SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is in addressing blood clots in the pulmonary artery. Venous thrombosis, comprising deep vein thrombosis (DVT) and pulmonary embolism (PE), occurs with an incidence of approximately 1 per 1000 annually in adult populations. Estimates suggest that 60k -100k Americans die of DVT/PE (also called venous thromboembolism). The current treatments are high risk to the patients and very expensive to the health care systems. Current treatment methods involve the use of systemic or catheter-directed thrombolytic medications to break down the clot and restore blood flow. The use of these medications carries the risk of bleeding in different parts of the body which can lead to death. Open-heart surgery is another treatment method, but the high risk of this critical surgery requires highly skilled physicians and advanced equipment that may not be available in most hospitals. The proposed device is simple and intuitive and allows the physicians to complete the treatment and restore the blood flow in less than 30 minutes of the patient arrival while other treatment methods take several hours for mechanical thrombectomy and several days for catheter-delivered thrombolysis. This will significantly reduce the total procedure cost by reducing the length of stay in the intensive care unit from the average of 2-3 days to only a few hours. The proposed project advances the current of the art of Nitinol medical device design, fabrication, and evaluation. The proposed clot removal device targets pulmonary embolism which is a common disease and may lead to death. The proposing team has established the technologies and know-how to produce the core Nitinol components of device. These include a simulation-based design optimization methodology, which has been used for the design of the main blood clot capturing funnels from Nitinol. The team has established innovative non-conventional fabrication and post-processing heat treatment procedures. Based on the anatomy and functionality of the circulation system an innovative test set up has been fabricated that can replicate the blockage of arteries. To this end, human blood clots are created and inserted in the test apparatus for a later retrieval. One of the main innovations is a Nitinol structure designed to allow for a 7-fold increase in the diameter of the blood capturing device when deployed: when deployed these Nitinol elements can expand from 2mm to 14mm in diameter, without any balloon or other external force. This innovative functionality has never been achieved before and is essential for the atraumatic functionality of the proposed device. This has been achieved by developing a mathematical method to systematically calculate the shape and size of laser cutting feature on a tube of Nitinol. With proper heat treatment, this tube can be formed to produce the two capturing baskets. The team has also used additive manufacturing and advanced computer simulation to create a test setup for in vitro testing of the capturing device.

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is about addressing pulmonary embolism as the third most common cause of death for hospitalized patients. Current modalities for treating pulmonary embolism are effective for most cases with the exception of the acute massive and submassive patients (45% of patients). The company's product is particularly suited for the massive and submassive pulmonary embolisms, respectively 5% and 40% of PE population. Based on the approximately 150K PE patient cases per year, with an estimated $3000 per QuickFlow catheter, the company's estimated target market at minimum 4% penetration within the first three years is $18 million. QuickFlow addresses a severely underserved market; hence, maximizing the value to both the patient and physicians. The value propositions of faster (less than one-hour procedure), safer (no thrombolysis, no vessel wall damage and whole clot removal), easy and intuitive to use (similar mechanism of use to the existent device), and less procedure cost (1 day in ICU instead of 2-3 days), make it appropriate for several key markets, with a global market opportunity in excess of $1.53 billion by 2022. The implications of this device for the thrombectomy device market and healthcare system can be significant in helping to treat underserved PE patients and reducing cost. This Small Business Innovation Research (SBIR) Phase II project is to develop a mechanical blood clot removal device to address pulmonary embolism and restore blood flow in 30 minutes of patient?s arrival. Reduced time of procedure, use a nonsurgical process, ease of use, and reduced cost make this minimally invasive mechanical thrombectomy procedure more desirable than the currently available treatment methods. The minimally invasive QuickFlow PE, offers these unique features based on the paradigm shifting technological innovation in Nitinol device design and manufacturing. The super expandable Nitinol baskets completely remove blood clots while significantly reducing the risk of complications associated with the current methods of treatment such as internal bleeding, and clot fragmentation. A multidisciplinary study on an advanced biomaterial and developing a new manufacturing technology has resulted in a paradigm shifting medical device which is being studied by a team of engineers, physicians, a sales consultant, and a commercial advisor. The team is uniquely positioned to conduct this multidisciplinary research. The success in commercializing QuickFlow will significantly advance our understanding of fabricating novel Nitinol medical devices for a wide spectrum of applications. 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.