Neural Prosthetic Control of Continence and Micturition

描述（由申请人提供）：由于神经系统疾病或损伤（如脊髓损伤（SCI））导致的膀胱控制丧失具有破坏性影响。脊髓损伤导致膀胱排空失去自主控制，膀胱反射过度和膀胱括约肌协同作用障碍。这些因素通常会导致输尿管反流和梗阻、肾脏感染、长期肾脏损害、自主神经反射障碍发作并伴有血压危险升高、导致皮肤破裂的尿失禁以及频繁的尿路感染。膀胱失控还会产生深远的社会影响，导致生活质量下降，以及从手术、用品和药物方面产生的大量直接医疗费用。本研究的长期目标是开发一种神经假体，以恢复神经系统疾病，特别是脊髓损伤患者的膀胱功能（失禁和排尿）。通过电刺激骶神经根和手术切断骶感觉神经根（背根切断术）来恢复脊髓损伤患者的膀胱排空和尿失禁，已经产生了文献记载的医疗、生活质量和经济效益。然而，现有技术的广泛应用受到潜在候选人对不可逆背根切开术和复杂的外科植入程序的反对。我们提出了一种创新的方法来恢复膀胱功能，使用植入阴部神经的单个多电极神经套，通过电记录来检测膀胱超反射性收缩的开始，通过电刺激阴部生殖器传入神经纤维来阻止新生的膀胱超反射性收缩，并通过电刺激阴部尿道传入神经纤维来产生按需膀胱排空。这种创新的方法与现有的电刺激脊髓根的方法有很大的不同，因为它不需要椎板切除术，不需要对骶感觉神经根进行不可逆转的手术切除，并且刺激系统的传入而不是传出侧。预计这将增加从神经假体技术中受益的个人人数，同时保持记录的好处。这项工作的目的是通过动物模型和脊髓损伤患者的补充实验来证明这种方法的可行性。该项目的成功完成将导致一种有效的神经修复系统的发展，用于恢复膀胱功能。

DESCRIPTION (provided by applicant): Loss of bladder control as a result of neurological disease or injury such as spinal cord injury (SCI) has devastating effects. SCI results in loss of voluntary control of bladder evacuation, bladder hyper-reflexia, and bladder sphincter dysynergia. These factors often lead to ureteric reflux and obstruction, infection of the kidneys, long-term renal damage, episodes of autonomic dysreflexia with dangerous rises in blood pressure, incontinence which contributes to skin breakdown, as well as frequent urinary tract infections. Loss of bladder control also has profound social impact and leads to decreased quality of life, as well as large direct medical costs from procedures, supplies, and medication. The long-term goal of this research is to develop a neural prosthesis to restore bladder function (continence and micturition) in persons with neurological disorders, particularly spinal cord injury. Restoration of bladder evacuation and continence in individuals with SCI by electrical stimulation of the sacral nerve roots and surgical transection of sacral sensory nerve roots (dorsal rhizotomy) has resulted in documented medical, quality of life, and financial benefits. However, the widespread application of existing technology is limited by the objection of potential candidates to the irreversible dorsal rhizotomy and the complex surgical implant procedure. We propose an innovative approach to restoration of bladder function using a single multi-electrode nerve cuff implanted on the pudendal nerve to detect the onset of hyper-reflexive bladder contractions by electrical recording, to arrest nascent hyper-reflexive bladder contractions by electrical stimulation of pudendal genital afferent nerve fibers, and to produce on-demand bladder evacuation by electrical stimulation of pudendal urethral afferent nerve fibers. This innovative approach differs substantially from existing approaches using electrical stimulation of the spinal roots in that it does not require a spinal laminectomy, does not require irreversible surgical transection of the sacral sensory nerve roots, and stimulates the afferent rather than the efferent side of the system. This is expected to increase the population of individuals who can benefit from neural prosthetic technology, while maintaining the documented benefits. The objective of the proposed work is to demonstrate the feasibility of this approach using complementary experiments in an animal model and in persons with spinal cord injury. Successful completion of this project will lead to the development of an effective neural prosthetic system for restoration of bladder function.