Stretchable electronic-bladder interface for neuroprosthetic control

用于神经假体控制的可拉伸电子膀胱接口

• 批准号: 8951115
• 负责人: Timothy M. Bruns
• 金额: $ 18.4万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8951115
• 关键词: Abdomen; Acute; Address; Adverse effects; Affect; Aging; Algorithms; American; Animals; Automobile Driving; Bladder; Bladder Control; Bladder Dysfunction; Bladder neck obstruction; Carbon Nanotubes; Caring; Catheterization; Catheters; Chronic; Clinical; Collaborations; Contracts; Development; Devices; Diabetes Mellitus; Dimensions; Effectiveness; Electric Stimulation; Electrodes; Electronics; Etiology; Evaluation; Event; Funding; Future; Generations; Genital system; Healthcare Systems; Human; Implant; Implantation procedure; Incontinence; Individual; Indwelling Catheter; Intervention; Lead; Lower urinary tract; Medical; Metals; Methods; Microfabrication; Modification; Monitor; Multiple Sclerosis; Muscle; Nerve; Neurologic; Organ; Overactive Bladder; Patients; Pattern; Pelvis; Pharmaceutical Preparations; Pharmacologic Substance; Population; Power Sources; Pregnancy Complications; Preparation; Process; Prostate; Quality of life; Research; Resistance; Risk; Secondary to; Spasm; Spinal cord injury; Spinal nerve root structure; Stretching; Stroke; Structure; Surface; System; Techniques; Technology; Testing; Time; Traction; Urinary Retention; Urinary tract infection; Urination; Viscera; Wireless Technology; age effect; biomaterial compatibility; cohort; density; design; functional restoration; improved; in vivo; internal control; migration; minimally invasive; nervous system disorder; neuroprosthesis; neuroregulation; novel; novel strategies; polydimethylsiloxane; prototype; public health relevance; radiofrequency; research study; response; scale up; success; urologic

 DESCRIPTION (provided by applicant): Millions of individuals have partial or full loss of bladder control. This large population cohort is due to the wide variety of etiologies, from neurological disorders like spinal cord injury and multiple sclerosis to non- neurological deficits like diabetes, pregnancy complications and the effects of aging. Typical medications and interventions like diapers and catheters provide limited benefit or are not well received. Neurostimulators have been developed to drive bladder nerves, however they do not provide fully effective bladder control. We propose an alternate neuroprosthetic approach that interfaces directly with the bladder, towards full closed- loop control. Through this proposal we will develop a stretchable electrode grid that will be placed directly on the bladder exterior surface. Previous research with electrodes on the bladder wall failed due to lead migration and current spread. We will use a novel substrate with stretchable stimulation contacts that maintains a tight fit to the bladder and uses current steering to optimize bladder recruitment, for effective micturition. Integrated within the electrode grid will be strain gauges that will detect the bladder state. In te ultimate implementation, this electrode grid will be wirelessly powered with an external or implanted power source and processing unit, which will also drive pudendal nerve branch stimulation for continence. The objective of this proposal is to develop the stretchable electrode grid, including determining an ideal size and layout for the stimulating electrodes and number and arrangement of the strain gauges to effectively detect bladder stretch. Across several design generations, wired prototypes will first be evaluated in ex vivo preparations followed by acute in vivo experiments. Finally, two four-week in vivo implants will be performed to evaluate the semi-chronic bladder response to the electrode grid. At the end of this proposed study we will have a robust electrode grid that can be scaled up for eventual human use and will have developed system specifications for an optimal wireless control system. Future studies will include implementation of and in vivo testing of a wireless electronics module on the electrode grid and integration of an external control module with pudendal nerve stimulator. Collaboration with clinicians will lead to development of a minimally invasive implant procedure and versatile algorithms for closed-loop control.

 描述（由申请人提供）：数以百万计的人部分或完全丧失膀胱控制。这一庞大的人群群体是由多种病因造成的，从脊髓损伤和多发性硬化症等神经系统疾病到非神经系统缺陷 例如糖尿病、妊娠并发症和衰老的影响。尿布和导尿管等典型药物和干预措施的效果有限，或者没有得到很好的接受。神经刺激器已被开发用于驱动膀胱神经，但它们不能提供完全有效的膀胱控制。我们提出了一种替代的神经假体方法，直接与膀胱连接，实现完全闭环控制。通过这个提案，我们将开发 将直接放置在膀胱外表面的可拉伸电极网格。以前的 由于铅迁移和电流扩散，膀胱壁电极研究失败了。我们将使用一种具有可拉伸刺激触点的新型基底，该基底与膀胱保持紧密贴合，并使用电流转向来优化膀胱募集，以实现有效排尿。电极网格内集成了应变仪，用于检测膀胱状态。在最终实施中，该电极网格将通过外部或植入电源和处理单元进行无线供电，这也将驱动阴部神经分支刺激以实现节制。该提案的目标是开发可拉伸电极网格，包括确定刺激电极的理想尺寸和布局以及应变计的数量和排列，以有效检测膀胱拉伸。在几代设计中，有线原型将首先在离体准备中进行评估，然后进行急性体内实验。最后，将进行两次为期四周的体内植入，以评估膀胱对电极网格的半慢性反应。在这项拟议研究结束时，我们将拥有一个强大的电极网格，可以扩大规模以供最终人类使用，并将开发最佳无线控制系统的系统规范。未来的研究将包括在电极网格上实施无线电子模块并进行体内测试，以及将外部控制模块与阴部神经刺激器集成。与临床医生的合作将导致微创种植手术和用于闭环控制的多功能算法的开发。