RAIL reduces variability and concentration of stress hormones in blood sampling

RAIL 减少血液采样中应激激素的变异性和浓度

基本信息

批准号：
8314887
负责人：
Ryan S Clement
金额：
$ 65.24万
依托单位：
ACTUATED MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-15 至 2014-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8314887
关键词：
Age Aging Aging-Related Process Anatomy Animal Experimentation Animals Antibodies Behavior Behavioral Biochemical Biological Biological Assay Biological Markers Blood Chemical Analysis Blood Glucose Blood specimen Cancer Immunology Science Cells Corticosterone Cross-Sectional Studies Development Device Designs Device or Instrument Development Devices Disease Electronics Focus Groups Funding Glucocorticoids Goals Grant Health Hormones Kinetics Laboratory Animals Life Link Location Longevity Longitudinal Studies Marketing Measurement Medical Medical Device Metabolism Methods Motion Movement Mus Needles Neurobiology Outcome Pain Performance Phase Physiological Plasma Play Procedures Production Proteins Psyche structure Public Health Puncture procedure Rattus Research Research Design Research Personnel Resort Rodent Rodent Model Role Sales Sampling Sampling Studies Science Scientist Site Small Business Innovation Research Grant South Carolina Stress System Techniques Testing Time Tissues Tube Universities Veins Venipunctures Veterinarians age difference age related animal pain biobehavior biological adaptation to stress commercial application commercialization cost design hypodermic needle improved innovation insight meetings nasogastric feeding nutrition professor programs prototype research study response success tool vocalization

项目摘要

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. 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 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, while reducing the number of animals required for the study.

描述（由申请人提供）：在此 II 期 SBIR 中，Actuated Medical, Inc.（原名 Piezo Resonance Innovations, Inc）将完成共振辅助插入柳叶刀 (RAIL") 系统的开发，以减少动物疼痛和实验室动物血液采样期间的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重点，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，这些研究通常需要在每个时间点进行许多动物，这不仅成本高昂。动物使用和成本方面，但限制了因果关系的研究，非常需要新的最小干扰血液采样策略，以在整个生命周期内进行连续血液采样，成功开发了 Alpha 原型，满足了特定目标，并进行了演示。 RAIL 设备使用 RAIL 原型获得的血液样本中皮质酮水平平均降低了 60%，对 RAIL 的反应平均降低了 71%。 9) 动物研究科学家和兽医高度肯定第二阶段将开发一种商业上可行的设备，最大限度地减少连续血液样本期间的动物压力，改善研究结果并消除第二阶段假设的需要。使用 RAIL 装置进行振动静脉穿刺可将血浆皮质酮水平降低 60% ¿ 10%，变异性降低 60% ¿在小鼠中进行的 24 个月纵向重复抽样研究中，与非振动静脉穿刺相比，减少了 10%（p<0.05）。 II 期具体目标： 1. 证明 RAIL 装置在小鼠中的皮质酮释放量与之前在大鼠中观察到的相似。 2. 证明 RAIL 装置可广泛适用于降低在不同解剖位置采集的血液样本中的皮质酮水平。 3. 量化 RAIL 的性能优势。设备在整个生命周期内进行连续血液采样实验（小鼠 24 个月研究）。 4. 完成设备设计并构建 60 台，经过测试并准备上市。公共健康相关性：了解衰老的生理和生物学机制以及激素在健康和异常衰老中的作用仍然是许多研究的重点，啮齿动物模型中激素水平的研究对于这项工作至关重要，但激素水平的影响。与传统血液采样技术相关的压力是有问题的，我们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与衰老过程之间的联系。，同时减少研究所需的动物数量。