Methods of manufacture and use of endoluminal devices

• US 8,795,322 B2
• Filed: 11/20/2012
• Issued: 08/05/2014
• Est. Priority Date: 04/01/2002
• Status: Active Grant

• 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
• Application Number:
  US13/682,257
• Publication Number:
  US 20130144327A1
• Time in Patent Office: 623 Days
• Field of Search: 606/127, 606/128, 606/159, 606/200
• 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. An embolic protection filter, comprising:

a unibody and seamless frame that includes a support member and a plurality of struts that extend in a generally proximal direction from the support member to a connecting member that is coupled to a guide wire;

a filter media that includes a base portion and a closed tapered portion, the base portion defining an open proximal end of the filter media and extending in a generally distal direction from the support member, wherein the closed tapered portion of the filter media is inverted toward the open proximal end of the filter media, and wherein an end region of the closed tapered portion of the filter media is located proximal of the open proximal end of the filter media.

2. The embolic protection filter of claim 1, wherein the support member is disposed about the guide wire.

3. The embolic protection filter of claim 1, wherein the support member is disposed about an axis defined by the guide wire.

4. The embolic protection filter of claim 1, wherein the connecting member is cooperatively associated with the guide wire.

5. The embolic protection filter of claim 1, wherein the filter media has a generally conical shape before it is inverted.

6. The embolic protection filter of claim 1, wherein the end region of the closed tapered portion of the filter media is located closer to the connecting member than to the open proximal end of the filter media.

7. The embolic protection filter of claim 1, wherein the guide wire extends through the end region of the closed tapered portion of the filter media.

8. The embolic protection filter of claim 1, wherein the filter media has a sombrero shape.

9. The embolic protection filter of claim 1, wherein the end region of the closed tapered portion of the filter media is rounded.

10. The embolic protection filter of claim 1, wherein the filter media further includes an intermediate region between the base portion and the closed tapered portion, and wherein the intermediate region is located distally of the base portion, and is located distally of the closed tapered portion.

11. The embolic protection filter of claim 10, wherein a distal-most portion of the intermediate region of the filter media has a circular cross section.

12. The embolic protection filter of claim 1, wherein the filter media is adapted to allow blood to pass through the filter media, and is adapted to trap embolic material by not allowing the embolic material to pass through the filter media.

13. A method of removing embolic debris from a vessel of a patient, comprising:

deploying a thrombectomy device distal of a thrombus in the vessel of the patient, the thrombectomy device comprising a filter media and a unibody and seamless frame that includes a support member and a plurality of struts that extend in a generally proximal direction from the support member to a connecting member that is coupled to a guide wire, wherein the filter media extends in a generally distal direction from the support member;

providing a proximally directed force at the guide wire to cause the frame of the thrombectomy device to be pulled at least partially through the thrombus, wherein the support member is adapted to shear thrombatic material of the thrombus as the frame of the thrombectomy device is pulled at least partially through the thrombus, and wherein the filter media is adapted to capture the thrombatic material.

14. The method of claim 13, wherein the support member comprises at least one sharp elongate member adapted to scrape the thrombus as the frame of the thrombectomy device is pulled at least partially through the thrombus.

15. The method of claim 13, wherein the filter media is attached to the support member.

16. The method of claim 13, wherein the filter media extends seamlessly from the support member of the unibody and seamless frame.

17. The method of claim 13, wherein the support member is disposed about an axis defined by the guide wire.

18. The method of claim 13, wherein the support member and the plurality of struts comprise Nitinol.

19. The method of claim 13, wherein the proximally directed force at the guide wire causes the frame of the thrombectomy device to be pulled completely through the thrombus.

20. A thrombectomy device, comprising:

a unibody and seamless frame that includes a support member and a plurality of struts that extend in a generally proximal direction from the support member to a connecting member that is coupled to a guide wire;

a filter media that extends in a generally distal direction from the support member, the filter media being adapted to permit blood to pass through the filter media and to capture embolic debris carried by the blood;

wherein the support member includes a sharp edge that is adapted to shear an intraluminal thrombus as the thrombectomy device is pulled through an area of a blood vessel that includes the intraluminal thrombus, and wherein the filter media is adapted to capture sheared debris from the intraluminal thrombus.

21. The thrombectomy device of claim 20, wherein the filter media includes a base portion and a closed tapered portion, the base portion defining an open proximal end of the filter media.

22. The thrombectomy device of claim 20, wherein the filter media is attached to the support member.

23. The thrombectomy device of claim 20, wherein the filter media extends seamlessly from the support member of the unibody and seamless frame.

24. The thrombectomy device of claim 20, wherein the support member is disposed about an axis defined by the guide wire.

25. The thrombectomy device of claim 20, wherein the support member and the plurality of struts comprise Nitinol.