WEARIFI, INC. — Department of Health and Human Services SBIR Phase I: NIA

Description

PROJECT SUMMARYVenous leg ulcersVLUsare the most common ulcerative wounds in the elderly affectingof all individuals older thanMore thanelderly individuals suffer from VLUswhich cost nearly $USDs to treat a single ulcerThe overall cost to the medical system is $billion USDs yearlyAlthough there have been significant advances in the science of wound care including the development of novel bioengineered wound productsthere remains significant uncertainty over the judicious use of these expensive treatmentsGiven the inherent differences of aged skin in regards to wounding and healingeven less is known in regards to optimal strategies for treating VLUs in the elderlyIn contrasttherapeutic compression garments are widely accepted as the standard of care to at least double the speed of VLU healing compared to placeboNumerous well designed clinical studies have demonstrated the clinical valuesafetyand cost effectiveness of compression garments when used consistently and with sufficient pressure deliveryandgtmmHgto prevent and heal VLUsCurrentlythere is a lack of clinical tools able to provide clinicians and patients with important diagnostic information regarding the pressure being delivered by compression stockings that is sensitive to limb volume changes over timeExisting pressure sensors are bulkyexpensiveand inaccurateThey are not conducive to wearable use given a lack of wireless communicationThis has limited these devices to only select research applicationsThusthere is a critical clinical need for a wearable diagnostic tool that is able to provide accurateand repeatable measurements of pressure and temperature that poses no risk to vulnerable lower extremitiesPressure measurements can be used by both trained clinical staff and the patient to adjust compression garments to ensure adequate pressure deliveryTemperature is useful to assess patient adherence but also serve as an independent marker of skin inflammation and wound riskThe proposed work addresses this need with a breakthrough sensor technologyThe ultra thin device incorporates an embedded pressure and temperature sensor within a softflexible silicone encapsulationThere is no rigid edgesthus eliminating the risk of skin injury to highly vulnerable lower limbsBy using near field communication paired to existing smartphonesthe technology is battery lessand wireless enabling a favorable cost profile and disposable useActivities in Phase I will establish the accuracy of the sensors through systematic testingand pilot testing with elderly individuals agesyears or older with a history of or active VLUsPROJECTNARRATIVE Thegoalofthisprojectistodevelopawearablepoint of caresystemusingaskin integratedsoftandultra thinpressureandtemperaturesensortoequipcliniciansspecificallynursing professionalsandpatientswiththeknowledgethatanygivencompressiongarmentis deliveringadequatetherapeuticpressureThesensorwithinthissystemusescuttingedge materialsscienceinnovationsandmechanicalengineeringoptimizationtoensuretheabilityto accuratelydetectlowpressuresassociatedwithcompressiongarmentswhilestillmaintaining highusercomfortWithclinicaldisseminationthissolutionwillreducethetimeofhealingfor venouslegulcersaconditionthatdisproportionatelyaffecttheelderlyandreduceoverall costs