A universal TET system for implanted life support systems

描述（由申请人提供）：这个拟议项目的最终目标是将具有高性能植入式电池的通用经皮能量转移（TET）系统商业化。这种集成动力系统将适应下一代全植入式机械循环支持（MCS）系统。迄今为止，完全植入式系统（即植入式电子MCS系统和TET系统的组合，允许电力在完整皮肤上传输）似乎是消除出口部位感染风险的最有希望的方法。目前临床使用的大多数MCS系统需要插管（如果血泵是体外的）或传动系统（如果血泵是体内的）穿过患者的皮肤。在这种经皮设计中，出口部位的感染是患者长期治疗中发病和死亡的主要原因。在项目的第一阶段，数字化、容错TET系统的可行性得到了验证。Abiomed用于fda批准的AbioCor植入式替代心脏的模拟TET系统使用数字电路进行了重新设计，增强了容错性，并重新配置以改善空间耦合。植入TET （iTET）和外部TET （eTET）电子设备的数字版本进行了原型和测试。然后选择了首选的TET配置作为第二阶段计划的基础。在拟议的II期项目中，Abiomed的关键创新将是通用TET系统，该系统集成了具有非常高容量（60 Wh）和循环寿命（1000次充放电循环）的植入式电池组。将采用数字化、容错的TET架构和新型固态锂电池化学。作为原始设备制造商（OEM）产品销售，这种灵活的电力系统将通过一系列MCS系统为越来越多的患者带来完全植入式技术的生存和生活质量效益。在持续的计划下，通用TET系统的设计和可行性测试将完成。基于我们第二阶段项目的成功，私人资金将支持进一步的开发和设计资格活动，以预期通用TET产品的商业推出。Abiomed将与至少一家其他公司合作，将通用TET系统集成到合作伙伴的MCS系统中；将通用TET系统转移到制造商并为合作伙伴生产临床单位；并在合作伙伴完成系统级安全性和合规性测试、进行临床试验并为其MCS系统寻求监管批准时提供技术支持。公共卫生叙述：现有的植入式机械循环支持（MCS）系统供电方案在电缆出口存在感染风险，特别是在长期使用期间。经皮能量传输（TET）系统通过在完整的皮肤上传输电力来降低这种风险，但这项技术尚未得到广泛应用。本研究提出的通用TET系统和高性能植入式电池将为下一代mcss提供一种通用的、高度可靠的供电方式。因此，这种原始设备制造商（OEM）产品既可以改善患者的生活质量，又可以促进MCS技术的长期应用商业化。

DESCRIPTION (provided by applicant): The ultimate objective of this proposed program is the commercialization of a universal transcutaneous energy transfer (TET) system with a high performance implantable battery. This integrated power system will be adaptable to a host of next generation fully implantable mechanical circulatory support (MCS) systems. To date, fully implantable systems (i.e. the combination of an implantable electric MCS system and a TET system allowing electrical power transfer across the intact skin) appear to be the most promising approach to eliminating the risk of exit site infection altogether. Most MCS systems in clinical use today require either cannulae (if the blood pump is extracorporeal) or drivelines (if the blood pump is intracorporeal) to cross the patient's skin. With such percutaneous designs, infection at the exit site is a primary cause of morbidity and mortality during long term management of patients. Under Phase I of the program, the feasibility of the digital, fault-tolerant TET system was demonstrated. Abiomed's analog TET system for the FDA-approved AbioCor Implantable Replacement Heart was redesigned using digital circuits, enhanced for fault-tolerance, and reconfigured for improved spatial coupling. Digital versions of both the implanted TET (iTET) and external TET (eTET) electronics were prototyped and tested. A preferred TET configuration was then selected as the basis for the Phase II program. Under the proposed Phase II program, Abiomed's key innovation will be a universal TET system, integrated with an implantable battery pack having very high capacity (60 Wh) and cycle life (>1,000 charge/discharge cycles). A digital, fault-tolerant TET architecture and novel solid state lithium battery chemistry will be employed. Sold as an original equipment manufacturer (OEM) product, this flexible power system will bring the survival and quality of life benefits of fully implantable technology to an increased number of patients through a host of MCS systems. Under the continued program, the design and feasibility testing of the universal TET system will be completed. Based on the success of our Phase II program, private funding would enable further development and design qualification activities in anticipation of commercial launch of the universal TET product. Abiomed would partner with at least one other company to integrate the universal TET system into the partner's MCS system; transfer the universal TET system to manufacturing and produce clinical units for the partner; and provide technical support while the partner completes system-level safety & compliance testing, conducts clinical trials, and seeks regulatory approval for its MCS system. PUBLIC HEALTH NARRATIVE: Existing schemes for powering implantable mechanical circulatory support (MCS) systems pose the risk of infection at cable exit sites, particularly during long term use. Transcutaneous energy transmission (TET) systems reduce this risk by delivering electrical power across the intact skin, but this technology has not yet come into widespread use. The universal TET system and high performance implantable battery proposed in this research would offer a general purpose, highly reliable means of powering a host of next generation MCSSs. This original equipment manufacturer (OEM) product would therefore both improve patient quality-of-life and enhance commercialization of MCS technology for long term applications.