Stretchable electronic-bladder interface for neuroprosthetic control

 描述（由申请人提供）：数百万人部分或完全失去膀胱控制。这个庞大的人群队列是由于病因的广泛多样性，从神经系统疾病如脊髓损伤和多发性硬化到非神经系统缺陷。 比如糖尿病、妊娠并发症和衰老的影响。典型的药物和干预措施，如尿布和导管，提供有限的好处或不受欢迎。神经刺激器已经被开发用于驱动膀胱神经，然而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，直接与膀胱接口，实现全闭环控制。通过这项提案，我们将开发 将直接放置在膀胱外表面上的可拉伸电极网格。先前 在膀胱壁上使用电极的研究由于铅迁移和电流扩散而失败。我们将使用具有可拉伸刺激触点的新型基底，其保持与膀胱的紧密配合，并使用电流引导来优化膀胱募集，以实现有效排尿。集成在电极网格内的应变仪将检测膀胱状态。在最终的实施方式中，该电极网格将利用外部或植入的电源和处理单元无线供电，其还将驱动阴部神经分支刺激以进行电刺激。本提案的目的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布置，以有效地检测膀胱拉伸。在几代设计中，将首先在离体制备中评价有线原型，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，以评价对电极网格的半慢性膀胱反应。在这项拟议的研究结束时，我们将有一个强大的电极网格，可以扩大规模，最终供人类使用，并将制定系统规格的最佳无线控制系统。未来的研究将包括电极网格上无线电子模块的实施和体内测试以及外部控制模块与阴部神经刺激器的集成。与临床医生的合作将导致开发微创植入程序和用于闭环控制的通用算法。

 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.