SBIR Phase II: Sprayable Reversible Hemostat for Treatment of Non-Compressible Hemorrhage

SBIR II 期：用于治疗不可压缩性出血的可喷雾可逆止血剂

• 批准号: 1256477
• 负责人: Matthew Dowling
• 金额: $ 50万
• 依托单位: GEL-E, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-01 至 2018-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1256477&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Sprayable; Reversible

This Small Business Innovation Research (SBIR) Phase II project aims to develop a sprayable foam hemostat for treatment of non-compressible hemorrhage, which is the leading cause of death (~90%) for bleeding-related trauma. The foam material is based on the biopolymer chitosan; a modification to this polymer with novel hydrophobic grafts allows the material to clot blood much more rapidly and adhere to tissue more strongly than the unmodified version. Also, a complementary cyclodextrin-based technology is able to reverse the hemostatic action of the modified chitosan on demand. The biopolymer is packaged into aluminum hand-held canisters with liquefied propellant and expelled via mechanical actuator creating a foam which is able to expand into irregularly shaped cavities. The desired outcome of the project is to develop a working prototype of the canister containing an optimized modified chitosan with respect to hydrophobic grafting density and hydrophobe length. Foam formulations will be tested for clotting and reversibility in vitro via dynamic and steady shear rheology studies in the presence of blood and in vivo using non-compressible bleeding models in pigs. Biocompatibility testing and tissue histology studies will be performed to determine the safety profile of the optimized formulations.The broader impact/commercial potential of this project falls in the arena of battlefield and trauma medicine. Foams are the future of acute wound treatment on the battlefield and in emergency medical services. Severe bleeding, especially internal bleeding, is not easily treated with a spatially contained product, such as a bandage. Furthermore, correct bandage placement on an acute wound requires a great deal of skill and experience. However, a sprayable foam is very user friendly and allows potential for adequate self-application or application by an unskilled 'buddy' for a wide range of hemorrhage types. Thus, we envision our chitosan foam as a necessary supply in the soldier's backpack, the emergency room and the home first aid kit. This vision is a viable economic prospect because the material is low cost, lightweight and highly durable even in extreme ambient conditions. Additionally, the reversibility provided by the complementary cyclodextrin system provides a streamlining tool for the trauma surgeon. Removal of hemostatic material and precise indentification of the injury site are necessary tasks in the operating room which are made much easier by this unique technological feature.

该小型企业创新研究（SBIR）第二阶段项目旨在开发一种可喷雾泡沫止血剂，用于治疗不可压缩出血，这是出血相关创伤的主要死亡原因（约90%）。泡沫材料基于生物聚合物壳聚糖;用新型疏水接枝物对这种聚合物进行改性，使材料能够更快地凝结血液，并且比未改性的版本更牢固地粘附在组织上。此外，基于环糊精的补充技术能够根据需要逆转改性壳聚糖的止血作用。将生物聚合物包装在带有液化推进剂的铝制手持式罐中，并通过机械致动器排出，从而产生能够膨胀成不规则形状腔体的泡沫。该项目的预期成果是开发一个工作原型的罐含有优化的改性壳聚糖的疏水接枝密度和疏水长度。将在存在血液的情况下通过动态和稳态剪切流变学研究在体外检测泡沫制剂的凝血和可逆性，并在猪体内使用不可压缩出血模型进行检测。将进行生物相容性试验和组织组织学研究，以确定优化配方的安全性。该项目的更广泛的影响/商业潜力福尔斯落在战场和创伤医学的竞技场。泡沫是战场和紧急医疗服务中急性伤口治疗的未来。严重出血，特别是内出血，不容易用空间封闭的产品（如绷带）治疗。此外，在急性伤口上正确放置绷带需要大量的技能和经验。然而，可喷雾泡沫是非常用户友好的，并且允许足够的自我应用或由不熟练的“伙伴”应用于广泛的出血类型的潜力。因此，我们设想我们的壳聚糖泡沫作为一个必要的供应在士兵的背包，急诊室和家庭急救箱。这种设想是可行的经济前景，因为该材料成本低、重量轻且即使在极端环境条件下也高度耐用。此外，互补环糊精系统提供的可逆性为创伤外科医生提供了一种流线型工具。去除止血材料和精确识别损伤部位是手术室中的必要任务，通过这种独特的技术特征，这些任务变得更加容易。