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

• US 20030004540A1
• Filed: 06/28/2002
• Published: 01/02/2003
• Est. Priority Date: 07/02/2001
• 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 6,997,939 B2
• Time in Patent Office: Days
• 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 adapted to be disposed substantially at a distal end of the filter device, said sleeve being adapted to apply 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 coupled to said sleeve, said at least one actuating member being adapted to release said restraining force of said sleeve and enable the plurality of struts of the filter device to extend outwardly.

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 comprises a plurality of apertures adapted to receive a securing member.

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.

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 16, wherein said means for applying the restraining force comprises a first side and a second side, each side comprises a plurality of extensions.

24. A restraining mechanism as recited in claim 23, 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.

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

26. 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.

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 member, each of which is coupled to a respective one of the plurality of struts.

32. A restraining mechanism as recited in claim 31, wherein said plurality of tubular members are adapted to receive and cooperate with said at least one actuating member, wherein the cooperation between said plurality of tubular members and said at least one actuating member prevents 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.

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.

7. A restraining mechanism as recited in claim 7, 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.

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 coupled to at least one of the plurality of struts; and

(b) at least one actuating member cooperating with said means for applying the restraining force, said at least one actuating member being adapted to release said restraining force of said means for applying said restraining force and enable the plurality of struts of the filter device to extend outwardly to deploy the 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, 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 cooperating with said plurality of struts to prevent said plurality of struts from extending outwardly; and

(b) actuating an actuating member cooperating with said restraining member, wherein actuating said actuating member releases said plurality of struts to deploy said filter.