WO2009146427A1 - Procédé et appareil de localisation quantitative de nerfs - Google Patents

Procédé et appareil de localisation quantitative de nerfs Download PDF

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Publication number
WO2009146427A1
WO2009146427A1 PCT/US2009/045689 US2009045689W WO2009146427A1 WO 2009146427 A1 WO2009146427 A1 WO 2009146427A1 US 2009045689 W US2009045689 W US 2009045689W WO 2009146427 A1 WO2009146427 A1 WO 2009146427A1
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WO
WIPO (PCT)
Prior art keywords
nerve
needle
response
detected
intensity
Prior art date
Application number
PCT/US2009/045689
Other languages
English (en)
Inventor
Changwang Wu
Shai Gozani
Xuan Kong
Original Assignee
Neurometrix, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US12/274,759 external-priority patent/US8029313B2/en
Application filed by Neurometrix, Inc. filed Critical Neurometrix, Inc.
Publication of WO2009146427A1 publication Critical patent/WO2009146427A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4821Determining level or depth of anaesthesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4887Locating particular structures in or on the body
    • A61B5/4893Nerves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/36021External stimulators, e.g. with patch electrodes for treatment of pain
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators

Definitions

  • This invention relates to methods and apparatus for electrically stimulating a nerve using a needle and a surface electrode, detecting the nerve response, and localizing the needle to the nerve based upon the characteristics of the detected nerve response. This localization information can then be used to improve the application of regional anesthesia, to apply therapy to the nerve, etc.
  • Nerve localization is a common procedure in the application of regional anesthesia and in the localized treatment of certain neuropathies.
  • the physician passes a needle through the skin and subcutaneous tissue of the patient, and then advances the needle into close proximity to a target nerve, at which point a pharmacologically-active agent (e.g., corticosteroids, lidocaine, etc.) is delivered to the nerve.
  • a pharmacologically-active agent e.g., corticosteroids, lidocaine, etc.
  • One of the clinical challenges associated with NL is the need to position the needle within close proximity to the target nerve, but without physical contact .
  • Electrical nerve stimulation may be used to help guide needle movement during a NL procedure. More particularly, after the needle is inserted in the patient, an electrical stimulator delivers an electrical current through the needle that is high enough (typically a few milliamps) to stimulate the nerve so that a visible muscle contraction response (for a motor nerve) or a patient-detectable sensory response (for a sensory nerve) is obtained. The magnitude of the current is thereafter manipulated (generally decreased) as the needle is being advanced. When targeted muscle contractions are visually observed (or when sensory responses are being reported by the patient) at a low pre-determined current magnitude (typically 0.2—0.5 milliamps), it is believed that the tip of the needle is sufficiently close to the nerve for effective delivery of the pharmacologically-active agent.
  • a low pre-determined current magnitude typically 0.2—0.5 milliamps
  • the assessment of a motor response to the electrical stimulation is based solely on a subjective visual observation of muscle contraction by the user (e.g., a physician or other healthcare provider) .
  • Quantitative and objective measures of motor response intensity are not utilized in current clinical techniques.
  • the stimulation threshold for an observable muscle contraction is higher than that of an electrically recordable response (i.e., a compound muscle action potential, also known as a CMAP) and therefore current methods are not optimally sensitive.
  • the assessment of a sensory response to the electrical stimulation which is critical to judging the proximity of the needle to a target sensory nerve, is based solely on the report of the patient. Again, quantitative and objective measures of sensory response are not utilized in current clinical techniques. Among other things, if the patient has a diminished capability of reporting sensory response (i.e., nerve sensations, or "feeling") because of neuropathy and/or because of sedation, the utility of a conventional nerve stimulator can be highly compromised. This is because a patient's sensory nerve may respond but the patient may not be able to sense it.
  • the target current is typically 0.2-0.5 milliamps (mA) .
  • the target current commonly varies from case to case.
  • the nerve stimulator response may not provide useful information and may even provide misleading information, e.g., when the target nerve has conduction problems and the motor/sensory responses are abnormal. More particularly, patients typically do not undergo a neuropathy diagnosis prior to the NL procedure.
  • the stimulation current may be still higher than the predetermined threshold (0.2-0.5 mA) that is appropriate for a healthy nerve but may not be appropriate for the nerve that has neuropathology. As a consequence, the operator may not believe that the needle is close enough to the target nerve and therefore advance the needle even further, which can result in nerve injury.
  • the nerve stimulators currently in use do not have the capability of logging data and tracking the outcome of the procedure, which can be important for both clinical and medicolegal purposes.
  • the present invention addresses the foregoing problems associated with the prior art by providing a novel method and apparatus for localizing a needle to a target nerve based upon a quantitative nerve localization procedure. More particularly, in the present invention, the target nerve is electrically stimulated using a needle and a surface electrode, the nerve responses are detected, and the needle is localized to the nerve based upon the characteristics of the nerve responses.
  • the target nerve is electrically stimulated using a needle and a surface electrode
  • the nerve response is detected (as one or more motor and/or sensory responses) , processed, quantitatively measured and displayed, with the nerve responses preferably being detected by a detector (or multiple detectors, if necessary) that is connected to the electrical stimulator by a wired or wireless connection;
  • the acquired data is logged (e.g., in memory local to, or embedded in, the electrical stimulator) and the outcome of the NL procedure is tracked;
  • the acquired data is transmitted to a data server (e.g., at a remote location) and a report is created.
  • a data server e.g., at a remote location
  • the novel apparatus of the present invention comprises a needle localization system which comprises a main unit (which includes a stimulator unit) , a detector unit, a data hub unit, and a data storage unit.
  • the stimulator unit applies an electrical stimulus to a nerve at a stimulation site, and the detector unit detects the nerve response at a detection site.
  • the detector unit may be in the same housing as the main unit, or it may be in a separate housing.
  • the detected nerve signal is transferred from the detector unit to the main unit for processing, analyzing, recording, and displaying. Alternatively, the detector unit may process and analyze the detected nerve signal, and then transfer the results to the main unit.
  • the connection between the detector unit and the main unit may be wired or wireless.
  • the main unit transfers the data to the data storage unit (e.g., over a telephone line, the Internet, etc.) via the data hub unit.
  • a method for localizing a needle to a nerve comprising: using the needle to electrically stimulate the nerve, with a known current intensity, so as to evoke a nerve response; detecting the nerve response; analyzing the detected nerve response so as to identify at least one attribute of the same; and confirming that the needle is in the immediate proximity of the nerve based upon known current intensity and at least one identified attribute of the detected nerve response.
  • a method for localizing a medical instrument to a nerve comprising: electrically stimulating the nerve using the medical instrument so as to evoke a nerve response; detecting the nerve response; analyzing the detected nerve response so as to identify at least one attribute of the same; and estimating the proximity of the medical instrument to the nerve based upon known current intensity and at least one identified attribute of the detected nerve response.
  • a method for localizing a needle to a nerve comprising: electrically stimulating the nerve, with a known current intensity, using the needle so as to evoke a nerve response; detecting the nerve response; analyzing the detected nerve response so as to identify at least one attribute of the same; and estimating the proximity of the needle to the nerve based upon known current intensity and at least one identified attribute of the detected nerve response .
  • a method for determining information about a nerve comprising: positioning sensors at a plurality of locations on a test subject; issuing a synchronization signal to each of the sensors so as to establish a common time reference for each of the sensors; using at least one electrode to electrically stimulate the nerve; using the sensors to generate a plurality of nerve traces, wherein each nerve trace is indicative of the nerve response at a given location; and analyzing the plurality of nerve traces so as to determine at least one attribute for each nerve trace, and using the common time reference to place the determined attributes in proper time registration with one another.
  • apparatus for localizing a needle to a nerve comprising: an electrical stimulator connected to the needle for electrically stimulating the nerve, with a known current intensity, so as to evoke a nerve response; at least one sensor for detecting the nerve response; an analysis unit connected to the sensor for receiving the detected nerve response and identifying at least one attribute of the same; and a localizing unit connected to the analysis unit for confirming that the needle is in the immediate proximity of the nerve based upon known current intensity and at least one identified attribute of the detected nerve response.
  • apparatus for localizing a medical device to a nerve comprising: an electrical stimulator connected to the medical device for electrically stimulating the nerve, with a known current intensity, so as to evoke a nerve response; at least one sensor for detecting the nerve response; an analysis unit connected to the sensor for receiving the detected nerve response and identifying at least one attribute of the same; and a localizing unit connected to the analysis unit for confirming that the medical device is in the immediate proximity of the nerve based upon known current intensity and at least one identified attribute of the detected nerve response.
  • apparatus for localizing a needle to a nerve comprising: means for electrically stimulating the nerve, with a known current intensity, using the needle so as to evoke a nerve response; means for detecting the nerve response; means for analyzing the detected nerve response so as to identify at least one attribute of the same; and means for estimating the proximity of the needle to the nerve based upon known current intensity and at least one identified attribute of the detected nerve response .
  • apparatus for determining information about a nerve comprising: sensors positioned at a plurality of locations on a test subject; means for issuing a synchronization signal to each of the sensors so as to establish a common time reference for each of the sensors; at least one electrode for electrically stimulating the nerve; means connected to the sensors for generating a plurality of nerve traces, wherein each nerve trace is indicative of the nerve response at a given location; and means for analyzing the plurality of nerve traces so as to determine at least one attribute for each nerve trace, and using the common time reference to place the determined attributes in proper time registration with one another.
  • Fig. 1 is a schematic block diagram showing one preferred needle localization system formed in accordance with the present invention
  • Fig. 2 is a schematic block diagram showing the main unit and the detector unit of the needle localization system shown in Fig. 1 ;
  • Fig. 3 is a diagram showing the relationship between (i) stimulation current magnitude and (ii) needle-nerve distance;
  • Fig. 4 is a diagram showing a stimulation pulse which may be applied by the needle localization system shown in Fig. 1; and Fig. 5 is a schematic block diagram showing how multiple detector units may be used in conjunction with the present invention.
  • a needle localization system 5 for electrically stimulating a nerve of a patient (also sometimes referred to herein as the test subject) using a needle and a surface electrode, detecting the nerve response, and localizing the needle to the nerve based upon the characteristics of the detected nerve responses.
  • the nerve responses detected by monitoring the muscle innervated by the nerve (in the case of a motor nerve) or by monitoring another portion of the nerve (in the case of a sensory nerve) so as to provide a nerve response trace, and then detecting variations in the nerve response trace which are indicative of nerve response (e.g., variations in the amplitude of the trace) .
  • needle localization system 5 generally comprises a main unit 10 for stimulating a nerve through stimulation electrodes 15 (which may include a mono-polar needle and a surface electrode, or a bi-polar needle) , detecting the nerve responses through an electrode 20, and then processing, quantitatively measuring and displaying the evoked nerve responses via a detector unit 25 and main unit 10.
  • stimulation electrodes 15 which may include a mono-polar needle and a surface electrode, or a bi-polar needle
  • main unit 10 comprises an adjustable, constant current stimulation circuit (also known as “the stimulator") 30 that delivers an electrical stimulus to the stimulation electrodes 15 so as to stimulate a nerve of the patient.
  • the nerve response is detected by electrode apparatus 20 which includes a pair of surface electrodes 35, 40, preferably in conjunction with a reference surface electrode (not shown) .
  • Electrode apparatus 20 is connected to detector unit 25.
  • a main controller 45 operates stimulator 30, and receives the detected nerve signal from detector unit 25.
  • the detected nerve signal (i.e., the nerve response trace) is processed and measured by the system so as to identify variations in the nerve response trace which are indicative of nerve response (e.g., amplitude variations which are indicative of nerve response) .
  • the nerve response may be detected by monitoring the muscle innervated by a nerve (in the case of a motor nerve) or by monitoring another portion of the nerve (in the case of a sensory nerve) so as to provide a nerve response trace, and then detecting variations in the nerve response trace which are indicative of nerve response (e.g., amplitude variations) .
  • the onset of a CMAP event in a nerve response trace may be used to identify a nerve response in a motor nerve.
  • the detected nerve signal may be processed and measured in either detector unit 25 or in main unit 10, or both.
  • Main unit 10 displays this nerve signal measurement and/or the detected nerve signal trace.
  • Main controller 45 may also receive the stimulation current trace and the stimulation voltage trace from stimulator 30.
  • the connection 50 between detector unit 25 and main unit 10 may be wired or wireless. Display 55, audio output 60 and buttons 65, as well as other optional input/output controls, permit a user to interact with the system.
  • the present invention allows the user to assess the motor or sensory nerve response to the electrical stimulation based on the additional quantitative and objective measurement, and visual display, of the nerve response trace, and does not require the user to rely on a subjective visual observation of the strength of a muscle contraction (for motor nerves) or a patient report of sensation (for sensory nerves) .
  • This feature of the present invention is particularly important where the target nerve has reduced response due to neuropathy or patient sedation.
  • needle-nerve distance the stimulation current intensity required to evoke a response decreases, and vice versa.
  • the target current typically 0.2—0.5 mA
  • the needle is considered to be in the proper position to inject the pharmacologically-active agent.
  • the preferred embodiment of the present invention automatically adjusts the stimulation current intensity based on the nerve response signals. This is a major advance over the prior art.
  • needle localization system 5 preferably uses the following approach to automatically adjust the stimulation current intensity based on the detected nerve response signals:
  • the system continuously delivers stimuli with increased intensity (i.e., increased current magnitude) and with a repetition rate in the 1 to 2 Hz range until an evoked nerve response is detected and displayed. This step verifies that a nerve response can be evoked.
  • the system delivers a single stimulus to the patient, and detects, processes and analyzes the evoked nerve response.
  • the stimulation current intensity is decreased.
  • the stimulation current intensity is increased.
  • Steps 4-6 are repeated until the magnitude of the nerve response signal is within the predetermined range.
  • main unit 10 If the stimulation intensity is higher than the target current (typically 0.2—0.5 mA) , main unit 10 signals the user that the system is ready for the needle to be advanced closer to the nerve, and steps 3-8 are repeated.
  • the target current typically 0.2—0.5 mA
  • main unit 10 If the stimulation intensity is equal to, or lower than, the target current, main unit 10 signals the user that the needle may be in the proper position to inject the pharmacologically-active agent.
  • the target nerve response can be evoked with a stimulation current that is equal to, or lower than, the target current (e.g., typically a 0.2-0.5 mA magnitude, using a 100 ⁇ s rectangular pulse width)
  • the target current e.g., typically a 0.2-0.5 mA magnitude, using a 100 ⁇ s rectangular pulse width
  • the appropriate target current which is used to limit further advancement of the needle toward the nerve, and hence is used to confirm proximity of the needle to the nerve, varies from case to case, i.e., from patient to patient, nerve to nerve, etc. Therefore, it is desirable to verify the position of the needle when the target current is achieved and before injection of the pharmacologically-active agent takes place .
  • Fig. 3 is a diagram conceptually describing the relationship between the stimulation current magnitude and the needle-nerve distance.
  • the horizontal coordinate represents the distance (in millimeters) from needle to nerve.
  • the vertical coordinate represents the magnitude of the stimulation current.
  • a stimulation current that has constant magnitude (e.g., a constant magnitude of Al) and a rectangular pulse waveform
  • the nerve response cannot be evoked if the needle-nerve distance is outside the region of line 70 (e.g., if the needle- nerve distance is greater than Xl) . This is because the needle is too far from the nerve and the current intensity is not strong enough to evoke an appropriate nerve response.
  • the nerve response can be evoked if the needle-nerve distance is less than the value defined by line 70 (e.g., if the needle-nerve distance is less than Xl), but greater than the value defined by line 75 (e.g., if the needle-nerve distance is greater than X3) .
  • the nerve response may or may not be evoked if the needle-nerve distance is inside the region of line 75 (e.g., if the needle-nerve distance is less than X3) .
  • the nerve response is less likely to be evoked if the needle-nerve distance is located between line 75 and line 80 (e.g., if the needle-nerve distance is less than X3, but greater than X4), but more likely to be evoked if the distance is less than the value defined by line 80 (e.g., if the needle- nerve distance is less than X4) .
  • the area within line 75 may be referred to as a "blocked area".
  • the blocked area is usually created due to a strong cathode stimulus.
  • Cathode stimulation creates a positive driving force to activate a nerve segment that is directly below the stimulus source, but negative driving force to deactivate the adjacent nerve segments.
  • the negative driving force is usually too weak to block the activated signal propagating through the side sections.
  • the needle stimulus becomes stronger and closer to the nerve, the negative driving force is increased and it may block the activating signal propagating through the nerve's side segments.
  • the nerve does not create a response, and the blocked area may be observed in the stimulus range.
  • this blocked phenomenon is not always observable if the stimulus signal (see Fig.
  • a stimulus signal with a gradual falling edge 85 (Fig. 4) is used to eliminate the "anode breakdown” phenomena by reducing the sudden changes of the nerve transmembrane voltage. Furthermore, it has been found that the stronger the stimulus, the longer that falling edge 85 needs to be.
  • the nerve response can be evoked if the needle-nerve distance is less than the value defined by line 90 (e.g., the needle-nerve distance is less than X2) .
  • the nerve response cannot be evoked if the needle-nerve distance is greater than the value defined by line 90 (e.g., greater than X2) .
  • needle localization system 5 preferably uses the following approach to automatically verify that the needle is close to the nerve :
  • the needle is advanced under guidance from system 5, which stimulates the nerve with stimulation current flowing from anode to cathode (cathode stimulation) .
  • This stimulation current has a rectangular pulse waveform.
  • the current intensity is gradually reduced while the needle is moving and the nerve response has been detected.
  • Advancement of the needle is stopped when the nerve response can be evoked by a stimulation current which has magnitude equal to, or lower than, the target current (typically 0.2-0.5 mA when the stimulation pulse width is 100 ⁇ s) .
  • needle localization system 5 preferably uses the following approach to provide an automated nerve locator: (1) The needle is advanced while stimulating the nerve with a constant stimulation current flowing from anode to cathode (cathodic stimulation) and which has a rectangular pulse waveform. The magnitude of the current is noted as Al in Fig. 3.
  • system 5 may switch the stimulation current direction so that it flows from cathode to anode (anodic stimulation) .
  • the nerve should not respond to the stimulation, so the stimulation is maintained at this level until the nerve responds again.
  • the position of the needle should have crossed line 90 (i.e., the needle-nerve distance is less than X2 mm) .
  • Ending edge 85 of stimulation waveform is changed so that it slowly decreases to 0.
  • the direction of the stimulation current is set so that it flows from anode to cathode (cathode stimulation) . This stimulation current is maintained until the nerve does not respond. At this time, the position of the needle should have crossed line 75 (i.e., the needle- nerve distance is less than X3 mm) .
  • System 5 then advises the user (through the user interface) that the needle is in the proper position for injection of the pharmacologically-active agent .
  • system 5 detects, processes and measures the nerve response signal when the system is used in a nerve localization procedure.
  • a neuropathy in the target nerve can be detected before advancing the needle further. This is a significant improvement over the prior art, and is made possible only because system 5 evokes, detects, processes and measures the nerve response signal. Further details regarding detection of neuropathies in the target nerve are disclosed in one or more of the following patents and patent applications (including the patents and patent applications referenced therein) :
  • main unit 10 is configured so that it can be connected to, and use the inputs from, multiple detector units 25A, 25B, 25C, etc., whereby to acquire signals from electrodes 2OA, 2OB, 2OC, etc., as shown in Fig. 5.
  • the connections between any detector unit 25 and main unit 10 can be wired or wireless. This allows system 5 to detect, process and measure nerve responses from multiple locations simultaneously.
  • a detector unit 25 can be used that is configured with multiple channels (i.e., for connection to multiple pairs of electrodes 20) . These multiple pairs of electrodes may share a common passive electrode.
  • a wireless connection 50 between main unit 10 and detector unit 25 allows the detector unit to detect the nerve response signal without requiring a cable to be used to connect detector unit 25 and main unit 10 (which would be the case if the connection were not wireless) .
  • a wireless connection 50 between main unit 10 and a detector unit 25 can be implemented by using a wireless module such as Bluetooth or other RF transceiver. Other wireless means such as optical units comprising infrared wavelengths can also be used.
  • a wireless module 95 is preferably included in main unit 10
  • a wireless module 100 is preferably included in each detector unit 25.
  • main unit 10 can check the status of the various detector units 25, set the gain of Analog Front End (AFE) 105 (which transmits data to the detector controller 120 through an analog-to-digital converter ADC 107), set waveform acquisition parameters, obtain the waveform data from the detector units, etc.
  • AFE Analog Front End
  • main unit 10 sends a signal to detector unit(s) 25 to start the data acquisition.
  • a signal may be referred to as a "Synchronization Signal”.
  • the synchronization between the stimulation and the data acquisition is preferably implemented as an RF signal (although a wireless optical signal can also be implemented) .
  • needle localization system 5 preferably uses the following approach to provide synchronization between the stimulation and the data acquisition:
  • An RF transmitter 110 in main unit 10 transmits a Synchronization Signal, which is preferably an RF signal modulated with a modulation signal.
  • the modulation signal may be a digital signal with a pre-defined bit combination, e.g., 11010110.
  • An RF receiver 115 in detector unit 25 receives the Synchronization Signal sent from main unit 10, and detects the modulation signal of the RF signal .
  • Detector unit 25 may send a message to main unit 10 to acknowledge that it receives a valid Synchronization Signal. Detector unit 25 will start the data acquisition. The detector controller 120 records the time when the detected modulation signal arrives. The duration from the time the modulation signal is detected to the time the data acquisition starts will be sent to main unit 10.
  • the detector unit may send a message to main unit 10 when it receives an invalid Synchronization Signal. Main unit 10 may then repeat the process again from Step 1 above until synchronization is successful or until the system times out.
  • wireless module 95 may be used as the RF transmitter so that RF transmitter 110 can be eliminated.
  • wireless module 100 may be used as the RF receiver so that RF receiver 115 can be eliminated.
  • Main unit 10 of the present invention records the data and outcome of the stimulator-guided nerve localization procedure for both clinical and medicolegal purposes.
  • the information recorded in main unit 10 may include but is not limit to:
  • the data recorded by system 5 can be transferred to a hub 125.
  • the connection 130 between hub 125 and main unit 10 can be wired or wireless.
  • Hub 125 receives the data and preferably transfers it to a central data storage 135 via telephone line or Internet or other transmission medium for data storage and report generation.
  • the present invention is discussed in the context of localizing a needle to a nerve.
  • it should be appreciated that it may sometimes be desirable to localize other medical instruments or devices to a nerve e.g., a probe, a sensor, a tissue separator, a cutting device, a biopsy device, a suturing device, a stapling device, an implant, etc.
  • the present invention may be used to localize any of these instruments or devices, or other instruments or devices, to a nerve. Modifications

Abstract

L'invention concerne un procédé de localisation d'une aiguille sur un nerf, le procédé comprenant l'utilisation de l'aiguille pour stimuler électriquement le nerf à une intensité de courant connue, de manière à provoquer une réponse nerveuse, la détection de la réponse du nerf, l'analyse de la réponse détectée du nerf, de manière à en identifier au moins un attribut et la confirmation que l'aiguille est à proximité immédiate du nerf en fonction de l'intensité connue du courant et d'au moins un attribut identifié de la réponse détectée du nerf.
PCT/US2009/045689 2008-05-29 2009-05-29 Procédé et appareil de localisation quantitative de nerfs WO2009146427A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US13020508P 2008-05-29 2008-05-29
US61/130,205 2008-05-29
US12/274,759 2008-11-20
US12/274,759 US8029313B2 (en) 2007-11-20 2008-11-20 Disposable needle electrode with identification, and alterable, connector interface

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WO2009146427A1 true WO2009146427A1 (fr) 2009-12-03

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012155190A1 (fr) * 2011-05-13 2012-11-22 National Ict Australia Ltd Procédé et appareil pour mesure de réponse neuronale
US9155892B2 (en) 2011-05-13 2015-10-13 Saluda Medical Pty Limited Method and apparatus for application of a neural stimulus
US9381356B2 (en) 2011-05-13 2016-07-05 Saluda Medical Pty Ltd. Method and apparatus for controlling a neural stimulus
US9386934B2 (en) 2011-05-13 2016-07-12 Saluda Medical Pty Ltd. Method and apparatus for measurement of neural response
US9872990B2 (en) 2011-05-13 2018-01-23 Saluda Medical Pty Limited Method and apparatus for application of a neural stimulus
US9974455B2 (en) 2011-05-13 2018-05-22 Saluda Medical Pty Ltd. Method and apparatus for estimating neural recruitment
US10206596B2 (en) 2012-11-06 2019-02-19 Saluda Medical Pty Ltd Method and system for controlling electrical conditions of tissue
US10368762B2 (en) 2014-05-05 2019-08-06 Saluda Medical Pty Ltd. Neural measurement
US10426409B2 (en) 2013-11-22 2019-10-01 Saluda Medical Pty Ltd Method and device for detecting a neural response in a neural measurement
US10500399B2 (en) 2014-12-11 2019-12-10 Saluda Medical Pty Ltd Method and device for feedback control of neural stimulation
US10568559B2 (en) 2011-05-13 2020-02-25 Saluda Medical Pty Ltd Method and apparatus for measurement of neural response
US10588698B2 (en) 2014-12-11 2020-03-17 Saluda Medical Pty Ltd Implantable electrode positioning
US10632307B2 (en) 2014-07-25 2020-04-28 Saluda Medical Pty Ltd Neural stimulation dosing
US10849525B2 (en) 2015-05-31 2020-12-01 Saluda Medical Pty Ltd Monitoring brain neural activity
US10894158B2 (en) 2015-04-09 2021-01-19 Saluda Medical Pty Ltd Electrode to nerve distance estimation
US10918872B2 (en) 2015-01-19 2021-02-16 Saluda Medical Pty Ltd Method and device for neural implant communication
US11006846B2 (en) 2014-11-17 2021-05-18 Saluda Medical Pty Ltd Method and device for detecting a neural response in neural measurements
US11006857B2 (en) 2015-06-01 2021-05-18 Closed Loop Medical Pty Ltd Motor fibre neuromodulation
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US11172864B2 (en) 2013-11-15 2021-11-16 Closed Loop Medical Pty Ltd Monitoring brain neural potentials
US11179091B2 (en) 2016-06-24 2021-11-23 Saluda Medical Pty Ltd Neural stimulation for reduced artefact
US11191966B2 (en) 2016-04-05 2021-12-07 Saluda Medical Pty Ltd Feedback control of neuromodulation
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5284153A (en) * 1992-04-14 1994-02-08 Brigham And Women's Hospital Method for locating a nerve and for protecting nerves from injury during surgery
US20030088185A1 (en) * 2001-11-06 2003-05-08 Prass Richard L. Intraoperative neurophysiological monitoring system
US20030093006A1 (en) * 2001-11-06 2003-05-15 Neurometrix, Inc. Method and apparatus for the detection of neuromuscular disease using disease specific evoked neuromuscular response analysis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5284153A (en) * 1992-04-14 1994-02-08 Brigham And Women's Hospital Method for locating a nerve and for protecting nerves from injury during surgery
US20030088185A1 (en) * 2001-11-06 2003-05-08 Prass Richard L. Intraoperative neurophysiological monitoring system
US20030093006A1 (en) * 2001-11-06 2003-05-15 Neurometrix, Inc. Method and apparatus for the detection of neuromuscular disease using disease specific evoked neuromuscular response analysis

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