Penile reconstruction

• US 6,547,719 B1
• Filed: 07/31/2000
• Issued: 04/15/2003
• Est. Priority Date: 10/31/1997
• Status: Expired due to Fees

• Current Assignee: Anthony J. Atala
• Original Assignee: Children's Medical Center Corporation
• Inventors: Atala, Anthony, Yoo, James J.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/601,257
• Time in Patent Office: 988 Days
• Field of Search: 600/40, 623/11.11, 623/13.11, 623/13.17, 623/13.18, 623/23.64, 623/23.65, 623/23.66, 623/23.71, 623/23.72, 623/23.75, 623/23.76
• US Class Current: 600/40
• CPC Class Codes: A61F 2/26 Penis implants
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A cartilaginous structural member (CSM) for use in penile reconstruction, for the correction of developmental defects, postoperative reconstruction, and for reconstructive preprosthetic surgery. The cartilaginous structural member (CSM) comprise of live cells seeded onto pre-formed shaped structure which may be biodegradable. The live cells may comprise chondrocyte and the cartilaginous structural member (CSM) 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 members of the body such as the penis, nose, ear and locations which naturally has cartilage. Further, the cartilaginous structural member (CSM) may be used in plastic surgery such as, for example, breast augmentation or pectoral augmentation. The cartilaginous structural member (CSM) may be a composite cartilaginous structural member (CSM) comprising additional anchoring and strengthening elements for anchoring or changing the structural strength of said composite cartilaginous structural member (CSM).

Claims

1. An implantable structural member for use in treating a patient having an anatomical defect not caused by absent, damaged, or diseased cartilage and which can be treated, at least in part, by providing structural support to adjacent tissue;

said structural member comprising a polymeric matrix shaped in the form of the desired support member and having dissociated cartilage-forming cells deposited on and in said matrix whereby upon implantation a cartilaginous structural member is formed having controlled biomechanical properties and a tensile strength of at least about 2.2 kg, providing the required structural support in the area of said defect.

2. The structural member 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, poly-4-rethylpentene, 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.

3. The structural member of claim 1 wherein the polymeric matrix comprises a biodegradable material.

4. The structural member of claim 3 wherein the biodegradable material is selected from the group consisting of a polyglycolic acid polymer, a polyglactin polymer, and mixtures and composites thereof.

5. The structural member of claim 3 which is strengthened by coating at least part of some structural member with a liquefied polymer.

6. The structural member of claim 5 wherein said liquefied polymer is a copolymer of 50:

50 poly-DL-lactide-co-glycolide.

7. The -structural member of claim 1 wherein said cartilage-forming cells are chondrocytes.

8. The structural member of claim 1 wherein said support member is an elongated cylinder further comprising means adapted to receive a urethra.

9. The structural member of claim 7 wherein said means adapted to receive a urethra is a longitudinal groove along its length.

10. The structural member of claim 1 where in said support member is a hollow cylindrical tube with a wall thickness and a bore along its length.

11. The structural member of claim 10 wherein the hollow cylindrical tube is adapted to receive a urethra.

12. The structural member of claim 10 wherein the wall thickness is variable longitudinally.

13. The structural member of claim 1 wherein said cylinder has a variable structural strength along its longitudinally length.

14. The structural member of claim 1 further comprising anchoring means on one end for the attachment of said implant to the descending pelvis.

15. The structural member of claim 1 which has a tensile strength of at least about 3.7 kg.

16. The structural member of claim 1 which can withstand cyclic compression performed at rates of from 500 μ

m per second to 20,000 μ

m per second.

17. 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 adopted to fit within the corpora cavernosa of said penis;

(b) depositing cartilage-forming cells on and in said matrix to form a matrix/cell construct and

(c) implanting said material construct into the corpora cavernosa of said patient, whereby a cartilaginous structural member is formed in vivo having controlled biomechanical properties providing the reconstructed penis with sufficient stiffness and bending strength to serve as a functional organ.

18. The method of claim 17 wherein the polymeric matrix comprises a biocompatible material selected from the group consisting of cellulose ether, cellulose, cellulosic ester, fluorinated polyethylene, phenolic, 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.

19. The method of claim 17 wherein the polymeric matrix comprises a biodegradable material.

20. The method of claim 19 wherein the biodegradable material is selected from the group consisting of a polyglycolic acid polymer, a polyglactin polymer, and mixtures and composites thereof.

21. The method of claim 17 wherein said cartilage-forming cells are chondrocytes.

22. The method of claim 17 wherein said support member is an elongated cylinder further comprising means adapted to receive a urethra.

23. The method of claim 22 wherein said means adapted to receive a urethra is a longitudinal groove along its length.

24. The method of claim 17 where in said support member is a hollow cylindrical tube with a wall thickness and a bore along its length.

25. The method of claim 24 wherein the hollow cylindrical tube is adapted to receive a urethra.

26. The method of claim 24 wherein the wall thickness is variable longitudinally.

27. The method of claim 17 wherein said cylinder has a variable structural strength along its longitudinally length.

28. The method of claim 17 further comprising anchoring means on one end for the attachment of said implant to the descending pelvis.

29. The method of claim 17 which has a tensile strength of at least about 2.2 kg.

30. The method of claim 17 which has a tensile strength of at least about 3.7 kg.

31. The method of claim 17 which can withstand cyclic compression performed at rates of from 500 μ

m per second to 20,000 μ

m per second.