Leadless Pacemaker Betavoltaic Power Source

无引线起搏器 Betavolta 电源

• 批准号: 10741913
• 负责人: Peter Cabauy
• 金额: $ 3.42万
• 依托单位: CITY LABS, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10741913
• 关键词: Address; Carbon; Cardiac pacemaker; Cells; Certification; Chemicals; Cities; Data; Devices; Electrons; Film; Goals; Head; Implant; Joints; Life; Lithium; Longevity; Mainstreaming; Manufacturer; Marketing; Metals; National Heart, Lung, and Blood Institute; Output; Pacemakers; Patients; Performance; Phase; Photons; Power Sources; Radioisotopes; Semiconductors; Small Business Innovation Research Grant; System; Technology; Testing; Tritium; Venous; battery size; cardiac pacing; density; energy density; heart rhythm; medical implant; minimally invasive; operation; patient population; seal; solid state

PROJECT ABSTRACT Leadless cardiac pacemakers (LCPs) represent a revolutionary leap forward in cardiac pacing technology because they circumvent transvenous leads. The current size of lithium-carbon mono-fluoride (Li/CFX) batteries results in an overall LCP device size of ~1 cc, and which only has a 10-year lifetime. LCPs are currently limited to single-chamber pacing, representing only 10-20% of current pacemaker users. To achieve dual-chamber and multi-chamber leadless pacing, a size reduction of the LCP is required. However, smaller batteries are required to shrink the LCP. This Phase 2 effort will result in a betavoltaic battery for LCPs that is one-sixth the size of Li/CFX batteries, enabling LCPs with a size of less than half the current LCP. Additionally, this new battery technology will have greater than twice the energy capacity compared to Li/CFX batteries, and also will have double the LCP lifespan, to a 20-year lifetime. This size reduction and increased longevity will allow for 2-3 implants over a patient’s lifetime, with minimal invasive overhead, facilitating mainstream use of LCPs, while challenging traditional pacemakers. Dual or multi-chamber LCPs will dramatically increase the use of LCPs but will require a ~0.1cc battery providing a consistent ≥3.8 microwatts for 20 years. Chemical-based batteries do not have the energy density or reliability to meet this requirement, which the City Labs NanoTritiumTM betavoltaic medical implant battery will effectively address. In Phase 2 the construction of the LCP betavoltaic battery will comprise stacking ultrathin III-V betavoltaic cells that utilize a new, high beta-flux, tritium metal hydride film. The betavoltaic battery will be ~0.1 cc with ≥14.9 microwatts power at beginning-oflife and have a 20-year projected life at ≥ 3.8 microwatts. Phase 1 data shows that the target power density for a ~ 0.1 cc LCP battery will be reached, resulting in a power density sufficient to meet pacemaker manufacturers’ performance goals, resulting in continuous power output for 20 years within a ~0.1 cc formfactor. Tritium betavoltaic technology is a solid- state power source that does not lose energy density with decreasing size, which occurs with lithium batteries. Its principles of operation are similar to a solar cell, but in place of photons impinging on the semiconductor cell, the electrons from the radioisotope’s beta decay are utilized. In the NHLBI SBIR Phase 2, City Labs will construct a tritium betavoltaic battery consisting of ultra-thin stacked betavoltaic cell layers in a cylindrical form factor for easy insertion into a leadless pacemaker package and deliver it to a pacemaker manufacturer to assess overall system performance. Post Phase 2, integrated FDA testing and certification of the joint LCP and betavoltaic will be performed by the pacemaker manufacturer through a Premarket Approval. A bioinert package with electrical feedthroughs will be constructed. Packaging of the cell stack, sealing, and electrical/regulatory testing will be performed. Milestone: Delivery of the betavoltaic within a ~0.1cc package to pacemaker manufacturer for testing and inclusion into a leadless pacemaker.

项目摘要 无铅心脏起搏器（LCP）代表心脏起搏技术的革命性飞跃 因为它们绕过透性引线。锂碳单氟化物（LI/CFX）电池的当前大小 总体LCP设备大小约为1 cc，并且只有10年的寿命。 LCP当前有限 单室起搏，仅占目前的起搏器用户的10-20％。实现双室和 多室无铅步调，需要降低LCP的尺寸。但是，需要较小的电池 收缩LCP。这阶段2的工作将导致LCP的Betavoltaic电池，这是六分之一的大小 LI/CFX电池，使LCP的大小小于当前LCP的一半。此外，这个新电池 与LI/CFX电池相比，技术的能源容量将大于两倍以上，并且还将具有 double the LCP lifespan, to a 20-year lifetime.这种尺寸降低和寿命增加将允许2-3 植入患者一生中的植入物，具有最小的侵入性开销，支持主流使用LCP，而 挑战传统的起搏器。双重或多室LCP会大大增加LCP的使用，但 将需要一个〜0.1cc的电池，可提供20年的一致性≥3.8微米。基于化学的电池可以 没有能量密度或可靠性来满足这一要求，该城市实验室纳米三位生 医疗植入物电池将有效解决。在第2阶段，LCP Betavoltaic电池的构建将 包括使用新的，高β-频率的金属氢化物膜的堆叠超薄III-V betavoltaic细胞。这 betavoltaic电池将〜0.1 cc，≥14.9microwatts Power在开始生命时的功率为20年 ≥3.8microwatts的寿命。第1阶段数据显示，A 〜0.1 cc LCP电池的目标功率密度将是 到达，导致功率密度足以满足起搏器制造商的性能目标，从而 在〜0.1 cc FormFactor中连续功率输出20年。 tritium betavoltaic技术是一种固体 state power source that does not lose energy density with decreasing size, which occurs with lithium batteries. 它的操作原理类似于太阳能电池，但代替撞击半导体电池的照片， 利用了放射性同位素β衰变的电子。在NHLBI SBIR第2阶段，城市实验室将构建 tritium betavoltaic电池，由圆柱形形式的超薄堆积的betavoltaic层层组成 轻松插入无铅的太空人包装，并将其交付给空间制造商以评估总体 系统性能。第2阶段，联合LCP和BETAVOLTAIC的集成FDA测试和认证将 由起搏器制造商通过预上市批准进行。带电气的生物渗透包 将构建进料。细胞堆的包装，密封和电气/调节测试将是 执行。里程碑：在一个〜0.1cc套件中向起搏器制造商进行测试的betavoltaic 并加入一个无领先的太空人。