Resonance Aided Insertion Lancet for serial blood sampling in age-related studies

描述(由申请人提供)：啮齿动物研究对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。在这样的研究中，激素、蛋白质、抗体和其他代谢物的浓度及其相关的动力学是受欢迎的生物标记物，因为它们随年龄和疾病状态而变化。通常，生化分析是在临时刺穿大的目标静脉后采集的血液样本上进行的。标准的采血程序会增加应激激素的释放，这可能会扰乱血液化学分析，并导致疼痛和不适。当要在整个生命周期内获得连续样本时，这种荷尔蒙释放尤其成问题。需要最小扰动的血液采样技术，以便能够研究单个动物生命周期中的激素波动。在NIH的SBIR项目中，Piezo Resonance Innovation Inc.(PRI)将展示Resonance Assisted Insertion Lancet的可行性，这是一种专门为减少尾部静脉穿刺术所需的插入力而设计的有源设备。在Prii进行的一项初步研究中，使用了一个原型来从大鼠的尾静脉中获取血液样本。这项研究表明，与传统的人工插入柳叶刀相比，根据行为指标和皮质酮水平，采集血液样本的压力较小。第一阶段提案的目标是确定最优原型设计的参数，并进行一套更全面的台架和动物试验，以确保安全性和有效性。这项拟议的工作将导致开发一种新的工具，在连续血液样本期间将动物压力降至最低，减少每个调查研究所需的动物数量-动物可以在整个研究中存活。这使得每项研究需要的动物更少，并改善了对动物的人道待遇。 公共卫生相关性：了解衰老的生理和生物机制以及激素在健康和异常衰老中所起的作用仍然是许多研究的重点。对啮齿动物模型中激素水平的研究对这一努力至关重要，但与传统血液采样技术相关的压力和疼痛的影响是有问题的。新的微扰采血策略，如将在这里开发的设备，非常希望能够在整个生命周期内进行连续血液采样，以更好地探索激素水平变化和衰老过程之间的联系。

DESCRIPTION (provided by applicant): Rodent studies have provided significant insights into the general aging process and age-related topics such as nutrition, behavior, immunology, cancer, and neurobiology. In such studies, concentrations of hormones, proteins, antibodies, and other metabolites and their associated kinetics are popular biomarkers because they vary with age and disease state. Typically biochemical assays are performed on blood samples collected following the temporary puncture of a large target vein. Standard blood sampling procedures can increase stress hormone release which may confound blood chemistry analysis, as well as cause pain and discomfort. This hormone release is especially problematic when serial samples are to be obtained over the lifespan. Minimally- perturbing blood sampling techniques are needed that enable studies of hormone fluctuations over the lifespan of individual animals. In this NIH SBIR program, Piezo Resonance Innovations Inc. (PRII) will demonstrate the feasibility of the Resonance Aided Insertion Lancet, an active device specifically designed to reduce the insertion forces required to perform tail venipuncture. In a pilot study conducted by PRII, a prototype was used to obtain blood samples from the tail vein of rats. The study suggested that blood samples were obtained with less stress according to behavioral indicators and corticosterone levels, compared to that of conventional manual lancet insertion. The goals of the Phase I proposal is to determine the parameters for the optimal prototype design, and conduct a more comprehensive set of bench and animal tests to ensure safety and efficacy. The proposed work will lead to the development of a new tool that minimizes animal stress during serial blood samples reducing the number of animals needed per investigational study - animal can survive entire study. This results in fewer animals needed per study, and improved humane treatment of the animals. PUBLIC HEALTH RELEVANCE: Understanding the physiological and biological mechanisms of aging and the role hormones play in healthy and abnormal aging continues to be the focus of much research. Studies of hormone levels in rodent models have been critical to this effort, but the effect of the stress and pain associated with traditional blood sampling techniques is problematic. New minimally-perturbing blood sampling strategies, such as the device to be developed here, are highly desired to enable serial blood sampling over the lifespan to better explore links between changing hormone levels and the aging process.