Internally configured prosthesis

• US 5,961,552 A
• Filed: 08/02/1997
• Issued: 10/05/1999
• Est. Priority Date: 08/02/1997
• Status: Expired due to Term

• Current Assignee: PMT Corporation
• Original Assignee: PMT Corporation
• Inventors: Iversen, Alfred A., Trinter, Stephen M.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/921,906
• Time in Patent Office: 794 Days
• Field of Search: 623/7, 623/8, 623/11
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

An improved mammary prosthesis for implantation in humans comprising: a soft, flexible outer membrane forming an enclosure for receiving a filler material; an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes and terraces without interstices disposed over at least a portion of said outer membrane; an internal structure within said membrane for supporting said outer membrane and providing an enhanced, life-like look and feel to the prosthesis; and a soft, partially-deformable, elastic filler material received within said outer membrane and cooperating with said internal structure to support said outer membrane.

Claims

1. An improved mammary prosthesis for implantation in humans comprising:

(a) a soft, flexible outer membrane having front, rear, and side portions forming an enclosure for receiving filler material;

(b) a soft, partially-deformable, elastic filler material within said outer membrane to support said outer membrane and provide an enhanced life-like look and feel to the prosthesis;

(c) an internal structure within said outer membrane for supporting said outer membrane and cooperating with said soft, partially-deformable, elastic filler material to support said outer membrane and providing an enhanced life-like look and feel to the prosthesis; and

(d) said internal structure having at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, said at least one first and second baffles having at least one weephole and wherein said internal structure further has louvers attached to the interior of said outer membrane and to said first and second baffles, whereby said first and second baffles are disposed generally perpendicular to each other, said first baffle being connected with said second baffles thereby forming compartments in said enclosure.

2. The prosthesis of claim 1, wherein said filler material is selected from the group consisting of sponge rubber, foam rubber, silicone cylindrical, spherical, or polygonal beads, and silicone fibers in fluid suspension.

3. The prosthesis of claim 1, wherein said filler material is silicone beads further comprising solid randomized spheres.

4. The prosthesis of claim 1, wherein said filler material is silicone beads further comprising a combination of cylinders and solid randomized spheres.

5. The prosthesis of claim 1, wherein said filler material is fractured silicone pyramids and tetrahedrons.

22. The prosthesis of claim 1, wherein said outer membrane has an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes, and terraces without interstices disposed over at least a portion of said outer membrane.

23. The prosthesis of claim 22, wherein the average height differential between the peaks and valleys is in a range of about 800 mm to about 2500 mm.

6. An improved mammary prosthesis for implantation in humans comprising:

(a) a soft, flexible outer membrane having front, rear, and side portions forming an enclosure for receiving a filler material;

(b) a soft, partially-deformable, elastic filler material received within said outer membrane to support said outer membrane and provide an enhanced life-like look and feel to the prosthesis;

(c) an internal structure within said outer membrane for supporting said outer membrane and cooperating with said soft, partially-deformable, elastic filler material to support said outer membrane and providing an enhanced life-like look and feel to the prosthesis;

(d) said internal structure having at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, whereby said first and second baffles are disposed generally perpendicular to each other, said first baffle being connected with said second baffle thereby forming compartments in said enclosure; and

(e) said first and second baffles of said internal structure further having weep holes therethrough.

7. The prosthesis of claim 6, wherein said filler material is selected from the group consisting of sponge rubber, foam rubber, silicone cylindrical spherical, or polygonal beads, and silicone fibers in fluid suspension.

8. The prosthesis of claim 6, wherein said filler material is silicone beads further comprising solid randomized spheres.

9. The prosthesis of claim 6, wherein said filler material is silicone beads further comprising a combination of cylinders and solid randomized spheres.

10. The prosthesis of claim 6, wherein said filler material is fractured silicone pyramids and tetrahedrons.

24. The prosthesis of claim 6, wherein said outer membrane has an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes, and terraces without interstices disposed over at least a portion of said outer membrane.

25. The prosthesis of claim 24, wherein the average height differential between the peaks and valleys is in a range of about 800 mm to about 2500 mm.

35. The prosthesis of claim 6, wherein said internal structure has a plurality of first and second baffles aligned generally parallel to each other and has louvers attached to the interior of said outer membrane and to said first and second baffles.

11. An improved mammary prosthesis for implantation in humans comprising:

(a) a soft, flexible outer membrane having front, rear, and side portions forming an enclosure for receiving a filler material;

(b) a soft, partially-deformable, elastic filler material within said outer membrane;

(c) an internal structure within said outer membrane for supporting said outer membrane and cooperating with said soft, partially-deformable, elastic filler material to support said outer membrane and providing an enhanced life-like look and feel to the prosthesis;

(d) said internal structure having at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, whereby said first and second baffles are disposed generally perpendicular to each other, said first baffle being connected with said second baffle thereby forming compartments in said enclosure; and

(e) said internal structure further having louvers attached to the interior of said outer membrane.

12. The prosthesis of claim 11, wherein said filler material is selected from the group consisting of sponge rubber, foam rubber, silicone cylindrical, spherical, or polygonal beads, and silicone fibers in fluid suspension.

13. The prosthesis of claim 11, wherein said filler material is silicone beads further comprising solid randomized spheres.

14. The prosthesis of claim 11, wherein said filler material is silicone beads further comprising a combination of cylinders and solid randomized spheres.

15. The prosthesis of claim 11, wherein said filler material is fractured silicone pyramids and tetrahedrons.

26. The prosthesis of claim 11, wherein said outer membrane has an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes, and terraces without interstices disposed over at least a portion of said outer membrane.

27. The prosthesis of claim 26, wherein the average height differential between the peaks and valleys is in a range of about 800 mm to about 2500 mm.

36. The prosthesis of claim 11, wherein said first and second baffles contain at least one weep hole.

37. The prosthesis of claim 11, wherein said first and second baffles have louvers attached thereto.

16. An improved mammary prosthesis for implantation in humans comprising:

(a) a soft, flexible outer membrane having front, rear, and side portions forming an enclosure for receiving a filler material;

(b) a soft, partially-deformable, elastic filler material within said outer membrane to support said outer membrane and provide an enhanced life-like look and feel to the prosthesis, said filler material is selected from the group consisting of sponge rubber, foam rubber, silicone beads, and silicone fibers in fluid suspension;

(c) an internal structure within said membrane for supporting said outer membrane and cooperating with said soft, partially deformable, elastic filler material to support said outer membrane and providing an enhanced, life-like look and feel to the prosthesis; and

(d) said internal structure having at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, said at least one first baffle being connected with said at least one second baffle thereby forming compartments in said internal structure, said at least one first and second baffles further having at least one weephole therethrough.

28. The prosthesis of claim 16, wherein said outer membrane has an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes, and terraces without interstices disposed over at least a portion of said outer membrane.

29. The prosthesis of claim 28, wherein the average height differential between the peaks and valleys is in a range of about 800 mm to about 2500 mm.

30. The prosthesis of claim 16, wherein said internal structure has at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, whereby said first and second baffles are disposed generally perpendicular to each other, said first baffle being connected with said second baffle thereby forming compartments in said enclosure.

31. The prosthesis of claim 16, wherein said filler material is silicone beads further comprising solid randomized spheres.

32. The prosthesis of claim 16, wherein said filler material is silicone beads further comprising combination of cylinders and solid randomized spheres.

17. An improved mammary prosthesis for implantation in humans comprising:

(a) a soft, flexible outer membrane having front, rear, and side portions forming an enclosure for receiving a filler material;

(b) an internal structure within said membrane for supporting said outer membrane and providing an enhanced, life-like look and feel to the prosthesis;

(c) a soft, partially-deformable, elastic filler material received within said outer membrane and cooperating with said internal structure to support said outer membrane;

(d) said internal structure having at least one first baffle extending between and connected to said front and rear portions, and at least one second baffle connected to said side portion, whereby said first and second baffles are disposed generally perpendicular to each other, said first baffle being connected with said second baffle thereby forming compartments in said enclosure;

(e) said internal structure further having louvers attached to the interior of said outer membrane and to said first and second baffles; and

(f) said first and second baffles of said internal structure further having weep holes therethrough.

18. The prosthesis of claim 17, wherein said filler material is selected from the group consisting of sponge rubber, foam rubber, silicone cylindrical, spherical, or polygonal beads, and silicone fibers in fluid suspension.

19. The prosthesis of claim 17, wherein said filler material is silicone beads further comprising solid randomized spheres.

20. The prosthesis of claim 17, wherein said filler material is silicone beads further comprising a combination of cylinders and solid randomized spheres.

21. The prosthesis of claim 17, wherein said filler material is fractured silicone pyramids and tetrahedrons.

33. The prosthesis of claim 17, wherein said outer membrane has an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes, and terraces without interstices disposed over at least a portion of said outer membrane.

34. The prosthesis of claim 33, wherein the average height differential between the peaks and valleys is in a range of about 800 mm to about 2500 mm.