MXPA00007874A - A universal electrocardiogram sensor positioning device and method - Google Patents

Abstract

This invention is a universal disposable ECG sensor positioning device, and method for use with electrocardiogram diagnostic equipment in which the mask (11) has nine sensors (15), six of which can be used at any one time to provide three different sizes to accommodate varying sized human torsos.

Description

DEVICE AND METHOD OF PLACEMENT OF SENSORS FOR ELECTROCARDIOGRAM Background of the Invention The present invention relates to a device for placing multiple electrical sensors. More specifically, it refers to a single-sensor mask and its method for use with diagnostic medical equipment. More particularly, the present invention relates to a disposable dermal pectoral mask to aid in the physical attachment to a human chest of sensors from electrocardiographic machines.

Description of the Previous Art The electrodes of the preceding art to make contact with a specific area of the human body, to be used with diagnostic medical equipment, are generally a combination of elements. A signal cable from an analysis apparatus is usually fixed to a metallic body contact electrode or in any manner, conductive, which is fixed to the REF .: 122183 skin of the patient at the desired point of contact. The combination of cable and electrode is generally referred to as a "load". The electrical current generated by the heart inside the patient's chest flows to the surface and the skin produces differences in electrical voltage, which can be measured between pairs of electrodes placed in two points on the skin. One of the most commonly performed tests that requires the attachment of electrodes to a patient's body is an electrocardiogram, sometimes alternatively referred to as an ECG. A twelve-charge electrocardiograph provides the most accurate signals to recognize ischemic electrocardiographic changes. To administer a resting electrocardiogram of twelve charges, it is necessary to apply 10 electrodes at various points on the torso and limbs of a patient to measure and analyze cardiac data. 12 recordings are made on the electrocardiogram from nine active loading positions with the tenth being used as ground. An electrode portion of a load may in fact consist of an alternative form of a sensor and the terms "electrode" or "sensor" are interchangeable for purposes of this description. A charging cable that connects a sensor to the diagnostic equipment may, in fact, possibly consist of a radio or an optical signal. Six of the 10 electrodes are applied to the patient's chest on pre-established anatomical landmarks. The remaining four electrodes are applied to each of the patient's extremities. The electrodes of the chest are known as precordial charges and the electrodes of the extremities are called limb loads. The precordial charges are designated as Vi, V2, V3, V4, V5 and V6. Limb loads are designated LA, RA, LL and RL (earth). It is generally known that it is critically important to place precordial charges accurately, in order to obtain accurate and reproducible recordings. However, the exact placement and fixing of a large number of loads can be a difficult and time consuming task, as well as requiring knowledge, skill and care on the part of the person who is fixing the electrodes or sensors. Mechanical problems in attaching multiple loads to a patient range from tangling the wires of the loads and a large time consuming in making pairs of load wires for the appropriate electrodes, up to the difficulty of accurately placing anatomical reference points on a patient.

Problems occur when loads are not properly located and are placed higher or lower than optimal. The position of precordial charges is determined by the anatomical characteristics of the patient's chest and not by the position of the heart itself. The researches have contributed in the literature of the electrocardiography, that the precordial charges placed an inch, or more, from their correct anatomical reference points, can result in the misinterpretation of the patient's electrocardiogram. This can result in or contribute to errors in diagnosis, wrong admissions to hospitals, sending sick people back to their homes, or having other impacts, diagnoses or negative treatments. The problem of placement is increased when several serial comparisons are made between two or more electrocardiograms taken over time. For example, if V4 was placed one inch higher during one test and one inch lower during the other, the difference of 5.0 cm can produce what may seem like a significant difference between two electrocardiograms, when in fact, there was no change physical in the cardiac condition of the patient.

To place the precordial loads with precision, training in the use of both visual and tactile indications is required to find the anatomical reference points of each patient. The accuracy of the placement is also affected by the time and alacrity dedicated to placing the precordial electrodes. An electrocardiologist with experience and conscience may require and last 10 minutes for the auscultation and determination of exact precordial reference points. However, in busy clinical settings or in emergency situations, medical personnel are often in such a hurry that they can not even auscultate the patient under these conditions, precordial charges are commonly placed with inadequate auscultation and little attention to the particular anatomy of the patient. As a consequence, individual loads are often erroneously placed at 5 or even 7.5 cm from their correct anatomical landmarks. In addition, the training and maintenance of the necessary expertise for the correct placement of individual loads, consumes time and resources, and is often not adequate. With six precordial charges, there are six opportunities to erroneously place the electrodes. Research shows that the Vi and V2 electrodes are typically placed higher up and further away from their targets - the fourth intercostal space on each side of the sternum. In the same way, the precordial electrodes V4, V5 and V6 are placed more frequently and erroneously downwards and outwards. The electrode V3 is wrongly placed more frequently below. The most obvious conclusion that can be drawn is that the placement of charges is often imprecise. After the individual electrodes are placed on a patient, it is necessary to fix the 10 load cables. Each charging cable is labeled to correspond to one of the anatomical reference points, that is, Vi, V2 ... V6 ... RL. If the cables are crossed, the electrocardiogram interpretation monitors can detect and alert the operator of a possible load wire crossing situation, but this requires additional time to verify the connections and take corrective actions. This is a time-consuming operation and increases the risk in an emergency situation. Cross-loading cables are an even more significant problem when the electrocardiogram monitor does not provide the interpretation of the recordings and can not alert the operator to this possibility. In this case, the electrocardiogram signals for each of the twelve charges are recorded on paper, to be read later. The doctor or technician who reads the recordings of the electrocardiogram can recognize the error but usually, at that moment the patient has already been disconnected from the monitor. The present invention reduces or eliminates the possibilities of any of these situations occurring. Periodic electrocardiograms are important to provide a patient's cardiographic profile for the early detection and diagnosis of cardiovascular diseases. In order to provide a precise profile, it is important not only that the electrocardiogram be taken with the sensors set exactly, but also that the sensors be placed in the same location on the patient in the subsequent examination as in the previous examination. The efficacy and reproducibility of the tests are critical, such that a series of electrocardiogram results can be compared to provide the continuous profile of a patient's medical history for the diagnosis and treatment of heart disease.

In urgent situations, including those electrocardiograms taken with the standard electrode charging cable system currently, during an acute symptomatic episode there may only be time to fix 2 to 4 individual electrodes to the patient. Consequently, it is desirable to have a device that allows more electrodes or sensors to be quickly and precisely secured during said acute symptomatic episode. Alternatively, it may be necessary to quickly remove some or all of the chest loads when a patient experiences a heart attack or in other emergencies, with the goal of administering cardiopulmonary resuscitation (CPR), massaging the heart, administering medications, applying defibrillation canals electrical, or for any other purpose. Accordingly, critical time can be lost both for the removal of chest loads from the electrocardiogram test equipment, for the purpose of administering help to a patient, and in their subsequent relocation after the aid has been administered. Because of the anomalies of the prior art devices to solve these problems, there has been a need for a system that: avoids or diminishes the possibility that charges or electrode electrode cables are entangled or crossed; provide rapid removal of some of the sensors when it is necessary to administer help to a patient who has a heart attack; provide an accurate and appropriate electrode placement in substantially the same location on the patient; obtain accurate and reproducible signals from the electrodes through efficient and effective electrical transmission; and can be fixed by people who have several levels of experience, including those who have little training. The inventions described in the four related applications, identified above, involve several alternatives of purpose to try to effect said objectives. The common invention in those applications is a disposable electrode placement device and uses a flexible non-conductive sheet having a predetermined dimensional sensor configuration. The flexible blade serves as a template to align the connectors or sensors, either of the type with or without electrode, on the chest of a patient to transmit electrical impulses. The blade has a predetermined dimensional sensor configuration V? -V6, such that Vi and V2 are positioned approximately on both sides of the sternum in the fourth intercostal space and the V3 configuration is placed at a midpoint between V2 and V4. V5 is equidistant between V and V6. The distance of Vi and V2 is predetermined plus minus a small amount and both are equidistant from the central line of the sternum. The distance of V2 and V4 is predetermined plus minus a small amount and V3 is located substantially at a midpoint between V2 and V4. An important aspect of the related inventions is that the non-conductive flexible sheet is provided in a plurality of sizes, with each size having configurations Vi, V2, V3 and V4, - to substantially the same locations and having configurations V5 and V6 in different locations , depending on the size. In this regard, the V5 V6 locations are based on a distance measured between the left midclavicular line and the left axillary line on a patient's chest. An alternative of the related inventions is that the dimensional configuration on the flexible non-conductive sheet is provided with cuts to form a template or mask that is placed on the patient's chest and thus, conventional electrodes can be placed within the cuts. Yet, another aspect of the related inventions is that the jig may be provided with a plurality of projections, pressure, or other electrodes fixed on its upper sides to the flexible sheet to be placed against the patient's chest. The electrodes are placed according to the predetermined dimensional configuration. Small cuts, or openings, inside the template expose the projections of the electrode to fix the clips of the charging cable. The pressure electrodes protrude through the template to allow the fixation of the pressure connectors of the charging cable. In a further aspect of the related inventions, the upper sides of the individual electrodes can be fixed slightly to the flexible sheet of the material at the locations of the predetermined dimensional configuration. The leaf can be placed on the patient's chest and then detached, leaving the electrodes located properly on the chest. Each of these concepts can be employed in a new and improved concept of the present invention. Yet, another aspect of those related inventions is a method for measuring a patient's size to fit a sensor placement device, having a flexible sheet with a fixed dimensional Vi-Vg configuration, placed in a specific size and appropriate configuration. for standard electrocardiographic recording. The distance between Vi and V2 is a predetermined distance, plus minus a small amount, and the distance of V2 and V4 is a predetermined distance plus minus a small amount, with V3 located substantially at the midpoint between V2 and V4, and V5 being equidistant between V4 and V6. The method for giving size to the related inventions comprises the steps of measuring the distance between the midclavicular line and a mid-maxillary line on the patient's chest, and selecting a placement device size for those inventions based on the measured distance. This method is eliminated by means of the present invention. U.S. Patent No. 4,583,349 assigned to Manoli and U.S. Patent No. 5,507,290 assigned to Kelly disclose precordial electrodes fixed in a pattern present on a flexible sheet, in positions corresponding to the patient's anatomical landmarks. The basic problem with all these inventions, is that they require multiple sizes of sensor placement device so they fit people of various sizes.

Manoli provides three sizes, - a pediatric, for middle adult and for large adult - without declaring any dimension, to fit most children and adults within the population. Kelly describes three sizes - small, medium and large adult - what fits most adults within the population. Manoli does not describe how the size of a device a patient may require is determined. Presumably, from Manoli's point of view, a small person requires the smallest size of the three, that is, the pediatric, and a large person requires the largest. The description of the invention is undefined. Consequently, Manoli does not describe how he assigns a size to a patient and it is very common for people who place individual electrodes to make mistakes. If similar errors are made when a size is assigned to a patient for the Manoli device, it is very likely that the wrong size device is selected. Once the device is applied to the patient, it may be possible to verify the certainty of adjustment. However, if this is not correct, that is, the V6 electrode was located at a certain distance from the patient's mid-maxillary line, the device must be removed and replaced by a device of a more appropriate size. This trial and error approach wastes time and materials, since the first device should be discarded without having ever been used to take an electrocardiogram. U.S. Patent No. 5, 678,545, most recently assigned to Stratbucker discloses an adhesive sheet having a fixed configuration of individual electrode groups, arranged at varying locations to provide a "one-size" system. Stratbucker describes multiple groupings of electrodes for a "one-way" system but it is necessary to determine which electrode within each group is within the region of the appropriate location on a patient's chest: for each group of electrodes there must be a determination of which electrode it is the closest to the anatomical reference point. Said determination is given and may at least be impeded by the fact that it may be difficult to perform auscultation, once the leaf has been placed on the patient's chest. Moreover, each group of electrodes provides a source of errors, since there are three electrodes to choose from each group. Assuming that one electrode in each group is the most correct, the probability of randomly selecting the best electrode from each of the groups is 0.33x, where X is equal to the number of groups. If there are three groups of electrodes, as described in a modality where V4, V5 and V6 consist of groups of three electrodes each, the probability of randomly selecting the appropriate electrode from each group is 0.037, or 1 of every 27 possibilities. Stratbucker is based on a judicious determination for each group of electrodes and consequently, the selection being delayed and inaccurate, because the device physically covers the anatomical characteristics of the patient. Although Stratbucker tries to avoid the possibility of placing conventional single electrodes very far from the proper placement region, by confining the decision to simply selecting an electrode from each group of three electrodes, medical personnel must still determine which electrode It is the appropriate one for each group of electrodes. Not only does this allow for errors, it also reduces the chances of electrode placement consistent from one test to another, thereby confusing any serial comparison between the tests. This also increases the length of time to administer an electrocardiogram on site, since a separate decision must be made for each group of electrodes. The present invention solves only these problems, by providing a multiple precordial configuration of sensor electrodes within a single device that will essentially fit all adults and whose sizes will be deduced simply by determining the location of a single sensor that is closest to a selected anatomical reference point. This is obtained by means of the invention in a device that has more precordial sensors than the six pectoral electrodes needed for the electrocardiogram on site, but significantly less than the number of those envisioned by Stratbucker. In the present invention, some sensors can serve as multiple roles to accommodate different patient sizes within a configuration, by using a particular set of sensors. Each set of sensors corresponds to a specific patient size that can be characterized as small, medium, or large. Once the device of the invention is applied to the patient, a person simply and quickly determines which of the three V6 sensors is on or closer to the patient's mid-maxillary line and then, connects the electrode or sensor load to the corresponding sensors. in which, Ve is designated as one of the three selections: small, medium or large. This greatly simplifies the one-size-fits-all problem, which has not yet been resolved, in which a size is adjusted to the patient during use, while at the same time providing the additional benefits of reducing the cost of production and eliminating the need to store devices of different sizes. sizes. Another aspect of the present invention is a mask comprised of conductive terminals that are selectively connected to an electrocardiogram machine by means of a single fixation point or an electronic clip. The clip mechanism includes means for connecting to any set of terminals exactly, by means of a positioning feature on the clip, which selectively aligns each set of terminals in an exact alignment with the conductive elements that are inside the clip. Essentially, the selective connection system makes electrical contact only with a set of precordial sensors at the same time, that is, a particular set that contains from Vi to V6 and excludes the rest.

The Vi and V2 sensors that are on the device are centered on the sternum of the patient in the fourth left and right intercostal spaces. Once Vi and V2 have been applied, all the remaining sensors are automatically applied by placing the flexible blade on the patient. The Vd sensor in particular, closest to the patient's mid-line, automatically identifies which set of sensors should be connected to an electrocardiogram machine. The clip is then used to selectively connect that set of precordial sensors to the electrocardiogram machine.

Brief Compendium of the Invention The present invention is a dermal pectoral mask of multiple electrocardiogram sensors, one-way and disposable, to be fixed or placed in different sizes of adult human bodies to perform electrocardiograms of twelve charges with clinical efficacy and reproducibility in the placement of the Vx sensors, V2, V3, V, V5 and V6, regardless of the sizes of all of the human body variants and the different distances between the anatomical landmarks of the human body. The mask is comprised of a flexible sheet of a non-conductive material to carry nine sensors in a single specific pattern, instead of a predetermined fixed configuration of individual groups of sensors or an arbitrary, individually located configuration and of six precordial sensors necessary for a resting electrocardiogram of twelve charges. The blade has nine sensors placed on it, in a specific geometric configuration with positions V1-V4 being used for all body sizes. Position V5 has two independent sensor positions and shares a third with V6. The position V6 has two additional positions, so that when the mask is used for a small size torso, the alternative position V5 closest to the position V4, be used together with the shared positions V5 and V6. When the mask is used for a medium-sized torso, the middle alternative V5 position, disposed between the first alternative V5 positioned closer to the V4 position and between the shared V5 and V6 positions, is used together with the V6 position disposed between the positions V5 and Ve shared and the other position V6 remaining. When the mask is used for a large size torso, the shared positions V5 and Ve are used together with the remaining V6 position. The present invention also includes a method for positioning sensors of six pectoral sensors typically used to perform twelve-charge electrocardiograms. The steps comprise providing a dermal pectoral mask of multiple electrocardiogram sensors, one-way and disposable, formed for the clinically effective placement of six precordial charges on a patient's chest, regardless of the size of their torso. The mask has a plurality of sensors that are configured in a specific geometric pattern, where as little as nine sensors can be used to serve as sensors for at least three different kinds of human torsal sizes. The mask includes indications to align it, both in the central line of the patient's sternum, and in the fourth intercostal space where at least three sets of sensors on the mask, comprising six sensors, each accommodate three different kinds of sizes of human torsos. Six of the nine sensors are selected to perform an electrocardiogram, depending on the size of the patient's torso and the sensor loads from the electrocardiogram test apparatus that are connected to the six selected sensors.

Objectives of the Invention It is therefore an important objective of the present invention to provide a multiple sensor placement device for electrocardiogram, that is a one size so that one size fits all sizes instead of requiring a plurality of different sizes, consequently obtaining economic benefits in high volume production and simplifying sales and distribution. It is another object of the present invention to provide a mask of single-electrocardiogram sensors and a method of use in which less time is needed to perform an electrocardiogram, since the steps used to determine the mask size to be used are eliminated. . It is a further objective of the present invention to provide a sensor placement device for electrocardiogram, one-way and disposable, It can be discarded after being used, providing less risk of transmitting infections and eliminating the maintenance logistics of devices in different sizes within the inventory. It is still another object of the present invention to provide a single-electrocardiogram sensor mask and its method of use in which reproducible, efficient and simplified sensor positioning results are guaranteed. It is still a further object of the present invention to provide a mask of multiple sensors and a method of use in which a twelve-charge electrocardiogram provides the most comprehensible recordings of cardiac electrical activity to recognize electrocardiographic ischemic changes and thus, can get quickly and reproducibly from a one-size mask. And still, it is another object of the present invention to provide an electrode mask for a single electrocardiogram and a method of use in which three different electrocardiograms can be made by means of the same device. Other objects and advantages of the present invention will be apparent when the method and apparatus of the present invention are considered in conjunction with the accompanying drawings.

Description of the Drawings Fig. 1 is a plan view of a Single Sensor Placement Device for Electrocardiogram of the present invention.

Description of the Preferred Modality Reference is made to the drawings for a description of the preferred embodiment of the present invention, wherein like reference numbers represent like elements on the corresponding views. Fig. 1 illustrates a plan view of a single and disposable electrocardiogram sensor placement device of the present invention for placing on a patient's chest and performing an electrocardiogram test. The word "one size" as used in the description of the device, is an abbreviation of descriptive colloquial terminology - one size fits all sizes. At present, the device of the present invention fits ninety percent (90%) or more of the adult population as well as most children. The term "disposable" means that the device is intended for single use. However, the physical form of the device can be reusable for more than one test and a more permanent design can be a truly reusable device that requires sterilization, cleaning, and / or a new adhesive for reuse. Accordingly, the term "disposable", as used in the descriptive preamble of the claims, is provided only as an aid to more precisely describe the preferred embodiment of the invention, in relation to the prior art, and should not be construed as a limitation. in the forms of the invention and the scope of the claims. The device is a dermal pectoral mask 11 which is formed by a sheet of flexible non-conductive material 13 for transporting or placing nine electrodes or sensors without pectoral electrodes 15, or simply holes to place them, to be connected by means of power cables. electrical charges (not shown) to a standard electrocardiographic diagnostic machine. The non-conductive flexible sheet or mesh can be formed by any transparent synthetic or natural material that is capable of accepting an impression. Generally, any cellulosic material, polyester, polyolefin, polyvinyl chloride, nylon or mixtures thereof can be suitable. If the cost is a consideration, cotton, polypropylene or polyethylene can be used. However, polyester is likely to be the most preferred. While the most practical form of the invention incorporates electrocardiogram sensors 15 into a flexible sheet 13, a less sophisticated form of the invention can simply use the specific sensor placement configuration envisioned here, by means of the placement of holes for the electrodes in a specific geometrical pattern, mentioned here on the sheet. Standard electrocardiogram electrodes can be placed in the holes and adhered to the patient's skin through the holes. Other masks using the specific sensor placement configuration and indications of the present invention are also contemplated as being within the scope of the invention. The load sensors of extremities 17 that can be uncoupled can also be easily provided integral to the mask during the manufacturing process. In a preferred embodiment, these are formed integrally to the mask with means for easy decoupling, such as a set of perforations along the line of a coupler 19 of the end load sensor with the mask 11. ends of the end load sensors are provided with an electrical contact area 21, by means of which a load can be connected to the sensor, by any appropriate means, such as an electrical connector clip. The receiver sensor electrodes 15, which are placed on the mask 11, are separated from each other in a specific geometrical configuration, suitable for electrocardiac recordings from all sizes of adult human torsos. Each sensor or electrode sensor is adapted to electrically connect to the skin of a patient's body to detect and transmit electrical signals generated by the patient. The mask includes conductive strips 23, each of which extends toward and electrically connects to a sensor. The other end of each conductive strip ends in a connector or terminal end that couples to any type of connection or articulation of cable to connect electrically with the electrocardiographic analyzer. Three groups of terminal areas or discrete electrical contacts are provided to connect to an electrocardiogram machine to house three different kinds of adult human torsos. The four individual terminals 25 for V? ~ V4 are contiguous and six discrete terminals 27 are provided for V5 and V6 in three size configurations. The terminal ends of the strips are preferably located adjacent to each other in three identical patterns, to facilitate connection to a common connector, which can be used for the three size classes. A custom clip is provided to simplify the use of the mask of the present invention, by allowing a single clip connection. The needle location cuts 29 and the clip indications 31 allow it to be selectively coupled to the mask to connect a certain set or selected set of 6 sensors to the electrocardiogram machine. In order to establish an electrical connection between the human body and the receiver sensors 15, an electrically biocompatible conductive adhesive, such as a hydrogel, is applied to the human body that contacts the sheet at each sensor site to open to the Patient's skin This is generally transparent and is shown as the outer line 16 in the drawings. The hydrogel is commercially available, as well as other suitable conductive adhesives and any appropriate electrodermal adhesive can serve this purpose. The size of the adhesive area is generally between 3 and 9 square centimeters. When the mask is pressed against the skin of the patient's chest, the sensors are electrically connected to the patient in each receiver. The gel-coated adhesive area of the mask 11 includes at least one peel-off tape in removable adhesive contact with the gel covering the sensors 15. Since the peel-off tape can be transparent and is simply a sheet of material, it will not be shown in the drawings. Detachable tapes can be provided separately for each sensor, but in the preferred embodiment, a single detachable tape covers all the sensors and the mask can be removed from the tape in a single operation to expose all the sensors as a unit (except for the end load sensors). The end load sensors 17 are released individually, having been separated in the perforations 19, along the line of the coupler with the mask. The flexible release tape covering the receivers can be made of a dielectric film or coated paper, which includes polypropylenes, polyesters, olefinic polymers, polyvinyl chloride and its copolymers, acrylic rubbers, ABS resin and the like. Commercial suppliers of these materials are listed in the related applications. The receiving electrodes 15 and the conductive strips 23 may be produced from any electrically conductive material, for example, metal, sheet metal, conductive polymers, graphite, carbon fibers and the like. These include gold, copper, silver, tin, aluminum, N-vinyl pyrrolidone and alloys or mixtures thereof, as the conductors / receivers also being able to be made of a conductive paste or a metal in the form of particles within a agglomerator appropriate, which is printed or printed by silkscreen on the flexible non-conductive sheet or deposited without electricity. A connector polymer can be melted or conventionally secured in any other way to the mesh or sheet. Copper strips can be used and deposited without electricity on the polymeric sheets with a range of approximately a thickness from 0.25 to 5 microns and more preferably 0.4 microns in thickness. A metallic ink such as a commercially available silver ink may be preferred. Each of the conductive strips are less than 10, and preferably less than 5 micrometers in thickness, whereby the flexibility of the connector and the version of the gel surface to the skin are substantially improved. The exposed conductive strips 23 can be partially covered by a dielectric layer to isolate the conductive tracks. This coating can be transparent and is also shown in the drawings as the outer line 24. The strips are coated with a dielectric polymeric material in such a way that only the selective portions comprising the sensor 15 and the electrical contact or terminal areas are exposed. 25.27. Suitable dielectric coatings include polyesters, ethylene-vinyl acetate copolymers, polyvinyl chloride and their copolymers, terpolymers such as acrylonitrile-butadiene styrene (ABS resins) and the like. Accordingly, a preferred laminate for the flexible sheet of the invention may comprise several layers, some of which may be transparent. A preferred embodiment of the invention may include: (1) a base layer of a flexible non-conductive film of polyethylene terphthalate; (2) a tie layer for the conductive strips such as a catalyst in contact with a conductive ink; (3) a conductive strip comprised of silver ink; (4) an adhesive layer such as a hydrogel superimposed on the silver ink in the sensor areas of the mask, or alternatively, a dielectric layer superimposed on the silver ink, in the area of the conductive strip of the mask; and (5) a flexible release tape as the top layer superimposed on at least the adhesive layer of the mask. Since the device of the present invention is designed for use by untrained personnel, as well as already trained personnel, the material of the mask sheet contains designation marks or indications to simplify the attachment or placement of the mask on the mask. the patient's chest It is in a sufficiently descriptive way to allow an untrained person to place the mask electrocardiographically to obtain highly reliable and reproducible electrocardiogram signals. This also includes indications to fit the patient's size. Fig. 1 shows the configuration of the sensors (Vi, V2, V3, V4, two V5, a shared V5 and V6, and two V6) and the indications for these. The indicators Vi, V2, V3 and V4 indicate a single position for each sensor. The V5C indicator indicates V5 Chica; the V5M indicator indicates V5 Medium; and the indicator V5G indicates V5 Large, respectively the indicators C, M and G are provided to help in the selection of which set of sensors should be used. Additional indicators between V6M and V6G help the user to place the mask. The indicator 31 approximates the needle location cuts 29, helping to select the electrical connection for the selection of the sensor set. Nine sensors 15 are configured in a configuration of precordial sensors of three sets of six sensors each in which, some of these sensors serve the same function in each of the sets of 6 and at least one of the sensors, serves as a different designated sensor within the different sets. The nine precordial sensors are arranged in a specific one-dimensional geometric configuration, rather than in predetermined fixed configurations for individual classes of sensor group sizes, as envisioned by the related cases and the Kelly and Manoli patents, or in group configurations. of multiple sensors all inclusive, as was thought by Stratbucker in his unique patent. Nor can they be placed in an arbitrarily localized configuration of six precordial sensors, as they could be placed by a technician for a resting electrocardiogram. In the present invention, nine sensors form three sets of sensor groups including three positions for each of sensors V5 and V6, in which one sensor serves for either V5 or V6, in two different sets of sensors , so three sets of six sensors each, are provided by the nine sensors, by placing the six sensors next to the anatomical reference points of the three different classes of human torso sizes. The sensors 15 are disposed on the flexible sheet 13, which is designed to adhere to the human torso in such a way that the reception sensors are located on the chest area and above the epigastric region of the abdomen. The flexible sheet can be essentially transparent and also include self-explanatory indicia 33 for aligning the mask, both in the central line of the patient's sternum, and in the fourth intercostal space 35, whereby at least three sets of sensors on the mask, which They comprise six sensors each, they contain three different types of human torsos. In addition to facilitate the correct placement of receivers on the precordial areas of the human torso, the indications also provide the correct selection of the sets of sensors for the size of the torso and show the sensors that should be used. The indications 29, 31 for the electrical connections to the electrocardiogram machine are also essentially self-explanatory and are based on the selected torso size of the patient. The precordial indication indicates which sets of sensors correlate with the sizes of torsos and that one of the sensors is shared or is used by two kinds of torso sizes, but they are numbered as differently designated sensors, V5 or V6. When the electrodermal connectors are properly positioned to be fixed to a patient, the position of the receivers in Vi and V2 is arranged to fall approximately on opposite sides of the patient's sternum in the fourth intercostal space, as shown by the indications 33,35 . The V3 and V4 receptors coupled on the ribs, with V3 placed approximately at the same distance between V2 and V4, and V4 placed approximately on the intersection of the fifth intercostal space and the medioclavicular left line. The receivers in V5 and V6 are placed next to the torso, so that V5 is substantially at a midpoint between V and V6. In locating the receiver configuration for the preferred embodiment of the present invention, it has been found that the distance between Vi, V2, V3 and V4 can be consistent for all human torsal sizes. The dimensions between Vi, V2, V3 and V have been developed to understand all adults, within the acceptable tolerances for the resting electrocardiogram. It has also been found that the body placement for connectors V5 and V6, varies depending on the individual size. These variations are only included in the one-size mask by the present invention. A novel method is provided by the present invention, to determine the appropriate size selection for the electrode assemblies, that is, to select six of the nine sensors to perform an electrocardiogram, depending on the size of the patient's torso. The selection of the six sensors is deduced by means of the determination of which of the sensors of same designation within each set, is placed closer to a reference point already selected, so the set that contains the closest sensor, is selected as the six sensors that will be used. With regard to V? ~ V4, it has been determined that the distance from position V to position V6 determines the size of a patient. In the inventions written in the four related applications, the measurement of this distance is determined by having to apply the measurement of a technician, such as using his index and thumb fingers to measure the distance between the midclavicular line and the mid-maxillary line on the chest of the patient. patient. This distance is then compared to a scale of sizes to select the appropriate size of the device. However, the present invention does not require any type of intermediate step to determine the size of a patient. Instead, the device is applied to the patient and a simple visual observation deduces which of the three V6 sensors is closest to the patient's dialysis line, to establish the patient's size. The distance between V4 and V6, that is, the distance between the midclavicular line and the mid-maxillary line of the patient, varies within the predetermined limits based on the size of the torso. For a small size, the distance between V4 and V6 can vary between 6 and 9 cm; for the medium size, the distance can vary between 10 and 15 cm; and for the large size, the distance can vary between 15 and 20 cm. In the present invention, the sensors Vi, V2, V3 and V4 are placed equally for all sizes of torsos. The center of Vi is located on a point generally around 5.0 cm from the center of V2, approximately over the radius of 270 degrees from the center of V2, where the radial is measured with zero degrees measured from the north in the part superior of V2. The center of V4 is located on a point generally 9 cm from the center of V2, approximately over the radius of 125 degrees from the center of V2. The center of V3 is in line with V2 and V4 and is located on a point that is substantially between the center of V2 and the center of V4. The receivers V5 and V6 have three alternative positions each: all the positions being arranged in the radius of 90 degrees from V4. The centers of positions V5 are located approximately 4, 6 and 9 cm from V4 and the centers of positions V6 are located approximately 9, 12 and 18 cm from V4, so the centers of V5 and V6 are both located approximately 9 cm from V4, they share a sensor in common in the different sets of sensors.

The table below corresponds to the measurements determined for the placement of electrodes that are related to the present invention. This shows the preferred dimensional configuration for V5 and V6, relative to V4, for different sizes of torsos. Obviously, small variations in the lengths of the measurements are within the scope of the invention: TABLE I Size ^ 4-v5 ^ 5-V6 ^ 4-V6 Girl 4.5 cm 4.5 cm 9 cm Medium 7.0 cm 6.4 cm 12.7 cm Large 8.9 cm 8.9 cm 17.8 cm The distance between Vi and V2 is 5.0 cm, the distance between the central line of the sternum and V4, along a horizontal line is 9.8 cm, and the distance of V2 and V4 along a vertical line is 12.5 cm, although this vertical distance can be up to 9 cm without significantly altering the effectiveness of the device. In addition, V3 is located on a diagonal line between V2 and V4, and is equidistant to V2 and V4. These variations can be combined to create a one-size mask for the use of only nine sensors to comprehend virtually any adult of any size. The reduction in the number of sensors required is an important consideration for the efficiency of manufacturing costs. The mask of the present invention provides a plurality of connectors or terminals, configured in a predetermined dimensional conformation V? -V6 on the flexible sheet inherently observing the dimensions dictated by Table I. When providing alternative locations of the sensors, the dimensional configuration on the flexible sheet is made aitaly and the specific size configuration of the dimensional configuration on the flexible sheet, is determined in the same way as for multiple sizes of masks, so as to allow the production of an exact electrocardiac recording during electrocardiogram tests that can be reproduced reliably. The nine sensors are placed on the sheet in a geometric pattern that approximates the standard precordial anatomical landmarks for any adult human being. The placement of the V? ~ V4 sensors is the same for all torsos sizes. The position of V5 has two independent sensors and this one shares a third with V6. The sensor position V6 has two additional positions separated from a sensor shared with V5. All sensors V5 and V6 relay along the same line and separate from the V sensor. When the mask is used for a small size torso, the alternative position of the V5 sensor that is closest to the V4 position is used together with the shared sensor position V5 and V6. When the mask is used for a medium-sized torso, the alternative average position of the sensor V5, disposed between the first alternative sensor V5, arranged closer to the V4 position, and between the shared sensor position V5 and V6, is used together with the V6 sensor position disposed between the shared sensor position V5 and V6 and the other remaining V6 sensor position. When the mask is used for a large size torso, the shared position of sensor V5 and V6 is used together with the remaining sensor position V6, which is located further away from V4. The shared sensors V5 and V6 function as V6 when the mask is used for a small size torso, and function as a V5 when used for a large size torso. The set of sensors selected to perform the electrocardiogram on a specific patient is recorded to be taken on subsequent electrocardiograms on this patient, to ensure the reproducibility of the positioning of the sensors. The present invention also contemplates a method of placing sensors to perform twelve-charge electrocardiograms by means of a multiple-sensor, single-lens, disposable electrocardiogram dermal mask to adjust or accommodate different sizes of adult human bodies with clinical efficacy and ability to reproduction of the placement of the sensors Vi, V2, V3, V4, V5 and V6, regardless of the variation of the torso sizes of human bodies, or the different distances between the anatomical reference points of the human body. The method of positioning of sensors is comprised of several steps. A mask is provided that is formed for the clinically effective placement of six precordial sensors on a patient's chest, regardless of the size of the torso. This has a plurality of precordial sensors disposed in a specific geometric pattern, rather than in predetermined fixed configurations of individual sensor groups or an individually and arbitrarily located configuration of six precordial sensors. They can be used as little and as nine sensors to serve as sensors that are, at least, between different kinds of human torsos. In the preferred method of the invention, the mask is provided with a configuration of nine sensors that are configured in three sets of six sensors, in each of which, certain sensors serve for the same function in each of the sets in at least one of the sensors that serves as a different designated sensor in each different set. In the preferred embodiment of the invention, nine sensors form three sets of sensor groups that include three positions for each of positions V5 and V6. In one group, one sensor serves for either V5 or V6 in two different sensor sets so three sets of six sensors are each provided by the nine sensors to place six of the sensors next to the reference points Standard precordial anatomies of three different kinds of human torsos. The mask is provided with indications to be placed on the central line of a patient's sternum and the fourth intercostal space and to determine which sensors correspond to the three sets of sensors. The mask is placed on the patient's chest and the mask placement indicators are aligned with the corresponding anatomical positions on the patient's chest. Six of the nine sensors are then selected to perform an electrocardiogram, depending on the size of the patient's torso by determining which of the same designation sensors within each set, are closest to a precordial reference point, so that the set of sensors that contains the sensor that is closest, is selected as the set of the six sensors that will be used. In the preferred embodiment of the invention, this is accomplished by means of deducting which of the three positions V6 is closest to the mid-maxillary line of the patient. The sensor charges from the electrocardiogram test apparatus are connected to the corresponding set of sensors that includes the identified V6 position. To summarize, both apparatuses and methods are provided for the determination of the size of the torso and the placement of sensors to perform twelve-charge electrocardiograms and thus achieve the stated objectives of the present invention. A unique mask design, having only nine sensors instead of three different mask sizes, as envisioned in the prior art, provides a one-size-fits-all that can be used to obtain the benefits of simplified production at high volume, with the objective to reduce costs to the user and reduce the time previously necessary to establish the size of a patient. The preferred embodiment of the present invention solves the problems associated with high variation in the placement of individual sensors that can produce inaccurate electrocardiograms and so, incorrect diagnosis and whose problems prevent comparisons valid and reliable series between ECGs repeated in same patient. The present invention eliminates the logistics to maintain sensor masks of different sizes. This includes storage in the central supply of a hospital, inventory warehouses in nurseries and clinics and shelves for individual electrocardiograms. A related benefit is that the inventory can be supplied equally, eliminating with this, the possibility that certain inventory, for example, a size that is less used in a system of three sizes, can not be used before reaching an expiration date. . The one-dimensional design of the present invention eliminates the steps required to determine the size of a patient's torso. Any possibility of error is eliminated when determining the size of a patient. The method of the present invention is a method in which there is less waste, since almost all adult patients are housed by a device. With more than one device size, there is the possibility that a wrong size is applied to a patient and it needs to be removed and discarded before applying the correct size device. This trial and error situation can also increase the time spent performing the electrocardiogram on a patient. This is eliminated by means of the present invention. The mask and the method for using the present invention, with which, the additional sensors with their respective adhesive areas increase the total area adhered to the patient. This will reduce the tension on each individual sensor, since any detachment caused by respiration or by the assembly of electrocardiogram wires will be shared by a greater number of sensors than would be possible with a precordial pad of six sensors. It is generally understood that too much tension on a sensor decreases its effectiveness. It is also an objective of the present invention to allow three different electrocardiograms to be taken simultaneously with the same device. Since the device contains three precordial sensor patterns, it is possible to take three different electrocardiograms by connecting to each pattern instead of simply reapplying the unique six-conductor connectors in series to the sets of three terminals. This can provide additional diagnostic information over what is now available from a conventional electrocardiogram, using six precordial sensors. Accordingly, it will be apparent from the foregoing description of the invention in its preferred form, which will satisfy all the objectives and advantages attributable thereto. While this is illustrated and described here in considerable detail, the invention is not limited to such details and has been established, except for what may be required by the appended claims. It is noted that, with regard to this date, the best method known by the requested, to carry out the present invention, is that which is clear from the present, discovering the invention.

Having described the invention as above, the content of the following is claimed as property.

Claims (1)

1. CLAIMS A method for positioning sensors of six pectoral sensors Vi, V2, V3, V4, V5 and V6, typically used to perform twelve-charge electrocardiograms, characterized in that it comprises the steps of: provide a multi-sensor, single-lens dermal pectoral mask, formed for clinically effective placement of the six precordial sensors on a patient's chest, regardless of the size of the torso, said mask having at least nine sensors that are configured in a specific geometric pattern and can be used to serve as sensors of at least three different kinds of human torsos, the mask including some first indications to align the mask in the central line of the patient's sternum, as well as in the fourth intercostal space, and second indications to determine which sensors correspond to the three options for the V6 sensor, so that at least three sets of sensors on the mask, comprising six sensors each, comprise three different kinds of sizes human torsos; place the mask on the chest of a patient with the indications on it, aligned with the corresponding anatomy of the patient; select six of the nine sensors to perform an electrocardiogram from the second indications, depending which of the V six sensors is closest to the patient's mid-maxillary line; Y connect the sensor loads from the electrocardiogram test device, with the six sensors selected. The method according to claim 1, characterized in that the nine sensors are geometrically configured in three different sets of six sensors each, in which certain sensors serve for the same function in each of the sets and at least one of the Sensors serves as a different designated sensor in different sets. A method of placing sensors to perform twelve-charge electrocardiograms by means of a multiple-sensor, single-skin, disposable electrocardiogram skin mask, formed to fit or accommodate different sizes of adult human bodies with clinical efficacy and reproductive capacity. placement of the sensors Vi, V2, V3, V4, V5 and V6, regardless of the variation of the sizes of the torsos of the human body, or the different distances between the anatomical reference points of the human body, the method of placement of sensors characterized in that it comprises the steps of: provide a mask having only nine precordial sensors arranged in a specific geometrical configuration, rather than in predetermined fixed configurations of individual sensor groups or an individually and arbitrarily located configuration of six precordial sensors necessary for a resting electrocardiogram, the configuration of nine sensors forming three sets of sensor groups including three positions for each of the sensors V5 and V6, in which one sensor serves each V5 or V6 position in two different sets of sensors, thereby providing three sets of six sensors each by means of only nine sensors to place six of the sensors next to the anatomical landmarks of three different kinds of human torsos, the mask including indications to place the mask on the center line of the sternum and the fourth intercostal space of a paci and to determine which sensors correspond to the three sets of sensors; place the mask on the chest of a patient and align the indications of placement on the mask with the corresponding anatomy of the patient; deduce which of the three positions V6 is closer to the mid-maxillary line of the patient; Y connect the sensor loads of the electrocardiogram test apparatus with the sensors of the corresponding set including V6. A mask pectoral dermal multiple electrocardiogram sensors, one size, to adjust or accommodate different sizes of adult human bodies to perform twelve-load electrocardiograms with clinical efficacy and ability to reproduce the sensor positions Vi, V2, V3, V4, V5 and V6, regardless of the variations in the sizes of the torsos of the human body and the different distances between the anatomical reference points of the human body, the mask characterized by: a flexible sheet of a non-conductive material for transporting nine sensors in a single, specific pattern instead of in predetermined fixed configurations of individual sensor groups or an individually and arbitrarily located configuration of six precordial sensors that are necessary for a resting electrocardiogram of twelve loads, the sheet having the nine sensors placed on the sheet in a specific geometrical configuration with V1-V4 being used for all body sizes, position V5 having two independent sensor positions and sharing a third with V6, and V6 having two additional positions so: when the mask is used for a small size torso, position V5 alternates closest to position V4, is used together with shared position V5 and V6, when the mask is used for a medium-sized torso, the position V5 alternating medium, arranged between the first position V5 alternates more closely disposed to the position V4, and between the positions V5 and V6 shared, is used together with the position V6 arranged between the position V5 and Ve shared and the other position V6 remaining, and when the mask is used for a large size torso, the shared position V5 and V6 is used together with the remaining position V6. The mask according to claim 4, characterized in that: Vi and V2 are arranged to rest on the opposite sides of the sternum of the patient equidistant to it and on the fourth intercostal space, the center of Vi being located approximately 5.0 cm from the center of V2 over the radius of 270 degrees thereof; the center of V4 being located approximately 9 cm from the center of V2 over the radius of 125 degrees thereof; the center of V3 being arranged on a line and being equidistant between V2 and V4; Y V5 and V6 having three alternative positions each, all the positions being arranged in the radius of 90 degrees from V4, the centers of the positions of V5 being located at 4.5, 6 and 9 cm of these and the centers of the V6 positions being located at 9, 12 and 18 cm of these, so the centers of V5 and V6 are both located at 9 cm from V4, sharing a sensor in common in the different sets of sensors.