THROMBECTOMY APPARATUS AND METHOD

• US 20080255596A1
• Filed: 02/05/2008
• Published: 10/16/2008
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: Walk Vascular, LLC
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Thielen, Joseph M.
• Granted Patent: US 8,430,837 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 thrombectomy system comprising:

an elongate shaft defining a high pressure lumen and a low pressure lumen,

the high pressure lumen terminating near an end of the low pressure lumen; and

an expandable capture basket disposed proximate the end of the low pressure lumen.

2. The thrombectomy system of claim 1, further comprising a source of pressurized fluid in fluid communication with the high pressure lumen such that the fluid forms at least one jet exiting the termination of the high pressure lumen.

3. The thrombectomy system of claim 1, further comprising a suction source in fluid communication with the low pressure lumen.

4. The thrombectomy system of claim 1, wherein the expandable capture basket comprises a membrane disposed over an actuatable filter frame.

5. The thrombectomy system of claim 4, wherein the actuatable filter frame comprises an actuation filament that can be advanced or withdrawn to open or close the expandable capture basket.

6. The thrombectomy system of claim 4, wherein the actuatable filter frame may be opened sufficiently to contact a vessel wall in which the thrombectomy apparatus is deployed.

7. The thrombectomy system of claim 5, wherein the actuatable filter frame is secured at one end to an elongate wire and at an opposite end to the actuation filament.

8. The thrombectomy system of claim 7, wherein the elongate shaft further comprises a wire lumen, and the elongate wire extends through the wire lumen.

9. The thrombectomy system of claim 8, wherein the actuation filament also extends through the wire lumen.

10. The thrombectomy system of claim 7, wherein the actuatable filter 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.

11. The thrombectomy system of claim 10, wherein the distal end of the first loop is secured to the proximal end of the second loop.

12. The thrombectomy system of claim 10, 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.

13. The thrombectomy system of claim 2, further comprising one or more high pressure fluid jets disposed in or near the expandable capture basket.

14. The thrombectomy system of claim 10, wherein at least one of the first loop and the second loop are in fluid communication with the high pressure lumen.

42. The thrombectomy system of claim 2, wherein the distal end of the low pressure lumen forms an angled opening with respect to the axis of the elongate shaft.

15. A thrombectomy apparatus comprising:

an elongate shaft having a distal region defining a distal end;

an evacuation lumen extending within the elongate shaft;

a high pressure lumen extending within the elongate shaft;

a wire lumen extending within the elongate shaft; and

a capture apparatus disposed within the wire lumen and extending distally therefrom.

16. The thrombectomy apparatus of claim 15, wherein the high pressure lumen extends alongside the evacuation lumen.

17. The thrombectomy apparatus of claim 15, wherein the high pressure lumen is disposed within the evacuation lumen.

18. The thrombectomy apparatus of claim 15, further comprising a guidewire lumen extending within the elongate shaft.

19. The thrombectomy apparatus of claim 15, wherein the capture apparatus is actuatable between an open configuration and a closed configuration.

20. The thrombectomy apparatus of claim 15, wherein the capture apparatus comprises a frame and a membrane disposed over the frame.

21. The thrombectomy apparatus of claim 20, wherein the membrane is at least substantially permeable to blood.

22. The thrombectomy apparatus of claim 15, wherein the evacuation lumen extends to the distal end of the elongate shaft.

23. The thrombectomy apparatus of claim 22, wherein the high pressure lumen extends to a position proximate the distal end of the elongate shaft.

24. The thrombectomy apparatus of claim 15, wherein the evacuation lumen includes a side opening within the distal region of the elongate shaft.

25. The thrombectomy apparatus of claim 24, wherein the high pressure lumen extends to a position distal of the side opening.

26. The thrombectomy apparatus of claim 24, wherein the high pressure lumen extends to a position midway across the side opening.

27. The thrombectomy apparatus of claim 15, wherein the high pressure lumen comprises a jet orifice disposed at an end of the high pressure lumen.

28. The thrombectomy apparatus of claim 15, wherein the high pressure lumen comprises a jet orifice disposed in a side of the high pressure lumen.

43. The thrombectomy system of claim 15, wherein the high pressure lumen terminates near the most distal portion of the angled opening of the low pressure lumen.

44. The thrombectomy system of claim 43, 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.

45. The thrombectomy system of claim 15, wherein the high pressure lumen terminates near the most proximal portion of the angled opening of the low pressure lumen.

46. The thrombectomy system of claim 45, wherein the high pressure lumen terminates in at least one jet directed within the low pressure lumen.

47. The thrombectomy system of claim 46, wherein the at least one jet is directed generally proximal with respect to the angled opening of the low pressure lumen.

48. The thrombectomy system of claim 15, 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.

49. The thrombectomy system of claim 48, wherein the at least one jet is directed generally within the low pressure lumen.

50. The thrombectomy apparatus of claim 15, wherein the high pressure lumen further comprises a plug associated with 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.

29. An assembly comprising:

a first catheter shaft segment comprising a suction lumen and a high pressure lumen; and

a second catheter shaft segment comprising a wire lumen and a capture apparatus disposed at least partially within the wire lumen.

30. The assembly of claim 29, wherein the first catheter shaft segment and the second catheter shaft segment are combined in a unitary catheter shaft.

31. The assembly of claim 29, wherein the first catheter shaft segment is formed as part of a first catheter and the second catheter shaft segment is formed as part of a second catheter that is distinct from the first catheter.

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

capturing thrombi within a capture apparatus;

disrupting the captured thrombi with a high pressure jet; and

suctioning the disrupted thrombi out of the vessel.

33. The method of claim 32, wherein the capture apparatus comprises an actuatable frame, and 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.

34. The method of claim 32, wherein the step of disrupting the captured thrombi comprises breaking the thrombi into smaller pieces so that they may pass through an evacuation lumen without clogging the evacuation lumen.

35. 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 an end of the low pressure lumen, and an expandable capture basket disposed generally adjacent the end of the low pressure lumen;

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 high pressure fluid source via the high pressure lumen to break apart the captured thrombi; and

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

36. A thrombectomy system comprising:

an elongate shaft defining a high pressure lumen and a low pressure lumen, the high pressure lumen terminating near the distal end of the low pressure lumen, wherein the high pressure lumen terminates in an distal opening directed generally between perpendicular to the axis of the low pressure lumen and axially within the low pressure lumen in the proximal direction.

37. The thrombectomy system of claim 36, further comprising a source of pressurized fluid in fluid communication with the high pressure lumen such that the fluid forms a Jet exiting the termination of the high pressure lumen.

38. The thrombectomy system of claim 36, further comprising a suction source in fluid communication with the low pressure lumen.

39. The thrombectomy system of claim 36, further comprising one or more high pressure fluid jets disposed at or near the distal end of the elongate shaft.

40. The thrombectomy system of claim 36, further comprising a plug associated with a distal end of the high pressure lumen, wherein the plug includes a distal opening directed generally between perpendicular to the axis of the low pressure lumen and axially within the low pressure lumen in the proximal direction.

41. 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 an end of the low pressure lumen;

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

providing a high pressure fluid source via the high pressure lumen to break apart the captured thrombi; and

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