DEVELOPMENT OF A SINGLE USE DEVICE INTENDED TO WASH BLOOD CLOT DEBRIS FROM A STENT RETRIEVER IN THE OPERATING ROOM

Ischemic stroke is a life-threatening condition that requires immediate surgical intervention to remove the blood clot that is lodged in the blood vessels of the brain. Mechanical thrombectomy, performed by an endovascular surgeon, involves inserting a stent retriever, which deploys distally and attempts to capture the clot when dragged backwards. A complication prevalent in 50% - 67% of cases is that the blood clot is only partially removed and clings to the mesh framework of the stent. The operating surgeon must either clean the debris from the stent retriever, to be reinserted or throw the stent retriever away and open a new one. At $7,000 - $10,000 per stent, most prefer to clean the stent retriever. For this paper, the terms “stent clot retriever”, “stent retriever” and “stent” will be interchanged for brevity. The current method is to use a syringe of sterile saline to squirt the clot off of the stent retriever, but this is ineffective and time-consuming. Stent retrievers are often only 3-6mm in diameter and 40-60mm long, and so they are incredibly fragile. This project’s objective was to create a method and medical device to: Wash thrombus debris off of an arterial stent retriever Reduce OR time in cleaning the stent retriever Result in a cleaner stent retriever Reduce the chances for stent retriever damage Per manufacturer’s IFU, allow the stent retriever to be used additional times for removing additional clot debris Allow the thrombus to be collected for composition analysis A device was successfully designed that satisfies the above criteria, and this paper will discuss the process of designing a physical product, exploration of manufacturing methods, evaluation of the prototypes, and the requirements in certifying a medical device