RIVANNA MEDICAL, INC. — Department of Health and Human Services SBIR Phase II: 300

Description

PROJECT SUMMARY ABSTRACTThoracic epidural analgesiaTEAis the gold standard for treating acute pain following major thoracic and abdominal surgeries and in patients with fractured ribsOf themillion inpatient surgeries performed in the US each yearan estimatedmillion are eligible for TEAMultiple randomized control trials have demonstrated significantly improved patient outcomes when receiving TEA instead of systemic opioidsincluding reducedday mortalityvsimproved postoperative pain controlreduced pulmonary and cardiovascular complicationsand reduced incidence of chronic pain syndromesIn additionTEA is associated with increased patient satisfactionshortened hospital staysand a significant reduction in the cost of perioperative caree gsavings between $$per patient vs systemic opioidsHoweverTEA is regarded as one of the most technically difficult procedures executed by anesthesiologistsin large part because epidural needle placement is guided by manual palpation of spinal bone landmarks followed byblindneedle insertionPalpation of spine landmarks is unreliable for identifying the epidural spacei eaccuracyand results in high TEA failure ratesdue to catheter misplacement outside of the intended epidural spaceHalving the number of TEA failures per year is estimated to reduce the number of postoperative deaths byper year and result in a $B yr economic benefit due to reduced cost of care and fewer premature deathsDuring the Phase I projectthe feasibility of a low costhandheld ultrasound system and new automated image guidance technologies was demonstrated by imaging in vitro thoracic spine phantoms and human thoracic spinesThis Phase II proposal seeks funding to support the continued development of a low costhandheld medical device for thoracic epidural guidanceThe key technological innovations of this project are focused on improvements to ultrasound based beamforming for enhanced bone visualization and include a new spinal bone imaging approach that enables the automatic detection of spinal bone landmarks and needle insertion siteThe long term goal of this project is to demonstrate a portablelow costultrasound based medical device that facilitates thoracic epidural placement in the postoperative patient populationimproves success ratesand lowers the risk of associated health complicationsThe Phase II hypothesis is that the handheld medical imaging device and associated technologies increases first attempt epidural analgesia success ratesdefined as successful epidural administration on the first needle insertion attemptNew ultrasound beamforming technologies for a low channel count ultrasound transducer design for improved bone imaging performance will be designedfabricatedand testedIn additionultrasound imaging technologies central to this project will be optimizedintegrated into the new deviceand validated in a clinical studyFinallythe Phase II hypothesis will be directly tested in anpatient clinical studyWith an estimatedmillion patients eligible for thoracic epidural administration each yearthe estimated US market size for the proposed device is $M yr