Prosthetic heart valves having fiber reinforced leaflets

Patent metadata

Field	Value
Publication number	US-2016296323-A1
Application number	US-201615082382-A
Country	US
Kind code	A1
Filing date	Mar 28, 2016
Priority date	Apr 9, 2015
Publication date	Oct 13, 2016
Grant date	—

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.

First claim

What is claimed is:

1 . A prosthetic heart valve comprising:
a tubular body; and three leaflets coupled to the tubular body, each leaflet comprising a fibrous composite material composed of a plurality of electrospun fibers at least partially embedded in a polymer matrix, wherein the polymer matrix comprises a polyisobutylene urethane copolymer and the electrospun fibers comprise a polyurethane, fluoropolymer, polyester or a tri-block polymer.

2 . The prosthetic heart valve of claim 1 , wherein the electrospun fibers comprise polyisobutylene urethane (PIB-PUR) copolymer, a fluoropolymer, a polyethylene terephthalate (PET), or a poly(styrene-isobutylene-styrene) (SIBS) tri-block polymer.

3 . The prosthetic heart valve of claim 1 , wherein the polymer matrix comprises a polyisobutylene urethane copolymer having a durometer from about 60 A to about 55 D shore hardness.

4 . The prosthetic heart valve of claim 1 , wherein the plurality of electrospun fibers comprise a polymeric material having a tensile strength from 20 MPa to 45 MPa and the polymer matrix has a tensile strength from 20 MPa to 45 MPa.

5 . A prosthetic heart valve leaflet comprising a plurality of electrospun fibers at least partially embedded in a polymer matrix, the plurality of electrospun fibers comprising a first polyisobutylene urethane copolymer having a first predetermined weight average percentage of hard segment portions and the polymer matrix comprising 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.

6 . The prosthetic heart valve leaflet of claim 5 , wherein the first and second hard segment portions are each prepared from a methylene diisocyanate and a butane diol.

7 . The prosthetic heart valve leaflet of claim 5 , wherein the first and second polyisobutylene urethane copolymers each comprise soft segment portions, the soft segment portions are prepared from a residual monomer of a polyisobutylene diol or a polyisobutylene diamine.

8 . The prosthetic heart valve leaflet of claim 7 , wherein the soft segment portions further comprises at least a polyether, a fluorinated polyether, a fluoropolymer, a polyester, a polyacrylate, a polymethacrylate, a polysiloxane, a fluorinated polysiloxane, or a polycarbonate.

9 . The prosthetic heart valve leaflet of claim 7 , wherein the first polyisobutylene urethane copolymer comprises a weight average percentage of the hard segment ranging between about 40 wt % to about 60 wt % and a weight average percent of the soft segment of about 40 wt % to about 60 wt %.

10 . The prosthetic heart valve leaflet of claim 7 , wherein the second polyisobutylene urethane copolymer comprises a weight average percentage of the hard segment ranging between about 30 wt % to about 40 wt % and a weight average percent of the soft segment of about 60 wt % to about 70 wt %.

11 . The prosthetic heart valve leaflet of claim 5 , further comprising a hydrogel coating disposed on the composite material.

12 . The prosthetic heart valve leaflet of claim 11 , wherein the hydrogel coating includes polyethylene glycol (PEG).

13 . The prosthetic heart valve leaflet of claim 5 , 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.

14 . The prosthetic heart valve leaflet of claim 5 , wherein the polyisobutylene urethane copolymer comprises hard segment portions, wherein each hard segment portion is made from a methylene diisocyanate and a butane diol.

15 . The prosthetic heart valve leaflet of claim 14 , wherein the polyisobutylene urethane copolymer is made using mole ratio of MDI/(BD+SS) of about 1.

16 . A method comprising:
disposing a plurality of electrospun fibers onto a mandrel, the electrospun fibers comprising a first polyisobutylene urethane copolymer comprising a first predetermined weight average percentage of hard segment portions; and disposing a layer of a second polyisobutylene urethane copolymer onto the mandrel, the second polyisobutylene urethane copolymer comprising a second predetermined weight average percentage of the hard segment portions.

17 . The method of claim 16 , wherein disposing the layer of the polyisobutylene urethane copolymer comprises a dip coating process, compression molding process or a spraying process.

18 . The method of one of claim 16 , wherein disposing the plurality of electrospun fibers comprises electrospinning the plurality of fibers onto a cylindrical or conical mandrel.

19 . The method of claim 16 , further comprising applying a hydrogel coating that comprises polyethylene glycol (PEG).

20 . The method of claim 19 , wherein the hydrogel coating comprises heparin.

Assignees

• Boston Scient Scimed Inc

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

Classifications

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61L27/18

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title

• A61L27/34

  Macromolecular materials · CPC title

• A61L27/16

  obtained by reactions only involving carbon-to-carbon unsaturated bonds · CPC title