High definition pressure mapping and electromyography for female pelvic floor guided therapy

 描述(申请人提供)：尿失禁(UI)和膀胱过度活动症(OAB)在女性中非常普遍，其患病率随着年龄的增长而增加。在一项具有代表性的美国调查中，据报道，UI影响了15%到38%的女性。OAB患病率的估计在不同的研究中差异很大，从3%到43%不等。这些情况在社会上令人尴尬，导致严重的发病率和生活质量影响。这个 盆底肌肉(PFM)构成女性盆底，通过积极支持盆腔器官，并在收缩时用其前部和头部动作关闭盆腔开口，帮助维持可控性。在老年人群中，盆底疾病表现为神经泌尿病理、功能和认知障碍以及组织生物力学条件变化的交集。治疗选择包括手术、植入电极的骶神经调节、药物、骨盆肌肉和膀胱训练，以及电肌肉刺激。到目前为止，还没有标准化的、可重复的工具来以解剖学上的特定方式准确地评估PFM功能，并为UI和OAB治疗应用指导性肌肉刺激。有必要对烤瓷冠状况进行成像和定量评估，以有效地管理这些疾病。我们建议开发一种名为Restore-IT的新设备，用于实时可视化PFM强度和EMG活动，并在特定位置进行有针对性的肌肉模拟，用于指导UI和OAB治疗。该方法基于我们最近发表的5项专利中披露的阴道触觉成像技术，并将其与肌电(EMG)成像融合在一个探针中用于引导治疗。在第一阶段，我们计划开发Restore-ITα原型，对其治疗指导所需的成像性能进行台架验证和临床评估。

 DESCRIPTION (provided by applicant): Urinary incontinence (UI) and overactive bladder (OAB) are highly prevalent in women and their prevalence is increased with the age. In a representative United States survey, UI was reported to affect from 15% to 38% of women. The OAB prevalence estimates vary considerably among studies, ranging from 3% to 43%. These conditions are socially embarrassing, causing significant morbidity and quality of life impact. The pelvic floor muscles (PFM) form the floor of the female pelvic basin and help maintaining continence by actively supporting the pelvic organs and closing the pelvic openings with their anterior and cephalad action when contracting. In the older population, pelvic floor disorders represent the intersection of neuro-urinary pathology, functional and cognitive impairments, and changing biomechanical conditions of tissues. The treatment options include surgery, sacral neuromodulation with implanted electrodes, medications, pelvic muscle and bladder training, and electrical muscle stimulation. To date, there is no standardized, reproducible tool to accurately assess the PFM function in anatomically specific manner, and to apply guided muscle stimulation for UI and OAB therapy. There is a need in imaging and quantitative assessment of PFM conditions for the effective management of the disorders. We propose to develop a new device entitled Restore-IT for real time visualization of PFM strength and EMG activity and targeted muscle simulation at specified locations for guided UI and OAB therapy. The proposed approach is based on the Vaginal Tactile Imaging technology, we disclosed recently in 5 issued patents, and its fusion with electromyographic (EMG) imaging in one probe to be used for the guided therapy. In the Phase I, we plan development of a Restore-IT α-prototype, bench verification and clinical assessment of its imaging performance needed for the therapy guidance.