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

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 atSuch alarmingly high rate of PIVC failure is primarily attributable to overpenetration through the back wall of the vein resulting in infiltration into the perivascular spaceThe resulting inflammation or phlebitis as characterized by local painrednessblood infiltration and swelling leads to catheter failure and eventual peripheral venous depletionCurrent evidence indicates that the presence of phlebitis during the dwell time of the first catheter causes afold greater chance of developing phlebitis and failure in subsequent cathetersWithof first attempt catheter insertions failinga strong correlation exists between the successful placement of the first catheter with the onset of phlebitis that stems from initial overpenetrationHencereducing the incidence of overpenetration and consequently phlebitis during the first attempt will improve the ability to deliver therapy and minimize patient complicationsIn recognition of this correlationspecialized IV teams have been implemented which have improved the success rates thus providing strong support to the importance of successful placement of PIVCs on the first attempt as well as the dependence on operator skill levelThe current proposal seeks to address these limitations by establishing the feasibility of a novel PIVC to provide first attemptsingle wall venous access regardless of operator skill level or ability to visualize the veinThe TrueCath system incorporates a mild vacuum in the flashback chamber which upon entering the vein and sensing the change in pressuresafely and quickly deploys the soft gel IV catheter forward via a simple spring mechanism that can easily be incorporated into current PIVC devicesImportantlythe catheter portion is deployed quickly enough to prevent overpenetration that would otherwise occur due to the delay in blood entering the flashback chamber which serves as the index of access and major limitation of current PIVCsInitial bench and in vivo studies 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 vivoHencethe system is ready for final refinement which includes modification to the current safety feature and addition of a hemostasis valve within the hub assemblyPerformance of the device and additional features will be characterized first on benchAimfollowed by in vivo assessment for reductions in overpenetrationphlebitis and number of attemptsAimSuccessful execution of these Phase I studies will appropriately position the TrueCath system for full developmentclinical studies and regulatory approvalfuture Phase IIof a novel and highly innovative approach to resolve PIVC complications and improve the standard of patient care NARRATIVE Approximatelyof peripheral IV catheters fail during first attempt at insertionwith the vast majority due to needle overpenetrationinfiltration and inflammationThe overall objective of this proposal is to validate the safety and efficacy of a novel peripheral IV catheter system to reliably provide first attemptsingle wall venous access to reduce patient discomfortvenous depletioncatheter failure and healthcare cost