ACTUATED MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: 200

Description

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 andapos 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 Rs 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 mL blood samples compared to standard practice Aim ONI is feasible for intravenous blood collection Aim 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 Finalize Design with Verification and validation to support CE Mark UL documentation Aim Demonstrate ONI reduces stress response and tissue trauma when delivering repeated injections in a rat study Aim 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 Demonstrate ONI reduces stress response and tissue trauma for serial blood collections in NHP Project Narrative Relevance This project addresses the two most common painful events experienced by laboratory animals when they are subjects in preclinical studies for new medical technology blood collections and injections Not only can the discomfort from serial needle insertions affect the reliability of results or introduce confounding factors for blood chemistry analysis but bruising or blown veins can also complicate collections or injections Introduction of a minimally perturbing vascular access strategy that enables more humane treatment for laboratory animals and improves confidence in long term preclinical results will ultimately help reduce the size of preclinical study populations or the number of repeat experiments and lead to a faster transition of medical treatments into clinical studies and beyond