better outcomes for patients suffering from Ischemic stroke
This innovative device is funded by the Frankel Innovation Initiative, a $20 million fund made possible by a generous donation from the Maxine and Stuart Frankel Foundation that supports the research and development of life-saving therapies at Michigan Medicine.
Every year, almost 800,000 patients suffer from strokes, and most of them are ischemic strokes, which occur when a blood clot blocks an artery supplying blood to the brain. Such stroke patients are treated with a minimally invasive thrombectomy technique. As an intracoronary catheter device, this technique allows for the recanalization of blood vessels to re-establish the blood flow into the formerly blocked region of the brain. Recanalization is essential for optimizing clinical outcomes; however, current techniques allow for complete recanalization in only 50 percent of cases. Also, thrombectomy is a delicate procedure with poorer outcomes in cases with high fibrin clots or cases where smaller brain vessels are blocked. There is a need for a thrombectomy device which leads to better outcomes, as well as having success on the high fibrin clots and clots in smaller brain vessels.
To meet this need, two investigators at the University of Michigan, Aditya S. Pandey, M.D., and Albert Shih, Ph.D., have developed a miniature mechanical thrombectomy device that can cut high fibrin clots and reach more of the brain vasculature.
“Our cutting-based thrombectomy device and unique technique will have the ability to remove high fibrin clots in both large and small vessels,” says Dr. Pandey, the surgical director of the Michigan Medicine Comprehensive Stroke Center. “In doing so, we can achieve better patient outcomes and become more successful at achieving complete recanalization when encountering high fibrin clots as well as clots within smaller vessels.”
Working alongside neurosurgeon Dr. Pandey is engineering Professor Albert Shih, Ph.D., whose Biomedical Manufacturing Design Lab specializes in the research of innovative interventional cardiology and neurosurgery devices.
“The catheter, with less than a one mm diameter, utilizes an innovative cutting tool and driveshaft,” says Shih regarding the innovative technology.
Current thrombectomy devices are unsuccessful at achieving complete recanalization when encountering high fibrin clots or clots within smaller blood vessels.
The effective cutting of high fibrin clots to small segments and removal through vacuum suction requires an in-depth understanding of the clot properties, characterization, and cutting mechanics. The miniaturization of the sub-mm diameter mechanical thrombectomy device, particularly the design and fabrication of sharp cutting edges, is challenging. Scribing tests of clots will reveal the fundamental science of the interaction between the sharp cutting edge and clots.
Compared to current mechanical thrombectomy devices, which are at least 2 mm in diameter, the device is much smaller in diameter and more capable of cutting high fibrin clots in brain arteries secondary to its unique cutting mechanism.
Three benefits of the innovative thrombectomy device include:
- Innovations of a small diameter cutting-based catheter
- Research in scribing-based cutting of clots
- Better durability and reliability by eliminating the fatigue failure of the driveshaft near the internal carotid artery region
- Intellectual Property: Patents to be filed; invention disclosure has been filed
- Commercialization Strategy: Exploring licensing and the formation of a start-up
- Regulatory Pathway: A Class II device to be regulated by one or both of product regulations 21 CFR Part 870.1250 and 21 CFR Part 882.5600
- Engage Investors: De-risk the technology sufficiently to attract research and venture capital funding, professional investors, and a professional management team
- Product Launch Strategy: Concept demonstrated in the laboratory; moving forward with clinical translation
- Demonstrate the concept of miniature mechanical thrombectomy device
- Fabrication of high-fibrin human blood clot analogs
- Conducting fundamental scribing and cutting experiments to quantify the properties of human clots and clot analogs
- Conducting mechanical thrombectomy device experiment in an anatomically accurate simulator to observe the clot segmentation and removal, as well as to optimize the cutting for both human clots and clot analogs