Cartridge embolic protection filter and methods of use

• US 7,001,406 B2
• Filed: 05/23/2002
• Issued: 02/21/2006
• Est. Priority Date: 05/23/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hansen, James G., Eskuri, Alan
• Primary Examiner(s): HO, UYEN T
• Application Number:
  US10/154,739
• Publication Number:
  US 20030220665A1
• Time in Patent Office: 1,370 Days
• Field of Search: 606/200
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

An embolic protection filter having a reduced profile for placement within a body lumen is disclosed. One embodiment has an embolic protection filter that includes a filter frame slidably and rotationally disposed along a guidewire, a plurality of retaining collars coupled to a proximal end of the filter frame, a plurality of expandable struts each having a proximal section adapted to slide within a corresponding retaining collar, and a filter mesh coupled to a distal section of the expandable struts for filtering embolic debris.

Claims

1. An embolic protection filter comprising:

a filter frame slidably and rotationally disposed along an elongate member, said filter frame having a proximal end and distal end;

a plurality of retaining collars coupled to the proximal end of said filter frame;

a plurality of expandable struts each having a proximal section and a distal section, the proximal section adapted to slide within the retaining collars, the distal section secured to the distal end of said filter frame, wherein, in use, said plurality of expandable struts are biased to radially expand from a collapsed, radially compact position to an open, radially expanded position;

a filter mesh coupled to said plurality of expandable struts for filtering embolic material; and

an actuator mechanism adapted to engage the proximal section of the struts and configured to place tension on the struts.

2. The embolic protection filter of claim 1, wherein said plurality of expandable struts are self-expanding within a body lumen upon actuation.

3. The embolic protection filter of claim 1, further comprising an advancing member for advancing the embolic protection filter along the elongate member.

4. The embolic protection filter of claim 3, wherein said advancing member comprises a tubular member.

5. The embolic protection filter of claim 1, further comprising an object at the proximal end of each one of said plurality of expandable struts, said object adapted to prevent each one of said plurality of expandable struts from exiting the retaining collars.

6. The embolic protection filter of claim 5, wherein said object is a weld bead.

7. The embolic protection filter of claim 1, wherein said actuator means is a tubular member having a proximal end and a distal end, the distal end defining a channel adapted to releasably lock onto the proximal ends of the struts.

8. The embolic protection filter of claim 1, wherein said plurality of expandable struts are comprised of a shape-memory material.

9. The embolic protection filter of claim 8, wherein said shape-memory material is nickel-titanium alloy.

10. The embolic protection filter of claim 1, wherein each of said plurality of expandable struts has a pre-formed bend region adapted to bias said plurality of expandable struts in an outward direction.

11. The embolic protection filter of claim 10, wherein said preformed bend region is centrally located along the length of each of said plurality of expandable struts.

12. The embolic protection filter of claim 1, wherein said filter mesh is attached to the distal section of said plurality of expandable struts.

13. The embolic protection filter of claim 1, wherein said filter mesh comprises a blood permeable sac.

25. The embolic protection filter of claim 1, wherein the actuator mechanism is configured to move the proximal end of the struts in the proximal direction relative to the filter frame.

26. The embolic protection filter of claim 25, wherein the filter is configured to move from an open position to a closed position when the actuator mechanism moves the proximal end of the struts in a proximal direction.

27. The embolic protection filter of claim 1, wherein the actuator mechanism is further adapted to push on the struts.

28. The embolic protection filter of claim 27, wherein the filter is configured to move from a closed position to an open position when the actuator mechanism pushes on the struts.

14. An embolic protection filter comprising:

a guidewire having a proximal end, a distal end, and a distal stop;

a filter frame slidably and rotationally disposed along the guidewire, said filter frame having a proximal end and a distal end;

a plurality of retaining collars coupled to the proximal end of said filter frame, each of said plurality of retaining collars defining a lumen;

a plurality of self-expanding struts each having a proximal section and a distal section, the proximal section adapted to slide within the lumen formed by a corresponding one of said plurality of retaining collars, the distal section secured to the distal end of said filter frame, wherein, in use, the plurality of self-expanding struts are biased to radially expand from a collapsed, radially compact position to an open, radially expanded position;

a filter mesh attached to the distal section of each one of said plurality of self-expanding struts, said filter mesh comprising a blood permeable sac;

an actuator mechanism for actuating said plurality of self expanding struts between the collapsed, radially compact position and the open, radially expanded position, the actuator mechanism adapted to engage the proximal section of the struts and configured to place tension on the struts; and

an advancing member for advancing the embolic protection filter along the guidewire.

15. The embolic protection filter of claim 14, wherein said advancing member comprises a tubular member.

16. The embolic protection filter of claim 14, further comprising an object at the proximal end of each of said plurality of self-expanding struts, said object adapted to prevent said plurality of self-expanding struts from exiting the lumen formed by the corresponding retaining collar.

17. The embolic protection filter of claim 16, wherein said object is a weld bead.

18. The embolic protection filter of claim 16, wherein said actuator mechanism is a tubular member having a proximal end and a distal end, the distal end defining a channel adapted to releasably lock onto said object.

19. The embolic protection filter of claim 14, wherein said plurality of expandable struts are comprised of a shape-memory material.

20. The embolic protection filter of claim 19, wherein said shape-memory material is nickel-titanium alloy.

21. The embolic protection filter of claim 14, wherein each of said plurality of expandable struts has a pre-formed bend region adapted to bias said plurality of self-expanding struts in an outward direction.

22. The embolic protection filter of claim 21, wherein said pre-formed bend region is centrally located along the length of each of said plurality of self-expanding struts.

23. A method of filtering embolic material from

a body lumen, comprising:

providing an embolic protection filter comprising a filter frame slidably and rotationally disposed along a guidewire, said filter frame having a proximal end and a distal end;

a plurality of retaining collars coupled to the proximal end of said filter frame, a plurality of expandable struts each having a proximal section and a distal section, the proximal section adapted to slide within the lumen formed by a corresponding one of said plurality of retaining collars, the distal section secured to the distal end of said filter frame; and

a filter mesh coupled to said plurality of expandable struts, and an actuator mechanism adapted to engage the proximal section of the struts and configured to place tension on the struts;

inserting the guidewire into a body lumen across a lesion;

advancing the embolic protection filter along the guidewire to a desired location distal the lesion;

actuating the plurality of expandable struts from a collapsed, radially compact position to an open, radially expanded position with the body lumen; and

collecting dislodged embolic material within the body lumen.

24. A method of filter embolic material from a body lumen as in claim 23, further comprising the step of removing the embolic protection filter and collected embolic material from the body lumen.

29. An embolic protection filter comprising:

a filter frame slidably and rotationally disposed along an elongate member, said filter frame having a proximal end and distal end;

a filter support structure that has an open position and a closed position and is predisposed to assume the open position;

a filter mesh covering at least a portion of the filter support structure wherein the position of the filter support structure covered by the filter mesh is called the filter zone, wherein the filter zone has an outer surface; and

an actuator mechanism adapted to engage a proximal section of the filter support structure and configured to place tension on the filter support structure, wherein the actuator mechanism is configured to move the proximal end of the filter support structure in the proximal direction relative to the filter frame.

30. The embolic protection filter of claim 29, wherein the filter support structure comprises a plurality of struts.

31. The embolic protection filter of claim 29, wherein a distal end of the filter support structure is attached to the filter frame.

32. The embolic protection filter of claim 29, the filter frame further comprising at least one collar at a proximal region of the filter frame.

33. The embolic protection filter of claim 32, wherein a proximal end of the filter support structure passes through the at least one collar.

34. The embolic protection filter of claim 29, wherein the filter is configured to move from an open position to a closed position when the actuator mechanism moves the proximal end of the filter support mechanism in a proximal direction relative to the filter frame.

35. The embolic protection filter of claim 29, wherein the actuator mechanism is further adapted to push on the filter support structure.

36. The embolic protection filter of claim 35, wherein the filter is configured to move from a closed position to an open position when the actuator mechanism pushes on the filter support structure.

37. The embolic protection filter of claim 29, wherein the embolic protection filter is configured to be actuated between open to closed positions while maintaining the outer surface in an unconstrained state.

38. The embolic protection filter of claim 29, wherein the embolic protection filter is configured to be delivered and deployed while maintaining the outer surface in an unconstrained state.

39. The embolic protection filter of claim 29 wherein the embolic protection filter is configured to be retrieved from a patient'"'"'s vasculature while maintaining the outer surface in an unconstrained state.