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.
Project Relevance Each year, as many as 600,000 Americans are affected by deep vein thrombosis (DVT) and pulmonary embolisms (PE) resulting in $6+ billion in health care costs annually. Individuals at risk of developing DVT or PE are often given a cuff(s) that delivers gentle compressions created by a pump and delivered through a series of tubes leading to an air bladder. This solution requires the patient to be bedridden, is made of polypropylene and has limited compliance outside the hospital setting. In this SBIR, Recovery Force will develop a redesigned DVT cuff that will allow patients to be ambulatory during use, that can be worn with normal clothing and eliminate the need for tubes and a pump. This will increase patient compliance and reduce the morbidity and mortality rates of those Americans suffering from risk factors associated with DVT and PE.
