Integrated Fiber Optic Sensor Umbilical Catheter for Blood Gas Monitoring

Project Summary
Neonatal Intensive Care Units NICUs admit babies every year in the U S The monitoring of arterial
blood gases is essential for managing any sick infant but especially important in vulnerable extremely premature
infants for whom even a minimal delay in appropriate interventions can be the difference between life and death
Intermittent monitoring of blood gases as is traditional provides only a spot check of physio pathological status
the results are often delayed from the actual event triggering blood gas analysis and the procedure besides
predisposing to iatrogenic infections in itself is painful and over time can result in significant blood loss
Continuous non invasive blood gas monitoring is preferable but current non invasive continuous modalities have
significant limitations An accurate precise and intrinsically safe system that exploits routinely performed
intravascular catheterization such as umbilical artery catheterization the standard of care for sick neonates
to obtain blood gas measurements continuously would be an important advance in monitoring critically ill
neonates in NICUs To address this need we are developing an integrated fiber optic sensor umbilical
ISUM catheter for blood gas monitoring in neonates The ISUM catheter will fill the technological gap in
continuous blood analysis by addressing the deficiencies shown in andquot classicalandquot intravascular sensor probes and
will take advantage of the fact that most critically sick newborns in NICUs receive at least one intravascular
catheter often an umbilical arterial catheter The sensor and the catheter are designed as an integrated unit for
this specific application and have the following advantages over previously described intravascular probes
novel large area gas sensors eliminating probe placement or movement artifacts dual O sensor and data
fusion eliminating andquot wall effect andquot and improving reliability and ready to use sensors with little or no delay in
data acquisition and reduced cost since highly repeatable sensor elements can be produced in batches of
hundreds In Phase I the first ISUM catheters were designed fabricated and tested in animal models
incorporating sensors for both pO and pCO Excellent correlation between sensor readings and the andquot gold
standardandquot technique for blood gas analysis was observed None of the erroneous readings associated with prior
intravascular devices were observed which highlights the potential of the novel sensors for use in both infants
and adults and the safety of the new catheter was demonstrated In the proposed Phase II work additional
sensors will be integrated and advanced catheters will be designed and validated in the laboratory and in
neonatal animal models closer to humans which will lead to initial validation in human subjects As soon as the
proposed milestones are achieved we will move to commercialize the ISUM catheter by starting the process for
an FDA k submission and negotiating with investors for clinical trials and commercialization Project Narrative
A vastly improved system for continuously monitoring blood gases of fragile premature infants and newborns fills
an important gap in critical care Our integrated fiber optic sensor umbilical catheter which can measure blood
oxygen carbon dioxide pH and bicarbonate could become a standard tool for critically sick neonates admitted
to NICUs reducing morbidity and mortality