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Hemorrhage Control device

The Swelling Hemostat is a small, lightweight wound dressing which will swell on contact with blood by absorbing the water content of that blood.  In this process the device dehydrates the blood and encourages faster coagulation and clotting than the body can produce on its own.  In addition, when inserted into a wound, the swelling action of the device exerts pressure on the walls of the wound cavity, reducing or stopping bleeding altogether.  The device is targeted for use in deep proximal extremity wounds, particularly in the groin and shoulder areas, where standard methods of treatment such as the tourniquet cannot be applied.

SEC is collaborating with Payload Systems Inc. and Massachusetts General Hospital in the development of this Swelling Hemostat.  Our roles and responsibilities include sourcing of research funds, liaising with and reporting to the client, design, technology integration, project and technology management, and intellectual property strategy and patent writing.

The Swelling Hemostat, first developed and refined in the laboratory, has now been tested by some of the world’s top medical experts in the field of trauma medicine on a large animal model of fatal groin injury.  The complex groin injury, including transection of the proximal thigh soft tissues and complete division of the femoral artery and vein just below the inguinal ligament, is inflicted to produce uncontrolled hemorrhage, simulating serious injury.  The test procedure requires the animal to be randomized into one of two groups, one destined for treatment with standard gauze and the other with the Swelling Hemostat.  The wound is then produced and free bleeding is allowed for 3 minutes.  After this, the wound is treated according to the selected group and manual compression is applied for 5 minutes.  At the end of this period, pressure is removed and fluid resuscitation is begun 15 minutes after the injury is first inflicted.  Two liters of standard 0.9% saline solution are then administered over 30 minutes and the animal is monitored for 120 minutes after injury.  During this period any reasonable procedure that could be applied in the field for survival is applied, if required.  This test protocol was examined and approved by the MGH Animal Ethics Committee.

The large animal tests conducted to date have obtained outstanding results, with our device recording a survival rate amongst test subjects of 100%, rivalling the best hemorrhage control agents available on the market today.  The principal goal of such testing is to demonstrate with statistical significance that the device works effectively.  Statistical significance is of critical important in such trials because biological experiments that rely on physiological response show huge amounts of variability.

The development, optimization and commercialization of this device continue.  Next steps require testing on different animal models simulating different types of injuries.  It is necessary to show efficacy on various types of wounds and wide applicability of the method and device in order for it to be commercially viable.  The model we have used to date represents a worst case scenario, which makes us extremely confident in the future of this device.  SEC has secured an exclusive license from Payload Systems Inc. for the continued development and commercialization of this device in Europe, Africa and the Middle East, and a non exclusive license for the rest of the world.  SEC seeks to develop partnerships with potential investors.  Individuals or companies interested in finding out more about this should contacts us at info@serra-engineering.com.

Click on the thumbnail to view larger image.
	Blood particulate is seen agglomerating on the surface of swollen polymer particles after absorption of the aqueous component of the blood.  White areas at the center of the polymer particles are caused by the of a glass slide cover before viewing on the microscope.
	Prototype Swelling Hemostats shown just before testing in a large animal model.
	Packaged and sterilized Swelling Hemostats.  Each package contains two hemostats.
	Mean arterial pressure measured for the two experiment groups – only includes surviving animals.
	Survival rate for the two test groups – Hemostat groups shows 100% survival versus 40% of the Control group.