SBIR Phase I: Development of Transcutaneous Electrical Spinal Cord Neuromodulator for Home Use

SBIR 第一阶段：开发家用经皮脊髓电神经调节器

• 批准号: 2112366
• 负责人: Parag Gad
• 金额: $ 25.56万
• 依托单位: SPINEX, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2112366&HistoricalAwards=false
• 关键词: SBIR; Phase; Development; Transcutaneous; Electrical

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to build a non-invasive device that can deliver sufficient electrical signals to activate the intrinsic circuits controlling bladder and sphincter function. This technology will reactivate the previously-dormant neural circuits. Current medical approaches focus on management of symptoms, rather than restoration of function. Indeed, they often completely obliterate one function of the bladder (sensation, storage or emptying) in order to facilitate the other. Noninvasive spinal neuromodulation offers a different approach, with a focus on functional restoration, not functional management.This project addresses a condition that impacts the quality of life of millions of Americans. Urinary incontinence, recurrent urinary tract infections and dependence on catheters for bladder emptying are some of the bladder problems experienced by people with paralysis. The company seeks to stimulate the spinal cord in a noninvasive manner called Transcutaneous Electrical Spinal Cord Neuromodulation. In preliminary studies, it was demonstrated that this therapy can reduce detrusor overactivity to increase bladder capacity and reduce episodes of incontinence, and facilitate retraining of the sensory component of bladder control to improve sensation of fullness. This project will focus on a reconfiguration of the device to make it compatible with home use. This reconfiguration includes designing a portable device for home use, testing and confirming electrical safety of the more compact design, and comparison of waveforms with prototype devices. This device has the potential to become a novel therapy for the treatment of Neurogenic Lower Urinary Tract Dysfunction (NLUTD). If successful, for the first time, this technology will give NLUTD patients a modality to improve their bladder symptoms without the side effects of medications or risks of invasive procedures.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响是建立一个非侵入性的设备，可以提供足够的电信号来激活控制膀胱和括约肌功能的内在电路。这项技术将重新激活之前休眠的神经回路。目前的医疗方法侧重于症状的管理，而不是功能的恢复。事实上，它们经常完全消除膀胱的一种功能（感觉，储存或排空），以促进其他功能。非侵入性脊髓神经调节提供了一种不同的方法，重点是功能恢复，而不是功能管理。该项目解决了影响数百万美国人生活质量的问题。尿失禁、复发性尿路感染和膀胱排空对导管的依赖是瘫痪患者经历的一些膀胱问题。该公司寻求刺激脊髓在一个非侵入性的方式称为经皮电脊髓神经调节。初步研究表明，这种疗法可以减少逼尿肌过度活动，以增加膀胱容量并减少失禁发作，并促进膀胱控制感觉成分的再训练，以改善饱腹感。该项目将侧重于重新配置该设备，使其与家庭使用兼容。这种重新配置包括设计一个家庭使用的便携式设备，测试和确认更紧凑的设计的电气安全性，并与原型设备的波形比较。该器械有可能成为治疗神经源性下尿路功能障碍（NLUTD）的新型疗法。如果成功，这项技术将首次为NLUTD患者提供一种改善膀胱症状的方式，而不会产生药物副作用或侵入性手术的风险。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。