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，以及涉及输血反应和使用同种异体血液传播疾病的损害后果，使得血液成分分离、栓子去除和患者自己流出的血液重新输注成为一个有吸引力的选择。此外，在许多外科手术中，特别是心血管手术中，有大量的失血被吸入，并在离心和过滤后重新输入。术后认知功能下降直接归因于心脏外科手术中回输不够纯净的流出血而导致的脑部脂质微栓子的栓塞。RMD公司与Parsus Medical、维克森林大学医学院的David Stump博士和John Hammon博士、瑞典隆德大学医院的Henrick Jonsson博士以及Mayo诊所的Jeff Riley博士合作，提出了一种基于超声波血液成分分离和栓子去除的新技术，以取代现有的基于离心机的血液回收和细胞保存系统。我们推测，拟议的技术有可能通过提供极高的性能来改善临床结果，包括：去除90%或更多的脂质微栓子，恢复95%的红细胞，手术预充量低于10ml，以及以接近每小时4升的流量输出。血液成分分离和栓子去除模块将是小型的，制造和一次性使用具有成本效益。在第一阶段，我们将分析和表征拟议技术的性能特征，并在血液样本中保留健康红细胞、清除血栓和回收血小板等可量化参数方面，将在第一阶段开发的原型超声波系统与现有的血液成分分离和洗涤技术进行比较。在第二阶段，我们将用一个动物模型来证明，通过对手术后的炎症和脑血栓等生理参数进行比较测量，使用新的超声波分离和栓子去除技术处理的血液可以产生更好的手术结果。该计划的结果将是一个新的产品平台，以克服现有的基于过滤器和离心机的自体输血产品的严重限制。这是超声波作为血液分离和解栓手段的第一次医学发展。通过利用超声波来完成血液分离而不是离心力，我们已经确定了一种分离有益血液成分的更好的方法，并增加了消除有害脂质微栓子的好处。 与公共卫生相关：在手术中回输患者自己的血液可以避免输血带来的并发症，并被广泛用于外科手术，但回输技术基于数十年的离心法和过滤技术，这种技术会破坏血细胞，只去除少量危险的微血栓。超声波血液净化有可能产生更健康的细胞和几乎没有血栓的血液，而复杂性和成本只有现有技术的一小部分。

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.