Embolic protection device for use in interventional procedures

• US 6,511,496 B1
• Filed: 09/12/2000
• Issued: 01/28/2003
• Est. Priority Date: 09/12/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Steadham, Christopher L., Huter, Scott J., Huter, Benjamin C.
• Primary Examiner(s): Calvert, John J.
• Assistant Examiner(s): Hurley, Shaun R
• Application Number:
  US09/659,949
• Time in Patent Office: 868 Days
• Field of Search: 606/191, 606/192, 606/194, 606/200
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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

Abstract

An intravascular filter device for capturing embolic particles entrained in blood flowing in an arterial vessel during an interventional procedure. The filter includes an expandable strut assembly and a filtering medium. Each strut is coated with an elastic polymer in order to minimize trauma to an arterial lumen upon deployment of the filter and to ensure secure adhesion of the filtering medium to the struts. Attached to the coating of the strut assembly is the filtering medium which is formed from a thin elastic polymer membrane containing a plurality of holes which allow blood to pass through filter while capturing embolic particles. The filtering medium is attached to the layer of polymeric material by laser welding, ultrasonic welding or adhesive bonding.

Claims

1. A filter device for capturing embolic particles released into a vessel lumen of a patient, comprising:

an expandable strut assembly having a plurality of expandable struts adapted to move between a collapsed position and an expanded position;

a layer of polymeric material disposed on the expandable struts; and

a filtering element attached to the polymeric layer disposed on the struts which is movable with the struts to expand and contact the wall of the vessel lumen, wherein embolic debris entrained in the fluid flow of the vessel is captured by the filtering element as fluid flows through the filtering element.

2. The filter device of claim 1, wherein:

the expandable struts are self-expanding.

3. The filter device of claim 1, wherein:

the layer of polymeric material disposed on the expandable struts is selected from the group consisting of polyester, polyamide, polyethylene, polytetrafluoroethylene (“

PTFE”

), expanded polytetrafluoroethylene (“

ePTFE”

), polyurethane, FEP, EAA copolymer and polyolefin.

4. The filter device of claim 1, further including:

a shaft member having proximal and distal ends; and

wherein the expandable strut assembly is rotatably affixed to the shaft member.

5. The filter device of claim 1, wherein:

the filtering element is a thin elastic membrane.

6. The filter device of claim 5, wherein:

the elastic membrane has a thickness within the range of about 0.001 inches to about 0.005 inches.

7. The filter device of claim 5, wherein:

the elastic membrane is made from a material selected from the group consisting of polyurethane, polytetrafluoroethylene (“

PTFE”

), expanded polytetrafluoroethylene (“

ePTFE”

), polyamide, polyolefin, and polyethylene.

8. The filter device of claim 7, wherein:

the layer of polymeric material disposed on the expandable struts is selected from the group consisting of polyester, polyamide, polyethylene, polytetrafluoroethylene (“

PTFE”

), expanded polytetrafluoroethylene (“

ePTFE”

), FEP, polyurethane, EAA copolymer, and polyolefin.

9. The filter device of claim 1, wherein:

the layer of polymeric material is made from the same material which forms the filtering element.

10. The filter device of claim 1, wherein:

the layer of polymeric material is the same class of polymer as the material which forms the filtering element.

11. The filtering device of claim 10, wherein:

the filtering element and the layer of polymeric material disposed on the expandable struts are made from polyurethane.

12. The filtering device of claim 1, wherein:

the filtering element is bonded to the layer of polymeric material by laser welding.

13. The filter device of claim 1, wherein:

the filtering element is bonded to the layer of polymeric element by ultrasonic welding.

14. The filtering device of claim 1, wherein:

the filtering element is bonded to the layer of polymeric material by adhesive bonding.

15. The filtering device of claim 14, wherein:

the adhesive is a plastic adhesive.

16. The filtering device of claim 1, wherein:

the filtering element is bonded to the layer of polymer material by solvent bonding.

17. The filtering device of claim 1, wherein:

the strut assembly is made from stainless steel.

18. The filtering device of claim 1, wherein:

the strut assembly is made from nickel-titanium alloy.

19. The filtering device of claim 1, wherein:

the layer of polymeric material encapsulates the expandable struts of the strut assembly.

20. The filtering device of claim 1, wherein:

the layer of polymeric material encapsulates the entire outer surface of the strut assembly.

21. The filter device of claim 1, wherein:

the filtering element includes a leading edge having a pattern of alternating peak and valley regions which prevent the leading edge from entering into a restraining sheath all at one time.

22. The filter device of claim 21, wherein:

the peak portions are attachable to the struts of the expandable strut assembly.

23. The filter device of claim 21, wherein:

the depth of the valley region on the filter edge is a progressively larger dimension from an adjoining valley portion.

24. The filter device of claim 21, wherein:

the depth of the valley portion from the peak portion is the same for each adjacent valley portion.

25. The filter device of claim 21, wherein:

the height of the peak region on the filter edge is a progressively larger dimension from an adjoining peak portion.

26. The filter element of claim 21, wherein:

the height of the peak portion from the valley portion is the same for each adjacent peak portion.

27. The filter device of claim 26, wherein the filtering element is made from a material selected from the group consisting of polyurethane, polytetrafluoroethylene (“

PTFE”

), expanded polytetrafluoroethylene (“

ePTFE”

), polyamide, polyolefin, and polyethylene.

28. A filter device for capturing embolic particles released into a vessel lumen of a patient, comprising:

an inner shaft member having proximal and distal ends;

an expandable strut assembly rotatably connected to the inner shaft member having a plurality expandable struts adapted to move between a collapsed position and expanded position;

a layer of polymeric material disposed on the expandable struts; and

a filtering element made from an elastic polymeric material which is attached to the polymeric layer disposed on each strut and is movable with the struts to expand to contact the wall of the vessel lumen, wherein blood is forced to flow through the filtering element to capture embolic debris entrained in the fluid flow of the vessel.

29. The filter device of claim 28, wherein the layer of polymeric material disposed on the expandable struts is selected from the group consisting of polyester, polyamide, polyethylene, polytetrafluoroethylene (“

PTFE”

), expanded polytetrafluoroethylene (“

ePTFE”

), FEP, polyurethane, EAA copolymer, and polyolefin.

30. A filter device for capturing embolic particles released into a vessel lumen of a patient, comprising:

a plurality of expandable struts adapted to move between a collapsed position and an expanded position;

means for moving the struts between the collapsed and expanded positions;

a layer of polymeric material disposed on the expandable struts; and

a filtering element attached to the polymeric layer disposed on the struts which is movable with the struts to expand and contact the wall of the vessel lumen, wherein embolic debris entrained in the fluid flow of the vessel is captured by the filtering element as fluid flows through the filtering element.