Intraoperative Acoustic Hemostasis

描述（申请人提供）：创伤是 45 岁以下个体死亡的主要原因，在军事战斗中死亡的人中占很大比例，其中失血是创伤死亡的主要原因。危及生命的出血既发生在实体器官大量出血（例如，AAST-OIS IV 级和 V 级复杂性肝损伤），也发生在难以进入的区域（特别是骨盆区域）出血。通过我们的前期工作，我们已经证明了高强度聚焦超声（HIFU）在动物模型中诱导血管和器官出血止血的潜力。超声还提供了一种在临床环境中广泛使用的有用且高度发达的成像方式。我们建议利用超声的成像和治疗能力来开发一种特定的设备和方法，用于术中治疗大量出血，特别是死亡率较高的 AAST-OIS IV 级和 V 级复杂性肝损伤以及骨盆区域的严重伤口。目前治疗严重肝损伤的临床方法是包扎伤口直至血流动力学稳定，然后将患者转移至血管造影室，对受损血管进行血管栓塞。由于无法在手术室进行血管造影，因此转移过程中浪费了宝贵的时间。我们在动物模型中拥有大量初步数据，表明图像引导的 HIFU 装置可用于在手术室范围内立即在伤口部位诱导止血，或闭塞供应出血部位的血管，从而避免血管栓塞和/或重大手术操作的需要。我们的提案描述了实现这一令人兴奋的目标需要完成的四项一般任务：（1）利用超声造影剂来改善出血检测； (2) 开发用于检测、定位和瞄准出血部位的超声技术和方案； （3）开发集成图像引导HIFU治疗系统； (4) 在猪模型上进行体内实验，以展示图像引导术中声波止血的能力。最后，这一领域的进展将为这项研究的最终目标奠定坚实的基础，即一种全自动、便携式、图像引导的经皮声学止血装置，可供急救人员用于平民创伤伤害。

DESCRIPTION (provided by applicant): Trauma is the major cause of mortality in individuals under 45 years of age and accounts for a large percentage of those killed in military combat, with exsanguination being the principal cause of trauma mortality. Life-threatening hemorrhages occur both in profuse bleeding from solid organs, (for example, AAST-OIS grades IV and V complex hepatic injuries), and from bleeding in regions that are difficult to access (particularly the pelvic area). Through our preliminary work, we have demonstrated the potential of High Intensity Focused Ultrasound (HIFU) to induce vascular and organ hemorrhage hemostasis in animal models. Ultrasound also provides a useful and highly-developed imaging modality that is in widespread use in a clinical environment. We propose to utilize both the imaging and therapeutic capabilities of ultrasound to develop a specific device and a methodology for the intraoperative treatment of profuse bleeding, particularly AAST-OIS grades IV and V complex hepatic injuries, which have a high mortality rate, and for severe wounds in the pelvic area. The current clinical approach to severe hepatic injuries is to pack the wounds until hemodynamic stability is achieved, and then to transfer the patient to the angiography suite where angioembolization of the damaged vessels is performed. Valuable time is lost in this transfer because angiography cannot be performed in the operating room. We have considerable preliminary data in animal models that suggests that an image-guided HIFU device could be used to induce hemostasis at the site of the wound, or to occlude the vessels supplying the bleeding site, immediately, and within the confines of the operating room, thus obviating the need for angioembolization, and/or significant operative maneuvers. Our proposal describes four general tasks that need to be accomplished to meet this exciting goal: (1) To utilize ultrasound contrast agents to improve bleeding detection; (2) To develop ultrasound techniques and protocols for detection, localization, and targeting of bleeding sites; (3) To develop an integrated image guided HIFU therapy system; and (4) To perform in vivo experiments on a porcine model to demonstrate the capabilities of image-guided intraoperative acoustic hemostasis. Finally, progress in this area would provide a firm foundation for the ultimate goal of this research-that of a fully automated, portable, image-guided transcutaneous acoustic hemostasis device that could be used by first responders in civilian trauma injuries.