Improved Continuous Autologus Blood Reinfusion Device Using an Ultrasonic System

描述（由申请人提供）：外科医生面临着与手术中和术后失血相关的几个挑战。可用于输血的血液供应有限，加上输血反应和使用同种异体血液传播疾病等有害结果，使得血液成分分离、栓子去除和患者自己的血液再输注成为一个有吸引力的选择。此外，在许多外科手术过程中，特别是心血管手术过程中，有大量的游离血液在离心过滤后被吸入和再输注。术后认知能力下降直接归因于心脏手术过程中再输注未充分纯化的流出血导致的脂质微栓子栓塞。RMD, Inc.与Parsus Medical， dr。维克森林大学医学院的David Stump和John Hammon、瑞典隆德大学医院的Henrick Jonsson博士和梅奥诊所的Jeff Riley博士提出了一种基于超声波血液成分分离和栓塞去除的新技术，以取代现有的、效果不太好的、基于离心机的血液回收和细胞保存系统。我们假设所提出的技术具有改善临床结果的潜力，它提供了非常优越的性能，包括：去除90%或更多的脂质微栓塞，恢复95%的红细胞，启动体积小于10毫升，输出流速接近每小时4升。血液成分分离和栓子去除模块将是小的，具有成本效益的制造和一次性。在第一阶段，我们将分析和表征所提出的技术的性能特征，并将第一阶段开发的原型超声系统与现有的血液成分分离和洗涤技术进行比较，比较可量化参数，如保留健康红细胞、去除栓塞和恢复血液样本中的血小板。在第二阶段，我们将通过动物模型，通过对术后炎症和脑栓塞等生理参数的比较测量，表明采用新的超声分离和栓塞去除技术处理的血液可以获得更好的手术效果。该计划的结果将是一个新的产品平台，以克服现有的过滤器和离心机为基础的自体输血产品的严重局限性。这是超声波作为血液分离和去栓塞手段的第一次医学发展。通过利用超声来完成与离心力的血液分离，我们已经确定了一种优越的方法来分离有益的血液成分，并消除有害的脂质微栓塞。

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.