Valve assemblies for expandable implants and tissue expanders
A valve assembly for an implant has an inner shell, a self-sealing material disposed within the inner shell, and an insertion pathway extending through the self-sealing material. At least one gap is formed in the self-sealing material that intersects with the insertion pathway to define a proximal pathway section and a distal pathway section. A filling tube is passed through the valve assembly for filling the outer shell of the implant with a fluid. After the implant is filled, the filling tube is removed. As the filling tube is removed, if the self-sealing material within the distal section of the pathway is unable to self-seal before the fluid reaches its proximal end, the fluid is diverted into the gap. The time that elapses before the gap is completely filled by the fluid provides sufficient time for the self-sealing material within the proximal section of the pathway to self-seal.
1. A valve assembly for an expandable implant, said valve assembly comprising:
an inner shell having an inlet and an outlet;
a self-sealing material disposed within said inner shell, wherein said self-sealing material is a liquid silicone material;
an insertion pathway extending through said liquid silicone material, wherein said insertion pathway extends from said inlet to said outlet of said inner shell;
at least one gap formed in said liquid silicone material and intersecting said insertion pathway to divide said insertion pathway into a proximal section and a distal section, wherein said at least one gap spaces said proximal and distal sections of said insertion pathway from one another.
2. The valve assembly as claimed in claim 1 , wherein said outlet of said inner shell comprises an outlet opening passing through said inner shell.
3. The valve assembly as claimed in claim 2 , wherein said outlet opening has a cylindrical or circular shape.
4. The valve assembly as claimed in claim 1 , wherein said insertion pathway extends along a straight line between said inlet and said outlet of said inner shell.
5. The valve assembly as claimed in claim 4 , wherein said insertion pathway extends diagonally through said self-sealing material disposed within said inner shell.
6. The valve assembly as claimed in claim 1 , wherein said expandable implant comprises an outer shell having an outer surface, an inner surface, and an outer shell opening extending from the outer surface to the inner surface of said outer shell, wherein said valve assembly covers said outer shell opening so that said inner shell is disposed inside said outer shell.
7. The valve assembly as claimed in claim 6 , further comprising a filling tube passing through said inlet of said inner shell of said valve assembly and having a distal end coupled with said outlet of said inner shell for being in fluid communication with an internal chamber of said outer shell of said implant.
8. The valve assembly as claimed in claim 7 , wherein said outer shell of said implant contains a solution having less viscosity than said liquid silicone material disposed within said inner shell of said valve assembly.
9. The valve assembly as claimed in claim 7 , wherein said self-sealing material comprises a liquid silicone rubber and said solution within said outer shell of said implant is selected from the group consisting of saline solution, silicone gel, foam, and combinations thereof.
10. The valve assembly as claimed in claim 1 , wherein said valve assembly further comprises a biocompatible patch and said inner shell is secured to said biocompatible patch, and wherein said expandable implant has an outer shell with an outer shell opening and said patch closes said outer shell opening for sealing said expandable implant.
11. The valve assembly as claimed in claim 1 , wherein said at least one gap in said liquid silicone material has a larger cross-sectional area than a cross-sectional area defined by said insertion pathway.
12. The valve assembly as claimed in claim 11 , wherein said gap has a cross-sectional area of 24-100 mm 2 and said insertion pathway has a cross-sectional area of 0.5-2.0 mm 2 .
13. An expandable implant comprising:
an outer shell having an outer surface, an inner surface, and an outer shell opening extending from the outer surface to the inner surface;
a valve assembly closing said outer shell opening, said valve assembly comprising
an inner shell having an inlet and an outlet,
a self-sealing material disposed within said inner shell, wherein said self-sealing material is a liquid silicone rubber,
an insertion pathway extending through said liquid silicone rubber, wherein said insertion pathway extends from said inlet to said outlet of said inner shell, and
at least one gap formed in said liquid silicone rubber and intersecting said insertion pathway extending through said liquid silicone rubber to define a proximal section of said insertion pathway and a distal section of said insertion pathway, wherein said at least one gap formed in said liquid silicone rubber spaces and divides said proximal and distal sections of said insertion pathway from one another.
14. The expandable implant as claimed in claim 13 , further comprising a filling tube extending through said valve assembly for opening said valve assembly for selectively inflating and deflating said implant using a solution.
15. The implant as claimed in claim 14 , wherein said filling tube, extending through said valve assembly, passes through said inlet of said inner shell, extends along said insertion pathway through said liquid silicone rubber, and is in communication with said outlet of said inner shell.
16. The implant as claimed in claim 13 , wherein said outlet of said inner shell comprises an outlet opening passing through said inner shell and being in communication with an internal chamber of said outer shell of said expandable implant.
17. The implant as claimed in claim 16 , wherein said outlet opening has a cylindrical or circular shape.
18. The implant as claimed in claim 13 , wherein said insertion pathway extends along a straight line between said inlet and said outlet of said inner shell.
19. The implant as claimed in claim 18 , wherein said insertion pathway extends diagonally through said liquid silicone rubber disposed within said inner shell.
20. The implant as claimed in claim 13 , further comprising:
a filling tube having a distal end insertable into said inlet of said inner shell of said valve assembly and advanceable to said outlet of said inner shell for filling said outer shell of said expandable implant with a solution that has less viscosity than said liquid silicone rubber.
21. The implant as claimed in claim 19 , wherein said self-sealing material comprises a liquid silicone gel, and wherein said solution within said expandable implant is selected from the group consisting of saline solution, silicone gel, foam, and combinations thereof.
22. The implant as claimed in claim 13 , wherein said valve assembly further comprises:
a biocompatible patch having an outer surface and an inner surface;
said inner shell being secured to said inner surface of said patch;
said patch closing said outer shell opening, wherein said inner shell is disposed inside said outer shell.