SONAVEX INC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

<p>DESCRIPTION provided by applicant Each year in the U S over patients undergo procedures where arteries or veins are surgically connected Invariably there is a risk of a clot thrombosis forming in the vessels postoperatively Early detection of clot formation would allow removing the clot before vessels are irreversibly blocked and is key to preventing catastrophic surgical failures Drawbacks of existing detection devices include high false positive rates delays in detection that limit success of salvage interventions and patient safety risks A device that reliably detects clot formation before total occlusion has been greatly needed for years and can dramatically improve surgical success rates decrease morbidity and length of stay and cut hospital costs The economic impact of eliminating unnecessary or failed procedures associated with reconstructive thrombosis alone is estimated at up to $ million year in the U S To have a successful clot monitoring device it is necessary to register the surgical site and acquire bloo flow data over time accurately and precisely from this location To solve this need we have developed EchoSure the first simple point of care system for direct visualization and flow quantification of post surgical blood vessels EchoSure will allow nurses to noninvasively monitor patients for clot formation without specialized sonographic training Our systemandapos s first component is a novel bio absorbable echogenic marker implant placed adjacent to the vessels intraoperatively The second component is ultrasound image analysis software that locks onto the unique marker signature determines the pose of the ultrasound probe vis vis the marker and guides the nurse to the correct location to monitor clot formation Doppler data is then collected to analyze blood flow over time In this Phase I proposal we will perform cadaver testing to optimize our navigation algorithms use a D probe system for ground truth validation of algorithm accuracy and obtain in vivo proof of concept for the system in a realistic surgical scenario OVERALL IMPACT By enabling routine detection of post operative vascular thrombosis with high accuracy before complete blockage has occurred EchoSure will solve a problem responsible for catastrophic patient morbidity and costs Our work will have broad impact on numerous other clinical applications where clots lead to disastrous consequences including organ transplantation and peripheral vascular surgery PUBLIC HEALTH RELEVANCE Each year over patients in the U S alone undergo procedures where arteries or veins are surgically connected anastomosis These procedures are performed in reconstructive transplant and vascular surgery Invariably there is a risk of a clot thrombosis forming in the vessels during the postoperative period Detecting clot formation allows intervention to remove the clot before it irreversibly blocks the vessels and is key to preventing catastrophic surgical failures time to detection directly correlates to the rate of salvage Existing detection devices suffer from high false positive rates delays in detection that limit success of salvage interventions and patient safety risks Because of these flaws routine use of devices for postoperative monitoring now occurs only in reconstructive plastic surgery where up to of cases will require emergency salvage for clot formation of which fail with a $ direct economic cost per failure A device that reliably and noninvasively detects clot formation before it is too late to save the surgery is urgently needed to improve patient outcomes and cut salvage costs Early non invasive recognition of impending clot formation is also key to developing minimally invasive interventions to disrupt or dissolve small thromboses to reduce the morbidity of open thrombectomy Here we propose to solve these public health needs using an ultrasound system that allows point of care quantitative measurement of the function and patency of post operative blood vessels</p>