Flow-Deflecting Prosthesis for Treating Venous Disease

• US 20090177270A1
• Filed: 01/08/2009
• Published: 07/09/2009
• Est. Priority Date: 01/08/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Agnew, Charles W., Paul, Ram H. JR.
• Granted Patent: US 8,100,962 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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

The disclosure relates to 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 redirecting 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 comprising a support structure and at least one flow-deflecting member at least partially evertible between a first position and a second position;

the at least one flow-deflecting member comprising an antegrade flow-receiving surface and a retrograde flow-receiving surface, a first portion operatively coupled to the support structure and a second portion being free of the support structure;

where in the first position, antegrade flow contacts the antegrade flow-receiving surface, urging the second portion proximal to the first portion;

where in the second position, retrograde flow contacts the retrograde-flow receiving surface, urging the second portion distal to the first portion, the at least one flow-deflecting member thereby receiving and redirecting the retrograde flow.

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

3. The medical 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 at least one flow-deflecting member 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, the at least one-flow-deflecting member further comprising 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. A flow-deflecting medical device comprising a support structure, a first flow-deflecting member, and a second flow-deflecting member, the flow-deflecting members at least partially evertible between a first position and a second position;

the first flow-deflecting member comprising an antegrade flow-receiving surface and a retrograde flow-receiving surface, a first portion operatively coupled to the support structure and a second portion being free of the support structure;

the second flow-deflecting member comprising an antegrade flow-receiving surface and a retrograde flow-receiving surface, a first portion operatively coupled to the support structure and a second portion being free of the support structure;

where in the first position, antegrade flow contacts the antegrade flow-receiving surfaces of the first flow-deflecting member and second flow-deflecting member, urging the first flow-deflecting member second portion proximal to the first portion and the second flow-deflecting member second portion proximal to the first portion;

where in the second position, retrograde flow contacts the retrograde-flow receiving surfaces of the first flow-deflecting member and second flow-deflecting member, urging the first flow-deflecting member second portion distal to the first portion and the second flow-deflecting member second portion proximal to the first portion, the first and second flow-deflecting members.

11. The device of claim 10, the second flow-deflecting member oriented oppositely the first flow-deflecting member.

12. The device of claim 10, where in the first position the first and second flow-deflecting members form an orifice through which antegrade flow may proceed substantially uninterrupted.

13. The device of claim 10, the support structure comprising a first portion and a second portion distal to the support structure first portion, the first flow-deflecting member first portion operatively coupled to the support structure first portion and the second flow-deflecting member first portion operatively coupled to the support structure second portion.

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

15. The device of claim 14, where the second flow-deflecting member is biased to the second position.

16. The device of claim 10, where in the second position the first-flow deflecting member does not contact the second flow-deflecting member.

17. The device of claim 10, where in the second position the first-flow deflecting member antegrade-flow receiving surface contacts the second flow-deflecting member retrograde-flow receiving surface.

18. A method of treating a body vessel valve-related condition comprising implanting a flow-deflecting medical device comprising at least one flow-deflecting member proximal to a native valve, where the flow-deflecting member redirects retrograde flow onto the native valve.

19. The method of claim 18, the native valve comprising a first leaflet and second leaflet and where implanting the flow-deflecting medical device comprises orienting the device in the body vessel such that retrograde flow is directed substantially evenly onto the first and second leaflets.

20. The method of claim 18, the native valve comprising a first leaflet and second leaflet and where implanting the flow-deflecting medical device comprises orienting the device in the body vessel such that retrograde flow is directed substantially evenly onto only the first or second leaflet.