Surgically implanted devices having reduced scar tissue formation

• US 6,534,693 B2
• Filed: 01/31/2001
• Issued: 03/18/2003
• Est. Priority Date: 11/06/2000
• Status: Expired due to Term

• Current Assignee: Ipxmedical, LLC
• Original Assignee: Afmedica, Inc. (Angiotech Pharmaceuticals Incorporated)
• Inventors: Fischell, Tim A., Fischell, Scott J. S., Fischell, David R., Fischell, Robert E.
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): Hamilton, Lalita M.
• Application Number:
  US09/772,693
• Publication Number:
  US 20020055701A1
• Time in Patent Office: 776 Days
• Field of Search: 606/151, 424/78.01, 424/422, 424/427, 424/428, 514/912.44, 623/66, 128/898, 602/41, 602/43, 602/46, 604/890.1, 604/891.1, 604/304
• US Class Current: 602/43
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2013/00451 for surgical sutures, e.g. butterfly type
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/424 Anti-adhesion agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 2300/626 Liposomes, micelles, vesicles
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

This invention is an anti-proliferative drug placed onto or within a sterile sheet or mesh that is designed to be placed between internal body tissues to prevent the formation of post-operative adhesions, which adhesions are really scar tissue formation. This mesh or gauze onto or into which the drug is placed may be either a permanent implant or it may be biodegradable. By impregnating an existing product such as the Johnson & Johnson SURGICEL™ absorbable hemostat gauze-like sheet with an anti-proliferative drug such as Rapamycin or Taxol, the biodegradable, drug impregnated mesh would act as a barrier to cell proliferation and hence be a deterrent to the formation of adhesions. Another embodiment of this invention is an anti-proliferative drug attached to a bandage that is placed onto a cut in the skin to decrease scar tissue formation. Still another embodiment of the invention is an anti-proliferative drug that is attached to a surgical suture or coated onto a surgical staple both of which are used for connecting human tissues. The suture or staple then being more capable for decreasing cellular proliferation where the suture or staple material passes through the human tissue.

Claims

1. A sheet of material adapted for implantation between tissues of a human body, the sheet of material including an attached anti-proliferative drug, the anti-proliferative drug being designed to reduce the generation of scar tissue, the anti-proliferative drug being selected from the group consisting of Rapamycin, taclolimus (FK506), and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

2. The apparatus of claim 1 wherein the sheet of material is biodegradable.

3. The apparatus of claim 1 wherein the sheet of material is in the form of a mesh.

4. In combination, including an anti-proliferative drug attached to a bandage for placement over a cut on the skin of a human subject, the anti-proliferative drug being selected from the group consisting of taclolimus (FK506), Rapamycin and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

5. In combination, including an anti-proliferative drug attached to a surgical suture, the suture being adapted to connect human tissue that is separated by a surgical procedure on a human subject, the anti-proliferative drug being selected from the group consisting of taclolimus (FK506), Rapamycin and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

6. In combination, including an anti-proliferative drug attached to a mesh having a generally cylindrical shape for introduction into a generally cylindrical cavity of the human body to decrease scar tissue formation in that generally cylindrical cavity after a surgical procedure on that generally cylindrical cavity, the anti-proliferative drug being selected from the group consisting of taclolimus (FK506), Rapamycin and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

7. The combination of claim 6 wherein the generally cylindrical cavity is a human nostril.

8. A device to reduce scar tissue formation within the eye of a human subject after a retinal attachment procedure, including a buckle designed to be placed onto the eye, the buckle including an attached anti-proliferative, the anti-proliferative drug being selected from the group consisting of taclolimus (FK506), Rapamycin and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

9. An implantable device adapted for surgical implantation within a space within a human body at a location that is external to any vessel of that human body, at least part of the device including an attached anti-proliferative drug, the action of the anti-proliferative drug being a reduction in the generation of scar tissue, the anti-proliferative drug being selected from the group consisting of Rapamycin, taclolimus (FK506), and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

10. The device of claim 9 wherein the device is in the form of a prosthetic breast implant.

11. The device of claim 9 wherein the device is in the form of an arterio-venus fistula shunt.

12. A method for improving the outcome of a surgical procedure, the method being the release into a human subject on whom the surgical procedure has been performed of an anti-proliferative agent in combination with at least one other drug selected from the group consisting of antiseptic agents, anti-biotic agents and analgesic agents, and the anti-proliferative agent being selected from the group consisting of Rapamycin, taclolimus (FK506), and one of the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamy-cin, 32-demethoxy, 2-desmethyl and proline.

13. The method of claim 12 wherein the anti-proliferative agent is used in an ointment that is applied to the skin.

14. The method of claim 12 wherein the anti-proliferative agent is attached to a mesh that is adapted to be placed within the human subject in whom the surgical procedure was performed.

15. The method of claim 12 wherein the anti-proliferative agent is attached to a breast implant.

16. The method of claim 12 wherein the anti-proliferative agent is attached to a suture.

17. The method of claim 12 wherein the anti-proliferative agent is released systemically.

18. A method for decreasing the formation of scar tissue after a surgical procedure, the method comprising the following steps:

a) attaching an anti-proliferative drug onto a sheet of material designed to be placed onto or into a human subject;

the anti-proliferative drug being selected from the group consisting of Rapamycin, taclolimus (FK506), and one of the following analogs of sirolimus;

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline; and

b) placing the mesh with the attached anti-proliferative drug onto or into a human subject during or after completing a surgical procedure.

19. The method of claim 18 further including the step of systemic application of at least one anti-proliferative drug at least one day prior to the surgical procedure.

20. The method of claim 18 further including the step of a continuing systemic application of at least one anti-proliferative drug for at least one day after the surgical procedure.

21. In combination, an anti-proliferative drug attached to a breast implant, the breast implant being designed to provide breast enlargement for a human female subject, the anti-proliferative drug being selected from the group that includes taclolimus (FK506), Rapamycin and the following analogs of sirolimus:

SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.