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Publication Number
US-9301711-B2
Publication Date
2016-04-05
Expiration Date
Abstract
A method of identifying a change in the health of a nerve during a surgical procedure includes determining a sensitivity of the nerve at a first time, determining a sensitivity of the nerve at a second time, and providing an indication to a user corresponding to a change in the sensitivity of the nerve from the first time to the second time. In each instance, the sensitivity of the nerve is determined by providing an electrical stimulus via an electrode disposed on a distal end portion of an elongate medical instrument, and monitoring a magnitude of a mechanical response of a muscle innervated by the nerve.
Core Innovation
The invention relates to a neural monitoring system and a method of identifying a change in the health of a nerve during a surgical procedure. The method determines a sensitivity of the nerve via Mechanomyography periodically throughout the surgical procedure, where the nerve extends within an intracorporeal treatment area and innervates a muscle of the subject. The nerve sensitivity is determined based on an electrical stimulus delivered through an electrode on a distal end portion of an elongate medical instrument and a mechanomyography output signal received by a non-invasive mechanical sensor mechanically communicated with the muscle.
The method provides an indication to a user corresponding to a difference in nerve sensitivity between a first time during the procedure and a second time during the procedure. The difference in nerve sensitivity corresponds to the change in the health of a nerve, including embodiments where the difference is based on response magnitude or sensitivity metrics derived from the mechanomyography output signal. The approach includes comparing a baseline nerve function value to a later value during the procedure, including during a retest.
The system and method include sensing and processing to distinguish mechanically induced responses from an artificially induced mechanical response and to generate user indication using thresholding and display graphics. The documented embodiments include monitoring during psoas retraction and assessing nerve root decompression efficacy in lumbar approaches involving L2–L4 nerves, with the elongate instrument including embodiments with electrodes integrated into retractor blades.
Claims Coverage
The partial content identifies two independent claims: clm-00001 and clm-00004. Across these, the core inventive coverage contains multiple inventive features related to periodic Mechanomyography-based nerve-sensitivity determination, non-invasive sensing of an induced muscle mechanical response, and user indication based on a difference between first and second time measurements.
Periodic nerve sensitivity determination by Mechanomyography
Determining a sensitivity of the nerve via Mechanomyography periodically throughout the surgical procedure.
User indication based on difference between first time and second time nerve sensitivity
Providing an indication to a user corresponding to a difference in nerve sensitivity between a first time during the procedure and a second time during the procedure, wherein the difference in nerve sensitivity corresponds to the change in the health of a nerve.
Electrical stimulus from distal electrode on elongate medical instrument with non-invasive mechanomyography sensing
Providing an electrical stimulus via an electrode disposed on a distal end portion of an elongate medical instrument configured to extend within the intracorporeal treatment area; receiving a mechanomyography output signal generated by a non-invasive mechanical sensor disposed in mechanical communication with the muscle of the subject, the mechanomyography output signal corresponding to a mechanical movement of the muscle that is induced by the electrical stimulus.
Periodic nerve health change identification using mechanically induced response magnitude
Determining a sensitivity of the nerve periodically throughout the surgical procedure by providing an electrical stimulus via an electrode disposed on a distal end portion of an elongate medical instrument; monitoring a magnitude of a mechanical response of the muscle, wherein the mechanical response of the muscle is artificially induced by the electrical stimulus; and providing an indication to a user corresponding to a difference between the magnitude of the mechanical response at a first time and the magnitude of the mechanical response at a second time, wherein the difference is indicative of a change in the health of the nerve.
Mechanomyography output signal from non-invasive mechanical sensor mechanically communicating with muscle
Monitoring the magnitude of the mechanical response includes receiving a mechanomyography output signal generated by a non-invasive mechanical sensor disposed in mechanical communication with the muscle, the mechanomyography output signal corresponding to a mechanical movement of the muscle that is induced by the electrical stimulus.
The independent claims broadly cover periodic Mechanomyography-based determination of nerve sensitivity during surgery using an electrode on a distal end of an elongate instrument and non-invasive mechanical sensing of an induced muscle movement, with user indication derived from a difference between first and second time measurements and corresponding to a change in nerve health.
Stated Advantages
Provides an indication to a user corresponding to a difference in nerve sensitivity between a first time and a second time during the surgical procedure.
The difference in nerve sensitivity corresponds to a change in the health of a nerve.
Documented Applications
Monitoring during psoas retraction.
Assessing nerve root decompression efficacy in lumbar approaches involving L2–L4 nerves (including foraminotomy, laminectomy, and discectomy).
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