Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

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DESCRIPTION (provided by applicant): Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women, however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology founded on the principles similar to those of manual palpation. In Phases I and II we designed and built a and prototypes of VTI with tactile sensor array and a motion tracking sensor, completed VTI testing and verification with the tissue mimicking phantoms, completed Phase I and initiated Phase II clinical study. Clinical results demonstrated capability of the proposed approach for 3-D imaging of the vagina and pelvic floor support structures. Our findings suggest that the normality ranges for tissue elasticity of vagina and its support structures evaluated by VTI might be used as the markers in diagnosis of pelvic floor conditions. We further demonstrated VTI capability in characterization of outcome of pelvic floor reconstructive surgery. Tactile Imaging technology developed at Artann Laboratories is highly innovative and unique. Artann scientists are the first in the world to introduce and develop Tactile Imaging technology into the practical and proven successful applications described in numerous publications and 21 issued patents. The main goal of Phase IIB is to transform the Phase II VTI ¿-prototype into medical device ready for regulatory review and commercialization. Upon completion of regulatory compliance testing, verification and clinical validation of the VTI, technical and clinical files will be prepared for FDA application. The endpoint for the Phase IIB of the project is the FDA 510(k) submission. The VTI commercialization will follow the FDA approval. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology.