Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
  • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/74—Suction control
  • A61M1/741—Suction control with means for varying suction manually
  • A61M1/7413—Suction control with means for varying suction manually by changing the cross-section of the line
  • A61M1/7415—Suction control with means for varying suction manually by changing the cross-section of the line by deformation of the fluid passage
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/76—Handpieces
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/71—Suction drainage systems
  • A61M1/79—Filters for solid matter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M39/0693—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00681—Aspects not otherwise provided for
  • A61B2017/00685—Archimedes screw
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
  • A61B2090/3966—Radiopaque markers visible in an X-ray image
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2217/00—General characteristics of surgical instruments
  • A61B2217/002—Auxiliary appliance
  • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

• VTE venous thromboembolic disease
• DVT and PE are part of the same continuum of disease, with over 95% of emboli originating in the lower extremities.
• PE pulmonary artery
• RV right ventricular
• the thrombectomy catheter is introduced through 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 guidewire provides a rail for a flexible guide catheter to be advanced through the right atrium into the right ventricle and into the pulmonary artery.
• the flexible guidewire is removed and replaced with a stiff guidewire.
• peripheral arterial occlusive (PAO) disease occurs in more than 4% of individuals over age 40 and markedly increases in incidence after the age of 70. Acute PAO is usually due to thrombosis of the peripheral vasculature and is associated with a significant risk of limb loss.
• Clot aspiration using certain commercial vacuum-assisted thrombectomy systems may sometimes need to be terminated due to the risk of excessive blood loss by the patient, especially when using large aspiration catheters.
• aspiration thrombectomy when the catheter tip falls out of contact with the thrombus or other occlusive material, the tip is exposed to healthy blood and full flow of blood through the catheter ensues. Under such conditions, the total volume of blood loss may be excessive, and in some cases, may result in premature termination of the procedure.
• the blood loss rate can be on the order of 30-40 cc per second with an 24 French size catheter.
• the catheter cannot run in unrestricted mode for more than approximately 10 to 15 seconds.
• the aggregate blood loss may reach an unacceptable level before sufficient clot is removed.
• a clot capture module for use in a thrombectomy system, such as within the sterile field.
• the clot capture module comprises a housing; a clot capture chamber in the housing; a window in the housing to permit 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.
• An incoming flow path is configured to direct incoming blood from an aspiration catheter against the upstream surface of the filter.
• An aspiration control valve is provided in the incoming flow path, configured to block or permit the flow of incoming blood.
• the clot capture module may further comprise a vent valve, openable to permit an optically transparent media such as air or saline to be drawn into the clot chamber, enabling blood to be evacuated from the clot chamber to a remote canister.
• the upstream surface of the filter may be visible through the window, so that clot accumulated on the upstream surface can be visually observed through the window, once the vent has been opened to evacuate blood from the clot capture chamber.
• the window may comprise a transparent cylindrical portion of the housing.
• the upstream surface of the filter may be substantially planar. Alternatively, the upstream surface of the filter may be convex.
• the filter may comprise a tubular porous membrane such as a cylinder, and the upstream surface of the filter may be on a radially outwardly facing surface of the membrane.
• the tubular filter membrane may enclose a filtered blood chamber which is in communication with the outgoing flow path.
• the module may further comprise an aspiration control, for controlling the aspiration control valve.
• the aspiration control may comprise a rocker switch, configured to selectively collapse or allow reopening of a collapsible tubing.
• the aspiration control valve may be normally closed, and may be spring biased into the closed configuration.
• the clot capture module may be provided in combination with a vacuum line leading to an aspiration pump and canister, wherein the clot capture module is configured to reside within a sterile field and the aspiration pump and canister are outside of the sterile field.
• the vacuum line may be at least about 30 inches or 50 inches or more in length.
• a manually actuated aspiration device e.g., a syringe
• a thrombus engagement tool configured to advance through an aspiration catheter and engage thrombus.
• the thrombus engagement tool comprises 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 comprise a helical thread; an advance segment on a distal side of the thread and a trailing segment on a proximal side of the thread.
• the advance segment, helical thread and trailing segment may all be molded onto the core wire.
• the thrombus engagement tool may further comprise a projection on the core wire, underneath at least one of the advance segment and the trailing segment, to form an interference fit with the thrombus engagement tip.
• the projection may comprise an annular ring, which may be a radiopaque marker.
• the thrombus engagement tool may comprise a first radiopaque marker under the advance segment and a second radiopaque marker under the trailing segment.
• An outer periphery of the helical thread may substantially conform to an inside surface of a cylinder.
• the thread may comprise a proximal surface which inclines radially outwardly in a proximal direction to define a proximally opening undercut.
• the thrombus engagement tool may further comprise a handle on the proximal end of the core wire configured for hand turning the core wire.
• a limit bearing surface may be provided on the handle, for limiting distal projection of the thrombus engagement tip relative to a distal end of the aspiration catheter.
• the method comprises the steps of providing an aspiration catheter having a central lumen and a distal end; advancing the distal end to obstructive material in a vessel; applying vacuum to the lumen to draw clot at least partially into the lumen; and introducing a thrombus engagement tool into the lumen.
• the thrombus engagement tool may have a tip with 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 smaller than an inside diameter of the lumen, to provide an aspiration flow path through the lumen around the outside of the tip.
• a method of aspirating a vascular occlusion from a remote site comprises the steps of advancing an elongate tubular body through a vascular access site and up to a vascular occlusion, the tubular body comprising a proximal end, a distal end, a central lumen, and a stop surface.
• a rotatable core is advanced distally through the lumen until a limit surface carried by the core rotatably slidably engages the stop surface to provide a rotatable bearing which limits further distal advance of the core within the lumen.
• Vacuum is applied to the lumen and the core is manually rotated to engage thrombus.
• the advancing the rotatable core may be accomplished after the step of advancing the elongate tubular body through the vascular access site and up to the vascular occlusion.
• the core may be a solid core wire or a cannulated structure such as a hypotube or microcatheter having a central lumen extending axially between a proximal opening and a distal opening.
• the core may carry a proximal handle, and the limit 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
• the engaging thrombus step may comprise pinning thrombus between a first side of the tip and an inside surface of the tubular body.
• an inserter for guiding a device through a hemostasis valve comprising an elongate 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 the sidewall, extending from the distal end to the landing zone.
• the tubular body may further comprise a tapered distal tip, and a proximal pull tab to facilitate removal of the inserter from the device.
• a surface of the landing zone may comprises a different color than an outside surface of the tubular body, to facilitate visualization of the landing zone and advancing the distal end of the device into the tubular body.
• a method of passing a device through a hemostasis valve may comprise the steps of providing an inserter, having a tubular body with a split sidewall; advancing the tubular body through a hemostasis valve; advancing a device through the tubular body and beyond the hemostasis valve; and proximally retracting the tubular body so that the device escapes laterally from the tubular body through the split sidewall, leaving the device in place across the hemostasis valve.
• the advancing the tubular body step may comprise advancing a tapered distal tip on the tubular body through the hemostasis valve.
• the advancing the tubular body through the hemostasis valve step may be accomplished with the device pre loaded inside the tubular body.
• FIG. 1 is a schematic view of a thrombus removal system in accordance with the present invention.
• Figure 2 is a perspective view of a flow control module.
• Figure 3 is an elevational of cross-sectional view through the flow control module of Figure 2.
• Figure 4 is a schematic view of the dual vacuum chamber configuration that produces an accelerated aspiration response.
• Figure 5 is a qualitative fluid flow rate diagram at the catheter tip following opening of the vacuum control valve.
• Figure 6A is a side elevational view of a thrombus engagement tool.
• Figure 6B is an enlarged detail view of the distal end of the thrombus engagement tool of Figure 6A.
• Figure 6C is a longitudinal elevational cross-section through the thrombus engagement tool of Figure 6B.
• Figures 7A-7E are side elevational views of various embodiments of thrombectomy catheters.
• Figure 8 is a cross-sectional view through a distal portion of the embolectomy catheter showing a side wall construction.
• Figure 9 is a cross-sectional view through a distal portion of the embolectomy catheter showing the radiopaque marker and inclined distal face.
• Figures 10A – 10B are perspective views of an inserter tool to facilitate passing a catheter through a hemostasis valve.
• Figure 10C is an end view of the inserter of Figures 10A and 10B.
• DETAILED DESCRIPTION Referring to FIG. 1, there is illustrated a thrombectomy system such as for PE or DVT aspiration procedures.
• the system 10 includes a thrombectomy catheter 12, having an elongate tubular body 14 extending between the proximal end 16 and a distal end 18.
• a central lumen 20 extends between a proximal catheter connector 22 and a distal port 24 on the distal end 18.
• catheters of the present invention can readily be modified to incorporate additional structures, such as permanent or removable column strength enhancing mandrels, two or more lumen such as to permit drug, contrast or irrigant infusion or to supply inflation media to an inflatable balloon carried by the catheter, or any combinations of these features, as will be readily apparent to one of skill in the art in view of the disclosure herein.
• the disclosure will be described primarily in the context of removing obstructive material from the vasculature, but it will be understood to have applicability as an access catheter for delivery and removal of any of a variety of diagnostics or therapeutic devices with or without aspiration.
• the catheters disclosed herein may readily be adapted for use throughout the body wherever it may be desirable to distally advance a low profile high flexibility catheter into a variety of type of vasculature, such as small or large vasculature and/or tortuous or relatively straight vasculature.
• catheter shafts in accordance with any embodiment described herein may be dimensioned for use throughout the neurovascular, coronary and peripheral vasculature, the gastrointestinal tract, the urethra, ureters, Fallopian tubes and other lumens and potential lumens, as well.
• the catheter shaft construction of any embodiment herein may also be used to provide minimally invasive percutaneous tissue access, such as for diagnostic or therapeutic access to a solid tissue target (e.g., breast or liver or brain biopsy or tissue excision), delivery of laparoscopic tools or access to bones such as the spine for delivery of screws, bone cement or other tools or implants.
• Catheter 12 will have a length and diameter suitable for the intended access point and target location. In one example, referring to FIG.
• the catheter 12 may have an effective length from the distal end of manifold or hub 22 to distal tip 18 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 typically from about 50 cm to about 150 cm, from about 90 cm to about 130 cm, or from about 105 cm to about 115 cm.
• the outer diameter of the catheter 10 may be from about 0.035 inches to about 0.15 inches, from about 0.09 inches to about 0.13 inches, and may be lower in a distal segment than in a proximal segment.
• the inner diameter of the catheter 12 in a single central lumen embodiment may 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 about 0.06.
• the inner diameter of the catheter 12 in a single central lumen embodiment may 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 often no more than about 0.095 inches.
• the catheter 12 is releasably connectable to a flow control module 28 by way of a complementary connector module 30.
• Connector module 30 provides a releasable connection to complementary catheter connector 22 and may include a side port 32 for releasable connection to tubing 34 which may lead to a valve 36.
• Connector module 30 may additionally comprise a hemostasis valve configured to receive another device such as a guidewire or thrombus engagement tool, discussed below.
• Valve 36 may selectively place tubing 34 into communication with side port 37 or the flow control module 28 discussed in greater detail below.
• Side port 37 may be placed into communication with a source of media such as saline, contrast solution or medication, or a manifold 38 which can provide selective communication with each.
• the use of valve 36 allows infusion of a desired media without detaching the tubing 34 from the connector module 30.
• the flow control module 28 is in communication with the valve 36 by way of a distal tube 44.
• Flow control module 28 is in communication with the selector valve 49 by way of a proximal tube 46. This establishes a flow path between the distal port 24 through the catheter 12 through the various tubing and flow control module 28 to the pump assembly 42.
• the flow control module 28 may be integrally formed within the hub of thrombectomy catheter 12 to which the catheter 12 may be removably or non-removably attached or within the connector module 30.
• a manually actuated aspiration device e.g., a syringe
• an aspiration pump assembly 42 may be used in addition to, or as an alternative to, an aspiration pump assembly 42 to permit a user to manually apply aspiration through the vacuum line.
• a manually actuated aspiration device may be in in addition to, or as an alternative to, the pump assembly described in any embodiment herein.
• Flow control module 28 may include a flow regulator such as an on-off control for regulating flow through the flow path between the catheter 12 and pump 42.
• the flow regulator is configured to provide a reversible restriction in the flow path, such as by an expandable or contractible iris, a ball valve or other rotary core valve, leaf valve, a pinch tubing, or others known in the art.
• the flow regulator comprises a collapsible portion 29 of the tubular wall defining the flow path, such as a section of polymeric tubing.
• An actuator 31 positioned adjacent the tubing is movable in response to a control such as a push button or toggle switch 48 between a first position where it compresses the tubing, thereby completely restricting flow, and a second position where it has moved away from the tubing, allowing the tubing to resume its full inside diameter and allow fluid flow.
• the actuator 31 may be spring biased or have another default driver in the direction of the first (restricted) position, and only movable into the second (open) position in the presence of an affirmative mechanical force or release of a constraint allowing the flow path to open. Upon removal of the momentary “on” command, the actuator 31 automatically resumes the first position, obstructing flow.
• the actuator 31 may be driven by a mechanical control such as a lever or rotatable knob, or an electrically driven system such as a solenoid, operated by any of a variety of buttons, levers, triggers, foot pedals or other switches known in the art, depending upon the desired functionality.
• the flow control module 28 may contain a filter chamber 33 for example, which is in communication with the vacuum canister 58 on the pump assembly 42 by way of elongate aspiration tubing 40.
• the toggle switch 48 is in between the filter chamber 33 and the catheter 12. In a default off position of some embodiments, this allows the entire length of the aspiration tubing 40 and the filter chamber 33 to reach the same low pressure as the aspiration canister 58 on the pump 42.
• FIG. 3 A filter assembly 35 includes an outer tubular sidewall 37 having a transparent window 39. In some implementations the entire tubular sidewall 37 can be a transparent window.
• the side wall 37 encloses a filter 41.
• the filter 41 includes a filter sidewall 43 defining an interior (downstream) chamber (not illustrated) for filtered blood.
• blood and thrombus are drawn in the direction from catheter 12 via vacuum line 44 through a first filter aperture 45 and into the clot collection chamber 33. Any thrombus will be captured on the outside (upstream side) of filter 43. Blood is drawn through the filter 43 and proximal tubing 46 en route to the canister 58.
• the filter 43 is tubular however it may alternatively be planar or other shape depending upon the desired configuration.
• the switch 48 may thereafter be closed to compress tubing 29 and isolate the catheter 12 from the vacuum source.
• a normally closed vent 47 may be momentarily opened, to permit intake of an optically transparent media such as saline or ambient air. This allows residual blood in the chamber 33 to be drawn through the filter 43 and aspirated out via proximal tubing 46, enabling visualization of any clot on the surface of the filter 43 through the window 39.
• the vent 47 may be manually actuated by a user and/or automatically actuated by the system. In some instances, a user may manually actuate the vent 47 through actuation of a button 62 located on the flow control module 28.
• the vent 67 may be normally closed, and then transitioned to an open configuration when the button 62 is being actuated (or vice versa).
• the vent 67 may expose the clot collection chamber 33 to an ambient environment. In some instances, exposure of the chamber 33 to the ambient environment allowing intake of air and acceleration of blood flow through the clot collection chamber 33 and towards the proximal tubing. Increased acceleration of blood flow due to vent 47 actuation may facilitate visualization of the clot by displacing the amount of blood or other fluids from the optical path between the window and the filter and/or decrease the amount of time required for the physician to accurately identify the clot in the chamber 33.
• the valved vent also allows the physician to deliver pulsatile negative pressure waves at the distal opening 24.
• the flow control module 28 comprises a proximal housing 31 and a distal housing 29 separated by the transparent tubular sidewall 35.
• the tubular sidewall 35 and the filter 43 are carried by the proximal housing 31.
• Housing 29 and tubular sidewall 35 may be joined at a releasable connection 33 that, in some instances, includes a gasket 59 to form a sealed connection.
• Complementary surface structures e.g., inclined corresponding grooves and pins or flanges
• the proximal housing 31 and the distal housing 29 may be rotated relative to each other (e.g., by relative rotation across the gasket) to disconnect the housings from each other.
• the filter 43 may be attached to any one of the distal housing 29 or the proximal housing 31 upon disconnection of the housings.
• the tubular sidewall 35 may be attached to either one of the distal housing 29 and/or the proximal housing 31 such that, upon disconnection, the tubular sidewall 35 may remain attached to one of the housings 29, 31.
• 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 instance, disconnection of the housings 29, 31 from each other can expose the filter 43 and allow a clot to be easily accessed and removed.
• the interior surface of the clot collection container 33 may comprise a coating to provide one or more of a variety of properties to the clot collection containers 33.
• the coating may be configured to enhance visualization through at least a portion of the clot collection container 33 (such as the transparent window 39).
• the coating may be configured to inhibit blood accumulation or increase blood repellant properties.
• the clot collection container 33 may comprise a coating to inhibit foam formation during an aspiration procedure.
• the coatings may be located at least partially along an interior surface of the tubular sidewall 35 and/or the clot collection container 33 or along an entire interior surface of the tubular sidewall 35 and/or the clot collection container 33. In some instance, the coating is located along an interior surface of the transparent window 39.
• Aspiration pump assembly 42 may be releasably placed into communication with flow control module 28 such as by a luer connection between selector valve 45 and tubing 40.
• Aspiration pump assembly 42 may include a vacuum pump 50, and may 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 to a specific vacuum pressure.
• Power button 56 activates the pump 50.
• the vacuum canister 58 may be provided with a vent 53 to atmosphere, opened or closed by a valve.
• the valve is normally closed to permit vacuum in the canister to reach a desired low pressure.
• the valve may be momentarily opened as desired to permit introduction of air and reduction of the vacuum, such as to reduce foaming within the vacuum canister 58.
• the vent may function to reduce foaming and increase visibility within the canister.
• the vent 53 comprises a permanently opened vent such as in a lid or side wall of the vacuum canister.
• the vent may comprise an aperture formed through the lid or side wall having a diameter of no more than about 0.5 mm or 0.25 mm and may be a laser cut hole through a metal sheet which may be in the form of a disc carried by the lid.
• the inside surface of the canister 58 may be provided with a coating of one or more materials to inhibit foaming of blood under vacuum.
• the coatings may be located at least partially along or entirely along an interior surface of the vacuum canister 58.
• the coating can be both hydrophobic and oleophobic. In some instances, the coating may have some hydrophilic features on a portion of the polymer to increase oleophobic properties.
• Aspiration pump 50 may alternatively be a manually activated pump such as a syringe.
• a flow restrictor may be coupled such as by luer connectors in series with the vacuum line 40. In one implementation the flow restrictors enables toggling between a low flow and a high flow configuration.
• the flow restrictors may comprise a variable restrictor that may be adjusted by a user.
• a rotatable drum is provided with a first transverse flow path having a first diameter.
• the drum is rotatable within a housing having an inlet port and an outlet port. The drum may be rotated to place the inlet port into fluid communication with the outlet port through the first flow path.
• a second flow path having a second, different diameter also extends transversely through the drum, rotationally offset from the first flow path.
• the drum may be rotated to place the inlet port into communication with the outlet port through the second flow path, thereby providing a flow rate through the drum different from the flow rate provided by the first flow path.
• the filter chamber 33 on the flow control module 28 or on the connector module 30 is spaced apart from the remote vacuum pump 42 and vacuum canister 58 to provide enhanced aspiration performance.
• Conventional aspiration pumps and filters are intended to be placed outside of the sterile field and may be far enough away from the patient to require a length of aspiration tubing 40 between the pump assembly 42 and the catheter 12 to be at least about 50 inches or about 100 inches or more.
• the tubing 40 may be about 102 inches.
• the pump typically includes an aspiration canister 58 for blood collection.
• a valve is opened to place the low pressure canister 58 in communication with the catheter 12 by way of the aspiration tubing 40, to aspirate material from the patient.
• the length of the aspiration tubing extending from inside to outside of the sterile field operates as a flow restrictor, causing a delay between the time of activating the vacuum button on the pump assembly 42 and actual application of suction to the clot at the distal end of the catheter.
• the only flow restriction between a source of vacuum (filter chamber 33) and the patient is the relatively short aspiration pathway between the on/off valve in the handpiece actuated by toggle switch 48 and the distal end 18 of the catheter.
• the aspiration control 48 is activated to open the flow path, the flow restriction and enclosed volume on the patient side of the filter chamber 33 is low relative to the flow restriction and enclosed volume through aspiration tubing 40 on the pump side of the filter chamber 33.
• This dual chamber configuration produces a rapid spike in negative pressure experienced at the distal end 18 of the catheter 12 upon activation of the aspiration control 48, and rapid filling of the chamber 33.
• the response time between activating the aspiration control 48 and realizing suction actually experienced at the clot is significantly faster and allows significantly higher initial flow than the response time realized in a conventional system having only a vacuum chamber 58 located at the pump assembly 42 outside of the sterile field.
• the spike of negative pressure experienced at the distal end of the catheter will fade as pressure equilibrium is reached between the filter chamber 33 and canister 58.
• the vacuum pump 50 will gradually bring the pressure in the filter chamber 33 back down to the level in the vacuum canister 58 at the pump.
• FIG. 4 A simplified fluid flow diagram is illustrated in FIG. 4, and a qualitative flow rate diagram is illustrated in FIG. 5.
• the flow restriction between chamber 33 and the distal end 18 of catheter 12 is small relative to the flow restriction between the vacuum canister 58 and the vacuum chamber 33. This allows a negative pressure peak experienced at distal end 18 almost instantaneously upon activation of vacuum switch 48.
• the flow rate of material into the catheter 12 rapidly reaches a peak and subsides as vacuum chamber 33 fills with aspirated material.
• the vacuum in chamber 33 declines to a minimum, and slowly recharges by the large vacuum chamber 58 and associated pump through tubing 40 when the toggle switch 48 is moved into the closed position.
• a clinician may choose to close the vacuum switch 48 at or shortly following the maximum flow rate, just giving a short burst or series of bursts of pulsatile vacuum to facilitate spiration of thrombus into the catheter 12.
• a similar effect may be established by utilizing the vent 47.
• the vacuum in chamber 33 may decline to a minimum as the button 62 is actuated such that the vent is opened. Thereafter, the vacuum chamber 33 may slowly recharge by the large vacuum chamber 58 and associated pump through tubing 40 when the button 62 and vent 47 are moved into the closed position.
• a clinician may choose to open the vent 47 at or shortly following the maximum flow rate, just giving a short burst or series of bursts of pulsatile vacuum to facilitate spiration of thrombus into the catheter 12.
• an elongate flexible thrombus engagement tool may be advanced through the aspiration catheter, to facilitate retrieval of the clot.
• the thrombus engagement tool may comprise an elongate flexible shaft having a proximal hand piece such as a knob configured to be rotated by hand.
• a thrombus engagement tool 80 may comprise an elongate flexible shaft 82 having a proximal end 84 and a distal end 86.
• a proximal hand piece such as a torquing handle 88 may be configured to be rotated by hand.
• Distal end 86 carries a clot engagement tip 90 which may include one or more radially outwardly extending structures such as a helical thread 92.
• the handle 88 may have an indicium of rotational direction such as a printed or molded arrow 94 which indicates the direction to rotate the handle 88 in order for the helical thread 92 to engage clot.
• the distal tip 90 includes a helical thread 92 extending between a distal thread end 96 and a proximal thread end 94 and supported by 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 no more than about 30 mm or 20 mm measured along the flexible shaft 98.
• the axial length will be within the range of from about 20 mm to about 25 mm.
• the helical thread 92 wraps around the axis at least about 1 or 2 or 4 or more full revolutions, but in some embodiments no more than about 10 or no more than about 6 revolutions. Preferably, the thread 92 wraps around the axis within the range of from about 2.5 to about 4.5 revolutions. In some embodiments the axial length along the threaded portion of the tip is within the range of from about 5 to about 15 mm, and preferably within the range of from about 8 mm to about 12 mm. [0075]
• the helical thread 92 on this implementation may have a constant pitch throughout its length. The pitch may be within the range of from about 5 to about 10 threads per inch depending upon desired performance.
• the thread to thread spacing in the axial direction may be within the range of from about 2 mm to about 6 mm, preferably from about 3 mm to about 4 mm.
• the thread may have multiple pitches (e.g. stepped or graduated) designed to engage, transport or grasp thrombus within the catheter lumen.
• a distal pitch may be less than a proximal pitch.
• the pitch may vary continuously along the length of the thread, or may step from a first, constant pitch in a proximal zone to a second, different pitch in a distal zone of the thread.
• the thread 92 may comprise a continuous single helical flange or may have a plurality of discontinuities to produce a plurality of teeth or serrations, arranged helically around the core wire.
• the maximum OD of the thread 92 is preferably smaller than the diameter of a sliding fit within the intended catheter lumen, and may generally be at least about 0.015 inches or at least about 0.010 inches smaller than the catheter lumen ID. In some implementations, the max OD of the tip may be significantly less than the inside diameter of the catheter lumen to allow more space for the thrombus along the side of the tip but still create significant grasping force via lateral engagement of the helical threads with the thrombus.
• the maximum helical thread diameter is about 0.110 inches
• the catheter lumen ID is about 0.275 inches (24F) (a 0.165 inch gap between the helical threads and catheter wall).
• the maximum OD of the tip is within the range of from about 0.03 to about 0.06 inches within a catheter having a distal end ID within the range from about 0.068 inches to about 0.073 inches. This leaves a substantial tip bypass flow path.
• the max OD of the tip is no more than about 35% or no more than about 40% or no more than about 60% of the ID of the corresponding catheter and may be within the range of from about 35% to about 55% of the catheter ID.
• the max OD of the tip may slightly less than the ID of the corresponding catheter to provide a sliding fit within the intended catheter lumen.
• the max 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 ID of the corresponding catheter.
• manual manipulation such as rotation of the tip 90 can engage the clot like a worm gear and either grasp the clot (e.g., by pinning it against the opposing catheter sidewall) for retraction or facilitate freeing the blockage and aid in ingestion of the clot into the catheter.
• Manual manipulation may also include axial proximal and distal reciprocation along with rotation, during aspiration, which can facilitate ingestion of the clot into the catheter.
• annular flow path cooperates with the vacuum and helical tip to grab and pull obstructive material into the catheter under rotation and vacuum.
• the annular flow path is significantly greater than any flow path created by manufacturing tolerances in a tip configured to shear embolic material between the tip and the catheter wall.
• Additional aspiration volume is obtained as a result of the helical channel defined between each two adjacent threads of the tip.
• a cross sectional area of the helical flow path of a tip having a maximum OD in the range of from about 0.0400 to about 0.0406 inches will generally be at least about 0.0003 square inches, and in some embodiments at least about 0.00035 or at least about 0.000375 inches.
• the total aspiration flow path across the helical tip is therefore the sum of the helical flow path through the tip and the annular flow path defined between the OD of the tip and the ID of the catheter lumen.
• Aspiration occurs both through the helical channel formed between adjacent helical threads as well as around the outside of the tip such that the assembly is configured for engaging and capturing embolic material but not shearing it between a sharp edge of the thread and the inside wall of the catheter.
• the distal advance segment 100 advantageously permits the thrombus engagement device 80 to at least partially move past the thrombus without “pushing” the thrombus in a distal direction as the tip 90 is advanced.
• the distal advance segment 100 can comprise a continuation of the helical thread 92.
• the distal advance segment 100 may comprise a threaded segment continuing from the helical thread 92.
• the threaded distal advance segment 100 may maintain an outer diameter consistent with the remainder of the helical thread 92.
• the threaded distal advance segment 100 in some instances, may comprise a thread that tapers in a distal direction towards a smaller outer diameter relative to the remainder of the helical thread 92.
• the helical thread 92 may comprise a proximal cylindrical segment and a distal tapered segment that extends along the distal advance segment 100.
• the profile of the tip 90 in an end view along the axis of rotation may be circular and/or, in some instances, may vary to create a non circular pattern around the axis of rotation.
• profile may comprise a helical pattern, such as an oval cross-section that rotates along the axis of rotation to create the helical profile.
• the tip as seen in an end elevational view thus may exhibit a major diameter and a minor diameter.
• the minor diameter may be no more than about 95% or 90% or 80% or 70% of the major diameter, depending upon desired performance.
• the outer edge 93 of the thread 92 lies along the surface of a cylinder.
• an outer edge 93 of the thread 92 thus has a linear surface in the axial direction, substantially conforming to the surface of a cylinder.
• a distal side 95 of the thread 92 is inclined radially outwardly in a proximal direction.
• a proximal side 97 of the thread 92 also inclines radially outwardly in a proximal direction thereby defining a proximally facing undercut along the length of the thread.
• the illustrated tip 90 includes an atraumatic, tapered distal advance segment 100 extending between an atraumatic distal tip at 102 and a transition to the distal end 96 of the thread 92.
• Helical thread 92 extends proximally from the transition to a proximal end 94 of the helical thread 92.
• a trailing segment 104 may extend between the proximal end 94 of the thread and the proximal end 106 of the tip.
• the axial length of the distal advance segment 100 may be at least about 5 mm or at least about 8 mm or 9 mm and generally less than about 15 mm, and in some implementations is within the range of from about 8 mm to about 12 mm.
• the outside diameter of the flexible shaft 82 is generally less than about 0.02 inches, or less than about 0.015 inches and, in one implementation, is about 0.008 inches.
• the flexible shaft 82 may comprise a distal tapered section. The distal tapered section may advantageously increase tip flexibility and/or maximize aspiration.
• the outside diameter at the distal end of the distal tapered section of the flexible shaft 82 is generally less than about 0.01 inches, or less than about 0.008 inches and, in one implementation, is no more than about 0.006 inches.
• the outside diameter of the advance segment 100 at distal tip 102 is generally less than about 0.024 inches, or less than about 0.020 inches and, in one implementation, is about 0.018 inches.
• the maximum outside diameter of the advance segment 100 and helical thread 92 may be within the range from about 0.020 to about 0.045 inches, and, in one implementation, is less than about 0.040 inches, such as about 0.035 inches.
• the advance segment, helical thread and trailing segment of the tip 90 may be molded as a single piece over the flexible shaft 82 using any of a variety of polymers known in the catheter arts.
• a first radiopaque marker 110 may be carried on the flexible shaft 82 beneath the advance segment 100.
• a second radiopaque marker 112 may be carried on the flexible shaft 82 within the trailing segment 104.
• Each radiopaque marker may comprise a radiopaque tube or a coil of radiopaque wire such as a platinum iridium alloy wire having a diameter about 0.002 inches and positioned or wrapped around the flexible shaft 82 and soldered to the flexible shaft 82 to produce an RO sleeve or coil having an outside diameter of less than about 0.020 inches, such as about 0.012 inches.
• the radiopaque markers may also provide an axial interference fit between the flexible shaft 82 and the advance segment 100 and trailing segment 104 to resist core wire axial pull out from the tip 90 (tip detachment).
• the maximum OD of the thread 92 exceeds the maximum OD of the advance segment 100 by at least about 15% or 25% or 30% or more of the OD of the advance segment 100, to facilitate crossing the clot with the advance segment 100 and engaging the clot with the thread 92.
• the distal tip 102 may be permitted to extend at least about 2 cm or 3 cm and preferably as much as 4 to 8 cm beyond the catheter (such as to permit manual removal of engaged thrombus), but generally will be limited to extend no more than a preset distance such as 12 cm or 8 cm or 5 cm beyond the catheter (e.g., within the range of from about 5 cm to about 10 cm) depending upon desired performance.
• Distal advance of the tip 102 may be limited by providing mechanical interference at the desired distal limit of travel.
• a distal stop surface 114 which may be on the handle 88 (see Figure 6A) provides an interference engagement with a complementary proximal surface (e.g.
• a distal engagement surface can be carried anywhere along the length of the thrombus engagement tool 80, for sliding rotational engagement with a complementary proximally facing stop surface carried by the catheter. Additional details of distal limit configurations may be found in U.S. patent application Serial No. 17/036,258 filed Sep.29, 2020 and entitled Embolic Retrieval Catheter, which is hereby expressly incorporated in its entirety herein by reference.
• the limit on distal advance of the helical tip may enable a first configuration in which the distal tip may be advanced through the catheter and placed at a first position approximately 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.
• a position indicator 85 may be carried by the flexible shaft 82 spaced apart from the distal surface 114 by a distance corresponding to the maximum length of the thrombus engagement tool intended to extend beyond the distal end of the catheter. When the position indicator 85 is located at a corresponding reference point relative to the catheter hub, the distal tip 102 may be positioned approximately at the distal end of the catheter.
• the position indicator 85 may comprise any of a variety of visual or tactile features, such as a color change or a colored band surrounding the flexible shaft 82.
• a visual indicium implementation color change or circumferential line
• the distal tip 102 may be positioned approximately at the distal end of the catheter when the indicator is visible just outside of the hub.
• the position indicator 85 comprises the transition between the distal end of the hypo tube 87 and the underlying flexible shaft 82.
• the hypo tube 87 additionally functions as a strain relief or anti buckling feature and may have an axial length within the range of from about 3 cm to about 15 cm and in some implementations within the range of from about 5 cm to about 9 cm.
• a distal segment 120 may have a length within the range of about 1 – 3 cm and a durometer of less than about 35D or 30D.
• An adjacent proximal segment 122 may have a length within the range of about 4 – 6 cm, and a durometer of less than about 35D or 30D.
• An adjacent proximal segment 124 may have a length within the range of about 4 – 6 cm, and a durometer of about 35D or less.
• An adjacent proximal segment 126 may have a length within the range of about 1 – 3 cm, and a durometer within the range of from about 35D to about 45D (e.g., 40D).
• An adjacent proximal segment 128 may have a length within the range of about 1 – 3 cm, and a durometer within the range of from about 50D to about 60D (e.g., about 55D).
• An adjacent proximal segment 130 may have a length within the range of about 1 – 3 cm, and a durometer within the range of from about 35D to about 50D to about 60D (e.g., about 55D).
• An adjacent proximal segment 132 may have a length within the range of about 1 – 3 cm, and a durometer of at least about 60D and typically less than about 75D. More proximal segments may have a durometer of at least about 65D or 70D.
• the distal most two or three segments may comprise a material such as Tecothane and/or PEBAX, and more proximal segments may comprise PEBAX or other catheter jacket materials known in the art.
• FIGS. 7A-7E illustrate various embodiments of catheters, at least some of which incorporate a plurality of catheter outer jacket segments with varying lengths and/or hardness for varying flexibility along the length of the catheter body. It will be understood that any of the features shown or described in connection with any of the catheters of FIGS.7A-7E can be used with any of the embodiments described and/or contemplated herein.
• FIGS. 7A-7E illustrates embodiments of various catheters 400, 500, 600.
• the catheters 400, 500, 600 may include differing properties (e.g., such as length, diameter, etc.) such that one or more of the catheters 400, 500, 600 may interact with any of the other catheters 400, 500, 600 in any various manner.
• each of catheters 400, 500, 600 may comprise a different size to permit the catheters 400, 500, 600 to at least partially extend through one or more of the other catheters 400, 500, 600.
• the lengths of each of the catheters 400, 500, 600 may vary so as to permit a smaller catheter to pass through and extend distally beyond a larger catheter in a telescoping manner.
• catheter 500 may be configured to pass through and extend beyond catheter 400.
• catheter 600 may be configured to pass through and extend beyond at least one of catheter 500 or catheter 400 in a telescoping manner. While FIG. 7E illustrates an example telescoping catheter stack including each of catheters 400, 500, 600, it will be understood by one having skill in the art that any combination of catheters 400, 500, 600 may be utilized.
• a system may incorporate 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.
• Catheter 400 may comprise an 8F catheter. In some instances, catheter 400 comprises a diameter larger than the diameter of any of the remaining catheters in a system.
• catheter 400 may comprise an overall length shorter than the length of any of the remaining catheters in a system.
• catheter 400 may comprise the outermost catheter in a telescoping system and may permit any of the remaining catheters 500, 600 to extend distally beyond a distal end of catheter 400.
• the catheter 400 may comprise a length between about 35 cm and about 105 cm or, a length between about 45 cm and about 95 cm.
• the catheter 400 may comprise a length of from about 50 cm to about 90 cm.
• the catheter 400 may comprise a length at least shorter than any catheter with a diameter smaller than catheter 400 (e.g., such as catheter 500, 600).
• Catheter 500 may comprise a 6F catheter.
• catheter 500 comprises a diameter in between the diameters of the remaining catheters in a system. Additionally, or alternatively, catheter 500 may comprise a length in between the lengths of the remaining catheters in the system. In this manner, catheter 500 may comprise a middle catheter in a telescoping system and may be configured to pass through and extend beyond one or more catheters while also permitting another catheter to extend distally beyond a distal end of catheter 500.
• the catheter 500 may comprise a length between about 120 cm and about 155 cm or between about 130 cm and about 145 cm.
• the catheter 500 may comprise a length of about from 135 cm to about 137 cm.
• the catheter 500 may comprise a length at least longer than any catheter with a diameter larger than catheter 500 (e.g., such as catheter 400).
• the catheter 500 may comprise a length at least shorter than any catheter with a diameter smaller than catheter 500 (e.g., such as catheter 600).
• Catheter 600 may comprise a 5F catheter. In some instances, catheter 600 comprises a diameter smaller than the diameters of the remaining catheters in a system. Additionally, or alternatively, catheter 600 may comprise a length longer than the lengths of any of the remaining catheters in the system. In this manner, catheter 600 may comprise an innermost catheter in a telescoping system and may be configured to pass through and extend beyond one or more of the other catheters.
• the catheter 600 may comprise a length between about 145 cm and about 175 cm or between about 155 cm and about 165 cm.
• the catheter 600 may comprise a length of about 160 cm.
• the catheter 600 may comprise a length at least longer than any catheter with a diameter larger than catheter 600 (e.g., such as catheter 400, 500).
• One or more of the catheters 400, 500, 600 may include a coil and/or a braid in the sidewall extending through at least a portion of the sidewall of the catheter 400, 500, 600, as discussed herein.
• the braid may have properties that vary along the length of each catheter 400, 500, 600 to generate a variety of desired characteristics of the catheter 400, 500, 600. For example, a wire density of the braid may vary gradually or in steps along the length of the catheter 400, 500, 600 and/or vary between discrete sections of the catheter 400, 500, 600.
• Catheter 600 may comprise one or more discrete sections with braid properties varying between one or more of the sections.
• catheter 600 may comprise a first section, a second (e.g., intermediate) section, and a third distal section.
• the catheter 600 may comprise a fewer number of sections (e.g., one section or two sections) or a greater number of sections (e.g., four sections or greater).
• a sidewall property such as a length and/or a wire density the braid along a respective section, may vary between the sections.
• a pics per inch (ppi) count of the braid in connection with the wire density of the braid may gradually transition between one or more of the catheter sections.
• the ppi count of the braid may remain generally consistent through a length of the first section and a length of the third section but gradually transition along the length of the second, intermediate section.
• the first section of catheter 600 may have a length of at least about 20 cm.
• the length of the first section may be from about 25 cm to about 35 cm or, in one example, about 30 cm.
• the braid through the first section may have a wire density of at least about 100 ppi.
• the braid through the first section may have wire density of at least about 120 ppi or, more specifically, about 130 ppi.
• the third section of catheter 600 may have a length of at least about 100 cm.
• the length of the third section may be from about 120 cm to about 140 cm or, more specifically, about 130 cm.
• the braid through the third section may have a wire density of no greater than about 85 ppi.
• the braid through the third section may have wire density from about 70 ppi to about 80 ppi.
• the second section of catheter 600 may be an intermediate section between the first section and the third section.
• the second section may have a length of at least about 3 cm. In some instances, the second section may have a length no greater than about 20 cm or, more specifically, no greater than about 10 cm. For example, the length of the second section may be about 5 cm.
• catheter 500 may comprise one or more discrete sections with braid properties varying between one or more of the sections.
• catheter 500 may comprise a first section, a second (e.g., intermediate) section, and a third section.
• the catheter may comprise a fewer number of sections (e.g., one section or two sections) or a greater number of sections (e.g., four sections or greater).
• a sidewall property such as a length and/or a wire density the braid along a respective section, may vary between the sections.
• a ppi count of the braid in connection with the wire density of the braid may gradually transition between one or more of the catheter sections.
• the ppi count of the braid in some instances, may remain generally consistent through a length of the first section and a length of the third section but gradually transition along the length of the second, intermediate section.
• the first section of catheter 500 may have a length of at least about 20 cm.
• the length of the first section may be from about 25 cm to about 35 cm or, in one example, about 30 cm.
• the braid through the first section may have a wire density of at least about 100 ppi.
• the braid through the first section may have wire density of at least about 120 ppi or, in one example, about 130 ppi.
• the third section of catheter 500 may have a length of at least about 80 cm.
• the length of the third section may be from about 100 cm to about 120 cm or, in one example, about 105 cm.
• the braid through the third section may have a wire density of no greater than about 100 ppi.
• the braid through the third section may have wire density from about 80 ppi to about 90 ppi.
• the second section of catheter 600 may be an intermediate section between the first section and the third section.
• the second section may have a length of at least about 3 cm. In some instances, the second section may have a length no greater than about 20 cm or, more specifically, no greater than about 10 cm. For example, the length of the second section may be about 5 cm.
• catheter 400 may comprise one or more discrete sections with braid properties varying between one or more of the sections. In some instances, catheter 400 may comprise one section. However, it will be understood by one having skill in the art that the catheter 400 may comprise a greater number of sections (e.g., two sections, three sections, four sections, or greater). For example, catheter 400 may comprise three sections as described in connection with either one or catheter 500 or catheter 600. A sidewall property, such as a length and/or a wire density the braid, may vary along catheter 400.
• a ppi count of the braid in connection with the wire density of the braid may gradually transition to increasing flexibility in a distal direction along catheter 400.
• the section of catheter 400 may have a length of at least about 40 cm.
• the length of the section may be from about 50 cm to about 60 cm or, in one example, about 55 cm.
• the braid through the section may have a wire density of at least about 80 ppi.
• the braid through the section may have wire density of at least about 90 ppi.
• the braid in some instances, may extend along an entire length of the catheter sidewall. In some instance, a junction between the braid and a coil is not present in the catheter and/or the catheter sidewall does not incorporate a coil.
• catheters 400, 500, 600 may an outer jacket segment stacking pattern for a progressive flexibility catheter.
• the outer jacket segment may each have properties that vary along the length of each catheter 400, 500, 600 to generate a variety of desired characteristics of the catheter 400, 500, 600.
• each segment of the outer jacket may have a corresponding Shore D hardness to vary the flexibility along the length of the catheter 400, 500, 600.
• the outer jacket segments may be made of a thermoplastic elastomer made of flexible polyether and rigid polyamide (e.g., Pebax®).
• each segment of the outer jacket may comprise a different variation of the thermoplastic elastomer to alter flexiblity.
• Catheter 600 may comprise a plurality of discrete segments of the outer jacket with varying flexibility between one or more of the segments. In some instances, catheter 600 may comprise a plurality of segments. A sidewall property, such as Shore D hardness and/or flexibility, may vary between the segments. In some instances, a Shore D hardness of the outer jacket segments may gradually transition from higher at proximal end segment of the outer jacket to lower at a distal end segment of the outer jacket. [0120] The proximal end segment of the outer jacket of the catheter 600 may have a Shore D hardness of at least about 60.
• the Shore D hardness of the proximal end segment may be from about 70 to about 80 or, more specifically, at least about 75.
• the distal end segment of the outer jacket of the catheter 600 may have a Shore D hardness of at most about 40.
• the Shore D hardness of the distal end segment may be from about 30 to about 20 or, more specifically, no more than about 27.
• a plurality of the intermediate segments between the distal end segment and the proximal end segment may each comprise a variety of Shore D hardness. In some instances, each segment decreases in a Shore D hardness in a distal direction and may have a smaller Shore D hardness than a proximally adjacent segment.
• the Shore D hardness of a first segment may be from about 30 to about 50 or, more specifically, about 40.
• the first segment in some instances, may be between positioned about 120 cm to about 160 cm or, more specifically, about 140 cm away from a distal end face of the catheter 600.
• the Shore D hardness of the second segment may be from about 50 to about 70 or, more specifically, about 65.
• the second segment in some instances, may be between positioned about 220 cm to about 260 cm or, more specifically, about 240 cm away from a distal end face of the catheter 600.
• Catheter 500 may comprise a plurality of discrete segments of the outer jacket with varying flexibility between one or more of the segments.
• catheter may comprise a plurality of segments.
• a sidewall property such as Shore D hardness and/or flexibility, may vary between the segments.
• a Shore D hardness of the outer jacket segments may gradually transition from higher at a proximal end segment of the outer jacket to lower at a distal end segment of the outer jacket.
• the proximal end segment of the outer jacket of the catheter 500 may have a Shore D hardness of at least about 60.
• the Shore D hardness of the proximal end segment may be from about 70 to about 80 or, more specifically, at least about 75.
• the distal end segment of the outer jacket of the catheter 500 may have a Shore D hardness of at most about 40.
• the Shore D hardness of the distal end segment may be from about 30 to about 20 or, more specifically, no more than about 27.
• a plurality of the intermediate segments between the distal end segment and the proximal end segment may each comprise a variety of Shore D hardness. In some instances, each segment decreases in a Shore D hardness in a distal direction and may have a smaller Shore D hardness than a proximally adjacent segment.
• the Shore D hardness of a first segment may be from about 30 to about 50 or, more specifically, about 40. The first segment, in some instances, may be between positioned about 70 cm to about 110 cm or, more specifically, about 90 cm away from a distal end face of the catheter 500.
• the Shore D hardness of a second segment may be from about 50 to about 70 or, more specifically, about 65.
• the second segment in some instances, may be between positioned about 160 cm to about 200 cm or, more specifically, about 180 cm away from a distal end face of the catheter 500.
• Catheter 400 may comprise a plurality of discrete segments of the outer jacket with varying flexibility between one or more of the segments.
• catheter 400 may comprise a plurality of segments.
• a sidewall property, such as Shore D hardness and/or flexibility, may vary between the segments.
• a Shore D hardness of the outer jacket segments may gradually transition from a proximal end segment of the outer jacket to a distal end segment of the outer jacket.
• the proximal end segment of the outer jacket of the catheter 400 may have a Shore D hardness of at least about 60.
• the Shore D hardness of the proximal end segment may be from about 70 to about 80 or, more specifically, about 75.
• the distal end segment of the outer jacket of the catheter 400 may have a Shore D hardness of at most about 40.
• the Shore D hardness of the distal end segment may be from about 30 to about 20 or, more specifically, no more than about 27.
• a plurality of the intermediate segments between the distal end segment and the proximal end segment may each comprise a variety of Shore D hardness.
• each segment decreases in a Shore D hardness in a distal direction and may have a smaller Shore D hardness than a proximally adjacent segment.
• the Shore D hardness of a first segment may be from about 30 to about 50 or, more specifically, about 40.
• a first segment in some instances, may be between positioned about 65 cm to about 105 cm or, more specifically, about 85 cm away from a distal end face of the catheter 400.
• the Shore D hardness of a second segment may be from about 40 to about 65 or, more specifically, about 55.
• the second segment in some instances, may be between positioned about 105 cm to about 145 cm or, more specifically, about 125 cm away from a distal end face of the catheter 400.
• the Shore D hardness of a third segment may be from about 60 to about 80 or, more specifically, about 70.
• the third segment in some instances, may be between positioned about 140 cm to about 180 cm or, more specifically, about 160 cm away from a distal end face of the catheter 400.
• Catheter 400 may comprise a tubular body length of about 90 +/-5 cm. In some instances, catheter 400 may comprise a tubular body length of about 50 +/-5 cm.
• a number of the plurality of discrete segments of the outer jacket of catheter 400 may vary with respect to the tubular body length of catheter 400.
• a length of the respective segments of the plurality of discrete segments of the outer jacket of catheter 400 may vary with respect to the tubular body length of catheter 400.
• a coating in some instances, may be located along an outer diameter of a distal portion of the catheter sidewall.
• the coating can be configured to decrease frictional resistance of the distal portion of the catheter sidewall with any adjacent structure (e.g., a vessel wall).
• the coating increases the lubriciousness of the catheter distal portion outer sidewall.
• the coating may advantageously reduce friction on the distal end of the catheter going through tortuous vasculature. This may facilitate advancement and rotation of the catheter distal end, particularly in situations where the catheter contains an increased flexibility along a distal end portion of the catheter.
• the coating may extend in a proximal direction from, or proximate to, a catheter distal end face.
• the coating may extend at least about 20 cm in a proximal direction. In some instances, the coating extends no farther than about 50 cm from the catheter distal end face. For example, the coating may extend for a length of about 25 cm to about 35 cm or, more specifically, about 30 cm from a catheter distal end face. It will be understood that the coating may be applied to any catheter disclosed herein, including, but not limited to, catheters 400, 500, 600.
• FIG. 8 illustrates a cross section through the sidewall of a distal portion of a single lumen catheter.
• An internal support layer may comprise either a coil or braid.
• adjacent loops or filars of the coil 140 may have a constant pitch throughout the length of the coil or may be closely tightly wound in a proximal zone with a distal section having looser spacing between adjacent loops.
• a coil section 140 with an axial length of at least between about 20% and about 30% of the overall catheter length, (e.g., 28 cm coil length in a 110 cm catheter shaft 16) at least the distal about 1 cm or about 2 cm or about 3 cm or about 4 cm of the coil will have a spacing that is at least about 130%, and in some implementations at least about 150% or more than the spacing in the proximal coil section.
• the spacing in the proximal coil may be about 0.004 inches and in the distal section may be at least about 0.006 inches or about 0.007 inches or more.
• the distal end of the coil or braid 140 can be spaced proximally from the distal end of the inner liner 142, for example, to provide room for an annular radiopaque marker 144.
• the coil or braid 140 may be set back proximally from the distal end, in some embodiments, by approximately no more than about 1 cm, about 2 cm, or about 3 cm.
• the distal end of the catheter 12 is provided with a beveled (inclined) distal surface 146 residing on a plane having an angle of at least about 10 degrees or about 20 degrees and in one embodiment about 30 degrees with respect to a longitudinal axis of the catheter 10.
• At least a distally facing edge of the annular radiopaque marker 144 may be an ellipse, residing on a plane which is inclined with respect to the longitudinal axis to complement the bevel angle of the distal surface 146. Additional details are described in connection with FIG. 9 below.
• the distal braid or coil and the RO marker 144 are provided with an outer jacket 156 such as a polymer tube formed from a plurality of axially adjacent cylindrical segments to enclose the catheter body 16.
• the outer sleeve 156 may comprise any of a variety of materials, such as polyethylene, polyurethane, polyether block amide (e.g., PEBAX TM ), nylon or others known in the art. Sufficient heat is applied to cause the polymer to flow into and embed the proximal braid and distal coil.
• the outer jacket 156 is formed by sequentially advancing a plurality of short tubular segments 133, 132, 130, 128, 126, 124, 122, 120 concentrically over the catheter shaft subassembly, and applying heat to shrink the sections on to the catheter 12 and provide a smooth continuous outer tubular body.
• the foregoing segmented construction may extend along at least the most distal about 10 cm, and preferably at least about the most distal about 20 cm, about 25 cm, about 30 cm, about 35 cm, about 40 cm, or more than about 40 cm of the catheter body 10.
• the entire length of the outer jacket 156 may be formed from tubular segments and the length of the distal tubular segments may be shorter than the one or more tubular segments forming the proximal portion of the outer jacket 156 proximal to the junction between the braid 150 and coil 140 in order to provide proximal backup support and steeper transitions in flexibility toward the distal end of the catheter 12.
• the durometer of the outer wall segments may decrease in a distal direction.
• proximal segments such as 133 and 132, may have a durometer of at least about 60D or about 70D, with gradual decrease in durometer of successive segments in a distal direction to a durometer of no more than about 35D or about 25D or lower.
• a 25 cm section may have at least about 3 or about 5 or about 7 or more segments and the catheter 12 overall may have at least about 6 or about 8 or about 10 or more distinct flexibility zones.
• the distal 1 or 2 or 4 or more segments 122, 120 may have a smaller OD following shrinking than the more proximal segments 133-124 to produce a step down in OD for the finished catheter body 16.
• the length of a lower OD section 160 may be within the range of from about 3 cm to about 15 cm and, in some embodiments, is within the range of from about 5 cm to about 10 cm such as about 7 cm or about 8 cm and may be accomplished by providing the distal segments 122, 120 with a lower wall thickness.
• the most distal portion of the catheter 12 may comprise a durometer of less than approximately 35D (e.g., 25D) to form a highly flexible distal portion of the catheter and have a length between approximately 25 cm and approximately 35 cm.
• the distal portion may comprise one or more tubular segments of the same durometer (e.g., segment 120).
• a series of proximally adjacent tubular segments may form a transition region between a proximal stiffer portion of the catheter 12 and the distal highly flexible portion of the catheter.
• the series of tubular segments forming the transition region may have the same or substantially similar lengths, such as approximately 1 cm.
• the relatively short length of each of the series of tubular segments may provide a steep drop in durometer over the transition region.
• a clot capture module as described in any embodiment herein, wherein the upstream surface of the filter is convex.
• the window comprises a transparent tubular portion of the housing.
• the vacuum line is at least about 30 inches in length.
• a clot capture module as described in any embodiment herein, wherein the aspiration control valve comprises collapsible tubing.
• a thrombus engagement tool configured to be advanced through a catheter and to engage thrombus, the thrombus engagement tool comprising one or more of the following: [0186] a rotatable core having a proximal end and a distal end; and [0187] a thrombus engagement tip on the distal end of the rotatable core, the thrombus engagement tip comprising: [0188] a helical thread; [0189] an advance segment on a distal side of the helical thread; and [0190] a trailing segment on a proximal side of the helical thread.
• the handle further comprises an indicium of rotational direction.
• a method of removing embolic material from a vessel with mechanical and aspiration assistance comprising one or more of the following: [0211] providing an aspiration catheter having a central lumen and a distal end; [0212] advancing the distal end to obstructive material in a vessel; [0213] applying vacuum to the central lumen to draw clot into the central lumen; [0214] introducing a thrombus engagement tool into the central lumen, the thrombus engagement tool having a tip comprising a helical thread having a major diameter that is at least about 0.015 inches smaller than an inside diameter of the central lumen, the helical thread being configured to provide an aspiration flow path around the tip; and [0215] manually manipulating the tip to engage clot between the tip and an inside wall of the central lumen.
• a method of removing embolic material as described in any embodiment herein, wherein the rotatable core is a wire.
• a method of removing embolic material as described in any embodiment herein comprising the step of introducing a thrombus engagement tool having a tip with a major diameter that is no more than about 60% of the inside diameter of the central lumen.
• a method of removing embolic material as described in any embodiment herein comprising introducing a thrombus engagement tool having a tip with a major diameter that is no more than about 40% of the inside diameter of the central lumen.
• a method of removing embolic material as described in any embodiment herein comprising extending the distal tip at least about 2 cm beyond the distal end of the catheter.
• a method of removing embolic material as described in any embodiment herein comprising axially aligning the distal tip with the distal end of the catheter using a position indicator on the rotatable core.
• a method of removing embolic material as described in any embodiment herein further comprising advancing the thrombus engagement tool through a rotating hemostasis valve before introducing the thrombus engagement tool into the central lumen.
• An inserter for guiding a device through a valve comprising one or more of the following: [0236] an elongate tubular body having a proximal end, a distal end, and a sidewall at least partially defining a central lumen; [0237] a laterally facing concave landing zone on the proximal end, the concave landing zone having a radius of curvature that increases in a proximal direction; and [0238] an axially extending slit in the sidewall, the axially extending slit extending from the distal end to the concave landing zone.
• a method of passing a device through a valve comprising one or more of the following: [0243] providing an inserter having a tubular body with a split sidewall; [0244] advancing the tubular body through a valve; [0245] advancing a device through the tubular body and beyond the valve; and [0246] proximally retracting the tubular body so that the device escapes laterally from the tubular body through the split sidewall, leaving the device in place across the valve. [0247] A 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.
• a method of passing a device through a valve as described in any embodiment herein, wherein the device is an aspiration catheter.

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• 2023
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