Embolic protection device

• US 7,833,242 B2
• Filed: 12/28/2006
• Issued: 11/16/2010
• 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:
  US11/617,249
• Publication Number:
  US 20070185526A1
• Time in Patent Office: 1,419 Days
• Field of Search: 606/200, 606/108, 606/191, 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 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 method for the capture of embolic material during an interventional vasculature procedure comprising the steps of:

advancing a guidewire through a vasculature;

advancing over the guidewire a collapsible embolic protection filter having a collapsed configuration;

deploying the filter downstream in a treatment location; and

introducing separate from the embolic protection filter an interventional catheter over the guidewire to the treatment location for carrying out the interventional procedure, embolic material generated during the procedure being captured by a deployed filter;

wherein the filter is mounted on a sleeve, the sleeve having a proximal end near a proximal end of the filter, wherein the sleeve is rotatably disposed on the guidewire when the filter is in an expanded deployed configuration.

2. A method as claimed in claim 1 wherein the filter is carried by a delivery sheath and the filter and the delivery sheath are advanced along the guidewire.

3. A method as claimed in claim 2 further comprising the step of removing the delivery sheath from the filter at the deployment location.

4. A method as claimed in claim 3 wherein shape memory properties in the filter expands the filter on removal of the delivery sheath from the filter.

5. A method as claimed in claim 3 comprising withdrawing the delivery sheath from the deployment location.

6. A method as claimed in claim 5 wherein the delivery sheath is withdrawn from the deployment location after deployment of the filter.

7. A method as claimed in claim 1 further comprising the step of withdrawing the filter from the treatment location.

8. A method as claimed in claim 7 which further includes the step of withdrawing the guidewire after withdrawal of the filter.

9. A method as claimed in claim 1 further comprising the steps removing the interventional catheter from the treatment location;

and advancing a capture sheath over the guidewire.

10. A method as claimed in claim 9 further comprising the steps engaging the filter with the capture sheath;

and

withdrawing the filter and the capture sheath from the treatment location.

11. A method as claimed in claim 1 wherein the filter is slidably disposed on the guidewire when the filter is in an expanded deployed configuration.

12. A method as claimed in claim 1 further comprising:

loading the filter in a collapsed configuration within a delivery catheter;

advancing the delivery catheter and the filter over the guidewire to deliver the filter to the deployment location; and

deploying the filter from the delivery catheter at the deployment location.

13. A method as claimed in claim 12 further comprising:

collapsing the filter from an expanded configuration for loading the filter into the delivery catheter;

the filter expanding to a deployment configuration on release from the delivery catheter.

14. A method as claimed in claim 1 wherein the treatment location is a region of stenosis.

15. A method as claimed in claim 14 wherein the interventional procedure includes a balloon dilation of the stenosis while the filter is deployed.

16. A method as claimed in claim 14 wherein the interventional procedure includes placing a stent at the treatment location while the filter is deployed.

17. A method as claimed in claim 1 wherein the filter comprises a filter body and a filter frame which supports the filter body in the deployed configuration.

18. A method according to claim 1 wherein the filter expands from shape memory properties in the collapsed filter.

19. A method according to claim 1 wherein the filter expands from shape memory properties in a filter support made from a memory material.

20. A method according to claim 19 wherein the memory material is an alloy.

21. A method according to claim 20 wherein the alloy is Nitinol.

22. A method according to claim 19 wherein the memory material is a polymer.

23. A method according to claim 19 wherein the memory material is stainless steel.

24. A method according to claim 19 wherein the memory material comprises compressible foam.

25. A method according to claim 1 wherein the filter is delivered to the treatment location in a pod.