Leadless Pacemaker Betavoltaic Power Source

项目摘要 无导线心脏起搏器（LCP）代表了心脏起搏技术的革命性飞跃 因为它们绕过了经静脉电极导线。锂-碳一氟化物（Li/CFX）电池的当前尺寸 导致LCP器械的整体尺寸约为1 cc，寿命仅为10年。LCP目前有限 到单腔起搏，仅占目前起搏器使用者的10-20%。为了实现双腔和 多腔无导线起搏，需要减小LCP的尺寸。然而，需要更小的电池 来缩小LCP第二阶段的工作将为LCP生产一种β伏打电池，其尺寸是LCP的六分之一。 Li/CFX电池，使LCP的尺寸小于当前LCP的一半。此外，这款新电池 与Li/CFX电池相比，该技术的能量容量将增加两倍以上， LCP的使用寿命增加一倍，达到20年。这种尺寸减小和寿命延长将允许2-3 在患者的一生中植入，具有最小的侵入性开销，促进LCP的主流使用， 挑战传统起搏器。双腔或多腔LCP将显著增加LCP的使用， 将需要约0.1cc的电池提供20年的稳定≥3.8微瓦。化学电池 没有能量密度或可靠性，以满足这一要求，城市实验室NanoTritiumTM betavoltaic 医疗植入电池将有效解决。在第二阶段，LCP β伏打电池的建造将 包括堆叠使用新的、高β通量的氚金属氢化物膜的III-V β伏打电池。的 β-伏打电池在寿命延长时的功率约为0.1 cc，功率≥14.9微瓦，预计使用20年 寿命≥ 3.8微瓦。第1阶段数据显示，约0.1 cc LCP电池的目标功率密度为 达到，导致功率密度足以满足起搏器制造商的性能目标， 在约0.1 cc的外形尺寸内连续输出功率20年。氚电池技术是一种固体- 状态电源，不会随着尺寸的减小而损失能量密度，这发生在锂电池上。 它的工作原理类似于太阳能电池，但不是光子撞击半导体电池， 利用来自放射性同位素的β衰变的电子。在NHLBI SBIR第2阶段，城市实验室将构建 一种氚β伏打电池，由圆柱形形状因子的超薄堆叠β伏打电池层组成， 易于插入无导线起搏器包装，并将其交付给起搏器制造商，以进行整体评估 系统性能在第2阶段后，LCP和betavoltaic联合产品的FDA综合测试和认证将 由起搏器制造商通过上市前批准执行。一种生物惰性包装， 将建设饲料基地。电池堆的包装、密封和电气/监管测试将在 执行。里程碑：向起搏器制造商交付约0.1cc包装内的betavoltaic进行测试 并纳入无导线起搏器。

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.