Abstract:
A myographic probe for detecting an electrical signal produced by a muscle and for reducing the influence of electrode disturbances. The probe includes electrodes and a disturbance reducing interface covering each electrode thereby segragating the electrodes from the muscle. Electrode disturbances include problems such as those related to the motion of the electrodes, changes in the pressure applied to the electrode, and/or intermittent contact with sourrounding tissue. The disturbance reducing interface is ion permeable and is, when dry, less conductive than the electrodes. The disturbance reducing interface may comprise a matrix of permeable material such as a mesh, foam, or other porous materials. The probe may be in the form of a catheter and be advantageously used in a human cavity such as the oesophagus. Another advantage of the invention is the possibility of using electrodes which are different from conventional wound wire electrodes.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to an apparatus for reducing disturbances induced in a signal measurement or recording, in particular, but not exclusively, by movement of the electrodes or changes in the pressure applied to the electrodes. 
     2. Brief Description of the Prior Art 
     Oesophageal recording of diaphragm electromyogram (EMG) has traditionally been problematic due to the low amplitude of the EMG signal relative to the artifactual disturbances such as, in particular, the so-called electrode motion artifacts. At high gain settings, large electrode motion artifacts lead to saturation of the output of the preamplifier, thereby causing a temporary loss of the EMG signal. This problem of the prior art makes EMG recording very difficult during dynamic manoeuvres, such as for example rapid shallow breathing or panting. 
     OBJECTS AND SUMMARY OF THE INVENTION 
     A first object of the present invention is to provide a technology capable of reducing disturbances induced in a measurement or recording by: 
     movements of detecting electrodes; 
     changes in the pressure applied to these electrodes; or 
     other mechanical influence on the electrodes, generally referred to as motion artifacts. 
     Another object of the present invention is to reduce the amplitude of motion artifacts relative to the amplitude of the EMG signal to thereby reduce the possibility for saturation of the preamplifier. 
     A third object of the present invention is to overcome the problems of the prior art related to low signal-to-artifact ratio. 
     A further object of the present invention is to improve bipolar electrode measurements of diaphragm electromyogram (EMG). 
     In a preferred embodiment of the invention, there is provided a measurement apparatus for detecting an electrical signal produced by a muscle while reducing signal disturbances caused by motion artifacts, the measurement apparatus comprises: 
     a) a probe; 
     b) at least one electrode mounted on said probe; and 
     c) a disturbance reducing interface attached to said probe and covering said at least one electrode, the interface being ion permeable and segregating said at least one electrode from the muscle. 
     The objects, advantages and other features of the present invention will become more apparent upon reading of the following non restrictive description of preferred embodiments thereof, given by way of example only with reference to the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In the appended drawings: 
     FIG. 1 is a schematic representation of a set-up of an EMG analysis system; 
     FIG. 2 is a side elevation view of the free end section of an oesophageal catheter on which an array of electrodes of the EMG analysis system of FIG. 1 is mounted; 
     FIG. 3 is a longitudinal, partial cross sectional view of the free end section of the oesophageal catheter of FIG. 2, showing an individual matrix of permeable material applied to each separate electrode of the array; 
     FIG. 4 is a longitudinal, partial cross sectional view of the free end section of the oesophageal catheter of FIG. 2, showing a continuous matrix of permeable material applied to and spanning the entire electrode array; 
     FIG. 5 is a partial perspective view of the free end section of an oesophagpal catheter, showing an array of semicircular electrodes and a continuous matrix of permeable material applied to and spanning the entire array of semicircular electrodes; 
     FIG. 6 is a partial perspective view of the free end section of an oesophageal catheter, showing an array of button electrodes which can be circular, square, rectangular, or of any other shape, and a continuous matrix of permeable material applied to and spanning the entire array of button electrodes; 
     FIG. 7 is a longitudinal, partial cross sectional view of the free end section of an oesophageal catheter, showing an electrode embedded in the material of the catheter, and a matrix of permeable material applied to the embedded electrode; 
     FIG. 8 is a longitudinal, partial cross sectional view of the free end section of an oesophageal catheter, showing a stud electrode and a matrix of permeable material applied to the stud electrode; 
     FIG. 9 is a partial perspective view of the free end section of the oesophageal catheter of FIG. 7, showing an array of electrodes such as shown in FIG. 7, embedded into the material of the catheter; 
     FIG. 10 is a partial perspective view of the free end; section of an oesophageal catheter, showing an array of button electrodes covered by a matrix of permeable material applied to the outer surface of the oesophageal catheter; 
     FIG. 11 is a partial perspective view of the free end section of an oesophageal catheter, showing an array of button electrodes as well as an array of grounding electrodes; and 
     FIG. 12 is an end cross sectional view of the array of button electrodes of FIG. 10 covered by the matrix applied to the outer surface of the oesophageal catheter. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention relates to a technology capable of reducing disturbances induced in an electrical signal measurement and/or recording by movement of detecting electrodes or changes in the pressure applied to these electrodes. The electrodes are conductive elements used to detect electrical activity. The range of applications of the present invention includes electrical signal measurement and/or recording wherein electrodes are immersed in an eleclectrolyte (so-called wet electrodes). A typical example is the measurement and/or recording of diaphragm electromyogram (EMG), oesophageal peristalsis, or ECG with electrodes positioned on a catheter which in turn is introduced in the oesophagus. 
     Although the preferred embodiments will be described hereinafter with reference to oesophageal catheters and an application to the measurement of diaphragm electromyogram (EMG), it should be kept in mind that it is within the scope of the present invention to envisage other applications for this technology using other types of catheters or probes. 
     Referring to FIGS. 1 and 2, to measure EMG activity of the diaphragm  11  of a human patient  14 , an array of electrodes such as  12  are mounted on the free end section  15  of an oesophageal catheter  13 , with an inter-electrode distance d (FIG.  2 ). The distance d is adjusted in relation to body size; distance d will be larger for an adult than for an infant. The catheter  13  is a hollow tube having a diameter related to body size; the diameter will be smaller for infants than for adults. The catheter diameter, electrode size as well as the inter-electrode distance d may also vary in relation to the purpose of the catheter use. 
     As shown in FIG. 1, the catheter  13  is introduced into the patient&#39;s oesophagus through one nostril or the mouth until the array of electrodes  12  is situated at the level of the gastro-oesophageal junction. Of course, positioning of the electrode array comprising a series of differentially and axially arranged electrode pairs (for example electrode, pairs  1 - 7  of FIG. 2) is guided by the electrocardiographic (ECG) recordings and the diaphragm EMG. Alternatively, the electrodes  12  are monopolar electrodes differentiated in a computer, for example computer  19  of FIG.  1 . When required, ground is obtained through a separate, grounding electrode structure  25  (FIG.  1 ). 
     Positioning of an electrode at the oesophageal hiatus (where the oesophagus passes through the diaphragm is guided by visual inspection and/or computer algorithms studying the intensity, shape and polarity of ECG and diaphragm EMG signals. When the electrode is close to the oesophageal hiatus, i.e. next to the heart, ECG signal amplitude is high. If the electrode array is positioned close to the mouth (away from the heart), ECG signals present lower amplitudes at the proximate electrodes, and higher amplitudes at the distal electrodes. If the electrode array is positioned too far in the stomach, ECG has a high amplitude at the proximate electrodes of the array and a low amplitude at the distal electrodes. If the electrode array spans the region of the heart, ECG signals will show a time shift along the electrode array. If the electrodes are positioned away from the heart, ECG signals show no time lag. Diaphragm EMG signals obtained through electrode pairs located above and below the diaphragm have opposite polarities (with no time shift). EMG signals obtained on the same side of the diaphragm show the same polarity (and no time shift). The characteristics described in this paragraph will help the operator to adequately position the array of electrodes. 
     According to a preferred embodiment, an electrode  12  is mounted on the free end section  15  of the catheter  13  by winding stainless steel wire (not shown) around catheter  13 . The wound stainless steel wire presents a rough surface smoothed out by solder, which in turn is electroplated with nickel, copper and then gold or silver. Use of other metallic elements such as semicylindrical electrodes  21  (FIG.  5 ), button electrodes  22  and  23  (FIG.  6 ), etc., could be contemplated. The button electrodes can be arranged into a longitudinal linear array (electrodes  22 ), or at least one button electrode (see  23 ) can be angularly offset from the electrodes  22  about the longitudinal axis of the catheter section  15 . 
     For larger diameter feeding tubes or catheters, electrodes such as electrode  26  in FIG. 7 can be embedded into the material  27  of the feeding tube or catheter  28 . FIG. 9 shows a longitudinal array of electrodes  26  embedded into the material  27  of the free end section of the oesophageal catheter  28 . FIG. 9 also shows the electric wires such as  30 , embedded in the material  27  of the catheter  28 , and individually connecting each electrode  26  to the amplifiers  16  of FIG.  1 . In the example of FIGS. 7 and 9, the electrodes  26  are oval. The electric wires such as  30  in FIG. 9 individually connect each electrode such as  26  with a respective input of the monopolar or differential (depending on the monopolar or differential arrangement of the electrodes  12  or  26 ) amplifiers  16  (FIG.  1 ). Obviously, these electric wires  30  follow the catheter such as  28  from the respective electrodes such as  26  to the corresponding amplifiers  16 ; the electric wires  30  can be embedded in the material such as  27  of the catheter such as  28  or passed separately outside (see for example  45  in FIG. 10) or inside (see for example  46  in FIG. 10) the catheter lumen  47  depending on the intended application. The electric wires such as  30  transmitting the EMG signals collected by the various electrodes such as  26  are necessarily electrically insulated from each other and preferably surrounded by a conductive mesh constituting a shield against external disturbances. 
     Referring now to FIG. 8, a stud electrode  31  is illustrated. Each stud electrode  31  is mounted in a hole  32  made through the wall of an oesophageal catheter  33 . 
     The electrodes such as  34  in FIG. 10 can also be applied by means of glue or any other suitable adhesive material or compound, including double adhesive tape. 
     In the example of FIGS. 10 and 12, a linear array of oval electrodes  34  is mounted on the outer surface  44  of a catheter  36  comprising two longitudinal lumens  47  and  48 . Referring to FIG. 12, each electrode  34  is applied to the catheter surface  44 . As described in the foregoing description, the electric wires (see  45  and  46 ) for individually connecting the electrodes  34  to the amplifiers  16  will extend either inside lumen  47  (see  46  in FIG.  10 ), inside lumen  48 , outside the catheter  36  (see  45  in FIG.  10 ), or embedded in the material of the catheter  36 . 
     FIG. 11 is a partial perspective view the free end section of an oesophageal catheter  37 , comprising a longitudinal, linear array of button electrodes  38 . FIG. 11 also shows an example of grounding electrode structure (see  25  in FIG.  1 ). In the example of FIG. 11, the grounding electrode structure comprises a helical array of grounding electrodes  39  mounted on the outer surface  40  of the catheter  37 . Of course, the array of grounding electrodes  39  is centered on the longitudinal axis of the catheter  37  and presents the general configuration of a cylindrical helix. 
     Pressure sensors, pH sensors, thermistors and other detector devices can be added onto the catheter in accordance with the requirements of the intended application. 
     Referring back to FIG. 1, the group of amplifiers  16  amplifies and band-pass filters each EMG signal. The amplified EMG signals are sampled by a personal computer  19  through respective isolation amplifiers of a unit  18 , to form signal segments of fixed duration. Unit  18  supplies electric power to the various electronic components of the amplifiers  16  and isolation amplifiers while ensuring adequate isolation of the patient&#39;s body from such power supply. The unit  18  also incorporates bandpass filters included in the respective EMG signal channels to eliminate the effects of aliasing. The successive EMG signal segments are then digitally processed into the personal computer  19  after analog-to-digital conversion thereof. This analog-to-digital conversion is conveniently carried out by an analog-to-digital converter implemented in the personal computer  19 . The personal computer  19  includes a monitor  40  and a keyboard  41 . 
     It is believed to be within the capacity of those of ordinary skill in the art to construct suitable amplifiers  16  and an adequate isolation amplifiers and power supply unit  18 . Accordingly, the amplifiers  16  and the unit  18  will not be further described in the present specification. 
     To eliminate the problems related to motion of the electrode, changes in the pressure applied to the electrode, and/or intermittent contact with surrounding tissue, a motion artifact reducing interface is applied to the electrode surface. The problems listed above can grouped as disturbances; the motion artifact reducing interface may therefore also be referred to as a disturbance reducing interface. The motion artifact reducing interface advantageously consists of a matrix of permeable material comprising, for example, a mesh, foam or other porous material, e.g. a fine filament matrix of nylon. The principle of operation is that the matrix of permeable material creates an interface that hosts ions and electrodes and prevents direct contact between the metal surface of the electrode and the surrounding body tissue. The type of permeable material and thickness thereof is not crucial for performance as long as it forms an ion saturated interface producing no direct contact between the electrode and body tissue. However, excessive thickness may cause increased distance between the electrode and muscle, which will weaken the signal strength and lower the frequency content of this signal. 
     As illustrated in FIGS. 3-8 and  10 , the matrix of permeable material is applied to the exposed surface of the electrodes where the ion concentration gradients are largest to reduce mechanically-caused movements of ions. 
     The matrix can be formed by separate single matrices  17  (FIG.  3 ),  29  (FIG. 7) or  42  (FIG. 8) individually applied to or integrated in the exposed surface of each electrode  12  (FIG.  3 ),  26  (FIG. 7) or  31  (FIG.  8 ). For example, each individual matrix  17 ,  29  or  42  can be glued on, or adhere to by other means, the outer surface of the catheter to cover the associated electrode. However no adhesive material may cover the electrode surface. 
     The matrix can also take the form of a continuous matrix  20  (FIGS. 4,  5  and  6 ) or  35  (FIGS.  10  and  12 ). For example, the continuous matrix may form a tube that can be pulled over the catheter to cover the entire span of the array of electrodes  12  (FIG.  4 ),  21  (FIG.  5 ),  22  and  23  (FIG.  6 ), and  34  (FIGS.  10  and  12 ). In the case of a continuous matrix spanning the entire electrode array, the conductivity of the material constituting the matrix, when dry, has to present a conductivity lower than the conductivity of the metal forming the electrodes, whereby electrical conduction is carried out across the matrix, i.e., through the electrolyte. These matrices provide a much more stable voltage with a reduction of the so-called electrode motion induced artifacts on the diaphragm EMG signal. 
     Also, the matrix can either cover the entire circumference of the catheter (see matrices  20  and  17  of FIGS. 3-6) or a portion of the circumference of the catheter (see matrices  29 ,  42  and  35  of FIGS. 7,  8 ,  10  and  12 ). Again these matrices can be adhered to the outer surface of the catheter to cover the electrodes; no adhesive material may cover the electrode surface. 
     Other alternatives (not shown) are (a) to wind or wrap the matrix around the catheter and the electrodes, and (b) to host or embed the electrodes into the matrix. 
     The electrode structure according to the invention can be applied to measurement of the diaphragm electromyogram (EMG) exclusively or in combination with a device for providing feeding/medication/liquid supply to the patient, and emptying of gastric liquids, common to the treatment of patients in need of ventilatory support. The electrode structure is usable to provide diaphragm EMG signals from a plurality of conductive elements which in turn can be used to: 
     monitor diaphragm EMG (frequency, amplitude or power); 
     trigger and control gas flow, gas volume or gas pressure delivered by a mechanical lung ventilator; and 
     control a closed loop ventilator system that will automatically adjust the level of inspiratory support in proportion to changes in the neuro-ventilatory efficiency such that the neural drive remains stable at a desired target level. 
     The closed loop ventilator system control can further use the intensity of the diaphragm electromyogram (EMG) obtained immediately before inspiratory flow occurs to quantify pre-inspiratory breathing efforts. 
     The catheter including the array of electrodes is aimed to be disposed of after a single use; however, when desired, conventional sterilization techniques can be applied in view of re-using the catheter. The catheter can stay in the same patient for extensive periods of time; it is therefore important that the electrodes and matrix be made out of a non-allergen material. 
     Retrocardiac recording of electrocardiogram and oesophageal peristalsis are other possible applications. 
     The electrode structure according to the invention is applicable in all patients on ventilatory support and will enhance the possibility of obtaining spontaneous breathing and of optimizing patient ventilator interaction. There exists also a utility for this electrode structure during anaesthesia for monitoring vital fonctions of the patient. The electrode structure can be used in connection with all kinds of ventilator systems in intensive care unit settings or other wards where assisted ventilation is required. 
     Although the present invention has been described hereinabove with reference to preferred embodiments thereof, these embodiments can be modified at will, within the scope of the appended claims, without departing from the spirit and nature of the subject invention.