WO2005107585A1

WO2005107585A1 - Electrocardigraphic diagnosis assistance apparatus

Info

Publication number: WO2005107585A1
Application number: PCT/IL2005/000463
Authority: WO
Inventors: Samuel Sclarovsky; Avi Shemesh
Original assignee: Sea Sclarovsky Ecg Analysis Ltd
Priority date: 2004-05-06
Filing date: 2005-05-03
Publication date: 2005-11-17
Also published as: IL161828A0

Abstract

An apparatus and method for selecting a group and at least one subgroup named syndrome associated with a patient electrocardigraphic chart for providing an accurate diagnosis of the patient medical condition. The apparatus comprises an patient electrocardigraphic module for selecting a group and an at least one syndrome associated with an electrocardigraphic chart stored in a database and associated with the patient and for comparing said picture with a picture associated with a pattern associated with said selected group and at least one syndrome.

Description

ELECTROCARDIGRAPHIC DIAGNOSIS ASSISTANCE APPARATUS

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The present invention generally relates to cardiology. More specifically, the present invention relates to a method and apparatus of classifying the condition of a patient using electrocardiographic charts. The present invention further relates to a computer program for assisting medical personnel to classify and diagnose a patient's heart disease condition and for providing a similarity factor between a patient's and a base electrocardiographic chart.

DISCUSSION OF THE RELATED ART Electrocardiograph (EKG) machines are used as a diagnosis tool in medicine, and measure electrical activity in the heart muscle. After each electrical impulse which is generated in the sinoatrial node (SA Node) a contraction of the heart appears. The EKG machine traces the path of the impulse as it spreads though the heart, and produces a graph or trace of the electrical impulses recorded by one or more leads attached to the patient body. The graph is often referred to as electrocardiogram or electrocardiographic chart (ECG). One use of those ECGs is associated with pharmacological interventions, genotypes and a like. For example, one specific need is to determine whether a given compound significantly modulates the repolarization duration process of cardiac beats. Another use is associated with determining abnormalities of a patient by a cardiologist or a skilled person. Such evaluation requires considerable training and skill. Despite a high degree of training and skill, an ECG chart can still be interpreted as indicating normal heart activity even in the presence of advanced coronary artery disease and vice versa: an ECG chart can be interpreted as indicating abnormality while the patient is considered in a good health having no disease at all. The later case is known in the art as a differential diagnosis. Experience has shown that conventional ECG charts, although useful, are not sufficiently used by doctors as reliable diagnosis tools for heart diseases, mainly due to insufficient training, specificity at an early stage of the heart disease. It has been estimated that over a large percentage of patients having coronary artery disease are examined using magnetic resonance imaging (MRI), echocardiography and a like once an ECG examination has been performed. The large percentage of such further tests is also related to the inability of the medical staff to properly identify the patient's condition using the ECG chart itself. More reliable diagnosis classification is needed in order to decreases the need for additional tests. Alternatively, an acute coronary artery disease may be untreated due to misjudgment of differential diagnosis resulting from the medical staff inability to interpret the ECG chart correctly. Various techniques were proposed in order to try and automatically diagnose coronary artery disease using mathematical and statistical calculation using the ECG chart. Measuring and calculating characteristics of the ECG charts such as duration, time intervals between different peaks and a like; using a computerized system in order to generate representational pictorial views of the heart; determining a set of indices for each type of coronary artery disease and comparing those indices to the one obtained from the current patient ECG; statistical prediction of clinical outcomes; using time to frequency transformation trying to identify the frequencies of the different nerves electrical pulses comprising the ECG signals assuming that same frequencies are incorporated with the same disease, are only few examples for unsuccessful attempts for achieving the goal analyzing ECG charts. The present invention overcomes the disadvantages of the present art by providing a new and novel ECG diagnosis assistance device without the need of making statistic calculation of the ECG charts. The present invention further provides a method and apparatus of classifying the condition of a patient using electrocardiographic charts and for assisting medical personnel to classify and diagnose a patient's heart disease condition and for providing a similarity factor between a patient's and a base electrocardiographic chart. Furthermore, the present invention provides benefits such as determining the appropriate treatment for a patient based on the patient's ECG chart, decreasing the need of further examinations and decrease the number of mistakes both in diagnosis of cardiac disease and in differential diagnosis.

SUMMARY OF THE PRESENT INVENTION It is a general object of the new invention to provide a simple, well- defined classification in order to improve the diagnosis process of ECG charts or patterns. The present invention will also provide a diagnosis assistance device with which accurate diagnosis of heart conditions can be made based solely on ECG charts. Another object of the present invention is to provide a series of pattern templates to be used as a database for pictorially comparing the template ECG charts to a patient's ECG chart in order to verify the said improved diagnosis. Yet, a further object of the present invention is to introduce to the user of the ECG diagnosis assistance device a list of differential diagnosis that should be taken into consideration while determining the final diagnosis. Another object of the new invention is to decrease the number of unnecessary additional examinations now commonly ordered by medical staff to complement the ECG test. In accordance with the present invention there is provided an apparatus for electrocardigraphic diagnosis assistance, the apparatus is implemented in a computing platform, said platform comprises a central processing unit, a storage device and an input and output device, the apparatus comprising a patient information module for receiving information about a patient, a database for storing one or more electrocardigraphic chart or pattern; and a patient electrocardigraphic module for selecting a group and one or more subgroups named syndromes associated with the electrocardigraphic charts stored in the database and associated with the patient. The selected group and the one or more syndromes can be associated with a pattern. The patient electrocardigraphic module retrieves a picture of an electrocardigraphic chart associated with the selected group and the one or more selected syndromes and compares the retrieved picture with a picture corresponding to the electrocardigraphic chart associated with the patient. The apparatus further comprises a setup configuration module for configuring the patient electrocardigraphic module, or the patient information module, or the database. The electrocardigraphic chart is a graph or trace of the electrical impulses recorded by an at least one lead attached to the patient body. The pattern is an electrocardigraphic chart associated with or without a heart disease. The patient information module comprises information associated with the patient. The database can comprise one or more table, said table comprising one or more electrocardigraphic chart to be used for comparison with a patient electrocardigraphic chart. The patient electrocardigraphic module can compare a picture obtained from the database with a picture associated with a patient electrocardigraphic chart. The patient electrocardigraphic module further presents the result of the picture comparison unto the output device. The patient electrocardigraphic module further provides a differential diagnosis for the group and the at least one syndrome selected. The group comprises different electrocardiographic patterns having similar anatomic and pathophysilogic characteristics. The group can comprise any one of the following: pre infarction; evolving infarction; final pattern infarction; normal electrocardigraphic chart; between normal limits; hypertrophic myocardiopathy; dilated myocardiopathy; recent myocardial infarction; chronic myocardial infarction; chronic myocardial ischemia; myocarditis pericarditis; atrial arrythmias; re-entry tachycardia; nodal arrythmias; ventricular arrythmias; atrial block; auricular ventricular blocks; intra- ventricular block; congenital heart disease; long Q-T syndrome; pre excitation syndromes; early repolarization syndromes; or metabolic disease. Each group includes different subgroups, named syndromes. The syndromes comprise a first type, a second type, a third type and a fourth type syndrome. For example, in the pre infraction group, the first type syndrome is a description of an artery disease location and culprit artery. The second type syndrome is a description of an artery size. The third type syndrome is a description of the level of obstruction. The fourth type syndrome is a description of the lateral wall involvement. The first type syndrome can comprise any one of the following: acute subtotal obstruction of left anterior descendant; acute obstruction of first marginal; acute obstruction of second marginal; acute obstruction of left anterior descent; acute obstruction of right coronary artery; acute obstruction of circunflex artery; acute obstruction of first diagonal; acute obstruction of first marginal; The second type syndrome can comprises any one of the following: small; large; co-dominant; dominant; reperfused; incomplete reperfused; and non reperfusion. The third type syndrome comprises proximal or distal states. The fourth type syndrome comprises protected or unprotected states. In accordance with the present invention there is also provided a method for electrocardigraphic characteristics classification, the method comprises the steps of selecting a patient for receiving information associated with the selected patient, selecting a group from a list of groups associated with characteristics of the patient's electrocardigraphic chart, selecting one or more syndrome from a list of syndromes associated with the characteristics of the patient electrocardigraphic chart for classifying a pattern associated with the patient's electrocardigraphic chart, whereby a patient medical condition is diagnosed. The method further comprises the step of obtaining a picture from a database, said picture associated with the said group and said at least one syndrome selected by a user. The information associated with the selected patient comprises an at least one patient electrocardigraphic chart. The one or more syndrome comprises a first type, a second type, a third type and a fourth type syndrome. The picture is an electrocardigraphic chart. The method further comprises the steps of comparing the picture obtained from the database with a picture associated with the patient electrocardigraphic chart in order to determine a similarity factor; and presenting the result of the picture comparison to an output device. The similarity factor is the degree of similarity between the two compared pictures. The method further comprises the step of showing a list of differential diagnosis for the group and the at least one syndrome selected for consideration of a user.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: Fig. 1 illustrates a block diagram of the main components of an electrocardigraphic (ECG) diagnosis assistance device, in accordance with a preferred embodiment of the present invention. Fig. 2 illustrates a block diagram of the method of operation of the patient ECG module, in accordance with the preferred embodiment of the present invention. Fig. 3 illustrates an exemplary user interface showing the patient ECG module implementation, in accordance with the preferred embodiment of the present invention. Fig. 4 illustrates an exemplary user interface showing the patient information module implementation, in accordance with the preferred embodiment of the present invention. Fig. 5 is a flow chart depicting the main steps of the ECG diagnosis assistance method, in accordance with the present invention. Fig. 6 is an example of a table describing the classification of different characteristics of an ECG chart into group and symptoms categories, in accordance with the present invention. Fig. 7 is a pictorial example of an ECG pattern, showing a specific syndrome of a pre infraction group, in accordance with the present invention. Fig. 8 is a pictorial example of an ECG pattern, showing a specific syndrome of an Evolving infarction group, in accordance with the present invention. Fig. 9 is a pictorial example of an ECG pattern, showing a specific syndrome of a final pattern of infarction group, in accordance with the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention relates to a novel device for assisting interpreting electrocardiographic (ECG) charts or patterns. An electrocardiographic examination is a cheap and relatively simple tool helping a cardiologist or a person skilled in the art to diagnose coronary artery or other heart diseases. A typical ECG chart, which is the outcome of an electrocardiograph (EKG) machines, comprises a series of electrical impulses which are generated in the sinoatrial node (SA Node) of the heart. The ECG chart is a graph or trace of the electrical impulses recorded by at least one lead attached to a patient body. The present invention introduces a new classification for dividing the different types of ECG characteristics into groups and subgroups named syndromes such that each series of groups and syndromes corresponds to only one ECG pattern. The corresponding ECG pattern is represented by a template pattern or an ECG chart to which the examined ECG chart is compared with. A more accurate interpretation of the examined ECG chart is enabled due to a comparison to the template pattern having the same pattern as the examined ECG chart. The groups and syndromes are classified such that medical staff can diagnose with ease a patient's heart disease based on the pattern classification alone. Choosing the series of groups and syndromes is being performed step by step by the user of the ECG diagnosis assistance device, while following well defined rules and guidelines which are presented by the new device. One advantage of the new device compared to previous inventions is that it is not an automatic tool, rather it is an assistive device designed to guide the user through the process of diagnosis and interpret an ECG chart. Consequently, the use of the new invention will always increase the number of successful diagnosis, diagnosis scope and accuracy. Another advantage of the present invention is the ability of medical personnel to make a quick and successful diagnosis solely based upon an ECG chart. The diagnosis enables the medical care provider to determine for example whether the patient should be urgently transferred to the closest hospital or be transferred to another more remote hospital having specific equipment needed for the treatment. Furthermore, in cases where sophisticated medical equipment is not present, the simple and available examination of an EKG machine combined with a quick and accurate diagnosis can save a patient's life. Persons skilled in the art would appreciate the difference between an air transfer and a vehicle transfer from a remote area to the hospital of a patient having a heart condition. The determination of the vehicle in which to transfer the patient may be crucial and could now depend on the initial diagnosis made by the medical care giver assisted by the device in accordance with the present invention. Fig. 1 illustrates a block diagram of the main components of the ECG diagnosis assistance device, in accordance with a preferred embodiment of the present invention. An apparatus for ECG diagnosis assistance 10 is implemented in a computing platform (not shown) including a central processing unit, storage device and an input and output device. The computing platform can be a personal computer such as manufactured by IBM of New York, USA. Alternatively, the computing platform can be a hand held device such as a Palm computer manufactured by 3Com. Other embodiments of the computing platforms can be associated with other portable devices such as portable telephones, portable terminals and the like. The central processing unit can be any type of CPU which is typically used within said computing platforms, such as CPUs manufactured by Intel. A storage device can comprise any one of the following: a random access memory (RAM), a read only memory (ROM), a hard disk, a floppy disk, a tape, a portable memory disk and any mechanical, biological or optical device that is configured and designed to maintain, store and retrieve data. An input output device can comprise one of the following: a keyboard, a mouse, a touch screen, a holographic screen, an audio visual screen and a like. It will be appreciated by persons skilled in the art that other computing platform may be used as well.

Apparatus 10 comprises a patient information module 20 for receiving information about a patient as explained in detail in association with Fig. 4; database 50 for storing at least one ECG chart or pattern examples as explained in detail in association with Figs. 6, 7, 8, 9; and patient ECG module 30 for identifying a group and an at least one syndrome and for comparing said group and the at least one syndrome to a corresponding electrocardigraphic chart or pattern as explained in detail in Figs. 2, 3. In addition, apparatus 10 comprise a setup configuration module (not shown) for configuring the patient ECG information module, or the patient ECG module, or user information and security or the database. The setup configuration module enables the user to add delete or change the classification used at the patient ECG module. For example a new group can be added to the diagnosis process or a syndrome definition can be changed, or a new ECG pattern can be added for comparison with the examined ECG chart. The setup configuration module further enables to add, delete or change informative details which are presented to the user during the diagnosis generating process. Examples for such details include a patient's age, name, sex, medical history, previous examination results including previous ECG results and diagnosis and the like. The setup configuration module enables the user to add, delete or change the patient information module 20. The following are few examples for entries that can be changed using the setup configuration module: patient name or identification, birth . date, sex, contact details, health care company, medical care giver, known conditions, medications, current and previous symptoms, cardiac or medical history, known heart diseases, related medical files or data, and the like. Database 50 comprises at least one table; the table comprising at least one ECG chart to be used for comparison with a patient's ECG chart. The database can be any structured collection of data, such as a relational database or the like. One database which can be used is an SQL database manufactured by Microsoft from Redmond, USA. Any other like database which enables the association of patient's with ECG charts and patterns with ECG charts can also be used for the purpose of the present invention. The setup configuration module enables the user to add, delete or change at least one table or at least one ECG chart or other data which is stored in database 50. Fig. 2 illustrates a block diagram of the method of operation of the patient ECG module 30 of Fig.1, in accordance with the preferred embodiment of the present invention. The method in accordance with the present invention provides steps for medical personnel to classify a group and at least one syndrome of a patient from the patient's ECG chart. In the first step a group is selected from a list of available groups 200. A group comprises different electrocardiographic patterns having similar anatomic and pathophysilogic characteristics. One example of a group is a pre-infarction group which describes a suddenly occlude of an artery resulting in blocking the blood flow through an artery. Another example of a group is an evolving infarction group which describes the possible heart condition after the patient received some form of medical treatment. An ECG chart belongs to the evolving infarction expressing the myocardial involvement, usually taken a few hours after medical or invasive treatment is administered to a patient suffering from a suspected coronary disease. The time for taking the ECG belonging to the evolving infarction group can range between 0.5 to 6 hours after the initial medical treatment is administered. Another example of a group is a final pattern of infarction group which defines the patient's condition after stabilization as a result of receiving or not receiving medical treatment. An ECG chart belongs to the final pattern of infarction group is usually taken between 6 hours to 72 hours post acute myocardial infarction and provides information of the prognostic significance of the myocardial injury. Additional groups comprise any one of the following: normal ECG; between normal limits, hypertrophic myocardiopathy, dilated myocardiopathy, recent myocardial infarction, chronic myocardial infarction, chronic myocardial ischemia, myocarditis pericarditis, atrial arrythmias, re-entry tachycardia, nodal arrythmias, ventricular arrythmias, atrial block, auricular ventricular blocks, intra- ventricular block, congenital heart disease, long Q-T syndrome, pre-excitation syndromes, early repolarization syndromes, metabolic disease. The second step is selecting at least one syndrome from a list of syndromes 210. A syndrome can be either a first, a second, a third or a fourth type syndrome. The typical ECG diagnosis assistance device according to the present invention comprises a first type, a second type, a third type and a fourth type syndrome. A first type syndrome associated with the pre infraction and evolving infraction groups is a description of an artery disease location and the culprit artery. The purpose of the first type syndrome is to recognize the culprit artery or to localize myocardial damage. First type syndromes associated with the pre infraction and evolving infraction groups, comprises any one of the following: acute subtotal obstruction of left anterior descendant, acute obstruction of first marginal, acute obstruction of second marginal, acute obstruction of left anterior descent, acute obstruction of right coronary artery, acute obstruction of circunflex artery, acute obstruction of first diagonal, acute obstruction of first marginal, inferoposterior wall, posterolateral, anterolateral, inferior wall, inferoposterior wall, high lateral wall, low lateral, lateral wall and anteroseptal wall. The third step is selecting an at least second type syndrome from a list of syndromes 220. And after selecting the at least second type syndrome, selecting an at least third type syndrome and an at least fourth type syndrome. The at least second type syndrome associated with the pre infraction group is a description of an artery disease size. A second type syndrome, associated with the pre infraction group, comprises one of the following: small, large, co- dominant and dominant. A second type syndrome, associated with the evolving infraction group, are: reperfused, incomplete reperfused and non- reperfusion. The purpose of the at least second type syndrome of the pre infarction group is to determine the dimension of the artery . The purpose of the at least second type syndrome of the evolving infarction group is to determine or the reaction of the myocardial to reinstitution of coronary flow. The at least third type syndrome, associated with the pre infraction group, is a description of an artery disease level of obstruction of the artery. The at least third type syndrome, associated with the pre infraction group, comprises any one of the following: proximal, distal. The at least fourth type syndrome, associated with the pre infraction group, is a description of an artery disease lateral wall involvement. The purpose of the at least fourth type syndrome is to grade the degree of protection of the neighboring area adjacent to the damaged area in the heart. The at least fourth type syndrome, associated with the pre infraction group, comprises any one of the following: protected, unprotected. The fourth step after selecting the syndromes according to the present invention is to select a pattern 230. A pattern is an ECG chart characteristics associated with a coronary artery disease. Usually, in order to perform a diagnosis using the electrocardigraphic diagnosis assistance device, the user selects a group and at least one syndrome. However in rare cases, for example if a patient has a metabolic disease, it is possible to perform a diagnosis by selecting only a group without selecting a syndrome. It is the objective of the present invention to provide a detailed classification for the various heart diseases and possible electrocardigraphic patterns, hence person skilled in the art would appreciate the various possible combination of groups and syndromes resulting in different diagnosis. Person skilled in the art would also appreciate that the above definitions for the at least first, second, third and fourth syndromes are examples associated with the pre infraction group. In other groups the definitions of the said first, second, third and fourth syndromes may change. Next, the patient ECG module compares a picture 240 obtained from the database (50 of Fig. 1) that is associated with the pattern that was selected in the fourth step with an ECG picture associated with the patient 250. The comparison made here in between the pattern's ECG chart picture and the patient ECG chart picture is based on the visual similarity between the two pictures. Thus, the two pictures obtained are normalized such that the background chart color is compared and is made equal in both pictures. Once, normalization the background of the pictures is completed, the ECG trace of the electrical impulses recorded by at least one lead remains as the sole significant image on each picture. The pictures are than divided into sections each showing the electrical pulses from each lead. Next, each two matching sections (one from the pattern ECG chart template and the other from the patient's ECG chart) are adjusted such that both are placed on a unified scale such that each ECG trace peak are located at the same location on the scale. If more than one peak exists in any given section, than the peak associated with the heart beat rate is selected as the peak to be located on the same location on the unified scale. Next, the sections are converted into bitmaps and the bitmaps are compared. The comparison is made based on each bit location and value or based on a vector presentation of the 2D chart. The result provided is a score detailing the percentage of overlapping between the two sections. Thus, if visually the sections are completely alike, the score will be higher than if the sections are visually different. Persons skilled in the art will appreciate that visual comparison can be accomplished by other means which are considered by the inventors as part of this invention. It is noted, that different patterns 230 are associated with different pictures 240 in database 50 of Fig. 1. Thus, if a particular pattern 230 is selected the comparison between the patient's ECG chart picture 250 will be with the picture 240 associated with the selected pattern 230. In addition, pattern 230 may exist in the ECG chart pictures 250 of many patients. Fig. 3 illustrates an exemplary user interface of the patient ECG module of the device, in accordance with the preferred embodiment of the present invention. The patient ECG module user interface 305 comprises a list of icons 310 for using the patient ECG module. For example: open a patient information and related data for diagnosis using the patient ECG module, close, or end the diagnosis process, save the diagnosis, zoom unto the patient ECG chart 395, back to the previous screen, and a like. The patient ECG module user interface 305 further comprises a list of patient relevant details 320 such as patient identification number, patient name, age, sex, birth date and an option to see additional patient details. The patient ECG module user interface 305 further comprises a list of additional details 330 such as urgency, entering date and time, worker (user) name, ECG filename and the like. The patient ECG module user interface 305 further comprises a window 340 showing the list of groups and syndromes from which the user selects the identified group and at least one, second, third and fourth syndromes related to the patient ECG 395. Alternatively, the user may select only an identified group without selecting a syndrome, while performing diagnosis using the electrocardigraphic diagnosis assistance device. In the present example, three main groups: evolving infarction 341, final pattern of infarction 342 and pre infarction 343 are shown, each divided into syndromes. For example the pre infarction group 343 is divided into acute obstruction of right coronary artery 344, acute obstruction of left anterior descent 350 and acute obstruction of circumflex artery 351 first type syndromes. In the present example, the first type syndrome acute obstruction of right coronary artery 344 is further divided into the following second type syndromes: co-dominant 345, small 348 and dominant 349. In the present example, the second type syndrome co-dominant 345 is divided into the following third type syndromes: proximal 346 and distal 347. It will be appreciated by persons skilled in the art the other groups and types of syndromes can be shown and the list of the groups and syndromes shown in the above example is in no way limiting and serves for a better description the present. The patient ECG module user interface 305 further comprises a window 360 showing full description of ECG characteristics of the pattern selected 346 associated with the specific group and syndromes that were selected by the user for the specific patient ECG chart 395 in window 340. Once the user has selected the pattern (in this example pre-infarction acute obstruction of right coronary artery co dominant proximal 346) the list of characteristics of the pattern will appear in window 360 and can be used by the user to examine the patient ECG chart 395 and ensure all the relevant characteristics appear therein. Thus, the window 360 and list of characteristics allow the care giver to better associate a pattern (346) with a patent ECG chart (395). The ECG characteristics 360 describes a typical shape of an electrical impulses recorded by the different leads attached to the patient's body. The patient ECG module user interface 305 further comprises a summary 361 of the group and syndromes related to ECG chart 395 as selected by the user. The patient ECG module user interface 305 also includes a summery part 380 comprising a final result 381 written by the user of the ECG diagnosis assistance device taking into consideration the summary 361 of the group and syndromes related to ECG chart 395 as well as the patient details 320, a differential diagnosis (not shown) that can be further provided by the patient ECG module for the group and at least one syndrome identified., medical history of the patient and other details that may affect final result 381. Summery part 380 further includes patient status, remarks, an approve check button 382. The patient ECG module user interface 305 also includes a link to a database Atlas 390. The Atlas includes at least one ECG chart or pattern examples, each associated with one combination of a group and at least one syndrome (the combination thereof results in a single pattern), to be compared with an ECG chart associated with a patient 395. The atlas is used to obtain a picture from database 240 in Fig. 2. The Atlas can be an additional tool in allowing better and quicker identification of a pattern. For example, if a user is not sure which syndrome he is identifying in the patient's ECG chart 395, he may request to view a number of pattern ECG charts stored in the atlas to make a final decision as to the appropriately pattern to be selected. Button 382 is also used for initiating the visual comparison between the ECG chart stored in the database (50 of Fog. 1) associated with the pattern selected (346, 360, 361) and the patient's ECG chart 395 as described in association with Figs. 3, 5. Fig. 4 illustrates an exemplary user interface showing the patient information module implementation, in accordance with the preferred embodiment of the present invention. The patient information module user interface further comprises a list of patient relevant details 410 such as patient identification number, name, age, sex, birth date, contact information such as phone number, address, and optionally additional patient details (not shown). The patient information module user interface further comprises a list of additional details 420 such as an indication for the ECG check such as pain, disease, routine insurance and the like, health care company, the referring doctor, the referring doctor's contact details, patient symptoms, cardiac history, medications, heart diseases and the like. The patient information module user interface further comprises a list of additional details 430 such as the measure of urgency in performing the diagnosis for said patient, date and time in which the record was received in the system, user name, patient ECG chart filename and the like. Patient information can be previously entered by the user or received electronically from a remote system such as another computer or diagnosis assistance apparatus. Any changes of the described patient information module user interface can be made using the setup configuration module. An example of such a change is to add or remove details that were received using the patient information module, to the patient ECG module which is described in Fig. 3. Fig. 5 is a flow chart depicting the main steps of the operation of the ECG diagnosis assistance device, in accordance with the present invention. The first step of providing diagnosis using the ECG diagnosis assistance device 10 is to select a patient. In step 510, device 10 opts the user of the ECG diagnosis assistance device to select a patient from a list of patients available in the system and previously entered into database 50 of Fig. 1 via the patient information module as described in Fig. 4. In selecting a patient, the user will receive relevant information associated with the selected patient. The information associated with said selected patient is received from the database (50 of Fig. 1) and is presented to the user on a display device, as shown in Fig. 3. The patient's ECG chart will be presented in window 395 of Fig. 3. In step 515, using the patient's ECG chart, device 10 requests the user to select a group from a list of groups appearing in window 340 of Fig. 3. The user may select any group appearing in the window 340 of Fig. 4. The user selects the group according to basic characteristics of the patent's ECG chart appearing in window 395 of Fig. 3. By selecting the group, the use may continue to later classifying and selecting at least one syndrome. A group comprises different electrocardiographic patterns having similar anatomic and pathophysilogic characteristics. Few examples of different groups are found in the description associated with Fig. 2. In step 520, device 10 opts the user to select at least one syndrome from a list of syndromes associated with said selected group for classifying the syndrome associated with the patient's ECG chart. A syndrome can be a first type, a second type, a third type or a fourth type syndrome. Few examples of different syndromes are found in the description associated with Fig. 2. In step 525, device 10 requests the user to decide whether to select an additional syndrome. It is noted that this request is based on and is dependant upon the structure of the group - syndrome classification. Thus, in order to classify a particular pattern, the user may have to select one or more syndromes. The selection of each pattern or at least one syndrome is based upon the characteristics appearing in the patient ECG chart while referring to characteristics of the group or at least one syndrome appearing in window 260. Prior to making the selection of a group or at least one syndrome, the user clicks the intended selection (group or at least one syndrome) and the device 10 presents the characteristics of said selection in window 360 of Fig. 3. The user may then compare the characteristics, such as for example, the ST elevation, with the patient ECG chart appearing in window 395 of Fig. 3. If the characteristics shown in window 361 and those observed by the user in the patient ECG chart 395 matches, then the user confirms the selection. Said confirmation can be performed via a double click of the mouse on said group or at least one syndrome. Next, in step 520 device 10 if the user opted to select an at least another syndrome the process of selection of a syndrome is repeated and a syndrome from a list of the syndromes, associated with the already selected group and already selected at least one syndrome is selected for further classification of the syndrome associated with the patient's ECG chart. In step 525 if the user selects not to continue with further classification of syndromes, the device 10 identifies that the pattern selected is the combination of the group and the at least one syndrome selected thus far. The device 10 optionally stores the selection of group and one or more syndromes selected by the user. In step 530, device 10 obtains a picture from the database associated with the group and at least one syndrome selected by the user.

A picture is an ECG chart associated with a pattern or a patient. In step 535, device 10 compares the picture obtained from the database and associated with the selected pattern with the selected patient's ECG chart in order to determine a similarity factor and generates a result of the comparison. The process of comparing said pictures was further described in detail in association with Fig. 2. In step 540, device 10 presents the result of the comparison and the similarity factor. The similarity factor determines the similarity between two compared pictures and hence the accuracy of the diagnosis made. A high similarity factor would suggest a high accuracy while a low similarity factor would suggest that the diagnosis might be incorrect based on the data stored in the database. The device 10 presents a notice to the user for reconsideration of the diagnosis made by the user in case of a low similarity factor below a predetermined threshold. The similarity predetermined threshold can be determined during the setup stage or installation of the device 10 onto the computing platform. Alternatively, the predetermined similarity factor can be updated or changed by the user of the device 10. In one non-limiting example the device 10 will alert the user to the possibility that the diagnosis is inaccurate if the similarity factor result is below 90% or the like. In addition, in case of low similarity the device 10 may optionally opt the user to store the patient ECG chart in the database 50 of Fig. 1 as a new pattern associated with the selected group and at least one syndrome as the low similarity factor might suggest that a heart disease, with no pattern or ECG chart example is stored in the database 50, was encountered by the user.. The new pattern is classified temporary as a non-approved and is not being used by the device until confirmation and classification by an authorized person. In step 545, device 10 shows a list of differential diagnosis for the group and the at least one syndrome selected that should be taken into consideration while determining the final diagnosis. The differential diagnosis helps the user to differentiate between various diseases having similar or the same ECG pattern. The following three examples may inteφret as a heart disease while they are not. It is an objective of the present invention to inform the user about the different possibilities so the user will be able to differentiate between those cases and a heart disease in order to produce an accurate diagnosis. The first example is an ST elevation from high take off, which may appears in a young male suffering no chest pain. The second example is acute pericardits, which may also appear in patient with continues chest pain and fever. The third example is hyperkalimia, which may appear in patients with renal failure or under drag influence. Fig. 6 is an example of a table describing the classification according to the present invention divided into groups and syndromes and showing the different characteristics of each group or syndrome as shown in an ECG chart, generally referenced 601. The table 601 is divided into six columns as follows: group name, four syndromes names, and a pattern name 600. The four syndromes names are: syndrome A name for the first type syndrome, syndrome B name for the second type syndrome, syndrome C name for the third type syndrome and syndrome D name for the fourth type syndrome. Each row of the table defines a combination of a group with at least one syndrome. Each row is associated with a different diagnosis and therefore a different pattern. Each row therefore includes a pattern summary which comprises the different characteristics of an ECG chart associated with said pattern according to which the user can select the group and the at least one syndrome associated with the patient's examined ECG chart, as further explained in detail in association with Figs. 7, 8, 9. For example, according to table 601 pre infarction group 605 includes in the V2 strip of the ECG chart ST elevation and T positive. As detailed above in association with Fig. 5 device 10 will request the user to select a first type syndrome from a list of syndromes (not shown). If the ECG chart has ST elevation and T positive both in the V2 and in the V3 strips a first syndrome 610 should selected. In table 601, first type syndrome 610 shown is acute obstruction of left anterior descent. A first type syndrome is a description of an artery disease location and culprit artery.

According with the method described above, the user can next select a second type syndrome from a list of syndromes as shown in table 601, for example the second type syndrome for the selected first type syndrome mentioned above is either small 615 or large 620 (left anterior descent) based on other characteristics of the patient ECG chart. A second type syndrome is a description of an artery disease size. After selecting a second type syndrome the user is opted by the device 10 to select a third type syndrome from a list of syndromes as shown in table 601. If a second type syndrome was selected to be small 615 a third type syndrome can be either proximal 645 or distal 650 (acute obstruction location in left anterior descent) can be chosen. If a second type syndrome was selected to be large 620 a third type syndrome can be either proximal 625 or distal 630 (acute obstruction location in left anterior descent). A third type syndrome is a description of the level of obstruction. After selecting a third type syndrome the device 10 will request the user to select a fourth type syndrome from a list of syndromes. If a third type syndrome proximal 625 was selected a fourth type syndrome can be either protected lateral wall 635 or unprotected lateral wall 640 (of left anterior descent). If a third type syndrome distal 650 was selected a fourth type syndrome can be either a protected lateral wall 655 or unprotected lateral wall 660 (of left anterior descent). A fourth type syndrome is a description of the lateral wall involvement. As was shown, for each group each one of the first type syndromes can be selected, for each one of the first type syndrome, each one of the second type syndrome, and so on. For example, pattern 670 is a combination of pre infarction group 605, acute obstruction of left anterior descent (first type syndrome) 610, large (second type syndrome) 620, proximal (third type syndrome) 625 and unprotected lateral wall (fourth type syndrome) 640. The characteristics of an ECG chart which are described in pattern 670 (V2 having r/S, ST elevated and T positive; v3 having R/S, ST elevated and T positive; v4 having R/s, ST elevated and T positive; V5 having R/s, ST elevated and T positive; AVL having R/S and ST attenuated; LIII having r/S and ST attenated associated with only one combination of a group and at least one syndrome. Fig. 7 is a pictorial example of an ECG pattern, showing a specific syndrome of a pre infraction group, in accordance with the present invention. The following example describes an ECG chart of a patient, which suffered for about

2 hours from severe chest pains. A person skilled in the art would appreciate the terminology which is used for describing the different strips of an ECG chart as VI to v6, LI to L3 and AVR, AVL and AVF. The pre infarction group is characterized by an ST elevation 710 of the signal above the zero potential level and non Q waves, both appear in V2 strip. Most of the patterns associated with the pre infarction group have non Q waves. An ST elevation 710 and positive T wave 720 appear in V2 and in V3 (725) define the first type syndrome associated to be an acute obstruction of left anterior descent. No change in the level of the ST signal (relative the zero potential level) appears in L3 (730) associate the examined ECG chart to small (second type syndrome). No change in the level of the ST signal (relative the zero potential level) in the shape of AVL (740) associate the examined ECG chart to distal third type syndrome. No change in the shape of V4 (750) and V5 (755) associate the examined ECG chart to Lateral protected fourth type syndrome. Persons skilled in the art would also appreciate the advantages of the exact, fast and accurate diagnosis which is enabled due to the new and novel classification presented in the present invention. Fig. 8 is a pictorial example of an ECG pattern, showing a specific syndrome of an evolving infarction group, in accordance with the present invention. The following example describes an ECG chart of a patient about 4 hours after angioplasty and about 6 hours after onset of chest pains. A person skilled in the art would appreciate the terminology which is used for describing the different strips of the ECG chart as VI to V6, LI to L3 and AVR, AVL and AVF. The Q wave appears in V2 (810) has negative deflection in the first 40 msec. The negative deflection of the Q wave together with the knowledge about the time of performing the ECG test defines the associated group as an evolving infarction group. The QS (no r appears) appears both in V2 (820) and in V3 (825) has a negative deflection so the first type syndrome associated is anteroseptal wall. ST elevation 830 and 832 and T wave inverted 835 and 837 appears both in

V2 and in V3 so the second type syndrome associated is Incomplete reperfused.

The clinical meaning is that the blood flow is restored to the myocardium. In the present case, no additional syndromes are required for completing the pattern diagnosis. The pattern includes one group and two syndromes. The example described in Fig. 8 emphasizes the importance of the new invention by enabling to determine the physiological condition of the myocardium and the damage of the artery coronary as a result of the heart disease. Fig. 9 is a pictorial example of an ECG pattern, showing a syndrome of a final pattern of infarction group, in accordance with the present invention. The following example describes an ECG chart of a patient about 10 hours after thrombolytic treatment. A person skilled in the art would appreciate the terminology which is used for describing the different strips of the ECG chart as VI to V6, LI to L3 and AVR, AVL and AVF. A final pattern of infarction defines the patient's condition after stabilization as a result of receiving or not receiving medical treatment. If the pattern appearing between 6-72 hr has no farther changes the group associated is the final pattern of infarction group. Alternatively, the final pattern of infarction group is defined based on the ECG performing time or more specifically based on the time that have passed after receiving or not receiving medical treatment. The QS (no r wave appears) appears both in V2 strip (920) and in V3 strip (925) has a negative deflection so the first type syndrome associated is anteroseptal wall. Alternatively, V3 strip sometimes have Q/r/S wave 927, however the first type syndrome associated is the same. V2 comprises iso-electric ST waves 930 and inverted T wave 940 while V3 strip comprises iso-electric ST waves 935 and inverted T wave 945 so the second type syndrome associated with these characteristics is reperfused and the blood flow is restored to the myocardium. In the present case, no additional syndromes are required for completing the pattern diagnosis. The pattern includes one group and two syndromes. The person skilled in the art will appreciate that table 601 is not limited to the number of groups or syndromes or patterns shown and that additional groups, syndromes and patterns can be defined in used in association with table 601 or a like table in order to enhance the process of selection of patterns and hence the diagnosis of ECG charts. The person skilled in the art will appreciate that what has been shown is not limited to the description above. The person skilled in the art will appreciate that examples shown here above are in no way limiting and are shown to better and adequately describe the present invention. Those skilled in the art to which this invention pertains will appreciate the many modifications and other embodiments of the invention. It will be apparent that the present invention is not limited to the specific embodiments disclosed and those modifications and other embodiments are intended to be included within the scope of the invention. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for puφoses of limitation. Persons skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.

Claims

I/We claim: 1. Apparatus for electrocardigraphic diagnosis assistance, the apparatus is implemented in a computing platform, said platform comprises a central processing unit, a storage device and an input and output device, the apparatus comprising: a patient information module for receiving information about a patient; a database for storing at least one electrocardigraphic chart or pattern; and a patient electrocardigraphic module for selecting a group and an at least one syndrome associated with the at least one electrocardigraphic chart stored in the database and associated with the patient.

2. The apparatus of claim 1 wherein the selected group and the at least one syndrome is associated with a pattern.

3. The apparatus of claim 1 wherein the patient electrocardigraphic module retrieves a picture of an electrocardigraphic chart associated with the selected group and the at least one selected syndrome and compares the retrieved picture with a picture corresponding to the electrocardigraphic chart associated with the patient.

4. The apparatus of claim 1 further comprises a setup configuration module for configuring the patient electrocardigraphic module, or the patient information module, or the database.

5. The apparatus of claim 1 wherein the electrocardigraphic chart is a graph or trace of the electrical impulses recorded by an at least one lead attached to the patient body.

6. The apparatus of claim 1 wherein the pattern is an electrocardigraphic chart associated with or without a heart disease.

7. The apparatus of claim 1 wherein the patient information module comprises information associated with the patient.

8. The apparatus of claim 1 wherein the database comprises at least one table, said table comprising at least one electrocardigraphic chart to be used for comparison with a patient electrocardigraphic chart.

9. The apparatus of claim 1 wherein the patient electrocardigraphic module compares a picture obtained from the database with a picture associated with a patient electrocardigraphic chart.

10. The apparatus of claim 9 wherein the patient electrocardigraphic module further presents the result of the picture comparison unto the output device.

1 1. The apparatus of claim 1 wherein the patient electrocardigraphic module further provides a differential diagnosis for the group and the at least one syndrome selected.

12. The apparatus of claim 1 wherein the group comprises different electrocardiographic patterns having similar anatomic and pathophysilogic characteristics.

13. The apparatus of claim 12 wherein the group comprises any one of the following: pre infarction; evolving infarction; final pattern infarction; normal electrocardigraphic chart; between normal limits; hypertrophic myocardiopathy; dilated myocardiopathy; recent myocardial infarction; chronic myocardial infarction; chronic myocardial ischemia; myocarditis pericarditis; atrial arrythmias; re-entry tachycardia; nodal arrythmias; ventricular arrythmias; atrial block; auricular ventricular blocks; intra-ventricular block; congenital heart disease; long Q-T syndrome; pre excitation syndromes; early repolarization syndromes; or metabolic disease.

14. The apparatus of claim 1 wherein the at least one syndrome comprises a first type, a second type, a third type and a fourth type syndrome.

15. The apparatus of claim 14 wherein the first type syndrome associated with the pre infraction group is a description of an artery disease location and culprit artery.

16. The apparatus of claim 14 wherein the second type syndrome associated with the pre infraction group is a description of an artery size.

17. The apparatus of claim 14 wherein the third type syndrome associated with the pre infraction group is a description of the level of obstruction.

18. The apparatus of claim 14 wherein the fourth type syndrome associated with the pre infraction group is a description of the lateral wall involvement.

19. Within a computerized platform, said computing platform comprises a central processing unit, a storage device and an input and output device, a method for electrocardigraphic characteristics classification, the method comprises the steps of: selecting a patient for receiving information associated with the selected patient; selecting a group from a list of groups associated with characteristics of the patient's electrocardigraphic chart; selecting an at least one syndrome from a list of syndromes associated with the characteristics of the patient electrocardigraphic chart for classifying a pattern associated with the patient's electrocardigraphic chart, whereby a patient medical condition is diagnosed.

20. The method of claim 19 further comprising the step of obtaining a picture from a database, said picture associated with the said group and said at least one syndrome selected by a user.

21. The method of claim 19 wherein the information associated with the selected patient comprises an at least one patient electrocardigraphic chart.

22. The method of claim 19 wherein the at least one syndrome comprises a first type, a second type, a third type and a fourth type syndrome.

23. The method of claim 20 wherein a picture is an electrocardigraphic chart.

24. The method of claim 20 further comprising the steps of: comparing the picture obtained from the database with a picture associated with the patient electrocardigraphic chart in order to determine a similarity factor; and presenting the result of the picture comparison to an output device.

25. The method of claim 24 wherein the similarity factor is the degree of similarity between the two compared pictures.

26. The method of claim 19 further comprising the step of showing a list of differential diagnosis for the group and the at least one syndrome selected for consideration of a user.