Low-Cost Sprayable Barrier for the Prevention of Surgical Adhesions

用于预防手术粘连的低成本可喷涂屏障

基本信息

批准号：
9145233
负责人：
Lauren Costella
金额：
$ 57.38万
依托单位：
LUNA INNOVATIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-02-15 至 2018-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9145233
关键词：
Abdomen Abdominal Cavity Address Adhesions Animal Model Animals Biocompatible Biocompatible Materials Biomedical Technology Businesses Characteristics Clinical Trials Development Drug Delivery Systems Engineering Exhibits Female infertility Fiber Optics Film Focus Groups Formulation Future Gel Goals Government Gynecologic Surgical Procedures Healed Health Health Sciences Healthcare Histocompatibility Hydrogels In Vitro Infertility Inflammatory Response Injury to Peritoneum Intellectual Property Intestinal Obstruction Intra-abdominal Knowledge Left Liquid substance Marketing Medical Device Medical Device Designs Methods Modeling Nature Operative Surgical Procedures Oryctolagus cuniculus Outcome Performance Peritoneum Persons Phase Postoperative Period Preclinical Testing Prevention Prevention approach Procedures Property Risk Scientist Series Small Intestines Solid Staging Surface Surgeon Surgical incisions System Technology Testing Tissues Unnecessary Procedures Wound Healing base clinical material combat commercialization cost crosslink healing in vivo injured innovation interest novel pre-clinical preclinical study prevent programs prototype research and development response technological innovation tool

项目摘要

DESCRIPTION (provided by applicant): Adhesion formation after intra-abdominal surgery poses a huge health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films which are difficult to place and are often restricted to use preventing adhesions to the surgical incision sie, leaving the bulk of the abdominal contents unprotected. This program is for the development of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing broader protection from adhesions throughout the abdominal cavity. Because of the nature of the components in this product, the proposed material will be biocompatible and biodegradable as it provides more complete protection than is available from currently marketed products. This program will focus on the development and characterization of the material components and delivery system to create the barrier formulations. These resultant formulations will then undergo a series of in vitro characterization tests to assess thei ability to effectively serve as a barrier to adhesion formation and small animal in vivo demonstration of efficacy. Finally, the most promising formulations will undergo assessment in a definitive preclinical animal model in rabbits. The results will be the basis for product commercialization efforts and submission to the FDA.

描述（由申请人提供）：腹腔内手术后形成的粘连会带来巨大的健康风险，被认为是导致小肠梗阻和女性不孕的主要原因。目前，防止这些粘连的方法仅限于难以放置和放置的屏障膜。通常仅限于防止手术切口粘连，使大部分腹部内容物不受保护。该计划旨在开发一种低成本、可喷涂的屏障，该屏障将在周围流动并粘附。由于该产品成分的性质，所提议的材料将具有生物相容性和可生物降解性，因为它提供了比目前市售的更全面的保护。该计划将重点关注材料成分和输送系统的开发和表征，以创建屏障配方，然后对这些所得制剂进行一系列体外表征测试，以评估其有效作为粘附形成屏障的能力。和小最后，最有希望的制剂将在兔子的临床前动物模型中进行评估，结果将作为产品商业化工作和提交给 FDA 的基础。