# US 11,304,798 B2 · Prosthetic heart valves having fiber reinforced leaflets > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,798 B2 - Document ID: US11304798B2 - Status: Granted - Kind: B2 - Application number: 16/413,104 - Filed: 2019-05-15 - Published: 2019-08-29 - Granted: 2022-04-19 - Earliest claimed: 2015-04-09 - Assignees: Boston Scientific Scimed, Inc. - Applicants: Boston Scientific Scimed, Inc. - Inventors: David Robert Wulfman; Thomas A. Wrobel; Crystal Marie Anderson-Cunanan; Joseph Thomas Delaney, Jr.; Patrick Willoughby; Mark W. Boden; Peter G. Edelman; Michael Eppihimer - Web page: https://patentgrep.com/patent/US11304798B2 ## CPC - A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves} - A61F 2/2415: {Manufacturing methods} - A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds - A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 27/34: Macromolecular materials - A61L 27/52: Hydrogels or hydrocolloids - A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces - A61L 2420/02: Methods for coating medical devices - A61L 2420/08: Coatings comprising two or more layers - A61L 2430/20: for reconstruction of the heart, e.g. heart valves - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## 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 ### Claim 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 block copolymer, wherein the plurality of electrospun fibers comprise a first polyisobutylene urethane block copolymer having a first predetermined weight average percentage of hard segment portions and soft segment portions; the polyisobutylene urethane block copolymer of the polymer matrix comprises a second polyisobutylene urethane block copolymer having a second predetermined weight average percentage of hard segment portions and soft segment portions; and the first predetermined weight average percentage of hard segment portions is greater than the second predetermined weight average percentage of hard segment portions. ### Claim 2 (depends on 1) The prosthetic heart valve of claim 1, wherein the polyisobutylene urethane block copolymer of the polymer matrix has a durometer from about 60 A to about 55D shore hardness. ### Claim 3 (depends on 1) The prosthetic heart valve of claim 1, wherein the plurality of electrospun fibers have a tensile strength from 20 MPa to 45 MPa; and wherein the polymer matrix has a tensile strength from 20 MPa to 45 MPa. ### Claim 4 (depends on 1) The prosthetic heart valve of claim 1, wherein the hard segment portions of the first and second polyisobutylene urethane block copolymers are each prepared from a methylene diisocyanate (MDI) and a butane diol (BD). ### Claim 5 (depends on 1) The prosthetic heart valve of claim 1, wherein the soft segment portions of the first and second polyisobutylene urethane block copolymers are each prepared from a residual monomer of a polyisobutylene diol or a polyisobutylene diamine. ### Claim 6 (depends on 5) The prosthetic heart valve of claim 5, wherein the soft segment portions of the first and second polyisobutylene urethane block copolymers 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, and a polycarbonate. ### Claim 7 (depends on 5) The prosthetic heart valve of claim 5, wherein the first polyisobutylene urethane block copolymer comprises the hard segment portions ranging from about 40 wt. % to about 60 wt. % of the total composition of the first polyisobutylene urethane block copolymer and the soft segment portions ranging from about 40 wt. % to about 60 wt. % of the total composition of the first polyisobutylene urethane block copolymer. ### Claim 8 (depends on 5) The prosthetic heart valve of claim 5, wherein the second polyisobutylene urethane block copolymer comprises the hard segment portions ranging from about 30 wt. % to about 40 wt. % of the total composition of the second polyisobutylene urethane block copolymer and the soft segment portions ranging from about 60 wt. % to about 70 wt. % of the total composition of the second polyisobutylene urethane block copolymer. ### Claim 9 (depends on 1) The prosthetic heart valve of claim 1, further comprising a hydrogel coating disposed on the composite material. ### Claim 10 (depends on 9) The prosthetic heart valve of claim 9, wherein the hydrogel coating includes polyethylene glycol (PEG) or heparin. ### Claim 11 (depends on 1) The prosthetic heart valve 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. ### Claim 12 (depends on 4) The prosthetic heart valve of claim 4, wherein each of the first and second polyisobutylene urethane block copolymers are made using a mole ratio of MDI/(BD+soft segments) of about 1. ### Claim 13 (depends on 1) The prosthetic heart valve of claim 1, wherein the composite material comprises an outer surface comprising one or more zwitterionic polymers configured to reduce calcification. ### Claim 14 (depends on 1) The prosthetic heart valve of claim 1, wherein at least a portion of the plurality of electrospun fibers comprises a first plurality of fibers and at least a portion of the plurality of electrospun fibers comprises a second plurality of fibers. ### Claim 15 (depends on 14) The prosthetic heart valve of claim 14, wherein the first plurality of fibers comprises an outer layer of the composite material and the second plurality of fibers comprises an inner layer of the composite material. ### Claim 16 (depends on 1) The prosthetic heart valve of claim 1, wherein the plurality of electrospun fibers within the composite material are present within a range from 0.1 wt. % to 50 wt. %. ### Claim 17 (depends on 1) The prosthetic heart valve of claim 1, wherein the plurality of electrospun fibers comprise at least one non-linear feature selected from the group consisting of a curved shape, a curvilinear shape, a repetitive pattern, an oscillating pattern, a sinusoidal pattern, and an undulating pattern.