本发明涉及医用器械的技术领域，特别是涉及一种可行多导联心电图检查和心电监测的手机。The present invention relates to the technical field of medical equipment, in particular to a mobile phone capable of multi-lead electrocardiogram inspection and electrocardiogram monitoring.
心血管疾病严重危害人类健康, 其发病时具有突发性、短暂性和危险性的特点，如心绞痛发作、阵发性心律失常、心源性晕厥发作等，其通常诊断金标准是发作当时的心电图，必要时需要和平时心电图对比。心源性晕厥虽然只占到晕厥病因的15%，然而却是晕厥导致猝死的首要原因，其直接原因主要是恶性室性心律失常，这就要求明确诊断。但是由于心绞痛、阵发性心律失常、晕厥的偶发性和不可预测性等特点，往往很难获得发作当时的心电图。目前临床上多采用24h 动态心电图（holter）捕捉短暂性的心电图心肌缺血改变、心律失常等，但对几天、几周、几个月甚至几年才发生一次的心绞痛、阵发性心律失常、晕厥还是存在局限，24h 动态心电图很难刚好捕捉到发作时的心电图。急性心肌梗死绝大部分可以通过心电图诊断出来，而且要求尽快行心电图检查以明确诊断，但是很多患者由于离医院、诊所等可以查心电图地方太远或者患者不重视而没有及时行心电图检查，因此耽误疾病的及时治疗甚至导致患者死亡。如果患者能够像糖尿病病人随身携带血糖仪进行自我血糖监测（SMBG）一样随身携带心电图仪以随时随地做心电图和心电监测，那么就能够解决这个问题。为了解决这个问题，那么就要求检查心电图的仪器应该足够小，并且电极应尽可能少，使用简单，容易操作。Cardiovascular disease seriously endangers human health. It has the characteristics of sudden, transient and dangerous when it occurs, such as angina pectoris, paroxysmal arrhythmia, cardiogenic syncope, etc. The gold standard for diagnosis is usually at the time of the attack Electrocardiogram, when necessary, need to compare with normal ECG. Although cardiogenic syncope accounts for only 15% of the causes of syncope, it is the primary cause of sudden death caused by syncope. The direct cause is mainly malignant ventricular arrhythmia, which requires a clear diagnosis. However, due to the sporadic and unpredictable characteristics of angina, paroxysmal arrhythmia, and syncope, it is often difficult to obtain the ECG at the time of the attack. At present, 24h dynamic electrocardiogram (holter) is often used clinically to capture transient ECG myocardial ischemia changes, arrhythmia, etc., but for angina pectoris and paroxysmal arrhythmia that occur only once in a few days, weeks, months, or even years , Syncope still has limitations. It is difficult for 24h dynamic ECG to capture the ECG at the time of the attack. Most acute myocardial infarction can be diagnosed by electrocardiogram, and ECG examination is required as soon as possible to confirm the diagnosis, but many patients are too far away from hospitals, clinics, etc. where the electrocardiogram can be checked, or the patients do not pay attention to the ECG examination in time, so it is delayed The timely treatment of the disease even led to the death of the patient. If patients can carry an electrocardiograph with them to do ECG and ECG monitoring anytime and anywhere like a diabetic patient with a blood glucose meter for self-blood glucose monitoring (SMBG), then this problem can be solved. In order to solve this problem, it is required that the instrument for checking the electrocardiogram should be small enough, and the electrodes should be as few as possible, simple to use and easy to operate.
目前市场流行的可穿戴/移动心电设备可分为：光学心率式（PPG）、单导接触/手持式、单导贴片式和标准导联式（多导）。除光学心率式外其他三种都是通过测量心电信号来判断使用者的心率情况，原理和心电图机类似。1.光学心率式（PPG）：光学心率式采用光电透射测量法，原理上来说就是血液是红色的，反射红光，吸收绿光。手环与皮肤接触的传感器会发出一束光打在皮肤上，测量反射/透射的光。因为血液对特定波长的光有吸收作用，每次心脏泵血时，该波长都会被大量吸收，以此就可以确定心跳。市场上大部分的可测心率的手环、手表均属这一类别。此类产品无论是原理还是精准度都不能满足医疗级别的要求，只能作为日常数据的追踪，不具医学参考价值。2.单导接触/手持式：即不使用粘贴电极片，常用的是模拟胸导联和双手导联（Ⅰ导联），满足用户进行快速心电检测的需求；此类心电设备只能监测一个导联，大部分是Ⅰ导联，部分是查胸导联或者二选一，可以检出较少部分（10-12种）的心律失常。由于此类设备需要用户手持或接触方能测量，仅能满足短时测量的场景，无法进行长时间监测，而短时的单导联的监测从医学角度来说是没有太多临床意义的，但是如果捕捉到心律失常发作时心电图还是有一定临床意义的。市场上高端的智能手环和智能手表多采用的是ECG+ PPG相结合的方式进行心率健康实时监测。3.单导贴片式：与手持/接触式不同，单导贴片式在有存储功能的前提下可适用于连续长时间检测。从临床的角度，单导设备当且仅当在连续长时间（>24h）佩戴测试场景下才有真正的临床意义，对心律失常的诊出率可以媲美动态心电（Holter）甚至优于Holter。然而很多厂商即便是单导贴片式，也并没有专门针对性的设计长时佩戴的场景，要么设备只能通过蓝牙连接实时显示，要么通过网络实时传输，没有涉及长时记录存储的领域，白白浪费了单导贴片式最适宜的长时动态监测性能；而且单导贴片只能监测心律失常，仅有一个导联，2个电极间距太短，波形常不稳定，从而限制临床应用。4.标准导联式（多导）：如果能够达到医疗级，那其实就是临床所使用的心电图和/或动态心电图。综上所述，目前光电心率式不具医学参考价值；单导接触/手持式、单导贴片只能监测一个导联，仅能用于心律失常监测，而且单导贴片式2个电极间距太短，波形常不稳定，从而限制临床应用；标准导联式、动态心电图、遥测心电监护导联多、结构复杂，患者无法自行行心电监测，无法长期随身携带，无法做到随时需要随时做心电图，而且作为非专业人员很难准确同时放置多个电极；所以目前市场上的可穿戴/移动心电设备均无法达到随时随地行心电图检查和自我心电监测的目标，也无法做出可真正用于临床使用分析的心电图。Wearable/mobile ECG devices currently popular in the market can be divided into: optical heart rate (PPG), single-lead contact/handheld, single-lead patch type and standard lead type (multi-lead). Except for the optical heart rate type, the other three are to determine the user's heart rate by measuring the ECG signal, and the principle is similar to that of an electrocardiograph. 1. Optical heart rate (PPG): Optical heart rate uses photoelectric transmission measurement method. In principle, blood is red, reflecting red light and absorbing green light. The sensor of the wristband in contact with the skin emits a beam of light hitting the skin to measure the reflected/transmitted light. Because blood absorbs light of a specific wavelength, every time the heart pumps blood, this wavelength is absorbed in a large amount, so that the heartbeat can be determined. Most of the bracelets and watches that can measure heart rate on the market belong to this category. Such products cannot meet the requirements of medical level in terms of principle and accuracy, and can only be used for daily data tracking, and have no medical reference value. 2. Single-lead contact/hand-held type: that is, without sticking electrode pads, the most commonly used are analog chest leads and two-hand leads (Lead Ⅰ) to meet the needs of users for rapid ECG testing; this type of ECG equipment can only Monitoring one lead, most of which is lead I, some of which is chest check or one of the two, can detect a small number (10-12 types) of arrhythmia. Because this type of equipment requires the user to hold or touch it to measure, it can only meet the short-term measurement scenario and cannot perform long-term monitoring. However, short-term single-lead monitoring does not have much clinical significance from a medical point of view. However, if the electrocardiogram is captured at the onset of arrhythmia, it still has certain clinical significance. High-end smart bracelets and smart watches on the market mostly use a combination of ECG + PPG for real-time heart rate health monitoring. 3. Single-guide patch type: Different from the handheld/contact type, the single-guide patch type can be used for continuous long-term detection under the premise of storage function. From a clinical point of view, a single-lead device has real clinical significance if and only if it is worn for a continuous long time (>24h) in the test scenario. The diagnosis rate of arrhythmia can be comparable to Holter or even better than Holter . However, many manufacturers do not specifically design long-term wear scenarios even if they are single-lead patch type. Either the device can only be displayed in real time via Bluetooth connection, or it can be transmitted in real time through the network, and there is no field involving long-term record storage. The most suitable long-term dynamic monitoring performance of the single-lead patch is wasted in vain; and the single-lead patch can only monitor arrhythmia, there is only one lead, the distance between the two electrodes is too short, and the waveform is often unstable, which limits clinical applications . 4. Standard lead type (multi-lead): If it can reach medical grade, it is actually the ECG and/or Holter used in clinic. In summary, the current photoelectric heart rate method has no medical reference value; single-lead contact/hand-held, single-lead patch can only monitor one lead, which can only be used for arrhythmia monitoring, and the single-lead patch type has 2 electrode spacing Too short, the waveform is often unstable, which limits clinical applications; standard lead type, Holter ECG, telemetry ECG monitoring leads are many, the structure is complicated, patients cannot perform ECG monitoring on their own, cannot be carried around for a long time, and cannot be needed anytime Do electrocardiogram at any time, and it is difficult for non-professionals to accurately place multiple electrodes at the same time; therefore, none of the wearable/mobile electrocardiogram devices currently on the market can achieve the goal of performing electrocardiogram examination and self-electrocardiogram monitoring anytime, anywhere. It can be really used for clinical analysis of ECG.
事实上根据电子学测试原理，任何心电导联系统本质上讲都是双极导联。将双极导联的两极（正极和负极）置于人体表面上任意两点都能记录出心电波波形来。标准导联系统的Wilson胸导联系统我们常常描述为单极胸导联，其实也是双极导联，只不过把左上肢、右上肢、左下肢所连接成的中心电站当成负极（也就是所谓的无关电极或者参考电极）。In fact, according to the principle of electronic testing, any ECG lead system is essentially a bipolar lead. Placing the two poles (positive and negative) of the bipolar lead on any two points on the surface of the human body can record the ECG waveform. The Wilson chest lead system of the standard lead system is often described as a unipolar chest lead, but it is also a bipolar lead, except that the central power station connected by the left upper limb, right upper limb, and left lower limb is regarded as the negative electrode (the so-called Irrelevant electrode or reference electrode).
尽管右上肢-胸部双极导联（CR导联）心电图和标准导联心电图存在着差异，但是国内外多项研究证实CR导联心电图在临床成功应用。CR导联曾经成功应用于心脏疾病诊断大约20年，所以相关研究比较多。目前国内外有不少双极胸导联（包括CR导联、CL导联、CF导联，主要研究是CR导联）和常规胸导联对比研究，研究表明CR导联比起CL、CF导联具有相当多的优势，而且CR导联和常规胸导联心电图十分相似。De Gasperi, R. N、McCulloh初步研究表明仅仅使用2个电极的双极导联就可以对心脏电位进行充分分析，该研究的双极导联包括CR导联、腹部-上肢导联（该研究为脐上分别和右上肢、左上肢相连接的2个双极导联）；De Gasperi, R. N、Duncan, R. CLowery, M. H、Chakko, C. S、Sequeira, R. F.研究表明尽管CR导联和标准导联P、Q、R、S和T低波幅有较小差异，但二者心电图诊断一致率接近90％；D. HMeneses-Hoyos J, Gonzalez-Tamayo A的研究表明CR导联和标准胸导联对比没有显著意义的差别，可以用于临床对心律失常、心肌缺血、心肌梗死等的诊断。CR导联更容易使用，而且仅仅要求2个导联就可以，可以将心电图仪做的更小，满足自我心电监测的硬件、软件要求。Although there are differences between the right upper limb-chest bipolar lead (CR lead) ECG and the standard lead ECG, many domestic and foreign studies have confirmed the successful clinical application of CR lead ECG. The CR lead has been successfully used in the diagnosis of heart diseases for about 20 years, so there are more related studies. At present, there are many bipolar chest leads at home and abroad (including CR, CL, CF, the main research is CR) and conventional chest leads. Research shows that CR leads are better than CL, CF The lead has quite a few advantages, and the CR lead is very similar to the conventional chest lead ECG. De Gasperi,The preliminary study by R. N and McCulloh showed that the bipolar lead of only two electrodes can be used to fully analyze the cardiac potential. The bipolar lead in this study includes CR lead, abdominal-upper limb lead (the study is on the umbilical Two bipolar leads connected to the right upper limb and left upper limb respectively); De Gasperi,R. N, Duncan, R. CLowery, M. H, Chakko, C. S, Sequeira, RF research shows that although the CR lead and the standard lead P, Q, R, S, and T have small differences in low amplitude, The agreement rate of the two ECG diagnosis is close to 90%; D. HMeneses-HoyosJ, Gonzalez-Tamayo A's research shows that there is no significant difference between CR lead and standard chest lead. It can be used for clinical diagnosis of arrhythmia, myocardial ischemia, and myocardial infarction. The CR lead is easier to use, and only 2 leads are required. The electrocardiograph can be made smaller to meet the hardware and software requirements of self-electrocardiogram monitoring.
右上肢-胸部双极导联（CR导联）仅仅需要2个导联就可以满足临床心电图需要，为满足机身足够小、并且电极应尽可能少、使用简单、容易操作的要求，所以采用双极导联心电图仪设计来达到体积小、导联少、操作简单目的，以达到随时随地行心电图检查和自我心电监测的目标。The right upper limb-chest bipolar lead (CR lead) only needs 2 leads to meet the needs of clinical ECG. In order to meet the requirements of small enough body, as few electrodes as possible, simple use and easy operation, it is adopted The bipolar lead electrocardiograph is designed to achieve the purpose of small size, fewer leads, and simple operation, so as to achieve the goals of ECG examination and self-electrocardiogram monitoring anytime and anywhere.
目前市场流行的可穿戴/移动心电设备：1.光电心率式不具医学参考价值；2.单导接触/手持式、单导贴片只能监测一个导联，仅能用于心律失常监测，而且单导贴片式2个电极间距太短，波形常不稳定，从而限制临床应用；3.标准导联式、动态心电图、遥测心电监护导联多、结构复杂，患者无法自行行心电监测，无法长期随身携带，无法做到随时需要随时做心电图，而且作为非专业人员很难准确同时放置多个电极。所以目前市场上的可穿戴/移动心电设备均无法达到随时随地行心电图检查和自我心电监测的目标，也无法做出可真正用于临床使用分析的心电图。Currently popular wearable/mobile ECG devices in the market: 1. The photoelectric heart rate type has no medical reference value; 2. The single-lead contact/hand-held, single-lead patch can only monitor one lead and can only be used for arrhythmia monitoring. Moreover, the distance between the two electrodes of the single-lead patch type is too short, and the waveform is often unstable, which limits the clinical application; 3. There are many standard leads, Holter ECG, and telemetry ECG monitoring leads, and the structure is complicated, so patients cannot perform ECG on their own Monitoring cannot be carried around for a long time, and it is impossible to do an electrocardiogram at any time, and it is difficult for non-professionals to accurately place multiple electrodes at the same time. Therefore, none of the wearable/mobile ECG devices currently on the market can achieve the goal of performing ECG inspection and self-ECG monitoring anytime and anywhere, and cannot produce ECG that can be used for clinical analysis.
为了解决目前临床上患者无法随时随地行心电图检查和自我心电监测的问题，本发明提供一种可行多导联心电图检查和心电监测的手机，解决临床患者无法随时随地做心电图和心电监测的临床空白，适合临床上的广泛应用。In order to solve the current clinical problem that patients cannot perform ECG examination and self-ECG monitoring anytime and anywhere, the present invention provides a mobile phone capable of multi-lead ECG examination and ECG monitoring, which solves the problem that clinical patients cannot do ECG and ECG monitoring anytime and anywhere The clinical blank is suitable for a wide range of clinical applications.
本发明采用手握式多点检测来解决上述技术问题，并且经过推导，用仅仅2个电极的心电图手机做出的心电图可以推导出标准导联心电图；也可以通过仅仅2-3个电极的导联线配合手机电极就可以进行标准导联心电图检查；也可以将导联线插入手机导联线连接端口进行心电监测，持续心电监测时可以和远程监护仪配合使用进行实时远程心电监护。The present invention uses hand-held multi-point detection to solve the above technical problems, and after derivation, the electrocardiogram made with an electrocardiogram phone with only 2 electrodes can be used to derive the standard lead electrocardiogram; it can also be obtained by the lead of only 2-3 electrodes The standard lead ECG can be checked by connecting the wire with the mobile phone electrode; you can also insert the lead wire into the lead wire connection port of the mobile phone for ECG monitoring, and can be used with the remote monitor for real-time remote ECG monitoring during continuous ECG monitoring .
如图1、图2所示，手机内置心电图模块，手机机身有由金属或者导电硅胶等导电材料形成电极（1），为心电图模块负极，手机底部有由金属或者导电硅胶等导电材料形成电极（2），为心电图模块正极。需要行心电图检查时，右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住手机负极，然后分别让底部正极和标准导联的V1 ~V6、左上肢（或者左侧锁骨外1/3的下方）、左下肢（或者左腋前线于肋下缘和髂骨上缘中点）等检测点相接触（必要时可以加做V7 ~V9、V3R~V6R、剑突处等导联），这样就形成了多个导联心电图。做完心电图在手机显示屏回放，通过相应软件进行心电图分析，也可以通过USB、蓝牙、WiFi、2G、3G、4G、5G等（依据不同型号、功能设定）发送到电脑或者监测中心，然后进行心电图分析。对行动不便的患者或者行自我心电图检查时明显肌颤者可以将手机连接导联线，由患者握住手机或者将负极用电极片贴于右上肢或者右侧锁骨外1/3的下方，正极接上导电金属，导电金属接上绝缘手柄，协助者拿着手柄在相应部位做心电图（依据手机不同型号、功能设定）。在实际临床使用时如果需要紧急情况而没有导电膏或者生理盐水等导电材料时，必要时可使用唾液湿化电极做出心电图，实际试用效果还不错。As shown in Figure 1 and Figure 2, the mobile phone has a built-in ECG module. The body of the mobile phone has electrodes formed of conductive materials such as metal or conductive silica gel (1), which is the negative electrode of the ECG module. The bottom of the mobile phone has electrodes formed of conductive materials such as metal or conductive silica gel. (2), is the positive electrode of the ECG module. When an electrocardiogram is required, clean the skin of the right hand and the detection point and apply conductive paste or saline. Hold the negative electrode of the mobile phone with the right hand, and then make the bottom positive and standard leads V1 ~ V6 and the left upper limb (or left clavicle) Below the outer 1/3), the left lower extremity (or the left anterior axillary line at the midpoint of the lower edge of the rib and the upper edge of the iliac bone) and other detection points contact (V7 ~V9 , V3R ~V6R , if necessary) Leads at the xiphoid process), thus forming a multiple-lead ECG. After the electrocardiogram is played back on the mobile phone display, the electrocardiogram can be analyzed through the corresponding software, or it can be sent to the computer or monitoring center via USB, Bluetooth, WiFi, 2G, 3G, 4G, 5G, etc. (depending on different models and function settings), and then Perform ECG analysis. For patients with mobility impairments or those with obvious muscle tremor during self-ECG examination, the mobile phone can be connected to the lead wire, and the patient can hold the mobile phone or stick the negative electrode pad on the right upper limb or under the 1/3 of the right clavicle, the positive electrode Connect the conductive metal, and the conductive metal to the insulated handle, and the helper takes the handle to make an ECG on the corresponding part (depending on the phone model and function settings). In actual clinical use, if there is an emergency and there is no conductive material such as conductive paste or saline, you can use the saliva moisturizing electrode to make an electrocardiogram if necessary. The actual trial effect is not bad.
心电图模块（12）主要由心电信号采集、放大、滤波电路、A/D 转换器、控制与数据处理器等构成。心电图模块控制与数据处理器采用手机处理器或者可支持并受控于手机上的处理器，因此手机可用于控制心电信号检测的启动、停止、存储和传送等操作。The ECG module (12) is mainly composed of ECG signal acquisition, amplification, filter circuit, A/D converter, control and data processor, etc. The ECG module control and data processor adopts the mobile phone processor or can support and be controlled by the processor on the mobile phone, so the mobile phone can be used to control the start, stop, storage and transmission of the ECG signal detection.
心电图导联连接端口（7）可连接导联线，根据机器不同型号设定，可连接2个或多个导联线（依据手机不同型号、功能设定），用于心电图检查和持续心电监测以检测出阵发性心律失常、阵发性心肌缺血以及早期发现心肌梗死等。做完心电图或者心电监测，可在手机显示屏回放，进行心电图分析，也可以通过USB、蓝牙、WiFi、2G、3G、4G、5G等（依据手机不同型号、功能设定）发送到电脑或者监测中心，然后通过相应软件进行心电图分析。持续心电监测时也可以和远程监护仪配合使用进行实时远程心电监护。一、双导联线：如图3所示，心电图导联连接端口可接2条导联线，这2条导联线分别对应手机机身负极和底部正极。具体是用导联线还是手机电极采集心电图信号可依据需要用手机设定。其具体应用如上述。二、三导联线：如图4所示，心电图导联连接端口可接3条导联线，这3条导联线分别为右上肢导联（对应手机机身负极）、左上肢导联、左下肢导联。手机底部正极没有对应的导联线。具体是用导联线还是手机电极采集心电图信号可用手机设定。具体操作可如前述采用握住手机采集心电图；也可以将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后握住手机用手机底部电极分别在胸导联检测点采集心电信号，用这种方法就可以采集标准导联心电图，而不是经过计算、推导的标准导联心电图。用这种方法仅仅需要3条导联线就可以采集标准导联心电图，强烈推荐应用。三、多导联线：如图5所示，心电图导联连接端口可接多条导联线，这些导联线分别为相应肢导联和胸导联（图示为9个导联线，实际应用依据不同型号、功能设定不同导联线数量）。具体是用导联线还是手机电极采集心电图信号可用手机设定。具体操作可如前述采用握住手机采集心电图；也可以将肢导导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，胸导连接在相应胸导联检测点；也可以将3条肢体导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后握住手机用手机底部电极分别在胸导联检测点采集心电信号，这时相当于三导联线方式。这个其实就是相当于普通心电图或者普通动态心电图。但可能会存在成本高、机身比较庞大、耗电量大、导联线多、操作复杂等问题。综上所述，心电图手机根据不同采集心电图的方法其心电图图像有右手导联心电图系统和常规标准导联心电图系统2种。The ECG lead connection port (7) can be connected to lead wires. It can be set according to different models of the machine and can be connected to 2 or more lead wires (depending on different models and function settings of mobile phones) for ECG inspection and continuous ECG Monitoring to detect paroxysmal arrhythmia, paroxysmal myocardial ischemia, and early detection of myocardial infarction. After the ECG or ECG monitoring is done, it can be played back on the phone display for ECG analysis, or sent to the computer via USB, Bluetooth, WiFi, 2G, 3G, 4G, 5G, etc. (depending on the phone model and function settings) or Monitoring center, and then through the corresponding software for ECG analysis. During continuous ECG monitoring, it can also be used with a remote monitor for real-time remote ECG monitoring. 1. Dual-lead wire: As shown in Figure 3, the ECG lead connection port can be connected to 2 lead wires, which correspond to the negative pole and the bottom positive pole of the phone body respectively. The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set with mobile phones according to needs. Its specific application is as described above. Two- and three-lead wires: As shown in Figure 4, the ECG lead connection port can be connected to 3 lead wires, which are the right upper limb leads (corresponding to the negative pole of the phone body) and the left upper limb leads , Left lower limb leads. There is no corresponding lead wire at the bottom of the phone. The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set by mobile phones. The specific operation can be performed as described above by holding the mobile phone to collect the ECG; you can also connect the 3 lead wires to the right upper limb, left upper limb, left lower limb, or under 1/3 of the outer clavicle on both sides, and the left anterior axillary line at the lower rib and At the midpoint of the upper edge of the iliac bone, then hold the mobile phone and use the bottom electrodes of the mobile phone to collect ECG signals at the chest lead detection points. In this way, standard lead ECG can be collected instead of the calculated and derived standard lead ECG. . With this method, only 3 leads are needed to collect standard lead ECG, which is highly recommended. 3. Multi-lead wire: as shown in Figure 5, the ECG lead connection port can be connected to multiple lead wires. These lead wires are the corresponding limb leads and chest leads (the figure shows 9 lead wires, The actual application sets the number of different lead wires according to different models and functions). The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set by mobile phones. The specific operation can be done by holding the mobile phone to collect the ECG; you can also connect the limb lead wires to the corresponding limbs or below the outer third of the clavicle on both sides, and the left anterior axillary line at the midpoint of the lower rib and the upper edge of the ilium , The chest lead is connected to the corresponding chest lead detection point; you can also connect the 3 limb lead wires to the corresponding limb or under the outer 1/3 of the bilateral clavicle, and the left anterior axillary line in the lower rib and upper edge of the ilium Then, hold the phone and use the bottom electrodes of the phone to collect ECG signals at the chest-lead detection points, which is equivalent to the three-lead wire method. This is actually equivalent to an ordinary electrocardiogram or an ordinary dynamic electrocardiogram. However, there may be problems such as high cost, relatively large body, high power consumption, many lead wires, and complicated operation. To sum up, according to different methods of collecting ECG, ECG mobile phone has two types of ECG images: right-hand lead ECG system and conventional standard lead ECG system.
多功能按键（9）：轻按一下则开始行心电图检查，启动后按照显示屏操作提示进行心电图检查，在做心电图时同时可查看波形，心电图检查完毕后再确定是否发送以及发送到哪儿，在进行持续心电监测是轻按可亮显示屏查看心电图波形；长按则启动紧急情况，这时则边做心电图边发送图像以免耽误病情，并且可以按事先设定仅作几个重要导联，情况允许再做其他导联；在行持续心电监测时长按可以发送按下按钮前后10秒（具体时间可以设定）的心电图并在心电监测记录中做标志，以方便回放查看；在实时远程监护时长按可以心电监测记录中做标志并同时可提醒监护医务人员。Multi-function button (9): lightly press it to start the ECG check. After starting, follow the operation prompts on the display to check the ECG. While doing the ECG, you can check the waveform at the same time. After the ECG check, you can confirm whether to send and where to send it. Continuous ECG monitoring is to lightly press the brightened display to view the ECG waveform; long press to initiate an emergency, then send the image while making the ECG to avoid delaying the condition, and can only be used for a few important leads according to the preset settings. The situation allows to do other leads; long press during continuous ECG monitoring can send the ECG 10 seconds before and after pressing the button (the specific time can be set) and mark it in the ECG monitoring record to facilitate playback and viewing; in real-time remote Long press during monitoring can mark the ECG monitoring record and remind the monitoring medical staff at the same time.
本发明的手机拥有一般手机该有的部件，如内置通信模块（13）、手机屏幕（11）、电源键（3）、音量键（4）、USB端口（8）后置摄像头（5）、前置摄像头（10）、闪光灯（6）等，还包括为实现多导联心电图检查和心电监测功能而设置的部件，如内置心电图模块（12）、手机机身的心电图电极（1）、手机底面的心电图电极（2）、心电图导联线连接端口（7）、多功能按键（9）等。The mobile phone of the present invention has the components that a general mobile phone should have, such as a built-in communication module (13), a mobile phone screen (11), a power button (3), a volume button (4), a USB port (8) and a rear camera (5), The front camera (10), flash (6), etc., also include components set up for multi-lead ECG inspection and ECG monitoring, such as the built-in ECG module (12), the ECG electrode (1) of the mobile phone body, ECG electrodes (2), ECG lead wire connection ports (7), multi-function buttons (9), etc. on the bottom of the mobile phone.
心电图手机导联设计包括：1. 右上肢-胸部双极导联（CR导联），可以模拟胸导联，其负极为右上肢，正极部位和Wilson导联系统的V导联一致；2.Ⅰ导联，其负极为右上肢（或者右侧锁骨外1/3的下方），正极位于左上肢（或者左侧锁骨外1/3的下方）；3.Ⅱ导联，其负极为右上肢（或者右侧锁骨外1/3的下方），正极为左下肢（或者左腋前线于肋下缘和髂骨上缘中点）。双极胸导联包括CR导联、CL导联、CF导联，Fontaine导联也称作双极胸导联，还有运动实验也有运动试验也有用双极胸导联，容易引起命名紊乱；而且本发明不仅包括右上肢-胸部双极导联（CR导联）还包括Ⅰ导联、Ⅱ导联，所有导联均采用负极为右上肢，所以为了方便直观，重新命名为右手导联（Right Hand Leads RH导联）。将各导联分别命名为：RHC1 ~RHC6、RHⅠ、RHⅡ，分别对应标准导联的V1 ~V6、Ⅰ、Ⅱ。统一将RHC1 ~RHC6等胸导联统称为RHC导联，等同于以前的CR导联。其实RHC1 ~RHC6就是CR1 ~CR6的重新命名；RHⅠ、RHⅡ分别为标准导联的Ⅰ导联、Ⅱ导联。The lead design of the ECG mobile phone includes: 1. The right upper limb-chest bipolar lead (CR lead), which can simulate the chest lead, the negative electrode is the right upper limb, and the positive part is the same as the V lead of the Wilson lead system; 2. In lead Ⅰ, the negative pole is the right upper limb (or below the outer 1/3 of the right clavicle), and the positive pole is located in the left upper limb (or below the 1/3 of the left clavicle); in lead 3.Ⅱ, the negative pole is the right upper limb (Or below the outer 1/3 of the right clavicle), the positive pole is the left lower extremity (or the left anterior axillary line is at the midpoint of the lower edge of the rib and the upper edge of the ilium). Bipolar chest leads include CR, CL, and CF leads. Fontaine lead is also called bipolar chest lead. There are also exercise experiments and exercise tests, as well as bipolar chest leads, which can easily cause naming confusion; Moreover, the present invention includes not only the right upper limb-chest bipolar lead (CR lead) but also leads I and II. All the leads adopt the negative pole as the right upper limb, so for convenience and intuitiveness, it is renamed the right hand lead ( Right Hand Leads RH lead). Name the leads respectively: RHC1 ~RHC6 , RHⅠ, RHⅡ, corresponding to the standard leads V1 ~V6 ,Ⅰ,Ⅱ. The chest leads such as RHC1 to RHC6 are collectively referred to as RHC lead, which is equivalent to the previous CR lead. In fact, RHC1 ~ RHC6 are the renames of CR1 ~ CR6 ; RHⅠ and RHⅡ are standard leads I and II respectively.
由右手导联推导出常规标准导联心电图：常规心电图导联连图如图10所示，其中R、L、F分别代表右上肢、左上肢、左下肢；－代表负极，＋代表正极；WCT为Wilson中心电站；V代表标准导联胸导联位置，V1 ~V6，共6个，取一个点做示意，其中标准胸导联用Vn表示，右手导联用RHCn表示。用E代表电势。Ⅰ导联：心电图机正极连于左上肢，负极连于右上肢。故Ⅰ=EL－ER。Ⅱ导联：心电图机正极连于左下肢，负极连于右上肢。故Ⅱ=EF－ER。Ⅲ导联：心电图机正极连于左下肢，负极连于左上肢。故Ⅲ=EF－EL。根据上述3个公式，可推导出Ⅲ= EF－EL= (EF－ER)－( EL－ER)=Ⅱ－Ⅰ。同理，可推算出RHⅢ=RHⅡ－RHⅠ。中心电站（WCT）为R、L、F连接中心点，经数学计算EWCT=(EF＋EL＋ER)/3。 VR=ER－EWCT=ER－(EF＋EL＋ER)/3=－[( EF－ER)＋( EL－ER)]/3=－(Ⅰ＋Ⅱ)/3 VL= EL－EWCT=EL－(EF＋EL＋ER)/3=[( EL－ER) －(EF－EL)]/3=(Ⅰ－Ⅲ)/3=[Ⅰ－(Ⅱ－Ⅰ)]/3=(2Ⅰ－Ⅱ)/3 VF= EF－EWCT=EF－(EF＋EL＋ER)/3=[ (EF－EL )＋( EF－ER)]/3=(Ⅲ＋Ⅱ)/3=(Ⅱ－Ⅰ－Ⅱ)/3=(2Ⅱ－Ⅰ)/3 为了提高单极肢体导联电压，1942年Glodberger修改Wilson的中心电端，把中心电端与探查的那一个肢体脱离，将得到的电位增加到一半，计算公式如下。 aVR= ER－(EF＋EL)/2= 3/2ER－(EF＋EL＋ER)/2=2/3 [ER－(EF＋EL＋ER)/3]=3/2VR=－(Ⅰ＋Ⅱ)/2 同理，aVL= 3/2VL= (2Ⅰ－Ⅱ)/2=Ⅰ－1/2Ⅱ；aVF= 3/2VF==(2Ⅱ－Ⅰ)/2=Ⅱ－1/2Ⅰ。导联Vn为正极连于在Vn，负极（无干电极）连于WCT。故Vn=EVn－EWCT。导联RHCn为正极连于在Vn，负极连于右上肢。故RHCn= EVn－ER。由此可推断出： Vn= EVn－EWCT= EVn－(EF＋EL＋ER)/3= EVn－ER＋[( EL－ER)＋( EF－ER)]/3=RHCn－(Ⅰ＋Ⅱ)/3。通过以上公式，本研究证实仅仅依靠2个电极的右手导联心电图系统在采集数据后经过计算机处理可以推断出常规标准导联心电图。常规标准的Ⅰ导联、Ⅱ导联、Ⅲ导联、aVR导联、aVL导联、aVF导联、胸导联的各个Vn导联分别用RHⅠ、RHⅡ、RHⅡ－ RHⅠ、－( RHⅠ＋ RHⅡ)/2、RHⅠ－1/2 RHⅡ、RHⅡ－1/2 RHⅠ、RHCn－( RHⅠ＋ RHⅡ)/3替代，从而导出标准导联心电图。因为右手导联心电图是新提出来的，而且大部分人对CR导联也不甚了解，所以经计算机转换出标准导联心电图有利于临床工作的开展，也有利于对心电图进行分析。注意RH导联系统RHⅠ和RHⅡ定位和标准导联系统区别，还有心电图不是多导联同步采集，所以计算后期合成心电图时心率不同时要先矫正后再合成，就算经校正，其本身可能存在偏差，不过手机采集心电图虽然不是同步的，但因间隔时间很短，心率变异小，矫正后其影响很小。The conventional standard lead electrocardiogram is derived from the right-hand leads: the conventional electrocardiogram leads are shown in Figure 10, where R, L, and F represent the upper right limb, the upper left limb, and the lower left limb respectively;-stands for negative pole, + stands for positive pole; WCT It is the Wilson Central Power Station; V represents the position of the standard lead chest lead, V1 ~ V6, there are 6 in total. Take one point as an indication. The standard chest lead is represented by Vn and the right-hand lead is represented by RHCn. Let E stand for electric potential. Lead I: The positive electrode of the electrocardiograph is connected to the upper left limb, and the negative electrode is connected to the upper right limb. Therefore Ⅰ=EL-ER. Lead II: The positive electrode of the electrocardiograph is connected to the left lower limb, and the negative electrode is connected to the right upper limb. Therefore Ⅱ=EF-ER. Lead III: The positive electrode of the electrocardiograph is connected to the left lower limb, and the negative electrode is connected to the left upper limb. Therefore Ⅲ=EF-EL. According to the above three formulas, Ⅲ=EF-EL=(EF-ER)-(EL-ER)=Ⅱ-I can be derived. In the same way, RHⅢ=RHⅡ－RHⅠ can be calculated. The central power station (WCT) is the central point of the connection of R, L, and F. After mathematical calculation, EWCT=(EF＋EL＋ER)/3. VR=ER－EWCT=ER－(EF＋EL＋ER)/3=－[( EF－ER)＋( EL－ER)]/3=－(Ⅰ＋Ⅱ)/3 VL= EL－EWCT=EL－(EF＋EL＋ER)/3 =[( EL－ER) －(EF－EL)]/3=(Ⅰ－Ⅲ)/3=[Ⅰ－(Ⅱ－Ⅰ)]/3=(2Ⅰ－Ⅱ)/3 VF= EF－EWCT= EF－(EF＋EL＋ER)/3=[ (EF－EL )＋( EF－ER)]/3=(Ⅲ＋Ⅱ)/3=(Ⅱ－Ⅰ－Ⅱ)/3=(2Ⅱ－Ⅰ)/3 To increase the order Polar limb lead voltage. In 1942, Glodberger modified Wilson's central electrical terminal, separated the central electrical terminal from the limb being probed, and increased the obtained potential to half. The calculation formula is as follows. aVR=ER－(EF＋EL)/2= 3/2ER－(EF＋EL＋ER)/2=2/3 [ER－(EF＋EL＋ER)/3]=3/2VR=－(Ⅰ＋Ⅱ)/2 Similarly, aVL= 3/2VL= (2Ⅰ－Ⅱ)/2=Ⅰ－1/2Ⅱ; aVF= 3/2VF==(2Ⅱ－Ⅰ)/2=Ⅱ－1/2Ⅰ. Lead Vn is the positive pole connected to Vn, and the negative pole (without dry electrode) is connected to WCT. Therefore Vn=EVn-EWCT. Lead RHCn is connected to Vn with the positive pole and the negative pole to the upper right limb. So RHCn = EVn-ER. It can be inferred from this: Vn=EVn－EWCT= EVn－(EF＋EL＋ER)/3= EVn－ER＋[( EL－ER)＋(EF－ER)]/3=RHCn－(Ⅰ＋Ⅱ)/3. Through the above formula, this study confirmed that the right-hand lead ECG system, which only relies on two electrodes, can infer the conventional standard lead ECG after data collection and computer processing. Conventional standard lead I, II, III, aVR, aVL, aVF, chest lead Vn leads respectively use RHⅠ, RHⅡ, RHⅡ-RHⅠ, -(RHⅠ＋RHⅡ) /2, RHⅠ－1/2 RHⅡ, RHⅡ－1/2 RHⅠ, RHCn－(RHⅠ＋RHⅡ)/3 replacement, so as to derive standard lead ECG. Because the right-hand lead ECG is newly proposed, and most people don't know much about the CR lead, the computer-converted standard lead ECG is beneficial to the development of clinical work and the analysis of the ECG. Pay attention to the difference between the RH I and RH II positioning of the RH lead system and the standard lead system, and the electrocardiogram is not collected simultaneously in multiple leads, so when the heart rate is different during the calculation of the later synthetic electrocardiogram, it must be corrected before synthesis. Even after correction, it may exist. Deviation, although the mobile phone's collection of ECG is not synchronized, but because the interval is very short, the heart rate variability is small, and its effect after correction is small.
1. 设计出小巧、可随身携带的自我多导联心电图检查和自我心电监测用的手机，解决临床患者无法随时随地做心电图和心电监测的临床空白。根据不同采集心电图的方法其心电图图像有右手导联心电图系统和常规标准导联心电图系统2种。1. Design a compact, portable mobile phone for self-multi-lead ECG examination and self-ECG monitoring, to solve the clinical gap that clinical patients cannot do ECG and ECG monitoring anytime and anywhere. According to different methods of collecting ECG, there are two types of ECG images: the right-hand lead ECG system and the conventional standard lead ECG system.
2. 对既往的右上肢-胸部双极导联（CR导联）进行扩展研究。除了CR导联外，本发明还包括了Ⅰ导联、Ⅱ导联，构成了一个完整的导联体系，重新命名为右手导联（Right Hand Leads RH导联）。首次利用仅仅2个电极的手机完成了一个完整的导联体系所必需的心电图数据采集，并构建成一个完整的导联体系。2. Conduct an extended study on the previous right upper limb-chest bipolar lead (lead CR). In addition to the CR lead, the present invention also includes lead I and lead II, forming a complete lead system, renamed the Right Hand Leads (RH Lead). For the first time, a mobile phone with only 2 electrodes was used to complete the collection of electrocardiogram data necessary for a complete lead system and build a complete lead system.
3. 创造性的利用完整的右手导联体系，经计算推导出完整的常规标准导联心电图，以利于心电图手机的临床推广应用。首次仅采用2个电极就推导出完整的常规标准导联的心电图。3. Creatively use the complete right-hand lead system to derive a complete conventional standard lead electrocardiogram after calculation to facilitate the clinical application of electrocardiogram phones. For the first time, only two electrodes are used to derive a complete conventional standard lead ECG.
4. 首次仅采用三条导联线就可以采集标准导联心电图。心电图导联连接端口可接3条肢体导联线，将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后握住手机用手机底部电极分别在胸导联检测点，用这种方法就可以采集标准导联心电图，而不是经过计算、推导的标准导联心电图。用这种方法仅仅需要3条导联线就可以采集标准导联心电图，强烈推荐临床应用。4. For the first time, only three lead wires can be used to collect standard lead ECG. The ECG lead connection port can be connected to 3 limb lead wires. Connect the 3 lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of the clavicle on both sides, and the left anterior axillary line at the lower rib and At the midpoint of the upper edge of the iliac bone, then hold the mobile phone and use the bottom electrodes of the mobile phone to test the points in the chest leads. In this way, standard lead ECGs can be collected instead of calculated and deduced standard lead ECGs. With this method, only 3 leads are needed to collect standard lead electrocardiograms, and clinical application is strongly recommended.
该装置可用在个人自我心电图检查和心电监测、远程实时心电监护，也可以用在院前急救、院内救治、突发紧急医疗救援事件时心电图检查和心电监测、远程实时心电监护。该心电图手机可以让患者、医生平时当手机使用，在需要时当抢救、治疗、监测的医疗用品。The device can be used for personal self-ECG examination and ECG monitoring, remote real-time ECG monitoring, as well as pre-hospital first aid, in-hospital treatment, ECG examination and ECG monitoring during emergency medical rescue events, and remote real-time ECG monitoring. The electrocardiogram mobile phone can be used by patients and doctors as mobile phones at ordinary times and as medical supplies for rescue, treatment and monitoring when needed.
图1 是该心电图手机侧面、背面、底面视图；Figure 1 is the side, back and bottom view of the ECG mobile phone;
图2 是该心电图手机上面、正面、侧面视图；Figure 2 is the top, front and side views of the ECG mobile phone;
图3是手机心电图导联连接端口为双导联线示意图；Figure 3 is a schematic diagram showing that the lead connection port of the cell phone ECG is a two-lead wire;
图4是手机心电图导联连接端口为三导联线示意图；Figure 4 is a schematic diagram showing that the lead connection port of the cell phone ECG is a three-lead wire;
图5是手机心电图导联连接端口为多导联线示意图；Figure 5 is a schematic diagram showing that the lead connection port of the cell phone ECG is a multi-lead wire;
图6是常规心电图导联连接示意图；Figure 6 is a schematic diagram of conventional ECG lead connection;
图中1. 位于手机机身的电极，为负极、2.位于手机底面的电极，为正极、3.电源键、4.音量键、5.后置摄像头、6.闪光灯、7.心电图导联线连接端口、8.USB端口、9.多功能按键、10.前置摄像头、11.手机屏幕、12.心电图模块、13.手机通讯模块，P1~P9代表心电图导联连接端口的连接导联线触点、R代表电阻。In the figure 1. The electrode located on the phone body is negative, 2. The electrode located on the bottom of the phone is positive, 3. Power button, 4. Volume button, 5. Rear camera, 6. Flash, 7. ECG lead Cable connection port, 8. USB port, 9. Multi-function buttons, 10. Front camera, 11. Mobile phone screen, 12. ECG module, 13. Mobile phone communication module, P1~P9 represent the connection leads of the ECG lead connection port Line contact, R represents resistance.
手机采用三导联线方案。需要行心电图检查时将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后由本人或者他人用手机底部电极分别和标准导联的V1 ~V6检测点相接触，用这种方法就可以采集标准导联心电图；紧急情况下或者不方便或者没有携带导联线时，可右手握住手机机身负极，然后让手机底部正极和相应检测点相接触，分别记录形成了多个导联心电图，用这种方法就可以采集右手导联心电图；需要行持续心电监测或者远程心电监护时根据需要将导联线连接于相应位置，用手机设定并进入持续心电监测或者远程实时心电监护。The mobile phone uses a three-lead wire solution. When an electrocardiogram is required, connect the three lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of the clavicle on both sides, and the left anterior axillary line at the midpoint of the lower rib and upper edge of the ilium, and then I or others use the bottom electrode of the mobile phone to contact the V1 ~ V6 detection points of the standard leads. This method can collect the standard lead ECG; in case of emergency or when it is inconvenient or without the lead wire, you can Hold the negative electrode of the phone with your right hand, and then contact the positive electrode at the bottom of the phone to the corresponding detection point, and record and form multiple lead ECGs. This method can collect the right-hand lead ECG; continuous ECG monitoring or remote monitoring is required During ECG monitoring, connect the lead wire to the corresponding position as needed, set it with a mobile phone and enter continuous ECG monitoring or remote real-time ECG monitoring.
方式一：右手握住手机机身负极，然后让手机底部正极和相应检测点相接触，分别记录形成了多个导联心电图，记录右手导联心电图。Method 1: Hold the negative electrode of the phone body with your right hand, and then contact the positive electrode on the bottom of the phone to the corresponding detection point, and record and form a multiple-lead ECG respectively, and record the right-hand lead ECG.
方式二：对行动不便的患者或者行自我心电图检查时明显肌颤者可以将手机连接导联线，由患者握住手机或者将负极用电极片贴于右上肢或者右侧锁骨外1/3的下方，正极接上导电金属，导电金属接上绝缘手柄，协助者拿着手柄在相应部位做心电图（依据手机不同型号、功能设定）。Method 2: For patients with mobility impairments or those with obvious muscle tremors during self-ECG examination, connect the mobile phone to the lead wire, and the patient holds the mobile phone or sticks the negative electrode pad to the right upper limb or 1/3 of the right clavicle Below, the positive electrode is connected to the conductive metal, and the conductive metal is connected to the insulated handle. The helper takes the handle to do the ECG on the corresponding part (depending on the different models of mobile phones and the function settings).
方式三：心电图手机连接导联线，根据机器不同型号设定，可连接2个或2个以上电极（依据手机不同型号、功能设定），用于持续心电监测以检测出心律失常、心肌缺血等问题。持续心电监测时也可以和远程监护仪配合使用进行远程心电监护。在心电监测时电极连接由临床医生依据病情及监测目的调试安装，而不是如目前市场上的可穿戴/移动心电设备简单粗暴连接上去了事。例如怀疑阵发性Brugada 综合征、阵发性左右束支传导阻滞、阵发性宽QRS波、左右室性期前收缩等，可采用改良CL1导联（MCL1导联：正极置于胸骨右缘第4肋间，负极放置于右侧锁骨外1/3的下方），该波形和V1相似；例如心律失常而为了更清楚显示P波，可以使用S5导联（把正极置于胸骨右缘第5肋间，负极置于胸骨柄处）；例如为了显示心肌缺血，使用RHC导联可以把负极放置于右侧锁骨外1/3的下方，正极放置于标准导联V2、V4、V4R、剑突等处，可分别监测室间隔、左室壁、右室、下壁的心肌缺血改变。当患者出现不适时立即按下紧急按钮，就可以马上把前后10秒钟（时间可设定）心电图发送出去，供医生参考决定下一步诊疗方案，是否需要紧急就诊。Method 3: Connect the lead wire of the ECG mobile phone, set according to the different models of the machine, and connect 2 or more electrodes (depending on the different models and function settings of the mobile phone) for continuous ECG monitoring to detect arrhythmia and myocardium Issues such as ischemia. During continuous ECG monitoring, it can also be used in conjunction with a remote monitor for remote ECG monitoring. During ECG monitoring, the electrode connection is adjusted and installed by the clinician according to the condition and monitoring purpose, rather than simply and roughly connected as the wearable/mobile ECG equipment on the market. For example, if suspected paroxysmal Brugada syndrome, paroxysmal left and right bundle branch block, paroxysmal wide QRS complex, left and right ventricular premature contraction, etc., modified CL1 lead (MCL1 lead: positive electrode placed The fourth intercostal space on the right edge of the sternum, the negative pole is placed below the outer 1/3 of the right clavicle), the waveform is similar to V1; for example, arrhythmia. In order to show the P wave more clearly, you can use lead S5 (put the positive pole on the The fifth intercostal space on the right edge of the sternum, the negative pole is placed at the stem of the sternum); for example, to show myocardial ischemia, the negative pole can be placed under the outer 1/3 of the right clavicle using the RHC lead, and the positive pole placed on the standard lead V2 , V4 , V4R , xiphoid process, etc., can monitor the changes of myocardial ischemia in the ventricular septum, left ventricular wall, right ventricle, and inferior wall respectively. When the patient is unwell, press the emergency button immediately, and the ECG can be sent out for 10 seconds before and after (the time can be set) for the doctor's reference to decide the next diagnosis and treatment plan and whether it needs emergency treatment.
方式四：心电图手机连接导联线，用于持续心电监测时，如果患者出现明显胸痛、胸闷等症状，立即拿起手机，切换到记录心电图模式，保持右上肢导联电极仍旧在右侧锁骨外1/3的下方，移动手机到各个位点做出心电图。或者干脆采用方式一进行心电图采集（具体方案可手机设定）。Method 4: When the ECG mobile phone is connected to the lead wire for continuous ECG monitoring, if the patient has obvious chest pain, chest tightness and other symptoms, immediately pick up the mobile phone and switch to the ECG recording mode, keeping the lead electrode of the right upper limb still on the right clavicle Below the outer 1/3, move the mobile phone to various locations to make an ECG. Or simply adopt method 1 for ECG acquisition (the specific plan can be set by mobile phone).
方式五-心电图连接端口双导联线方案：如图4所示，心电图导联连接端口可接2条导联线，这2条导联线分别对应手机机身和底部电极。具体是用导联线还是手机电极采集心电图信号可手机设定。具体操作见上述方式一到方式四。Method 5-Two-lead cable solution for ECG connection port: As shown in Figure 4, the ECG lead connection port can be connected to 2 lead wires, which correspond to the phone body and bottom electrode respectively. The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set by mobile phones. For specific operations, see Mode 1 to Mode 4 above.
方式六-心电图连接端口三导联线方案：如图5所示，心电图导联连接端口可接3条导联线，这3条导联线分别为右上肢导联（对应手机机身电极）、左上肢导联、左下肢导联。手机底部电极没有对应的导联线。具体是用导联线还是手机电极采集心电图信号可手机设定。具体操作可采用可握住手机采集心电图；也可以将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后握住手机用手机底部电极分别在胸导联检测点，用这种方法就可以采集标准导联心电图，而不是经过计算、推导的标准导联心电图。用这种方法仅仅需要3条导联线就可以采集标准导联心电图，强烈推荐应用。其余具体操作见上述方式一到方式四。Method 6-ECG connection port three-lead wire solution: As shown in Figure 5, the ECG lead connection port can be connected to 3 lead wires, which are the leads of the right upper limb (corresponding to the electrodes of the phone body) , Left upper limb lead, left lower limb lead. There is no corresponding lead wire for the bottom electrode of the phone. The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set by mobile phones. The specific operation can be performed by holding the mobile phone to collect the ECG; you can also connect the 3 lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of the clavicle on both sides, and the left anterior axillary line to the lower rib and iliac At the midpoint of the upper edge of the bone, then hold the mobile phone and use the bottom electrodes of the mobile phone to test points in the chest leads. In this way, standard lead ECGs can be collected instead of calculated and deduced standard lead ECGs. With this method, only 3 leads are needed to collect standard lead ECG, which is highly recommended. For the rest of the specific operations, see the above method one to the four.
方式七-心电图连接端口多导联线方案：如图5所示，心电图导联连接端口可接多条导联线，这些导联线分别为相应肢导联和胸导联（图示为9个导联线，实际应用依据不同型号、功能设定不同导联线数量）。具体是用导联线还是手机电极采集心电图信号可手机设定。具体操作可采用可握住手机采集心电图；也可以将肢导导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，胸导连接在相应胸导联检测点。这个其实就是相当于普通心电图或者普通动态心电图。但可能会存在成本高、导联线多、机身比较庞大、耗电量大、操作复杂等问题。其具体操作见上述方式一到方式四。Method 7-ECG connection port multi-lead wire solution: As shown in Figure 5, the ECG lead connection port can be connected to multiple lead wires, which are the corresponding limb leads and chest leads (9 A lead wire, the actual application is based on different models and functions to set the number of different lead wires). The specific use of lead wires or mobile phone electrodes to collect ECG signals can be set by mobile phones. For specific operations, you can use a mobile phone to collect ECG; you can also connect the limb lead wires to the corresponding limbs or below the outer 1/3 of the clavicle on both sides, and the left anterior axillary line at the midpoint of the lower rib and upper edge of the ilium. The chest lead is connected to the corresponding chest lead detection point. This is actually equivalent to an ordinary electrocardiogram or an ordinary dynamic electrocardiogram. However, there may be problems such as high cost, multiple lead wires, relatively large body, high power consumption, and complicated operation. For the specific operation, see the above method one to the four method.
本发明不限定于上述特定的实施方案，而是扩展至所附的权利要求书的范围内的多种改型。本领域的技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的精神和范围，其均应涵盖在本发明的权利要求范围当中。 The present invention is not limited to the above-mentioned specific embodiments, but extends to various modifications within the scope of the appended claims. Those skilled in the art should understand that modifications or equivalent replacements can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, which should be covered by the scope of the claims of the present invention. To
目前市场上可穿戴/移动心电设备产品众多，比如智能手表类的Apple Watch Series4、巴顿N58智能手表、翰林智能手表等等，心电图智能手环的AMAZFIT米动健康手环、欧瑞特智能手环、dido 智能运动手环、jsk智能手环等等，单导贴片式有心书科技、泰控心仪、胡桃心贴、好朋友EL-191心电仪、掌上心电等等众多类似产品，这些产品均具有心电图功能，并且均具有体积小巧的特点，所以目前可穿戴/移动心电设备产品成熟，制作工艺没有问题。以目前的工艺将心电图模块集成到手机是一件非常容易的事。目前可行多导联心电图检查和心电监测、远程心电监护的手机仍处于空白，同时临床上对随时随地行多导联心电图检查和心电监测、远程心电监护有很大的需求，所以具有很好的应用前景。At present, there are many wearable/mobile ECG equipment products on the market, such as the Apple Watch Series4 of smart watches, Barton N58 smart watches, Hanlin smart watches, etc., the AMAZFIT meter health bracelet of ECG smart bracelets, and the Oruite smart hand Ring, dido smart sports bracelet, jsk smart bracelet, etc., single-guide patch type heart book technology, Thai control favorite, walnut heart sticker, good friend EL-191 electrocardiograph, palm card and many other similar products, These products all have ECG function, and all have the characteristics of small size, so the current wearable/mobile ECG products are mature, and there is no problem with the manufacturing process. It is very easy to integrate the ECG module into the mobile phone with the current technology. At present, the mobile phones that can perform multi-lead ECG examination, ECG monitoring, and remote ECG monitoring are still blank. At the same time, there is a great demand for multi-lead ECG examination, ECG monitoring, and remote ECG monitoring anytime and anywhere in the clinic. It has good application prospects.
| Application Number | Priority Date | Filing Date | Title |
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| CN201910241594.8ACN109893122A (en) | 2019-03-28 | 2019-03-28 | The mobile phone of feasible multi-lead ECG examination and cardioelectric monitor |
| CN201910241594.8 | 2019-03-28 |
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| WO2020192008A1true WO2020192008A1 (en) | 2020-10-01 |
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| PCT/CN2019/102919CeasedWO2020192008A1 (en) | 2019-03-28 | 2019-08-28 | Mobile phone capable of realizing multi-lead electrocardiogram examination and electrocardiogram monitoring |
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