Methods, systems, and devices for deploying an embolic protection filter

• US 6,997,939 B2
• Filed: 06/28/2002
• Issued: 02/14/2006
• Est. Priority Date: 07/02/2001
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Baxter, Jessica R.
• Application Number:
  US10/186,292
• Publication Number:
  US 20030004540A1
• Time in Patent Office: 1,327 Days
• Field of Search: 606/191, 606/192, 606/194, 606/195, 606/198, 606/200, 606/159, 623/1.12, 623/1.23
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility

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 is cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

Claims

1. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device, the restraining mechanism comprising:

(a) a sleeve disposable substantially at a distal end of the filter device, said sleeve being attached to least one of the plurality of struts of the filter and applies a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly; and

(b) at least one actuating member at least partially interwoven with said sleeve, said at least one actuating member releasing said restraining force of said sleeve so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction.

2. A restraining mechanism as recited in claim 1, wherein said at least one actuating member is adapted to cause said sleeve to move in a proximal direction upon moving said at least one actuating member in said proximal direction.

3. A restraining mechanism as recited in claim 1, wherein said sleeve is coupled to at least two of said plurality of struts.

4. A restraining mechanism as recited in claim 1, wherein said sleeve comprises at least one preferential separation region.

5. A restraining mechanism as recited in claim 4, wherein said at least one actuating member cooperates with said at least one preferential separation region and is adapted to preferentially separate said sleeve at said at least one preferential separation region.

6. A restraining mechanism as recited in claim 1, wherein said sleeve includes a plurality of apertures adapted to receive a securing member.

7. A restraining mechanism as recited in claim 1, wherein said sleeve 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.

8. A restraining mechanism as recited in claim 7, wherein said apertures in said first end and second end alternately receive said securing member to apply said restraining force against the plurality of struts.

9. A restraining mechanism as recited in claim 8, wherein said securing member is adapted to be removed from said plurality of apertures to allow said plurality of struts to extend outwardly.

10. A restraining mechanism as recited in claim 1, wherein said actuating member is stitched through said sleeve.

11. A restraining mechanism as recited in claim 1, wherein said sleeve comprises a first end and a second end, each of said first end and said second end comprising a plurality of extensions.

12. A restraining mechanism as recited in claim 11, 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.

13. A restraining mechanism as recited in claim 11, wherein each of said plurality of extensions are folded to form an channel through which said at least one actuating member is disposed to apply the restraining force against the plurality of struts.

14. A restraining mechanism as recited in claim 1, wherein said sleeve further comprises a plurality of hoops, each of said plurality of hoops being adapted to receive said at least one actuating member.

15. A filter device as recited in claim 1, wherein said sleeve comprises a first portion and a second portion, said first portion and said second portion being maintained substantially together by stitching said at least one actuating member through said sleeve substantially at said first portion and said second portion.

16. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device, the restraining mechanism comprising:

(a) means for applying a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said means for apply the restraining force being attached to at least one of the plurality of struts of the filter; and

(b) at least one actuating member at least partially interwoven with said means for applying the restraining force, said at least one actuating member releasing said restraining force of said means for applying said restraining force and enabling the plurality of struts of the filter device to extend outwardly to deploy the filter as said at least one actuating member moves in a proximal direction.

17. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve attached to each of said plurality of struts, said sleeve comprising at least one preferential separation region.

18. A restraining mechanism as recited in claim 17, wherein said at least one actuating member cooperates with said at least one preferential separation region, said at least one actuating member being adapted to cause said means for applying the restraining force to preferentially separate at said at least one preferential separation region.

19. A restraining mechanism as recited in claim 17, wherein said preferential separation region dissolves based upon a chemical reaction between a material forming said means for applying the restraining force and a fluid within a body lumen.

20. A restraining mechanism as recited in claim 17, wherein said preferential separation region separates under the influence of at least one of heat, ultrasonic energy, or radio frequency energy.

21. A restraining mechanism as recited in claim 16, wherein said means for applying said restraining force comprises a plurality of hoops formed by a sleeve of said means for applying the restraining force, each of said plurality of hoops being adapted to receive said at least one actuating member.

22. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve having a first portion and a second portion, said first and second portions being maintained substantially together by stitching said at least one actuating member through said sleeve substantially at said first portion and said second portion.

23. A restraining mechanism as recited in claim 22, wherein said sleeve comprises a first side and a second side, each side comprises a plurality of extensions.

24. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a first side and a second side, each side comprises a plurality of extensions.

25. A restraining mechanism as recited in claim 24, 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.

26. A restraining mechanism as recited in claim 25, wherein each of said plurality of extensions being folded to form a channel through which said at least one actuating member is disposed to cause said sleeve to prevent said plurality of struts extending outwardly.

27. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve substantially surround the plurality of struts.

28. A restraining mechanism as recited in claim 27, wherein said sleeve is adapted to slide in a proximal direction upon moving said actuating member in the proximal direction.

29. A restraining mechanism as recited in claim 28, wherein said sleeve is a polymer sleeve.

30. A restraining mechanism as recited in claim 28, wherein said sleeve is a metallic sleeve.

31. A restraining mechanism as recited in claim 16, wherein said means for applying said restraining force comprises a plurality of tubular members attached to the plurality of struts of the filter.

32. A restraining mechanism as recited in claim 31, wherein said plurality of tubular members receive said at least one actuating member with respective lumens of said plurality of tubular members, the at least one actuating member preventing movement of adjacent tubular members of said plurality of tubular member to prevent the plurality of struts extending outwardly to deploy said filter.

33. A system as recited in claim 16, wherein said means for applying said restraining force comprises at least one flap formed in the filter, said flap being adapted to substantially surround the plurality of struts and prevent the plurality of struts extending outwardly to deploy said filter.

34. A method for releasing a plurality of struts of a filter device during a procedure, comprising:

(a) positioning a filter device in a vasculature of a patient, distal of a portion of a blood vessel to be accessed during a procedure, to collect emboli, the filter device comprising;

(i) a guide member comprising a distal end;

(ii) a plurality of struts cooperating with said distal end of said guide member;

(iii) a filter coupled to said guide member; and

(iv) a restraining member attached to at least one of said plurality of struts to prevent said plurality of struts from extending outwardly; and

(b) actuating an actuating member at least partially interwoven through at least a portion of said restraining member, wherein actuating said actuating member in a proximal direction releases said plurality of struts to deploy said filter, wherein following collecting emboli, said filter device and said actuating member are removed from the blood vessel.

35. The method as recited in claim 34, wherein actuating said actuating member comprises moving said actuating member in a proximal direction.

36. The method as recited in claim 34, wherein actuating said actuating member further comprises moving said actuating member in a proximal direction to remove said actuating member from cooperating with said restraining member.

37. The method as recited in claim 36, wherein said actuating member is stitched into said restraining member.

38. The method as recited in claim 36, wherein said restraining member further comprises one or more apertures and said actuating member cooperates with said one or more apertures to prevent said plurality of struts from extending outwardly.

39. The method as recited in claim 36, wherein said restraining member further comprises a first side with one or more extensions forming one or more first channels and a second side with one or more extensions forming one or more second channels, wherein said actuating member cooperates with said one or more first channels and said one or more second channels to prevent said plurality of struts from extending outwardly.

40. The method as recited in claim 36, wherein said restraining member further comprises one or more preferential separation regions, wherein said actuating member cooperates with said one or more preferential separation regions to prevent said plurality of struts from extending outwardly.

41. The method as recited in claim 40, wherein moving said actuating member in the proximal direction causes said actuating member to separate said restraining member at said one or more preferential separation regions.

42. The method as recited in claim 34, wherein actuating said actuating member comprises removing said actuating member from engaging with a plurality of tubular members coupled to said plurality of struts, said plurality of struts forming said restraining member.

43. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising:

(a) a sleeve disposable substantially at a distal end of the filter device to surround the plurality of struts of the filter device and apply a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said sleeve at least partially attached to at least one of the plurality of struts and having a proximal end, a distal end, and one or more preferential separation regions extending from said distal end toward said proximal end, and

(b) at least one actuating member at least partially interwoven with said sleeve, said at least one actuating member releasing said restraining force of said sleeve so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction to preferentially separate said sleeve, while at least a portion of said sleeve remains attached to at least one of the plurality of struts of the filter device.

44. The restraining mechanism of claim 43, wherein said at least one actuating member comprises a proximal end and a distal end, said proximal end being distal to a proximal end of said sleeve.

45. The restraining mechanism of claim 44, wherein said proximal end of said at least one actuating member is disposed between said sleeve and the plurality of struts.

46. The restraining mechanism of claim 43, wherein said at least one actuating member cuts said sleeve from a distal end of said sleeve toward a proximal end of said sleeve generally parallel to a longitudinal axis of said sleeve.

47. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts the restraining mechanism comprising:

(a) at least one flap formed on the filter of the filter device, said at least one flap substantially surrounding said plurality of struts to prevent said plurality of struts from moving outwardly; and

(b) at least one actuating member at least partially interwoven with said at least one flap, said at least one actuating member releasing said restraining force of said at least one flap so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction.

48. The restraining mechanism of claim 47, wherein a first portion of said at least one flag is coupled to a second portion of said at least one flag by an adhesive.

49. The restraining mechanism of claim 47, wherein said at least one flap is disposed between two struts of the plurality of struts.

50. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising:

(a) a sleeve disposable substantially at a distal end of the filter device to surround the plurality of struts of the filter device and apply a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said sleeve at least partially attached to at least one of the plurality of struts and having a first end and a second end, said first end comprising a plurality of first tongues and said second end comprising a plurality of second tongues offset from said plurality of second tongues, said first tongues and said second tongues forming a plurality of channels, and

(b) at least one actuating member disposed within said plurality of channels to maintain said plurality of first tongues and said plurality of second tongues relative one to another and prevent said plurality of struts extending outwardly to deploy the filter.

51. A restraining mechanism as recited in claim 50, wherein said at least one actuating member passes through said plurality of channels alternating between passing through a first channel of said plurality of first tongues and a second channel of said plurality of second tongues.

52. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising:

(a) a plurality of tubular members, each tubular member of said plurality of tubular members having a lumen therethrough and being attached to one of the plurality of struts of the filter device; and

(b) an actuating member disposed within said lumen of each tubular member of said plurality of tubular members as said lumen of each tubular member substantially align to prevent said plurality of struts extending outwardly to deploy the filter.

53. A restraining mechanism of claim 52, wherein said actuating member moves in a proximal direction to be removed from said lumen of each tubular member.

54. A restraining mechanism of claim 52, wherein each said tubular member is disposed upon an interior surface of each strut of said plurality of struts of the filter device.

55. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts the filter device having a proximal end and a distal end, the restraining mechanism comprising:

(a) a wire at least attached to and partially surrounding at least one of the plurality of struts, said wire forms a plurality of hoops having lumens therethrough, said wire forms one hoop of said plurality of hoops at a first location distant from the distal end of the filter device and at least partially surrounds the plurality of struts to form an another hoop of said plurality of struts at a second location closer to the distal end of the filter device than the first location of said one hoop; and

(b) at least one actuating member disposed within said lumens of each hoop of said plurality of hoots to prevent said plurality of struts extending outwardly to deploy the filter.

56. A restraining mechanism of claim 55, wherein said at least one actuating member moves in a proximal direction to be removed from said lumen of each tubular member.