INVERTING THROMBECTOMY APPARATUSES AND METHODS

• US 20170348014A1
• Filed: 06/01/2017
• Published: 12/07/2017
• Est. Priority Date: 06/03/2016
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Wallace, Michael P., Greenhalgh, E. Skott
• Granted Patent: US 10,517,624 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2230/0056 W-shaped, e.g. M-shaped, sigma-shaped

Abstract

Rolling tractor tube mechanical thrombectomy apparatuses that may be deployed from out of a catheter in situ are described herein. These apparatuses may be delivered out of a catheter from a collapsed delivery configuration within the catheter to a deployed configuration out of the catheter, in which the same catheter is re-inserted between a tubular tractor and an elongate puller. In particular, any of these methods and apparatuses may be adapted to work with a tractor tube having an open end that is biased open, including using an annular bias.

Claims

1. A mechanical thrombectomy apparatus for removing a clot from a vessel, the apparatus comprising:

an elongate inversion support catheter having a distal end and a distal end opening;

an elongate puller extending within the elongate inversion support catheter;

a flexible tractor tube having a free first end and a second end that is coupled to a distal end region of the elongate puller, wherein the flexible tractor tube is inverted over the elongate puller and is held within the elongate inversion support catheter in a collapsed first configuration; and

an annular bias disposed at least partially around the free first end of the flexible tractor tube,

wherein the flexible tractor tube is configured to be extended from the distal end opening of the elongate inversion support catheter and to expand into an expanded second configuration, and

wherein the annular bias has a diameter that is larger than an outer diameter of the elongate inversion support catheter when the flexible tractor tube is in the expanded second configuration.

2. The apparatus of claim 1, wherein the annular bias comprises a ring.

3. The apparatus of claim 1, wherein the annular bias comprises a stent having a zig-zag strut pattern.

4. The apparatus of claim 1, wherein the annular bias has a diameter that is between 1.1×

and 5×

of the outer diameter of the elongate inversion support catheter when the flexible tractor tube is in the expanded second configuration.

5. The apparatus of claim 1, wherein the annular bias comprises a plurality of pre-determined collapse locations about which the annular bias is configured to collapse or expand.

6. The apparatus of claim 1, wherein the annular bias comprises a plurality of lobes, wherein the plurality of lobes comprise a respective plurality of collapse locations on the annular bias.

7. The apparatus of claim 1, wherein the annular bias is coupled to one or more of an inner side and an outer side diameter of the flexible tractor tube.

8. The apparatus of claim 1, wherein the annular bias comprises a plurality of lead-in arms oriented along a long axis of the flexible tractor tube.

9. The apparatus of claim 1, further wherein the flexible tractor tube in an un-inverted configuration is biased to expand to between 1.1 and 4 times an outer diameter of the elongate inversion support catheter and wherein the flexible tractor tube is further biased in an inverted configuration to expand to greater than 0.5×

an inner diameter of the elongate inversion support catheter.

10. The apparatus of claim 1, wherein the elongate inversion support catheter is configured to be pushed through the annular bias and between the flexible tractor tube and an outer wall of the elongate puller when the flexible tractor tube is in the expanded second configuration.

11. The apparatus of claim 1, wherein the flexible tractor tube comprises a woven, braided, mesh or knitted material.

12. The apparatus of claim 1, wherein the flexible tractor tube is sufficiently soft so as to collapse radially under an axial compression of less than 200 g of force.

13. The apparatus of claim 1, further comprising a guidewire lumen extending through the elongate puller, the guidewire lumen being configured to allow passage of a guidewire therethrough.

14. The apparatus of claim 1, wherein the flexible tractor tube is knitted.

15. The apparatus of claim 1, wherein the flexible tractor tube comprises one or more of steel, polyester, nylon, expanded Polytetrafluoroethylene (ePTFE), Nitinol, and a fabric.

16. The apparatus of claim 1, wherein a material hardness of the elongate inversion support catheter decreases along a length of the distal end thereof, wherein the distal end opening has a material hardness that is greater than a material hardness of a region immediately proximal to the distal end, and wherein the distal end opening has a rounded lip profile.

17. The apparatus of claim 1, wherein the elongate puller comprises a hypotube.

18. The apparatus of claim 1, wherein the flexible tractor tube has a length between 3 cm to 50 cm.

19. A mechanical thrombectomy apparatus for removing a clot from a vessel, the apparatus comprising:

an elongate inversion support catheter having a distal end and a distal end opening;

an elongate puller extending within the elongate inversion support catheter, wherein the elongate puller comprises a central lumen;

a flexible tractor tube having a free first end and a second end that is coupled to a distal end region of the elongate puller, wherein the flexible tractor tube comprises a woven, braided, mesh and/or knitted material, is inverted over the elongate puller, and is held within the elongate inversion support catheter in a collapsed first configuration, and wherein the flexible tractor tube is biased in an un-inverted configuration to expand to between 1.1 and 4 times an outer diameter of the elongate inversion support catheter in and is further biased in an inverted configuration to expand to greater than 0.5×

an inner diameter of the elongate inversion support catheter; and

an annular bias disposed at least partially around the free first end of the flexible tractor tube, wherein the flexible tractor tube is configured to be extended from the distal end opening of the elongate inversion support catheter and to expand into an expanded second configuration, wherein the annular bias has a diameter that is larger than an outer diameter of the elongate inversion support catheter in the expanded second configuration so that the elongate inversion support catheter may be pushed through the annular bias and between the flexible tractor tube and an outer wall of the elongate puller.

20. A method of deploying a mechanical thrombectomy apparatus for removing a clot from a vessel, the method comprising:

positioning an elongate inversion support catheter within a lumen of the vessel;

extending an elongate puller and a flexible tractor tube out of a distal end of the elongate inversion support catheter, wherein the flexible tractor tube has a free first end coupled to an annular bias and a second end that is coupled to a distal end region of the elongate puller, so that the flexible tractor tube expands from a collapsed first configuration within the elongate inversion support catheter into an expanded second configuration, and wherein the annular bias holds the flexible tractor tube open to a diameter that is larger than an outer diameter of the elongate inversion support catheter when the flexible tractor tube is in the expanded second configuration;

advancing the elongate inversion support catheter distally through the annular bias and between the flexible tractor tube and the elongate puller; and

pulling the elongate puller proximally to roll the flexible tractor tube over a distal end opening of the elongate inversion support catheter so that the flexible tractor tube inverts into the elongate inversion support catheter, wherein the flexible tractor tube is biased in an un-inverted configuration to expand to between 1.1 and 4 times an outer diameter of the elongate inversion support catheter and is further biased in an inverted configuration to expand to greater than 0.5×

an inner diameter of the elongate inversion support catheter within the elongate inversion support catheter.

21. The method of claim 20, further comprising retrieving a clot from within the vessel into the elongate inversion support catheter by rolling the flexible tractor tube over the distal end opening.

22. The method of claim 20, wherein positioning the elongate inversion support catheter within the lumen of the vessel comprises extending the elongate inversion support catheter over a guidewire.

23. The method of claim 20, wherein extending the elongate puller and the flexible tractor tube out of the distal end of the elongate inversion support catheter comprises pushing the elongate puller distally out of the elongate inversion support catheter.

24. The method of claim 20, wherein extending the elongate puller and the flexible tractor tube out of the distal end of the elongate inversion support catheter comprises expanding the annular bias, and wherein the annular bias comprises a stent coupled to the free first end of the flexible tractor tube.

25. The method of claim 20, wherein extending the elongate puller and the flexible tractor tube out of the distal end opening of the elongate inversion support catheter comprises extending a woven, braided, mesh and/or knitted material forming the flexible tractor tube out of the distal end opening of the elongate inversion support catheter.

26. The method of claim 20, further comprising supporting the flexible tractor tube over the distal end opening so that the flexible tractor rube does not radially collapse under axial compression, wherein the flexible tractor tube is sufficiently soft such that without support it collapses radially under an axial compression of less than 200 g of force.