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WO2008028572A1 - Dispositif et procédé permettant de mesurer l'activité musculaire - Google Patents

Dispositif et procédé permettant de mesurer l'activité musculaire Download PDF

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Publication number
WO2008028572A1
WO2008028572A1 PCT/EP2007/007450 EP2007007450W WO2008028572A1 WO 2008028572 A1 WO2008028572 A1 WO 2008028572A1 EP 2007007450 W EP2007007450 W EP 2007007450W WO 2008028572 A1 WO2008028572 A1 WO 2008028572A1
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WO
WIPO (PCT)
Prior art keywords
balloon
physiological object
physiological
hand
muscle
Prior art date
Legal status (The legal status 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 status listed.)
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Application number
PCT/EP2007/007450
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English (en)
Inventor
Ashraf Dahaba
Helmar Bornemann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medizinische Universitaet Graz
Original Assignee
Medizinische Universitaet Graz
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Filing date
Publication date
Application filed by Medizinische Universitaet Graz filed Critical Medizinische Universitaet Graz
Publication of WO2008028572A1 publication Critical patent/WO2008028572A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1104—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb induced by stimuli or drugs
    • A61B5/1106—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb induced by stimuli or drugs to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224—Measuring muscular strength
    • A61B5/225—Measuring muscular strength of the fingers, e.g. by monitoring hand-grip force
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/168—Fluid filled sensor housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand

Definitions

  • the invention relates to a device for determining a muscle activity of a physiological object.
  • the invention further relates to a method of determining a muscle activity of a physiological object. Moreover, the invention relates to a program element.
  • the invention relates to a computer-readable medium.
  • the invention relates to a method of using a device for determining a medication induced muscle relaxation of the physiological object.
  • Myography may be denoted as the science of describing muscles, including the study of muscular contraction.
  • MMG Mechanomyography
  • Electromyography (EMG) devices are available (for instance M-NMT module, Datex Ohmeda, Finland) and are based on the measurement of an electric voltage which is generated by a stimulation in a muscle.
  • Acceleromyography is disclosed in Loan PB, Paxton LD, Mirakhur RK, et al., "The TOF-Guard neuromuscular transmission monitor. A comparison with the Myograph 2000", Anaesthesia 1995, 50:699-702, and is based on the measurement of an acceleration of a thumb of a patient.
  • the bending of a piezo strip arranged between two fingers of a patient may be used, generating an electric signal indicative of the degree of bending (see Dahaba AA, Klobucar F, Rehak PH, List WF, "Comparison of a new piezoelectric train-of-four neuromuscular monitor, the ParaGraph, and the Relaxometer mechanomyograph", Br J Anaesthesia, 1999, 82:780-2).
  • a device for determining a muscle activity of a physiological object a method of determining a muscle activity of a physiological object, a program element, a computer-readable medium, and a method of using a device for determining a medication induced muscle relaxation of the physiological object according to the independent claims are provided.
  • a device for determining a muscle activity of a physiological object comprising a pneumatic mechanism adapted for pneumatically determining (or monitoring) the muscle activity of the physiological object.
  • a method of determining a muscle activity of a physiological object comprising pneumatically determining (or monitoring) the muscle activity of the physiological object.
  • a computer-readable medium in which a computer program of determining a muscle activity of a physiological object is stored which, when being executed by a processor, is adapted to control or carry out a method having the above mentioned features.
  • a program element of determining a muscle activity of a physiological object is provided, which program element, when being executed by a processor, is adapted to control or carry out a method having the above mentioned features.
  • a device having the above mentioned features is used for determining a medication induced muscle relaxation of the physiological object.
  • Device control, signal generation and signal processing which may be performed according to embodiments of the invention can be realized by a computer program, that is by software, or by using one or more special electronic optimization circuits, that is in hardware, or in hybrid form, that is by means of software components and hardware components.
  • the term “pneumatic mechanism” may particularly denote a system being operated, operable, powered or inflated by a hydraulic (liquid) pressure or by a compressed gas, like air.
  • the term “pneumatic mechanism” may relate to or may use a medium like a fluid, a liquid, a gas (under pressure), a gel, a semisolid (like mercury); or a solid (for instance a powder or a granulate material).
  • physiological object may particularly denote a human being (child or adult, woman or man), or an animal (for instance a monkey).
  • balloon (or cuff) may particularly denote a physical structure which may be selected, for instance, from the following list:
  • a myograph may be provided in which an inflated balloon is fixed in a palm of a hand of a human being or an animal.
  • the physiological object that is to say the human being or the animal
  • the stimulation may result in a muscle contraction in the hand of the physiological object, thereby modulating or modifying the pressure in the balloon.
  • Such a pressure response may be measured and may be taken as a basis for a decision whether the muscle relaxation of the physiological object has occurred or not.
  • the muscle relaxation characteristics may be monitored or adjusted based on the measurement of the (remaining) muscle activity of a patient, for instance for a surgical operation or the like. Therefore, a simple muscle stimulation in combination with a pneumatic measurement of the degree of muscle activity or muscle relaxation may be carried out according to embodiments of - A -
  • a pneumatic myograph may be provided.
  • a medication induced muscle relaxation may be employed in order to simplify for a surgeon to perform a surgical work with a patient, by a reduction or an elimination of muscle tension.
  • a patient has to be brought in a specific position during surgery.
  • Embodiments of the invention may enable an accurate monitoring of the muscle relaxation and simultaneously a high degree of flexibility in positioning the patient without disturbing the measurement of the muscle activity.
  • a specific nerve for instance the ulnar nerve
  • a rectangular signal with a duration of 200 ms and a frequency of 2 Hz may be applied for 2 seconds ("train-of-four", TOF).
  • TOF train-of-four
  • this treatment may result in a stimulation of the adductor pollicis muscle, resulting in an adduction of the thumb.
  • relaxation i.e., loss of muscle activity
  • this motion is increasingly suppressed, and at a sudden state completely eliminated.
  • MMG mechanomyography
  • force may be measured which is generated by the stimulated muscle. Due to the direct measurement of the clinically relevant parameter (force), the performance of such a system may be satisfactory.
  • EMG electromyography
  • an electric voltage is measured which results from a stimulation in the muscle. The electric voltage may allow to derive relaxation information, however with insufficient accuracy.
  • a balloon may be filled with a medium (for instance a gas and/or a liquid), for instance can be filled with 20 ml of air, and may be put on the palm of the patient.
  • a medium for instance a gas and/or a liquid
  • a plate can be placed or positioned along the forefingers of the open hand and/or along the thumb.
  • Such force transmission elements may allow to efficiently transmit a pressure or force from the thumb onto the balloon, thereby increasing accuracy of the measurement.
  • the hand of the patient may be closed and may be fixed with an elastic bandage.
  • the balloon may be connected to a pressure sensor.
  • the pressure in the balloon without relaxation can be calibrated as a reference value (for instance value "100").
  • a stimulation of the ulnar nerve may be performed using a conventional nerve stimulator. With increasing muscle relaxation (for instance promoted by a medication administered during anesthesia), the force with which the thumb compresses the balloon is reduced, therefore the pressure in the balloon is reduced.
  • the resulting measurement data may then be interpreted to derive a degree of muscle relaxation. Therefore, according to an exemplary embodiment, the clinically interesting target parameter may be directly measured, namely the pressure and/or the force which can (still) be generated by the patient (for instance being subject of an anesthetic treatment).
  • the clinically interesting target parameter may be directly measured, namely the pressure and/or the force which can (still) be generated by the patient (for instance being subject of an anesthetic treatment).
  • a very large flexibility with regard to the (intra-)operative positional opportunities is maintained.
  • Such an embodiment may be used as a module in an anesthesia monitor or as a (separate) stand-alone module for neuromuscular monitoring.
  • the muscle relaxation (for instance under the influence of anesthesia) based on a pressure generated by a patient's muscle force and acting on a balloon in a patient's hand may be measured, wherein the muscle activity may be initiated by a (for instance electric) muscle stimulation.
  • a neuromuscular transmission monitor may be provided, which may be denoted as a pneumatomyograph (PMG), and which may be used for neuromuscular monitoring.
  • PMG pneumatomyograph
  • the pneumatic mechanism may comprise a balloon being inflatable with a medium.
  • the term "pneumatic" may particularly denote that a pressure of a compressible fluid may be measured which a patient exerts on a balloon or the like.
  • a balloon may have an essentially spherical shape. Other geometries are possible, like a flattened elliptic configuration, a cuboid configuration or the like. The shape may be adjusted to an anatomy of a human or animal patient.
  • Such a balloon may be made of a plastic material which may be flexible so as to allow a patient to considerably modify the shape of the balloon when applying a pressure on the balloon.
  • the balloon may be inflatable, that is to say may be pumped up, or the fluid may also be removed from the balloon.
  • the balloon may be adapted to be accommodated in a hand of the physiological object. Therefore, shape, material, and pressure response characteristics may be adjusted to values which are suitable for use with a specific physiological object.
  • the pneumatic mechanism may comprise a medium conduit (like a plastic tube) being in fluid communication with the balloon.
  • a medium conduit may be a hollow tube, for instance made of a plastics material, and connecting the balloon with an inflation unit adapted for inflating the balloon.
  • an inflation unit may be a pressure reservoir like a gas bottle, a pump, a pressure air connection in a lab, etc. Therefore, by coupling the balloon with the inflating unit via the fluid conduit (which may be made of an essentially rigid material and which may have a small inner diameter to reduce "dead volume"), the balloon can selectively be brought in an extended/inflated state or in a loose state.
  • a valve mechanism or the like may be provided between inflation unit and balloon, so that a selective opening or closing of such a valve may allow to adjust the default pressure of the balloon.
  • the device may comprise a fastening element which may be adapted to fasten the balloon in a hand of the physiological object. By fastening the balloon in a hand of the patient, the reliability of the system may be significantly increased since a proper force transmission from the hand to the balloon may be ensured.
  • a fastening element may be an elastic tape binding or bandage which may be wound around a hand of a patient enclosing the balloon, and which may have a fastening mechanism like a click connection, a snap-in connection, or a Velcro fastener.
  • the device may comprise a stimulator unit adapted for stimulating a nerve, particularly the ulnar nerve of the physiological object.
  • the ulnar nerve may be denoted as a nerve that in humans runs down the arm and forearm, and into the hand.
  • Such a stimulator unit may comprise electrodes to be connected to the physiological object for electrically stimulating the physiological object. For instance, two electrodes may be placed on a specific portion of the skin of a patient, and a stimulating electric signal may be applied to the patient, resulting in an activation of a muscle of the thumb.
  • Such a stimulator unit may be programmable by a human user so as to define a stimulation procedure like a time sequence, electric amplitudes, etc.
  • a pressure sensor may be provided to measure a pressure in the balloon (or in the conduit), particularly when being at least partially inflated.
  • the pressure sensor/manometer may be any kind of pressure sensor (for example a MEMS, a pressure gauge, an air speed indicator, a piezo based sensor, a membrane based force sensor, a spring based sensor, or a flow meter) and may be connected in a medium conduit and connected to the balloon.
  • the pressure sensor may detect the time dependence of the pressure in the balloon which may be modified when a muscle is activated in response to a stimulation of a nerve of the physiological object. Therefore, the muscle activity or the muscle relaxation may be measured by the pressure sensor.
  • the conduit connecting the balloon and the pressure sensor may be essentially incompressible so as to prevent that pressure changes in the balloon due to a muscle activity of the patient is manipulated by a compression or expansion of such a conduit. Therefore, the accuracy of the system may be significantly improved.
  • a force transmitting element may be provided and adapted for promoting a transmission of a force from a hand of the physiological object to the balloon.
  • a force transmitting element may be any physical element or component which improves the force coupling between the balloon and the hand.
  • a first rigid element like a plastic strip
  • a second rigid element may be located along a thumb of a palm of the physiological object and may be a plastic strip as well. The two plastic strips may functionally cooperate and may serve as two legs of a lever action unit. Therefore, even small muscle forces may be converted into a significant compression of the balloon in case of an intact muscle activity of the patient.
  • the pneumatic mechanism may be adapted for pneumatically monitoring a muscle relaxation of the physiological object.
  • a muscle relaxation may be a partial reduction or a complete elimination of muscle activity, for instance caused by a muscle relaxants or inhalational anesthetics for example administered to the patient.
  • the device may comprise a user interface unit adapted for enabling a user a control of the device, an operation of the device, and/or an inspection of the muscle activity of the physiological object.
  • a user interface may comprise a display unit (for instance an LCD display, a cathode ray tube, a plasma display device or the like) and may therefore be a graphical user interface (GUI).
  • GUI graphical user interface
  • the user interface may further include input elements like buttons, a keypad, a joystick, a trackball, or even a microphone of a voice recognition system.
  • Such a user interface unit may be a computer or a handheld device assisting a user of the device for convenience.
  • the user interface unit may communicate with a control unit for centrally controlling cooperation of components of the device so as to improve the degree of automation of the system.
  • Systems according to exemplary embodiment of the invention may be used for determining a medication induced muscle relaxation of the physiological object, particularly for determining a dose of a medication to be administered to the physiological object to maintain a muscle relaxation of the physiological object at a desired level. Therefore, during a surgical procedure, an anesthetist may monitor continuously or from time to time the muscle relaxation state of a patient being subj ect of a surgical operation.
  • Fig. 1 illustrates a device for determining a muscle activity of a physiological object according to an exemplary embodiment of the invention.
  • Fig. 2 to Fig. 11 show components of a device for determining a muscle activity of a physiological object and illustrate a method of using such a device according to an exemplary embodiment of the invention.
  • Fig. 12 illustrates a Bland and Airman scatterplot of the pneumatomyograph and a mechanomyograph.
  • Fig. 13 illustrates a regression plot of the pneumatomyograph against the mechanomyograph.
  • Fig. 14 illustrates a Bland and Altaian scatterplot of the pneumatomyograph and the mechanomyograph.
  • Fig. 15 illustrates a regression plot of the pneumatomyograph against the mechanomyograph.
  • Fig. 16 illustrates a mean Tl% and TOF measured by a pneumatomyograph (PMG) and a mechanomyograph (MMG) during muscle relaxation with rocuronium in six patients.
  • PMG pneumatomyograph
  • MMG mechanomyograph
  • Fig. 17 shows a sequence of response signals of a hand of a patient after being excited before and after administering a muscle relaxing agent to the patient.
  • Fig. 18 illustrates geometrical shapes of plate-like rigid elements for a device for determining a muscle activity of a physiological object according to an exemplary embodiment of the invention.
  • FIG. 1 The illustration in the drawing is schematically. In different drawings, similar or identical elements are provided with the same reference signs.
  • a device 100 for determining a muscle activity of a patient according to an exemplary embodiment of the invention will be described.
  • the device 100 comprises a pneumatic mechanism adapted for pneumatically monitoring the muscle activity of the physiological object, as will be explained in the following in more detail.
  • the pneumatic mechanism comprises a compressible plastic balloon 101 having a volume of, for instance, 20 ml in an inflated state, thereby being dimensioned to be accommodated in the hand of an average adult human being as the physiological object.
  • the balloon 101 is made of a flexible plastic material and is inflatable with air.
  • a conduit 102 is foreseen as a hollow tubular component which is essentially incompressible and couples the inflatable balloon 101 for fluid communication with a three-way valve 120.
  • the three-way valve 120 may selectively couple the balloon 101 to a pressure sensor 103 or, via an optional further valve 104, with a gas container 105 or a pump.
  • a bandage 106 is provided which is adapted for fastening the balloon 101 when received or accommodated in a hand of a human patient.
  • the bandage 106 is made of a flexible fabric 107 having an oblong rectangular shape and having a VeI cro fastener element 108 for fastening the bandage 106 when wound around a hand of the patient holding the balloon 101. As can further be taken from Fig.
  • a muscle stimulator unit 109 which is adapted for stimulating a nerve, particularly a ulnar nerve, of the patient.
  • the stimulator unit 109 comprises a control unit 110 controlling operation of the stimulator unit 109, application of electric potentials, etc. and comprises two electrodes 111 connected via cables 112 with the control unit 110.
  • the stimulator unit may stimulate the ulnar nerve which may trigger a motion in the hand of the human, when the muscles of the human patient are in an active state.
  • the pressure sensor 103 is adapted to measure a pressure in the balloon 101 when being at least partially inflated. This pressure may change in the balloon 101 in response to a stimulation of a nerve of the human patient, since this stimulation may result in a muscle motion in the hand.
  • a plate-like rigid element 113 which is shaped and dimensioned to be properly positionable along a thumb of a palm of the human patient.
  • a plate-like rigid element 114 is provided as to a second force transmitting element and is adapted and shaped to be positioned along a finger row of a palm of the human patient.
  • a control unit for instance a computer, a CPU, a microprocessor or the like
  • the control unit 115 may communicate bidirectionally particularly with an input/output unit 116, with the pressure sensor 103, with the valve 104, with the inflation unit 105 and with the muscle stimulator unit 109. Therefore, the control unit 115 may provide each of these and other components of the system 100 with control commands or may receive information from these components.
  • the input/output device 116 may be a user interface which may enable a user to control operation of the device 100 and inspect muscle activity of the human patient.
  • Each of the communication channels 117 may be wired or wireless, hi a wired configuration, the connections 117 may comprise cables, and in a wireless configuration a Bluetooth, infrared or other wireless communication scheme may be implemented.
  • the balloon 101 and both plates 113 and 114 may be integrally formed, that is to say particularly formed as a single piece.
  • the bandage 106 may be fixedly connected to the balloon 101 and/or both plates 113 and 114 to form an integrally formed configuration. This may improve user convenience when operating the device 100. It is also possible to omit the plates 113 and 114. In such a scenario, it may be possible to substitute the plates 113 and 114 by correspondingly positioned hardened portions of the balloon, improving or promoting force transmission. Thus, it is possible that the force transmitting components 113, 114 are integrally formed with the balloon 101.
  • an inflatable balloon 101 is realized using an endotracheal tube (as available, for instance, as a product called Hi-Contour from the company Mallinckrodt).
  • an endotracheal tube as available, for instance, as a product called Hi-Contour from the company Mallinckrodt.
  • Hi-Contour from the company Mallinckrodt
  • a tube component 1102 is shown which is not used in the described embodiment.
  • An interior of the inflatable balloon 101 is coupled for fluid communication with the conduit 102 via an opening 200.
  • An end 201 of the conduit 102 is closed.
  • Fig. 2 illustrates the inflatable balloon 101 together with the tube component 1102.
  • the balloon 101 is dimensioned, shaped and foreseen of such a material that it can be inflated or pumped up with 20 ml of air.
  • Fig. 3 shows a hand 300 of a patient comprising a palm 301 , a thumb 302 and a finger row 303. In the operation state of Fig. 3, the inflatable balloon 101 is positioned on the palm 301 of the patient.
  • the plates 113, 114 are positioned in order to improve the capability of transmitting a thumb 302 motion accurately onto the balloon 101.
  • a thumb motion is indicated schematically with reference numeral 400.
  • the plate 113 is positioned to extend essentially along the thumb 302 up to the palm 301 of the hand 300.
  • the plate 114 is positioned along the finger row 303, in a direction essentially perpendicular to an extension of the fingers 303.
  • the bandage 106 is positioned around the hand 300 to ensure the positioning of the balloon 101 and/or of the plates 113, 114 and simultaneously provides a counter pressure to the force of the inflated balloon 101.
  • Fig. 6 shows the bandage 106 in an operation state in which it is wound around the hand 300 of the human being, and is fastened.
  • the system is properly fixed, and the hand 300 of the patient can be freely moved.
  • Fig. 7 shows a further view of the hand 300 of the patient when the bandage 106 is wound around the hand 300.
  • Fig. 8 shows a nerve stimulator unit 110 which may serve for transmitting pulses through electrodes to the ulnar nerve of the human patient.
  • the stimulator unit 110 comprises an LCD display 700 and control buttons 701.
  • electrodes 111 of the stimulator unit 110 stimulate the ulnar nerve via surface electrodes on the skin or needle electrodes subcutaneous placed through the skin of the arm of the human being.
  • the adduction 400 of the thumb 302 will compress the balloon 101 and will make the pressure sensor 103 to measure a modified pressure in the balloon 101.
  • This information may be transmitted via the connection 117 to the control unit 115 which will output a corresponding information at a display element of the I/O device 116.
  • no adduction 400 or only a reduced or delayed adduction
  • no pressure modification is measured in the balloon 101, and the surgeon can be sure that the patient has no remaining muscle relaxation.
  • a neuromuscular transmission monitor which may be denoted as a Pneumatomyograph (PMG).
  • PMG Pneumatomyograph
  • MMG Relaxometer ® mechanomyo graph
  • the first twitch of the train-of- four (TOF) expressed as percentage of control response and the TOF ratio (T 4 : Ti) were used for evaluating the neuromuscular block.
  • the PMG monitor exhibited no pre-relaxation Ti exceeding 100%. There was no significant difference in the mean (min) ⁇ SD onset time, time to 25% Ti recovery, or time to 0.8 TOF ratio recovery measured by the PMG (1.5+0.3, 21.7 ⁇ 3.3, 40.3 ⁇ 9.9) compared to MMG (1.8+0.6, 22.9+3.1, 40.1+9.6) respectively.
  • the difference in Ti % between the two monitors showed a bias of -0.16%.
  • the limits of agreement were -8% and +8%.
  • the bias for the TOF ratio was -0.009, and the limits of agreement were -0.04 and +0.04.
  • the PMG monitor exhibited no drift phenomenon at recovery.
  • the PMG could precisely indicate the time to tracheal intubation, time to repeat dose administration, as well as full recovery from neuromuscular block at least as efficaciously as the MMG.
  • the PMG has also the advantage of having a simple, small, quick fit sensor, which does not require time to set up or a rigid support of the arm. Thus, the PMG is a reliable clinical monitor for the daily anesthesia practice.
  • the neuromuscular transmission monitor Pneumatomyograph can efficaciously indicate time to tracheal intubation, time to rocuronium repeat dose administration and full recovery from 0.6 mg kg "1 rocuronium neuromuscular block.
  • Mechanomyography has been regarded for many years as the standard method for precise quantification of neuromuscular block (Viby-Mogensen J, Engbaek J, Eriksson LI, et al. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand 1996;40:59-74).
  • the conventional MMG measures the exact force of muscle contraction in response to electric stimulation of a motor nerve. It quantifies the neuromuscular function by measurement of the force displacement.
  • the equipment is rather bulky, takes time to set up, requires a rigid support of the arm in an often crowded operating room. All this limits its clinical use in the daily anesthesia practice.
  • several versatile and small, stand-alone neuromuscular monitoring devices such as the ParaGraph, TOF-Guard and TOF- Watch or the integrated neuromuscular monitoring module M-NMT are all based on either bending of a piezo-strip or correlating the acceleration of a piezo-electrode to the force of the thumb movement.
  • versatility and mobility comes at the expense of accuracy as all these monitors were shown not to accurately correlate to mechanomyography, due to the simple fact that all these monitors are based on a different physiological phenomenon.
  • a neuromuscular transmission monitor is provided, the Pneumatomyograph (PMG) that quantifies the neuromuscular function by measurement of the signal generated from the squeezing of a small balloon between two small plastic strips held by a simple strap in the patient's hand.
  • PMG Pneumatomyograph
  • the two monitors MMG and PMG quantify the neuromuscular function based upon the principle of force transduction.
  • the described study analyzed the PMG by comparing the neuromuscular block of 0.6 mg kg "1 rocuronium (2 x 95% effective dose 2 x EDg 5 ) monitored by the PMG with that monitored by the Relaxometer ® mechanomyograph (Groningen University, Holland, Rowaan CJ, Vandenbrom RHG, Wierda JMKH.
  • the Relaxometer a complete and comprehensive computer-controlled neuromuscular transmission measurement system developed for clinical research on muscle relaxants. J Clin Monit 1993;9:38- 44.).
  • the two monitors were alternately allocated to the left or right hands.
  • the force transducer of the Relaxometer (MMG) was attached to one hand, and the preload on the thumb was maintained within 200-400 g throughout the whole procedure.
  • the PMG balloon was placed between the 2 small plastic strips in the patient's other hand and held by a special strap for simultaneous monitoring, as shown in Fig. 2 to Fig. 11.
  • the Pneumatomyograph (PMG) quantifies the neuromuscular function by measurement of the signal generated from the squeezing of a small balloon between two small plastic strips held by a simple strap in the patient's hand.
  • the balloon was then inflated with 20 ml air. hi response to evoked stimulation of the ulnar nerve, the patient squeezed the PMG balloon. This generated a pressure motion that was directly measured by the PMG pressure transducer. The pressure in the PMG line was calibrated to 100%. The area under the positive voltage wave curve over time was calculated and quantified. The signal was then filtered, amplified, displayed and recorded.
  • the ulnar nerves were stimulated by train-of-four (TOF) stimuli (2-Hz, pulse width 200 ⁇ s, square wave for 2 s) at 12-s intervals.
  • TOF train-of-four
  • T 1 first twitch of the TOF expressed as percentage of control response and the TOF ratio (T 4 : T 1 ) were used for evaluating the neuromuscular block.
  • Table 1 Patients' demographics.
  • T 1 monitored by MMG exceeded 100% (111.9 ⁇ 7.1). MMG required 4.9 ⁇ 1.5 min to establish a stable control response. T 1 monitored by PMG did not exceed 100%.
  • Fig. 12 shows a Bland and Airman scatterplot of the difference between the first twitch (Ti %) of the Pneumatomyograph (PMG) and the mechanomyograph
  • MMG mean of the two measurements, during recovery from neuromuscular block.
  • the middle dotted line represents the bias.
  • the upper and lower dotted lines represent the limits of agreement between the two monitors.
  • the Ti% regression plot showed a linear relationship between the two monitors (see Fig. 13).
  • Fig. 13 illustrates a regression plot of the first twitch (T i%) of the Pneumatomyograph (PMG) against the mechanomyograph (MMG), during recovery from neuromuscular block.
  • T i% the first twitch
  • MMG mechanomyograph
  • Fig. 14 shows a Bland and Altman scatterplot of the difference between the train-of-four (TOF) ratio of the Pneumatomyograph (PMG) and the mechanomyograph (MMG) against the mean of the two measurements, during recovery from neuromuscular block.
  • the middle dotted line represents the bias.
  • the upper and lower dotted lines represent the limits of agreement between the two monitors.
  • Fig. 15 shows a regression plot of the train-of-four (TOF) ratio of the Pneumatomyograph (PMG) against the mechanomyograph (MMG), during recovery from neuromuscular block.
  • the middle dotted line represents the line of identity.
  • Hand temperature ⁇ 32°C could be a contributing factor in the "drift" from baseline (Ti >100%) after full recovery from neuromuscular block (Viby-Mogensen J, Engbaek J, Eriksson LI, et al. Good clinical research practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents. Acta Anaesthesiol Scand 1996;40:59-74). Although the hand temperature of all the study patients was kept constant >34°C the results revealed that MMG was still prone to drift. One possible explanation of this manifestation is that MMG requires frequent preload adjustments in response to even minor repositioning of the patient's hand on its rigid armboard to maintain it within 200-400 g.
  • the PMG monitor exhibited no pre-relaxation Ti exceeding 100%, no drift phenomenon at recovery, and could precisely indicate the time to tracheal intubation, time to repeat dose administration, as well as full recovery from neuromuscular block as efficaciously as the MMG.
  • the PMG has also the advantage of having a simple, small, quick fit sensor, which does not require time to set up or a rigid support of the arm. Thus, the PMG may be a reliable clinical monitor in the daily anesthesia practice.
  • Fig. 16 illustrates a mean Tl% and TOF measured by a pneumatomyograph
  • PMG mechanomyograph
  • MMG mechanomyograph
  • Reference numeral 1600 illustrates a point of time of an injection
  • reference numeral 1601 illustrates a point of time of a state of recovery
  • Reference numeral 1602 indicates a lag time
  • reference numeral 1603 indicates an onset time
  • Fig. 17 shows a sequence of response signals of a hand of a patient after being excited four times, respectively, before and after administering a muscle relaxing agent (during anesthesia) to the patient.
  • Fig. 17 shows a diagram 1700 having an abscissa 1701 along which the time is plotted, and having an ordinate 1702 along which the intensity of a muscle contraction as measured by a pressure sensor in a pneumatic system (as depicted in Fig. 1) is plotted.
  • a first sequence of four equidistant signals 1703 is measured by applying a muscle stimulation pulse to a patient after having mounted the apparatus of Fig. 1 at a hand of the patient. Then, a muscle relaxing substance is administered to the patient at a point of time indicated with reference numeral 1704. After that, a second sequence of four equidistant signals 1705 is measured by applying a muscle stimulation pulse to a patient in an operation state in which the apparatus of Fig. 1 is still mounted at the hand of the patient. As a result of the administration of the muscle relaxing substance, the muscle activity becomes slower and slower.
  • Fig. 18 illustrates alternative geometrical shapes of plate-like rigid elements
  • the plate-like rigid element 1800 is functionally shaped and dimensioned to be properly positionable along a thumb (indicated schematically with reference numeral 1801 ) of a palm of the human patient.
  • a closed main portion of the hand is indicated schematically with reference numeral 1802.
  • the plate-like rigid element 1800 is designed to match with a human hand's anatomy and allows a patient to carry the plate 1800 without pain or inconvenient feeling.
  • the plate-like rigid element 1800 comprises a thickened portion 1803 having a mechanically stabilizing effect. Beyond this, the plate-like rigid element 1800 comprises a thinner elongated portion 1804 to extend along a palm of the patient in a convenient manner.
  • Corners 1805 of the plate-like rigid element 1800 are rounded for convenience.
  • the essentially rectangular plate-like rigid element 1800 is therefore adapted to fit to a human's hand anatomy.
  • the plate-like rigid element 1810 is functionally shaped and dimensioned to be positioned along a finger row of a palm of the human patient of the human patient.
  • the plate-like rigid element 1810 is designed to match with a human hand's anatomy and allows a patient to carry the plate 1810 without pain or inconvenient feeling.
  • the plate-like rigid element 1800 has a straight geometry and comprises an essentially rectangular plate, wherein corners 1811 of the plate-like rigid element
  • a flattened portion is adapted to fit to a human's hand anatomy.
  • a force transmitting element may be provided comprising components 1800, 1810 being designed to match to an anatomy of a human being's hand.

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Abstract

L'invention porte sur un dispositif (100) qui permet de mesurer l'activité musculaire d'un objet physiologique, lequel dispositif (100) comprend un mécanisme pneumatique (101 à 105) apte à mesurer de manière pneumatique l'activité musculaire de l'objet physiologique.
PCT/EP2007/007450 2006-09-05 2007-08-24 Dispositif et procédé permettant de mesurer l'activité musculaire Ceased WO2008028572A1 (fr)

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US82454106P 2006-09-05 2006-09-05
EP06018557 2006-09-05
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US60/824,541 2006-09-05

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009150417A3 (fr) * 2008-06-11 2010-02-11 Imperial Innovations Limited Systèmes de mesure d'habileté motrice
WO2011080237A1 (fr) * 2009-12-28 2011-07-07 Msys Ag Dispositif et procédé permettant de consigner et de mesurer une douleur
US20220031198A1 (en) * 2019-04-16 2022-02-03 Worcester Polytechnic Institute Surgical muscle paralysis measurement device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3898983A (en) * 1973-10-03 1975-08-12 James O Elam Device and method for detecting the degree of muscle relaxation of a medical patient
FR2625092A1 (fr) * 1987-12-24 1989-06-30 Uziel Alain Appareil de surveillance per-operatoire du nerf facial
EP1059064A2 (fr) * 1999-06-09 2000-12-13 Colin Corporation Appareil moniteur de profondeur d'anesthésie
US20020123700A1 (en) * 2001-03-02 2002-09-05 Tung Thomas J.K. Apparatus and method for monitoring neuromuscular function

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3898983A (en) * 1973-10-03 1975-08-12 James O Elam Device and method for detecting the degree of muscle relaxation of a medical patient
FR2625092A1 (fr) * 1987-12-24 1989-06-30 Uziel Alain Appareil de surveillance per-operatoire du nerf facial
EP1059064A2 (fr) * 1999-06-09 2000-12-13 Colin Corporation Appareil moniteur de profondeur d'anesthésie
US20020123700A1 (en) * 2001-03-02 2002-09-05 Tung Thomas J.K. Apparatus and method for monitoring neuromuscular function

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009150417A3 (fr) * 2008-06-11 2010-02-11 Imperial Innovations Limited Systèmes de mesure d'habileté motrice
WO2011080237A1 (fr) * 2009-12-28 2011-07-07 Msys Ag Dispositif et procédé permettant de consigner et de mesurer une douleur
US20220031198A1 (en) * 2019-04-16 2022-02-03 Worcester Polytechnic Institute Surgical muscle paralysis measurement device

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