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.
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.
