Atraumatic prosthetic heart valve prosthesis

• US 8,840,661 B2
• Filed: 05/13/2009
• Issued: 09/23/2014
• Est. Priority Date: 05/16/2008
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sorin Group Italia SRL (LivaNova Plc)
• Inventors: Manasse, Eric
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): COBURN, LESLIE ANN
• Application Number:
  US12/464,923
• Publication Number:
  US 20090287296A1
• Time in Patent Office: 1,959 Days
• Field of Search: 623/2.1, 623 212- 219, 623/2.36, 623/2.38, 623/1.24, 623/1.26
• US Class Current: 623/2.1
• 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, Valsalva sinuses, and an aortic tunica intima, the prosthesis having a principal axis extending longitudinally therethrough and 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 sinuses, an inflow portion that is sized and shaped to be positioned within and secured adjacent the annulus, and a plurality of anchoring members, angularly spaced from one another about the principal axis, extending between the outflow portion and the inflow portion, wherein the anchoring members are angularly distributed in three pairs, and only three pairs, around the prosthesis at an angular distance apart of about 120°

about the principal axis, such as to be configured to extend into the sinuses of Valsalva;

further wherein, in the radially expanded configuration, each of the plurality of anchoring members arches radially outward from the principal axis; and

wherein, in the expanded configuration, the outflow portion includes a proximal outflow ring having a first distal end having a first diameter and a distal outflow ring having a second distal end having a second diameter, the second diameter being smaller than the first diameter, such that the distal end tapers inwardly and thus imparts less force than a proximal portion upon the aortic tunica intima, wherein the proximal outflow ring is disposed proximal to the distal outflow ring, and wherein the first distal end of the proximal outflow ring and the second distal end of the distal outflow ring are coupled together by the anchoring members.

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 distal outflow ring defines a concave curved configuration.

4. The prosthesis of claim 3 further comprising a prosthetic heart valve including three coapting leaflets, the valve coupled to the anchoring support structure.

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

6. The prosthesis of claim 1 further wherein the second distal end of the distal outflow ring has a smaller diameter than a proximal end of the distal outflow ring and wherein the second distal end of the distal outflow ring is disposed between about 0.5 and about 3 mm closer to a longitudinal axis of the anchoring structure than is the first distal end of the proximal outflow ring.

7. A heart valve prosthesis configured for delivery to an implantation site in a minimally invasive manner, the prosthesis having a principal axis extending longitudinally therethrough and comprising an expandable anchoring structure having a tapered outflow portion adapted to engage a vessel wall at a location distal to Valsalva sinuses, an inflow portion that is sized and shaped to be positioned within and secured adjacent a valve annulus, and a plurality of anchoring members extending between the outflow portion and the inflow portion and angularly spaced about the principal axis, wherein the anchoring members are angularly distributed in three pairs, and only three pairs, around the prosthesis at an angular distance apart of about 120°

about the principal axis, so as to allow the anchoring members to extend into the sinuses of Valsalva, and wherein each of the plurality of anchoring members arches radially outward from the principal axis, the outflow portion including a proximal outflow ring having a first distal end having a first diameter and a distal outflow ring having a second distal end having a second diameter, the second diameter being smaller than the first diameter, so as to minimize damage to an aortic tunica intima, and wherein the first distal end of the proximal outflow ring and the second distal end of the distal outflow ring are coupled together by the anchoring members.

8. The heart valve prosthesis of claim 7 further comprising an expandable prosthetic heart valve including three leaflets coupled to the anchoring support structure.

9. The heart valve prosthesis of claim 7 wherein the anchoring structure is a stented structure and the outflow portion is curved away from the aortic tunica intima.

10. The heart valve prosthesis of claim 7 wherein the outflow portion is blunt.

11. The heart valve prosthesis according to claim 10 wherein the distal end is configured so as not to snag tissue at the implantation site.

12. The heart valve prosthesis of claim 7 wherein the outflow portion is covered with a protective coating or material.

13. The heart valve prosthesis according to claim 7 wherein the outflow portion is dimensioned to minimize shearing of blood cells passing by the outflow portion.

14. The heart valve prosthesis according to claim 7 wherein the outflow portion is configured to minimize blood flow turbulence through the prosthesis.

15. The heart valve prosthesis of claim 7 wherein an outside surface of the outflow portion is smooth and free from rough edges.

16. The heart valve prosthesis of claim 7 wherein the outside surface of the anchoring support structure includes a lubricious coating.