SBIR Phase II: Wirelessly Operated Implantable Micropump for On-demand Drug Administration in Laboratory Animals

SBIR 第二阶段：用于实验动物按需给药的无线操作植入式微型泵

• 批准号: 1353643
• 负责人: Tuan Hoang
• 金额: $ 75万
• 依托单位: Fluid Synchrony, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1353643&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Wirelessly; Operated

This Small Business Innovation Research (SBIR) Phase II project couples the precision of microtechnology with low-power microfluidics to realize a fully-implantable micropump specifically tailored for drug delivery applications in rodents. Currently, drug administration is predominantly conducted by manual handling and needle injection which is labor-intensive, induces stress and other ?white-coat? effects and is limited to simple drug release profiles. There is a need for advanced drug administration capability in animals that enables new complex dosing profiles, provides automation for chronic studies, and improves scientific validity. Technical challenges include the development of a low-power inductively-powered pump actuator, ten-fold pump miniaturization and wireless control of a large number of implanted pumps. The research objectives are (1) to optimize pump performance and usability (2) to extend cage size compatibility and connectivity (3) to optimize software usability (4) to optimize system design and establish quality assurance processes for scale-up and (5) to conduct an in-vivo validation study. Successful demonstration of the remotely-controlled implantable infusion pump system will enable new dosing schemes, provide precise temporally controlled dosing for more reproducible results from acute and chronic studies, and enable new approaches to drug therapy that would not otherwise be possible. The broader impact/commercial potential of this project lies in uniquely improving scientific outcomes and facilitating the drug development/discovery process. Currently, only one in 10,000 drug candidates successfully attain FDA approval with a significant number of candidates failing or discarded due to inadequate drug administration. Rapid and accurate evaluation of efficacy, safety and toxicity early in the drug development process is improved through the fully automated, wirelessly-controlled drug dosing technology supported by this Phase II project. This project targets the international laboratory animal market estimated at $3.4B in 2012. Animal models are employed throughout the drug development pipeline and in particular, rodents are critical to drug candidate target validation, screening, and optimization. Included in this effort are several significant first-to-market capabilities such as chronic dosing capability in freely-moving, tether-free mice and high-throughput evaluation of multiple new drugs through automation. The controlled delivery of agents, including emerging biologics, siRNA, peptides, and small molecules, is an important capability in a multitude of clinical and preclinical research applications including neuroscience, pharmacology, toxicology, and physiology. More importantly, this project will enable drug studies that to be performed in a manner that will facilitate and enhance the translation of candidate therapies from animal to human.

这个小型企业创新研究（SBIR）第二阶段项目将微技术的精度与低功耗微流体技术相结合，以实现专为啮齿动物药物输送应用量身定制的完全植入式微泵。目前，给药主要通过手工操作和针头注射进行，这是劳动密集型的，会产生压力等。白大褂影响，并限于简单的药物释放曲线。需要先进的动物给药能力，以实现新的复杂给药曲线，为慢性研究提供自动化，并提高科学有效性。技术挑战包括开发低功率感应供电泵致动器、泵小型化十倍以及大量植入泵的无线控制。研究目标是（1）优化泵性能和可用性（2）扩展融合器尺寸兼容性和连通性（3）优化软件可用性（4）优化系统设计并建立质量保证过程以扩大规模和（5）进行体内确认研究。 遥控植入式输注泵系统的成功演示将实现新的给药方案，提供精确的时间控制给药，以获得急性和慢性研究的更可重现的结果，并实现否则不可能的药物治疗新方法。该项目更广泛的影响/商业潜力在于独特地改善科学成果和促进药物开发/发现过程。目前，只有万分之一的候选药物成功获得FDA批准，大量候选药物由于药物管理不当而失败或被丢弃。 通过该II期项目支持的全自动、无线控制药物给药技术，可以在药物开发过程的早期快速准确地评估疗效、安全性和毒性。 该项目的目标是2012年估计为34亿美元的国际实验动物市场。动物模型在整个药物开发管道中使用，特别是啮齿动物对候选药物靶标验证，筛选和优化至关重要。这项工作包括几个重要的首次上市能力，例如自由移动、无栓系小鼠的长期给药能力，以及通过自动化对多种新药进行高通量评估。包括新兴生物制剂、siRNA、肽和小分子在内的药剂的受控递送是包括神经科学、药理学、毒理学和生理学在内的多种临床和临床前研究应用中的重要能力。更重要的是，该项目将使药物研究能够以促进和增强候选疗法从动物到人类的转化的方式进行。