SBIR Phase I: Development of a barrier film to prevent post-operative internal scarring

SBIR 第一阶段：开发隔离膜以防止术后内部疤痕

• 批准号: 1520284
• 负责人: Erik Robinson
• 金额: $ 15万
• 依托单位: Sintact Medical Systems, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1520284&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; barrier; film

Phase I project is to improve the quality of care for patients who suffer from internalscarring triggered by abdominal surgery. Patients with severe scar formation often require afollow-up surgical procedure called adhesiolysis. Adhesiolysis is performed to cut away theinternal scars that have bridged different organs or caused intestinal obstructions. Annually,540,000 adhesiolysis procedures are performed in the US. These secondary surgicalprocedures can also cause additional scar formation resulting in cycles of repeat procedures.While current barrier products reduce the severity of internal scarring by 51%, they all degradeafter a few weeks. Furthermore, none are approved for use during laparoscopic procedures, apreferred technique for adhesiolysis. Traditionally, products used for scar reduction have beenmade from materials that degrade. In contrast, the proposed device is made from a nondegradingmaterial that has been safely used in the body for the past 40 years. This strongermaterial enables laparoscopic use and ensures separation of internal organs. As such, thisproposed device has shown promising results in pilot studies and could lead to a new standardof care for patients at risk for severe internal scar formation.The proposed project aims to develop an implantable barrier film to reduce scarformation inside the body after abdominal surgery. Current conventional thinking in biomaterialselection for scar reducing barrier films has relied primarily on resorbable materials. However,these barriers do not perform well enough to be utilized in severe adhesion cases norlaparoscopic procedures. The implementation of a permanent barrier in this space stems fromthe development of non-resorbable synthetic meshes for the repair of abdominal and pelvichernias. Furthermore, the non-degrading property of the permanent film ensures long-termcontrol over the surface topography, which has been shown to play a substantial role in celladhesion. The project goals are to evaluate a non-resorbable barrier that maintains anextremely smooth, mildly hydrophobic surface in the healing process of internal tissue surfaces.A twelve week definitive animal (rabbit) study utilizing an established surgical adhesionabdominal model will determine the efficacy of the proposed device to reduce surgical adhesionformation as compared to a control group and a commercially available product. If successful,the results will influence decisions concerning material composition for future anti-adhesion,anti-scarring, and other implants in addition to providing a better understanding of internalwound healing pathways

第一阶段项目旨在提高腹部手术引发的内部疤痕患者的护理质量。严重疤痕形成的患者通常需要进行后续手术，称为粘连松解术。进行粘连松解术是为了切除桥接不同器官或引起肠梗阻的内部疤痕。美国每年进行 540,000 例粘连松解手术。这些二次手术还会导致额外的疤痕形成，从而导致重复手术的循环。虽然目前的屏障产品可将内部疤痕的严重程度降低 51%，但它们都会在几周后降解。此外，没有一种药物被批准用于腹腔镜手术，腹腔镜手术是粘连松解术的首选技术。传统上，用于减少疤痕的产品是由可降解的材料制成的。相比之下，所提出的装置是由一种不可降解的材料制成的，这种材料在过去 40 年来一直在体内安全使用。这种更坚固的材料可用于腹腔镜检查并确保内部器官的分离。因此，该提议的设备在试点研究中显示出有希望的结果，并可能为有严重内部疤痕形成风险的患者带来新的护理标准。该提议的项目旨在开发一种可植入的屏障膜，以减少腹部手术后体内的疤痕形成。当前用于减少疤痕屏障膜的生物材料选择的传统思维主要依赖于可吸收材料。然而，这些屏障的性能不够好，无法用于严重粘连病例或腹腔镜手术。在这个空间中实施永久性屏障源于用于修复腹部和盆腔疾病的不可吸收合成网的开发。此外，永久膜的不降解特性确保了对表面形貌的长期控制，这已被证明在细胞粘附中发挥着重要作用。该项目的目标是评估一种不可吸收的屏障，该屏障在内部组织表面的愈合过程中保持极其光滑、轻度疏水的表面。利用已建立的手术粘连腹部模型进行的为期十二周的最终动物（兔子）研究将确定所提议的效果与对照组和市售产品相比，该装置可减少手术粘连形成。如果成功，结果将影响有关未来抗粘连、抗疤痕和其他植入物的材料成分的决策，此外还可以更好地了解内部伤口愈合途径