TRANSONIC SYSTEMS, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT SUMMARY ABSTRACT For infants born with a single ventricle heartthe Norwood Stage I operation is a life saving procedureThis procedure is the first in a three step pathway that begins to correct a newborn s circulation by providing flow to both the systemic circulation and pulmonary circulation from the one ventricleAfter the surgery howeverthere is no way to continually monitor the flow that is going to the pulmonary and systemic circulationscardiac outputto be sure each has adequate flowThe long term objective of this project is to provide the first implantable wireless blood flow monitor for patients after Norwood Stage I Single Ventricle Palliation surgeryThe perivascular sensor used for measuring flow cardiac output will be placed on the right ventricle pulmonary artery shunt that is created during the surgeryUnlike existing technologythis will be able to provide continuous measurements to identify changes in cardiac output after surgeryThis will allow for timely therapy for the patientAdditionally intermittent measurements using an injection of saline with provide information regarding the distribution of blood flow in the heartBased on preliminary work and the prototype algorithmsthis project will begin by developing a sensor system capable of transmitting and recording changes in the ultrasound velocity of bloodThe meter component of the system will be made to receive these changes and programmed to automatically produce and display the flow measurementsAnimal studies will then be performed onpiglets at the Animal Research Facility at Children s National Medical Center in order to validate the Qp Qs calculations in a single ventricle animal modelPhase I will end with a preliminary clinical study at Children s National Medical Centerpatients will be recruited for a feasibility test of the sensor placement and dilution calculationsPROJECT NARRATIVE A wireless implantable blood flow monitor for patients after StageSingle Ventricle Palliation surgery will assist physicians in guiding urgent treatmentIn the operating roomin the intensive care unitand at home after surgeryphysicians will be able to monitor the distribution of blood flow in the patient s heart and lungs to ensure proper treatment and decrease mortality associated with lack of blood flow