PROSTHETIC HEART VALVE SYSTEMS

• US 20110264207A1
• Filed: 07/07/2011
• Published: 10/27/2011
• Est. Priority Date: 02/28/2008
• Status: Active Grant

• Current Assignee: Phillip Bonhoeffer, Timothy R. Ryan
• Original Assignee: Phillip Bonhoeffer, Timothy R. Ryan
• Inventors: Bonhoeffer, Phillip, Ryan, Timothy R.
• Granted Patent: US 8,613,765 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

A heart valve that can be expanded following its implantation in a patient, such as to accommodate the growth of a patient and the corresponding growth of the area where the valve is implanted, and to minimize paravalvular leakage. In one aspect, the invention may maximize the orifice size of the surgical valve. The invention includes expandable implantable conduits and expandable bioprosthetic stented valves. In one aspect of the invention, the valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

Claims

1. A prosthetic heart valve comprising:

a valved conduit comprising;

a generally tubular structure comprising a proximal end, a distal end, and a central portion between the proximal and distal ends, wherein a length of the tubular structure adjacent to at least one of the proximal and distal ends has a larger diameter in its unexpanded condition than a diameter of the central portion in its unexpanded condition; and

at least one leaflet attached within an interior area of the tubular structure in the central portion;

a plurality of support structures spaced from each other and attached to the central portion of the tubular structure, wherein each of the support structures is expandable from a first configuration to a second configuration when subjected to internal radial stress, wherein the internal area of each support structure is smaller in its first configuration than in its second configuration.

2. The heart valve of claim 1, wherein each of the support structures is attached to an outer surface of the central portion of the tubular structure.

3. The heart valve of claim 1, wherein each of the support structures is attached to an inner surface of the central portion of the tubular structure.

4. The heart valve of claim 1, wherein each of the support structures is embedded within an outer wall of the central portion of the tubular structure.

5. The heart valve of claim 1, wherein the heart valve is surgically implantable in a patient with the support structures in their first configuration, and wherein the support structures are expandable to their second configuration in response to the application of radial stress by a radial expansion system.

6. The heart valve of claim 1, wherein the first configuration of each of the support structures comprises a shaped portion, and wherein the shaped portion of each of the support structures is at least partially straightened when the support structure is in its second configuration.

7. A prosthetic heart valve comprising:

a sewing ring from which a plurality of stent posts extend in an axial direction, wherein the sewing ring is a generally tubular structure that is expandable from a first configuration to a second configuration, wherein an internal area of the sewing ring is smaller in its first configuration than in its second configuration;

at least one leaflet attached within an interior area of the sewing ring; and

a reconfigurable support structure, wherein at least a portion of the support structure is attached to at least one of the stent posts.

8. The heart valve of claim 7, wherein the support structure is reconfigurable from the first configuration to the second configuration when the sewing ring is subjected to internal radial stress.

9. The heart valve of claim 7, wherein the sewing ring comprises a frame having a gap between two frame ends that is smaller when the sewing ring is in its first configuration than when the sewing ring is in its second configuration, and wherein the frame and the gap between the two frame ends are covered by a flexible covering material.

10. The heart valve of claim 9, wherein the flexible covering material further surrounds the stent posts.

11. The heart valve of claim 9, wherein the support structure is a self-expanding structure.

12. The heart valve of claim 11, further comprising at least one restraining member positioned to compress a portion of the support structure to maintain the support structure is in its first configuration.

13. The heart valve of claim 7, wherein the support structure comprises a plurality of U-shaped wire portions that each extend in an axial direction toward a distal end of one of the plurality of stent posts.

14. The heart valve of claim 9, wherein the support structure comprises a U-shaped wire portion adjacent to the gap between two frame ends.

15. A prosthetic heart valve comprising a valved conduit comprising a generally tubular structure having at least one leaflet attached within its interior area, wherein the tubular structure comprises:

a plurality of longitudinal support members spaced from each other around the perimeter of the tubular structure;

at least one deformable member attached at a first end to a first longitudinal support member and at a second end to an adjacent second longitudinal support member, wherein the at least one deformable member is reconfigurable when the tubular structure is subjected to an internal radial stress.

16. The heart valve of claim 15, wherein the at least one deformable member is permanently deformable.

17. The heart valve of claim 15, wherein the at least one deformable member is breakable.

18. The heart valve of claim 15, wherein at least one of the deformable members has a first length in an unexpanded condition of the tubular structure and a second length in an expanded condition of the tubular structure, wherein the first length is smaller than the second length.

19. The heart valve of claim 18, wherein the first and second lengths of at least one of the deformable members corresponds to a distance between two adjacent longitudinal support members.

20. The heart valve of claim 15, further comprising at least one connector member attached at a first end to the first longitudinal member and at a second end to the second longitudinal member, wherein the at least one connector member has a higher strength than a strength of the at least one deformable member such that when the tubular structure is subjected to an internal radial stress, the at least one deformable member will deform by a sufficient amount that the distance between the first and second longitudinal support members will increase while the connector member remains attached to the first and second longitudinal support members.