Development of an electrical impedance myography (EIM) vaginal device for the evaluation of pelvic skeletal muscles

1篇摘要 2 Bold Type正在开发“SenseWand”，一种无线骨盆底诊断系统（设备和应用程序） 3.应用电阻抗肌电描记术（EIM）评价盆底肌肉健康状况。PFDs很复杂 4种疾病（如盆腔器官脱垂、压力性尿失禁、高张力盆底功能障碍）影响 全球500万女性。据估计，PFDs将影响高达50%的50岁以上的女性。风险 6个因素包括怀孕，分娩，肥胖，衰老和遗传易感性，尽管发病机制 第七，了解不多。因此，PFDs与显著的医疗保健支出相关 8由于缺乏预防措施，目前的干预措施失败率高，需要再治疗。的 9骨骼骨盆底肌肉（PFMs）支持骨盆和腹部内脏，损伤和功能障碍起着重要的作用。 10在PFDs中的作用这些疾病需要相当多的持续评估，以有效地管理症状 11名患者。目前的诊断方法是有限的，没有无创诊断方法可用于 12评价PFM质量。具体来说，我们目前缺乏诊断工具来帮助临床医生更好地诊断 13例患者接受PFDs治疗。 14我们建议开发和评估“SenseWand”，一种无线骨盆底诊断系统 15（设备和应用程序）使用EIM评估骨盆底肌肉健康。EIM适用于微弱的，不可检测的， 通过两个激励电极向肌肉（或肌肉群）提供16个多频电流，并且产生 通过两个感测电极测量17个电压。测量速度快（<2秒/肌肉），操作简单， 18个定量的，高度可重复的。从这些测量中提取的参数与 19种不同的神经肌肉状况，灵敏地跟踪肌肉健康和疾病进展。多项研究 20已经证明了EIM在肌肉损伤或功能障碍的各种领域的广泛应用潜力 21发生。EIM可能对骨盆底肌肉的评估产生特别的影响， 22定量和无痛性尤为重要。 23 Bold Type是一家专注于互联无线医疗设备的产品开发公司。我们的团队已被 24年的产品开发经验，拥有医疗器械、质量和法规事务方面的专业知识。 25我们开发了专有的硬件和软件开发工具包，使我们能够设计和实施 通过利用设计和记录符合以下要求的可重复使用子系统， 27 FDA法规在这些资源的基础上，我们提出了以下具体目标：1）开发一个 28.“SenseWand”：一种无线阴道内EIM设备。2)在10名绝经后妇女中使用SenseWand 29例有症状的前室脱垂患者和10例绝经前未经产对照。3)评价 30 SenseWand与FDA批准的非阴道生物阻抗系统（SFB 7）进行对比，以验证其准确性。

1 Abstract 2 Bold Type is developing the “SenseWand”, a wireless pelvic floor diagnostic system (device and app) 3 to evaluate pelvic floor muscle health using electrical impedance myography (EIM). PFDs are complex 4 conditions (e.g. pelvic organ prolapse, stress urinary incontinence, high tone pelvic floor dysfunction) that impact 5 millions of women worldwide. It is estimated that PFDs will affect up to 50% of women older than 50 years. Risk 6 factors include pregnancy, childbirth, obesity, aging, and genetic predisposition, though the pathogenesis 7 continues to be poorly understood. Consequently, PFDs are associated with significant health care expenditure 8 due to lack of preventive measures, high failure rate of current interventions, and the need for retreatments. The 9 skeletal pelvic floor muscles (PFMs) support the pelvic and abdominal viscera and injury and dysfunction play a 10 role in PFDs. These disorders require considerable ongoing evaluation to be managed effectively in symptomatic 11 patients. Current diagnostic methods are limited, and no noninvasive diagnostic methods are available to 12 evaluate PFM quality. Specifically, we currently lack diagnostic tools to help clinicians better diagnose 13 and treat patients with PFDs. 14 We propose development and evaluation of the “SenseWand”, a wireless pelvic floor diagnostic system 15 (device and app) to evaluate pelvic floor muscle health using EIM. EIM applies weak, non-detectable, 16 multifrequency electrical currents to a muscle (or muscle group) through two excitation electrodes, and resulting 17 voltages are measured via two sense electrodes. Measurements are fast (<2 s/muscle), simple to perform, 18 quantitative, and highly repeatable. Parameters extracted from these measurements correlate strongly with 19 different neuromuscular conditions and sensitively track muscle health and disease progression. Multiple studies 20 have demonstrated wide application potential for EIM in a variety of fields in which muscle injury or dysfunction 21 occurs. EIM could have a particular impact in the assessment of pelvic floor muscles, where its rapid, 22 quantitative and painless nature is especially important. 23 Bold Type is a product development firm specializing in connected, wireless medical devices. Our team has 24 decades of product development experience with expertise in medical devices, quality, and regulatory affairs. 25 We have developed proprietary hardware and software development kits that allow us to design and implement 26 medical devices efficiently by leveraging reusable subsystems that are designed and documented to comply with 27 FDA regulations. Building off these resources we propose the following Specific Aims: 1) Develop a prototype of 28 the “SenseWand”: a wireless, intravaginal EIM device. 2) Validate the SenseWand in 10 postmenopausal women 29 with symptomatic anterior compartment prolapse and 10 premenopausal nulliparous controls. 3) Evaluate 30 SenseWand against an FDA cleared, non-vaginal bioimpedance system (SFB7) to validate its accuracy.