Prosthetic heart valves having fiber reinforced leaflets

• US 10,314,696 B2
• Filed: 03/28/2016
• Issued: 06/11/2019
• 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: Wulfman, David Robert, Wrobel, Thomas A., Anderson-Cunanan, Crystal Marie, Delaney, Jr., Joseph Thomas, Willoughby, Patrick, Boden, Mark W., Edelman, Peter G., Eppihimer, Michael
• Primary Examiner(s): Sanderson, Lee E
• Assistant Examiner(s): Romanowski, Michael C
• Application Number:
  US15/082,382
• Publication Number:
  US 20160296323A1
• Time in Patent Office: 1,170 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: A61L 2400/12 Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

A prosthetic heart valve leaflet includes a plurality of electrospun fibers at least partially embedded in a polymer matrix. The plurality of fibers includes a first polyisobutylene urethane copolymer having a first predetermined weight average percentage of hard segment portions and the polymer matrix includes a second polyisobutylene urethane copolymer having a second predetermined weight average percentage of the hard segment portions, wherein the first predetermined weight average percentage of the hard segment portions is greater than the second predetermined weight average percentage of the hard segment portions.

Claims

1. A prosthetic heart valve leaflet comprising a composite material, the composite material comprising:

a plurality of electrospun fibers at least partially embedded in a polymer matrix, the plurality of electrospun fibers comprising a first polyisobutylene urethane block copolymer comprising hard and soft segment portions, having a first predetermined weight average percentage of hard segment portions and the polymer matrix comprising a second polyisobutylene urethane block copolymer comprising hard and soft segment portions, having a second predetermined weight average percentage of hard segment portions, wherein the first predetermined weight average percentage of the hard segment portions is greater than the second predetermined weight average percentage of the hard segment portions.

2. The prosthetic heart valve leaflet of claim 1, wherein the hard segment portions of the first and second polyisobutylene urethane block copolymers are prepared from a methylene diisocyanate and a butane diol.

3. The prosthetic heart valve leaflet of claim 1, wherein the first and second polyisobutylene urethane block copolymers comprise soft segment portions, wherein the soft segment portions are prepared from a residual monomer of a polyisobutylene diol or a polyisobutylene diamine.

4. The prosthetic heart valve leaflet of claim 3, wherein the soft segment portions further include at least one selected from the group consisting of a polyether, a fluorinated polyether, a fluoropolymer, a polyester, a polyacrylate, a polymethacrylate, a polysiloxane, a fluorinated polysiloxane, or a polycarbonate.

5. The prosthetic heart valve leaflet of claim 3, wherein the first polyisobutylene urethane block copolymer comprises a weight average percentage of the hard segment ranging between 40 wt % to 60 wt % and a weight average percent of the soft segment of 40 wt % to 60 wt %.

6. The prosthetic heart valve leaflet of claim 3, wherein the second polyisobutylene urethane block copolymer comprises a weight average percentage of the hard segment ranging between 30 wt % to 40 wt % and a weight average percent of the soft segment of 60 wt % to 70 wt %.

7. The prosthetic heart valve leaflet of claim 1, further comprising a hydrogel coating disposed on the composite material.

8. The prosthetic heart valve leaflet of claim 7, wherein the hydrogel coating includes polyethylene glycol (PEG).

9. The prosthetic heart valve leaflet of claim 1, wherein a first portion of the plurality of electrospun fibers have a first predetermined orientation and a second portion of the plurality of electrospun fibers have a second predetermined orientation.

10. The prosthetic heart valve leaflet of claim 1, wherein the first polyisobutylene urethane block copolymer and the second polyisobutylene block copolymer both comprise hard segment portions, wherein individual hard segment portions are made from a methylene diisocyanate (MDI) and a butane diol (BD).

11. The prosthetic heart valve leaflet of claim 10, wherein the first and second polyisobutylene urethane block copolymers are made using a mole ratio of MDI/(BD+soft segments) of 1.