Neural-Enabled Prosthesis with Sensorimotor Integration

描述（由申请人提供）：尽管假肢技术取得了许多进展，但现有系统在肢体丧失后完全恢复功能的能力方面受到极大限制。这些局限性表现在可以完成的活动类型、完成任务的难易程度以及经验的丰富程度上。真正先进的假肢系统将需要完整的感觉运动生活系统与先进的高性能假肢无缝集成。 我们的生物工程研究伙伴关系建议开发一种先进的假肢系统，该系统使用植入周围神经束内的电极，为上肢截肢者提供假肢的感觉反馈和主动意志控制。将追求两个具体目标。在该项目的第一个目标，这将集中在感觉，我们将开发一个系统，可以很容易地在人体试验中进行评估。这项工作将利用成熟的植入式神经刺激技术，以一种新的方式，以引起有意义的感觉，手打开和握力。这项技术将通过在经桡截肢者中临床部署假手系统来设计和实施。 在第二个目标中，我们将专注于使用神经接口来提供感觉和控制的双重能力。该技术的增强版本将提供刺激传入纤维以引发感觉的能力和记录传出纤维以利用信号控制假体的能力。该系统的一个关键特征是双向通信（与植入的刺激器之间），其速度能够实现假体的实时感觉运动控制。这项技术将被设计和开发，其能力将在使用动物模型的实验中得到证明。 拟议的工作将汇集一个多学科团队，该团队在康复，生物医学工程，无线和传感器技术开发，亚利桑那州立大学的运动学和神经生理学，亚利桑那州斯科茨代尔的马约诊所的手部手术和职业治疗实践，亚利桑那州凤凰城的假肢实践，一家领先的国际医疗神经植入设备公司，美国领先的肌电和外部动力假肢系统制造商。在FDA流程和技术转让方面具有专业知识的关键顾问将成为指导委员会的一部分。我们的长期目标是假体系统的临床交付，最终将从假体向用户提供多模态感官感知，并通过捕获用户的意图来提供对假体的动态控制。仅在美国就有超过120万截肢者，其中70%的人肘部以下截肢。 这项新技术将使这些用户在日常生活中受益，并为他们提供更多的手指和拇指运动和灵活性，以及减少对视觉注意力的需求。

DESCRIPTION (provided by applicant): Though there have been many advances in prosthetic technologies, existing systems are significantly limited in their ability to fully restore function after limb loss. These limitations are manifest in the types-of activities that can be achieved, the ease with which the tasks can be performed and the richness of the experience. Truly advanced prosthetic systems will require seamless integration of the intact sensory-motor living system with advanced highly capable artificial limbs. Our bioengineering research partnership proposes to develop an advanced prosthetic system that uses electrodes implanted within the fascicles of peripheral nerves to provide upper extremity amputees with sensory feedback and active volitional control of the prosthesis. Two specific aims will be pursued. In the first aim of the project, which will focus on sensation, we will develop a system that can be readily evaluated in trials with human subjects. This work will utilize well-established implantable neural stimulation technology in a novel manner to elicit meaningful sensations of hand opening and grip force. This technology will be designed and implemented through clinical deployment of a prosthetic hand system in transradial amputees. In the second aim, we will focus on using the neural interface to provide the dual capabilities of sensation and control. This enhanced version of the technology will provide both the ability to stimulate afferent fibers in order for eliciting sensations and the ability to record from efferent fibers for harnessing signals to control the prosthesis. A key feature of this system will be bidirectional communication (to and from the implanted stimulator) at speeds that enable real-time sensorimotor control of the prosthesis. This technology will be designed and developed and its capabilities will be demonstrated in experiments using an animal model. The proposed work will bring together a multidisciplinary team with expertise in rehabilitation, biomedical engineering, wireless and sensor technology development, kinesiology and neurophysiology from Arizona State University, hand surgery and occupational therapy practice at Mayo Clinic Arizona in Scottsdale, AZ, aprosthetics practice in Phoenix, AZ, a leading international medical neural implant device company, and a leading U.S. manufacturer of myoelectric and externally powered prosthetic arm systems. Key consultants with expertise in FDA processes and Technology Transfer will be part of the steering committee. Our long term goal is clinical delivery of prosthetic systems that will ultimately provide multimodal sensory perception to the user from the prosthesis and provide dynamic control of the prosthesis by capturing the intent of the user. More than 1.2 million amputees live in the US alone and of these 70% have below elbow amputations. The new technology will benefit these users in daily living tasks and provide them increased digit and thumb movement and dexterity, in addition to decreased requirement for visual attention.