Methods, systems, and devices for providing embolic protection

• US 6,962,598 B2
• Filed: 06/28/2002
• Issued: 11/08/2005
• Est. Priority Date: 07/02/2001
• Status: Expired due to Term

• Current Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Original Assignee: Rubicor Medical Incorporated (Encapsule Medical Devices LLC)
• Inventors: Edmiston, Daryl R., Linder, Richard J., Johnson, Steven W.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US10/186,304
• Publication Number:
  US 20030004541A1
• Time in Patent Office: 1,229 Days
• Field of Search: 606/200, 606/191, 606/192, 606/194, 606/198, 606/113, 606/114, 606/127, 606/195, 623/1.11, 623/1.23
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/008 paraboloidal

Abstract

A filter device is adapted to function as a guidewire, an exchange guidewire, and provide embolic protection during a procedure. The filter device includes a filter assembly that is either integral with or coupled to a guide member. The filter assembly includes a plurality of struts that expand outwardly to deploy a filter that collects or captures material flowing along the blood vessel within which the filter device is deployed. The plurality of struts are constrained by a restraining member or mechanism that prevents the plurality of struts from expanding or extending outwardly to deploy the filter. Cooperating with the restraining member or mechanism is an actuating assembly that is adapted to release the restraining member or mechanism and enable the filter to be deployed from the guide member. A capture catheter that cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

Claims

1. A filter device comprising:

(a) a guide member comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end;

(b) a filter assembly coupled to said guide member, said filter assembly comprising;

(i) a filter comprising a proximal end with an opening formed therein; and

(ii) a plurality of struts coupled to said proximal end of said filter, each of said plurality of struts being biased to open said opening; and

(c) an actuating assembly coupled to said guide member and said filter assembly, said actuating assembly comprising;

(i) a restraining member cooperating with said plurality of struts, said restraining member applying a restraining force to the plurality of struts to prevent the plurality of struts from extending outwardly;

(ii) an actuating member coupled to said restraining member and extending toward said proximal end of said guide member, said actuating member is at least partially disposed in said lumen of said guide member; and

(d) an actuating element coupled to a proximal end of said actuating member, said actuating element being adapted to move in a proximal direction to release the restraining force to enable said plurality of struts to extend outwardly.

2. A filter device as recited in claim 1, wherein said actuating member is disposed in said lumen of said guide member.

3. The filter device as recited in claim 1, wherein said proximal end of said filter, when deployed, is constrained against the vessel wall.

4. The filter device as recited in claim 1, wherein said guide member further comprises at least one radiopaque marker.

5. The filter device as recited in claim 1, wherein at least one of said plurality of struts is biased to extend inwardly to a center of said lumen.

6. The filter device as recited in claim 1, wherein disposed upon a distal end of the at least one of said plurality of struts is a coiled tip that extends beyond a distal end of said filter when it is deployed.

7. The filter device as recited in claim 1, wherein said coiled tip extends through said filter.

8. The filter device as recited in claim 1, wherein said coiled tip is coupled to said filter and said top extends beyond a distal end of said filter when it is deployed.

9. The filter device as recited in claim 1, wherein said coiled tip extends through an aperture in said filter.

10. The filter device as recited in claim 1, wherein said restraining member further comprises at least one preferential separation region.

11. The filter device as recited in claim 10, further comprising at least one actuating member cooperating with said at least one preferential separation region, said at least one actuating member adapted to cause said restraining member to preferentially separate at said at least one preferential separation region.

12. The filter device as recited in claim 1, wherein said restraining member comprises a plurality of apertures adapted to receive said actuating member.

13. The filter device as recited in claim 12, wherein said restraining member comprises a first end and a second end, each of said first end and said second end comprising one or more of said plurality of apertures.

14. The filter device as recited in claim 13, wherein said apertures in said first end and second end alternately receive said actuating member to maintain said restraining member in a closed position to prevent said plurality of struts from extending outwardly.

15. The filter device as recited in claim 13, wherein said actuating member is adapted to be removed from said plurality of apertures to allow said plurality of struts to extend outwardly.

16. The filter device as recited in claim 13, wherein said actuating member is stitched through said restraining member.

17. The filter device as recited in claim 1, wherein said restraining member comprises a plurality of channels.

18. The filter device as recited in claim 17, wherein one or more channels of said plurality of channels on said first end are offset from one or more channels of said plurality of channels on said second end.

19. The filter device as recited in claim 17, wherein each of said plurality of channels is adapted to receive said actuating member so that said sleeve prevents said plurality of struts extending outwardly.

20. The filter device as recited in claim 1, where said plurality of struts are integrally coupled to said guide member.

21. The filter device as recited in claim 1, wherein said plurality of struts are separate members that are coupled to a distal end of said guide member.

22. The filter device as recited in claim 21, wherein said restraining member comprises at least one tubular member coupled to at least one of said plurality of struts, said at least one tubular member being adapted to receive said actuating member.

23. A filter device as recited in claim 21, wherein said restraining member is formed from at least one flap extending from said filter, each flap passing through a gap between adjacent struts of said plurality of struts and surrounding said plurality of struts to prevent said plurality of struts from extending outwardly.

24. A filter device comprising:

(a) a guide member comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end,

(b) a plurality of struts extending from the distal end of said guide member, at least one of said plurality of struts being biased to extend outwardly, each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a length of each strut is varied to control a biasing force of each strut;

(c) a filter coupled to at least two of said plurality of struts, said filter being adapted to filter material from a blood stream and having an open proximal end and a closed distal end; and

(d) means for preventing said plurality of struts extending outwardly until said filter is to be deployed into a blood vessel.

25. A filter device as recited in claim 24, wherein each strut of said plurality of struts is adapted to extend outwardly away from a longitudinal axis of said lumen.

26. A filter device as recited in claim 24, wherein each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a cross-sectional dimension of said distal portion is larger than a cross-sectional dimension of said intermediate portion.

27. A filter device as recited in claim 24, wherein each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a curvature of each strut is varied to control a biasing force of each strut.

28. A filter device as recited in claim 24, wherein said means for filtering comprises a filter, said filter comprising a plurality of pores.

29. A filter device as recited in claim 24, wherein said guide member comprises an atraumatic tip.

30. A filter device as recited in claim 24, wherein at least one of said plurality of struts is biased toward a longitudinal axis of said lumen.

31. A filter device as recited in claim 24, wherein at least one of said plurality of struts comprises an atraumatic tip.

32. A filter device as recited in claim 24, further comprising at least one radiopaque marker.

33. A filter device as recited in claim 24, wherein a portion of said guide member is made radiopaque.

34. A filter device comprising:

(a) a guide member comprising a distal end, a proximal end, and a lumen extending from the distal end to the proximal end;

(b) a plurality of struts extending from the distal end of said guide member, at least one of said plurality of struts being biased to extend outwardly;

(c) a filter coupled to at least two of said plurality of struts, said filter being adapted to filter material from a blood stream and having an open proximal end and a closed distal end; and

(d) means for preventing said plurality of struts extending outwardly until said filter is to be deployed into a blood vessel, said means for preventing comprising a restraining member cooperating with said plurality of struts and applying a restraining force to said plurality of struts and an actuating member selectively coupled to said restraining member, said actuating member is at least partially disposed within said lumen of said guide member and extends toward said proximal end of said guide member.

35. A filter device as recited in claim 34, wherein each strut of said plurality of struts is adapted to extend outwardly away from a longitudinal axis of said lumen.

36. A filter device as recited in claim 34, wherein each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a cross-sectional dimension of said distal portion is larger than a cross-sectional dimension of said intermediate portion.

37. A filter device as recited in claim 34, wherein each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a length of each strut is varied to control a biasing force of each strut.

38. A filter device as recited in claim 34, wherein each strut of said plurality of struts comprises a proximal portion separated from a distal portion by an intermediate portion, wherein a curvature of each strut is varied to control a biasing force of each strut.

39. A filter device as recited in claim 34, wherein said means for filtering comprises a filter, said filter comprising a plurality of pores.

40. A filter device as recited in claim 34, wherein said guide member comprises an atraumatic tip.

41. A filter device as recited in claim 34, wherein at least one of said plurality of struts is biased toward a longitudinal axis of said lumen.

42. A filter device as recited in claim 34, wherein at least one of said plurality of struts comprises an atraumatic tip coil.

43. A filter device as recited in claim 34, further comprising at least one radiopaque marker.

44. A filter device as recited in claim 34, wherein a portion of said guide member is made radiopaque.