Stent valves and uses of same

• US 20040049262A1
• Filed: 06/09/2003
• Published: 03/11/2004
• Est. Priority Date: 01/31/2000
• Status: Active Grant

• Current Assignee: Francisco Jose Osse, Joseph F. Obermiller, Patricia E. Thorpe
• Original Assignee: Francisco Jose Osse, Joseph F. Obermiller, Patricia E. Thorpe
• Inventors: Obermiller, Joseph F., Thorpe, Patricia E., Osse, Francisco Jose
• Granted Patent: US 8,906,083 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

The invention includes a medical device and more specifically relates to a valve found generally within a frame. In a preferred device, the frame preferably comprises a self-expanding stent frame, and the valve has at least one expandable and contractible pocket member within the stent frame for resisting and permitting fluid flow, respectively.

Claims

1. A stent valve, suitable for placement in a vessel, the vessel further having a diameter and an inner lumenal surface, comprising:

a) a stent having a diameter, a proximal end, and a distal end, the stent sized to permit contact with the inner lumenal surface of the vessel;

b) a valve having a proximal end and a distal end, the valve being at least partially located within an inner portion of the stent, wherein the valve comprises a biocompatible material.

2. The stent valve of claim 1, wherein the stent is a self-expanding stent.

3. The stent valve of claim 1, wherein a sheath partially covers the stent.

4. The stent valve of claim 3, wherein the sheath further comprises substantially biocompatible material.

5. The stent valve of claim 4, wherein the stent is a self-expanding stent.

6. The stent valve of claim 1, wherein the stent has a diameter greater than the vessel diameter.

7. The stent valve of claim 6, wherein the stent has a diameter 110 percent greater than the vessel diameter.

8. The stent valve of claim 6, wherein a sheath partially covers the stent.

9. The stent valve of claim 8, wherein the sheath comprises a biological material.

10. The stent valve of claim 9, wherein the sheath comprises tissue submucosa.

11. The stent valve of claim 10, wherein the submucosa further comprises at least one of a gastric, liver, intestinal, urinary, stomach, and genito-urinary tissue.

12. The stent valve of claim 1, wherein the valve further comprises at least one leaflet, wherein the at least one leaflet is capable of preventing a backflow of blood.

13. The stent valve of claim 1, wherein the valve proximal end is connected to the stent proximal end.

14. The stent valve of claim 13, wherein the valve proximal end is sutured to the stent proximal end.

15. The stent valve of claim 13, wherein the valve proximal end is sutured at least 4 times to the stent proximal end.

16. The stent valve of claim 13, wherein the valve proximal end is sutured at least 7 times to the stent proximal end.

17. The stent valve of claim 1, wherein the valve distal end is connected to the stent distal end.

18. The stent valve of claim 1, wherein the valve distal end is sutured to the stent distal end.

19. The stent valve of claim 18, wherein the valve distal end is sutured at least 2 times to the stent distal end.

20. The stent valve of claim 18, wherein the valve distal end is sutured at least 3 times to the stent distal end.

21. The stent valve of claim 1, wherein an intermediate portion of the valve is connected to an intermediate portion of the stent.

22. The stent valve of claim 1, wherein an intermediate portion of the valve is connected to the stent distal end.

23. The stent valve of claim 1, wherein a valve opening extends substantially across the stent diameter.

24. The stent valve of claim 23, wherein the valve opening terminates at least 1 mm from a stent perimeter.

25. The stent valve of claim 23, wherein a reinforcement is generally located at a valve opening and a stent perimeter.

26. The stent valve of claim 1, wherein said stent is a radially expandable stent, said radially expandable stent having a first configuration adapted for delivery through a lumen of a delivery device, and a second configuration for conforming to an interior wall of a body vessel.

27. The stent device of claim 26, wherein the body vessel is a vein.

33. A medical assembly, comprising a stent valve device of any of claims 2, 5, 26 and 29 received within a lumen of a delivery device.

34. A method for providing a valve in a body lumen, comprising:

providing a delivery device having a lumen having received therein a stent valve device of any of claims 2, 5, 26 and 29;

deploying said stent valve device from said delivery device within said body lumen.

35. The method of claim 34, wherein said body lumen is a venous lumen.

36. The method of claim 35, wherein said venous lumen is within a vein selected from a saphenous vein, a popliteal vein, a femoral vein, a tibial vein, and the inferior vena cava.

28. A medical device, suitable for placement in a vessel, the vessel further having a diameter and an inner lumenal surface, comprising:

a) at least one stent, the at least one stent having a proximal end, a distal end, and a lumen extending therethrough;

b) a valve having a proximal end and a distal end, the valve generally located within the lumen of the at least one stent;

c) the valve distal end being secured to an intermediate portion of the at least one stent; and

d) the valve further comprising a biological material.

29. A medical device, suitable for placement in a vessel, the vessel further having a diameter and an inner lumenal surface, comprising:

a) at least one stent, the at least one stent having a proximal end, a distal end, and a lumen extending therethrough;

b) a valve having a proximal end and a distal end, the valve generally located within the lumen of the at least one stent;

c) the valve distal end being secured to an intermediate portion of the at least one stent; and

d) the valve further having a valve opening, the valve opening also further comprising a reinforcement disposed on the valve opening.

30. A medical device, suitable for placement in a vessel, the vessel further having a diameter and an inner lumenal surface, comprising:

a) at least one stent, the at least one stent having a proximal end, a distal end, and a lumen extending therethrough;

b) at least one valve having a proximal end and a distal end, the valve generally located within the lumen of the at least one stent

c) the at least one valve distal end being partially secured to an inner portion of the at least one stent; and

d) the valve further comprising a biological material.

31. A radially-expandable stent valve device for placement in a body vessel, comprising:

a self-expanding stent frame, said self-expanding stent frame conformable to a first, contracted state adapted for delivery through a lumen of a delivery device, and a second, expanded state for conforming a lumen of the vessel;

a valve attached to said frame and functional to resist fluid flow in a first direction through said stent frame and permit fluid flow in a second direction through said stent frame opposite said first direction;

said valve comprising a compliant biocompatible material defining at least one pocket member within said frame, said pocket member having an opening for receiving fluid flowing in said first direction and adapted to thereupon expand, said pocket member further adapted to contract upon impingement with fluid flowing in said second direction; and

said biocompatible material sufficiently compliant and said pocket member defined wherein said valve remains functional after contraction of said stent frame to said first, contracted state and expansion of said stent frame to said second, expanded state.

32. The stent valve device of claim 31, wherein said valve comprises at least two of said pocket members.