Prosthetic valve devices and methods of making and using such devices

• US 20060265053A1
• Filed: 05/16/2006
• Published: 11/23/2006
• Est. Priority Date: 05/17/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Hunt, James B.
• Granted Patent: US 8,475,512 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

The present invention relates to medical devices and in particular to frameless grafting prostheses and methods of making and using such devices. The frameless grafting prostheses include a stiffening member useful in the attachment of the frameless grafting prostheses to a wall of a body lumen.

Claims

1. A frameless grafting prosthesis for implantation in a body lumen having a lumen wall, the frameless grafting prosthesis comprising at least one shaped valve cusp comprising:

a valve body having a top edge, a base edge, and side edges extending from the base edge to the top edge,

at least one anchoring element attached to the base edge, and

a stiffening member positioned within the valve body between the at least one anchoring element and a pushing surface on the top edge,

wherein the stiffening member allows a force sufficient to attach the anchoring element to the lumen wall to be transmitted from the pushing surface to the anchoring element.

2. The frameless grafting prosthesis of claim 1, wherein the anchoring element is configured to attach to or partially or fully penetrate the lumen wall.

3. The frameless grafting prosthesis of claim 1, wherein the anchoring element is selected from a group consisting of a barb, a hook, and an adhesive.

4. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp is deformable around an axis generally parallel to the stiffening member.

5. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp is deformable between a first position allowing fluid flow in a first, antegrade, direction and a second position restricting flow in a second, retrograde, direction in response to a change in a direction of fluid flow in the body lumen.

6. The frameless grafting prosthesis of claim 1, further comprising an adhesive applied to the pushing surface.

7. The frameless grafting prosthesis of claim 1, wherein the pushing surface is adapted to receive an end of a push rod.

8. The frameless grafting prosthesis of claim 1, wherein the pushing surface further comprises a magnetic or magnetically responsive element.

9. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp comprises a polymer.

10. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp 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, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate, polyhydroxyalkanoate, a biodegradable polymer, a collagenous material, and mixtures or copolymers thereof.

11. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp comprises an extracellular matrix.

12. The frameless grafting prosthesis of claim 1, wherein the valve cusp comprises a polyetherurethane urea and a surface modifying additive.

13. The frameless grafting prosthesis of claim 4, wherein the stiffening element has a thickness greater than a deformable portion of the body of the shaped valve cusp.

14. The frameless graphing prosthesis of claim 1, wherein the stiffening member comprises a material selected from a group consisting of stainless steel, tantalum, titanium, nitinol, gold, platinum, inconel, iridium, silver, tungsten, a biocompatible metal, and alloys of any of these;

carbon, carbon fiber;

cellulose acetate, cellulose nitrate, silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, a fluoroplastic material, polytetrafluoroethylene, a biocompatible polymeric material, and mixtures or copolymers of these;

polylactic acid, polyglycolic acid and copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate or another biodegradable polymer, and mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin, a biologic agent; and

a suitable mixture of any of these.

15. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp comprises a bioactive agent.

16. The frameless grafting prosthesis of claim 1, wherein the shaped valve cusp further comprises an aperture, wherein the aperture allows limited retrograde flow in the body lumen.

20. A method of attaching a frameless grafting prosthesis to a wall of a body lumen, comprising:

positioning the system of claim 16 at a required position within the body lumen, and

applying a force to the pushing surface of the first shaped valve cusp with the push rod;

wherein the force is transmitted to the anchoring element by the stiffening member and wherein the transmitted force is sufficient to push frameless grafting prosthesis out of the enclosure and to push the anchoring element against, into or through the wall of the body lumen and to attach frameless grafting prosthesis to the wall of a body lumen.

17. A system for deployment of a frameless grafting prosthesis in a body lumen having a lumen wall, the system comprising:

(a) frameless grafting prosthesis comprising at least a first shaped valve cusp, the first shaped valve cusp comprising a valve body having a top edge, a base edge, and side edges extending from the base edge to the top edge, at least one anchoring element attached to the base edge, and a stiffening member extending from the base edge and terminating at a pushing surface on the top edge, wherein the stiffening member is rigid so as to allow a force sufficient to attach the anchoring element to the lumen wall to be transmitted from the pushing surface to the anchoring element, and

(b) a deployment device comprising;

a central portion,

a retractable sheath surrounding the central portion and defining an enclosure between the central portion and the retractable sheath, and

a push rod having an end surface,

wherein the first shaped valve cusp is positioned within the enclosure and the push rod extends through the deployment device so that a portion of the end surface is adjacent to or in contact with the pushing surface.

18. The system of claim 17, wherein the frameless grafting prosthesis further comprises a second shaped valve cusp having a pushing surface positioned within the enclosure and wherein a portion of the end surface is adjacent to or in contact with the pushing surface of the second shaped valve cusp.

19. The system of claim 17, wherein the anchoring element is selected from a group consisting of a barb, a hook, and an adhesive.