Embolic protection device

• US 6,645,224 B2
• Filed: 08/27/2001
• Issued: 11/11/2003
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Brady, Eamon, Vale, David, Taylor, Charles, Maher, Padraig, Gilson, Paul
• Primary Examiner(s): BUI, VY Q
• Assistant Examiner(s): Webb, Sarah
• Application Number:
  US09/938,548
• Publication Number:
  US 20020002384A1
• Time in Patent Office: 806 Days
• Field of Search: 606/200, 606/159, 606/194, 606/108, 604/96, 604/101-104
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped

Abstract

An embolic protection device has a collapsible filter element (105) mounted on a carrier such as a guidewire (101). The filter element (105) collapses into the outer end of a catheter (118) for deployment and retrieval through a vascular system of a patient. The filter element (105) has a collapsible filter body with a proximal inlet end and a distal outlet end. The proximal inlet end has inlet openings sized to allow blood and embolic material enter the filter body. The outlet end has outlet openings which allow through passage of blood but retain embolic material within the filter body. After use, the catheter (118) is movable along the guidewire (101) to engage the proximal end of the filter element and close the inlet openings before sliding over the filter element from the proximal end to the distal end to progressively collapse the filter body on the guidewire (101) for retrieval. The filter element (105) may conveniently be mounted on a tubular sleeve (104) which is slidable and rotatable on the guidewire (101) between spaced-apart stops (106, 120) on the guidewire (101) which allows some manipulation of the guidewire independently of the filter when the filter is in use.

Claims

1. A vascular filtration device for removing embolic material in body fluid flowing within a vessel, the vascular filtration device having a pre-deployment state and a deployment state, comprising:

a guidewire having a longitudinal axis; and

a filter assembly comprising;

a tubular member, the guidewire extending through the tubular member and being rotatable relative to the tubular member;

a filter frame coupled to the tubular member, the filter frame being collapsed and substantially adjacent the longitudinal axis of the guidewire in the pre-deployment state; and

a filter supported by the filter frame, the filter having at least one inlet opening provided at a proximal end of the filter and a plurality of outlet openings towards a distal end of the filter, the outlet openings allowing the body fluid to flow through the filter but retaining embolic material within the filter, and the inlet opening being larger than any of the outlet openings;

the tubular member extending substantially the entire length of the filter, the tubular member being adapted to be entirely inside the vessel in the deployment state, and in the deployment state the center of the inlet opening being offset from the longitudinal axis of the guidewire.

2. The device according to claim 1 wherein the filter is attached to the tubular member.

3. The device according to claim 1 wherein the tubular member is coupled to the outside wall of the filter.

4. The device according to claim 1 wherein the filter is attached to the tubular member along substantially the entire length of the filter.

5. The device according to claim 1 which further includes a delivery member for the filter assembly, wherein the filter frame and the filter are collapsed within the delivery member during the pre-deployment state, and upon release from the delivery member, the deployed filter frame supports the filter.

6. The device according to claim 5 which further includes a retrieval member for removing the filter assembly, wherein the retrieval member covers at least a portion of the filter and permits the filter and the retained embolic material to be retrieved from the vessel.

7. The device according to claim 6 wherein a single member is both the delivery member and the retrieval member.

8. The device according to claim 5 wherein the delivery member comprises a pod for the reception of the filter.

9. The device according to claim 6 wherein the retrieval member comprises a pod for the reception of the filter.

10. The device according to claim 1 wherein the inlet opening of the deployed filter is angled toward the distal end of the filter.

11. The device according to claim 1 wherein the inlet opening is a single fluid inlet.

12. The device according to claim 1 wherein the filter frame is provided at a proximal end of the filter.

13. The device according to claim 1 wherein the filter frame defines the inlet opening.

14. The device according to claim 1 wherein the filter frame is made from a shape memory material.

15. The device according to claim 1 wherein the filter frame is made from Nitinol.

16. The device according to claim 1 wherein the filter frame is made from wire.

17. The device according to claim 1 wherein the filter is made from a film material.

18. The device according to claim 1 wherein the filter is made from a shaped thin film material.

19. The device according to claim 1 wherein the filter is made from a polymeric material.

20. The device according to claim 19 wherein the polymeric material is polyurethane.

21. The device according to claim 1 wherein the filter is made using blow-moulding.

22. The device according to claim 1 wherein the filter is made using dip casting.

23. The device according to claim 1 wherein the filter is made using solution casting.

24. The device according to claim 1 wherein the filter is made using spin casting.

25. The device according to claim 1 wherein the filter is made using film welding.

26. The device according to claim 1 wherein the filter is made using adhesive joining.

27. The device according to claim 1 which further includes at least one tubular member stop disposed on the guidewire.

28. The device according to claim 3 which further includes at least one tubular member stop disposed on the guidewire.

29. The device according to claim 27 wherein a first tubular member stop is disposed on the guidewire proximally of the filter assembly.

30. The device according to claim 27 wherein a second tubular member stop is disposed on the guidewire distally of the filter assembly.

31. The device according to claim 27 wherein the tubular member is translatable along the axis of the guidewire towards the tubular member stop.

32. The device according to claim 1 wherein the filter has a predetermined pattern of outlet openings.

33. The device according to claim 32 wherein the outlet openings are laser drilled.

34. The device according to claim 5 wherein relative movement between the filter assembly and the delivery member causes deployment of the filter frame and the filter.

35. The device according to claim 29 wherein member terminates distally of the first tubular member stop.

36. The device according to claim 5 which further includes a tubular member stop, disposed proximally of the filter assembly, that fits inside the delivery member.

37. The device according to claim 1 which further includes a tapered tip disposed distally to the filter.

38. The device according to claim 37 wherein the tapered tip is attached to the guidewire.

39. The device according to claim 37 wherein the tapered tip is fabricated from a polymeric material.

40. The device according to claim 5 which further includes a tapered tip disposed distally to the filter, wherein the tapered tip engages the distal end of the delivery member.

41. The device according to claim 3 which further includes a tapered tip disposed distally to the filter.

42. The device according to claim 41 wherein the tapered tip is attached to the guidewire.

43. The device according to claim 41 wherein the tapered tip is fabricated from a polymeric material.

44. The device according to claim 5 which further includes a tapered tip disposed distally to the filter, wherein the tapered tip engages the distal end of the delivery member.

45. The device according to claim 27 which further includes a tapered tip disposed distally to the filter.

46. The device according to claim 45 wherein the tapered tip is attached to the guidewire.

47. The device according to claim 45 wherein the tapered tip is fabricated from a polymeric material.

48. The device according to claim 5 which further includes a tapered tip disposed distally to the filter, wherein the tapered tip engages the distal end of the delivery member.

49. The device according to claim 1 wherein the tubular member is adapted such that in the deployment state it is entirely inside the vessel distal of a lesion.

50. The device according to claim 1 wherein the tubular member is adapted such that in the deployment state it moves independently of the user.

51. The device according to claim 49 wherein the tubular member is adapted such that in the deployment state it moves independently of the user.

52. The device according to claim 1 wherein the tubular member is adapted for independent movement of the guidewire relative to the tubular member in the deployment state.

53. The device according to claim 49 wherein the tubular member is adapted for independent movement of the guidewire relative to the tubular member in the deployment state.