Fiber reinforced prosthetic heart valve having undulating fibers

• US 10,426,609 B2
• Filed: 03/28/2016
• Issued: 10/01/2019
• 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, Jr., Joseph Thomas
• Primary Examiner(s): Lopez, Leslie
• Application Number:
  US15/082,239
• Publication Number:
  US 20160296325A1
• Time in Patent Office: 1,282 Days
• Field of Search: None
• 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 plurality of leaflets comprising;

a composite material comprising a first plurality of polymeric fibers embedded in a polymer matrix, each fiber of the first plurality of polymeric fibers having a first common extending direction and a plurality of regularly spaced repeating undulations, wherein the plurality of regularly spaced repeating undulations of the first plurality of polymeric fibers is adapted to provide the composite material with multi-stage elastic properties; and

wherein the plurality of regularly spaced repeating undulations of the first plurality of polymeric fibers has crests that extend in a direction orthogonal to the first common extending direction;

wherein each leaflet comprises a first sleeve portion, a second sleeve portion, and a body portion disposed between the first and the second sleeve portions; and

wherein at least a portion of the first plurality of polymeric fibers extend along a linear path along the first common extending direction comprising a circumferential direction between the first sleeve portion and the second sleeve portion.

2. The prosthetic heart valve of claim 1, wherein at least a portion of the first plurality of polymeric fibers extends along at least a portion of an edge contour of one or more of the plurality of leaflets of the prosthetic heart valve in the first common extending direction.

3. The prosthetic heart valve of claim 1, wherein the plurality of regularly spaced repeating undulations of each fiber is adapted to straighten along the linear path when the composite material is stretched in the first common extending direction.

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

5. 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.

6. The prosthetic heart valve of claim 1, wherein the regularly spaced repeating undulations have a predetermined average amplitude and a predetermined average wavelength.

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

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

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

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

11. The prosthetic heart valve of claim 10, wherein the first common extending direction of the first plurality of fibers defines a first longitudinal axis and the second common extending direction of the second plurality of fibers defines a second longitudinal axis, wherein the first longitudinal axis is orthogonal to the second longitudinal axis.