Leadless Pacemaker Betavoltaic Power Source

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。一氟化碳锂（Li/CFX）的电流大小 电池导致LCP器械的整体尺寸约为1 cc，寿命仅为10年。lcp是 目前仅限于单腔起搏，仅占目前起搏器使用者的10 - 20%。实现 双腔和多腔无导线起搏，需要减小LCP的尺寸。然而，较小 需要电池来缩小LCP。第二阶段的工作将产生用于LCP的β伏打电池， 尺寸是Li/CFX电池的六分之一，使LCP的尺寸不到当前LCP的一半。此外，本发明还 与Li/CFX电池相比，这种新电池技术的能量容量将超过两倍， LCP的使用寿命也将增加一倍，达到20年。这种尺寸的减小和寿命的延长将 允许在患者的一生中进行2 - 3次植入，具有最小的侵入性开销，促进主流使用 LCP，同时挑战传统起搏器。双腔或多腔LCP将显著增加 但需要约0.1cc的电池提供20年一致的≥ 3.8微瓦。基于化学 电池没有能量密度或可靠性来满足这一要求，城市实验室 NanoTritiumTM betavoltaic医用植入电池将有效解决.在第二阶段， LCP β伏打电池将包括堆叠的III-V β伏打电池，其利用新的高β通量， 氚金属氢化物薄膜β伏打电池将为~0.1 cc，功率≥ 14.9微瓦， 寿命，并在≥ 3.8微瓦时具有20年的预期寿命。阶段1数据显示， 将达到约0.1 cc LCP电池，导致功率密度足以满足起搏器 制造商的性能目标，导致在约0.1 cc的形式下连续输出功率20年- 因子氚β伏打技术是一种固态电源， 减小尺寸，这发生在锂电池上。它的工作原理类似于太阳能电池，但在 在光子撞击半导体电池的地方，来自放射性同位素的β衰变的电子被 利用。在NHLBI SBIR第2阶段，城市实验室将建造一个氚β伏打电池， 易于插入无引线起搏器封装的圆柱形形状因子的堆叠β伏打电池层 并将其交付给起搏器制造商以评估整体系统性能。第2阶段后，综合 起搏器制造商将对LCP和Betavoltaic联合器械进行FDA测试和认证 通过上市前批准。将建造一个带有电馈电线的生物惰性包。包装 将进行电池堆的密封和电气/法规测试。里程碑：交付 将约0.1cc包装内的β伏打电压提供给起搏器制造商进行测试，并纳入无导线 起搏器

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-of- life 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 form- factor. 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.