Neural-Enabled Prosthesis with Sensorimotor Integration

描述(申请人提供)：尽管假体技术有了许多进步，但现有系统在肢体丧失后完全恢复功能的能力明显有限。这些限制体现在可以实现的活动类型、执行任务的容易程度和丰富的体验上。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能力假肢的无缝集成。 我们的生物工程研究伙伴关系建议开发一种先进的假体系统，该系统使用植入周围神经束的电极，为上肢截肢者提供感觉反馈和假体的主动意志控制。我们将追求两个具体目标。在该项目的第一个目标，将重点放在感觉，我们将开发一个系统，可以很容易地评估在人体受试者的试验。这项工作将以一种新颖的方式利用成熟的植入式神经刺激技术来引发有意义的手部张开和握力感觉。这项技术将通过临床部署假手系统在横径截肢者身上进行设计和实施。 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。这项技术的增强版将提供刺激传入纤维以产生感觉的能力，以及从传出纤维记录信号以控制假体的能力。该系统的一个关键特征是双向通信(与植入的刺激器之间)，速度能够实现假体的实时运动控制。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展示。 拟议的工作将汇集一个多学科团队，他们拥有亚利桑那州立大学的康复、生物医学工程、无线和传感器技术开发、运动学和神经生理学方面的专业知识，亚利桑那州斯科茨代尔的亚利桑那州梅奥诊所的手外科和职业治疗实践，亚利桑那州菲尼克斯的假体实践，国际领先的医疗神经植入设备公司，以及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成员。我们的长期目标是临床交付假体系统，最终将从假体向用户提供多模式感官感知，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120多万截肢者，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任务中受益，并为他们提供更多的手指和拇指运动和灵活性，此外还减少了对视觉注意力的要求。

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.