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 method for creating a silicone shell, the method comprising:
a) providing a mandrel suitably sized and shaped for forming a desired shell;
b) applying a coating silicone dispersion to the mandrel by spraying the silicon dispersion at low pressure to create a shell having a desired thickness;
c) at least partially curing the silicone shell; and
d) removing the silicone shell from the mandrel.
2 . A method for creating a silicone shell, the method comprising:
a) providing a mandrel suitably sized and shaped for forming a desired shell;
b) applying a coating silicone dispersion to the mandrel by spraying the silicon dispersion at low pressure;
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 having a desired thickness is formed;
c) at least partially curing the silicone shell; and
d) removing the silicone shell from the mandrel.
3 . The method of claim 1 wherein the silicone dispersion is sprayed onto the mandrel using a high volume low pressure spray device.
4 . The method of claim 1 wherein the silicone dispersion is sprayed onto the mandrel using a rotary atomizer.
5 . The method of claim 1 wherein the silicone dispersion is an HTV silicone dispersion.
6 . The method of claim 1 wherein the silicone dispersion is an RTV silicone dispersion.
7 . The method of claim 2 wherein at least two coats of dispersion are applied to the mandrel.
8 . The method of claim 2 wherein at least three coats of dispersion are applied to the mandrel.
9 . The method of claim 2 wherein at least four coats of dispersion are applied to the mandrel.
10 . The method of claim 1 wherein at least five coats of dispersion are applied to the mandrel.
11 . The method of claim 1 wherein the dispersion is sprayed by atomizing the dispersion using a flow of air below 20 psi.
12 . The method of claim 1 wherein the dispersion is sprayed by atomizing the dispersion using a flow of air below 10 psi.
13 . The method of claim 1 wherein the shell is 0.00±0.004″ thick.
14 . The method of claim 1 wherein the shell is 0.012″±0.004″ thick.
15 . The method of claim 1 wherein the shell is 0.014±0.004″ thick.
16 . The method of claim 1 wherein the shell is 0 . 013 ″± 0 . 004 ″ thick.
17 . The method of claim 1 further comprising applying a coat of silicone dispersion to a portion of the mandrel to create a partial coat of dispersion.
18 . The method of claim 17 wherein the mandrel includes an anterior surface and a posterior surface that meet at a perimeter region.
19 . The method of claim 18 wherein the partial coat of dispersion is applied to the perimeter region of the mandrel.
20 . The method of claim 17 wherein the mandrel has at least one relatively planar region and at least on region that is curved.
21 . The method of claim 20 wherein the partial coat of dispersion is applied to the at least one region that is curved.
22 . The method of claim 20 wherein the mandrel has a first region having a first radius of curvature and a second region having a second smaller radius of curvature.
23 . The method of claim 22 wherein the region having the partial coat of dispersion is applied to the region having a second, smaller radius of curvature.
24 . The method of claim 17 wherein at least one partial coat of dispersion is applied to at least a first portion of the mandrel.
25 . The method of claim 1 wherein the mandrel is appropriately sized and shaped for forming an implantable prosthesis.
26 . The method of claim 25 wherein the mandrel is appropriately sized and shaped for forming an implantable mammary prosthesis.
27 . The method of claim 1 wherein the mandrel is appropriately sized and shaped for forming a tissue expander.
28 . The method of claim 1 wherein the mandrel is appropriately sized and shaped for forming a round body implant.
29 . The method of claim 1 wherein the mandrel is appropriately sized and shaped for forming a crescent-shaped body implant.
30 . The method of claim 1 wherein the mandrel is appropriately sized and shaped for forming an oval body implant.
31 . A shell for a tissue expander formed by the method of claim 1 .
32 . A shell for an implantable prosthesis formed by the method of claim 1 .
33 . A prosthesis formed by a method comprising:
a) providing a mandrel that is appropriately sized and shaped for forming a body implant;
b) applying a coating silicone dispersion to the mandrel by spraying the silicon dispersion at low pressure;
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 having a desired thickness is formed;
e) at least partially curing the silicone shell;
f) removing the silicone shell from the mandrel; and
g) applying a seal to the shell.
34 . The prosthesis of claim 33 wherein the shell is shaped and sized for use as a mammary prosthesis.
35 . A tissue expander formed by a method comprising:
a) providing a mandrel that is appropriately sized and shaped for forming a body implant;
b) applying a coating silicone dispersion to the mandrel by spraying the silicon dispersion at low pressure;
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 having a desired thickness is formed;
e) at least partially curing the silicone shell;
f) removing the silicone shell from the mandrel;
g) providing the shell with a filling port; and
h) sealing the shell.
36 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming an implantable prosthesis.
37 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming an implantable mammary prosthesis.
38 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming a tissue expander.
39 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming a round body implant.
40 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming a crescent-shaped body implant.
41 . The prosthesis of claim 33 wherein the mandrel is appropriately sized and shaped for forming an oval body implant.
42 . The prosthesis of claim 33 wherein at least a portion of the external surface of the shell is textured.
43 . The tissue expander of claim 34 wherein the shell is shaped and sized for use as a mammary tissue expander.
44 . The tissue expander of claim 34 wherein at least a portion of the external surface of the shell is textured.
45 . The method of claim 1 wherein the silicone dispersion contains 10% to 50% silicone solids.
46 . The method of claim 1 wherein the silicone dispersion contains 20% to 40% silicone solids.
47 . The method of claim 1 wherein the silicone dispersion contains 25% to 35% silicone solids.
48 . The method of claim 1 wherein the dispersion contains 28% to 32% solids.
49 . The method of claim 33 further comprising filling the prosthesis with a liquid.
50 . The method of claim 33 further comprising filling the prosthesis with a gel.
51 . The method of claim 33 further comprising filling the prosthesis with a saline solution.
52 . The method of claim 33 further comprising filling the prosthesis with silicone filler.