Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment
Department of Health and Human Services
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Small Business Information
ARTANN LABORATORIES, INC.
ARTANN LABORATORIES, INC., 1459 LOWER FERRY RD, TRENTON, NJ, 08618
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (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 visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology based on principles similar to those of manual palpation. In Phase I we will design and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor. Developed VTI software will support real time data processing and visualization. We plan to fabricate a realistic setup mimicking female pelvic floor for VTI bench validation and operator training. A clinical study with 30 patients will support optimization of the VTI with particular focus on examination procedure, the probe design, tactile data visualization and feature calculation algorithms. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess results of reconstructive surgery. PUBLIC HEALTH RELEVANCE: 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. 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. To date, there is no standardized and non-invasive tool to accurately assess the circumferential elastic properties of the vagina. The goal of this FastTrack project is to develop Vaginal Tactile Imager (VTI) for pelvic floor tissues elasticity imaging and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our preliminary data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.
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