Embolic protection device

• US 7,510,565 B2
• Filed: 01/05/2006
• Issued: 03/31/2009
• Est. Priority Date: 11/07/1997
• Status: Expired due to Fees

• Current Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Taylor, Charles, Maher, Padraig, Brady, Eamon, Vale, David, Gilson, Paul
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen
• Assistant Examiner(s): Tyson; Melanie
• Application Number:
  US11/325,480
• Publication Number:
  US 20060129182A1
• Time in Patent Office: 1,181 Days
• Field of Search: 606/200
• 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 filtration device for removing embolic material in body fluid, the filtration device having a pre-deployment state and a deployment state, comprising:

a guidewire having a longitudinal axis; and

a filter assembly comprising;

a first collar, the guidewire extending through the first collar, the first collar being slidably movable on the guidewire;

a second collar, the guidewire extending through the second collar, the second collar being slidably movable on the guidewire;

a filter element coupled to the first collar and the second collar, the filter element comprising a filter membrane and a filter support frame for the membrane;

the filter frame being collapsed in the pre-deployment state and the filter frame being expanded in the deployment state, the filter frame and collars being slidable in the pre-deployment and in the expanded deployment state;

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

the filter membrane having a proximal end which terminates distal of a proximal end of the filter support frame.

2. The device according to claim 1, wherein the second collar is spaced-apart along the guidewire from the first collar.

3. The device according to claim 2, wherein the second collar is located distal of the first collar.

4. The device according to claim 2, wherein the second collar is located proximal of the first collar.

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

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 element and permits the filter element and the retained embolic material to be retrieved from the vessel.

7. The device according t 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 element.

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

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

11. The device according to claim 1, wherein there are at least two fluid inlets.

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

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 membrane is made from a film material.

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

19. The device according to claim 1, wherein the filter membrane 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 which further includes at least one stop disposed on the guidewire.

22. The device according to claim 21, wherein the first collar is translatable along the axis of the guidewire towards the stop.

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

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

25. The device according to claim 2, wherein the filter frame comprises a number of wires, at least some of the wires being coupled to at least one collar.

26. The device according to claim 25, wherein the wires are coupled to the first collar.

27. The device according to claim 25, wherein the wires are coupled to the second collar.

28. The device according to claim 1, wherein a collar defines an abutment for engagement by a deployer.

29. The device according to claim 28, wherein the deployer comprises a sleeve for engagement with the abutment.

30. The device according to claim 28, wherein the deployer is slidable over the guidewire.

31. The device according to claim 1, wherein a collar defines an engagement element for docking with a retriever.

32. The device according to claim 31, wherein the retriever comprises a pre-shaped component for docking with the collar.