Amputation Clinical Trial
Official title:
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.
Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external
equipment used to control an electromechanical prosthetic device, together comprise the IMES
System (investigational product, medical device).
Each IMES acts as an independent differential amplifier consisting of custom electronics
housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The
end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse
telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and
forward telemetry is used to transmit power and configuration settings to the sensors. The
coil and associated electronics are housed within the frame of a prosthesis. A control system
that sends data associated with muscle contraction to the motors of the prosthetic joints is
housed in a belt-worn, battery-powered device. A cable attaches the control unit to the
prosthetic frame.
An IMES is implanted into each targeted muscle that will be used to control a function of the
prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would
control fingers opening and another device would control fingers closing.
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