CN111714774A - An implantable medical device capable of counting and identifying ventricular rate - Google Patents

Abstract

Translated fromChinese

本发明描述了一种具备计数和识别心室速率的植入式医疗设备，根据心电信号进行心脏事件的计数和识别。所述植入式医疗设备通过计算机软件实现执行单元对心脏事件的计数和识别。所述植入式医疗设备包括植入式心脏除颤器(ICD)、植入式心脏监视器(ICM)、植入式心脏起搏器(Cardiac Pacemaker)、无导线植入心脏起搏器和皮下式植入心脏除颤器(SICD)。

The invention describes an implantable medical device capable of counting and recognizing ventricular rate, and counting and recognizing cardiac events according to electrocardiographic signals. The implantable medical device implements the counting and identification of cardiac events by the execution unit through computer software. The implantable medical device includes an implantable cardiac defibrillator (ICD), an implantable cardiac monitor (ICM), an implantable cardiac pacemaker (Cardiac Pacemaker), a leadless implanted cardiac pacemaker and Subcutaneously implanted cardiac defibrillator (SICD).

Description

Translated fromChinese

一种具备计数和识别心室速率功能的植入式医疗设备An implantable medical device capable of counting and identifying ventricular rate

技术领域technical field

本发明涉及一种植入式医疗设备，该种植入式医疗设备通过对心电信号的监测，能够实现对心脏事件类型或心脏疾病种类的计数和识别，用于临床上对心脏事件或心律失常的监测、识别或治疗。The invention relates to an implantable medical device, which can realize the counting and identification of cardiac event types or cardiac disease types by monitoring electrocardiographic signals, and is used for clinical diagnosis of cardiac events or arrhythmias. monitor, identify or treat.

背景技术Background technique

植入式心脏复律除颤器(ICD)、植入式心脏监视器(ICM)、心脏心脏起搏器(cardiac pacemaker)或无导线植入心脏除颤器和皮下式植入心脏除颤器(SICD)是临床上治疗持续性或致命性室性心律失常的重要医疗设备。Implantable cardioverter-defibrillator (ICD), implantable cardiac monitor (ICM), cardiac pacemaker (cardiac pacemaker) or leadless implantable defibrillator and subcutaneously implanted defibrillator (SICD) is an important medical device for the clinical treatment of persistent or fatal ventricular arrhythmias.

植入式心脏复律除颤器(ICD)是临床上治疗持续性或致命性室性心律失常的一项重要治疗设备，具有支持性、抗心动过速起搏、低能量心脏转复以及高能量除颤等作用。Implantable cardioverter-defibrillator (ICD) is an important clinical device for the treatment of persistent or fatal ventricular arrhythmias, with supportive, anti-tachycardia pacing, low-energy cardioversion and high Energy defibrillation, etc.

目前，对心室速率的感知已经成为一种现有技术，既可以通过将装载感知部件的设备植入到心脏内部进行感知，也可以将其置于患者体外进行感知。感知心室内部的信号包括心音、速率、振幅、频率、周期等。At present, the sensing of ventricular rate has become an existing technology, which can be sensed either by implanting a device loaded with sensing components inside the heart, or by placing it outside the patient's body. Signals sensed inside the ventricle include heart sounds, rates, amplitudes, frequencies, periods, and the like.

患者发生室颤时，如果治疗不及时，会导致患者错过最佳治疗时机，严重时会导致生命危险。ICD能够在数秒钟内识别病人的快速室性心律失常，后然自动放电除颤，这样就能明显避免恶性室性心律失常的猝死发生率，从而避免治疗不及时的状况。When a patient develops ventricular fibrillation, if the treatment is not timely, the patient will miss the best time for treatment, and in severe cases, it will be life-threatening. The ICD can identify the patient's rapid ventricular arrhythmia within seconds, and then automatically discharge the defibrillation, which can significantly avoid the sudden death rate of malignant ventricular arrhythmia, thereby avoiding the situation of untimely treatment.

心脏疾病是所有心脏病的统称，但是在临床过程中，心脏疾病的治疗需要结合疾病的严重程度和发病位置等情况具体确定，不同种类的心脏疾病需要采用不同的治疗方法。Heart disease is a general term for all heart diseases, but in the clinical process, the treatment of heart disease needs to be determined in combination with the severity and location of the disease. Different types of heart disease require different treatment methods.

为了精确识别患者所患心脏病的种类从而达到更好的治疗效果，临床上有必要对心脏疾病的类型进行更细致的划分，此目的通常在心脏疾病的识别过程中实现。In order to accurately identify the type of heart disease in a patient and achieve better treatment effects, it is clinically necessary to classify the type of heart disease in more detail, which is usually achieved during the identification process of heart disease.

目前，心脏疾病类型的一种典型的识别方法是通过实时心率计数判断是否存在心室过速或心室颤动，并根据判断结果进行治疗。At present, a typical method of identifying the type of heart disease is to judge whether there is ventricular tachycardia or ventricular fibrillation by real-time heart rate counting, and treat according to the judgment result.

发明内容SUMMARY OF THE INVENTION

本发明提供了通过对心室速率从而实现对有生命的生物活体内部心脏疾病类型的计数和判断方法，适用于医疗器械和临床领域。The invention provides a method for counting and judging heart disease types in a living organism by measuring the ventricular rate, and is suitable for medical instruments and clinical fields.

本发明公开描述了通过对患者心电信号的测量触发心室速率的计数和识别的植入式医疗设备。在一些示例中，可以自动地完成对这些测量的触发(例如，没有从外部源发起的触发输入，例如基于从患者发起的或由医生从外部设备发起的请求)，并且至少部分地基于监测与患者相关联的一个或多个生理参数，触发对室速的测量可以发生在某些数值范围内。The present disclosure describes an implantable medical device that triggers counting and identification of ventricular rate by measurement of a patient's electrocardiographic signal. In some examples, triggering of these measurements may be done automatically (eg, without triggering input from an external source, eg, based on a request from a patient or by a physician from an external device), and based at least in part on monitoring and One or more physiological parameters associated with the patient that trigger the measurement of VT can occur within certain ranges of values.

本发明提供了包括植入式医疗设备(IMD)的系统。所述IMD系统可以包括：被配置成与外部计算设备通信的通信电路系统，被配置成感测根据患者的心室速率变化的心脏信号的感测电路系统，以及处理电路系统。所述处理电路系统可以被配置成：基于感知到的心脏信号来确定一系列连续的心脏疾病门限值范围；以及基于所述不同种类型的心脏疾病中的每一种心脏疾病门限值来识别心脏疾病的类型。所述处理电路系统可以进一步被配置成：基于感知到的心脏信号来检测所述患者的心脏疾病的暂停发作，以及控制通信电路系统将检测到的心脏疾病暂停发作的指示传输到外部计算设备。The present invention provides a system including an implantable medical device (IMD). The IMD system may include communication circuitry configured to communicate with an external computing device, sensing circuitry configured to sense cardiac signals that vary according to the patient's ventricular rate, and processing circuitry. The processing circuitry may be configured to: determine a series of consecutive ranges of cardiac disease thresholds based on the sensed cardiac signal; and to determine the cardiac disease thresholds based on each of the different types of cardiac diseases; Identify the type of heart disease. The processing circuitry may be further configured to detect a pause of cardiac disease in the patient based on the sensed cardiac signal, and to control the communication circuitry to transmit an indication of the detected pause of cardiac disease to an external computing device.

本发明提供了一种具备室速计数功能的植入式医疗设备，其特征在于，所述植入式医疗设备被配置为：The present invention provides an implantable medical device with a function of counting ventricular tachycardia, characterized in that the implantable medical device is configured as:

步骤a根据心电信号更新实时心率值；Step a updates the real-time heart rate value according to the ECG signal;

步骤b由室速计数器更新室速计数值；In step b, the VT count value is updated by the VT counter;

所述步骤b还包括：The step b also includes:

步骤b1所述实时心率值与室速门限值进行比较，当实时心率值小于室速门限值时，室速计数值归零并重新开始计数；The real-time heart rate value described in step b1 is compared with the VT threshold value, and when the real-time heart rate value is less than the VT threshold value, the VT count value returns to zero and starts counting again;

步骤b2当所述实时心率值大于或等于室速门限值且小于快速室速门限值时，室速计数值加1；Step b2, when the real-time heart rate value is greater than or equal to the VT threshold value and less than the fast VT threshold value, the VT count value is increased by 1;

步骤b3当所述实时心率值大于或等于快速室速门限值时，室速计数器不计数。In step b3, when the real-time heart rate value is greater than or equal to the fast ventricular tachycardia threshold value, the ventricular tachycardia counter does not count.

本发明提供了一种具备室速识别功能的植入式医疗设备，其特征在于，所述植入式医疗设备被配置为：The present invention provides an implantable medical device with a ventricular tachycardia identification function, characterized in that the implantable medical device is configured as:

步骤a根据心电信号更新实时心率值；Step a updates the real-time heart rate value according to the ECG signal;

步骤b由室速计数器更新室速计数值；In step b, the VT count value is updated by the VT counter;

所述步骤b还包括：The step b also includes:

步骤b1所述实时心率值与室速门限值进行比较，当实时心率值小于室速门限值时，室速计数值归零并重新开始计数；The real-time heart rate value described in step b1 is compared with the VT threshold value, and when the real-time heart rate value is less than the VT threshold value, the VT count value returns to zero and starts counting again;

步骤b2当所述实时心率值大于或等于室速门限值且小于快速室速门限值时，室速计数值加1；Step b2, when the real-time heart rate value is greater than or equal to the VT threshold value and less than the fast VT threshold value, the VT count value is increased by 1;

步骤b3当所述实时心率值大于或等于快速室速门限值时，室速计数器不计数；In step b3, when the real-time heart rate value is greater than or equal to the fast ventricular tachycardia threshold value, the ventricular tachycardia counter does not count;

步骤b4当室速计数值达到第一阈值时，识别为室速，否则，继续更新实时心率值。In step b4, when the ventricular tachycardia count value reaches the first threshold, it is identified as ventricular tachycardia, otherwise, the real-time heart rate value is continued to be updated.

所述识别模块能诱发相应的治疗模块。The identification modules can induce corresponding treatment modules.

所述的一种具备室速识别功能的植入式医疗设备，当室速计数值加1后且未达到第一阈值时，室速计数值在原室速计数值的基础上叠加计数。In the described implantable medical device with VT recognition function, when the VT count value is incremented by 1 and does not reach the first threshold, the VT count value is superimposed and counted on the basis of the original VT count value.

本发明提供了一种具备心脏事件计数功能的植入式医疗设备，其特征在于，所述医疗设备被配置为：The present invention provides an implantable medical device with a cardiac event counting function, characterized in that the medical device is configured as:

步骤a根据心电信号更新实时心率值；Step a updates the real-time heart rate value according to the ECG signal;

步骤B根据所述实时心率值不断更新室颤计数值，室颤计数值等于所述移位寄存器中实时心率值大于快速室速门限值的个数；Step B continuously updates the ventricular fibrillation count value according to the real-time heart rate value, and the ventricular fibrillation count value is equal to the number of the real-time heart rate value in the shift register that is greater than the fast ventricular tachycardia threshold value;

步骤B1当室颤计数值小于第二阈值时，返回步骤a继续更新实时心率值；In step B1, when the ventricular fibrillation count value is less than the second threshold, return to step a to continue updating the real-time heart rate value;

步骤B2当室颤计数值达到第二阈值时，触发联合计数器，由联合计数器更新联合计数值，联合计数值＝室速计数值+室颤计数值。In step B2, when the ventricular fibrillation count value reaches the second threshold, the combined counter is triggered, and the combined count value is updated by the combined counter, where the combined count value = ventricular tachycardia count value + ventricular fibrillation count value.

步骤b由室速计数器更新室速计数值；In step b, the VT count value is updated by the VT counter;

所述步骤b还包括：The step b also includes:

步骤b1所述实时心率值与室速门限值进行比较，当实时心率值小于室速门限值时，室速计数值归零并重新开始计数；The real-time heart rate value described in step b1 is compared with the VT threshold value, and when the real-time heart rate value is less than the VT threshold value, the VT count value returns to zero and starts counting again;

步骤b2当所述实时心率值大于或等于室速门限值且小于快速室速门限值时，室速计数值加1；Step b2, when the real-time heart rate value is greater than or equal to the VT threshold value and less than the fast VT threshold value, the VT count value is increased by 1;

步骤b3当所述实时心率值大于或等于快速室速门限值时，室速计数器不计数。In step b3, when the real-time heart rate value is greater than or equal to the fast ventricular tachycardia threshold value, the ventricular tachycardia counter does not count.

所述室颤计数值的运算方法为：The calculation method of the ventricular fibrillation count value is:

步骤a根据心电信号更新实时心率值；Step a updates the real-time heart rate value according to the ECG signal;

步骤C根据实时心率值更新移位寄存器x(n-m+1)，x(n-m)，...，x(n)；Step C updates the shift registers x(n-m+1), x(n-m), . . . , x(n) according to the real-time heart rate value;

步骤D室颤计数值等于所述移位寄存器中实时心率值大于快速室速门限值的个数。In step D, the ventricular fibrillation count value is equal to the number of real-time heart rate values in the shift register that are greater than the fast ventricular tachycardia threshold value.

所述的一种具备心脏事件计数功能的植入式医疗设备，每更新一次实时心率值，所述移位寄存器移位一次。In the described implantable medical device with the function of counting cardiac events, the shift register shifts once every time the real-time heart rate value is updated.

本发明提供了12.一种具备心脏事件识别功能的植入式医疗设备，所述植入式医疗设备被配置为：The present invention provides 12. An implantable medical device with a cardiac event recognition function, the implanted medical device is configured as:

步骤a根据心电信号更新实时心率值；Step a updates the real-time heart rate value according to the ECG signal;

步骤C根据实时心率值更新移位寄存器x(n-m+1)，x(n-m)，...，x(n)；Step C updates the shift registers x(n-m+1), x(n-m), . . . , x(n) according to the real-time heart rate value;

步骤B根据所述实时心率值不断更新室颤计数值，室颤计数值等于所述移位寄存器中实时心率值大于快速室速门限值的个数；Step B continuously updates the ventricular fibrillation count value according to the real-time heart rate value, and the ventricular fibrillation count value is equal to the number of the real-time heart rate value in the shift register that is greater than the fast ventricular tachycardia threshold value;

步骤B1当室颤计数值小于第二阈值时，返回步骤a继续更新实时心率值；In step B1, when the ventricular fibrillation count value is less than the second threshold, return to step a to continue updating the real-time heart rate value;

步骤B2当室颤计数值达到第二阈值时，触发联合计数器，由联合计数器更新联合计数值，联合计数值＝室速计数值+室颤计数值；In step B2, when the ventricular fibrillation count value reaches the second threshold, the combined counter is triggered, and the combined count value is updated by the combined counter, where the combined count value = ventricular tachycardia count value + ventricular fibrillation count value;

步骤D当联合计数值达到第三阈值时，启动回溯窗口，回溯窗口的运算方法为：Step D: When the joint count value reaches the third threshold, start the backtracking window, and the operation method of the backtracking window is:

步骤E检测所述回溯窗口内是否存在位于室颤区范围内的实时心率值，如果存在至少一个实施心率值位于室颤区范围内，则识别心脏事件为室颤，如果不存在，则继续识别所述回溯窗口内是否存在位于快速室速区范围内的实时心率值，如果存在至少实施心率值位于快速室速区范围内，则识别为快速室速，否则识别为室速。Step E detects whether there is a real-time heart rate value within the range of the ventricular fibrillation zone in the retrospective window, and if there is at least one implemented heart rate value within the range of the ventricular fibrillation zone, then identify the cardiac event as ventricular fibrillation, if not, continue to identify Whether there is a real-time heart rate value within the fast VT zone in the retrospective window, if there is at least the implemented heart rate value within the fast VT zone, it is identified as a fast VT, otherwise it is identified as a VT.

附图说明Description of drawings

图1为植入式医疗设备中的ICD的结构示意图Figure 1 is a schematic diagram of the structure of an ICD in an implantable medical device

图2为植入式医疗设备室速计数方法流程示意图Figure 2 is a schematic flow chart of a method for counting ventricular tachycardia in an implantable medical device

图3为植入式医疗设备室速识别方法流程示意图Figure 3 is a schematic diagram of the flow chart of the method for ventricular tachycardia identification of implantable medical equipment

图4为回溯窗口的实时心率值序列逻辑结构示意图Figure 4 is a schematic diagram of the logical structure of the real-time heart rate value sequence of the retrospective window

图5为植入式医疗设备心脏事件计数方法中室颤计数流程示意图Figure 5 is a schematic diagram of the counting flow of ventricular fibrillation in the method for counting cardiac events of implantable medical devices

图6为植入式医疗设备心脏事件识别方法中室颤识别流程示意图Fig. 6 is a schematic diagram of the ventricular fibrillation identification process in the cardiac event identification method of the implantable medical device

图7为植入式医疗设备的心脏事件计数方法流程示意图FIG. 7 is a schematic flowchart of a method for counting cardiac events in an implantable medical device.

图8为植入式医疗设备的心脏事件识别方法流程示意图FIG. 8 is a schematic flowchart of a cardiac event identification method for an implantable medical device

具体实施方式Detailed ways

本文所提供的附图和说明书示出并描述了本公开的发明方法、设备和系统的各种示例。然而，本公开的方法、设备和系统不限于如本文所示出和所描述的具体示例，以及如将被本领域普通技术人员所理解的，本公开的方法、设备和系统的其他示例和变型被认为是在本申请的范围内。The drawings and description provided herein illustrate and describe various examples of the inventive methods, apparatus, and systems of the present disclosure. However, the methods, devices, and systems of the present disclosure are not limited to the specific examples shown and described herein, and other examples and variations of the methods, devices, and systems of the present disclosure will be understood by those of ordinary skill in the art are considered to be within the scope of this application.

本发明所述计数和识别方法适用的医疗设备包括：植入式心脏除颤器(ICD)、植入式心脏监视器(ICM)、植入式心脏起搏器(Cardiac Pacemaker)、无导线植入心脏起搏器和皮下式植入心脏除颤器(SICD)。能够自动实现对室速事件的识别。以植入式心率转复除颤器(ICD)为例，说明心室速率(简称室速)的计数方法及其对应的室速识别方法、心脏事件联合计数方法及其对应的联合识别方法。The medical devices to which the counting and identifying method of the present invention is applicable include: implantable cardiac defibrillator (ICD), implantable cardiac monitor (ICM), implantable cardiac pacemaker (Cardiac Pacemaker), leadless implant implanted pacemakers and subcutaneously implanted cardiac defibrillators (SICDs). The recognition of ventricular tachycardia events can be achieved automatically. Taking the implantable cardioverter defibrillator (ICD) as an example, the counting method of ventricular rate (referred to as ventricular tachycardia) and its corresponding ventricular tachycardia identification method, the combined counting method of cardiac events and its corresponding joint identification method are described.

所述医疗设备配置成当检测到室速心率、室性快速性心率失常事件和室颤事件时增加计数器的计数值；所述植入式医疗设备通过执行单元实现对心脏事件的计数，所述执行单元被配置成随后从所述执行电路传输编程指令到所述植入式医疗设备。通过对心电信号参数的感知对心脏事件进行计数和识别。所述计数方法为一种通过程序语言实现的计算机程序方法，计数为识别的一部分，识别由相应的计数结果触发。本发明按照实时心率值的大小将心脏事件的计数和识别分为室速、快速室速、室颤三个区域，三个区域将所有的实时心率值覆盖，并且实时心率值按照室速、快速室速、室颤三个区域不断增大。The medical device is configured to increase the count value of the counter when ventricular tachyarrhythmia events, ventricular tachyarrhythmia events and ventricular fibrillation events are detected; the implantable medical device implements the counting of cardiac events through the execution unit, and the execution The unit is configured to then transmit programming instructions from the execution circuit to the implantable medical device. Cardiac events are counted and identified through the perception of ECG signal parameters. The counting method is a computer program method implemented by a programming language, the counting is a part of the recognition, and the recognition is triggered by the corresponding counting result. The present invention divides the counting and recognition of cardiac events into three regions: ventricular tachycardia, fast ventricular tachycardia, and ventricular fibrillation according to the size of the real-time heart rate value. The three areas of ventricular tachycardia and ventricular fibrillation continued to increase.

本发明中，所有流程图中所标“Y”表示“Yes”，意思为“是”，所标“N”表示“No”，意思为不是。In the present invention, the marked "Y" in all the flowcharts means "Yes", which means "Yes", and the marked "N" means "No", which means no.

图1为ICD100的外观结构及其植入心脏内部时各部分组件在心脏中所处相对位置的示意图。ICD包括主体结构和导线115构成，主体结构由主体外壳105和主体外壳上的连接器107两部分构成。主体外壳内部通常含有电源、电容、混合电路三部分组成，混合电路通常通过芯片进行程序的编码实现。ICD功能的发挥可以通过两种方式实现，一种为ICD机体内部自动化式调控，不需要人为手动触发和控制，能够自动实现。另一种通过外部调控设备190发出通讯信号185实现，ICD的外部调控设备190一般为程控仪、者患者助手或者其他等能够对其下达指令或者感知其内部信号的器件。ICD和外部调控设备190之间的通讯方式185可以是有线通讯、蓝牙、WIFI、LTE或CDMA等无线通讯网络中的一种或者多种。本图1所示ICD导线115为单导线，临床使用过程中还可能是双导线、三导线、四导线，导线的基本结构与导线115类似。导线115由线圈118电极120A和电极120B构成，线圈118通过连接器107与ICD主体相连，线圈的功能为：通过放电达到治疗的目的。电极120A和电极120B对心脏事件的信号参数进行感测。电极120B也叫螺旋头，内部含有螺旋的线圈，当使用时可以从导线另一侧悬出，与心脏内部的组织进行固定，使得ICD在植入人体心脏后，设备上的电极能够与心肌内连接较牢固。FIG. 1 is a schematic diagram of the appearance structure of theICD 100 and the relative positions of various components in the heart when it is implanted into the heart. The ICD includes a main body structure andwires 115, and the main body structure is composed of two parts: themain body shell 105 and theconnector 107 on the main body shell. The inside of the main shell usually consists of three parts: power supply, capacitor, and hybrid circuit. The hybrid circuit is usually realized by the coding of the program by the chip. The ICD function can be realized in two ways. One is the automatic regulation inside the ICD body, which does not require manual triggering and control, and can be realized automatically. The other is realized by sending thecommunication signal 185 from theexternal control device 190. Theexternal control device 190 of the ICD is generally a program controller, a patient assistant or other devices that can give instructions to it or sense its internal signals. Thecommunication mode 185 between the ICD and theexternal control device 190 may be one or more of wireless communication networks such as wired communication, Bluetooth, WIFI, LTE or CDMA. The ICD lead 115 shown in FIG. 1 is a single lead, and may also be two leads, three leads, or four leads during clinical use. The basic structure of the lead is similar to that of thelead 115 . Thelead 115 is composed of acoil 118, anelectrode 120A and anelectrode 120B. Thecoil 118 is connected to the main body of the ICD through theconnector 107. The function of the coil is to achieve the purpose of treatment by discharging.Electrodes 120A and 120B sense signal parameters of cardiac events. Theelectrode 120B is also called a helical head, which contains a helical coil. When in use, it can be suspended from the other side of the wire and fixed with the tissue inside the heart, so that after the ICD is implanted in the human heart, the electrodes on the device can be connected to the heart muscle. The connection is firm.

图2为植入式医疗设备的室速计数流程示意图。先由步骤202根据心电信号更新实时心率值，步骤204将所述实时心率值与室速门限值进行比较，如果实时心率值小于室速门限值时，室速计数器清零重新开始计数，返回步骤202重新更新实时心率值；如果所述实时心率值大于等于于室速门限值时，再进行步骤206将其与快速室速门限值进行比较，如果所述实时心率值小于快速室速门限值，则室速计数值加1，室速计数值的更新由室速计数器完成；如果实时心率值大于等于室速门限值，室速计数值不变，即此次事件不进行计数，并回到步骤202继续更新实时心率值。本发明中，室速门限值取值范围为150-200bpm，快速室速门限值取值范围为200-250bpm。FIG. 2 is a schematic diagram of a flow chart of ventricular tachycardia counting in an implantable medical device. First, step 202 updates the real-time heart rate value according to the ECG signal, and step 204 compares the real-time heart rate value with the VT threshold value, if the real-time heart rate value is less than the VT threshold value, the VT counter is cleared and starts counting again , return to step 202 to re-update the real-time heart rate value; if the real-time heart rate value is greater than or equal to the VT threshold, go to step 206 to compare it with the fast VT threshold, if the real-time heart rate value is less than the fast VT threshold If the real-time heart rate value is greater than or equal to the VT threshold value, the VT count value will remain unchanged, that is, the event will not change. Count, and go back to step 202 to continue updating the real-time heart rate value. In the present invention, the value range of the VT threshold value is 150-200bpm, and the value range of the fast VT threshold value is 200-250bpm.

图3为植入式医疗设备的室速识别流程示意图。识别事件的由相应的计数结果触发。首先，步骤302根据心电信号更新实时心率值。然后，步骤304将所述实时心率值与室速门限值进行比较，如果实时心率值小于室速门限值时，室速计数器清零重新开始计数，返回步骤302重新更新实时心率值；如果所述实时心率值大于等于于室速门限值时，再进行步骤306将其与快速室速门限值进行比较，如果所述实时心率值小于快速室速门限值，则室速计数值加1，室速计数值的更新由室速计数器完成；如果实时心率值大于等于室速门限值，室速计数值不变，即此次事件不进行计数，并回到步骤302继续更新实时心率值。所诉室速计数值在大于室速门限值小于快速室速门限值时，此次室速计数事件为有效事件，则室速计数器触发计数步骤。随着实时心率值的不断更新，当室速计数值未达到第一阈值且满足室速计数条件时，室速计数值不断叠加计数。当室速计数值达到第一阈值见步骤310时，识别为室速。所述第一阈值取值为12。FIG. 3 is a schematic diagram of a ventricular tachycardia identification flow diagram of an implantable medical device. The identification of the event is triggered by the corresponding count result. First, step 302 updates the real-time heart rate value according to the ECG signal. Then, step 304 compares the real-time heart rate value with the VT threshold value, if the real-time heart rate value is less than the VT threshold value, the VT counter is cleared to restart counting, and returns to step 302 to re-update the real-time heart rate value; if When the real-time heart rate value is greater than or equal to the VT threshold value, go to step 306 to compare it with the rapid VT threshold value, if the real-time heart rate value is less than the rapid VT threshold value, then the VTcount value Add 1, the update of the VT count value is completed by the VT counter; if the real-time heart rate value is greater than or equal to the VT threshold value, the VT count value remains unchanged, that is, the event will not be counted, and go back to step 302 to continue updating the real-time heart rate value. When the said VT count value is greater than the VT threshold value and less than the fast VT threshold value, the VT count event is a valid event, and the VT counter triggers the counting step. With the continuous update of the real-time heart rate value, when the ventricular tachycardia count value does not reach the first threshold and meets the ventricular tachycardia count condition, the ventricular tachycardia count value is continuously counted. When the VT count value reaches the first threshold, see step 310, it is identified as VT. The first threshold value is 12.

图5为植入式医疗设备心脏事件计数方法中室颤计数流程示意图。首先，步骤502通过心电信号不断更新实时心率值，步骤504更新移位寄存器x(n-m+1),x(n-m+2)，...，x(n)，本发明中室颤计数过程中移位寄存器包含的实时心率数据序列为24位，即每次更新当前实时心率和依此向前的共计24个实时心率数列。步骤506表示室颤计数值的计数条件，即室颤计数值等于所述移位寄存器更新的24位实时心率值序列中大于室速门限值的个数。FIG. 5 is a schematic diagram of a counting flow of ventricular fibrillation in a method for counting cardiac events of an implantable medical device. First, step 502 continuously updates the real-time heart rate value through the ECG signal, and step 504 updates the shift registers x(n-m+1), x(n-m+2), . . . , x(n), in the present invention The real-time heart rate data sequence contained in the shift register in the ventricular fibrillation counting process is 24 bits, that is, the current real-time heart rate is updated each time and a total of 24 real-time heart rate sequences are forwarded accordingly. Step 506 represents the counting condition of the ventricular fibrillation count value, that is, the ventricular fibrillation count value is equal to the number of the 24-bit real-time heart rate value sequence updated by the shift register that is greater than the ventricular tachycardia threshold value.

图6为植入式医疗设备心脏事件识别方法中室颤识别流程示意图。总体包含更新室颤计数器和回溯窗口室颤事件的判断两个部分。第一部分更新室颤计数器中，将高于快速室速区的实时心率值作为室颤事件的判断依据。首先，步骤602根据心电信号更新实时心率值，步骤604将实时心率值与快速室速门限值比较，步骤606根据比较结果确定室颤事件计数值，所述室颤计数值为移位寄存器中实时心率值大于快速室速门限值的个数，快速室速门限值取值200-250bpm。如果室颤计数值达到第三阈值时,启动第二部分回溯窗口内室颤事件的判断，如果室颤计数值未达到第三阈值时，返回步骤602继续更新实时心率值。图6中第三阈值取值18，即移位寄存器中的24个实时心率值中有18个实时心率值位于室颤区时，室颤计数值达到阈值18，则启动回溯窗口，所述室颤区的心率取值范围为200-250bpm。按照步骤610更新回溯窗口内的实时心率值序列，步骤610将所述回溯窗口内的所有实时心率值与室颤区心率值进行比较，如果存在至少一个实时心率值位于室颤区范围内，则识别为室颤，否则，识别为快速室速。FIG. 6 is a schematic diagram of a ventricular fibrillation identification process in an implantable medical device cardiac event identification method. The whole includes two parts: updating the ventricular fibrillation counter and judging the retrospective window ventricular fibrillation event. In the first part of updating the ventricular fibrillation counter, the real-time heart rate value higher than the fast VT zone is used as the judgment basis for ventricular fibrillation events. First, step 602 updates the real-time heart rate value according to the ECG signal, step 604 compares the real-time heart rate value with the fast ventricular tachycardia threshold value, step 606 determines the ventricular fibrillation event count value according to the comparison result, and the ventricular fibrillation count value is a shift register The number of real-time heart rate values greater than the fast ventricular tachycardia threshold value, the fast ventricular tachycardia threshold value is 200-250bpm. If the ventricular fibrillation count value reaches the third threshold, the judgment of the ventricular fibrillation event in the second part of the retrospective window is started, and if the ventricular fibrillation count value does not reach the third threshold, return to step 602 to continue updating the real-time heart rate value. In Fig. 6, the third threshold value is 18, that is, when 18 real-time heart rate values in the 24 real-time heart rate values in the shift register are located in the ventricular fibrillation zone, and the ventricular fibrillation count value reaches the threshold value of 18, the backtracking window is started, and the room The heart rate in the flutter zone ranges from 200-250bpm. Update the real-time heart rate value sequence in the look-back window according to step 610. Step 610 compares all real-time heart rate values in the look-back window with the heart rate values in the ventricular fibrillation zone. If there is at least one real-time heart rate value within the range of the ventricular fibrillation zone, then It was identified as ventricular fibrillation, otherwise, it was identified as fast ventricular tachycardia.

图7为植入式医疗设备心脏事件计数方法流程示意图。包括室颤条件的判断和启动联合计数器两个部分。第一部分根据实时心率值进行室颤条件的判断。首先，步骤702根据心电信号更新实时心率值。步骤704在702获得实时心率值的基础上不断更新室速计数器和室颤计数器。室速计数器更新计算室速计数值的方法见图2，室颤计数器更新计算室颤计数值的方法见图5。步骤706将所述室颤计数值与第二阈值进行比较，当室颤计数值达到第二阈值时，进入第二部分。本发明所述室颤计数器的第二阈值取值为6，实际操作中，可以结合实际需求，对第二阈值进行略微修改。步骤708启动联合计数器，步骤710由联合计数器更新计算联合计数值，联合计数器在室速计数器和室颤计数器的基础上更新，联合计数值＝室速计数值+室颤计数值。FIG. 7 is a schematic flowchart of a method for counting cardiac events in an implantable medical device. Including the judgment of ventricular fibrillation conditions and the activation of the joint counter. The first part judges the condition of ventricular fibrillation according to the real-time heart rate value. First, step 702 updates the real-time heart rate value according to the ECG signal. Step 704 continuously updates the ventricular tachycardia counter and the ventricular fibrillation counter based on the real-time heart rate value obtained at 702 . The method of updating the VT counter to calculate the ventricular tachycardia count value is shown in Figure 2, and the method of updating the ventricular fibrillation counter to calculate the ventricular fibrillation count value is shown in Figure 5. Step 706 compares the ventricular fibrillation count value with the second threshold value, and when the ventricular fibrillation count value reaches the second threshold value, the second part is entered. The value of the second threshold value of the ventricular fibrillation counter of the present invention is 6. In actual operation, the second threshold value may be slightly modified according to actual requirements. Step 708 starts the joint counter, and step 710 updates the joint counter to calculate the joint count value. The joint counter is updated on the basis of the VT counter and the ventricular fibrillation counter, and the joint count value = VT count value + ventricular fibrillation count value.

图4为回溯窗口的实时心率值序列逻辑结构示意图。所述回溯窗口指实时心跳速率的几个数量单元，即当前实时心跳速率向前追溯一定数量的实时心率值。回溯窗口的数量可以根据实际需求进行调整，本发明所述所有回溯窗口数量单元为8。将实时心率值记为x(n)，则回溯窗口为x(n-7)、x(n-6)、.....x(n-1)、x(n)。回溯窗口中实时心率存储在移位寄存器上，实时心率值每更新一次，移位寄存器移位一次。所述移位寄存器不仅具有更新实时心率值的功能，还具有记录和储存实时心率值序列的功能，能够储存当前回溯窗口内的所有实时心率值数据序列。FIG. 4 is a schematic diagram of the logical structure of the real-time heart rate value sequence of the retrospective window. The retrospective window refers to several quantitative units of the real-time heart rate, that is, the current real-time heart rate traces forward a certain number of real-time heart rate values. The number of backtracking windows can be adjusted according to actual requirements, and the unit of the number of all backtracking windows described in the present invention is 8. Denote the real-time heart rate value as x(n), then the lookback window is x(n-7), x(n-6), ...... x(n-1), x(n). The real-time heart rate in the lookback window is stored in the shift register, and the shift register is shifted once every time the real-time heart rate value is updated. The shift register not only has the function of updating the real-time heart rate value, but also has the function of recording and storing the real-time heart rate value sequence, and can store all the real-time heart rate value data sequence in the current retrospective window.

图8植入式医疗设备心脏事件识别方法流程示意图。包括室颤条件的判断、启动联合计数器和启动回溯窗口三个部分。第一部分根据实时心率值进行室颤条件的判断。步骤802根据心电信号更新实时心率值。步骤804在802获得实时心率值的基础上不断更新室速计数器和室颤计数器。步骤806将所述室颤计数值与第二阈值进行比较，当室颤计数值达到第二阈值时，进入第二部分。步骤808启动联合计数器，步骤810由将联合计数值与第三阈值进行比较，联合计数值＝室速计数值+室颤计数值，如果联合计数值未达到第三阈值，则返回步骤804继续更新室颤计数器和室速计数器；如果联合计数值达到第三阈值，则按照步骤812启动回溯窗口。本发明所述联合计数阈值T5取值为21。启动回溯窗口后，根据图4获得回溯窗口内的实时心率值序列，步骤814判断回溯窗口内是否存在室颤事件，即判断回溯窗口内是否存在位于室颤区的实时心率值，若存在，则识别为室颤；若不存在，则继续判断所述回溯窗口内是否存在快速室速事件，即判断回溯窗口内是否存在位于快速室速区的实时心率值，若存在，则识别为快速室速；否则，识别为室速。FIG. 8 is a schematic flowchart of a method for identifying cardiac events in an implantable medical device. It includes three parts: judgment of ventricular fibrillation condition, activation of joint counter and activation of retrospective window. The first part judges the condition of ventricular fibrillation according to the real-time heart rate value. Step 802 updates the real-time heart rate value according to the ECG signal. Step 804 continuously updates the ventricular tachycardia counter and the ventricular fibrillation counter based on the real-time heart rate value obtained in 802 . Step 806 compares the ventricular fibrillation count value with the second threshold value, and when the ventricular fibrillation count value reaches the second threshold value, the second part is entered. Step 808 starts the joint counter, and step 810 compares the joint count value with the third threshold, the joint count value = VT count value + ventricular fibrillation count value, if the joint count value does not reach the third threshold, return to step 804 to continue updating ventricular fibrillation counter and ventricular tachycardia counter; if the combined count value reaches the third threshold, the lookback window is started according to step 812 . The joint count threshold T5 in the present invention takes a value of 21. After starting the retrospective window, the real-time heart rate value sequence in the retrospective window is obtained according to FIG. 4, and step 814 judges whether there is a ventricular fibrillation event in the retrospective window, that is, determines whether there is a real-time heart rate value located in the ventricular fibrillation area in the retrospective window, and if so, then Identify it as ventricular fibrillation; if it does not exist, continue to judge whether there is a rapid VT event in the retrospective window, that is, determine whether there is a real-time heart rate value located in the rapid VT zone in the retrospective window, and if so, identify it as rapid VT ; otherwise, ventricular tachycardia is identified.

所述算法可用于植入式医疗设备对心脏内部心室速率的计算和识别。这两种功能的实现方式有两种，一、自动运行完成心电信号的测定和心脏事件的计数和识别；二、人工调控执行完成心电信号的测定和心脏事件的计数和识别。第二种方式能够与患者助手进行连接，将感知的心电信号数据传输到患者助手上，通过将患者助手送到医院进行识别，这样不需要患者亲自到医院，很大程度上为患者带来了方便。也可以与远程设别进行连接，通过远程设备对植入体内的医疗设备进行参数设置和调控。The algorithm can be used for the calculation and identification of the intra-cardiac ventricular rate by an implantable medical device. There are two ways to realize these two functions, one is automatic operation to complete the measurement of ECG signals and the counting and identification of cardiac events; the other is to perform manual regulation and execution to complete the measurement of ECG signals and the counting and identification of cardiac events. The second method can connect with the patient assistant, transmit the perceived ECG signal data to the patient assistant, and send the patient assistant to the hospital for identification, so that the patient does not need to go to the hospital in person, which greatly brings benefits to the patient. convenience. It can also be connected to a remote device to set and control the parameters of the medical equipment implanted in the body through the remote device.

所述识别结果分为三个区:室速，快速室速和室颤。相应的治疗模块分为三个模块：室速治疗模块，快速室速治疗模块和室颤治疗模块。治疗的工作状态(激活/休眠)由识别阶段的结果确定。当前治疗模块实施治疗措施后，该模块会监视治疗后患者心跳速率并准备下一次治疗。如果该模块发现治疗失败，它会继续实施下一次的治疗措施，直至患者心跳回复正常或治疗措施次数达到上限。The identification results are divided into three zones: ventricular tachycardia, fast ventricular tachycardia and ventricular fibrillation. The corresponding treatment module is divided into three modules: VT treatment module, fast VT treatment module and ventricular fibrillation treatment module. The working state (active/dormant) of the treatment is determined by the results of the identification phase. After the current treatment module implements treatment measures, the module monitors the patient's heart rate after treatment and prepares for the next treatment. If the module finds that the treatment fails, it will continue to implement the next treatment until the patient's heartbeat returns to normal or the number of treatments reaches the upper limit.

Claims (14)

1. An implantable medical device with chamber rate counting functionality, the implantable medical device configured to:

step a, updating a real-time heart rate value according to an electrocardiosignal;

step b, updating the chamber speed counting value by a chamber speed counter;

the step b further comprises the following steps:

step b1, comparing the real-time heart rate value with a chamber rate threshold value, when the real-time heart rate value is smaller than the chamber rate threshold value, the chamber rate count value returns to zero and starts counting again;

step b2, when the real-time heart rate value is larger than or equal to the chamber speed threshold value and smaller than the rapid chamber speed threshold value, adding 1 to the chamber speed count value;

step b3 when the real-time heart rate value is greater than or equal to the fast chamber speed threshold value, the chamber speed counter does not count.

2. The implantable medical device of claim 1, wherein the chamber velocity threshold value is derived by: take some integer value in 150-.

3. The implantable medical device of claim 1, wherein the rapid chamber velocity threshold value is derived by: take 200 and 250 bpm.

4. An implantable medical device with chamber rate identification, the implantable medical device configured to:

step a, updating a real-time heart rate value according to an electrocardiosignal;

step b, updating the chamber speed counting value by a chamber speed counter;

the step b further comprises the following steps:

step b1, comparing the real-time heart rate value with a chamber rate threshold value, when the real-time heart rate value is smaller than the chamber rate threshold value, the chamber rate count value returns to zero and starts counting again;

step b2, when the real-time heart rate value is larger than or equal to the chamber speed threshold value and smaller than the rapid chamber speed threshold value, adding 1 to the chamber speed count value;

step b3, when the real-time heart rate value is larger than or equal to the fast chamber speed threshold value, the chamber speed counter does not count;

step b4 identifies chamber velocity when the chamber velocity count reaches a first threshold, otherwise, continues to update the real-time heart rate value.

5. The implantable medical device of claim 4, wherein the identification module is capable of inducing the corresponding therapy module.

6. The implantable medical device of claim 5, wherein the chamber velocity count value is added to the original chamber velocity count value and is counted when the chamber velocity count value is increased by 1 and does not reach the first threshold value.

7. The implantable medical device of claim 6, wherein the first threshold value is 6.

8. An implantable medical device having cardiac event counting functionality, the medical device configured to:

step a, updating a real-time heart rate value according to an electrocardiosignal;

step B, continuously updating a ventricular fibrillation count value according to the real-time heart rate value, wherein the ventricular fibrillation count value is equal to the number of the real-time heart rate values in the shift register which are larger than the quick ventricular speed threshold value;

step B1, when the ventricular fibrillation count value is smaller than the second threshold value, returning to the step a to continuously update the real-time heart rate value;

step B2 triggers the joint counter when the ventricular fibrillation count reaches the second threshold, and the joint counter updates the joint count, which is the ventricular speed count + the ventricular fibrillation count.

Step b, updating the chamber speed counting value by a chamber speed counter;

the step b further comprises the following steps:

step b1, comparing the real-time heart rate value with a chamber rate threshold value, when the real-time heart rate value is smaller than the chamber rate threshold value, the chamber rate count value returns to zero and starts counting again;

step b2, when the real-time heart rate value is larger than or equal to the chamber speed threshold value and smaller than the rapid chamber speed threshold value, adding 1 to the chamber speed count value;

step b3 when the real-time heart rate value is greater than or equal to the fast chamber speed threshold value, the chamber speed counter does not count.

9. The implantable medical device of claim 8, wherein the ventricular fibrillation count value is calculated by:

step a, updating a real-time heart rate value according to an electrocardiosignal;

step C, updating a shift register x (n-m +1), x (n-m), according to the real-time heart rate value;

and D, the ventricular fibrillation count value is equal to the number of real-time heart rate values larger than the quick ventricular rate threshold value in the shift register.

10. The implantable medical device of claim 9, wherein the shift register shifts once per updated real-time heart rate value.

11. The implantable medical device having cardiac event counting as claimed in claim 10, wherein the second threshold is equal to 6.

12. An implantable medical device with cardiac event recognition, the implantable medical device configured to:

step a, updating a real-time heart rate value according to an electrocardiosignal;

step C, updating a shift register x (n-m +1), x (n-m), according to the real-time heart rate value;

step B, continuously updating a ventricular fibrillation count value according to the real-time heart rate value, wherein the ventricular fibrillation count value is equal to the number of the real-time heart rate values in the shift register which are larger than the quick ventricular speed threshold value;

step B1, when the ventricular fibrillation count value is smaller than the second threshold value, returning to the step a to continuously update the real-time heart rate value;

step B2, when the ventricular fibrillation count value reaches the second threshold, triggering the joint counter, and updating the joint count value by the joint counter, where the joint count value is ventricular speed count value + ventricular fibrillation count value;

and D, when the combined count value reaches a third threshold value, starting a backtracking window, wherein the operation method of the backtracking window comprises the following steps:

and E, detecting whether a real-time heart rate value in the range of the ventricular fibrillation region exists in the backtracking window, if at least one implemented heart rate value in the range of the ventricular fibrillation region exists, identifying the heart event as ventricular fibrillation, if not, continuously identifying whether a real-time heart rate value in the range of the rapid ventricular rate region exists in the backtracking window, if at least one implemented heart rate value in the range of the rapid ventricular rate region exists, identifying the heart event as rapid ventricular rate, and if not, identifying the heart event as rapid ventricular rate, otherwise, identifying the heart event as ventricular rate.

13. The implantable medical device having cardiac event recognition as in claim 12, wherein the backtracking window comprises a unit length of 8.

14. The implantable medical device with cardiac event recognition as set forth in claim 13, wherein the third threshold value is 21.

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