JP5575281B2 - Thrombectomy catheter system - Google Patents

Description

(Refer to related applications)
This application claims the benefit and priority of US Provisional Application No. 61 / 591,165, filed Jan. 26, 2012. The entire contents of the above documents are incorporated herein by reference.

(Technical field)
The present disclosure relates to a system for removing occlusive material from a blood vessel, and more particularly to a vascular catheter system.

(background)
Devices that remove occlusive material from a body lumen and maintain patency of the body lumen are well known in the art. These devices may be mechanical, electrical or chemical types. In general, each type of device is particularly suitable for removal of a particular type of occlusive material (eg, a chronic clot, subacute clot or acute clot) from a body lumen. For example, a device that injects chemicals into a body lumen to remove occlusive material from the lumen is effective in removing acute clots, but less effective in removing chronic clots .

  The difficulties associated with designing a device that removes all types of occlusive material from a body lumen can minimize the potential for causing damage to the body lumen while efficiently removing the occlusive material. Is to create a device.

  Accordingly, it would be desirable to provide an apparatus that can efficiently remove a variety of different occlusive substances from a body lumen while minimizing the risk of causing damage to the body lumen.

(wrap up)
The present disclosure is directed to a thrombectomy catheter system. The thrombectomy catheter system includes a thrombectomy catheter that defines a drain lumen and an infusion lumen and includes a catheter body that includes a high pressure tube. In one aspect, the high pressure tube has a nozzle opening positioned to direct the fluid jet into the distal opening of the drain lumen. A source of infusion fluid is in communication with the proximal end of the infusion lumen, and a fluid control device is fluidly coupled between the thrombectomy catheter and the source of infusion fluid. The fluid control device is adapted to regulate the flow rate of the infusion fluid from the source of infusion fluid to the infusion lumen of the thrombectomy catheter.

  In one embodiment of the thrombectomy catheter system, the infusion fluid and the fluid in the high pressure tube is saline.

  In another embodiment, the thrombectomy catheter system includes a high pressure tube, the high pressure tube defining a bent portion at the distal end of the high pressure tube. The nozzle opening is positioned at a curved portion that extends along an axis that is substantially transverse to the longitudinal axis of the thrombectomy catheter.

  In another embodiment, the thrombectomy catheter system further includes a source of high pressure fluid in communication with the high pressure tube. The source of high pressure fluid supplies high pressure fluid to the high pressure tube at a pressure between about 100 psi and about 10,000 psi.

  In another embodiment, the thrombectomy catheter system further includes a substantially rigid positioning band secured to the distal end of the catheter body. The positioning band defines a drain lumen in communication with the drain lumen of the catheter body and an injection lumen in communication with the injection lumen of the catheter body.

  In one embodiment, the high pressure tube is coupled to a positioning band. The high pressure tube can be formed from metal or plastic.

  In one embodiment, the high pressure tube extends through the positioning band and the infusion lumen of the catheter body.

  In one embodiment, the infusion lumen of the positioning band defines a pair of concave surfaces that are sized to receive the high pressure tube and prevent lateral movement of the high pressure tube in communication with the positioning band.

  In one embodiment, the positioning band injection lumen is adjacent to the positioning band discharge lumen and covers an arc angle of at least 140 °.

  In another embodiment, a fluid control device is provided and includes an adjustable valve adapted to regulate the flow of fluid from a source of infusion fluid into the infusion lumen of a thrombectomy catheter.

  In one embodiment, the fluid control device includes a fluid pump that supplies infusion fluid from a source of infusion fluid to a thrombectomy catheter. The fluid pump or adjustable valve can be adapted to cyclically change the flow rate of the infusion fluid to the thrombectomy catheter.

  In another embodiment, the thrombectomy catheter includes an intact tip that includes a pair of infusion channels that communicate with the infusion lumen of the positioning band and a reservoir that receives the bent portion of the high pressure tube. The reservoir has an upper opening that defines a cutting window.

  In another embodiment, the infusion channel extends distal to the bent portion of the high pressure tube and allows longitudinal or lateral infusion of the infusion fluid at the tip.

  In another embodiment, the intact tip has a microchannel to allow fluid connection between the central cavity and the injection channel. The microchannel is an opening in the wall that separates the central cavity and the injection channel, or an open channel formed by a recess in the surface of the intact tip.

  In another embodiment, the thrombectomy catheter system further includes a guide catheter that defines a guide lumen sized to receive the thrombectomy catheter, a proximal balloon, and a distal balloon.

  In another embodiment, a portion of the guide catheter between the proximal balloon and the distal balloon has a sinusoidal shape and defines a plurality of openings that allow for the suction of occlusive material into the thrombectomy catheter. To do.

  In yet another embodiment, the thrombectomy catheter system can include a portion of a guide catheter that is flexible between the proximal balloon and the distal balloon, the portion from a vessel that contacts the thrombectomy catheter. A plurality of openings are provided that allow suction of the occlusive material. The flexibility of a portion of the guiding catheter is such that once the thrombectomy catheter is inserted into the guiding catheter, the sinusoidal shape applied to the thrombectomy catheter is such that the guiding catheter has a sinusoidal shape. Seems to be taken by.

  In one embodiment, the sensor is positioned to measure pressure in the body lumen. The sensor can be connected to the fluid control device to control the operation of the fluid control device.

  In one embodiment, the recirculation channel is positioned to recirculate fluid back from within the drain lumen into the body lumen. The filter is positioned upstream of the recirculation channel, and the filter is sized to prevent the passage of solids in the recirculation channel.

  In one embodiment, the drainage lumen is divided into a first drainage lumen section and a second drainage lumen section by a dividing wall, and the filter and recirculation channel are in the first drainage lumen section. Positioned. The filter may be positioned at one end of the first drainage lumen section and angled to direct solid objects into the second drainage lumen section.

  In one embodiment, a recirculation channel is provided and extends between the drain lumen and the high pressure tube. A filter may be provided in the recirculation channel to allow small solids to enter the high pressure tube so as to create a sandblasting effect adjacent to the nozzle opening.

  In one embodiment, a structure configured to break the occlusive material is positioned within the drain lumen. The structure may include a grid with sharp cutting edges. Alternatively, the structure may include a rotatable turbine configured to grind the occluding material.

  In one embodiment, the thrombectomy catheter includes a body that defines a window between the nozzle opening and the entrance to the drain lumen, and the cage is positioned adjacent the window so as to cover the window.

  The devices disclosed herein may be implemented to achieve one or more of the following advantages. Thrombectomy catheters use a high pressure water jet that removes occlusive material from within the blood vessels, which can be safer than mechanical cutting devices. The thrombectomy catheter system disclosed herein is particularly suitable for the treatment and removal of various clots (eg, deep vein thrombus (DVT)) regardless of the timing or tissue of the thrombus and clot. For example, a thrombectomy catheter can be configured in various ways to protect a body lumen while allowing a water jet to remove clots. The body lumen may be protected by a specific structure positioned adjacent to the water jet that provides a physical barrier to the body lumen. In addition, the body lumen is adjacent to the water jet to stop cutting (ie, turn off the water jet) or signal the controller to inject fluid into the body lumen. It can be protected by monitoring the pressure inside.

  The disclosed thrombectomy catheter also provides infusion fluid to provide a fluid balance within the body lumen to prevent excessive drainage of blood and body fluids.

  Furthermore, there is no need for a separate means of transmitting the clot through the thrombectomy catheter and out of the body lumen because the high pressure fluid provides the necessary kinetic force to move the clot through the thrombectomy catheter. Still further, the disclosed thrombectomy catheter is provided with a means for chopping the removed clot and can better deliver the clot through the thrombectomy catheter. The means for shredding the agglomerate may return a portion of the smaller pieces of the shredded clot back into the fluid flow to help further break up the agglomerate.

  Other features and advantages of the disclosure will be apparent from the following description and from the claims.

For example, the present invention provides the following items.
(Item 1)
A thrombectomy catheter system comprising:
A catheter including a catheter body defining an exhaust lumen and an infusion lumen, the catheter body including a high pressure tube that directs a fluid jet into a distal opening of the drain lumen. A catheter having a nozzle opening positioned to direct;
A source of infusion fluid in communication with the proximal end of the infusion lumen;
A fluid control device fluidly coupled between the thrombectomy catheter and the source of infusion fluid;
The thrombectomy catheter system, wherein the fluid control device is adapted to regulate the flow rate of infusion fluid from the source of infusion fluid to the infusion lumen of the thrombectomy catheter.
(Item 2)
A source of high pressure fluid in communication with the high pressure tube, the source of high pressure fluid supplying the high pressure fluid to the high pressure tube at a pressure between about 100 psi and about 10,000 psi. The thrombectomy catheter system according to item.
(Item 3)
The catheter body further includes a substantially rigid positioning band secured to the distal end of the catheter body, the positioning band being in communication with the draining lumen of the catheter body, and the infusion of the catheter body The thrombectomy catheter system according to any of the preceding items, wherein an infusion lumen communicating with the lumen is defined.
(Item 4)
The thrombectomy catheter system according to any of the preceding items, wherein the high pressure tube is coupled to the positioning band.
(Item 5)
The thrombectomy catheter system according to any of the preceding items, wherein the high pressure tube extends through the catheter body and the injection lumen of the positioning band.
(Item 6)
Any of the preceding items, wherein the fluid control device includes an adjustable valve adapted to regulate a flow rate of the infusion fluid from a source of the infusion fluid into the infusion lumen of the thrombectomy catheter The thrombectomy catheter system described in 1.
(Item 7)
The thrombectomy catheter system according to any of the preceding items, wherein the adjustable valve is adapted to cyclically change the flow rate of infusion fluid to the thrombectomy catheter.
(Item 8)
The thrombectomy catheter system according to any of the preceding items, wherein the fluid control device includes a fluid pump that circulates an infusion fluid from a source of the infusion fluid to the thrombectomy catheter.
(Item 9)
The thrombectomy catheter further includes an intact tip that includes a pair of infusion channels in communication with the infusion lumen of a positioning band, and a reservoir that receives the high pressure tube, the reservoir comprising an upper opening. The thrombectomy catheter system according to any one of the above items, comprising:
(Item 10)
The thrombectomy catheter system according to any of the preceding items, wherein the infusion channel extends distal to a bent portion of the high pressure tube.
(Item 11)
The thrombectomy catheter system according to any of the preceding items, further comprising a guide catheter defining a guide lumen sized to receive the thrombectomy catheter, a proximal balloon, and a distal balloon.
(Item 12)
Any of the preceding items, wherein a portion of the guide catheter between the proximal balloon and the distal balloon has a sinusoidal shape and defines a plurality of openings that provide access to the thrombectomy catheter. A thrombectomy catheter system according to claim 1.
(Item 13)
A portion of the guide catheter between the proximal balloon and the distal balloon is flexible and defines a plurality of openings that provide access to the thrombectomy catheter, Flexibility is any of the above items, wherein the sine wave shape applied to the thrombectomy catheter is taken by the guide catheter when the thrombectomy catheter is inserted into the guide catheter. Thrombectomy catheter system.
(Item 14)
The thrombectomy catheter system according to any of the preceding items, further comprising a sensor configured to measure pressure in the body lumen.
(Item 15)
The thrombectomy catheter system according to any of the preceding items, wherein the sensor is configured to control operation of the fluid control device.
(Item 16)
The thrombectomy catheter system of any of the preceding items, further comprising a recirculation channel positioned to recirculate fluid from within the drain lumen into the body lumen.
(Item 17)
The thrombus according to any of the preceding items, further comprising a filter positioned upstream of the recirculation channel, wherein the filter is sized to prevent passage of solid matter within the recirculation channel. Extraction catheter system.
(Item 18)
The drainage lumen is divided into a first drainage lumen section and a second drainage lumen section by a dividing wall, and the filter and the recirculation channel are positioned in the first drainage lumen section. The thrombectomy catheter system according to any one of the above items.
(Item 19)
Any of the preceding items, wherein the filter is positioned at one end of the first drainage lumen section and is angled to direct solid objects into the second drainage lumen section. A thrombectomy catheter system according to claim 1.
(Item 20)
It further includes a chopped structure positioned within the drain lumen and configured to break the occlusive material. The thrombectomy catheter system according to any one of the above items.
(Item 21)
The thrombectomy catheter system according to any of the preceding items, wherein the shredded structure includes a grid having sharp cutting edges.
(Item 22)
A thrombectomy catheter system according to any of the preceding items, wherein the shredded structure includes a rotatable turbine configured to grind occlusive material.
(Item 23)
Further comprising a body defining a cutting window between the nozzle opening and the inlet to the discharge lumen, and a separator positioned adjacent to the window to cover the window, the separator comprising: The thrombectomy catheter system according to any of the preceding items, configured to minimize the amount of tissue entering the cutting window.

(Summary)
A thrombectomy catheter system is disclosed and includes a catheter having a drain lumen, an infusion lumen and a high pressure tube. The high pressure tube includes a nozzle opening that forms a high pressure jet of fluid that cuts the occluding material from within the body lumen. The nozzle opening is positioned to direct a high pressure jet of fluid that creates a suction effect into the distal end of the discharge lumen. The infusion lumen displaces fluid that is removed from the body lumen through the drainage lumen by the suction effect generated by the fluid jet.

  Various embodiments of the thrombectomy catheter system disclosed herein are described herein with reference to the drawings.

FIG. 1 is a schematic diagram of one embodiment of a thrombectomy catheter system disclosed herein. FIG. 1A is a diagram illustrating the flow rate of infusion fluid per unit of time for one embodiment of the system disclosed herein. FIG. 1B is a diagram illustrating the flow rate of infusion fluid per unit of time for another embodiment of the system disclosed herein. 2 is a side perspective view of the distal portion of one embodiment of the thrombectomy catheter disclosed herein of the system shown in FIG. 2A is a perspective view of the distal end of the catheter body shown in FIG. 2 with the distal end of a high pressure tube in cross section. 3A is a front perspective view of the positioning band of the thrombectomy catheter shown in FIG. 3B is a rear perspective view of the positioning band shown in FIG. 3A. FIG. 4 is a side perspective view of the distal portion of an alternative embodiment of the thrombectomy catheter disclosed herein. FIG. 5 is a side cross-sectional view of the thrombectomy catheter shown in FIG. FIG. 6 is a perspective sectional view taken along section line 6-6 of FIG. FIG. 7 is a perspective view of the distal end of the catheter body and the catheter tip of the thrombectomy catheter shown in FIG. FIG. 8 is a side view of the catheter body and the catheter tip shown in FIG. FIG. 9 is a front view of the thrombectomy catheter shown in FIG. FIG. 10 is a side schematic view of an alternative embodiment of the thrombectomy catheter system disclosed herein including a thrombectomy catheter and a guide catheter. FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. FIG. 12 is a cross-sectional view taken along section 12-12 of FIG. FIG. 13 is a side view of an alternative embodiment of a thrombectomy catheter disclosed herein. FIG. 14 is a side view of yet another embodiment of a thrombectomy catheter disclosed herein. FIG. 15 is a side cross-sectional view of the distal end of another embodiment of a thrombectomy catheter disclosed herein. 16 is a cross-sectional view taken along section 16-16 of FIG. FIG. 17 is a side cross-sectional view of another embodiment of a thrombectomy catheter disclosed herein. 18 is a cross-sectional view taken along section line 18-18 of FIG. FIG. 19 is a side cross-sectional view of another embodiment of a thrombectomy catheter disclosed herein. FIG. 20 is a side cross-sectional view of yet another embodiment of a thrombectomy catheter disclosed herein. FIG. 21 is a side cross-sectional view of another embodiment of a thrombectomy catheter disclosed herein. FIG. 22 is a side cross-sectional view of yet another embodiment of a thrombectomy catheter disclosed herein.

  Embodiments of the thrombectomy catheter system disclosed herein will now be described in detail with reference to the drawings. Like numbers identify similar or similar elements in each of the several drawings. As used herein, the term “distal” refers to the portion of a thrombectomy catheter system disclosed herein that is more distant from the user (eg, clinician), or its The term “proximal” refers to a component of the thrombectomy catheter system that is closer to the user during proper use, or a component thereof. The term “lumen” should also be understood to include any natural or artificial lumen in the body (eg, blood vessels, vascular grafts, fistulas, etc.). Furthermore, the term “occlusion” should be understood to cover any partial or total obstruction of the lumen (eg, thrombus, mass, platelets, tumor, etc.).

  FIG. 1 is a schematic diagram of one embodiment of a thrombectomy catheter system disclosed herein, generally indicated as 10. The thrombectomy catheter system 10 includes a thrombectomy catheter 12, an infusion fluid source 14, a high pressure fluid source 16, and a reservoir 18 that receives fluid drained from the surgical site. Each of infusion fluid source 14, high pressure fluid source 16, and drain fluid reservoir 18 communicates with thrombectomy catheter 12 via a suitable fluid conduit 20a-20c, respectively. The control device 22 may be provided in a fluid conduit 20 a that connects the source 14 of infusion fluid to the thrombectomy catheter 12. The control device 22 may include a pump or valve that is operable to regulate the flow rate of infusion fluid into the thrombectomy catheter 12, as will be described in more detail below.

  With reference to FIGS. 2-3B, the thrombectomy catheter 12 includes a catheter body 24, a positioning band 26 and a high pressure tube 28. The catheter body 24 of the catheter 12 defines at least two lumens and is made from any suitable and sufficiently flexible biocompatible material (eg, extruded) to facilitate insertion of the catheter 12 into the body lumen. Can be formed. Suitable materials include polymeric materials, elastomeric materials (eg, silicone and fiber materials), or synthetic resins (eg, polyurethane, polyethylene, polypropylene, nylon, polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), PEBAX (Registered trademark) or polyimide), but is not limited thereto. In one embodiment, the catheter body 24 defines an exhaust lumen 30 and an infusion lumen 32 (see FIG. 2A). The drain lumen 30 defines a lumen for draining fluid and includes a proximal end in fluid communication with the fluid conduit 20 c (FIG. 1) and the drain fluid reservoir 18. Infusion lumen 32 defines a lumen for infusing fluid and is in fluid communication with fluid conduit 20a (FIG. 1) and infusion fluid source. Although the drain lumen 30 is illustrated as being circular and the infusion lumen 32 is illustrated as having a crescent shape, various other configurations are possible with respect to the drain and infusion lumens 30 and 32. Conceivable.

  A positioning band 26 is supported at the distal end of the catheter body 24 and defines drain and infusion lumens 30a and 32a in communication with the drain and infusion lumens 30 and 32 of the catheter body 24, respectively. The positioning band 26 has a first proximal extension 34 having a shape corresponding to the shape of the drainage lumen 30 of the catheter body 24 and a second shape having a shape corresponding to the shape of the injection lumen 32 of the catheter body 24. A proximal extension 36. Proximal extensions 34 and 36 are disposed within the distal ends of the drainage and infusion lumens 30 and 32 of the catheter body 24 to frictionally secure the positioning band 26 to the distal end of the catheter body 24. Acceptable. Alternatively, or in addition to frictional engagement, the positioning band 26 may be secured to the distal end of the catheter body 24 by other clamping techniques including using gluing, welding, crimping, and the like. In one embodiment, the injection lumen 32a of the positioning band 26 has an area adjacent to the discharge lumen 30a of the positioning band 26 and extending for an arc angle θ greater than about 140 °, preferably greater than 180 °. (See FIG. 18). The positioning band 26 may be formed from a suitable biocompatible plastic including polymeric materials including thermoplastics or the like, or a suitable biocompatible metal including stainless steel, titanium and the like.

  The high pressure tube 28 is positioned to extend through the infusion lumen 32 and includes a closed distal end and a bent portion 40 that defines a nozzle opening 40a (see FIG. 5). As illustrated, the bent portion 40 causes the nozzle opening 40 a to direct the fluid jet 50 into the drain lumen 30 a of the positioning band 26 in a direction substantially parallel to the longitudinal axis of the catheter 12. Positioned transversely to the longitudinal axis of the catheter body 24 so as to be positioned. Although the bent portion 40 is shown as being offset about 90 degrees from the longitudinal axis of the catheter body 24, the bent portion 40 can be bent at about 180 degrees, and the nozzle opening 40a is It is anticipated that it may be formed at the distal end of high pressure tube 28. In one embodiment, the high pressure tube 28 is formed from a metal (eg, nitinol or stainless steel). Alternatively, the high pressure tube 28 may be formed from a thermoplastic (eg, polyetheretherketone (PEEK)). The high pressure tube 28, as will be described in more detail below, to ensure that the nozzle opening 40a of the tube 28 is properly positioned relative to the drain lumen 30a of the positioning band 26, for example, It may be fixed or coupled to the positioning band 26 using adhesion, welding or the like. Alternatively, the high pressure tube 28 is associated with the drain lumen 30a of the positioning band 26 to allow the spacing between the nozzle opening 40a and the drain lumen 30a to be selectively varied. It can be slidably positioned. In one embodiment, the positioning band 26 receives the high pressure tube 28 and is sized to minimize lateral movement of the tube 28 associated with the band 26, upper and lower concave surfaces 46a and 46b ( 3A).

  As discussed above, the nozzle opening 40a may be spaced a predetermined distance distal to the drain lumen 30a of the positioning band 26. The nozzle opening 40a can be cylindrical in shape to produce a substantially symmetrical conical jet (see FIG. 2). In one embodiment, the nozzle opening 40a has a diameter between 0.001 inch and 0.01 inch. Alternatively, the nozzle opening 40a may be conical and the entry opening of the nozzle opening 40a may have a larger diameter than the discharge opening of the nozzle opening 40a. Such a conical nozzle opening is better suited for use with lower fluid pressures. As discussed above and shown in FIG. 2, the fluid jet 50 generated by the nozzle opening 40 a is configured to be received entirely within the drain lumen 30 a of the positioning band 26.

  In one embodiment of the thrombectomy catheter 12 disclosed herein, the diameter of the drain lumen 30a is about 0.050 inch, the diameter of the cylindrical jet nozzle 40a is about 0.005 inch, and the nozzle opening The spacing between 40a and the drain lumen 30a is about 0.008 inches. Alternatively, the spacing between the nozzle opening 40a and the drain lumen 30a is about 0.060 inches. Alternatively, other dimensions may be selected to optimize fluid aspiration through the drain lumens 30a and 30 of the catheter 12.

  With reference to FIGS. 1 and 2, when the thrombectomy catheter system 10 is used to remove occlusive material from within a blood vessel, the thrombectomy catheter 12 is inserted into the patient's venous system using standard percutaneous access techniques. Is positioned. Although not shown, the catheter body 24 and positioning band 26 may be formed to include guidewire holes to assist in the placement of the catheter 12 within the patient's vascular lumen. Alternatively, a guide wire can be passed through the infusion lumen 32 to effect placement of the catheter 12. As the catheter 12 is positioned within the vascular lumen, the catheter 12 is advanced to position the distal end of the catheter 12 in or adjacent to the occlusive material. A pressurized fluid (eg, saline or water) is then supplied from the high pressure fluid source 16 to the high pressure tube 28 through the fluid conduit 20b at a pressure of about 100 psi to about 10,000 psi. Alternatively, a thrombolytic agent (eg, tPA) can be mixed with a pressurized fluid. The high pressure fluid travels through the high pressure tube 28 and exits from the nozzle opening 40a (FIG. 5) as a high pressure fluid jet 50. As the high pressure fluid jet 50 passes through the discharge lumen 30a of the positioning band 26, the fluid jet 50 entrains ambient fluid and occlusive material into the jet proximal to the discharge lumen 30a. cause. Depending on the various parameters disclosed, a vacuum is generated and can range from 10 to 760 mmHg. When this occurs, the occlusive material is withdrawn into contact with the high pressure fluid jet 50 and cut. The severed occlusive material and fluid (eg, blood) in the vascular lumen are drained from the vascular lumen into the drain lumens 30a, 30 of the catheter body 24, from the catheter 12 to the conduit 20c, and It flows into the exhaust fluid reservoir 18.

  Fluid from the infusion fluid source 14 through the infusion lumen 32 of the catheter body 24 to replace fluid removed from the vascular lumen as a result of the suction effect generated by the high pressure jet 50 within the vascular lumen. Is delivered or infused into the vascular lumen. The injection lumen 32 can also be used to introduce a thrombolytic or contrast agent into the vascular lumen, as described below. In one embodiment, the infusion fluid, which may be saline, is injected into the infusion lumen 32 by the negative pressure generated in the vascular lumen adjacent the distal end of the infusion lumen 32 by the high pressure jet 50. Passively pulled out into the. In such embodiments, the control device 22 that can be positioned in the fluid conduit 20a that connects the infusion fluid source 14 to the catheter 12 can be selectively operated to control the flow rate of the infusion fluid into the catheter 12. Possible valves may be included. In such embodiments, the flow rate of the fluid supplied to the infusion lumen 32 of the catheter 12 can be varied cyclically by an adjustable valve to assist in breaking the occlusive material. Specifically, fluid pulsations caused by cyclically changing the flow rate of fluid supplied through the infusion lumen 32 may help to shred or break the occlusive material. In other passive embodiments, the control device 22 may not be present and the fluid in the infusion fluid source 14 can be moved freely by the vacuum created in the vascular lumen.

  In alternative embodiments, the control device 22 may include a pump (eg, a gear pump or a peristaltic pump) for providing a pressurized flow of infusion fluid to the infusion lumen 32 of the catheter 12. In such embodiments, the flow rate of fluid supplied to the infusion lumen 32 of the catheter 12 can be varied cyclically to assist in breaking the occlusive material, as described above. Circulatingly changing the flow rate of the fluid supplied to the infusion lumen 32 of the catheter 12 may also minimize the likelihood that the vessel lumen wall will be withdrawn into contact with the high pressure jet 50. The cyclic variation in flow rate can be in the form of a square wave or sine wave, as shown in FIGS.

  With reference to FIG. 1, the restrictor 23 may be provided in a fluid conduit 20 c that connects the drain lumen 30 of the catheter 12 to the drain fluid reservoir 18. The restrictor 23 may include a mechanical device that compresses or crimps the fluid conduit 20c. Alternatively, other variable restrictor devices can be incorporated within the fluid conduit 20c. The restrictor 23 functions to selectively change the amount of fluid drawn by the suction generated by the high pressure fluid jet 50, and thus control the vacuum generated at the distal end of the drain lumen 30. Can make it possible. In one embodiment, the limiter 23 can be selectively operated to periodically change the limit over time. Alternatively, a flow meter (not shown) may be provided to measure the flow rate of fluid aspirated in the fluid conduit 20C attached to the reservoir 18. The restrictor 23 can be operated to control the fluid flow rate in the drain lumen 30 to match the fluid flow rate in the infusion lumen 32.

  In one embodiment, the pressure sensor is integrated within the thrombectomy catheter to assist in balancing the volume of fluid aspirated from the body lumen and the volume of fluid infused into the body lumen. It becomes. Referring to FIG. 2, one or more sensors 80a-c may be located at various locations on thrombectomy catheter 12 (eg, at high pressure tube 28 (80c), at the front of positioning band 26 (80b), and / or It can be positioned on the outer surface of the positioning band 26 (80a). Alternatively, the sensor can be positioned at other external or internal locations on thrombectomy catheter 12. In one embodiment, the sensor is a miniature fiber optic sensor (eg, that manufactured by Fiso Technologies, Inc. or Opsens, Inc.). Alternatively, other types of pressure sensors can be used to measure pressure within a body lumen that is treated by a thrombectomy catheter. The location of the sensor should be selected to provide an accurate measurement of the pressure in the body lumen rather than the pressure immediately adjacent to the distal end of the catheter 12. Thus, the best location for sensor placement is at a location spaced from the distal end of the drain lumens 30a, 30, especially at locations that are protected from fluid flow into and out of the catheter 12. possible.

  Alternatively, the sensor 80 may be positioned within the lumen of the catheter 12 or at the catheter accessory (eg, a guide wire or a separate guide catheter). In addition, a separate pressure monitoring lumen (not shown) can be provided in the catheter 12. The pressure monitoring lumen communicates with the body lumen and with strain gauges etc. external to the body to monitor the pressure of the fluid within the body lumen. When the sensor is positioned within the outflow lumen (eg, the drain lumen 30) of the catheter 12, pressure measurements can be taken to obtain a reading that reflects the pressure in the body lumen rather than the pressure in the drain lumen. It is noted that the flow through the lumen must be stopped before doing so. In such embodiments, the flow restrictor 23 can be used to circulate the flow cyclically to allow periodic measurement of pressure within the body lumen.

  The purpose of providing a pressure sensor for measuring pressure in a body lumen is to provide a volume of fluid that is removed from the body lumen through the drain lumen 30 and a fluid that is injected into the body lumen through the infusion lumen 32. This is to maintain a balance between the volume of the two. In use, prior to operating the catheter 12, lumen pressure is measured to establish a baseline pressure within the lumen. The high pressure fluid is then supplied through the high pressure tube 28 so that the jet 50 passes into the discharge lumens 30a, 30. As the jet 50 passes into the drain lumens 30a, 30, a venturi effect is created and a fluid containing an occlusive material is created by creating a vacuum around the drain lumen 30a and within the body lumen. , 30a. If the pressure sensor 80 senses that the pressure in the body lumen has dropped below a threshold pressure (eg, 90% of the luminal baseline pressure), the signal will begin infusion through the infusion lumen 32. Provided to. If a second threshold pressure is reached (eg, 105% of baseline pressure), a signal is provided to stop the infusion. The process of starting and stopping infusion can be controlled automatically using known fluid control devices. Alternatively, the sensor can be used to operate the control device 22 or restrictor 23 to balance the fluid into and out of the catheter 12.

  Although the thrombectomy catheter 12 described above is best suited for removal of acute to semi-acute occlusion material, the catheter 12 removes all types of occlusion material (including chronic clots) from within the vascular lumen. It is completely possible to do. In order to remove all types of occlusive material from the vascular lumen, the distal end of the catheter 12 is positioned adjacent to the distal end of the catheter 12 such that the occlusive material is jetted. It needs to be pulled into the occluding material to allow it to be drawn into 50, cut and chopped.

  4-8, in order to minimize the possibility that the vascular lumen may be damaged during insertion of the catheter 12 into the vascular lumen or operation of the catheter 12 therein. The catheter 12 can be fitted with an intact tip 60. Intact tip 60 includes a body 62 that decreases from the proximal end of body 62 toward the distal end of body 62 so that the distal end defines a blunt surface 64. Has height and width. Alternatively, the distal end of the body 62 may be sharper to allow the catheter 12 to enter more occlusive material. The body 62 also defines a central cavity 66, an upper opening or cutting window 68 that receives the occlusive material, and a pair of infusion channels 70 that communicate with the infusion lumen 32 a of the positioning band 26 and the infusion lumen 32 of the catheter body 24. To do. The injection channel 70 can include an enclosed portion 70a and an open portion 70b. The injection channel 70 may each have a proximal end of an open portion 70b that is generally longitudinally aligned with the nozzle opening 40a and a distal end that extends distally of the nozzle opening 40a. The distal opening of the injection channel 70 of the intact tip 60 can be longitudinal (shown in FIGS. 7-9) or lateral (not shown).

  Intact tip 60 is secured to the distal end of catheter body 24 using any known clamping technique including gluing, welding, and the like. When the tip 60 is secured to the catheter body 24, the bent portion 40 of the high pressure tube 28 causes the central cavity of the intact tip 60 so that the nozzle opening 40a is aligned with the drain lumen 30a of the positioning band 26. Positioned within 66.

  Intact tip 60 provides several advantages to thrombectomy catheter 12 disclosed herein. In particular, the tapered configuration of the intact tip 60 can assist in positioning the distal end of the catheter 12 within the occlusive material and can facilitate the positioning of the occlusive material within the high pressure jet 50. In addition, the configuration and positioning of the infusion channel 70 along the sidewall of the intact tip 60 at the longitudinal position adjacent to the nozzle opening 40a or at a distal longitudinal position thereof is adjacent to the intact tip 60 of the catheter. A recirculation pattern of fluid within the vascular lumen may be generated, which assists in the entry of the catheter 12 into the robust occlusive material and removal of the occlusive material from the vascular lumen. Further, the tapered configuration of the intact tip 60 may further allow the occlusive material to enter the cutting window 68. Specifically, when the intact tip 60 is pushed into the occlusive material and the occlusive material moves along the inclined surface of the intact tip 60, any elasticity of the occlusive material is applied to the intact tip 60. On the other hand, it is pushed back, so it pushes into the cutting window 68.

  In an alternative embodiment, shown in phantom lines in FIG. 7, one or more microchannels 82 may be provided in the body 62 of the tip 60 between the injection channel 70 and the cavity 66. The microchannel 82 maintains a path for infusion fluid to flow between the infusion lumen 32 of the catheter body 24 and the central cavity 66 of the intact tip 60. With the intact tip 60 positioned in the occlusive material such that the channel 70 is occluded, the microchannel 82 allows fluid to flow into the infusion lumens 32, 32 a and the central cavity 66 within the intact tip 60. Allowing circulation between. Alternatively, the microchannel 82 may be formed along the outer surface of the intact tip 60 and extend between the injection channel 70 and the cutting window 68.

  In another embodiment, the intact tip 60 has a microchannel 82 to allow fluid connection between the central cavity 66 and the injection channel 70. Microchannel 82 is a wall opening separating central cavity 66 and injection channel 70 or formed by a recess in the surface of intact tip 60 between injection channel 70 and cutting window 68. It is an open channel.

  With reference to FIGS. 10-12, guide catheter 100 may be used to assist in positioning thrombectomy catheter 12 within vascular lumen 102 (FIG. 10). In one embodiment, guide catheter 100 includes a guide catheter body 104, a proximal balloon 106 and a distal balloon 108. The guide catheter body 104 may be formed from nylon, polyurethane, or elastomer (eg, PeBax®) and may include a reinforcing material such as stainless steel or nitinol. Guide catheter body 104 includes guide lumen 110 sized to receive thrombectomy catheter 12, inflation lumen 112 for inflating / deflating proximal balloon 106, and inflation tube for inflating / deflating distal balloon 108. A plurality of lumens including the cavity 114 are included. Guide catheter 100 is of an appropriate size, for example, a 10F or 12F catheter. Alternatively, a single inflation lumen can be provided for both the proximal and distal balloons 106 and 108. Guide catheter 100 may be used to introduce additional lumens (shown for infusion of saline or thrombolytic agents (eg, tissue plasminogen activator (tPA), streptokinase, urokinase, or heparin) into the vascular lumen. Not).

  Referring to FIG. 10, at least a portion of the guide catheter 100 between the proximal and distal balloons 106 and 108 includes a sinusoidal shape 116. As shown, the sinusoidal shape 116 may extend the entire length of the guide catheter 100 between the proximal and distal balloons 106 and 108. In addition, the sinusoidal shape 116 can be formed by heat treating the PEEK material. Alternatively, other ways of forming the sinusoidal shape 116 are envisaged. Alternatively, a sinusoidal shape can be imparted to the thrombectomy catheter 12. In such a case, at least a portion of the guide catheter 100 between the proximal and distal balloons 106 and 108 is sufficient to assume a sinusoidal shape when the thrombectomy catheter 12 is inserted into the guide catheter 100. High flexibility.

  As shown in FIG. 12, guide catheter 100 includes a series of openings 120a-120d positioned around the catheter to provide access to the vessel lumen from within guide catheter 100.

  In use, guide catheter 100 is intravascularly located using standard placement techniques (eg, using a guide wire) such that occlusive material is positioned between proximal balloon 106 and distal balloon 108. Can be positioned. Balloons 106 and 108 may be inflated to confine occlusive material between balloons within the vascular lumen. Thereafter, if necessary, a thrombolytic agent (eg, tPA) is intravascularly added through an additional lumen (not shown) provided in the guide catheter to chemically treat the occlusive material. Can be injected. The thrombolytic agent can be delivered into the vascular lumen through different passages of the guide catheter, but injecting the thrombolytic agent through the smaller diameter passage so that the thrombolytic agent is directed to the occlusive material with a velocity. Is advantageous.

  After the occlusive material has been treated with a thrombolytic agent, the thrombectomy catheter 12 can be inserted through the guide catheter 100. As illustrated in FIG. 11, the thrombectomy catheter 12 is preferably positioned within the guide catheter 100 at a position spaced a distance “D” from the sinusoidal apex “C”. Separating the distal end of thrombectomy catheter 12 at a distance “D” from apex “C” because the apex “C” in the form of a sine wave is positioned adjacent to the wall of vessel 102. Minimizing the possibility that the walls of the vessel 102 will be drawn into the fluid jet 50 (FIG. 5) and further maximizing device safety. After the thrombectomy catheter 12 is properly positioned within the guide catheter 100, the thrombectomy catheter 12 may be operated in the manner described above to remove additional occlusive material from the vessel 102.

  It is anticipated that guide catheter 100 and thrombectomy catheter 12 may be used together without first injecting a thrombolytic agent through the guide catheter. It is further anticipated that the thrombolytic agent can be injected into the vessel 102 through the thrombectomy catheter 12 (eg, through the injection lumen 32 of the catheter body 24).

  FIGS. 13 and 14 illustrate an alternative embodiment of the thrombectomy catheter disclosed herein, generally designated as 212 (FIG. 13) and 312 (FIG. 14). Catheter 212 and 213 are configured so that high pressure tubes 228, 328 are configured to direct high pressure jets 250, 350 into discharge lumens 230, 330 in a direction that is angled relative to the longitudinal axis of the catheter. Is substantially similar to In particular, the catheter 212 includes a high pressure tube 228 having a nozzle opening, the nozzle opening being along an axis J that defines an angle β between about 15 degrees and about 75 degrees with respect to the longitudinal axis K of the catheter 212. Direct high pressure jet 250. In one embodiment, β is between 30 degrees and 60 degrees, and may be about 45 degrees. The configuration of the catheter 212 facilitates easier entry of the catheter 212 into the occlusive material.

  Referring to FIG. 14, the catheter 312 includes a high pressure tube 328 that includes a nozzle opening that directs the high pressure jet 350 along an axis J that defines an angle β of about 90 degrees with respect to the longitudinal axis K of the catheter 312. Each of the catheters 212 and 312 includes an infusion lumen similar to the infusion lumen 32 contained within the catheter 12, but the infusion lumen is not shown.

  FIGS. 15 and 16 illustrate yet another alternative embodiment of the presently disclosed thrombectomy catheter, shown generally as 412. Catheter 412 includes an annular infusion lumen 432, a central drain lumen 430 and a high pressure supply tube 428. Supply tube 428 includes a curved portion 440 that defines a nozzle 440a. The nozzle 440 a is positioned to direct the fluid jet 450 into the distal end of the drain lumen 430. As illustrated, the catheter 412 can be integrally formed with the high pressure tube 428. Although not shown, a stiffer bent portion 440 can be provided at the distal end of the high pressure tube 428 to prevent deflection of the bent portion 440 caused by the jet 450 injection.

  FIGS. 17 and 18 illustrate yet another embodiment of a thrombectomy catheter, shown generally as 512. Catheter 512 includes an exhaust lumen 530, an infusion lumen 532, and a high pressure fluid supply lumen 528. The distal end of the high pressure fluid supply lumen 528 includes a bent portion 540 having a nozzle opening 540a. The nozzle opening 540 a is positioned to direct the fluid jet 550 into the distal end of the drain lumen 530. As illustrated, the infusion lumen 532 is centrally disposed in the catheter body 524 as opposed to the infusion lumen 432 of the catheter 412 that is annularly positioned about the catheter body 424.

  Other than the different orientations and configurations of the various lumens, the embodiment shown in FIGS. 15-18 is configured and operates similarly to the previous embodiment shown in FIGS. Variations in the injection lumens 432, 532 provide the ability to change the angular range of the injection lumen around the drain lumen at any angle between 0 and 360 °. In addition, the injection lumen 532 shown in FIGS. 17-18 provides injection directly adjacent to the cutting jet 550. Maximizing the angular range ensures a means of maximizing recirculation of the infused fluid and then minimizes the amount of blood drawn from the body lumen.

  FIG. 19 illustrates an alternative embodiment of the presently disclosed thrombectomy catheter, shown generally as 612. Catheter 612, similar to catheter 12, includes a catheter body 624 that defines an exhaust lumen 630, an infusion lumen 632, and a high pressure fluid supply lumen 628. The distal end of the high pressure fluid supply lumen 628 includes a bent portion 640 having a nozzle opening 640a. The nozzle opening 640 a is positioned to direct high pressure fluid into the drain lumen 630.

  The drain lumen 630 includes a dividing wall 660 that divides the drain lumen 630 into first and second drain lumen sections 630a and 630b. First drain lumen section 630a allows a portion of the fluid aspirated into first drain lumen section 630a to be recirculated into the body lumen in the direction indicated by arrow “X”. Channel 662 to be included. A filter 666 is provided at the entrance to the first drain lumen section 630a to prevent the passage of solid objects (eg, occlusive material and solid blood components) within the first drain lumen section 630a. In one embodiment, the filter 666 is positioned at an angle to direct solid matter that is filtered from fluid entering the first drain lumen section 630a into the second drain lumen section 630b. The proximal end of each of the drain lumen sections 630a and 630b communicates with a drain reservoir (eg, reservoir 18) as described above for the system 10 shown in FIG.

  Another embodiment of the thrombectomy catheter disclosed herein is shown generally as 712 in FIG. 20, and a second recirculation channel 770 is provided, as will be discussed in further detail below. Catheter 712 includes a body 724 that defines a high pressure fluid supply lumen 728 that includes a drain lumen 730, an infusion lumen (not shown), and a curved portion 740 having a nozzle opening 740a. The drain lumen 730 includes a dividing wall 760 that divides the drain lumen 730 into first and second drain lumen sections 730a and 730b. A first filter 766 is positioned at the distal end of the first drain lumen section 730a. The first filter 766, similar to the filter 666, prevents solids from passing into the first drain lumen section 730a and through the recirculation channel 762. The recirculation channel 762 allows a portion of the fluid entering the first drain lumen section 730a to return into the patient lumen. Catheter 712 has a second recirculation with filter 766 not angled, but filter 766 extending across first drain lumen section 730a (but filter 766 can be angled). Channel 770 differs from catheter 612 in that a portion of the fluid exiting second drain lumen section 730b is recirculated into high pressure fluid supply lumen 728. A second filter 772 is positioned in the recirculation channel 770. In one embodiment, the second filter 722 has a mesh size that allows fluids and very small solids (eg, less than 0.0005 inches) to pass into the supply lumen 728. In particular, the solid object should have a size that is at least an order of magnitude smaller than the diameter of the nozzle opening. By allowing solids to pass into the high pressure fluid supply lumen 728, effects such as sand blasting are achieved from the nozzle 740a, making the occluding material more efficient from the body lumen. To remove. Although not shown, the catheter 712 can be provided with only one of the recirculation channels 770 and 762. In addition, while it has been disclosed that solids are supplied from the discharge lumen 730 to the high pressure fluid supply lumen 728, the solids are directly supplied from the high pressure fluid supply 16 (FIG. 1). It is anticipated that it can be delivered to cavity 728.

  FIG. 21 illustrates another embodiment of the presently disclosed thrombectomy catheter shown generally as 812. Catheter 812 includes a catheter body 824 that defines an exhaust lumen 830 and an infusion lumen 832 and has a high pressure fluid supply lumen 828. High pressure fluid supply lumen 828 includes a curved portion 840 having a nozzle opening 840 a positioned to direct high pressure fluid into discharge lumen 830.

  The thrombectomy catheter 812 includes a chopped structure 876 in the drain lumen 830 to break the occlusive material. This helps to prevent clogging of the drain lumen 830 with occlusive material. The chopped structure 876 may include a component having a sharp cutting edge (eg, a lattice or perforated plate) that is positioned to break the occlusive material that is aspirated into the drain lumen 830. Alternatively, the shredding structure 876 is positioned at or along the wall of the rotatable turbine or grinder or the exhaust lumen 830 that rotates in response to fluid flow through the exhaust lumen 830. Various configurations including a series of grindable protrusions may be employed.

  FIG. 22 illustrates yet another embodiment of the presently disclosed thrombectomy catheter, shown generally as thrombectomy catheter 912. The thrombectomy catheter 912 includes a catheter body 924 that defines a drain lumen 930 and an infusion lumen 932 and has a high pressure fluid supply lumen 928 that includes a curved portion 940 and a nozzle opening 940a. Intact tip 960 is positioned around the distal end of thrombectomy catheter 912 and defines a window 980 between nozzle 940a and the entrance to drain lumen 930. A separator 982 (eg, a cage or shielding structure) is positioned over the window 980. Separator 982 minimizes the amount of tissue drawn into the cutting window 980 to minimize the potential for damage to the vessel caused by the vessel wall contacting the fluid jet 950. To do. Although not shown, separator 982 is slidably positioned about or within catheter 912 such that separator 982 can be selectively positioned across window 980 or moved away from window 980. obtain.

  Those skilled in the art will appreciate that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary and not limiting. The components and features illustrated or described in connection with one exemplary embodiment can be combined with the components and features of another exemplary embodiment without departing from the scope of the present disclosure. Is expected. For example, the sensors 80a-80c described for the thrombectomy catheter 12 shown in FIG. 2 may be incorporated into any of the thrombectomy catheters described herein. Similarly, those skilled in the art will appreciate further features and advantages of the disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims.

Claims (20)

A thrombectomy catheter system comprising:
A catheter including a catheter body defining an exhaust lumen and an infusion lumen, the catheter body including a high pressure tube that directs a fluid jet into a distal opening of the drain lumen. A catheter having a nozzle opening positioned to direct;
A source of infusion fluid in communication with the proximal end of the infusion lumen;
A fluid control device that is fluidly connected between the source of the blood plug removal catheter and infusion fluid, fluid control devices, infusion pipe of the blood plugs excised catheter from a source of infusion fluid A fluid control device adapted to regulate the flow rate of infusion fluid into the cavity ;
A recirculation channel positioned to recirculate fluid back from within the drain lumen into the body lumen;
A filter positioned upstream of the recirculation channel, wherein the filter is sized to prevent passage of solids in the recirculation channel ;
The drain lumen is divided into a first drain lumen section and a second drain lumen section by a dividing wall, and the filter and the recirculation channel are positioned in the first drain lumen section. A thrombectomy catheter system. The high pressure fluid source in communication with the high pressure tube, wherein the high pressure fluid source supplies the high pressure fluid to the high pressure tube at a pressure between 690 kPa and 69 MPa. The thrombectomy catheter system described in 1.   The positioning body further includes a substantially rigid positioning band secured to the distal end of the catheter body, the positioning band communicating with the draining lumen of the catheter body, and the infusion of the catheter body The thrombectomy catheter system according to claim 1 defining an infusion lumen in communication with the lumen.   The thrombectomy catheter system according to claim 3, wherein the high pressure tube is coupled to the positioning band.   The thrombectomy catheter system according to claim 3, wherein the high pressure tube extends through the catheter body and the infusion lumen of the positioning band.   The fluid control device includes an adjustable valve adapted to regulate a flow rate of the infusion fluid from the source of infusion fluid into the infusion lumen of the thrombectomy catheter. Thrombectomy catheter system.   The thrombectomy catheter system according to claim 6, wherein the adjustable valve is adapted to cyclically change the flow rate of infusion fluid to the thrombectomy catheter. The thrombectomy catheter system of claim 1, wherein the fluid control device includes a fluid pump that circulates infusion fluid from a source of the infusion fluid to a thrombectomy catheter. The thrombectomy catheter further comprises an intact tip , the intact tip comprising a pair of infusion channels communicating with the infusion lumen of a positioning band , a central cavity, and an upper opening, The thrombectomy catheter system of claim 1 , wherein a bent portion of the high pressure tube is positioned within the central cavity . It said injection channel extends distally of the bent portion of said high pressure tube, thrombectomy catheter system according to claim 9.   The thrombectomy catheter system of claim 1, further comprising a guide catheter defining a guide lumen dimensioned to receive the thrombectomy catheter, a proximal balloon, and a distal balloon.   The portion of the guide catheter between the proximal balloon and the distal balloon has a sinusoidal shape and defines a plurality of openings that provide access to the thrombectomy catheter. The thrombectomy catheter system as described. A portion of the guide catheter between the proximal balloon and the distal balloon is flexible and defines a plurality of openings that provide access to the thrombectomy catheter, flexibility, the blood plug removal catheter is inserted into the induction the catheter is such that the shape of the sine wave given to the thrombectomy catheter taken by the guiding catheter, according to claim 11 Thrombectomy catheter system.   The thrombectomy catheter system of claim 1, further comprising a sensor configured to measure pressure in the body lumen.   The thrombectomy catheter system according to claim 14, wherein the sensor is configured to control operation of the fluid control device. The filter, the first being positioned at one end of the exhaust lumen sections are angled to direct the solids to the second discharge lumen section to claim 1 The thrombectomy catheter system as described.   It further includes a chopped structure positioned within the drain lumen and configured to break occlusive material. The thrombectomy catheter system according to claim 1. The thrombectomy catheter system according to claim 17 , wherein the chopped structure comprises a grid having sharp cutting edges. The thrombectomy catheter system of claim 17 , wherein the shredded structure includes a rotatable turbine configured to grind occlusive material.   A body defining a cutting window between the nozzle opening and the entrance to the discharge lumen, and a separator positioned adjacent to the window to cover the window, the separator comprising: The thrombectomy catheter system of claim 1, wherein the thrombectomy catheter system is configured to minimize the amount of tissue that enters the cutting window.

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