ADVANCED TACTILE IMAGING INC — Department of Health and Human Services SBIR Phase I: NICHD

Description

SUMMARY Pelvic organ prolapsePOPis a highly prevalent condition affecting at leastof women in the US during their lifetimesUrinary incontinenceUIas found in the US surveyaffects fromtoof womenThe true etiology of POP and UI and variations seen among individuals are not entirely understoodThese disorders are thought to share a common pathogenesisweakeningelasticity changesof the muscular and connective support tissuesand pelvic floor muscle dysfunctionsFurther progress in womenandapos s healthcare is possible if a patient with a damaged pelvic floor could undergo medical imaging and biomechanical diagnostic teststhe results of which could be fed into a patient specific assessment and optimal treatment for that patientIn this projectwe propose to develop and clinically validate a new approach for biomechanical characterization of structure componentsligamentsmusclesand fasciaein the female pelvic floorIt will be based on a new device for TactileUltrasound Imaging to allow staticdynamicunder tissue deformationand functionalmuscle contractioncharacterization of the female pelvic floorTactile and ultrasound imaging fusion has a special fundamental importance because of the complementary nature of these technologiestactile images provide stress data and ultrasound images provide strain data for the same region during tissue deformationThis allows elasticity assessment as a stress to strain ratiophysical parameter of tissue with high sensitivity to the pathology developmentIn the Phase I researchwe plan development of a deviceprototype and validation of its imaging performance in a pilot clinical study withsubjects at two clinical sites NARRATIVE This project targets the development a new device for real time fusion of tactile imaging and ultrasound imaging to provide staticdynamicunder tissue deformationand functionalmuscle contractionimaging and characterization of female pelvic floor prolapse and urinary incontinence conditionswhich are common among women and require accurate diagnostics due to complexity of these disorders