusion pathway tubing; and A second connector is coupled to the return path tubing.

18. The system of claim 17, wherein the suction device comprises: A first suction device, which can be removably coupled to the first connector, the first suction device comprising a first syringe body and a first plunger movable within the first syringe body; and A second suction device, which can be removably coupled to the second connector, the second suction device comprising A second syringe body and a second plunger movable within the second syringe body.

19. The system of claim 18, further comprising: a first rack gear coupled to the first plunger; a second rack gear coupled to the second plunger; a pinion gear abutting and movably engaging the first and second rack gears, the pinion gear being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body; and A clamping assembly is coupled to the pinion gear and the first and second syringe bodies.

20. The system of claim 18, further comprising: A pump coupled to the first and second plungers, the pump being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body.

21. The system of claim 5 or 6, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; a second port integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the hub lumen; a filter assembly removably coupleable to the second port, the filter assembly disposed in fluid communication with the hub lumen; and A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the inflation lumen.

22. The system of claim 21, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

23. The system of claim 22, wherein the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and a central lumen.

24. The access sheath of claim 22, wherein the proximal hub further comprises: a first valve integrally formed with or coupled to the first port; an infusion pathway tubing integrally formed with or coupled to the first valve, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a second valve coupled to the second port and the filter assembly, the second valve being in fluid communication with the hub lumen; a return path tubing coupled to the filter assembly, the return path tubing being arranged in fluid communication with the canister lumen; and A connector is coupled to the infusion path tubing and the return path tubing, the connector being removably coupleable to a suction device.

25. The system of claim 24, wherein the first valve and the second valve each comprise at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

26. The system of claim 24, wherein the hub lumen is arranged linearly with or along the longitudinal axis and the filter assembly, and the return path tubing and the infusion path tubing are arranged laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

27. The system of claim 24, wherein the proximal hub further comprises: A third valve is coupled to the hub housing and arranged linearly with or along the longitudinal axis.

28. The system of claim 27, wherein the third valve is a hemostatic valve having a button actuator, and wherein a catheter is insertable through the hemostatic valve inline with or along the longitudinal axis and into the hub lumen and the central lumen.

29. The system of claim 2, wherein the tubular shaft comprises: an outer shaft wall having a plurality of infusion ports radially arranged about a periphery of the outer shaft wall and spaced from the second distal end; and An inner shaft wall forms the central lumen, the inner shaft wall being coaxial with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls, the inner shaft wall being removably coupleable to the outer shaft wall, the inner shaft wall having a flared distal end.

30. The system of claim 29, wherein the access sheath further comprises: An inflatable sealing and anchoring balloon is arranged at a distance from the second distal end and proximal to the multiple infusion ports, the inflatable sealing and anchoring balloon is radially coupled around the outer wall, and the inflatable sealing and anchoring balloon has a balloon lumen arranged to be connected to the inflation lumen fluid, and the inflation lumen is arranged on the outside of the outer shaft wall.

31. The system of claim 30, wherein the proximal hub comprises: a first proximal hub segment coupled to the outer shaft wall; a first port integrally formed with or coupled to the first proximal hub segment, the first port being arranged in fluid communication with the inflation lumen; a second proximal hub segment coupled to the inner shaft wall and removably coupleable to the first proximal hub segment; a second port integrally formed with or coupled to the second proximal hub segment, the second port being arranged in fluid communication with the one or more peripheral lumens; and An in-line port or connector is integrally formed with or coupled to the second proximal hub segment.

32. The system of claim 2, wherein the central lumen has an inner diameter between 8 and 10 mm (24 and 30 Fr), wherein the access sheath has a length between 12 and 18 cm.

33. The system of claim 2, wherein the central lumen has an inner diameter between 8 mm and 12 mm, wherein the access sheath has a length between 5 cm and 40 cm.

34. The system of claim 2, wherein the proximal hub comprises: a housing having a hub lumen that is continuous with and in fluid communication with the shaft lumen; a first valve disposed in the hub lumen; and A second valve is disposed in the hub lumen, the second valve being spaced apart from the first valve to form a hub lumen between the first and second valves.

35. The system of claim 34, wherein the first valve and the second valve are each self-sealing valves.

36. A system according to claim 34, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

37. The system of claim 34, wherein the proximal hub further comprises: one or more access ports integrally formed with the housing and disposed at a distal end of the first valve, the one or more access ports being in fluid communication with the hub lumen; and A central inline access port is in fluid communication with the hub lumen.

38. The access sheath of claim 37, wherein the proximal hub further comprises: One or more third valves disposed within or coupleable to the one or more access ports.

39. The system of claim 34, wherein the proximal hub further comprises: The first coupling member includes a first tab recess and a second tab recess.

40. The system of claim 34, wherein the proximal hub further comprises: A first coupling member includes a connector having a flexible ring or gasket.

41. The system of claim 2, wherein the proximal hub comprises: a housing having a hub lumen that is continuous with and in fluid communication with the shaft lumen; and At least one valve is disposed in the hub lumen.

42. The system of claim 41 , wherein the proximal hub further comprises: one or more access ports integrally formed with the housing and disposed at a distal end of the first valve, the one or more access ports being in fluid communication with the hub lumen; and A central inline access port is in fluid communication with the hub lumen.

43. The system of claim 41 , wherein the proximal hub further comprises: The first coupling member includes a first tab recess and a second tab recess.

44. The system of claim 41 , wherein the proximal hub further comprises: A first coupling member includes a connector having a flexible ring or gasket.

45. The system of claim 2, wherein the access sheath further comprises: A flexible self-expanding member is coupled to the proximal hub.

46. ​​The system of claim 2, wherein the tubular shaft further comprises one or more internal longitudinal partitions forming a plurality of separate shaft lumens.

47. The system of claim 2, wherein the access sheath is curved, tapered, or angled.

48. The system of claim 1, wherein the suction device comprises: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and A plunger is movable within the interior lumen of the syringe body.

49. The system of claim 48, wherein the suction device further comprises: A first injection valve is coupled to the extended distal tip.

50. The system of claim 49, wherein the suction device further comprises: A second injection valve is coupled to the injection tube body.

51. A system according to claim 50, wherein the first injection valve and the second injection valve each include at least one valve or adapter selected from the group consisting of: duckbill valve; cross-slit valve; plug valve, gate valve, rotary valve; ball valve; Luer valve; Tuohy-Borst adapter; and combinations thereof.

52. The system of claim 48, wherein the plunger comprises: a plunger body having a plunger lumen extending longitudinally within said plunger body; a plunger access port disposed linearly with the plunger lumen and in fluid communication with the plunger lumen; and A plunger handle is coupled to the plunger body.

53. The system of claim 52, wherein the catheter is further removably insertable through the plunger access port and plunger lumen and into the shaft lumen of the access sheath.

54. The system of claim 1, wherein the conduit has a longitudinal dimension and a transverse dimension, wherein the conduit comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

55. The system of claim 54, wherein one or more of the plurality of struts are coupled to each other at a first end of the basket or cage, and one or more of the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

56. The system of claim 54, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter steering shaft at a second end of the basket or cage.

57. The system of claim 56, wherein the catheter further comprises: An atraumatically molded end cap is coupled to the strut ring.

58. The system of claim 54, wherein the plurality of struts are arranged only longitudinally without crossing each other.

59. The system of claim 54, wherein the inner catheter steering shaft is further movable longitudinally to extend out of the outer catheter tube.

60. The system of claim 59, wherein the basket or cage is movable both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

61. The system of claim 60, wherein the basket or cage is further movable longitudinally to extend out of the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended out of the distal end of the outer catheter tube.

62. The system of claim 60, wherein the basket or cage has a diameter of from 20.0 mm to 50.0 mm in the expanded state.

63. The system of claim 54, wherein the plurality of struts comprises eight to twelve struts.

64. The system of claim 54, wherein each of the plurality of struts has a width or diameter from 0.25 mm to 0.7 mm and a length from 55 mm to 104 mm.

65. The system of claim 54, wherein in the expanded state of the basket or cage, a maximum gap width between each of the plurality of struts is from 10.0 to 15.0 mm.

66. The system of claim 54, wherein the basket or cage comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metals, metal alloys, carbon fiber, polymers, and combinations thereof.

67. The system of claim 54, further comprising: A comminution or fracturing device is longitudinally and rotationally movable within the conduit.

68. The system of claim 67, wherein the comminution or fracturing device is longitudinally and rotationally movable within the inner catheter lumen.

69. The system of claim 67, wherein the comminuting or fracturing device is further movable longitudinally to extend out of the inner catheter lumen and the outer catheter tube.

70. The system of claim 67, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A pulverizing or fracturing tip is integrally formed with or coupled to the pulverizing or fracturing shaft at a first end, the pulverizing or fracturing tip having one or more pulverizing or fracturing spears at a second distal end.

71. A method of using the system of claim 70, comprising: longitudinally moving the inner catheter steering shaft to extend out of the outer catheter lumen of the outer catheter tube; using the basket or cage to capture at least one gallstone or gallstone fragment within an interior of the basket or cage; longitudinally moving the inner catheter steering shaft to at least partially retract the basket or cage; and The comminuting or fracturing device is longitudinally moved to extend out of the inner catheter lumen and impact the at least one gallstone or gallstone fragment.

72. The system of claim 70, wherein each of the one or more pulverizing or fracturing spears comprises at least two beveled and chamfered inner edges terminating in a sharp point.

73. The system of claim 72, wherein each of the one or more pulverizing or fracturing spears further comprises an opening, a protrusion, or a cutout.

74. The system of claim 70, wherein the crushing or fracturing tip is at least partially hollow.

75. The system of claim 70, wherein each of the one or more crushing or fracturing spears comprises at least two beveled edges.

76. The system of claim 67, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A crushing or fracturing tip is integrally formed with the crushing or fracturing shaft or coupled to the crushing or fracturing shaft at a first end, the crushing or fracturing tip having at least one configuration selected from the group consisting of an angled configuration, a pointed configuration, a sharp edge or bevel configuration, a bullet configuration, a spherical or "button" configuration, a concave three-pointed configuration, a spear configuration, a concave spear configuration, a drill core configuration, a grooved configuration, a hollow configuration, and combinations thereof.

77. The system of claim 67, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter steering shaft at a second end of the basket or cage.

78. The system of claim 67, wherein the plurality of struts are arranged only longitudinally and do not cross each other.

79. The system of claim 67, wherein the inner catheter steering shaft is further movable longitudinally to extend out of the outer catheter tube.

80. The system of claim 79, wherein the basket or cage is movable both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

81. The system of claim 80, wherein the basket or cage is further movable longitudinally to extend out of the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended out of the distal end of the outer catheter tube.

82. The system of claim 67, wherein the comminution or fracturing device comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metal, metal alloy, carbon fiber, polymer, and combinations thereof.

83. The system of claim 1, wherein the catheter comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft movable within the outer catheter lumen, the inner catheter steering shaft having an inner catheter shaft distal end; and A basket or cage is coupled to the distal end of the outer catheter tube and the distal end of the inner catheter steering shaft, the basket or cage comprising a plurality of struts.

84. The system of claim 83, wherein the catheter further comprises: a catheter tip cover coupled to the plurality of struts, the catheter tip cover having a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

85. The system of claim 83, wherein the catheter further comprises: a catheter tube collar coupled to the first end of the basket or cage and the distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter tube collar and the outer catheter tube; and A catheter tip cap is coupled to the second end of the basket or cage and the distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cap and the inner catheter steering shaft.

86. The system of claim 83, wherein the catheter further comprises: a catheter tube collar coupled to the first end of the basket or cage and the distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter tube collar and the outer catheter tube; and a catheter tip cover coupled to the second end of the basket or cage and the distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cover and the inner catheter steering shaft, the catheter tip cover further comprising a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

87. The system of claim 83, wherein the catheter further comprises: a catheter tube collar coupled to the plurality of struts; and A catheter tip cover is coupled to the plurality of struts.

88. The system of claim 83, wherein the catheter further comprises: a catheter tube collar coupled to the plurality of struts; and a catheter tip cover coupled to the plurality of struts, the catheter tip cover having a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

89. The system of claim 83, wherein the plurality of struts are arranged in a selected cross pattern to form a grid having a plurality of pores of varying pore sizes.

90. The system of claim 83, wherein the plurality of struts are arranged in a selected cross pattern to form a grid having relatively larger pores or openings at a proximal region of the basket or cage and relatively smaller pores or openings at a distal region of the basket or cage.

91. The system of claim 83, wherein the outer catheter tube further comprises: A proximal flush port is disposed at the distal end of the outer catheter tube.

92. The system of claim 83, wherein the plurality of struts are arranged to form a plurality of grappling hooks.

93. The system of claim 83, wherein the basket or cage further comprises: A plurality of sharp teeth, points or wedges, one or more of the plurality of sharp teeth, points or wedges being coupled to or integrally formed with an interior surface of a corresponding one of the plurality of posts.

94. The system of claim 93, wherein the plurality of sharp teeth, points or wedges have one or more shapes selected from the group consisting of: triangle, square, rectangle, circle, arc, and combinations thereof.

95. The system of claim 83, further comprising: A comminuting or fracturing instrument is movable within the outer catheter tube, the comminuting or fracturing instrument terminating at a distal end in a sharp or pointed tip.

96. The system of claim 95, further comprising: A shaft drive is coupled to the comminuting or fracturing apparatus, the shaft drive being selected from the group consisting of a linear actuator, a compression spring drive, an extension spring drive, a torsion spring drive, a spring drive, a constant force spring drive, and combinations thereof.

97. The system of claim 83, further comprising: A pulverizing or fracturing device capable of moving within the outer catheter tube, the pulverizing or fracturing device terminating at the distal end in a tip having a shape selected from the group consisting of: sharp, pointed, rounded, spearhead, diamond-shaped, chamfered, chisel-shaped, bullnose, bullet-head, hollow, drill bit, hole saw, pitted, screw, spiral, finned, and combinations thereof.

98. The system of claim 1, wherein the system further comprises: A comminution or fracturing instrument is insertable into the access sheath.

99. The system of claim 1, wherein the access sheath comprises: A tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen, the tubular shaft comprising: an inner shaft wall forming the central lumen; an outer shaft wall coaxially disposed with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and an inflation lumen disposed between the inner and outer shaft walls; and a proximal hub coupled to the first end of the tubular shaft, the proximal hub comprising: a hub shell having a hub lumen arranged to be in fluid communication with the central lumen; a filter assembly removably coupled to the hub shell, the filter assembly arranged to be in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub shell, the first port arranged to be in fluid communication with the one or more peripheral lumens; and a second port integrally formed with or coupled to the hub shell, the second port arranged to be in fluid communication with the inflation lumen; The suction device comprises: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and a plunger movable within the interior lumen of the syringe body; and wherein the catheter comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

100. A method of using the system of claim 99, the method comprising: percutaneously inserting at least one dilator into a selected location of the patient's gallbladder to form a tract; inserting the access sheath into the tract; attaching the suction device to the proximal hub; Aspiration of one or more gallstones; and Remove the suction device from the proximal hub.

101. The method of using the system of claim 100, further comprising: inserting the catheter through the access sheath; expanding the basket or cage; capturing one or more gallstones using the inflatable basket or cage; shrinking the basket or cage around the one or more gallstones; and The catheter is removed through the access sheath.

102. The method of using the system of claim 101, further comprising: The one or more gallstones are fractured or crushed using a crushing or fracturing instrument inserted into the lumen of the inner catheter.

103. The method of using the system of claim 100, further comprising: The patient's gallbladder is irrigated using the suction device.

104. The system of claim 1, further comprising: crushing or fracturing control equipment; and A comminution or fracturing device is coaxially arranged in the guide tube.

105. The system of claim 104, wherein the pulverization or fracturing control device comprises: case; a control device shaft coupled to the housing, the control device shaft having a control device shaft lumen configured to retain the catheter and the comminuting or fracturing tool disposed within the catheter; A catheter control assembly is arranged in the housing, the catheter control assembly comprising: catheter control actuator; and crushing or fracturing pins; a first handle pivotably coupled to the housing; a control linkage lever pivotally coupled to the first handle and pivotally coupled to the catheter control actuator; a crush or fracturing spring coupled about the crush or fracturing pin; and A second handle is coupled to the pulverizing or fracturing pin.

106. The system of claim 105, wherein the catheter control actuator comprises: A tubular catheter grip is linearly aligned with the control device shaft lumen, the tubular catheter grip being capable of being coupled around the inner catheter steering shaft of the catheter to secure the inner catheter steering shaft and to longitudinally move the inner catheter steering shaft within the catheter in response to movement of the first handle and the control linkage lever.

107. The system of claim 106, wherein the pulverizing or fracturing pin is linearly aligned with the tubular grip within the housing for engagement with the pulverizing or fracturing device.

108. The system of claim 106, wherein the pulverizing or fracturing pin is coaxially disposed within the tubular handle within the housing to engage with the pulverizing or fracturing device, the pulverizing or fracturing device being coaxially disposed within the inner catheter steering shaft.

109. The system of claim 105, wherein the second handle is slidable proximally with the crushing or fracturing pin within the housing to compress the crushing or fracturing spring.

110. The system of claim 105, wherein the pulverization or fracturing control device further comprises: A retaining clip is removably coupled to the second handle to retain the second handle in a proximal position with the compressed crushing or fracturing spring.

111. The system of claim 110, wherein the retaining clip is removable to release the compressed pulverizing or fracturing spring and advance the pulverizing or fracturing pin to impact the pulverizing or fracturing device.

112. A method of using the system of claim 111, comprising: Inserting a catheter and a crushing or fracturing device into the control device shaft, wherein the crushing or fracturing device is coaxially arranged within the inner catheter control shaft of the catheter; securing the proximal end of the catheter in the catheter control actuator; inserting the distal end of the control device shaft into a gall bladder of a human or veterinary subject with the first handle in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and Moving the first handle toward the first position retracts the basket or cage and secures the captured gallstones or gallstone fragments in the basket or cage.

113. The method of claim 112, further comprising: When the captured gallstone or gallstone fragment is smaller than a predetermined size, the control device shaft is withdrawn from the gall bladder of the human or veterinary subject.

114. The method of claim 113, further comprising: When the captured gallstone or gallstone fragment is not smaller than the predetermined size, pulling or sliding the second handle at the proximal end to compress the crushing or fracturing spring; and The second handle is released to advance the pulverizing or fracturing pin to impact the pulverizing or fracturing instrument and move the pulverizing or fracturing instrument into the captured gallstones or gallstone fragments to pulverize or fracture the captured gallstones or gallstone fragments.

115. The method of claim 114, further comprising: Any crushed or crushed gallstone fragments are aspirated using the suction device.

116. The method of claim 112, wherein the step of inserting the distal end of a control device shaft into the gall bladder of the human or veterinary subject further comprises: inserting the access sheath into the gall bladder of the human or veterinary subject; The distal end of the control device shaft is inserted into the access sheath.

117. The system of claim 104, wherein the pulverization or fracturing control device comprises: a housing having a housing slot; a control device shaft coupled to the housing, the control device shaft having a control device shaft lumen configured to retain the catheter and the comminuting or fracturing tool disposed within the catheter; A catheter control assembly is arranged in the housing, the catheter control assembly comprising: catheter control linkage; and crushing or fracturing pins; a first handle coupled to the catheter control linkage assembly and slidable within the housing slot; a second handle coupled to the comminution or fracturing pin; and A trigger actuator is pivotally coupled to the housing and further coupled to engage the catheter control linkage.

118. A system according to claim 117, wherein the catheter control linkage assembly is linearly aligned with the control device shaft lumen and is capable of coupling to the inner catheter steering shaft of the catheter to fix the inner catheter steering shaft and longitudinally move the inner catheter steering shaft within the catheter.

119. The system of claim 118, wherein the pulverizing or fracturing pin is linearly aligned with the conduit control linkage within the housing to engage the pulverizing or fracturing apparatus.

120. The system of claim 118, wherein the pulverizing or fracturing pin is disposed coaxially within the lumen of the catheter control linkage assembly within the housing to engage with the pulverizing or fracturing device, the pulverizing or fracturing device being coaxially disposed within the inner catheter manipulation shaft.

121. The system of claim 120, wherein the second handle is slidable proximally with the comminuting or fracturing pin within the housing to impact the comminuting or fracturing device.

122. The system of claim 121, wherein the trigger actuator is arranged to slidably move the catheter control linkage proximally to retract a basket or cage of the catheter toward the comminution or fracturing device.

123. A method of using the system of claim 122, comprising: Inserting a catheter and a crushing or fracturing device into the control device shaft, wherein the crushing or fracturing device is coaxially arranged within the inner catheter control shaft of the catheter; securing the proximal end of the catheter in the catheter control linkage assembly; inserting the distal end of the control device shaft into a gall bladder of a human or veterinary subject with the first handle in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and Moving the first handle toward the first position retracts the basket or cage and secures the captured gallstones or gallstone fragments in the basket or cage.

124. The method of claim 123, further comprising: When the captured gallstone or gallstone fragment is smaller than a predetermined size, the control device shaft is withdrawn from the gall bladder of the human or veterinary subject.

125. The method of claim 124, further comprising: When the captured gallstones or gallstone fragments are not smaller than the predetermined size, the second handle is slid at the distal end to advance the crushing or fracturing pin to impact the crushing or fracturing instrument and move the crushing or fracturing instrument into the captured gallstones or gallstone fragments to crush or fracture the captured gallstones or gallstone fragments.

126. The method of claim 125, further comprising: The trigger actuator is depressed to slidably move the catheter control linkage proximally to retract the basket or cage of the catheter toward the comminution or fracturing instrument.

127. The method of claim 125, further comprising: Any crushed or crushed gallstone fragments are aspirated using the suction device.

128. The method of claim 123, wherein the step of inserting the distal end of a control device shaft into the gall bladder of the human or veterinary subject further comprises: inserting the access sheath into the gall bladder of the human or veterinary subject; The distal end of the control device shaft is inserted into the access sheath.

129. An access sheath for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the access sheath comprising: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen; and A proximal hub is coupled to the first end of the tubular shaft.

130. The access sheath of claim 129, wherein the second end of the tubular shaft is angled or beveled.

131. The access sheath of claim 129, wherein the tubular shaft comprises: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and A gas-filled lumen is disposed between the inner and outer shaft walls.

132. The access sheath of claim 131 , wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

133. The access sheath of claim 131, further comprising: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

134. The access sheath of claim 132 or 133, further comprising: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

135. The access sheath of claim 134, further comprising: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

136. An access sheath according to claim 132 or 133, wherein the central lumen forms an aspiration channel for aspirating fluid and one or more gallstones or gallstone fragments from the gallbladder of the human or veterinary subject, and the one or more peripheral lumens and multiple infusion ports together form an infusion channel for infusing fluid into the gallbladder of the human or veterinary subject.

137. The access sheath of claim 132 or 133, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a filter assembly removably coupleable to the hub housing, the filter assembly disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; A second port is integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the inflation lumen.

138. The access sheath of claim 137, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

139. The access sheath of claim 138, wherein the filter assembly is arranged linearly with or along the longitudinal axis.

140. The access sheath of claim 138, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a first valve integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the hub housing and in fluid communication with the canister lumen; A connector is coupled to the first valve and the second valve, and the connector is removably coupleable to a suction device.

141. The access sheath of claim 140, further comprising: A third valve is formed integrally with the infusion pathway tubing and the first port or is coupled between the infusion pathway tubing and the first port.

142. An access sheath according to claim 140, wherein the first valve and the second valve each comprise at least one valve or adapter selected from the group consisting of: a pressure lysis valve; a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

143. The access sheath of claim 140, further comprising: A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the central lumen for inserting a catheter into the central lumen.

144. The access sheath of claim 138, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; one or more first valves integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the filter assembly or the hub housing and in fluid communication with the canister lumen; a return path tubing integrally formed with or coupled to the second valve; a connecting tubing having a third valve coupled between the infusion path tubing and the return path tubing and in fluid communication with the infusion path tubing and the return path tubing; a first connector coupled to the infusion pathway tubing; and A second connector is coupled to the return path tubing.

145. The access sheath of claim 144, further comprising: A first suction device, which can be removably coupled to the first connector, the first suction device comprising a first syringe body and a first plunger movable within the first syringe body; and A second suction device, which can be removably coupled to the second connector, the second suction device comprising A second syringe body and a second plunger movable within the second syringe body.

146. The access sheath of claim 145, further comprising: a first rack gear coupled to the first plunger; a second rack gear coupled to the second plunger; a pinion gear abutting and movably engaging the first and second rack gears, the pinion gear being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body; and A clamping assembly is coupled to the pinion gear and the first and second syringe bodies.

147. The access sheath of claim 145, further comprising: A pump coupled to the first and second plungers, the pump being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body.

148. The access sheath of claim 132 or 133, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; a second port integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the hub lumen; a filter assembly removably coupleable to the second port, the filter assembly disposed in fluid communication with the hub lumen; and A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the inflation lumen.

149. The access sheath of claim 148, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

150. The access sheath of claim 149, wherein the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

151. The access sheath of claim 149, wherein the proximal hub further comprises: a first valve integrally formed with or coupled to the first port; an infusion pathway tubing integrally formed with or coupled to the first valve, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a second valve coupled to the second port and the filter assembly, the second valve being in fluid communication with the hub lumen; a return path tubing coupled to the filter assembly, the return path tubing being arranged in fluid communication with the canister lumen; and A connector is coupled to the infusion path tubing and the return path tubing, the connector being removably coupleable to a suction device.

152. An access sheath according to claim 151, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure lysis valve; a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

153. The access sheath of claim 151, wherein the hub lumen is linearly arranged with or along the longitudinal axis and the filter assembly, and the return path tubing and the infusion path tubing are laterally spaced apart from the hub lumen, the longitudinal axis and the central lumen.

154. The access sheath of claim 151, further comprising: A third valve is coupled to the hub housing and arranged linearly with or along the longitudinal axis.

155. The access sheath of claim 26, wherein the third valve is a hemostatic valve with a button actuator, and wherein a catheter is insertable through the hemostatic valve inline with or along the longitudinal axis and into the hub lumen and the central lumen.

156. The access sheath of claim 129, wherein the tubular shaft comprises: an outer shaft wall having a plurality of infusion ports radially arranged about a periphery of the outer shaft wall and spaced from the second distal end; and An inner shaft wall forms the central lumen, the inner shaft wall being coaxial with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls, the inner shaft wall being removably coupleable to the outer shaft wall, the inner shaft wall having a flared distal end.

157. The access sheath of claim 156, further comprising: An inflatable sealing and anchoring balloon is arranged at a distance from the second distal end and proximal to the multiple infusion ports, the inflatable sealing and anchoring balloon is radially coupled around the outer wall, and the inflatable sealing and anchoring balloon has a balloon lumen arranged to be connected to the inflation lumen fluid, and the inflation lumen is arranged on the outside of the outer shaft wall.

158. The access sheath of claim 157, wherein the proximal hub comprises: a first proximal hub segment coupled to the outer shaft wall; a first port integrally formed with or coupled to the first proximal hub segment, the first port being arranged in fluid communication with the inflation lumen; a second proximal hub segment coupled to the inner shaft wall and removably coupleable to the first proximal hub segment; a second port integrally formed with or coupled to the second proximal hub segment, the second port being arranged in fluid communication with the one or more peripheral lumens; and An in-line port or connector is integrally formed with or coupled to the second proximal hub segment.

159. The access sheath of claim 129, wherein the central lumen has an inner diameter between 8 and 10 mm (24 and 30 Fr), wherein the access sheath has a length between 12 and 18 cm.

160. The access sheath of claim 129, wherein the central lumen has an inner diameter between 8 mm and 12 mm, wherein the access sheath has a length between 5 cm and 40 cm.

161. The access sheath of claim 129, wherein the proximal hub comprises: a housing having a hub lumen that is continuous with and in fluid communication with the shaft lumen; a first valve disposed in the hub lumen; and A second valve is disposed in the hub lumen, the second valve being spaced apart from the first valve to form a hub lumen between the first and second valves.

162. The access sheath of claim 161, wherein the first valve and the second valve are each self-sealing valves.

163. An access sheath according to claim 161, wherein the first valve and the second valve each comprise at least one valve or adapter selected from the group consisting of: a pressure lysis valve; a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

164. The access sheath of claim 161, wherein the proximal hub further comprises: one or more access ports integrally formed with the housing and disposed at a distal end of the first valve, the one or more access ports being in fluid communication with the hub lumen; and A central inline access port is in fluid communication with the hub lumen.

165. The access sheath of claim 164, wherein the proximal hub further comprises: One or more third valves disposed within or coupleable to the one or more access ports.

166. The access sheath of claim 161 , wherein the proximal hub further comprises: The first coupling member includes a first tab recess and a second tab recess.

167. The access sheath of claim 161, wherein the proximal hub further comprises: A first coupling member includes a connector having a flexible ring or gasket.

168. The access sheath of claim 129, wherein the proximal hub comprises: a housing having a hub lumen that is continuous with and in fluid communication with the shaft lumen; and At least one valve is disposed in the hub lumen.

169. The access sheath of claim 168, wherein the proximal hub further comprises: one or more access ports integrally formed with the housing and disposed at a distal end of the first valve, the one or more access ports being in fluid communication with the hub lumen; and A central inline access port is in fluid communication with the hub lumen.

170. The access sheath of claim 168, wherein the proximal hub further comprises: The first coupling member includes a first tab recess and a second tab recess.

171. The access sheath of claim 168, wherein the proximal hub further comprises: A first coupling member includes a connector having a flexible ring or gasket.

172. The access sheath of claim 129, wherein the access sheath further comprises: A flexible self-expanding member is coupled to the proximal hub.

173. The access sheath of claim 129, wherein the tubular shaft further comprises one or more internal longitudinal partitions forming a plurality of separate shaft lumens.

174. An access sheath for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the access sheath comprising: A tubular shaft having a first proximal end and a second angled or beveled distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen, the tubular shaft comprising: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and a gas-filled lumen disposed between the inner and outer shaft walls; and a proximal hub coupled to the first end of the tubular shaft, the proximal hub comprising: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a filter assembly removably coupleable to the hub housing, the filter assembly disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; A second port is integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the inflation lumen.

175. The access sheath of claim 174, wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

176. The access sheath of claim 174, further comprising: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

177. The access sheath of claim 175 or 176, further comprising: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

178. The access sheath of claim 177, further comprising: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

179. The access sheath of claim 174, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

180. An access sheath for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the access sheath comprising: A tubular shaft having a first proximal end and a second angled or beveled distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen, the tubular shaft comprising: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and a gas-filled lumen disposed between the inner and outer shaft walls; and a proximal hub coupled to the first end of the tubular shaft, the proximal hub comprising: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; a second port integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the hub lumen; a filter assembly removably coupleable to the second port, the filter assembly disposed in fluid communication with the hub lumen; and A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the inflation lumen.

181. The access sheath of claim 180, wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

182. The access sheath of claim 180, further comprising: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

183. The access sheath of claim 181 or 182, further comprising: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

184. The access sheath of claim 183, further comprising: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

185. The access sheath of claim 180, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

186. The access sheath of claim 180, wherein the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

187. A catheter having a longitudinal dimension and a transverse dimension, the catheter comprising: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

188. The catheter of claim 187, wherein one or more of the plurality of struts are coupled to each other at a first end of the basket or cage, and one or more of the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

189. The catheter of claim 187, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

190. The catheter of claim 189, further comprising: An atraumatically molded end cap is coupled to the strut ring.

191. The catheter of claim 187, wherein the plurality of struts are arranged only longitudinally without crossing each other.

192. The catheter of claim 187, wherein the inner catheter steering shaft is capable of further longitudinal movement to extend out of the outer catheter tube.

193. The catheter of claim 192, wherein the basket or cage is capable of moving both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

194. The catheter of claim 193, wherein the basket or cage is further movable longitudinally to extend out of the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended out of the distal end of the outer catheter tube.

195. The catheter of claim 193, wherein the basket or cage has a diameter of from 20.0 mm to 50.0 mm in the expanded state.

196. The catheter of claim 187, wherein the plurality of struts comprises eight to twelve struts.

197. The catheter of claim 187, wherein each of the plurality of struts has a width or diameter from 0.25 mm to 0.7 mm and a length from 55 mm to 104 mm.

198. The catheter of claim 187, wherein in the expanded state of the basket or cage, the maximum gap width between each of the plurality of struts is from 10.0 to 15.0 mm.

199. The catheter of claim 187, wherein the basket or cage comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metals, metal alloys, carbon fiber, polymers, and combinations thereof.

200. A system for capturing and fracturing gallstones or gallstone fragments for percutaneous removal of said gallstones or said gallstone fragments from a human or veterinary subject for the treatment of cholelithiasis, said system comprising: catheter; and A comminution or fracturing device is longitudinally and rotationally movable within the conduit.

201. The system of claim 200, wherein the conduit has a longitudinal dimension and a transverse dimension, and wherein the conduit comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

202. The system of claim 201, wherein the comminution or fracturing device is capable of longitudinally and rotationally moving within the inner catheter lumen.

203. The system of claim 202, wherein the comminution or fracturing device is further movable longitudinally to extend out of the inner catheter lumen and the outer catheter tube.

204. The system of claim 201, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A pulverizing or fracturing tip is integrally formed with or coupled to the pulverizing or fracturing shaft at a first end, the pulverizing or fracturing tip having one or more pulverizing or fracturing spears at a second distal end.

205. A method of using the system of claim 204, comprising: longitudinally moving the inner catheter steering shaft to extend out of the outer catheter lumen of the outer catheter tube; using the basket or cage to capture at least one gallstone or gallstone fragment within an interior of the basket or cage; longitudinally moving the inner catheter steering shaft to at least partially retract the basket or cage; and The comminuting or fracturing device is longitudinally moved to extend out of the inner catheter lumen and impact the at least one gallstone or gallstone fragment.

206. The system of claim 204, wherein each of the one or more crushing or fracturing spears comprises at least two beveled and chamfered inner edges terminating in a sharp point.

207. The system of claim 206, wherein each of the one or more crushing or fracturing spears further comprises an opening, a protrusion, or a cutout.

208. The system of claim 204, wherein the crushing or fracturing tip is at least partially hollow.

209. The system of claim 204, wherein each of the one or more crushing or fracturing spears comprises at least two beveled edges.

210. The system of claim 201, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A crushing or fracturing tip is integrally formed with the crushing or fracturing shaft or coupled to the crushing or fracturing shaft at a first end, the crushing or fracturing tip having at least one configuration selected from the group consisting of an angled configuration, a pointed configuration, a sharp edge or bevel configuration, a bullet configuration, a spherical or "button" configuration, a concave three-pointed configuration, a spear configuration, a concave spear configuration, a drill core configuration, a grooved configuration, a hollow configuration, and combinations thereof.

211. The system of claim 201, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

212. A system according to claim 201, wherein the plurality of struts are arranged only longitudinally and do not cross each other.

213. The system of claim 201, wherein the inner catheter steering shaft is capable of further longitudinal movement to extend out of the outer catheter tube.

214. The system of claim 213, wherein the basket or cage is capable of moving both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

215. The system of claim 214, wherein the basket or cage is further movable longitudinally to extend beyond the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended beyond the distal end of the outer catheter tube.

216. The system of claim 201, wherein the comminution or fracturing device comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metal, metal alloy, carbon fiber, polymer, and combinations thereof.

217. A catheter comprising: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft movable within the outer catheter lumen, the inner catheter steering shaft having an inner catheter shaft distal end; and A basket or cage is coupled to the distal end of the outer catheter tube and the distal end of the inner catheter steering shaft, the basket or cage comprising a plurality of struts.

218. The catheter of claim 217, further comprising: a catheter tip cover coupled to the plurality of struts, the catheter tip cover having a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

219. The catheter of claim 217, wherein the catheter further comprises: a catheter tube collar coupled to the first end of the basket or cage and the distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter tube collar and the outer catheter tube; and A catheter tip cap is coupled to the second end of the basket or cage and the distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cap and the inner catheter steering shaft.

220. The catheter of claim 217, wherein the catheter further comprises: a catheter tube collar coupled to the first end of the basket or cage and the distal end of the outer catheter tube, wherein one or more corresponding first ends of the plurality of struts are coupled between the catheter tube collar and the outer catheter tube; and a catheter tip cover coupled to the second end of the basket or cage and the distal end of the inner catheter steering shaft, wherein one or more corresponding second ends of the plurality of struts are coupled between the catheter tip cover and the inner catheter steering shaft, the catheter tip cover further comprising a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

221. The catheter of claim 217, wherein the catheter further comprises: a catheter tube collar coupled to the plurality of struts; and A catheter tip cover is coupled to the plurality of struts.

222. The catheter of claim 217, wherein the catheter further comprises: a catheter tube collar coupled to the plurality of struts; and a catheter tip cover coupled to the plurality of struts, the catheter tip cover having a tip opening; The inner catheter steering shaft further comprises an inner catheter shaft lumen coupled to the tip opening and in fluid communication with the tip opening to form a catheter distal flushing port.

223. The catheter of claim 217, wherein the plurality of struts are arranged in a selected crossing pattern to form a grid of a plurality of pores having different pore sizes.

224. The catheter of claim 217, wherein the plurality of struts are arranged in a selected cross pattern to form a grid having relatively larger pores or openings at a proximal region of the basket or cage and relatively smaller pores or openings at a distal region of the basket or cage.

225. The catheter of claim 217, wherein the outer catheter tube further comprises: A proximal flush port is disposed at the distal end of the outer catheter tube.

226. The catheter of claim 217, wherein the plurality of struts are arranged to form a plurality of grabbers.

227. The catheter of claim 217, wherein the basket or cage further comprises: A plurality of sharp teeth, points or wedges, one or more of the plurality of sharp teeth, points or wedges being coupled to or integrally formed with an interior surface of a corresponding one of the plurality of posts.

228. The catheter of claim 227, wherein the plurality of sharp teeth, points or wedges have one or more shapes selected from the group consisting of: triangle, square, rectangle, circle, arc, and combinations thereof.

229. The catheter of claim 217, further comprising: A comminution or fracturing instrument is movable within the outer catheter tube, the shaft terminating at the distal end in a sharp or pointed tip.

230. The catheter of claim 229, further comprising: A shaft drive is coupled to the comminuting or fracturing apparatus, the shaft drive being selected from the group consisting of a linear actuator, a compression spring drive, an extension spring drive, a torsion spring drive, a spring drive, a constant force spring drive, and combinations thereof.

231. The catheter of claim 217, further comprising: A pulverizing or fracturing device capable of moving within the outer catheter tube, the pulverizing or fracturing device terminating at the distal end in a tip having a shape selected from the group consisting of: sharp, pointed, rounded, spearhead, diamond-shaped, chamfered, chisel-shaped, bullnose, bullet-head, hollow, drill bit, hole saw, pitted, screw, spiral, finned, and combinations thereof.

232. A suction device comprising: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and A plunger is movable within the interior lumen of the syringe body.

233. The suction device of claim 232, further comprising: A first injection valve is coupled to the extended distal tip.

234. The suction device of claim 233, wherein the suction device further comprises: A second injection valve is coupled to the injection tube body.

235. The suction device of claim 234, wherein the first injection valve and the second injection valve each comprise at least one valve or adapter selected from the group consisting of: a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

236. The suction device of claim 232, wherein the plunger comprises: a plunger body having a plunger lumen extending longitudinally within said plunger body; A plunger handle is coupled to the plunger body.

237. The suction device of claim 232, wherein the plunger comprises: a plunger body having a plunger lumen extending longitudinally within said plunger body; a plunger access port disposed linearly with the plunger lumen and in fluid communication with the plunger lumen; and A plunger handle is coupled to the plunger body.

238. The aspiration device of claim 232, wherein the extended distal tip further comprises: A coupling includes an annular recess for inserting a mating flexible ring or gasket.

239. The suction device of claim 232, wherein the suction device further comprises: An injection valve is coupled to the injection tube body.

240. The suction device of claim 239, wherein the first injection valve and the second injection valve each comprise at least one valve or adapter selected from the group consisting of: a duckbill valve; a cross-slit valve; a stopcock valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

241. A comminution or fracturing control device for capturing gallstones or gallstone fragments with a catheter and for comminution or fracturing the gallstones or gallstone fragments with a comminution or fracturing device coaxially disposed within the catheter for percutaneous removal of the gallstones or the gallstone fragments from a human or veterinary subject for the treatment of cholelithiasis, the comminution or fracturing control device comprising: case; a control device shaft coupled to the housing, the control device shaft having a control device shaft lumen configured to retain the catheter and the comminuting or fracturing tool disposed within the catheter; A catheter control assembly is arranged in the housing, the catheter control assembly comprising: catheter control actuator; and crushing or fracturing pins; a first handle pivotably coupled to the housing; a control linkage lever pivotally coupled to the first handle and pivotally coupled to the catheter control actuator; a crush or fracturing spring coupled about the crush or fracturing pin; and A second handle is coupled to the pulverizing or fracturing pin.

242. The pulverizing or fracturing control device of claim 241, wherein the conduit control actuator comprises: A tubular catheter grip is linearly aligned with the control device shaft lumen, the tubular catheter grip being capable of being coupled around the inner catheter steering shaft of the catheter to secure the inner catheter steering shaft and to longitudinally move the inner catheter steering shaft within the catheter in response to movement of the first handle and the control linkage lever.

243. A pulverizing or fracturing control apparatus as claimed in claim 242, wherein the pulverizing or fracturing pin is linearly aligned with the tubular grip within the housing to engage with the pulverizing or fracturing apparatus.

244. A crushing or fracturing control device according to claim 242, wherein the crushing or fracturing pin is coaxially arranged in the tubular handle within the housing to engage with the crushing or fracturing device, and the crushing or fracturing device is coaxially arranged in the inner catheter operating shaft.

245. A crushing or fracturing control device according to claim 241, wherein the second handle is capable of sliding proximally with the crushing or fracturing pin within the housing to compress the crushing or fracturing spring.

246. The pulverizing or fracturing control device of claim 241, further comprising: A retaining clip is removably coupled to the second handle to retain the second handle in a proximal position with the compressed crushing or fracturing spring.

247. A pulverizing or fracturing control apparatus as claimed in claim 246, wherein the retaining clip is removable to release the compressed pulverizing or fracturing spring and advance the pulverizing or fracturing pin to impact the pulverizing or fracturing device.

248. A method of using the pulverizing or fracturing control device of claim 247, comprising: Inserting a catheter and a crushing or fracturing device into the control device shaft, wherein the crushing or fracturing device is coaxially arranged within the inner catheter control shaft of the catheter; securing the proximal end of the catheter in the catheter control actuator; inserting the distal end of the control device shaft into a gall bladder of a human or veterinary subject with the first handle in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and Moving the first handle toward the first position retracts the basket or cage and secures the captured gallstones or gallstone fragments in the basket or cage.

249. The method of claim 248, further comprising: When the captured gallstone or gallstone fragment is smaller than a predetermined size, the control device shaft is withdrawn from the gall bladder of the human or veterinary subject.

250. The method of claim 249, further comprising: When the captured gallstone or gallstone fragment is not smaller than the predetermined size, pulling or sliding the second handle at the proximal end to compress the crushing or fracturing spring; and The second handle is released to advance the pulverizing or fracturing pin to impact the pulverizing or fracturing instrument and move the pulverizing or fracturing instrument into the captured gallstones or gallstone fragments to pulverize or fracture the captured gallstones or gallstone fragments.

251. The method of claim 250, further comprising: Aspirate any crushed or crushed gallstone fragments.

252. The method of claim 248, wherein the step of inserting the distal end of a control device shaft into the gall bladder of the human or veterinary subject further comprises: The distal end of the control device shaft is inserted into an access sheath positioned within the gall bladder of the human or veterinary subject.

253. A comminution or fracturing control device for capturing gallstones or gallstone fragments with a catheter and for comminution or fracturing the gallstones or gallstone fragments with a comminution or fracturing device coaxially disposed within the catheter for percutaneous removal of the gallstones or the gallstone fragments from a human or veterinary subject for the treatment of cholelithiasis, the comminution or fracturing control device comprising: a housing having a housing slot; a control device shaft coupled to the housing, the control device shaft having a control device shaft lumen configured to retain the catheter and the comminuting or fracturing tool disposed within the catheter; A catheter control assembly is arranged in the housing, the catheter control assembly comprising: catheter control linkage; and crushing or fracturing pins; a first handle coupled to the catheter control linkage assembly and slidable within the housing slot; a second handle coupled to the comminution or fracturing pin; and A trigger actuator is pivotally coupled to the housing and further coupled to engage the catheter control linkage.

254. A comminution or fracturing control device according to claim 253, wherein the catheter control linkage group is linearly aligned with the control device shaft lumen and is capable of being coupled to the inner catheter steering shaft of the catheter to fix the inner catheter steering shaft and longitudinally move the inner catheter steering shaft within the catheter.

255. A pulverizing or fracturing control apparatus as claimed in claim 254, wherein the pulverizing or fracturing pin is linearly aligned with the conduit control linkage set within the housing to engage with the pulverizing or fracturing apparatus.

256. A crushing or fracturing control device according to claim 254, wherein the crushing or fracturing pin arranged in the tubular cavity of the catheter control link group in the shell is coaxial to engage with the crushing or fracturing device, and the crushing or fracturing device is coaxially arranged in the inner catheter operating shaft.

257. A pulverizing or fracturing control device according to claim 256, wherein the second handle is capable of sliding proximally together with the pulverizing or fracturing pin within the housing to impact the pulverizing or fracturing device.

258. A comminution or fracturing control apparatus according to claim 257, wherein the trigger actuator is arranged to slidably move the catheter control linkage group proximally to retract the basket or cage of the catheter toward the comminution or fracturing device.

259. A method of using the pulverizing or fracturing control device of claim 258, comprising: Inserting a catheter and a crushing or fracturing device into the control device shaft, wherein the crushing or fracturing device is coaxially arranged within the inner catheter control shaft of the catheter; securing the proximal end of the catheter in the catheter control linkage assembly; inserting the distal end of the control device shaft into a gall bladder of a human or veterinary subject with the first handle in a first position; moving the first handle to a second position to advance the inner catheter steering shaft and expand a basket or cage at the distal end of the catheter; capturing gallstones or gallstone fragments in the basket or cage; and Moving the first handle toward the first position retracts the basket or cage and secures the captured gallstones or gallstone fragments in the basket or cage.

260. The method of claim 259, further comprising: When the captured gallstone or gallstone fragment is smaller than a predetermined size, the control device shaft is withdrawn from the gall bladder of the human or veterinary subject.

261. The method of claim 260, further comprising: When the captured gallstones or gallstone fragments are not smaller than the predetermined size, the second handle is slid at the distal end to advance the crushing or fracturing pin to impact the crushing or fracturing instrument and move the crushing or fracturing instrument into the captured gallstones or gallstone fragments to crush or fracture the captured gallstones or gallstone fragments.

262. The method of claim 261, further comprising: The trigger actuator is depressed to slidably move the catheter control linkage proximally to retract the basket or cage of the catheter toward the comminution or fracturing instrument.

263. The method of claim 261, further comprising: Aspirate any crushed or crushed gallstone fragments.

264. The method of claim 259, wherein the step of inserting the distal end of a control device shaft into the gall bladder of the human or veterinary subject further comprises: The distal end of the control device shaft is inserted into an access sheath positioned within the gall bladder of the human or veterinary subject.

265. A system for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the system comprising: Access sheath; and A suction device can be removably coupled to the access sheath.

266. The system of claim 265, wherein the access sheath comprises: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen; and A proximal hub is coupled to the first end of the tubular shaft.

267. The system of claim 266, wherein the second end of the tubular shaft is angled or beveled.

268. The system of claim 266, wherein the tubular shaft comprises: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and A gas-filled lumen is disposed between the inner and outer shaft walls.

269. The system of claim 268, wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

270. The system of claim 268, wherein the access sheath further comprises: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

271. The system of claim 269 or 270, wherein the access sheath further comprises: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

272. The system of claim 271, wherein the access sheath further comprises: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

273. A system according to claim 269 or 270, wherein the central tubular lumen forms an aspiration channel for aspirating fluid and one or more gallstones or gallstone fragments from the gallbladder of the human or veterinary subject, and the one or more peripheral tubular lumens and multiple infusion ports together form an infusion channel for infusing fluid into the gallbladder of the human or veterinary subject.

274. The system of claim 269 or 270, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a filter assembly removably coupleable to the hub housing, the filter assembly disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; and A second port is integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the inflation lumen.

275. The system of claim 274, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

276. The system of claim 275, wherein the filter assembly is arranged linearly with or along the longitudinal axis.

277. The system of claim 275, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a first valve integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the hub housing and in fluid communication with the canister lumen; A connector is coupled to the first valve and the second valve, and the connector is removably coupleable to a suction device.

278. The system of claim 277, wherein the proximal hub further comprises: A third valve is formed integrally with the infusion pathway tubing and the first port or is coupled between the infusion pathway tubing and the first port.

279. A system according to claim 277, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

280. The system of claim 277, wherein the proximal hub further comprises: A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the central lumen for inserting a catheter into the central lumen.

281. The system of claim 275, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; one or more first valves integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the filter assembly or the hub housing and in fluid communication with the canister lumen; a return path tubing integrally formed with or coupled to the second valve; a connecting tubing having a third valve coupled between the infusion path tubing and the return path tubing and in fluid communication with the infusion path tubing and the return path tubing; a first connector coupled to the infusion pathway tubing; and A second connector is coupled to the return path tubing.

282. The system of claim 281, further comprising: A first suction device, which can be removably coupled to the first connector, the first suction device comprising a first syringe body and a first plunger movable within the first syringe body; and A second suction device, which can be removably coupled to the second connector, the second suction device comprising A second syringe body and a second plunger movable within the second syringe body.

283. The system of claim 282, further comprising: a first rack gear coupled to the first plunger; a second rack gear coupled to the second plunger; a pinion gear abutting and movably engaging the first and second rack gears, the pinion gear being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body; and A clamping assembly is coupled to the pinion gear and the first and second syringe bodies.

284. The system of claim 282, further comprising: A pump coupled to the first and second plungers, the pump being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body.

285. The system of claim 269 or 270, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; a second port integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the hub lumen; a filter assembly removably coupleable to the second port, the filter assembly disposed in fluid communication with the hub lumen; and A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the inflation lumen.

286. The system of claim 285, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

287. The system of claim 286, wherein the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

288. The access sheath of claim 286, wherein the proximal hub further comprises: a first valve integrally formed with or coupled to the first port; an infusion pathway tubing integrally formed with or coupled to the first valve, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a second valve coupled to the second port and the filter assembly, the second valve being in fluid communication with the hub lumen; a return path tubing coupled to the filter assembly, the return path tubing being arranged in fluid communication with the canister lumen; and A connector is coupled to the infusion path tubing and the return path tubing, the connector being removably coupleable to a suction device.

289. A system according to claim 288, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

290. The system of claim 288, wherein the hub lumen is linearly arranged with or along the longitudinal axis and the filter assembly, and the return path tubing and the infusion path tubing are laterally spaced apart from the hub lumen, the longitudinal axis, and the central lumen.

291. The system of claim 288, wherein the proximal hub further comprises: A third valve is coupled to the hub housing and arranged linearly with or along the longitudinal axis.

292. The system of claim 291 wherein the third valve is a hemostatic valve having a button actuator and wherein a catheter is insertable through the hemostatic valve inline with or along the longitudinal axis and into the hub lumen and the central lumen.

293. The system of claim 266, wherein the tubular shaft comprises: an outer shaft wall having a plurality of infusion ports radially arranged about a periphery of the outer shaft wall and spaced from the second distal end; and An inner shaft wall forms the central lumen, the inner shaft wall being coaxial with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls, the inner shaft wall being removably coupleable to the outer shaft wall, the inner shaft wall having a flared distal end.

294. The system of claim 293, wherein the access sheath further comprises: An inflatable sealing and anchoring balloon is arranged at a distance from the second distal end and proximal to the multiple infusion ports, the inflatable sealing and anchoring balloon is radially coupled around the outer wall, and the inflatable sealing and anchoring balloon has a balloon lumen arranged to be connected to the inflation lumen fluid, and the inflation lumen is arranged on the outside of the outer shaft wall.

295. The system of claim 294, wherein the proximal hub comprises: a first proximal hub segment coupled to the outer shaft wall; a first port integrally formed with or coupled to the first proximal hub segment, the first port being arranged in fluid communication with the inflation lumen; a second proximal hub segment coupled to the inner shaft wall and removably coupleable to the first proximal hub segment; a second port integrally formed with or coupled to the second proximal hub segment, the second port being arranged in fluid communication with the one or more peripheral lumens; and An in-line port or connector is integrally formed with or coupled to the second proximal hub segment.

296. The system of claim 266, wherein the central lumen has an inner diameter between 8 and 10 mm (24 and 30 Fr), wherein the access sheath has a length between 12 and 18 cm.

297. The system of claim 266, wherein the central lumen has an inner diameter between 8 mm and 12 mm, wherein the access sheath has a length between 5 cm and 40 cm.

298. The system of claim 265, wherein the suction device comprises: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and A plunger is movable within the interior lumen of the syringe body.

299. The system of claim 298, wherein the suction device further comprises: A first injection valve is coupled to the extended distal tip.

300. The system of claim 299, wherein the suction device further comprises: A second injection valve is coupled to the injection tube body.

301. A system according to claim 300, wherein the first injection valve and the second injection valve each include at least one valve or adapter selected from the group consisting of: duckbill valve; cross-slit valve; stopcock valve, gate valve, rotary valve; ball valve; Luer valve; Tuohy-Borst adapter; and combinations thereof.

302. The system of claim 298, wherein the plunger comprises: a plunger body having a plunger lumen extending longitudinally within said plunger body; a plunger access port disposed linearly with the plunger lumen and in fluid communication with the plunger lumen; and A plunger handle is coupled to the plunger body.

303. The system of claim 302, wherein the catheter is further removably insertable through the plunger access port and plunger lumen and into the shaft lumen of the access sheath.

304. The system of claim 265, further comprising: A conduit having a longitudinal dimension and a transverse dimension, the conduit comprising: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

305. The system of claim 304, wherein one or more of the plurality of struts are coupled to each other at a first end of the basket or cage, and one or more of the plurality of struts are coupled to the distal end manipulated by the inner catheter at a second end of the basket or cage.

306. The system of claim 304, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

307. The system of claim 306, wherein the catheter further comprises: An atraumatically molded end cap is coupled to the strut ring.

308. A system according to claim 304, wherein the plurality of struts are arranged only longitudinally and do not cross each other.

309. The system of claim 304, wherein the inner catheter steering shaft is capable of further longitudinal movement to extend out of the outer catheter tube.

310. The system of claim 309, wherein the basket or cage is capable of moving both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

311. The system of claim 310, wherein the basket or cage is further movable longitudinally to extend beyond the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended beyond the distal end of the outer catheter tube.

312. The system of claim 304, wherein the basket or cage comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metals, metal alloys, carbon fiber, polymers, and combinations thereof.

313. The system of claim 304, further comprising: A comminution or fracturing device is longitudinally and rotationally movable within the conduit.

314. The system of claim 313, wherein the comminution or fracturing device is capable of longitudinally and rotationally moving within the inner catheter lumen.

315. The system of claim 313, wherein the comminuting or fracturing device is further movable longitudinally to extend out of the inner catheter lumen and the outer catheter tube.

316. The system of claim 313, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A pulverizing or fracturing tip is integrally formed with or coupled to the pulverizing or fracturing shaft at a first end, the pulverizing or fracturing tip having one or more pulverizing or fracturing spears at a second distal end.

317. A method of using the system of claim 316, comprising: longitudinally moving the inner catheter steering shaft to extend out of the outer catheter lumen of the outer catheter tube; using the basket or cage to capture at least one gallstone or gallstone fragment within an interior of the basket or cage; longitudinally moving the inner catheter steering shaft to at least partially retract the basket or cage; and The comminuting or fracturing device is longitudinally moved to extend out of the inner catheter lumen and impact the at least one gallstone or gallstone fragment.

318. The system of claim 316, wherein each of the one or more crushing or fracturing spears comprises at least two beveled and chamfered inner edges terminating in a sharp point.

319. The system of claim 318, wherein each of the one or more crushing or fracturing spears further comprises an opening, a protrusion, or a cutout.

320. The system of claim 316, wherein the crushing or fracturing tip is at least partially hollow.

321. The system of claim 316, wherein each of the one or more crushing or fracturing spears comprises at least two beveled edges.

322. The system of claim 313, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A crushing or fracturing tip is integrally formed with the crushing or fracturing shaft or coupled to the crushing or fracturing shaft at a first end, the crushing or fracturing tip having at least one configuration selected from the group consisting of an angled configuration, a pointed configuration, a sharp edge or bevel configuration, a bullet configuration, a spherical or "button" configuration, a concave three-pointed configuration, a spear configuration, a concave spear configuration, a drill core configuration, a grooved configuration, a hollow configuration, and combinations thereof.

323. The system of claim 304, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

324. A system according to claim 304, wherein the plurality of struts are arranged only longitudinally and do not cross each other.

325. A system for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the system comprising: Access sheath; and A catheter is removably insertable into the access sheath.

326. The system of claim 325, wherein the access sheath comprises: a tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen; and A proximal hub is coupled to the first end of the tubular shaft.

327. The system of claim 326, wherein the second end of the tubular shaft is angled or beveled.

328. The system of claim 326, wherein the tubular shaft comprises: an inner shaft wall forming the central lumen; an outer shaft wall disposed coaxially with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and A gas-filled lumen is disposed between the inner and outer shaft walls.

329. The system of claim 328, wherein the outer shaft wall further comprises: A plurality of infusion ports and at least one inflation port, wherein the plurality of infusion ports are radially arranged around the periphery of the outer shaft wall and spaced from the second distal end, the inflation lumen is spaced from the second distal end, and the plurality of infusion ports are fluidically connected to the one or more peripheral lumens.

330. The system of claim 328, wherein the access sheath further comprises: An access sheath tip is coupled to the second distal end of the tubular shaft, the access sheath tip having a beveled tip and a plurality of infusion ports, the plurality of infusion ports being radially arranged and spaced apart from the beveled tip and being in fluid communication with the one or more peripheral lumens, the access sheath tip further comprising a plurality of tabs insertable between the inner shaft wall and the outer shaft wall.

331. The system of claim 329 or 330, wherein the access sheath further comprises: An inflatable sealing and anchoring balloon is spaced apart from the second distal end and proximal to the plurality of infusion ports, the inflatable sealing and anchoring balloon being radially coupled around the outer wall, the inflatable sealing and anchoring balloon having a balloon lumen arranged to be in fluid communication with the inflation lumen.

332. The system of claim 331 , wherein the access sheath further comprises: An adjustable plug is spaced proximally from the inflatable sealing and anchoring balloon and radially coupled about the outer wall.

333. A system according to claim 329 or 330, wherein the central tubular lumen forms an aspiration channel for aspirating fluid and one or more gallstones or gallstone fragments from the gallbladder of the human or veterinary subject, and the one or more peripheral tubular lumens and multiple infusion ports together form an infusion channel for infusing fluid into the gallbladder of the human or veterinary subject.

334. The system of claim 329 or 330, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a filter assembly removably coupleable to the hub housing, the filter assembly disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; and A second port is integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the inflation lumen.

335. The system of claim 334, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

336. The system of claim 335, wherein the filter assembly is arranged linearly with or along the longitudinal axis.

337. The system of claim 335, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a first valve integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the hub housing and in fluid communication with the canister lumen; A connector is coupled to the first valve and the second valve, and the connector is removably coupleable to a suction device.

338. The system of claim 337, wherein the proximal hub further comprises: A third valve is formed integrally with the infusion pathway tubing and the first port or is coupled between the infusion pathway tubing and the first port.

339. A system according to claim 337, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

340. The system of claim 337, wherein the proximal hub further comprises: A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the central lumen for inserting a catheter into the central lumen.

341. The system of claim 335, wherein the proximal hub further comprises: an infusion pathway tubing integrally formed with or coupled to the first port, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; one or more first valves integrally formed with or coupled to the infusion pathway tubing; a second valve integrally formed with or coupled to the filter assembly or the hub housing and in fluid communication with the canister lumen; a return path tubing integrally formed with or coupled to the second valve; a connecting tubing having a third valve coupled between the infusion path tubing and the return path tubing and in fluid communication with the infusion path tubing and the return path tubing; a first connector coupled to the infusion pathway tubing; and A second connector is coupled to the return path tubing.

342. The system of claim 341, further comprising: A first suction device, which can be removably coupled to the first connector, the first suction device comprising a first syringe body and a first plunger movable within the first syringe body; and A second suction device, which can be removably coupled to the second connector, the second suction device comprising A second syringe body and a second plunger movable within the second syringe body.

343. The system of claim 342, further comprising: a first rack gear coupled to the first plunger; a second rack gear coupled to the second plunger; a pinion gear abutting and movably engaging the first and second rack gears, the pinion gear being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body; and A clamping assembly is coupled to the pinion gear and the first and second syringe bodies.

344. The system of claim 342, further comprising: A pump coupled to the first and second plungers, the pump being arranged to advance the first plunger within the first syringe body while concurrently retracting the second plunger from the second syringe body and to advance the second plunger within the second syringe body while concurrently retracting the first plunger from the first syringe body.

345. The system of claim 329 or 330, wherein the proximal hub comprises: a hub housing having a hub lumen disposed in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub housing, the first port being arranged in fluid communication with the one or more peripheral lumens; a second port integrally formed with or coupled to the hub housing, the second port being arranged in fluid communication with the hub lumen; a filter assembly removably coupleable to the second port, the filter assembly disposed in fluid communication with the hub lumen; and A third port is integrally formed with or coupled to the hub housing, the third port being arranged in fluid communication with the inflation lumen.

346. The system of claim 345, wherein the filter assembly comprises: a canister removably coupleable to the housing, the canister having a canister lumen; and A filter is disposed within the canister and is in fluid communication with the hub lumen, the filter forming a filter cavity within the canister.

347. The system of claim 346, wherein the filter assembly is laterally spaced from the hub lumen, the longitudinal axis, and the central lumen.

348. The access sheath of claim 346, wherein the proximal hub further comprises: a first valve integrally formed with or coupled to the first port; an infusion pathway tubing integrally formed with or coupled to the first valve, the infusion pathway tubing being arranged in fluid communication with the one or more peripheral lumens; a second valve coupled to the second port and the filter assembly, the second valve being in fluid communication with the hub lumen; a return path tubing coupled to the filter assembly, the return path tubing being arranged in fluid communication with the canister lumen; and A connector is coupled to the infusion path tubing and the return path tubing, the connector being removably coupleable to a suction device.

349. A system according to claim 348, wherein the first valve and the second valve each include at least one valve or adapter selected from the group consisting of: a pressure pyrolysis valve; a duckbill valve; a cross-slit valve; a plug valve, a gate valve, a rotary valve; a ball valve; a Luer valve; a Tuohy-Borst adapter; and combinations thereof.

350. The system of claim 348, wherein the hub lumen is linearly arranged with or along the longitudinal axis and the filter assembly, and the return path tubing and the infusion path tubing are laterally spaced apart from the hub lumen, the longitudinal axis, and the central lumen.

351. The system of claim 348, wherein the proximal hub further comprises: A third valve is coupled to the hub housing and arranged linearly with or along the longitudinal axis.

352. The system of claim 351 wherein the third valve is a hemostatic valve having a button actuator and wherein a catheter is insertable through the hemostatic valve inline with or along the longitudinal axis and into the hub lumen and the central lumen.

353. The system of claim 325, wherein the conduit has a longitudinal dimension and a transverse dimension, wherein the conduit comprises: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and A basket or cage is coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts.

354. The system of claim 353, wherein one or more of the plurality of struts are coupled to each other at a first end of the basket or cage, and one or more of the plurality of struts are coupled to the distal end manipulated by the inner catheter at a second end of the basket or cage.

355. The system of claim 353, wherein the plurality of struts are coupled to a strut ring at a first end of the basket or cage, and the plurality of struts are coupled to the distal end of the inner catheter manipulation at a second end of the basket or cage.

356. The system of claim 355, wherein the catheter further comprises: An atraumatically molded end cap is coupled to the strut ring.

357. A system according to claim 353, wherein the plurality of struts are arranged only longitudinally and do not cross each other.

358. The system of claim 353, wherein the inner catheter steering shaft is capable of further longitudinal movement to extend out of the outer catheter tube.

359. The system of claim 358, wherein the basket or cage is capable of moving both longitudinally and rotationally within the outer catheter lumen along with the inner catheter steering shaft in a collapsed or compressed state.

360. The system of claim 359, wherein the basket or cage is further movable longitudinally to extend beyond the distal end of the outer catheter tube, and wherein the basket or cage has an expanded state when the basket or cage is fully extended beyond the distal end of the outer catheter tube.

361. The system of claim 359, wherein the basket or cage has a diameter of from 20.0 mm to 50.0 mm in the expanded state.

362. The system of claim 353, wherein the plurality of struts comprises eight to twelve struts.

363. The system of claim 353, wherein each of the plurality of struts has a width or diameter from 0.25 mm to 0.7 mm and a length from 55 mm to 104 mm.

364. The system of claim 353, wherein in the expanded state of the basket or cage, a maximum gap width between each of the plurality of struts is from 10.0 to 15.0 mm.

365. The system of claim 353, wherein the basket or cage comprises one or more materials selected from the group consisting of: nitinol, titanium, stainless steel, metals, metal alloys, carbon fiber, polymers, and combinations thereof.

366. The system of claim 353, further comprising: A comminution or fracturing device is longitudinally and rotationally movable within the conduit.

367. The system of claim 366, wherein the comminution or fracturing device is capable of longitudinally and rotationally moving within the inner catheter lumen.

368. The system of claim 366, wherein the comminution or fracturing device is further movable longitudinally to extend out of the inner catheter lumen and the outer catheter tube.

369. The system of claim 366, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A pulverizing or fracturing tip is integrally formed with or coupled to the pulverizing or fracturing shaft at a first end, the pulverizing or fracturing tip having one or more pulverizing or fracturing spears at a second distal end.

370. The system of claim 369, wherein each of the one or more crushing or fracturing spears comprises at least two beveled and chamfered inner edges terminating in a sharp point.

371. The system of claim 370, wherein each of the one or more crushing or fracturing spears further comprises an opening, a protrusion, or a cutout.

372. The system of claim 369, wherein the crushing or fracturing tip is at least partially hollow.

373. The system of claim 369, wherein each of the one or more crushing or fracturing spears comprises at least two beveled edges.

374. The system of claim 366, wherein the comminution or fracturing device comprises: crushing or fracturing shafts; and A crushing or fracturing tip is integrally formed with the crushing or fracturing shaft or coupled to the crushing or fracturing shaft at a first end, the crushing or fracturing tip having at least one configuration selected from the group consisting of an angled configuration, a pointed configuration, a sharp edge or bevel configuration, a bullet configuration, a spherical or "button" configuration, a concave three-pointed configuration, a spear configuration, a concave spear configuration, a drill core configuration, a grooved configuration, a hollow configuration, and combinations thereof.

375. The system of claim 325, further comprising: A suction device comprising: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and A plunger is movable within the interior lumen of the syringe body.

376. The system of claim 375, wherein the suction device further comprises: A first injection valve is coupled to the extended distal tip.

377. The system of claim 376, wherein the suction device further comprises: A second injection valve is coupled to the injection tube body.

378. A system according to claim 377, wherein the first injection valve and the second injection valve each include at least one valve or adapter selected from the group consisting of: duckbill valve; cross-slit valve; stopcock valve, gate valve, rotary valve; ball valve; Luer valve; Tuohy-Borst adapter; and combinations thereof.

379. The system of claim 375, wherein the plunger comprises: a plunger body having a plunger lumen extending longitudinally within said plunger body; a plunger access port disposed linearly with the plunger lumen and in fluid communication with the plunger lumen; and A plunger handle is coupled to the plunger body.

380. The system of claim 379 wherein a catheter is further removably insertable through the plunger access port and plunger lumen and into the shaft lumen of the access sheath.

381. A system for percutaneously removing gallstones from a human or veterinary subject to treat cholelithiasis, the system comprising: An access sheath comprising: A tubular shaft having a first proximal end and a second distal end, the tubular shaft having a longitudinal axis and a longitudinally disposed central lumen, the tubular shaft comprising: an inner shaft wall forming the central lumen; an outer shaft wall coaxially disposed with the inner shaft wall and radially spaced from the inner shaft wall to form one or more peripheral lumens between the inner and outer shaft walls; and an inflation lumen disposed between the inner and outer shaft walls; and a proximal hub coupled to the first end of the tubular shaft, the proximal hub comprising: a hub shell having a hub lumen arranged to be in fluid communication with the central lumen; a filter assembly removably coupled to the hub shell, the filter assembly arranged to be in fluid communication with the central lumen; a first port integrally formed with or coupled to the hub shell, the first port arranged to be in fluid communication with the one or more peripheral lumens; and a second port integrally formed with or coupled to the hub shell, the second port arranged to be in fluid communication with the inflation lumen; a suction device removably couplable to the access sheath, the suction device comprising: an injection tube body having an internal lumen; an extended distal tip coupled to or integrally formed with the syringe body; and a plunger movable within the interior lumen of the syringe body; a catheter removably insertable into the access sheath, the catheter comprising: an outer catheter tube having an outer catheter lumen and an outer catheter tube distal end; an inner catheter steering shaft capable of longitudinally and rotationally moving within the outer catheter lumen, the inner catheter steering shaft having an inner catheter lumen and an inner catheter shaft distal end; and a basket or cage coupled to the inner catheter steering shaft, the basket or cage comprising a plurality of longitudinally arranged struts; a comminution or fracturing device capable of longitudinally and rotationally moving within the lumen of the inner catheter; and A comminution or fracturing control apparatus has a control apparatus, wherein the control apparatus shaft has a control apparatus shaft lumen configured to hold the catheter and the comminution or fracturing tool disposed within the catheter.

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