Characterization and testing of a blood pump maintenance system

摘要 心力衰竭（HF）是一种全球流行病，影响全球2300万人， 美国，每年有65万例新确诊病例。这是一种无情的疾病， 进展到预后极差的终末期，其中心脏移植或左 心室辅助装置（LVAD）治疗成为唯一可用的治疗选择。一 LVAD用于终末期HF的显著增加是由于严重的供体短缺。然而，在这方面， 连续泵运行，24/7/365，无法维护或清洁泵导致凝块， 中风和感染，这极大地限制了临床益处。这类似于驾驶一辆没有 更换机油和过滤器或进行任何维护五到十年。 泵的定期维护不仅是汽车的必要条件， 在整个泵行业的做法，以保持他们正常运行。然而，目前的LVAD 一旦植入，就无法清洁泵，除非另一个高度侵入性的心脏直视手术 进行手术。设备耐用性，确保24/7/365连续运行， 机械故障一直是几代LVAD的主要技术焦点， 代价是侵入性，24小时护理，感染，出血，血栓形成， 患者余生的生活质量。清洁和维护体内LVAD的能力 可能会彻底改变LVAD患者的管理。临床经验表明， LVAD可以在短时间内安全关闭，同时支持循环， 正性肌力药，提供了在体内清洁和进行维护的机会。 邦德创新有限责任公司和耶鲁大学的人工心脏实验室开发了一种 VAD维护系统包含称为生物阀（球囊隔离）的独特组件 可在体内隔离泵，并允许清洁、维护和维修泵。 当它仍然被植入人体内时，两个生物瓣膜连接到一个 接入端口设计用于控制程序的所有四个步骤-隔离、吹扫、维护 和维修时不接触血液或体液。这是一个简单的所有功能于一身的单位适用于任何 植入式心室辅助装置在SBIR第一阶段的提案中，我们将证明体内VAD的可行性 维护系统，然后计划提交第二阶段的建议，开发产品级的VAD 通过设计优化、设计冻结和广泛的临床前维护系统 做好临床试验的准备。提供常规泵的前所未有的机会 维持在体内有可能减少常见和严重的并发症， 康复和缩短住院时间，带来VAD技术和管理的创新。

ABSTRACT Heart failure (HF), a global pandemic affecting 23 million people worldwide and 6 million in the US, with 650,000 new cases diagnosed in the US each year. It is a relentless disease that progresses to end stages with very poor prognosis, in which heart transplantation or left ventricular assist device (LVAD) therapy becomes the only available treatment option. A significant rise in the LVAD use for end-stage HF is due to critical donor shortage. However, continuous pump operation, 24/7/365, with no ability to maintain or clean the pump leads to clots, stroke, and infection, which greatly limits the clinical benefit. This is akin to driving a car without changing its oil and filter or doing any maintenance for five to ten years. Not only is regular pump maintenance necessary for cars, it is also an essential and standard practice in the entire pump industry to keep them running properly. However, current LVADs do not have access to clean the pump once it is implanted unless another highly invasive open-heart surgery is performed. Device durability to ensure 24/7/365 continuous operation without mechanical failure has been the major technical focus throughout generations of LVAD, which comes at the price of invasiveness, 24-hour care, infection, bleeding, thrombosis, and reduced quality of life for the remainder of the patient’s life. Ability to clean and maintain the LVAD in-vivo may completely change the management of LVAD patients. Clinical experience demonstrates that an LVAD can be safely turned off for short durations while supporting circulation with inotropes, giving an opportunity to clean and carry out maintenance in-vivo. Bonde Innovations LLC and the Artificial Heart Laboratory at Yale University have developed a VAD maintenance system incorporating a unique component called BiO-valve (Balloon isolation Occluding valves) that can isolate the pump in-vivo and allows to clean, maintain, and service the pump when it is still implanted within a human body. Two BiO-valves are connected to a single access port designed to control all four steps of the procedure - isolation, purging, maintenance, and service with no exposure to blood or body fluids. It is a simple all-in-one unit applicable to any implantable VAD. In this SBIR phase I proposal, we will demonstrate the feasibility of in-vivo VAD maintenance system, and then plan to submit a Phase II proposal to develop product level of VAD maintenance system through design optimization, design freeze, and extensive pre-clinical studies to make it ready for clinical trials. An unprecedented opportunity of providing routine pump maintenance in-vivo has potential to reduce common and severe complications, promote patient recovery, and shorten hospitalizations, bringing innovations in VAD technology and management.