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.

概括骨盆器官脱垂（POP）是一种高度普遍的状况，影响美国40-50％的妇女在她们期间一生。尿失禁（UI）最多影响48％的妇女。流行音乐和UI在女性中都更为普遍而不是男性，随着年龄的增长，他们的患病率也会增加。除了身体和生活质量影响之外，这些疾病会引起明显的发病率。 POP和UI的真实病因及其变体观察到在个人中，并不完全理解。这些疾病被认为具有共同的病原体，结缔组织和骨盆底肌功能障碍的弱化（弹性变化）。这到80岁时，女性或POP的终身手术风险约为20％。流行手术失败子宫韧带悬浮液的率为61.5％，arap孢子韧带固定组的速率为70.3％据报道了代表性的研究。如果骨盆差异患者，可以进行大量改善地板条件进行成像和生物力学诊断测试；结果可以送入患者特定的最佳治疗。在第一阶段研究中，阴道触觉的概念α-概率设计了超声成像探针，并在一项试点研究中证明了其成像性能。触（压力）和超声（解剖，应变）图像融合为雌性骨盆底提供了新的见解通过生物力学映射的条件在多个测试中。在第二阶段，我们将设计和建造一个阴道触觉超声影像仪（TIUSV）的生产β-蛋白质，该型将结合I期产品开发过程的课程。我们将通过基准测试对其进行验证，并在多站点临床中验证它研究，准备并向FDA提交510（k）申请。