Nanofiber-based graft for heart valve replacement and methods of using the same
Nanofiber-based biomaterials containing fibroin for wound repair and tissue replacement and, more particularly, heart valve replacement.
1. A porous electrospun graft material configured to replace biological tissue, the electrospun graft material comprising a collagen, a fibroin, and a hemocompatible synthetic elastomer,
wherein the hemocompatible synthetic elastomer is a polyglycerol derivative ester comprising a polycarboxylic acid, and
wherein collagen comprises 45 wt. % of the total composition weight, fibroin comprises 45 wt. % of the total composition weight, and the polyglycerol derivative ester comprising a polycarboxylic acid comprises 10 wt. % of the total composition weight.
2. The porous electrospun graft material according to claim 1 , wherein the biological tissue is heart tissue.
3. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has the shape of a heart valve.
4. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has the shape of an aortic heart valve.
5. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has the shape of a stent.
6. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has a percentage weight loss of no more than 0.3% per week over a 30 week period incubated at 37° C. in phosphate buffered saline (PBS) containing 0.1% sodium azide, with percentage weight loss calculated according to the formula weight loss (%)=W l /W i ×100%, where W i is the initial weight and W l is the weight loss.
7. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material is structurally and mechanically similar to native tissue.
8. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material is structurally and mechanically similar to native heart valve tissue.
9. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material is configured to promote cell adherence and proliferation.
10. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material is resorbable.
11. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material comprises a porous network of interconnected fibers effective to facilitate nutrient transport and cell signaling.
12. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material comprises a sheet material.
13. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material is sufficiently porous to facilitate cell adhesion, nutrient transport and signal transmission.
14. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material comprises a fibrous structure.
15. The porous electrospun graft material according to claim 14 , wherein the fibers of the fibrous structure have a diameter of 2712 to 3192 nm.
16. The porous electrospun graft material according to claim 14 , wherein the fibers of the fibrous structure have a diameter of 2900 to 3000 nm.
17. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material comprises a porous network of interconnected fibers, wherein the porous network is 100 to 300 μm thick.
18. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has a porosity of 67% to 80%, with the porosity calculated as
ɛ
=
V
liq
V
liq
+
V
MAT
,
where V liq is volume of intruded water and V MAT is the volume of the electrospun graft material.
19. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has an elastic modulus from 3.98 to 4.24 Mpa, with the modulus calculated using a 500 N load cell to perform uniaxial tensile tests after hydration of the porous electrospun graft material in 100 ml DDH 2 O for 10 minutes at an elongation rate of 10 mm/min.
20. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has a stress value of 1.40 to 1.50 Mpa, with the stress value calculated using a 500 N load cell to perform uniaxial tensile tests after hydration of the porous electrospun graft material in 100 ml DDH 2 O for 10 minutes at an elongation rate of 10 mm/min.
21. The porous electrospun graft material according to claim 1 , wherein the porous electrospun graft material has a strain value of 0.40 to 0.42 mm/mm, with the strain value calculated using a 500 N load cell to perform uniaxial tensile tests after hydration of the porous electrospun graft material in 100 ml DDH 2 O for 10 minutes at an elongation rate of 10 mm/min.
22. The porous electrospun graft material according to claim 1 , wherein the collagen is type I collagen.
23. The porous electrospun graft material according to claim 1 , wherein the fibroin is silk fibroin.
24. The porous electrospun graft material according to claim 1 , wherein the hemocompatible synthetic elastomer is poly (glycerol sebacate).
25. The porous electrospun graft material according to claim 1 , further comprising an electronegative carbohydrate.
26. The porous electrospun graft material of claim 25 , wherein the electronegative carbohydrate comprises a glycosaminoglycan, a growth factor, a cell signaling molecule, or a combination thereof.
27. A graft for heart valve replacement, comprising the porous electrospun graft material of claim 1 .
28. The graft of claim 27 , wherein the poly glycerol derivative is poly (glycerol sebacate).
29. A porous electrospun graft material configured to replace biological tissue, wherein the porous electrospun graft material comprises collagen: fibroin: poly (glycerol sebacate) at 4.5:4.5:1 weight ratio.