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，在美国至少有50%的女性在她们的一生中受到影响。大多数成年女性会失去子宫-阴道支持；然而，脱垂的真正原因和个体之间的差异并不完全清楚。阴道壁、结缔组织和肌肉弹性的变化被认为是盆腔器官脱垂发生的重要因素。我们建议开发一种名为阴道触觉成像仪(VTI)的设备，用于三维可视化和评估盆底组织的机械特性。VTI基于触觉成像(TI)技术，其原理类似于手动触诊。在第一阶段，我们设计和制造了带有触觉传感器阵列和运动跟踪传感器的1-VTI原型，用体模测试了训练过程，并与30名患者启动了临床开发研究，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，所提出的方法适用于阴道及其周围结构的3D成像，以及正常和盆腔器官脱垂情况的表征。在第二阶段，我们计划构建VTI 2原型，根据法规遵从性完成工作台验证研究、EMC和安全测试，以将该设备带到200名患者、2个地点和5名操作员的临床验证研究中。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、杨氏模数、弹性对比度、异常组织的大小和形状，提供脱垂特征和评估重建手术的结果。拟议项目的完成有望获得科学知识，提供新的技术能力，并改善妇科的临床实践。 与公共卫生相关：盆腔器官脱垂是一种非常普遍的疾病，在美国至少有50%的女性在一生中受到影响。本项目的目标是开发阴道触觉成像仪(VTI)，用于盆底组织的三维弹性成像和脱垂的定性，以提高盆底疾病的诊断和治疗水平。我们的临床数据表明，VTI有可能预测发生脱垂的风险，并为手术修复的最佳方法提供洞察。

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.