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

该快速通道SBIR开发、测试和商业化“压电环安装振荡注射器” 用于改善数据的低痛苦、低作用力、实验室动物血管通路和注射的系统 质量和实验室动物福利。振荡针头插入器（ONI）是一种简单的单手， 血管通路装置，其使用新颖的振动压电环来直接施加纵向微 振荡到注射器，实现大量血液采集和注射，同时减少针头 穿透力、组织损伤和动物应激。ONI：a）减少重复针头插入， 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， （c）提供更人道的待遇。公共卫生问题：动物模型是 生物医学研究人们越来越关注研究对象的人道待遇， 相当重视改善动物待遇（动物使用的3R-细化、减少和 替换）。采血和注射是实验室动物最常见的做法， 承受。疼痛的针刺会引起动物的不适并增加应激激素水平- 可能混淆血液化学分析，增加数据变异性并触发血管收缩， 使得随后的访问更加困难。这种痛苦是使用动物的调查人员的主要关注点 需要重复静脉针头插入进行连续采血和多次给药的模型， 满足实验方案-如药代动力学研究，多克隆抗体生产， 需要仔细监测发情或月经周期曲线的生殖研究，因为这可能 使正在研究的生物标志物变得模糊。需要一种装置来减少或消除压力 在注射和静脉注射以及通过注射器采血期间的反应和创伤。 第一阶段假设。ONI静脉穿刺减少实验动物的痛苦和组织创伤 与标准实践相比，当采集重复的2 mL血液样本时，目标1 - ONI可行 静脉采血目的2 -证明ONI可减少应激反应和组织创伤， 在兔子研究中提高手术成功率。第二阶段假设。静脉穿刺和ONI注射 在大鼠和NHP动物模型中， 递送试剂或进行血管内血液收集。目的 3 -通过验证和确认完成设计，以支持CE认证和UL文档。目标4 - 证明ONI在大鼠中重复注射时可减少应激反应和组织创伤 study.目标5 -证明ONI减少了应激反应和组织创伤，同时增加了采样的便利性 由动物技术人员在NHP中进行隐静脉和股静脉采血。目标6 - 证明ONI减少了NHP中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.