Piezoelectric Ring Mounted Oscillated Syringe System for Lower Distress, Lower Force, Laboratory Animal Vascular Access and Injection to Improve Data Quality and Laboratory Animal Welfare

这种快速跟踪SBIR开发、测试并商业化了一种‘压电环安装式振荡注射器 用于改善数据的低损伤、低作用力、实验动物血管通路和注射系统 质量和实验动物福利‘振荡针插入器(ONI)是一种简单的单手， 一种使用新型振动压电环直接施加纵向微通道的血管接入装置 注射器的摆动，在减少针头的同时实现大量的血液采集和注射 穿透力、组织损伤和动物压力。ONI：a)减少重复插入针头和 相关的组织损伤，b)减少由于疼痛/应激反应引起的血液化学中的混杂因素， 以及c)提供更人道的待遇。公共卫生问题：动物模型是 生物医学研究。对研究对象的人道待遇越来越受到重视， 相当重视改善动物治疗(动物使用的3R--精炼、减少和 替换)。血液采样和注射是实验动物最常见的一些做法 经历。刺痛的针头会引起动物受试者的不适，并增加压力荷尔蒙水平。 潜在地混淆了血液化学分析，增加了数据的可变性，并引发了血管收缩， 使得后续访问变得更加困难。这种痛苦是使用动物的调查人员的主要担忧 需要反复静脉注射针头以进行连续采血和多次给药的型号 满足实验方案--如药代动力学研究、多克隆抗体生产和 需要仔细监测动情期或月经周期的激素的生殖研究，因为这可能 给正在研究的生物标志物蒙上一层阴影。需要一种装置来减少或消除压力 在注射和静脉注射过程中的反应和创伤，以及通过注射器采集血液。 第一阶段假设。ONI静脉穿刺术减少兔实验动物痛苦和组织损伤 与标准做法相比，当重复采集2毫升血液样本时，该模型具有可比性。目标1-ONI是可行的 用于静脉采血。目标2-演示ONI减少应激反应和组织创伤 在一项兔子研究中提高手术成功率。第二阶段假设。ONI静脉穿刺术和注射 在大鼠和NHP动物模型中减少实验动物的痛苦和组织创伤 与标准做法相比，分别递送试剂或进行血管内采血。目标 3-通过验证和确认最终确定设计，以支持CE标志和UL文件。目标4- 证明ONI在大鼠体内重复注射可减少应激反应和组织损伤 学习。目标5-证明ONI减少了应激反应和组织创伤，同时提高了样本的易用性 动物技术人员在NHP进行隐静脉和股静脉采血。目标6- 证明在NHP中，ONI减少了连续采血的应激反应和组织创伤。

This Fast-track SBIR develops, tests, and commercializes a `Piezoelectric Ring Mounted Oscillated Syringe System for Lower Distress, Lower Force, Laboratory Animal Vascular Access and Injection to Improve Data Quality and Laboratory Animal Welfare.' The Oscillated Needle Inserter (ONI) is a simple one-handed, vascular access device that uses a novel vibratory piezoelectric ring to directly apply longitudinal micro- oscillations to syringes, enabling large volume blood collections and injections while reducing needle penetration force, tissue damage, and animal stress. ONI: a) reduces repeated needle insertions and associated tissue injury, b) reduces confounding factors in blood chemistry due to the pain/stress response, and c) provides more humane treatment. Public Health Problem: Animal models are a critical component of biomedical research. There is an increasing focus on the humane treatment of research subjects, with a considerable emphasis on improving animal treatment (3Rs of animal usage - Refinement, Reduction and Replacement). Blood sampling and injections are some of the most frequent practices that laboratory animals undergo. Painful needle punctures cause discomfort in animal subjects and increase stress hormone levels - potentially confounding blood chemistry analysis, increasing data variability and triggering vasoconstriction, making subsequent access more difficult. This distress is a major concern for investigators using animal models requiring repeated intravenous needle insertions for serial blood collections and multiple dosing to satisfy experimental protocols- such as pharmacokinetic studies, polyclonal antibody production, and reproductive studies requiring careful hormone monitoring for estrus or menstrual cycle profiles, as this can cloud the biomarkers that are being investigated. A device is needed to reduce or eliminate the stress response and trauma during injections and intravenous access and blood collection via syringe. Phase I Hypothesis. Venipuncture with ONI reduces laboratory animal distress and tissue trauma in a rabbit model when acquiring repeated 2 mL blood samples compared to standard practice. Aim 1 – ONI is feasible for intravenous blood collection. Aim 2 – Demonstrate ONI reduces stress response and tissue trauma while improving procedure success in a rabbit study. Phase II Hypothesis. Venipuncture and Injection with ONI reduces laboratory animal distress and tissue trauma in a rat and NHP animal models when repeatedly delivering agents or performing intra-vessel blood collections, respectively compared to standard practice. Aim 3 – Finalize Design with Verification and validation to support CE Mark, UL documentation. Aim 4 – Demonstrate ONI reduces stress response and tissue trauma when delivering repeated injections in a rat study. Aim 5 – Demonstrate ONI reduces stress response and tissue trauma while increasing ease of sample collection by animal technicians performing saphenous and femoral vein blood collections in NHP. Aim 6 – Demonstrate ONI reduces stress response and tissue trauma for serial blood collections in NHP.