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

项目摘要/摘要 本建议书介绍了墨丘利生物化工有限责任公司将新的和 创新的WarmSmart技术，在麻醉手术期间更有效地为患者保暖。这个 WarmSmart技术是基于德克萨斯大学奥斯汀分校授予的知识产权，他是学者 此STTR计划书的合作伙伴。WarmSmart在生物热传输方面体现了几个突破性的概念 管理核心温度。我们期望一种具有成本竞争力的技术能够提供同等或更好的性能 与现有技术相比，热性能具有多种独特的优势，这将远远超过 使用方便、简单、安全。 目前应用最广泛的手术保暖技术是使用加热技术。 通过放置在身体表面上的外袋强制对流热空气，在大范围的身体表面上 有耐心的。最近的一项综合研究表明，这项技术未能使患者保持在 2/3的病例在整个手术过程中可接受的最低核心温度，加上它占据了 身体表面，在手术过程中对接触病人施加不必要的限制。WarmSmart 只需要接触到手部和脚部，通过无毛组织可以产生独特的高血流量 皮肤，构成了人体已经存在的表面和表面之间的高性能热流路径 核心。WarmSmart不仅更有效地增加热量来对抗核心温度的下降，而且这样做 阻断和逆转麻醉引起的主要散热过程，使其加倍有效。 该项目将有两个具体目标，为在第二阶段与WarmSmart进行临床试验做准备。 在SA#1中，水星公司现有的热电驱动装置将进行重新设计和重新设计 以满足最低75W的加热能力。现有技术的核心是一种热电 一种可以为手部和脚部的加热垫提供精确调节的水流的源泉 温度。改进措施将包括更高效的水流热交换器设计和 流量更大的水泵。新的水流垫将采用最先进的热交换器设计 原则。我们将根据麻醉师顾问小组的意见创建一个新的操作员界面 以确保对WarmSmart的实际接受。在SA#2中，将设计WarmSmart的工作原型， 制造并通过实验验证了其热性能。德克萨斯大学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，以进行最终精炼 为临床试验和随后的FDA注册做准备。可交付的结果是10个测试 WarmSmart设备可以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.