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

• US 20050096692A1
• Filed: 09/09/2004
• Published: 05/05/2005
• Est. Priority Date: 09/12/2003
• Status: Active Grant

• 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.
• Granted Patent: US 8,535,344 B2
• Time in Patent Office: Days
• 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; and

(d) a second restraining means for restraining said filtering means, said second restraining means cooperating with said first restraining means.

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 first restraining means comprises a sleeve at least partially surrounding said plurality of struts and said filter media.

4. The filter device of claim 3, wherein said sleeve is secured at a distal end to at least one of said struts and a core member.

5. The filter device of claim 3, wherein said sleeve is secured at a proximal end to at least one of said struts.

6. The filter device of claim 3, 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.

7. The filter device of claim 6, wherein said second restraining means comprises at least two loops, said loops passing in opposite directions around a plurality of said struts to hold said filter in a desired position.

8. The filter device of claim 7, wherein said tether wire secures said loops around said plurality of struts.

9. 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.

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

11. The filter device of claim 10, wherein said pores are sized and configured to allow blood to flow through said filter media while blocking an occlusive material.

12. The filter device of claim 11, wherein said pores are between 50 and 200 micrometers in diameter.

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

14. The filter device of claim 13, wherein said guide member further includes a soft tip at said distal end.

15. 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 coupled to said guide member and having a proximal end and a distal end;

(c) a first restraining device for selectively restraining said filter assembly; and

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

16. The filter device of claim 15, 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.

17. The filter device of claim 16, wherein said first restraining device comprises a sleeve at least partially surrounding said plurality of struts and said filter.

18. The filter device of claim 17, wherein said sleeve is secured at a distal end to said distal end of said guide member.

19. The filter device of claim 17, wherein said sleeve is secured at a proximal end to at least one of said struts.

20. The filter device of claim 17, wherein said sleeve is releasably secured with a tether member, said tether member passing through a plurality of openings in said sleeve.

21. The filter device of claim 20, wherein said second restraining device comprises at least two loops, said loops passing in opposite directions around a plurality of said struts to hold said filter in a desired position.

22. The filter device of claim 21, wherein said tether wire secures said loops around said plurality of struts.

23. A method for capturing an embolic protection device having an emboli capturing mechanism that is disposed within a body lumen of a patient, the method comprising:

(a) a step for positioning a distal end of a capture catheter at a proximal end of the emboli capturing mechanism, the capture catheter having a capture sleeve that extends over a distal tip of the capture catheter when activated;

(b) a step for fixing a relative position of the capture catheter to the embolic protection device; and

(c) a step for activating the capture catheter to slide the capture sleeve over the distal tip and substantially enclose the emboli capturing mechanism of the embolic protection device.

24. The method as recited in claim 23, wherein the step for positioning comprises sliding the capture catheter along a guide member of the embolic protection device until movement of a distal end of the capture catheter is prevent by a proximal end of the emboli capturing mechanism.

25. The method as recited in claim 23, wherein the step for fixing comprises a step for holding a portion of the capture catheter against a portion of the embolic protection device.

26. The method as recited in claim 25, wherein the step for fixing further comprises a step for preventing movement of the capture catheter relative to the embolic protection device during the step for activating.

27. The method as recited in claim 25, wherein the step for fixing further comprises a step for clamping the capture catheter relative to the embolic protection device.

28. The method as recited in claim 27, wherein the step for clamping further comprises a step for clamping the capture catheter relative to the embolic protection device using at least one of a hemostat, a hemostat valve, and a clamping means for maintaining the relative position of one structure to another structure.

29. The method as recited in claim 23, wherein the step for activating comprises at step for moving a control member attached to the capture sleeve in a distal direction to move the capture sleeve in the distal direction.

30. The method as recited in claim 29, further comprising a step for moving a plunger disposed at a proximal end of the capture catheter, the plunger being connected to the control member.

31. The method as recited in claim 30, further comprising a step for moving the plunger within a barrel and relative to a visual representation of the emboli capturing mechanism depicted upon the barrel.