ATRAUMATIC PROSTHETIC HEART VALVE PROSTHESIS

• US 20090287296A1
• Filed: 05/13/2009
• Published: 11/19/2009
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: MANASSE, ERIC
• Granted Patent: US 8,840,661 B2
• Time in Patent Office: Days
• US Class Current: 623/1.180
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

An atraumatic heart valve prosthesis includes a prosthetic valve coupled to an expandable anchoring structure including a outflow portion configured to taper inwardly in a distal direction towards a central axis of the prosthesis. By this configuration, the distal end of the anchoring structure imparts less force upon the vessel wall (e.g., the aortic tunica intima) during continued expansion and contraction of the heart. The expandable anchoring structure can be balloon expandable or self-expanding.

Claims

1. A heart valve prosthesis adapted for minimally invasive delivery to an implantation site of a patient, the implantation site having an annulus, a Valsalva sinus, and an aortic tunica intima, the prosthesis comprising:

an anchoring structure having a radially collapsed configuration for delivery and a radially expanded configuration for deployment;

a valve coupled to the anchoring structure and configured such that in the expanded configuration, the valve permits blood flow through the lumen in a first direction and substantially prevents blood flow through the lumen in a second direction generally opposite the first direction;

wherein the anchoring structure includes a generally cylindrical portion adapted to engage an annular vessel wall at the implantation site;

wherein the generally cylindrical portion includes an outflow portion adapted to engage the vessel wall at a location distal to the Valsalva sinus; and

wherein, in the expanded configuration, the outflow portion tapers inwardly towards a distal end, such that the distal end imparts less force than a proximal portion upon the aortic tunica intima.

2. The prosthesis of claim 1 wherein the implantation site is the aortic annulus of the patient.

3. The prosthesis of claim 1 wherein the outflow portion includes a proximal outflow ring and a distal outflow ring.

4. The prosthesis of claim 1 wherein the distal outflow ring has a tapered configuration, such that a distal end of the distal outflow ring has a smaller diameter than a proximal end of the distal outflow ring.

5. The prosthesis of claim 4 wherein the distal outflow ring defines a concave curved configuration.

6. The prosthesis of claim 4 further comprising a prosthetic heart valve including three coapting leaflets, the valve coupled to the anchoring support structure.

7. The prosthesis of claim 1 wherein the anchoring structure is configured to be self-expanding.

8. A heart valve prosthesis configured for delivery to an implantation site in a minimally invasive manner, the prosthesis comprising an expandable anchoring structure having a concave, tapered outflow portion configured to minimize damage to the aortic tunica intima.

9. The heart valve prosthesis of claim 8 further comprising an expandable prosthetic heart valve including three leaflets coupled to the anchoring support structure.

10. The heart valve prosthesis of claim 8 wherein the anchoring structure is a stented structure and the outflow portion is curved away from the aortic tunica intima.

11. The heart valve prosthesis of claim 8 wherein the outflow portion is blunt.

12. The heart valve prosthesis of claim 8 wherein the outflow portion is covered with a protective coating or material.

13. The heart valve prosthesis according to claim 11 wherein the distal end is configured so as not to snag tissue at the implantation site.

14. The heart valve prosthesis according to claim 8 wherein the outflow portion is dimensioned to minimize shearing of blood cells passing by the outflow portion.

15. The heart valve prosthesis according to claim 8 wherein the outflow portion is configured to minimize blood flow turbulence through the prosthesis.

16. The heart valve prosthesis of claim 8 wherein an outside surface of the outflow portion is smooth and free from rough edges.

17. The heart valve prosthesis of claim 8 wherein the outside surface of the anchoring support structure includes a lubricious coating.

18. A heart valve prosthesis adapted for minimally invasive delivery to an implantation site of a patient, the implantation site having an annulus, a Valsalva sinus, and an aortic tunica intima, the prosthesis comprising an expandable stent structure sized and shaped to prevent a locus minoris resistentiae in an aortic wall when the prosthesis is balloon expanded.

19. A system for delivering a heart valve prosthesis to an implantation site within a patient'"'"'s heart and implanting the prosthesis at the implantation site, the system comprising:

an implantation catheter; and

an expandable stent and valve, the stent selected from the group consisting of a balloon-expandable stent and a self-expandable stent, the stent having a first portion for supporting the valve and a second portion opposite the first portion, the second portion dimensioned to minimize damage to the aortic tunica intima caused by repeated expansion and contraction of the heart after implantation

20. The system according to claim 19 wherein the stent comprises a shape memory material.