Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

用于盆底生物力学评估的阴道触觉成像仪

• 批准号: 8228035
• 负责人: Vladimir Egorov
• 金额: $ 53.72万
• 依托单位: ARTANN LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8228035
• 关键词: 3-Dimensional; Adult; Affect; Algorithms; Architecture; Biomechanics; Breast Cancer Detection; Clinical; Clinical Data; Clinical Research; Computer software; Development; Devices; Diagnosis; Documentation; Elasticity; Etiology; Goals; Grant; Gynecology; Image; Imagery; Imaging Device; Imaging technology; Individual; Knowledge; Laboratories; Legal patent; Manuals; Marketing; Mechanics; Metric; Motion; Muscle; Operative Surgical Procedures; Organ; Outcome; Palpation; Patients; Pelvic Floor Disorders; Pelvic floor structure; Pelvis; Phase; Procedures; Property; Prostate; Ptosis; Quantitative Evaluations; Reconstructive Surgical Procedures; Recording of previous events; Reporting; Risk; Safety; Shapes; Site; Software Design; Speed; Staging; Structure; System; Tactile; Testing; Three-Dimensional Image; Three-Dimensional Imaging; Time; TimeLine; Tissues; Training; United States National Institutes of Health; Vagina; Validation; Woman; base; clinical practice; computerized data processing; data acquisition; design; human IFITM1 protein; improved; insight; multicore processor; multithreading; operation; performance tests; prototype; public health relevance; repaired; safety testing; sensor; software systems; tool; validation studies

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.

描述（由申请人提供）：骨盆器官脱垂是一种高度普遍的状况，一生中影响至少50％的妇女。大多数成年妇女发生了一些子宫阴道支持。但是，尚未完全理解过脱垂和差异的真正病因。阴道壁，结缔组织和肌肉的弹性变化被认为是骨盆器官脱垂发展的重要因素。我们建议开发标题为“阴道触觉成像仪”（VTI）的设备，用于3-D可视化和评估骨盆底组织的机械性能。 VTI基于触觉成像（TI）技术，基于与手动触诊相似的原理。在第一阶段，我们设计并构建了具有触觉传感器阵列和运动跟踪传感器的VTI的1-原型，使用幻影测试了训练程序，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，建议的方法适用于阴道及周围结构的3-D成像以及正常和骨盆器官脱垂条件的表征。在第二阶段，我们计划构建VTI 2-原型，在监管合规性中完成基准验证研究，EMC和安全性测试，以使该设备与200名患者，2个站点和5个操作员一起进行临床验证研究。所提出的装置将定量评估阴道壁的多种机械和结构特性，例如弹性分布，Young的模量，弹性对比度，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。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中的临床实践。 公共卫生相关性：骨盆器官脱垂是一种高度普遍的状况，一生中影响至少50％的妇女。该项目的目的是开发阴道触觉成像仪（VTI），用于骨盆底组织的3-D弹性成像和脱垂表征，以改善骨盆底障碍诊断和治疗。我们的临床数据表明，VTI有可能预测出现脱垂的风险，并洞悉最佳手术修复方法。