Flow-deflecting prosthesis for treating venous disease

• US 8,100,962 B2
• Filed: 01/08/2009
• Issued: 01/24/2012
• Est. Priority Date: 01/08/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles W., Paul, Ram H. Jr.
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/350,456
• Publication Number:
  US 20090177270A1
• Time in Patent Office: 1,111 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.12, 623/2.14, 623 216- 218, 609/4
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A flow-deflecting medical device comprising a support structure and at least one flow-deflecting member attached to the support structure. The flow-deflecting member is at least partially evertible between a first position and a second position. In the first position, antegrade flow contacts the antegrade surface of the flow-deflecting member, urging the flow-deflecting member proximally in the body vessel, such that antegrade flow is substantially uninterrupted. In the second position, retrograde flow contacts the retrograde surface of the flow-deflecting member, urging the flow-deflecting member distally in the body vessel, such that retrograde flow is received and redirected by the flow-deflecting member. Also provided is a method for treating a body vessel valve-related condition comprising implanting a flow-deflecting medical device proximal to a native valve.

Claims

1. A flow-deflecting medical device for implantation in a body vessel, comprising:

a support structure having compressed and expanded configurations, a lengthwise axis, first and second opposing sides relative to the lengthwise axis, a first support structure portion positioned on the first side, and a second support structure portion positioned on the second side and distal to the first support structure portion, the support structure defining a lumen; and

first and second flow-deflecting members attached to the support structure;

the first flow-deflecting member having a first edge attached to the first support structure portion and a second edge free of the support structure, and being at least partially evertible between a first position in which the second edge is positioned proximal to the first edge and a second position in which the second edge is positioned distal to the first edge;

the second flow-deflecting member having a third edge and a fourth edge, the third edge attached to the second support structure portion such that the third edge is positioned distal to the first support structure portion and the first edge of the first flow-deflecting member relative to the lengthwise axis of the support structure, the fourth edge being free of the support structure and being at least partially evertible between a third position in which the fourth edge is positioned proximal to the third edge and a fourth position in which the fourth edge is positioned distal to the third edge;

the second and fourth edges extending across the lumen and creating a central orifice;

wherein antegrade flow in said body vessel contacts the first and second flow-deflecting members and urges the first flow-deflecting member into the first position and the second flow-deflecting member into the third position to allow the antegrade flow to flow through said body vessel substantially unobstructed by said flow-deflecting medical device;

wherein retrograde flow in said body vessel contacts the first and second flow-deflecting members and urges the first flow-deflecting member into the second position and the second flow-deflecting member into the fourth position to minimize the central orifice and redirect the retrograde flow; and

wherein a portion of the second edge of the first flow-deflecting member is positioned opposite the first edge of the first flow-deflecting member and a portion of the fourth edge of the second flow-deflecting member relative to the lengthwise axis of the support frame when the first flow-deflecting member is in the second position.

2. The device of claim 1, where the rate of fluid flow in the antegrade direction through said flow-deflecting medical device is reduced by less than the rate of fluid flow in the retrograde direction through said flow-deflecting medical device.

3. The device of claim 2, where the rate of fluid flow is reduced by about 0.5% to about 20% more in the retrograde direction than in the antegrade direction.

4. The device of claim 1, the first and second flow-deflecting members further comprising a material selected from the group consisting of polymeric material, extracellular matrix material, xenogenic biomaterial, autologous tissue, and allogeneic tissue.

5. The device of claim 4, where the polymeric material is selected from the group consisting of biocompatible polyurethane, polyethylene terephthlate, and polytetrafluoroethylene.

6. The device of claim 1, wherein at least one of the first and second flow-deflecting members comprises a dipped or sprayed polymeric material.

7. The device of claim 1, the support structure comprising at least two interconnected stents.

8. The device of claim 7, the at least two interconnected stents comprising z-stents or stents having a serpentine configuration.

9. The device of claim 1, further comprising anchoring devices.

10. The device of claim 1, where the first flow-deflecting member is biased to the first position.

11. The device of claim 1, where the second flow-deflecting member is biased to the third position.

12. The device of claim 1, where in the second position the first flow-deflecting member does not contact the second flow-deflecting member.

13. The device of claim 1, where in the second position the first flow-deflecting member contacts the second flow-deflecting member.

14. The device of claim 1, wherein at least one of the first and second flow-deflecting members comprise an extracellular matrix material.

15. The device of claim 14, wherein the extracellular matrix material comprises small intestine submucosa.

16. The device of claim 1, wherein at least one of the first and second flow-deflecting members comprise allograph tissue.

17. The device of claim 16, wherein the allograph tissue comprises native valve tissue.

18. The device of claim 1, wherein at least one of the first and second flow-deflecting members comprise autologous tissue.