Design and Fabrication of a Wearable Therapeutic Ultrasound Device for Peripheral Arterial Disease

Project SummaryPeripheral arterial diseasePADis a highly prevalent condition that is growing rapidly due to shifting demographicsaffectingM people worldwide andM in the USAwith an annual growth rate ofApproximately one third of PAD patients experience lower extremity pain that limits activityand one third of these patients suffer from critical limb ischemiaCLIwhich lacks any effective treatment option and is associated with devastating complications including resting painskin ulcersand gangreneoften requiring amputationInvasive surgical or catheter based treatments are ineffective in CLI and associated with complications and up torate of long term restenosisAcoustic energy modalities have been shown to promote collateral vessel growthangiogenesisand to improve perfusion in animal models of coronary artery diseaseCADand PADwith promising early human data in CADVibrato Medical is developing a groundbreaking new treatment with the first wearable therapeutic ultrasoundTUSdevice for the non invasiveoutpatient treatment of PAD that promotes collateral vessel growth and angiogenesisand restores perfusionThe VibratoSleeve is a disruptiveparadigm shifting device that will fundamentally alter the PAD CLI treatment landscape with a non invasivewearableoutpatient treatment that will prevent amputationshospitalizations and other complications of advanced PADThe goal of this NIH PhaseSBIR proposal is to modelfabricate and acoustically verify a phased array transducer sleeve to treat the posterior tibial angiosomeIn AimVibrato will perform acoustic modeling and simulation of TUS transducer arrays to identify the optimal transducer frequencysizenumber and configuration to optimize acoustic delivery to the posterior tibial angiosomeBased on results from AimVibrato will partner with PiezoTechnologies for Aimwhich will deliver VibratoSleeve prototypes that can then be used for verification testing in AimAcoustic verification in degassed waterbaths and human calf tissue phantoms will assess size and peak positive and negative pressures of the acoustic field generated by the VibratoSleeveMeasurement of power requirements will inform future design of the power source for the wearable VibratoSleeveand transducer phantom interface thermocouple measurements will assess the possibility of skin heating with long term useVibrato has assembled a diverse group of technicalclinical and strategic advisorsas detailed inFacilities and Other Resourcesincluding Key Opinion Leader DrMahmood Razavi whowhile not within the scope of this proposalwill perform Vibratoandapos s Phaseclinical trials upon completion of this Phaseapplication Project NarrativePeripheral arterial diseasePADaffectsM people worldwide andM in the USand is growing rapidly at a rate ofCurrent PAD therapies have limited efficacyandpatients per year in the US progress to critical limb ischemiaCLIwith resting painskin ulcersgangreneand often requiring amputationBased upon recent studies demonstrating that therapeutic ultrasoundTUSis effective in promoting collateral vessel growth and angiogenesis and improving perfusionVibrato Medical is developing a disruptiveparadigm shifting PAD treatment with the first wearable device for non invasiveoutpatient use in order to improve symptoms and reduce amputations in PAD patients without other treatment options