SBIR Phase I: Design and validation of a novel skin-contacting electrode to provide pelvic floor toning for treatment of female stress urinary incontinence

SBIR 第一阶段：设计和验证新型皮肤接触电极，为治疗女性压力性尿失禁提供盆底调节

• 批准号: 1519784
• 负责人: Gloria Kolb
• 金额: $ 15万
• 依托单位: Elidah, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2016-06-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1519784&HistoricalAwards=false
• 关键词: SBIR; Phase; Design; validation; novel

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the expedited development of a novel non?]surgical medical device and therapeutic treatment for the approximately 1 in 3 women over the age of 30 who suffer from urinary incontinence, two thirds of whom, in part due to notable deficiencies of available solutions, elect to live without treatment while their symptoms progressively worsen. Urinary incontinence, although a very private concern, has far?]reaching physical, psychological, social, and economic implications. For example, urinary incontinence has been found to reduce health-related quality of life measures on par with depression, incontinence is the number one reason for admittance into nursing homes, and the annual cost to the US healthcare system is estimated at $25 billion. Through design and validation activities this project will demonstrate the functionality of a wearable device that provides discreet, comfortable, easy?]to?]use therapy for female stress urinary incontinence. The technological understanding gained through this work lays the groundwork for subsequent development of a commercially viable, FDA cleared product that will enhance the lives of tens of millions of American women.The proposed project provides a new framework for wearable therapeutics by enabling the patient to treat incontinence via discreet surface electrical stimulation without interruption to daily activity. Current non?]surgical care often involves electrical stimulation via intravaginal probe, a treatment most woman are not willing to adopt or maintain. The goal of this project is to demonstrate the ability of a contiguous array of cutaneous electrodes placed proximate the perineal tissue to deliver sufficient electrical muscle stimulation to promote pelvic floor toning, and further to maintain this efficacy under conditions associated with continuous wear. Building on a successful proof?]of?]concept prototype, multiple candidate designs will be developed, fabricated and validated using benchtop models. Testing will explore challenges with maintaining electrode?]skin contact during patient mobility and effective management of bodily fluids (i.e. leakage). Throughout the project, increasingly complex models will be utilized, concluding with assessment in human cadaveric tissue. The project is expected to identify a preferred candidate electrode design suitable for future evaluation in a human clinical study, FDA clearance and product commercialization.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是加快开发一种新的非？]为大约三分之一的30岁以上患有尿失禁的妇女提供外科医疗器械和治疗，其中三分之二的人选择不接受治疗，而她们的症状却在逐渐恶化，部分原因是现有解决方案明显不足。尿失禁，虽然是一个非常私人的问题，有多远？]达到生理、心理、社会和经济影响。例如，尿失禁已被发现与抑郁症一样降低与健康相关的生活质量，尿失禁是进入疗养院的首要原因，美国医疗保健系统的年度成本估计为250亿美元。通过设计和验证活动，该项目将展示可穿戴设备的功能，提供谨慎，舒适，容易？]是吗？]女性压力性尿失禁的治疗方法通过这项工作获得的技术理解为后续开发一种商业上可行的、FDA批准的产品奠定了基础，该产品将改善数千万美国妇女的生活。拟议的项目为可穿戴治疗提供了一个新的框架，使患者能够通过谨慎的表面电刺激治疗失禁，而不中断日常活动。目前没有？]外科护理通常包括通过阴道内探针进行电刺激，这是大多数妇女不愿意采用或维持治疗。本项目的目标是证明靠近会阴组织放置的皮肤电极连续阵列能够提供足够的肌肉电刺激，以促进骨盆底色调，并在持续佩戴相关条件下进一步保持这种功效。#21453;的成功证明）。的？]概念原型，多个候选设计将开发，制造和验证使用台式模型。测试将探索维护电极的挑战？]患者活动期间的皮肤接触和体液的有效管理（即泄漏）。在整个项目中，将使用越来越复杂的模型，最后在人体尸体组织中进行评估。该项目预计将确定一种首选的候选电极设计，适用于人体临床研究、FDA批准和产品商业化中的未来评价。