Intravascular filtering membrane and method of making an embolic protection filter device

• US 20040138694A1
• Filed: 01/15/2003
• Published: 07/15/2004
• Est. Priority Date: 01/15/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Lin, Horng-Ban, Miller, Paul J., Crank, Justin M., Hansen, James G., Spencer, Steven M., Traxler, Richard J., Anderson, Narin, Tran, The Thomas Trinh, Smith, Mark S.
• Application Number:
  US10/342,546
• Publication Number:
  US 20040138694A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection filter device having a filtering membrane, an integrally formed waist, and a flexible hoop affixed to the filtering membrane by melt bonding. A method of making filtering membranes for an embolic protection filter device comprising blow molding the filtering membranes. A method of making an embolic protection filter device comprising blow molding a filtering membrane and simultaneously melt bonding a flexible hoop to the filtering membrane.

Claims

1. An embolic protection filter, comprising:

a flexible hoop; and

a filtering membrane melt-bonded to the flexible hoop at a first end.

2. The filter of claim 1, wherein the filtering membrane substantially encapsulates the flexible hoop.

3. The filter of claim 1, further comprising a polymeric tie layer between the filtering membrane and the flexible hoop.

4. The filter of claim 1, wherein the flexible hoop defines a lumen.

5. The filter of claim 4, wherein the flexible hoop includes a circumferential gap.

6. The filter of claim 1, wherein the flexible hoop comprises a shape memory alloy.

7. The filter of claim 1, wherein the filtering membrane defines a cavity having a lumen at the first end.

8. The filter of claim 1, wherein the filtering membrane comprises oriented polymer.

9. The filter of claim 1, wherein the filtering membrane comprises a polymer selected from the group consisting of polyether block amide, olefin/ionomer copolymers, nylon, polyurethane, polyethylene terephthalate, polyvinyl chloride, polyethylene naphthalene dicarboxylate and mixtures or copolymers thereof.

10. The filter of claim 1, wherein the filtering membrane has a thickness of between 0.0006″

and 0.0009″

.

11. The filter of claim 1, wherein the filtering membrane has a thickness of between 0.0003″

and 0.0006″

.

12. An embolic protection filter, comprising:

a flexible hoop;

a filtering membrane having a first end and a second end and a lumen extending therebetween, the filtering membrane disposed on the wire frame at the first end, and the filtering membrane being movable between an expanded position and a collapsed position; and

a waist integrally formed with the filtering membrane at the second end, the waist having a first end, a second end and a lumen extending therebetween.

13. The embolic protection filter of claim 12, further comprising an elongate member disposed longitudinally through the filter membrane and through the distal waist.

14. The embolic protection filter of claim 12, wherein the elongate member is heat bonded to the distal waist.

15. The embolic protection filter of claim 12, wherein the elongate member is laser bonded to the distal waist.

16. The embolic protection filter of claim 12, wherein the filtering membrane comprises an oriented polymer.

17. A method of manufacturing a filter, the method comprising the steps of:

providing a moldable tube having an outer surface and an inner surface;

providing a blow molding apparatus;

positioning the moldable tube in the blow molding apparatus;

blow molding the tube to form a membrane movable between a first expanded position and a second contracted position; and

forming a plurality of holes in the membrane to form a filtering membrane.

18. The method of claim 17, further comprising the step of shaping the outer surface of the tube.

19. The method of claim 17, wherein the blow molding apparatus includes a mold cavity having a region corresponding to the desired profile of the filtering membrane in an expanded position, and further comprising the steps of:

positioning a flexible hoop in the mold cavity; and

affixing the flexible hoop to the membrane during blowing.

20. The method of claim 19, further comprising the step of heating the flexible hoop.

21. The method of claim 19, further comprising the step of pre-encapsulating the flexible hoop with polymer.

22. The method of claim 19, further comprising the step of providing a tie layer between the flexible hoop and the polymer.

23. The method of claim 19, further comprising the step of providing means in the mold cavity to secure the flexible hoop.

24. The method of claim 23, wherein the means comprises a notch in the mold cavity.

25. The method of claim 23, wherein the means comprises a temporary adhesive selectively applied between the flexible hoop and the mold cavity.

26. The method of claim 23, wherein the means comprises additional shafts affixed to the flexible hoop.

27. The method of claim 17, further comprising the step of trimming the filtering membrane.

28. The method of claim 17, further comprising the step of blow molding the tube to form a waist integrally formed with the membrane.

29. The method of claim 28, further comprising the step of providing a lubricious layer on at least a portion of the inner surface of the tube.

30. The method of claim 28, further comprising the steps of:

providing an elongate member; and

heat welding at least a portion of the waist to the elongate member.

31. The method of claim 28, further comprising the step of laser welding at least a portion of the waist to the elongate member.

32. The method of claim 17, further comprising the steps of:

providing a strut;

providing an elongate member;

attaching the strut to the flexible hoop and to the elongate member.

33. A method of making two filters concurrently, the steps comprising:

providing a moldable tube having an inner surface and an outer surface;

providing a blow molding apparatus;

positioning the moldable tube in the blow molding apparatus;

blow molding the tube to form a membrane;

forming a plurality of holes in the membrane to form a porous membrane; and

removing excess material from the porous membrane to form a first filtering membrane and a second filtering membrane.

34. The method of claim 33, further comprising the step of providing a mold cavity having a first interior region corresponding in shape to the desired profile of a first filtering membrane and a second interior region corresponding in shape to the desired profile of a second filtering membrane.

35. The method of claim 34, wherein the first interior region and the second interior region are longitudinally aligned.

36. The method of claim 35, wherein the first interior region and the second interior region each have a first end and a second end, wherein the transverse cross sectional area of the first ends is less than the transverse cross sectional area of the second ends, and wherein the second ends of the first interior region and the second interior region face each other.

37. The method of claim 34, further comprising the steps of:

providing a first and a second flexible hoop; and

positioning the first and the second flexible hoops in the mold cavity.

38. The method of claim 37, further comprising the steps of:

providing a first strut having a first end attached to the first flexible hoop and a second end;

providing a second strut having a first end attached to the second flexible hoop and a second end; and

providing an attachment between the second end of the first strut and the second end of the second strut.

39. The method of claim 37, further comprising the step of providing two or more elongate members, each elongate member having a first end attached to the first flexible hoop and a second end attached to the second flexible hoop.

40. The method of claim 39, wherein the step of providing two or more elongate members includes the step of configuring the two or more elongate members to receive the moldable tube to position the first and the second flexible hoops with respect to the moldable tube.

41. The method of claim 40, wherein the moldable tube includes an indentation in the outer surface.