Miniature External Components for CircuLite's Pediatric Circulatory Support Syste

用于 CircuLite 儿科循环支持系统的微型外部组件

• 批准号: 8525131
• 负责人: ARIELLE DRUMMOND
• 金额: $ 49.23万
• 依托单位: CIRCULITE, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-25 至 2014-04-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8525131
• 关键词: Adolescent; Adult; Animal Model; Animals; Area; Cardiovascular Diseases; Cardiovascular system; Child; Childhood; Computer software; Coupled; Data; Development; Electromagnetics; Emergency Situation; Feedback; Goals; Heart; Human; In Vitro; Infant; Legal patent; Mechanics; Medical Device; Methods; Minor; Modification; Monitor; Motor; Movement; Patients; Phase; Phase I Clinical Trials; Process; Pump; Secure; Small Business Innovation Research Grant; Software Validation; Specific qualifier value; Stress Tests; Support System; System; Testing; Transplantation; United States; Work; base; design; hazard; in vitro testing; in vivo; miniaturize; novel; operation; preference; prevent; programs; prototype; public health relevance; research study

DESCRIPTION (provided by applicant): Project Summary Development towards treating small children and infants with mechanical circulatory support systems to bridge to transplant purposes is underway. However, implantable systems with miniaturized external components have delayed the process. To date, the need for mechanical circulatory support systems for infant and children with congenital and acquired cardiovascular disease has largely been unmet. In the United States, hundreds of infant and children die each year while waiting for a donor heart. The goal of this "Fast Track" SBIR application is to develop a miniaturized controller module and other external components for both CircuLite's Infant and Child Circulatory Support Systems. Leveraging our proprietary and patented adult Synergy external components, refinements to the software and hardware will be made to produce miniature components for infants and small children. The goal of the Phase I project is to demonstrate the feasibility of modifying the current software and hardware used for the Synergy patient controller to provide fail - safe redundant operating mode. In Phase II, the software and hardware will be integrated to complete a miniaturized beta prototype of the pediatric controller. Additionally, the accessory components will be designed and fabricated to aid in patient mobility while supported by the systems. The milestones for Phase I will be the delivery of an alpha prototype of the fail - safe pediatric controller. In Phase II, we will deliver a miniature beta prototype of the controller, complete a human factors study and test the complete Child System in short-term animal studies to assess the functionality and durability of the newly integrated system.

描述（由申请人提供）：项目概要开发正在进行中，旨在用机械循环支持系统治疗幼儿和婴儿，以达到移植目的。然而，具有小型化外部组件的植入式系统延迟了这一过程。迄今为止，患有先天性和获得性心血管疾病的婴儿和儿童对机械循环支持系统的需求在很大程度上尚未得到满足。在美国，每年有数百名婴儿和儿童在等待捐赠心脏时死亡。这一“快速通道”SBIR应用的目标是为CircuLite的婴儿和儿童循环支持系统开发小型化控制器模块和其他外部组件。利用我们专有和专利的成人Synergy外部组件，将对软件和硬件进行改进，以生产婴儿和儿童的微型组件。第I阶段项目的目标是证明修改Synergy患者控制器所用的当前软件和硬件以提供故障安全冗余操作模式的可行性。在第二阶段，软件和硬件将被集成，以完成儿科控制器的小型化测试原型。此外，辅助组件的设计和制造将有助于患者在系统支持下移动。第一阶段的里程碑将是交付一个阿尔法原型的故障安全儿科控制器。在第二阶段，我们将提供控制器的微型测试原型，完成人为因素研究，并在短期动物研究中测试完整的儿童系统，以评估新集成系统的功能和耐用性。