A universal TET system for implanted life support systems

用于植入生命支持系统的通用 TET 系统

• 批准号: 7690308
• 负责人: HONG ZHANG
• 金额: $ 52.32万
• 依托单位: ABIOMED, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7690308
• 关键词: Architecture; Cannulas; Cells; Charge; Chemistry; Clinical; Conduct Clinical Trials; Coupling; Development; Devices; Early treatment; Electronics; Energy Transfer; Equipment; FDA approved; Funding; Generations; Heart; Heart failure; Implant; In Vitro; Infection; Life Cycle Stages; Life Support Systems; Lithium; Manufacturer Name; Mechanics; Morbidity - disease rate; Patients; Performance; Phase; Public Health; Quality of life; Research; Risk; Running; Safety; Scheme; Site; Skin; Staging; Support System; System; Technology; Testing; Tetanus Helper Peptide; analog; base; biomaterial compatibility; blood pump; commercialization; design; digital; flexibility; improved; in vivo; innovation; mortality; next generation; novel; programs; solid state; success; therapy development; total artificial heart; transmission process

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.

描述（由申请人提供）：该提议的程序的最终目标是具有高性能植入电池的通用经皮转移（TET）系统的商业化。该集成的电源系统将适应许多下一代完全可植入的机械循环支持（MCS）系统。迄今为止，完全植入的系统（即植入电动MCS系统和允许整个完整皮肤的电力传递的TET系统的组合）似乎是消除完全出口现场感染风险的最有希望的方法。如今，大多数临床使用中的MCS系统都需要插管（如果血泵是体外的）或驱动线（如果血泵是体内的）才能越过患者的皮肤。有了这样的经皮设计，出口部位的感染是患者长期治疗期间发病率和死亡率的主要原因。在该计划的第一阶段，证明了数字耐故障TET系统的可行性。使用数字电路重新设计了用于FDA批准的Abiocor植入式替代心脏的Abiomed模拟TET系统，可增强耐受性的耐受性，并重新配置以改进空间耦合。对植入的TET（ITET）和外部TET（ETET）电子产品的数字版本进行了原型和测试。然后选择首选的TET配置作为II期计划的基础。在拟议的II期计划下，Abiomed的关键创新将是通用TET系统，该系统与具有很高容量（60 WH）和循环寿命（> 1,000充电/放电周期）的可植入电池组集成。将采用数字耐故障的TET架构和新型的固态锂电池化学。作为原始设备制造商（OEM）产品出售，这种灵活的电力系统将通过许多MCS系统将完全植入技术的生存和生活质量带给增加患者的生存和质量。在持续计划下，通用TET系统的设计和可行性测试将完成。根据我们II阶段计划的成功，私人资金将在预期通用TET产品的商业推出中实现进一步的开发和设计资格活动。 Abiomed将与至少一家公司合作，将通用TET系统集成到合作伙伴的MCS系统中；将通用TET系统转移到为合作伙伴制造和生产临床单位；并在合作伙伴完成系统级安全与合规性测试，进行临床试验并寻求其MCS系统的监管批准时提供技术支持。公共卫生叙事：为植入式机械循环支持（MCS）系统供电的现有方案构成了有线出口地点感染的风险，尤其是在长期使用期间。经经皮输送（TET）系统通过在完整的皮肤上传递电力来降低这种风险，但是该技术尚未广泛使用。这项研究中提出的通用TET系统和高性能植入电池将提供通用的，高度可靠的方法，可以为许多下一代MCSS提供动力。因此，这款原始设备制造商（OEM）产品既可以提高患者生活质量，又可以增强MCS技术的长期应用商业化。