Prosthetic valves, valve leaflets and related methods

Patent metadata

Field	Value
Publication number	US-11559394-B2
Application number	US-201916526150-A
Country	US
Kind code	B2
Filing date	Jul 30, 2019
Priority date	May 19, 2016
Publication date	Jan 24, 2023
Grant date	Jan 24, 2023

Abstract

Examples herein include prosthetic valves, valve leaflets and related methods. In an example, a prosthetic valve is included having a plurality of leaflets. The leaflets can each have a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion. The leaflets can include a fibrous matrix including polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers. A coating can surround the polymeric fibers within the fibrous matrix. The coating can have a thickness of about 3 to about 30 nanometers. The coating can be formed of a material selected from the group consisting of a metal oxide, a nitride, a carbide, a sulfide, or fluoride. In an example, a method of making a valve is included. Other examples are also included herein.

First claim

The invention claimed is:

1. A prosthetic valve comprising:
a plurality of leaflets,
the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets,
the leaflets comprising a fibrous matrix, the fibrous matrix comprising polymeric fibers;
a coating surrounding individual polymeric fibers within the fibrous matrix, the coating comprising a first layer and a second layer,
wherein one layer of the first layer and the second layer comprises a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide, and the other layer of the first layer and the second layer comprises a polymer.

2. The prosthetic valve of claim 1 , wherein the one layer comprises a metal oxide.

3. The prosthetic valve of claim 2 , the metal oxide comprising aluminum oxide (Al 2 O 3 ).

4. The prosthetic valve of claim 1 , wherein a density of the fibrous matrix is symmetric across a thickness of at least one of the plurality of leaflets.

5. The prosthetic valve of claim 1 , wherein a density of the fibrous matrix is asymmetric across a thickness of at least one of the leaflets.

6. The prosthetic valve of claim 1 , each leaflet having an upstream side and a downstream side, wherein a density of the fibrous matrix is greater on the upstream side of each leaflet than on the downstream side of each leaflet.

7. The prosthetic valve of claim 1 , wherein a flexural stiffness of at least one of the leaflets is less than 8 g/cm.

8. The prosthetic valve of claim 1 , the fibrous matrix comprising polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers.

9. The prosthetic valve of claim 1 , further comprising a frame, wherein the leaflets are attached to the frame.

10. A prosthetic valve comprising:
a plurality of leaflets,
the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets,
each leaflet among the plurality of leaflets comprising a fibrous matrix, the fibrous matrix comprising polymeric fibers; and
a coating surrounding individual polymeric fibers within the fibrous matrix, wherein the coating comprises a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide;
wherein a flexural stiffness of the leaflets is less than 8 g/cm.

11. The prosthetic valve of claim 10 , the coating comprising a metal oxide, the metal oxide comprising aluminum oxide (Al 2 O 3 ).

12. The prosthetic valve of claim 10 , wherein a density of the fibrous matrix is asymmetric across a thickness of the leaflets.

13. The prosthetic valve of claim 10 , each leaflet having an upstream side and a downstream side, wherein a density of the fibrous matrix is greater on the upstream side of each leaflet than on the downstream side of each leaflet.

14. The prosthetic valve of claim 10 , the fibrous matrix comprising polymeric fibers having an average diameter of about 10 nanometers to about 10 micrometers.

15. The prosthetic valve of claim 10 , further comprising a frame, wherein the leaflets are attached to the frame.

16. A prosthetic valve comprising:
a plurality of leaflets,
the leaflets each having a root portion and an edge portion substantially opposite the root portion and movable relative to the root portion to coapt with a respective edge portion of at least one of the other leaflets of the plurality of leaflets,
the leaflets comprising a first zone and a second zone across a thickness thereof,
the first zone comprising a first fibrous matrix, the first fibrous matrix comprising polymeric fibers;
the second zone comprising a second fibrous matrix, the second fibrous matrix comprising polymeric fibers;
a coating surrounding individual polymeric fibers within the first fibrous matrix, the coating comprising a material selected from the group consisting of a metal oxide, a nitride, a carbide, or a sulfide.

17. The prosthetic valve of claim 16 , the first zone having a different fiber density than the second zone.

18. The prosthetic valve of claim 16 , wherein the first zone and the second zone have a combined thickness of 0.002″ to 0.02″.

19. The prosthetic valve of claim 16 , the polymeric fibers of the first fibrous matrix comprising a polymer selected from the group consisting of poly(ethylene oxide), polyethylene, polyisobutylene polyurethane (PIBU), poly(styrene-block-isobutylene-block-styrene (SIBS), polypropylene, polystyrene, polyvinylchloride, polyisobutylene (PIB), poly(styrene) polyurethanes, polyvinylidene difluoride, poly(methyl methacrylate), polyethylene glycol, polyanilines, polypyrroles, polythiophenes, polyphenols, polyacetylenes, polyphenylenes, polyacrylonitriles, polylactic acids, polycaprolactone, polyglycolides, polyvinyl acetates, cellulose acetate, chitosan, proteins, carbohydrates and copolymers including one or more of these.

Assignees

• Boston Scient Scimed Inc

Inventors

• Weber Jan
• Zhou Haiying
• Forsyth Bruce R

Classifications

• D04H1/5412

  sheath-core · CPC title

• C08K2003/2227

  of aluminium · CPC title

• A61F2250/0036

  differing in thickness · CPC title

• A61F2250/0023

  differing in porosity · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title