Testing and Commercialization of a Superior Device to Maintain Perioperative Normothermia In Anesthetized Patients.

项目总结/摘要 本提案介绍了Mercury Biomed，LLC计划的第一阶段， 创新的WarmSmart技术，在麻醉手术期间更有效地为患者保暖。的 WarmSmart技术基于德克萨斯大学奥斯汀分校的IP许可，该大学是学术界 合作伙伴的STTR提案。WarmSmart体现了生物传热领域的几个突破性概念， 管理核心温度。我们期待一种具有成本竞争力的技术，它将提供等同或上级的 热性能比现有技术具有多个独特的优势， 使用方便、简单、安全。 用于在手术期间保持患者温暖的最广泛应用的现有技术使用施加的加热 通过放置在身体表面上的外袋的热空气的强制对流， 病人最近的一项综合研究表明，这项技术未能将患者维持在 在2/3的情况下，在整个手术过程中最低可接受的核心温度，加上它占据了大面积的 身体表面，在手术期间对接近患者施加不必要的限制。WarmSmart 只需要接触到手和脚，在那里，通过光滑的皮肤， 皮肤，构成身体的已经存在的高性能热流路径之间的表面和 核心WarmSmart不仅可以更有效地增加热量来对抗核心温度的下降， 阻断和逆转麻醉引起的主要热量损失过程，使其加倍有效。 该项目将有两个具体目标，为在第二阶段进行WarmSmart临床试验做准备。 在SA #1中，Mercury现有的热电驱动设备将被重新设计和重新设计 以满足最低75W的加热能力。现有技术的核心是热电能 一个可以提供水流到加热垫应用于手和脚在精确调节的来源 温度改进将包括更有效的水流热交换器设计和 高流量水泵。新的水流垫将采用最先进的热交换器设计 原则一个新的操作界面将根据我们的麻醉师顾问小组的输入创建 以确保“暖心计划”获得实际接纳。在SA #2中，将设计WarmSmart的工作原型， 制造并实验验证了热性能。UT将进行科学和初步的人类 热传递分析，水星将执行14点验证协议的最终完善， 准备临床试验和随后的FDA注册。可交付成果经过10次测试 WarmSmart设备可与我们在克利夫兰诊所的医疗合作者一起应用于临床试验。

Project Summary/Abstract This proposal presents Phase 1 of the plan of Mercury Biomed, LLC for commercializing the new and innovative WarmSmart technology to more effectively keep patients warm during anesthetized surgery. The WarmSmart technology is based on IP licensed from the University of Texas at Austin, who is the academic partner for this STTR proposal. WarmSmart embodies several breakthrough concepts in bioheat transfer to manage core temperature. We anticipate a cost competitive technology that will offer equivalent or superior thermal performance than existing technologies with multiple unique advantages and that will be much more convenient, simple, and safe to use. The most widely applied existing technology for keeping patients warm during surgery uses heating applied over large areas of the body surface via forced convection of hot air through an outer bag placed onto the patient. A recent comprehensive study shows that this technology failed to maintain patients above the minimum acceptable core temperature throughout surgeries in 2/3 of the cases, plus it occupies large areas of the body surface, placing unnecessary restrictions on access to the patient during surgery. WarmSmart requires access to only the hands and feet where uniquely high rates of blood flow can occur through glabrous skin, constituting the body's already existing high performance heat flow pathway between the surface and the core. Not only does WarmSmart add heat more effectively to combat drops in core temperature, in doing so it blocks and reverses the primary heat loss process caused by anesthesia, making it doubly effective. The project will have two specific aims to prepare for conducting clinical trials with WarmSmart in Phase 2. In SA #1 an existing thermoelectric powered device available to Mercury will be redesigned and reengineered to meet the minimum of 75W heating capacity. The heart of the existing technology is a thermoelectric energy source that can provide a water flow to heating pads applied to the hands and feet at precisely regulated temperatures. Enhancements will include a more efficient design for the water flow heat exchangers and a higher flow capacity water pump. New water flow pads will incorporate state-of-the-art heat exchanger design principles. A new operator interface will be created based on input from our advisory panel of anesthesiologists to ensure practical acceptance of WarmSmart. In SA #2 working prototypes of WarmSmart will be designed, fabricated, and experimentally verified for thermal performance. UT will conduct scientific and initial human heat transfer analysis, and Mercury will perform a 14-point verification protocol for final refinement in preparation for clinical trials and subsequent FDA registration. The deliverable outcome is ten tested WarmSmart devices that can be applied in clinical trials with our medical collaborators at Cleveland Clinic.