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

开发用于评估盆腔骨骼肌的电阻抗肌动描记 (EIM) 阴道装置

• 批准号: 10822537
• 负责人: Jose Luis Bohorquez
• 金额: $ 38.46万
• 依托单位: BOLD TYPE LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-25 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10822537
• 关键词: Abdomen; Affect; Aging; Amyotrophic Lateral Sclerosis; Anterior; Caring; Cattle; Childbirth; Complex; Computer software; Custom; Denervation; Development; Devices; Diagnosis; Diagnostic Equipment; Diagnostic Procedure; Disease; Disease Progression; Electrodes; Electronics; Evaluation; Failure; Fibrosis; Frequencies; Functional disorder; Genetic Predisposition to Disease; Goals; Growth; Health; Health Expenditures; Health Status; Healthcare Systems; Injury; Intervention; Marketing; Measurement; Measures; Medical Device; Modeling; Muscle; Muscular Atrophy; Muscular Dystrophies; Myography; Nature; Neuromuscular Diseases; Neuromuscular conditions; Nulliparity; Obesity; Occupations; Painless; Participant; Pathogenesis; Patients; Pelvic Examination; Pelvic Floor Disorders; Pelvic Floor Muscle; Pelvic floor dysfunction; Pelvic floor structure; Pelvis; Performance; Physical Examination; Play; Postmenopause; Pregnancy; Premenopause; Preventive measure; Production; Ptosis; Quality of life; Regulation; Regulatory Affairs; Resources; Retreatment; Risk; Risk Factors; Role; Sales; Shipping; Skeletal Muscle; Standardization; Stress Urinary Incontinence; System; Tablets; Testing; Thick; Tissues; United States; Vagina; Variant; Viscera; Woman; deconditioning; design; diagnostic platform; diagnostic tool; efficacy evaluation; electric impedance; electrical potential; experience; improved; noninvasive diagnosis; novel diagnostics; older women; pelvic organ prolapse; product development; prototype; rapid technique; skeletal; software development; success; tool; voltage; wireless

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.

1摘要 2 Bold Type正在开发“SenseWand”，这是一种无线盆底诊断系统(设备和APP) 3应用电阻抗肌图(EIM)评价盆底肌肉健康状况。PFD是复杂的 4种情况(如盆腔器官脱垂、压力性尿失禁、高张力盆底功能障碍) 全世界有500万女性。据估计，产后发育迟缓将影响50岁以上的妇女，比例高达50%。风险 6个因素包括怀孕、分娩、肥胖、衰老和遗传易感性，尽管其发病机制 7仍然鲜为人知。因此，PFDs与巨大的医疗保健支出有关 8由于缺乏预防措施、当前干预措施失败率高以及需要重新治疗。这个 9骨盆底肌(PFM)支持盆腔和腹部内脏，损伤和功能障碍起着重要作用 10在PFDs中的角色。这些疾病需要大量的持续评估，以便在有症状的情况下得到有效的管理 11例患者。目前的诊断方法有限，而且没有非侵入性诊断方法可用于 12对烤瓷修复体质量进行评价。具体地说，我们目前缺乏帮助临床医生更好地诊断 13和治疗PFDs患者。 14我们建议开发和评估“SenseWand”，一个无线盆底诊断系统 15(设备和APP)使用EIM评估盆底肌肉健康。EIM适用于微弱的、不可检测的、 通过两个激励电极向肌肉(或肌群)注入16个多频电流，并产生 通过两个传感电极测量17个电压。测量速度快(2个S/肌肉)，操作简单， 18量化，重复性强。从这些测量中提取的参数与 19种不同的神经肌肉状况，并敏感地跟踪肌肉健康和疾病进展。多项研究 20在肌肉损伤或功能障碍等领域展示了EIM的广泛应用潜力 发生了21起。EIM在评估盆底肌肉方面可能会有特别的影响，在那里它的快速， 22量化和无痛苦的性质尤为重要。 23 Bold Type是一家专门从事联网无线医疗设备的产品开发公司。我们队有 24年的产品开发经验，在医疗器械、质量和监管事务方面拥有专业知识。 25我们开发了专有硬件和软件开发套件，使我们能够设计和实施 通过利用可重复使用的子系统高效地使用26台医疗设备，这些子系统的设计和文档记录符合 27 FDA的规定。在这些资源的基础上，我们提出以下具体目标：1)开发一个原型 28“SenseWand”：一种无线的阴道内EIM设备。2)对10名绝经后妇女进行SenseWand验证 有症状性前脑室脱垂29例，绝经前未产妇10例。3)评估 30 SenseWand与FDA批准的非阴道生物阻抗系统(SFB7)进行比对，以验证其准确性。