Methods, systems, and devices for providing embolic protection and removing embolic material

• US 8,535,344 B2
• Filed: 09/09/2004
• Issued: 09/17/2013
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• Current Assignee: Rubicon Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: Rubicon Medical, Inc. (Boston Scientific Corporation)
• Inventors: Linder, Richard J., Edmiston, Daryl R., Johnson, Steven W.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US10/936,857
• Publication Number:
  US 20050096692A1
• Time in Patent Office: 3,295 Days
• Field of Search: 606/200, 606/108, 606/194, 606/198, 623/1.12, 623/1.11, 623/1.23
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection device includes a guide member having a distal end, a proximal end, and a lumen extending from the distal end to the proximal end. Additionally, the embolic protection device includes a filter assembly having a plurality of struts extending from the distal end of the guide member. The filter assembly further includes a filter media adapted to filter material from a blood stream coupled to at least two of the plurality of struts. The filter media can have an open proximal end and a closed distal end. The device can also include a sleeve at least partially surrounding the plurality of struts and the filter media for restraining the filter device in a collapsed position during an insertion procedure. The embolic protection device can also include additional loops of material surrounding the struts and a tether wire securing the sleeve and loops in the collapsed position.

Claims

1. 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 the distal end to the proximal end;

(b) filtering means for filtering material from a blood stream, said means being coupled to said guide member and having a proximal end and a distal end;

(c) a first restraining means for restraining said filtering means, wherein said first restraining means comprises a sleeve at least partially surrounding said filtering means, wherein said sleeve is releasably secured with a tether wire, said tether wire passing through a plurality of openings in said sleeve, said tether wire being at least partially releasable by an operator to allow deployment of said filter; and

(d) a second restraining means for restraining said filtering means, said second restraining means cooperating with said first restraining means in restraining said filtering means in an undeployed position.

2. The filter device of claim 1, wherein said filtering means comprises:

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

(b) a filter media coupled to at least two of said plurality of struts, said filter media comprising a plurality of pores configured to filter material from a blood stream.

3. The filter device of claim 2, wherein said filter media comprises at least one of a woven plastic mesh, a braided plastic mesh, a woven metallic mesh, a braided metallic mesh, a perforated polymer film, and a shape memory material mesh.

4. The filter device of claim 2, wherein said plurality of pores are at least one of circular, oval and polygonal in shape.

5. The filter device of claim 4, wherein said pores are sized and configured to allow blood to flow through said filter media while blocking an occlusive material.

6. The filter device of claim 5, wherein said pores are between 50 and 200 micrometers in diameter.

7. The filter device of claim 1, wherein said sleeve is secured at a distal end to at least one of said struts and a core member.

8. The filter device of claim 1, wherein said sleeve is secured at a proximal end to at least one of said struts.

9. The filter device of claim 1, wherein said second restraining means comprises at least two loops, said loops passing around a plurality of said struts to hold said filter in a undeployed position.

10. The filter device of claim 9, wherein said tether wire secures said loops around said plurality of struts.

11. The filter device of claim 1, wherein said guide member is steerable through the blood vessel.

12. The filter device of claim 11, wherein said guide member further includes a soft tip at said distal end.

13. 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 the distal end to the proximal end;

(b) a filter assembly for filtering material from a blood stream, said filter assembly being fixedly attached to said guide member and having a proximal end and a distal end;

(c) a first restraining device for selectively restraining said filter assembly, wherein said first restraining device comprises a sleeve at least partially surrounding said filter assembly, wherein said sleeve is releasably secured with a tether member, said tether member passing through a plurality of openings in said sleeve; and

(d) a second restraining device for selectively restraining said filter assembly.

14. The filter device of claim 13, wherein said filter assembly further comprises:

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

(b) a filter media coupled to at least two of said plurality of struts, said filter media selectively filtering material from a blood stream and having an open proximal end and a closed distal end.

15. The filter device of claim 14, wherein said sleeve is secured at a proximal end to at least one of said struts.

16. The filter device of claim 14, wherein said second restraining device comprises at least two loops, said loops passing around a plurality of said struts to hold said filter in a desired position.

17. The filter device of claim 16, wherein said tether wire secures said loops around said plurality of struts.

18. The filter device of claim 13, wherein said sleeve is secured at a distal end to said distal end of said guide member.

19. 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 the distal end to the proximal end;

(b) a filter assembly for filtering material from a blood stream, the filter assembly including a plurality of struts and a filter media, the filter assembly being fixedly attached to said guide member and having a proximal end and a distal end;

(c) a sleeve for restraining the filter assembly, wherein the sleeve at least partially surrounds the filter assembly,

(d) a tether wire releasably secured with the sleeve, the tether wire passing through a plurality of openings in the sleeve, the tether wire being at least partially releasable by an operator to allow deployment of the filter assembly.

20. The filter device of claim 19 further comprising at least two restraining loops for restraining said filter assembly, wherein the at least two restraining loops hold the filter assembly in a desired position.

21. The filter device of claim 19, wherein the plurality of struts extend from the distal end of said guide member, at least one of the plurality of struts being biased to extend outwardly, and a distal end of at least one strut of the plurality of struts moving independently of the other struts of the plurality of struts, and the filter media coupled to at least two of the plurality of struts, the filter media comprising a plurality of pores configured to filter material from a blood stream.

22. The filter device of claim 21, wherein said sleeve is secured at a distal end to at least one of said struts and a core member.

23. The filter device of claim 21, wherein said sleeve is secured at a proximal end to at least one of said struts.

24. The filter device of claim 19, wherein said filter media comprises at least one of a woven plastic mesh, a braided plastic mesh, a woven metallic mesh, a braided metallic mesh, a perforated polymer film, and a shape memory material mesh.

25. 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 the distal end to the proximal end;

(b) a filter assembly for filtering material from a blood stream, the filter assembly including a plurality of struts and a filter media, the filter assembly being coupled to said guide member and having a proximal end and a distal end;

(c) a restraining sleeve for restraining the filter assembly, wherein the sleeve at least partially surrounding the plurality of struts and filter media; and

(d) at least two restraining loops for restraining the filter assembly, the at least two restraining loops passing around a plurality of the struts to hold the filter assembly in an undeployed position.

26. The filter device of claim 25 further comprising a tether wire, wherein the sleeve is releasably secured with the tether wire, the tether wire passing through a plurality of openings in the sleeve, the tether wire being at least partially releasable by an operator to allow deployment of said filter assembly.

27. The filter device of claim 26, wherein the plurality of struts extend from the distal end of said guide member, at least one of the plurality of struts being biased to extend outwardly, and a distal end of at least one strut of the plurality of struts moving independently of the other struts of the plurality of struts, and the filter media coupled to at least two of the plurality of struts, the filter media comprising a plurality of pores configured to filter material from a blood stream.

28. The filter device of claim 27, wherein said sleeve is secured at a distal end to at least one of said struts and a core member.

29. The filter device of claim 27, wherein said sleeve is secured at a proximal end to at least one of said struts.

30. The filter device of claim 26, wherein said filter media comprises at least one of a woven plastic mesh, a braided plastic mesh, a woven metallic mesh, a braided metallic mesh, a perforated polymer film, and a shape memory material mesh.