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.

这项小型企业创新研究（SBIR）I期项目的更广泛影响是建立一种非侵入性设备，该设备可以提供足够的电信号，以激活控制膀胱和括约肌功能的内在电路。该技术将重新激活以前的状态神经回路。当前的医学方法集中于症状的管理，而不是恢复功能。实际上，它们通常完全消除膀胱（感觉，存储或排空）的一个功能，以促进另一个功能。非侵入性脊柱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条件。尿失禁，反复发生的尿路感染以及对膀胱排空导管的依赖是麻痹患者遇到的一些膀胱问题。该公司试图以一种称为经皮脊髓神经调节的无创方式刺激脊髓。在初步研究中，有证明这种疗法可以减少迫害者的过度活动，从而增加膀胱容量并降低失禁发作，并促进膀胱控制的感觉成分的重新培训，以改善饱满感。该项目将着重于对设备的重新配置，以使其与家庭使用兼容。这种重新配置包括设计一种用于家庭使用，测试和确认更紧凑设计的电气安全的设备，以及将波形与原型设备进行比较。该装置有可能成为一种新型疗法，用于治疗神经源性下尿路功能障碍（NLUTD）。如果成功，这项技术将为NLUTD患者提供一种方法，以改善膀胱症状而没有药物的副作用或入侵性程序的风险。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的知识分子优点和更广泛的审查标准来通过评估来通过评估来支持的。