Abstract:
A disposal ECG Chest Electrode Template with built-in defibrillation electrodes has a location tab so that the template can be easily, quickly and correctly placed on the patient&#39;s chest during emergency situations. The template and its electrodes is transparent to x-ray allowing it to remain on the patient&#39;s chest throughout x-ray diagnosis and evaluation for so long as monitoring of the heart&#39;s electrical activity is required. The template carries ten electrodes, the standard six precardial electrodes and four limb electrodes. A pair of defibrillation electrodes are incorporated into the template are also correctly located on the patient when the template is placed on the chest by its location tab.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The present invention relates generally to improvements in disposable electrode devices and more particularly pertains to a new and improved template for placing a plurality of electrodes on a patient&#39;s chest.  
           [0003]    2. Description of Prior Art  
           [0004]    An electrocardiogram (ECG) is a painless recording of the heart&#39;s electrical activity. This electrical activity is detected by small metal electrodes which are placed on the patient&#39;s chest and sometimes on the wrists and ankles. The electrical signals detected are carried from the electrodes through wires to an ECG machine. The ECG machine transforms the signals into standard patterns or waves. The different waves represent the different areas of a human heart through which tiny electrical currents flow, causing the heart to contract and relax. The P wave, for example, represents the current in the atria, or the upper chambers of the heart. The QRS complex represents the current in the ventricles. The T wave represents the heart&#39;s rest period as it repolarizes, or recharges electrically between heart beats.  
           [0005]    The paper tracing of the ECG waves produced by the ECG machine shows not only the heart rate and heart rhythum, it can also give important clues about damage to the heart muscle or pericardium, the membrane around the heart. Furthermore, changes in ECG waves from one session to another may reflect the action of certain cardiac medications. ECG abnormalities may also indicate that a serious chemical imbalance exists in the blood which is affecting the heart&#39;s electrical activity. An ECG can distinguish between a heart attack that occurred in the past and one in progress at the time the ECG is being taken.  
           [0006]    Besides obtaining the recording of the heart&#39;s electrical activity during rest, the more important ECG readings are taken while during exercise or while going about normal ambulatory activity. The exercise ECG records heart patterns while a person walks on a treadmill or pedals a stationary bicycle, for example. This technique is also called a stress test. This type of ECG is more likely to spot abnormal heart patterns, and an insufficient blood or oxygen supply to the heart muscle during exercise. Ambulatory ECG or Holter monitoring (ECH) records heart patterns usually over a  24 -hour or longer period of time while a person goes about his daily activities. The standard Holter monitoring process requires that small electrodes that stick to the skin are connected to a portable recording device on a shoulder strap or belt worn under the patient&#39;s clothing. The recorded information can then later be analyzed by a computer and printed out much like a standard ECG. These ambulatory monitoring systems also can be used to transmit heart patterns to a hospital or doctor while a person is having symptoms. When a symptom develops while wearing the ECH, the patient simply dials a telephone number and transmits the readings from the Holter recorder over a telephone line.  
           [0007]    The ECH systems are used generally to detect or monitor abnormal heart rhythms, or arrhythmias, which arise from problems with the electrical conduction system of the heart. Arrhythmias can occur anywhere in the atria or the ventricles of the heart. These arrhythmias can be either too slow or too fast. Abnormally slow rhythms sometimes results from slower firing of impulses, a condition called sinus bradycardia. An abnormally slow heart beat is dangerous. The heart does not pump enough blood to supply the brain and the rest of the body with oxygen. In such cases, episodes of dizziness, light headedness or fainting may occur.  
           [0008]    Abnormally fast heart rhythms, such as for example, atrial fibrillation in which the atria contracts in a rapid uncoordinated manner, reduces the pumping efficiency of the heart. In a person with heart disease, the reduced pumping efficiency may lead to heart failure or stroke. Another more dangerous type of rapid arrhythmia is ventricular fibrillation in which ventricular contractions are rapid and chaotic. This fibrillation prevents the ventricles from pumping blood efficiently and can lead to death within minutes. Ventricular fibrillation is usually reversed with an electrical defibrillator, a device that delivers a shock to the heart. The shock briefly stops the heart from beating and when the heart beat starts again, the SA node is usually able to resume a normal beat.  
           [0009]    The current standard method of obtaining ECG data requires the placement of up to ten single electrodes upon a patient&#39;s chest in order to monitor the heart rhythm and obtain the ECG tracings. The manual placement of these electrodes is tedious with technical error resulting in increased variance from monitor session to monitor session with decreased reproducible results. Moreover, these individual ECG electrodes are produced by a variety of manufacturers in different ways using different materials and styles and having different sensitivities.  
           [0010]    There have been attempts in the prior art to provide a flexible sheet which carries a plurality of fixed electrodes positioned in a specific configuration which allows the placement of these plurality of electrodes on a patient&#39;s chest in a manner which provides consistency in the dimensional relationship between the electrodes on the flexible sheet. However, these prior art methods do not have any way of ensuring that the flexible sheet, with its plurality of electrodes, is placed in the correct position on the patient&#39;s chest every time.  
         SUMMARY OF THE INVENTION  
         [0011]    The present invention permits quick, easy and correct placement of a ten electrode array carried by a flexible template to monitor the electrical activity of a patient&#39;s heart, by a locating tab on the template. A pair of defibrillation electrodes may also be located on the template ready for use, if necessary. The template and electrodes are x-ray invisible so that the template and electrodes need not be removed during diagnostic procedures. The template is adapted to connect to the three or four most popular monitoring and defibrillation machines used by paramedics and in hospital emergency rooms, critical care units, telemetry wards, outpatient Holter and Event monitors. The template also allows quick and accurate placement by the lay person in any setting. The template proves its critical worthiness when applied by the lay person during an out of hospital cardiac event when used in conjunction with an AED.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0012]    The exact nature of this invention as well as its objects and advantages will become readily apparent from consideration of the following detailed description when considered in conjunction with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:  
         [0013]    [0013]FIG. 1 is a schematic illustration of a human chest with individual electrodes located thereon;  
         [0014]    [0014]FIG. 2 is a schematic illustration of the template of the present invention;  
         [0015]    [0015]FIG. 3 is a schematic illustration of a human chest with the template of the present invention located thereon; and  
         [0016]    [0016]FIG. 4 is a schematic illustration of an alternate embodiment of the template of the present invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0017]    [0017]FIG. 1 illustrates the chest  11  of a patient with the outline, for reference, of a left lung  15 , the right lung  13 , left clavicle  19 , right clavicle  17 , left shoulder bone  21 , and the right shoulder bone  23 . A constant point of reference on every patient&#39;s chest is the super sternal notch  27  and the mid-axillary line  29  at the right shoulder  21 .  
         [0018]    [0018]FIG. 1 illustrates the placement of ten electrodes, with seven electrodes located on the left side, and three located on the right side. The six main electrodes,  45 ,  31 ,  33 ,  35 ,  37  and  39 , also known as the precordial electrodes, monitor activity in the heart&#39;s horizontal plane through the lateral and anteroseptal walls. These electrodes are all positive. A left shoulder electrode  49  is the negative electrode. When manually placing these electrodes, they are placed across the chest in successive steps starting from electrode  45  going left to electrode  39 .  
         [0019]    Electrode  45  is a positive electrode that is placed at about the fourth intercostal space to the right of the sternum  25 . Electrode  31  is a positive electrode that is placed in the fourth intercostal space to the left of the sternum  25 . Electrode  33  is a positive electrode that is placed between the fourth and the fifth intercostal spaces. Electrode  35  is a positive electrode that is placed at the fifth intercostal space in the midclavicular line (not shown). Electrode  37  is a positive electrode that is placed at the fifth intercostal space between the midclavicular and the mid-axillary line. Electrode  39  is a positive electrode that is placed in the fifth intercostal space in the mid-axillary line.  
         [0020]    Electrodes  43 ,  47 ,  49 , and  41  act as standard leads in the formulation of Einthoven&#39;s Triangle. The standard leads are bipolar leads because they are composed of two electrodes, one that is negative and one that is positive. The ECG records the difference in electrical potential between them.  
         [0021]    Electrode  49  is placed at the left shoulder for the purpose of providing the positive lead in relationship to electrode  43 . This relationship forms Lead I in Einthoven&#39;s Triangle. Electrode  49  also provides the negative lead in relationship to electrode  41 . This relationship forms Lead III in Einthoven&#39;s Triangle. Electrode  41  is placed at the mid-axillary line on the inferior aspect of the left chest wall for the purpose of providing the positive lead in relationship to electrode  49 . This relationship forms Lead III in Einthoven&#39;s Triangle. Electrode  41  also provides the positive lead in relationship to electrode  43 . This relationship forms Lead II in Einthoven&#39;s Triangle. Electrode  43  is placed at the right shoulder for the purpose of providing the negative lead in relationship to electrode  49 . This relationship forms Lead I in Einthoven&#39;s Triangle. Electrode  43  also provides the negative lead in relationship to electrode  41 . This relationship forms Lead II in Einthoven&#39;s Triangle. Electrode  47  is placed at the mid-axillary line on the inferior aspect of the right chest wall for the purpose of stabilizing the ECG, but this electrode takes no part in lead information.  
         [0022]    As FIG. 1 illustrates, the individual placement of these electrodes is tedious, time consuming, and complicated with respect to their correct location. The chances of the electrodes being incorrectly located in an emergency high-stress situation is more than probable.  
         [0023]    [0023]FIG. 2 illustrates the template  50  of the present invention carrying the 10 electrodes  47 ,  43 ,  45 ,  31 ,  33 ,  35 ,  37 ,  39 ,  41 , and  49  in the arrangement illustrated in FIG. 1. The spacing between each electrode and its placement with respect to the other is correct for the chest of an average sized human. The distances between the electrodes can be modified to accommodate a larger chest by increasing the distances between them, or a smaller chest by decreasing the distances between them. A larger template for large chests, and a smaller template for small chests is equally contemplated.  
         [0024]    For medium sized chests as illustrated, the electrodes are laid out according to the following dimensions. The three electrodes  39 ,  37  and  35  lie on a line  56  that is at an angle  51  from a horizontal line. Angle  51  is approximately ten degrees (10°). Electrode  39  lies along the vertical mid-axillary line  29 . Electrode  37  is spaced from electrode  39  on line  56  by distance  52  which is about six centimeters. Electrode  35  is spaced from electrode  37  by distance  53  which is about six centimeters. The bottom left side electrode  41  is on a line  57  spaced from electrode  39  by about ten centimeters. The line  57  is at an angle  55  from the line  56  of electrodes  39 ,  37  and  35 . Angle  55  is about ninety degrees (90°). Electrodes  31 ,  33  and  35  lie on a line  54  which is at an angle  63  from a vertical line. Angle  63  is approximately forty degrees (40°). Electrode  33  is at a distance  61  from electrode  35 , which is about  4  centimeters. Electrode  31  is at a distance  59  from electrode  33  which is about 4 centimeters. Left shoulder electrode  49  lies along a line  67  which is at an angle  65  from the line  54  of electrodes  31 ,  33 , and  35 . Angle  65  is about ninety degrees (90°). The distance between electrode  49  and electrode  31  is approximately 14 centimeters. In this manner, the seven electrodes on the left side of the chest are accurately located with respect to each other for a medium or average size chest.  
         [0025]    On the right side of the chest, electrode  45  lies along a horizontal line  71  at 12 centimeters from electrode  31 . Right shoulder electrode  43  lies on a line  79  which is at an angle  77  from horizontal line  71  of electrode  45 . Angle  77  is approximately one hundred and thirty-five degrees (135°). The distance between electrode  43  and electrode  45  is approximately 13 ½ centimeters. The bottom right chest electrode  47  lies along a line  89  that is at an angle  81  from line  79  of electrode  43 . The angle  81  between lines  79  and  89  is about seventy degrees (70°). The distance between electrode  47  and electrode  43  is about 18 centimeters. In this manner, the right side three electrodes are accurately located with respect to each other for a medium or average size chest. These ten electrodes are fixed to the template and thereby retain their spatial relationship.  
         [0026]    In order to enable the correct placement of the template  50  on the chest of a patient, the template includes a tab  52  which has a certain length  75  which is approximately ten (10) centimeters and a certain width  73 , approximately four (4) centimeters. The length of the tab  75  is determined for the average size chest. The tab is designed to be easily removed by the patient if the template is to be used on a long-term basis.  
         [0027]    The template is preferably made up of a pad of an electrically conducive gel such as Ludlow Tech Corp. Promeon RG 73 P, electrically insulative and x-ray transparent PE foam, and a removable carrier sheet, such as PTFE. The electrodes may be made of silver/silver chloride metal which are embedded in the pad. Conduction conduits or wires (not shown) made of x-ray transparent metal coated carbon fiber such as produced by Amoco Performance Products, Inc. of Atlanta, Ga. and more specifically described in U.S. Pat. No. 3,677,705, or conductive channels of graphite filled polyvinyl chloride film, known as “Conduction,” and available from Burkhardt/Freeman, Holyoke, Mass. or from Prime Label and Screen, Inc. of New Berlin, Wis. are used to connect each of the electrodes to a connection point  63  on the template  50 . External wires are connected to the internal conduction conduits (not shown) by conductive tabs  63 . It is contemplated that a variety of adapters between the conductive tab  63  and the major pre-hospital and in-hospital cardiac monitor units available today would be part of a kit that includes this ECG electrode template  50 .  
         [0028]    The ECG template  50  is quickly and correctly located on the chest  11  of a patient, as shown in FIG. 3, by placing the top of the tab  52  at the supra sternal notch  27  and the left most precordial electrode  39  on the vertical mid-axillary line  29 , which drops straight down from the shoulder. Once these two points are located, the entire template  50  is smoothed across the chest of the patient on its left and right side, thereby completely locating all ten electrodes.  
         [0029]    In acute response situations where a patient is in great difficulty, it sometimes becomes necessary to defibrillate the patient. The monitoring electrodes on a patient&#39;s chest would have to be removed before defibrillation. The alternate embodiment of the template  54  shown in FIG. 4 includes a pair of defibrillation electrodes  91  and  93  located in the template  54  in relation to the electrodes as shown. The area of electrode  91 , plus the area of electrode  93 , total the required defibrillation surface area of  150  centimeters. Electrode  93  is placed in the right infra-scapular region of the patient&#39;s chest. Electrode  91  is placed on the left side, close to the mid-axillary line. These defibrillation electrodes  91  and  93  are also x-ray invisible. Conductors that may or may not be x-ray invisible (not shown) would lead from the defibrillation electrodes to a connection point (not shown) for connection to a standard defibrillation machine.