BiVACOR Rotary Total Artificial Heart

摘要/摘要 心力衰竭(HF)是一种毁灭性的疾病，全世界有2000多万患者受到影响，其中570万人 美国每年的新增病例为87万例。虽然心脏移植提供了最好的治疗选择 在这些患者中，全球每年进行的心脏移植手术不到4200例。此外，目前的增长率 预计到2030年，心力衰竭的发病率将增加25%，预计每年的费用为697亿美元。美国国民警卫队 卫生研究所(NIH)估计，100,000名患者可以立即受益于机械循环支持 (MCS)。严重心力衰竭患者在没有干预的情况下前景不佳。药物治疗不是有效的 而供体心脏的有限供应表明，目前唯一可行的替代方案是MCS。 心脏辅助装置(VADs)和人工心脏总量(Tahs)是外科手术的机械泵 严重心力衰竭患者植入心脏旁或置换术，以恢复足够的血流量。 该领域的技术进步已经解决了与孤立性左心室心衰相关的许多问题，导致 一些左心室辅助装置(LVAD)的商业化。然而，高达30%的心衰患者 双室心衰，或在LVAD植入后发展。这需要摘除心脏并植入。 TAH，或在右心旁植入第二个VAD以提供双心室辅助(BiVAD)。 然而，由于人们的担忧，目前还没有能够充分满足这一人群需求的长期双心室装置。 关于耐久性和不良事件。BiVACOR设备正准备利用这一市场缺口。 BiVACOR TAH采用了与现代成功的基于旋转血液的LVAD相同的方法 具有磁悬浮转子的泵(RBP)技术，并应用于提供同步、可靠和 对体循环和肺循环的生物相容支持。该设备在概念和技术方面取得了进展 可行性第一阶段通过私人资金来源，目前正在进入开发第二阶段。因此，这项SBIR 提案的目标是直接应用到第二阶段，具体目标如下：(1)实施和完善速度 控制算法以恢复脉动和流出适应，(2)改进可植入部件的设计，同时 实现最佳的人体解剖适合性，(3)在设计控制下建造密封设备，以及(4) 在体外和体内进行工艺验证和设备功能验证。达到这些里程碑 将导致设计冻结，同时展示该产品的临床实用，提高 技术，从而鼓励进入第三阶段商业化所需的额外投资。 长期实用机械置换对男性、女性和儿童衰竭心脏的影响 将是巨大的。患者将不再需要等待心脏移植手术，心脏移植的质量将大大提高。 生活的一部分。将类似VAD技术的成功耐用性和小型性引入BiVACOR TAH 提供了一条明确的途径，以实现实际替代衰竭的人类心脏的目标。

SUMMARY/ABSTRACT Heart Failure (HF) is a devastating disease affecting more than 20 million patients worldwide, with 5.7 million of these American at an incidence of 870,000 new cases each year. Whilst heart transplants provide the best treatment option for many of these patients, less than 4200 heart transplants take place globally each year. Furthermore, current growth rates predict a 25% increase in the incidence of HF by 2030 at an expected cost of USD$69.7 B per annum. The US National Institute of Health (NIH) estimated that 100,000 patients could immediately benefit from mechanical circulatory support (MCS). Patients with severe heart failure have a poor outlook without intervention. Drug therapy is not an effective option, and the limited availability of donor hearts suggests the only viable alternative at this point in time is MCS. Ventricular assist devices (VADs) and Total Artificial Hearts (TAHs) are mechanical pumps that are surgically implanted alongside or in replacement of the heart of patients with severe HF, to restore the adequate blood flow. Technological advances in the field have addressed many issues associated with isolated left ventricular HF resulting in the commercialization of a number of left ventricular assist devices (LVADs). However, up to 30% of HF patients have biventricular HF, or it develops after LVAD implantation. This necessitates the removal of the heart and implantation of a TAH, or the implantation of a second VAD alongside the right heart to provide biventricular assistance (BiVAD). However, there are no long-term biventricular devices that adequately meet the needs of this population due to concerns regarding durability and adverse events. The BiVACOR device is poised to take advantage of this market gap. The BiVACOR TAH utilizes the same approach as the modern successful LVADs which are based on rotary blood pump (RBP) technology with magnetically levitated rotors, and applies it to provide simultaneous, reliable and biocompatible support for both the systemic and pulmonary circulations. The device has progressed though concept and feasibility phase I via private funding sources, and is now entering the development phase II. Therefore, this SBIR proposal is targeting a direct to phase II application, with the following specific aims (1) Implement and refine speed control algorithms to restore pulsatility and outflow adaptation, (2) Refine the design of implantable components while achieving an optimized human anatomical fit, (3) Construct hermetically sealed devices under design controls, and (4) Verification of processes and validation of device function in vitro and chronic in vivo. Attainment of these milestones would lead to a design freeze whilst demonstrating the clinical utility of this product, raising the profile of the technology, and thus encouraging the additional investment needed to enter into Phase III commercialization. The impact of a long-term practical mechanical replacement to the failing human heart for men, women and children would be tremendous. Patients would no longer need to wait for a heart transplant to return to a vastly improved quality of life. Leveraging the successful durability and small size of similar VAD technologies into the BiVACOR TAH provides a clear pathway to achieve the goal of a practical replacement of the failing human heart.