Valve device with inflatable chamber

• US 20060235512A1
• Filed: 03/30/2006
• Published: 10/19/2006
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Flagle, Jacob A., Osborne, Thomas A., Brumleve, John A.
• Granted Patent: US 8,197,534 B2
• Time in Patent Office: Days
• US Class Current: 623/2.170
• 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 having a proximal portion and a distal portion; and

an inflatable chamber at least partially attached to the proximal portion of the at least one flexible member, the chamber being adapted for receiving inflating media;

wherein a portion of the inflatable chamber is adapted to contact the body vessel to hold the chamber in the body vessel.

2. The prosthetic valve of claim 1, wherein at least one of the flexible member or the inflatable chamber comprises a resorbable material.

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

4. The prosthetic valve of claim 1, wherein a portion of the valve comprises a synthetic material.

5. The prosthetic valve of claim 1 further comprising inflating media.

6. The prosthetic valve of claim 5, wherein the inflating media comprises a resorbable material.

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

8. The prosthetic valve of claim 5, wherein the inflating media is ECM and a polymerizable material.

9. The prosthetic valve of claim 1, wherein the at least a portion of the valve comprises a synthetic material.

10. The prosthetic valve of claim 1, wherein the valve comprises a pair of flexible members.

11. The prosthetic valve of claim 10, wherein the pair of flexible members forms a member contact area when the flow is in the second direction.

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

13. 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.

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

15. A delivery system for implanting a prosthetic valve in a body vessel, the system comprising:

a prosthetic 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; and

an inflatable chamber at least partially attached to the at least one flexible member, the chamber being adapted for receiving inflating media and for engaging the body vessel; and

a delivery apparatus, the delivery apparatus having a member adapted for filling the chamber with the inflating media.

16. The delivery system of claim 15, wherein at least a portion of the valve comprises an extracellular matrix material (ECM).

17. The delivery system of claim 16, wherein at least a portion of the valve comprises a synthetic material.

18. The delivery system of claim 15 further comprising inflating media.

19. A method of making a prosthetic valve for implantation in a body vessel, the method comprising:

providing a flexible, main body member having an outer edge;

folding over the outer edge onto the main body member;

attaching the folded-over outer edge to the main body member to form an inflatable chamber around at least a portion of a circumference of the body member, the inflatable chamber having an opening adapted to receive inflating media;

providing at least one flexible member for at least partial connection to the main body member, the 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.

20. The method of claim 19 wherein the main body member and the at least one flexible member are formed as an integral, one piece member.