RAIL reduces variability and concentration of stress hormones in blood sampling

描述（由申请人提供）：在这个II期SBIR中，Actuated Medical, Inc. （f/k/a Piezo Resonance Innovations, Inc）将完成共振辅助插入针（RAIL”）系统的开发，以减少实验动物血液采样期间动物的疼痛和应激反应。公共卫生问题：了解衰老的生理和生物学机制是许多研究的焦点。纵向啮齿动物研究为一般衰老过程和与年龄相关的主题（如营养、行为、免疫学、癌症和神经生物学）提供了重要的见解。为了避免应激激素升高影响血液化学的问题，通常进行横断面研究。这些研究需要在每个时间点使用许多动物，这不仅在动物使用和成本方面昂贵，而且限制了因果关系的研究。新的最小干扰的血液采样策略是非常需要的，以便在整个生命周期内进行连续的血液采样。第一阶段成功开发了Alpha原型，满足了特定目标，并证明RAIL设备将插入力减少了68%。使用RAIL原型获得的血液样本的皮质酮水平平均降低了60%。测量的平均方差减少了71%。由9位动物研究科学家和兽医组成的焦点小组对铁路的反应非常积极。第二阶段将开发一种商业上可行的设备，以最大限度地减少动物在连续血液样本中的压力，改善研究结果并消除对横断面研究的需要。第二阶段假设：在24个月的小鼠纵向重复采样研究中，与非振动静脉穿刺相比，使用RAIL装置进行振动静脉穿刺将使血浆皮质酮水平降低60% ~ 10%，变异性降低60% ~ 10% （p<0.05）。第二阶段具体目标：证明RAIL装置在小鼠中提供与先前在大鼠中看到的类似的皮质酮释放减少。2. 证明RAIL装置广泛适用于在其他解剖部位取样的血液中降低皮质酮水平。3. 量化RAIL装置在整个生命周期的连续血液采样实验中的性能优势（小鼠24个月研究）。4. 完成设备设计并制造60台，经过测试并准备投放市场。

DESCRIPTION (provided by applicant): In this Phase II SBIR, Actuated Medical, Inc. (f/k/a Piezo Resonance Innovations, Inc) will complete the development of the Resonance Assisted Insertion Lancet (RAIL") System to reduce animal pain and stress response during laboratory animal blood sampling. Public Health Problem: Understanding the physiological and biological mechanisms of aging is the focus of much research. Longitudinal rodent studies provide significant insights into the general aging process and age-related topics such as nutrition, behavior, immunology, cancer, and neurobiology. To avoid the problem of elevated stress hormones influencing blood chemistry, cross-sectional studies are often performed. These studies require many animals for each time-point, which is not only expensive in terms of animal use and cost, but limits the study of cause/effect relationships. New minimally-perturbing blood sampling strategies are highly desired to enable serial blood sampling over the lifespan. Phase I successfully developed Alpha prototypes, met the Specific Aims, and demonstrated that the RAIL device reduced insertion force by up to 68%. Blood samples obtained with the RAIL prototype had on average a 60% reduction in corticosterone level. The average variance in measurements was reduced by 71%. Response to the RAIL, from a focus group of nine (9) animal research scientists and veterinarians, was highly positive. Phase II will develop a commercially viable device that minimizes animal stress during serial blood samples, improving study results and eliminating the need for cross-sectional studies. Phase II Hypothesis: Vibrated venipuncture with RAIL device will reduce plasma corticosterone level by 60% ¿ 10% with decreased variability by 60% ¿ 10% compared to non-vibrated venipuncture in a 24-month longitudinal repeat sampling study in mice (p<0.05). Phase II Specific Aims: 1. Demonstrate that RAIL device offers similar reduction of corticosterone release in mice as that seen previously in rats. 2. Demonstrate widespread applicability of RAIL device to lower corticosterone levels in blood sampled at alternate anatomic locations. 3. Quantify the performance advantage of RAIL device in serial blood sampling experiment over the lifespan (24 Month Study in Mice). 4. Finalize device design and build 60 units, tested and ready for market release.