Implantable valve device

• US 10,722,365 B2
• Filed: 01/25/2017
• Issued: 07/28/2020
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Chambers, Sean, Paul, Ram, Jaffe, Norman
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/414,794
• Publication Number:
  US 20170128212A1
• Time in Patent Office: 1,280 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• 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
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Valve devices, methods of making valve devices, and methods of treating various venous-related conditions, disorders and/or diseases are described. In one embodiment, a valve device includes an expandable support frame and a bioprosthetic valve attached to the support frame. The bioprosthetic valve comprises a leaflet and a contiguous wall portion harvested from a multi-leaflet xenogeneic valve. The contiguous wall portion includes the attachment region where the leaflets attaches to the vessel wall and, in some embodiments, includes the natural margins of attachment between the leaflet and vessel wall.

Claims

1. A valve device for implantation in a recipient vessel, said valve device comprising:

an expandable support frame having a longitudinal axis, a radially compressed configuration, a radially expanded configuration, and comprising first and second connector segments disposed substantially opposite each other with respect to the longitudinal axis, and a third connector segment disposed circumferentially between the first and second connector segments with respect to the longitudinal axis, the first connector segment including substantially straight first and second struts that are substantially parallel to each other in the radially expanded configuration, the second connector segment including substantially straight third and fourth struts that are substantially parallel to each other in the radially expanded configuration, and the third connector segment defining an outwardly-projecting curve; and

a bioprosthetic valve attached to the support frame along the first, second, and third connector segments, the bioprosthetic valve comprising a single leaflet and a contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve, the leaflet defining a free edge and having an inside surface disposed substantially opposite the third connector segment with respect to the longitudinal axis;

wherein the contiguous portion of a vessel wall harvested from a multi-leaflet vascular valve comprises a non-circumferential portion of a vessel wall harvested from a multi-leaflet vascular valve.

2. The valve device according to claim 1, wherein the bioprosthetic valve is attached to the support frame along an attachment pathway with at least one attachment element.

3. The valve device according to claim 2, wherein the at least one attachment element passes through only a partial thickness of the contiguous wall portion at least one point on the attachment pathway.

4. The valve device according to claim 2, wherein the at least one attachment element comprises a single suture extending along the entire attachment pathway.

5. The valve device according to claim 2, wherein the second strut is disposed circumferentially between the first strut and the third connector segment;

and

wherein the attachment pathway includes the first strut.

6. The valve device according to claim 1, wherein the second strut is disposed circumferentially between the first strut and the third connector segment with respect to the longitudinal axis.

7. The valve device according to claim 1, wherein the fourth strut is disposed circumferentially between the third strut and the third connector segment with respect to the longitudinal axis.

8. The valve device according to claim 1, wherein the bioprosthetic valve is harvested from a xenogeneic valve.

9. The valve device according to claim 1, wherein the bioprosthetic valve is harvested from a xenogeneic valve selected from porcine valves, ovine valves, and equine valves.

10. The valve device according to claim 1, wherein the bioprosthetic valve is harvested from a porcine valve.

11. The valve device according to claim 10, wherein the bioprosthetic valve is harvested from a non-aortic valve.

12. The valve device according to claim 10, wherein the bioprosthetic valve is harvested from an aortic valve.

13. The valve device according to claim 12, wherein the leaflet comprises a noncoronary leaflet of the aortic valve.

14. The valve device according to claim 1, wherein the contiguous portion of the vessel wall comprises a natural sinus formed in the vascular valve.

15. The valve device according to claim 1, wherein the support frame includes one or more struts and defines a window portion substantially free of the one or more struts and positioned to allow the leaflet to close against a portion of an inner wall of said recipient vessel.

16. The valve device according to claim 1, wherein the support frame includes one or more struts and defines a window portion substantially free of the one or more struts and positioned to allow the leaflet to close against and directly contact a portion of an inner wall of said recipient vessel.

17. The valve device according to claim 1, wherein the outwardly-projecting curve creates a sinus region in said recipient vessel upon implantation.

18. The valve device according to claim 17, wherein the leaflet has a base portion positioned substantially adjacent the outwardly-projecting curve.

19. The valve device according to claim 1, wherein the outwardly-projecting curve extends away from the longitudinal axis in the radially expanded configuration.

20. The valve device according to claim 19, wherein the third connector segment is disposed in a plane that contains the longitudinal axis.