Multiple-layer prosthesis implant with tissue tactility

• US 5,358,521 A
• Filed: 04/01/1992
• Issued: 10/25/1994
• Est. Priority Date: 04/01/1992
• Status: Expired due to Fees

• Current Assignee: Shane, Fred
• Original Assignee: Shane, Fred
• Inventors: Shane, Fred
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/861,522
• Time in Patent Office: 937 Days
• Field of Search: 623/8, 623/7, 623/11, 623/66
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants

Abstract

A multi-layer prosthesis simulates tissue tactility by structuring the plurality of layers of material making up the prosthesis to include lubricant coating between the layers. It is the plurality of layers and the lubricity of their movement which contributes greatly to the tactile simulation of human tissue. Present in the prosthesis is a ballast lumen which moves freely and contributes mass and motility to the prosthesis. The prosthesis finds ready use in the augmentation or restructuring of the human breast as well as in cosmetic modification of other portions of the anatomy as, for example, the chin, the pectorals, the calf muscles, etc.

Claims

1. A multiple lumen prosthesis comprising:

a first, ballast lumen;

a second lumen enclosing said ballast lumen;

each said lumen having flexible exterior and interior walls, said interior walls defining an interior void, said ballast lumen being enclosed within said interior void of said second lumen;

a first thin coating of lubricant on the interior walls of said second lumen;

a second thin coating of lubricant on the exterior walls of said ballast lumen;

said first coating and said second coating of lubricant being insufficient in quantity of lubricant contained therein to inflate said second lumen and of a volume selected to provide a thin coating of lubricant sufficient for inhibiting direct contact of said exterior walls of said ballast lumen with said interior walls of said second lumen; and

means coupling said first and second coatings of lubricant for renewing said first and said second coatings of lubricant by redistributing lubricant within said first and said second coatings,

said means for renewing said first and said second coatings of lubricant comprises an interstitial, distribution layer of lubricant, immiscible in said first and said second coatings of lubricant,

said distribution layer of lubricant being generally located between said first and said second coatings of lubricant, further inhibiting direct contact of said exterior walls of said ballast lumen with said interior walls of said second lumen, and redistributing lubricant in said first and second coatings of lubricant along boundaries at which said distribution layer of lubricant moves relative to said first and said second coatings.

2. The prosthesis of claim 1 wherein said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen bringing said first and said second coatings of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

3. The prosthesis of claim 2 wherein said flexible interior and exterior walls of said first and said second lumens are hereinafter denoted tissue simulating walls and comprise a material selected, in combination with the multiplicity of said walls and the lubricity of relative motion among said walls, to impart the tactility and movement of natural body tissue when said prosthesis is implanted in a patient'"'"'s body, said relative motion being induced, in part, by movement of said ballast lumen within said second lumen.

4. The prosthesis of claim 3 further comprising a multiplicity of additional lumens, third through N, where N represents a selected maximum number of lumens comprising said prosthesis,

each of said third through N lumens having flexible exterior and interior walls defining an interior void in each of said lumens;

said interior walls of said third through N lumens having a said first coating of lubricant thereon;

said exterior walls of said second through (N-1) lumens having a said second coating of lubricant thereon;

each said third through N lumens being graduated in size to accept, and accepting, its preceding one of said second through (N-1) lumens within its said interior void, the size gradation being sufficient to permit free relative motion between the interior walls of a given one of said third through N lumens and the exterior walls of its preceding one of said second through (N-1) lumens enclosed within said interior void of said given one of said lumens,

said prosthesis being a sac-en-sac assembly of said first through N lumens.

5. The prosthesis of claim 4 further comprising means coupling said first and said second coatings of lubricant between adjacent interior and exterior walls of said multiplicity of additional lumens for renewing said first and said second coatings.

6. The prosthesis of claim 5 wherein said means for renewing said first and said second coating of lubricants comprises said adjacent interior and exterior walls of said multiplicity of additional lumens, said free relative motion between said walls bringing said first and said second coating of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

7. The prosthesis of claim 6 wherein said means for renewing said first and said second coatings of lubricant further comprises an interstitial, distribution layer of lubricant, immiscible in said first and said second coatings of lubricant, said distribution layer of lubricant being generally located between said first and said second coatings of lubricant, further inhibiting direct contact of said exterior walls of said ballast lumen with said interior walls of said second lumen, and redistributing lubricant in said first and second coatings of lubricant along boundaries at which said distribution layer of lubricant moves relative to said first and said second coatings.

8. The prosthesis of claim 3 further comprising a plurality of tissue simulating walls each coupled to a first wall of said second lumen;

each one of said plurality of tissue simulating walls being concentric, one to the other;

said tissue simulating walls being graduated in size;

each one of said tissue simulating walls, so coupled to said second lumen, defining an interior void; and

each one of said tissue simulating walls having thereon at least one of said first and said second coatings of lubricant for inhibiting direct contact between adjacent said tissue simulating walls within each said interior void so defined.

9. The prosthesis of claim 8 further comprising means coupled to each of said at least one of said first and said second coatings of lubricant for redistributing lubricant on said tissue simulating walls.

10. The prosthesis of claim 9 wherein said means for redistributing lubricant on said tissue simulating walls comprises said ballast lumen, the free movement of said ballast lumen within said second lumen communicating motion to said tissue simulating walls whereby said lubricant coatings are brought into repeated moving contact whereby lubricant within said lubricant coatings is exchanged and redistributed.

11. The prosthesis of claim 1 wherein said flexible interior and exterior walls of said first and said second lumens comprise a material selected, in combination with the multiplicity of said walls and the lubricity of relative motion among said walls, to impart the tactility and movement of natural body tissue when said prosthesis is implanted in a patient'"'"'s body, said relative motion being induced, in part, by movement of said ballast lumen within said second lumen.

12. The prosthesis of claim 11 further comprising a multiplicity of additional lumens, third through N, where N represents a selected maximum number of lumens comprising said prosthesis,

each of said third through N lumens having flexible exterior and interior walls defining an interior void in each of said lumens;

said interior walls of said third through N lumens having a said first coating of lubricant thereon;

said exterior walls of said second through (N-1) lumens having a said second coating of lubricant thereon;

each said third through N lumens being graduated in size to accept, and accepting, its preceding one of said second through (N-1) lumens within its said interior void, the size gradation being sufficient to permit free relative motion between the interior walls of a given one of said third through N lumens and the exterior walls of its preceding one of said second through (N-1) lumens enclosed within said interior void of said given one of said lumens,

said prosthesis being a sac-en-sac assembly of said first through N lumens.

13. The prosthesis of claim 12 further comprising means coupling said first and said second coatings of lubricant between adjacent interior and exterior walls of said multiplicity of additional lumens for renewing said first and said second coatings.

14. The prosthesis of claim 13 wherein said means for renewing said first and said second coating of lubricants comprises said adjacent interior and exterior walls of said multiplicity of additional lumens, said free relative motion between said walls bringing said first and said second coating of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

15. The prosthesis of claim 14 wherein said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen bringing said first and said second coatings of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

16. The prosthesis of claim 11 wherein said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen bringing said first and said second coatings of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

17. The prosthesis of claim 11 further comprising a plurality of tissue simulating walls each coupled to a first wall of said second lumen;

each one of said plurality of tissue simulating walls being concentric, one to the other;

said tissue simulating walls being graduated in size;

each one of said tissue simulating walls, so coupled to said second lumen, defining an interior void; and

each one of said tissue simulating walls having thereon at least one of said first and said second coatings of lubricant for inhibiting direct contact between adjacent said tissue simulating walls within each said interior void so defined.

18. The prosthesis of claim 17 further comprising means coupled to each of said at least one of said first and said second coatings of lubricant for redistributing lubricant on said tissue simulating walls.

19. The prosthesis of claim 18 wherein said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen bringing said first and said second coatings of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed.

20. The prosthesis of claim 19 wherein said means for redistributing lubricant on said tissue simulating walls comprises said ballast lumen, the free movement of said ballast lumen within said second lumen communicating motion to said tissue simulating walls whereby said lubricant coatings are brought into repeated moving contact whereby lubricant within said lubricant coatings is exchanged and redistributed.

21. The prosthesis of claim 1 wherein said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen moving said second coating of lubricant relative to said first coating of lubricant whereby lubricant within said first and said second coatings is exchanged and redistributed.

22. The prosthesis of claim 1 further comprising a plurality of tissue simulating walls each coupled to a first wall of said second lumen;

each one of said plurality of tissue simulating walls being concentric, one to the other;

said tissue simulating walls being graduated in size;

each one of said tissue simulating walls, so coupled to said second lumen, defining an interior void; and

each one of said tissue simulating walls having thereon at least one of said first and said second coatings of lubricant for inhibiting direct contact between adjacent said tissue simulating walls within each said interior void so defined.

23. A multiple lumen prosthesis comprising:

a first, ballast lumen;

a second lumen enclosing said ballast lumen;

each said lumen having flexible exterior and interior walls, said interior walls defining an interior void, said ballast lumen being enclosed within said interior void of said second lumen;

a first thin coating of lubricant on the interior walls of said second lumen;

a second thin coating of lubricant on the exterior walls of said ballast lumen;

said first coating and said second coating of lubricant being insufficient in quantity of lubricant contained therein to inflate said second lumen and of a volume selected to provide a thin coating of lubricant sufficient for inhibiting direct contact of said exterior walls of said ballast lumen with said interior walls of said second lumen;

means coupling said first and second coatings of lubricant for renewing said first and said second coatings of lubricant by redistributing lubricant within said first and said second coatings;

said means for renewing said first and said second coatings of lubricant comprises said ballast lumen;

said ballast lumen having its said interior void filled with fluid of a selected density,

said ballast lumen being freely movable within said interior void of said second lumen, the free movement of said ballast lumen within said second lumen bringing said first and said second coatings of lubricant into repeated, moving contact whereby lubricant within said first and said second coatings is exchanged and redistributed; and

said flexible interior and exterior walls of said first and said second lumens comprise a material selected, in combination with the multiplicity of said walls and the lubricity of relative motion among said walls, to impart the tactility and movement of natural body tissue when said prosthesis is implanted in a patient'"'"'s body, said relative motion being induced, in part, by movement of said ballast lumen within said second lumen; and

said means for renewing said first and said second coatings of lubricant further comprises an interstitial, distribution layer of lubricant, immiscible in said first and said second coatings of lubricant, said distribution layer of lubricant being generally located between said first and said second coatings of lubricant, further inhibiting direct contact of said exterior walls of said ballast lumen with said interior walls of said second lumen, and redistributing lubricant in said first and second coatings of lubricant along boundaries at which said distribution layer of lubricant moves relative to said first and said second coatings.

24. The prosthesis of claim 23 further comprising a multiplicity of additional lumens,

each of said additional lumens having flexible exterior and interior walls defining an interior void in each of said additional lumens;

said interior walls of said additional lumens having a non-inflating volume of said first coating of lubricant thereon;

said exterior walls of all said second through a last one of said additional lumens having a non-inflating volume of said second coating of lubricant thereon;

each of said additional lumens being graduated in size to accept, and accepting, its preceding one of said second through a next-to-the-last one of said additional lumens within its said interior void, the size gradation being sufficient to permit free relative motion between the interior walls of a given one of said additional lumens and the exterior walls of its preceding one of said second through said next-to-the-last one of said additional lumens enclosed within said interior void of said given one of said additional lumens,

said prosthesis being a sac-en-sac assembly of said first through said last one of said additional lumens.