PRE-LOADED INVERTING TRACTOR THROMBECTOMY APPARATUSES AND METHODS

• US 20170303942A1
• Filed: 04/25/2017
• Published: 10/26/2017
• Est. Priority Date: 04/25/2016
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Stryker Corporation
• Inventors: Greenhalgh, E. Skott, Wallace, Michael P., Garabedian, Robert
• Granted Patent: US 9,962,178 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• 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 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3435 using everted sleeves
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

Mechanical thrombectomy apparatuses including an inverting, rolling conveyor region (“tractor”) at the distal end that are configured to grab and remove thrombus material. In particular, described herein are mechanical thrombectomy apparatuses that are adapted to prevent premature deployment of the tractor, e.g., by including a tractor hold (e.g., a housing, a lock, a clamp, etc.) or the like to secure the outer end of the tractor against and/or relative to the elongate inversion support.

Claims

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

a catheter having a proximal end and a distal end and a distal end opening;

a tractor comprising a flexible tube that extends within the catheter, inverts over the distal end opening of the catheter and extends over the distal end of the catheter, wherein the tractor is configured to invert by rolling over the distal end opening of the catheter when a first end of the tractor is pulled proximally within the catheter;

a puller coupled to the first end of the tractor, wherein the puller extends within the catheter to the proximal end of the catheter; and

a tractor hold attached to an outer diameter of the catheter proximal to the distal end of the catheter, wherein the tractor hold secures a second end of the tractor to an outside surface of the catheter until a force greater than a threshold force is applied by pulling the first of the tractor proximally within the catheter

wherein the threshold force is between 50 g of force and 500 g of force.

2. The apparatus of claim 1, further comprising a guidewire lumen extending through the catheter, the puller and the tractor, and configured to pass a guidewire.

3. The apparatus of claim 1, further wherein the tractor hold does not extend to the proximal end of the catheter.

4. The apparatus of claim 1, wherein the tractor hold extends proximally along the catheter for less than 10 cm.

5. The apparatus of claim 1, wherein the tractor hold compresses the tractor against the catheter.

6. The apparatus of claim 1, wherein the tractor hold is configured to hold the second end of the tractor until the threshold force is applied, wherein the threshold force is between 200 g of force and 500 g of force.

7. The apparatus of claim 1, wherein tractor is biased to expand beyond an outer diameter of the distal end of the catheter in a first relaxed configuration, further wherein the tractor is biased to expand to a second relaxed configuration having an outer diameter that is greater than an inner diameter of the distal end of the catheter, wherein the tractor converts between the first configuration and the second configuration by inverting.

8. The apparatus of claim 1, wherein a proximal end of the tractor hold is attached to the catheter.

9. The apparatus of claim 1, wherein the catheter comprises a larger outer diameter region and a smaller outer diameter region that is proximal to the larger outer diameter region, further wherein the tractor hold secures the tractor at one or more of:

over the smaller outer diameter region, and between the larger outer diameter region and the smaller outer diameter region.

10. The apparatus of claim 9, wherein an outer diameter of the tractor hold is flush with the larger outer diameter region.

11. The apparatus of claim 9, further comprising a stepped transition between the larger outer diameter and the smaller outer diameter.

12. The apparatus of claim 1, wherein the tractor hold comprises one or more of:

a polyether block amide, a polyolefin, a polyethylene, a polypropylene, a polyethylene terephthalate (PET), and a Polytetrafluoroethylene (PTFE).

13. The apparatus of claim 1, further comprising a tractor lock on the second end of the tractor, wherein the tractor lock engages with the tractor hold to secure the tractor lock on a proximal side of the tractor hold until the threshold force is applied by pulling the first of the tractor proximally within the catheter.

14. The apparatus of claim 13, wherein the tractor lock comprises a band configured to slide over the outer diameter of the catheter.

15. The apparatus of claim 13, wherein the tractor hold comprises a projection extending from the outer diameter of the catheter.

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

a catheter having a proximal end and a distal end and a distal end opening, wherein the catheter comprises a larger outer diameter region and a smaller outer diameter region that is proximal to the larger outer diameter region;

a tractor comprising a flexible tube that extends within the catheter, inverts over the distal end opening of the catheter and extends over the distal end of the catheter, wherein the tractor is configured to invert by rolling over the distal end opening of the catheter when a first end of the tractor is pulled proximally within the catheter;

a puller coupled to first end of the tractor, wherein the puller extends within the catheter to the proximal end of the catheter; and

a tractor hold on an outer diameter of the catheter proximal to the distal end of the catheter, wherein the tractor hold secures a second end of the tractor that extends over the distal end of the catheter until a force greater than a threshold force is applied by pulling the first of the tractor proximally within the catheter, further wherein the tractor hold secures the tractor at one or more of;

over the smaller outer diameter region, and between the larger outer diameter region and the smaller outer diameter region.

17. A method of removing a clot using a mechanical thrombectomy apparatus, the method comprising:

positioning a distal end of the mechanical thrombectomy apparatus adjacent to the clot within a vessel, wherein the mechanical thrombectomy apparatus includes a tractor region that extends along a distal region of a catheter and inverts over a distal end of the catheter so that a first end of the tractor extends proximally within the catheter;

disengaging a second end of the tractor from a tractor hold that secures the second end of the tractor to an outer diameter of the catheter by applying a first force that is greater than a threshold force to the first end of the tractor;

pulling the distal end of the tractor proximally within the catheter to roll the tractor over the distal end of the catheter so that the tractor inverts over the distal end of the catheter; and

drawing the clot into the catheter with the inverting tractor.

18. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging the second end of the tractor from a tractor hold attached to an outer diameter of the catheter.

19. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging the second end of the tractor from a tractor hold that extends proximally along the catheter for less than 10 cm.

20. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging the second end of the tractor from a tractor hold that is open at a distal-facing end and wherein a proximal end of the tractor hold is attached to the outer diameter of the catheter.

21. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging the second end of the tractor from a tractor hold that secures the second end of the tractor over a smaller outer diameter region of the catheter that is distal to a larger outer diameter region of the catheter.

22. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging the second end of the tractor from a tractor hold that secures the second end of the tractor between a larger outer diameter region of the catheter and a larger outer diameter region of the catheter, wherein the larger diameter outer region is distal to the smaller outer diameter region.

23. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises disengaging a tractor hold from a tractor lock, wherein the tractor lock is on the second end of the tractor.

24. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises compressing either or both the tractor hold and a tractor lock on the second end of the tractor so that the tractor lock moves from a position proximal to the tractor hold to a position that is distal to the tractor hold.

25. The method of claim 17, wherein disengaging the second end of the tractor from the tractor hold comprises pulling the first end of the tractor with the first force wherein the threshold force is between 50 g of force and 500 g of force.

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

a catheter having a proximal end and a distal end and a distal end opening;

a tractor comprising a flexible tube that extends within the catheter, inverts over the distal end opening of the catheter and extends over the distal end of the catheter, wherein the tractor is configured to invert by rolling over the distal end opening of the catheter when a first end of the tractor is pulled proximally within the catheter;

a puller having a proximal end and a distal end, wherein the first end of the tractor is coupled to the puller at a region that is proximal to the distal end, further wherein the puller extends within the catheter to the proximal end of the catheter;

a guidewire lumen extending through the catheter, the puller and the tractor, and configured to pass a guidewire.

27. The apparatus of claim 26, further comprising a stop between the distal end of the puller and the distal end opening.

28. The apparatus of claim 26, further comprising a stop on the puller between the distal end of the puller and the first end of the tractor, wherein first end of the tractor is coupled to a sliding ring configured to slide over the puller until it engages the stop.

29. The apparatus of claim 26, wherein there is 2 mm or greater distance between the distal end of the puller and the region of the puller to which the first end of the tractor is coupled.

30. The apparatus of claim 26, wherein the proximal end of the puller is configured to couple to a vacuum source.

31. The apparatus of claim 26, wherein the proximal end of the puller comprises a Tuohy-Borst valve/rotating hemostasis valve (RHV).