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Combination drug therapy for reducing scar tissue formation

A composition and polymer technology, applied in the field of anti-platelet drug devices, medical devices for preventing scar tissue and/or adhesion formation, and anti-proliferative drug devices, which can solve the problem of low medical risk and high therapeutic benefit And other issues

Inactive Publication Date: 2007-08-08
AFMEDICA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Existing art fails to significantly reduce scar tissue and / or adhesion formation with drugs of low medical risk and high therapeutic benefit in post-operative and post-traumatic care

Method used

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  • Combination drug therapy for reducing scar tissue formation
  • Combination drug therapy for reducing scar tissue formation
  • Combination drug therapy for reducing scar tissue formation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment I

[0308] Study on Prevention of Pericardial Adhesion in Rabbits

[0309] This example predicts that one embodiment of a hydrogel-based bioadhesive comprising sirolimus and analogs of sirolimus, gemmilofiban, and bivalirudin is effective in preventing postoperative adhesions and scarring. ability in. A standardized pericardial attrition protocol known in the art was performed on 18 New Zealand white female rabbits weighing 3-4 kg. Bennett et al., "Next Generation Hydrogel Films as Tissue Sealants and Adhesion Barriers" - J Card Surg 18:1-6 (2003); and Wiseman et al., "Fibrinolytic Drugs to Prevent Adhesions of the Rabbit Pericardium" - J Surg Res 53:362-368 (1992).

[0310] Rabbits were sedated, placed supine, intubated and maintained under inhalation anesthesia. A median sternotomy was performed to expose the heart. The pericardium was opened and standardized superficial abrasion with dry gauze on the anterior (anterior) surface of the heart produced a "central streak" (CS...

Embodiment 2

[0314] General PEA Polymer Materials and Methods

[0315] This example represents the base material used in the following examples concerning PEA efficacy, biocompatibility.

[0316] polymer

[0317] Poly(ester amides) (PEA) are manufactured by MediVas, Inc. Poly(D,L-lactide-co-glycolide) (PLGA) was purchased from Boehringer-Ingelheim. Poly(n-butyl methacrylate) (PBMA) was purchased from Polysciences.

[0318] synthesis

[0319] PEA is prepared by synthesizing monomers of two alpha amino acids, L-leucine and L-lysine, from diols (x) and diacids (y) in the presence of hexanediol and sebacic acid. See accompanying drawing 15. The carboxyl group of the side L-lysine of the polymer chain (BnO) serves as the binding site for coupling drugs or biologics to the polymer backbone. For this study, nitrous oxide-based 4-aminoTEMPO was conjugated to PEA. See accompanying drawing 16.

[0320] cell culture

[0321] Human peripheral blood mononuclear cells were isolated by density...

Embodiment 3

[0323] macrophage development

[0324] Monocyte-to-macrophage phenotype progression and contact-induced fusion to form multinucleated cells proceeded at similar rates during the three-week culture. PEA surfaces support human monocyte adhesion and differentiation, but qualitatively, as judged by morphology and differentiation / fusion rates, PEA surfaces do not exhibit an induced hyperactivation state. See accompanying drawing 17.

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PUM

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Abstract

The present invention describes various devices and methods wherein a cytostatic antiproliferative drug, either alone or in combination with other drugs, is placed between internal body tissues to prevent the formation of scar tissue and / or adhesions during healing of a wound or surgical site. Specific devices to achieve this administration include, but are not limited to, a permanent implant or a biodegradable material having an attached antiproliferative drug such as sirolimus. These antiproliferative drugs may be combined with other drugs including, but not limited to, antiplatelets, antithrombotics or anticoagulants. The present invention also contemplates methods to a reduce scar tissue and / or adhesions or adhesion formation at an anastomosis site. In particular, a cytostatic antiproliferative drug is administered to an arteriovenous shunt anastomoses in patients having end-stage renal disease.

Description

field of invention [0001] The present invention relates to devices and methods for preventing scar tissue formation and / or adhesions following surgical procedures, trauma or trauma. In one embodiment, the invention relates to a medical device comprising an antiproliferative drug. In another embodiment, the present invention is directed to devices and methods comprising antiplatelet agents (ie, eg, GPIIb / IIIa inhibitors). In another embodiment, the present invention relates to a medical device for the prevention of scar tissue and / or adhesion formation comprising cytostatic antiproliferative drugs in combination with other drugs including, but not limited to, antiplatelet agents, antithrombotic agents forming medicines or anticoagulants. Background technique [0002] Postoperative scar tissue and / or adhesion formation and vascular narrowing are major problems after abdominal, neurovascular, or other types of surgery. For example, narrowing of blood vessels at the site of a...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61B17/00A61B17/06A61B17/064A61F13/00A61L15/44A61L27/54A61L31/16
CPCA61L2300/432A61L2300/424A61L29/16A61L29/085C08L77/12A61L31/16A61L2300/602A61K31/192A61K38/58A61K31/4745A61K31/4433A61B2017/00831A61F2013/00451A61K31/216A61B2017/1135A61B17/11A61B17/064A61K31/787A61L15/44A61B2017/00889A61L27/54A61K45/06A61L27/34A61K38/02A61B2017/1107A61L2300/416A61B2017/00893A61B17/06166A61L31/10A61L2300/45A61L2300/42A61L2300/436A61P17/02A61P41/00A61P43/00A61K2300/00
Inventor R·J·谢布斯基J·R·勒德尔T·A·菲谢尔
Owner AFMEDICA INC
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