NL2037702B1 - Device for performing a multi-channel ecg and a method for performing a multi-channel ecg - Google Patents
Device for performing a multi-channel ecg and a method for performing a multi-channel ecgInfo
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- NL2037702B1 NL2037702B1 NL2037702A NL2037702A NL2037702B1 NL 2037702 B1 NL2037702 B1 NL 2037702B1 NL 2037702 A NL2037702 A NL 2037702A NL 2037702 A NL2037702 A NL 2037702A NL 2037702 B1 NL2037702 B1 NL 2037702B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/327—Generation of artificial ECG signals based on measured signals, e.g. to compensate for missing leads
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/332—Portable devices specially adapted therefor
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Abstract
The invention relates to a computer-implemented method for providing leads for a 12-lead ECG, the method comprising: - receiving data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes comprising a first right frontal electrode (RA), a first left frontal electrode (LA), a second left frontal electrode (LL) and a second right frontal electrode (RL); - determining, from the received data, 12 leads for a 12-lead ECG, wherein the step of determining comprises determining at least one precordial lead based on the data representing a measured voltage or voltage difference from at least one of the frontal electrodes. The invention further relates to a computer-implemented method for providing a 12-lead ECG and a 12-lead ECG-device configured for measuring a 12-lead ECG. The invention also relates to a computer program and a computer-readable storage medium.
Description
DEVICE FOR PERFORMING A MULTI-CHANNEL ECG AND A METHOD FOR
PERFORMING A MULTI-CHANNEL ECG
The invention relates to a device for performing a multi-channel ECG and a method for performing a multi-channel ECG.
A heart generates an electric pulse which causes the heart to pump and circulates blood through the blood vessels. Due to the electrical pulses an electrical field is generated which can be detected by electrodes. These electrodes can be positioned on the body or inside the body.
Conventional devices for recording a multi-channel-ECG, for example those used in hospitals, provide a 12-lead ECG, which contains three bipolar leads, three augmented bipolar leads and six precordial leads. In order to perform a 12-lead ECG, at least ten electrodes are required, which are positioned on various places on the body. This contains four frontal or limb electrodes, which are placed at or at least near each of the limbs. The four frontal electrodes are used to measure and/or calculate the bipolar and augmented unipolar leads. In order to measure the precordial leads six electrodes are placed at specific places at the chest. The electrodes generally form a slightly curved line on the chest. This approach will then result in a 12-channel-ECG which shows the electrical activities of the heart in a frontal, sagittal and/or horizontal plane.
A disadvantage of this method is that it requires complex and large equipment as well as an (experienced) operator to perform the various actions required to obtain (and interpret) the ECG. As a result, registering a diagnostic 12-lead ECG is complex and time-consuming and not easily performed by non-professionals.
The object of the invention is to provide a method for registering a diagnostic 12-lead
ECG that is less complex and time-consuming.
This object is achieved with a computer-implemented method for providing 12 leads for a 12-lead ECG, the method comprising: - receiving data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes comprising a first right frontal electrode (RA), a first left frontal electrode (LA), a second left frontal electrode (LL) and a second right frontal electrode (RL); and - determining, from the received data, 12 leads for a 12-lead ECG, wherein the step of determining comprises determining at least one precordial lead based on the data representing a measured voltage or voltage difference from at least one of the frontal electrodes.
It is noted that the data received from the frontal electrodes may also be referred to as ‘frontal electrode data’. The data on which the precordial lead is based may also be referred to as ‘precordial data’. It is furthermore noted that the term ‘providing’ is, in the context of this application, interchangeably used in several places with the word ‘registering’ with regard to the leads of the 12-lead ECG.
An advantage of the computer-implemented method according to the invention is that is allows registering one or more precordial leads for a 12-lead ECG without requiring precordial electrodes to obtain these precordial leads. This means that one or more precordial electrodes can be obviated using the method according to the present invention. As such, it is noted that the method is directed to determining at least one precordial lead based on data representing a measured voltage or voltage difference from at least one of four frontal electrodes. It is further noted that the four frontal electrodes need not be positioned on the limbs, yet may also be positioned on the chest at a relatively short distance from each other, such as in the range of 5 to 25 centimeter apart from each other.
Another advantage is that, due to the precordial leads being determined based on one or more frontal electrodes, as little as four (frontal) electrodes are needed to obtain 12 leads fora 12-lead ECG. This decreases the number of electrodes needed, allowing a higher speed in obtaining the 12 leads.
Yet another advantage, due to the low amount of electrodes needed, is that preparation time for registering the 12 leads is relatively low and at least significantly lower than in existing 12 lead ECGs. It is noted that the registration of the 12 leads is performed without loss of accuracy of the 12 leads.
A further advantage is that the equipment required to register the 12 leads may be reduced in size, even to the point of providing a hand-held device for registering the 12 leads.
An advantage of the computer-implemented method according to the invention, is that it allows the detection of rhythm disorders. In addition, due to the capability of providing 12 leads based on the frontal electrodes, the data representing the 12 leads is also sufficient for use in a 12-lead ECG that in turn can be used to detect occlusive myocardial infarction (OMI) in patients with chest pain. The latter has not been possible with the existing methods without the use of precordial electrodes.
In an embodiment of the computer-implemented method according to the invention, the step of determining of the at least one precordial lead is performed exclusively based on the data representing the measured voltage or voltage difference from at least one of the frontal electrodes.
It is preferred that at least one, preferably all, precordial leads are registered exclusively based on data from the frontal electrodes (i.e. without using precordial electrodes).
This provides a maximum increase in speed and effectiveness without compromising on accuracy of the registration of the 12 leads.
In an embodiment of the computer-implemented method according to the invention, the step of determining of the at least one precordial lead comprises determining six precordial leads, wherein the determining of each of the six precordial leads is performed exclusively based on the data representing the measured voltage or voltage difference from the frontal electrodes.
To rapidly register all 12 leads for a 12 lead ECG, it is preferred that all precordial leads are registered exclusively based on data from the frontal electrodes. This obviates the use of precordial electrodes and may reduce the number of required electrodes to as little as four electrodes.
In an embodiment of the computer-implemented method according to the invention the at least one precordial lead is determined on the basis of data representing a measured absolute potential of the first right frontal electrode RA. Preferably, this is mentioned as the first precordial lead.
An advantage of the abovementioned embodiment is that the data representing a measured absolute potential of the first right frontal electrode RA is comparable to the data obtained by using a precordial electrodes for measuring the fourth intercostal space to the right of the sternum of a patient. It is often also referred to as the first anterior lead.
In an embodiment of the computer-implemented method according to the invention the least one precordial lead is determined on the basis of data representing a measured absolute potential of the first left frontal electrode LA. Preferably, this is mentioned as the second precordial lead.
An advantage of the abovementioned embodiment is that the data representing a measured absolute potential of the first left frontal electrode LA is comparable to the data obtained by using a precordial electrodes for measuring the fourth intercostal space to the left of the sternum of a patient. It is often also referred to as the second anterior lead.
In an embodiment of the computer-implemented method according to the invention the at least one precordial lead is determined on the basis of data representing a measured absolute potential of the second left frontal electrode LL. Preferably, this is mentioned as the third precordial lead.
An advantage of the abovementioned data is that it represents comparable data as can be obtained by a precordial electrode positioned to register the third anterior lead, which is the same as the first anterior lead.
In the abovementioned embodiments of the computer-implemented method according to the invention, the ground electrode in the data representing one or more precordial lead is defined as a Wilson Central Terminal (WCT), which can be expressed as %% *( the value of RA + the value of LA + the value of LL) or is the second right frontal electrode RL in the data representing one or more precordial leads.
All data representing a precordial lead require that the measured value is referenced to a ground (i.e. electric potential of zero), which in the abovementioned embodiments is provided by the second right frontal electrode RL or is defined by a Wilson Central Terminalln an alternative embodiment, the computer-implemented method according to the invention, the number of electrodes is five, wherein the fifth electrode is a central electrode (CE) configured to function as ground electrode in the data representing one or more precordial leads.
All data representing a precordial lead require that the measured value is referenced to a ground (i.e. electric potential of zero), which in the abovementioned embodiment is a central electrode (CE). An advantage of the central electrode is that it reduces the amount of noise in the data representing the one or more precordial leads. It is preferred that, when using a central electrode, the first right and left frontal electrodes (RA, LA) and the second left and right frontal electrodes (LL, RL) are positioned in a rectangular configuration. The central electrode (CE) is in this case positioned at the central point of the rectangle formed by the other electrodes RA, LA, LL, RL).
In an embodiment of the computer-implemented method according to the invention the at least one precordial lead is determined on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second left frontal electrode LL. Preferably, this is mentioned as the fourth precordial lead.
An advantage of the abovementioned data is that it represents comparable data as can be obtained by a precordial electrode positioned to register the fourth anterior lead, which is the same as the second anterior lead.
In an embodiment of the computer-implemented method according to the invention the at least one precordial lead is determined on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second right frontal electrode RL. Preferably, this is mentioned as the fifth precordial lead.
An advantage of the abovementioned data is that it represents comparable data as can be obtained by a precordial electrode positioned to register the first lateral lead, which is often also referred to as the fifth anterior lead.
In an embodiment of the computer-implemented method according to the invention the at least one precordial lead is determined on the basis of data representing a measured absolute potential of the second right frontal electrode RL. Preferably, this is mentioned as the sixth precordial lead.
An advantage of the abovementioned data is that it represents comparable data as can be obtained by a precordial electrode positioned to register the second lateral lead, which is often also referred to as the sixth anterior lead.
In the abovementioned embodiment of the computer-implemented method according to the invention, the ground electrode in the data representing the mentioned precordial lead is defined as a Wilson Central Terminal (WCT), which can be expressed as 4 *( the value of
RA + the value of LA + the value of LL) or is the second left frontal electrode LL in the data representing the mentioned precordial lead.
The data representing a measured absolute potential of the second right frontal 5 electrode RL to determine the precordial lead requires that the measured value is referenced to a ground (i.e. electric potential of zero). In the abovementioned embodiment, the ground is formed by the second left frontal electrode LL or is defined by a Wilson Central Terminal.
In an alternative embodiment, the computer-implemented method according to the invention, the number of electrodes is five, wherein the fifth electrode is a central electrode (CE) configured to function as ground electrode in the data representing a measured absolute potential of the second right frontal electrode RL to determine the precordial lead.
All data representing a precordial lead require that the measured value is referenced to a ground (i.e. electric potential of zero), which in the abovementioned embodiment is a central electrode (CE). An advantage of the central electrode is that it reduces the amount of noise in the data representing the one or more precordial leads. It is preferred that, when using a central electrode, the first right and left frontal electrodes (RA, LA) and the second left and right frontal electrodes (LL, RL) are positioned in a rectangular configuration. The central electrode (CE) is in this case positioned at the central point of the rectangle formed by the other electrodes RA, LA, LL, RL).
It is noted that the abovementioned embodiments specifically describing one of the precordial leads may also be provided as the first to the sixth precordial lead.
In an embodiment of the computer-implemented method according to the invention, the step of determining 12 leads for the 12-lead ECG further comprises determining one or more bipolar leads, wherein: - a first bipolar lead is determined on the basis of data representing a measured voltage between the first left frontal electrode LA and the first right frontal electrode RA; and/or - 4 second bipolar lead is determined on the basis of data representing a measured voltage between the first right frontal electrode RA and the second left frontal electrode LL; and/or - a third bipolar lead is determined on the basis of data representing a measured voltage between the second left frontal electrode LL and the first left frontal electrode LA.
An advantage of the method according to the invention is that the data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes can also be used to determine the bipolar leads of a 12 lead ECG. This means that no additional electrodes are required beyond four frontal electrodes. It is noted that, if desired, it is possible to utilize more than four electrodes even though this is not required.
A further advantage of the method according to the invention is that, due to the abovementioned number of electrodes, the time required to register 12 leads of the 12 lead
ECG can be reduced significantly compared to the known methods for registering 12 lead
ECGs.
In an embodiment of the computer-implemented method according to the invention, the step of determining 12 leads for a 12-lead ECG further comprises the step of determining one or more augmented unipolar leads determined on the basis of data representing a measured absolute potential of the first left frontal electrode LA and/or the first right frontal electrode RA and/or the second left frontal electrode LL, wherein: - a first augmented unipolar lead aVL is calculated using the formula: aVL =LA— Rat LL 2 and/or - a second augmented unipolar lead aVF is calculated using the formula: aVF = LL — LA + RA 2 and/or - a third augmented unipolar lead aVR is calculated using the formula: aVR=RA- LA LL 2
An advantage of the method according to the invention is that the data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes can also be used to determine the augmented unipolar leads of a 12 lead
ECG. This means that no additional electrodes are required beyond four frontal electrodes. It is noted that, if desired, it is possible to utilize more than four electrodes even though this is not required.
A further advantage of the method according to the invention is that, due to the abovementioned number of electrodes, the time required to register 12 leads of a 12 lead ECG can be reduced significantly compared to the known methods for registering 12 lead ECGs.
The invention further relates to a computer-implemented method for providing a 12- lead ECG, the method comprising: - determining 12 leads using the computer-implemented method for providing 12 leads for a 12-lead ECG according to the invention; and - combining the 12-leads into an ECG, preferably into a graphic representation of the ECG, more preferably a graphic representation of the ECG according to the Cabrera system.
An advantage of the abovementioned computer-implemented method is that, due to the effective determination of the 12 leads, an ECG with a high amount of sensitivity and accuracy can be provided. It is noted that the method according to the invention is particularly useful in detecting ischemic ST-segment deviations from different coronary artery culprits, which can not be achieved with single-lead ECG wearables, such as the Apple Watch. Such wearables have been found not useful for detection of ischemic ST-segment deviations from different coronary artery culprits as their single lead design leads to a sensitivity that is insufficiently high. Workarounds have been proposed, but these have been found to be too time-consuming and complicated for real-world use.
It is noted that the computer-implemented method for providing a 12-lead ECG as described above may alternatively also be performed using standard ECG-recording methods instead of the computer-implemented method for providing 12 leads for a 12-lead ECG. This alternative may also be used in conjunction with one or more of the embodiments mentioned below.
In an embodiment of the computer-implemented method according to the invention, the 12-lead ECG may be a personalized ECG and wherein the method further comprises detecting patient specific anomalies in the ECG for personalizing the ECG and outputting the information to a computing device and/or a memory.
This embodiment allows patient specific anomalies, which are also present in a normal situation (i.e. a situation in which no pathological conditions are present), to be disregarded as indicators or markers for pathological conditions that need immediate (medical) attention.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of receiving data comprising at least one reference 12-lead ECG at a first time and storing the data comprising at least one reference 12-lead
ECG in a memory.
An advantage of providing and storing data representing a reference 12-lead ECG is that the data can be used at any subsequent time or point in time as a reference or basis for acomparison. The data representing the reference ECG preferably provides a reference ECG of the person that is made at a first time point. The first time point is a time point at which the person does not have any complaints and/or does not have any pathological (heart) conditions. As such, it forms a base line. The data representing the at least one reference
ECG preferably comprises data representing three or more reference ECG’s, which include a reference ECG of the person sitting, a reference ECG of the person standing and a reference
ECG of the person lying down. It has been found that this, especially when the reference
ECGs are combined in a single reference ECG, provides a high reliability and sensitivity. The three ECGs in the different positions are generally all made on the first time.
It is noted that where a time or time point is mentioned, this may also be considered a first time period of predetermined length. Generally, the various time periods do not overlap.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of:
- receiving comparison data representing 12-lead ECGs from a database; - comparing, using a processor and preferably using a neural network, the data representing the determined at least one reference 12-lead ECG with the comparison data to identify person-specific ECG-markers, wherein the person-specific ECG-markers are deviations of the data representing the at least one reference 12-lead ECG relative to the received comparison data; and - storing the person-specific ECG-markers in a memory, and - optionally, outputting an overview of the person specific ECG-markers to an external device, such as a computing device or a remote memory.
An advantage of the abovementioned embodiment is that it provides a personalization of the received data and, in particular, the data representing the ECGs. This may advantageously serve two purposes.
Firstly, the identification and storing of person-specific ECG-markers allows these markers to be considered irrelevant in data representing subsequent ECGs, for example data representing subsequent ECGs in which pathological conditions are evaluated. By ignoring or removing the known conditions, the analysis may be focused on deviations that, up to the time point that the subsequent ECG was made, were not known.
Secondly, the data may, under certain predetermined conditions, such as legal allowability, also be used for research purposes, for example to further and/or more accurately understand the relationship between a pathological condition and a deviation in data representing the ECG.
It is noted that the step of storing the person-specific ECG-markers in a memory may comprise the step of storing the person-specific ECG-markers as part of a personal ECG. In this case the person-specific ECG-markers are part of ECG that is stored in the memory, for example for later use.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of: - receiving data representing at least one subsequent 12-lead ECG at a subsequent time; - storing the data representing the at least one subsequent 12-lead ECG in the memory; - upon receiving the data representing the at least one subsequent 12-lead ECG, comparing, using a processor and preferably using a neural network, the data representing the subsequent 12-lead ECG with the data representing at least one of the at least one reference 12-lead ECGs stored in the memory to identify deviations between the subsequent 12-lead ECG and data representing the at least one reference 12-lead ECG; - outputting the identified deviations to an external source, such as a computing device or a user interface for further review; and - optionally storing the identified deviations in the memory.
An advantage of the abovementioned embodiment is that it allows the presence and/or (further) development of any known (pathological) conditions or heart disorders to be followed in a consistent and reliable manner. The subsequent ECG is thereto made at a subsequent time, for example at a second time that is later than the first time. The development can be identified by identifying and/or tracking changes in the person-specific ECG-markers, which changes may be outputted to a computing device or memory for later use by a medical professional or, in some embodiments, even an automated evaluation system.
Another advantage is that the person-specific markers, if not changed at the subsequent time, will be removed in the comparison between the reference ECG and the subsequent ECG. As a result, only deviations that are not person-specific markers will remain and can be evaluated.
In an embodiment according to the invention, the method may optionally include one or more of the steps of comparing, the subsequent 12-lead ECG with one or more preceding subsequent ECGs and coupling the identified deviations stored in the memory to the subsequent 12-lead ECG from which they were derived.
An advantage of coupling the deviations with the subsequent ECG in which thse deviations were detected allows easy retrieval of both the source data (representing the ECG) and the deviations that emerge after comparing. In some embodiments, the deviations may be included in a modified ECG that includes the changes.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the method further comprises the step of, based on the outputted identified deviations, diagnosing, preferably automatically diagnosing, whether the deviations are indicative of a pathological condition.
The deviations may according to the method be automatically diagnosed in order to provide an indication on whether a pathological condition is present. This may provide the person using the ECG (i.e. a patient) with a direct indication of whether the deviation is a reason for concern and requires a medical specialist to be contacted and/or action to be taken.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of: - comparing, using a processor, and preferably using a neural network, the data representing the at least one subsequent ECG with the comparison data to identify general markers, wherein the general markers are deviations of the data representing the at least one subsequent ECG relative to the comparison data; - comparing the general markers with person-specific ECG-markers; - removing any general markers that match a person-specific ECG-marker;
- identifying any anomalies in the data representing the at least one subsequent 12-lead
ECG, if any, wherein the anomalies are any general markers remaining after the steps of comparing and removing; and - outputting, to a computing device or an external memory, data representing at least the anomalies and/or storing in a memory, data representing at least the anomalies.
It is noted that comparison data may contain data representing normal and/or abnormal
ECGs from a database. The data representing a normal ECG may include an ECG that it is known to contain no specific pointers that indicate a pathological (heart) condition, whereas data representing abnormal ECGs may contain one or more deviations or pointers that indicate that a pathological condition of the heart may be present. The deviations or pointers are generally deviations that are known to be (likely) connected to a pathological condition.
The abovementioned embodiment provides several advantages. First of all, the identification and subsequent removal of the person-specific ECG-markers in the data representing the subsequent ECG allows any subsequent analysis of the data to be focused on general markers that, up to the time point that the subsequent ECG was made, were not known.
Another advantage is that the heart condition of a person, including any deviations, can be monitored in a consistent manner over a longer period of time due to the fact that the data representing this heart condition (i.e. the data representing the ECGs) is stored in a memory.
A further advantage is that, when the anomalies are outputted to a computing device, these may be used for early detection of a pathological condition in that particular computing device. This will require additional diagnostic steps, which may for example be incorporated in the computing device.
An even further advantage is the data collection, by means of the storage in memory, can be used for research purposes as it represents a consistent and reliable measurement over a longer period of time. At present, such long-time monitoring is not performed. This is mainly due to the fact that providing a 12-lead ECG requires complex equipment only available in hospitals and care centers.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the step of removing any deviations that match a person-specific
ECG-marker comprises removing any deviations from the at least one subsequent ECG to provide data representing a person-specific subsequent ECG.
Advantageously, the data representing each of the subsequent ECGs is subjected to the step of removing deviations and is subsequently outputted as data representing a person- specific subsequent ECG. This allows the person-specific subsequent ECGs to be compared with each other in a later stage for one or more purposes.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the method may comprise the step of providing the anomalies as part of a person-specific subsequent ECG to provide data representing a modified person- specific subsequent ECG.
The data representing the person-specific subsequent ECG may advantageously be processed further data representing a modified person-specific subsequent ECG. This particular data includes the anomalies and may for example be used as basis for an analysis by a medical professional or medical specialist.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the step of outputting may comprise the step of outputting the modified person-specific subsequent ECG to a computing device or a memory.
The data representing a modified person-specific subsequent ECG may also be provided to a computing device for automatic analysis by software configured to identify pathological conditions. It may also be provided to a memory, such as a digital patient dossier or file, to provide a reliable and consistent overview in time of the heart condition of the person (i.e. patient) to which the data relates.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of: - performing at least one fingerprint 12-lead ECG at a first time; - performing at least one subsequent 12-lead ECG at a subsequent time; - comparing, preferably using a neural network, the subsequent 12-lead ECG with at least one of the at least fingerprint 12-lead ECGs; and - identifying, preferably using a neural network, whether the subsequent 12-lead ECG deviates from the one or more preceding 12-lead ECGs with respect to one or more predetermined parameters; - optionally processing the differences, wherein processing may comprise one or more of: - storing the identified differences in a memory; - outputting the identified differences to an external source, such as a user interface.
It is noted that the term fingerprint ECG is meant to be identical to the term reference
ECG, which is an ECG that is made as a reference point that can be used for any comparison with subsequent ECGs.
An advantage of the abovementioned embodiment is that the subsequent ECGs are checked for pathological conditions (i.e. coronary diseases or conditions) based on a personalized ECG. As a result, some anomalies that would have been identified as possible problem, are disregarded since they were also already present in the ‘normal situation’ as presented by the fingerprint ECG. As a result, a more detailed and personalized approach is made to the ECG, thus increasing the safety of the patient.
The abovementioned embodiment may optionally include one or more of the steps of comparing, the subsequent 12-lead ECG with one or more preceding subsequent ECGs and/or the step of storing each determined 12-lead ECG in a memory.
In an embodiment of the computer-implemented method according to the invention, the method may further comprise the steps of: - receiving comparison data representing normal and/or abnormal ECGs from a database; - comparing, preferably using a neural network, the comparison data with the data representing the determined at least one fingerprint 12-lead ECG; - identifying, preferably using a neural network, differences between the data representing the determined at least one fingerprint 12-lead ECG and the received comparison data; - marking, and preferably storing in a memory, the identified differences as personalized
ECG markers that are not anomalies; and - optionally, outputting anomaly data containing the determined differences.
An advantage of the abovementioned embodiment is that deviations or anomalies that are present in a patient, for example due to a known heart condition, can be disregarded as anomalies that require action based on the ECG. In other words, the specificity of the ECG is increased due to the personalization of the ECG using markers. Another advantage is that the markers can easily be retrieved by a patient or medical professional for review, for example if the patient is assisted by a professional who is not his regular doctor.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the method may further comprise the steps of: - benchmarking, preferably using a neural network, the determined at least one fingerprint 12-lead ECG with the received comparison data for classifying the determined 12-lead
ECG as normal or abnormal; - if the determined 12-lead ECG is classified as abnormal, comparing the determined fingerprint 12-lead ECG with the normal ECGs from the comparison data to determine the differences; - removing any differences that are marked as personalized ECG markers from the identified differences, - marking any remaining differences, if any, as an anomaly in the determined subsequent 12-lead ECG; and - if an anomaly is marked, outputting data representing anomaly information.
An advantage of this embodiment is that, when comparing the ECG with a benchmarking group, such as a comparison group, the personalized markers can be used to disregard differences that otherwise would have been marked as anomaly.
In an embodiment of the computer-implemented method for providing a 12-lead ECG according to the invention, the method may further comprise the steps of:
- receiving the comparison data representing normal and/or abnormal ECGs from a database; - identifying, preferably using a neural network, differences between the one or more subsequent ECGs and the comparison data; - removing any differences that are marked as personalized ECG markers from the identified differences, - marking any remaining differences, if any, as an anomaly in the determined subsequent 12-lead ECG; and - if an anomaly is marked, outputting data representing anomaly information.
An advantage of this embodiment is that, when comparing the ECG with a benchmarking group, such as a comparison group, the personalized markers can be used to disregard differences that otherwise would have been marked as anomaly.
Another advantage of the abovementioned embodiment is that deviations or anomalies that are present in a patient, for example due to a known heart condition, can be disregarded as anomalies that require action based on the ECG. In other words, the specificity of the ECG is increased due to the personalization of the ECG using markers.
It is noted that the computer-implemented method for providing a 12-lead ECG as described above may alternatively also be performed using standard ECG-recording methods instead of the computer-implemented method for providing 12 leads for a 12-lead ECG. This alternative may also be used in conjunction with one or more of the embodiments mentioned in relation to the computer-implemented method for providing a 12-lead ECG.
The invention further relates to a 12-lead ECG-device configured for measuring a 12- lead ECG, the device having means adapted to execute the method according to the invention.
The device according to the invention has similar effects and advantages as the method according to the invention. The embodiments disclosed in relation to any one of the claims or embodiments of the method can also be, alone or in combination, be applied to the device according to the invention.
In an embodiment of the device according to the invention, the means comprise: - a computing device; and - atleast four electrodes that are configured to be positioned on a user's body and that are operatively connected to the computing device, wherein the four electrodes comprise frontal electrodes, wherein the frontal electrodes comprise: - aright frontal electrode RA that is configured to be placed on a right frontal of a user; - a left frontal electrode LA that is configured to be placed on a left frontal of a user; - a left frontal electrode LL that is configured to be placed on a left frontal of a user; and - aright frontal electrode RL that is configured to be placed on a right frontal of a user.
An advantage of the abovementioned means is that a reliable ECG with sufficient sensitivity can be registered using a relatively small device.
The device according to the invention allows a person to monitor his/her own heart condition at home without the assistance of a medical professional. An advantage thereof is that, especially when the results are stored, a more consistent, long-term and reliable monitoring of the heart condition becomes possible to identify any developments and/or (indicators of) pathological conditions at an early stage. It is preferred that the device, during use, is positioned on the sternum in a rectangular position using the xyphoid as a reference point. Not only does this positioning serve to ensure reproducibility of consecutive ECGs made using the device, it also provides a clear reference point which provides easy access to left and right frontal positions.
In an embodiment of the 12-lead ECG-device according to the invention, the at least four electrodes are four electrodes.
It has been found that the use of (exactly) four electrodes in the device is sufficient to provide data representing a 12-lead ECG. As a result, the device can be kept compact and easy to use, especially when compared to the known devices used in hospitals and care centers.
In an embodiment of the 12-lead ECG-device according to the invention, the four electrodes are positioned in a rectangular pattern (i.e. one electrode on each corner of a rectangle), and preferably a distance between the electrodes is in the range of 5 to 25 centimeters, more preferably in the range of 5 to 20 centimeters and even more preferably in the range of 5 to 15 centimeters. It is further preferred that a distance measured along a longitudinal side of the rectangle is larger than a distance measured along a lateral side of the rectangle.
It has been found that, by using four electrodes, preferably frontal electrodes, the four electrodes do not necessarily have to be connected to the limbs of a patient to be able to obtain data representing the 12 leads. In fact, it has been found that by maintaining a distance between the electrodes in the abovementioned ranges, the data representing the 12 leads of the 12-lead ECG is sufficiently accurate and sensitive to be able to obtain a 12-lead ECG therefrom. It is preferred that the device, during use, is positioned on the sternum in a rectangular position using the xyphoid as a reference point. Although this is not a necessity, such positioning will serve to ensure reproducibility of consecutive ECGs made using the device.
In an embodiment of the 12-lead ECG-device according to the invention, the computing device may be configured for: - receiving data representing a measured electrical potential from at least the frontal electrodes;
- determining, from the received data, 12 leads for a 12-lead ECG, wherein the step of determining comprises: - determining at least one precordial lead based on the data representing a measured electrical potential from at least one of the frontal electrodes.
The invention further relates to a computer program comprising instructions that, when the program is carried out by a computer, cause the computer to execute the method of the invention.
The computer program according to the invention has similar effects and advantages as the method and the device according to the invention. The embodiments disclosed in relation to any one of the claims or embodiments of the method or the device can also be, alone or in combination, be applied to the computer program according to the invention.
The invention further relates to a computer-readable storage medium having stored thereon the computer program according to the invention.
The computer-readable storage medium according to the invention has similar effects and advantages as the method, the device and the computer program according to the invention. The embodiments disclosed in relation to any one of the claims or embodiments of the method, the device and/or the computer program can also be, alone or in combination, be applied to the computer-readable storage medium according to the invention.
Further advantages, features and details of the invention are elucidated on the basis of preferred embodiments thereof, wherein reference is made to the accompanying drawings, in which:
Figures 1a, 1b shows a perspective view of an example of a device according to the invention;
Figure 2a shows a perspective view of the example of figure 1, when used to collect data representing a measured voltage or voltage difference;
Figure 2b shows an example of data representing the measured electric potential for the various leads according to figure 2a;
Figure 3 is an example of a comparison of data representing a known 12-lead ECG and an example of data representing an ECG of the method according to the invention;
Figure 4a shows a schematic overview of a computing device displaying several aspects that may be used as input when generating the data representing an ECG;
Figure 4b shows an example of the data representing the ECG as can be displayed on a screen of the computing device;
Figure 5 shows a schematic overview of an example of the computer-implemented method for providing 12 leads for a 12-lead ECG according to the invention; and
Figure 6 shows a schematic overview of an example of the computer-implemented method for providing a 12-lead ECG according to the invention.
In an example of device 2 according to the invention (see figure 1a, 1b), device 2 comprises housing 4, which in this example is made of plastic. Housing 4 has upper housing part 6 and lower housing part 8, both of which are substantially shaped as a rounded-off rectangular. Housing 4 extends over length L in first direction x and over width W in second direction y, which is perpendicular to first direction x. In this example, upper housing part 6 is slightly smaller in both length and width as lower housing part 8 to allow device 2 to be gripped (more easily) by a user. Upper housing part 6 is further provided with on/off switch 10 and indicator lights 12, 14 that, in this example, provide information on connectivity 14 and on battery status 12. Upper housing part 14 further comprises recording button 16, which in this example is positioned below progress indicator 18. Progress indicator 18 in this example comprises a number of lights that can light up sequentially to indicate the progress of collecting data.
Lower housing part 18 comprises four electrodes 20, 22, 24, 26 (see also figure 1b) that are positioned near respective corners 28, 30, 32, 34 of lower housing part 18. When viewed in third direction z, which is perpendicular to first direction x and second direction y, electrodes 20, 22, 24, 26 project from bottom surface 36 of housing 4 to allow electrodes 20, 22, 24, 26 to be more easily be placed on a chest of a user/patient.
In use of device 202, device 202 is placed on the chest of person P (see figure 2a) such that electrodes 222, 224, 226, 228 are positioned over heart H of person P. After pressing recording button 216, device 202 starts collecting data representing the various leads of the 12-lead ECG using to the methods according to the invention. In the present example, data representing measurement of six precordial leads S1, A2, L2, 11, 12, 13 are shown based using frontally placed electrodes 222, 224, 226, 228. The data representing the measured electric potential for the various leads is shown in figure 2b.
In the example (see figure 3), data representing four leads on different locations is shown. The locations are the anterior, the antero-lateral, the inferior and the IPL/posterior positions.
In an example of computer-implemented method 1000 (see figure 5) for providing 12 leads for a 12-lead ECG, method 1000 may comprise the steps of receiving 1002 frontal electrode data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes comprising a first right frontal electrode (RA), a first left frontal electrode (LA), a second left frontal electrode (LL) and a second right frontal electrode (RL) and determining 1004, from the received data, 12 leads for a 12-lead ECG.
The step of determining comprises in this example the step of determining 1006 at least one precordial lead based on the data representing a measured voltage or voltage difference from at least one of the frontal electrodes. In this example, the determining of the at least one precordial lead consists of determining 1006a six precordial leads, each of which is performed exclusively based on the data representing the measured voltage or voltage difference from the frontal electrodes. This obviates the use of precordial electrodes and, in fact, makes it possible to obtain 12 leads using four (and only four) frontal electrodes.
In particular, first precordial lead is determined 1012 on the basis of data representing ameasured absolute potential of the first right frontal electrode RA and second precordial lead is determined 1014 on the basis of data representing a measured absolute potential of the first left frontal electrode LA. Third precordial lead is determined 1016 on the basis of data representing a measured absolute potential of the second left frontal electrode LL. In the mentioned data, second right frontal electrode RL is the ground electrode. Fourth precordial lead is determined 1018 on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second left frontal electrode LL, whereas a fifth precordial lead is determined 1020 on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second right frontal electrode RL.
Finally, a sixth precordial lead is determined 1022 on the basis of data representing a measured absolute potential of the second right frontal electrode RL. In this case, second left frontal electrode LL is the ground electrode.
Method 1000 in this example further comprises, in the step of determining 1004 12 leads for the 12-lead ECG, determining 1024 one or more bipolar leads, wherein a first bipolar lead is determined 1026 on the basis of data representing a measured voltage between the first left frontal electrode LA and the first right frontal electrode RA. A second bipolar lead is determined 1026 on the basis of data representing a measured voltage between the first right frontal electrode RA and the second left frontal electrode LL and a third bipolar lead is determined 1028 on the basis of data representing a measured voltage between the second left frontal electrode LL and the first left frontal electrode LA.
The step of determining 1004 12 leads for a 12-lead ECG in method 1000 may further also comprise the step of determining 1032 one or more augmented unipolar leads determined on the basis of data representing a measured absolute potential of the first left frontal electrode
LA and/or the first right frontal electrode RA and/or the second left frontal electrode LL. A first augmented unipolar lead aVL is calculated 1034 using the formula: aVL=LA- rh
A second augmented unipolar lead aVF is calculated 1036 using the formula: aVF = LL — At RA 2
A third augmented unipolar lead aVR is calculated 1038 using the formula: aVR=RA- LA LL 2
It is also possible to determine, based on the data, to determined one or several of the mentioned leads. In other words, step 1004 may include a single step of the steps 1012 to 1038 or may include several or all steps 1012 to 1038. In any case, method 1000 always includes at least one of the steps 1012 to 1022.
In an example of computer-implemented method 2000 for providing a 12-lead ECG (see figure 8), the method in this example comprises the steps of determining 2004 12 leads using steps 1012 to 1038 of method 1000 and combining 2040 the 12-leads into an ECG, preferably into a graphic representation of the ECG, more preferably a graphic representation of the ECG according to the Cabrera system.
Method 2000 may further also comprise the optional steps of receiving 2042, at a first time, data representing at least one reference 12-lead ECG and storing 2044 the data representing at least one reference 12-lead ECG in a memory. Further optionally, method 2000 may also include the steps of receiving 2045 comparison data representing 12-lead
ECGs from a database and automatically comparing 2046, using a processor and preferably using a neural network, the data representing the determined at least one reference 12-lead
ECG with the comparison data to identify deviations of the data representing the at least one reference 12-lead ECG relative to the received comparison data. Subsequent optional steps are marking 2048 the identified deviations as person-specific ECG-markers, storing 2050 the person-specific ECG-markers in a memory, and optionally, outputting 2052 an overview of the person specific ECG-markers to an external device, such as a computing device or a remote memory.
Method 2000 may further comprise the optional steps of receiving 2054, at a subsequent time, data representing at least one subsequent 12-lead ECG and storing 2056 the data representing the at least one subsequent 12-lead ECG in the memory. Upon receiving 2054 the data representing the at least one subsequent 12-lead ECG, the optional step of automatically comparing 2058, using a processor and preferably using a neural network, the data representing the subsequent 12-lead ECG with the data representing at least one of the at least one reference 12-lead ECGs stored in the memory to identify deviations between the data representing the subsequent 12-lead ECG and the data representing the at least one reference 12-lead ECG. Subsequent optional steps in method 2000 are outputting 2060 the identified deviations to an external source, such as a computing device or a user interface for further review and/or storing 2062 the identified deviations in the memory.
Method 2000 optionally further comprises the steps of comparing 2064, using a processor, and preferably using a neural network, the data representing the at least one subsequent ECG with the comparison data to identify deviations of the data representing the at least one subsequent ECG relative to the comparison data. To that end, data representing the at least one subsequent ECG is obtained from step 2054. The optional method steps further include the step of comparing 2066 the identified deviations with person-specific ECG- markers and removing 2068 any deviations that match a person-specific ECG-marker. The person-specific markers are obtained in this example from step 2048. Further optionally, method 2000 includes the step of identifying 2070 any remaining deviations, if any, and marking each of said remaining deviations as an anomaly in the at least one subsequent 12- lead ECG and outputting 2072, to a computing device or an external memory, data representing at least the anomalies and/or storing in a memory, data representing at least the anomalies.
In an example (see figure 4a), a computing device is used to display data obtained using the computer-implemented method according to the invention. The computing device, for example a smart phone, may display data representing information about a user of device 2, 202 according to the invention.
Additionally or alternatively, a computing device may also be used to display a graphic representation of the ECG after combining these 12 leads into an ECG using method 2000 according to the invention (see figure 4b). It is noted that, although the different reference letters are used, the data representing the ECG in figure 2b is similar (though not identical) to the data representing the ECG in figure 4b. In particular, the data representing the various
ECG-leads in figure 2b is similar to the data representing the various ECG-leads in figure 4b according to the following structure. Data A1 is similar to data |, data A2 is similar to data II, data S1 is similar to data C1, data A2 is (also) similar to data C2, data L2 is similar to data C3, data 11 is similar to data C4, data 12 is similar to data C5 and data I3 is similar to data C6.
The present invention is by no means limited to the above described preferred embodiments and/or experiments thereof. The rights sought are defined by the following claims within the scope of which many modifications can be envisaged.
CLAUSES
1. Computer-implemented method for providing 12 leads for a 12-lead ECG, the method comprising: - receiving data representing a measured voltage or voltage difference from a number of electrodes that at least include frontal electrodes comprising a first right frontal electrode (RA), a first left frontal electrode (LA), a second left frontal electrode (LL) and a second right frontal electrode (RL); - determining, from the received data, 12 leads for a 12-lead ECG, wherein the step of determining comprises determining at least one precordial lead based on the data representing a measured voltage or voltage difference from at least one of the frontal electrodes. 2. Computer-implemented method according to clause 1, wherein the determining of the at least one precordial lead is performed exclusively based on the data representing the measured voltage or voltage difference from at least one of the frontal electrodes. 3. Computer-implemented method according to clause 2, wherein the determining of the at least one precordial lead comprises determining six precordial leads, and wherein the determining of each of the six precordial leads is performed exclusively based on the data representing the measured voltage or voltage difference from the frontal electrodes. 4. Method according to any one of the preceding clauses, wherein: — afirst precordial lead is determined on the basis of data representing a measured absolute potential of the first right frontal electrode RA; and/or — a second precordial lead is determined on the basis of data representing a measured absolute potential of the first left frontal electrode LA; and/or — athird precordial lead is determined on the basis of data representing a measured absolute potential of the second left frontal electrode LL; and/or — a fourth precordial lead is determined on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second left frontal electrode LL; and/or — afifth precordial lead is determined on the basis of data representing a measured potential difference between the first left frontal electrode LA and the second right frontal electrode
RL; and/or — a sixth precordial lead is determined on the basis of data representing a measured absolute potential of the second right frontal electrode RL.
5. Computer-implemented method according to clause 4, wherein in the data representing the sixth precordial lead the second left frontal electrode LL is the ground electrode, and wherein the second right frontal electrode RL is the ground electrode in the data representing the first, second and third precordial leads.
6. Computer-implemented method according to any one of the preceding clauses, wherein the step of determining 12 leads for the 12-lead ECG further comprises determining one or more bipolar leads, wherein:
- a first bipolar lead is determined on the basis of data representing a measured voltage between the first left frontal electrode LA and the first right frontal electrode RA; - a second bipolar lead is determined on the basis of data representing a measured voltage between the first right frontal electrode RA and the second left frontal electrode LL;
- a third bipolar lead is determined on the basis of data representing a measured voltage between the second left frontal electrode LL and the first left frontal electrode LA.
7. Computer-implemented method according to any one of the preceding clauses, wherein the step of determining 12 leads for a 12-lead ECG further comprises the step of determining one or more augmented unipolar leads determined on the basis of data representing a measured absolute potential of the first left frontal electrode LA and/or the first right frontal electrode RA and/or the second left frontal electrode LL, wherein: - afirst augmented unipolar lead aVL is calculated using the formula: aVL=LA- Rat LL 2 and/or - asecond augmented unipolar lead aVF is calculated using the formula: aVF=LL- LA + RA 2 and/or - athird augmented unipolar lead aVR is calculated using the formula:
aVR=RA- LA+LL 2
8. Computer-implemented method for providing a 12-lead ECG, the method comprising: - determining 12 leads using the computer-implemented method according to any one of the preceding clauses; and - combining the 12 leads into an ECG, preferably into a graphic representation of the ECG,
more preferably a graphic representation of the ECG according to the Cabrera system.
9. Computer-implemented method according to clause 8, further comprising the steps of: - receiving data representing at least one reference 12-lead ECG at a first time; - storing the data comprising at least one reference 12-lead ECG in a memory.
10. Computer-implemented method according to clause 9, further comprising the steps of:
- receiving comparison data representing 12-lead ECGs from a database;
- comparing, using a processor and preferably using a neural network, the data representing the determined at least one reference 12-lead ECG with the comparison data to identify person-specific ECG-markers, wherein the person-specific ECG-markers are deviations of the data representing at least one reference 12-lead ECG relative to the received comparison data; and
- storing the person-specific ECG-markers in a memory, and
- optionally, outputting an overview of the person specific ECG-markers to an external device, such as a computing device or a remote memory. 11. Computer-implemented method according to clause 9 or 10, further comprising the steps of:
- receiving data representing at least one subsequent 12-lead ECG at a subsequent time;
- storing the data representing the at least one subsequent 12-lead ECG in the memory;
- upon receiving the data representing the at least one subsequent 12-lead ECG, comparing, using a processor and preferably using a neural network, the subsequent 12- lead ECG with data representing at least one of the at least one reference 12-lead ECG stored in the memory to identify deviations between data representing the subsequent 12-
lead ECG and data representing the at least one reference 12-lead ECG;
- outputting the identified deviations to an external source, such as a computing device or a user interface; and
- optionally storing the identified deviations in the memory.
12. Computer-implemented method according to clause 11, when dependent on clause
10, further comprising the steps of:
- comparing, using a processor, and preferably using a neural network, the data representing at least one subsequent ECG with the comparison data to identify general markers, wherein the general markers are deviations of the data representing the at least one subsequent ECG relative to the comparison data; - comparing the general markers with person-specific ECG-markers; - removing any general markers that match a person-specific ECG-marker;
- identifying anomalies in the data representing the at least one subsequent 12-lead ECG if any, wherein the anomalies are any deviations remaining after the steps of comparing and removing; and - outputting, to a computing device or an external memory, data representing at least the anomalies and/or storing in a memory, data representing at least the anomalies.
13. An 12-lead ECG-device configured for measuring a 12-lead ECG, the device having means adapted to execute the method according to any one of the clauses 1 — 7 or the method according to any one of the clauses 8 — 12.
14. The 12-lead ECG-device according to clause 13, wherein the means comprise: - a computing device; and - atleast four electrodes that are configured to be positioned on a user's body and that are operatively connected to the computing device, wherein the four electrodes comprise frontal electrodes, wherein the frontal electrodes comprise:
- aright frontal electrode RA that is configured to be placed on a right frontal of a user;
- a left frontal electrode LA that is configured to be placed on a left frontal of a user;
- a left frontal electrode LL that is configured to be placed on a left frontal of a user; and
- aright frontal electrode RL that is configured to be placed on a right frontal of a user.
15. The 12-lead ECG-device according to clause 14, wherein the at least four electrodes are four electrodes.
16. The 12-lead ECG-device according to clause 14 or 15, wherein the computing device is configured for: - receiving data representing a measured electrical potential from at least the frontal electrodes; - determining, from the received data, 12 leads for a 12-lead ECG, wherein the step of determining comprises: - determining at least one precordial lead based on the data representing a measured electrical potential from at least one of the frontal electrodes.
17. Computer program comprising instructions that, when the program is carried out by a computer, cause the computer to execute the method of any one of the preceding method clauses.
18. Computer-readable storage medium having stored thereon the computer program of clause 17.
Claims (1)
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