Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

描述（由申请人提供）：盆腔器官脱垂是一种非常普遍的疾病，影响了美国至少50%的女性。大多数成年妇女会出现子宫阴道支持的一些丧失；然而，脱垂的真正病因和个体之间的差异还不完全清楚。阴道壁、结缔组织和肌肉弹性的改变被认为是盆腔器官脱垂的重要因素。我们建议开发一种名为阴道触觉成像仪（VTI）的设备，用于骨盆底组织的三维可视化和机械特性评估。VTI是基于触觉成像（TI）技术，其原理与手动触诊相似。在第一阶段，我们设计并制作了带有触觉传感器阵列和运动跟踪传感器的VTI原型机1台，并使用幻影测试了训练程序，并启动了30例患者的临床开发研究，以优化VTI、检查程序、数据处理算法和可视化方法。临床结果表明，该方法适用于阴道和周围结构的三维成像，以及正常和盆腔器官脱垂的特征。在第二阶段，我们计划建立VTI 2-原型，完成台架验证研究，EMC和安全测试，符合法规要求，将该设备带入临床验证研究，涉及200名患者，2个站点和5个操作员。该装置将定量评估阴道壁的多种力学和结构特性，如弹性分布、杨氏模量、弹性对比、异常组织的大小和形状，提供脱垂特征并评估重建手术的结果。本课题的完成有望获得科学知识，提供新的技术能力，提高妇科临床水平。

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 based on principles similar to those of manual palpation. In Phase I we designed and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor, tested the training procedure with the phantoms and initiated the clinical development study with 30 patients to optimize the VTI, examination procedure, data processing algorithms and visualization approaches. Clinical results demonstrate applicability of proposed approach for 3-D imaging of the vagina and surrounding structures and characterization of normal and pelvic organ prolapse conditions. In Phase II we plan to build VTI 2-prototype, complete the bench verification studies, EMC and safety testing in the accordance with regulatory compliance to bring the device to clinical validation study with 200 patients, 2 sites, and 5 operators. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as elasticity distribution, Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess results of reconstructive surgery. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology. PUBLIC HEALTH RELEVANCE: Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. The goal of this project is to develop Vaginal Tactile Imager (VTI) for 3-D elasticity imaging of pelvic floor tissues and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our clinical data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.