Prosthetic heart valves with elastic support structures and related methods

• US 10,231,833 B2
• Filed: 10/26/2017
• Issued: 03/19/2019
• Est. Priority Date: 10/28/2016
• Status: Active Grant

• Current Assignee: Foldax, Inc.
• Original Assignee: Foldax, Inc.
• Inventors: Beith, Jason G.
• Primary Examiner(s): Prone, Christopher D.
• Application Number:
  US15/795,049
• Publication Number:
  US 20180116794A1
• Time in Patent Office: 509 Days
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

Prosthetic heart valves having elastic leaflets and an elastic support structure are described. The support structure can store a load transferred from the leaflets as potential energy and then release it in the form of kinetic energy to exhibit a precursory transition from the closed position to the open position. The support structures can exhibit a sinusoidal movement profile at a base edge during the precursory transition.

Claims

1. A method of using a prosthetic heart valve, comprising:

using the prosthetic heart valve within a living subject, wherein the prosthetic heart valve comprises a plurality of synthetic leaflets and a support structure, the support structure comprising;

a plurality of projections coupled with the plurality of leaflets; and

a base upstream of the plurality of projections, wherein the plurality of projections and the base are elastic, wherein the support structure has a rigidity per unit force (R_UF) of 900 to 1400 square millimeters,

wherein the prosthetic heart valve has a closed position and an open position, and the plurality of leaflets and the support structure move between the closed position and the open position during use,

wherein the prosthetic heart valve permits fluid flow in an upstream to downstream direction when a transvalve fluid pressure is positive, and the plurality of leaflets are in a coapted state when the transvalve fluid pressure is a peak negative pressure, and

when the transvalve fluid pressure is a negative value less than the peak negative pressure, the plurality of projections automatically begin movement from the closed position to the open position.

2. The method of claim 1, wherein the support structure has a periphery and the base comprises an edge that extends around the periphery of the support structure.

3. The method of claim 2, wherein each leaflet of the plurality of leaflets has an upstream end, and wherein each projection of the plurality of projections has a downstream end, the edge comprising:

a first location directly upstream from each downstream end of the plurality of projections such that a plurality of first locations are present on the edge; and

a second location directly upstream from each upstream end of the plurality of leaflets such that a plurality of second locations are present on the edge,

wherein, at a first time during movement of the support structure from the closed position to the open position, each first location moves in a upstream direction and each second location moves in an downstream direction.

4. The method of claim 3, wherein the first time is when the transvalve fluid pressure is 90-99.9% of the peak negative pressure.

5. The method of claim 3, wherein the first time is when the transvalve fluid pressure is 85-95% of the peak negative pressure.

6. The method of claim 3, wherein the first time is when the transvalve fluid pressure is 25-75% of the peak negative pressure.

7. The method of claim 3, wherein the first time is when the transvalve fluid pressure is at the negative value.

8. The method of claim 3, wherein each first location of the edge moves in a downstream direction and each second location of the edge moves in an upstream direction continually as the transvalve fluid pressure transitions from 75% of the peak negative pressure to zero.

9. The method of claim 3, wherein each first location of the edge moves in a downstream direction and each second location of the edge moves in an upstream direction in immediate response to the transvalve fluid pressure transitioning from the peak negative pressure to a less negative pressure.

10. The method of claim 3, wherein the plurality of leaflets begin to exit the coapted state at the first time.

11. The method of claim 3, wherein, at the first time, each downstream end of the plurality of projections moves in a radially outward direction.

12. The method of claim 1, wherein the heart valve is an aortic replacement valve or a mitral replacement valve, the heart valve comprising exactly three synthetic leaflets.

13. The method of claim 1, wherein the support structure and the plurality of leaflets are formed of the same material.

14. The method of claim 1, wherein the support structure comprises a coating and wherein the plurality of leaflets are a continuation of the coating.

15. The method of claim 1, wherein the plurality of leaflets are seamlessly coupled to the support structure.

16. The method of claim 1, wherein the plurality of leaflets are not sewn to the support structure.

17. The method of claim 1, wherein the plurality of leaflets and the support structure are a monolithic body.

18. The method of claim 1, wherein the prosthetic heart valve is not part of a cardiopulmonary bypass machine nor an implantable artificial heart.

19. The method of claim 1, wherein the prosthetic heart valve is not powered by an artificial power source.

20. The method of claim 1, wherein the support structure has an inner diameter selected from the group consisting of:

a 17 millimeters (mm), 19 mm, 21 mm, 23 mm, 25 mm, 27 mm, 29 mm, and 31 mm.

21. The method of claim 1, wherein the plurality of leaflets have a first elasticity and the support structure has a second elasticity, the first elasticity being in the range of 10-45 MegaPascals (MPa) and the second elasticity being in the range of 3000-5000 MPa.

22. The method of claim 1, wherein the plurality of leaflets have a first elasticity and the support structure has a second elasticity, the first elasticity being in the range of 20-35 MegaPascals (MPa) and the second elasticity being in the range of 3300-3500 MPa.

23. The method of claim 1, wherein the plurality of leaflets have a first elasticity and the support structure has a second elasticity, the first elasticity being in the range of 25-30 MegaPascals (MPa) and the second elasticity being in the range of 3300-3500 MPa.

24. The method of claim 1, wherein the support structure has a rigidity per unit force of between 1100 and 1300 square millimeters.