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%的女性在其一生中受到影响。大多数成年女性都会出现子宫阴道支持的丧失，然而，脱垂的真正病因和个体差异还不完全清楚。阴道壁、结缔支持组织和肌肉弹性的变化被认为是盆腔器官脱垂发展的重要因素。我们建议开发一种名为阴道触觉成像仪（VTI）的设备，用于可视化和评估骨盆底组织的力学性能。VTI基于触觉成像（TI）技术，其原理与手动触诊相似。在第一阶段，我们将设计和建立一个原型的VTI与触觉传感器阵列和运动跟踪传感器。开发的VTI软件将支持真实的时间数据处理和可视化。我们计划制作一个逼真的设置模仿女性骨盆底VTI台验证和操作员培训。30例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。申报器械将定量评价阴道壁的多种机械和结构特性，如杨氏模量、弹性对比、异常组织的大小和形状，提供脱垂表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高度流行的疾病，影响美国至少50%的女性。大多数成年女性都会失去子宫阴道支持。阴道壁、结缔支持组织和肌肉弹性的变化被认为是盆腔器官脱垂发展的重要因素。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向弹性特性。该FastTrack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像仪（VTI），以改善盆底疾病的诊断和治疗。我们的初步数据表明，VTI有可能预测发生脱垂的风险，并为手术修复提供最佳方法。

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.