ECG and heart sound sensor integrated patch

Abstract

The integrated patch of ECG and phonocardiogram sensors includes a patch with an adhesive layer, a phonocardiogram probe and a plurality of ECG electrodes on the patch, wherein the ECG probe and the phonocardiogram probe are both exposed from the adhesive layer, wherein three ECG electrodes are arranged in a triangular structure, and two of the three ECG electrodes form limb leads respectively. The present invention integrates both ECG electrodes and phonocardiogram probes on one patch, and can obtain an ECG and a phonocardiogram at the same time.

Description

Technical Field

[0001] The present invention relates to the field of wearable cardiac health monitoring medical devices, and in particular to an integrated electrode patch for simultaneously monitoring electrocardiogram and heart sounds. Background Art

[0002] In the human heart, the sinoatrial node automatically and rhythmically generates electric current, which is transmitted to various parts of the heart in the order of the conducting tissue, thereby causing the contraction and relaxation of the myocardial cells. The excitement generated by the sinoatrial node is transmitted to the atria and ventricles in a certain way and process, causing the excitement of the entire heart. Therefore, the direction, path, order and time of the electrical changes that occur in the excitement process of various parts of the heart are regular. This bioelectric change is reflected to the body surface through the conductive resistance value and body fluids around the heart, causing regular electrical changes in various parts of the body in each cardiac cycle. The heart electrical change curve recorded by placing the guide electrode on the designated part of the limbs or body is called an electrocardiogram.

[0003] Electrocardiograms are usually recorded by ECG leads. ECG leads refer to the connection method in which the input wires and electrodes are placed at specific test sites (positive input terminals), reference sites (negative input terminals) and ground sites of the substrate when recording ECG signals. Among them, if one or two electrodes are connected to the heart, it is called a direct lead; if the electrodes are far away from the heart (more than 2 times the diameter of the heart), it is called an indirect lead; when one or two electrodes are close to the heart but not directly connected to the heart, it is called a semi-direct lead. Currently, the most commonly used clinical system is the standard 12-lead system, among which standard I, II, and III leads are indirect bipolar leads, V1 to V6 unipolar chest leads are semi-direct unipolar leads; aVR, aVL, and aVF unipolar pressurized limb leads are indirect unipolar leads.

[0004] The phonocardiogram displays the graphics of heart sounds and extracardiac sounds and murmurs. The phonocardiogram plays a great role in determining the shape and frequency composition of heart murmurs, and can also determine the time of heart sounds and murmurs, clearly distinguish the order in which certain heart sounds occur, and identify continuous murmurs in the cardiac cycle. The phonocardiogram has four waveforms, atrial contraction wave A, ventricular contraction wave SW, rapid filling wave RFW, and slow filling wave SFW. The first heart sound S1 usually consists of four waveforms, A, SW, RFW, and SFW, and the second heart sound S2 has two waveforms, A and P. There is a tricuspid valve between the right atrium and the right ventricle, a mitral valve between the left atrium and the left ventricle, a pulmonary valve between the right ventricle and the pulmonary artery, and an aortic valve between the left ventricle and the aorta. When the right atrium is excited, the tricuspid valve opens, and blood flows into the right ventricle. When the tricuspid valve closes, the right ventricle is excited, and blood flows into the pulmonary artery. The blood after pulmonary circulation enters the left atrium, the mitral valve opens and the blood enters the left ventricle, the mitral valve closes, the left ventricle is excited, and the blood flows into the aorta. The generation of S1 is related to the closure of the mitral valve (T1) and the tricuspid valve (M1), and the generation of S2 is caused by the closure of the aortic valve (A2) and the pulmonary valve (P2).

[0005] The initiating factors of heart changes are first manifested when the cardiac potential changes. The first heart sound S1 lags behind the R wave of the electrocardiogram, and the second heart sound S2 follows the electrocardiogram repolarization wave (T wave).

[0006] There are usually five areas for auscultation of heart valves: ①Mitral valve area M: located at the strongest point of apical pulsation, also known as the apex area; ②Pulmonary valve area P: at the 2nd intercostal space on the left edge of the sternum; ③Aortic valve area A: right side of the heart base, located at the 2nd intercostal space on the right edge of the sternum; ④Second auscultation area of ​​aortic valve E: left side of the heart base, at the 3rd intercostal space on the left edge of the sternum, also known as the Erb area, which is helpful for diagnosing aortic valve regurgitation; ⑤Tricuspid valve area T: at the left edge of the lower end of the sternum, that is, between the 4th and 5th intercostal spaces on the left edge of the sternum. The order of auscultation of heart sounds is: ①Starting from the mitral valve area M—②Pulmonary valve area P—③Aortic valve area A—④Second auscultation area of ​​aortic valve E—⑤Tricuspid valve area T. Or: ⑤Starting from the tricuspid valve area—④Second auscultation area of ​​aortic valve—③Aortic valve area—②Pulmonary valve area—①Mitral valve area. In a normal heart, the first heart sound is clearest at the apex, and the second heart sound is clearest at the heart base.

[0007] Existing ECG or heart sound monitoring instruments require that multiple ECG electrodes be pasted on the surface of human skin respectively. After the ECG electrodes are in contact with the human body, the heart sound probe is placed on the heart stethoscope area, which easily leads to mismatch between the heart electrode pieces. In addition, when the position of the heart electrode pieces is deviated, it will affect the correct positioning of the heart sound probe, which is troublesome to use and inefficient. Summary of the invention

[0008] The object of the present invention is to provide an integrated electrocardiograph and phonocardiograph sensor patch in which an electrocardiograph electrode and a phonocardiograph probe are integrated simultaneously.

[0009] The integrated patch of ECG and phonocardiac sensors includes a patch with an adhesive layer, which is characterized in that: the patch is provided with a phonocardiac probe and a plurality of ECG electrodes, the ECG electrodes and the phonocardiac probe are both exposed from the adhesive layer, three ECG electrodes are arranged in a triangular structure, and the three ECG electrodes form limb leads in pairs.

[0010] The ECG electrodes and the phonocardiac probe are not covered by the adhesive layer, so the phonocardiac probe and the ECG electrodes can directly contact the human skin, so the phonocardiac probe measures the bioelectric changes on the human body surface, and the phonocardiac probe measures the sound waves generated by the heart movement. The areas on the patch except the ECG electrodes and the phonocardiac probe are covered by the adhesive layer, so that the patch can be reliably attached to the human skin.

[0011] The scheme for forming six ECG leads: the heart sound probe is a membrane-type auscultation probe, and the membrane of the heart sound probe has a central electrode, which is located at the center of the triangular structure, and the three ECG electrodes form leads with the central electrode respectively. In this way, the four ECG electrodes form six leads.

[0012] A preferred solution is that the central electrode is fixed to the center of the membrane and protrudes from the membrane.

[0013] A scheme for forming additional leads: the patch has additional ECG electrodes, each of which forms a lead with the central electrode. Therefore, N additional ECG electrodes form N leads in addition to the six leads.

[0014] Regarding the scheme of ECG electrode and phonocardiac probe wires: All ECG electrode wires and phonocardiac probe wires are gathered together with the phonocardiac probe to form a wire bundle, which is connected to the signal connector through a connecting wire harness. The signal connector has signal terminals corresponding to the wires one by one. The signal connector connects the patch and the ECG electrodes and phonocardiac probe on it to the host.

[0015] A scheme for setting up a detector to determine whether the applied ECG electrode is in contact with the skin: an ECG patch detector includes a housing, a weak power supply, a probe, a detection terminal and a signal light. The probe and each detection terminal are connected in series with an indicator light to form a detection path. All detection paths are connected in parallel, and the weak power supply supplies power to the detection path. The detection terminals correspond to the signal terminals of the signal connector one by one, and the probe is a conductor that can contact the skin.

[0016] The detection terminal and signal terminal of the detector are both conductors. After the detection terminal and the signal terminal are in good contact, the probe contacts the user's skin. Only when the ECG electrode contacts the user's skin, the indicator light of the corresponding detection path will light up. If the indicator light of one or several detection paths is not on, it means that the corresponding ECG electrode is not in contact with the skin. After the test is completed, remove the detector, connect the signal connector of the patch to the host, and monitor the user's electrocardiogram and phonocardiogram.

[0017] As a preferred solution, when the signal connector is a raised male connector, the detector is a female connector with a slot or a hole; or when the signal connector is a female connector with a slot or a hole, the detector is a raised male connector.

[0018] As a preferred solution, the weak power source is a detachable battery, or a lithium battery built into the detector, and the detector has a charging port for the lithium battery.

[0019] The advantages of the present invention are:

[0020] 1. The ECG electrodes and the phonocardiogram probe are integrated on a disposable patch, so that the user's ECG and phonocardiogram can be obtained simultaneously using one patch.

[0021] 2. Integrate more than six leads on one patch to synchronously monitor the user's ECG.

[0022] 3. All the wires required for the leads are led out uniformly, which is convenient for connecting to the host using a standard signal connector.

[0023] 4. The patch is disposable, one patch per person, clean and hygienic.

[0024] 5. After the detector is connected to the signal connector, it can detect whether each ECG electrode is in good contact with the skin and give a status indication, that is, when the ECG electrode is in contact with the skin, the indicator light is on; when the ECG electrode is not in contact with the skin, the indicator light is off. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a schematic diagram of the first type of application.

[0026] Figure 2 It is a schematic diagram of the second type of application with integrated ECG electrodes on the heart sound probe.

[0027] Figure 3 is a schematic diagram of a third type of application with additional ECG electrodes.

[0028] Figure 4 It is a schematic diagram of a heart sound probe integrated with ECG electrodes.

[0029] Figure 5 is a schematic diagram of the detector. DETAILED DESCRIPTION

[0030] In some embodiments, Figure 1 As shown, the integrated ECG and heart sound sensor patch includes a patch 2 with an adhesive layer, on which is a heart sound probe 1 and a plurality of ECG electrodes, the ECG electrodes and the heart sound probe 1 are both exposed from the adhesive layer, wherein three ECG electrodes D1, D2, and D3 are arranged in a triangular structure, and the three ECG electrodes D1, D2, and D3 form limb leads in pairs.

[0031] The ECG electrodes and the phonocardiogram probe 1 are not covered by the adhesive layer, so the phonocardiogram probe 1 and the ECG electrodes can be in direct contact with the human skin, so the phonocardiogram probe 1 measures the bioelectric changes on the human body surface, and the phonocardiogram probe 1 measures the sound waves generated by the movement of the heart. The areas on the patch other than the ECG electrodes and the phonocardiogram probe 1 are covered by the adhesive layer, so that the patch can be reliably attached to the human skin. This disposable patch integrates both the ECG electrodes and the phonocardiogram probe 1, and one patch can simultaneously obtain the user's ECG and phonocardiogram.

[0032] In some embodiments, a six-lead ECG patch structure is formed: Figure 2 As shown, the cardiac sound probe 1 is a membrane auscultation probe, and the membrane 11 of the cardiac sound probe 1 has a central electrode DC, which is located at the center of the triangular structure, and the three ECG electrodes D1, D2, and D3 form leads with the central electrode DC respectively. In this way, the three ECG electrodes D1, D2, and D3 form three leads in pairs, and the central electrode DC and the three ECG electrodes D1, D2, and D3 form three leads respectively, and there are a total of six leads on the patch.

[0033] Preferred solution: Figure 4 As shown, the central electrode DC is fixed to the center of the membrane 11, and the central electrode DC protrudes from the membrane 11. The heart sound probe 1 is placed close to the skin, and the central electrode DC makes the membrane 11 tense, and the tiny gap between the membrane 11 and the skin forms a primary harmonic cavity, and the original cavity of the heart sound probe 1 forms a secondary harmonic cavity, and the two-stage harmonic cavity amplifies the heart sound twice.

[0034] In some embodiments, a scheme for forming additional leads is as follows: Figure 3 As shown, the patch has additional ECG electrodes DF, and each additional ECG electrode DF forms a lead with the central electrode DC. Therefore, N additional ECG electrodes DF form N leads in addition to the six leads. More than six leads are integrated on one patch to synchronously monitor the user's ECG.

[0035] In some embodiments, regarding the wires of the ECG electrodes and the phonocardiac probe 1, the wires of all ECG electrodes and the phonocardiac probe 1 are gathered in the phonocardiac probe 1 to form a wire bundle, which is connected to the signal connector, and the signal connector has signal terminals corresponding to the wires one by one. The signal connector connects the patch and the ECG electrodes and phonocardiac probe 1 thereon to the host. The wires required for all leads are uniformly led out, which is conducive to connecting to the host using a standard signal connector.

[0036] In some embodiments, a detector is provided to determine whether the applied ECG electrode is in contact with the skin: Figure 5As shown, the ECG patch detector includes a housing, a weak power supply, a probe 3, a detection terminal and a signal light 4. The probe 3 and each detection terminal are connected in series with an indicator light to form a detection path. All detection paths are connected in parallel, and the weak power supply supplies power to the detection path. The detection terminals correspond to the signal terminals of the signal connector one by one, and the probe 3 is a conductor that can contact the skin.

[0037] The detection terminal and signal terminal of the detector are both conductors. After the detection terminal and the signal terminal are in good contact, the probe 3 contacts the user's skin. Only when the ECG electrode contacts the user's skin, the indicator light of the corresponding detection path will light up. If the indicator light of one or several detection paths is not on, it means that the corresponding ECG electrode is not in contact with the skin. After the test is completed, remove the detector, connect the signal connector of the patch to the host, and monitor the user's electrocardiogram and phonocardiogram.

[0038] As a preferred solution, when the signal connector is a raised male connector, the detector is a female connector with a slot or a hole; or when the signal connector is a female connector with a slot or a hole, the detector is a raised male connector.

[0039] As a preferred solution, the weak power source is a detachable battery, or a lithium battery built into the detector, and the detector has a charging port for the lithium battery.

[0040] After the detector is connected to the signal connector, it can detect whether each ECG electrode is in good contact with the skin and give a status indication, that is, when the ECG electrode is in contact with the skin, the indicator light is on; when the ECG electrode is not in contact with the skin, the indicator light is off.

[0041] In some embodiments, using the method of the cardiac monitoring unit, a disposable cardiac sound probe is attached to the cardiac sound auscultation area, and the triangular structure formed by the three ECG electrodes has the apex at the bottom and the bottom at the top, and the adhesive layer is close to the human skin; the detector is connected to the disposable signal connector, and the probe of the detector is close to the skin. When all the indicator lights on the detector are on, the detector is removed, the signal connector is connected to the ECG and phonocardiogram, and the ECG and phonocardiogram are turned on to obtain the user's ECG and phonocardiogram. The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, without departing from the concept of the present invention, several improvements and modifications can be made, and these improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. An integrated patch of an electrocardiogram and heart sound sensor for simultaneously monitoring electrocardiogram and heart sound, the integrated patch comprising a patch having an adhesive layer, characterized in that: The patch is provided with a cardiac sound probe and a plurality of ECG electrodes. The areas on the patch except the ECG electrodes and the cardiac sound probe are covered by an adhesive layer. The ECG electrodes and the cardiac sound probe are not covered by the adhesive layer, so that the ECG electrodes and the cardiac sound probe can be in direct contact with human skin. The ECG electrodes and the cardiac sound probe are exposed from the adhesive layer, wherein three ECG electrodes are arranged in a triangular structure, and the three ECG electrodes form limb leads in pairs; the cardiac sound probe is a membrane-type stethoscope probe, and the membrane of the cardiac sound probe has a central electrode, which is located at the center of the triangular structure, and the three ECG electrodes form three leads with the central electrode respectively, so that on the patch, four electrodes form a total of six leads; the central electrode is fixed to the center of the membrane, and the central electrode protrudes from the membrane; The phonocardiogram probe is pressed against the skin, and the central electrode stretches the membrane so that the tiny gap between the membrane and the skin forms a primary harmonic cavity. The original cavity of the phonocardiogram probe forms a secondary harmonic cavity, and the phonocardiogram is amplified twice by the two-stage harmonic cavity. By integrating a six-lead structure on one patch, an electrocardiogram and a phonocardiogram can be obtained simultaneously. The patch is provided with additional ECG electrodes, each of which forms a lead with the central electrode. The number of additional ECG electrodes is N, and the N additional ECG electrodes form N leads outside the six leads. The wires of all ECG electrodes and the wires of the phonocardiogram probe are gathered on the phonocardiogram probe to form a wire bundle, which is connected to the signal connector through a connecting wire bundle. The signal connector has signal terminals corresponding to the wires one by one, and the signal connector connects the patch and the ECG electrodes and phonocardiogram probe on the patch to the host. The patch also includes an ECG patch detector The electrocardiogram patch detector comprises a shell, a weak power supply, a probe, a detection terminal and a signal light. An indicator light is connected in series between the probe and each detection terminal to form a detection path. All detection paths are connected in parallel. The weak power supply supplies power to the detection path. The detection terminals correspond to the signal terminals of the signal connector one by one. The probe is a conductor that can contact the skin. The detection terminals and the signal terminals of the detector are both conductors. After the detection terminals contact the signal terminals, the probe contacts the user's skin. Only when the electrocardiogram electrodes contact the user's skin, the indicator lights of the corresponding detection paths will light up. If the indicator lights of one or several detection paths are not lit, it means that the corresponding electrocardiogram electrodes are not in contact with the skin. When the signal connector is a raised male connector, the detector is a female connector with a slot or a hole; or when the signal connector is a female connector with a slot or a hole, the detector is a raised male connector.

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