Methods for development of hybrid tissue engineered valve with polyurethane core

1. A hybrid tissue engineered heart valve leaflet comprising a polyurethane core, wherein the polyurethane core is enclosed within two layers of cells, wherein a first layer comprises smooth muscle cells and/or fibroblast cells and a second layer comprises endothelial cells.

2. The hybrid tissue engineered heart valve leaflet according to claim 1 , wherein the polyurethane core is a polycarbonate-based thermoplastic polyurethane.

3. The hybrid tissue engineered heart valve leaflet according to claim 2 , wherein the polycarbonate-based thermoplastic polyurethane is carbothane.

4. The hybrid tissue engineered heart valve leaflet according to claim 1 , wherein the two layers of cells further comprise collagen.

5. The hybrid tissue engineered heart valve leaflet according to claim 1 , wherein the cells are extracted from a patient's vasculature.

6. The hybrid tissue engineered heart valve leaflet according to claim 5 , wherein the cells are extracted from a peripheral vein of the patient.

7. The hybrid tissue engineered heart valve leaflet according to claim 6 , wherein the peripheral vein is a saphenous or a jugular vein.

8. The hybrid tissue engineered heart valve leaflet according to claim 4 , wherein the collagen is collagen type I.

9. The hybrid tissue engineered heart valve leaflet according to claim 1 , wherein the first layer comprises 80-95% fibroblast cells and 5-20% smooth muscle cells.

10. A hybrid tissue engineered heart valve, comprising a frame; and at least two leaflets attached thereto in a configuration of a heart valve, wherein the leaflets are hybrid tissue engineered heart valve leaflets according to claim 1 .

11. The hybrid tissue engineered heart valve according to claim 10 , wherein the leaflets are made of a polycarbonate-based thermoplastic polyurethane.

12. The hybrid tissue engineered heart valve according to claim 11 , wherein the polycarbonate-based thermoplastic polyurethane is carbothane.

13. The hybrid tissue engineered heart valve according to claim 10 , wherein the valve is a tri-leaflet valve.

14. The hybrid tissue engineered heart valve according to claim 10 , wherein the valve is a mitral valve with a dynamic saddle-shaped annulus.

15. The hybrid tissue engineered heart valve according to claim 10 , wherein said frame comprises titanium.

16. A method of making the hybrid tissue engineered heart valve according to claim 10 for deployment in a patient, the method comprising:

cutting a polyurethane mesh into the shape of heart valve leaflets to obtain a polyurethane mesh leaflet,

attaching at least two polyurethane mesh leaflets to a heart valve frame,

harvesting autologous cells from the patient; and

growing the cells on the surface of the polyurethane mesh leaflets under culture conditions sufficient to enclose the polyurethane mesh leaflets.

17. The method according to claim 16 , wherein the cells are harvested from a peripheral vessel, selected from a saphenous or a jugular vein.

18. The method according to claim 16 , wherein the cells are smooth muscle cells, fibroblast cells and/or endothelial cells.

19. The method according to claim 18 , comprising at least two steps of growing cells, a first step of growing smooth muscle cells and/or fibroblast cells on the leaflets to obtain first cell-enclosed leaflets, and a second step of growing endothelial cells on the surface of the first-cell enclosed leaflets to obtain endothelial cell-enclosed polyurethane mesh leaflets.