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

Period of Performance: 09/01/2016 - 05/31/2017

$224K

Phase 2 SBIR

Recipient Firm

Actuated Medical, Inc.
Bellefonte, PA 16823
Principal Investigator

Abstract

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.