Spray method for forming shells for prostheses
Shells for mammary prostheses and other devices are created by spraying a silicone dispersion onto a mandrel. Several coats of dispersion are applied with an interval for evaporation of solvent from the dispersion between application of coats. The shells created are uniform in thickness and have a desirably defect-free surface.
1. A shell for an implantable prosthesis formed by:
a) providing a mandrel;
b) applying a silicone dispersion coating having a varying thickness and a concentration of silicone to solvent of greater than 20 percent to the mandrel by spraying the silicone dispersion at a pressure of less than 20 psi;
c) allowing evaporation of at least a portion of the solvent in the coating silicone dispersion;
d) repeating steps b) and c) until a silicone shell is formed having a thickness of approximately 0.009+/−0.003 inches on an anterior and posterior face of the shell, and a thickness of approximately 0.024+/−0.003 inches at the perimeter interface where the anterior and posterior faces meet;
e) at least partially curing the silicone shell; and
f) removing the silicone shell from the mandrel.
2. The shell according to claim 1 , wherein the shell is sized and shaped for use as a mammary prosthesis.
3. The shell according to claim 2 , wherein at least a portion of an external surface of the shell is textured.
4. The shell according to claim 3 , wherein the shell is sealed.
5. The shell according to claim 1 , and further formed by, following the removing step, sealing the shell while providing the shell with a filling port.
6. The shell according to claim 5 , wherein the shell is sized and shaped for use as a mammary tissue expander.
7. The shell according to claim 6 , wherein at least a portion of an external surface of the shell is textured.
8. A mammary prosthesis formed by:
a) providing a mandrel;
b) applying a silicone dispersion coating having a concentration of silicone to solvent of greater than 20 percent to the mandrel by spraying the silicone dispersion at pressure of less than 20 psi;
c) allowing evaporation of at least a portion of the solvent in the coating silicone dispersion;
d) repeating steps b) and c) until a silicone shell is formed having a thickness of approximately 0.009+/−0.003 inches on an anterior and posterior face of the shell, and a thickness of approximately 0.024+/−0.003 inches at the perimeter interface where the anterior and posterior faces meet;
e) at least partially curing the silicone shell; and
f) removing the silicone shell from the mandrel.
9. The prosthesis according to claim 8 , wherein the prosthesis is adapted to be filled with fluid, and wherein when so filled the prosthesis is sized and shaped for use as a mammary implant.
10. The prosthesis according to claim 9 , wherein at least a portion of an external surface of the prosthesis is textured.
11. The prosthesis according to claim 10 , wherein the prosthesis is sealed.
12. The prosthesis according to claim 8 , and further formed by, following the removing step, sealing the prosthesis while providing the prosthesis with a filling port.
13. The prosthesis according to claim 12 , wherein the prosthesis is sized and shaped for use as a mammary implant.
14. The prosthesis according to claim 13 , wherein at least a portion of an external surface of the prosthesis is textured.