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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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44OD023024-02
Agency Tracking Number: R44OD023024
Amount: $1,430,930.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 200
Solicitation Number: PAR15-186
Solicitation Year: 2015
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-05-01
Award End Date (Contract End Date): 2021-04-30
Small Business Information
Bellefonte, PA 16823-8445
United States
DUNS: 791379030
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (814) 355-0003
Business Contact
Phone: (814) 355-0003
Research Institution

This Fast track SBIR developstestsand commercializes aPiezoelectric Ring Mounted Oscillated Syringe System for Lower DistressLower ForceLaboratory Animal Vascular Access and Injection to Improve Data Quality and Laboratory Animal WelfareThe Oscillated Needle InserterONIis a simple one handedvascular access device that uses a novel vibratory piezoelectric ring to directly apply longitudinal microoscillations to syringesenabling large volume blood collections and injections while reducing needle penetration forcetissue damageand animal stressONIareduces repeated needle insertions and associated tissue injurybreduces confounding factors in blood chemistry due to the pain stress responseand cprovides more humane treatmentPublic Health ProblemAnimal models are a critical component of biomedical researchThere is an increasing focus on the humane treatment of research subjectswith a considerable emphasis on improving animal treatmentRs of animal usageRefinementReduction and ReplacementBlood sampling and injections are some of the most frequent practices that laboratory animals undergoPainful needle punctures cause discomfort in animal subjects and increase stress hormone levelspotentially confounding blood chemistry analysisincreasing data variability and triggering vasoconstrictionmaking subsequent access more difficultThis 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 protocolssuch as pharmacokinetic studiespolyclonal antibody productionand reproductive studies requiring careful hormone monitoring for estrus or menstrual cycle profilesas this can cloud the biomarkers that are being investigatedA device is needed to reduce or eliminate the stress response and trauma during injections and intravenous access and blood collection via syringePhase I HypothesisVenipuncture with ONI reduces laboratory animal distress and tissue trauma in a rabbit model when acquiring repeatedmL blood samples compared to standard practiceAimONI is feasible for intravenous blood collectionAimDemonstrate ONI reduces stress response and tissue trauma while improving procedure success in a rabbit studyPhase II HypothesisVenipuncture 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 collectionsrespectively compared to standard practiceAimFinalize Design with Verification and validation to support CE MarkUL documentationAimDemonstrate ONI reduces stress response and tissue trauma when delivering repeated injections in a rat studyAimDemonstrate ONI reduces stress response and tissue trauma while increasing ease of sample collection by animal technicians performing saphenous and femoral vein blood collections in NHPAimDemonstrate ONI reduces stress response and tissue trauma for serial blood collections in NHP RelevanceThis project addresses the two most common painful events experienced by laboratory animals when they are subjects in preclinical studies for new medical technologyblood collections and injectionsNot only can the discomfort from serial needle insertions affect the reliability of results or introduce confounding factors for blood chemistry analysisbut bruising or blown veins can also complicate collections or injectionsIntroduction of a minimally perturbing vascular access strategy that enables more humane treatment for laboratory animalsand improves confidence in long term preclinical resultswill 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

* Information listed above is at the time of submission. *

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