FIBER REINFORCED PROSTHETIC HEART VALVE HAVING UNDULATING FIBERS

• US 20160296325A1
• Filed: 03/28/2016
• Published: 10/13/2016
• Est. Priority Date: 04/09/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Edelman, Peter G., Delaney, Joseph Thomas Jr.
• Granted Patent: US 10,426,609 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2210/0071 thermoplastic
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: B29C 70/30 Shaping by lay-up, i.e. applying fibres, tape or broadsheet on a mould, former or core; Shaping by spray-up, i.e. spraying of fibres on a mould, former or core
• CPC Class Codes: B29K 2995/0046 Elastic
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A prosthetic heart valve includes a composite material that has a first plurality of fibers embedded in a polymer matrix. Each fiber can have a first extending direction and a plurality of undulations.

Claims

1. A prosthetic heart valve comprising a composite material comprising a first plurality of fibers embedded in a polymer matrix, each fiber having a first extending direction and a plurality of undulations, wherein the plurality of undulations of the first plurality of fibers are adapted to provide the composite material with multi-stage elastic properties.

2. The prosthetic heart valve of claim 1, wherein composite material is comprised in a leaflet and wherein at least a portion of the first plurality of fibers extends along at least a portion of an edge contour of a leaflet of the prosthetic heart valve.

3. The prosthetic heart valve of claim 1, wherein the first extending direction is one of a circumferential direction and a radial direction on a leaflet of the prosthetic heart valve.

4. The prosthetic heart valve of claim 1, wherein the plurality of undulations of each fiber is adapted to straighten when the composite material is stretched in the first extending direction.

5. The prosthetic heart valve of claim 1, wherein the composite material is more elastic when the plurality of fibers have the plurality of undulations and less elastic when at least a portion of the plurality of fibers have been stretched into a substantially straight fibers.

6. The prosthetic heart valve of claim 1, wherein the composite material has a first elasticity when an average segment distance of the plurality of fibers is less than an average total fiber length of the plurality of fibers and a second elasticity when the average segment distance of the plurality of fibers is equal to or greater than the average total fiber length of the plurality of fibers, wherein the first elasticity is greater than the second elasticity.

7. The prosthetic heart valve of claim 1, wherein the undulations have a predetermined average amplitude and predetermined average wavelength.

8. The prosthetic heart valve of claim 1, wherein the plurality of fibers comprise a thermoplastic polymer.

9. The prosthetic heart valve of claim 1, wherein the plurality of fibers comprise a liquid crystalline polymer.

10. The prosthetic heart valve of claim 1, wherein the polymer matrix comprises an elastomeric polymer.

11. The prosthetic heart valve of claim 1, further comprising a second plurality of fibers embedded in the polymer matrix, each fiber having a second extending direction and a plurality of undulations.

12. The prosthetic heart valve of claim 11, wherein the direction of the first plurality of fibers defines a first longitudinal axis and the direction of the second plurality of fibers defines a second longitudinal axis, wherein the first longitudinal axis is orthogonal to the second longitudinal axis.

13. The prosthetic heart valve of claim 11, wherein the direction of the first plurality of fibers defines a first longitudinal axis and the direction of the second plurality of fibers defines a second longitudinal axis, wherein the first longitudinal axis is oblique to the second longitudinal axis.

14. A prosthetic heart valve comprising:

a tubular body having an annular region; and

a plurality of leaflets, each leaflet having a free end and a bottom edge, the bottom edge being coupled to the annular region of the tubular body, each leaflet having a free edge substantially opposite the bottom edge, at least a portion of the leaflet made of a composite material comprising a plurality of curved fibers embedded in a polymer matrix, wherein the plurality of curved fibers comprises a liquid crystal polymer.

15. The prosthetic heart valve of claim 14, wherein the plurality of curved fibers are composed of a polyester-based liquid crystal polymer formed by the polycondensation of 4-hydroxybenzoic acid and 6-hydroxynaphthalene-2-carboxylic acid.

16. The prosthetic heart valve of claim 14, wherein the plurality of curved fibers are each encapsulated within a jacket comprising a polyurethane or a derivative of a polyurethane.

17. The prosthetic heart valve of claim 14, wherein each curved fiber of the plurality of curved fibers has a first extending direction and a plurality of undulations.

18. A method of forming a prosthetic heart valve leaflet, the method comprising:

forming a composite material comprising;

disposing a first polymeric layer on a mandrel;

disposing a plurality of fibers comprising a plurality of undulations on the first polymeric layer; and

disposing a second polymeric layer on the plurality of fibers,

wherein the composite material is elastic when a plurality of fibers are in a relaxed state having a plurality of undulations and less elastic when at least a portion of the plurality of fibers are stretched into substantially straight fibers.

19. The method of claim 18, wherein the plurality of fibers are disposed using an electrospinning process.

20. The method of claim 18, wherein the first polymer layer is disposed on the mandrel using a dipping or spraying process.