Wearable technology to reduce risk of DVT and increase patient compliance

可穿戴技术可降低 DVT 风险并提高患者依从性

基本信息

批准号：
9255115
负责人：
Jeffrey Schwegman
金额：
$ 24.42万
依托单位：
RECOVERY FORCE, LLC
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-02-01 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9255115
关键词：
Acute Address Affect Age Air Air Sacs Ambulatory Surgical Procedures American Ankle Anticoagulants Area Arizona Bed rest Benchmarking Blood Blood Vessels Blood coagulation Businesses Capital Caring Clinical Clothing Coagulation Process Complication Compression Stocking Computer software Data Deep Vein Thrombosis Development Devices Diabetes Mellitus Diagnosis Disease Doctor of Philosophy Edema Elderly Engineering Equipment Health Care Costs Healthcare Market Home environment Hospitalization Hospitals Hygiene Immobilization Indiana Individual Ions Leg Length Life Lithium Logic Long-Term Care Lower Extremity Lung Malignant Neoplasms Mechanics Medical Medical Device Memory Morbidity - disease rate Obesity Operative Surgical Procedures Orthopedic Surgery procedures Outpatients Pain Participant Patients Performance Pharmacologic Substance Phase Polypropylenes Population Postoperative Period Postphlebitic Syndrome Power Sources Pregnancy Pregnant Women Preparation Prevention Pulmonary Embolism Pump Randomized Controlled Trials Recovery Recovery Room Recurrence Risk Risk Factors Series Small Business Innovation Research Grant Stream Sudden Death Surgeon Sweat Symptoms System Technology Temperature Testing Thrombectomy Time Training Trauma Travel Tube United States Universities Vena caval structure Walking Work base catalyst comparative compliance behavior cost deep vein design handheld mobile device high risk innovation mortality multi-site trial patient home care patient population phase change pressure prevent professor prototype standard of care thrombolysis usability wearable technology

项目摘要

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.

项目摘要深静脉血栓 (DVT) 是一种导致深部静脉系统形成血凝块的疾病。血栓可能会脱落，通过血流进入肺部，导致肺栓塞 (PE)。在美国，每年有 350,000 人面临生命危险，需要立即就医。 600,000 人的腿部或肺部出现血栓，每年产生 6B 美元的相关费用。肺栓塞 (PE) 的影响率为每 1000 人中 2 人，80 岁以上的人中，每 100 人中就有 1 人。估计为 100,000 人美国人每年死于 DVT/PE，10-30% 会在诊断后一个月内死亡，猝死是第一位 25% 的 DVT 患者中，50% 会出现长期并发症，33% 会出现这种症状。 10 年内复发。目前 DVT/PE 的治疗标准是血液稀释剂、血栓破坏剂（给予）。通过静脉注射），将过滤器插入腔静脉，长期使用压力袜以预防和 DVT 袖带，是连接到软管和泵上的聚丙烯气囊包裹物，然后放置在患者周围目前的护理标准对诊断有反应，具有侵入性且昂贵。它们不舒服且笨重，这显着降低了患者的依从率。 Recovery Force 是一家位于印第安纳州的小型企业，将使用相变内存技术、集成逻辑和可充电电源创造了全新的 DVT 袖带设计，舒适、可穿戴的技术将。积极应对 DVT/PE 风险，提高有 DVT/PE 风险人群的患者依从性，包括糖尿病患者、老年人、孕妇、癌症患者以及术后患者。 Recovery Force 将实现以下第一阶段目标：目标 1) 进行比较工程测试：确定所需的基准与临床使用的空气 DVT 袖带一致膀胱压力15、循环时间、接触面积和温度均符合设计和测试要求。根据 Recovery's Force 质量体系 ISO33875 执行，为 FDA 510(k) II 级做好准备目标 2) 进行初步临床可用性研究以评估舒适度、接受度、易用性和设计的主要假设是优化原型，预计参与者将对产品的设计、舒适度和耐磨性非常满意。他们对佩戴该设备的接受度很高。 PI 将与亚获奖者阿姆斯特朗博士合作。 (UofAz) 进行初步可用性研究，第一阶段结束时，恢复部队将拥有。一种新的以 DVT 为重点的压缩产品的可行性，该产品将允许用户移动，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，并提供第二阶段将重点关注用于医疗保健的更大规模的多站点试验。市场在康复室和长期护理设施中进行测试。