Adjustable gel filled mammary prosthesis and method
First Claim
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1. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation comprising:
- an outer closed envelope of medical grade elastomer sized and adapted to receive a predetermined volume of a gel of given density, wherein said outer closed envelope is filled to between about 90–
95% of its predetermined volume with said gel;
a collapsible inner closed envelope of medical grade elastomer disposed within said outer closed envelope, wherein said inner closed envelope is sized to receive a predetermined volume of a second fluid of greater density than the density of said gel in said outer closed envelope, and wherein said collapsible inner closed envelope is filled to between about 5 to about 10% of the volume of said outer closed envelope with said second fluid;
a self-sealing valve means in said envelopes; and
a removable soft and flexible filling tube having first and second ends and a reservoir attached to said filling tube at said first end thereof; and
wherein said second end of said filling tube passes through said self-sealing valve means and into said inner closed envelope.
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Abstract
An adjustable gel filled mammary implant includes inner and outer envelopes with the outer envelope containing about 95% of its volume filled with a silicone gel or the like. The inner envelope is attached to a bottom portion of the outer envelope and defines a volume of about 5%–10% of the volume of the outer envelope and is filled with saline. The implant also includes a self-sealing valve, filling tube and mini-reservoir for adjusting the size of the implant. A method for implanting, adjusting the size and removal of the filling tube and mini-reservoir are also disclosed.
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Citations
23 Claims
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1. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation comprising:
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an outer closed envelope of medical grade elastomer sized and adapted to receive a predetermined volume of a gel of given density, wherein said outer closed envelope is filled to between about 90–
95% of its predetermined volume with said gel;a collapsible inner closed envelope of medical grade elastomer disposed within said outer closed envelope, wherein said inner closed envelope is sized to receive a predetermined volume of a second fluid of greater density than the density of said gel in said outer closed envelope, and wherein said collapsible inner closed envelope is filled to between about 5 to about 10% of the volume of said outer closed envelope with said second fluid; a self-sealing valve means in said envelopes; and a removable soft and flexible filling tube having first and second ends and a reservoir attached to said filling tube at said first end thereof; and
wherein said second end of said filling tube passes through said self-sealing valve means and into said inner closed envelope. - View Dependent Claims (2, 3, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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4. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation comprising:
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an expandable outer closed envelope of medical grade elastomer adapted to receive a predetermined volume of a silicone gel of given density, wherein said outer closed envelope is filled up to about 95% of its predetermined volume with said silicone gel; a collapsible inner closed envelope of medical grade elastomer disposed within said outer closed envelope, and wherein said inner closed envelope is sized to receive a predetermined volume of a saline fluid of greater density than the density of said silicone gel in said outer closed envelope to expand said collapsible inner closed envelope to about 5% of the volume of said outer closed envelope; a self-sealing valve means; and a removable soft and flexible filling tube having first and second ends and a mini-reservoir attached to said filling tube at first end thereof; and
wherein said second end of said filling tube extends through said self-sealing valve means and into said inner closed envelope for injecting and removing saline through said mini-reservoir and said filling tube into and out of said inner closed envelope to thereby adjust the size of the implant. - View Dependent Claims (5, 6, 7, 8, 9, 10, 11, 22, 23)
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12. A method for implanting an adjustable gel filled multi-lumen mammary prosthesis and for adjusting the size of the prosthesis after implantation comprising the steps of:
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providing a gel of a given density and an outer closed envelope of medical grade elastomer with a predetermined volume and filling the outer closed envelope with a gel to between about 90% to about 95% of the predetermined volume; providing a saline fluid of a greater density then the density of the gel and a collapsible inner closed envelope of medical grade elastomer disclosed in a bottom lower portion on the outer closed envelope and wherein the inner closed envelope is sized to receive a predetermine volume of the saline solution and filling the inner closed envelope to expand the collapsible inner closed envelope to between about 5% to about 10% of the volume of the outer closed envelope and filling the inner closed envelope with the saline fluid to provide a volume of between about 5% to about 10% of the volume of the outer closed envelope; providing a removable soft and flexible filling tube having two ends and a mini-reservoir attached to one end and the other end passing through the outer closed envelope and into the inner closed envelope to thereby provide an adjustable gel filled multi-lumen mammary prosthesis having a fill tube and a mini-reservoir attached thereto; implanting the adjustable gel filled mammary prosthesis in a patient with the filling tube and mini-reservoir under the patient'"'"'s skin; percutaneously injecting and/or removing saline solution from the inner closed envelope through the filling tube and the mini-reservoir; and removing the filling tube and mini-reservoir from the patient.
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Specification