Devices and methods for reducing scar tissue formation
First Claim
1. A cytostatic anti-proliferative surgical wrap sheet of material adapted for being wrapped generally around tissues of a human body at the site of a surgical procedure, the sheet of material having a cytostatic anti-proliferative drug attached, the action of the cytostatic anti-proliferative drug being a reduction in the generation of scar tissue, the cytostatic anti-proliferative drug being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus and the any functional analog of sirolimus including:
- 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.
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Accused Products
Abstract
Disclosed is a cytostatic drug attached to a sterile sheet 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 sheet 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 sirolimus, the biodegradable, drug impregnated mesh would act as a barrier to cell proliferation and hence be a deterrent to the formation of adhesions or scar tissue. Another embodiment of this invention is a cytostatic drug attached to a sheet that is placed at the site of an anastamosis to decrease scar tissue formation from within the vessel at the site of the anastomosis.
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Citations
22 Claims
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1. A cytostatic anti-proliferative surgical wrap sheet of material adapted for being wrapped generally around tissues of a human body at the site of a surgical procedure, the sheet of material having a cytostatic anti-proliferative drug attached, the action of the cytostatic anti-proliferative drug being a reduction in the generation of scar tissue, the cytostatic anti-proliferative drug being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus and the any functional analog of sirolimus including:
- 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.
- View Dependent Claims (2, 3, 4)
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5. In combination, a cytostatic 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 cytostatic anti-proliferative drug being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus and the following functional 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.
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6. In combination, a cytostatic anti-proliferative drug attached to a sheet for placement at an anastamosis of a vessel of the human body, the drug and sheet combination being adapted to prevent narrowing of the vessel at the site of the anastamosis of that vessel, the cytostatic anti-proliferative drug being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus or any other functional analog of sirolimus including:
- 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.
- View Dependent Claims (7, 8)
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9. A means for improving the outcome of a surgical procedure on a human subject, the means being the systemic release into the human subject on whom the surgical procedure has been performed of a cytostatic anti-proliferative agent in combination with at least one other drug selected from the group that includes antiseptic agents, anti-biotic agents and analgesic agents, the cytostatic anti-proliferative agent being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus and other analog of sirolimus including:
- 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.
- View Dependent Claims (10, 11, 12)
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13. A method for decreasing the formation of scar tissue after a surgical procedure, the method comprising the following steps:
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a) attaching a cytostatic anti-proliferative drug onto a mesh that is adapted for placement generally around tissue of a human subject;
the antiproliferative drug being selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus and any other analog of sirolimus including;
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.b) placing the mesh with attached cytostatic anti-proliferative drug generally around tissue of the human subject during or after completing a surgical procedure. - View Dependent Claims (14, 15, 16, 17, 18)
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19. A method for decreasing scar tissue formation on a cut in the skin of a human subject, the method comprising the following steps:
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a) placing an ointment onto the skin at the site of the cut, the ointment including a cytostatic anti-proliferative agent selected from the group that includes sirolimus, anti-sense to c-myc (Resten-NG), tacrolimus (FK506), Everolimus or any other functional analog of sirolimus including;
SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline; and
b) placing a bandage over the ointment, the bandage being attached to the skin in the vicinity of the cut. - View Dependent Claims (20, 21)
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22. A sheet for placement at or near the site of a surgical procedure to reduce the formation of scar tissue and adhesions, the sheet including a cytostatic drug that is released from the mesh or sheet over a period that is longer than a day, the cytostatic drug being capable of preventing the initiation of DNA replication of cells in the vicinity of the mesh by acting as a cell cycle mitosis inhibitor that acts on the cells in the vicinity of the mesh at or before the S-phase of cellular mitosis.
Specification