Minimally invasive nerve monitoring device and method
Inventors
Bartol, Stephen • Wybo, Christopher
Assignees
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Publication Number
US-9084550-B1
Publication Date
2015-07-21
Expiration Date
Abstract
A neural monitoring device includes a stimulator configured to provide a stimulus, a mechanical sensor configured to generate an output signal corresponding to a sensed event, and a receiver configured to receive an output signal from the mechanical sensor and determine if the output signal corresponds to the stimulus provided by the stimulator.
Core Innovation
The invention relates to a minimally invasive neural monitoring system that uses a stimulator to provide a stimulus within an intracorporeal treatment area of a subject while monitoring a muscle for a mechanical response. A non-invasive mechanical sensor is placed in contact with an external skin surface and in direct mechanical communication with a muscle, generating an output signal corresponding to the sensed mechanical response.
A processor receives the output signal from the mechanical sensor and provides a first indicator when the sensed mechanical response is attributable to a depolarization of a nerve caused by the provided stimulus, and provides a second indicator when the sensed mechanical response is not attributable to the provided stimulus. The system includes user indications representative that the distal end portion of the elongate stimulator is proximate to the nerve and that it is safe to proceed with a medical procedure.
The description also includes sensor readiness and context discrimination, including contact detection devices that indicate whether the mechanical sensor is in contact with the subject. The device uses decision logic based on signal processing of the mechanical sensor output, including derived signal metrics such as time derivatives of acceleration, comparisons to one or more threshold values, and distinguishing stimulus-induced responses from environmental bumps.
Claims Coverage
The partial content includes two independent claims, a device and a method. Across these independent claims, the inventive features focus on stimulus delivery within an intracorporeal treatment area, non-invasive mechanical sensing of muscle mechanical response in direct mechanical communication with a muscle, and processor-based determination and user indications representing nerve proximity and safety to proceed.
Stimulator and intracorporeal stimulus delivery
A stimulator configured to provide a stimulus within an intracorporeal treatment area of a subject.
Non-invasive mechanical sensing in direct muscle communication
A non-invasive mechanical sensor configured to be placed in contact with an external skin surface of the subject and in direct mechanical communication with a muscle of the subject, and to generate an output signal corresponding to a sensed mechanical response of the muscle.
Depolarization attribution with first and second indicators
A processor configured to receive the output signal from the mechanical sensor, provide a first indicator if the sensed mechanical response is attributable to a depolarization of a nerve caused by the provided stimulus, and provide a second indicator if the sensed mechanical response is not attributable to the provided stimulus.
Distal end electrical stimulation with user indications tied to nerve proximity and safety
Providing an electrical stimulus to a distal end portion of an elongate stimulator, monitoring a muscle for a mechanical response using a non-invasive mechanical sensor placed in contact with an external skin surface of a subject, generating an output signal corresponding to the monitored mechanical response, determining via a processor whether the output signal corresponds to a depolarization of a nerve in response to the stimulus, and providing first and second indications to a user, wherein the first indication is representative that the distal end portion of the elongate stimulator is proximate to the nerve and the second indication is representative that it is safe to proceed with a medical procedure.
The independent claims collectively cover a neural monitoring device and method that combine intracorporeal electrical stimulation with non-invasive mechanical sensing of muscle response, using a processor to attribute the sensed mechanical response to stimulus-caused nerve depolarization and to present first and second user indications representing nerve proximity and safety to proceed.
Stated Advantages
Provides a first indication representative that the distal end portion of the elongate stimulator is proximate to the nerve.
Provides a second indication representative that it is safe to proceed with a medical procedure.
Documented Applications
Monitoring a muscle mechanical response to an electrical stimulus during use of a medical procedure involving an intracorporeal treatment area, where the indications support whether it is safe to proceed.
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