Development of Self-Expanding Foams for Percutaneous Damage Control of Retroperitoneal Pelvic Exsanguination

 描述(申请人提供)：意义：创伤性盆腔出血是发病率和死亡率的重要原因，许多患者死于潜在的可存活损伤。在美国，这些伤害每年夺走多达4万人的生命。这一事实突显了迫切需要创新技术来控制最严重受伤患者的出血。方法：FastTrack SBIR的这一应用将开发用于治疗出血性盆腔出血的新型、自我膨胀的聚亚安酯泡沫系统。在该提案的第一阶段，阿森纳医疗公司将与马萨诸塞州总医院(MGH)合作，创建一种新的、具有临床相关性的盆腔出血动物模型。将使用包括血管损伤、软组织损伤和组织破坏的三模式方法。为了建立基线性能和优化区域，将测试现有的治疗方法，包括阿森纳医疗公司的ResQFoam技术(专为腹部使用)。在该提案的第二阶段，将开发一种泡沫塑料，通过调节开孔微结构和改善聚氨酯支柱的泡沫机械性能(拉伸强度、弹性)来提高骨盆空间的功效和清除效果。这种自我膨胀的泡沫对盆腔出血有效的合适剂量将通过剂量范围研究来确定。最终结果将是一种有效的治疗盆腔出血的生物材料干预。在优化泡沫后，将对缺血再灌注动力学进行全面的生理学研究。第二阶段将在准备向FDA提交初步监管报告时达到高潮。创新： 创伤学界缺乏强大的动物模型来评估治疗方法、手术方法和治疗盆腔出血的设备。建立这种动物模型，以及对缺血-再灌注损伤的关键研究，将为创伤学界提供实质性的好处。根据这一建议的目标，自膨式泡沫疗法将有效地用于临床治疗腹膜后盆腔出血，从而产生一种新的挽救生命的疗法。一个成熟的、多产的跨学科团队、已建立的监管途径和现有的制造基础设施增加了用于骨盆创伤的自我膨胀泡沫的成功和商业化的可能性。这项拟议的研究将开发第一个封闭的、致命的盆腔出血模型，并创建一个用于盆腔止血的微创泡沫平台，该平台将优于现有的护理标准。

 DESCRIPTION (provided by applicant): Significance: Traumatic pelvic bleeding is a significant cause of morbidity and mortality, and many patients die from potentially survivable injuries. These injuries claim up to 40,000 lives every year in the United States. This fact highlights an emergent need for innovative technologies to control bleeding in the most severely injured patients. Approach: This FastTrack SBIR application will develop novel, self-expanding polyurethane foam systems for treatment of exsanguinating pelvic hemorrhage. In Phase I of the proposal, Arsenal Medical will collaborate with Massachusetts General Hospital (MGH) to create a novel, clinically relevant animal model of pelvic hemorrhage. A trimodal approach incorporating vascular injury, soft-tissue injury, and tissue disruption will be utilized. To estabish baseline performance and areas for optimization, existing treatments will be tested, including Arsenal Medical's ResQFoam technology (designed for intraabdominal use). In Phase II of the proposal, a foam will be developed for efficacy and removal in the pelvic space by modulating open-cell microstructure and improving foam mechanical properties (tensile strength, elasticity) of the polyurethane struts. The appropriate dose of this self-expanding foam for effectiveness in pelvic bleeding will be determined through a dose ranging study. The net result will be an effective biomaterial intervention for treatment of pelvic bleeding. After optimizing the foam, a comprehensive physiological study of ischemia-reperfusion dynamics will be conducted. Phase II will culminate in the preparation of a preliminary regulatory submission to the FDA. Innovation: The trauma community lacks a robust animal model for the assessment of therapeutics, surgical approaches, and devices for the treatment of pelvic hemorrhage. Establishing this animal model, as well as critical research in ischemia-reperfusion injuries, will provide substantial benefit to the trauma community. Self-expanding foam treatment will be effectively developed for clinical use in retroperitoneal pelvic bleeding based on the aims of this proposal, resulting i a new life-saving therapy. An established, productive interdisciplinary team, established regulatory pathway, and existing manufacturing infrastructure increase the probability of success and commercialization of self-expanding foams for pelvic trauma. The proposed research will develop the first closed-cavity, lethal model of pelvic exsanguination and create a minimally invasive foam platform for pelvic hemostasis that will be superior to the existing standard of care.