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

SBIR 第一阶段：用于维持围术期正常体温的热压缩装置

• 批准号: 2034065
• 负责人: Jeffrey Thompson
• 金额: $ 25.57万
• 依托单位: Flotherm Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2034065&HistoricalAwards=false
• 关键词: SBIR; Phase; Thermal; Compression; Device

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.

这项小型企业创新研究（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，即意外围手术期体温过低（IPH）。在美国，每年进行5750万例具有IPH显著风险的手术，估计有2200万例手术患者发生与IPH相关的临床并发症。IPH导致伤口感染、失血、心脏问题增加，机械通气使用增加，住院时间延长，导致100万个额外住院日和16亿美元的年度费用。该技术将开发一种新型设备来预防IPH，估计每位患者可节省2，000 - 3，500美元或10亿美元。这一小型企业创新研究（SBIR）第一阶段项目旨在创建一个身体热传递模型，该模型将新型设备与下肢组织模型准确集成。所得模型将能够在广泛的临床环境（扩展外科手术和患者人口统计学）中对器械性能（热输出）、有效性（热传递）和安全性（烧伤风险）进行计算机模拟评价。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。将根据优化设计开发和制造物理原型（包括子组件）。原型将在受控的台架测试下进行热性能评估，并将经验结果与模型产生的预期值进行比较。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。