Thrombectomy apparatus and method

• US 8,430,837 B2
• Filed: 02/05/2008
• Issued: 04/30/2013
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: Walk Vascular, LLC (Abbott Laboratories)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Thielen, Joseph M.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US12/026,317
• Publication Number:
  US 20080255596A1
• Time in Patent Office: 1,911 Days
• Field of Search: 604/19
• US Class Current: 604/19
• 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 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A thrombectomy system may include an elongate shaft that defines a high pressure lumen and a low pressure lumen. The high pressure lumen may terminate near an end of the low pressure lumen. An expandable capture basket may be disposed near the end of the low pressure lumen. A thrombectomy apparatus may include an elongate shaft, an evacuation lumen extending within the elongate shaft and a high pressure lumen extending within the elongate shaft. A capture apparatus may be disposed within a wire lumen that extends within the elongate shaft such that the capture apparatus extends distally from the wire lumen.

Claims

1. A method of removing thrombi, the method comprising the steps of:

providing a thrombectomy apparatus comprising an elongate shaft defining a high pressure lumen and a low pressure lumen, the high pressure lumen terminating near a distal end of the low pressure lumen, and an expandable capture basket disposed generally adjacent the distal end of the low pressure lumen;

wherein the expandable capture basket includes an actuatable frame and a blood permeable membrane disposed over at least a portion of the frame;

advancing the thrombectomy apparatus to a desired location within a patient'"'"'s vasculature;

expanding the expandable capture basket;

capturing thrombi within the expandable capture basket;

providing a source of pressurized fluid in fluid communication with the high pressure lumen;

breaking apart the captured thrombi using the pressurized fluid; and

providing suction to the low pressure lumen to evacuate the broken apart thrombi.

2. The method of claim 1, wherein the actuatable frame comprises an actuation filament that can be advanced or withdrawn to open or close the expandable capture basket.

3. The method of claim 1, wherein the actuatable frame contacts a vessel wall when the expandable capture basket is expanded.

4. The method of claim 2, wherein the actuatable frame is secured at one end to an elongate wire and at an opposite end to the actuation filament.

5. The method of claim 4, wherein the elongate shaft further comprises a wire lumen, and the elongate wire extends through the wire lumen.

6. The method of claim 5, wherein the actuation filament also extends through the wire lumen.

7. The method of claim 4, wherein the actuatable frame comprises a first loop having a proximal end and a distal end, and a second loop having a proximal end and a distal end.

8. The method of claim 7, wherein the distal end of the first loop is secured to the proximal end of the second loop.

9. The method of claim 8, wherein the proximal end of the first loop is secured to the actuation filament and the distal end of the second loop is secured to the elongate wire.

10. The method of claim 1, wherein the distal end of the low pressure lumen forms an angled opening with respect to the axis of the elongate shaft.

11. The method of claim 10, wherein the high pressure lumen terminates near the most distal portion of the angled opening of the low pressure lumen.

12. The method of claim 11, wherein the high pressure lumen terminates in one or more jets directed within the low pressure lumen and generally directed proximal with respect to the opening of the low pressure lumen.

13. The method of claim 10, wherein the high pressure lumen terminates near the most proximal portion of the angled opening of the low pressure lumen.

14. The method of claim 13, wherein the high pressure lumen terminates in at least one jet directed within the low pressure lumen.

15. The method of claim 14, wherein the at least one jet is directed generally proximal with respect to the angled opening of the low pressure lumen.

16. The method of claim 10, wherein the angled opening of the low pressure lumen has an area less than the cross-sectional area of the low pressure lumen proximal the angled opening.

17. The method of claim 16, wherein the high pressure lumen terminates in at least one jet directed generally within the low pressure lumen.

18. The method of claim 1, wherein the high pressure lumen further comprises a plug inserted into the distal end of the high pressure lumen, wherein the plug includes a distal opening directed generally between perpendicular to the axis of the evacuation lumen and axially within the evacuation lumen in the proximal direction.

19. The method of claim 1, wherein the actuatable frame includes a first loop and a second loop, at least one of the first loop and the second loop being formed of a hollow tube having a lumen in fluid communication with the high pressure lumen.

20. The method of claim 19, wherein the actuatable frame includes one or more high pressure jets disposed at one or more locations along the actuatable frame, the one or more high pressure jets configured to break apart captured thrombi using the pressurized fluid.

21. A method of removing thrombi from within a vessel, the method comprising steps of:

capturing thrombi within a capture apparatus comprising an actuatable frame and a blood permeable membrane disposed over at least a portion of the frame, the membrane defining an interior of the capture apparatus therein;

advancing a thrombectomy catheter defining a high pressure lumen and an evacuation lumen into the interior of the capture apparatus;

disrupting the captured thrombi with a high pressure jet exiting a distal end of the high pressure lumen; and

suctioning the disrupted thrombi out of the interior of the capture apparatus through the evacuation lumen.

22. The method of claim 21, wherein the step of capturing thrombi is preceded by a step of actuating the actuatable frame to move the capture apparatus against a wall of the vessel in order to loosen thrombi from the vessel wall.

23. The method of claim 21, wherein the step of disrupting the captured thrombi comprises breaking the thrombi into smaller pieces so that they may pass through the evacuation lumen without clogging the evacuation lumen.

24. The method of claim 21, wherein the high pressure lumen extends alongside the evacuation lumen.

25. The method of claim 21, wherein the high pressure lumen is non-concentrically disposed within the evacuation lumen.

26. The method of claim 21, wherein the evacuation lumen extends to a distal end of the thrombectomy catheter.

27. The method of claim 26, wherein the high pressure lumen extends to a position proximate the distal end of the thrombectomy catheter.

28. The method of claim 21, wherein the evacuation lumen includes a side opening within the distal region of the thrombectomy catheter.

29. The method of claim 28, wherein the high pressure lumen extends to a position distal of the side opening.

30. The method of claim 28, wherein the high pressure lumen extends to a position midway across the side opening.

31. The method of claim 21, wherein the high pressure lumen comprises a jet orifice disposed at an end of the high pressure lumen.

32. The method of claim 21, wherein the high pressure lumen comprises a jet orifice disposed in a side of the high pressure lumen.