Embolic protection devices one way porous membrane

• US 6,656,351 B2
• Filed: 08/31/2001
• Issued: 12/02/2003
• Est. Priority Date: 08/31/2001
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Boyle, William J.
• Primary Examiner(s): Drodge, Joseph
• Assistant Examiner(s): Cecil, Terry K.
• Application Number:
  US09/945,151
• Publication Number:
  US 20030042186A1
• Time in Patent Office: 823 Days
• Field of Search: 606/200, 606/194, 604/106, 210/97, 210/136, 210/251, 210/359, 137/511
• US Class Current: 210/136
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. The filtering assembly is capable of allowing controlled backwards flow of blood through the filter assembly, or blocking the backwards flow entirely, during aspiration of embolic material trapped within the filter assembly.

Claims

1. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element, the wall of the filter element being capable of capturing embolic material while allowing fluid to flow from the interior volume to the exterior of the filter element; and

a flow control device mounted on the filter assembly in cooperation with the filter element, the flow control device configured to allow fluid to flow from the interior volume of the filter element through the filter element wall in a forward direction, but occluding the filter element wall to prevent flow in a backwards direction.

7. The embolic protection device of claim 1, wherein the filter element further includes a plurality of openings and the flow control device comprises a plurality of sheaths attached to the exterior of the filter element and configured to occlude at least portion of the plurality of openings.

8. The embolic protection device of claim 7, wherein the plurality of sheaths are integrally formed of the filter element.

9. The embolic protection device of claim 1, wherein the filter element includes a plurality of openings and the flow control device comprises at least one sheath configured to occlude at least one of the plurality of openings.

10. The embolic protection device of claim 1, wherein the flow control device is a flap configured to cooperate with the wall to allow fluid to flow through the wall from the interior of the filter element in a forward direction and to prevent flow through the wall in a backwards direction.

2. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element, the wall of the filter element being capable of capturing embolic material while allowing fluid to flow from the interior volume to the exterior of the filter element; and

a flow control device mounted on the filtering assembly in cooperation with the filter element, the flow control device configured to allow fluid to flow from the interior volume of the filter element through the filter element wall in a forward direction, but preventing flow through the filter element wall in a backwards direction, wherein the filter element further includes an opening in the wall providing fluid communication between the interior volume of the filter element and the exterior of the filter element, and the flow control device comprises a one-way valve configured to occlude the opening to prevent flow through the filter element in a backwards direction.

3. The embolic protection device of claim 2, wherein the one-way valve is a flexible flap attached to the filter element adjacent the opening such that the flexible flap has an open position when fluid flows through the opening from the interior of the filter element and has a closed position when aspiration is applied to the interior of the filter element.

4. The embolic protection device of claim 2, wherein the one-way valve is a sheath attached to the filter element in such a manner so as to occlude the opening and prevent fluid flow through the opening when aspiration is applied to the interior of the filter element.

5. The embolic protection device of claim 4, wherein the filter element includes a plurality of openings and the sheath is configured to occlude at least a portion of the plurality of openings.

6. The embolic protection device of claim 2, wherein the one-way valve is formed as part of the filter element.

11. An embolic protection device for capturing embolic debris released into a body vessel of a patient, comprising:

a shaft member having distal and proximal ends;

a filtering assembly rotatably mounted on the shaft member, the filtering assembly including

an expandable strut assembly and a filter element attached to the strut assembly for capturing embolic debris, the expandable strut assembly having a set of expandable struts, each strut having a first and second end, and

a deployment member movable between a collapsed position and an expanded position, wherein the first ends of the set of struts each are attached to the deployment member at different locations along the deployment member and the set of expandable struts are movable between a collapsed position and an expanded position, the filter element being movable with the struts to the expanded position so that at least a portion thereof contacts the wall of the vessel to capture embolic debris released into the body vessel; and

a flow control device mounted on the filter assembly in cooperation with the filter element, the flow control device configured to allow fluid to flow through the filter element but occluding the filter element to prevent flow in a backwards direction.

12. The embolic protection device of claim 11, wherein the filter element includes a central region having an inlet opening and defining a storage reservoir for capturing embolic debris, the central region having a plurality of openings adapted to allow blood to flow therethrough to an exterior of the filter element but capture embolic debris larger than the size of the openings and contain the debris within the reservoir and the flow control device is configured to prevent blood flow from the exterior of the filter element through at least a portion of the plurality of openings into the central region.

13. The embolic protection device of claim 12, wherein the flow control device comprises at least one flexible flap mounted on the filter element adjacent at least one of the plurality of openings such that the flexible flap has an open position when fluid flows through the at least one of the plurality of openings from the central region of the filter element and has a closed position when aspiration is applied to the central region of the filter element.

14. The embolic protection device of claim 12, wherein the flow control device is at least one sleeve attached to the filter element in such a manner so that the at least one sleeve occludes at least one of the plurality of openings and prevents fluid flow through the at least one opening when aspiration is applied to the central region of the filter element.

15. The embolic protection device of claim 11, wherein the flow control device is formed as part of the filter element.

16. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a filter element wall defining an interior volume of the filter element and an exterior of the filter element, the filter element wall having at least one opening sized to capture embolic material while allowing fluid to flow from the interior volume of the filter element to the exterior of the filter element; and

a flow control device mounted on the filter assembly in cooperation with the filter element, the flow control device configured to allow fluid to flow from the interior volume of the filter element through the at least one opening in a forward direction, but occluding the at least one opening to prevent flow in a backwards direction.

17. The embolic protection device of claim 16, wherein the flow control device comprises a one-way valve configured to occlude the at least one opening to prevent flow through the at least one opening in a backwards direction.

18. The embolic protection device of claim 17, wherein the one-way valve is a flexible flap joined to the filter element adjacent the at least one opening such that the flexible flap has an open position when fluid flows through the at least one opening from the interior of the filter element and has a closed position when aspiration is applied to the interior of the filter element.

19. The embolic protection device of claim 17, wherein the one-way valve is a sleeve attached to the filter element in such a manner so as to occlude the at least one opening and prevent fluid flow through the at least one opening when aspiration is applied to the interior of the filter element.

20. The embolic protection device of claim 19, wherein in the filter element includes a plurality of openings and the sleeve is configured to occlude at least a portion of the plurality openings.

21. The embolic protection device of claim 17, wherein the one-way valve is formed as part of the filter element.

22. The embolic protection device of claim 17, wherein the filter element further includes a plurality of openings and wherein the flow control device comprises a plurality of sleeves attached to the exterior of the filter element and configured to occlude at least portion of the plurality of openings.

23. The embolic protection device of claim 22, wherein the plurality of sleeves are integrally formed of the filter element.

24. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element, the wall allowing fluid to flow from the interior volume to the exterior of the filter element while capturing embolic material contained within the fluid; and

a one-way valve mounted on the filter assembly in cooperation with the filter element, the one-way valve configured to allow fluid to flow from the interior volume of the filter element through the wall in a forward direction, but to occlude the wall to prevent fluid flow in a backwards direction.

25. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element the wall allowing fluid to flow from the interior volume to the exterior of the filter element while capturing embolic material contained within the fluid; and

at least one flexible flap configured to cooperate with the wall to allow fluid to flow from the interior volume of the filter element through the wall in a forward direction and to occlude the wall to prevent flow in a backwards direction.

26. The embolic protection device of claim 25, wherein the wall has at least one opening and the at least one flexible flap is mounted to the filter element adjacent the at least one opening such that the at least one flexible flap has an open position to allow fluid to flow through the at least one opening from the interior volume of the filter element and has a closed position to prevent fluid flow from the exterior of the filter element through the at least one opening into the interior volume of the filter element.

27. The embolic protection device of claim 25, wherein the filter element includes a plurality of openings and a plurality of flexible flaps configured to cooperate with a portion of the plurality of openings.

28. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element, the wall allowing fluid to flow from the interior volume to the exterior of the filter element while capturing embolic material contained within the fluid; and

at least one sleeve configured to cooperate with the wall to allow fluid to flow from the interior volume of the filter element through the wall in a forward direction and to occlude the wall to prevent flow in a backwards direction.

29. The embolic protection device of claim 28, wherein the wall has at least one opening providing fluid communication between the interior volume of the filter element and the exterior of the filter element, the at least one sleeve being configured to allow fluid to flow through the at least one opening from the interior volume of the filter element to the exterior of the filter element and to prevent fluid flow from the exterior of the filter element through the at least one opening into the interior volume of the filter element.

30. The embolic protection device of claim 28, wherein the filter element includes a plurality of openings and the at least one sleeve is configured to allow fluid to flow through at least a portion of the plurality of openings from the interior volume of the filter element to the exterior of the filter element and to prevent fluid flow from the exterior of the filter element through the at least portion of the plurality of openings into the interior volume of the filter element.

31. The embolic protection device of claim 30, wherein the at least one sleeve includes a plurality of sleeves, each sleeve of the plurality of sleeves configured to cooperate with a portion of the plurality of openings to allow fluid to flow through the portion of the plurality of openings from the interior volume of the filter element to the exterior of the filter element and to prevent fluid flow from the exterior of the filter element through the portion of the plurality of openings into the interior volume of the filter element.

32. The embolic protection device of claim 31, wherein a portion of the plurality of openings do not cooperate with any of the plurality of sleeves.

33. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element and an exterior of the filter element, the wall of the filter element having a capability to capture embolic material while allowing fluid to flow from the interior volume to the exterior of the filter element; and

means mounted on the filtering assembly in cooperation with the wall for allowing fluid to flow from the interior volume of the filter element through the wall in a forward direction and for occluding flow through the wall in a backwards direction.

34. An embolic protection device for capturing embolic debris contained within a fluid flowing through a lumen of a vessel of a patient, comprising:

a filtering assembly having a filter element having a wall defining an interior volume of the filter element an exterior of the filter element, the wall of the filter element having a capability to capture embolic material while allowing fluid to flow from the interior volume to the exterior of the filter element; and

means mounted on the filtering assembly in cooperation with the wall for allowing fluid to flow from the interior volume of the filter element through the wall in a forward direction and for allowing some limited flow through the wall in a backwards direction.