MINIATURE PROGRAMMABLE INFUSION SYSTEM FOR PEDIATRIC USE

儿科微型可编程输液系统

• 批准号: 6014722
• 负责人: Tomasz J Petelenz
• 金额: $ 12.62万
• 依托单位: STERLING RESEARCH CORPORATION
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-16 至 2002-05-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6014722
• 关键词: artificial endocrine pancreas; bioengineering /biomedical engineering; biomedical equipment development; computer program /software; computer system design /evaluation; dosage; drug delivery systems; injection /infusion; miniature biomedical equipment; pediatrics

The objective of this proposed effort is to provide pediatricians and neonatologists with a miniature, precision, programmable drug infusion system designed specifically for use in newborn and children. The system will facilitate pediatric infusion therapies, will be convenient and comfortable in use, and will reduce morbidity and mortality associated with dosing errors. In this effort, Sarcos proposes to adapt its MicroPiston pump technology to design, test, and commercialize a small size, lightweight, precise and programmable drug infusion system for administration of medications in newborn and pediatric patients, for hospital and home treatments. The system will also find applications in administration of anticoagulants, thrombolytics, insulin, pain control and protein-based medications. Proposed phased approach, based on the already existing Sarcos' proprietary micropiston technology, is cost effective and maximizes probability of successful outcome. In Phase I, detailed system specifications will be defined, adaptation of the core pumping units, development of a remote programmer and testing of the prototype infusion system prototype system will be accomplished. In subsequent Phase II, clinical studies, regulatory submission / clearance and pilot production will be completed, and system commercialization will be initialized. Development work and subsequent system evaluations and studies will be performed in close collaboration with clinicians. PROPOSED COMMERCIAL APPLICATIONS: When fully developed and commercialized, the pump will be used in both hospital and home settings for pediatric (including newborn) patients, as well as for other applications where precision, programmable parenteral administration of non-diluted (low volume) medications is desired, (continuous anticoagulation, thrombolysis, pain control, administration of protein drugs or releasing factors, or baseline and postprandial delivery of insulin in diabetic patients). 10-15% of all newborn in the United States (approx. 400,000 - 600,000 patients) require continuous coverage by neonatologist and they will be the primary candidates for the proposed system.

这项提议的努力的目的是为儿科医生和新生儿学家提供专门用于新生儿和儿童使用的微型，精确，可编程的药物输液系统。该系统将促进小儿输注疗法，使用方便且舒适，并降低与给药错误相关的发病率和死亡率。在这项工作中，Sarcos建议将其Micropiston Pump Technology调整，以设计，测试和商业化新生儿和儿科患者的药物治疗的小型，轻巧，精确和可编程药物输液系统，用于医院和家庭治疗。该系统还将在抗凝剂，溶栓，胰岛素，控制疼痛和基于蛋白质的药物的给药中找到应用。根据已经存在的Sarcos专有的Micropiston技术，提议的分阶段方法具有成本效益，并最大程度地提高了成功结果的可能性。在第一阶段，将定义详细的系统规范，核心泵单元的适应，开发远程程序员以及对原型输液系统原型系统的测试。在随后的第二阶段，将完成临床研究，监管提交 /清除和试点生产，并将初始化系统商业化。开发工作以及随后的系统评估和研究将与临床医生密切合作进行。拟议的商业应用：当充分发达和商业化时，该泵将用于儿科（包括新生儿）患者的医院和家庭环境，以及其他应用，在这些应用中，需要进行精确，可编程性肠胃外给药（低容量（低容量）药物（需要连续的抗凝药物，螺栓分解，螺栓分解，垂直溶栓，垂体，疼痛，疼痛，疼痛控制，蛋白质药物的疼痛或固定性因素或固定性因素和底线），或固定性因素和底线。美国新生儿（约400,000-600,000名患者）中有10-15％的新生儿需要持续覆盖新生儿学家，这将是拟议系统的主要候选人。