Prosthetic heart valve composed of composite fibers

• US 10,716,671 B2
• Filed: 06/27/2016
• Issued: 07/21/2020
• Est. Priority Date: 07/02/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Eppihimer, Michael, Edelman, Peter G.
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US15/193,794
• Publication Number:
  US 20170000610A1
• Time in Patent Office: 1,485 Days
• Field of Search: 428377
• 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 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A prosthetic heart leaflet includes a fiber-reinforced structure including a plurality of composite fibers. Each composite fiber includes a core fiber and a sheathing fiber disposed about the core fiber, wherein the core fiber or the sheathing fiber has a curvilinear shape.

Claims

1. A prosthetic heart valve leaflet comprising a fiber-reinforced structure including a plurality of composite fibers, each composite fiber comprising a plurality of elastomeric core fibers encapsulated within a common sheathing fiber disposed about the plurality of elastomeric core fibers,

wherein the common sheathing fiber fills a space between the plurality of elastomeric core fibers such that they do not touch one another;

wherein each elastomeric core fiber in the plurality of elastomeric core fibers has an undulating, non-linear shape within the common sheathing fiber when the composite fiber is in a relaxed state, and a straight, linear shape within the common sheathing fiber when the composite fiber is stretched in a strained state.

2. The prosthetic heart valve leaflet of claim 1, wherein weight ratio of the elastomeric core fibers to the sheathing fiber ranges from 1:

5 to 5;

1.

3. The prosthetic heart valve leaflet of claim 1, wherein the elastomeric core fibers and the sheathing fiber are made of different polymeric materials.

4. The prosthetic heart valve leaflet of claim 1, wherein the sheathing fiber comprises a thermoplastic polymer.

5. The prosthetic heart valve leaflet of claim 1, wherein the elastomeric core fibers comprise a tensile modulus that is greater than a tensile modulus of the sheathing fiber.

6. The prosthetic heart valve leaflet of claim 1, wherein the elastomeric core fibers or the sheathing fiber comprises carbon fillers.

7. The prosthetic heart valve leaflet of claim 1, wherein the composite fiber includes a coating comprising polyethylene glycol.

8. The prosthetic heart valve leaflet of claim 1, wherein the composite fibers are electrospun composite fibers.

9. The prosthetic heart valve leaflet of claim 1, each composite fiber comprising at least three elastomeric core fibers encapsulated within the sheathing fiber.

10. The prosthetic heart valve leaflet of claim 9, wherein the at least three elastomeric core fibers form a helical shape within the sheathing fiber.