TRANSCATHETER STENT AND VALVE ASSEMBLY

• US 20180098844A1
• Filed: 10/10/2017
• Published: 04/12/2018
• Est. Priority Date: 10/10/2016
• Status: Active Grant

• Current Assignee: PECA Labs, Inc.
• Original Assignee: PECA Labs, Inc.
• Inventors: BERNSTEIN, C. Douglas, KALRA, Arush, FAULK, Denver
• Granted Patent: US 10,631,979 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2002/30011 differing in porosity
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0024 made from both porous and non-porous parts, e.g. adjacent parts

Abstract

Valves constructed from low porosity leaflets are disclosed. The valves disclosed herein may be integrated into a variety of structures, such as valved conduits and transcatheter stents, and may be constructed of one or more layers. Embodiments herein are also directed to methods of using the same and methods of making the same.

Claims

1. A valve comprising one or more leaflets, wherein the leaflets are constructed from a layer of a material which has a surface porosity of about 1% to less than 15%.

2. The valve of claim 1, wherein the material is a fluoropolymer.

3. The valve of claim 1, wherein the layer includes a surface coating.

4. The valve of claim 1, wherein the layer has an average pore area of less than or about 1 square micron.

5. The valve of claim 1, wherein the layer has an average pore diameter of less than or about 1 micron.

6. The valve of claim 1, wherein the layer has a thickness of less than or about 0.1 mm.

7. The valve of claim 1, wherein the one or more leaflets comprise more than one layer of the material.

8. The valve of claim 7, wherein at least two layers of the more than one layer are anisotropic with orientations that are offset by an angle of at least 10 degrees.

9. The valve of claim 8, wherein the orientations of the at least two layers are offset by about 10 degrees to about 90 degrees relative to each other.

10. The valve of claim 7, wherein the one or more leaflets have a total thickness of less than or about 0.1 mm.

11. A valved conduit comprising:

a conduit having an inner surface and an outer surface;

a valve attached to the inner surface of the conduit at a plurality of attachment points, the valve further comprising one or more leaflets,

wherein the one or more leaflets are constructed from a layer of material which has a surface porosity of about 1% to less than 15%.

12. The valved conduit of claim 11, wherein the conduit is a stent.

13. The valved conduit of claim 11, wherein the material is a fluoropolymer.

14. The valved conduit of claim 11, wherein the layer includes a surface coating.

15. The valved conduit of claim 11, wherein the layer has an average pore area less than or about 1 square micron.

16. The valved conduit of claim 11, wherein the layer has an average pore diameter less than or about 1 micron.

17. The valve conduit of claim 11, wherein the layer has a thickness of less than or about 0.1 mm.

18. The valved conduit of claim 11, wherein the one or more leaflets comprise more than one layer of the material.

19. The valved conduit of claim 18, wherein at least two layers of the more than one layer are anisotropic with orientations that are offset by an angle of at least 10 degrees.

20. The valve of claim 19, wherein the orientations of the at least two layers are offset by about 10 degrees to about 90 degrees relative to each other.

21. The valved conduit of claim 18, wherein the one or more leaflets have a total thickness less than or about 0.1 mm.

22. A valved conduit comprising:

a fluoropolymer conduit having an inner surface and an outer surface;

a valve attached to the inner surface of the conduit at a plurality of attachment points, wherein the valve includes one or more leaflets,

wherein the one or more leaflets are constructed from at least two layers of a fluoropolymer having a surface porosity of about 1% to about 7% and a total thickness of about 0.045 mm,

wherein the at least two layers are anisotropic with orientations that offset by an angle of at least 10 degrees.