Soft Silicone Electrode Nets: implantable technology for visceral organ neural interfacing and functional evaluation

软硅胶电极网：用于内脏器官神经接口和功能评估的植入技术

• 批准号: 10246110
• 负责人: Robert A Gaunt
• 金额: $ 50.06万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10246110
• 关键词: 3D Print; Acute; Address; Adherence; Affect; Anatomy; Animal Experiments; Animal Model; Animals; Autonomic ganglion; Autonomic nervous system; Benchmarking; Biosensor; Bladder; Catheters; Chronic; Code; Colon; Custom; Development; Devices; Electrodes; Electrophysiology (science); Evaluation; Felis catus; Fiber; Film; Goals; Health; Human; Implant; Inferior hypogastric plexus structure; Intestines; Laboratories; Lower urinary tract; Maps; Measurement; Measures; Mechanics; Medicine; Modeling; Molecular Conformation; Monitor; Muscle; Nerve; Nerve Plexus; Nervous system structure; Neural Pathways; Organ; Organ Model; Overactive Bladder; Pattern; Pelvis; Performance; Peripheral; Peripheral Nerves; Peripheral Nervous System; Physiologic Monitoring; Physiological; Physiology; Positioning Attribute; Quality of life; Recording of previous events; Resolution; Series; Silicones; Stomach; Surface; Technology; Testing; Thinness; Tissues; United States; Urethra; Urinary Incontinence; Visceral; Work; awake; base; biomaterial compatibility; body system; burden of illness; clinically relevant; cost; design; electrical impedance tomography; experimental study; implantable device; improved; in vivo; manufacturing process; nerve supply; neuroregulation; new technology; novel strategies; pressure; prevent; programs; relating to nervous system; sensor; tool

Visceral organs present unique challenges to studying functional physiology and neural control. Visceral organs are often surrounded by a nerve plexus that provides distributed innervation along the organ surface and contain autonomic ganglia that can modulate function locally. Given this complexity, creating functional maps of visceral organ innervation is challenging. Another challenge is measuring organ state itself. This is significantly exacerbated by the fact that many of these organs are soft, elastic, and undergo large volume changes. In this proposal, we will develop soft silicone electrode nets compatible with these unique challenges and that can envelop visceral organs and deploy high-resolution electrodes to arbitrary positions on the organ surface. This approach is based on a 3D printed silicone electrode technology. These electrode nets will be augmented with strain gauge sensors and electrical impedance tomography electrodes to monitor physiological organ state. Ultimately, this new class of devices will 1) be intrinsically soft and elastic to allow conformation with visceral organs that undergo large volume changes, 2) integrate organ state sensors based on strain gauges and electrical impedance tomography, 3) prevent delamination issues typically associated with other thin film electrode manufacturing processes, and 4) allow rapid customization to cost-effectively transition to any organ system in animals or humans. This technology is based on materials that have a history of use in biomedical implants and are therefore potentially suitable for conducting neural mapping and electrophysiological studies of human organs in vivo. We will evaluate device performance using the bladder and urethra as a model due to the challenging interface requirements (e.g. large volume changes) and potential clinical relevance. Overactive bladder and urinary incontinence affects millions of people worldwide, is associated with costs upwards of $60 billion each year in the United States, and leads to significant decreases in quality of life. Electrode nets will be tested in acute cat experiments where we will determine the electrode-tissue mechanical stability, evaluate embedded sensor performance, and develop functional neural maps of the surface of the bladder and urethra. We will also validate device performance in a series of chronic animal experiments where device performance will be monitored for up to four months post-implant. An important feature of this enabling technology and associated manufacturing process is that these devices will be able to be quickly and cost-effectively redesigned to study other visceral organ systems including the stomach, intestines, and colon across a range of animal models as well as humans.

内脏器官对研究功能生理学和神经控制提出了独特的挑战。内脏器官 通常被神经丛包围，神经丛沿着器官表面提供分布式神经支配，并包含 自主神经节可以局部调节功能。鉴于这种复杂性，创建内脏功能图 器官神经支配具有挑战性。另一个挑战是测量器​​官状态本身。这显着 由于许多这些器官是柔软的、有弹性的并且经历较大的体积变化，这一事实加剧了这种情况。 在本提案中，我们将开发能够应对这些独特挑战的软硅胶电极网，并且 可以包裹内脏器官并将高分辨率电极部署到器官表面的任意位置。 该方法基于 3D 打印硅胶电极技术。这些电极网将得到增强 带有应变计传感器和电阻抗断层扫描电极来监测生理器官状态。 最终，这类新型设备将 1) 本质上柔软且有弹性，以允许与内脏的构象 经历较大体积变化的器官，2）集成基于应变计的器官状态传感器和 电阻抗断层扫描，3) 防止通常与其他薄膜相关的分层问题 电极制造工艺，4) 允许快速定制，以经济有效地过渡到任何器官 动物或人类的系统。该技术基于具有生物医学使用历史的材料 植入物，因此可能适合进行神经映射和电生理学研究 人体体内的器官。 由于界面具有挑战性，我们将使用膀胱和尿道作为模型来评估设备性能 要求（例如大体积变化）和潜在的临床相关性。膀胱过度活动症和尿频 失禁影响着全世界数百万人，每年造成的损失高达 600 亿美元 美国，并导致生活质量显着下降。电极网将在急性猫身上进行测试 我们将确定电极组织机械稳定性、评估嵌入式传感器的实验 性能，并开发膀胱和尿道表面的功能神经图。我们还将验证 一系列慢性动物实验中的设备性能，其中设备性能将被监测 植入后最多四个月。这种使能技术和相关制造的一个重要特征 过程是这些设备将能够快速且经济有效地重新设计以研究其他内脏器官 一系列动物模型以及人类的器官系统，包括胃、肠和结肠。