LCP Nerve Cuff with Telemetry for Prosthetic Sensation

DESCRIPTION (provided by applicant): Three companies have partnered to develop advanced systems for upper extremity prosthetics control. The combined expertise includes chronic nerve interface technology, bioresistant/biocompatible materials, polymer substrate electronics assembly and packaging, low impedance electrodes, sensory neurophysiology, coding techniques for prosthetic sensation, and advanced control, powered upper extremity prostheses. The specific aim is to improve upper extremity amputee prosthetic dexterity by providing important sensory feedback information beginning with grasp force, and slip detection but ultimately extending to joint angle and other sensory modalities. To accomplish this specific aim, implantable multi-channel peripheral nerve stimulation cuffs to provide prosthetic sensation to amputees will be further developed and marketed. Multi-channel nerve stimulation cuffs allow the input of sensory information with graded activity levels within individual fascicles of the residual median nerve for example. Since individual fascicles of cutaneous afferents are primarily associated with particular areas of the hand, and represented proportional to the importance of the function, the proposed selective stimulation system will provide anatomically appropriate loci of cutaneous perceptions. These implantable devices will have monolithic Liquid Crystal Polymer (LCP) substrates with integral interconnects and electronics with telemetry of power and data. LCP substrates are a novel, dimensionally stable, biocompatible and bioresistant material. This material can be processed in similar fashion to printed circuit boards and integrated circuits using photolithographic and micromachining methods. Prototype devices that are based on the successful Phase I developmental work will be fabricated thoroughly tested and then evaluated in an animal model. Following successful animal testing, 3 devices will be implanted in volunteer amputee subjects for providing sensory feedback from their instrumented powered arms. Appropriate sensors and feedback control software will be developed and fitted to each prosthesis. Where possible quantitative testing and analyses are planned finishing with independent performance evaluations by an independent occupational therapist. Early marketing to physiology groups will help further develop the technology. Based on results of the preliminary human testing, FDA approval will be obtained, limited sales will begin, and a full clinical test will be planned to further refine, evaluate and deploy the technology. LCP Nerve Cuff Project Narrative This new technology for providing sensory information from a prosthetic limb to the correlate neural pathways will substantially improve the quality of life of amputees by dramatically improving the utility of the prosthesis, improving the "body image" of the prosthesis, and may reduce the incidence of phantom pain since the neural pathways will be more normally active. This same technology will find application in re-animation of paralyzed limbs of the spinal cord injured and stroke patients, and restore bladder and bowel function as examples.