Prosthetic heart valve including self-reinforced composite leaflets

• US 10,413,403 B2
• Filed: 07/08/2016
• Issued: 09/17/2019
• Est. Priority Date: 07/14/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Boden, Mark W., Edelman, Peter G., Delaney, Jr., Joseph Thomas
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/205,098
• Publication Number:
  US 20170014227A1
• Time in Patent Office: 1,166 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures
• CPC Class Codes: A61L 27/20 Polysaccharides

Abstract

A prosthetic heart valve leaflet is composed of a self-reinforced composite (SRC) structure that includes a first layer. The first layer can include a first plurality of fused fibers composed of a first polymeric material in which each fiber is fused to at least one adjacent fiber by a reflowed fiber domain region.

Claims

1. A prosthetic heart valve leaflet comprising

a self-reinforced composite (SRC) structure comprising

a first layer comprising a first plurality of fused fibers composed of a first polymeric material and characterized by each fiber being fused to at least one adjacent fiber by a reflowed fiber domain region;

and

a second layer comprising a second plurality of fused fibers composed of a second polymeric material and characterized by each fiber being fused to at least one adjacent fiber by a reflowed fiber domain region;

wherein the first and second polymeric materials are different materials.

2. The prosthetic heart valve leaflet of claim 1, wherein the first plurality of fused fibers and the second plurality of fused fibers are generally aligned in at least two directions such that the first plurality of the fused fibers are oriented at a first predetermined fiber angle relative to the second plurality of fused fibers.

3. The prosthetic heart valve leaflet of claim 2, wherein the predetermined fiber angle is an orthogonal angle.

4. The prosthetic heart valve leaflet of claim 2, wherein the predetermined fiber angle can range from about 10 degrees to 20 degrees, from about 20 degrees to 30 degrees, from about 30 degrees to about 40 degrees, from about 40 degrees to about 45 degrees, from about 45 degrees to about 50 degrees, from about 50 degrees to about 60 degrees, from about 60 degrees to about 70 degrees, from about 70 degrees to about 80 degrees.

5. The prosthetic heart valve leaflet of claim 1, wherein the first plurality of fused fibers are generally aligned in a direction defining a first longitudinal axis, the first longitudinal axis being oriented at an angle relative to a free edge of the prosthetic heart valve leaflet.

6. The prosthetic heart valve leaflet of claim 5, wherein each fiber of the first plurality of fused fibers comprises an aligned polymer crystal orientation that is generally parallel with the first longitudinal axis.

7. The prosthetic heart valve leaflet of claim 1, wherein the first layer is disposed adjacent to the second layer.

8. The prosthetic heart valve leaflet of claim 1, wherein the first plurality of fused fibers of the first layer are oriented in a first direction and the second plurality of fused fibers of the second layer are oriented in a second direction to form a biaxial orientation within the SRC structure.

9. The prosthetic heart valve leaflet of claim 1, wherein the SRC structure comprises additional layers to form a three-, four-, or a five-composite-layered SRC structure.

10. The prosthetic heart valve of claim 9, wherein the three-, four- or five-composite-layered of the SRC structure forms a triaxial, a quadaxial or a quinaxial orientation, respectively.

11. The prosthetic heart valve leaflet of claim 1, wherein the first polymeric material is a polyurethane, a polyisobutylene urethane (PIB-PUR) copolymer, a polyamide, a polyimide, a polycarbonate, a polyester, a polyetherether ketone, or a fluorinated polyolefin.

12. The prosthetic heart valve leaflet of claim 1, wherein the first polymeric material is a high-melt-temperature polyurethane and second polymeric material is a low-melt-temperature polyurethane.

13. The prosthetic heart valve leaflet of claim 1, wherein the first layer at least partially overlaps the second layer.

14. The prosthetic heart valve leaflet of claim 1, wherein at least a portion of the first layer is fused to at least a portion of the second layer.

15. The prosthetic heart valve leaflet of claim 1, wherein each fiber of the first plurality of fibers has a generally square, oval, or hexagonal cross-sectional shape.