PROSTHETIC VALVES, VALVE LEAFLETS AND RELATED METHODS

• US 20170333185A1
• Filed: 05/15/2017
• Published: 11/23/2017
• Est. Priority Date: 05/19/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Weber, Jan, Zhou, Haiying, Forsyth, Bruce R.
• Granted Patent: US 10,368,982 B2
• Time in Patent Office: Days
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0017 differing in yarn density
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0076 waterproof
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/306 Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• CPC Class Codes: B32B 27/02 in the form of fibres or filaments not used
• CPC Class Codes: C08K 2003/2227 of aluminium
• CPC Class Codes: C08K 2003/2241 Titanium dioxide
• CPC Class Codes: C08K 2003/2255 of molybdenum
• CPC Class Codes: C08K 3/22 of metals
• CPC Class Codes: D01F 8/00 Conjugated, i.e. bi- or multicomponent, artificial filaments or the like; Manufacture thereof
• CPC Class Codes: D04H 1/5412 sheath-core
• CPC Class Codes: D04H 3/147 Composite yarns or filaments

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.

Claims

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 having an average diameter of about 10 nanometers to about 10 micrometers;

a coating surrounding the polymeric fibers within the fibrous matrix, the coating have a thickness of about 3 to about 30 nanometers, wherein the coating is formed of a material selected from the group consisting of a metal oxide, a nitride, a carbide, a sulfide, or fluoride.

2. The valve of claim 1, the leaflets each having a thickness between an upstream side and a downstream side of about 0.003″

(0.0762 mm) to about 0.015″

(0.381 mm).

3. The valve of claim 1, the polymeric fibers 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.

4. The valve of claim 1, the coating material comprising a metal oxide selected from the group consisting of aluminum oxide, titanium dioxide, silicon dioxide, ruthenium oxide, rhodium oxide, palladium oxide, silver oxide, osmium oxide, iridium oxide, platinum oxide and gold oxide.

5. The valve of claim 4, the metal oxide comprising aluminum oxide (Al₂O₃).

6. The valve of claim 1, wherein the coating surrounding the polymeric fibers prevents the penetration of water there through.

7. The valve of claim 1, the coating surrounding the polymeric fibers comprising a multilaminate layer comprising metal oxide and polymeric sublayers.

8. The valve of claim 1, wherein the density of the fibrous matrix is substantially uniform across the thickness of the leaflet.

9. The valve of claim 1, wherein the density of the fibrous matrix is asymmetric across the thickness of the leaflet.

10. The valve of claim 1, wherein the density of the fibrous matrix is greater on the upstream side of the valve leaflet than on the downstream side of the valve leaflet.

11. The valve of claim 1, wherein the density of the fibrous matrix varies across the width of the leaflet.

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

13. The valve of claim 1, wherein the valve is a TAVI valve.

14. The valve of claim 1, wherein the flexural stiffness of the leaflet is less than 8 g/cm.

15. A method of making a valve comprising:

depositing polymeric fibers in a layer to form a fibrous matrix;

cutting the fibrous matrix into the shape of a valve leaflet; and

applying a layer of a metal oxide onto the polymeric fibers using a gas phase deposition technique.

16. The method of claim 15, further comprising attaching the valve leaflet onto a frame.

17. The method of claim 15, the gas phase deposition technique comprising atomic layer deposition (ALD).

18. The method of claim 15, wherein depositing the polymeric fibers comprising electro spinning.

19. The method of claim 15, wherein depositing the polymeric fibers comprises weaving.

20. A method of making a valve comprising:

depositing polymeric fibers onto a frame to form a valve leaflet; and

applying a layer of a metal oxide onto the polymeric fibers using a gas phase deposition technique.