Systems and methods for removing biological objects from anatomical structures in vivo
By utilizing the Venturi effect and fluid flow regulation through a catheter system to generate a vacuum or liquid jet, combined with an ablation device, the issues of precision and safety in the removal of biological objects in minimally invasive surgery have been resolved, achieving efficient and safe removal of biological objects.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- VENTALIS SURGICAL INC
- Filing Date
- 2024-10-31
- Publication Date
- 2026-07-28
AI Technical Summary
Minimally invasive surgery presents challenges in precisely manipulating and removing biological objects within the body while preventing damage to adjacent tissues, especially in fluid-filled environments and intact organs such as the kidneys, gallbladder, bladder, and urinary tract. These challenges include blurred vision, difficulty in retrieving residual fragments, stone repositioning, high intracavitary pressure, and limitations in instrument size.
The catheter system utilizes the Venturi effect to attract biological objects through the opening of the catheter body. By regulating the liquid flow in the drainage and supply chambers, a vacuum or liquid jet is generated. Combined with an ablation device, the biological object is fragmented, achieving precise capture and removal.
It improves the precision and safety of manipulating and removing biological objects in liquid environments, reduces operation time and complications, enhances protection of adjacent tissues, and improves stone clearance rates.
Smart Images

Figure CN122477009A_ABST
Abstract
Description
[0001] Cross-references to related applications This application claims priority to U.S. Provisional Patent Applications Nos. 63 / 595272 and 63 / 595291, filed November 1, 2023, the disclosure of each of which is incorporated herein by reference in its entirety. Technical Field
[0002] This disclosure generally relates to medical systems and related methods, such as minimally invasive surgical devices and systems for manipulating and removing biological objects from anatomical structures. Background Technology
[0003] Minimally invasive surgery offers numerous advantages over traditional open surgery techniques. These advantages include reduced surgical trauma, shorter recovery time, shorter hospital stays, and / or a potentially lower risk of infection and other complications. However, certain challenges remain in minimally invasive surgery, particularly the requirement to precisely manipulate and remove objects from the body while preventing damage to adjacent tissues. This precision is crucial in fluid-filled environments and / or in intact organs such as the kidneys, gallbladder, bladder, urinary tract, blood vessels, or other body cavities or organs.
[0004] For the treatment of kidney stones, two main approaches include ureteroscopic lithotripsy and percutaneous nephrolithotomy (PCNL), with a variant called mini-PCNL. Both procedures, whether using a ureteroscope or a nephroscope, typically present concurrent challenges, including prolonged procedure time, blurred vision, difficulty in retrieving residual fragments, stone retropulsion, intraluminal high pressure, challenges in temperature regulation, and / or instrument size limiting ureteral access. Therefore, improved systems and methods are needed to safely and effectively remove biological objects. Summary of the Invention
[0005] This article describes systems, apparatus, and methods for removing biological objects from anatomical structures. Some of these systems, apparatus, and methods can be applied to remove biological objects such as kidney stones from the urinary tract. Some of the systems and methods described herein can utilize the Venturi effect to attract the biological object toward one or more openings.
[0006] A system may include: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into a urinary tract, the catheter body including one or more openings configured to receive at least a portion of a biological object; an evacuation lumen at least partially located within the catheter body, the evacuation lumen being in fluid communication with the one or more openings, the evacuation lumen being configured to be in fluid communication with a means for regulating fluid flow within the evacuation lumen; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to eject the fluid as a liquid jet from a constriction in the supply lumen to the outside of the supply lumen, and to create a vacuum at the one or more openings.
[0007] A system may include: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into a urinary tract, the catheter body including one or more openings configured to receive at least a portion of a biological object; a drainage lumen at least partially located within the catheter body, wherein the drainage lumen is in fluid communication with the one or more openings; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to eject the fluid as a liquid jet from a constriction portion therein to the exterior of the supply lumen, and to create a vacuum at the one or more openings.
[0008] A medical device may include: a fluid supply chamber configured to receive and deliver pressurized fluid to a nozzle positioned at one end of the fluid supply chamber when connected to a source of pressurized fluid; and a drainage tube providing the drainage chamber and including at least one aspiration port in the form of one or more openings in a sidewall of the drainage tube, the aspiration port being configured such that, when the device is in operation, fluid ejected from the nozzle is guided through the aspiration port to generate a Venturi-generated or Venturi-assisted vacuum for capturing a biological object at a location within a subject.
[0009] In some embodiments, a plurality of vent port openings may be formed in the catheter body and fluidly connected to the drainage lumen, the plurality of vent port openings being configured to resupply at least some of the fluid ejected from the supply lumen into the urinary tract to maintain fluid and pressure balance within the urinary tract.
[0010] In some embodiments, the supply cavity may include a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
[0011] In some implementations, the controller may be configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0012] In some embodiments, a temperature sensor may be configured to monitor the temperature proximal to the catheter body, and the controller may be configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
[0013] In some embodiments, the catheter body may be configured to receive an ablation device configured to fragment the biological object into multiple fragments.
[0014] In some implementations, the vacuum can be configured to attract the biological object toward the one or more openings.
[0015] The device for regulating fluid flow may include a vacuum source.
[0016] In some implementations, a liquid jet-driven aspiration and / or Venturi-assisted medical device is provided. In some instances, a medical device includes: a drainage tube comprising at least one aspiration port opening formed in a sidewall of the drainage tube and at least one return port opening positioned downstream of the at least one aspiration port opening when the device is in operation, wherein, when the device is in operation, the at least one aspiration port opening is positioned downstream relative to an outlet, and wherein, when the device is in operation, a first return port opening is positioned on a different side of the drainage tube relative to a second return port opening; a liquid supply chamber comprising a nozzle adapted to form a liquid jet at an outlet of the liquid supply chamber, the outlet being configured and positioned to guide the liquid jet formed by the nozzle into and along the drainage chamber of the drainage tube, wherein, when the device is in operation, the at least one aspiration port opening is positioned downstream relative to the outlet, and wherein, when the device is in operation, after exiting the nozzle, the liquid flows through at least a portion of the at least one aspiration port opening, thereby creating a vacuum at the at least one aspiration port opening relative to the environment outside the drainage chamber.
[0017] In some embodiments, a medical device includes: a drainage tube including at least one aspiration port opening formed in a sidewall of the drainage tube and at least one return port opening positioned downstream of the at least one aspiration port opening when the device is in operation; a liquid supply chamber including a nozzle adapted to form a liquid jet at an outlet of the liquid supply chamber, the outlet being configured and positioned to guide the liquid jet formed by the nozzle into and along the drainage chamber of the drainage tube; and a liquid source in fluid communication with the liquid supply chamber, the liquid source being configured... To supply pressurized liquid to the liquid supply chamber such that, as the liquid flows through the nozzle and passes through the at least one suction port, a vacuum is generated at the suction port relative to the environment outside the drainage chamber, the vacuum being sufficient to aspirate at least a portion of the surrounding liquid from a location within the subject's body; and a controller configured to operate or adjust the operation of the liquid source such that the at least one return port opening ejects at least a portion of the liquid supplied by the liquid source from the cavity of the drainage tube into a location within the subject's body, the portion being smaller than the volume of liquid aspirated into the drainage chamber when the system is in operation.
[0018] In some embodiments, a medical device includes: a drainage tube including at least one aspiration port opening formed in a sidewall of the drainage tube and at least one return port opening positioned downstream of the at least one aspiration port opening when the device is in operation; a liquid supply chamber including a nozzle adapted to form a liquid jet at an outlet of the liquid supply chamber, the outlet being configured and positioned to guide the liquid jet formed by the nozzle into and along the drainage chamber of the drainage tube; and a liquid source flowing with the liquid supply chamber. The device includes a fluid source configured to supply pressurized fluid to the fluid supply chamber such that, as the pressurized fluid flows through the nozzle and passes through the at least one aspiration port, a vacuum is generated at the aspiration port relative to the environment outside the drainage chamber, the vacuum being sufficient to aspirate at least a portion of the surrounding fluid from a location within the subject's body; and a controller configured to operate or regulate the operation of the fluid source such that, during operation of the device system, the pressure and / or volume of the surrounding fluid is less than or equal to 50% of the initial pressure and / or initial volume of the surrounding fluid prior to the operation of the device.
[0019] In some embodiments, a medical device includes: a fluid supply chamber configured to receive and deliver pressurized fluid to a nozzle positioned at one end of the fluid supply chamber when connected to a source of pressurized fluid; and a drainage tube providing the drainage chamber and including at least one aspiration port in the form of one or more openings in a sidewall of the drainage tube, the aspiration port being configured such that, when the device is in operation, fluid ejected from the nozzle is guided through the aspiration port to generate a Venturi-generated or Venturi-assisted vacuum for capturing a biological object at a location within the subject's body.
[0020] In some embodiments, a medical device includes: a liquid-jetforming aspiration catheter, the liquid-jetforming aspiration catheter including: a drainage tube including at least one aspiration port opening formed in a sidewall of the drainage tube; a liquid supply chamber including a nozzle adapted to form a liquid jet at an outlet of the liquid supply chamber, the outlet being configured and positioned to guide the liquid jet formed by the nozzle into and along the drainage chamber of the drainage tube, wherein, when the device is in operation, the at least one aspiration port opening is positioned downstream of the nozzle, such that when When the device is in operation, liquid flows through at least a portion of the at least one suction opening after exiting the nozzle, thereby creating a vacuum at the at least one suction opening relative to the environment outside the drainage cavity; and an outer sheath in which the liquid jet forming suction conduit is disposed, wherein the liquid jet forming suction conduit is axially and rotatably movable within the sheath to adjust the angular orientation of the distal end of the liquid jet forming suction conduit when the device is in operation, and to expose the at least one suction port to the environment outside the drainage cavity.
[0021] In some embodiments, a medical aspiration-ablation system includes: a liquid jet-driven aspiration device including a nozzle configured and positioned to direct a liquid jet into a drainage chamber of the device to create a vacuum at an aspiration port in fluid communication with the drainage chamber, wherein, when the system is aspirating, the aspiration port is sized and shaped to retain and fix solid deposits within a closed position of the subject; and an ablation device formed part of or functionally and structurally integrated with the liquid jet-driven aspiration device, such that the ablation device of the ablation device is movable relative to the liquid jet-driven aspiration device so that, when the system is in operation, the operator of the system can position the ablation device close to the aspiration port to break the solid deposits into multiple smaller deposits.
[0022] In some embodiments, a method includes: forming a liquid jet with a nozzle and directing the liquid jet into a drainage cavity of a drainage tube and close to one or more suction port openings in the sidewall of the drainage tube to generate a Venturi-generated or Venturi-assisted vacuum at the one or more suction port openings, and capturing and retaining the biological object at the one or more suction openings; and returning a selectable fraction of the total volumetric flow rate of the liquid suctioned by the Venturi-generated or Venturi-assisted vacuum in the formation step to the location, wherein the returned liquid exits the drainage cavity through one or more return port openings located downstream of the one or more suction port openings in the sidewall of the drainage tube and enters a location around the drainage tube.
[0023] In some embodiments, a method includes: forming a liquid jet with a nozzle and directing the liquid jet into a drainage cavity of a drainage tube and close to one or more suction port openings in the sidewall of the drainage tube to generate a Venturi-generated or Venturi-assisted vacuum at the one or more suction port openings; capturing and retaining a biological object at the one or more suction port openings; ablating the biological object into a plurality of particles using an ablation device; and removing the plurality of particles from a location within the subject via a Venturi-based vacuum at the one or more suction port openings.
[0024] This disclosure covers methods of manufacturing one or more of the embodiments described herein (e.g., a suction device). In yet another instance, this disclosure covers methods of using one or more of the embodiments described herein (e.g., a suction device). Attached Figure Description
[0025] Non-limiting examples of this disclosure will be described by way of example with reference to the accompanying drawings. For clarity, not every component is labeled in every drawing, nor is every component of every example of this disclosure shown where it is not necessary to illustrate it in order to enable a person skilled in the art to understand this disclosure.
[0026] Figure 1 This is a top view of a patient preparing for a ureteroscopy.
[0027] Figure 2A This is a top view of a ureteroscope being inserted into a patient.
[0028] Figure 2B This is a top view of a ureteroscope positioned inside the patient's kidney.
[0029] Figures 2C to 2H This is a cross-sectional view of the procedure for removing kidney stones from a patient's kidney.
[0030] Figure 3A This is a schematic diagram of the distal end of an example liquid jet suction device.
[0031] Figure 3B This is a schematic diagram of the distal end of an example liquid jet suction device.
[0032] Figure 3C This is a schematic diagram of an example liquid jet suction device demonstrating the effect of the Venturi principle.
[0033] Figure 3D yes Figure 3A A cross-sectional view along line DD of an example liquid jet suction device.
[0034] Figure 4A This is a schematic diagram of the distal end of a liquid jet-driven medical device that is movable within a surrounding guide channel or sheath and suitable for use in a surgical setting within a subject's body.
[0035] Figure 4B Is with Figure 4A The illustration of a liquid jet-driven medical device is similar to that depicted in the illustration, illustrating (arrow) the typical liquid ingress and egress pattern during the removal of the surrounding sheath.
[0036] Figure 4C Is with Figure 4A Examples of liquid jet-driven medical devices, similar to those depicted, illustrate a typical liquid inlet and outlet pattern when the peripheral sheath is in a first axial position relative to the distal tip of the device.
[0037] Figure 4DIs with Figure 4A Examples of liquid jet-driven medical devices, similar to those depicted, illustrate a typical liquid inlet and outlet pattern when the peripheral sheath is in a second axial position relative to the distal end of the device.
[0038] Figure 4E Is with Figure 4A Examples of liquid jet-driven medical devices, similar to those depicted, illustrate a typical liquid inlet and outlet pattern when the peripheral sheath is in a third axial position relative to the distal end of the device.
[0039] Figure 5A This is a schematic diagram of the distal end of an example combined aspiration-ablation system.
[0040] Figure 5B and Figure 5C This is a description of a combined aspiration-ablation system, which is combined with... Figure 5A The schematically illustrated combined aspiration-ablation system is similar, but deploys a multi-lumen access catheter or access catheter that accommodates a multi-lumen guiding insert (as illustrated), and has a guide channel for the aspiration catheter (as illustrated, for fixing kidney stones) and ablation tools.
[0041] Figure 6A This is a schematic diagram of an example operating system used to power and control the operation of a fluid jet-driven, Venturi-assisted medical aspiration device for use in other locations within an organ or subject.
[0042] Figures 6B to 6F yes Figure 6A The diagram shows several specific and exemplary embodiments of an operating system for powering and controlling the operation of a liquid jet-driven Venturi-assisted medical aspiration device.
[0043] Figure 7 This is a schematic diagram of the distal end of an example liquid jet-driven Venturi-assisted medical aspiration device, the device having one or more aspiration port openings sized to retain and fix solid deposits of interest.
[0044] Figure 8A This is a schematic diagram of the distal end of an example liquid jet-driven Venturi-assisted medical aspiration device having at least one aspiration port opening.
[0045] Figures 8B to 8C It is used with or without a mesh to prevent larger debris from entering through the suction port opening. Figure 8AA schematic diagram of an example configuration of the suction port opening of a liquid jet-driven venturi-assisted medical aspiration device.
[0046] Figures 8D to 8E It is used for purposes such as having or not having a mesh for preventing larger debris from entering through one or more return port openings. Figure 8A A schematic diagram of an example configuration of one or more return port openings of the device depicted in the illustration.
[0047] Figures 9A to 9F An illustration (partially transparent to show internal details) of the distal end of an example liquid jet-driven medical aspiration device with multiple circumferentially arranged aspiration ports is shown, along with several cross-sectional views of the device. Figures 9B to 9D ), and a reversing plate downstream of the high-pressure liquid delivery pipe and upstream of the liquid jet forming nozzle ( Figure 9E ) and reversing cap ( Figure 9F ) detailed view.
[0048] Figures 10A to 10B This is a schematic diagram of an example operating system used for integrated sensing.
[0049] Figure 11 This is a schematic diagram of an example operating system with integrated sensing.
[0050] Figure 12 This is a schematic diagram of an example implementation for controlling the motorized movement and automated manipulation of solid deposits.
[0051] Figures 13A to 13E This is an example of multiple views of a ureteroscope, including the aspiration-ablation system.
[0052] Figures 14A to 14C This is an example of a ureteroscope with concentric cavities.
[0053] Figure 15 This is a schematic diagram of a ureteroscope system.
[0054] Figures 16A to 16B This is a schematic diagram of an example implementation of a drainage tube that includes an aspiration-ablation system. Detailed Implementation
[0055] Embodiments of this disclosure generally relate to biological object removal systems, apparatuses, and related methods. Some embodiments generally relate to apparatuses and systems configured to generate a vacuum, which, for example, is capable of manipulating, securing, and / or aspirating solid objects and / or debris from ablated or pulverized solid objects in a liquid-filled environment. In some cases, the vacuum is generated and / or maintained via the Venturi effect. The configurations described herein can be useful, for example, for capturing, manipulating, securing, and / or removing biological objects (such as intact kidney stones, portions of kidney stones, or debris from ablated kidney stones) from anatomical structures within the body. For example, some kidney stones may normally be small enough to pass through a subject's ureter, but may be unable to pass due to, for example, a subject's disease condition. In some cases, kidney stones are too large or unable to pass through a subject's ureter for other reasons. In some cases, the systems and apparatus described herein include ablation devices (such as lasers or ultrasound devices) configured to ablate one or more solid objects into a plurality of smaller solid objects. Ultrasound devices may include ultrasound ablation tools configured to provide ultrasonic lithotripsy. Such a system can be useful, for example, for kidney stones that are too large to pass through the subject's ureter. Additionally or alternatively, the vacuum generated by the device and system described herein can be useful for drawing multiple smaller solid objects into the device, thereby removing them from a fluid-filled environment (e.g., the kidney).
[0056] Some implementations generally involve methods using the systems and apparatus disclosed herein. The apparatus and systems described herein can be useful for capturing and / or removing biological objects at locations within a subject's body, such as from anatomical structures. Biological objects can include blood clots, tumors, tissue samples, and whole or fragmented urinary stones, such as bladder stones, ureteral stones, and kidney stones.
[0057] The phrase “location within the subject’s body” as used herein generally refers to cavities, openings, anatomical structures, or organs within the subject’s body. For example, in some cases, locations within the subject’s body include the kidneys, bladder, heart, colon, duodenum, ileum, jejunum, stomach, esophagus, intestines, oral cavity, liver, lungs, pancreas, spleen, lymph nodes, (blood) vessels, glands, ear canal, urethra, uterus, gallbladder, ovaries, or nasal cavity. In one set of example cases, the location within the subject’s body is either the kidneys or the bladder.
[0058] As used herein, the term "subject" refers to an individual organism, such as a human or animal. In some cases, the subject is a mammal (e.g., a human, a non-human primate, or a non-human mammal), a vertebrate, a laboratory animal, a domesticated animal, an agricultural animal, or a companion animal. In some cases, the subject is a human. In some cases, the subject is a rodent, mouse, rat, hamster, rabbit, dog, cat, cow, goat, sheep, or pig.
[0059] In some cases, the articles and systems described herein are administered to a subject. In some cases, the system may be administered surgically (e.g., by insertion) or through an incision, typically via an endoscope using a catheter or similar device; in other cases, the device may be inserted into the body via the mouth, rectum, vagina, nose, or urethra. In some cases, the system is administered such that at least a portion of the system enters a location within the subject's body, such as an organ (e.g., a kidney).
[0060] In some cases, the system is configured to manipulate the position of a fluid within a subject's body. As used herein, "fluid" is given its general meaning. Fluids are generally unable to maintain a defined shape and will flow over an observable timeframe to fill the container in which they are placed. Therefore, a fluid can have any suitable viscosity that allows for flow. If two or more fluids are present, each fluid can be independently selected by a person skilled in the art from substantially any fluid. Typically, the fluid will be sterile water or sterile saline or phosphate-buffered saline or other osmotically balanced fluids or other IV fluids suitable for use in human patients.
[0061] Embodiments of this disclosure relate to devices and systems suitable for use in surgical procedures at locations within a subject's body. In some cases, the devices are suitable for use at locations within a subject's body (e.g., an organ of the subject) that are at least partially filled with surrounding fluid.
[0062] In some cases, the devices described herein are liquid jet driven instruments. In some cases, the devices described herein are Venturi-assisted instruments. In some cases, the devices described herein can be useful for ablation and / or ablation assistance (e.g., for solid deposits such as kidney stones). For example, the devices described herein can be useful for capturing solid deposits so that they can be ablated (e.g., by means of an ablation device such as a laser, ultrasound probe, or other suitable ablation device). As described herein, liquid jet driven instruments, Venturi-assisted instruments, and / or other instruments can guide catheters, aspiration catheters, and / or drainage catheters.
[0063] Overview Kidney stones affect approximately 10% of the population in the United States, with nearly 470,000 surgical procedures performed annually to relieve symptoms and prevent complications. Current treatment options include extracorporeal shock wave lithotripsy (ESWL), ureteroscopy (URS), and percutaneous nephrolithotomy (PCNL). URS is the most common, accounting for about two-thirds of all kidney stone surgeries due to its versatility in treating a wide range of stone sizes—using a lithotripter to break up the stone and a basket to remove fragments and smaller stones. Since 2012, URS surgeries have been steadily increasing at approximately 15% per year.
[0064] Kidney stone surgery aims to maximize the removal of stones and fragments. Despite advancements in lithotripsy and ureteroscopy techniques, stone clearance remains inconsistent, particularly for larger or more complex stones, in which case the stone-free rate (defined as the absence of residual stones on subsequent CT scans) often drops to 50%. Residual fragments can lead to symptoms and complications, including acute stone events, regrowth, and infection. Therefore, achieving complete stone removal is crucial for reducing the rate of readmission and optimizing long-term outcomes.
[0065] The efficiency and safety of URS still need improvement, including the management of pressure and temperature inside the kidney, maintaining a clear view, and preventing stone fragments from moving away from the operating device. Enhancing these aspects of URS aims to prevent injury and reduce procedure time.
[0066] Recent innovations such as direct in-scope suction (DISS) and flexible and navigable sheaths (FANS) aim to improve stone-free rates and surgical efficiency, despite their limitations. DISS uses a small working channel of a ureteroscope to aspirate powder and small debris, which improves visibility and helps regulate intrarenal pressure (IRP). However, the narrow diameter of this working channel limits the removal of larger fragments and results in a loss of vacuum pressure at the distal end, reducing its ability to effectively remove debris and control retraction. This impaired visibility and the resulting retraction increase the risk of accidental ablation of the kidney wall and reduce surgical efficiency. Furthermore, reduced aspiration can lead to elevated IRP, which can have serious consequences (as described below).
[0067] Ureteral access sheaths (UAS) include vacuum-assisted FANS models, which offer an alternative approach by combining aspiration with irrigation to maintain low IRP and reduce the "snowball" effect caused by debris during lithotripsy. FANS provide additional maneuverability, allowing navigation through the renal calyces to aspirate larger fragments. High-pressure irrigation is required for efficient use of FANS, especially for debris removal. However, manual control of irrigation and aspiration often leads to renal dilatation or collapse during the procedure due to the difficulty in balancing inflow and outflow and maintaining IRP. This complexity increases the surgeon's workload, as they must also manage laser ablation time and wattage to prevent temperature spikes, further distracting them and reducing surgical efficiency, while amplifying the risks associated with managing pressure and temperature.
[0068] Current limitations of laser lithotripsy techniques during URS often result in prolonged procedures and incomplete stone removal. Surgeons may attempt to mechanically capture and remove residual fragments using stone removal tools, increasing time and complexity and requiring coordination with support staff. Alternatively, a "pulverization" technique can be used to break the stone into passable particles, although residual powder and small fragments may lead to acute stone events. Limited visibility (often caused by powder clouds and bubbles) hinders precise targeting, resulting in residual stone fragments and requiring increased irrigation, thus prolonging the procedure. To prevent thermal damage, surgeons may reduce laser wattage or operate the laser intermittently, which also increases procedure time.
[0069] Effective IRP management is crucial for preventing complications during ureteroscopy. While increased irrigation flow improves visibility during laser manipulation, it can simultaneously increase IRP, thereby increasing the risk of reflux into the renal pelvis, renal veins, lymph nodes, and sinuses. This can lead to serious outcomes such as urosepsis, systemic infection, and kidney damage. These risks not only increase surgical costs due to prolonged hospital stays but also increase the risk of patient mortality. Although UAS and FANS improve fluid outflow to help manage IRP, their use also carries risks. Larger diameter UASs, while effectively reducing IRP, increase the risk of ureteral injury, especially in patients with ureteral strictures. One study found that nearly 50% of patients experienced ureteral wall damage with UASs larger than 11 Fr, and this risk increased for even larger sheaths. Although UAS and FANS techniques can control IRP to prevent overpressure and dilation, they also expose the kidney to collapse under vacuum aspiration, leading to bleeding and other complications.
[0070] Emerging pressure-sensing ureteroscopes provide real-time IRP monitoring, but do not actively control IRP, thus leaving pressure adjustment to the surgeon. The surgeon must monitor the pressure and manually adjust irrigation or use aspiration to lower the IRP. This reactive approach relies on the surgeon's ability to interpret and respond promptly to prevent complications.
[0071] Temperature management when using lasers (especially holmium:YAG lasers and thulium fiber lasers) also presents challenges. Temperatures above 43°C can cause tissue damage, thus requiring techniques such as increased or cooled irrigation, reduced laser activation, or reduced wattage, which often prolong the procedure time.
[0072] Despite advancements, current ureteroscopic lithotripsy techniques still present challenges for surgeons in observing, effectively removing stones and fragments, and managing pressure and temperature to safely navigate and treat upper urinary tract kidney stones. Existing methods often leave fragments, resulting in complications in over 40% of patients, and up to one-third of cases require repeat treatment within a year.
[0073] The systems and methods described herein aim to address many of these limitations, thereby providing substantial improvements in effectiveness, safety, and efficiency. This novel approach has the potential to reduce complications, lower readmission rates, and set new standards for kidney stone surgery.
[0074] Biological object removal like Figure 1 As shown, patient 10 may include a first kidney 14A and a second kidney 14B. Patient 10 may also include a first ureter 16A, a second ureter 16B, a bladder 18, and a urethra 20.
[0075] The first kidney 14A and the second kidney 14B may be visceral organs located within the trunk of the patient 10, positioned below or below the thoracic cage and laterally on either side of the patient's spine. The first kidney 14A and the second kidney 14B may be configured to process fluids. For example, the first kidney 14A and the second kidney 14B may filter blood, remove waste and excess fluid, balance fluids, and produce hormones and red blood cells. The first kidney 14A and the second kidney 14B may filter fluids, thereby producing urine. In some cases, the first kidney 14A and / or the second kidney 14B may produce solid deposits or kidney stones. Solid deposits may form when the fluid within the first kidney 14A and / or the second kidney 14B contains a crystal-forming substance in excess relative to the fluid volume. In some examples, the first kidney 14A and / or the second kidney 14B may contain a high concentration of calcium, oxalate, and / or uric acid relative to the fluid volume. Therefore, the fluid is insufficient to dilute the crystal-forming substance and is insufficient to prevent the crystal-forming substance from forming solid deposits.
[0076] The first ureter 16A and the second ureter 16B can each be a hollow tube configured to deliver fluid. The first ureter 16A and the second ureter 16B can be located in the patient's trunk or abdomen.
[0077] The bladder 18 may be a hollow, elastic visceral organ located in the lower part of the patient's abdomen. The bladder 18 may be configured to collect and store fluids. For example, the bladder 18 may be configured to collect and store urine from the first kidney 14A and / or the second kidney 14B.
[0078] The urethra 20 can be a hollow tube configured to deliver fluid. The urethra can be in fluid communication with the external environment. Therefore, the urethra 20 can be configured to drain fluid from the patient's body.
[0079] The first kidney 14A and the second kidney 14B can be in fluid communication with the bladder 18 via a corresponding first ureter 16A or second ureter 16B. For example, the first ureter 16A can extend between the first kidney 14A and the bladder 18, and the second ureter 16B can extend between the second kidney 14B and the bladder 18. Therefore, fluid can be transferred from the first kidney 14A and / or the second kidney 14B to the bladder 18 via the corresponding first ureter 16A or second ureter 16B. The bladder can be in fluid communication with the external environment via the urethra 20.
[0080] The organs identified above can define a patient's urinary tract or urinary system. In healthy patients, fluids such as urine can pass through the urinary system without obstruction. Solid deposits that form within the kidneys can obstruct fluid flow within the urinary system. Obstruction of fluid flow can lead to fluid and pressure buildup, causing pain and / or discomfort in the patient. Furthermore, in some cases, solid deposits may have irregular shapes. For example, solid deposits may have sharp edges. Sharp edges can puncture tissue, leading to additional pain, discomfort, bleeding, and potential infection. Methods for removing solid deposits have been developed to alleviate pain, discomfort, and / or to treat or prevent further damage.
[0081] Apparatus and methods for removing solid deposits from a patient’s urinary system may include an operating table 12 and instruments (i.e., devices), said instruments including drainage tubes (such as ureteroscopes 22).
[0082] The operating table 12 may be a device configured to support and / or restrain a patient during a medical procedure. For example, the operating table 12 may support an unconscious and / or medication-taking patient 10 during a medical procedure such as ureteroscopy.
[0083] The ureteroscope 22 may include a thin tubular shaft. This thin tubular shaft may have a lumen sized to receive at least a portion of a solid deposit. The ureteroscope 22 may be configured to pass through a patient's urinary system to reach solid deposits (such as kidney stones). The ureteroscope 22 may also include a light source and a lens to assist a physician in navigating the patient's urinary system and / or identifying solid deposits. The ureteroscope 22 may include a working channel. In some cases, a laser may be placed within the working channel of the ureteroscope 22. The laser may be configured to apply energy and break up solid deposits. Additionally or alternatively, in some cases, a grasping mechanism may be placed within the working channel of the ureteroscope 22. The grasping mechanism may be configured to hold one or more solid deposits for extraction.
[0084] Figures 2A to 2H The method and procedures for removing solid deposits from a patient's kidney using a ureteroscope 22 are illustrated. Although Figures 2A to 2H The illustration shows a ureteroscope 22 being applied to the second kidney 14B, but the methods described herein can be used to remove solid deposits from either kidney and / or from any location along the urinary system, or more generally, from any location within the body.
[0085] like Figure 2AAs shown, patient 10 can be supported on operating table 12. In some cases, patient 10 can be administered medication. For example, patient 10 can be under general and / or local anesthesia. Ureteroscope 22 can be introduced into the patient's urinary system. For example, ureteroscope 22 can be introduced via urethra 20. In some cases, ureteroscope 22 may include sheath 26, the size of which is set to pass through the patient's urethra 20, bladder 18, ureters 16A / 16B and / or kidneys 14A / 14B. Sheath 26 can be a tube. For example, sheath 26 may have an outer diameter between approximately 0.5 mm and 4 mm or between approximately 1.5 mm and 3.5 mm. In some cases, sheath 26 may have a length between 40 cm and 100 cm. In some cases, sheath 26 may have a length between 50 cm and 70 cm. For example, sheath 26 may have a length of approximately 60 cm. Sheath 26 may include the working channel of ureteroscope 22. The working channel may extend through the length of the sheath 26. The outer diameter of the working channel may be smaller than the outer diameter of the sheath 26. In some cases, the working channel may have an outer diameter between approximately 1.2 mm and 1.5 mm. The ureteroscope 22 may also include a handle portion 24 and a fluid supply catheter 28. The handle portion 24 may include an eyepiece or camera for a physician to observe, navigate, and identify solid deposits. For example, the handle portion 24 may include a digital complementary metal-oxide-semiconductor ("CMOS") camera. The handle portion 24 may be a Y-connector configured to fluidly connect the ureteroscope 22 to a first fluid supply device (also referred to as a first fluid source and / or a first fluid reservoir) for irrigation, a second fluid supply device (also referred to as a second fluid source and / or a second fluid reservoir) for aspiration, and / or for laser or grasping mechanism insertion.
[0086] Figure 2B The illustration shows a sheath 26 extending through the patient's urinary system and positioned within the second kidney 14B via the second ureter 16B, bladder 18, and urethra 20. The ureteroscope 22 can typically be used to identify and remove solid deposits.
[0087] Figure 2C The steps for dilating the second kidney 14B are illustrated. As described herein, the ureteroscope 22 may include a sheath 26. The sheath 26 may be in fluid communication with a fluid source. The fluid source may also be referred to as a fluid supply device and / or fluid reservoir. The fluid source may be an inlet supply device for fluid used by the ureteroscope 22 to irrigate and / or flush the patient's urinary system. In some cases, the sheath 26 may introduce fluid 28 into the second kidney 14B to dilate the kidney and improve visibility. For example, dilating the second kidney 14B may help a physician identify one or more solid deposits 30.
[0088] In some cases, the ureteroscope 22 may include an end effector located at the distal end of the sheath 26. The end effector may be configured to grasp and secure solid deposits. After securing the solid deposits, the sheath 26 and / or the ureteroscope 22 may be removed from the patient 10. In some cases, the ureteroscope 22 may be in fluid communication with an aspiration source. For example, the ureteroscope 22 may be in fluid communication with a vacuum source. Therefore, the ureteroscope 22 may be configured to aspirate solid deposits through the sheath 26. In some cases, the solid deposits may be too large to be removed by the ureteroscope 22.
[0089] Figure 2D The steps of applying energy 32 to at least one of one or more solid deposits 30 are illustrated. In some cases, the energy 32 may be a laser. For example, a laser fiber may extend through a sheath 26 and be configured to emit laser energy toward at least one of one or more solid deposits 30.
[0090] like Figures 2E to 2G As shown, energy 32 can be sufficient to break down and / or fragment the solid sediment 30 into fragmented pieces. The fragmented solid sediment can be smaller than the original solid sediment. For example, the fragmented solid sediment can be reduced to dust particles. Therefore, the size of the fragments can be set small enough to be sucked through the sheath 26. In some cases, the fragments may still be too large to be sucked through the sheath 26. Therefore, energy 32 can be applied to the fragments to further break down and / or fragment the solid sediment 30, such as... Figure 2G As shown in the figure.
[0091] Figure 2H The procedure of aspirating solid deposits through sheath 26 is illustrated. After successful removal of solid deposits from patient 10, ureteroscope 22 can be withdrawn and removed from patient 10.
[0092] In some embodiments, the device 100 (sometimes referred to as a apparatus) described herein may include a liquid jet-driven aspiration tool or catheter. Such an apparatus typically includes a drainage tube. For example, such as Figure 3AAs illustrated herein (which depicts the distal end of a liquid jet-driven aspiration catheter), device 100 may include a drainage tube 105. In some cases, device 100 may be identical to the ureteroscope 22 described herein. In some cases, drainage tube 105 may include one or more aspiration port openings 110 and one or more reflux port openings 115. In some cases, one or more aspiration port openings 110 are formed on the sidewall of drainage tube 105. In some cases, one or more reflux port openings 115 are located downstream of one or more aspiration port openings 110 (e.g., relative to the flow of fluid within drainage tube 105 when the device is in operation), as described in more detail herein and as... Figure 3A As shown in the illustration. Based on the teachings of this specification, those skilled in the art will understand that the device 100 is generally considered to be in operation when fluid flows in one or more components of the device 100 (e.g., drainage tube, fluid supply chamber, etc.).
[0093] As described herein, in some cases, device 100 may be configured to remove a biological object from a location within the subject (e.g., by ablation of the biological object, such as a solid deposit, and aspiration of at least a portion of the biological object from a location within the subject).
[0094] In some cases, a biological object can be a urinary stone. For example, in some cases, a biological object can be a solid deposit or stone that forms in an anatomical structure, such as the urinary tract. For example, a biological object can form in the kidneys, ureters, bladder, prostate, and / or urethra. In some cases, the stone is a kidney stone, a bladder stone, and / or a ureteral stone. In some cases, the stone can be whole (i.e., undisturbed) or fragmented. Fragmented urinary stones can include at least a portion of the urinary stone. In some cases, the anatomical structure can include other specific identifiable parts of the patient's body. For example, the anatomical structure can include the gallbladder, salivary glands, and pancreas.
[0095] Although Figure 3A A single suction port opening among one or more suction port openings 110 and a single return port opening among one or more return port openings 115 are shown, but the device 100 may include any suitable number of suction port openings 110 (e.g., one or more, two or more, three or more, four or more, etc. suction port openings 110) and / or any suitable number of return port openings 115 (e.g., one or more, two or more, three or more, four or more, etc. return port openings 115). In some cases, the device 100 may include a fluid supply chamber 120.
[0096] Although Figure 3AOne or more suction port openings 110 and one or more return port openings 115 are shown on the same side of the drainage tube 105, but in some cases, one or more suction port openings 110 and one or more return port openings 115 may be located on different sides of the drainage tube 105, as described in more detail herein.
[0097] In some cases, the drainage tube 105 may include a liquid supply chamber 120. In some cases, the liquid supply chamber 120 may include an outlet 130. In some cases, the liquid supply chamber 120 may include a nozzle adapted to form a liquid jet at the outlet 130. The liquid jet may have a flow rate between 20 ml / min and 60 ml / min. In some cases, the liquid jet may have a flow rate of approximately 40 ml / min. In some cases, the outlet 130 may be configured and positioned to guide a liquid jet (e.g., a liquid jet formed at a nozzle associated with the outlet 130) into, for example, the drainage tube 105 (e.g., along the drainage chamber 135 of the drainage tube 105). In some cases, after exiting the outlet 130 (and / or the nozzle positioned at the outlet 130), liquid 122 flows through at least a portion of one or more suction port openings 110, thereby creating a vacuum at one or more suction port openings 110 relative to the environment outside the drainage tube 105, for example, when the instrument 100 is in operation. In some cases, the generated vacuum is sufficient to aspirate at least a portion of the surrounding fluid 170 from the environment outside the drainage tube 105 (e.g., at a location within the subject or patient, as described in more detail herein). In some cases, when the instrument 100 is in operation, the fluid jet generates a Venturi-generated and / or Venturi-assisted vacuum at one or more aspiration port openings 110 (e.g., sufficient to capture and / or fix and / or aspirate solid deposits, such as kidney stones, bladder stones, gallstones, etc., at a location within the subject). Nozzles suitable for use with the described articles and systems are described in more detail below. Utilizing the Venturi effect (as explained herein) at or near the distal end of the ureteroscope to generate negative pressure overcomes the limitation of existing ureteroscopes that only include a suction pump at the proximal end. Higher aspiration can improve surgical outcomes by maintaining solid deposits at an optimal distance from the ablation device, thereby reducing potential backflow. Furthermore, improved aspiration can target solid deposits away from organ tissue, thereby reducing the risk of patient movement and accidental tissue ablation.
[0098] In some cases, one or more reflux port openings 115 may be sized, positioned, and configured to eject at least a portion of the fluid 122 flowing along the drainage cavity 135 under at least some normal operating conditions, as described in more detail herein. The drainage cavity 135 may include any suitable cross-sectional shape. Non-limiting examples of suitable cross-sectional shapes include triangles, squares, rectangles (e.g., with any suitable aspect ratio), circles, ellipses, polygons (e.g., pentagons, hexagons, heptagons, octagons, nonagons, dodecagons, etc.), annular, irregular shapes, etc. In some cases, the device 100 disclosed herein includes a fluid source. Any suitable fluid source capable of being pressurized and passing through the device disclosed herein may be used. For example, in some cases, the fluid source is a physiological fluid. In some cases, the physiological fluid is a saline solution (e.g., 0.9% wt NaCl), a glucose solution (e.g., 5% wt), lactated Ringer's solution, Ringer's solution, dextran solution, plasmalyte solution, etc. Depending on other circumstances, other solutions are also possible.
[0099] Based on the teachings of this specification, as will be understood by those skilled in the art, one or more aspiration port openings 110 and / or one or more return port openings 115 may be configured and designed such that an internal portion (i.e., lumen) of the drainage tube 105 is in fluid communication with the surrounding fluid 170 (e.g., during device operation). In some cases, one or more return port openings 115 may be configured and designed such that at least a portion of the surrounding fluid 170 enters the drainage tube 105 via one or more return port openings 115 when the device 100 is in operation. In some cases, aspiration port openings 110 may be configured and designed such that at least a portion of the fluid 122 present and / or flowing within the drainage tube 105 during device 100 operation leaves the drainage tube 105 via aspiration port openings 110 (e.g., to the surrounding environment at a location within the subject's body). In some cases, fluid may not substantially pass through one or more aspiration port openings 110 when the device 100 is in operation. For further details regarding flow patterns and operating modes associated with aspiration ports and return ports, see [link to relevant documentation]. Figure 4B And related discussions in this article.
[0100] Although Figure 3A The illustration shows a device 100 including one or more reflux port openings 115; however, in some cases, the device 100 may not include any one of the one or more reflux port openings 115 (including only the suction port opening 110), such as... Figure 3B As shown and described in more detail below.
[0101] Device 100 can be configured as a liquid jet-driven aspiration medical device. For example, such as Figure 4A As illustrated herein, device 200 (which may be similar to device 100 or any other device described herein, except as otherwise described herein) may include drainage tube 205. In some cases, the size of drainage tube 205 may be set relative to the size of one or more aspiration port openings 210 such that biological objects (e.g., solid deposits, such as kidney stones, at least a portion of ablated kidney stones, etc.) can be aspirated through aspiration port openings 210 and removed via drainage tube 205 (see, for example...). Figure 3D It depicts the relative dimensions of the drainage tube 105 and one or more suction port openings 110.
[0102] In some cases, the drainage tube 205 may include (e.g., formed in the sidewall of the drainage tube) one or more aspiration port openings 210. In some cases, the drainage tube 205 may include one or more reflux port openings 215. The one or more reflux port openings 215 may be located downstream of the one or more aspiration port openings 210 (e.g., when the instrument is in operation). In some cases, the instrument includes a fluid supply chamber 220. Figure 4A As shown, the liquid supply chamber 220 can be positioned against the sidewall of the drainage tube 205. In some cases, the liquid supply chamber 220 includes a nozzle 225. The nozzle 225 can be configured to form a liquid jet at the outlet 230 of the liquid supply chamber 220. In some cases, the outlet 230 of the liquid supply chamber 220 can be configured and positioned to guide the liquid jet formed by the nozzle 225 into and along the drainage chamber 235 of the drainage tube 205. Figure 4A As shown, the drainage cavity 235 can extend from the sidewall of the drainage tube 205 opposite to the liquid supply cavity 220 to the sidewall of the liquid supply cavity 220. In some cases, when the device 200 is in operation, one or more aspiration port openings 210 are positioned downstream of the outlet 230 (e.g., relative to the flow of liquid within the drainage tube 205 when the device 200 is in operation). As described herein, the device 200 may include any suitable number of aspiration port openings 210 (e.g., one or more aspiration port openings 210, two or more aspiration port openings 210, three or more aspiration port openings 210, four or more aspiration port openings 210, five or more aspiration port openings 210, ten or more aspiration port openings 210, or any suitable number of aspiration port openings 210, e.g., circumferentially distributed around the drainage tube).
[0103] In some cases, one or more reflux port openings 215 may be positioned on a different side of the drainage tube 205 relative to at least another of the one or more reflux port openings 215, and may be positioned downstream of one or more aspiration port openings 210 when the device 200 is in operation. For example, in some cases, a first reflux port opening 215 may be positioned on a different side of the drainage tube 205 relative to a second reflux port opening 215. As described herein, the device 200 may include any suitable number of reflux port openings 215 (e.g., one or more reflux port openings 215, two or more reflux port openings 215, three or more reflux port openings 215, four or more reflux port openings 215, five or more reflux port openings 215, ten or more reflux port openings 215, or any suitable plurality of reflux port openings 215).
[0104] In some cases, the number of suction port openings 210 and return port openings 215 may include any suitable combination of each (e.g., one or more suction port openings 210 and one or more return port openings 215, as described herein).
[0105] In some cases, the positioning of the suction port opening 210 relative to the return port opening 215 allows liquid (e.g., liquid contained within the liquid source 240) to flow through at least a portion of one or more suction port openings 210 after exiting the nozzle, thereby creating a vacuum at one or more suction port openings 210 relative to the environment outside the drainage chamber 235 when the device 200 is in operation. As described in more detail herein, in some cases, the flow of liquid through one or more suction port openings 210 generates a Venturi effect suction, thereby creating the aforementioned vacuum at one or more suction port openings 210.
[0106] For example, such as Figure 3C As illustrated herein, and without wishing to be bound by theory, the flow of liquid (e.g., pressure, flow rate) within the liquid supply chamber 120 can be altered, and the design of the nozzle can be changed, such that a desired level of Venturi effect suction is produced near at least one of the one or more suction port openings 110.
[0107] Without being bound by any particular theory, the Venturi effect can explain the decrease in fluid pressure caused by the increase in the flow rate of fluid passing through a constricted section. The Venturi effect obeys the conservation of flow rate with respect to pressure and velocity. For example, the Venturi effect follows Bernoulli's principle related to pressure and kinetic energy density. For example, the Venturi effect follows the relationship P1 + ½ ρV1 2= P2 + ½ ρ V2 2 Where P1 is the pressure at the first position along the flow path, V1 is the fluid velocity at the first position along the flow path, P2 is the pressure at the second position along the flow path, and V2 is the fluid velocity at the second position along the flow path, ρ is the fluid density, which is assumed to be constant, and the first and second positions are at the same height. Therefore, velocity and pressure are inversely related. For example, a decrease in pressure is proportional to the square of the increase in velocity, and vice versa. P2 = P1 + ½ ρ(V1) 2 - V2 2 Based on this relationship, negative pressure (suction) can be generated as the fluid velocity increases.
[0108] Fluid flow rate can also be defined as the velocity of a fluid passing through an area. For example, fluid flow rate can follow the relationship: AV, where A is the cross-sectional area of the pipe, conduit, or other channel, and V is the velocity of the fluid passing through that cross-sectional area. For incompressible fluids, the flow rate within an internal passage can be constant. Therefore, for a constant flow rate, the following relationship can be applied: A1V1 = A2V2, where A1 is the cross-sectional area at a first location along the flow path, V1 is the velocity of the fluid at the first location along the flow path, A2 is the cross-sectional area at a second location along the flow path, and V2 is the velocity of the fluid at the second location along the flow path. Thus, velocity and area are inversely related. For example, velocity can increase as the cross-sectional area decreases. Therefore, the Venturi effect can be associated with a constant flow rate, such that the change in pressure is proportional to the square of the change in cross-sectional area. Therefore, pressure can decrease as the cross-sectional area decreases, and vice versa. Therefore, nozzles or constrictions in a fluid flow path can increase the velocity of the fluid flow and decrease the pressure, thereby creating a vacuum.
[0109] In some cases, the instrument 100, device, and / or system may not include one or more return port openings 115. For example, refer again... Figure 3B The device 100' may include one or more suction port openings 110, but not one or more return port openings 115. The device 100' may be generally similar to the device 100 described herein. In some cases, the device 100' may be a modification of the device 100. For example, the device 100' may not include one or more return port openings 115.
[0110] Figure 3DA cross-sectional view of the drainage tube 105 is illustrated. The aspiration catheter described herein can have any suitable maximum outer diameter and cross-sectional size. For example, in some cases, the size of the drainage catheter can be set for administration to a subject (e.g., via the ureter or via an endoscope through a conventionally sized cannula or access catheter). In some cases, the drainage tube 105 can have an outer diameter greater than or equal to 1 French (Fr), greater than or equal to 2 Fr, greater than or equal to 3 Fr, greater than or equal to 3.6 Fr, greater than or equal to 4 Fr, greater than or equal to 5 Fr, greater than or equal to 6 Fr, greater than or equal to 7 Fr, greater than or equal to 8 Fr, greater than or equal to 9 Fr, greater than or equal to 10 Fr, greater than or equal to 12 Fr, greater than or equal to 14 Fr, greater than or equal to 16 Fr, greater than or equal to 18 Fr, or 20 Fr. In some cases, the drainage tube has an outer diameter less than or equal to 25 Fr, less than or equal to 18 Fr, less than or equal to 16 Fr, less than or equal to 14 Fr, less than or equal to 12 Fr, less than or equal to 10 Fr, less than or equal to 9 Fr, less than or equal to 8 Fr, less than or equal to 7 Fr, less than or equal to 6 Fr, less than or equal to 5 Fr, less than or equal to 4 Fr, less than or equal to 3.6 Fr, less than or equal to 3 Fr, or less than or equal to 2 Fr. In one set of example cases, the drainage tube has an outer diameter greater than or equal to 2 Fr and less than or equal to 4 Fr. Other combinations of ranges are also possible (e.g., greater than or equal to 1 Fr and less than or equal to 20 Fr). Other ranges are also possible.
[0111] Turn Figures 4A to 4EThe device 200 may include a liquid jet forming aspiration conduit. In some cases, the aspiration conduit may include a drainage tube 205, which includes one or more aspiration port openings 210 formed in the sidewall of the drainage tube. In some cases, the drainage tube 205 may include a liquid supply chamber 220, which includes a nozzle 225. In some cases, the nozzle 225 may be adapted to form a liquid jet at an outlet 230 of the liquid supply chamber 220. In some cases, the outlet 230 may be configured and positioned to guide the liquid jet formed by the nozzle 225 into and along the drainage chamber 235 of the drainage tube 205. The device 200 may include one or more aspiration port openings 210 formed in the sidewall of the drainage tube 205. In some cases, one or more aspiration port openings 210 may be positioned downstream of the outlet 230 and / or the nozzle 225. In some cases, one or more suction port openings 210 may be configured and positioned at or near the distal end of the drainage cavity 235. In some cases, during operation of the instrument 100, fluid exiting the nozzle 225 may flow through at least a portion of one or more suction port openings 210. Without wishing to be bound by any particular theory, it is considered that such a configuration allows for the creation of a vacuum (e.g., via the Venturi effect) at one or more suction port openings 210 relative to the environment outside the drainage cavity 235. For example, the pressure within the drainage cavity 235 at the one or more suction port openings 210 may be less than the pressure outside the drainage tube 205. Therefore, fluid may flow into one or more suction port openings 210 in an attempt to equalize or balance the respective pressures. In some cases, the fluid flow may carry solid deposits along with the fluid, thereby drawing the solid deposits into the drainage tube 205.
[0112] In some cases, the device 200 may include one or more reflux port openings 215, for example, one or more reflux port openings 215 comprising a hole in the sidewall of the drainage tube 205, the hole providing fluid communication with the drainage cavity 235. The one or more reflux port openings 215 may be configured and positioned closer to the proximal end of the drainage cavity 235 than the aspiration port opening 210. Based on the teachings of this specification, those skilled in the art will understand that the one or more reflux port openings 215 may be configured and positioned at any suitable location on the device 200.
[0113] In some cases, the device 200 may be an aspiration catheter disposed within the outer sheath 260 (the outer sheath 260 may, in some cases, be the lumen of a multi-lumen cannula or access catheter, such as...). Figure 6A and Figure 6B (As shown in the diagram). In some cases, the device 200 may be axially and / or rotatably movable within the outer sheath 260.
[0114] In some cases, the outer sheath 260 may be axially and / or rotatably movable relative to the drainage tube 205. For example, such a configuration allows adjustment of the angular orientation of the distal end 270 of the instrument 200 when the instrument 100 is in operation, and exposes at least one of one or more aspiration port openings 210 and optionally one or more reflux port openings 215 to the environment outside the outer sheath 260. In some cases, axial movement of the instrument 100 relative to the sheath 260 allows the operator to control the exposure of one or more aspiration port openings 210 and / or one or more reflux port openings 215 to the surrounding environment for different operating modes. For example, in some cases, the operator (such as a physician) may move the outer sheath 260 relative to the instrument 200 such that at least a portion or all of one or more reflux port openings 215 are closed (e.g., preventing fluid from passing through one or more reflux port openings 215). In some cases, an operator (such as a doctor) may move the outer sheath 260 relative to the drainage tube 205 such that at least part or all of one or more reflux port openings 215 are opened (e.g., allowing fluid to pass through one or more reflux port openings 215).
[0115] Figures 4B to 4E Exemplary entry and exit flow patterns of the aspiration catheter in response to the position of the outer sheath 260 are illustrated. For example, as... Figures 4B to 4E As illustrated, one or more reflux port openings 215 and / or suction port openings 210 can be selectively opened or closed during device operation (e.g., using the outer sheath 260).
[0116] like Figure 4B As shown, the outer sheath 260 may not be arranged around the aspiration catheter. Therefore, one or more reflux port openings 215 and aspiration port openings 210 can be unobstructed. Unobstructed one or more reflux port openings 215 and aspiration port openings 210 can allow fluid flow through them. Figure 4B As shown, the Venturi effect can create a low-pressure zone within the drainage cavity 235 at the suction port opening 210. Therefore, external liquids (and solid deposits) can enter the drainage cavity 235 through the suction port opening 210. In some cases, liquids from the drainage cavity 235 can exit from the drainage cavity 235 to the external environment through one or more return port openings 215. Figure 4BAs shown, the outflow of liquid can proceed in any direction away from one or more return port openings 215. In some cases, pressure can build up within the drainage chamber 235 downstream of the suction port opening 210. Therefore, one or more return port openings 215 can provide an outlet to release the pressure downstream of the suction port opening 210. In some cases, the return port opening 215 can allow for increased volumetric flow rate at the suction port opening 215 by providing recirculation. For example, the return port opening 215 can increase the volumetric flow rate at the suction port opening 215 located at the distal tip of the drainage tube 205, as described herein. In the absence of a return port opening 215, a vacuum source, such as a peristaltic pump, as described herein, can slow the volumetric flow rate of fluid pumped by the instrument 200 and / or from the anatomical structure, thereby reducing the vacuum generated at the distal end of the drainage tube 205. The return port opening 215 can also be used to filter debris and / or fragments. In some cases, the reflux port opening 215 can prevent the drainage tube 205 from becoming blocked or obstructing the flow of volumetric fluid through the drainage tube 205. Therefore, the reflux port opening 215 can mitigate the risk of over-pressurization within the anatomical structure.
[0117] like Figure 4C As shown, the outer sheath 260 can be positioned in a first axial position relative to the distal end of the aspiration catheter. In the first axial position, the outer sheath 260 can cover and / or block at least a portion of one or more reflux port openings 215, while the aspiration port opening 210 remains unobstructed. In this configuration, lateral aspiration of the liquid can be generated. Figure 4C As shown, the Venturi effect can create a low-pressure zone within the drainage cavity 235 at the suction port opening 210. Therefore, external liquids (and solid deposits) can enter the drainage cavity 235 through the suction port opening 210. Figure 4C As further illustrated, fluid from the drainage chamber 235 can exit from the drainage chamber 235 to the external environment via one or more reflux port openings 215. However, because the outer sheath 260 covers and / or blocks one or more reflux port openings 215, fluid flow can occur along the outer sheath 260. In some cases, fluid can flow laterally toward the distal end of the aspiration catheter and the aspiration port opening 210. At least a portion of the exiting fluid can be retained in the external volume.
[0118] like Figure 4D As shown, the outer sheath 260 can be positioned in a second axial position relative to the distal end of the aspiration catheter. In the second axial position, the outer sheath 260 can cover and / or block at least a portion of one or more reflux port openings 215, while the aspiration port opening 210 remains unobstructed. In this configuration, forced irrigation and / or repulsion of the fluid can be achieved. Figure 4C As shown, the Venturi effect can create a low-pressure zone within the drainage cavity 235 at the suction port opening 210. Therefore, external liquids (and solid deposits) can enter the drainage cavity 235 through the suction port opening 210. Figure 4D As further illustrated, fluid from the drainage chamber 235 can exit from the drainage chamber 235 to the external environment via one or more return port openings 215. However, fluid flow can occur along the outer sheath 260 because the outer sheath 260 covers and / or blocks one or more return port openings 215. In some cases, fluid can flow laterally toward the distal end of the aspiration catheter and the aspiration port opening 210. At least a portion of the exiting fluid can be retained in the external volume.
[0119] like Figure 4E As shown, the outer sheath 260 can be positioned in a third axial position relative to the distal end of the aspiration catheter. In the third axial position, the outer sheath 260 can cover and / or block at least a portion of one or more reflux port openings, thereby generating generally forward-oriented (e.g., distal) aspiration. The sheath and other mechanisms for controlling flow through one or more reflux port openings 215 and / or aspiration port openings 210 are described in more detail herein.
[0120] In some cases, one or more suction port openings 110 are positioned downstream of nozzle 225, such as Figure 4A As illustrated in the illustration. In some cases, one or more suction port openings are configured and positioned at the distal end of the drainage cavity 235. In some cases, during operation of the instrument 100, liquid exiting the nozzle 225 can flow through at least a portion of one or more suction port openings 110, thereby creating a vacuum at one or more suction port openings relative to the environment outside the drainage cavity 135. In some cases, each of the one or more suction port openings 110 may be characterized by a maximum opening size smaller than the minimum cross-sectional size of the drainage cavity 135 to ensure that no solid particles that could potentially clog the drainage cavity 135 are suctioned. In such a particular case, each of the one or more suction port openings 110 may be characterized by a maximum opening size not exceeding 80% of the minimum cross-sectional size of the drainage cavity 135. In some cases, the maximum opening size does not exceed approximately 5%, approximately 10%, approximately 15%, approximately 20%, approximately 25%, approximately 30%, approximately 35%, approximately 40%, approximately 45%, approximately 50%, approximately 55%, approximately 60%, approximately 65%, approximately 70%, approximately 75%, or approximately 80% of the minimum cross-sectional size of the drainage cavity 135.
[0121] In some cases, the maximum opening size is greater than or equal to 5%, 10%, 20%, 30%, 40%, 50%, 60%, or 70% of the minimum cross-sectional size of the drainage cavity 135. In other cases, the maximum opening size is less than or equal to 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or 5% of the minimum cross-sectional size of the drainage cavity 135.
[0122] refer to Figure 4A The device 200 includes a nozzle 225 having an outlet 230 disposed within or adjacent to, or very close to, the inlet of the drainage chamber 235 upstream of the inlet. In some cases, the outlet 230 may be configured and positioned at or near the distal end 270 of the device 200 such that the outlet 230 of the nozzle 225 faces and ejects a jet of liquid toward the proximal end 280 of the device 200. In some cases, one or more suction port openings 210 may be positioned closer to the proximal end 280 of the device 200 than the outlet 230. One or more return port openings 215 may generally be positioned closer to the proximal end 280 of the device 100 than the one or more suction port openings 210.
[0123] In some cases, a portion of the fluid aspirated by the instrument 100 through one or more aspiration port openings 210 may be ejected from the drainage chamber 235 of the drainage tube into the surrounding environment via one or more return port openings 215 while the instrument is in operation. In some cases, when the instrument 200 is in operation, greater than or equal to 1%, greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, greater than or equal to 30%, greater than or equal to 40%, or greater than or equal to 50% of the fluid aspirated by the instrument may be ejected from the cavity of the drainage chamber 235 into the surrounding environment via each of one or more return port openings 215. In some cases, when the instrument 200 is in operation, less than or equal to 50%, less than or equal to 40%, less than or equal to 30%, less than or equal to 20%, less than or equal to 15%, less than or equal to 10%, or less than or equal to 5%, or less than or equal to 1% of the fluid aspirated by the instrument 200 may be ejected from the drainage chamber 235 into the surrounding environment via each of one or more return port openings 215. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 1% and less than or equal to 50%). For example, refer again... Figures 4B to 4E Operating modes that allow the liquid aspirated by the instrument 200 to be sprayed into the surrounding environment can prevent, for example, the accumulation of excessive pressure and / or volume in the surrounding organs during instrument operation.
[0124] In some cases, the device is part of the operation and control system (see example...). Figures 6A to 6F The system also includes a controller (e.g., Figure 4A The controller 245 is configured to operate a liquid source (e.g., Figure 4A The liquid source 240) generates pressure and flow conditions for the delivered liquid, thereby adjusting the relative axial position of the device 200 within the outer sheath 260 or channel (e.g., Figure 4B The device described herein (for such a configuration) is positioned such that one or more reflux port openings 215 spray at least a portion of the volume of fluid supplied by the fluid source 240 from the drainage cavity 235 of the drainage tube 205 into the body of the subject (e.g., the patient). By controlling the inflow and outflow of fluid in this manner, a favorable recirculating flow can be established within an organ (e.g., the kidney) to facilitate visualization, capture, and retention of solid deposits, and advantageously, the total pressure and fluid volume conditions within the organ or operating space can be balanced and maintained within safe physiological operating limits. A more detailed operating and control system for this purpose is described in Figures 6A to 6F The terms “capture” or “retention” are illustrated and described in more detail herein. For the purposes of this disclosure, the terms “capture” or “retention” do not require that the biological object and / or solid sediment be physically and securely attached to the suction port opening. Instead, “capture” or “retention” may mean the continuous attraction of the biological object and / or solid sediment toward the suction port opening.
[0125] In some cases, during at least some periods of operation, the volume of fluid ejected back into the subject's body (e.g., via one or more return port openings 215) may be less than or equal to the volume of fluid aspirated into the drainage chamber 235 while the system is in operation (e.g., via one or more aspiration port openings 210). In some cases, the volume of fluid ejected back into the subject's body is greater than or equal to the volume of fluid aspirated into the drainage chamber 235 while the system is in operation. In one set of example cases, on average over the total operating time of the system, the volume of ejected fluid is substantially the same as the volume of aspirated fluid (e.g., the ejected volume is less than or equal to 10%, less than or equal to 5%, less than or equal to 2%, or less than or equal to 1% of the aspirated volume).
[0126] In some cases, during at least some periods of operation, the total flow rate of the liquid being pumped through one or more suction port openings 210 is greater than or equal to the total flow rate of the liquid exiting the operating space through one or more return port openings 215. In some cases, during at least some periods of operation, the total flow rate of the liquid through one or more suction port openings 210 is greater than or equal to the total flow rate of the liquid through one or more return port openings 215. In a set of example cases, integrated over a substantial period of operation, the total flow rate of the liquid being sprayed is substantially the same as the total flow rate of the liquid being pumped (e.g., the total flow rate of the liquid being sprayed via one or more return port openings 215 is less than or equal to 10%, less than or equal to 5%, less than or equal to 2%, or less than or equal to 1% of the total flow rate of the liquid being pumped through one or more suction port openings 210).
[0127] In some cases, controller 245 is configured to operate fluid source 240 such that the pressure and / or volume of the surrounding fluid is regulated during operation of device 200, as described herein. For example, in some cases, controller 245 may be configured to operate fluid source 240 and other operating parameters such that the pressure and / or volume of the surrounding fluid during operation of device 200 is less than or equal to 50% of the initial pressure and / or initial volume of the surrounding fluid. Without wishing to be bound by any particular theory, control of the pressure and / or volume of the fluid source can be useful for ensuring the patency of positions within the subject's body, such as the renal pelvis or calyces of the kidneys and / or ureters (e.g., to ensure that positions within the subject's body do not substantially collapse or expand while the device is in operation). In some cases, controller 245 can be configured to operate liquid source 240 such that at any point during operation of instrument 200, the pressure and / or volume of the surrounding liquid during operation is within 50%, 40%, 30%, 20%, 10%, or 5% of the initial pressure and / or volume of the surrounding liquid. (See again) Figure 4B Example operating modes, such as, with the instrument 200 within the surrounding outer sheath 260 or with a guiding catheter (e.g., Figure 5A When the liquid (302) can be moved axially and / or rotatably together with the liquid, the inflow and / or outflow of liquid through one or more suction port openings 210 and / or one or more return port openings 215 can be controlled (e.g., to control the volume and / or pressure balance and / or recirculation mode of the liquid). In some such cases, control over the inflow and / or outflow of liquid through one or more suction port openings 210 and / or one or more return port openings 215 can advantageously provide desired control over liquid pressure, flow and / or volume balance and / or control over liquid supply.
[0128] As described herein, in some cases, the devices and systems are suitable for use in surgical procedures, e.g., within a subject's body. In some cases, the devices and systems described herein are suitable for use within a subject's body that is at least partially filled with surrounding fluid, such that the aspiration port opening 210 and optionally one or more reflux port openings 215 are submerged during operation. In some cases, the described devices and / or systems combine any one or more of the Venturi-assisted medical devices or liquid jet-driven aspiration medical devices and ablation tools (e.g., lasers, ultrasound ablation tools (such as high-intensity focused ultrasound (HIFU) tools), etc.) disclosed herein. In some cases, the Venturi-assisted medical devices or liquid jet-driven aspiration medical devices and ablation tools disclosed herein are on the same device.
[0129] Figure 5A System 301, which includes an ablation system, is illustrated. For example, as shown... Figure 5A As illustrated, system 301 may include aspiration device 300, sheath 302, and ablation device 350. In some cases, aspiration device 300 may be provided via a catheter and may be liquid jet driven. Aspiration device 300 may include nozzle 325 configured and positioned to guide a liquid jet into drainage chamber 335 to create a vacuum at aspiration port opening 310, which is in fluid communication with drainage chamber 335. In some cases, drainage chamber 335 may be located within and / or in fluid communication with sheath 302. Sheath 302 may be a guide tube or a cannula. In some cases, sheath 302 may be in fluid communication with one or more fluid sources. For example, sheath 302 may be in fluid communication with liquid source 340. Liquid source 340 may also be referred to as a liquid supply device or liquid reservoir. In some cases, liquid reservoir may be a body or housing defining a volume for containing a bulk liquid. Additionally or alternatively, the liquid source 340 may be referred to as a fluid source, fluid supply device, and / or fluid reservoir. In some cases, the sheath 302 may be in fluid communication with a vacuum source. For example, the sheath 302 may be configured to apply an external vacuum (e.g., a suction force exceeding that generated by the suction produced by the liquid jet) to the drainage cavity 335. In other cases of this or any other Venturi-assisted medical device or liquid jet-driven aspiration medical device disclosed herein, the drainage cavity 335 may be in fluid communication with an external vacuum at its proximal end to supplement or assist or replace the suction generated by the liquid jet aspiration. In some cases, one or more aspiration port openings 310 may be selectively sized and shaped to retain and secure solid deposits 345 of predetermined size and shape (e.g., kidney stones of measured size) within a closed position of the subject.
[0130] In some cases, the ablation device 350 may be part of or integrated with the aspiration device 300 in function and construction. In some cases, the ablation device 350 may include an ablation apparatus movable relative to the aspiration device 300. Such a configuration may be useful, for example, for enabling the operator of the system to position the ablation apparatus near one or more aspiration port openings 310 (e.g., holding solid deposits 345) to pulverize the solid deposits 345. In some cases, the ablation device 350 may be operatively coupled to the aspiration device 300 (e.g., the aspiration device 300 and the ablation device 350 may be mechanically coupled to a common component, such as the sheath 302 and / or guide tube / cannula as illustrated). In some cases, the aspiration device 300 and the ablation device 350 may be separate instruments.
[0131] In some cases, the drainage cavity 335 may include one or more suction port openings 310 and / or one or more return port openings 315. In some cases, one or more suction port openings 310 may be located at or near the distal end 370 of the drainage cavity 335. One or more return port openings 315 may be configured and located proximal to the suction port openings 310 on the drainage tube 305.
[0132] Other configurations are also possible. In some cases, the system can be a multi-chamber system. Figure 5B and Figure 5C An example configuration of a multi-chamber system as described herein is shown. For example, in some cases, the system may include a fluid supply chamber 320 disposed within a drainage tube 305. Additionally or alternatively, in some cases, the system may include a dual-chamber sheath. In some cases, the dual-chamber sheath may include a first chamber and a second chamber, the first chamber including a movable, liquid-jet-driven aspiration device, and the second chamber including a movable ablation device 350. The aspiration device may be any suitable aspiration device known to those skilled in the art, including but not limited to the aspiration devices of this disclosure. For example, the aspiration device may be the drainage tube 305. In some cases, the device may include a dual-chamber drainage tube 305 having a first chamber and a second chamber, the first chamber including... Figure 5A The drainage cavity 335, the second cavity including ablation instruments (e.g., lasers, ultrasound instruments, electro-hydraulic instruments, pneumatic instruments, cryoablation, radiofrequency (RF), water jet, morcellation blades, etc.), such as Figure 5A (Ablation device 350). In some cases, the ablation device may include a laser.
[0133] Figure 6AOne embodiment of system 400 is shown, which includes a liquid jet-driven aspiration device 401. The aspiration device 401 includes a liquid supply chamber 420 configured to receive pressurized liquid when connected to a liquid source 440 and to deliver the pressurized liquid to a nozzle positioned at one end of the liquid supply chamber 420. In some embodiments, the aspiration device 401 may include a drainage tube 405 including a drainage chamber 435. The liquid supply chamber 420 may be configured to output a liquid jet into the drainage chamber 435. As described herein, pressure can be inversely proportional to fluid velocity. The drainage chamber 435 can accommodate high flow rates. For example, as described above, the liquid jet may have a high flow rate between approximately 20 mL / min and 60 mL / min, which can result in the formation of low pressure. In some cases, the drainage tube 405 may also include one or more suction port openings 410, which are in the form of one or more openings in the sidewall of the drainage tube 405. In some cases, the drainage tube 405 may be configured such that liquid ejected from the nozzle is guided through one or more suction port openings 410 to create a Venturi-generated or Venturi-assisted vacuum. For example, a pressure difference between the environment and the low pressure caused by the flow of the liquid jet can create a relative negative pressure or suction through one or more suction port openings 410. The Venturi-generated or Venturi-assisted vacuum may be a first vacuum level. Thus, the liquid jet can create a negative pressure at the distal end of the drainage cavity 435. In some cases, when the aspiration device 401 is in operation, the first vacuum level is sufficient to capture biological objects, such as solid deposits, within one or more suction port openings 410 at a location within the subject's body. In some cases, the aspiration device 401 may also include one or more return port openings 415 in the sidewall of the drainage tube 405. One or more reflux port openings 415 may be located downstream of one or more suction port openings 410 and may be configured to eject at least a portion of the liquid flowing along the drainage cavity 435.
[0134] In some cases, system 400 may also include a high-pressure fluid pump 455 configured to pump liquid from liquid source 440 into liquid supply chamber 420. In some cases, a vacuum source 465 may be connected to the proximal end of drainage chamber 435. Vacuum source 465 may be configured to assist in suction from drainage chamber 435 by pumping fluid from drainage chamber 435 into waste container. Vacuum source 465 may generate a second vacuum level. For example, vacuum source 465 may generate a negative pressure at the proximal end of drainage chamber 435. In some cases, the second vacuum level may be lower than a standard vacuum level. For example, the second vacuum level generated by vacuum source 465 may result in a fluid flow rate lower than the flow rate of the liquid jet. For example, the second vacuum level may result in a fluid flow rate between approximately 0 mL / min and 150 mL / min. In some cases, the second vacuum level may result in a nominal fluid flow rate of approximately 70 mL / min. Therefore, vacuum source 465 can be used as a flow regulator to adjust the fluid flow rate through drainage chamber 435 and counteract the higher vacuum level generated by the flow of the liquid jet. In some examples, in addition to or instead of vacuum source 465, another flow regulator for adjusting the fluid flow rate through drainage chamber 435 can be used. For example, a valve can be used.
[0135] Controller 445 can be programmed and configured to operate high-pressure fluid pump 455 and / or vacuum source 465. In some cases, controller 445 can be used to ensure that the pressure and / or volume at a location within the subject remains substantially constant during operation of system 400. In some cases, system 400 may also include a peristaltic pump connected to the proximal end of drainage cavity 435. The peristaltic pump may include a pinch-and-roll mechanism to generate negative pressure or suction at the inlet. In some cases, controller 445 can be programmed and configured to operate high-pressure fluid pump 455 and, when present, an optional peristaltic pump, such that the pressure and / or volume at a location within the subject remains substantially constant during operation of system 400. In some cases, vacuum source 465 and peristaltic pump may operate simultaneously in parallel or in series. In some examples, controller 445 may be configured to control a flow regulator (such as a valve) for regulating the flow rate of fluid through drainage cavity 435. In some cases, controller 445 can be configured to independently control high-pressure fluid pump 455 and vacuum source 465.
[0136] The internal pressure within the suction device 401 can be regulated and / or controlled by a fluid pump 455 and a vacuum source 465. In some cases, the fluid pump 455 and the vacuum source 465 can be matched 1:1. For example, a controller 445 can be configured to operate the fluid pump 455 and the vacuum source 465 simultaneously to regulate and control the pressure within the suction device 401.
[0137] Figures 6B to 6F Example systems with various open-loop and closed-loop control systems are shown. While some examples describe one or more sensors located proximally to the aspiration device 401, these sensors may also be located within the aspiration device 401, at the distal end of the aspiration device 401, or between the distal and proximal ends of the aspiration device 401. In some cases, the one or more sensors may be located within the drainage tube 405. In some cases, the one or more sensors may be located within the drainage cavity 435. These one or more sensors may be configured to monitor pressure and / or temperature within the system 400.
[0138] Figure 6B An example implementation of system 400 is shown, which includes open-loop control of at least one or more pumps. In some cases, the one or more pumps may include a displacement pump and / or a suction pump. For example, system 400 may include a high-pressure fluid pump 455 and a vacuum source 465. Controller 445 may be in electrical communication with the one or more pumps. For example, as... Figure 6B As shown, controller 445 can be configured to send a first control signal 446A to high-pressure fluid pump 455 and a second control signal 446B to vacuum source 465. In this configuration, the first control signal 446A controls the fluid flow from liquid source 440 toward drain tube 405, and the second control signal 446B controls the suction assistance from vacuum source 465. In some examples, in addition to or instead of vacuum source 465, a flow regulator, as described herein, can be used. Figure 6B As further illustrated, controller 445 can be configured to operate without receiving feedback signals. Open-loop control can operate without feedback from sensors. Therefore, the system can be implemented as a simple control system without sensors, thereby reducing costs. Open-loop control can also passively control the fluid flow through the system without actively changing the flow rate based on sensed or measured values.
[0139] Figure 6C An example implementation of system 400 is shown, which includes at least open-loop control of a first group of one or more pumps and closed-loop control of a second group of one or more pumps. In some cases, the first group of one or more pumps may include a displacement pump. For example, the first group of one or more pumps may include a high-pressure fluid pump 455. In some cases, the second group of one or more pumps may include a suction pump. For example, the second group of one or more pumps may include a vacuum source 465. Controller 445 may be in electrical communication with both the first group of one or more pumps and the second group of one or more pumps. For example, as... Figure 6CAs shown, controller 445 can be configured to send a first control signal 446A to high-pressure fluid pump 455 and a second control signal 446B to vacuum source 465. In some examples, a flow regulator, as described herein, can be used in addition to or in place of vacuum source 465. In some cases, system 400 may also include one or more sensors. For example, system 400 may include pressure sensor 452. This pressure sensor can be configured to monitor the pressure at suction port opening 410 and / or detect blockage within drainage cavity 435. Controller 445 can communicate electrically with the one or more sensors. In some cases, the one or more sensors can be configured to provide feedback signal 453 to controller 445. For example, pressure sensor 452 can provide a pressure signal within drainage cavity 435 to controller 445. Controller 445 can adjust one or more control signals based on the feedback. Therefore, system 400 can provide open-loop control of the high-pressure fluid pump 455 and has online pressure monitoring for closed-loop control of the vacuum source 465 (and / or flow regulator). As discussed herein, open-loop control can operate without feedback from sensors, thereby reducing costs.
[0140] Figure 6D An example implementation of system 400 is shown, which includes at least closed-loop control of one or more pumps. In some cases, the one or more pumps may include a displacement pump and a suction pump. For example, the one or more pumps may include a high-pressure fluid pump 455 and a vacuum source 465. In some examples, a flow regulator, as described herein, may be used in addition to or in place of the vacuum source 465. Controller 445 may be in electrical communication with the one or more pumps. For example, controller 445 may be configured to send a first control signal 446A to the high-pressure fluid pump 455 and a second control signal 446B to the vacuum source 465 (and / or the flow regulator). In some cases, system 400 may also include one or more sensors. For example, such as... Figure 6DAs shown, system 400 may include a first flow meter 454A and a second flow meter 454B. The first flow meter 454A may be configured to measure the flow rate within a liquid supply chamber 420. The second flow meter 454B may be configured to measure the flow rate within a drainage chamber 435. Controller 445 may be in electrical communication with the one or more sensors. In some cases, the one or more sensors may be configured to provide feedback signals to controller 445. For example, the first flow meter 454A may be configured to provide a first feedback signal 453A to controller 445, and the second flow meter 454B may be configured to provide a second feedback signal 453B to controller 445. Controller 445 may adjust one or more control signals based on the feedback. Therefore, system 400 may provide closed-loop control of the high-pressure fluid pump 455 and the vacuum source 465 (and / or flow regulator) via flow feedback. Closed-loop control can improve the accuracy of fluid flow rate by actively responding to sensed or measured values. Furthermore, the system may respond to unexpected events detected by the sensors.
[0141] Figure 6E An example implementation of system 400 is shown, which includes at least open-loop control of one or more pumps. In some cases, the one or more pumps may include a shift pump and a suction pump. For example, the one or more pumps may include a high-pressure fluid pump 455 and a vacuum source 465. In some examples, a flow regulator, as described herein, may be used in addition to or in place of the vacuum source 465. Controller 445 may be in electrical communication with the one or more pumps. For example, controller 445 may be configured to send a first control signal 446A to the high-pressure fluid pump 455 and a second control signal 446B to the vacuum source 465 (and / or the flow regulator). In some cases, system 400 may also include one or more valves. For example, system 400 may include a throttle valve 457. Controller 445 may be in electrical communication with the one or more valves. For example, controller 445 may be configured to send a third control signal 446C to the throttle valve 447. In some cases, system 400 may also include one or more sensors. For example, such as... Figure 6EAs shown, system 400 may include a flow meter 454. Flow meter 454 may be configured to measure the flow rate within liquid supply chamber 420. Controller 445 may be in electrical communication with the one or more sensors. In some cases, the one or more sensors may be configured to provide feedback signals to controller 445. For example, flow meter 454 may be configured to provide feedback signal 453 to controller 445. Controller 445 may adjust one or more control signals based on the feedback. Thus, system 400 can provide open-loop control of vacuum source 465 and has online fluid flow monitoring for closed-loop control of high-pressure fluid pump 455 and / or throttle valve 457. Hybrid loop control simultaneously achieves open-loop and closed-loop control. Selected portions of the system may not include sensors or feedback from sensors to actively control various actuators, while other selected components of the system may receive feedback from sensors to actively control various other actuators. Hybrid loop control can combine the advantages of both open-loop and closed-loop control by providing precise control of sensitive components while reducing costs.
[0142] Figure 6F An example implementation of system 400 is shown, which includes at least closed-loop feedback control of one or more pumps and a pressure vessel. In some cases, the one or more pumps may include a displacement pump and a suction pump. For example, the one or more pumps may include a high-pressure fluid pump 455 and a vacuum source 465. In some examples, a flow regulator, as described herein, may be used in addition to or in place of the vacuum source 465. Controller 445 may be in electrical communication with the one or more pumps. For example, controller 445 may be configured to send a first control signal 446A to the high-pressure fluid pump 455 and a second control signal 446B to the vacuum source 465 (and / or the flow regulator). In some cases, system 400 may also include one or more valves. For example, system 400 may include a throttle valve 457. Controller 445 may be in electrical communication with the one or more valves. For example, controller 445 may be configured to send a third control signal 446C to the throttle valve 447. In some cases, system 400 may also include one or more sensors. For example, such as... Figure 6FAs shown, system 400 may include a first flow meter 454A and a second flow meter 454B. The first flow meter 454A may be configured to measure the flow rate within the liquid supply chamber 420. The second flow meter 454B may be configured to measure the flow rate within the drainage chamber 435. Controller 445 may be in electrical communication with the one or more sensors. In some cases, the one or more sensors may be configured to provide feedback signals to controller 445. For example, the first flow meter 454A may be configured to provide a first feedback signal 453A to controller 445, and the second flow meter 454B may be configured to provide a second feedback signal 453B to controller 445. Controller 445 may adjust one or more control signals based on the feedback. Thus, system 400 can provide closed-loop control of the high-pressure fluid pump 455 and the vacuum source 465 (and / or flow regulator) via flow feedback, and can also provide open-loop control of the throttle valve 457. As discussed herein, hybrid loop control can combine the advantages of both open-loop and closed-loop control by providing precise control of sensitive components while reducing costs.
[0143] Other combinations and / or other configurations of these features are also possible. Based on the teachings of this specification, those skilled in the art will be able to select suitable open-loop control systems, closed-loop control systems, flow feedback systems, pumps, pressure vessels, etc.
[0144] This disclosure also relates to methods of using the apparatus disclosed herein. Figure 7 The distal end of drainage tube 505 is illustrated. Drainage tube 505 may be similar to drainage tube 105 or 205 or any of the drainage tubes described herein, except for the differences described herein. In some cases, the method involves capturing a biological object (such as solid deposit 545 (e.g., kidney stone)) at a location within the subject's body (e.g., kidney), for example, using any of the devices disclosed herein. Figure 7 As shown, the method may include: forming a liquid jet 585 with a nozzle 525, and guiding the liquid jet 585 from an outlet 530 into a drainage cavity 535 of a drainage tube 505 and close to one or more suction port openings 510 in the side wall of the drainage cavity 535 of the drainage tube 505, at one or more suction port openings 510.
[0145] As described herein, a Venturi-generated or Venturi-assisted vacuum is generated by increasing the velocity of a fluid (e.g., a physiological fluid, such as water or saline) through a constriction (e.g., a nozzle) according to the principle of mass continuity. This increase in velocity is balanced by a decrease in static pressure according to the conservation of mechanical energy (e.g., Bernoulli's principle). Figure 3CAs illustrated in the illustration, this process, in some cases, reduces the pressure within the drainage cavity relative to the external environment (e.g., the renal pelvis or calyces of the kidney), thereby creating a vacuum near one or more suction port openings.
[0146] In some cases, a venturi-generated or venturi-assisted vacuum produces a suction force greater than or equal to 50 mmHg and less than or equal to 600 mmHg. In some cases, the generated vacuum produces a suction force greater than or equal to 50 mmHg, greater than or equal to 100 mmHg, greater than or equal to 200 mmHg, greater than or equal to 300 mmHg, greater than or equal to 400 mmHg, greater than or equal to 500 mmHg, or greater than or equal to 600 mmHg. In some cases, the suction force is less than or equal to 600 mmHg, less than or equal to 500 mmHg, less than or equal to 400 mmHg, less than or equal to 300 mmHg, less than or equal to 200 mmHg, less than or equal to 100 mmHg, or less than or equal to 50 mmHg. The desired suction force can be determined by balancing various factors, including the force necessary to aspirate the biological object and patient safety. In some cases, the suction force can be selected to adequately aspirate biological objects (such as urinary stones) in a balanced manner without damaging or harming surrounding tissues. For example, the suction force may be strong enough to pull loose fragments and pieces of urinary stones toward the suction port opening, but not strong enough to aspirate surrounding tissues and / or mucosal walls.
[0147] In some cases, the method may include balancing the suction force with the internal pressure of a location within the subject's body, for example, to ensure that a location (such as an organ) within the subject's body does not collapse spontaneously during device operation. Therefore, in some cases, the method includes operating the device such that, while the device is in operation, the pressure within a location within the subject's body is maintained within 10% (e.g., within 5%, within 1%) of the initial pressure at that location.
[0148] In some cases, the method may further include capturing and retaining biological objects, such as solid deposits 545, at one or more suction port openings 510. The biological object can be any suitable biological object capable of being captured using the Venturi-generated or Venturi-assisted vacuum disclosed herein. For example, in some cases, the biological object is a solid deposit 545, such as stones known to form in the kidneys, bladder, prostate, gallbladder, salivary glands, and pancreas (e.g., kidney stones, bladder stones, prostate stones, gallstones, salivary gland stones, bile duct stones, pancreatic duct stones). A Venturi-generated or Venturi-assisted vacuum can be used to attract the biological object toward the suction port opening 510. The suction port opening 510 can be configured to receive the biological object through the suction port opening if it is smaller than the opening. If the biological object is larger than the suction port opening 510, the suction port opening 510 can capture and retain the biological object by continuously attracting it toward the opening. In some cases, biological objects can be fixedly attached to the suction port opening 510 via aspiration. Other biological objects can also be captured using the Venturi aids and the vacuum generated by the Venturi as disclosed herein, such as blood clots, tissue samples (e.g., those obtained through biopsy), tissue debris, cellular debris (e.g., endometrial cells, prostate cells), necrotic tissue, mucus, sputum, cysts, emboli, bone marrow, fetal cells, ovaries, and parts and / or components thereof. In some cases, biological objects are byproducts of surgeries (e.g., surgeries using ablation techniques / tools), such as cardiac surgeries (e.g., cardiac tissue ablation), lung surgeries (e.g., tumor ablation), liver surgeries (e.g., tumor ablation), kidney surgeries (e.g., tumor ablation), endometrial ablation surgeries, prostate ablation surgeries, brain tumor ablation surgeries, or gastrointestinal surgeries (e.g., polyp removal). Other types of biological objects are also possible.
[0149] In some cases, the method further includes refluxing a selectable small portion of the total volumetric flow rate of the fluid generated or aspirated by a Venturi-assisted vacuum back to a location within the subject's body. In some cases, this portion of the refluxing total volumetric flow rate of the fluid generated or aspirated by a Venturi-assisted vacuum is selected to maintain a substantially constant pressure and / or volume within the location within the subject's body, as described herein.
[0150] In some cases, the refluxed liquid exits the drainage chamber 535 through one or more reflux port openings 515 in the side wall of the drainage chamber 535 of the drainage tube 505 and enters a location around the drainage tube 505, the one or more reflux port openings 515 being located downstream of one or more suction port openings 510.
[0151] In some cases, the method further includes removing biological objects, such as solid deposits 545, from a location within the subject's body, for example, using one or more of the devices disclosed herein. In some cases, the method includes forming a liquid jet 585 with a nozzle 525 and directing the liquid jet 585 into a drainage cavity 535 of a drainage tube 505 and close to one or more suction port openings 510 in the sidewall of the drainage cavity 535 of the drainage tube 505 to generate a Venturi-generated or Venturi-assisted vacuum at one or more suction port openings 510.
[0152] In some cases, the method also includes using suction forces generated by or assisted by a venturi to capture and retain biological objects, such as solid deposits 545, at one or more suction port openings 510.
[0153] In some cases, the method also includes using an ablation device to ablate a biological object (such as solid deposit 545) into multiple (smaller) particles. In some cases, the ablation device may be a laser; however, other ablation devices are also envisioned herein. Non-limiting examples of suitable ablation devices include ultrasonic devices, electro-hydraulic devices, and pneumatic devices. In some cases, the multiple particles are configured to be removed from a location within the subject's body via a venturi-based vacuum at one or more aspiration port openings.
[0154] The examples described are not intended to be limiting in any way, and based on the teachings of this specification, those skilled in the art will understand that any of the devices (e.g., instruments) and / or systems and / or methods disclosed herein may also include one or more additional cases, such as those described in detail herein. For example, in some cases, the devices (e.g., instruments) and / or systems described herein may include drainage tubes (e.g., drainage tubes 105, 205, 305, 405, or 505) having an outer diameter greater than or equal to 1 mm and less than or equal to 10 mm. In some cases, the outer diameter of the drainage tube 505 may be greater than or equal to 0.5 mm, greater than or equal to 1 mm, greater than or equal to 2 mm, greater than or equal to 3 mm, greater than or equal to 4 mm, greater than or equal to 5 mm, greater than or equal to 6 mm, greater than or equal to 7 mm, greater than or equal to 8 mm, greater than or equal to 9 mm, or greater than or equal to 9.5 mm. In some cases, the outer diameter of the drainage tube 505 may be less than or equal to 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, 1 mm, or 0.5 mm. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 1 mm and less than or equal to 10 mm). Other ranges are also possible. The diameter of the drainage tube 505 can be determined based on a variety of factors, including flow rate, desired aspiration pressure, maneuverability, efficiency, and patient safety. For a given flow rate through the fluid supply chamber 520 and / or nozzle, a smaller diameter can provide a higher flow rate and correspondingly lower pressure to enhance aspiration / suction. A smaller diameter can also maintain the deflectability of the endoscope tip (such as a ureteroscope). A larger diameter can provide a larger aspiration port opening 510 to aspirate larger biological objects, improve efficiency, and reduce the duration of the procedure. Therefore, the outer diameter can be selected by balancing several factors.
[0155] In some cases, the apparatus (e.g., instrument) and / or system described herein may include two or more and six or fewer aspiration port openings (e.g., aspiration port openings 510). In some cases, the number of aspiration port openings 510 may be greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6. In some cases, the number of aspiration port openings may be less than or equal to 6, less than or equal to 5, less than or equal to 4, less than or equal to 3, or less than or equal to 2. The number of aspiration port openings 510 may be determined based on a variety of factors, including fluid recirculation and the maneuverability of the apparatus and / or biological object. The number of aspiration port openings 510 may facilitate fluid recirculation. In some embodiments, the number of aspiration port openings 510 may be selected to provide sufficient recirculation. The number of aspiration port openings 510 may also provide multiple locations for aspirating biological objects, including debris and fragments, toward the drainage tube 505.
[0156] In some cases, one or more aspiration port openings (e.g., one or more aspiration port openings 510) may be positioned along and / or around the drainage cavity in a particular configuration. One or more aspiration port openings 510 may be positioned on the drainage cavity in any suitable configuration known to those skilled in the art. For example, in some cases, one or more aspiration port openings 510 may be positioned in a circular configuration around the circumference of the drainage cavity. In such cases, a circular configuration can reduce the chance of clogging the drainage cavity and can allow the drainage tube 505 to rotate without affecting aspiration around the drainage tube 505. Additionally or alternatively, the aspiration port openings 510 may be within the line of sight (LOS) of an endoscopic camera and / or an ablation device as described herein. In such cases, debris and / or fragments of the biological object fragmented from the biological object can remain clearly visible when the ablation device fragments the biological object.
[0157] In some cases, each of one or more suction port openings 510 may have an average cross-sectional dimension greater than or equal to 0.01 mm, greater than or equal to 0.025 mm, greater than or equal to 0.05 mm, greater than or equal to 0.1 mm, greater than or equal to 0.5 mm, greater than or equal to 1 mm, greater than or equal to 1.5 mm, greater than or equal to 2 mm, greater than or equal to 4 mm, or greater than or equal to 5 mm. In some cases, each of one or more suction port openings 510 may have an average cross-sectional dimension less than or equal to 6 mm, less than or equal to 5 mm, less than or equal to 4 mm, less than or equal to 2 mm, less than or equal to 1.5 mm, less than or equal to 1 mm, less than or equal to 0.5 mm, less than or equal to 0.1 mm, or less than or equal to 0.05 mm. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 0.01 mm and less than or equal to 6 mm, greater than or equal to 0.05 mm and less than or equal to 1 mm). Other ranges are also possible. The selection of the size for one or more aspiration port openings 510 can be determined by balancing various factors, including the size of the biological object and the available suction force. A larger aspiration port opening 510 can allow larger particles and biological material to pass through it. Large biological objects may become stuck and pose a risk of obstructing the aspiration flow. Therefore, in some embodiments, the size of the aspiration port opening 510 can be limited to prevent large biological objects from entering the drainage cavity. Additionally or alternatively, a smaller aspiration port opening 510 can contribute to generating greater suction force at the distal tip due to the increased velocity of the liquid passing through it.
[0158] One or more suction port openings 510 may have any suitable cross-sectional shape. Non-limiting examples of suitable cross-sectional shapes include triangles, squares, rectangles (e.g., with any suitable aspect ratio), circles, ellipses, polygons (e.g., pentagons, hexagons, heptagons, octagons, nonagons, dodecagons, etc.), rings, irregular shapes, etc.
[0159] In some cases, one or more suction port openings 610 and / or one or more return port openings 615 may include a mesh 600. Figure 8A A drainage tube 605 is shown, which has one or more suction port openings 610, one or more return port openings 615, a fluid supply chamber 620, a nozzle 625, and a drainage chamber 635. The drainage tube 605 may be the same as or similar to any of the drainage tubes described herein, such as drainage tube 105 or 205. In some cases, the drainage tube 605 may be positioned within an outer sheath 660.
[0160] Figure 8BOne of one or more suction port openings 610 is shown, which does not have a mesh 600. Therefore, suction port opening 610A can be unobstructed. Without the mesh 600, particles can freely enter and exit through suction port opening 610A. In this case, the only limitation on the particle size that suction port opening 610A can receive is its outer perimeter.
[0161] Figure 8C One of one or more suction port openings 610 is shown, which has a mesh 600. Therefore, the suction port opening 610B can be at least partially blocked. With the mesh 600 present, particles are prevented from freely entering and exiting through the suction port opening 610B.
[0162] Figure 8D One of one or more return port openings 615 is shown, which does not have a mesh 600. Therefore, the return port opening 615A can be unobstructed. Without the mesh 600, particles can freely enter and exit through the return port opening 615A. In this case, the only limitation on the particle size that the return port opening 615A can receive is its outer perimeter.
[0163] Figure 8E One of one or more return port openings 615 is shown, which has a mesh 600. Therefore, the return port opening 615B can be at least partially blocked. With the mesh 600 present, particles are prevented from freely entering and exiting through the return port opening 615B.
[0164] like Figure 8C and Figure 8EThe mesh 600 shown can have any suitable pore size, and those skilled in the art will be able to select a suitable pore size based on the teachings of this specification. For example, in some cases, the mesh 600 can have a US mesh number greater than or equal to 35, greater than or equal to 50, greater than or equal to 75, greater than or equal to 100, greater than or equal to 150, greater than or equal to 200, greater than or equal to 250, greater than or equal to 300, or greater than or equal to 350. In some cases, the mesh 600 can have a US mesh number less than or equal to 400, less than or equal to 350, less than or equal to 300, less than or equal to 250, less than or equal to 200, less than or equal to 150, less than or equal to 100, less than or equal to 75, or less than or equal to 50. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 35 and less than or equal to 400). Other ranges are also possible. As will be understood by those skilled in the art, the U.S. mesh number (sometimes referred to as Tyler Mesh Size) is the number of holes per linear inch of the mesh. Each hole in the mesh can have any suitable size (e.g., a diameter greater than or equal to 0.037 mm and less than or equal to 0.500 mm) according to the U.S. mesh number standard.
[0165] In some cases, one or more aspiration port openings 610 can be configured to selectively retain and / or exclude biological objects, such as solid deposits (e.g., multiple kidney stones). The selective adjustment of biological objects can be performed using any suitable technique known to those skilled in the art.
[0166] In some cases, the devices (e.g., instruments) and / or systems described herein include two or more and six or fewer return port openings (e.g., such as...). Figure 4A The number of one or more return port openings 615 shown is greater than or equal to 2, greater than or equal to 3, greater than or equal to 4, greater than or equal to 5, or greater than or equal to 6. In some cases, the number of one or more return port openings 615 is less than or equal to 6, less than or equal to 5, less than or equal to 4, less than or equal to 3, or less than or equal to 2.
[0167] In some cases, one or more reflux port openings 615 may be positioned along and / or around the drainage cavity 635 in a particular configuration. One or more reflux port openings 615 may be positioned on the drainage cavity 635 in any suitable configuration known to those skilled in the art. For example, in some cases, one or more reflux port openings 615 may be positioned linearly along the length of the drainage cavity 635. In some cases, one or more reflux port openings 615 may be positioned circularly around the circumference of the drainage cavity 635.
[0168] In some cases, each of one or more return port openings 615 may have an average cross-sectional dimension greater than or equal to 0.01 mm, greater than or equal to 0.025 mm, greater than or equal to 0.05 mm, greater than or equal to 0.1 mm, greater than or equal to 0.5 mm, greater than or equal to 1 mm, greater than or equal to 1.5 mm, greater than or equal to 2 mm, greater than or equal to 4 mm, or greater than or equal to 5 mm. In some cases, each of one or more return port openings 615 may have an average cross-sectional dimension less than or equal to 6 mm, less than or equal to 5 mm, less than or equal to 4 mm, less than or equal to 2 mm, less than or equal to 1.5 mm, less than or equal to 1 mm, less than or equal to 0.5 mm, less than or equal to 0.1 mm, or less than or equal to 0.05 mm. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 0.01 mm and less than or equal to 6 mm, greater than or equal to 0.05 mm and less than or equal to 1 mm). Other ranges are also possible.
[0169] One or more return port openings 615 may have any suitable cross-sectional shape. Non-limiting examples of suitable cross-sectional shapes include triangles, squares, rectangles (e.g., with any suitable aspect ratio), circles, ellipses, polygons (e.g., pentagons, hexagons, heptagons, octagons, nonagons, dodecagons, etc.), rings, irregular shapes, etc.
[0170] In some cases, one or more return port openings 615 may include a mesh 600. The mesh 600 may have any suitable pore size, and those skilled in the art will be able to select a suitable pore size based on the teachings of this specification.
[0171] In some cases, the devices (e.g., instruments) and / or systems described herein may include an outer sheath (e.g., outer sheath 660). In some cases, a liquid jet forming aspiration device is disposed within the outer sheath 660. Any of the liquid jet forming aspiration devices disclosed herein (e.g., instrument 200) may be disposed within the outer sheath 660. In some cases, the liquid jet forming aspiration device may be a liquid jet forming aspiration catheter disposed within the outer sheath 660.
[0172] In some cases, the liquid jet forming aspiration device may be movable within the outer sheath 660. In some cases, the catheter may be movable axially and rotationally within the outer sheath 660, for example, to allow adjustment of the angular orientation of the distal end of the liquid jet forming aspiration catheter when the device is in operation, and to expose one or more aspiration port openings 610 to the environment outside the drainage lumen 635 (e.g., the lumen of the renal pelvis or calyces of the kidney). For example, refer again... Figure 4A The outer sheath 260 can be moved relative to the drainage tube 205.
[0173] In some cases, the outer sheath 660 may be associated with auxiliary devices. For example, in some cases, the outer sheath 660 may be associated with catheters, endoscopes, cannulas, etc.
[0174] In some cases, the outer sheath 660 can be a double-lumen sheath. In some cases, the double-lumen sheath can be a double-lumen catheter or a double-lumen endoscope, such as a double-lumen endoscope.
[0175] In some cases, the outer sheath 660 may have an inner diameter greater than or equal to 1 mm and less than or equal to 10 mm. In some cases, the inner diameter of the outer sheath 660 may be greater than or equal to 0.5 mm, greater than or equal to 1 mm, greater than or equal to 2 mm, greater than or equal to 3 mm, greater than or equal to 4 mm, greater than or equal to 5 mm, greater than or equal to 6 mm, greater than or equal to 7 mm, greater than or equal to 8 mm, greater than or equal to 9 mm, or greater than or equal to 9.5 mm. In some cases, the inner diameter of the outer sheath 660 may be less than or equal to 10 mm, less than or equal to 9 mm, less than or equal to 8 mm, less than or equal to 7 mm, less than or equal to 6 mm, less than or equal to 5 mm, less than or equal to 4 mm, less than or equal to 3 mm, less than or equal to 2 mm, less than or equal to 1 mm, or less than or equal to 0.5 mm. Combinations of the ranges mentioned above are also possible (e.g., greater than or equal to 1 mm and less than or equal to 10 mm). Other ranges are also possible. In some cases, the inner diameter of the outer sheath 660 can be substantially similar to the outer diameter of the drainage tube 605. As disclosed herein, the outer sheath 660 can have any suitable geometry. For example, in some cases, the outer sheath 660 can be shaped as, for example, a circle, a triangle, a square, a rhombus, etc.
[0176] In some cases, the liquid jet forming suction device can be configured to fit within a conduit. The conduit can have any suitable size known to those skilled in the art. For example, in some cases, the conduit size is between 3 Fr and 20 Fr. In some cases, the conduit size is between 2 Fr and 4 Fr. In some cases, the conduit size is 3.6 Fr.
[0177] In some cases, the controller can be adapted and configured to allow liquid to flow through the liquid supply chamber 620 at a flow rate greater than or equal to 10 mL / min to 200 mL / min. In some cases, the controller can be adapted and configured to allow liquid to flow through the liquid supply chamber 620 at a flow rate greater than or equal to 10 mL / min, greater than or equal to 20 mL / min, greater than or equal to 30 mL / min, greater than or equal to 40 mL / min, greater than or equal to 50 mL / min, greater than or equal to 60 mL / min, greater than or equal to 70 mL / min, greater than or equal to 80 mL / min, greater than or equal to 90 mL / min, or greater than or equal to 100 mL / min. In some cases, the controller can be adapted and configured to allow fluid to flow through the fluid supply chamber 620 at a flow rate of less than or equal to 100 mL / min, less than or equal to 90 mL / min, less than or equal to 80 mL / min, less than or equal to 70 mL / min, less than or equal to 60 mL / min, less than or equal to 50 mL / min, less than or equal to 40 mL / min, less than or equal to 30 mL / min, less than or equal to 20 mL / min, or less than or equal to 10 mL / min. The flow rate through the fluid supply chamber 620 can be selected by balancing various factors, including the resulting suction force, heat transfer, fluid management, and the risk of injury to the patient. Providing an insufficient flow rate may result in insufficient suction, preventing the aspiration of one or more biological objects, and / or insufficient heat transfer from the ablation device to the fluid, making it impossible to regulate and maintain the temperature within the system. Therefore, the system may be unable to remove biological objects and / or may result in injury to the patient. In contrast, providing an excessively high flow rate may overpower the vacuum source, causing the outlet flow rate caused by the vacuum source to mismatch the inlet flow rate through the fluid supply chamber 620. Therefore, providing excessive flow carries the risk of over-expansion of the receiving system's anatomy, which could potentially cause injury to the patient. Furthermore, providing excessive flow may pose a risk of injury to the patient because it may be difficult to detect the difference between inflow and outflow and to respond to that difference in a timely manner.
[0178] In some cases, the devices (e.g., instruments) and / or systems described herein include a fluid supply chamber (e.g., Figure 8AThe liquid supply chamber 620. In some cases, the liquid supply chamber 620 may include an inlet configured to receive liquid at a pressure greater than or equal to 500 psi and less than or equal to 15,000 psi. In some cases, the inlet may be configured to receive liquid at pressures greater than or equal to 500 psi, greater than or equal to 1000 psi, greater than or equal to 2500 psi, greater than or equal to 5000 psi, greater than or equal to 7500 psi, greater than or equal to 10,000 psi, greater than or equal to 12,500 psi, or greater than or equal to 15,000 psi. In some cases, the inlet may be configured to receive liquid at pressures less than or equal to 15,000 psi, less than or equal to 12,500 psi, less than or equal to 10,000 psi, less than or equal to 7500 psi, less than or equal to 5000 psi, less than or equal to 2500 psi, less than or equal to 1000 psi, or less than or equal to 500 psi. The pressure within the fluid supply chamber 620 can be determined by balancing various factors, including material strength, fluid flow rate, maneuverability, visibility, required suction force, and patient safety. Fluid flow rate is measured as the volume of fluid passing through a location over a given time period. As described herein, velocity and pressure can be inversely related. Therefore, the size of the fluid supply chamber 620 can be inversely proportional to the pressure that can be contained within it to provide a given target flow rate. For example, the higher the pressure, the smaller the fluid supply chamber 620 can be to provide the same target flow rate as a larger fluid supply chamber 620. In some cases, a smaller fluid supply chamber 620 can be more flexible than a larger one. Therefore, the maneuverability of the system can be increased by implementing a smaller fluid supply chamber 620. Excessively high pressure within the fluid supply chamber 620 can cause cavitation of the fluid jet within the drainage tube 605, introducing air bubbles into the field of vision and impairing visibility. Insufficient pressure can result in a low flow rate that cannot effectively generate sufficient suction.
[0179] Figures 9A to 9FAn instrument 700 is shown, having a drainage tube 705 coupled to a reversing cap 706. As described herein, the drainage tube may guide the tube body. For example, the drainage tube 705 may be the outer wall of a catheter. In some cases, the reversing cap 706 may be a high-pressure fluid reversing device. In some cases, the reversing cap 706 may be located at the distal end of the instrument 700. In some cases, the reversing cap 706 may be dome-shaped. The dome shape of the reversing cap 706 may advantageously provide a rounded and smooth end that may come into contact with the patient's internal tissues. The rounded and smooth geometry of the reversing cap 706 may prevent damage to the patient's internal tissues due to axial contact. Furthermore, the reversing cap 706 may have an internal geometry to help redirect the fluid jet from the fluid supply chamber 720 to the drainage chamber 735. For example, the reversing cap 706 may have an internal concave structure configured to redirect the fluid flow by 180 degrees.
[0180] Figure 9A A perspective view of the distal end of device 700 is shown. Device 700 may be identical or similar to other devices described herein, such as device 100 or 200. For example, device 700 may include a drainage tube 705 having a plurality of aspiration port openings 710, one or more return port openings 715, a fluid supply chamber 720, and a drainage chamber 735. The aspiration port openings 710, one or more return port openings 715, the fluid supply chamber 720, and the drainage chamber 735 may be identical or similar to the aspiration port openings, one or more return port openings, the fluid supply chamber, and the drainage chamber described herein with respect to other cases. Device 700 may include a reversing cap 706. In some cases, device 700 may also include a reversing plate 707. In some cases, the reversing plate 707 may be positioned proximally within the drainage chamber near the reversing cap 706. For example, the reversing plate 707 may be positioned between the drainage tube 705 and the reversing cap 706. In some cases, the commutator cap 706 can be fixedly attached to the commutator plate 707. For example, the commutator cap 706 can be laser-welded to the commutator plate 707. In some cases, the commutator plate 707 can be an annular structure configured to surround the liquid supply chamber 720.
[0181] Figures 9B to 9D A side cross-sectional view of the distal end of the device 700 is shown. (See diagram.) Figure 9B As shown, the device 700 may include a nozzle 725. The nozzle 725 may include any suitable cross-sectional geometry known to those skilled in the art. Non-limiting cross-sectional geometries contemplated herein include conical geometries, bell-shaped or wavy geometries, and annular or plug-shaped geometries.
[0182] In some cases, nozzle 725 may include a cross-sectional dimension greater than or equal to 50 µm or less than or equal to 200 µm. In some cases, the nozzle cross-sectional diameter may be greater than or equal to 50 µm, greater than or equal to 75 µm, greater than or equal to 100 µm, greater than or equal to 125 µm, greater than or equal to 150 µm, greater than or equal to 175 µm, or greater than or equal to 200 µm. In some cases, the nozzle cross-sectional diameter may be less than or equal to 200 µm, less than or equal to 150 µm, less than or equal to 125 µm, less than or equal to 100 µm, less than or equal to 75 µm, or less than or equal to 50 µm. In some cases, nozzle 725 may have a cross-sectional dimension that tapers at least a portion of the length of nozzle 725. The size of the cross-sectional dimension of nozzle 725 can be determined by balancing various factors, including fluid flow rate, required suction force, and patient safety. As described herein, fluid flow rate is measured as the volume of fluid passing through a location over a given time period. A larger cross-sectional dimension can provide a larger volume than a smaller cross-sectional dimension. An insufficiently small cross-sectional dimension may result in insufficient fluid flow to generate suction within a cavity with a larger cross-section (such as drain tube 705). In contrast, an excessively large cross-sectional dimension may require a larger flow rate to generate a flow rate with sufficient velocity to produce a fluid jet.
[0183] In some cases, nozzle 725 can be configured to rotate about an axis. In some cases, nozzle 725 is configured to rotate relative to the axis of rotation to any angle between +90° and -90°. In some cases, rotating nozzle 725 can change the direction of the liquid jet formed by passing high-pressure fluid through nozzle 725.
[0184] Nozzle 725 may also include an outlet 730 for guiding fluid flow from liquid supply chamber 720 to drainage chamber 735. Outlet 730 may include any suitable cross-sectional shape. Non-limiting examples of suitable cross-sectional shapes include triangles, squares, rectangles (e.g., with any suitable aspect ratio), circles, ellipses, polygons (e.g., pentagons, hexagons, heptagons, octagons, nonagons, dodecagons, etc.), rings, irregular shapes, etc.
[0185] like Figure 9C As shown, outlet 730 can be positioned at the proximal end of nozzle 725.
[0186] Figure 9E Various views of the commutator 707 are shown. (e.g.) Figure 9EAs shown, the commutator 707 may have an annular structure with one or more openings extending through it. For example, the one or more openings may include a first opening 708 and a second opening 709. In some cases, the first opening 708 may be configured to receive a liquid supply chamber 720 and / or be part of a liquid supply chamber 720. In some cases, the second opening 709 may be configured to receive a nozzle 725 and / or be part of a nozzle 725.
[0187] Figure 9F Various views of the commutator cap 706 are shown. (e.g.) Figure 9F As shown, the reversing cap 706 may have a dome-shaped body. In some cases, the reversing cap 706 may have a first surface 711 and a second surface 712. The first surface 711 may be an outer surface, and the second surface 712 may be an inner surface. In some cases, the second surface 712 may be configured to redirect fluid flow. For example, fluid from the liquid supply chamber 720 may enter the volume defined by the second surface 712 and be redirected by the dome-shaped second surface 712 toward the nozzle 725.
[0188] In some cases, the device may include one or more feedback mechanisms. In some cases, the feedback mechanism may be configured to control one or more device parameters in response to changes in temperature or pressure. Other parameters may also trigger the feedback mechanism, such as, for example, changes in the suction force generated by the device. In some cases, the feedback mechanism may include one or more sensors to detect the proximity of a biological object, thereby aiding in accurate targeting. In some cases, the feedback mechanism adjusts the vacuum force in real time based on the size and properties of the biological object being captured. In some cases, the feedback mechanism regulates the operating temperature of the device to maintain an optimal temperature within the body of the subject.
[0189] Figures 10A to 10B Device 800 is shown. Device 800 may be the same as or similar to the devices described herein, such as device 100 or 200. For example, device 800 may include a drainage tube 805, one or more suction port openings 810, and one or more return port openings 815. The drainage tube 805 may be in fluid communication with a fluid supply device via a first flow channel 820 and may be in fluid communication with a fluid waste channel 835. In some cases, device 800 may also include an integrated sensing system 802. In some cases, the integrated sensing system 802 may include one or more sensors 852 (e.g., temperature sensors, pressure sensors, etc.).
[0190] Figure 10AAn example is illustrated in which one or more sensors 852 may be positioned proximally to the drainage tube 805. For example, one or more sensors 852 may be positioned along the fluid waste channel 835. Thus, one or more sensors 852 may be configured to monitor the pressure and / or temperature of the waste fluid. Positioning one or more sensors 852 proximally to the drainage tube 805, by intermittently starting and stopping the vacuum source, can result in accurate readings of pressure within the anatomical structures (urinary tract and / or kidneys (i.e., intrarenal pressure)). For example, when flow is paused, the pressure proximally to the drainage tube 805 and distal to the vacuum source may be substantially similar to the pressure at the distal end of the drainage tube 805. In some cases, one or more sensors 852 are positioned at the same elevation or height as the distal end of the drainage tube 805. In some cases, positioning one or more sensors 852 on the proximal side of the drainage tube 805 allows the controller to detect the formation of obstruction or blockage at the distal end of the drainage tube 805. In some cases, positioning one or more sensors 852 on the proximal side of the drainage tube 805 allows the controller to detect imbalances in inflow and outflow from anatomical structures.
[0191] Figure 10B Another scenario is illustrated where one or more sensors 852 may be positioned distal to the drainage tube 805. In some cases, the device 800 may include a separate, smaller lumen, for example, to introduce and mount a pressure sensor, temperature sensor, proximity sensor, or any other sensor. In some cases, additional lumens / channels accommodate wiring, optical fibers, etc. In some cases, signals travel through the inside or outside of the catheter and are connected to a computer.
[0192] Figure 11 System 900 is illustrated, which includes online pressure monitoring for monitoring pressure at the aspiration site and / or for detecting blockages in the aspiration tubing. System 900 may include a controller 945, which can be configured to adjust one or more pumps (e.g., inflow / outflow) to advantageously allow for optimal adjustment of parameters and stone targeting. System 900 may be similar to System 400 described herein. For example, System 900 may include a drainage tube 905, one or more aspiration port openings 910, one or more return port openings 915, a fluid supply chamber 920, a drainage chamber 935, a fluid source 940, a first control signal 946A, a second control signal 946B, one or more sensors 952, a feedback signal 953, a high-pressure fluid pump 955, and a vacuum source 965. One or more sensors 952 may be configured to monitor online pressure at the aspiration site and / or detect blockages in the drainage chamber 935.
[0193] In some cases, the device may include an automated aspiration system and / or power source. In some cases, the automated aspiration system and / or power source may include a bio-object engagement system that, upon detection and / or capture of a bio-object, triggers subsequent procedures for manipulation and aspiration without manual intervention. In some cases, the automated aspiration system and / or power source are integrated with a sensing mechanism capable of detecting when the bio-object is securely held by the catheter, thereby prompting the power source to automatically advance and manipulate the object for manipulation. In some cases, the sensing mechanism employs optical, ultrasonic, pressure, or tactile sensors to confirm the position of the bio-object and ensure its secure holding within the aspiration port.
[0194] For example, such as Figure 12 As illustrated herein, system 1000 may include instruments similar to those described herein (such as instruments 100 or 200). For example, system 1000 may include a drainage tube 1005, one or more aspiration port openings 1010, one or more reflux port openings 1015, a fluid supply lumen 1020, and a drainage lumen 1035. In some cases, system 1000 may also include an external motorization device 1040. The external motorization device 1040 may be configured to control one or both of the longitudinal and rotational movement of the catheter, as well as its articulation movements, whether to the catheter itself or to the entire ureteroscope. In some cases, system 1000 may be integrated with one or more sensors 1052 (e.g., embedded in the sheath, endoscope, or distal tip of the catheter) or via computer vision (e.g., based on images received by a camera located proximal to the distal tip), advantageously enabling it to determine the most effective way to manipulate the stone. In some cases, the automated process involves: intelligently advancing a drainage tube 1005 toward a solid deposit (such as a stone); securing the solid deposit to the drainage tube 1005 via suction; withdrawing the solid deposit toward an ablation source; performing ablation on the solid deposit to break it into fragmented segments; then aspirating the fragments into a drainage cavity 1035 via suction; and optionally repeating the process as needed. In some cases, computer vision (e.g., based on real-time analysis of endoscopic video) can be used to determine the position of the fragments relative to both the drainage tube 1005 and the ablation source. In some cases, a motorized system senses, rotates, translates, and / or articulates as needed to locate / attract biological objects (such as solid deposits), ablate, aspirate, and optionally repeat (e.g., thus achieving a fully automated closed-loop system).
[0195] In some cases, the automated suction system 1000 and / or energy source may include one or more feedback loops that adjust the intensity and duration of the energy source based on the size of the solid deposit, the composition of the solid deposit, and positioning data obtained from the sensing mechanism. In some cases, the automated suction system 1000 and / or energy source may include a controller programmed to automate the sequence of capturing, manipulating, and suctioning solid deposits based on predefined criteria or real-time feedback.
[0196] In some cases, the automated suction system 1000 and / or energy source may include one or more sensors 1052 that continuously monitor the manipulation process and adjust the energy source parameters or pause the process if the manipulation of solid deposits is considered complete or if a potential complication is detected.
[0197] In some cases, the automated suction system 1000 and / or energy source can be overrode or adjusted at any stage of the procedure, thus allowing manual control when deemed necessary.
[0198] In some cases, the automated suction system 1000 can be configured to retrieve and process imaging and / or sensor feedback data to guide the energy source, thereby ensuring optimal positioning and alignment for effective manipulation of solid deposits.
[0199] In some cases, the automated suction system 1000 and / or the energy source may include one or more removal mechanisms that activate the suction process to remove debris from the body location after sensing successful manipulation and breakup of solid deposits.
[0200] In some cases, the automated aspiration system 1000 and / or energy source can be configured with machine learning capabilities, allowing the automated aspiration system 1000 to adapt and enhance its engagement and manipulation procedures with solid deposits based on accumulated data from multiple surgeries.
[0201] In some cases, the automated suction system 1000 may include a high-pressure fluid source connected to a nozzle that can operate in a constant or pulsating flow mode as needed to achieve optimal engagement and manipulation of solid deposits.
[0202] In some cases, the automated suction system 1000 may include a pump or vacuum source coupled to the proximal end of the drainage chamber 1035 and may be able to operate with constant or intermittent flow, thereby allowing adaptive adjustments to the suction based on the characteristics and size of the solid deposit fragments or debris.
[0203] In some cases, the automated suction system 1000 can be configured to be integrated with a controller that can switch between a constant flow mode and a pulsating flow mode based on real-time feedback or preset program requirements for fluid supply via the liquid supply chamber 1020 and a pump or vacuum source connected to the proximal end of the drainage chamber 1035.
[0204] In some cases, the automated aspiration system 1000 and / or power source may include a user interface to manually select between a constant flow mode and a pulsating flow mode for fluid supply via the fluid supply chamber 1020 and drainage via the drainage chamber 1035, based on the specific needs of the surgery.
[0205] In some cases, the apparatus and / or system described herein may include one or more blockage detection and removal mechanisms. In some cases, the one or more blockage detection and removal mechanisms include one or more sensors configured to detect blockages and / or obstructions at one or more suction port openings 1015. In some cases, the sensors may be selected from the group consisting of pressure sensors, flow sensors, acoustic sensors, optical sensors, and combinations thereof.
[0206] In some cases, upon detection of a blockage, the device can activate a blockage removal mechanism that uses an energy source to directly target and break down the blockage at the suction port opening 1015. In some cases, the blockage removal mechanism can adjust the liquid jet dynamics, including changing the jet pulse frequency, pressure, or flow rate, to expel the blockage.
[0207] In some cases, one or more blockage detection and removal mechanisms may include a flexible wire or probe configured to be manually or automatically advanced through the drainage cavity 1035 upon detection of a blockage to mechanically expel or break up the blockage.
[0208] In some cases, one or more blockage detection and removal mechanisms may be configured to be integrated with a controller programmed to reverse or adjust the direction of vacuum or peristaltic flow at the proximal end of the drainage chamber 1035 in response to a detected blockage.
[0209] In some cases, when a blockage is detected, the blockage removal mechanism combines multiple strategies, including energy application, jet regulation, and mechanical intervention, to ensure comprehensive blockage management.
[0210] In some cases, at least a portion of the device and / or system described herein may have specific articulations and / or curvatures (e.g., drainage tube 1005, fluid supply chamber 1020, drainage chamber 1035, sheath). In some cases, the device may include a drainage tube 1005 with a curved geometry, for example, to facilitate enhanced navigation and positioning within a location within the subject's body. In some cases, the device and / or system may include an articulation mechanism integrated with the drainage tube 1005, thereby enabling manual or automatic bending or flexion of the drainage tube 1005 to enhance retrieval or manipulation of solid deposits. In some cases, the articulation mechanism includes one or more joints, pivot points, or flexure regions, thereby allowing multidirectional movement of the distal end of the device. In some cases, the articulation mechanism may enable precise orientation of solid deposits relative to an energy source, thereby optimizing the effectiveness of object manipulation or fragmentation.
[0211] In some cases, the device and / or system may also include a control interface at the proximal end, thereby allowing the user to adjust the joint movement of the instrument in real time during surgery.
[0212] Figures 13A to 13E Endoscope 1100 is illustrated. Endoscope 1100 can be a custom endoscope. However, as contemplated herein, any suitable endoscope known to those skilled in the art can be used. Endoscope 1100 may include components similar to those described herein. For example, endoscope 1100 may include a drainage tube 1105 (which may be similar to any of the drainage tubes described herein), having one or more aspiration port openings 1110, one or more return port openings 1115, a fluid supply lumen 1120, and a drainage lumen 1135. Drainage tube 1105 may be integrated into a custom ureteroscope. In some cases, endoscope 1100 may also include an ablation device 1150. Ablation device 1150 may be an ablation tool configured to break up and fragment solid deposits 1145 into one or more smaller pieces (e.g., debris). As described herein, ablation device 1150 may be a laser or laser fiber, an ultrasonic ablation tool (such as HIFU), etc. For example, as Figures 13A to 13E As shown, the ablation device 1150 may be a laser fiber. In some cases, an outer sheath may be provided together with a custom-made endoscope 1100. Depending on the circumstances, devices disposed within the outer sheath may allow simultaneous imaging, irrigation, manipulation of solid deposits 1145, and aspiration during the procedure. In some cases, integration of the devices and / or systems disclosed herein with endoscope 1100 may provide synchronous control or articulation mechanisms, thereby allowing simultaneous imaging, aspiration, irrigation, and object manipulation.
[0213] Figure 13A A perspective view of mirror 1100 is shown. (As shown) Figure 13A As shown, the drainage tube 1105 can extend distally from the endoscope 1100. The drainage tube 1105 can be configured to aspirate one or more solid deposits 1145. The one or more solid deposits 1145 can include large solid deposits that are too large to pass through one or more aspiration port openings 1110 and / or through the drainage cavity 1135, as well as small solid deposits that can pass through one or more aspiration port openings 1110 and / or through the drainage cavity 1135. In some cases, the one or more aspiration port openings 1110 can hold large solid deposits 1145 in place for ablation by the ablation device 1150 and break down the large solid deposits 1145 into fragmented pieces. The ablation device 1150 can be positioned laterally offset from the longitudinal axis of the drainage tube 1105 and aligned with the solid deposits 1145. In some cases, the ablation device 1150 can have a diameter of approximately 0.7 mm.
[0214] Figure 13B A front view of a scope 1100 is shown. The scope 1100 may include a plurality of openings extending through it. In some cases, the plurality of openings may include a first opening 1101 and a second opening 1102. The first opening 1101 may be sized to receive a drainage tube 1105. For example, the size of the first opening 1101 may be associated with the external dimensions of the drainage tube 1105. In some cases, the size of the first opening 1101 may be larger than the external dimensions of the drainage tube 1105. For example, the diameter of the first opening 1101 may be approximately 1.4 mm (4.2 French). The second opening 1102 may be sized to receive an ablation device 1150. For example, the size of the second opening 1102 may be associated with the external dimensions of the ablation device 1150. In some cases, the size of the second opening 1102 may be larger than the external dimensions of the ablation device 1150. For example, the diameter of the second opening 1102 may be approximately 0.8 mm (2.4 French). The mirror 1100 may also include one or more illumination elements 1103. The one or more illumination elements 1103 may be configured to provide light to the subject's urinary system. For example, the one or more illumination elements 1103 may be light-emitting diodes (LEDs). In some cases, the one or more illumination elements 1103 may be oriented distally and / or positioned on the distal side of the mirror 1100. The mirror 1100 may also include an optical element 1104. In some cases, the optical element 1104 may be configured to provide a physician with an optical view of the distal end of the mirror 1100. For example, the optical element 1104 may be a camera.
[0215] Figure 13C Another front view of mirror 1100 is shown, in which drainage tube 1105, multiple solid deposits 1145, and ablation device 1150 are shown. Figure 13C As shown, solid deposit 1145 can be secured to drainage tube 1105 via suction at one or more suction port openings 1110. One or more suction port openings 1110 can be positioned on the side of drainage tube 1105 facing ablation device 1150. In some cases, the longitudinal axis of the ablation device can be parallel to the longitudinal axis of drainage tube 1105. Therefore, ablation device 1150 can be configured to ablate and / or fragment the solid deposit 1145 secured to this side of drainage tube 1105. Figure 13C As shown, the first opening 1101 may be larger than the drainage tube 1105. In some cases, the space between the first opening 1101 and the external dimensions of the drainage tube 1105 can provide irrigation fluid. For example, irrigation fluid (such as saline solution) can be provided into the subject's urinary system via the space between the first opening 1101 and the drainage tube 1105. The irrigation fluid can be used to inflate and / or dilate organs of the urinary system.
[0216] Figure 13D A side view of mirror 1100 is shown, in which drainage tube 1105, solid deposit 1145, and ablation device 1150 are shown. Figure 13D As shown, the longitudinal axes of the drainage tube 1105 and the ablation device 1150 can be coplanar. The longitudinal axis of the ablation device 1150 can intersect with the solid deposit 1145. Therefore, the ablation device 1150 can emit energy along its longitudinal axis to break up and fragment the solid deposit 1145 into debris.
[0217] Figure 13E A top view of mirror 1100 is shown, in which drainage tube 1105, multiple solid deposits 1145, and ablation device 1150 are shown. Figure 13E As shown, the longitudinal axis of the ablation device 1150 may intersect with the solid deposit 1145 fixed to the drainage tube 1105 via one or more suction port openings 1110.
[0218] Figures 14A to 14C An example of a device 1200 with a concentric design is illustrated. Device 1200 may be similar to any of the devices described herein (such as device 100 or 200), except for the differences described herein. In some cases, device 1200 may include a concentric device design for energy delivery and suction at the distal end.
[0219] In some cases, the device 1200 may include a drainage tube 1205 having multiple radially nested inner tubes. For example, the drainage tube 1205 may include at least one inner tube. Figures 14A to 14CAs shown, the drainage tube 1205 may have a first inner tube 1207 and a second inner tube 1208. The first inner tube 1207 may be radially nested and disposed within the second inner tube 1208. The second inner tube 1208 may be radially nested and disposed within the outer body portion of the drainage tube 1205. Therefore, the drainage tube 1205 may include a plurality of longitudinal volumes extending from the proximal end to the distal end.
[0220] like Figures 14A to 14C As shown, the plurality of volumes may include a first internal volume, a second internal volume, and a third internal volume. The first volume may be defined by the wall of the first inner tube 1207. In some cases, the first volume may be defined approximately by the cross-sectional area and length of the first inner tube 1207. For example, the first volume may be defined as: πr 1207 2 L 1207 , where r 1207 It is the radius of the first inner tube 1207, and L 1207 This is the length of the first inner tube 1207. The second volume can be defined by the space between the wall of the second inner tube 1208 and the wall of the first inner tube 1207. In some cases, the second volume can be approximately defined by the cross-sectional area of the second inner tube 1208, the length of the second inner tube 1208, the cross-sectional area of the first inner tube 1207, and the length of the first inner tube 1207 minus any supporting structure. For example, the second volume can be defined as: (πr 1208 2 L 1208 ) - (π r 1207 2 L 1207 ) – nt r L 1208 , where r 1208 It is the radius L of the second inner tube 1208. 1208 It is the length of the second inner tube 1208, r 1207 It is the radius L of the first inner tube 1207. 1207 is the length of the first inner tube 1207, n is the number of supporting structures, t is the thickness of the supporting structure, and r is the radial distance between the first inner tube 1207 and the second inner tube 1208. The third volume can be defined by the space between the wall of the outer body portion of the drainage tube 1205 and the wall of the second inner tube 1208. In some cases, the third volume can be approximately defined by the cross-sectional area of the drainage tube 1205, the length of the drainage tube 1205, the cross-sectional area of the second inner tube 1208, and the length of the second inner tube 1208 minus any supporting structures. For example, the third volume can be defined as: (πr) 1205 2 L 1205) - (π r 1208 2 L 1208 ) – nt r L 1205 , where r 1205 It is the radius L of the drainage tube 1205. 1205 It is the length of the drainage tube 1205, r 1208 It is the radius L of the second inner tube 1208. 1208 is the length of the second inner tube 1208, n is the number of supporting structures, t is the thickness of the supporting structure, and r is the radial distance between the second inner tube 1208 and the drainage tube 1205.
[0221] The plurality of longitudinal volumes can be configured as a fluid supply chamber, a drainage chamber, or a suction chamber, and / or an inlet chamber for providing the ablation device 1250. For example, one of the plurality of volumes can be in fluid communication with a suction source (such as a vacuum source or a suction pump). In some cases, the volume in fluid communication with the suction source can be a drainage chamber 1235. For example, a second volume can be a drainage chamber 1235. A different one of the plurality of volumes can be in fluid communication with a fluid source and can be configured to receive pressurized fluid. In some cases, the volume in fluid communication with the fluid source can be a fluid supply chamber 1220. For example, a third volume can be a fluid supply chamber 1220. A different one of the plurality of volumes can be configured to receive the ablation device 1250. For example, a first volume can be a chamber configured to receive the ablation device 1250.
[0222] The device 1200 may also include an optional reversing cap 1206. The reversing cap 1206 may be configured to redirect fluid flow toward the drainage tube 1205. As described herein, the reversing cap 1206 may be configured to redirect fluid flow by 180 degrees. In some cases, the reversing cap 1206 may have an annular structure having a central cavity extending therethrough. In some embodiments, the fluid supply cavity 1220 may be shaped to redirect fluid flow toward the proximal end without using the reversing cap 1206 (see, for example...). Figure 3A ).
[0223] The central cavity may include a suction port opening 1210. For example... Figures 14A to 14CAs shown, the suction port opening 1210 can be positioned on the distal side of the instrument 1200. In some cases, the suction port opening 1210 can be funnel-shaped, wherein the suction port opening 1210 is larger on the distal side than on the proximal side. The reversing cap 1206 can include a first surface 1211 and a second surface 1212 opposite to the first surface 1211. In some cases, the first surface 1211 can be positioned on the distal end of the reversing cap 1206, and the second surface 1212 can be positioned on the proximal end of the reversing cap 1206. The second surface 1212 can include an annular groove extending circumferentially along the second surface 1212. The annular groove can be circular. For example, the annular groove can be semi-circular. Thus, fluid entering the second surface 1212 can be redirected by the annular groove. The reversing cap 1206 can be coupled to the distal end of the drainage tube 1205. In some cases, the annular groove can be axially displaced from the second and third volumes of the drainage tube 1205. For example, the annular groove on the second surface 1212 can be axially displaced by a distance X. Therefore, fluid flow from one of the second or third volumes can be redirected to the other of the second or third volumes. For example, fluid flow from the liquid supply chamber 1220 can be redirected by the annular groove on the second surface 1212 into the drainage chamber 1235. Axial displacement also allows external fluids and solid deposits to be drawn through the drainage chamber 1235.
[0224] The device 1200 may also include an ablation device 1250. In some cases, the ablation device 1250 may be housed within the first inner tube 1207. The ablation device 1250 may be an ablation tool configured to break up and fragment solid deposits into one or more smaller pieces (e.g., debris). As described herein, the ablation device 1250 may be a laser or laser fiber, an ultrasonic ablation tool (such as HIFU), etc. For example, as... Figures 14A to 14C As shown, the ablation device 1250 can be a laser fiber. Therefore, the first volume defined by the wall of the first inner tube 1207 can be filled by the ablation device 1250 configured to fragment solid deposits. In some cases, the ablation device 1250 can deliver energy through the first inner tube 1207 while the second inner tube 1208 provides suction, thereby facilitating simultaneous energy delivery and suction.
[0225] In some cases, radially nested tubes may include an outer tube and an inner tube. The outer tube may resemble the outer body portion of the drainage tube 1205, and the inner tube may be identical to the second inner tube 1208 described above. Therefore, the drainage tube 1205 may resemble the drainage tube 1205 described above without the first inner tube 1207. In such embodiments, the plurality of volumes may include an inner volume and an outer volume. The inner volume may be substantially defined by the cross-sectional area and length of the inner tube. For example, the outer volume may be defined as: πr inner 2 L inner , where r inner It is the radius of the inner tube, and L inner This is the length of the inner tube. The outer volume can be approximately defined by the cross-sectional area of the drainage tube 1205, the length of the drainage tube 1205, the cross-sectional area of the inner tube, and the length of the inner tube minus any supporting structures. For example, the outer volume can be defined as: (πr) outer 2 L outer ) - (π r inner 2 L inner ) – nt r, where r outer It is the radius L of the drainage tube 1205. outer It is the length of the drainage tube 1205, r inner L is the radius of the inner tube. inner 'n' is the length of the inner tube, 'n' is the number of supporting structures, and 't' is the thickness of the supporting structure. r is the radial distance between the inner tube and the drainage tube 1205.
[0226] The effective cross-sectional areas of the volumes within the drainage tube 1205 can be different. In some cases, the effective cross-sectional area of the volume between the drainage tube 1205 and the inner tube can be smaller than the effective cross-sectional area of the inner tube. For example, the third volume described above can have an effective cross-sectional area: (π r 1205 2 ) - (π r 1208 2 ) – nt r, and the second volume described above can have an effective cross-sectional area: (π r 1208 2 ) - (π r 1207 2 ) – nt r, where r 1205 2 -r 1208 2 Less than r1208 2 -r 1207 2 Additionally or alternatively, the external volume described above may have an effective cross-sectional area: (πr) outer 2 ) - (π r inner 2 ) – nt r, and the internal volume described above can have an effective cross-sectional area: (π r outer 2 ) - (π r inner 2 ), where r outer 2 -r inner 2 Less than r inner 2 Therefore, the flow rate from the third volume and / or outer volume to the second volume and / or inner volume is transferred from the contraction chamber to the expansion chamber. In such a case, the supply chamber may include a first effective cross-sectional area and the drainage chamber and / or suction chamber may include a second effective cross-sectional area greater than the first effective cross-sectional area, wherein the fluid flow can be injected from the volume of the supply chamber having the first effective cross-sectional area into the volume of the catheter body having the second effective cross-sectional area.
[0227] In some cases, Figures 14A to 14C The concentric design of the device 1200 illustrated herein can be modified so that the ablation device 1250 can emit energy through the second inner tube 1208 and can be easily aspirated through the first inner tube 1207, thereby allowing solid deposits to be aspirated, retained, and removed from the distal end of the drainage tube 1205 when the ablation device 1250 is in motion. Additionally or alternatively, Figures 14A to 14C The concentric design of the device 1200 illustrated herein can be modified to include only two radially nested tubes, comprising an inner tube and an outer tube as described above. In such a case, the ablation device can be positioned within either the inner or outer volume.
[0228] The concentric design of Instrument 1200 offers several advantages. The concentric design allows for uninterrupted operation of the energy source while the suction process captures, retains, and removes solid deposits. In some cases, the removal of debris, flakes, and dust can be enhanced by applying a vacuum at the energy application site near the suction port opening. For example, as... Figures 14A to 14CAs shown, a high-speed flow can be provided at the energy application site from the fluid supply lumen to the drainage lumen and / or aspiration lumen. Furthermore, the temperature generated by the ablation device 1250 can be reduced by directing the fluid flow from the fluid supply lumen to a drainage lumen proximal to the ablation device 1250 (e.g., anterior to the ablation device 1250). The concentric design of the device 1200 provides the fluid supply lumen, drainage lumen, and / or aspiration lumen, as well as the ablation device 1250, within a single working channel of the ureteroscope. Therefore, the concentric design of the device 1200 is compatible with existing ureteroscopes having a single working channel. By connecting the discrete lumens in a concentric configuration, manipulation of the device 1200 is facilitated by controlling a single component rather than managing separate parts. Furthermore, positioning the ablation device 1250 at the aspiration port opening minimizes the risk of blockage and obstruction of the drainage lumen, as debris and fragments cannot bypass the ablation device 1250 until they become small enough to pass through the gap at the distal end of the device 1200.
[0229] Figure 15 A schematic diagram of a ureteroscopy system 1300 is shown, which may be similar to any of the systems described herein. Although system 1300 is described in the context of ureteroscopy, system 1300 or any of the systems described herein can be used in any medical procedure that uses a catheter.
[0230] The ureteroscopic system 1300 may include a ureteroscope 1302. The ureteroscope 1302 may include one or more lumens 1304. The ureteroscope 1302 may include one or more inlets 1306 and one or more outlets 1308 in fluid communication with the one or more lumens 1304. In some examples, the one or more inlets 1306 may be configured to deliver energy emitted from an ablation device and / or a fluid supply lumen 1320 in fluid communication with a fluid source 1340 via a high-pressure fluid pump 1355. In some examples, the one or more inlets 1306 may be sealed to prevent leakage from the one or more lumens 1304. The one or more outlets 1308 may be in fluid communication with the one or more lumens 1304. In some examples, the one or more outlets 1308 may be configured to provide openings to drain waste material from the ureteroscope 1302 to a waste container 1360. The waste material may include biological objects. In some examples, the ureteroscopic system 1300 may include a suction pump 1365 to assist in aspirating waste material into the waste container 1360.
[0231] The ureteroscopic system 1300 may also include a drainage tube 1305. The drainage tube 1305 may be any of the drainage tubes described herein (such as drainage tube 105 or 205). For example, the drainage tube 1305 may have the following characteristics as described above. Figures 14A to 14C The concentric design described.
[0232] A ureteroscope 1302 can be introduced into a part of the subject's urinary system. For example, the ureteroscope 1302 can be introduced into one of the subject's kidneys. A high-pressure fluid pump 1355 can be activated to provide a high-flow-rate fluid stream to the distal end of the drainage tube 1305 through the fluid supply chamber 1320. The drainage tube 1305 can redirect fluid from the fluid supply chamber 1320 to a drainage chamber within one or more chambers 1304.
[0233] As described herein, fluid redirection can induce a Venturi effect to provide low pressure at the distal end of the ureteroscope 1302. While the suction pump 1365 can provide suction to the proximal end of the ureteroscope 1302, the additional suction provided by the fluid jet at the proximal end of the ureteroscope 1302 facilitates the sustained capture of kidney stones (or more generally, biological objects) at or near the distal tip of the drainage tube 1305 and allows for the suction level necessary for efficient and safe removal of kidney stones. Energy from the ablation source can be used to break down the kidney stones into fragments, which are aspirated through one or more lumens 1304 into the waste container 1310.
[0234] Figures 16A to 16B A drainage tube 1405 is illustrated, in which an ablation device (e.g., a laser fiber) is disposed within the drainage tube 1405 itself. The drainage tube 1405 may be part of a custom-made endoscope. The drainage tube 1405 may resemble any of the drainage tubes described herein. For example, the drainage tube 1405 may include one or more aspiration port openings, one or more return port openings, a fluid supply lumen 1420, and a drainage lumen 1435. In some examples, the drainage tube 1405 may also include an ablation device 1450. The ablation device 1450 may be an ablation tool configured to break up and fragment solid deposits into one or more smaller pieces (e.g., debris). As described herein, the ablation device 1450 may be a laser or laser fiber, an ultrasonic ablation tool (such as HIFU), etc. Integrating a ureteroscope as described herein with the drainage tube 1405 may provide synchronous control or articulation mechanisms, thereby allowing simultaneous imaging, aspiration, irrigation, and object manipulation.
[0235] Figure 16A A front view of drainage tube 1405 is shown. Figure 16AAs shown, the drainage tube 1405 may include a fluid supply chamber 1420 and a drainage chamber 1435. The fluid supply chamber 1420 may be the same as or similar to the fluid supply chamber described herein. The drainage chamber 1435 may be the same as or similar to the drainage chamber described herein. The drainage tube 1405 may also include a reversing cap 1406. The reversing cap 1406 may be configured to redirect fluid flow from the fluid supply chamber 1420 to the drainage chamber 1435.
[0236] Figure 16B A side cross-sectional view of the drainage tube 1405 is shown. Figure 16B As shown, the drainage tube 1405 may also include a reversing plate 1407. The reversing plate 1407 may have an annular structure with one or more openings extending therethrough. The one or more openings may be configured to receive a fluid supply chamber and / or a drainage chamber 1435 and / or as part thereof.
[0237] Therefore, in some cases, the ablation device 1450 described herein (e.g., a laser) may be disposed within a portion of the drainage tube 1405 and / or drainage cavity 1435. In some cases, the ablation device 1450 may be manipulated (e.g., via a motorized device) to move and / or rotate within the drainage tube 1405. In some cases, the ablation device 1450 may be retracted (e.g., behind the reversing cap 1406 and / or reversing plate 1407 relative to the distal end of the drainage tube 1405), allowing fluid to flow through the opening in which the ablation device 1450 is inserted. In some cases, the opening configured to receive the ablation device 1450 may be converted into a suction port opening after the ablation device 1450 is retracted within the drainage tube 1405.
[0238] Example Implementation Examples of embodiments of this disclosure may be described according to the following example clauses. Features described in the example embodiments below may be combined with additional features disclosed herein. Furthermore, additional inventive combinations of features are disclosed herein that are not specifically described in the example embodiments below, and such combinations do not include the same features as those in the specific embodiments below. For the sake of brevity, the example embodiments below do not identify every inventive aspect of this disclosure. The example embodiments below are not intended to identify key or essential features of any subject matter described herein. One or more features in the example clauses listed below may be a combination of one or more features in any of the other example clauses listed below or any of the features described herein.
[0239] Clause 1. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; a drainage lumen at least partially located within the catheter body, wherein the drainage lumen is in fluid communication with the one or more openings; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to jet the fluid as a liquid jet outside the supply lumen and to generate a vacuum at the one or more openings via a Venturi effect; wherein the vacuum generated via the Venturi effect is configured to attract the biological object toward the one or more openings, and the system is configured to remove multiple fragments of the biological object from the urinary tract with a regulated fluid flow through the drainage lumen toward the proximal end of the catheter body.
[0240] Clause 2. The system according to Clause 1 further includes a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage lumen, the plurality of reflux port openings being configured to resupply at least some of the fluid ejected from the supply lumen into the urinary tract to maintain fluid and pressure balance within the urinary tract.
[0241] Clause 3. The system according to any one of Clauses 1 to 2, wherein the supply chamber comprises a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
[0242] Clause 4. The system according to any one of Clauses 1 to 3 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0243] Clause 5. The system according to Clause 4 further includes a temperature sensor configured to monitor the temperature proximal to the catheter body, and wherein the controller is configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
[0244] Clause 6. The system according to any one of Clauses 1 to 5, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into the plurality of fragments.
[0245] Clause 7. The system according to any one of Clauses 1 to 6 further includes a vacuum source in fluid communication with the drainage cavity to regulate the fluid flow through the drainage cavity.
[0246] Clause 8. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; a drainage lumen at least partially located within the catheter body, the drainage lumen being in fluid communication with the one or more openings, the drainage lumen being configured to be in fluid communication with a vacuum source configured to provide a vacuum at a first vacuum level to aspirate and deliver the multiple fragments of the biological object from the one or more openings toward the proximal end of the catheter body; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to jet the fluid as a liquid jet outside the supply lumen and to generate a vacuum at a second vacuum level at the one or more openings via a Venturi effect to attract the biological object toward the one or more openings.
[0247] Clause 9. The system according to Clause 8 further includes a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage lumen, the plurality of reflux port openings being configured to resupply at least some of the fluid ejected from the supply lumen into the urinary tract to maintain fluid and pressure balance within the urinary tract.
[0248] Clause 10. The system according to any one of Clauses 8 to 9, wherein the supply chamber comprises a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
[0249] Clause 11. The system according to any one of Clauses 8 to 10 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0250] Clause 12. The system according to Clause 11 further includes a temperature sensor configured to monitor the temperature proximal to the catheter body, and wherein the controller is configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
[0251] Clause 13. The system according to any one of Clauses 8 to 12, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into the plurality of fragments.
[0252] Clause 14. The system according to any one of Clauses 8 to 13, wherein the vacuum generated by the Venturi effect is configured to attract the biological object toward the one or more openings.
[0253] Clause 15. The system according to any one of Clauses 8 to 14, wherein the vacuum source is configured to regulate the fluid flow rate within the drainage chamber.
[0254] Clause 16. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including an opening at a tip of the distal end of the catheter body, the opening being configured to receive at least a portion of the biological object; a supply lumen at least partially located within the catheter body and configured to deliver fluid from the proximal end toward the distal end, eject the fluid, and cause a vacuum at the opening to aspirate a plurality of the biological object. Fragments; and a drainage cavity at least partially located within the catheter body and in fluid communication with the opening, wherein the drainage cavity is configured to deliver the plurality of fragments of the biological object from the distal end toward the proximal end of the catheter body, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into the plurality of fragments, and wherein the supply cavity is configured to direct fluid flow toward the distal end of the catheter body and redirect the fluid at the distal end toward the proximal end of the catheter body.
[0255] Clause 17. The system according to Clause 16, wherein the drainage cavity is configured to allow the ablation device to be positioned within the drainage cavity and downstream of the opening.
[0256] Clause 18. The system according to any one of Clauses 16 to 17, wherein the drainage cavity is configured to support the ablation device along the central axis of the catheter body.
[0257] Clause 19. The system according to any one of Clauses 16 to 18, wherein the drainage cavity includes an ablation device tube configured to support the ablation device.
[0258] Clause 20. The system according to Clause 19, wherein the plurality of fragments are configured to be delivered through an annular space formed between the inner surface of the catheter body and the outer surface of the ablation device tube.
[0259] Clause 21. The system according to any one of Clauses 16 to 20, wherein the supply chamber is configured to deliver the liquid from the proximal end of the conduit body toward the distal end through a first cross-sectional area of the supply chamber, and to spray the liquid at the distal end into a second cross-sectional area greater than the first cross-sectional area, thereby causing the vacuum to be generated at the opening.
[0260] Clause 22. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including one or more openings configured to receive the biological object; a drainage lumen at least partially located within the catheter body and in fluid communication with the one or more openings, wherein the drainage lumen is configured to aspirate a plurality of fragments of the biological object and deliver the plurality of fragments of the biological object from the one or more openings toward the proximal end of the catheter body; and a supply lumen at least partially located within the catheter body and configured to deliver fluid to the distal end of the catheter body. The catheter body includes a supply chamber comprising a first portion and a second portion, the first portion guiding the flow of fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of fluid toward the proximal end of the catheter body. The second portion is configured to eject the fluid outside the supply chamber and create a vacuum at the one or more openings via a Venturi effect to facilitate the aspiration of the biological object at the one or more openings. The catheter body also includes a plurality of vents formed within the catheter body and fluidly connected to the drainage chamber, the vents being configured to resupply at least some of the fluid ejected from the supply chamber and aspirated from the drainage chamber into the urinary tract.
[0261] Clause 23. The system according to Clause 22, wherein the second portion is located proximal to the distal end of the catheter body.
[0262] Clause 24. The system according to any one of Clauses 22 to 23 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0263] Clause 25. The system according to Clause 24 further includes a temperature sensor configured to monitor temperature, wherein the controller is configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
[0264] Clause 26. The system according to Clause 25, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into the plurality of fragments.
[0265] Clause 27. The system according to Clause 26 further includes a liquid source configured to supply fluid to the supply chamber.
[0266] Clause 28. The system according to Clause 27 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the pressure within the urinary tract at or below a pressure threshold indicating a safe operating pressure.
[0267] Clause 29. The system according to Clause 28 further includes a pressure sensor configured to monitor pressure, wherein the controller is configured to adjust the flow rate of the liquid in the supply chamber based on the pressure.
[0268] Clause 30. A method for removing a biological object from a urinary tract, the method comprising: creating a vacuum using a catheter positioned within the urinary tract, wherein the catheter includes a proximal end and a distal end, a drainage lumen at least partially positioned within a catheter body of the catheter, and a supply lumen configured to deliver fluid to the distal end of the catheter, wherein the vacuum is created at one or more openings in the catheter body to attract the biological object toward the one or more openings, and wherein the vacuum is created via a Venturi effect by delivering the fluid through the supply lumen and ejecting the fluid as a liquid jet outside the supply lumen (optionally, via a constriction); and regulating fluid flow within the drainage lumen when at least a portion of the biological object enters the drainage lumen; wherein the regulation of the vacuum and the fluid flow facilitates attracting the biological object toward the one or more openings and removing the biological object from the urinary tract through the drainage lumen and toward the proximal end of the catheter.
[0269] Clause 31. The method according to Clause 30 further includes breaking up the biological object attracted toward the one or more openings using an ablation device.
[0270] Clause 32. The method according to Clause 31, wherein the ablation device is positioned within the drainage cavity.
[0271] Clause 33. The method according to any one of Clauses 30 to 32 further includes resupplying at least a portion of the fluid to the urinary tract through a plurality of reflux port openings formed in the catheter body.
[0272] Clause 34. The method according to Clause 33, wherein the plurality of reflux port openings are configured to resupply at least a portion of the liquid into the urinary tract to maintain fluid balance and pressure balance within the urinary tract.
[0273] Clause 35. The method according to any one of Clauses 30 to 34, wherein generating the vacuum comprises guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and redirecting the flow of the fluid proximal.
[0274] Clause 36. The method according to Clause 35, wherein the supply cavity directs the flow of the liquid toward the distal end of the catheter body through a first cross-sectional area, and redirects the flow of the liquid at the distal end of the catheter body toward the proximal end of the catheter body and into a second cross-sectional area greater than the first cross-sectional area.
[0275] Clause 37. The method according to any one of Clauses 30 to 36, wherein regulating the fluid flow comprises applying a vacuum source to the drainage cavity at the proximal end of the catheter.
[0276] Clause 38. A method for removing a biological object from a urinary tract, the method comprising: creating a vacuum using a catheter positioned within the urinary tract, wherein the catheter includes a proximal end and a distal end, a drainage lumen at least partially positioned within a catheter body of the catheter, and a supply lumen configured to deliver fluid to the distal end of the catheter, wherein the vacuum is created at an opening in the catheter body to attract the biological object toward the opening, and wherein the vacuum is created via a Venturi effect by delivering the fluid through the supply lumen and ejecting the fluid outside the supply lumen (optionally, via a constriction); aspirating at least a portion of the biological object through the opening and delivering at least said portion of the biological object along the drainage lumen toward the proximal end of the catheter; and maintaining fluid balance and pressure balance within the urinary tract by resupplying at least some of the fluid ejected from the supply lumen into the urinary tract.
[0277] Clause 39. The method according to Clause 38, wherein at least some of the fluid ejected from the supply chamber is resupplied into the urinary tract by means of a plurality of reflux ports formed in the catheter body.
[0278] Clause 40. The method according to any one of Clauses 38 to 39, wherein maintaining fluid balance and pressure balance within the urinary tract comprises operating a vacuum source in fluid communication with the drainage cavity to regulate flow rate.
[0279] Clause 41. The method according to Clause 40, wherein the vacuum source is in fluid communication with the proximal end of the catheter.
[0280] Clause 42. The method according to any one of Clauses 40 to 41 further includes controlling the vacuum source with a controller configured to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0281] Clause 43. The method according to Clause 42, wherein the controller is in electrical communication with one or more sensors.
[0282] Clause 44. The method according to any one of Clauses 42 to 43, wherein controlling the vacuum source with a controller includes receiving feedback from one or more sensors.
[0283] Clause 45. The method according to Clause 44, wherein the one or more sensors include one or more temperature sensors or one or more pressure sensors.
[0284] Clause 46. A method for removing a biological object from a urinary tract, the method comprising: creating a vacuum using a catheter positioned within the urinary tract, wherein the catheter includes a proximal end and a distal end, a drainage lumen at least partially positioned within a catheter body of the catheter, and a supply lumen configured to deliver fluid to the distal end of the catheter, wherein the vacuum is created at an opening in the catheter body to attract the biological object toward the opening, and wherein the vacuum is created by delivering the fluid from the proximal end to the distal end through the supply lumen, redirecting the fluid toward the proximal end, and ejecting the fluid outside the supply lumen into the drainage lumen; aspirating at least a portion of the biological object through the opening, and delivering the biological object along the drainage lumen toward the proximal end of the catheter; and maintaining fluid balance and pressure balance within the urinary tract by resupplying at least some of the fluid ejected from the supply lumen into the urinary tract.
[0285] Clause 47. The method according to Clause 46, wherein the liquid is provided to the supply chamber as a liquid jet.
[0286] Clause 48. The method according to Clause 47, wherein the liquid is a first liquid, and the jet of the liquid is injected into the drainage cavity to cause a flow of a second liquid from a volume outside the catheter into the drainage cavity.
[0287] Clause 49. The method according to any one of Clauses 46 to 48, wherein maintaining fluid balance and pressure balance within the urinary tract comprises operating a vacuum source in fluid communication with the drainage cavity to regulate flow rate.
[0288] Clause 50. The method according to Clause 49, wherein the vacuum source is in fluid communication with the proximal end of the catheter.
[0289] Clause 51. The method according to any one of Clauses 49 to 50 further includes controlling the vacuum source with a controller configured to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0290] Clause 52. The method according to Clause 51, wherein the controller is in electrical communication with one or more temperature sensors.
[0291] Clause 53. The method according to any one of Clauses 51 to 52, wherein controlling the vacuum source with a controller includes receiving feedback from one or more temperature sensors.
[0292] Clause 54. The method according to any one of Clauses 49 to 53 further includes controlling the vacuum source with a controller configured to maintain the pressure in the urinary tract at or below a pressure threshold indicating a safe operating pressure.
[0293] Clause 55. The method according to Clause 54, wherein the controller is in electrical communication with one or more pressure sensors.
[0294] Clause 56. The method according to any one of Clauses 54 to 55, wherein controlling the vacuum source with a controller includes receiving feedback from one or more pressure sensors.
[0295] Clause 57. The method according to any one of Clauses 46 to 56, wherein redirecting the liquid toward the proximal end comprises redirecting the distal flow direction within the radially outward supply chamber to the proximal flow direction of the radially inward suction chamber.
[0296] Clause 58. The method according to Clause 57, wherein the radially outward supply cavity includes a first volume having a first cross-sectional area smaller than the second cross-sectional area of the second volume included in the radially inward suction cavity.
[0297] Clause 59. The method according to Clause 58, wherein the conduit includes a third volume in fluid communication with an external volume at a proximal end of the conduit, wherein redirecting the distal flow direction to the proximal flow direction causes the flow of the liquid to be ejected through the third volume, thereby causing a second fluid within the external volume to flow through the radially inward suction chamber along the proximal flow direction.
[0298] Clause 60. A medical device for use in a location within a subject, the medical device comprising: a fluid supply chamber configured to receive and deliver pressurized fluid to a nozzle positioned at one end of the fluid supply chamber when connected to a source of pressurized fluid; and a drainage tube providing the drainage chamber and including at least one aspiration port in the form of one or more openings in a sidewall of the drainage tube, the aspiration port being configured such that, when the device is in operation, fluid ejected from the nozzle is guided through the aspiration port to generate a Venturi-generated or Venturi-assisted vacuum for capturing a biological object at a location within the subject.
[0299] Clause 61. The medical device according to Clause 60, wherein at least one reflux port includes one or more openings in the sidewall of the drainage tube, the one or more openings being located downstream of the at least one aspiration port and configured to eject at least a portion of the liquid flowing along the drainage cavity.
[0300] Clause 62. A Venturi-assisted medical device system for use at a location within a subject's body, wherein the location is at least partially filled with surrounding fluid, the Venturi-assisted system comprising: a medical device according to Clause 60, a high-pressure fluid pump including a source of the fluid, an optional vacuum source connected to a proximal end of the drainage cavity, and a controller programmed and configured to operate the high-pressure pump system and, when present, the optional vacuum source, such that the pressure and / or volume at the location within the subject's body remains substantially constant during operation of the system.
[0301] Clause 63. The Venturi-assisted medical device system according to Clause 62 further includes an optional peristaltic pump connected to the proximal end of the drainage cavity.
[0302] Clause 64. A Venturi-assisted medical device system according to any one of Clauses 60 to 63, wherein the controller is programmed and configured to operate the high-pressure pump system and, when present, the optional peristaltic pump, such that during operation of the system, the pressure and / or volume at a location within the subject's body remains substantially constant.
[0303] Clause 65. A Venturi-assisted medical device system according to any one of Clauses 60 to 64, wherein the optional vacuum source and the optional peristaltic pump may operate simultaneously in parallel or in series.
[0304] Clause 66. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; a drainage lumen at least partially located within the catheter body, the drainage lumen being in fluid communication with the one or more openings, the drainage lumen being configured to be in fluid communication with means for regulating fluid flow within the drainage lumen; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to eject the fluid as a liquid jet from a constriction portion in the supply lumen to the exterior of the supply lumen, and to create a vacuum at the one or more openings.
[0305] Clause 67. The system according to Clause 66 further includes a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage lumen, the plurality of reflux port openings being configured to resupply at least some of the fluid ejected from the supply lumen into the urinary tract to maintain fluid and pressure balance within the urinary tract.
[0306] Clause 68. The system according to any one of Clauses 66 to 67, wherein the supply chamber comprises a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
[0307] Clause 69. The system according to any one of Clauses 66 to 67 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0308] Clause 70. The system according to Clause 69 further includes a temperature sensor configured to monitor the temperature proximal to the catheter body, and wherein the controller is configured to adjust the flow rate of the fluid within the supply chamber based on the temperature.
[0309] Clause 71. The system according to any one of Clauses 66 to 70, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into multiple fragments.
[0310] Clause 72. The system according to any one of Clauses 66 to 71, wherein the vacuum is configured to attract the biological object toward the one or more openings.
[0311] Clause 73. The system according to any one of Clauses 66 to 72, wherein the means for regulating the flow of the fluid includes a vacuum source.
[0312] Clause 74. A system for use in a surgical procedure to remove a biological object from a urinary tract, the system comprising: a catheter body including a proximal end and a distal end, the distal end being configured for insertion into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; a drainage lumen at least partially located within the catheter body, wherein the drainage lumen is in fluid communication with the one or more openings; and a supply lumen at least partially located within the catheter body and configured to deliver fluid from a fluid source to the distal end of the catheter body, the supply lumen being configured to eject the fluid as a liquid jet from a constriction portion therein to the exterior of the supply lumen and to create a vacuum at the one or more openings.
[0313] Clause 75. The system according to Clause 74 further includes a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage lumen, the plurality of reflux port openings being configured to resupply at least some of the fluid ejected from the supply lumen into the urinary tract to maintain fluid and pressure balance within the urinary tract.
[0314] Clause 76. The system according to any one of Clauses 74 to 75, wherein the supply chamber comprises a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
[0315] Clause 77. The system according to any one of Clauses 74 to 76 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
[0316] Clause 78. The system according to Clause 77 further includes a temperature sensor configured to monitor the temperature proximal to the catheter body, and wherein the controller is configured to adjust the flow rate of the fluid within the supply chamber based on the temperature.
[0317] Clause 79. The system according to any one of Clauses 74 to 78, wherein the catheter body is configured to receive an ablation device configured to fragment the biological object into multiple fragments.
[0318] Clause 80. The system according to any one of Clauses 74 to 79 further includes a vacuum source in fluid communication with the drainage cavity to regulate the fluid flow through the drainage cavity.
[0319] Clause 81. A medical device for use in a location within a subject, the medical device comprising: a fluid supply chamber configured to receive and deliver pressurized fluid to a nozzle positioned at one end of the fluid supply chamber when connected to a source of pressurized fluid; and a drainage tube providing the drainage chamber and including at least one aspiration port in the form of one or more openings in a sidewall of the drainage tube, the aspiration port being configured such that, when the device is in operation, fluid ejected from the nozzle is guided through the aspiration port to generate a Venturi-generated or Venturi-assisted vacuum for capturing a biological object at a location within the subject.
[0320] Clause 82. The medical device according to Clause 81, wherein the at least one reflux port includes one or more openings in the sidewall of the drainage tube, the one or more openings being located downstream of the at least one aspiration port and configured to eject at least a portion of the liquid flowing along the drainage cavity.
[0321] Clause 83. A Venturi-assisted medical device system for use at a location within a subject, wherein the location is at least partially filled with surrounding fluid, the Venturi-assisted system comprising: a medical device according to any one of Clauses 81 to 82; a high-pressure fluid pump including a source of the fluid; an optional vacuum source connected to a proximal end of the drainage cavity; and a controller programmed and configured to operate the high-pressure pump system and, when present, the optional vacuum source, such that the pressure and / or volume of the location within the subject remains substantially constant during operation of the system.
[0322] Clause 84. The Venturi-assisted medical device system according to Clause 83 further includes an optional peristaltic pump connected to the proximal end of the drainage cavity.
[0323] Clause 85. A Venturi-assisted medical device system according to any one of Clauses 83 to 84, wherein the controller is programmed and configured to operate the high-pressure pump system and, when present, the optional peristaltic pump, such that during operation of the system, the pressure and / or volume at a location within the subject's body remains substantially constant.
[0324] Clause 86. A Venturi-assisted medical device system according to any one of Clauses 83 to 85, wherein the optional vacuum source and the optional peristaltic pump may operate simultaneously in parallel or in series.
[0325] Other changes While some examples are described in the context of ureteroscopy, the methods described herein can be used for any medical procedure that utilizes a catheter, such as any medical procedure designed to remove a biological object from the body. While some examples are described in the context of removing solid deposits, the methods described herein can be used to remove any biological object, which does not necessarily have to be solid.
[0326] The foregoing description details certain examples of the systems, apparatuses, and methods disclosed herein. However, it should be understood that the systems, apparatuses, and methods described may be practiced in many ways, however detailed they may appear in words. It should be noted that the use of specific terms in describing certain features or aspects of this disclosure should not be construed as implying that such terms are redefined herein to be limited to any particular characteristic of the technology associated with that term.
[0327] Those skilled in the art will understand that various modifications and changes can be made without departing from the scope of the described techniques. Such modifications and changes are intended to fall within the scope of the examples. Those skilled in the art will also understand that portions included in one example may be interchangeable with other examples; one or more portions from one depicted example may be included in any combination with other depicted examples. For example, any of the various components described herein and / or depicted in the accompanying drawings may be combined, interchanged, or excluded from other examples.
[0328] Regarding the use of any plural and / or singular terms in this document, those skilled in the art may, at their discretion, convert plural to singular and / or singular to plural depending on the context and / or application. For clarity, various singular / plural substitutions may be explicitly described herein.
[0329] The conditional language used herein, such as “can,” “may,” “possibly,” “can,” “for example,” etc., unless otherwise expressly stated or otherwise understood as in the context in which they are used, is generally intended to convey that certain implementations include certain features, elements, and / or states that are not included in other implementations. Therefore, such conditional language is not generally intended to imply that features, elements, and / or states are necessary in any way for one or more implementations, or that one or more implementations necessarily include logic for determining whether such features, elements, and / or states are included in or will be performed in any particular implementation, with or without author input or prompts. The term “each,” as used herein, in addition to having its ordinary meaning, may mean any subset of the set of elements to which the term “each” is applied.
[0330] Those skilled in the art will understand that, generally, the terms used herein are intended to be “open-ended” terms (e.g., the term “comprising” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “including” should be interpreted as “including but not limited to,” etc.). Those skilled in the art will further understand that if a particular number is intended to be introduced in the claim, such intention will be explicitly stated in the claim, and where no such statement is present, such intention does not exist. For example, to aid understanding, the appended claims may contain the use of the introductory phrases “at least one” and “one or more” to introduce the claim statement. However, the use of such phrases should not be construed as implying that the introduction of the claim statement by the indefinite article “a” or “an” limits any particular claim containing such an introduction to an example containing only one such statement, even when the same claim includes the introductory phrase “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and / or “an” should generally be interpreted as meaning “at least one” or “one or more”); the same applies to the use of definite articles used to introduce the claim statement. Furthermore, even if a specific number is explicitly stated in the introduced claims, those skilled in the art will recognize that such a statement should generally be interpreted as meaning at least the number stated (e.g., in the absence of other modifiers, a simple statement of "two statements" generally means at least two statements, or two or more statements). Additionally, when using conventions such as "at least one of A, B, and C," such a construction is generally intended to convey the meaning of that convention as would be understood by those skilled in the art (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B together, having A and C together, having B and C together, and / or having A, B, and C together). When using conventions such as "at least one of A, B, or C," such a construction is generally intended to convey the meaning of that convention as would be understood by those skilled in the art (e.g., "a system having at least one of A, B, or C" will include, but is not limited to, systems having A alone, having B alone, having C alone, having A and B together, having A and C together, having B and C together, and / or having A, B, and C together). Those skilled in the art will further understand that any transitional word and / or phrase that substantially presents two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, any, or both of the terms. For example, the phrase “A or B” would be understood to include the possibility of “A” or “B” or “A and B”.
[0331] All references cited herein are incorporated herein by reference in their entirety. Where any disclosure or patent or patent application incorporated herein by reference contradicts any disclosure contained herein, this specification is intended to supersede and / or give precedence to any such contradictory material.
[0332] As used herein, the term “comprising” is synonymous with “including,” “containing,” or “characterized by,” and is inclusive or open-ended, and does not exclude additional, undocumented elements or method steps.
[0333] As used herein, terms such as “about,” “approximately,” “generally,” and “substantially” indicate a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic but still performs the desired function or achieves the desired result. For example, the terms “about,” “approximately,” “generally,” and “substantially” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, or less than 0.01% of the stated value.
[0334] Note that some of the examples above can be described as processes, depicted as flowcharts, diagrams, block diagrams, or block diagrams. While flowcharts can describe operations as a sequential process, many operations can be performed in parallel or simultaneously, and processes can be repeated. Furthermore, the order of operations can be rearranged. A process terminates when its operations are complete. A process can correspond to a method, function, process, subroutine, subprogram, etc. When a process corresponds to a software function, its termination corresponds to the function returning to the calling function or the main function.
[0335] The various components illustrated in the accompanying drawings or described herein can be implemented as software and / or firmware on a processor, controller, ASIC, FPGA, and / or dedicated hardware. The software or firmware may include instructions stored in a non-transitory computer-readable storage medium. These instructions may be executed by a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components (such as controllers, processors, ASICs, FPGAs, etc.) may include logic circuitry. Furthermore, the features and properties of the specific examples disclosed above may be combined in different ways to form additional implementations, all of which fall within the scope of this disclosure.
[0336] The foregoing description discloses several methods and materials of this disclosure. Modifications may be made to the methods and materials, as well as to the manufacturing methods and equipment. Such modifications will become apparent to those skilled in the art from consideration of this disclosure or from the practice of the examples disclosed herein. Therefore, this disclosure is not intended to be limited to the specific examples disclosed herein, but rather to cover all modifications and alternatives falling within the true scope and spirit of this disclosure as set forth in the appended claims.
Claims
1. A system for use in a surgical procedure to remove a biological object from the urinary tract, the system comprising: A catheter body including a proximal end and a distal end, the distal end being configured to be inserted into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; A drainage cavity, at least partially located within the catheter body, the drainage cavity being in fluid communication with the one or more openings, and the drainage cavity being configured to be in fluid communication with a means for regulating fluid flow within the drainage cavity; as well as A supply chamber, at least partially located within the catheter body, is configured to deliver liquid from a liquid source to the distal end of the catheter body. The supply chamber is configured to eject the liquid as a liquid jet from a constriction portion within the supply chamber to the outside of the supply chamber and to create a vacuum at the one or more openings.
2. The system of claim 1 further includes a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage cavity, the plurality of reflux port openings being configured to resupply at least some of the liquid ejected from the supply cavity into the urinary tract to maintain fluid balance and pressure balance within the urinary tract.
3. The system according to claim 1, wherein, The supply chamber includes a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
4. The system of claim 1 further includes a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
5. The system of claim 4, further comprising a temperature sensor configured to monitor the temperature proximal to the catheter body, wherein, The controller is configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
6. The system according to claim 1, wherein, The catheter body is configured to receive an ablation device, which is configured to fragment the biological object into multiple fragments.
7. The system according to claim 1, wherein, The vacuum is configured to attract the biological object toward the one or more openings.
8. The system according to claim 1, wherein, The device for regulating fluid flow includes a vacuum source.
9. A system for use in a surgical procedure to remove a biological object from the urinary tract, the system comprising: A catheter body including a proximal end and a distal end, the distal end being configured to be inserted into the urinary tract, the catheter body including one or more openings configured to receive at least a portion of the biological object; A drainage cavity, at least partially located within the catheter body, wherein the drainage cavity is in fluid communication with the one or more openings; as well as A supply chamber, at least partially located within the catheter body, is configured to deliver liquid from a liquid source to the distal end of the catheter body. The supply chamber is configured to eject the liquid as a liquid jet from a constriction portion within the supply chamber to the outside of the supply chamber and to create a vacuum at the one or more openings.
10. The system of claim 9, further comprising a plurality of reflux port openings formed in the catheter body and fluidly connected to the drainage cavity, the plurality of reflux port openings being configured to resupply at least some of the fluid ejected from the supply cavity into the urinary tract to maintain fluid and pressure balance within the urinary tract.
11. The system according to claim 9, wherein, The supply chamber includes a first portion and a second portion, the first portion guiding the flow of the fluid from the proximal end of the catheter body toward the distal end of the catheter body, and the second portion redirecting the flow of the fluid toward the proximal end of the catheter body.
12. The system of claim 9, further comprising a controller configured to regulate the flow rate of the fluid through the supply chamber to maintain the temperature within the urinary tract at or below a temperature threshold indicating a safe operating temperature.
13. The system of claim 12, further comprising a temperature sensor configured to monitor the temperature proximal to the catheter body, wherein, The controller is configured to adjust the flow rate of the liquid in the supply chamber based on the temperature.
14. The system according to claim 9, wherein, The catheter body is configured to receive an ablation device, which is configured to fragment the biological object into multiple fragments.
15. The system of claim 9 further includes a vacuum source in fluid communication with the drainage cavity to regulate the fluid flow through the drainage cavity.
16. A medical device for use at a location within a subject's body, the medical device comprising: A liquid supply chamber configured to receive pressurized liquid and deliver the pressurized liquid to a nozzle located at one end of the liquid supply chamber when connected to a source of pressurized liquid; A drainage tube that provides a drainage cavity and includes at least one suction port, the suction port being in the form of one or more openings in the sidewall of the drainage tube, the suction port being configured such that, when the device is in operation, liquid ejected from the nozzle is guided through the suction port to generate a Venturi-generated or Venturi-assisted vacuum for capturing a biological object at a location within the subject's body.
17. The medical device according to claim 16, wherein, At least one return port includes one or more openings in the sidewall of the drainage tube, the one or more openings being located downstream of the at least one suction port and configured to eject at least a portion of the liquid flowing along the drainage cavity.
18. A Venturi-assisted medical device system for use at a location within a subject's body, wherein, The location is at least partially filled with surrounding fluid, and the Venturi-assisted system includes: the medical device of claim 16, a high-pressure fluid pump including the source of the fluid, an optional vacuum source connected to the proximal end of the drainage cavity, and a controller programmed and configured to operate the high-pressure pump system and, when present, the optional vacuum source such that the pressure and / or volume at the location within the subject remains substantially constant during operation of the system.
19. The Venturi-assisted medical device system of claim 18, further comprising an optional peristaltic pump connected to the proximal end of the drainage cavity.
20. The Venturi-assisted medical device system according to claim 18, wherein, The controller is programmed and configured to operate the high-pressure pump system and, when present, the optional peristaltic pump, such that the pressure and / or volume at a location within the subject's body remains substantially constant during system operation.
21. The Venturi-assisted medical device system according to claim 18, wherein, The optional vacuum source and the optional peristaltic pump can be operated simultaneously in parallel or in series.
22. A method of operating a system / or apparatus according to any one of the preceding claims.