Wearable technology to reduce risk of DVT and increase patient compliance

项目摘要 深静脉血栓形成（DVT）是其中在深部系统的静脉中形成血凝块的病症。这些 凝块会松动，通过血流进入肺部，引起肺栓塞（PE）。 这是危及生命的，需要立即就医。每年在美国， 60万人的腿部或肺部出现血栓，每年的相关费用为60亿美元。DVT和 肺栓塞（PE）影响每1000人中有2人，在80岁以上的人群中，每100人中有1人。据估计， 美国人每年死于DVT/PE，10-30%的人在确诊后一个月内死亡，猝死是第一位的 25%的PE患者出现症状。在DVT患者中，50%会有长期并发症，33%会有 10年内复发。目前DVT/PE的标准治疗是血液稀释剂、凝块破坏剂（给予 通过静脉注射），过滤器插入腔静脉，长期使用压缩袜预防， DVT袖带是连接到软管和泵上的聚丙烯气囊包裹物，然后放置在 下肢目前的护理标准是对诊断的反应，侵入性和昂贵的。此外，本发明还 它们是不舒服的和麻烦的-这显著地降低了患者的依从率。在这个SBIR中， Recovery Force是一家位于印第安纳州的小型企业，它将使用相变存储器技术， 和可充电电源，以创建新的DVT袖带设计。舒适的可穿戴技术将 主动解决DVT/PE的风险，增加DVT/PE风险人群的患者依从性， 包括糖尿病患者、老年人、孕妇和癌症患者以及手术后患者。 恢复力将实现以下第一阶段目标：目标1）进行比较工程 测试：确定所需基准与临床使用中可用的DVT袖带一致，空气 气囊压力、循环时间、接触面积和温度。所有设计和测试要求将 根据Recovery's Force的质量体系ISO 33875执行，以准备FDA 510（k）II类 医疗器械提交。目的2）进行初步临床可用性研究，以评估舒适度， 接受度、易用性和设计。主要假设是在优化原型之后， 参加者将对该产品的设计，舒适度和耐磨性有很强的认识。另据预测 他们对佩戴该设备的接受度会很高。PI将与次级获奖者阿姆斯特朗博士合作 （UofAz）进行初步可用性研究。在第一阶段结束时，复原部队将 证明了一种新的DVT压缩产品的可行性，该产品将允许用户移动的， 由舒适的材料制成，实现与现有解决方案相似（或更好）的结果，并提供 提高患者依从性。第二阶段将集中在一个更大规模的多中心试验，用于医疗保健 在康复室和长期护理机构进行测试。

Project Abstract Deep Vein Thrombosis (DVT) is a condition wherein a blood clot forms in a vein of the deep system. These clots can break loose, travel through the blood stream and into the lungs causing pulmonary embolism (PE). This is life threatening and requires immediate medical care. Each year in the United States, between 350,000 and 600,000 people get a blood clot in the legs or in the lungs, with associated costs $6B annually. DVT and pulmonary embolism (PE) effect 2 per 1000 people and in those 80+, 1 in 100. Estimates suggest 100,000 Americans die of DVT/PE annually, 10-30% will die within one month of diagnosis and sudden death is the first symptom in 25% of people with PE. Of those with DVT, 50% will have long-term complications, 33% will have a recurrence within 10 years. The current standard of care for DVT/PE are blood thinners, clot busters (given through an IV), filters inserted into the vena cava, long term use of compression stockings for prevention and DVT cuffs, which are polypropylene air bladder wraps attached to hoses and a pump, then placed around the lower extremities. The current standards of care are reactive to the diagnosis, invasive and expensive. Further, they are uncomfortable and cumbersome—which significantly reduces patient compliance rates. In this SBIR, Recovery Force, an Indiana-based small business, will use phase change memory technology, integrated logic and a rechargeable power source to create a new DVT cuff design. The comfortable, wearable technology will proactively address the risk of DVT/PE with increased patient compliance for people at risk of DVT/PE, including individuals with diabetes, the elderly, pregnant women, and cancer as well as post-operative patients. Recovery Force will achieve the following Phase I Aims: Aim 1) Conduct Comparative Engineering Testing: Determine that desired benchmark is consistent with available DVT cuffs in clinical use with an air bladder pressures15, cycle time, contact area and temperature. All design and testing requirements will be performed under the Recovery's Force's quality system ISO33875 in preparation for a FDA 510(k) Class II medical device submission. Aim 2) Conduct a preliminary clinical usability study to assess comfort, acceptance, ease of use and design. The primary hypothesis is following optimizing the prototype, participants will be strongly statisfied with design, comfort and wearability of the product. It is also predicted that their acceptance to wearing the device will be high. The PI will work with subawardee Dr. Armstrong (UofAz) to conduct a preliminary usability study. At the conclusion of Phase I, the Recovery Force will have demonstrated the feasibility of a new DVT-focused compression product that will allow the user to be mobile, be made out of comfortable material, achieve similar (or better) results than existing solutions and offer increased patient compliance. Phase II will focus on a larger scale multi-site trial for use in the healthcare market with testing in recovery rooms and long term care facilities.