BiVACOR Rotary Total Artificial Heart

BiVACOR 旋转式全人工心脏

• 批准号: 9410265
• 负责人: Daniel Timms
• 金额: $ 115.86万
• 依托单位: BIVACOR, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9410265
• 关键词: Address; Adverse event; Affect; Algorithms; American; Anatomy; Animals; Artificial Heart; Blood Circulation; Blood flow; Cardiac; Cardiovascular Diseases; Cause of Death; Child; Chronic; Clinical; Development; Device or Instrument Development; Devices; Disease; Epidemic; Equilibrium; Europe; Evaluation; Excision; Failure; Freezing; Funding Agency; Future; Goals; Growth; Health; Health Care Costs; Heart; Heart Transplantation; Heart failure; Hemorrhage; Home environment; Human; Impairment; Implant; In Vitro; Incidence; International; Intervention; Investments; Lead; Left; Longevity; Magnetism; Mechanics; Medical; Modernization; Operative Surgical Procedures; Organ Donor; Pathway interactions; Patient-Focused Outcomes; Patients; Performance; Pharmacotherapy; Phase; Physiological; Population; Privatization; Procedures; Process; Pulmonary Circulation; Pump; Quality of life; Reporting; Reproducibility; Role; Safety; Small Business Innovation Research Grant; Speed; System; Technology; Thrombosis; Time; Transplantation; United States; United States National Institutes of Health; Validation; Ventricular; Woman; base; biomaterial compatibility; blood pump; commercial application; commercialization; cost; cost effective; course development; design; implantation; improved; in vivo; innovation; left ventricular assist device; manufacturing process; men; patient population; practical application; product development; research and development; response; seal; success; total artificial heart; ventricular assist device

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.

摘要/摘要 心力衰竭（HF）是一种毁灭性疾病，影响了全球超过2000万患者，其中570万 美国人每年发生870,000例新病例。心脏移植提供了最好的治疗选择 这些患者中有许多人每年在全球范围内进行少于4200次心脏移植。此外，当前增长率 预测到2030年HF的发病率将增加25％，预计每年69.7 b美元。美国国民 卫生研究院（NIH）估计，有100,000名患者可以立即从机械循环支持中受益 （MC）。严重心力衰竭的患者没有干预，外观不佳。药物治疗不是有效的 选项，供体心脏的有限可用性表明，此时唯一可行的替代方案是MC。 心室辅助设备（VAD）和总人工心脏（TAH）是手术上的机械泵 与严重HF患者的心脏并植入或替代，以恢复足够的血流。 该领域的技术进步已经解决了与孤立左心室HF相关的许多问题，从而导致 许多左心室辅助设备（LVADS）的商业化。但是，多达30％的HF患者患有 双室HF，或在LVAD植入后发展。这需要消除心脏和植入 tah或右心旁边的第二个vad植入以提供双室援助（Bivad）。 但是，由于担心 关于耐用性和不良事件。 Bivacor设备有望利用这一市场差距。 双子tah使用与现代成功的LVAD相同的方法，该方法基于旋转血液 带有磁性转子的泵（RBP）技术，并将其应用于同时，可靠且可靠 生物相容性支持全身和肺循环。该设备的概念已经进步 可行性I阶段通过私人资助来源，现在正在进入II阶段。因此，这个sbir 提案是针对II阶段申请的目标，其以下特定目的（1） 控制算法以恢复脉动和流出适应，（2）完善可植入组件的设计 实现优化的人类解剖拟合，（3）在设计控件下构建密封的密封设备，以及（4） 在体外和慢性体内对过程的验证和设备功能的验证。达成这些里程碑 将导致设计冻结，同时展示该产品的临床实用性，从而提高 技术，从而鼓励进入第三阶段商业化所需的额外投资。 长期实际的机械替代者对男性，女人和儿童的人心脏的影响 会很棒。患者不再需要等待心脏移植才能恢复质量大大提高 生活。将成功的耐用性和相似VAD技术的较小尺寸纳入双向tah 提供了一个明确的途径，以实现实际替代失败的人心的目标。