A Novel, Low-Cost Device to Guide Peripherally Inserted Central Catheter (PICC) Line Placement

Abstract Improper placement of peripherally inserted central cathetersPICCsis costly and has serious complications for critically ill patientsMore than one million PICCs are placed each year to provide IV therapieswhere navigation through the venous system is typically performed blindor without navigation guidanceAs a resultof PICC tips are not optimally placed on the first attempt and require repositioningwhich has an average direct cost of $per patient and often necessitates the removal and reinsertion of the catheter lineApproximatelyof these improperly positioned PICCs are placed into the right atriumwhich is associated with a multitude of life threatening complicationsFurtherof malpositioned PICCs are improperly navigated through the venous systemwhich increases the risk of venous or arterial perforationlocal venous thrombosisand catheter dysfunctionImproper placement of a PICC line also often requires referral to an interventional radiologist for fluoroscopic guided central line placementwhich is expensive$Not surprisinglyhalf of all PICCs are administered to patients over the age ofso safe and accurate PICC placement is critical for providing high quality care to older AmericansDespite serious adverse events associated with blind placementavailable guidance systems have not been widely adoptedThe Teleflex ARROWGVPS and the Bard SherlockCGare overeffective for placement of a catheter tip into the superior vena cavaSVCor cavoatrial junctionCAJHowevercompared with standardblind placementthese devices aremore expensiverequire skilled staffand have longer procedure timesAdditionallythese guidance systems rely on the use of ECGso they are contraindicated for patients with cardiac arrhythmiasa common condition in older adultsTo address the need for accuratesafeand cost effective PICC placement in all patientsTheraNova has developed PICCOLOa thermodilution based navigationor thermo navigationcatheter system for realtime vascular access guidanceWe have designed PICCOLO with the following key innovationsProvides real time hemodynamic data for identification of key vascular landmarksExpands the patient population indicated for PICC guidanceandProvides a cost effective and easy to use solutionIn a proof of concept animal studynpigwe found that the unique thermo navigation signatures of five anatomical locations could be distinguished with our PICCOLO prototypeIn this Phase I proposalwe willOptimize the signal resolution of the PICCOLO prototype by evaluating saline infusion parameters over varying pulsatile venous flow conditions in a benchtop modelSpecific AimandCompare the thermo navigation profiles for PICC tip placement in several key vascular locations as compared to the CAJ in six pigsSpecific AimThe data obtained through this proposal will demonstrate the feasibility of thermo navigation to provide accurate guidance for vascular accessThese data will also support a Phase II submissionwhich will include preclinical and clinical studies to validate accurate PICC placement in all adultsincluding older adults with arrhythmias Narrative Peripherally inserted central cathetersPICCsare widely used to provide life sustaining intravenous therapiesbut complications are associated with the standard placement procedure that is done without navigation guidanceCommercially available PICC guidance systems can be effective for accurate placementbut have limited adoption into the clinic due to high costs and are contraindicated in patients with cardiac arrhythmiasa common condition in older adultsWe propose an inexpensiveeasily operatedthermo navigation catheter system for real time PICC guidance in all patients