Leadless Pacemaker Betavoltaic Power Source

项目摘要 无铅心脏起搏器代表着心脏起搏技术的革命性飞跃。 因为他们绕过了静脉引线。目前锂-一氟化碳(Li/CFX)电池的尺寸 导致总LCP器件大小约为1毫升，并且只有10年的寿命。LCP目前是有限的 到单腔起搏，仅占当前起搏器用户的10%-20%。要实现双室和双室 多腔无铅起搏，需要缩小LCP的尺寸。然而，需要较小的电池 以缩小LCP。这项第二阶段的工作将产生一种用于LCP的Betavoltaic电池，其尺寸是 Li/CFX电池，使LCP的尺寸不到当前LCP的一半。此外，这款新电池 与Li/CFX电池相比，技术将拥有两倍以上的能量容量，并且 LCP寿命增加一倍，达到20年。这种尺寸的缩小和寿命的增加将允许2-3 以最小的侵入性开销在患者的一生中植入，促进LCP的主流使用，同时 挑战传统起搏器。双室或多室LCP将显著增加LCP的使用，但 将需要一个~0.1cc的电池，提供持续20年的≥3.8微瓦。基于化学物质的电池可以 没有满足这一要求的能量密度或可靠性，城市实验室NanoTritiumTM Betavoltaic 医用植入式电池将有效解决。在第二阶段，LCP Betavavtaic电池的建造将 包括堆叠超薄III-V Betavoltaic电池，该电池利用一种新的高β通量的氚金属氢化物薄膜。这个 Betavavtaic电池在使用初期将为约0.1cc，≥为14.9微瓦，预计使用20年 ≥3.8微瓦的寿命。第一阶段数据显示，~0.1cc LCP电池的目标功率密度将为 达到，导致功率密度足以满足起搏器制造商的性能目标，从而 在20年的连续功率输出中，外形因数为~0.1毫升。氚Betavoltaic技术是一种固体- 国家电源，不会随着尺寸的减小而损失能量密度，锂电池会发生这种情况。 它的工作原理类似于太阳能电池，但代替了光子撞击半导体电池， 放射性同位素的β衰变产生的电子被利用了。在NHLBI SBIR第二阶段，城市实验室将构建 一种氚贝塔伏安电池，由超薄堆叠的贝塔伏安电池层组成，形状因数为圆柱形，用于 轻松插入到无铅起搏器包装中，并将其交付给起搏器制造商进行全面评估 系统性能。第二阶段后，FDA对LCP和Betavoltaic联合遗嘱进行综合测试和认证 由起搏器制造商通过上市前批准进行。一种生物惰性包装，带有电子设备 将建造馈通通道。电池组的包装、密封和电气/监管测试将 已执行。里程碑：将~0.1cc包装的Betavoltaic交付给起搏器制造商进行测试 并包含在无铅起搏器中。

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.