Medical device

• US 20040093013A1
• Filed: 03/31/2003
• Published: 05/13/2004
• Est. Priority Date: 06/23/2000
• Status: Active Grant

• Current Assignee: Salviac Ltd. (Abbott Laboratories)
• Original Assignee: Salviac Ltd. (Abbott Laboratories)
• Inventors: Brady, Eamon, Kelly, Ronald
• Granted Patent: US 7,452,496 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 2002/018 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

Abstract

A collapsible filter element (40) for a transcatheter embolic protection device (1). The filter element (40) comprises a collapsible filter body (41) which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element (40). A proximal inlet portion of the filter body (41) has two inlet openings (50) sized to allow blood and embolic material enter the filter body (41), and a distal outlet portion of the filter body (41) has a plurality of small outlet openings (51) to allow through-passage of blood, but to retain embolic material within the filter body (41). The filter body (41) is of an oriented polymeric material.

Claims

1. A collapsible filter element for a transcatheter embolic protection device, the filter element comprising:

a collapsible filter body which is movable between a collapsed stored position for movement through a vascular system and an expanded position for extension across a blood vessel such that blood passing through the blood vessel is delivered through the filter element;

a proximal inlet portion of the filter body having one or more inlet openings sized to allow blood and embolic material enter the filter body;

a distal outlet portion of the filter body having a plurality of outlet openings to allow through-passage of blood, but to retain embolic material within the filter body;

the filter body being of an oriented polymeric material.

2. A filter element as claimed in claim 1 comprising a collapsible support frame, the support frame being movable between a collapsed position for movement through the vascular system and an extended outwardly projecting position to support the filter body in the expanded position.

3. A filter element as claimed in claim 2 wherein the filter body is independent of the support frame.

4. A filter element as claimed in any preceding claim wherein the filter body comprises a membrane.

5. A filter element as claimed in any preceding claim wherein the filter body has a stored axial orientation in excess of 15%.

6. A filter element as claimed in any preceding claim wherein the filter body has a stored axial orientation in excess of 20%.

7. A filter element as claimed in any preceding claim wherein the filter body has a stored axial orientation in excess of 30%.

8. A filter element as claimed in any preceding claim wherein the filter body has a stored axial orientation in excess of 40%.

9. A filter element as claimed in any preceding claim wherein the material is biaxially oriented.

10. A filter element as claimed in any preceding claim wherein the filter body has a stored biaxial orientation in excess of 30%.

11. A filter element as claimed in any preceding claim wherein the filter body has a stored biaxial orientation in excess of 60%.

12. A filter element as claimed in any preceding claim wherein the filter body has a stored biaxial orientation in excess of 80%.

13. A filter element as claimed in any preceding claim wherein the filter body has a stored biaxial orientation in excess of 100%.

14. A filter element as claimed in any preceding claim wherein the ultimate tensile strength of the oriented polymeric material of the filter body is at least 15,000 psi (103.425 MPa).

15. A filter element as claimed in claim 14 wherein the ultimate tensile strength is at least 25,000 psi (172.375 MPa).

16. A filter element as claimed in claim 14 or 15 wherein the ultimate tensile strength is at least 35,000 psi (241.325 MPa).

17. A filter element as claimed in any of claims 14 to 16 wherein the ultimate tensile strength is at least 40,000 psi (275.8 MPa).

18. A filter element as claimed in any preceding claim wherein the material of the filter body is of polyester or polyamide.

19. A filter element as claimed in any preceding claim wherein the material of the filter body is of polyester.

20. A filter element as claimed in any preceding claim wherein the material of the filter body is selected from polyethyleneterephthalate (PET), polybutyleneterephthalate (PBT) and polynapthylterephthalate (PNT).

21. A filter element as claimed in any preceding claim wherein the material of the filter body is of PET.

22. A filter element as claimed in any of claims 1 to 18 wherein the material of the filter body is of polyamide.

23. A filter element as claimed in any of claims 1 to 17 wherein the material of the filter body is an elastomer.

24. A filter element as claimed in any of claims 1 to 17 or 23 wherein the material of the filter body is a polyurethane.

25. A filter element as claimed in any preceding claim wherein the polymeric material of the filter body is oriented at a temperature below the glass transition temperature of the material.

26. A filter element as claimed in any preceding claim wherein the material of the filter body is oriented by stretch blow moulding.

27. A filter element as claimed in any preceding claim wherein the filter body comprises a proximal body section, a distal body section and an intermediate body section interconnecting the proximal and distal body sections.

28. A filter element as claimed in any of claims 2 to 27 wherein the frame comprises a plurality of engagement segments, the engagement segments being spaced-apart longitudinally and transversely when the filter is in the deployed expanded configuration to urge the filter body into apposition with the vessel wall.

29. A filter element as claimed in claim 28 wherein the engagement segments define at least one at least partially substantially helical engagement track.

30. A method for manufacturing a filter body for a transcatheter embolic protection device comprising forming a filter body of oriented polymeric material.

31. A method as claimed in claim 30 wherein the filter body is formed by applying an axial stretching force to a hollow body of polymeric material.

32. A method as claimed in claim 30 or 31 wherein the filter body is formed by applying a circumferential force to a hollow body of polymeric material.

33. A method as claimed in any of claims 30 to 32 comprising stretch blow moulding a polymeric material.

34. A method as claimed in any of claims 30 to 33 wherein the polymeric material is oriented at a temperature above the glass transition temperature of the material or one of its phases, and below the melting temperature of the material.

35. A method as claimed in any of claims 30 to 34 comprising the step of conditioning the formed filter body.

36. A method as claimed in claim 35 wherein the conditioning is carried out at a temperature in the region of the crystallisation temperature of the material.

37. A method as claimed in any of claims 30 to 36 comprising providing inlet and outlet holes in the body of oriented material.

38. A method as claimed in claim 37 wherein the holes are provided by

filling the formed body with a filler material;

machining holes in the filled body; and

removing the filter material.

39. A method as claimed in claim 38 wherein the filler material is a soluble material, such as polyethyleneglycol.