This invention relates to the medical industry in general, in particular to the field of medical services, such as devices for monitoring and surveillance of physiological issues related to human health. Specifically, it refers to a system, method and portable apparatus for measuring, classifying and displaying electrical cardiac activity which allows for the assessment of the heart's current condition and heart rate.
Millions of people die or are injured every year due to lack of timely assistance or inappropriate response. The adoption of immediate measures with proper techniques may significantly reduce deaths and injuries. First aid is not a substitute for the emergency services; however, it is a first vital step in providing a quick and efficient response to help reduce serious injuries and improve chances of survival.
The chances of surviving a sudden cardiac arrest decrease to almost zero if the patient does not receive proper medical care during the first 10 minutes of the event.
Regarding cardiac activity, there are different studies to determine and diagnose multiple cardiac issues using a variety of devices.
There are devices capable of measuring cardiac activity, like the widely known Holter monitor, which has electrodes that are connected to the chest with an adhesive and which are then connected to a recording device. A doctor may use the information captured on the Holter monitor recording device to find out if the user has a heart rate problem. However, it is bulky and uncomfortable.
Cardiac activity may also be measured by an electrocardiogram, which is a short, non-invasive test that uses electrodes attached to the chest to monitor the heart rate. However, sometimes the electrocardiogram does not detect any irregularity in the heart rate as the machine is only connected for a short period.
A device, a system and a method for measuring, classifying and displaying the electrical activity of the heart in order to immediately treat heart issues would be very valuable.
A search to determine the prior art was made, in which the following cited reference documents were found.
Patent document U.S. Pat. No. 9,113,794 B2 by Jung Ook Hong and Shelten Gee Jao Yuen dated Jun. 3, 2014 (hereinafter document D1), refers to methods and devices to activate, in an efficient manner from an energy viewpoint, heart rate monitoring based on movement and skin proximity. In addition, it provides methods to operate an LED and a photodetector aimed at obtaining an accurate reading of the adaptive heart rate. The invention presented in document D1 is aimed at efficiently activating an LED for heart rate monitoring, unlike our invention, which seeks to classify the cardiac electrical activity in healthy or diseased state, like fibrillation, and generate visual and audible feedback alerts of the emergency event.
Both our invention and the above-mentioned patent share technical characteristics, as expected in the field of electronic inventions such as: Signal acquisition means, physiological sensors, analog and digital signal conditioning means, data processing circuits, means for feeding back to the user through audio, like speakers, or visual feedback through a screen, and energy sources.
However, the physical and functional principles of the above-mentioned patent and our invention have the following differences:
1. The physical origin of the signal to be processed in document D1 is obtained through an optical measurement, an LED and a photoreceptor, with which a plethysmographic curve is estimated. On the other hand, our invention obtains its signal by the principle of oxide-reduction of a metal with its salt, with which the heart electrical activity (ECG) signal, which is not sensitive to skin color, painted nails, CO2 intoxication or severe bleeding, is obtained.
2. In the signal conditioning part, document D1 states that its bandwidth is in the range of between 0.1 and 10 Hz, unlike our system that has a bandwidth between 0.01 and 500 Hz. This allows for a signal with a wider frequency spectrum and for the detection of anomalies in the ECG signal in the signal processing stage.
3. Document D1 in combination with intensity modulation and its movement sensors is aimed at detecting a heart attack. However, since the signal is of optical origin, other disease conditions, like fibrillation, heart arrhythmias, deviation and lengthening of PRQ wave or any PQ, ST segment, cannot be detected. This is not the case in our invention, which does allows for the knowledge of such cardiac electrical activity details and provides a classification of a diseased or healthy cardiac electrical condition.
Patent application document US20160206277 A1 by Sameer Bidichandani et al. dated Jan. 21, 2015 (hereinafter document D2) was also considered, which refers in general to techniques to determine the heart rate in a user and, specifically, heart rate measurement using multiple acoustic sensors in a portable device. The invention concerns a method for heart rate monitoring of a user, which comprises: obtaining signals from multiple acoustic sensors of a portable monitor; identifying sequential heartbeats using the obtained signals; and calculating the heart rate based on at least an interval between the sequential heart beats.
The invention presented in document D2 is aimed at, and is limited to, determining a user's heart rate through acoustic sensors, unlike our invention which seeks to classify the cardiac electric activity into healthy or diseased, like fibrillation, and generate alerts through visual and audible means of the emergency event through the electrocardiogram (ECG) signal.
Similarly, both our invention and invention in document D2 share technical characteristics, as expected in the field of electronic inventions such as signal acquisition means, sensors, analog and digital signal conditioning means, data processing circuits, visual or audio feedback means and energy sources.
However, regarding physical, chemical and functional principles, document D2 and our invention differ in the following characteristics, which require an inventive step for their implementation altogether:
1. The invention in document D2 estimates heart rate through a sound sensor, normally a microphone, placed on the wrist, unlike our invention, in which sensors such as electrodes are placed on the chest or neck to obtain the ECG. The foregoing prevents the invention in document D2 from classifying the cardiac electrical activity as diseased, like fibrillation or arrhythmia though analytical methods based on an ECG wave. It is expected that the invention in document D2 could estimate heart sounds, however, this procedure is not described in the document.
2. Regarding the signal conditioning, document D2 does not state the bandwidth, only that for a signal audible to humans it may be expected to be between 20 and 20,000 Hz. However, there is no information to assume an obvious inventive step, unlike our defined range of 0.01 to 500 Hz, since it concerns cardiac electrical activity.
Patent application US2016175683 A1 by Caroli-lames H. Carnell dated Dec. 22, 2015 (hereinafter document D3) was also found, which refers to a data analysis method for fitness and athletic training, unlike our invention, which allows for the classification of cardiac electrical activity.
Both our invention and the invention in document D3 share purely technical characteristics such as a microprocessor, an energy source and a visualization screen, in the field of electronic inventions. However, the invention in document D3 describes a technology that allows for the processing of speed, strength and pressure measurements that is totally unrelated to our invention, which processes biopotentials obtained from the electrode oxide reduction physicochemical principles and, above all, classifies the cardiac electrical activity into healthy or diseased, like fibrillation.
Although document D3 concerns a speed and inertial quantification method, neither document D1, D2 and D3 by themselves or altogether reveal the elements needed to obtain, process, monitor and classify cardiac electrical activity.
In the case of document D1, the objective of information extraction is similar since they are both aimed at obtaining physiological parameters like heart rate, but the method for obtaining the signal, processing and classification differ. Also, the characteristics proposed in D2 completely differ in the type of energy used as source of information and in the classification approach, highlighting the fact that the proposed invention is related to specific conditions in the first-aid area.
In the same way, document D3 describes a technology that is totally unrelated to our invention, since it presents a system for measuring hits in boxing training. Therefore, we can easily understand that these technological developments have totally different approaches and cannot be considered to affect inventive step since they are not similar in their approach to obtaining, treatment and classification of biopotentials like cardiac electrical activity.
As a result of the foregoing, this invention could not be inferred or deduced in an obvious or evident manner from D1, D2 or D3, neither independently by themselves nor altogether, nor being compared. Therefore, neither D1, D2 nor D3 may affect the inventive step.
The main objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity, which allows the classification of cardiac electrical activity into a stable or diseased state of fibrillation, in situ and without the need for the patient to be moved.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity which is also portable and lightweight (500 g), below the average weight of cardiac electrical activity devices such as: heart monitors, automatic or semiautomatic defibrillators.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity which, moreover, in the case of stable condition, can provide an estimate of heart rate and its bradycardia, normocardia and tachycardia indicators, which can be used when the conditions for using the heart rate monitor are not appropriate, for example, when nails are painted, under CO2 intoxication, severe bleeding, morbid obesity, etc.
Another objective of the invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity which, moreover, can provide visual and audible feedback of cardiac electrical activity, so that receipt of information and decision-making by primary health care professionals are simplified.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity that also allows for the acquisition of the signal from the neck or the chest of the patient, following the physiological principle of Einthoven's triangle.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity that also allows the acquisition of relevant information on the heart condition of the patient in emergency situations and situations of poor access.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity also that also allows for a better accessibility of the primary health care professionals to acquire high-quality and functional technologies.
Another objective of this invention is to make available a novel system, method and apparatus for measuring, classifying and displaying cardiac electrical activity that also allow for the knowledge of the cardiac electrical activity condition in a faster manner, improving hospital practices.
All qualities and objectives that will become apparent when describing this invention are supported by illustrated embodiments.
Broadly speaking, the system and apparatus for measuring, classifying and displaying electrical cardiac activity comprises a device for acquiring, processing and conditioning electrical cardiac signals, which consists of a signal acquisition module, a signal-conditioning module, a processing and logical control module, a module for feeding back to the user, a connectivity module and a power source module; this apparatus is configured to connect to the Internet through a local network using any technological assembly such as smartphones, tablets and computers, etc., with the option of connecting to the Internet or at least to a server/client with the ability to store and process information and optimize algorithms. The system is integrated in such a way that it is portable and can be handheld.
The signal acquisition module consists of more than two sensors for measuring electrical cardiac activity, including but not limited to passive and active electrodes made of Ag/AgCl or other metals or materials, designed to be put on the phalanges of the patient, for measuring the cardiac electrical activity, which are directly connected to a signal conditioning module through metal wires. Such sensors are placed on the patient according to Einthoven's triangular pattern to record cardiac electrical activity signals, with the aim of obtaining a percentage of the lead projection, either I, II, III.
Sensors are directly connected to a high active impedance stage to preserve the signal-noise ratio and avoid information loss. The output of the high impedance stage is directly connected to the signal conditioning module through metal wires.
In addition, the signal acquisition module has a stage for the identification of the sensor type that is connected to the apparatus. The identification stage consists of an integrated circuit and a resistive circuit where the sensor's unique identification number is coded and stored. This circuit is directly connected to the processing and logical control module in order to be able to adjust the signal selector sampling frequency, which has a high-pass and low-pass filter effect depending on the commutation speed, and to implement a Finite Impulse Response (FIR) Filter specific to that type of sensor.
The signal conditioning module consists of an electronic circuit with a differential input with high impedance, an electrical insulation circuit, a pre-amplifier, a band-pass filter (high-pass filter and low-pass filter) and, lastly, an amplifier to obtain a signal limited in voltage and frequency. This module is directly connected to the processing and logical control module through metal tracks.
This processing and logical control module allows for obtaining information from the conditioned signal through the implementation of algorithms and the start and update of the feedback module. It is subdivided into four stages:
The module for feeding back to the user consists of: a) a sound device activated by the processing and logical control module logical stage; b) a visual device or screen for displaying the information on the electrical activity condition and heart rate. Initializing and updating of the logical stage of such processing and logical control module.
The portable power source module provides power to the signal acquisition module, the signal conditioning module, the processing and logical control module, and the module for feeding back to the user.
To better understand the characteristics of this invention, illustrative drawings described below are attached to this description as an integral part thereof.
a and 5b are a conventional perspective view, a left lateral view and a right lateral view, respectively, of the apparatus for measuring, classifying and displaying cardiac electrical activity, together with its sensors and grips.
a and 6b are conventional perspective, front and back views, respectively, of the apparatus for measuring, classifying and displaying cardiac electrical activity.
For a better understanding of the invention, a detailed description of some of its embodiments will be provided, shown in the illustrative, but not limiting, drawings attached to this description.
The characteristics of the system, method and apparatus for measuring, classifying and displaying cardiac electrical activity are clearly shown in the following description and in the illustrative drawings attached, the same reference signs being used to indicate the same parts. Those skilled in the art acknowledge that alternatives or possible variations of the invention may be generated within the scope of the same claims.
The embodiments of the invention described in this document are not limiting but illustrative. The invention embodiments described should not be understood in that they are unique, preferred or to be interpreted verbatim.
According to
Regarding
Based on
The signal acquisition module (18) consists of two or more sensing elements (8) to measure the cardiac electrical activity, including but not limited to passive and active electrodes of Ag/AgCl or other metals or materials, to be placed on the user's phalanges. Such sensing elements (8) are placed on the tissue or skin of the patient (21) following a triangular pattern, commonly known as Einthoven's triangle, aimed at acquiring cardiac electrical activity signals. Sensing elements (8) are directly connected to a high active impedance stage (22, see
In addition, the signal acquisition module (18) has an identification stage of the type of sensor (23) that is connected to the apparatus. The sensor type identification stage (23) consists of an integrated circuit and a resistive circuit where the sensor unique identification number is coded and stored (24). This stage is directly connected to the processing and logical control module (14) aimed at adjusting the sampling frequency of a signal selector (25) that receives data from the signal averaging network (26) and which comprises an analog signal filtering (27), which has a low-pass filter (28) that depends on the commutation speed, and implements a finite impulse response filter specific for this type of specific sensor.
The signal conditioning module (13) consists of three stages:
This module is directly connected to the processing and logical control module (14) through metal tracks.
The processing and logical control module (14) is comprised of an electronic circuit that allows for obtaining a conditioned signal information through the signal conversion from analog into digital, the implementation of algorithms, including but not limited to analysis in the time-frequency and time domain, and the signal classification. Also, it starts and controls the module for feeding back to the user (19) with a display (17) and the sound supply system (16), which may be a horn for alarms, and the connectivity module (20). This module may be subdivided into four stages: (See
The module for feeding back to the user (19) aims at stimulating the user's sensory channels, including but is not limited to visual (46) and audible (47) feedback, through components like: buttons, power switches, lights, LEDs, eight-segment circuits, LED, OLED and LCD displays (17, see
The connectivity module (20) (see
The power source module (15) is portable and serves as the energy supply for the different modules, which may include, but is not limited to, batteries, rechargeable batteries, photovoltaic cells, solar cells.
Once again, in reference to
Another object of the local networks (2) is to allow for the reception of user's feedback of the information obtained with the device, such as the heart rate, any disease detected, asystole, segments increased duration, pre-infarctions or heart attacks, among others. These are used, but are not limited to be used, as supervised training mechanisms, validations, tests, optimizations, fuzzy sets, classes in the classification algorithms of the cardiac electrical activity. In the same way, when the user wishes to export the information generated up to that moment, either through printing, PDF, e-mail or another existing media, a new user's feedback is requested to validate non-sensible data for statistical purposes, such as sex, age, population, etc., which are used, without limitation, for supervised training mechanisms, validations, tests, optimizations, fuzzy sets, classes in the classification algorithms of the cardiac electrical activity. (See
The server/client (3) on the cloud (4, see
This way, with the interaction of the apparatus (1), the local network (2) and the server (3), a dynamic device capable of updating the method for measuring, classifying and displaying the cardiac electrical activity as feedback validated by the users is acquired, as shown in
Regarding
Taking into consideration
Classification Method:
1. The user, with the apparatus (1) on their hand, as illustrated in
2. The user turns on the apparatus (1)
3. The user starts recording the cardiac electrical activity signal.
4. The processing and logical control module (14) identifies the ID of the sensing elements (8);
5. The processing and logical control module (14) sets the multiplexing speed of the signal selector (25);
6. The processing and logical control module (14) adjusts the parameters of the digital filters that depend on the ID of the sensing elements (8);
7. The processing and logical control module (14) adjusts the number of times that it must obtain the signal to process it depending on the ID;
8. The cardiac electrical activity recording starts;
a. Depending on the ID of the sensing element (8) and the signal selector configuration (25), the reading of a network voltage is obtained to average the signal, which goes to the signal conditioning module (13), where it is pre-amplified, filtered and amplified, to then be captured in the ADC (35) of the processing and logical control module (14).
b. The data captured by the ADC is stored (35).
c. According to the ID of the sensing elements (8), the storage of an n-number of data shall be generated. Once the storage of this signal is obtained, the signal selector (25) is switched to a different signal averaging network input (26).
9. Records another n-number of signals and switches again;
a. According to the ID of the sensing elements (8), the signal selector (25) switches for n-inputs of the signal averaging network (26);
b. Once all the n-inputs were switched, the signal record starts again until it gets to the n-number of times of signals to average according to the ID of the sensing element (8);
10. It reaches the average number of signals to be recorded;
11. The information processing starts;
a. Depending on the ID of the sensing elements (8), the processing and logical control module (14) applies digital filters (FIR/IRR) to each of the recorded signals;
b. Time and time-frequency analysis are applied to the signal to extract information characteristics of the previously stored signals;
c. Each of the indicators obtained is averaged.
12. Indicator classifiers are implemented, which also depend on the ID of the sensing elements (8) and the algorithms preset from the local network (2) and the server (3) in the apparatus (1);
13. Visual (46) and audible (47) feedback is generated through the feedback module (19);
14. Once the cardiac electrical activity signal acquisition is finished and it is connected to the local network (2);
15. The local network (2)
16. If the user wishes to export the information for any reason, including but not limited to: printing, sending it to a health professional;
17. If it is connected to the server, then
18. For the apparatus algorithm updating (1):
Application example of the apparatus for measuring, classifying and displaying the electrical cardiac activity pursuant to this invention.
An application example of the apparatus arises when a pre-hospital, emergency or primary health care professional faces an emergency situation where they need to know the patient's heart condition. The user simply turns on the apparatus (1), puts the sensing elements (8) on the neck or on the chest of the patient (see
A second example may be that the health professional synchronizes the apparatus (1) with the local network (2) such as their cellphone and sees the graphs and indicators extracted from the analysis of the record. Finally, the health professional will have the option, depending on the time, the severity of the situation and the availability of equipment, to export the information for their personal use. In this way, they will contribute to the generation of validated information. As shown in
For cases where the apparatus (1) was turned on but there is no instruction to record cardiac electrical activity, the apparatus (1) will remain in this power saving mode until it turns off or an instruction to record the cardiac electrical activity is generated.
Sometimes, not in critical moments and under the responsibility of the user, the updating of the apparatus (1) classification algorithms can be managed, as shown in
The main improvements of the system include the following:
1. It is a portable system, it can be carried in the hand, kept in a backpack or an ambulance, the weight is below the average weight of the cardiac electrical activity measurement devices like: cardiac monitors, automatic or semi-automatic defibrillators, of approximately 3.3 kg compared to the 500 g of this system.
2. It extracts basic parameters of the electrical activity condition, including but not limited to: Heart rate, heart rhythm, interval duration and multiple segments like the QRS complex, ST segment, T wave.
3. It classifies the cardiac electrical activity into stable and diseased conditions, like fibrillation, in situ not needing to transfer the patient.
4. In the case of a stable condition, it provides an estimate of the heart rate and its indication of bradycardia, normocardia or tachycardia.
5. It provides visual and audible feedback of the cardiac electrical activity so that the receipt of information and the decision-making by the first-contact health professionals are simplified.
6. The placement and instrumentation of the modules allows the acquisition of the signal from the patient's neck or chest, following the physiological principle of Einthoven's triangle.
7. The system operation method allows for updating the classification algorithms of the apparatus.
8. The system operation method allows for updating of extraction algorithm characteristics.
9. The system allows the tracking and identification of the apparatus.
10. The system allows for the identification of the types of sensors used for the recording of the cardiac electrical activity and thus the processing and conditioning of the recorded signals, the multiplexor sampling frequency and the bandwidths of the FIR can be adjusted.
11. It allows the export of the information to a local network (2) like cellphones, tablets, computers, laptops for the display and handling of the information by the user.
12. The specialist's feedback together with their specialist profile allows the extraction of information for the training, testing and validation of the classifiers, either neural networks, support vector machines, fuzzy systems or any other possible method in the area of artificial intelligence or deep learning machines.
13. It allows for the creation of medical condition models related to the cardiac electrical activity from the analysis of the information extracted from the records and the database.
The invention has been sufficiently described so that a person with average knowledge in the field may be able to replicate it and obtain the results mentioned herein. However, any expert in the field of this invention may be able to make modifications not described herein; however, if in the application of these modifications in a specific structure or in its manufacturing process, the subject matter claimed in the following claims is required, such structures shall be comprised within the scope of this invention.
Number | Date | Country | Kind |
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MX/A/2017/012013 | Sep 2017 | MX | national |
Filing Document | Filing Date | Country | Kind |
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PCT/MX2017/000111 | 9/27/2017 | WO | 00 |