Methods of manufacture and use of endoluminal devices

• US 8,597,322 B2
• Filed: 12/20/2012
• Issued: 12/03/2013
• Est. Priority Date: 04/01/2002
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Vonesh, Michael J.
• Primary Examiner(s): SEVERSON, RYAN J
• Application Number:
  US13/721,975
• Publication Number:
  US 20130184737A1
• Time in Patent Office: 348 Days
• Field of Search: 606/200, 264/299, 623/901
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A seamless, self-expanding implantable device having a low profile is disclosed along with methods of making and using the same. The implantable device includes a frame cut out of a single piece of material that is formed into a three-dimensional shape. The implantable device may comprise an embolic filter, stent, or other implantable structure. The present invention also allows complicated frame structures to be easily formed from planar sheets of starting material, such as through laser cutting, stamping, photo-etching, or other cutting techniques.

Claims

1. A device for occluding blood flow through a blood vessel of a patient, comprising:

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

an occluder media attached to the support member, wherein the occluder media is adapted to substantially obstruct blood flow through the occluder media.

2. The device of claim 1, wherein the positioning element comprises a guide wire.

3. The device of claim 1, wherein the positioning element comprises a support wire.

4. The device of claim 1, wherein the coupling feature comprises a threaded coupling.

5. The device of claim 1, wherein the coupling feature comprises a magnetic coupling.

6. The device of claim 1, wherein the coupling feature comprises a ball-and-socket coupling.

7. The device of claim 1, wherein the coupling feature comprises a male/female coupling.

8. The device of claim 1, wherein the coupling feature comprises a bayonet coupling.

9. The device of claim 1, wherein the occluder media substantially covers the support member.

10. The device of claim 1, wherein the support member is circumferentially disposed about an axis defined by the positioning element.

11. The device of claim 1, wherein the frame includes at least two support members, and wherein each strut of the plurality of struts extends in a generally proximal direction from a proximal support member of the at least two support members.

12. A method of occluding a blood vessel of a patient, comprising:

providing an occluder device that comprises;

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

an occluder media attached to the support member, wherein the occluder media is adapted to substantially obstruct blood flow through the occluder media;

positioning, using the positioning element, the occluder device at a deployment site within the blood vessel of the patient; and

detaching the positioning element from the connecting member.

13. The method of claim 12, further comprising, after detaching the positioning element from the connecting member, retrieving and repositioning the occluder device within the blood vessel of the patient.

14. The method of claim 12, further comprising, after detaching the positioning element from the connecting member, retrieving and removing the occluder device from the blood vessel of the patient.

15. The method of claim 12, wherein the positioning element comprises a guide wire.

16. The method of claim 12, wherein the positioning element comprises a support wire.

17. A method of occluding a blood vessel of a patient, comprising:

providing an occluder device that comprises;

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

an occluder media attached to the support member, wherein the occluder media is adapted to substantially obstruct blood flow through the occluder media;

positioning, using the positioning element, the occluder device at a first deployment site within the blood vessel of the patient;

moving, using the positioning element, the occluder device to a second deployment site within the blood vessel of the patient; and

detaching the positioning element from the connecting member.

18. The method of claim 17, wherein the moving of the occluder device using the positioning element to a second deployment site includes capturing the occluder device within a catheter.

19. A device for filtering blood in a blood vessel of a patient, comprising:

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

a filter media attached to the support member, wherein the filter media is adapted to permit blood to pass through the filter media to not permit embolic debris to pass through the filter media.

20. The device of claim 19, wherein the positioning element comprises a guide wire.

21. The device of claim 19, wherein the positioning element comprises a support wire.

22. The device of claim 19, wherein the coupling feature comprises a threaded coupling.

23. The device of claim 19, wherein the coupling feature comprises a magnetic coupling.

24. The device of claim 19, wherein the coupling feature comprises a ball-and-socket coupling.

25. The device of claim 19, wherein the coupling feature comprises a male/female coupling.

26. The device of claim 19, wherein the coupling feature comprises a bayonet coupling.

27. The device of claim 19, wherein the support member is circumferentially disposed about an axis defined by the positioning element.

28. The device of claim 19, wherein the frame includes at least two support members, and wherein each strut of the plurality of struts extends in a generally proximal direction from a proximal support member of the at least two support members.

29. The device of claim 28, wherein the at least two support members define a plurality of diamond-shaped cells of the frame.

30. The device of claim 19, wherein the blood vessel is an artery.

31. The device of claim 19, wherein the blood vessel is a vein.

32. The device of claim 19, wherein the blood vessel is the vena cava.

33. A method of filtering blood in a blood vessel of a patient, comprising:

providing a filter device that comprises;

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

a filter media attached to the support member, wherein the filter media is adapted to permit blood to pass through the filter media to not permit embolic debris to pass through the filter media;

positioning, using the positioning element, the filter device at a deployment site within the blood vessel of the patient; and

detaching the positioning element from the connecting member.

34. The method of claim 33, further comprising, after detaching the positioning element from the connecting member, retrieving and repositioning the filter device within the blood vessel of the patient.

35. The method of claim 33, further comprising, after detaching the positioning element from the connecting member, retrieving and removing the filter device from the blood vessel of the patient.

36. The method of claim 33, wherein the positioning element comprises a guide wire.

37. The method of claim 33, wherein the positioning element comprises a support wire.

38. A method of filtering blood in a blood vessel of a patient, comprising:

providing a filter device that comprises;

a unibody and seamless frame that includes a support member and a plurality of struts, wherein each strut of the plurality of struts extends from the support member to a connecting member that is detachably coupled to a positioning element via a coupling feature; and

a filter media attached to the support member, wherein the filter media is adapted to permit blood to pass through the filter media to not permit embolic debris to pass through the filter media;

positioning, using the positioning element, the filter device at a first deployment site within the blood vessel of the patient;

moving, using the positioning element, the filter device to a second deployment site within the blood vessel of the patient; and

detaching the positioning element from the connecting member.

39. The method of claim 38, wherein the moving of the filter device using the positioning element to a second deployment site includes capturing the filter device within a catheter.

40. A method of assembling a filter for filtering blood in a blood vessel of a patient, comprising:

providing a filter element;

providing a uni-body three-dimensional seamless filter frame; and

attaching the filter element to the filter frame by coating the filter frame with a fluorinated ethylene propylene material, placing the filter element in contact with the coated filter frame, and applying heat.

41. A method of assembling device for occluding blood flow through a blood vessel of a patient, comprising:

providing an occluder media;

providing a uni-body three-dimensional seamless frame; and

attaching the occluder media to the frame by coating the frame with a fluorinated ethylene propylene material, placing the occluder media in contact with the coated frame, and applying heat.