Trans-vascular thrombus resection system

Abstract

A transvascular thrombectomy system includes an aspiration catheter and a first vacuum chamber having a clot filter and configured for use within a sterile region. A vacuum line connects the first vacuum chamber to a second vacuum chamber and a suction pump, the second vacuum chamber and suction pump being configured for use outside the sterile region. The first chamber and the second chamber may reach a low pressure by a suction pump. Opening of the valve enables rapid aspiration from the patient to the first chamber. A clot engaging tool having a distal helical thread may be advanced through the catheter to engage the clot.

Description

[0001] Join by reference

[0002] This application incorporates by reference the entire contents of each of the following applications: U.S. Patent Application No. 17 / 857,598, filed on July 5, 2022, and issued on January 17, 2023 as U.S. Patent No. 11,553,935; U.S. Patent Application No. 17 / 857,649, filed on July 5, 2022, and issued on April 25, 2023 as U.S. Patent No. 11,633,272; U.S. Patent Application No. 17 / 857,919, filed on July 5, 2022, and issued on May 2, 2023 as U.S. Patent No. 11,638,637; U.S. Patent Application No. 17 / 810,743, filed on July 5, 2022; U.S. Patent Application No. 17 / 810,743, filed on May 13, 2022 U.S. Provisional Patent Application No. 63 / 341,926, filed on June 24, 2021; U.S. Provisional Patent Application No. 17 / 357,490, filed on June 24, 2021, and published as U.S. Patent No. 11,457,936 on October 4, 2022; U.S. Provisional Patent Application No. 63 / 044,511, filed on June 26, 2020; U.S. Patent Application No. 17 / 125,723, filed on December 17, 2020, and published as U.S. Patent No. 11,065,018 on July 20, 2021; U.S. Provisional Patent Application No. 62 / 950,058, filed on December 18, 2019; and U.S. Provisional Patent Application No. 63 / 064,273, filed on August 11, 2020. Background Art

[0003] Removal of clots from the vascular system using a transvascular approach (thrombectomy) can be accomplished in any of a variety of treatment sites, such as arteries of the limbs, veins for deep vein thrombosis (DVT), large veins and arteries (central vessels) such as the iliac veins and arteries, aorta, inferior vena cava, and pulmonary arteries to treat pulmonary embolism (PE).

[0004] For example, venous thromboembolic disease (VTE) is a global crisis. More than 10 million cases of DVT and PE are diagnosed worldwide each year, with 1 million cases occurring annually in the United States and more than 700,000 cases annually in France, Italy, Germany, Spain, Sweden, and the United Kingdom combined. Approximately 60,000-100,000 people die from PE each year in the United States. DVT and PE are part of the same family of diseases, with more than 95% of emboli originating from the lower extremities. When PE occurs, its severity depends on the embolic burden and its effect on the right ventricle as well as underlying cardiopulmonary comorbidities. Acute increases in pulmonary artery (PA) pressures with increased right ventricular (RV) afterload and dysfunction can result in death.

[0005] Patients with high-risk PE are primarily treated with thrombolytic therapies delivered via catheter-directed thrombolytic systems or more locally. These approaches result in multiple catheterization laboratory visits, prolonged hospital stays, and often lead to bleeding complications. Newer approaches to PE treatment include single-course thrombectomy therapies without the use of thrombolytics. These thrombectomy therapies involve delivery of a catheter into the PA to remove the clot via aspiration, and adjunctive tools may also macerate or disrupt the clot prior to aspiration. While thrombectomy results in fewer bleeding complications and reduced hospital stays compared with thrombolytics, there is still much room for improvement given the challenges of the procedure itself, including the ability to capture multiple clot types and to reduce overall blood loss during surgery.

[0006] The thrombectomy catheter is introduced via an introducer puncture in a large diameter vein. A flexible guide wire is passed through the introducer into the vein, and the introducer is removed. The flexible guide wire provides a track for the flexible guide catheter to be advanced through the right atrium into the right ventricle and into the pulmonary artery. The flexible guide wire is removed and replaced with a rigid guide wire. The large diameter thrombectomy catheter with a supported dilator is then advanced over the rigid guide wire into the pulmonary artery, and the dilator is removed. If the large diameter thrombectomy catheter fails to successfully enter or aspirate a thrombus in a more distal portion of the vessel, a smaller diameter catheter may be inserted through the large diameter catheter.

[0007] In addition, peripheral arterial occlusive (PAO) disease occurs in more than 4% of individuals over the age of 40, with incidence increasing significantly after age 70. Acute PAO is usually due to thrombosis of the peripheral vasculature and is associated with a significant risk of limb loss. To preserve the limb, treatment of acute PAO centers on rapid restoration of arterial patency and blood flow, such as by mechanical thrombectomy in procedures similar to those described above.

[0008] Thrombus aspiration using certain commercial vacuum-assisted thrombectomy systems may sometimes need to be terminated because the patient is at risk for excessive blood loss, particularly when using large aspiration catheters. During aspiration thrombectomy, when the catheter tip is disengaged from contact with a thrombus or other occluding material, the tip is exposed to healthy blood, and a complete flow of blood through the catheter ensues. In such cases, the total blood loss may be excessive and, in some cases, may lead to premature termination of the procedure. For example, during an operation in which the catheter enters healthy blood and a complete aspiration flow ensues, the blood loss rate may be approximately 30-40cc per second using a 24 French size catheter. With a maximum allowable blood loss of approximately 500 mL, the catheter cannot be operated in a non-restrictive mode for more than approximately 10 to 15 seconds. The total blood loss may reach unacceptable levels before sufficient clots are removed.

[0009] Therefore, despite previous efforts, there remains a need for improved techniques to remove or reduce thrombotic restrictions and occlusions within a patient's arterial or venous vessels. Summary of the invention

[0010] According to one aspect of the present invention, a clot capture module for use in a thrombectomy system is provided, such as within a sterile field. The clot capture module includes a housing; a clot capture chamber in the housing; a window in the housing to allow visual inspection of the clot chamber; and a filter in the clot chamber visible through the window, the filter having an upstream surface and a downstream surface.

[0011] The input flow path is configured to direct the input blood from the aspiration conduit to the upstream surface of the filter. A suction control valve is provided in the input flow path, which is configured to block or allow the flow of the input blood. The output flow path is configured to direct the blood from the second side of the filter to a remote vacuum tank.

[0012] The clot capture module may further include a vent valve that is openable to allow an optically transparent medium such as air or saline to be drawn into the clot chamber so that blood can be drained from the clot chamber to a remote tank. An upstream surface of the filter may be visible through the window so that clots accumulated on the upstream surface are visually observed through the window when the vent is opened to drain blood from the clot capture chamber. The window may include a transparent cylindrical portion of the housing.

[0013] The upstream surface of the filter may be substantially planar. Alternatively, the upstream surface of the filter may be convex. The filter may include a tubular porous membrane such as a cylinder, and the upstream surface of the filter may be on a radially outward surface of the membrane. The tubular filter membrane may surround a blood filtration chamber that is in communication with the output flow path.

[0014] The module may further include a suction control for controlling the suction control valve. The suction control may include a rocker switch configured to selectively collapse or allow reopening of the collapsible conduit. The suction control valve may be normally closed and may be spring biased into the closed configuration.

[0015] The clot capture module can be provided in combination with a vacuum line leading to a suction pump and a canister, wherein the clot capture module is configured to be located within a sterile field, and the suction pump and canister are located outside the sterile field. The length of the vacuum line can be at least about 30 inches or 50 inches or longer. In some cases, in addition to or as an alternative to the suction pump, a manually actuated suction device (e.g., a syringe) can be used to allow a user to manually apply suction through the vacuum line.

[0016] According to another aspect of the present invention, a thrombus engagement tool is provided, which is configured to be advanced through an aspiration catheter and engage a thrombus. The thrombus engagement tool includes a rotatable core wire having a proximal end and a distal end; and a thrombus engagement tip on the distal end of the core wire. The tip may include a helical thread; an advancement segment on the distal side of the thread, and a tail segment on the proximal side of the thread. The advancement segment, helical thread, and tail segment may all be molded on the core wire.

[0017] The thrombus engaging tool may further include a protrusion on the core wire, the protrusion below at least one of the pusher segment and the tail segment to form an interference fit with the thrombus engaging tip. The protrusion may include an annular ring, which may be a radiopaque marker. The thrombus engaging tool may include a first radiopaque marker below the pusher segment and a second radiopaque marker below the tail segment.

[0018] The outer edge of the helical thread may substantially conform to the inner surface of the cylinder.The thread may include a proximal surface that slopes radially outward in a proximal direction to define a proximal opening undercut.

[0019] The thrombus engagement tool may further include a handle on the proximal end of the core wire configured for manually rotating the core wire. A limiting bearing surface may be provided on the handle for limiting the thrombus engagement tip from extending distally relative to the distal end of the aspiration catheter.

[0020] A method for mechanically and suction-assisted removal of embolic material from a blood vessel is further provided. The method includes the steps of providing an aspiration catheter having a central lumen and a distal end; advancing the distal end toward the occluding material in the blood vessel; applying a vacuum to the lumen to at least partially draw the clot into the lumen; and introducing a thrombus engagement tool into the lumen. The thrombus engagement tool may have a tip having an axial length of no more than about 1 cm or about 5 mm and a helical thread having a major diameter that is at least about 0.015 inches less than the inner diameter of the lumen to provide a suction flow path around the outside of the tip through the lumen. The method further includes manually rotating the tip to engage the clot between the tip and the inner wall of the lumen.

[0021] A method for aspirating a vascular occlusion from a remote site comprises the steps of advancing an elongated tubular body through a vascular access site and to the vascular occlusion, the tubular body comprising a proximal end, a distal end, a central lumen and a stop surface. A rotatable core is advanced through the lumen toward the distal end until a limiting surface carried by the core rotatably and slidably engages the stop surface to provide a rotatable support that limits further distal advancement of the core within the lumen. A vacuum is applied to the lumen and the core is manually rotated to engage a thrombus. Advancing of the rotatable core may be completed after the step of advancing the elongated tubular body through the vascular access site and to the vascular occlusion. The core may be a solid core wire or a cannula structure, such as a hypotube or a microcatheter, having a central lumen extending axially between a proximal opening and a distal opening.

[0022] The core may carry a proximal handle, and the limiting surface may be carried by the handle. The tubular body may include a proximal hub, and the stop surface may be carried by the hub. The core may carry an engagement tip having a helical thread, and the step of engaging the thrombus may include pinning the thrombus between a first side of the tip and an inner surface of the tubular body.

[0023] Also provided is an inserter for introducing a device through a hemostatic valve, comprising an elongated tubular body having a proximal end, a distal end, and a central lumen; a laterally facing concave landing zone on the proximal end having a radius of curvature that increases in the proximal direction; and an axially extending slit in a sidewall extending from the distal end to the landing zone. The tubular body may further include a tapered distal tip, and a proximal pull tab to facilitate removal of the inserter from the device. The surface of the landing zone may include a different color than the outer surface of the tubular body to facilitate visualization of the landing zone and advancement of the distal end of the device into the tubular body.

[0024] A method for passing a device through a hemostatic valve may include the steps of providing an inserter having a tubular body with a split sidewall; advancing the tubular body through the hemostatic valve; advancing a device through the tubular body and beyond the hemostatic valve; and retracting the tubular body proximally so that the device laterally detaches from the tubular body through the split sidewall, leaving the device in a position passing through the hemostatic valve.

[0025] The step of advancing the tubular body may include advancing a tapered distal tip on the tubular body through the hemostatic valve. The step of advancing the tubular body through the hemostatic valve may be accomplished with the device preloaded within the tubular body.

[0026] The distal nose section of the tubular body may expand in diameter in response to advancement of the device therein. The device may be a thrombus engagement tool or an auxiliary catheter. The auxiliary catheter may be an aspiration catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 is a schematic diagram of a thrombus removal system according to the present invention.

[0028] Figure 2 is a perspective view of the flow control module.

[0029] Figure 3 yes Figure 2 Cross-sectional front view of the flow control module.

[0030] Figure 4 is a schematic diagram of a dual vacuum chamber configuration for producing an accelerated pumping reaction.

[0031] Figure 5 is a qualitative fluid velocity plot at the catheter tip after the vacuum control valve is opened.

[0032] Fig. 6A is a side elevation view of a thrombus engaging tool.

[0033] Figure 6B yes Fig. 6A Detailed enlargement of the distal end of the thrombus engagement tool.

[0034] Figure 6C It passes through Figure 6B Longitudinal front cross-section of a thrombus engagement tool.

[0035] 7A to 7E are side elevation views of various embodiments of thrombectomy catheters.

[0036] Figure 8 is a cross-sectional view through the distal end of the embolectomy catheter, showing the sidewall structures.

[0037] Fig. 9 is a cross-sectional view through the distal end of the embolectomy catheter, showing the radiopaque markers and the angled distal face.

[0038] FIG. 10A to FIG. 10B is a perspective view of an introducer tool that facilitates passage of a catheter through a hemostasis valve.

[0039] Fig. 10C yes Fig. 10A and Fig. 10B End view of the inserter. DETAILED DESCRIPTION

[0040] refer to Figure 1, shows a thrombectomy system, for example, for use in a PE or DVT aspiration procedure. The system 10 includes a catheter 12 having an elongated tubular body 14 extending between a proximal end 16 and a distal end 18. A central lumen 20 (not shown) is provided. Figure 1 ) extends between a proximal catheter connector 22 and a distal port 24 on the distal end 18.

[0041] Although described primarily in the context of an aspiration catheter having a single central lumen, the catheter of the present invention can be readily modified to incorporate other structures, such as a permanent or removable column strength reinforcing mandrel, two or more lumens, for example, to allow for the infusion of drugs, contrast media or flushing agents or to supply an inflation medium to an inflatable balloon carried by the catheter, or any combination of these features, as will be apparent to one skilled in the art in view of the disclosure herein. In addition, the present disclosure will be described primarily in the context of removing obstructive material from the vasculature, but it will be understood that the present disclosure has applicability as an access catheter for the delivery and removal of various diagnostic or therapeutic devices, whether or not aspiration is being performed.

[0042] The catheter disclosed herein can be easily adapted for use throughout the body, as long as it is desirable to advance a low-profile, highly flexible catheter toward the distal end into various types of vasculature, such as small or large vasculature and / or curved or relatively straight vasculature. For example, the catheter shaft according to any embodiment described herein can also be sized for use throughout the neurovascular system, coronary and peripheral vascular systems, gastrointestinal tract, urethra, ureter, fallopian tubes, and other cavities and potential cavities. The catheter shaft structure of any embodiment herein can also be used to provide minimally invasive percutaneous tissue access, such as for diagnosis or treatment access for solid tissue targets (e.g., breast or liver or brain biopsy or tissue resection), delivery of laparoscopic tools, or access to bones such as the spine for delivery of screws, bone cement or other tools or implants.

[0043] The length and diameter of the catheter 12 will be appropriate for the intended access and target location. Figure 1 The effective length of the catheter 12 from the distal end of the manifold or hub 22 to the distal tip 18 is generally no more than about 230 cm, no more than about 210 cm, no more than about 180 cm, or no more than about 160 cm. And is typically about 50 cm to about 150 cm, about 90 cm to about 130 cm, or about 105 cm to about 115 cm. The outer diameter of the catheter 10 can be about 0.035 inches to about 0.15 inches, about 0.09 inches to about 0.13 inches, and the outer diameter of the distal section can be smaller than the outer diameter of the proximal section.

[0044] In a single lumen embodiment, the inner diameter of the catheter 12 can be greater than or equal to about 0.1 inches, greater than or equal to about 0.088 inches, or greater than or equal to about 0.08 inches, or greater than or equal to 0.06 inches. In a single lumen embodiment, the inner diameter of the catheter 12 can be less than about 0.20 inches or 0.15 inches, or less than or equal to about 0.11 inches, less than or equal to about 0.1 inches, less than or equal to about 0.088 inches, or less than or equal to about 0.07 inches, and typically does not exceed about 0.095 inches.

[0045] In the illustrated embodiment, the catheter 12 is releasably connectable to the flow control module 28 by means of a complementary connector module 30. The connector module 30 provides a releasable connection with the complementary catheter connector 22 and may include a side port 32 for releasable connection with a conduit 34 that may lead to a valve 36. The connector module 30 may additionally include a hemostatic valve configured to accept another device, such as a guidewire or a thrombus engagement tool, as described below.

[0046] The valve 36 can selectively connect the tubing 34 to a side port 37 or to the flow control module 28 discussed in more detail below. The side port 37 can be connected to a source of media such as saline, contrast solution, or medication or to a manifold 38, which can provide selective communication with each. The use of the valve 36 allows the desired media to be infused without removing the tubing 34 from the connector module 30.

[0047] refer to Figure 2 and Figure 3 , the flow control module 28 is connected to the valve 36 by means of the distal tube 44. The flow control module 28 is connected to the selector valve 49 by means of the proximal tube 46. This establishes a flow path between the distal port 24 and the pump assembly 42 via the catheter 12, various pipelines and the flow control module 28. In an alternative embodiment of the present invention, the flow control module 28 can be integrally formed in the hub of the thrombectomy catheter 12, and the catheter 12 can be detachably or non-detachably attached to the hub, or integrally formed in the connector module 30. In some cases, in addition to or as a substitute for the suction pump assembly 42, a manually actuated suction device (e.g., a syringe) can be used to allow the user to manually apply suction through a vacuum line. Those skilled in the art will understand that the manually actuated suction device can be an addition or replacement for the pump assembly described in any embodiment herein.

[0048] The flow control module 28 may include a flow regulator, such as an on-off control, for regulating the flow of the fluid path between the conduit 12 and the pump 42. The flow regulator is configured to provide a reversible restriction in the fluid path, such as by an expandable or retractable iris, a ball valve or other rotating core valve, a leaf valve, a pinch tube, or other means known in the art.

[0049] In one embodiment, the flow regulator includes a collapsible portion 29 (such as a section of polymeric tubing) of a tubular wall that defines a flow path. An actuator 31 positioned adjacent the conduit is responsive to a control such as a button or toggle switch 48 and is movable between a first position in which the actuator 31 compresses the conduit, thereby completely restricting flow, and a second position in which the actuator has moved away from the conduit, allowing the conduit to resume its full inner diameter and allowing fluid flow. The actuator may be spring biased or have another default drive in the direction of the first (restricted) position and may be moved to the second (open) position only in the presence of a positive mechanical force or release of a constraint, allowing the flow path to be opened. Upon removal of the momentary "on" command, the actuator 31 automatically resumes the first position, blocking flow.

[0050] The actuator 31 can be driven by a mechanical control (such as a joystick or rotatable knob) or an electrically driven system (such as a solenoid) operated by any of a variety of buttons, joysticks, triggers, foot pedals, or other switches known in the art, depending on the desired function.

[0051] For example, the flow control module 28 may include a filter chamber 33 that communicates with a vacuum tank 58 on the pump assembly 42 via an elongated suction conduit 40. The toggle switch 48 is between the filter chamber 33 and the conduit 12. In some embodiments of the default closed position, this allows the suction conduit 40 and filter chamber 33 to reach the same low pressure as the suction tank 58 on the pump 42 over the entire length.

[0052] Additional details of the filter assembly and related structure are as follows Figure 3 Filter assembly 35 includes an outer tubular sidewall 37 having a transparent window 39. In some embodiments, the entire tubular sidewall 37 can be a transparent window. Sidewall 37 surrounds filter 41. Filter 41 includes filter sidewall 43 that defines an interior (downstream) cavity (not shown) for filtered blood.

[0053] After the flow path is opened by activating switch 48, blood and thrombus are drawn in a direction from catheter 12 via vacuum line 44 through first filter aperture 45 and into clot collection chamber 33. Any thrombus will be captured by the exterior (upstream side) of filter 43. Blood is drawn through filter 43 and proximal tubing 46 on the way to canister 58. In the illustrated embodiment, filter 43 is tubular, but it may alternatively be planar or other shapes depending on the desired configuration.

[0054] Thereafter, the switch 48 can be closed to compress the tubing 29 and isolate the catheter 12 from the vacuum source. The normally closed vent 47 can be opened momentarily to allow an optically transparent medium, such as saline or ambient air, to be sucked in. This allows residual blood in the chamber 33 to be drawn through the filter 43 and aspirated out through the proximal tubing 46, so that any clots on the surface of the filter 43 can be seen through the window 39. The vent 47 can be manually actuated by the user and / or automatically actuated by the system. In some cases, the user can manually actuate the vent 47 by actuating a button 62 located on the flow control module 28.

[0055] For example, the vent 67 can be normally closed and then converted to an open configuration when the button 62 is actuated (or vice versa). When in the open configuration, the vent 67 can expose the clot collection chamber 33 to the surrounding environment. In some cases, the chamber 33 is exposed to the surrounding environment, allowing air to be drawn in and accelerating blood flow through the clot collection chamber 33 and then to the proximal conduit. The increased blood flow acceleration due to the actuation of the vent 47 can facilitate the visualization of the clot by removing blood or other fluids from the optical path between the window and the filter and / or reducing the time required to accurately identify the clot in the chamber 33. The valved vent also allows the physician to deliver a negative pressure pulse wave at the distal opening 24.

[0056] In the illustrated embodiment, the flow control module 28 includes a proximal housing 31 and a distal housing 29 separated by a transparent tubular sidewall 35. The tubular sidewall 35 and the filter 43 are carried by the proximal housing 31. The housing 29 and the tubular sidewall 35 can be connected at a releasable connection 33, in some cases, the connection includes a gasket 59 to form a sealed connection. Complementary surface structures (e.g., inclined corresponding grooves and pins or flanges) can allow for quick connection and disassembly. For example, the proximal housing 31 and the distal housing 29 can be rotated relative to each other (e.g., by relative rotation across the gasket) to disassemble the housings from each other.

[0057] The filter 43 may be attached to either the distal housing 29 or the proximal housing 31 after the housings are disassembled. The tubular sidewall 35 may be attached to either the distal housing 29 and / or the proximal housing 31 such that after disassembly, the tubular sidewall 35 may remain attached to one of the housings 29, 31. After the proximal housing 31 is disassembled and separated from the distal housing 29, the tubular sidewall 35 may be configured to remain around the filter 43, or may be configured to be removed from over the filter 43. In either case, disassembly of the housings 29, 31 from one another may expose the filter 43 and allow for easy access and removal of clots.

[0058] The inner surface of the clot collection container 33 may include a coating to provide one or more of various properties to the clot collection container 33. In some cases, the coating may be configured to enhance visualization through at least a portion of the clot collection container 33 (e.g., a transparent window 39). The coating may be configured to inhibit blood accumulation or increase blood repellency. In some cases, the clot collection container 33 may include a coating to inhibit foam formation during suction. The coating may be positioned at least partially along the inner surface of the tubular sidewall 35 and / or the clot collection container 33, or along the entire inner surface of the tubular sidewall 35 and / or the clot collection container 33. In some cases, the coating is positioned along the inner surface of the transparent window 39. The coating may be either hydrophobic or oleophobic. In some cases, the coating may have some hydrophilic features on a portion of the polymer to increase oleophobicity.

[0059] The suction pump assembly 42 can be releasably connected to the flow control module 28, such as through a Luer connection between the selector valve 45 and the pipeline 40. The suction pump assembly 42 can include a vacuum pump 50, and can also include a vacuum gauge 51 and an optional pressure adjustment control 54. The vacuum gauge 51 is in fluid communication with the vacuum pump and indicates the vacuum pressure generated by the pump. The pressure adjustment control 54 allows the user to set it to a specific vacuum pressure. The power button 56 activates the pump 50.

[0060] The vacuum tank 58 can be equipped with a vent 53 to the air, which is opened or closed by a valve. In one embodiment, the valve is normally closed to allow the vacuum in the tank to reach the desired low pressure. The valve can be opened momentarily as needed to allow the introduction of air and reduce the vacuum, for example to reduce foaming in the vacuum tank 58.

[0061] The vent can serve to reduce foaming and increase visibility within the can. In some cases, the vent 53 comprises a permanently open vent, such as in the lid or sidewall of the vacuum can. The vent can include a hole formed through the lid or sidewall, with a diameter not exceeding about 0.5 mm or 0.25 mm, and can be a laser cut hole through a metal sheet that can be in the form of a disc carried by the lid.

[0062] In addition to or as an alternative to the vent, the inner surface of the canister 58 can be provided with a coating of one or more substances to inhibit bubbling of blood under vacuum. The coating can be located at least partially along or completely along the inner surface of the vacuum canister 58. The coating can be either hydrophobic or oleophobic. In some cases, the coating can have some hydrophilic characteristics on a portion of the polymer to increase oleophobicity.

[0063] The various pump functions may be operated using any of a variety of controls, including switches, buttons, joysticks, rotatable knobs, and other controls apparent to those skilled in the art in light of this disclosure. The aspiration pump 50 may alternatively be a manually activated pump such as a syringe.

[0064] In some applications, it may be desirable to provide a non-occlusive flow restriction between the vacuum tank 58 and the flow control module 28. The flow restrictor can be connected in series with the vacuum line 40, for example, through a Luer connector. In one embodiment, the flow restrictor enables switching between low flow and high flow configurations. The flow restrictor may include a variable restrictor that can be adjusted by the user. This can be achieved by selectively diverting the flow between relatively small diameter and larger diameter holes, holes of variable diameter, or other flow regulators, such as any flow regulator disclosed in U.S. Patent Publication No. 2021 / 0315597 to Buck et al., entitled Aspiration System with Accelerated Response, the disclosure of which is incorporated herein in its entirety.

[0065] In a specific embodiment, the rotatable barrel is equipped with a first lateral flow path of a first diameter. The barrel is rotatable in a housing having an inlet port and an outlet port. The barrel can be rotated so that the inlet port is communicated with the outlet port fluid via the first flow path. The second flow path with a second different diameter also extends laterally through the barrel, rotationally deviating from the first flow path. The barrel is rotatable so that the inlet port is communicated with the outlet port via the second flow path, thereby providing a flow velocity different from the flow velocity provided by the first flow path of the barrel.

[0066] The filter chamber 33 on the flow control module 28 or connector module 30 is spaced from the remote vacuum pump 42 and vacuum canister 58 to provide enhanced suction performance. Conventional suction pumps and filters are intended to be placed outside the sterile field and can be far enough away from the patient that the length of the suction tubing 40 between the pump assembly 42 and the catheter 12 is required to be at least about 50 inches or about 100 inches or more. For example, the tubing 40 can be about 102 inches.

[0067] The pump typically includes a suction canister 58 for blood collection. In prior art systems, when aspiration is desired, a valve is opened to connect the low pressure canister 58 to the catheter 12 via the suction tubing 40 to aspirate material from the patient. However, the length of the suction tubing extending from the interior to the exterior of the sterile field acts as a flow restrictor, resulting in a delay between the time the vacuum button on the pump assembly 42 is activated and the time aspiration of the clot at the distal end of the catheter is actually applied.

[0068] In the illustrated embodiment, the only flow restriction between the vacuum source (filtration chamber 33) and the patient is the relatively short suction path between the on / off valve in the handpiece actuated by the toggle switch 48 and the distal end 18 of the catheter. When the suction control 48 is activated to open the flow path, the flow restriction and enclosed volume on the patient side of the filtration chamber 33 are low relative to the flow restriction and enclosed volume through the suction tubing 40 on the pump side of the filtration chamber 33.

[0069] This dual chamber configuration produces a rapid peak in negative pressure experienced at the distal end 18 of the catheter 12 upon activation of the suction control 48 and rapid filling of the chamber 33. The response time between activation of the suction control 48 and actual suction experienced at the clot is significantly faster and allows for significantly higher initial flows than the response time achieved in conventional systems having only the vacuum chamber 58 at the pump assembly 42 located outside the sterile field.

[0070] When pressure balance is reached between the filtration chamber 33 and the tank 58, the negative pressure peak experienced at the distal end of the catheter will subside. When the suction control 48 is closed, the vacuum pump 50 will gradually reduce the pressure in the filtration chamber 33 to the level in the vacuum tank 58 at the pump.

[0071] Figure 4 A simplified fluid flow diagram is shown in Figure 5 A qualitative flow rate graph is shown in FIG. 4 . The flow restriction between the chamber 33 and the distal end 18 of the catheter 12 is smaller than the flow restriction between the vacuum tank 58 and the vacuum chamber 33. This allows a negative pressure peak to occur almost instantaneously at the distal end 18 when the vacuum switch 48 is activated. The flow rate of material entering the catheter 12 quickly reaches a peak and decreases as the vacuum chamber 33 is filled with the aspirated material. When the toggle switch 48 is moved to the off position, the vacuum in the chamber 33 drops to a minimum value and is slowly refilled through the large vacuum chamber 58 and the associated pump through the conduit 40. In some use cases, the clinician may choose to close the vacuum switch 48 at or shortly after the maximum flow rate, providing only a short or series of short vacuum pulses to promote the aspiration of thrombi into the catheter 12. In use, a similar effect can be established by utilizing the vent 47. When the button 62 is actuated so that the vent is opened, the vacuum in the chamber 33 can drop to a minimum value. Thereafter, when the button 62 and vent 47 are moved to the closed position, the vacuum chamber 33 can be slowly refilled through the large vacuum chamber 58 and associated pump through the tubing 40. In some use cases, the clinician may choose to open the vent 47 at or shortly after the maximum flow rate to provide only a brief vacuum pulse or series of brief vacuum pulses to facilitate aspiration of the thrombus into the catheter 12.

[0072] If the application of vacuum fails to draw the clot into the catheter, the elongated flexible thrombus engagement tool may be advanced through the aspiration catheter to facilitate retrieval of the clot. The thrombus engagement tool may include an elongated flexible shaft having a proximal hand piece, such as a knob configured to be turned by hand. The distal end carries a clot engagement tip, which may include one or more radially outwardly extending structures, such as a helical thread.

[0073] refer to FIG. 6A to FIG. 6C , the thrombus engaging tool 80 may include an elongated flexible shaft 82 having a proximal end 84 and a distal end 86. A proximal hand piece, such as a twist handle 88, may be configured to be rotated by hand. The distal end 86 carries a clot engaging tip 90, which may include one or more radially outwardly extending structures, such as helical threads 92. The handle 88 may have indicia of rotation direction (such as a printed or molded arrow 94) that indicates the direction to rotate the handle 88 so that the helical threads 92 engage the clot.

[0074] refer to Figure 6B , the distal tip 90 includes helical threads 92 extending between a distal threaded end 96 and a proximal threaded end 94, and is supported by a flexible shaft 98. The axial length of the distal tip 90 is at least about 5 mm or 10 mm or 15 mm or 20 mm, and in some embodiments, the axial length measured along the flexible shaft 98 does not exceed about 30 mm or 20 mm. Preferably, the axial length will be about 20 mm to about 25 mm.

[0075] The helical threads 92 wrap around the axis for at least about 1 or 2 or 4 or more complete turns, but in some embodiments, no more than about 10 or no more than about 6 turns. Preferably, the threads 92 wrap around the axis for about 2.5 to about 4.5 turns. In some embodiments, the axial length of the threaded portion along the tip is about 5 mm to about 15 mm, and preferably about 8 mm to about 12 mm.

[0076] The helical thread 92 in this embodiment can have a constant pitch throughout its length. Depending on the desired performance, the pitch can be about 5 to about 10 threads per inch. For example, the thread spacing in the axial direction can be about 2mm to about 6mm, preferably about 3mm to about 4mm.

[0077] Alternatively, the thread can have multiple pitches (e.g., stepped or progressive) designed to engage, deliver or capture thrombi in the guide lumen. The distal pitch can be less than the proximal pitch. The pitch can vary continuously along the length of the thread, or can span from a first constant pitch in the proximal region of the thread to a second different pitch in the distal region of the thread. The thread 92 can include a continuous single spiral flange, or can have multiple discontinuities to produce a plurality of teeth or serrations arranged around the core wire spiral.

[0078] The maximum OD of the threads 92 is preferably smaller than the diameter of the sliding fit in the target catheter lumen, and can generally be at least about 0.015 inches or at least about 0.010 inches smaller than the catheter lumen ID. In some embodiments, the maximum OD of the tip can be significantly smaller than the inner diameter of the catheter lumen to allow more thrombus space along the sides of the tip, but still generate significant gripping force through the lateral engagement of the helical threads with the thrombus.

[0079] In one embodiment, the maximum helical thread diameter is about 0.110 inches, and the catheter lumen ID is about 0.275 inches (24F) (0.165 inches of clearance between the helical thread and the catheter wall). In another embodiment, within the catheter, the maximum OD of the tip is about 0.03 inches to about 0.06 inches, and the distal ID of the catheter is about 0.068 inches to about 0.073 inches. This forms a substantial tip bypass flow path.

[0080] In some applications, the maximum OD of the tip is no more than about 35% or no more than about 40% or no more than about 60% of the corresponding catheter ID, and can be about 35% to about 55% of the catheter ID. In some cases, the maximum OD of the tip may be slightly less than the corresponding catheter ID to provide a sliding fit in the target catheter cavity. For example, the maximum OD of the tip may be no less than about 90% or no less than about 95% or no less than about 97% of the corresponding catheter ID.

[0081] Since this embodiment of the thrombus engagement tool does not have any centering structure for the tip 90 or the shaft 82, the tip 90 will generally be pushed to one side of the aspiration chamber. When a clot is received between the tip 90 and the opposing inner surface of the catheter side wall, manual operation such as rotating the tip 90 can engage the clot like a worm gear and either grab the clot (e.g., by securing it to the opposing catheter side wall) for retraction, or facilitate release of the obstruction and assist in ingestion of the clot into the catheter. During aspiration, manual operation can also include axial proximal and distal reciprocating motion accompanied by rotation, which can facilitate ingestion of the clot into the catheter.

[0082] Thus, an unobstructed flow path is formed in the annular (if the tip is centered) space between the tip maximum OD and the catheter lumen ID. This annular flow path cooperates with the vacuum and spiral tip to grab and pull obstructive material into the catheter under rotation and vacuum. The annular flow path is significantly larger than any flow path created by manufacturing tolerances in a tip configured to shear embolic material between the tip and the catheter wall.

[0083] As a result of the spiral passage defined between every two adjacent threads at tip, other aspiration volumes are obtained. The cross-sectional area of ​​the spiral flow path at the tip with a maximum OD of about 0.0400 inch to about 0.0406 inch will be at least about 0.0003 square inches generally, and in some embodiments be at least about 0.00035 inch or at least about 0.000375 inch. Therefore, the total aspiration flow path through the spiral tip is the summation of the spiral flow path through tip and the annular flow path between the OD at tip and the ID of the catheter lumen that is defined.

[0084] Suction occurs through the helical channels formed between adjacent helical threads and around the exterior of the tip such that the assembly is configured to engage and capture embolic material but not shear embolic material between the sharp edges of the threads and the inner wall of the catheter.

[0085] The distal advancement section 100 advantageously allows the thrombus engagement device 80 to be moved at least partially past the thrombus without "pushing" the thrombus in the distal direction as the tip 90 is advanced. This can inhibit the passage of the thrombus (or any particles thereof) downstream within the vessel during engagement of the device 80 with the thrombus.

[0086] In some cases, the distal advancement segment 100 can include a continuation of the helical thread 92. For example, the distal advancement segment 100 can include a thread segment that is continuous from the helical thread 92. In some cases, the threaded distal advancement segment 100 can maintain an outer diameter that is consistent with the remainder of the helical thread 92. In some cases, the threaded distal advancement segment 100 can include threads that taper in the distal direction to a smaller outer diameter relative to the remainder of the helical thread 92. For example, the helical thread 92 can include a proximal cylindrical segment and a distal tapered segment extending along the distal advancement segment 100.

[0087] In the end view along the axis, the cross-section of the tip 90 can be circular and / or in some cases, can be varied to produce a non-circular pattern about the axis of rotation. For example, the cross-section can include a spiral pattern, such as an oval cross-section rotated along the axis of rotation to produce a spiral cross-section. Thus, the tip seen in the end elevation view can exhibit a major diameter and a minor diameter. The minor diameter can be no more than about 95% or 90% or 80% or 70% of the major diameter, depending on the desired performance. In the embodiment shown, the outer edge 93 of the thread 92 is along the surface of the cylinder.

[0088] In the embodiment shown, the outer edge 93 of the thread 92 thus has a linear surface in the axial direction, substantially conforming to the surface of a cylinder. The distal side 95 of the thread 92 is inclined radially outward in the proximal direction. The proximal side 97 of the thread 92 is also inclined radially outward in the proximal direction, thereby defining an undercut toward the proximal end along the length of the thread.

[0089] refer to Figure 6B and Figure 6C , the tip 90 shown includes an atraumatic distal tip at 102 and an atraumatic tapered distal advancement segment 100 extending between a transition portion with a distal end 96 of the threads 92. The helical threads 92 extend proximally from the transition portion to a proximal end 94 of the helical threads 92. In some cases, a tail segment 104 may extend between the proximal end 94 of the threads and a proximal end 106 of the tip.

[0090] The axial length of the distal advancement segment 100 may be at least about 5 mm or at least about 8 mm or 9 mm and typically less than about 15 mm, and in some embodiments, from about 8 mm to about 12 mm.

[0091] The outer diameter of the flexible shaft 82 is typically less than about 0.02 inches, or less than about 0.015 inches, and in one embodiment, about 0.008 inches. In some cases, the flexible shaft 82 can include a distal tapered portion. The distal tapered portion can advantageously increase tip flexibility and / or maximize suction. The outer diameter at the distal end of the distal tapered portion of the flexible shaft 82 is typically less than about 0.01 inches, or less than about 0.008 inches, and in one embodiment, no more than about 0.006 inches.

[0092] The outer diameter of the pusher segment 100 at the distal tip 102 is typically less than about 0.024 inches, or less than about 0.020 inches, and in one embodiment, about 0.018 inches. The maximum outer diameter of the pusher segment 100 and the helical threads 92 can be about 0.020 inches to about 0.045 inches, and in one embodiment, less than about 0.040 inches, such as about 0.035 inches. The pusher segment, helical threads, and tail segment of the tip 90 can be integrally molded onto the flexible shaft 82 using any of a variety of polymers known in the catheter art.

[0093] refer to Figure 6C , a first radiopaque marker 110 can be carried on the flexible shaft 82 below the pusher section 100. A second radiopaque marker 112 can be carried on the flexible shaft 82 within the tail section 104. Each radiopaque marker can include a radiopaque tube or a coil of radiopaque wire, such as a platinum-iridium alloy wire having a diameter of about 0.002 inches, and is installed or wrapped around the flexible shaft 82 and welded to the flexible shaft 82 to produce a RO sleeve or coil having an outer diameter of less than about 0.020 inches, such as about 0.012 inches. The radiopaque marker can also provide an axial interference fit between the flexible shaft 82 and the pusher section 100 and the tail section 104 to resist axial pullout of the core wire from the tip 90 (tip separation).

[0094] In certain embodiments, the maximum OD of threads 92 exceeds the maximum OD of pusher segment 100 by at least about 15%, 25%, or 30% or more of the OD of pusher segment 100 to facilitate intersecting the clot with pusher segment 100 and engaging the clot with threads 92.

[0095] Depending on the clinical application, it may be desirable to control the extent to which the distal tip 102 may extend beyond the distal end of the catheter 12, if at all. In certain embodiments, the distal tip 102 may be permitted to extend beyond the catheter by at least about 2 cm or 3 cm, and preferably as much as 4 cm to 8 cm (e.g., to allow for manual removal of an engaged thrombus), but will typically be limited to extending beyond the catheter by no more than a preset distance, such as 12 cm or 8 cm or 5 cm (e.g., about 5 cm to about 10 cm), depending on the desired performance.

[0096] The distal advancement of the tip 102 can be limited by providing mechanical interference at the desired distal travel limit. In one embodiment, the distal stop surface 114 (which can be on the handle 88) (see Fig. 6A ) provides interference engagement with a complementary proximal surface carried by the aspiration catheter (e.g., proximal surface 33 on connector module 30 or on a catheter hub) through which the thrombus engagement tool 80 is advanced. Alternatively, the distal engagement surface can be carried at any position along the length of the thrombus engagement tool 80 for sliding rotational engagement with a complementary proximal stop surface carried by the catheter. Additional details of the distal restraining structure can be found in U.S. Patent Application No. 17 / 036,258, filed on September 29, 2020, entitled Embolic Retrieval Catheter, which is expressly incorporated herein by reference in its entirety.

[0097] The limitation of distal advancement of the helical tip may enable a first configuration in which the distal tip may be advanced through the catheter and placed in a first position generally aligned with the distal end of the catheter 12. The physician may then advance the tip to a second position extending beyond the distal end of the catheter, such as for inspection and cleaning purposes.

[0098] A position indicator 85 can be carried by the flexible shaft 82, the distance between the position indicator 85 and the distal surface 114 corresponding to the maximum length that the thrombus engaging tool is intended to extend beyond the distal end of the catheter. When the position indicator 85 is at a corresponding reference point relative to the catheter hub, the distal tip 102 can be approximately at the distal end of the catheter. In this way, the physician will know that any further distal advancement of the thrombus engaging tool will extend beyond the distal end of the catheter. When the distal surface 114 contacts the catheter hub, the maximum extension will be reached.

[0099] The position indicator 85 can include any of a variety of visual or tactile features, such as a color change or color band around the flexible shaft 82. In a visual marking embodiment (color change or circumferential line), the distal tip 102 can be positioned approximately at the distal end of the catheter when the indicator is visible just outside the hub. In another embodiment, the position indicator 85 includes a transition between the distal end of a hypo tube 87 and the flexible shaft 82 below. This provides tactile feedback when the indicator (step in the outer diameter) encounters and passes through the valve of the RHV. The hypo tube 87 additionally acts as a strain relief or anti-buckling feature, and the axial length can be about 3 cm to about 15 cm, and in some embodiments, about 5 cm to about 9 cm.

[0100] refer to Fig. 7A , showing an embodiment of an outer jacket segment stacking pattern, which is used in connection with Figure 1 The progressive flexible catheter of the type discussed. The distal segment 120 can be about 1cm to 3cm in length, and the hardness is less than about 35D or 30D. The adjacent proximal segment 122 can be about 4cm to 6cm in length, and the hardness is less than about 35D or 30D. The adjacent proximal segment 124 can be about 4cm to 6cm in length, and the hardness is about 35D or less. The adjacent proximal segment 126 can be about 1cm to 3cm in length, and the hardness is about 35D to about 45D (e.g., 40D). The adjacent proximal segment 128 can be about 1cm to 3cm in length, and the hardness is about 50D to about 60D (e.g., about 55D). The adjacent proximal segment 130 can be about 1cm to 3cm in length, and the hardness is about 35D to about 50D to about 60D (e.g., about 55D). The adjacent proximal segment 132 may be about 1 cm to 3 cm in length and have a durometer of at least about 60 D, and typically less than about 75 D. Further proximal segments may have a durometer of at least about 65 D or 70 D.

[0101] The two or three most distal segments may comprise materials such as Tecothane and / or PEBAX, and the more proximal segments may comprise PEBAX or other catheter sheath materials known in the art. At least three or five or seven or nine or more discrete segments may be used, having a hardness between a maximum and minimum hardness along the length of the catheter shaft, at least about 10D, preferably at least about 20D, and in some embodiments at least about 30D or 40D or greater.

[0102] 7A to 7E Various embodiments of catheters are shown, wherein at least some of the catheters include multiple catheter outer sheath segments having varying lengths and / or stiffnesses for varying flexibility along the length of the catheter body. 7A to 7EAny features related to any catheter of the present invention may be used with any embodiment described and / or considered herein. It should also be understood that any features described and / or considered with respect to any embodiment disclosed herein may be used with respect to any embodiment of the present invention. 7A to 7E For all embodiments in this specification, 7A to 7E Any feature, structure, material, method or step described and / or shown in the embodiment of the present invention may be used together with or substituted for any feature, structure, material, method or step described and / or shown in any other embodiment of the present specification.

[0103] FIG. 7B to FIG. 7E Various embodiments of catheters 400, 500, 600 are shown. The catheters 400, 500, 600 can include different characteristics (e.g., such as length, diameter, etc.) so that one or more of the catheters 400, 500, 600 can interact with any of the other catheters 400, 500, 600 in any of a variety of ways. In one embodiment, as shown in FIG. Fig. 7E As shown, each of the catheters 400, 500, 600 may include different sizes to allow the catheter 400, 500, 600 to at least partially extend through one or more of the other catheters 400, 500, 600. The length of each of the catheters 400, 500, 600 may vary to allow a smaller catheter to telescope through and extend distally beyond a larger catheter.

[0104] For example, conduit 500 may be configured to pass through and extend beyond conduit 400. By way of further example, conduit 600 may be configured to pass through and extend beyond at least one of conduit 500 or conduit 400 in a telescopic manner. Fig. 7E The example telescoping catheter stack shown includes each of catheters 400, 500, 600, and those skilled in the art will appreciate that any combination of catheters 400, 500, 600 may be used. For example, the system may include the use of catheter 400 and catheter 500, the use of catheter 400 and catheter 600, or the use of catheter 500 and catheter 600.

[0105] Catheter 400 may include an 8F catheter. In some cases, catheter 400 includes a diameter greater than any other catheter diameter in the system. In addition, or alternatively, catheter 400 may include a total length shorter than any other catheter length in the system. In this way, catheter 400 may include the outermost catheter in the telescopic system, and any other catheters 500, 600 may be allowed to extend distally beyond the distal end of catheter 400. Catheter 400 may include a length of about 35cm to about 105cm, or a length of about 45cm to about 95cm. Catheter 400 may include a length of about 50cm to about 90cm. Catheter 400 may include a length of at least shorter than any catheter (e.g., such as catheter 500, 600) less than the diameter of catheter 400.

[0106] Catheter 500 may include a 6F catheter. In some cases, the diameter of catheter 500 is between the diameters of the remaining catheters in the system. In addition, or alternatively, catheter 500 may include a length between the lengths of the remaining catheters in the system. In this way, catheter 500 may include an intermediate catheter in a telescopic system, and may be configured to pass through and extend beyond one or more catheters, while also allowing another catheter to extend distally beyond the distal end of catheter 500. Catheter 500 may include a length of about 120cm to about 155cm, or about 130cm to about 145cm. Catheter 500 may include a length of about 135cm to about 137cm. Catheter 500 may include a length that is at least longer than any catheter (e.g., such as catheter 400) having a diameter greater than catheter 500. Catheter 500 may include a length that is at least shorter than any catheter (e.g., such as catheter 600) having a diameter less than catheter 500.

[0107] Catheter 600 may include a 5F catheter. In some cases, catheter 600 includes a diameter that is less than the diameter of the remaining catheters in the system. In addition, or alternatively, catheter 600 may include a length that is longer than any remaining catheter length in the system. In this way, catheter 600 may include the innermost catheter in the telescopic system, and may be configured to pass through and extend beyond one or more other catheters. Catheter 600 may include a length of about 145cm to about 175cm, or about 155cm to about 165cm. Catheter 600 may include a length of about 160cm. Catheter 600 may include a length that is at least longer than any catheter (e.g., such as catheter 400, 500) that is greater than the diameter of catheter 600.

[0108] As discussed herein, one or more of the catheters 400, 500, 600 may include a coil and / or braid in the sidewall that extends through at least a portion of the sidewall of the catheter 400, 500, 600. The braid may have properties that vary along the length of each catheter 400, 500, 600 to produce various desired characteristics of the catheters 400, 500, 600. For example, the linear density of the braid may vary gradually or stepwise along the length of the catheter 400, 500, 600 and / or between discrete sections of the catheter 400, 500, 600.

[0109] Conduit 600 can include one or more discrete sections, wherein braid properties change between one or more sections.In some cases, conduit 600 can include a first section, a second (e.g., middle) section and a third distal section.However, it will be appreciated by those skilled in the art that conduit 600 can include a smaller number of sections (e.g., one section or two sections) or a larger number of sections (e.g., four sections or more).Sidewall properties, such as the length and / or linear density of the braid along each section, can change between sections.In some cases, the images per inch (ppi) count of the braid, together with the linear density of the braid, can gradually change between one or more conduit sections.For example, in some cases, the ppi count of the braid can keep substantially the same on the length of the first section and the length of the third section, but gradually change along the length of the second intermediate section.

[0110] The length of the first section of the catheter 600 can be at least about 20 cm. For example, the length of the first section can be about 25 cm to about 35 cm, or about 30 cm in one embodiment. The braid passing through the first section can have a linear density of at least about 100 ppi. For example, the braid passing through the first section can have a linear density of at least about 120 ppi, or more specifically, about 130 ppi.

[0111] The length of the third section of the catheter 600 can be at least about 100 cm. For example, the length of the third section can be about 120 cm to about 140 cm or more specifically about 130 cm. The braid passing through the third section can have a linear density of no more than about 85 ppi. For example, the braid passing through the third section can have a linear density of about 70 ppi to about 80 ppi.

[0112] The second section of the catheter 600 can be an intermediate section between the first section and the third section. The length of the second section can be at least about 3 cm. In some cases, the length of the second section can be no greater than about 20 cm, or more specifically, no greater than about 10 cm. For example, the length of the second section can be about 5 cm. The linear density of the braid passing through the second section can be no greater than the linear density of the first section, and no less than the linear density of the third section.

[0113] Conduit 500 may include one or more discrete sections, wherein the braid property changes between one or more sections. In some cases, conduit 500 may include a first section, a second (e.g., middle) section, and a third section. However, it will be appreciated by those skilled in the art that conduit may include a smaller number of sections (e.g., one section or two sections) or a larger number of sections (e.g., four sections or more). Sidewall properties, such as the length and / or linear density of the braid along each section, may change between sections. In some cases, the ppi count of the braid may gradually change with the linear density of the braid between one or more conduit sections. For example, in some cases, the ppi count of the braid may remain substantially consistent at the length of the first section and the length of the third section, but gradually change along the length of the second intermediate section.

[0114] The length of the first section of the catheter 500 can be at least about 20 cm. For example, the length of the first section can be about 25 cm to about 35 cm, or about 30 cm in one embodiment. The braid passing through the first section can have a linear density of at least about 100 ppi. For example, the braid passing through the first section can have a linear density of at least about 120 ppi, or about 130 ppi in one embodiment.

[0115] The length of the third section of the catheter 500 can be at least about 80 cm. For example, the length of the third section can be about 100 cm to about 120 cm, or about 105 cm in one embodiment. The braid passing through the third section can have a linear density of no more than about 100 ppi. For example, the braid passing through the third section can have a linear density of about 80 ppi to about 90 ppi.

[0116] The second section of the catheter 600 can be an intermediate section between the first section and the third section. The length of the second section can be at least about 3 cm. In some cases, the length of the second section can be no more than about 20 cm, or more specifically no more than about 10 cm. For example, the length of the second section can be about 5 cm. The braid passing through the second section can have a linear density no greater than that of the first section and no less than that of the third section.

[0117] The catheter 400 may include one or more discrete sections, wherein the braid property changes between one or more sections. In some cases, the catheter 400 may include a section. However, it will be appreciated by those skilled in the art that the catheter 400 may include a greater number of sections (e.g., two sections, three sections, four sections or more). For example, the catheter 400 may include three sections, as described in conjunction with the catheter 500 or the catheter 600. Sidewall properties, such as the length and / or linear density of the braid, may change along the catheter 400. In some cases, the ppi count of the braid together with the linear density of the braid may gradually change to increase flexibility along the distal end direction of the catheter 400. The length of the section of the catheter 400 may be at least about 40 cm. For example, the length of the section may be about 50 cm to about 60 cm, or about 55 cm in one embodiment. The braid passing through the section may have a linear density of at least about 80 ppi. For example, the braid passing through the section may have a linear density of at least about 90 ppi.

[0118] In some cases, the braid can extend along the entire length of the catheter sidewall. In some cases, there is no bonding between the braid and the coil in the catheter and / or the catheter sidewall does not contain the coil. It should be understood that this braid configuration can be applied to any catheter disclosed herein, including but not limited to catheters 400, 500, 600.

[0119] One or more of the catheters 400, 500, 600 can include an outer jacket segment stacking pattern for a progressively flexible catheter. The outer jacket segments can each have properties that vary along the length of each catheter 400, 500, 600 to produce various desired properties of the catheters 400, 500, 600. For example, the various segments of the outer jacket can have corresponding Shore D hardnesses to vary the flexibility along the length of the catheter 400, 500, 600. The outer jacket segments can be made of a thermoplastic elastomer that is a combination of a flexible polyether and a rigid polyamide (e.g., In some cases, various segments of the outer sheath can include different variations of the thermoplastic elastomer to vary the flexibility.

[0120] The catheter 600 may include multiple discrete segments of the outer sheath, wherein the flexibility varies between one or more segments. In some cases, the catheter 600 may include multiple segments. Sidewall properties, such as Shore D hardness and / or flexibility, may vary between segments. In some cases, the Shore D hardness of the outer sheath segments may gradually transition from a higher hardness at the proximal segment of the outer sheath to a lower hardness at the distal segment of the outer sheath.

[0121] The proximal section of the outer sheath of the catheter 600 can have a Shore D hardness of at least about 60. For example, the Shore D hardness of the proximal section can be about 70 to about 80, or more specifically, at least about 75.

[0122] The distal section of the outer sheath of the catheter 600 can have a Shore D hardness of at most about 40. For example, the Shore D hardness of the distal section can be about 30 to about 20, or more specifically, no more than about 27.

[0123] A plurality of intermediate segments between the distal segment and the proximal segment may each include a plurality of Shore D hardnesses. In some cases, the Shore D hardness of each segment in the distal direction decreases, and may have a Shore D hardness smaller than that of the adjacent segment on the proximal side. For example, the Shore D hardness of the first segment may be about 30 to about 50, or more specifically about 40. In some cases, the first segment may be located about 120 cm to about 160 cm from the distal face of the catheter 600, or more specifically, located about 140 cm from the distal face of the catheter 600. By means of another embodiment, the Shore D hardness of the second segment may be about 50 to about 70, or more specifically about 65. In some cases, the second segment may be located about 220 cm to about 260 cm from the distal face of the catheter 600, or more specifically, located about 240 cm from the distal face of the catheter.

[0124] The catheter 500 may include multiple discrete segments of the outer sheath, wherein the flexibility varies between one or more segments. In some cases, the catheter may include multiple segments. Sidewall properties, such as Shore D hardness and / or flexibility, may vary between segments. In some cases, the Shore D hardness of the outer sheath segments may gradually transition from a higher hardness at the proximal segment of the outer sheath to a lower hardness at the distal segment of the outer sheath.

[0125] The proximal section of the outer sheath of the catheter 500 can have a Shore D hardness of at least about 60. For example, the Shore D hardness of the proximal section can be about 70 to about 80, or more specifically, at least about 75.

[0126] The distal section of the outer sheath of the catheter 500 can have a Shore D hardness of at most about 40. For example, the Shore D hardness of the distal section can be about 30 to about 20, or more specifically, no more than about 27.

[0127] A plurality of intermediate segments between the distal segment and the proximal segment may each include a plurality of Shore D hardnesses. In some cases, the Shore D hardness of each segment in the distal direction decreases, and may have a Shore D hardness smaller than that of the adjacent segment on the proximal side. For example, the Shore D hardness of the first segment may be about 30 to about 50, or more specifically about 40. In some cases, the first segment may be located about 70 cm to about 110 cm from the distal face of the catheter 500, or more specifically, about 90 cm. By means of another embodiment, the Shore D hardness of the second segment may be about 50 to about 70, or more specifically about 65. In some cases, the second segment may be located about 160 cm to about 200 cm from the distal face of the catheter 500, or more specifically, located about 180 cm from the distal face of the catheter.

[0128] The catheter 400 may include multiple discrete segments of the outer sheath, wherein the flexibility varies between one or more segments. In some cases, the catheter 400 may include multiple segments. Sidewall properties, such as Shore D hardness and / or flexibility, may vary between segments. In some cases, the Shore D hardness of the outer sheath segments may gradually transition from the proximal segment of the outer sheath to the distal segment of the outer sheath.

[0129] The proximal section of the outer sheath of the catheter 400 can have a Shore D hardness of at least about 60. For example, the Shore D hardness of the proximal section can be about 70 to about 80, or more specifically about 75.

[0130] The distal section of the outer sheath of the catheter 400 can have a Shore D hardness of at most about 40. For example, the Shore D hardness of the distal section can be about 30 to about 20, or more specifically, no more than about 27.

[0131] A plurality of intermediate segments between the distal segment and the proximal segment may each include a variety of Shore D hardnesses. In some cases, the Shore D hardness of each segment in the distal direction decreases, and may have a Shore D hardness smaller than that of the adjacent segment on the proximal side. For example, the Shore D hardness of the first segment may be about 30 to about 50, or more specifically about 40. In some cases, the first segment may be located about 65 cm to about 105 cm from the distal face of the catheter 400, or more specifically, about 85 cm from the distal face of the catheter. By means of another embodiment, the Shore D hardness of the second segment may be about 40 to about 65, or more specifically about 55. In some cases, the second segment may be located about 105 cm to about 145 cm from the distal face of the catheter 400, or more specifically, about 125 cm from the distal face of the catheter. By further embodiments, the Shore D hardness of the third segment may be about 60 to about 80, or more specifically about 70. In some cases, the third segment can be located between about 140 cm and about 180 cm from the distal face of the catheter 400, or more specifically, located about 160 cm from the distal face of the catheter.

[0132] The catheter 400 may include a tubular body length of about 90 + / - 5 cm. In some cases, the catheter 400 may include a tubular body length of about 50 + / - 5 cm. The number of the plurality of discrete segments of the outer sheath of the catheter 400 may vary relative to the tubular body length of the catheter 400. The length of each segment in the plurality of discrete segments of the outer sheath of the catheter 400 may vary relative to the tubular body length of the catheter 400.

[0133] In some cases, the coating can be positioned along the outer diameter of the distal portion of the catheter side wall. The coating can be configured to reduce the friction resistance of the distal portion of the catheter side wall and any adjacent structure (e.g., vascular wall). In some cases, the coating increases the lubricity of the outer side wall of the distal portion of the catheter. The coating can advantageously reduce the friction of the distal end of the catheter through the curved vascular system. This can promote the advancement and rotation of the distal end of the catheter, particularly when the catheter includes increased flexibility along the distal portion of the catheter. The coating can extend in the proximal direction from the distal end face of the catheter, or near the distal end face of the catheter. The coating can extend at least about 20cm in the proximal direction. In some cases, the coating extends no more than about 50cm from the distal end face of the catheter. For example, the coating can extend from the distal end face of the catheter to a length of about 25cm to about 35cm, or more specifically, from the distal end face of the catheter to extend a length of about 30cm. It will be understood that the coating can be applied to any catheter disclosed herein, including but not limited to catheter 400,500,600.

[0134] Figure 8A cross section through the side wall of the distal portion of a single lumen catheter is shown. The internal support layer may include a coil or braid. In a coil embodiment, adjacent loops or threads of the coil 140 may have a constant pitch throughout the coil length, or may be tightly wound in a proximal region, with the distal end section of the proximal region having a looser spacing between adjacent loops. In an embodiment having a coil segment 140 having an axial length of at least about 20% to about 30% of the total catheter length (e.g., a coil length of 28 cm in a 110 cm catheter shaft 16), at least about 1 cm or about 2 cm or about 3 cm or about 4 cm of the distal end of the coil will have a spacing of at least about 130% compared to the proximal coil section, and in some embodiments, at least about 150% or greater. In a 110 cm catheter shaft 3000 with a nitinol coil, the spacing in the proximal coil may be about 0.004 inches, and the spacing in the distal section may be at least about 0.006 inches or about 0.007 inches or greater.

[0135] The distal end of the coil or braid 140 can be spaced apart in the proximal direction from the distal end of the inner liner 142, for example, to provide space for an annular radiopaque marker 144. In some embodiments, the coil or braid 140 can be set back from the distal end to the proximal side by no more than about 1 cm, about 2 cm, or about 3 cm. In one embodiment, the distal end of the catheter 12 is provided with a chamfered (inclined) distal surface 146 that is located on a plane having an angle of at least about 10 degrees or about 20 degrees, and in one embodiment, about 30 degrees, relative to the longitudinal axis of the catheter 10. At least the distal-facing edge of the annular radiopaque marker 144 can be elliptical and located on a plane inclined relative to the longitudinal axis to complement the bevel of the distal surface 146. The following description will be made in conjunction with Fig. 9 Additional details are described.

[0136] After the braid or braid and coil is applied to the connecting layer 152 and / or the liner, the distal braid or coil and RO marker 144 are provided with an outer sheath 156, such as a polymer tube formed from a plurality of axially adjacent cylindrical segments, to encapsulate the catheter body 16. The outer sheath 156 may include any of a variety of materials, such as polyethylene, polyurethane, polyether block polyamide (e.g., PEBAX®), or polyurethane. TM ), nylon or other materials known in the art. Sufficient heat is applied to cause the polymer to flow into and embed into the proximal braid and distal coil.

[0137] In one embodiment, the outer sheath 156 is formed by sequentially advancing a plurality of short tubular segments 133, 132, 130, 128, 126, 124, 122, 120 concentrically on the catheter shaft subassembly and applying heat to shrink the segments onto the catheter 12 and provide a smooth, continuous outer tubular body. The aforementioned segmented configuration may extend along at least the distal end of the catheter body 10 about 10 cm, and preferably at least about the distal end about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, or more than about 40 cm. The entire length of the outer sheath 156 may be formed by the tubular segments, and the length of the distal tubular segment may be shorter than the one or more tubular segments that make up the proximal portion of the outer sleeve 156, which is adjacent to the connection of the braid 150 to the coil 140, so as to provide proximal backup support and a sharper flexibility transition along the distal end of the catheter 12.

[0138] The hardness of the outer wall segment can be reduced in the distal direction. For example, the proximal segments such as 133 and 132 can have a hardness of at least about 60D or about 70D, wherein the hardness of the continuous segments is gradually reduced to a hardness of no more than about 35D or about 25D or lower in the distal direction. The 25cm segment can have at least about 3 or about 5 or about 7 or more segments, and the catheter 12 as a whole can have at least about 6 or about 8 or about 10 or more different flexible areas. The distal 1 or 2 or 4 or more segments 122, 120 can have an OD smaller than the more proximal segments 133-124 after contraction, to produce a stepped reduction of the OD of the finished catheter body 16. The length of the smaller OD segment 160 can be about 3cm to about 15cm, and in some embodiments, about 5cm to about 10cm, for example, about 7cm or about 8cm, and can be achieved by providing a distal segment 122, 120 with a smaller wall thickness.

[0139] In another embodiment, the distal end portion of the catheter 12 may include a hardness of less than about 35D (e.g., 25D) to form a highly flexible distal portion of the catheter and have a length of about 25 cm to about 35 cm. The distal portion may include one or more tubular segments (e.g., segment 120) of the same hardness. A series of proximal adjacent tubular segments may form a transition zone between the proximal harder portion of the catheter 12 and the distal highly flexible portion of the catheter. The series of tubular segments forming the transition zone may have the same or substantially similar lengths, e.g., about 1 cm.

[0140] The relatively short length of each of the series of tubular segments can provide a sharp drop in hardness over the transition zone. For example, the transition zone can have a proximal tubular segment 122 (adjacent to the distal portion in the proximal direction) of about 35D hardness. The adjacent proximal segment 124 can have a hardness of about 55D. The adjacent proximal segment 126 can have a hardness of about 63D. The adjacent proximal segment 128 can have a hardness of about 72D.

[0141] More proximal segments may include one or more durometers greater than about 72D and may extend to the proximal end of the catheter. For example, a catheter segment may include a proximal portion greater than about 72D from about 1 cm to about 3 cm. In some embodiments, the proximal portion may be about 2 cm long. In some embodiments, the distal-most segment (e.g., 120, 122) may include PEBAX TM , and more proximal segments may include generally stiffer materials, e.g.

[0143] The inner diameter of the catheter 10 can be about 0.06 to 0.08 inches, about 0.065 to 0.075 inches, or about 0.068 to 0.073 inches. In some embodiments, the inner diameter is about 0.071 inches.

[0144] In some embodiments, the distal most distal portion, such as below segments 122 and 120, can span or gradually decrease to a reduced internal diameter. The gradual decrease can occur roughly between the distal highly flexible portion and the transition zone (e.g., on the most proximal portion of the distal highly flexible portion). The gradual decrease can be relatively gentle (e.g., occurring at about 10 cm or longer) or can be relatively sharp (e.g., occurring at less than about 5 cm). The internal diameter can be gradually reduced to an internal diameter of about 0.03 inches to about 0.06 inches. For example, at the distal end of catheter 12, the internal diameter can be about 0.035 inches, about 0.045 inches, or about 0.055 inches. In some embodiments, the internal diameter can remain constant at least on the catheter extension.

[0145] In some coil / braid hybrid embodiments, the coil 140 can extend proximally from the distal end of the catheter 12 along a highly flexible distal portion, terminating at or overlapping the distal end of the braid 150. In other embodiments, the coil 140 can extend the entire length of the catheter 12. The braid 150, when present, can extend approximately from the proximal transition 163 of the coil 140 to the proximal end of the catheter 12.

[0146] Any of the catheters disclosed herein may provide an angled distal tip. Fig. 9, the distal catheter tip 18 includes a tubular body 14 including a pusher segment 200 and a marker band 144. An inner tubular liner 142 may extend throughout the length of the distal catheter tip and may include dip-coated PTFE.

[0147] A reinforcing element 140, such as a braid and / or spring coils, is embedded in an outer sheath that may extend the entire length of the catheter proximal to the radiopaque marker.

[0148] The pusher segment 200 terminates distally in the angled surface 146 to provide a front sidewall portion 202 having a length measured between the distal end 204 of the marker band 144 and the distal tip 206. In the illustrated embodiment, the axial length of the rear sidewall portion 208 of the pusher segment 200 is approximately equal to the axial length of the front sidewall portion 202, as measured from the front sidewall portion 202 about 180 degrees around the catheter. The axial length of the front sidewall portion 202 can be about 0.1 mm to about 5 mm, and typically about 1 mm to 3 mm. The rear sidewall portion 208 can be shorter than the axial length of the front sidewall portion 202 by at least about 0.1 mm or 0.5 mm or 1 mm or 2 mm or more, depending on the desired performance.

[0149] The angled face 146 is inclined at an angle A of about 45 degrees to about 80 degrees from the longitudinal axis of the catheter. For certain embodiments, the angle is about 50 degrees to about 70 degrees or about 55 degrees to about 65 degrees from the longitudinal axis of the catheter. In one embodiment, angle A is about 60 degrees. A result of angle A being less than 90 degrees is a lengthening of the major axis of the distal port region, which increases the surface area of ​​the port and can enhance clot aspiration or clot retention. Compared to the surface area of ​​a circular lateral port (angle A is 90 degrees), the area of ​​the angled port is typically at least about 105%, and no more than about 130%, in some embodiments about 110% to about 125%, and in one embodiment about 115%.

[0150] In the illustrated embodiment, the axial length of the advancement segment is substantially constant around the circumference of the catheter, such that the angled face 146 is approximately parallel to the distal surface 210 of the marker band 144. The marker band 144 has a proximal surface approximately transverse to the longitudinal axis of the catheter, resulting in a marker band 144 having a right-angled trapezoidal configuration in a side elevation view. The short sidewall 212 is rotatably aligned with the rear sidewall portion 208 and has an axial length of about 0.2 mm to about 4 mm, and typically about 0.5 mm to about 2 mm. The opposing long sidewall 214 is rotatably aligned with the front sidewall portion 202. The long sidewall 214 of the marker band 144 is typically at least about 10% or 20% longer than the short sidewall 212, and may be at least about 50% or 70% or 90% or more longer than the short sidewall 212, depending on the desired performance. Typically, the length of the long sidewall 214 will be at least about 0.5 mm or 1 mm and less than about 5 mm or about 4 mm.

[0151] Any marker band described herein may be a continuous annular structure, or may optionally have at least one and optionally two or three or more axially extending slits throughout its length. The slits may be located on the short sidewall 212 or the long sidewall 214 or between the two, depending on the desired bending characteristics. Any marker band described herein may include any of a variety of radiopaque materials such as a platinum / iridium alloy, wherein the wall thickness preferably does not exceed about 0.003 inches, and in one embodiment is about 0.001 inches.

[0152] The pusher segment 200 may include an outer polymer sheath and an optional distal extension of an inner liner, without other internal support structures distal to the marker band 144. The outer sheath may include extruded Tecothane and / or PEBAX. The pusher segment 200 may have a bending stiffness and a radial extrusion stiffness of no more than about 50%, and in some embodiments no more than about 25%, 15%, or 5%, or less than the corresponding values ​​of the adjacent proximal catheter body.

[0153] The proximal end of the catheter 12 is preferably provided with a hemostatic valve to facilitate the introduction of a thrombus engagement tool or an auxiliary catheter therethrough. The hemostatic valve may be carried by the connector module 30, or directly by the proximal catheter connector 22. Any of a variety of hemostatic valve configurations may be used.

[0154] refer to FIG. 10A to FIG. 10C , a valve inserter according to another embodiment is shown. The inserter enables opening of a valve (e.g., a hemostatic valve and / or a sheath valve having an elastomeric membrane valve with a passive slit) and supports the valve in an open configuration while providing an access lumen, thereby enabling a delicate auxiliary device such as a thrombus engagement tool or a catheter to be advanced therein without any resistance or damage from the valve.

[0155] The inserter 300 includes an elongated tubular body 302 having a proximal end 304, a distal end 306, and a central lumen 308 extending therethrough. The tubular body 302 has an inner diameter sufficient to accommodate an auxiliary device and an outer diameter capable of passing through a compatible hemostatic valve. Typically, the outer diameter of the tubular body is about 0.04" to about 0.1" and the length is 1" to about 4". The tubular body 302 can be extruded from any of a variety of common catheter polymers, such as nylon, PEEK, polyethylene, polyimide, or other polymers known in the art to have sufficient extrusion resistance and column strength to enter and remain open under the closing pressure of the hemostatic valve.

[0156] The proximal end 304 of the tubular body 302 can be provided with a funnel-shaped landing zone 322 leading to the central cavity to facilitate the introduction of the distal tip of the auxiliary device into the inserter. In the illustrated embodiment, the proximal end of the tubular body is provided with an inclined surface 314. The distal front edge 316 of the inclined surface 314 is axially spaced a distance D from the rear proximal edge 318 of the surface 314 in the distal direction. The distance D [between 316 and 318] can be at least about 0.1", and typically does not exceed about 0.5".

[0157] The inclined surface cooperates with the curved side wall of the tube to create a side opening for delivering the distal tip of the auxiliary device into the proximal end of the cavity. To this end, the side wall at the rear edge 318 can be provided with a curvature having a larger radius than the radius of curvature at the front edge 316, and a gradually changing radius in between, creating a funnel shape for the landing area 322.

[0158] The tubular body 302 is provided with an axially extending slit 310 extending between the distal end 306 and a leading edge 316 of the angled surface 314 to enable the inserter to be laterally peeled away from the ancillary device extending therethrough once the inserter has enabled the ancillary device to pass through the hemostatic valve.

[0159] A pull tab 312 may be provided on the proximal end of the tubular body 302 to enable the inserter 300 to be grasped and pulled away from an auxiliary device extending therethrough. The pull tab 312 may be integrally formed with the tubular body 302 (e.g., as shown, as part of the sidewall of the tube blank), or attached thereto, for example, by adhesive bonding or mechanical compression or interference engagement. In the illustrated embodiment, the pull tab 312 is laterally inclined from the longitudinal axis of the tubular body to allow coaxial access and introduction of a catheter into the inserter 300.

[0160] In one embodiment of the inserter, the tubular body has a substantially constant diameter throughout a majority of its entire length (e.g., at least about 80% or 90%). However, the outer diameter in at least the distal nose segment 324 can be necked down to a smaller outer diameter at the distal end. This enables the inserter to better enter the hemostatic valve under distal compression. In one embodiment, the tubular body has an 8 French ID along most of its length, but necks down to 6 French in the distal nose segment 324. The inserter will facilitate the introduction of a 6 French catheter or an 8 French catheter through the hemostatic valve because the 8 French catheter can simply force expansion of the necked distal end due to the axial slit 310.

[0161] In one embodiment, the concave inlet funnel surface of the landing zone 322 can be provided with visual indicia, such as a different color than the outer surface of the tubular body 302, to facilitate visualization of the funnel opening and to assist in loading the auxiliary catheter into the funnel. This can be achieved by providing a colored coating on the inner or outer surface of the tube blank, or by forming at least a portion of the tube blank as a coextrusion of a different color material.

[0162] Exemplary embodiments

[0163] A clot capture module for a thrombectomy system, the clot capture module comprising one or more of the following:

[0164] case;

[0165] a clot capture chamber in the housing;

[0166] a window in the housing to allow visual inspection of the clot capture chamber;

[0167] a filter in the clot capture chamber, the filter visible through the window, the filter having an upstream surface and a downstream surface;

[0168] an input flow path configured to direct input blood from an aspiration catheter toward the upstream surface of the filter;

[0169] a normally closed aspiration control valve in the input flow path, the aspiration control valve being configured to block the flow of input aspiration blood until actuated to allow inflow of the aspiration blood; and

[0170] An output flow path is configured to direct blood from a downstream side of the filter to a remote vacuum canister.

[0171] The clot capture module as described in any embodiment herein further comprises a normally closed vent that is openable to allow air to be drawn into the clot capture chamber.

[0172] A clot capture module as described in any embodiment herein, wherein the upstream surface of the filter is visible through the window.

[0173] A clot capture module as described in any embodiment herein, wherein the upstream surface of the filter is substantially planar.

[0174] A clot capture module as described in any embodiment herein, wherein the upstream surface of the filter is convex.

[0175] The clot capture module as described in any embodiment herein, wherein the filter comprises a blood permeable membrane, and wherein the upstream surface of the filter is on a radially outward surface of the blood permeable membrane.

[0176] The clot capture module as described in any embodiment herein, wherein the blood permeable membrane at least partially surrounds a blood filtering chamber, and the blood filtering chamber is in fluid communication with the output flow path.

[0177] A clot capture module as described in any embodiment herein, wherein the window comprises a transparent tubular portion of the housing.

[0178] The clot capture module as described in any embodiment herein further includes a suction actuator configured to control the suction control valve.

[0179] A clot capture module as described in any embodiment herein, wherein the suction actuator comprises a rocker switch.

[0180] The clot capture module as described in any embodiment herein is combined with a vacuum line leading to an aspiration pump and a canister, wherein the clot capture module is configured to be located within a sterile field and the aspiration pump and canister are located outside the sterile field.

[0181] The clot capture module of any embodiment herein, wherein the vacuum line has a length of at least about 30 inches.

[0182] A clot capture module as described in any embodiment herein, wherein the suction control valve includes a collapsible conduit.

[0183] The clot capture module as described in any embodiment herein further comprises a selector valve in the vacuum line.

[0184] The clot capture module as described in any embodiment herein, wherein the aspiration pump comprises a syringe.

[0185] The clot capture module as described in any embodiment herein comprises a proximal housing and a distal housing separated by a transparent tubular sidewall.

[0186] A clot capture module as described in any embodiment herein, wherein at least one of the proximal housing and the distal housing is releasably connected to the transparent tubular sidewall.

[0187] The clot capture module as described in any embodiment herein further comprises a coating to inhibit blood from accumulating on the inner surface of the window.

[0188] A thrombus engaging tool configured to be advanced through a catheter and engage a thrombus, the thrombus engaging tool comprising one or more of the following:

[0189] a rotatable core having a proximal end and a distal end; and

[0190] a thrombus engaging tip on the distal end of the rotatable core, the thrombus engaging tip comprising:

[0191] Helical threads;

[0192] An advancement section on the distal side of the helical thread; and

[0193] A tail section on the proximal side of the helical thread.

[0194] The thrombus engaging tool as described in any embodiment herein further comprises a protrusion carried by the rotatable core, the protrusion being below at least one of the advancement section and the trailing section to form an interference fit with the thrombus engaging tip.

[0195] The thrombus engaging tool as described in any embodiment herein, wherein the protrusion comprises an annular ring.

[0196] The thrombus engaging tool as described in any embodiment herein, wherein the protrusion comprises a radiopaque marker.

[0197] The thrombus engaging tool as described in any embodiment herein comprises a first radiopaque marker under the advancing section and a second radiopaque marker under the trailing section.

[0198] The thrombus engaging tool as described in any embodiment herein, wherein the outer edge of the helical thread substantially conforms to the inner surface of the cylinder.

[0199] The thrombus engaging tool as described in any embodiment herein, wherein the helical thread includes a proximal surface that slopes radially outward in a proximal direction to define a proximal opening undercut.

[0200] The thrombus engaging tool as described in any embodiment herein further comprises a handle on the proximal end of the rotatable core.

[0201] The thrombus engaging tool as described in any embodiment herein comprises a limiting bearing surface on the handle, wherein the limiting bearing surface is configured to limit the extension of the thrombus engaging tip in a distal direction relative to the distal end of the aspiration catheter.

[0202] A thrombus engaging tool as described in any embodiment herein, wherein the advancement segment, the helical threads, and the tail segment are all molded on the rotatable core.

[0203] The thrombus engaging tool as described in any embodiment herein, wherein the rotatable core is a cannula.

[0204] The thrombus engaging tool as described in any embodiment herein, wherein the rotatable core is a solid wire.

[0205] The thrombus engaging tool as described in any embodiment herein, wherein the advancement section comprises an atraumatic tip.

[0206] The thrombus engaging tool as described in any embodiment herein, wherein the atraumatic tip comprises a soft polymer.

[0207] The thrombus engaging tool as described in any embodiment herein, wherein the handle further comprises a marking of the rotation direction.

[0208] The thrombus engaging tool as described in any embodiment herein, wherein the thrombus engaging tip has an axial length of about 15 mm to about 30 mm.

[0209] The thrombus engaging tool as described in any embodiment herein is combined with a catheter having an inner diameter, wherein the outer diameter of the helical thread is no more than about 60% of the inner diameter of the catheter.

[0210] A thrombus engaging tool as described in any embodiment herein, wherein an outer diameter of the helical thread is no more than about 40% of the inner diameter of the catheter.

[0211] The thrombus engaging tool as described in any embodiment herein further comprises a position indicator carried by the rotatable core.

[0212] The thrombus engaging tool as described in any embodiment herein, wherein the position indicator comprises a distal end of a tube surrounding the rotatable core.

[0213] A method for mechanically and suction-assisted removal of embolic material from a blood vessel, the method comprising one or more of the following steps:

[0214] providing an aspiration catheter having a central lumen and a distal end;

[0215] advancing the distal end toward an obstructing substance in a blood vessel;

[0216] applying a vacuum to the central cavity to draw clot into the central cavity;

[0217] introducing a thrombus engaging tool into the central lumen, the thrombus engaging tool having a tip, the tip including helical threads having a major diameter at least about 0.015 inches less than an inner diameter of the central lumen, the helical threads configured to provide an aspiration flow path around the tip; and

[0218] The tip is manually manipulated to engage clot between the tip and the inner wall of the central cavity.

[0219] The method of removing embolic material as described in any embodiment herein, wherein the tip is carried by a rotatable core having a proximal handle.

[0220] The method for removing embolic material as described in any embodiment herein, wherein the rotatable core is a cannula.

[0221] The method for removing embolic material as described in any embodiment herein, wherein the rotatable core is a microcatheter.

[0222] The method for removing embolic material as described in any embodiment herein, wherein the rotatable core is a guide wire.

[0223] The method for removing embolic material as described in any embodiment herein, wherein the axial length of the threaded portion of the tip is about 5 mm to about 15 mm.

[0224] The method for removing embolic material as described in any embodiment herein further comprises the step of introducing the catheter through the femoral artery before the advancing step.

[0225] The method of removing embolic material as described in any embodiment herein comprises the step of advancing the catheter to the pulmonary embolism.

[0226] The method for removing embolic material as described in any embodiment herein comprises the step of advancing the catheter into the deep vein thrombosis.

[0227] The method of removing embolic material as described in any embodiment herein comprises the step of introducing a thrombus engaging tool having a tip having a major diameter no greater than about 60% of the inner diameter of the central lumen.

[0228] The method of removing embolic material as described in any embodiment herein comprises introducing a thrombus engaging tool having a tip having a major diameter no greater than about 40% of the inner diameter of the central lumen.

[0229] The method for removing embolic material as described in any embodiment herein, wherein the tip moves laterally within the lumen in response to ingestion of a clot.

[0230] A method for removing embolic material as described in any embodiment herein, wherein in an end view, the outer cross-section of the threaded tip is substantially circular.

[0231] The method for removing embolic material as described in any embodiment herein, wherein the thread has a proximal surface and a distal surface, and the proximal surface is inclined radially outward in the proximal direction.

[0232] The method for removing embolic material as described in any embodiment herein further comprises reciprocating the thrombus engaging tool axially within the catheter.

[0233] The method of removing embolic material as described in any embodiment herein further comprises extending the tip axially beyond the distal end of the catheter.

[0234] The method of removing embolic material as described in any embodiment herein comprises extending the distal tip at least about 2 cm beyond the distal end of the catheter.

[0235] The method of removing embolic material as described in any embodiment herein comprises axially aligning the distal tip with the distal end of the catheter using a position indicator on the rotatable core.

[0236] The method of removing embolic material as described in any embodiment herein further comprises advancing the thrombus engaging tool through a rotary hemostatic valve prior to introducing the thrombus engaging tool into the central lumen.

[0237] The method for removing embolic material as described in any embodiment herein, wherein the position indicator provides tactile feedback when the position indicator passes through the hemostatic valve.

[0238] An inserter for introducing a device through a valve, the inserter comprising one or more of the following:

[0239] an elongated tubular body having a proximal end, a distal end, and a sidewall at least partially defining a central lumen;

[0240] a laterally facing concave landing zone on the proximal end, the radius of curvature of the concave landing zone increasing in the proximal direction; and

[0241] an axially extending slot in the sidewall, the axially extending slot extending from the distal end to the concave landing area.

[0242] The inserter as described in any embodiment herein further comprises a tapered distal tip.

[0243] The inserter as described in any embodiment herein further comprises a pull tab.

[0244] An inserter as described in any embodiment herein, wherein the surface of the concave landing zone comprises a different color than the outer surface of the elongated tubular body.

[0245] A method of passing a device through a valve, the method comprising one or more of the following steps:

[0246] providing an inserter having a tubular body with a split sidewall;

[0247] advancing the tubular body through the valve;

[0248] advancing a device through the tubular body and beyond the valve; and

[0249] The tubular body is retracted proximally such that the device is laterally disengaged from the tubular body through the split sidewall, leaving the device in place across the valve.

[0250]

[00136] The method of passing a device through a valve as described in any embodiment herein, wherein advancing the tubular body through the valve comprises advancing a tapered distal tip on the tubular body through the valve.

[0251] A method of passing a device through a valve as described in any embodiment herein, wherein advancing the tubular body through the valve is accomplished with the device preloaded within the tubular body.

[0252] A method of passing a device through a valve as described in any embodiment herein, wherein the distal nose section of the tubular body expands in diameter in response to advancement of the device therein.

[0253] A method of passing a device through a valve as described in any embodiment herein, wherein the device is a thrombus engaging tool.

[0254] A method of passing a device through a valve as described in any embodiment herein, wherein the device is an auxiliary catheter.

[0255] A method of passing a device through a valve as described in any embodiment herein, wherein the device is a suction catheter.

Claims

1. A clot capture module for a thrombectomy system, the clot capture module comprising: case; a clot capture chamber in the housing; a window in the housing to allow visual inspection of the clot capture chamber; a filter in the clot capture chamber, the filter visible through the window, the filter having an upstream surface and a downstream surface; an input flow path configured to direct input blood from an aspiration catheter toward the upstream surface of the filter; a normally closed aspiration control valve in the input flow path, the aspiration control valve being configured to block the flow of input aspirated blood until actuated to allow inflow of the aspirated blood; as well as An output flow path is configured to direct blood from a downstream side of the filter to a remote vacuum canister.

2. The clot capture module of claim 1 further comprising a normally closed vent that is openable to allow air to be drawn into the clot capture chamber.

3. The clot capture module of claim 1, wherein the upstream surface of the filter is visible through the window.

4. The clot capture module of claim 1, wherein the upstream surface of the filter is substantially planar.

5. The clot capture module of claim 1, wherein the upstream surface of the filter is convex.

6. The clot capture module of claim 5, wherein the filter comprises a blood-permeable membrane, and wherein the upstream surface of the filter is on a radially outward surface of the blood-permeable membrane.

7. The clot capture module of claim 6, wherein the blood permeable membrane at least partially surrounds a blood filtering chamber, the blood filtering chamber being in fluid communication with the output flow path.

8. The clot capture module of claim 1, wherein the window comprises a transparent tubular portion of the housing.

9. The clot capture module of claim 1, further comprising a suction actuator configured to control the suction control valve.

10. The clot capture module of claim 9, wherein the suction actuator comprises a rocker switch.

11. The clot capture module of claim 1 in combination with a vacuum line leading to an aspiration pump and a canister, wherein the clot capture module is configured to be located within a sterile field and the aspiration pump and canister are located outside the sterile field.

12. The clot capture module of claim 11, wherein the vacuum line is at least about 30 inches in length.

13. The clot capture module of claim 1, wherein the suction control valve comprises a collapsible conduit.

14. The clot capture module of claim 11, further comprising a selector valve in the vacuum line.

15. The clot capture module of claim 11, wherein the aspiration pump comprises a syringe.

16. The clot capture module of claim 1, comprising a proximal housing and a distal housing separated by a transparent tubular sidewall.

17. The clot capture module of claim 16, wherein at least one of the proximal housing and the distal housing is releasably connected to the transparent tubular sidewall.

18. The clot capture module of claim 1, further comprising a coating to inhibit accumulation of blood on an inner surface of the window.

19. A thrombus engaging tool configured to pass through a catheter and engage a thrombus, the thrombus engaging tool comprising: a rotatable core having a proximal end and a distal end; as well as a thrombus engaging tip at the distal end of the rotatable core, the thrombus engaging tip comprising: Helical threads; an advancement section on the distal side of the helical thread; and A tail section is on the proximal side of the helical thread.

20. The thrombus engaging tool of claim 19, further comprising a protrusion carried by the rotatable core, the protrusion underlying at least one of the pusher section and the trailing section to form an interference fit with the thrombus engaging tip.

21. The thrombus engaging tool of claim 20, wherein the protrusion comprises an annular ring.

22. The thrombus engaging tool of claim 21, wherein the protrusion comprises a radiopaque marker.

23. The thrombus engaging tool of claim 22, comprising a first radiopaque marker under the advancing segment and a second radiopaque marker under the trailing segment.

24. The thrombus engaging tool of claim 19, wherein an outer edge of the helical thread substantially conforms to an inner surface of the cylinder.

25. The thrombus engaging tool of claim 24, wherein the helical thread includes a proximal surface that slopes radially outward in a proximal direction to define a proximal opening undercut.

26. The thrombus engaging tool of claim 19, further comprising a handle on the proximal end of the rotatable core.

27. The thrombus engagement tool of claim 26, comprising a limiting bearing surface on the handle, the limiting bearing surface being configured to limit extension of the thrombus engagement tip in a distal direction relative to the distal end of the aspiration catheter.

28. The thrombus engaging tool of claim 19, wherein the pusher segment, the helical threads, and the tail segment are all molded onto the rotatable core.

29. The thrombus engaging tool of claim 19, wherein the rotatable core is a sleeve.

30. The thrombus engaging tool of claim 19, wherein the rotatable core is a solid wire.

31. The thrombus engaging tool of claim 19, wherein the advancement section comprises an atraumatic tip.

32. The thrombus engaging tool of claim 31, wherein the atraumatic tip comprises a soft polymer.

33. The thrombus engaging tool of claim 19, wherein the handle further comprises a marking for a rotational direction.

34. The thrombus engaging tool of claim 19, wherein the thrombus engaging tip has an axial length of about 15 mm to about 30 mm.

35. The thrombus engaging tool of claim 19 in combination with a catheter having an inner diameter, wherein the outer diameter of the helical thread is no more than about 60% of the inner diameter of the catheter.

36. The thrombus engaging tool of claim 35, wherein an outer diameter of the helical thread is no more than about 40% of the inner diameter of the catheter.

37. The thrombus engaging tool of claim 19, further comprising a position indicator carried by the rotatable core.

38. The thrombus engaging tool of claim 37, wherein the position indicator comprises a distal end of a tube surrounding the rotatable core.

39. A method for mechanically and suction-assisted removal of embolic material from a blood vessel, the method comprising: providing an aspiration catheter having a central lumen and a distal end; advancing the distal end toward an obstructing substance in a blood vessel; applying a vacuum to the central cavity to draw clot into the central cavity; introducing a thrombus engaging tool into the central lumen, the thrombus engaging tool having a tip, the tip including helical threads having a major diameter at least about 0.015 inches less than an inner diameter of the central lumen, the helical threads configured to provide an aspiration flow path around the tip; and The tip is manually manipulated to engage clot between the tip and the inner wall of the central cavity.

40. The method of removing embolic material of claim 39, wherein the tip is carried by a rotatable core having a proximal handle.

41. The method for removing embolic material of claim 39, wherein the rotatable core is a cannula.

42. The method for removing embolic material of claim 39, wherein the rotatable core is a microcatheter.

43. The method for removing embolic material of claim 39, wherein the rotatable core is a guide wire.

44. The method for removing embolic material of claim 39, wherein the threaded portion of the tip has an axial length of about 5 mm to about 15 mm.

45. The method for removing embolic material of claim 39, further comprising the step of introducing the catheter through the femoral artery prior to the advancing step.

46. ​​The method of removing embolic material of claim 39, comprising the step of advancing the catheter to a pulmonary embolism.

47. The method of removing embolic material of claim 39, comprising the step of advancing the catheter into a deep vein thrombosis.

48. The method of removing embolic material of claim 39, comprising the step of introducing a thrombus engaging tool having a tip having a major diameter no greater than about 60% of the inner diameter of the central lumen.

49. The method of removing embolic material of claim 48, comprising introducing a thrombus engaging tool having a tip having a major diameter no greater than about 40% of the inner diameter of the central lumen.

50. The method for removing embolic material according to claim 39, wherein: In response to ingestion of clot, the tip moves laterally within the central lumen.

51. The method for removing embolic material of claim 48, wherein in end view, the outer cross-section of the threaded tip is substantially circular.

52. The method for removing embolic material of claim 39, wherein the threads have a proximal face and a distal face, and wherein the proximal face slopes radially outward in a proximal direction.

53. The method for removing embolic material of claim 39, further comprising reciprocating the thrombus engaging tool axially within the catheter.

54. The method of removing embolic material of claim 53, further comprising extending the tip axially beyond the distal end of the catheter.

55. The method of removing embolic material of claim 54, comprising extending the distal tip at least about 2 cm beyond the distal end of the catheter.

56. The method of removing embolic material of claim 40 comprising axially aligning the distal tip with the distal end of the catheter using a position indicator on the rotatable core.

57. The method of removing embolic material of claim 56, further comprising advancing the thrombus engaging tool through a rotary hemostatic valve prior to introducing the thrombus engaging tool into the central lumen.

58. The method for removing embolic material of claim 57, wherein the position indicator provides tactile feedback when the position indicator passes through the hemostatic valve.

59. An inserter for introducing a device through a valve, the inserter comprising: an elongated tubular body having a proximal end, a distal end, and a sidewall at least partially defining a central lumen; a laterally facing concave landing zone on the proximal end, the radius of curvature of the concave landing zone increasing in the proximal direction; as well as an axially extending slot in the sidewall, the axially extending slot extending from the distal end to the concave landing area.

60. The inserter of claim 59, further comprising a tapered distal tip.

61. The inserter of claim 59, further comprising a pull tab.

62. The inserter of claim 59 wherein the surface of the concave landing zone comprises a different color than the outer surface of the elongated tubular body.

63. A method of passing a device through a valve, the method comprising: providing an inserter having a tubular body with a split sidewall; advancing the tubular body through the valve; advancing a device through the tubular body and beyond the valve; as well as The tubular body is retracted proximally such that the device is laterally disengaged from the tubular body through the split sidewall, leaving the device in place across the valve.

64. The method of claim 63, wherein advancing the tubular body through the valve comprises passing a tapered distal tip on the tubular body through the valve.

65. The method of claim 63, wherein advancing the tubular body through the valve is accomplished with the device preloaded within the tubular body.

66. The method of claim 63, wherein the distal nose segment of the tubular body expands in diameter in response to advancement of the device therein.

67. The method of claim 63, wherein the device is a thrombus engaging tool.

68. The method of claim 63, wherein the device is an auxiliary catheter.

69. The method of claim 63, wherein the device is a suction catheter.

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