Adjustable gel filled mammary prosthesis and method

• US 7,081,136 B1
• Filed: 04/18/2005
• Issued: 07/25/2006
• Est. Priority Date: 04/18/2005
• Status: Expired due to Fees

• Current Assignee: Techno Investments, LLC
• Original Assignee: Techno Investments, LLC
• Inventors: Becker, Hilton
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US11/107,956
• Time in Patent Office: 463 Days
• Field of Search: 623/7, 623/8, 623 2364- 2368
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants

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.

Claims

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.

2. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said gel is a silicone gel.

3. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said gel is a hydrogel.

13. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, wherein said second end of said filing tube provides an attachment for a needle or syringe.

14. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, wherein said reservoir is adapted to receive a needle or syringe.

15. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said outer closed envelope defines a generally oval or generally tear-shape.

16. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said inner closed envelope defines a shape which is generally similar to the shape of said outer closed envelope.

17. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said inner closed envelope is fixed to a rear bottom portion of said outer closed envelope.

18. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said inner closed envelope is free to move with respect to said outer closed envelope.

19. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said valve means comprises a plug valve and a flap valve.

20. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, wherein said filling tube and said mini-reservoir are made of a medical grade elastomer.

21. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 1, in which said gel is a soft pliable non-fluid mass of material which approximates the feel of a normal breast.

4. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation comprising:

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.

5. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said outer closed envelope defines a generally oval or generally tear-shape.

6. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said inner closed envelope defines a shape which is generally similar to the shape of said outer closed envelope.

7. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said inner closed envelope is fixed to a rear bottom portion of said outer closed envelope.

8. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said inner closed envelope is free to move with respect to said outer closed envelope.

9. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said valve means comprises a plug valve and a flap valve.

10. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, wherein said filling tube and said mini-reservoir are made of a medical grade elastomer.

11. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, in which said gel is a soft pliable non-fluid mass of material which approximates the feel of a normal breast.

22. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, wherein said second end of said filing tube provides an attachment for a needle or syringe.

23. An adjustable gel filled multi-lumen mammary prosthesis for surgical implantation according to claim 4, wherein said reservoir is adapted to receive a needle or syringe.

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:

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.