SBIR-STTR Award

Intraoperative autotransfusion system (IOAT) aspirates waste blood from surgical wound site, purifies and returns it to the same patient. We developed and evaluated in-vitro and in-vivo a new IOAT system which is designed to purify the aspirated waste blood using hollow fiber membrane filters instead of using centrifuges, and return the purified blood cells to the patient in a closed loop continuous on line operation without significant wastage of blood cells.Preliminary in-vivo evaluations of our IOAT system have lead us to redefine the design parameters. We rebuilt our system so that it could respond to the rapidly changing operating conditions, such as blood flow rate, hematocrit, air emboli & froth, macroaggregates, irrigating fluid, shear rate, transmembrane pressure, duration of operation, and systemic heparinization.Phase-I involves extensive in-vitro studies using calf and human blood with an objective to establish the consistency of performance of our system in response to the rapid changes in operating conditions. Phase II involves evaluations in calves, where bleeding will be simulated in open chest cavity, and the shed blood will be salvaged by our IOAT system. Total available market is expected to be over $120,000,000 in the U. S..Awardee's statement of the potential commercial applications of the research:Nearly 12 million red blood cell units are being transfused to approximately 3.5 million patients annually in the U.S.. There is a strong need for this device for salvaging the shed blood during surgery in view of the present scare in donor blood transfusions related to transmission of AIDS and hepatitis.National Heart, Lung and Blood Institute (NHLBI)

Intraoperative blood salvage (IBS) system aspirates waste blood from surgical wound site, purifies it by "cell-washing", and returns it to the same patient. We developed a new IBS device called membrane autotransfusion (MAT) which purifies the waste blood using a hollow fiber membrane filter instead of a centrifuge. Phase I program involved in-vitro studies using bovine blood which established the operating characteristics of the MAT. Two animal studies were also completed in Phase I and showed that the recovered blood cells (RBC, WBC, and platelets) retained their normal functions and the MAT procedure had no observable side effects. Phase-II program proposes to further evaluate the MAT in ten calves. The animal experiment is designed to simulate controlled bleeding in an open surgical wound site, so the MAT procedure will be applied to salvage the shed blood and reinfuse it to the animal. Interaction of other systems such as heart-lung bypass and oxygenators are eliminated in this procedure so that effects of only the MAT procedure on the animal could be determined. About 3 liters of blood will be processed in each experiment. Blood samples of the shed and the purified blood will be subjected to hematological and cell function tests. Health of the animal will be monitored for one week post-operation. This study is expected to establish the efficiency and the safety features of the MAT procedure.Awardee's statement of the potential commercial applications of the research: An intraoperative blood salvaging device has the potential to be applied in 2.5 million surgeries in the U. S. A. each year.National Heart, Lung, and Blood Institute (NHLBI)