Valve assemblies for implantable prostheses and tissue expanders
An expandable implant includes an implant shell having an opening and a valve assembly closing the opening. The valve assembly has a first elastic patch, and a second elastic patch juxtaposed with the first elastic patch. A major face of the first elastic patch opposes a major face of the second elastic patch, and the opposing major faces have a bonded area in which the opposing faces are joined together and an unbonded area in which the opposing faces are not joined together and are free to move away from one another. A plug is disposed between the opposing major faces. A first opening extends through the first elastic patch and a second opening extends through the second elastic patch. The first and second openings are offset from one another and the unbonded area defines an elongated channel extending between the first and second openings.
1. An expandable implant comprising:
an implant shell having an outer surface, an inner surface, and an opening extending from the outer surface to the inner surface;
a valve assembly closing said opening in said implant shell, said valve assembly comprising
a first elastic patch,
a second elastic patch juxtaposed with said first elastic patch, wherein a major face of said first elastic patch opposes a major face of said second elastic patch, and wherein the opposing major faces have a bonded area in which the opposing major faces are joined together and an unbonded area in which the opposing major faces are free to move away from one another,
a plug disposed between the opposing major faces of said first and second elastic patches,
a first opening extending through said first elastic patch and being in communication with said unbonded area,
a second opening extending through said second elastic patch and being in communication with said unbonded area, wherein said second opening is offset from said first opening,
said unbonded area defining an elongated channel extending between said first and second openings of said first and second elastic patches, said elongated channel having a proximal end and a distal end, wherein said plug is located between the distal end of said elongated channel and said second opening of said second elastic patch, and wherein said plug is spaced from the proximal end of said elongated channel and said first opening of said first elastic patch.
2. The implant as claimed in claim 1 , wherein said plug has less elasticity than said first and second elastic patches.
3. The implant as claimed in claim 1 , wherein the opposing major faces of said elastic patches are free to move away from one another within said elongated channel.
4. The implant as claimed in claim 1 , further comprising a filling tube extending through said valve assembly from outside said implant shell to inside said implant shell for opening said valve assembly for inflating and deflating said implant.
5. The implant as claimed in claim 4 , wherein said filling tube passes through said first opening in said first elastic patch, through said elongated channel between said first and second openings, around a first section of an outer surface of said plug, and through said second opening in said second elastic patch.
6. The implant as claimed in claim 5 , wherein a first section of said outer surface of said plug is unbonded to said second elastic patch, a second section of said outer surface of said plug is bonded to said second elastic patch, and a third section of said outer surface of said plug is bonded to said first elastic patch.
7. The implant as claimed in claim 5 , wherein said plug is disposed between the opposing major faces of said first and second elastic patches and aligned with said second opening in said second elastic patch.
8. The implant as claimed in claim 1 , wherein said first and second elastic patches are substantially planar, and said plug has a shape selected from the group consisting of circular, ellipsoid, oblate spheroid, square and rectangular.
9. The implant as claimed in claim 1 , wherein said plug has a thickness that is greater than the thickness of each of said first and second elastic patches.
10. The implant as claimed in claim 9 , wherein said plug has a thickness of about 2-5 mm, each said elastic patch has a thickness of about 0.25-1.0 mm.
11. A valve assembly for an expandable implant comprising:
a first elastic patch;
a second elastic patch juxtaposed with said first elastic patch, wherein a major face of said first elastic patch opposes a major face of said second elastic patch, and wherein the opposing major faces have a bonded area in which the opposing major faces are joined together and an unbonded area in which the opposing major faces are free to move away from one another;
a plug disposed between the opposing major faces of said first and second elastic patches, wherein said plug has less elasticity than said first and second elastic patches;
a first opening extending through said first elastic patch and being in communication with said unbonded area;
a second opening extending through said second elastic patch and being in communication with said unbonded area, wherein said second opening is offset from said first opening;
said unbonded area defining an elongated channel extending between said first and second openings and the opposing major faces of said first and second elastic patches, wherein the opposing major faces along said elongated channel are free to move away from one another, and wherein said plug is located between a distal end of said elongated channel and said second opening of said second elastic patch and said plug is spaced from a proximal end of said elongated channel and said first opening of said first elastic patch.
12. The valve assembly as claimed in claim 11 , further comprising a filling tube passing through the first opening, through the elongated channel, around at least a first section of said plug, and through the second opening.
13. The valve assembly as claimed in claim 11 , wherein said plug has an outer surface including a first section that is in contact with and unbonded to said second elastic patch, a second section that is bonded to said second elastic patch, and a third section that is bonded with said first elastic patch.
14. The valve as claimed in claim 11 , wherein said plug has a thickness that is greater than the thickness of each of said first and second elastic patches.
15. The valve as claimed in claim 14 , wherein said plug has a thickness of about 2-5 mm and a diameter of about 7-12 mm.
16. The valve as claimed in claim 14 , wherein each said elastic patch has a thickness of about 0.25-1.0 mm and a diameter of about 30-50 mm.
17. The valve as claimed in claim 11 , wherein said plug comprises a material selected from the group consisting of silicone, vulcanized silicone, silicone gel, LSR elastomer, and high-consistency elastomer.
18. The valve as claimed in claim 11 , wherein said elastic patches comprise a material selected from the group consisting of silicone, LSR elastomer, and high-consistency elastomer.
19. The valve as claimed in claim 11 , wherein said plug has a shape selected from the group consisting of circular, spheroid, ellipsoid, square and rectangular.
20. A valve assembly for an expandable implant comprising:
a first elastic patch;
a second elastic patch juxtaposed with said first elastic patch, wherein opposing major faces of said elastic patches have a bonded area in which the opposing major faces are joined together and an unbonded area in which the opposing major faces are free to move away from one another;
a plug disposed between the opposing major faces of said first and second elastic patches, wherein said plug has less elasticity than said first and second elastic patches;
a first opening extending through said first elastic patch and being in communication with said unbonded area;
a second opening extending through said second elastic patch and being in communication with said unbonded area, wherein said second opening is offset from said first opening;
said unbonded area defining an elongated channel extending between said first and second openings and the opposing major faces of said first and second elastic patches; and
a flexible filling tube passing through said first opening, said elongated channel, around a section of said plug, and through said second opening for opening said valve assembly, wherein said flexible filling tube changes direction a first time between said first opening and said elongated channel, a second time between said elongated channel and said plug, and a third time between said plug and said second opening.
21. The valve assembly as claimed in claim 20 , wherein said plug is located at a distal end of the elongated channel and is in alignment with the second opening of said second elastic patch and said plug is spaced away from a proximal end of the elongated channel and is spaced away from the first opening of said first elastic patch.