TW201707645A - Contactless electric cardiogram system - Google Patents

Abstract

A system for providing a standard electrocardiogram (ECG) signal for a human body using contactless ECG sensors for outputting to exiting medical equipment or for storage or viewing on a remote device. The system comprises a digital processing module (DPM) adapted to connect to an array of contactless ECG sensors provided in a fabric or the like. A selection mechanism is embedded into the DPM which allows the DPM to identify body parts using the ECG signals of the different ECG sensors and select for each body part the best sensor lead. The DPM may then produce the standard ECG signal using the selected ECG signals for the different body parts detected. The system is adapted to continuously re-examine the selection to ensure that the best leads are selected for a given body part following a movement of the body part, thereby, allowing for continuous and un-interrupted ECG monitoring of the patient.

Description

Non-contact electronic electrocardiogram system [Cross-Reference to Related Applications]

Priority is claimed on US Provisional Application Serial No. 62/206,542, filed on Aug. 18, 2015, the disclosure of which is hereby incorporated by reference.

The subject matter of the present invention is generally related to an electrocardiogram system.

An electrocardiogram (hereinafter referred to as ECG) is the only reliable measure of heart rhythm, arrhythmia detection, and static ECG abnormalities, which requires mandatory further testing of previous ECG changes.

ECG is one of the basic diagnostic and follow-up screening tools used in medicine for many cardiac and non-cardiac diseases. Although the standard 12-lead ECG has a wealth of information, it only takes 10 seconds of data. Long-term monitoring with multiple leads provides more information and makes it easier to see changes in the ECG.

The lack of long-term monitoring for a variety of reasons is an important medical issue. The lack of an ECG benchmark in the patient's file often leads to confusion and unnecessary extra checks among the first patients whose ECG is normal, but which is abnormal according to established diagnostic criteria. In general, if the old ECG (even the ECG 10 years ago) is available when it is considered to be an abnormal ECG, no further inspection is required. In other words, the ability to compare current ECGs with older ECGs has led to enormous medical value. No change in ECG can reduce the need for inspection.

Traditionally relying on contact electrodes (electrodes that form a current connection with the patient's body) ECG measurement systems present challenges when it comes to monitoring ECGs immediately, unobtrusively or frequently. Traditional contact electrodes need to be placed on a clean, prepared skin surface by trained medical personnel to ensure precise position (and hence body shape) and signal quality. The limitations of standard wet gel contact electrode locations include proper placement on the body and removal within its time limit to avoid skin reactions.

In addition to their inability to provide long-term monitoring, their availability is limited, as discussed below.

Ideally, an electrocardiogram should be performed on a regular basis as part of a routine visit to all patients, especially if the patient has a need for medical attention. However, the availability of inspections is limited. The availability is limited by the cost of the ECG device and the inability to easily find the technicians who need to be placed on the patient to properly examine the patient. As far as ECG costs are concerned, most physicians do not invest in the on-site inspections. Even in hospitals, telemetry units in large hospitals are limited to about 6 to 10 units in the intensive care unit for all patients.

Another disadvantage is that multiple problems with standard electrodes can limit the proper and widespread use of ECGs. These problems are as follows: 1. The electrodes will react with the skin due to the metal, gel and adhesion reactions required to be replaced several times during hospitalization; 2. Lack of knowledge required for proper placement of the electrodes; 3. Time for placement of the electrodes; 4. Complications associated with long-term monitoring, such as when the electrodes are often detached due to sweating, patient movement, improper placement, etc. 5. Electrocardiograms derived from standard electrodes are prone to muscle interference waves that can cause false electrocardiograms.

Another disadvantage is that the electrocardiogram obtained with the standard electrode is labor and materials. Intensive. Even in some cases, each patient care time telemetry device can take more than 2-3 hours to install and reinstall the standard electrode.

Yet another disadvantage is that the electrocardiogram becomes a source of nosocomial infections that are transmitted in hospitals because of the electrocardiograph's wire and its contact with nursing and hospital staff, as well as frequent electrode care maintenance.

Therefore, there is a need in the market for a system and method that addresses the above disadvantages.

These embodiments of the present invention describe an ECG system that can be easily and unobtrusive by eliminating the need to manually identify and prepare areas of the patient's body to contact the sensor and place sensors on those areas. Frequent, inexpensive, and convenient ECG data recordings are quickly made from any patient or individual. The system avoids the controversy associated with contact electrodes by being contactless and capable of monitoring daily and lifetime through hours and multiple leads.

In one aspect, it provides a medical device (aka DPM) that provides an electrocardiogram (ECG) signal using a non-contact ECG sensor, the medical device comprising: an input adapted to be from a contactless The ECG sensor array receives the contactless ECG signal; a processor adapted to perform a selection process, the selection process comprising: detecting a body part located adjacent to the non-contact ECG sensor array; and placing a non-contact type An ECG sensor group is coupled to each detected body part; a non-contact ECG sensor having the highest signal quality is selected from each group; the processor is adapted to receive each selected non-contact based on the received The ECG signal of the ECG sensor generates a standard ECG signal; and an output for transmitting the standard ECG signal.

The medical device can be a lightweight portable device weighing less than 2 pounds.

In an embodiment, the selection procedure further comprises the step of: using the non-contact ECG signals associated with the non-contact ECG sensors located adjacent to the body. Determining the body contour of the human body; determining the position of the human body on the non-contact ECG sensor array; dividing the non-contact ECG sensors into groups, and using the body contour and the human body position to group each group with a body The location is coupled; and a non-contact ECG sensor that provides the highest signal quality non-contact ECG signal is selected from each group.

In one embodiment, the processor can identify the non-contact ECG sensor located in close proximity to the body by measuring the impedance between each of the non-contact ECG sensors and the human body.

In another embodiment, the medical device can be adapted to select another non-contact ECG sensor for a given body part after the human body movement associated with the non-contact ECG sensor array. In another embodiment, the processor can be adapted to continuously re-run the selection procedure to perform selection of other non-contact ECG sensors. The processor can also be adapted to continuously monitor the signal quality of the selected non-contact ECG sensor associated with each body part to re-run the selection procedure when the signal quality drops below a given threshold.

The medical device can include different operating modes, including: a non-contact mode, outputting a first standard ECG signal generated by the non-contact ECG signal; and a mixed mode, the output of which is generated by the non-contact ECG signal The second standard ECG signal and the conventional ECG signal for receiving the self-experimental contact electrode; and a bypass mode, the output of which is a third standard ECG signal generated by the conventional ECG signal received from the learned contact electrode.

The medical device can further include an automatic gain control mechanism adapted to control the relative impedance difference between the different non-contact ECG sensors, and because of the distance or clothing material between each non-contact ECG sensor and the human body Difference, the absolute impedance of each non-contact ECG sensor to the human body.

A wired/wireless data port can be provided for transmitting the standard ECG signal to a remote device on a data network.

In another aspect, it is provided using a non-contact ECG sensor A system for electrocardiogram (ECG) signals of a human body, the system comprising: a sensing pad comprising a non-contact ECG sensor array; a processor operatively coupled to the sensing pad and adapted to The non-contact ECG sensors receive the non-contact ECG signal and perform a selection procedure comprising: detecting a body part located adjacent to the non-contact ECG sensor array; and applying a non-contact ECG sense The detector group is coupled to each detected body part; a non-contact ECG sensor having the highest signal quality is selected from each group; the processor is adapted to generate a sense based on each selected non-contact ECG The standard ECG signal of the non-contact ECG signal of the detector; and an output for transmitting the standard ECG signal.

In one embodiment, the sensing pad includes a ground pad for placement at a distance from the human body, the ground pad being adapted to provide a capacitively coupled ground reference level with respect to the human body to reduce interference.

In another embodiment, the ground pad can be driven by a feedback signal derived from the non-contact ECG signals.

The system can further include a drive signal generator configured to supply the ground pad to a high frequency signal outside the ECG band for determining the capacitive coupling ground reference for each non-contact ECG sensor Level.

In an embodiment, the non-contact ECG sensor may include: a capacitor electrode adapted to be capacitively coupled to the human body to output a charge representing electrical activity of the heart; and an electrodynamic sensor Configuring to detect and amplify the charge generated by the capacitor electrode; and an electrode shield disposed adjacent to the electrode body for reducing stray interference at the input of the electrodynamic sensor.

The non-contact ECG sensor can be made of a flexible material.

In an embodiment, the sensing pad can be placed on the fabric that the human body is in contact with.

In another aspect, it provides a use of a non-contact ECG sensor A method of providing an electrocardiogram (ECG) signal of a human body, the method comprising: receiving a non-contact ECG signal from a non-contact ECG sensor array; detecting a body part located adjacent to the non-contact ECG sensor array; A non-contact ECG sensor group is coupled to each detected body part; a non-contact ECG sensor having the highest signal quality is selected from each group; and a selected non-contact ECG is generated based on each Standard ECG signal for the sensor's non-contact ECG signal.

The method can further include: obtaining a body contour of the human body using a non-contact ECG signal associated with the non-contact ECG sensor located adjacent to the human body; determining a human body on the non-contact ECG sensor array Positioning; dividing the non-contact ECG sensors into groups, and using the body contour and body position to connect each group with a body part; and selecting from each group to provide the highest quality non-contact ECG signal Non-contact ECG sensor.

In an embodiment, the method further includes identifying the non-contact ECG sensor located proximate the human body by measuring impedance between the respective non-contact ECG sensor and the human body.

The method may further repeat the step of detecting for continuous selection for selecting another non-contact ECG sensing for a given body part after the human body movement associated with the non-contact ECG sensor array Device. In one embodiment, it is possible to continuously monitor the signal quality of the selected non-contact ECG sensor associated with each body part and after the body movement associated with the non-contact ECG sensor array When the quality of the signal drops below a given threshold, the step of repeating the detection is continuously selected to select another non-contact ECG sensor for a given body part.

The following terms are defined as follows: The term "lead" is intended to mean the measured electrical energy between two locations on the human body. The difference is pressed and it provides and displays the PQRSTU waveform.

The term "ECG lead" is intended to mean a medically defined ECG signal based on the measured voltage difference between two medically defined locations on the human body.

The standard ECG signal is an ECG signal that interfaces with existing medical devices and complies with ECG standards. A standard ECG signal can include a single rhythm bar graph or any number of standard medically defined ECG leads.

The rhythm bar graph is any lead that shows the heart rhythm between the PQRSTU wavelengths. The heart rhythm bar graph does not require the use of ECG signals from these medically defined ECG locations.

The features and advantages of the subject matter of the invention will be more apparent from the detailed description of the embodiments illustrated in the <RTIgt; It is to be understood that the subject matter disclosed and claimed herein can be modified in various aspects without departing from the scope of the appended claims. The drawings and the description are to be regarded as illustrative and not restrictive

2‧‧‧Digital Processing Module (DPM)

3‧‧‧Mobile devices

4‧‧‧Cloud

5‧‧‧Relay cable

6‧‧‧ medical instruments

7‧‧‧Sense pad

8‧‧‧Standard cable

9‧‧‧ cable

10, 10a, 10b‧‧‧ sensor

13‧‧‧A/D converter

14‧‧‧RLD generator

15‧‧‧Grounding mat

17‧‧‧ADC

18‧‧‧Digital Signal Processing Unit

19‧‧‧Digital Analog Converter Stage

20‧‧‧ Relay

21‧‧‧Low-power Bluetooth interface

22‧‧‧ Wi-Fi

23‧‧‧Ethnet

24‧‧‧Integrated audible alarm

25‧‧‧Read-only memory

26‧‧‧Flash memory

27‧‧‧Encryption Processing Module

29‧‧‧Switching matrix

32‧‧‧Electrode screen

33‧‧‧Conductive electrode

34‧‧‧Amplifier

35‧‧‧Bias circuit

36‧‧‧Shield drive circuit

37‧‧‧Substrate

38‧‧‧Dielectric layer

39, 40, 41‧‧‧ layered structure

42‧‧‧Sensor channel

43‧‧‧Programmable Gain Amplifier

44‧‧‧ADC

45‧‧‧Processor

200‧‧‧ECG system

202‧‧‧Sensor matrix

204‧‧‧Select algorithm

210, 212, 214, 216‧ ‧ steps

220‧‧‧gain control mechanism

250‧‧‧Users

252‧‧‧ contour

260‧‧‧ method

262, 264, 266, 268‧ ‧ steps

Further features and advantages of the present invention will be apparent from the following detailed description in conjunction with the accompanying drawings in which: FIG. 1 is a block diagram of an exemplary ECG system in accordance with an embodiment; A non-limiting example of a sensor matrix; FIG. 3 is a flow diagram illustrating the main steps performed by a selection algorithm in accordance with an embodiment; and FIG. 4 is a system for using a patient according to an embodiment Obtain an example of a complete PQRSTU waveform; Figure 5 illustrates how the sensor array captures ECG signals without direct contact with the patient's skin; 6 is a block diagram showing an exemplary sensor design of a non-contact ECG sensor according to an embodiment; FIG. 7 is a block diagram showing a physical design example of a non-contact ECG sensor according to an embodiment; 8 is an exemplary block diagram showing an overall design of a system according to an embodiment; FIG. 9 is a block diagram illustrating an exemplary gain control mechanism according to an embodiment; FIG. 10 is a block diagram according to an embodiment. An illustrative block diagram illustrating the function of the RLD generator; Figure 11 shows the medically recognized ECG position for obtaining a standard ECG lead; Figure 12 shows an example of a standard ECG lead, each lead shows an adult body The vector between the two positions; the 13a and 13b diagrams show an example of how the system determines the contour of the patient's body; and the 14th figure is an electrocardiogram (ECG) that provides the human body using a non-contact ECG sensor. Flow chart of the method of signal.

It should be noted that throughout the drawings, the same features are identified by the same reference numerals.

A system for providing a standard electrocardiogram (ECG) signal of a human body using a non-contact ECG sensor for outputting signals to an existing medical instrument (as well as a new/dedicated display or for display associated with a computer device) Watch on the device), or for a remote end / Store or watch on a local device. The system includes a digital processing module (DPM) that is adapted to be coupled to a non-contact ECG sensor array disposed on a fabric or the like. A selection mechanism is embedded in the DPM to enable the DPM to identify body parts using ECG signals from different ECG sensors and to select the best sensor lead for each body part. The DPM can then generate the standard ECG signal using the ECG signal selected for the detected different body parts. The system is adapted to continuously re-examine its selection to ensure that an optimal lead can be selected for a given body part after movement of the body part, thereby allowing continuous and uninterrupted ECG monitoring of the patient.

The invention will be more readily understood by reference to the following examples which are illustrated by the accompanying claims.

Referring now to the drawings, FIG. 1 is a block diagram of an exemplary ECG system 200 in accordance with an embodiment. As shown in FIG. 1, the system 200 includes a non-contact sensor array disposed in the sensing pad 7 (in a non-limiting embodiment), and an operationally connected cable 9 The sensor array takes the digital processing module (DPM) 2 of the sensor readings from the sensors provided in the sensing pad 7. DPM 2 can be configured to simultaneously record the electrophysiological activity of the heart (body surface potential map) and identify the best electrode/sensor to output a standard ECG signal (+posterior) to the existing medical instrument (6) within. DPM can be connected to the mobile device (3) or the cloud (4) via the Internet or data network, making the data readily available to doctors, allowing doctors to quickly diagnose arrhythmia and defects detected by DPM 2. Bloody changes.

In a non-limiting example, the DPM 2 can be configured as a lightweight portable device that weighs less than about 2 pounds or less and can be carried around to perform continuous ECG monitoring.

As described above, the DPM 2 can be configured to generate an output signal that conforms to existing medical standards so that the output signal is identical to that obtained by the standard contact ECG system, and the existing medical instrument can be used in a plug-and-play manner. 6 watch / read (there is no existing The medical instrument changes, while the reading and output are received from the standard ECG signal of the DPM). The DPM 2 can include a data output plug adapted to receive a standard cable (8) for outputting a signal and simultaneously reading using the existing medical instrument 6. The DPM 2 is also capable of simultaneously recording contact ECG information with the attached trunk cable 5 attached.

However, the DPM 2 can also have its own display device embedded in or connected to itself, and can be adapted to transmit/move the standard ECG signal via the communication/data network so that the standard ECG signal can be Obtained by a local/remote personal computer or portable device.

It should be noted that Figure 1 shows a non-limiting example of implementation. The system 200 can be modified without departing from the scope defined in the scope of the invention. For example, although Figure 1 shows a cable for communicating data between different modules, it is contemplated that wireless connections may be used including, but not limited to, Wi-Fi, Bluetooth, and the like.

Furthermore, the sensor array can be located in a variety of other items including: clothing, bed and vehicle devices/components. In another example, the sensor array can be disposed in a plurality of devices including, but not limited to: furniture (eg, chair, bed/mattress/bed cover, sofa, seat, mat), on-board device (such as seats, headrests, steering wheels, etc.) or in a wearable device (such as a jacket, shirt, T-shirt, sweater, bra, etc.).

Selection algorithm

Conventional ECGs govern electrode position based on the patient's physiology and thereby adhere conventional contact electrodes to these locations, maintaining relative body position regardless of patient movement problems. For example, the V1 electrode should be placed in the fourth intercostal space to the right side of the sternum, the RA electrode should be placed in the right arm, the LA electrode should be placed in the same position on the left arm as the RA electrode, and the RL electrode should be placed in the right leg. Lateral gastrocnemius, etc., as illustrated in Figure 11. The importance of these electrodes and their location is that the voltage difference between two specific locations represents a medically defined ECG lead (as discussed in Figures 11 and 12), and this lead represents the measurement and electrocardiogram Record the heart to go Polarization to produce a vector along which the electrocardiogram is placed.

Therefore, in order to generate an ECG signal that is compatible with the traditional ECG standard, although the data is collected in a non-contact manner, the same principle must be followed.

FIG. 2 shows a non-limiting example of a sensor matrix 202 in accordance with an embodiment. As shown in FIG. 2, the matrix 202 includes n columns and m rows of sensors 10 arranged in a matrix configuration such that no matter how the patient is placed on the matrix 202, there will always be at least one sensor located. On the patient's body at the position where the conventional ECG electrode is actually placed. Using the adaptive algorithm embedded in DPM 2, the matrix 202 can be used to obtain continuous ECG readings by selecting a given sensor 10 from the matrix 202 that corresponds to a defined ECG position on the patient's body. .

3 is a flow diagram of the main steps performed by a selection algorithm 204 in accordance with an embodiment. In step 210, the algorithm detects which sensors 10 are immediately following the patient's body by measuring the impedance between each sensor 10 and the patient. This allows the detectable sensor 10 to be used to retrieve data from the ECG signal output by the sensors 10 (ie, sensors that are determined to be immediately next to the body), and then analyze to obtain the patient's body. profile.

In one non-limiting embodiment, the embodiments may use different types of information to obtain a body contour. The first type is the coupled impedance representing the distance between the body and the sensor. When the coupling impedance is too high, the sensor is too far away from the body to be used. The second type is the signal itself, such as the type characteristic of the signal and the appearance of the signal, to see if the signal has a general ECG pattern or not (PQRSTU waveform). The third type of information relates to the geometric location of the ECG sensors that provide good ECG signals. These sensors and their locations provide an indication of the geometry of the human body, as illustrated in Figures 13a and 13b. In the example of Figure 13a, assume that the user 250 lies on a mattress in which the sensing pad 202 is embedded, The sensor 10a that is close to the patient's body will get a good ECG signal, and the sensor 10b outside the patient's body will not be able to get a good signal. Based on this information and the position of each sensor on the sensing pad 202, the DPM 2 can take the contour 252 of the patient's body by determining the shape, width, and other patient's body dimensions, as illustrated in Figure 13b. Using this information and a set of rules embedded in the DPM 2, the DPM 2 can then detect/determine the position of the body part and link one or more sensors 10 to various body parts/body positions for ECG use. , as described below.

In step 212, the algorithm analyzes the ECG signals received from the sensors and combines them with the detected body contour to find the patient's body position on the sensing pad. In step 214, the algorithm performs the mapping of the various sensors 10 at the seat on the body using the information obtained by steps 210 and 212. Once a sensor group (right arm, left arm, etc.) close to each major body part for ECG use is found, the signals from the adjacent sensors are compared and filtered in step 216 to select a single A sensor with the best ECG signal to receive and record ECG data from individual body parts.

In an embodiment, DPM 2 may be adapted to continuously and dynamically run the selection algorithm 204 to instantly re-examine the readings taken from the sensors 10 to re-verify the sensor 10 with the best ECG readings. The choice, and thus the patient's movement, is continually taken into consideration, thereby selecting a new sensor 10 that provides better readings than those previously selected prior to the move.

In another embodiment, the system can detect when the patient is moving and determine when it is necessary to run the algorithm again to recalculate whether a new selection is needed. For example, the system can monitor the strength/quality of the signal and re-run the selection algorithm 204 when the signal quality drops below a given threshold.

PQRSTU waveform detection

As described above, the system can be configured to record electrophysiological activity and ECG of the heart. In particular, the system can be designed to obtain an ECG waveform of the complete PQRSTU spectrum. As illustrated in Figure 4, it shows an example of a patient complete PQRSTU waveform taken using a system in accordance with an embodiment. The PQRSTU waveform shown in Figure 4 is generated by the heart and taken by the system for the doctor to view the diagnosis. In one embodiment, the system takes ECG readings and processes them to produce ECG signals that can be read and viewed using existing medical instruments and produces waveforms that are identical to those produced by standard contact ECG systems. And thus can be used to replace the standard ECG system at all application levels.

Needless to say, the non-contact sensor 10 does not produce an output signal compatible with existing medical instruments (such as a screen or the like) and thus cannot be interconnected with these instruments, and thus requires further processing. In one embodiment, the DPM converts the obtained signals into a format that is consistent with international standards for existing medical instruments. This allows seamless replacement of conventional contact ECG systems without the need to replace existing diagnostic medical devices or retrain doctors and medical experts. This type of conversion can be performed in DPM 2 using a combination of digital signal processing and analog output circuitry in the digital analog converter stage (19).

Sensor design

As described above, the embodiments use the non-contact ECG sensor 10 to take the patient's ECG reading. The sensors 10 are specifically designed to draw high quality ECGs from the patient without the need to directly contact the patient's skin with the electrodes. This allows the sensors 10 to be placed at a distance from the patient and/or separated from the patient's skin by a fabric (such as clothes, sheets, etc.), as illustrated in Figure 5, which shows the sensor An example of how the array captures ECG signals without directly contacting the patient's skin.

Figure 6 is a block diagram showing an exemplary sensor design in accordance with an embodiment. As shown in FIG. 6, the sensor 10 can include a conductive electrode 33, an electrode shield 32, and an electric power sensor. The electric power sensor includes an amplifier 34 and a bias circuit 35. Voltage. In the exemplary design of Figure 6, the gain/current buffer amplifier 34 can be a negative feedback cloth. The type of office is used, and the input bias network 35 is adapted to increase the effective input impedance of the amplifier 34 to preserve the signal quality of the obtained ECG. The input end of the electrodynamic sensor is connected to the conductive electrode 33. A shield drive circuit (36) can be used to generate a feedback signal to connect the electrode shield 32, thereby increasing the signal-to-noise ratio (SNR) by reducing the parasitic capacitance seen at the input of the electrodynamic sensor. ratio.

The electrode 33 can be capacitively coupled to the patient's body by approaching but not touching the skin/body. This can be accomplished by wearing a garment while lying on a bed with an array of sensors 10 embedded therein. The electric field established by the electrical activity of the heart near the surface of the patient's skin capacitively induces charge on the conductive electrode 33 without direct electrical contact. This charge can then be collected and amplified by the electrokinetic sensor to produce a electrical signal (voltage) representative of the electrical activity of the heart at that location (complete PQRSTU).

The electrode shield 32 is configured to reduce the amount of stray interference received by the electrodynamic sensor and also to reduce the effective capacitance of the input of the amplifier 34 to help preserve the signal quality of the obtained ECG.

In a non-limiting embodiment, both the electrode 33 and the electrode shield 32 can be made of an elastic/flexible material, making the sensor 10 more suitable for the geometry of the human body and achieving better results. ECG reading. At the same time, this configuration allows the sensors 10 to be seamlessly disposed on the fabric to be placed in the sensor array (or one of the following: gel/silicone/rubber pad/pad, etc.) Inside.

Fig. 7 shows an example of the physical design of the sensor 10. As illustrated in FIG. 7, the physical design includes a conductive electrode 33 physically implemented as a layered structure 39, physically implemented as an electrode shield 32 of the layered structure 40, and the remaining circuitry is embedded in the layered structure. 41 inside. The entire structure can be generated, for example, on a substrate 37 (which can also be a printed circuit board). In the design shown in FIG. 7, the layered structures 39, 40, 41 can be mutually separated by the dielectric layer 38. Edge to provide electrical insulation.

Figure 8 is an illustration of an exemplary block diagram showing the overall design of a system in accordance with an embodiment.

Referring to FIG. 8 and the above-mentioned part relating to FIG. 1, the system may include a sensing pad 7 including a non-contact ECG sensor (hereinafter referred to as CECG sensor 10), and the sensors may be It is arranged in the form of an array 202, such as shown in FIG. The sensing pad 7 can also include a ground pad 15, a drive circuit (e.g., a right leg drive (RLD) generator 14, as described below) and an A/D converter 13. The sensing pad 7 outputs the digitized ECG readings of the sensors 10 to the DPM 2. The RLD generator 14 is configured to supply the ground pad 15 with a high frequency signal outside of the ECG band. This high frequency signal is then coupled to the CECG sensors through the patient's body, which record the amplitude and are analyzed by DPM 2. This gives a measure of the degree to which each sensor of the system is coupled to the patient, and an effective impedance measurement to determine the level of signal quality from each sensor.

In addition to digitizing the CECG sensor data, the DPM 2 can also be configured to receive standard ECG data in an analog format for conventional electrodes. Such an analog ECG data system is selectively available through the use of standard contact electrodes and relay cables (5). This analog signal can be converted using ADC17. The signals can then be filtered using the digital signal processing unit 18 and output to various wired and wireless interfaces (Wi-Fi (22) / Ethernet (23) to the handheld device (3) / cloud server ( 4) And through the "analog CECG & ECG output" interface to existing medical instruments (6)).

DPM 2 may contain certain types of non-volatile memory, such as flash memory 26 for storing ECG data (if necessary). The DPM 2 can also be configured to perform an acute problem diagnosis and transmit an alert through one of the communication interfaces or an integrated audible alarm (24). DPM 2 can also include a low power Bluetooth interface (21) to enable the user to pass the mobile device Configure it. A read-only memory (25) can also be included to store the unique identification code. An encryption processing module (27) can also be used to encrypt and decrypt the data transmitted/received through the communication interfaces and securely store the key of the encrypted data.

All sensor data (contactless and contact) can be sent through these wired and wireless interfaces. The selection algorithm 204 (as described in FIG. 3 above) determines which sensor information should be output through the analog interface 19 to an existing medical instrument. A relay 20 can be provided to switch between analog data received from the conventional electrodes and the non-contact sensors 10, and the DPM 2 is compared between the two. The DPM 2 can be configured to be turned off without affecting the contact ECG signal (if needed) and function as a straight-through cable (controlled by the processing unit and relay (20)). It can also be used in "Mixed Mode", during which the combined output of the CECG and ECG sensors can be passed through the analog interface (if it improves the quality of the ECG signal).

Automatic gain correction

Since the input impedance of the electrophysiological sensor 10 is large (but limited), the capacitive coupling change (eg,) between each sensor 10 and the patient's body can cause a change in the gain of each sensor channel. This has the effect of affecting the amplitude of the ECG lead, and the dry contact electrode in the same way produces a lower quality signal than the new electrode. To solve this problem, a gain control mechanism is provided to allow the system to control the relative impedance difference between different non-contact ECG sensors, as well as between each non-contact ECG sensor and the human body. The absolute impedance between the individual non-contact ECG sensors and the human body. As shown in FIG. 9, a programmable gain amplifier 43 (analog or digital range) can be placed on each of the sensor channels 42 to compensate for gain variations caused by the difference in coupling between the sensors 10 and the patient. . Figure 9 is a block diagram showing an exemplary gain control mechanism 220 in accordance with an embodiment. As shown in FIG. 9, the gain control mechanism 220 can include a feedback loop including a coupling to the PGA 43 and the processor 45. The ADC 44 is in between and the processor itself is connected to the PGA 43 to control its gain as soon as the change occurs.

The processor 45 can be a dedicated processor or a processor module embedded in the processing unit 18 of the DPM 2.

Right leg drive

Referring again to Fig. 8, a ground pad 15 is shown which is operationally close to but not in contact (at a distance) to the patient's body. The ground pad is driven by a feedback signal derived from the ECG signals to provide a capacitively coupled ground reference level for the patient's body. The feedback signal is derived by increasing the common mode rejection ratio (CMRR) of the system (typically over 10 dB). This reduces interference from common mode signals and preserves the signal quality of the acquired ECG.

Figure 10 is an illustrative block diagram illustrating the functionality of RLD generator 14 in accordance with an embodiment. As shown in FIG. 10, the data received from the sensors is selected (or discarded) using a switching matrix (29) that selects a particular sensor 10 and uses the processing unit (18). The data is obtained by digitally implementing the RLD algorithm. The signals are then summed (29), inverted and amplified (30). This constitutes a drive signal for the ground pad 15.

The RLD algorithm is configured to monitor the common mode signals obtained by the various sensors (and to extend the ECG signal from the selection algorithm). The RLD algorithm can select the set of sensors that increase the system common mode rejection ratio after the RLD signal is applied to the feedback configuration for the patient.

Obtained lead

As mentioned above, the ability to compare current ECGs with older ECGs has led to enormous medical value, and this is not possible in existing systems that do not allow long-term monitoring. E.g, Abnormal ECG does not confirm acute heart disease, and normal ECG does not rule out heart disease. Therefore, it is necessary to compare the new ECG with the ECG made in the past. Features include:

● Is there a change in heart rate?

● Is there a change in frequency?

● Is there a change in conduction time?

● Is there a change in the mandrel?

● Is there a new pathological Q wave?

● Is there a change in the R wave size?

● Is there a change in ST?

● Is there a change in the T wave?

The above changes immediately led to further investigation. Changes in the electrocardiogram can be further classified as acute and chronic, however, both need to compare ECG.

In general, when the number of electrodes is increased, it is possible to reduce the monitoring time. Currently, one of the main limitations of current standards is the difficulty of obtaining long-term monitoring with multiple electrodes because of the inherent limitations of placing multiple electrodes and maintaining their body.

The above system allows for a continuous comparison of the electrocardiogram for the first time. This system has been shown to obtain a posterior ECG lead. According to the modified Mason-Likar lead system, a 16-lead ECG can be obtained from a patient lying on a sensor matrix embedded in a mattress, chair or the like. The obtained lead includes: Leads I, II, III, aVr, aV1, aVf, V1, V1R, V2, V2R, V3, V3R, V4, V4R, V5, V5R, as illustrated in FIGS. 11 and 12 . Figure 11 shows a medically recognized ECG position in order to obtain a standard ECG lead, while Figure 12 shows an example of a standard ECG lead, each lead showing a vector between two positions on an adult body.

The sensing pads containing the sensors 10 can be placed under the mattress in an imperceptible manner such that the ECG data can be obtained from a posterior lead (eg, a prone position). The system can be based The Mason-Likar sensor placement position was used to obtain the ECG during the stress test. Because of the myoelectric potential, motion and interference waves, and the 12-lead ECG print that limits 10 seconds, the standard 12-lead placement is not used and is not practical for short to long range monitoring.

The electrode disposed at the rear is an acceptable method of obtaining an ECG, and it is actually assisted in some cases for the more commonly used front wire arrangement method. The front wire arrangement is the only type of wire arrangement currently used for convenience. However, the prone position ECG lead is performed with standard electrodes in some cases, but is not inherently difficult due to inherent difficulties.

Figure 14 is a flow diagram of a method of providing a human body electrocardiogram (ECG) signal using a non-contact ECG sensor. As shown in FIG. 14, method 260 begins in step 262 by receiving a contactless ECG signal from a non-contact ECG sensor array. Step 264 includes detecting a body part located adjacent the body part of the non-contact ECG sensor array. Step 266 includes selecting a contactless ECG sensor having the highest signal value from each group. Step 268 includes generating a standard ECG signal based on the contactless ECG signals of the respective selected non-contact ECG sensors.

While the preferred embodiment has been described in the foregoing embodiments and shown in the drawings, the invention may Such modifications are considered as possible variations included in the scope of the invention.

2‧‧‧Digital Processing Module (DPM)

3‧‧‧Mobile devices

4‧‧‧Cloud

5‧‧‧Relay cable

6‧‧‧ medical instruments

7‧‧‧Sense pad

8‧‧‧Standard cable

9‧‧‧ cable

200‧‧‧ECG system

Claims (22)

A digital processing module (DPM) for providing an electrocardiogram (ECG) signal of a human body to an external device, the digital processing module comprising: - an input adapted to receive the non-contact ECG sensor array a non-contact ECG signal of the human body; - a processor adapted to perform a selection procedure comprising: ○ obtaining a body contour of the human body; ○ detecting a body part located in the body contour; ○ placing a non-contact type The ECG sensor group is coupled to each detected body part; ○ selecting a non-contact ECG having the highest signal quality of the body part associated with the non-contact ECG sensor group from each group a processor; the processor is adapted to generate a standard ECG signal based on the contactless ECG signal received from the selected non-contact ECG sensor; and - an output for transmitting the standard ECG signal to The external device. The digital processing module of claim 1, wherein the processor is further adapted to perform the steps of: a. determining a human body position on the non-contact ECG sensor array; b. The contact ECG sensors are divided into groups, and the groups are connected to a body part using the body contour and the body position; c. The non-contact ECG sensor with the highest signal quality is selected for each group. The digital processing module of claim 2, wherein the processor identifies the non-contact ECG sense located close to the human body by measuring the impedance between each non-contact ECG sensor and the human body. Detector. The digital processing module of claim 1, wherein the digital processing module is adapted to select another one for a given body part after the human body movement associated with the non-contact ECG sensor array Non-contact ECG sensor. The digital processing module of claim 4, wherein the processor is adapted to continuously re-run the selection procedure to perform selection of other non-contact ECG sensors. The digital processing module of claim 4, wherein the processor is adapted to continuously monitor current signal quality of the selected non-contact ECG sensor associated with each body part for the current Re-run the selector when the signal quality drops below a given threshold. The digital processing module of claim 1, wherein the digital processing module comprises different operating modes, including: - a non-contact mode, the output of which is generated by the non-contact ECG signal a standard ECG signal; - a mixed mode, which outputs a second standard ECG signal generated by the non-contact ECG signal and a conventional ECG signal received from the contact electrode; and - a bypass mode, the output of which is received by The third standard ECG signal generated by the conventional ECG signal of the contact electrode for self-study. The digital processing module of claim 1, further comprising an automatic gain control mechanism adapted to control a relative impedance difference between different non-contact ECG sensors and due to each non-contact The absolute impedance between each non-contact ECG sensor and the human body of the difference between the ECG sensor and the human body or the type of clothing material. The digital processing module of claim 1, further comprising a wired/wireless data packet for transmitting the standard ECG signal to a remote device on a data network. A system for providing an electrocardiogram (ECG) signal of a human body to an external device, the system comprising: a sensing pad comprising a non-contact ECG sensor array; - a processor operatively coupled to the sensing pad and adapted to receive non-contact from the non-contact ECG sensors ECG signal and executing a selection procedure comprising: ○ obtaining the body contour of the human body; ○ detecting a body part located in the body contour; ○ placing a non-contact ECG sensor group and each detection The body parts are connected; ○ selecting a non-contact ECG sensor having the highest signal quality of the body part associated with the non-contact ECG sensor group from each group; the processor is adapted Generating a standard ECG signal based on the contactless ECG signal received from the selected non-contact ECG sensor; and - an output for transmitting the standard ECG signal to the external device. The system of claim 10, wherein the sensing pad comprises a ground pad for placement at a distance from the human body, the ground pad being adapted to provide a capacitively coupled ground reference level with respect to the human body to reduce interference. The system of claim 11, wherein the ground pad is driven by a feedback signal derived from the non-contact ECG signals. The system of claim 11, further comprising a driving signal generator configured to supply the grounding pad with a high frequency signal outside the ECG band for each non-contact type The ECG sensor determines the capacitive coupling ground reference level. The system of claim 10, wherein the non-contact ECG sensor comprises: - a capacitive electrode adapted to be capacitively coupled to the human body to output a charge representative of electrical activity of the heart; An electrodynamic sensor configured to detect and amplify charge generated by the capacitor electrode; and - an electrode shield disposed adjacent to the electrode body for reducing electrical power sensing Spurious interference at the input of the device. The system of claim 14, wherein the non-contact ECG sensor is made of a flexible material. The system of claim 14, wherein the sensing pad is disposed on a fabric contacted by a human body or on one of the following: gel, silicone, rubber pad and pad. . A method of using a non-contact ECG sensor to provide an electrocardiogram (ECG) signal of a human body, the method comprising: - receiving a non-contact ECG signal from a non-contact ECG sensor array; - obtaining a body contour of the human body; - detecting body parts located in the contour of the body; - coupling a non-contact ECG sensor group to each detected body part; - selecting one from each group with the non-contact ECG sense Non-contact ECG sensor with the highest signal quality of the body part associated with the tester group; - generating and outputting a standard ECG signal based on the contactless ECG signal received from the selected non-contact ECG sensor . The method of claim 17, further comprising: - determining a position of the human body on the non-contact ECG sensor array; - dividing the non-contact ECG sensors into groups, and using the Body contours and body position connect each group to a body part; - Select the non-contact ECG sensor with the highest signal quality for each group selection. The method of claim 18, further comprising identifying the non-contact ECG sensor located in close proximity to the human body by measuring impedance between each of the non-contact ECG sensors and the human body. The method of claim 17, further comprising: repeating the step of detecting to continuously select for a human body movement associated with the non-contact ECG sensor array Select another non-contact ECG sensor for the body part. The method of claim 17, further comprising continuously monitoring the current signal quality of the selected non-contact ECG sensor associated with each body part, and the non-contact ECG sensor The step of repeating detection is continuously selected to select another non-contact ECG sensor for a given body part after the array-related human body motion drops below a given threshold. The method of claim 17, further comprising controlling a relative impedance difference between different non-contact ECG sensors and a distance between each non-contact ECG sensor and the human body. The absolute impedance between each non-contact ECG sensor and the human body, or the difference in the type of clothing material.