SBIR-STTR Award

Junctional hemorrhage precludes the use of externally applied tourniquets in extremity and proximal cervical injuries at the base of the neck. It is responsible for >60% of deaths in military trauma, with >90% of fatalities occurring in the prehospital environment despite the presence of an on-site medic. To address the unique challenges associated with trauma, especially junctional hemorrhage, Amsel Medical has developed a unique family of rapid needle delivered (18G) site specific mechanical clamping solutions to provide permanent or temporary occlusion of vessels proximal to a bleeding site. Amsel's ScureClamp™ permanent occluder provides rapid (<30 seconds) hemorrhage control to minimize blood loss and eliminate the need for cutdown, and is removed at the time of the subsequent surgical intervention for wound repair. Amsel has further developed the Scure Temporary Occluder ScureTO™ to enable temporary occlusion and variable flow control to further minimize the risks of local vessel thrombosis and distal prolonged ischemia with its accompanying morbid metabolic effects and enable simple removal when no longer required, without injury to the vessel and without the need for any open surgical procedure or repair. This temporary occlusion device functions as an adjustable and removable internal tourniquet.

Despite the development of numerous methods for proximal vessel compression and control, even today, the exsanguination rates associated with junctional and non-compressible hemorrhage in the battlefield prior to surgical intervention are extremely high, with a greater than 60% mortality amongst US combatants. Junctional hemorrhage due to trauma is also a major cause of mortality and morbidity for civilian victims. The ability to rapidly and effectively reduce blood loss and improve survival has broad significance. Amsel Medical Corporation, a medical device company, based in Cambridge, Massachusetts, has developed a percutaneous, minimally invasive fine-needle (~1mm diameter, 18 gauge) delivered temporary mechanical clamp (SCureTOTM) for fast, secure mechanical ligation as well as variable and controllable occlusion of the targeted blood vessel once applied, with simple removal of the occluding device when no longer required, without the need for any surgical procedure. This technology offers the ability to very specifically clamp and control blood flow in a targeted vessel above the site of injury in trauma scenarios allowing control of junctional and non-compressible hemorrhage in seconds, while enabling the patient to be evacuated for definitive care. This provides similar benefits to that of an externally applied tourniquet but in a much more targeted manner, and in regions not accessible for a traditional tourniquet. Furthermore, the unique, patented, interdigitated clamping design of the SCureTO prevents crushing injury to the vessel while it is clamped, allowing effective flow to be restored to the vessel once the clamp is removed.