Methods, systems, and devices for providing embolic protection

• US 20030004541A1
• Filed: 06/28/2002
• Published: 01/02/2003
• Est. Priority Date: 07/02/2001
• Status: Active Grant

• Current Assignee: Rubicon Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: Rubicon Medical, Inc. (Boston Scientific Corporation)
• Inventors: Edmiston, Daryl R., Linder, Richard J., Johnson, Steven W.
• Granted Patent: US 6,962,598 B2
• Time in Patent Office: Days
• 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 plurality of struts coupled to 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

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

2. A filter device as recited in claim 1, wherein each strut of said plurality of struts is adapted to extend outwardly away from a longitudinal axis of said lumen.

3. A filter device as recited in claim 1, 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.

4. A filter device as recited in claim 1, 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.

5. A filter device as recited in claim 1, 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.

6. A filter device as recited in claim 1, wherein said means for filtering comprises a filter, said filter comprising a plurality of pores.

7. A filter device as recited in claim 1, wherein said guide member comprises an atraumatic tip.

8. A filter device as recited in claim 1, wherein at least one of said plurality of struts is biased toward a longitudinal axis of said lumen.

9. A filter device as recited in claim 1, wherein at least one of said plurality of struts comprises an atraumatic tip coil.

10. A filter device as recited in claim 1, further comprising at least one radiopaque marker.

11. A filter device as recited in claim 1, wherein a portion of said guide member is made radiopaque.

13. A filter device as recited in claim 12, wherein each strut of said plurality of struts has at least one portion that has a cross-sectional dimension larger than at least one another portion thereof.

14. A filter device as recited in claim 12, wherein a length of each strut of said plurality of struts is varied to control a biasing force of each strut.

15. A filter device as recited in claim 12, wherein a curvature of each strut of said plurality of struts is varied to control a biasing force of each strut.

16. A filter device as recited in claim 12, wherein said filter comprises a plurality of pores, at least two of said plurality of pores being differently configured one from another.

17. A filter device as recited in claim 16, wherein each of said plurality of pores is sized in the range from about 50 microns to about 200 microns.

18. A filter device as recited in claim 12, wherein said restraining member is adapted to be moved in a proximal direction to enable said plurality of struts to extend outwardly.

19. A filter device as recited in claim 18, further comprising an actuating member coupled to said restraining member and extending substantially to said proximal end of said guide member, said actuating member being adapted to move in the proximal direction to move said restraining member in the proximal direction.

20. A filter device as recited in claim 12, wherein said restraining member is attached to each of said plurality of struts, said restraining member comprising at least one preferential separation region.

21. A filter device as recited in claim 20, 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.

22. A filter device as recited in claim 20, wherein said preferential separation region dissolves based upon a chemical reaction between said restraining member and said fluid.

23. A filter device as recited in claim 20, wherein said preferential separation region separates under the influence of at least one of heat, ultrasonic energy, or radio frequency energy.

24. A filter device as recited in claim 12, wherein said restraining member comprises a plurality of hoops, each of said plurality of hoops being adapted to receive a securing member.

25. A filter device as recited in claim 12, wherein said restraining member comprises a first portion and a second portion, said first and second portions being maintained substantially together by stitching a securing member through said restraining member substantially at said first portion and said second portion.

26. A filter device as recited in claim 12, wherein said restraining member comprises a first side and a second side, each side comprises a plurality of extensions.

27. A filter device as recited in claim 26, wherein one or more extensions of said plurality of extensions on said first end are offset from one or more extensions of said plurality of extensions on said second end.

28. A filter device as recited in claim 27, wherein each of said plurality of extensions are folded to form one or more channels through which a securing member is disposed to cause said restraining member to prevent said plurality of struts extending outwardly.

29. A filter device as recited in claim 12, 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 a securing member.

30. A filter device as recited in claim 12, wherein said restraining member comprises at least one flap coupled to said filter, said at least one flap being adapted to surround said plurality of struts and prevent said plurality of struts from extending outwardly.

12. 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 strut assembly coupled to said distal end of said guide member, said strut assembly comprising a plurality of struts, at least one of said plurality of struts being biased to extend outwardly away from a longitudinal axis of said lumen of said guide member;

(c) a filter coupled to at least one of said plurality of struts, said filter being adapted to filter material from fluid flowing in a fluid stream within which said filter is disposed; and

(d) a restraining member surrounding at least one of said plurality of struts and said distal end of said guide member, said restraining member being adapted to prevent said plurality of struts extending outwardly and subsequently release said plurality of struts when said filter is to be deployed into the fluid stream.

31. A filter device for percutaneous insertion into a blood vessel during a procedure, the filter device comprising:

(a) a guide member comprising a distal end, a proximal end, and a lumen extending from said distal end to said proximal end, said guide member being configured to act as an exchange guidewire;

(b) a filter assembly coupled to said guide member, said filter assembly comprising a filter adapted to filter material from a blood stream and a plurality of struts; and

(c) means for preventing said plurality of struts from extending outwardly to allow said filter to deploy into the blood stream in the blood vessel.

32. A filter device as recited in claim 31, wherein each of said plurality of struts is biased to open said filter.

33. A filter device as recited in claim 31, wherein said filter comprises an open proximal end and a closed distal end, said proximal end being adapted to conform to an inner surface of the blood vessel.

34. A filter device as recited in claim 31, wherein said filter opens in response to a force applied by the blood flowing through the blood vessel.

35. A filter device as recited in claim 31, wherein said filter is fabricated from at least one of a woven mesh material, a braided material, or a film material.

36. A filter device as recited in claim 31, wherein said filter comprises a material comprising a plurality of pores.

37. A filter device as recited in claim 36, wherein each of said plurality of pores is sized in the range from about 50 microns to about 200 microns.

38. A filter device as recited in claim 36, wherein a major axis and a minor axis of each of said plurality of pores is sized in the range from about 50 microns to about 200 microns.

39. A filter device as recited in claim 31, further comprising means for radiopacity coupled to at least one of said guide member, said filtering, said plurality of struts, and said means for preventing.

40. A filter device as recited in claim 39, wherein said means for radiopacity comprises at least one of (i) a plurality of markers fabricated from a radiopaque material (ii) a plurality of markers coated with a radiopaque material and (iii) a plurality of markers doped with a radiopaque material

41. A filter device as recited in claim 31, wherein said guide member comprises a flexible, atraumatic tip coupled to said filter assembly.

42. A filter device as recited in claim 41, wherein said tip extends through said filter.

43. A filter device as recited in claim 31, wherein said filter assembly is integral with said guide member.

44. A filter device as recited in claim 31, wherein said filter assembly is a separate assembly coupled to said guide member.

46. The filter device as recited in claim 45, wherein said actuating member is disposed in said lumen of said guide member.

47. The filter device as recited in claim 45, wherein said actuating member is partially disposed in said lumen of said guide member.

48. The filter device as recited in claim 45, wherein said proximal end of said filter, when deployed, is constrained against the vessel wall.

49. The filter device as recited in claim 45, wherein said guide member further comprises at least one radiopaque marker.

50. The filter device as recited in claim 45, wherein at least one of said plurality of struts is biased to extend inwardly to a center of said lumen.

51. The filter device as recited in claim 45, wherein disposed upon a distal end of the at least one of said plurality of struts is a coiled tip.

52. The filter device as recited in claim 51, wherein said coiled tip extends through said filter.

53. The filter device as recited in claim 51, wherein said coiled tip is coupled to said filter.

54. The filter device as recited in claim 51, wherein said coiled tip extends through an aperture in said filter.

55. The filter device as recited in claim 45, wherein said restraining member further comprises at least one preferential separation region.

56. The filter device as recited in claim 55, 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.

57. The filter device as recited in claim 45, wherein said restraining member comprises a plurality of apertures adapted to receive said actuating member.

58. The filter device as recited in claim 57, 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.

59. The filter device as recited in claim 58, 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.

60. The filter device as recited in claim 58, wherein said actuating member is adapted to be removed from said plurality of apertures to allow said plurality of struts to extend outwardly.

61. The filter device as recited in claim 58, wherein said actuating member is stitched through said restraining member.

62. The filter device as recited in claim 45, wherein said restraining member comprises a plurality of channels.

63. The filter device as recited in claim 62, 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.

64. The filter device as recited in claim 62, 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.

65. The filter device as recited in claim 45, where said plurality of struts are integrally coupled to said guide member.

66. The filter device as recited in claim 45, wherein said plurality of struts are separate members that are coupled to a distal end of said guide member.

67. The filter device as recited in claim 66, 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.

68. A filter device as recited in claim 66, wherein said restraining member comprises at least one flap coupled to said filter, said at least one flap being adapted to surround said plurality of struts and prevent said plurality of struts from extending outwardly.

45. 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; and

(iii) 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.