Development of a Low-Profile Dual Hormone Patch Pump with Novel Occlusion Sensor

开发带有新型闭塞传感器的薄型双激素贴片泵

• 批准号: 9788425
• 负责人: Forrest Payne
• 金额: $ 64.86万
• 依托单位: SFC FLUIDICS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788425
• 关键词: Adolescent; Algorithms; Artificial Pancreas; Biocompatible Materials; Blood Glucose; Bluetooth; Cannulas; Child; Development; Devices; Dose; Drug Carriers; Drug Contamination; Drug Delivery Systems; Drug Formulations; Dyes; Electronics; Ensure; Evaluation; FDA approved; Failure; Family suidae; Formulation; Glucagon; Goals; Government; Guidelines; Hand; Hormones; Hour; Hypoglycemia; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Liquid substance; Manuals; Manufacturer Name; Measurement; Measures; Mechanics; Methods; Persons; Pharmaceutical Preparations; Phase; Power Sources; Production; Protocols documentation; Pump; Safety; Series; Syringes; System; Techniques; Testing; Update; Wireless Technology; Work; biomaterial compatibility; cost; design; glucose monitor; glycemic control; improved; in vitro testing; manufacturability; meetings; microfluidic technology; next generation; novel; prototype; response; sensor

Development of a Low-Profile Dual Hormone Patch Pump with Novel Occlusion Sensor Project Summary: The Specific Aim of this project is to develop a discrete, low-profile, dual hormone drug delivery system using SFC Fluidics’ enabling microfluidic technologies. A DualPump™ will be developed in which one proprietary ePump® body will independently and accurately deliver both insulin and glucagon from two separate reservoirs. Latching safety valve sets will independently and safely control the delivery of each hormone and a dispense confirmation sensor will notify the user of any dosing errors resulting from occlusions or electrical/mechanical failures. Phase II will see the integration of all components into an accurate, discrete, low-profile wearable pod, extensive benchtop testing and initial testing in swine. The end goal of Phase II is production of a DualPump module that has been introduced to the FDA and is ready to be integrated with all other components required for a dual hormone artificial pancreas. During Phase IIB, SFC Fluidics will work with manufacturers of continuous glucose monitors, control algorithms and stable drug formulations to develop an FDA-approved, robust, and reliable dual hormone artificial pancreas.

薄型双激素贴片泵的研制 新型阻塞传感器 项目概要： 该项目的具体目标是开发一种离散的，低调的，双激素药物 使用SFC Fluidics的微流控技术的输送系统。DualPump™将 一个专有的ePump®机构将独立和准确地提供 胰岛素和胰高血糖素。闭锁式安全阀组将独立 并安全地控制每种激素的输送， 用户因堵塞或电气/机械故障而导致的任何剂量错误。相 II将看到所有组件集成到一个准确的，离散的，低姿态的可穿戴吊舱， 广泛的实验室试验和猪的初步试验。第二阶段的最终目标是生产 DualPump模块已被引入FDA，并准备与所有 双激素人工胰腺所需的其他成分。在IIB期，SFC Fluidics将与连续葡萄糖监测仪、控制算法和 稳定的药物配方，以开发FDA批准的，强大的，可靠的双重激素 人工胰腺