Leadless Pacemaker Betavoltaic Power Source

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-一氟碳(Li/CFX)的大小 电池导致LCP器件的总尺寸为~1cc，并且只有10年的寿命。LCP是 目前仅限于单腔起搏，仅占目前起搏器用户的10%-20%。要实现 对于双腔和多腔无铅起搏，需要缩小LCP的尺寸。然而，较小的 需要电池来缩小LCP。这一第二阶段的努力将导致LCP的Betavoltaic电池 尺寸是锂/CFX电池的六分之一，使LCP的尺寸不到当前LCP的一半。另外， 这项新电池技术的能量容量将是Li/CFX电池的两倍以上，并且 还将使LCP的寿命翻一番，达到20年。这种尺寸的缩小和寿命的延长将 允许在患者一生中植入2-3个植入物，具有最小的侵入性开销，便于主流使用 LCPS，同时挑战传统的起搏器。双室或多室LCP将显著增加使用量 但将需要~0.1cc电池，在20年内提供稳定的≥3.8微瓦。以化学药品为主 电池没有足够的能量密度或可靠性来满足这一要求，而城市实验室 NanoTritiumTM Betavoltaic医疗植入电池将有效解决。在第二期，建造 LCP Betavoltaic电池将包括堆叠超薄III-V Betavoltaic电池，该电池利用新的高Beta-通量， 氚金属氢化物薄膜。Betavoltaic电池的功率为~0.1cc，≥为14.9微瓦。 寿命为20年，预计寿命为≥3.8毫瓦特。第一阶段数据显示，目标功率密度为 将达到约0.1cc的LCP电池，从而产生足以满足起搏器的功率密度 制造商的性能目标，导致在约0.1毫升的形式下连续输出功率20年- 因素。氚Betavoltaic技术是一种固态电源，不会损失能量密度 体积变小，这发生在锂电池上。它的工作原理类似于太阳能电池，但在 光子撞击半导体单元的位置，放射性同位素的β衰变产生的电子是 被利用了。在NHLBI SBIR第二阶段，City Labs将建造一种由超薄 圆柱形状的堆叠的Betavoltaic细胞层，便于插入无铅起搏器组件中 并将其交付给起搏器制造商，以评估系统的整体性能。第二阶段后，集成 起搏器制造商将对LCP和Betavoltaic联合LCP进行FDA测试和认证 通过上市前的批准。将建造一个带有电气馈通的生物惰性组件。包装 将执行电池组、密封性和电气/调节测试。里程碑：交付 ~0.1cc包装内的Betavoltaic提供给起搏器制造商进行测试并纳入无铅 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.