Corporal tissue penile reconstruction

• US 6,514,292 B1
• Filed: 11/21/2000
• Issued: 02/04/2003
• Est. Priority Date: 05/21/1998
• Status: Expired due to Fees

• Current Assignee: Anthony J. Atala
• Original Assignee: Children's Medical Center Corporation
• Inventors: Atala, Anthony
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): Blanco, Javier G.
• Application Number:
  US09/700,962
• Time in Patent Office: 805 Days
• Field of Search: A61/F.226, 623/23.66, 623/23.72, 623/23.75, 424/425, 600/38-41
• US Class Current: 623/23.75
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61L 27/3808 Endothelial cells
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3826 Muscle cells, e.g. smooth muscle cells
• CPC Class Codes: A61L 27/383 Nerve cells, e.g. dendritic cells, Schwann cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C12N 2502/1347 Smooth muscle cells
• CPC Class Codes: C12N 2502/28 Vascular endothelial cells
• CPC Class Codes: C12N 2533/40 Polyhydroxyacids, e.g. polymers of glycolic or lactic acid (PGA, PLA, PLGA); Bioresorbable polymers
• CPC Class Codes: C12N 5/0068 General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: C12N 5/0661 Smooth muscle cells
• CPC Class Codes: C12N 5/0697 Artificial constructs associating cells of different lineages, e.g. tissue equivalents blood vessels C12N5/0691

Abstract

A prosthetic corporal cavernosal structure (PCCS) for use in penile reconstruction, for the correction of developmental defects, for postoperative reconstruction, and for reconstructive preprosthetic surgery. The prosthetic corporal cavernosal structure (PCCS) comprises live cells seeded onto pre-formed shaped structure which may be biodegradable. The live cells may comprise smooth muscle cells such as corporal cavernosal cells, and the prosthetic corporal cavernosal structure (PCCS) for use in reconstructive surgery may be constructed of polyglycolic acid. The implant structure is applicable to use for the regeneration and reconstruction or augmentation of semirigid erectile members of the body such as the penis, and the clitoris. The prosthetic corporal cavernosal structure (PCCS) may be a composite prosthetic corporal cavernosal structure (PCCS) comprising additional anchoring and strengthening elements for anchoring or changing the structural strength of said composite prosthetic corporal cavernosal structure (PCCS).

Claims

1. An implantable prosthetic corporal cavernosa structure for use in penile reconstruction, said structure comprising a polymeric matrix having an elongated shape and having corporal cavernosal smooth muscle cells seeded thereon, whereby upon implantation said structural member induces the growth of smooth muscle cells such that an artificial cavernosa member is formed.

2. The prosthetic corporal cavernosal structure of claim 1 wherein the polymeric matrix comprises a biocompatible material selected from the group consisting of cellulose ether, cellulose, cellulosic ester, fluorinated polyethylene, phenolic polymers, poly-4-methylpentene, polyacrylonitrile, polyamide, polyamideimide, polyacrylate, polybenzoxazole, polycarbonate, polycyanoarylether, polyester, polyestercarbonate, polyether, polyetheretherketone, polyetherimide, polyetherketone, polyethersulfone, polyethylene, polyfluoroolefin, polyimide, polyolefin, polyoxadiazole, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polysulfide, polysulfone, polytetrafluoroethylene, polythioether, polytriazole, polyurethane, polyvinyl, polyvinylidene fluoride, regenerated cellulose, silicone, urea-formaldehyde, and copolymers or physical blends thereof.

3. The prosthetic corporal cavernosal structure of claim 1 wherein the polymeric matrix comprises a biodegradable material.

4. The prosthetic corporal cavernosal structure of claim 3 wherein the biodegradable material is a polyglycolic acid polymer.

5. The prosthetic corporal cavernosal structure of claim 1 wherein said structural member is an elongated cylinder further comprising means adapted to receive a urethra.

6. The prosthetic corporal cavernosal structure of claim 5 wherein said means adapted to receive a urethra is a longitudinal groove along its length.

7. The prosthetic corporal cavernosal structure of claim 1 wherein said structural member is a hollow cylindrical balloon with a wall thickness and a bore along its length.

8. The prosthetic corporal cavernosal structure of claim 7 wherein the hollow cylindrical balloon tube is adapted to receive a urethra along its length.

9. The prosthetic corporal cavernosa structure of claim 1 further comprising at least one end for the attachment of said implant to the descending pelvis.

10. The prosthetic corporal cavernosa structure of claim 1 wherein said structure further comprises smooth muscle cells that release prostaglandin E₁ (PGE₁).

11. The implantable prosthetic corporal cavernosa structure of claim 1 further comprising endothelial cells seeded on said polymeric matrix.

12. The implantable prosthetic corporal cavernosa structure of claim 11, wherein the endothelial cells are EC 304 human endothelial cells.

13. A method for treating a patient with a penile defect comprising the steps of:

a) providing a polymeric matrix shaped in the form of a desired structural member;

b) seeding said matrix by depositing dissociated smooth muscle cells on and in said matrix to form a matrix/cell construct; and

c) implanting said matrix/cell construct within the penis of said patient wherein said construct forms a prosthetic corporal cavernosa structure having controlled biomechanical properties.

14. The method of claim 13 wherein the polymeric matrix comprises a biocompatible material selected from the group consisting of cellulose ether, cellulose, cellulosic ester, fluorinated polyethylene, phenolic polymers, poly-4-methylpentene, polyacrylonitrile, polyamide, polyamideimide, polyacrylate, polybenzoxazole, polycarbonate, polycyanoarylether, polyester, polyestercarbonate, polyether, polyetheretherketone, polyetherimide, polyetherketone, polyethersulfone, polyethylene, polyfluoroolefin, polyimide, polyolefin, polyoxadiazole, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polysulfide, polysulfone, polytetrafluoroethylene, polythioether, polytriazole, polyurethane, polyvinyl, polyvinylidene fluoride, regenerated cellulose, silicone, urea-formaldehyde, and copolymers and physical blends thereof.

15. The method of claim 13 wherein the polymeric matrix comprises a biodegradable material.

16. The method of claim 15 wherein the biodegradable material is a polyglycolic acid polymer.

17. The method of claim 13 wherein said smooth muscle cells are corporal cavernosal cells.

18. The method of claim 17 wherein said smooth muscle cells have reduced expression of TGF-1.

19. The method of claim 18 wherein said smooth muscle cells has a elevated expression of prostaglandin E₁ (PGE₁).

20. The method of claim 13 wherein said polymetric matrix is in the shape of an hollow elongated balloon having a wall surrounding a bore extending along at least a part of its length and further comprising a means adapted to receive a urethra.

21. The method of claim 20 wherein said means adapted to receive a urethra is a longitudinal groove along its length.

22. The method of claim 13 further comprising at least one end for the attachment of said implant to the descending pelvis.

23. A method for reconstructing the penis of a patient in need of such treatment comprises the steps of

(a) providing a biocompatible synthetic or natural polymeric matrix shaped to form a structural member adapted to fit within the corpora cavernosa of said penis;

(b) depositing smooth muscle cells on and in said matrix to form a matrix/cell construct; and

(c) implanting said matrix/cell construct into the corpora cavernosa of said patient, whereby a prosthetic corporal cavernosal structure is formed in vivo, said structure having controlled biomechanical properties providing the reconstructed penis with sufficient stiffness and bending strength when erect to serve as a functional organ.

24. The method of claim 23 wherein the polymeric matrix comprises a biocompatible material selected from the group consisting of cellulose ether, cellulose, cellulosic ester, fluorinated polyethylene, phenolic polymer, poly-4-methylpentene, polyacrylonitrile, polyamide, polyamideimide, polyacrylate, polybenzoxazole, polycarbonate, polycyanoarylether, polyester, polyestercarbonate, polyether, polyetheretherketone, polyetherimide, polyetherketone, polyethersulfone, polyethylene, polyfluoroolefin, polyimide, polyolefin, polyoxadiazole, polyphenylene oxide, polyphenylene sulfide, polypropylene, polystyrene, polysulfide, polysulfone, polytetrafluoroethylene, polythioether, polytriazole, polyurethane, polyvinyl, polyvinylidene fluoride, regenerated cellulose, silicone, urea-formaldehyde, or copolymers or physical blends thereof.

25. The method of claim 23 wherein the polymeric matrix comprises a biodegradable material.

26. The method of claim 25 wherein the biodegradable material is a polyglycolic acid polymer.

27. The method of claim 23 wherein said smooth muscle cells are corpora cavernosa cells.

28. The method of claim 23 wherein said structural member is an elongated cylinder further comprising means adapted to receive a urethra.

29. The method of claim 28 wherein said means adapted to receive a urethra is a longitudinal groove along its length.

30. The method of claim 28 wherein said structural member is a hollow elongated balloon with wall thickness and a bore along its length.

31. The method of claim 30 wherein the structural member is adapted to receive a urethra.

32. The method of claim 23 wherein said structure member further comprising at least one end for the attachment of said implant to the descending pelvis.