技术领域technical field
本发明涉及植入式动态心电监测仪技术领域，具体涉及动态调整电极配置的植入式动态心电监测仪。The invention relates to the technical field of implantable dynamic electrocardiogram monitors, in particular to implantable dynamic electrocardiogram monitors for dynamically adjusting electrode configurations.
背景技术Background technique
普通的植入式动态心电监测仪，如Medtronic Reveal LINQ等产品，均为两个电极，不具有根据医疗监护需求进行患者个性化调整的功能。Ordinary implantable dynamic ECG monitors, such as Medtronic Reveal LINQ and other products, have two electrodes and do not have the function of individualized adjustment of patients according to medical monitoring needs.
美国专利(US 2014/0257072 A1)中，提出了一种三电极的皮下心电信号监护装置，具有两个机械臂，三个电机分布在两个臂上，其中一臂一个电极、另一臂两个电极。在植入皮下前，两个机械臂合并，植入皮下后，利用枢状结构打开，两臂通过细绳连接保持角度。构成两个垂直的心电导联。虽然该专利采用了3个电极的结构，但是电极组成的导联为固定导联，在植入后不能根据医疗监护需求进行患者个性化的动态调整。In the U.S. patent (US 2014/0257072 A1), a three-electrode subcutaneous ECG signal monitoring device is proposed, which has two mechanical arms, and three motors are distributed on the two arms, one arm has one electrode, and the other arm two electrodes. Before subcutaneous implantation, the two robotic arms are merged. After subcutaneous implantation, they are opened using a pivot structure, and the two arms are connected by strings to maintain the angle. Form two vertical ECG leads. Although the patent uses a structure of 3 electrodes, the lead composed of electrodes is a fixed lead, which cannot be adjusted dynamically according to the patient's individualized medical monitoring needs after implantation.
美国专利(US 7212849 B2)中，提出了一种心电起搏器上的皮下电极阵列，四个电极位于植入肩窝中的植入式心电起搏器的窄边侧面，可以编程改变四个电极的开启和关闭，检测心脏信号。该专利的电极排布选择只有4个固定模式，可以根据医疗需求进行设置。但在植入患者皮下之后，不具有动态调整的功能。In the U.S. Patent (US 7212849 B2), a subcutaneous electrode array on a cardiac pacemaker is proposed. The opening and closing of each electrode detects the heart signal. The patented electrode layout selection has only 4 fixed modes, which can be set according to medical needs. However, it does not have the function of dynamic adjustment after being implanted subcutaneously in the patient.
发明内容Contents of the invention
为了克服上述现有技术的缺点，本发明的目的在于提供动态调整电极配置的植入式动态心电监测仪，具有动态调整的功能。In order to overcome the above-mentioned shortcomings of the prior art, the purpose of the present invention is to provide an implantable dynamic electrocardiogram monitor that dynamically adjusts electrode configuration, and has the function of dynamic adjustment.
为了达到上述目的，本发明采取的技术方案为：In order to achieve the above object, the technical scheme that the present invention takes is:
动态调整电极配置的植入式动态心电监测仪，包括外壳2,外壳2上排布有多个电极1，外壳2内部封装有电路板3以及电池4，电极1和电路板3连接实现心电信号的获取，电池4和电路板3连接进行供电；The implantable dynamic ECG monitor that dynamically adjusts the electrode configuration includes a housing 2, on which a plurality of electrodes 1 are arranged, and a circuit board 3 and a battery 4 are packaged inside the housing 2, and the electrodes 1 and the circuit board 3 are connected to realize cardiopulmonary monitoring. Acquisition of electrical signals, battery 4 and circuit board 3 are connected for power supply;
所述的电极1能够组成多个心电导联，心电导联由两个不同位置的电极1组成双极导联，测量两个电极1之间的电位差即双极导联心电信号，或由单个电极1和中心电端组成单极导联，测量电极所在部位心脏电位变化即单导联心电信号；采用单极导联时，还需要有两个或两个以上的电极1获得中心电端，中心电端由两个或多个参考电极通过电路板上的电路模块获得；The electrode 1 can form a plurality of ECG leads, and the ECG lead is composed of two electrodes 1 in different positions to form a bipolar lead, and the potential difference between the two electrodes 1 is measured, that is, the bipolar lead ECG signal, or A unipolar lead is composed of a single electrode 1 and a central electrical terminal, and the change of the cardiac potential at the location of the electrode is measured, that is, the single-lead ECG signal; when a unipolar lead is used, two or more electrodes 1 are required to obtain the center The electric terminal, the central electric terminal is obtained by two or more reference electrodes through the circuit module on the circuit board;
所述的电路板3的前端采集电路采用多通道设计，每个通道有对应的模拟工频滤波器、低噪声低功耗高增益放大器、增益可调放大器、阻抗提升回路、共模噪声抑制、抗混叠滤波器、低功耗高精度的模数转换器；其中，每个采集通道上的模数转换器是一个独立的模数转换器，或是一个与其他通道共用的模数转换器，或是一个多通道模数转换器中的一个通道，即前端采集电路为含有多个独立配置的单通道模数转换器，每个采集通道使用一个单通道模数转换器，各个采集通道之间是独立的，能够独立的设置滤波、增益、采样率参数；或只含有一个单通道的模数转换器，每个通道通过时分复用共用同一个模数转换器，各个采集通道能够设置独立的滤波、增益，但采样率为统一设置；或含有一个或多个多通道模数转换器，每个采集通道使用多通道模数转换器中的一个通道进行模数转换，各个采集通道能够设置独立的滤波、增益，但采样率为统一设置。The front-end acquisition circuit of the circuit board 3 adopts a multi-channel design, and each channel has a corresponding analog power frequency filter, a low-noise low-power high-gain amplifier, an adjustable gain amplifier, an impedance boosting loop, common-mode noise suppression, Anti-aliasing filter, low-power high-precision analog-to-digital converter; where the ADC on each acquisition channel is an independent ADC or an analog-to-digital converter shared with other channels , or a channel in a multi-channel analog-to-digital converter, that is, the front-end acquisition circuit is a single-channel analog-to-digital converter with multiple independent configurations, and each acquisition channel uses a single-channel analog-to-digital converter. The intervals are independent, and the filtering, gain, and sampling rate parameters can be set independently; or there is only one single-channel analog-to-digital converter, and each channel shares the same analog-to-digital converter through time-division multiplexing, and each acquisition channel can be set independently filter, gain, but the sampling rate is uniformly set; or contains one or more multi-channel analog-to-digital converters, each acquisition channel uses one of the multi-channel analog-to-digital converters for analog-to-digital conversion, and each acquisition channel can be set Independent filtering and gain, but the sampling rate is set uniformly.
所述的电极1和外壳2间做绝缘处理。The electrode 1 and the shell 2 are insulated.
所述的电极1在形状、大小、面积、薄厚、材料和镀膜上一致。The electrodes 1 are consistent in shape, size, area, thickness, material and coating.
所述的电极1和电路板3之间通过导电性良好的连线连接，连接线使用柔性材料以弯折减小体积，或做成硬质材料通过分布减小体积。The electrode 1 and the circuit board 3 are connected by a connection wire with good conductivity, and the connection wire is made of a flexible material to reduce the volume by bending, or made of a hard material to reduce the volume by distribution.
所述的电池4采用低漏电电流、高能量密度的电池。The battery 4 is a battery with low leakage current and high energy density.
所述的电路板3选择PCB板或柔性材料制作，电路板3做成一个，或多个拼接或叠放，便于优化分布减小体积和减小电路噪声。The circuit board 3 is made of a PCB board or flexible material, and one or more circuit boards 3 are spliced or stacked to facilitate optimal distribution, reduce volume and reduce circuit noise.
所述的外壳2采用生物兼容性良好的钛材料或其他具有生物兼容性的材料。The shell 2 is made of titanium material with good biocompatibility or other materials with biocompatibility.
所述的电极1采用生物兼容性良好、导电性良好的钛材料或钛合金，或Ti材料上溅射一层TiN薄膜的结构。The electrode 1 is made of titanium material or titanium alloy with good biocompatibility and good conductivity, or a TiN film sputtered on the Ti material.
动态调整电极配置的植入式动态心电监测仪的调整方法，包括以下步骤：The adjustment method of the implantable dynamic electrocardiogram monitor which dynamically adjusts electrode configuration comprises the following steps:
1)调整参数预设：记录、生成患者个性化的心电模板，设定动态调整时间间隔和参考特征，包括形态、振幅、持续时间、频谱、特殊波形及出现时间、心电轴偏移的特征；1) Adjust parameter presets: record and generate personalized ECG templates for patients, set dynamic adjustment time intervals and reference features, including shape, amplitude, duration, frequency spectrum, special waveforms and time of occurrence, and ECG axis offset feature;
所述的心电模板从特殊波形库中选择一个心电波形模板，或人工生成一个新的心电波形模板；The ECG template selects an ECG waveform template from a special waveform library, or artificially generates a new ECG waveform template;
所述的动态调整时间间隔是两次动态调整电极配置之间的时间间隔；The dynamic adjustment time interval is the time interval between two dynamic adjustment electrode configurations;
参考特征当选择为振幅、持续时间、频谱、心电轴偏移特征时，直接通过采集到的心电数据进行计算获得参考特征；在选择形态、特殊波形及出现时间等特征时，需要使用心电模板，比较采集数据与心电模板的差异，通过计算最大值、均方差、线性相关和小波分解系数的间接特征，通过间接特征进行代数运算，间接获得参考特征；When the reference features are selected as amplitude, duration, frequency spectrum, and ECG axis offset features, the reference features can be obtained by directly calculating the collected ECG data; when selecting features such as shape, special waveform, and appearance time, it is necessary to use Electric template, compare the difference between the collected data and the ECG template, and obtain the reference feature indirectly by calculating the indirect features of the maximum value, mean square error, linear correlation and wavelet decomposition coefficient, and performing algebraic operations through the indirect features;
2)电极配置的初始设定：包括设置电极配置模式、备选导联列表和备选导联个数，2) The initial setting of the electrode configuration: including setting the electrode configuration mode, the list of candidate leads and the number of candidate leads,
电极配置模式有最大导联模式、多导联模式、单导联模式三种，使用植入式动态心电监测仪配套的程控仪通过无线方式配置；在复杂的、不明原因的心脏疾病患者使用中，在植入时将电极配置初始设定为最大导联模式；当只需要记录病患的几个特定导联心电图时，将电极配置初始设定为多导联模式，并选择所需记录的导联；当只需记录单一导联时，选择单导联模式，并选择所需记录的导联；There are three electrode configuration modes: maximum lead mode, multi-lead mode, and single-lead mode. It is configured wirelessly by using the program controller matched with the implantable dynamic ECG monitor; it is used in patients with complicated and unknown heart diseases. In , the electrode configuration is initially set to the maximum lead mode at the time of implantation; when only a few specific leads of the patient need to be recorded, the electrode configuration is initially set to the multi-lead mode, and the required recording is selected. lead; when only a single lead needs to be recorded, select the single lead mode and select the lead to be recorded;
备选导联列表是动态调整电极配置时调整导联选取的优先级，动态调整电极配置时，会根据初始设定的备选导联列表中的顺序进行选择；默认的备选导联列表是根据电极位置排列设置的：越靠近初始设定的导联，在备选导联列表中优先级越高；备选导联列表称为表，但在数据结构上不限于线性表，是表、树或有向图；在数据结构以表的形式记录时，优先级通过表存储时的先后顺序确定；在数据结构以树的形式记录时，优先级通过树的遍历方式确定；在数据结构以有向图形式记录时，优先级通过有向图的指向确定；The candidate lead list is to adjust the priority of lead selection when dynamically adjusting the electrode configuration. When dynamically adjusting the electrode configuration, it will be selected according to the order in the initially set candidate lead list; the default candidate lead list is Arranged according to electrode position: the closer to the initially set lead, the higher the priority in the candidate lead list; the candidate lead list is called a table, but the data structure is not limited to a linear table, it is a table, tree or directed graph; when the data structure is recorded in the form of a table, the priority is determined by the order in which the table is stored; when the data structure is recorded in the form of a tree, the priority is determined by traversing the tree; When recording in the form of a directed graph, the priority is determined by the direction of the directed graph;
备选导联个数N是每次进行动态调整时，同时从备选导联列表中选取的参与比较的备选导联的数目；The number N of candidate leads is the number of candidate leads selected from the list of candidate leads to participate in the comparison at the same time when dynamic adjustment is performed each time;
3)记录心电波形：3) Record ECG waveform:
植入式动态心电监测仪根据电极配置的初始设定，连续记录患者皮下心电波形，同时计时；经过一个动态调整时间间隔，进入步骤4)，The implantable Holter monitor continuously records the patient's subcutaneous ECG waveform according to the initial setting of the electrode configuration, and timing at the same time; after a dynamic adjustment time interval, enter step 4),
4)检测一次电池电量和数据存储容量：4) Detect primary battery power and data storage capacity:
当电池电量过低时，会在电池电量状态寄存器中记录一个电量过低标识符；当数据存储容量不够时，会在数据存储容量寄存器中记录一个存储容量过低标识符；When the battery power is too low, a low battery identifier will be recorded in the battery power status register; when the data storage capacity is not enough, a low storage capacity identifier will be recorded in the data storage capacity register;
检测电池电量和数据存储容量后，需要根据电池电量和数据存储容量检测结果进行跳转，分为以下几种情况：After detecting the battery power and data storage capacity, you need to jump according to the battery power and data storage capacity detection results, which are divided into the following situations:
i.当电池电量和数据容量都充足时，进入步骤5)；i. When the battery power and data capacity are sufficient, enter step 5);
ii.当发现电池电量过低，且处于最大导联模式或多导联模式时，调整导联设置；此时自动调整导联模式，进入单导联模式，关闭其他导联的记录功能；如果初始设定时设置了优先级，则保留导联中优先级最高的，如果未设置优先级，则保留动态调整特征值最大的导联；ii. When it is found that the battery power is too low and it is in the maximum lead mode or multi-lead mode, adjust the lead setting; at this time, automatically adjust the lead mode, enter the single-lead mode, and turn off the recording function of other leads; if If the priority is set during the initial setting, the lead with the highest priority among the leads will be reserved; if the priority is not set, the lead with the largest dynamically adjusted characteristic value will be reserved;
在处于单导联模式或调整导联模式进入单导联模式时，同时停止动态调整电极配置的功能，跳过步骤5)，进入步骤6)；When in the single-lead mode or adjust the lead mode to enter the single-lead mode, stop the function of dynamically adjusting the electrode configuration at the same time, skip step 5), and enter step 6);
iii.当发现数据存储容量过低而电池电量充足时，且处于对于工作在最大导联模式和多导联模式时，仍然保留当前导联设置，仅减小数据记录的数据量，即只记录发生数据异常的对应导联数据，进入步骤5)；iii. When it is found that the data storage capacity is too low and the battery power is sufficient, and it is working in the maximum lead mode and multi-lead mode, the current lead setting is still retained, and only the data volume of data recording is reduced, that is, only recording For the lead data corresponding to abnormal data, go to step 5);
5)电极动态调整：电极动态调整过程分为以下步骤：5) Electrode dynamic adjustment: The process of electrode dynamic adjustment is divided into the following steps:
a.当连续记录时间达到动态调整的时间间隔后，从当前导联的备选导联列表中，根据备选导联个数N，选取优先级最高的N个导联，作为备选最优导联；a. When the continuous recording time reaches the dynamically adjusted time interval, select the N leads with the highest priority from the candidate lead list of the current lead according to the number N of candidate leads as the best candidate leads;
b.开启这N个备选最优导联对应的采集通路并获取一段时间的心电波形，分别计算对应的参考特征计算值；b. Open the acquisition channels corresponding to the N alternative optimal leads and acquire ECG waveforms for a period of time, and calculate corresponding reference characteristic calculation values;
c.参考特征计算值和参考特征阈值相比较：如果有参考特征计算结果超过参考特征阈值，则进入下一步d；如果当前导联和备选最优导联所计算出的参考特征计算值都小于设定的参考特征阈值，则先按照当前导联进行心电波形异常分析，同时，重新从备选导联列表中选取优先级仅次于当前备选最优导联的N个导联，作为新的备选最优导联，重复记录心电波形、计算参考特征、比较参考特征阈值这个步骤，直到有导联的参考特征计算结果超过参考特征阈值；c. Compare the reference feature calculation value with the reference feature threshold: if any reference feature calculation result exceeds the reference feature threshold, go to the next step d; if the reference feature calculation values calculated by the current lead and the alternative optimal lead are both If it is less than the set reference feature threshold, the ECG waveform abnormality analysis will be performed according to the current lead first, and at the same time, N leads whose priority is second only to the current best candidate lead are re-selected from the candidate lead list. As a new candidate optimal lead, repeat the steps of recording the ECG waveform, calculating the reference feature, and comparing the reference feature threshold until the calculation result of the reference feature of a lead exceeds the reference feature threshold;
d.在参考特征计算结果超过参考特征阈值的导联中，选择参考特征计算值最大的导联，作为新的最优导联，替代当前导联；d. Among the leads whose reference feature calculation results exceed the reference feature threshold, select the lead with the largest reference feature calculation value as the new optimal lead to replace the current lead;
e.记录动态调整后的导联，以及调整时的时间戳；e. Record the dynamically adjusted leads and the time stamp when adjusted;
f.计时器清零，重新开始计时；f. The timer is cleared and restarted;
6)继续记录心电波形：植入式动态心电监测仪根据电极动态调整后的配置，连续记录患者皮下心电波形，同时计时；经过一个动态调整时间间隔，重新进入步骤4)；6) Continue to record the ECG waveform: the implantable Holter monitor continuously records the subcutaneous ECG waveform of the patient according to the configuration after the dynamic adjustment of the electrodes, and timing at the same time; after a dynamic adjustment time interval, re-enter step 4);
7)人工修改：只有在使用程控仪对植入式动态心电监测仪编程，选择人工修改功能时,通过中断，进入步骤7)，其他情况都不会进入；在人工修改结束后，重新进入步骤3)，继续动态调整。7) Manual modification: Only when the program controller is used to program the implantable Holter monitor and the manual modification function is selected, enter step 7) through interruption, and will not enter in other cases; after the manual modification is completed, re-enter Step 3), continue to dynamically adjust.
本发明的有益效果为：The beneficial effects of the present invention are:
本发明植入式动态心电监测仪及调整方法具有患者个性化和可动态配置两个特征，获得的心电信号更准确、更有效、更高质量，从而更好的辅助医疗诊断。The implantable dynamic electrocardiogram monitor and the adjustment method of the present invention have two characteristics of individualization of patients and dynamic configuration, and the obtained electrocardiogram signals are more accurate, more effective, and of higher quality, thereby better assisting medical diagnosis.
通过设置心电模板和参考特征，定义出对医疗诊断有帮助的特殊波形和特定波形特征。该特殊波形和特定波形特征可以对不同症状的患者进行个性化设置，可以针对特定患者的偶发性症状做个性化调整，从而更准确的获得对诊断有帮助的心电波形。By setting ECG templates and reference features, special waveforms and specific waveform features that are helpful for medical diagnosis are defined. The special waveform and specific waveform features can be personalized for patients with different symptoms, and personalized adjustments can be made for the occasional symptoms of specific patients, so as to obtain more accurate ECG waveforms that are helpful for diagnosis.
电极可动态配置的方法，使得在植入手术后还可以自动的、定时的对导联进行优化。通过自动、定时配置最优导联，能够从全部可能的导联中获得信号质量最高的心电波形。同时，动态配置方法，还可以修正由于植入位置偏移带来的人工伪差，确保记录信号的有效性。The electrode can be dynamically configured, so that the lead can be automatically and regularly optimized after the implantation operation. By automatically and regularly configuring the optimal lead, the ECG waveform with the highest signal quality can be obtained from all possible leads. At the same time, the dynamic configuration method can also correct the artificial artifacts caused by the offset of the implant position to ensure the validity of the recorded signal.
附图说明Description of drawings
图1为本发明的结构示意图。Fig. 1 is a structural schematic diagram of the present invention.
图2为本发明的外壳和电极分布示意图。Fig. 2 is a schematic diagram of the casing and electrode distribution of the present invention.
图3为本发明电路结构示意图。Fig. 3 is a schematic diagram of the circuit structure of the present invention.
图4为本发明调整方法的流程图。Fig. 4 is a flow chart of the adjustment method of the present invention.
图5为动态电极配置流程图。Figure 5 is a flow chart of dynamic electrode configuration.
图6为电极自动分配优先级列表示意图。Fig. 6 is a schematic diagram of a priority list for automatic assignment of electrodes.
图7为使用本发明获得的心电波形示例。Fig. 7 is an example of an electrocardiographic waveform obtained by using the present invention.
具体实施方式detailed description
下面结合附图和实施例对本发明作详细描述。The present invention will be described in detail below in conjunction with the accompanying drawings and embodiments.
参照图1和图2，动态调整电极配置的植入式动态心电监测仪，包括：外壳2、电极1、电路板3，电池4。Referring to FIG. 1 and FIG. 2 , the implantable Holter monitor for dynamically adjusting electrode configurations includes: a housing 2 , electrodes 1 , a circuit board 3 , and a battery 4 .
多个电极1排布在外壳2上，外壳2内部封装有电路板3和电池4。电路板3上分布若干芯片、天线和电阻、电容、电感等其他元器件和连线，元器件之间通过电气连接组成一个完整的电子系统。电极1通过导线连接电路板3，实现心电信号的获取。电池4通过导线连接到电路板3上，进行供电。A plurality of electrodes 1 are arranged on a casing 2 , and a circuit board 3 and a battery 4 are packaged inside the casing 2 . A number of chips, antennas, resistors, capacitors, inductors and other components and connections are distributed on the circuit board 3, and the components are electrically connected to form a complete electronic system. The electrodes 1 are connected to the circuit board 3 through wires to realize the acquisition of electrocardiographic signals. The battery 4 is connected to the circuit board 3 through wires to supply power.
其中，外壳2由两个平行放置的对称面，和连接两个对称面边缘的侧壁组成。对称面可做成长方形，还可做成椭圆形或圆形或者弧形，对称面上排布有多个电极。侧壁平滑连接两个对称面。外壳整体为对称面相对大、侧壁相对小的薄型立体结构，以便于植入皮肤下。外壳每个面之间形成有弧度的平滑过渡，还具备固定在皮下所需的孔或其他结构。Wherein, the housing 2 is composed of two parallel symmetrical planes and a side wall connecting the edges of the two symmetrical planes. The symmetrical surface can be made into a rectangle, and can also be made into an ellipse, a circle or an arc, and a plurality of electrodes are arranged on the symmetrical surface. The side walls smoothly connect the two symmetry planes. The shell as a whole is a thin three-dimensional structure with a relatively large symmetrical plane and relatively small side walls, so as to facilitate implantation under the skin. Each face of the shell forms a smooth transition with a curvature, and also has holes or other structures required for fixation under the skin.
所述的电池4采用低漏电电流、高能量密度的电池，如LiCFx电池、LiCFx-SVO、LiMnO2电池等，电池4形状根据植入式动态心电监测仪内的空间定制，最大程度的增加电池体积、获得更大的电池容量。The battery 4 is a battery with low leakage current and high energy density, such as LiCFx battery, LiCFx-SVO, LiMnO2 battery, etc. The shape of the battery 4 is customized according to the space in the implantable Holter monitor, so as to increase the battery capacity to the greatest extent. volume, to obtain a larger battery capacity.
所述的电路板3选择PCB板或柔性材料制作，电路板3做成一个，或多个拼接或叠放，便于优化分布减小体积和减小电路噪声，比如包裹住电池或弯折成几小片；电路中的各个模块可以分布在不同电路板上，比如收发机与采集通路分布于不同电路板上，以减小收发机对采集通路的噪声干扰。The circuit board 3 is made of a PCB board or a flexible material, and the circuit board 3 is made into one, or multiple splicing or stacking, which is convenient for optimizing the distribution, reducing the volume and reducing the circuit noise, such as wrapping the battery or bending it into several Small pieces; each module in the circuit can be distributed on different circuit boards, for example, the transceiver and the acquisition channel are distributed on different circuit boards, so as to reduce the noise interference of the transceiver on the acquisition channel.
所述的外壳2采用生物兼容性良好的钛材料或其他具有生物兼容性的材料,如ABS等。当外壳2采用金属材料时，外壳2和电极1、电极1到电路板3之间的连接需要做绝缘处理，外壳2上还需再覆盖一层生物兼容性好的绝缘材料薄膜，以达到绝缘和生物兼容性的目的；当外壳2采用ABS等不导电材料时，外壳2无需做特殊的绝缘处理。The shell 2 is made of titanium material with good biocompatibility or other materials with biocompatibility, such as ABS and the like. When the shell 2 is made of metal material, the connection between the shell 2 and the electrode 1, and the connection between the electrode 1 and the circuit board 3 needs to be insulated, and the shell 2 needs to be covered with a layer of insulating material film with good biocompatibility to achieve insulation and biological compatibility; when the shell 2 is made of non-conductive materials such as ABS, the shell 2 does not need to be specially insulated.
所述的电极1采用生物兼容性良好、导电性良好的钛材料或钛合金(如TiN等)，或Ti材料上溅射一层TiN薄膜等结构；每两对电极1组成一个电极对(可能是采集电极对，用于采集心电信号，也可能是参考电极对，用于获得参考信号)；电极对中的两个电极1间的差异会引入噪声干扰，影响采集到的心电信号质量；植入式动态心电监测仪采集到的心电信号在微伏到百微伏左右，因此电极对间差异引入的噪声会远超过信号幅度；因此电极1在形状、大小、面积、薄厚、材料和镀膜(如制作Ti-TiN电极)分布上都需要有良好的一致性；另一方面，电极1、电极1到电路板3(采集通路)的连接线及其他结构的导电性也会严重影响采集到的心电信号质量，人体相当于信号源，电极1、电极1到电路板3(采集通路)的连接和人体自身阻抗一起等效于信号源内阻，而电路的等效输入阻抗相当于负载；信号源内阻越大，实际采集到的信号幅度越小。因此除差分电极的匹配外，减小电极1、电极1到电路板3(采集通路)的连接的阻抗非常重要。The electrode 1 adopts a titanium material or titanium alloy (such as TiN, etc.) with good biocompatibility and good conductivity, or a structure such as a layer of TiN film sputtered on the Ti material; every two pairs of electrodes 1 form an electrode pair (possibly It is an acquisition electrode pair, used to collect ECG signals, and may also be a reference electrode pair, used to obtain reference signals); the difference between the two electrodes 1 in the electrode pair will introduce noise interference and affect the quality of the collected ECG signals ; The ECG signal collected by the implantable dynamic ECG monitor is about microvolts to hundreds of microvolts, so the noise introduced by the difference between the electrode pairs will far exceed the signal amplitude; The distribution of materials and coatings (such as making Ti-TiN electrodes) needs to have good consistency; on the other hand, the conductivity of electrode 1, the connection line from electrode 1 to circuit board 3 (collection path) and other structures will also be serious. Affects the quality of the collected ECG signal. The human body is equivalent to the signal source. The connection between electrode 1 and electrode 1 to the circuit board 3 (acquisition path) and the impedance of the human body are equivalent to the internal resistance of the signal source, and the equivalent input impedance of the circuit is equivalent to The load; the greater the internal resistance of the signal source, the smaller the actual collected signal amplitude. Therefore, in addition to the matching of the differential electrodes, it is very important to reduce the impedance of the electrode 1 and the connection between the electrode 1 and the circuit board 3 (acquisition path).
所述的外壳2上分布多个电极1。电极1和外壳2间做绝缘处理。多个电极1在形状、大小、面积、薄厚、材料和镀膜上都有良好的一致性。电极1和电路板3之间通过导电性良好的连线连接，连接线使用柔性材料以弯折减小体积，或做成硬质材料通过合理分布减小体积。A plurality of electrodes 1 are distributed on the shell 2 . The electrode 1 and the shell 2 are insulated. The plurality of electrodes 1 have good consistency in shape, size, area, thickness, material and coating. The electrode 1 and the circuit board 3 are connected by a connection wire with good conductivity, and the connection wire is made of a flexible material to reduce the volume by bending, or made of a hard material to reduce the volume by reasonable distribution.
所述的外壳2上的电极1分布在一个对称面上，或两个对称面都分布电极1；其中一个面上的电极1作为采集电极，用于采集心电信号，另一个面上的电极1作为参考电极，用做噪声处理，或者组成电极对记录辅助波形(如肌电等)，帮助诊断。The electrodes 1 on the shell 2 are distributed on a symmetrical plane, or the electrodes 1 are distributed on both symmetrical planes; the electrodes 1 on one of the planes are used as collection electrodes for collecting ECG signals, and the electrodes on the other plane are used as collecting electrodes. 1 As a reference electrode, used for noise processing, or composed of electrode pairs to record auxiliary waveforms (such as myoelectricity, etc.), to help diagnosis.
参照图3，所述的电路板3上分布若干芯片、天线和电阻、电容、电感其他元器件和连线，元器件之间通过电气连接组成一个完整的电子系统；电路板3可以选择普通PCB板，也可以选择柔性材料制作，电路板3可做成一个，也可有多个拼接或叠放，便于优化分布减小体积和减小电路噪声，比如包裹住电池或弯折成几小片。电路板3中的各个模块可以分布在不同电路板上，比如收发机与采集通路分布于不同电路板上，以减小收发机对采集通路的噪声干扰。Referring to Fig. 3, several chips, antennas, resistors, capacitors, inductors and other components and connections are distributed on the circuit board 3, and a complete electronic system is formed by electrical connection between the components; the circuit board 3 can be selected from ordinary PCB The board can also be made of flexible materials. The circuit board 3 can be made into one, or multiple splicing or stacking, so as to optimize the distribution, reduce the volume and reduce the circuit noise, such as wrapping the battery or bending it into several small pieces. Each module in the circuit board 3 can be distributed on different circuit boards, for example, the transceiver and the acquisition channel are distributed on different circuit boards, so as to reduce the noise interference of the transceiver on the acquisition channel.
所述的电路结构包括：前端采集电路、数字滤波器、专用心电信号处理电路、控制单元、收发机、电源管理电路、时钟电路、总线、启动电路、参考电路、存储器、电阻、电容等元器件。The circuit structure includes: front-end acquisition circuit, digital filter, dedicated ECG signal processing circuit, control unit, transceiver, power management circuit, clock circuit, bus, start-up circuit, reference circuit, memory, resistors, capacitors and other elements device.
所述的前端采集电路，包括模拟工频滤波器、斩波调制器和解调器、低噪声低功耗高增益放大器、增益可调放大器、抗混叠滤波器、低功耗高精度的模数转换器。低噪声低功耗高增益放大器还包括阻抗提升回路、共模噪声抑制回路、直流伺服回路等，以实现提高输入阻抗、减小共模噪声、消除基线漂移等作用。The front-end acquisition circuit includes an analog power frequency filter, a chopper modulator and a demodulator, a low-noise, low-power high-gain amplifier, an adjustable gain amplifier, an anti-aliasing filter, and a low-power high-precision analog number converter. Low-noise, low-power, high-gain amplifiers also include impedance boosting loops, common-mode noise suppression loops, DC servo loops, etc., to increase input impedance, reduce common-mode noise, and eliminate baseline drift.
前置采集电路采用多通道设计，每个通道有对应的模拟工频滤波器、低噪声低功耗高增益放大器、增益可调放大器、阻抗提升回路、共模噪声抑制、抗混叠滤波器、低功耗高精度的模数转换器。其中，每个采集通道上的模数转换器可以是一个独立的模数转换器，也可以是一个与其他通道共用的模数转换器，还可以是一个多通道模数转换器中的一个通道。即，前端采集电路可以含有多个独立配置的单通道模数转换器，每个采集通道使用一个单通道模数转换器，各个采集通道之间是独立的，可以独立的设置滤波、增益、采样率等参数；也可以只含有一个单通道的模数转换器，每个通道通过时分复用共用同一个模数转换器，各个采集通道可以设置独立的滤波、增益，但采样率为统一设置。还可以含有一个或多个多通道模数转换器，每个采集通道使用多通道模数转换器中的一个通道进行模数转换，各个采集通道可以设置独立的滤波、增益，但采样率为统一设置。。电极和每个通道的连接方式、以及通道的开启和关闭由动态调整方法进行控制。The pre-acquisition circuit adopts a multi-channel design, and each channel has a corresponding analog power frequency filter, low-noise, low-power high-gain amplifier, gain-adjustable amplifier, impedance boosting loop, common-mode noise suppression, anti-aliasing filter, Low-power high-precision analog-to-digital converter. Wherein, the analog-to-digital converter on each acquisition channel can be an independent analog-to-digital converter, or an analog-to-digital converter shared with other channels, or a channel in a multi-channel analog-to-digital converter . That is, the front-end acquisition circuit can contain multiple independently configured single-channel analog-to-digital converters, and each acquisition channel uses a single-channel analog-to-digital converter. Each acquisition channel is independent, and the filtering, gain, and sampling can be set independently. Rate and other parameters; it can also only contain a single-channel analog-to-digital converter, and each channel shares the same analog-to-digital converter through time-division multiplexing. Each acquisition channel can be set with independent filtering and gain, but the sampling rate is set uniformly. It can also contain one or more multi-channel analog-to-digital converters. Each acquisition channel uses one channel of the multi-channel analog-to-digital converter for analog-to-digital conversion. Each acquisition channel can be set with independent filtering and gain, but the sampling rate is uniform. set up. . The way the electrodes are connected to each channel, and the opening and closing of the channels is controlled by a dynamic adjustment method.
数字滤波器包括：数字工频陷波器、数字带通滤波器。数字带通滤波器可由低通滤波和高通滤波叠加完成。为了实时处理和低功耗要求，每个数字滤波器使用相应的硬件电路实现。无限脉冲响应滤波器比有限脉冲响应滤波器的阶数低，因此为了减小运算量，即减小运算时间和电路翻转功耗，采用无限脉冲响应滤波器的方法具体实现数字低通、高通、带通滤波器。Digital filters include: digital power frequency notch filter, digital bandpass filter. The digital band-pass filter can be completed by superposition of low-pass filter and high-pass filter. For real-time processing and low power consumption requirements, each digital filter is implemented using corresponding hardware circuits. The infinite impulse response filter has a lower order than the finite impulse response filter. Therefore, in order to reduce the amount of calculation, that is, to reduce the calculation time and power consumption of circuit reversal, the method of infinite impulse response filter is used to specifically realize digital low-pass, high-pass, bandpass filter.
专用心电信号处理电路，包括QRS波提取、R-R间隔计算、QRS波宽度计算、相关性计算、最大值计算、最大方差计算等实时处理电路和程序。Special ECG signal processing circuit, including real-time processing circuits and programs such as QRS wave extraction, R-R interval calculation, QRS wave width calculation, correlation calculation, maximum value calculation, and maximum variance calculation.
控制单元，使用MCU单片机或状态机或微代码控制器实现整体电子系统的控制。The control unit uses MCU single-chip microcomputer or state machine or microcode controller to realize the control of the whole electronic system.
收发机，包括射频收发机和近场收发机，射频收发机用于定时上传数据、在心电异常时发出警报，近场收发机用于和程控仪或手持装置通讯，实现读取、删除存储数据，读取、修改设置参数，读取、复位状态位，标记、保存当前采集数据等功能；收发机还需配备天线。Transceivers, including radio frequency transceivers and near-field transceivers, radio frequency transceivers are used to upload data regularly and send out alarms when the ECG is abnormal, and near-field transceivers are used to communicate with program-controlled instruments or handheld devices to read and delete stored data , read and modify setting parameters, read and reset status bits, mark and save the current collected data and other functions; the transceiver also needs to be equipped with an antenna.
电源管理电路，包括电荷泵、若干受控制单元控制的LDO稳压源，以便于对电路模块分块管理电源，将不处于工作状态中的电路下电，减少漏电功耗。比如收发机中的发射机模块，在不发送数据时关闭对应的LDO稳压源，在发送数据前再开启对应的LDO稳压源，从而消除模块电路上电、但没有动作时的晶体管漏电功耗。The power management circuit includes a charge pump and a number of LDO voltage regulators controlled by the control unit, so as to manage the power supply of the circuit modules in blocks, power off the circuits that are not in the working state, and reduce leakage power consumption. For example, for the transmitter module in the transceiver, turn off the corresponding LDO voltage regulator when not sending data, and then turn on the corresponding LDO voltage regulator before sending data, thereby eliminating the leakage power of the transistor when the module circuit is powered on but not in action. consumption.
时钟包括一个快频率的时钟和一个慢频率的时钟模块，快频率的时钟应用于射频收发机，慢频率的时钟应用于控制单元、数字滤波器、采集电路、电源管理等其他模块。时钟模块由环形振荡器、放大器、晶振、校准电路、分频电路、锁相环等组成。The clock includes a fast-frequency clock and a slow-frequency clock module. The fast-frequency clock is used in RF transceivers, and the slow-frequency clock is used in control units, digital filters, acquisition circuits, power management and other modules. The clock module is composed of ring oscillator, amplifier, crystal oscillator, calibration circuit, frequency division circuit, phase-locked loop and so on.
总线包括数据总线、控制总线、地址总线等，是电路模块之间的连接，实现信息交互。The bus includes data bus, control bus, address bus, etc. It is the connection between circuit modules to realize information exchange.
启动电路包括一个超低电流的传感电路、计数模块和滞回模块，其中超低电流的传感电路在检测到动态调整电极配置的植入式动态心电监测仪离开仓储状态时，输出产生变化，计数模块开始计数，当连续计数超过开启阈值时，启动电路产生启动信号，电子系统中的其他电路模块开始上电工作；当计数中断时，滞回模块将计数器清零，启动电路不发出启动信号，电子系统中的其他电路模块处于下电状态，不工作、不耗电。The start-up circuit includes an ultra-low current sensing circuit, a counting module and a hysteresis module. When the ultra-low current sensing circuit detects that the implantable dynamic ECG monitor that dynamically adjusts the electrode configuration leaves the storage state, the output generates change, the counting module starts counting, when the continuous counting exceeds the threshold, the starting circuit generates a starting signal, and other circuit modules in the electronic system start to work on power; when the counting is interrupted, the hysteresis module clears the counter, and the starting circuit does not send out The start signal means that other circuit modules in the electronic system are in a power-off state, do not work, and do not consume power.
参考电路产生电子系统中使用到的多个参考电压，多个参考电流和心电采集中使用的中心电端。The reference circuit generates a plurality of reference voltages used in the electronic system, a plurality of reference currents and a central terminal used in ECG acquisition.
存储器存储心电数据、时间、导联状态变更等信息。The memory stores information such as ECG data, time, and lead status changes.
参照图4，动态调整电极配置的植入式动态心电监测仪的调整方法流程图，包括以下步骤：Referring to FIG. 4 , a flow chart of an adjustment method for an implantable Holter monitor that dynamically adjusts electrode configurations includes the following steps:
1)调整参数预设：记录、生成患者个性化的心电模板，设定动态调整时间间隔和参考特征，具体包括形态、振幅、持续时间、频谱、特殊波形及出现时间、心电轴偏移等特征；1) Adjust parameter presets: record and generate personalized ECG templates for patients, set dynamic adjustment time intervals and reference features, including shape, amplitude, duration, frequency spectrum, special waveforms and time of occurrence, and ECG axis offset and other features;
其中，心电模板可以从特殊波形库中选择一个心电波形模板，也可以人工生成一个新的心电波形模板；对于有偶发性、不易在记录心电模板时发生的、患者可能患有的、且具有临床诊断意义的心电波形，可以通过程控设置，在已有的特殊波形库中选择对应的心电图波形，如早起复极综合征的典型心电图等，并将其设定为患者的个性化心电模板；对于特殊波形库中没有记录的波形，可以通过程控仪的外接接口，录入数字化的波形文件，将其加入特殊波形库，生成一个新的特殊心电波形模板，然后将新记录的波形设定为心电模板；Among them, the ECG template can select an ECG waveform template from a special waveform library, or manually generate a new ECG waveform template; , and has clinical diagnostic significance, the ECG waveform can be programmed to select the corresponding ECG waveform in the existing special waveform library, such as the typical ECG of early repolarization syndrome, etc., and set it as the patient's personality ECG template; for waveforms that are not recorded in the special waveform library, digital waveform files can be input through the external interface of the program controller, added to the special waveform library to generate a new special ECG waveform template, and then the newly recorded The waveform is set as the ECG template;
动态调整时间间隔是两次动态调整电极配置之间的时间间隔；The dynamic adjustment time interval is the time interval between two dynamic adjustments to the electrode configuration;
参考特征当选择为振幅、持续时间、频谱、心电轴偏移等特征时，可以直接通过采集到的心电数据进行计算获得参考特征；在选择形态、特殊波形及出现时间等特征时，需要使用心电模板，比较采集数据与心电模板的差异，通过计算最大值、均方差、线性相关和小波分解系数等间接特征，通过间接特征进行代数运算，间接获得参考特征；When selecting reference features such as amplitude, duration, frequency spectrum, and ECG axis offset, the reference features can be obtained by directly calculating the collected ECG data; when selecting features such as shape, special waveform, and appearance time, you need to Use the ECG template to compare the difference between the collected data and the ECG template, calculate the indirect features such as the maximum value, mean square error, linear correlation and wavelet decomposition coefficient, and perform algebraic operations on the indirect features to indirectly obtain reference features;
心电模板和参考特征可以描述、分类出特定类别的波形，从而准确识别、记录这一类波形的出现时间、前后一段时间内的心电波形等，帮助医疗诊断；采用心电模板和参考特征，便于面向每个患者做个性化调整；便于医护人员根据患者的症状、医学检查结果、病史等信息，对该患者设定个性化的特定波形筛选机制，从而更准确的获得对诊断有帮助的心电波形；ECG templates and reference features can describe and classify specific types of waveforms, so as to accurately identify and record the occurrence time of this type of waveforms, ECG waveforms before and after a period of time, etc., to help medical diagnosis; use ECG templates and reference features It is convenient for personalized adjustment for each patient; it is convenient for medical staff to set a personalized specific waveform screening mechanism for the patient according to the patient's symptoms, medical examination results, medical history and other information, so as to obtain more accurate and helpful diagnosis. ECG waveform;
2)电极配置的初始设定：包括设置电极配置模式、备选导联列表和备选导联个数；2) The initial setting of the electrode configuration: including setting the electrode configuration mode, the list of candidate leads and the number of candidate leads;
电极配置模式有最大导联模式、多导联模式、单导联模式三种，使用植入式动态心电监测仪配套的程控仪通过无线方式配置，在复杂的、不明原因的心脏疾病患者使用中，在植入时可以将电极配置初始设定为最大导联模式，尽可能多的记录心电导联，为主治医师进行确诊提供尽可能多的导联信号，以便于确诊疾病；当主治医师对病患个体分析后，确认只需要记录病患的几个特定导联心电图，可以将电极配置初始设定为多导联模式，并选择所需记录的导联；在主治医师对病患个体分析认为只需记录单一导联时，可选择单导联模式，并选择所需记录的导联；There are three electrode configuration modes: maximum lead mode, multi-lead mode, and single-lead mode. The implantable dynamic ECG monitor is used to configure the program controller wirelessly. It is used in patients with complex and unknown heart diseases. During implantation, the electrode configuration can be initially set to the maximum lead mode, as many ECG leads as possible can be recorded, and as many lead signals as possible can be provided for the attending physician to make a diagnosis, so as to facilitate the diagnosis of the disease; when the attending physician After analyzing the individual patient and confirming that only a few specific leads of the patient need to be recorded, the electrode configuration can be initially set to multi-lead mode, and the lead to be recorded can be selected; When the analysis considers that only a single lead needs to be recorded, the single lead mode can be selected and the lead to be recorded can be selected;
备选导联列表是动态调整电极配置时调整导联选取的优先级，动态调整电极配置时，会根据初始设定的备选导联列表中的顺序进行选择；默认的备选导联列表是根据电极位置排列设置的：越靠近初始设定的导联，在备选导联列表中优先级越高；备选导联列表称为表，但在数据结构上不限于线性表，可以是表、树或有向图；在数据结构以表的形式记录时，优先级通过表存储时的先后顺序确定；在数据结构以树的形式记录时，优先级通过树的遍历方式确定；在数据结构以有向图形式记录时，优先级通过有向图的指向确定；The candidate lead list is to adjust the priority of lead selection when dynamically adjusting the electrode configuration. When dynamically adjusting the electrode configuration, it will be selected according to the order in the initially set candidate lead list; the default candidate lead list is Arranged according to the electrode position: the closer to the initially set lead, the higher the priority in the candidate lead list; the candidate lead list is called a table, but the data structure is not limited to a linear table, it can be a table , tree or directed graph; when the data structure is recorded in the form of a table, the priority is determined by the order in which the table is stored; when the data structure is recorded in the form of a tree, the priority is determined by the traversal of the tree; in the data structure When recording in the form of a directed graph, the priority is determined by the direction of the directed graph;
备选导联个数N是每次进行动态调整时，同时从备选导联列表中选取的参与比较的备选导联的数目；The number N of candidate leads is the number of candidate leads selected from the list of candidate leads to participate in the comparison at the same time when dynamic adjustment is performed each time;
在一些应用中，需要采集多导联心电图，可以按照最大电极对方式，配置电极和电极的连接方式，打开多个通道，构成所需的多导联，以记录多导联心电图，计算心电轴，完成对心脏电活动特性的多导联记录；例如应用于复杂的、不明原因的心脏疾病中。In some applications, it is necessary to collect multi-lead ECG. You can configure the connection mode of electrodes and electrodes according to the maximum electrode pair mode, open multiple channels, and form the required multi-leads to record multi-lead ECG and calculate ECG. Axis, to complete the multi-lead recording of the electrical activity characteristics of the heart; for example, it is applied to complex and unexplained heart diseases.
在一些应用中，医生对病患个体问诊分析后，只需要记录病患的几个特定导联心电图，可以在植入前或植入时开启多通道，采集多导联心电图，然后根据医生对患者个体情况的分析，通过专用编程仪选取诊断需要的导联和电极对，关闭其他不使用的通道，从而获取诊断、监护患者个体的最优心电图。In some applications, the doctor only needs to record several specific leads of the patient’s ECG after the individual patient’s consultation and analysis. You can turn on the multi-channel before or during the implantation, collect the multi-leads ECG, and then according to the doctor’s To analyze the individual condition of the patient, select the leads and electrode pairs required for diagnosis through a dedicated programmer, and close other unused channels, so as to obtain the optimal electrocardiogram for diagnosis and monitoring of individual patients.
在一些应用中，医生对患者个体情况分析后，对特殊心电波形有检测需求，则可以通过编程仪所需监测的波形特征(比如选择R波幅度最大的通道或者与特殊波形最相似的通道等特征)，以及通道更新频率；在植入式动态心电监测仪记录过程中，自动按照设定的动态调整的时间间隔，采集并计算所需监测的心电波形特征，选择发生对应波形特征的通道进行记录，从而获得诊断、监护患者个体的自动更新最优心电图。In some applications, after the doctor analyzes the individual condition of the patient and needs to detect the special ECG waveform, he can use the waveform characteristics to be monitored by the programmer (such as selecting the channel with the largest R wave amplitude or the channel most similar to the special waveform) and other characteristics), as well as channel update frequency; during the recording process of the implantable dynamic ECG monitor, it automatically collects and calculates the ECG waveform characteristics to be monitored according to the set dynamic adjustment time interval, and selects the corresponding waveform characteristics The channels are recorded, so as to obtain the automatic update optimal ECG for diagnosis and monitoring of individual patients.
在一些应用中，患者所处环境中电磁干扰强、或患者需要进行大量运动等采集到的噪声相对大的情况，此时可以选取一个、一对或多个电极，作为参考电极，采用噪声消除方法，对采集到的心电信号进行噪声对消，消除背景噪声，获得信噪比更优、更利于诊断的心电图；例如，可以选取一对参考电极，通过一个通道记录参考信号，一对或若干对采集电极，通过对应通道记录心电信号，然后使用参考信号对记录的心电信号进行自适应滤波处理，消除电磁干扰。或者，也可以参考心电图仪常用的威尔逊中心中端方式，选取一个或多个电极，通过计算获得平均电位，作为差分电极的等效共享负电极，实现噪声对消，获得清晰的心电图；In some applications, when the electromagnetic interference is strong in the patient's environment, or the patient needs to perform a lot of exercise, the collected noise is relatively large. At this time, one, one pair or more electrodes can be selected as reference electrodes, and noise elimination method, noise cancellation is performed on the collected ECG signals, background noise is eliminated, and an ECG with a better signal-to-noise ratio and more conducive to diagnosis is obtained; for example, a pair of reference electrodes can be selected to record reference signals through one channel, and a pair or Several pairs of acquisition electrodes record ECG signals through corresponding channels, and then use reference signals to perform adaptive filtering on the recorded ECG signals to eliminate electromagnetic interference. Alternatively, one or more electrodes can be selected with reference to the middle-end method of Wilson center commonly used in electrocardiographs, and the average potential can be obtained through calculation, which can be used as the equivalent shared negative electrode of the differential electrode to achieve noise cancellation and obtain a clear ECG;
3)记录心电波形：3) Record ECG waveform:
植入式动态心电监测仪根据电极配置的初始设定，连续记录患者皮下心电波形，同时计时；经过一个动态调整时间间隔，进入步骤4)；The implantable Holter monitor continuously records the patient's subcutaneous ECG waveform according to the initial setting of the electrode configuration, and timing at the same time; after a dynamic adjustment time interval, enter step 4);
4)检测一次电池电量和数据存储容量：4) Detect primary battery power and data storage capacity:
当电池电量过低时，会在电池电量状态寄存器中记录一个电量过低标识符；When the battery power is too low, a low battery identifier will be recorded in the battery power status register;
当数据存储容量不够时，会在数据存储容量寄存器中记录一个存储容量过低标识符；When the data storage capacity is insufficient, a low storage capacity identifier will be recorded in the data storage capacity register;
电池电量和数据存储容量的状态信息在异常心电数据回传时上传；在数据回传后，患者终端或医护平台会进行状态信息判断，当发现电量过低或存储容量过低时，患者终端发出声音和图文提示，提醒患者尽快回访，医护平台会发出图文提示和声音，提醒医生需要联系对应患者，对数据存储容量过低的植入式动态心电监测仪进行存储容量释放，对电池电量过低的植入式动态心电监测仪进行更换。The status information of the battery power and data storage capacity is uploaded when the abnormal ECG data is returned; after the data is returned, the patient terminal or the medical care platform will judge the status information. When the battery power or storage capacity is too low, the patient terminal Issue sound and text prompts to remind patients to return as soon as possible. The medical care platform will issue graphic prompts and sounds to remind doctors that they need to contact corresponding patients, and release the storage capacity of implantable dynamic ECG monitors with too low data storage capacity. Implantable Holter monitors with low batteries should be replaced.
检测电池电量和数据存储容量后，需要根据电池电量和数据存储容量检测结果进行跳转，分为以下几种情况：After detecting the battery power and data storage capacity, you need to jump according to the battery power and data storage capacity detection results, which are divided into the following situations:
i.当电池电量和数据容量都充足时，进入步骤5)；i. When the battery power and data capacity are sufficient, enter step 5);
ii.当发现电池电量过低，且处于最大导联模式或多导联模式时，调整导联设置；因为维持多个导联记录会有相对大的电量消耗，而监护仪在患者回访前需保证正常工作、不因为电池电量不足发生错误操作；此时自动调整导联模式，进入单导联模式，关闭其他导联的记录功能；如果初始设定时设置了优先级，则保留导联中优先级最高的，如果未设置优先级，则保留动态调整特征值最大的导联；ii. When it is found that the battery power is too low and it is in the maximum lead mode or multi-lead mode, adjust the lead settings; because maintaining multiple lead records will consume a relatively large amount of power, and the monitor needs to be monitored before the patient returns. Guarantee normal work and no wrong operation due to insufficient battery power; at this time, the lead mode is automatically adjusted, enters the single-lead mode, and the recording function of other leads is turned off; if the priority is set in the initial setting, the lead in the lead The highest priority, if no priority is set, the lead with the largest dynamically adjusted eigenvalue will be reserved;
为了降低功耗、保证监护仪在患者回访前正常采集和记录心电信号，在处于单导联模式或调整导联模式进入单导联模式时，同时停止动态调整电极配置的功能，以保证在患者回访前不出现因电量不足造成的误动作，避免记录错误的数据、将已记录但未上传的数据误操作删除等问题；跳过步骤5)，进入步骤6)；In order to reduce power consumption and ensure that the monitor collects and records ECG signals normally before patient return visits, when the monitor is in single-lead mode or adjusts the lead mode to enter single-lead mode, the function of dynamically adjusting the electrode configuration is stopped at the same time to ensure Before the patient’s return visit, there will be no misoperation caused by insufficient power, avoid recording wrong data, and misoperation and deletion of recorded but not uploaded data; skip step 5) and go to step 6);
iii.当发现数据存储容量过低而电池电量充足时，且处于对于工作在最大导联模式和多导联模式时，仍然保留当前导联设置，仅减小数据记录的数据量，即只记录发生数据异常的对应导联数据，进入步骤5)；iii. When it is found that the data storage capacity is too low and the battery power is sufficient, and it is working in the maximum lead mode and multi-lead mode, the current lead setting is still retained, and only the data volume of data recording is reduced, that is, only recording For the lead data corresponding to abnormal data, go to step 5);
5)电极动态调整：参照图5，电极动态调整过程分为以下步骤：5) Electrode dynamic adjustment: Referring to Figure 5, the electrode dynamic adjustment process is divided into the following steps:
a.当连续记录时间达到动态调整的时间间隔后，从当前导联的备选导联列表中，根据备选导联个数N，选取优先级最高的N个导联，作为备选最优导联；a. When the continuous recording time reaches the dynamically adjusted time interval, select the N leads with the highest priority from the candidate lead list of the current lead according to the number N of candidate leads as the best candidate leads;
b.开启这N个备选最优导联对应的采集通路并获取一段时间的心电波形，分别计算对应的参考特征计算值；b. Open the acquisition channels corresponding to the N alternative optimal leads and acquire ECG waveforms for a period of time, and calculate corresponding reference characteristic calculation values;
c.参考特征计算值和参考特征阈值相比较；如果有参考特征计算结果超过参考特征阈值，则进入下一步d；如果当前导联和备选最优导联所计算出的参考特征计算值都小于设定的参考特征阈值，则先按照当前导联进行心电波形异常分析，同时，重新从备选导联列表中选取优先级仅次于当前备选最优导联的N个导联，作为新的备选最优导联，重复记录心电波形、计算参考特征、比较参考特征阈值这个步骤，直到有导联的参考特征计算结果超过参考特征阈值；c. The reference feature calculation value is compared with the reference feature threshold value; if the reference feature calculation result exceeds the reference feature threshold value, then enter the next step d; if the reference feature calculation values calculated by the current lead and the alternative optimal lead are both If it is less than the set reference feature threshold, the ECG waveform abnormality analysis will be performed according to the current lead first, and at the same time, N leads whose priority is second only to the current best candidate lead are re-selected from the candidate lead list. As a new candidate optimal lead, repeat the steps of recording the ECG waveform, calculating the reference feature, and comparing the reference feature threshold until the calculation result of the reference feature of a lead exceeds the reference feature threshold;
d.在参考特征计算结果超过参考特征阈值的导联中，选择参考特征计算值最大的导联，作为新的最优导联，替代当前导联；d. Among the leads whose reference feature calculation results exceed the reference feature threshold, select the lead with the largest reference feature calculation value as the new optimal lead to replace the current lead;
e.记录动态调整后的导联，以及调整时的时间戳，以便于读取心电数据时进行区别；e. Record the dynamically adjusted leads, as well as the time stamp of the adjustment, so as to distinguish when reading the ECG data;
f.计时器清零，重新开始计时；f. The timer is cleared and restarted;
6)继续记录心电波形：6) Continue to record the ECG waveform:
植入式动态心电监测仪根据电极动态调整后的配置，连续记录患者皮下心电波形，同时计时；经过一个动态调整时间间隔，重新进入步骤4)；The implantable Holter monitor continuously records the subcutaneous ECG waveform of the patient according to the configuration after the dynamic adjustment of the electrodes, and timing at the same time; after a dynamic adjustment time interval, re-enter step 4);
7)人工修改：只有在使用程控仪对植入式动态心电监测仪编程，选择人工修改功能时,通过中断，进入步骤7)，其他情况都不会进入；7) Manual modification: Only when the program controller is used to program the implantable Holter monitor and the manual modification function is selected, enter step 7) through interruption, and will not enter in other cases;
在患者回访时，主治医师可通过程控仪，在患者植入位置的皮肤表面通过无线方式交换信息，对调整参数预设、电极配置的初始设定中的某一个或某几个设置进行参数获取和修改，如获取、修改当前电极配置模式，获取、修改当前导联等；During the patient's return visit, the attending physician can use the program controller to exchange information wirelessly on the skin surface of the patient's implantation site, and obtain parameters for one or several settings in the initial settings of the adjustment parameter preset and electrode configuration. and modification, such as obtaining and modifying the current electrode configuration mode, obtaining and modifying the current lead, etc.;
在一些应用中，植入式动态心电监测仪植入患者皮下后，但由于外力影响或固定松动，产生了位置偏移，电极动态调整呈现明显的轨迹。医生可以通过专用编程仪，修改电极配置的初始设定，即，修改电极连接方式，选择合适位置的电极组成新的导联以代替旧导联，避免因电极位置偏移使得所测数据有人为引入的干扰，以避免造成误诊。In some applications, after the implantable dynamic ECG monitor is implanted subcutaneously in the patient, the position is shifted due to external force or loose fixation, and the dynamic adjustment of the electrodes presents an obvious trajectory. The doctor can modify the initial setting of the electrode configuration through a special programmer, that is, modify the electrode connection mode, select the electrode at the appropriate position to form a new lead to replace the old lead, and avoid the measured data due to the electrode position offset. Introduced interference to avoid misdiagnosis.
除此之外，在发现存储容量过低时，通过程控仪还可以读取、删除存储在植入式动态心电监测仪中的异常心电数据记录，随后复位数据存储容量寄存器的标识符。删除部分存储的数据后，空闲的存储器空间继续存储异常心电数据。In addition, when the storage capacity is found to be too low, the program controller can also read and delete the abnormal ECG data records stored in the implantable dynamic ECG monitor, and then reset the identifier of the data storage capacity register. After part of the stored data is deleted, the free memory space continues to store abnormal ECG data.
当发现电池容量过低时，应尽快更换植入式动态心电监测仪。When the battery capacity is found to be too low, the implantable dynamic ECG monitor should be replaced as soon as possible.
在人工修改结束后，重新进入步骤3)，继续动态调整。After manual modification, re-enter step 3) to continue dynamic adjustment.
参照图6，图6给出一个电极自动分配优先级列表示例，由于电极数量增多，导致可选导联个数增多，无法全部列出。因此对于实施例中所给出的电极分布，针对一个特定导联，给出了依据距离设定的默认备选导联列表。此处需说明的是，备选导联列表虽然名称是“表”，但实际的数据结构还可以树形或有向图的方式呈现，以便于电极自动分配时进行搜索。如图6所示，实施例中给出的当前导连由位于外壳两端的两个电极构成，其默认备选列表是按照二叉树的方式排列。在搜索中，每次搜索的备选导联个数N＝2，因此第一次搜索，选择第一层的两个备选导联，采集对应导联的心电数据，再计算参考特征并比较，当不满足要求时，再选择第二层中的备选导联。第二层中的备选导联，默认左支优先级高于右支。参照图7，图7为实施例获得的心电波形的一个示例。Referring to Fig. 6, Fig. 6 shows an example of an electrode automatic assignment priority list. Due to the increase in the number of electrodes, the number of optional leads increases and cannot be listed all. Therefore, for the electrode distribution given in the embodiment, for a specific lead, a default candidate lead list set according to the distance is given. It should be noted here that although the name of the candidate lead list is "table", the actual data structure can also be presented in the form of a tree or a directed graph, so as to facilitate searching during automatic electrode assignment. As shown in FIG. 6 , the current lead provided in the embodiment is composed of two electrodes located at both ends of the housing, and its default candidate list is arranged in a binary tree. In the search, the number of candidate leads for each search is N=2, so for the first search, select two candidate leads on the first layer, collect the ECG data of the corresponding leads, and then calculate the reference features and Comparison, when the requirements are not met, select the alternative leads in the second layer. Alternative leads in the second layer, the default priority of the left branch is higher than that of the right branch. Referring to Fig. 7, Fig. 7 is an example of the ECG waveform obtained in the embodiment.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710518009.5ACN107212880B (en) | 2017-06-29 | 2017-06-29 | Implantable Holter Monitor with Dynamic Adjustment of Electrode Configuration |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710518009.5ACN107212880B (en) | 2017-06-29 | 2017-06-29 | Implantable Holter Monitor with Dynamic Adjustment of Electrode Configuration |
| Publication Number | Publication Date |
|---|---|
| CN107212880Atrue CN107212880A (en) | 2017-09-29 |
| CN107212880B CN107212880B (en) | 2020-02-21 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710518009.5AActiveCN107212880B (en) | 2017-06-29 | 2017-06-29 | Implantable Holter Monitor with Dynamic Adjustment of Electrode Configuration |
| Country | Link |
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| CN (1) | CN107212880B (en) |
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| CN108836308A (en)* | 2018-05-17 | 2018-11-20 | 南京大学 | A kind of device removing wearable electrocardio motion artifacts |
| CN109497993A (en)* | 2018-12-28 | 2019-03-22 | 北京品驰医疗设备有限公司 | Physiological signal collection sensitivity regulation method and implantable medical equipment |
| CN111714113A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implanted medical device for sensing electrocardiosignals |
| CN111714085A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implantable heart monitor and manufacturing method thereof |
| CN111714115A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implantable Heart Monitor |
| CN112568911A (en)* | 2019-09-30 | 2021-03-30 | 深圳市理邦精密仪器股份有限公司 | Method and equipment for classifying electrocardiogram data and device with storage function |
| CN113317795A (en)* | 2020-02-29 | 2021-08-31 | 华为技术有限公司 | Signal measurement method and device |
| CN113827248A (en)* | 2021-09-18 | 2021-12-24 | 宁波慈溪生物医学工程研究所 | Non-contact electrocardio detects multilayer combined electrode system |
| CN115990021A (en)* | 2021-10-19 | 2023-04-21 | 南京大学 | Electrocardiogram detection device and system |
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| CN103505197A (en)* | 2012-06-26 | 2014-01-15 | 中国科学院电子学研究所 | Neural signal detector |
| CN105534492A (en)* | 2015-11-30 | 2016-05-04 | 张胜国 | Intelligent human body sign mobile phone monitoring system |
| CN106160701A (en)* | 2016-07-01 | 2016-11-23 | 中国科学院地质与地球物理研究所 | The method for designing of multichannel data acquisition system, wave trap and wave trap |
| CN106510696A (en)* | 2016-12-22 | 2017-03-22 | 蓝色传感（北京）科技有限公司 | Active noise control digital electrode collecting system and collecting method thereof |
| CN106859632A (en)* | 2015-12-11 | 2017-06-20 | 包骏 | A kind of contactless electrocardiogram equipment of wearable real time multi-channel and its cardioelectric monitor method |
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| CN1253761A (en)* | 1999-09-27 | 2000-05-24 | 复旦大学 | Dynamic ECG mapping method and device thereof |
| CN103505197A (en)* | 2012-06-26 | 2014-01-15 | 中国科学院电子学研究所 | Neural signal detector |
| CN105534492A (en)* | 2015-11-30 | 2016-05-04 | 张胜国 | Intelligent human body sign mobile phone monitoring system |
| CN106859632A (en)* | 2015-12-11 | 2017-06-20 | 包骏 | A kind of contactless electrocardiogram equipment of wearable real time multi-channel and its cardioelectric monitor method |
| CN106160701A (en)* | 2016-07-01 | 2016-11-23 | 中国科学院地质与地球物理研究所 | The method for designing of multichannel data acquisition system, wave trap and wave trap |
| CN106510696A (en)* | 2016-12-22 | 2017-03-22 | 蓝色传感（北京）科技有限公司 | Active noise control digital electrode collecting system and collecting method thereof |
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| CN108836308A (en)* | 2018-05-17 | 2018-11-20 | 南京大学 | A kind of device removing wearable electrocardio motion artifacts |
| CN109497993A (en)* | 2018-12-28 | 2019-03-22 | 北京品驰医疗设备有限公司 | Physiological signal collection sensitivity regulation method and implantable medical equipment |
| CN109497993B (en)* | 2018-12-28 | 2022-08-05 | 北京品驰医疗设备有限公司 | Physiological signal acquisition sensitivity adjusting method and implanted medical equipment |
| CN112568911A (en)* | 2019-09-30 | 2021-03-30 | 深圳市理邦精密仪器股份有限公司 | Method and equipment for classifying electrocardiogram data and device with storage function |
| CN113317795A (en)* | 2020-02-29 | 2021-08-31 | 华为技术有限公司 | Signal measurement method and device |
| CN111714113A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implanted medical device for sensing electrocardiosignals |
| CN111714085A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implantable heart monitor and manufacturing method thereof |
| CN111714115A (en)* | 2020-04-30 | 2020-09-29 | 苏州无双医疗设备有限公司 | Implantable Heart Monitor |
| CN113827248A (en)* | 2021-09-18 | 2021-12-24 | 宁波慈溪生物医学工程研究所 | Non-contact electrocardio detects multilayer combined electrode system |
| CN115990021A (en)* | 2021-10-19 | 2023-04-21 | 南京大学 | Electrocardiogram detection device and system |
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| CN107212880B (en) | 2020-02-21 |
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| CN107212880B (en) | Implantable Holter Monitor with Dynamic Adjustment of Electrode Configuration | |
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