Embolic protection device

• US 7,837,701 B2
• Filed: 03/08/2005
• Issued: 11/23/2010
• Est. Priority Date: 11/07/1997
• Status: Expired due to Fees

• Current Assignee: Salviac Ltd. (Abbott Laboratories)
• Original Assignee: Salviac Ltd. (Abbott Laboratories)
• Inventors: Brady, Eamon, Vale, David, Taylor, Charles, Maher, Padraig, Gilson, Paul
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US11/073,936
• Publication Number:
  US 20060089663A1
• Time in Patent Office: 2,086 Days
• Field of Search: 606/200, 606/108, 606/191, 606/192, 606/198, 623/1.24
• 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 slops (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 for delivery to a treatment site and a deployment state for filtering the body fluid flowing within the vessel, 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 and axially slidable relative to the tubular member;

a filter coupled to the tubular member, the filter having at least one inlet opening provided towards a proximal end of the filter and a plurality of outlet openings, 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;

a filter frame attached to the tubular member, the filter frame coupled to the filter in the deployment state to maintain the inlet opening open, the filter frame being collapsed towards the guidewire in the pre-deployment state;

in the deployment state the center of the inlet opening being offset from the longitudinal axis of the guidewire; and

in the deployment state, rotation or distal translation imparted to the guidewire is not imparted to the filter.

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

3. The device according to claim 1 wherein the inlet opening of the filter in the deployment state is angled toward a distal end of the filter.

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

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

6. The device according to claim 5 wherein the filter frame is made from Nitinol wire.

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

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

9. The device according to claim 1 wherein the filter comprises a mesh.

10. The device according to claim 1 wherein the filter comprises Nitinol mesh.

11. The device according to claim 1 which further comprises 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.

12. The device according to claim 11 which further comprises 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.

13. The device according to claim 12 wherein a single member is both the delivery member and the retrieval member.

14. The device according to the claim 12 wherein the retrieval member comprises a pod for the reception of the filter.

15. The device according to claim 11 wherein the delivery member comprises a pod for the reception of the filter.

16. The device according to claim 1 comprising a proximal tubular member and a distal tubular member, the tubular members being spaced-apart along the longitudinal axis of the guidewire.

17. The device according to claim 16 wherein the distal tubular member comprises a radiopaque marker band.

18. The device according to claim 1 further comprising a stop to limit the extent of axial movement of the tubular member relative to the guidewire.

19. The device according to claim 18 wherein the stop is located distally of the proximal end of the filter.

20. The device according to claim 19 wherein the stop is located proximally of the distal end of the filter.

21. A vascular filtration device for removing embolic material in body fluid flowing within a vessel, the vascular filtration device having a pre-deployment state for delivery to a treatment site and a deployment state for filtering the body fluid flowing within the vessel, 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 and axially slidable relative to the tubular member;

a filter coupled to the tubular member, the filter having a single inlet opening provided towards a proximal end of the filter and a plurality of outlet opening, 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;

a wire frame coupled to the filter in the deployment state to maintain the inlet opening open, the wire frame being collapsed towards the guidewire in the pre-deployment state;

in the deployment state the center of the inlet opening being offset from the longitudinal axis of the guidewire; and

in the deployment state, rotation or distal translation imparted to the guidewire is not imparted to the filter.

22. The device according to claim 21 comprising a proximal tubular member and a distal tubular member, the tubular members being spaced-apart along the longitudinal axis of the guidewire.

23. The device according to claim 21 further comprising a stop to limit the extent of axial movement of the tubular member relative to the guidewire.

24. The device according to claim 23 wherein the stop is located distally of the proximal end of the filter.

25. The device according to claim 24 wherein the stop is located proximally of the distal end of the filter.

26. The device according to claim 23 wherein the stop is located proximally of the distal end of the filter.

27. The device according to claim 21 wherein the distal tubular member comprises a radiopaque marker band.

28. A vascular filtration system for removing embolic material in body fluid flowing within a vessel, the vascular filtration system having a pre-deployment state for delivery to a treatment site and a deployment state for filtering the body fluid flowing within the vessel, comprising:

a guidewire having a longitudinal axis;

a filter assembly comprising;

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

a filter coupled to the tubular member, the filter having at least one inlet opening provided towards a proximal end of the filter and a plurality of outlet opening, 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;

a filter frame coupled to the filter in the deployment state to maintain the inlet opening open, the filter frame being collapsed towards the guidewire in the pre-deployment state;

in the deployment state the center of the inlet opening being offset from the longitudinal axis of the guidewire;

in the deployment state, rotation or distal translation imparted to the guidewire is not imparted to the filter;

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; and

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;

a single member being both the delivery member and the retrieval member.

29. The system according to claim 28 comprising a proximal tubular member, and a distal tubular member, the tubular members being spaced apart along the longitudinal axis of the guidewire.

30. The system according to claim 28 further comprising a stop to limit the extent of axial movement of the tubular member relative to the guidewire.

31. The system according to claim 30 wherein the stop is located distally of the proximal end of the filter.

32. The system according to claim 31 wherein the stop is located proximally of the distal end of the filter.

33. The system according to claim 30 wherein the stop is located proximally of the distal end of the filter.

34. The system according to claim 28 wherein the distal tubular member comprises a radiopaque marker band.