Valve device with inflatable chamber

• US 8,197,534 B2
• Filed: 03/30/2006
• Issued: 06/12/2012
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Osborne, Thomas A., Flagle, Jacob A., Brumleve, John A.
• Primary Examiner(s): Matthews, William H
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US11/394,303
• Publication Number:
  US 20060235512A1
• Time in Patent Office: 2,266 Days
• Field of Search: 623 124- 126, 623 212- 219, 623/2.42
• US Class Current: 623/1.25
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: Y10T 29/494 Fluidic or fluid actuated device making

Abstract

Prosthetic valve devices for implantation in body vessels are provided. The prosthetic valve device includes at least one flexible member that permits fluid flow in a first direction and substantially prevents fluid flow in a second. The valve device also includes an inflatable chamber at least partially attached to the flexible member. The inflatable chamber is adapted to receive inflating media and is adapted to contact the body vessel. A delivery system is also provided that includes a valve device and a delivery apparatus. The delivery apparatus includes a member adapted for filling the chamber of the valve device with inflating media. A related method of making the valve device is also provided.

Claims

1. A prosthetic valve for implantation in a body vessel, the valve comprising:

at least one flexible member movable between a first position that permits fluid flow in a first direction and a second position that substantially prevents fluid flow in a second direction, the at least one flexible member comprising a resorbable material and having a proximal portion, a distal portion, an outer edge, and a contact area at a distal end; and

an inflatable chamber having a first portion formed in and extending along the entire outer edge of the at least one flexible member and a second portion extending from the first portion and across the at least one flexible member from the proximal portion to the distal portion and between the outer edge and the contact area, the inflatable chamber adapted for receiving inflating media; and

a portion of the inflatable chamber is adapted to contact the body vessel to hold the chamber in the body vessel and together with the at least one flexible member to form a sinus having a proximal end and a distal end.

2. The prosthetic valve of claim 1, wherein the at least one flexible member comprises an extracellular matrix material (ECM).

3. The prosthetic valve of claim 1 further comprising inflating media disposed within the inflatable chamber.

4. The prosthetic valve of claim 3, wherein the inflating media comprises a resorbable material.

5. The prosthetic valve of claim 4, wherein the inflating media comprises a polymerizable material.

6. The prosthetic valve of claim 4, wherein the inflating media is ECM and a polymerizable material.

7. The prosthetic valve of claim 1, wherein the at least one flexible member comprises first and second flexible members.

8. The prosthetic valve of claim 7, wherein the first and second flexible members forms a member contact area when the fluid flow is in the second direction.

9. The prosthetic valve of claim 1, further comprising a vessel engaging member disposed on at least a portion of an outer surface of the inflatable chamber.

10. The prosthetic valve of claim 1, wherein the at least one flexible member and the inflatable chamber are formed from a single sheet of material.

11. The prosthetic valve of claim 1, wherein the inflatable chamber further comprises a fill valve for receiving the inflating media.

12. The prosthetic valve of claim 1, wherein the inflatable chamber comprises at least two separate chamber portions that are adapted to separately receive inflating media.

13. The prosthetic valve of claim 1, wherein a gathered portion of the outer edge of the at least one flexible member defines the inflatable chamber.

14. The prosthetic valve of claim 13, wherein the gathered portion comprises a rolled portion of the outer edge of the at least one flexible member.

15. The prosthetic valve of claim 13, wherein the gathered portion comprises a folded portion of the outer edge of the at least one flexible member.

16. The prosthetic valve of claim 1, wherein the at least one flexible member comprises a bioremodelable material.

17. The prosthetic valve of claim 1, wherein the at least one flexible member comprises a naturally-derived material.

18. The prosthetic valve of claim 1, wherein the at least one flexible member comprises small intestinal submucosa.

19. A prosthetic valve for implantation in a body vessel, said prosthetic valve comprising:

at least one flexible member comprising a resorbable material and having a proximal portion, a distal portion, an outer edge and defining an opening, the at least one flexible member adapted to permit fluid flow through the opening in a first direction and to substantially prevent fluid flow through the opening in a second direction, the at least one flexible member defining an inflatable chamber having a first portion that extends along the entire outer edge of the at least one flexible member and a second portion that extends from the first portion and across the at least one flexible member from the proximal portion to the distal portion and between the outer edge and the opening, the inflatable chamber adapted for receiving inflating media; and

wherein a portion of the inflatable chamber cooperates with a portion of the at least one flexible member to form a sinus that prevents fluid flow in the second direction.