SBIR Phase I: Thermal Compression Device for Maintenance of Perioperative Normothermia

这一小型企业创新研究(SBIR)第一阶段项目的更广泛影响和商业潜力是降低患者在手术期间体温严重下降的风险，这种风险被称为围手术期意外低体温(IPH)。在美国，每年有5750万例手术存在严重的IPH风险，估计有2200万外科患者出现与IPH相关的临床并发症。IPH导致伤口感染增加、失血、心脏问题、更多地使用机械通风，以及更长的住院时间，导致100万天的额外住院日和每年16亿美元的成本。这项拟议的技术将开发一种预防IPH的新型设备，估计可为每个患者节省2000-3500美元或10亿美元。这项小型企业创新研究(SBIR)第一阶段项目旨在创建一种精确地将新型设备与下肢组织模型相结合的人体热传递模型。由此产生的模型将能够在广泛的临床环境(扩大的手术程序和患者人口统计)中对设备性能(热输出)、有效性(热传递)和安全性(烧伤风险)进行电子评估。我们将从概念验证可行性研究中收集临床数据，以创建和验证模型。支持原型开发工作的进一步模拟能够优化关键参数。将在优化设计的基础上开发和制造物理原型(包括子部件)。原型将在受控台式测试下进行热性能评估，并将实验结果与模型生成的预期值进行比较。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to reduce the risk of patients experiencing a severe drop in body temperature during surgery, known as inadvertent perioperative hypothermia (IPH). In the United States, 57.5 million procedures are performed annually with significant risk of IPH and an estimated 22 million surgical patients develop clinical complications associated with IPH. IPH leads to increased wound infections, blood loss, cardiac problems, increased use of mechanical ventilation, and longer stays in hospital, contributing to 1 million excess inpatient days and $1.6 billion in yearly costs. The proposed technology will develop a novel device to prevent IPH, saving an estimated $2,000-$3,500 per patient or $1 billion.This Small Business Innovation Research (SBIR) Phase I project aims to create a body heat transfer model that accurately integrates the novel device with a tissue model of the lower limb. The resulting model will enable in silico evaluation of device performance (heat output), efficacy (heat transfer), and safety (burn risk) across a broad clinical setting (expanded surgical procedures and patient demographics). We will collect clinical data from a proof-of-concept feasibility study to create and validate a model. Further simulation in support of prototype development efforts enable the optimization of critical parameters. Physical prototypes (including sub-components) will be developed and manufactured based on the optimized design. Prototypes will be evaluated for thermal performance under controlled bench-top tests, with empirical results compared to expected values generated by the model.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.