TRUECATH INC. — Department of Health and Human Services SBIR Phase I: NICHD

Description

ABSTRACT Venous access is the most commonly performed invasive medical procedure with overmillion peripherally inserted venous cathetersPIVCused annually in the US andbillion globallyHoweverthe rate of failure prior to completion of therapy remains unacceptably high in pediatric patientswith a reportedciting complications and removal withinhours of placementThe high rate of PIVC failure in pediatric patients is primarily attributable to overpenetration through the back wall of the vein resulting in infiltration into the perivascular space inof casesThe lowfirst attempt success rate with repeated failed access eventual requires conversion to intraosseous or central line placementparticularly in emergency or neonatal patientsNotwithstanding the stresstrauma and long term psychological impairment towards receiving future medical treatmentresulting phlebitislocal painrednessblood infiltrationswellingfrom a failed first attempt causes afold greater chance of failure in subsequent local catheter placementsAttempts to reduce the incidence of overpenetration has led to the implementation of specialized IV teams which emphasizes the need for improved PIVC placement as well as dependence on operator skill levelThe current proposal seeks to address these limitations by establishing the feasibility of a novel pediatric PIVCPPIVCto provide first attemptsingle wall venous access in pediatric patients regardless of operator skill level or ability to visualize the veinThe TrueCath system facilitates PPIVC placement by incorporating a mild vacuum in the flashback chamberwhich upon entering the vein and sensing the change in pressuresafely and quickly deploys the soft gel IV catheter forwardvia a simple spring mechanismThe Truecath sensor can easily be incorporated into current PPIVC devices at equivalent costImportantlythe catheter portion is deployed quickly enough to prevent overpenetration that would otherwise occur due to the delay in blood entering the flashback chamberwhich usually serves as both the index of access and major limitation of current PPIVCsInitial bench and in vivo studies of an adult variant have demonstrated the ability of the TrueCath system to sustain vacuum and release the catheter portion at the appropriate force and speed to provide afirst attempt success rate in vivoThe current proposal will translate these excellent results into a pediatric version which has unique design challenges of catheter size and deployment force in order to accommodate smallermore fragile veins and tissues in pediatric patientsPerformance of the device will be characterized first on benchAimfollowed by in vivo assessment for reductions in overpenetration and number of attemptsAimSuccessful execution of these Phase I studies will appropriately position the TrueCath system for full development and regulatory approvalfuture Phase IIof a novel and highly innovative approach to resolve PIVC complications and improve the standard of pediatric patient care NARRATIVE Approximatelyof pediatric peripheral IV catheters fail during first attempt at insertionwith the vast majority due to needle overpenetration and infiltrationThe overall objective of this proposal is to validate the safety and efficacy of a novel pediatric peripheral IV catheter system to reliably provide first attemptsingle wall venous access to reduce patient discomfortvenous depletioncatheter failure and healthcare cost