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，该神经丛沿着器官表面提供分布的神经 可以在本地调节功能的自主神经节。考虑到这种复杂性，创建内脏功能图 器官神经具有挑战性。另一个挑战是衡量器官状态本身。这是显着的 这些器官中的许多人都是软，弹性且体积大的变化，这加剧了这一事实。 在此提案中，我们将开发与这些独特挑战兼容的软硅电极网，并 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。 这种方法基于3D打印的硅电极技术。这些电极网将得到增强 带有应变量表传感器和电阻抗断层扫描电极以监测生理器官状态。 最终，这类新的设备将1）本质上柔软且弹性，以允许与内脏结合 经历大量变化的器官，2）基于应变计的整合器官状态传感器和 电阻抗层析成像，3）防止通常与其他薄膜相关的分层问题 电极制造过程，4）允许快速自定义以成本效益过渡到任何器官 动物或人类的系统。该技术基于具有生物医学使用史的材料 植入物，因此有可能适合进行神经映射和电生理研究 人体器官在体内。 由于具有挑战性的界面，我们将使用膀胱和尿道作为模型评估设备性能 要求（例如大量变化）和潜在的临床相关性。过度活跃的膀胱和尿液 尿失禁会影响全球数百万的人，每年的成本超过600亿美元 美国，并导致生活质量大幅下降。电极网将在急性猫中测试 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，并发展膀胱和尿道表面的功能性神经图。我们还将验证 设备性能在一系列慢性动物实验中，将监视设备性能 植入后最多四个月。这项促成技术和相关制造的重要特征 过程是这些设备将能够快速和成本地重新设计以研究其他内脏 在各种动物模型和人类中，包括胃，肠和结肠在内的器官系统。