Improved Continuous Autologus Blood Reinfusion Device Using an Ultrasonic System

DESCRIPTION (provided by applicant): Surgeons face several challenges associated with intra- and post-operative blood loss. A limited supply of blood available for transfusion and injurious results involving transfusion reactions and disease transmission using allogenic blood, make blood component separation, embolus removal, and reinfusion of the patient's own shed blood an attractive option. In addition, during many surgical procedures, particularly cardiovascular surgery, there is a significant amount of shed blood suctioned and reinfused after centrifugation and filtering. Post-operative cognitive decline has been directly attributed to the cerebral embolization of lipid microemboli associated with the reinfusion of insufficiently purified shed blood during cardiac surgery procedures. RMD, Inc. in collaboration with Parsus Medical, Drs. David Stump and John Hammon at Wake Forest University School of Medicine, Dr. Henrick Jonsson at Lund University Hospital, Sweden, and Dr. Jeff Riley at the Mayo Clinic propose a novel technology based on ultrasonic blood component separation and embolus removal to replace existing, marginally effective, centrifuge-based blood salvage and cell saver systems. We hypothesize that the proposed technology has the potential to improve clinical outcomes by offering vastly superior performance including: Removal of 90% or more of lipid microemboli, recovery of 95% of red blood cells, operation with priming volume under 10 ml, and output at a flow rate near 4 liters per hour. The blood component separation and embolus removal module will be small, cost-effective to fabricate and disposable. During Phase I, we will analyze and characterize the performance characteristics of the proposed technology and compare a prototype ultrasonic system developed during Phase I to existing blood component separation and washing technologies in terms of quantifiable parameters such as the retention of healthy red blood cells, the removal of emboli, and the recovery of platelets in blood samples. In Phase II, we will work with an animal model to show that blood treated with the new ultrasonic separation and embolus removal technology yields better surgical outcomes by making comparative measurements of physiological parameters such as inflammation and cerebral embolization post surgery. The result of the program will be a new product platform to overcome the serious limitations of existing, filter and centrifuge-based autotransfusion products. This is the first medical development of ultrasonics as a means of blood separation and de-embolization. By utilizing ultrasound to accomplish blood separation versus centrifugal force, we have identified a superior methodology for segregating beneficial blood components with the added benefit of eliminating harmful lipid microemboli. PUBLIC HEALTH RELEVANCE: Reinfusion of a patient's own blood during surgery avoids complications with transfusion of blood from donors and is widely used for surgery, yet reinfusion technology is based on decades-old centrifugation and filtering which damage blood cells and remove only a modest percentage of hazardous micro-emboli. Ultrasonic blood purification has the potential to yield blood with healthier cells and virtually no emboli at a fraction of the complexity and cost of existing technology.