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（由适用提供）：腹腔内手术后的粘附形成构成了巨大的健康风险，被认为是小肠异议和女性不孕症的主要原因。预防这些粘附的方法目前仅限于难以放置的屏障膜，并且通常仅限于防止对手术切口Sie的粘连，而使大部分腹部含量不受保护。该程序是为了开发低成本，可喷涂的屏障，该屏障将四处流动并粘附在腹腔的内部时机，从而为整个腹腔的粘附提供了更广泛的保护。由于该产品中组件的性质，因此所提出的材料将具有生物相容性和可生物降解，因为它提供了比当前销售产品更完整的保护。该计划将着重于材料组件和交付系统的开发和表征，以创建屏障公式。然后，这些结果将经过一系列体外表征测试，以评估有效地成为粘合剂形成的障碍的能力，并在体内表现出有效性的小动物。最后，最有希望的公式将在兔子中确定的临床前动物模型中进行评估。结果将是产品商业化工作和提交FDA的基础。