Artificial valve prosthesis

• US 20070288087A1
• Filed: 05/30/2007
• Published: 12/13/2007
• Est. Priority Date: 05/30/2006
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated)
• Inventors: Roeder, Blayne, Paul, Ram, Fearnot, Neal, Voorhees, William, Leewood, Alan
• Granted Patent: US 8,038,710 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded

Abstract

A self-expanding or otherwise expandable artificial valve prostheses for deployment within a body passageway, such as a vessel or duct of a patient. The valve prostheses include a support structure having an outer frame, a supporting member and a valve leaflet. The portion of the valve leaflet is supported by the supporting member and is positioned away from the wall of the body passageway when the device is deployed within the body passageway.

Claims

1. An artificial valve prosthesis for regulating fluid flow through a body vessel having a wall, comprising:

an outer frame having a first, unexpanded configuration and a second, expanded configuration;

a first support element positioned within a lumen formed by the expanded outer frame and having a first end attached to the outer frame, wherein the first support element extends, in a direction of antegrade fluid flow, into the lumen formed by the outer frame;

a first valve leaflet supported by the outer frame and by the first support element, wherein at least a portion of an perimeter of the first valve leaflet is attached to the first support element and wherein the first valve leaflet is deformable between a first position allowing fluid flow in the first, antegrade direction and a second position restricting fluid flow in a second, retrograde direction.

2. The artificial valve prosthesis of claim 1, further comprising:

a second valve leaflet supported by the outer frame and by the first support element, wherein the first and second valve leaflets are attached at a first commissural point positioned on the first support element and at a second commissural point, wherein the first and second valve leaflets co-apt between the first and second commissural points and wherein the first and second valve leaflets are deformable between a first position allowing fluid flow in the antegrade direction and a second position restricting fluid flow in the retrograde direction.

3. The artificial valve prosthesis of claim 2, wherein the second commissural point is positioned on the outer frame.

4. The artificial valve prosthesis of claim 1, wherein, when positioned within the body vessel, the portion of an edge of the valve leaflet supported by the first support element is not in contact with the wall of the vessel.

5. The artificial valve prosthesis of claim 2, further comprising:

a second support element having a first end attached to the outer frame, wherein the second commissural point is positioned on the second support element.

6. The artificial valve prosthesis of claim 2, wherein the first valve leaflet and the second valve leaflet form a continuous piece of material.

7. The artificial valve prosthesis of claim 6, wherein the first and second support elements are reinforced portions of the continuous piece of material.

8. The artificial valve prosthesis of claim 1, wherein the outer frame comprises a polymeric material.

9. The artificial valve prosthesis of claim 1, wherein the outer frame comprises a material selected from a group consisting of stainless steel, nickel, silver, platinum, palladium, gold, titanium, tantalum, iridium, tungsten, a self-expanding nickel titanium alloy and inconel.

10. The artificial valve prosthesis of claim 9, wherein the outer frame comprises a self-expanding nickel titanium alloy.

11. The artificial valve prosthesis of claim 1, wherein the first valve leaflet comprises a material selected from the group consisting of a synthetic biocompatible polymer, cellulose acetate, cellulose nitrate, silicone, polyethylene, teraphthalate, polyurethane, polyamide, polyester, polyorthoester, poly anhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, a fluoroplastic material, polytetrafluoroethylene, polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate, polyhydroxyalkanoate, a polyetherurethane urea, naturally derived or synthetic collagenous material, an extracellular matrix material, submucosa, small intestinal submucosa, stomach submucosa, urinary bladder submucosa, uterine submucosa, renal capsule membrane, dura mater, pericardium, serosa, peritoneum or basement membrane materials, liver basement membrane and mixtures or copolymers thereof.

12. The artificial valve prosthesis of claim 1, where the first valve leaflet comprises a bioremodelable material.

13. The artificial valve prosthesis of claim 1, wherein the first valve leaflet comprises small intestinal submucosa.

14. The artificial valve prosthesis of claim 1, wherein the first valve leaflet comprises a polyurethane.

15. The artificial valve prosthesis of claim 2, wherein when the outer frame is in the expanded configuration, the first and second commissural points are separated by a distance less than a diameter of the outer frame.

16. The artificial valve prosthesis of claim 1, wherein the first support element comprises a polymeric material.

17. The artificial valve prosthesis of claim 1, wherein the first support element comprises a material selected from a group consisting of stainless steel, nickel, silver, platinum, palladium, gold, titanium, tantalum, iridium, tungsten, a self-expanding nickel titanium alloy, and inconel.

18. The artificial valve prosthesis of claim 1, further comprising a suture attaching the first support element to the outer frame.

19. The artificial valve prosthesis of claim 1, wherein at least 40% of an attached perimeter of the first valve leaflet is attached to the first support element.

20. A method of regulating flow within a body vessel, the method comprising:

delivering an artificial valve prosthesis within a lumen of a catheter to a position within the vessel; and

deploying the artificial valve prosthesis from the lumen, wherein the artificial valve prosthesis comprises;

an outer frame having a first, unexpanded configuration and a second, expanded configuration;

a first support element positioned within a lumen formed by the expanded outer frame and having a first end attached to the outer frame;

wherein the first support element extends, in a direction of antegrade fluid flow, into a lumen formed by the outer frame;

a first valve leaflet supported by the outer frame and by the first support element, wherein at least a portion of an perimeter of the first valve leaflet is attached to the first support element and wherein the first valve leaflet is deformable between a first position allowing fluid flow in the first, antegrade direction and a second position restricting fluid flow in a second, retrograde direction.

21. A medical device comprising:

a catheter having a lumen; and

an artificial valve prosthesis positioned within the lumen in a compressed configuration, the artificial valve prosthesis comprising;

an outer frame having a first, unexpanded configuration and a second, expanded configuration;

a first support element positioned within a lumen formed by the expanded outer frame and having a first end attached to the outer frame;

wherein the first support element extends, in a direction of antegrade fluid flow, into a lumen formed by the outer frame;

a first valve leaflet supported by the outer frame and by the first support element, wherein at least a portion of an perimeter of the first valve leaflet is attached to the first support element and wherein the first valve leaflet is deformable between a first position allowing fluid flow in the first, antegrade direction and a second position restricting fluid flow in a second, retrograde direction.