Tactile and ultrasound imaging fusion for functional assessment of the female pelvic floor

触觉和超声成像融合用于女性盆底功能评估

基本信息

批准号：
10325038
负责人：
Vladimir Egorov
金额：
$ 83.88万
依托单位：
ADVANCED TACTILE IMAGING, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-02-08 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10325038
关键词：
Affect Age Algorithmic Software Anatomy Atopobium vaginae Biomechanics Clinical Clinical Research Data Devices Diagnostic tests Disease Disinfection Documentation Effectiveness Elasticity Electromagnetics Electronics Etiology Failure Feasibility Studies Female Functional disorder Goals Grant Image Individual Legal patent Length Letters Ligaments Measurement Medical Morbidity - disease rate Multi-site clinical study Notification Operative Surgical Procedures Patients Pelvic Floor Muscle Pelvic floor structure Pelvis Performance Phase Pilot Projects Postoperative Period Prevalence Process Production Quality of life Reporting Reproducibility Research Resolution Risk Risk Management Safety Secure Side Signal Transduction Site Software Design Speed Stress Structure Suspensions System Tactile Test Result Testing Time TimeLine Tissues Ultrasonic Transducer Ultrasonography United States National Institutes of Health Update Urethra Urinary Incontinence Vagina Validation Variant Woman base biomaterial compatibility data acquisition design imager imaging probe imaging system improved innovative technologies insight men optimal treatments pelvic organ prolapse predictive modeling pressure pressure sensor product development prototype safety testing sample fixation soft tissue surgical risk temporal measurement tissue phantom tool verification and validation

项目摘要

Summary Pelvic organ prolapse (POP) is a highly prevalent condition affecting 40-50% of women in the US during their lifetimes. Urinary incontinence (UI) affects up to 48% of women. Both POP and UI are more common in women than in men, and their prevalence is increased with age. Beyond the physical and the quality of life impacts, these conditions cause significant morbidity. The true etiology of POP and UI and their variations observed among individuals is not entirely understood. These disorders are thought to share common pathogeneses, weakening (elasticity changes) of the connective support tissues and pelvic floor muscle dysfunction. The lifetime surgery risk for either UI or POP in women is about 20% by the age of 80 years. A POP surgical failure rate of 61.5% for uterosacral ligament suspension and 70.3% for sacrospinous ligament fixation groups in a representative study was reported. Substantial improvement is possible if patients with the diseased pelvic floor conditions undergo imaging and biomechanical diagnostic tests; the results of which could be fed into a patient-specific optimal treatment. In the Phase I research, a conceptual α-prototype of a vaginal tactile and ultrasound imaging probe was designed and its imaging performance demonstrated in a pilot study. Tactile (stress) and ultrasound (anatomy, strain) image fusion furnishes new insights into the female pelvic floor conditions through biomechanical mapping in multiple tests. In Phase II, we will design and build a pre- production β-prototype of a Vaginal Tactile Ultrasound Imager (TIUSv), which will incorporate the Phase I lessons in product development process. We will verify it via bench testing, validate it in a multi-site clinical study, prepare and submit a 510(k) application to the FDA.

概括盆腔器官脱垂 (POP) 是一种非常普遍的疾病，影响 40-50% 的美国女性尿失禁 (UI) 影响高达 48% 的女性，POP 和 UI 在女性中更为常见。其患病率随着年龄的增长而增加，除了对身体和生活质量的影响外，这些情况会导致显着的发病率 POP 和 UI 的真正病因及其观察到的变化。人们认为这些疾病具有共同的发病机制，结缔支持组织减弱（弹性变化）和盆底肌肉功能障碍。到 80 岁时，女性发生 UI 或 POP 的终生手术风险约为 20%。子宫骶韧带悬吊组的成功率为 61.5%，骶棘韧带固定组的成功率为 70.3% 代表性研究报告称，如果骨盆患病的患者可能会出现实质性改善。地板状况经过成像和生物力学诊断测试；其结果可以输入到在 I 期研究中，阴道触觉和概念性 α 原型。设计了超声成像探头，并在触觉研究中展示了其成像性能。（压力）和超声（解剖、应变）图像融合为女性盆底提供了新的见解在第二阶段，我们将通过多次测试中的生物力学绘图来设计和构建一个预制模型。阴道触觉超声成像仪 (TIUSv) 的生产 β 原型，其中将包含第一阶段我们将通过实验室测试来验证它，并在多站点临床中进行验证。研究、准备并向 FDA 提交 510(k) 申请。