POLY(GLYCEROL SEBACATE) URETHANE ELASTOMERIC LEAFLET FOR HEART VALVE REPLACEMENT
A leaflet for a heart valve replacement includes poly(glycerol sebacate) urethane. A heart valve replacement includes a leaflet including poly(glycerol sebacate) urethane. A process forms a leaflet for a heart valve replacement. The process includes casting a first solution including poly(glycerol sebacate) and isocyanate to form a leaflet composition including poly(glycerol sebacate) urethane. The process also includes shaping the leaflet composition to form the leaflet.
1 . A leaflet for a heart valve replacement, the leaflet comprising poly(glycerol sebacate) urethane.
2 . The leaflet of claim 1 , wherein the leaflet consists of poly(glycerol sebacate) urethane.
3 . The leaflet of claim 1 , wherein the leaflet comprises a leaflet substrate material and a coating on the leaflet substrate material, the coating comprising poly(glycerol sebacate) urethane.
4 . The leaflet of claim 3 , wherein the leaflet substrate material comprises a textile.
5 . The leaflet of claim 3 , wherein the coating conforms to the leaflet substrate material.
6 . The leaflet of claim 3 , wherein the coating has a smooth, flat surface obfuscating the substrate.
7 . The leaflet of claim 1 , wherein the poly(glycerol sebacate) urethane comprises poly(glycerol sebacate) urethane in fiber form.
8 . The leaflet of claim 1 , wherein the poly(glycerol sebacate) urethane is formed from a poly(glycerol sebacate) resin having a weight average molecular weight in the range of 14,000 Da to 20,000 Da.
9 . The leaflet of claim 1 , wherein the leaflet is shelf stable.
10 . A heart valve replacement comprising a plurality of leaflets of claim 1 .
11 . The heart valve replacement of claim 10 further comprising a heart valve frame having a valve opening, wherein the plurality of leaflets extend from the heart valve frame to cover the valve opening.
12 . The heart valve replacement of claim 10 , wherein at least one of the plurality of leaflets comprises a first portion having a first crosslinking density and a second portion having a second crosslinking density different from the first crosslinking density.
13 . The heart valve replacement of claim 10 , wherein at least a portion of the heart valve replacement comprises a coating of poly(glycerol sebacate) urethane.
14 . A process of forming a leaflet for a heart valve replacement, the process comprising:
casting a first solution comprising poly(glycerol sebacate) and isocyanate to form a leaflet composition comprising poly(glycerol sebacate) urethane; and
shaping the leaflet composition to form the leaflet.
15 . The process of claim 14 , wherein the casting forms a film of the leaflet composition.
16 . The process of claim 14 , wherein the process further comprises applying a second solution comprising poly(glycerol sebacate) and isocyanate as a coating overlying a layer formed by the first solution, wherein the second solution is different from the first solution, wherein the application comprises a process selected from the group consisting of casting, spray coating, dip coating, electrospinning, and electrospraying.
17 . The process of claim 14 , wherein the casting comprises reaction injection molding the solution to form the leaflet composition.
18 . The process of claim 17 , wherein the reaction injection molding comprises varying a ratio of poly(glycerol sebacate) to isocyanate during injection to vary a crosslinking density of the poly(glycerol sebacate) urethane in the composition.
19 . The process of claim 14 , wherein the casting comprises a process selected from the group consisting of closed molding and open molding.
20 . The process of claim 14 , wherein the casting comprises casting the first solution onto a leaflet substrate material to form a coating of the composition on the leaflet substrate material.
21 . The process of claim 14 , wherein the casting further comprises casting the first solution to form at least a portion of at least one other heart valve replacement component.
22 . The process of claim 14 further comprising attaching the leaflet to a heart valve frame.
23 . The process of claim 14 , wherein the casting comprises casting the first solution around a heart valve frame of the heart valve replacement.
24 . A process of forming a heart valve replacement, the process comprising:
providing a heart valve replacement substrate; and
applying a solution comprising poly(glycerol sebacate) and isocyanate to form a coating overlying at least a portion of at least one component of the heart valve replacement substrate, by a process selected from the group consisting of casting, spray coating, dip coating, electrospinning, and electrospraying;
wherein the coating comprises poly(glycerol sebacate) urethane.