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。一些子宫阴道支持的丧失发生在大多数成年女性，然而，脱垂的真正病因和个体之间的差异尚不完全清楚。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，用于可视化和评估盆底组织的力学特性。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，我们将设计和建造一个带有触觉传感器阵列和运动跟踪传感器的VTI原型机。开发的VTI软件将支持实时数据处理和可视化。我们计划制造一个逼真的装置，模拟女性骨盆底，用于VTI实验验证和操作员培训。一项涉及30名患者的临床研究将支持VTI的优化，特别关注检查程序、探头设计、触觉数据可视化和特征计算算法。该装置将定量评估阴道壁的多种力学和结构特性，如杨氏模量、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。公共卫生相关性：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。大多数成年妇女都有子宫阴道支持的丧失。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。到目前为止，还没有标准化和非侵入性的工具来准确评估阴道的周弹性特性。本快速通道项目的目标是开发用于盆底组织弹性成像和脱垂表征的阴道触觉成形仪（VTI），以改善盆底疾病的诊断和治疗。我们的初步数据表明，VTI具有预测脱垂风险的潜力，并为外科修复的最佳方法提供见解。

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 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.