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）：本拟定项目的最终目标是将带有高性能植入式电池的通用经皮能量传输（泰特）系统商业化。该集成电源系统将适用于下一代完全植入式机械循环支持（MCS）系统。到目前为止，完全植入式系统（即植入式电动MCS系统和泰特系统的组合，允许通过完整皮肤进行电力传输）似乎是完全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）或传动线（如果血泵是颅内的）穿过患者皮肤。对于这种经皮设计，出口部位的感染是患者长期管理期间发病率和死亡率的主要原因。在第一阶段的计划，数字，容错泰特系统的可行性进行了论证。Abiomed的模拟泰特系统用于FDA批准的Abiocor植入式置换心脏，使用数字电路进行了重新设计，增强了容错能力，并重新配置以改善空间耦合。对植入式泰特（i泰特）和外部泰特（e泰特）电子器件的数字版本进行原型制作和测试。然后选择首选的泰特配置作为II期项目的基础。根据拟议的第二阶段计划，Abiomed的关键创新将是一个通用的泰特系统，与具有非常高的容量（60 Wh）和循环寿命（>1,000次充电/放电循环）的植入式电池组集成。将采用数字容错泰特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，这种灵活的电源系统将通过一系列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优势。在后续计划中，将完成通用泰特系统的设计和可行性测试。基于我们的第二阶段计划的成功，私人资金将使进一步的开发和设计资格活动，预期商业推出的通用泰特产品。Abiomed将与至少一家其他公司合作，将通用泰特系统集成到合作伙伴的MCS系统中;将通用泰特系统转移到制造业，并为合作伙伴生产临床单元;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：用于为可植入机械循环支持（MCS）系统供电的现有方案在电缆出口部位处造成感染的风险，特别是在长期使用期间。经皮能量传输（泰特）系统通过在完整皮肤上输送电力来降低这种风险，但是该技术尚未得到广泛使用。本研究中提出的通用泰特系统和高性能植入式电池将为下一代MCSS的主机提供通用的、高度可靠的供电方式。因此，这种原始设备制造商（OEM）产品将改善患者的生活质量，并增强MCS技术的商业化，以实现长期应用。