技术领域technical field
本发明属于医疗器械领域，具体涉及一种多腔室无导线起搏器系统的感知起搏方法。The invention belongs to the field of medical devices, and in particular relates to a sensing pacing method for a multi-chamber leadless pacemaker system.
背景技术Background technique
心脏起搏器是一种植入于体内的电子治疗仪器，通过脉冲发生器发放由电池提供能量的电脉冲，通过导线电极的传导，刺激电极所接触的心肌，使心脏激动和收缩，从而达到治疗由于某些心律失常所致的心脏功能障碍的目的。起搏系统除了上述起搏功能外，还会具有将心脏自身心电活动回传至脉冲发生器的感知功能。A pacemaker is an electronic therapy device implanted in the body. The pulse generator emits electrical pulses powered by batteries, and through the conduction of lead electrodes, it stimulates the myocardium in contact with the electrodes to excite and contract the heart, so as to achieve treatment. The purpose of cardiac dysfunction due to certain cardiac arrhythmias. In addition to the above-mentioned pacing function, the pacing system also has the sensing function of returning the heart's own cardiac electrical activity to the pulse generator.
在一些示例中，一种无导线起搏器可植入患者心室，在其外壳上包括一个或多个电极，以发放起搏脉冲和/或感知心脏电活动。虽然该无导线起搏器的感测和起搏功能可解决诸如缓慢心律失常等病况，但是例如窦房结功能障碍、房室传导阻滞等病况可能需要多腔室同步起搏，以便维持规律的心率。In some examples, a leadless pacemaker implanted in a patient's ventricle includes one or more electrodes on its housing to deliver pacing pulses and/or sense cardiac electrical activity. While the sensing and pacing capabilities of this leadless pacemaker address conditions such as bradyarrhythmias, conditions such as sinus node dysfunction, atrioventricular block, etc. may require synchronized multi-chamber pacing in order to maintain rhythm heart rate.
利用中国专利数据库、中国期刊全文数据库（CNKI），PubMed，美国专利商标（USPTO）、欧洲专利局（EPO）等，查阅发现有类似于本发明的专利存在。相似度较高的例如，Matthew D. Bonner等人专利号为US2014/0121720 A1的美国专利，描述了通过电极感知心室电信号和/或利用传感器感知心室机械信号（加速度计感知心房中加速度或压力传感器感知心房压力）进行同步起搏的方法；S·戈什等人公开号为CN108883281A的中国发明专利，描述了心内心室起搏器利用运动传感器来检测心房事件并进行同步起搏的方法；杰弗里·E·施塔曼公开号为CN106132478A的中国发明专利，描述了通过通信脉冲进行装置之间通信的多室无引线起搏器系统；基思·P·迈莱公开号为CN107073273A的中国发明专利，描述了起搏器通过传感器感测与心脏的心肌收缩力有关的参数，获取心脏电活动，根据感测到的心脏电活动信号对传感器进行电力管理，达到低功耗的目的。Using China Patent Database, China Periodicals Full-text Database (CNKI), PubMed, United States Patent and Trademark (USPTO), European Patent Office (EPO), etc., it is found that there are patents similar to the present invention. For example, US Patent No. US2014/0121720 A1 by Matthew D. Bonner et al. describes sensing ventricular electrical signals through electrodes and/or sensing ventricular mechanical signals using sensors (accelerometer sensing acceleration or pressure in the atrium). Sensor sensing atrial pressure) method for synchronous pacing; S. Ghosh et al. Chinese invention patent number CN108883281A, describes the method of cardiac ventricular pacemaker using motion sensor to detect atrial events and perform synchronous pacing; Geoffrey E. Starman's Chinese invention patent with publication number CN106132478A describes a multi-chamber leadless pacemaker system that communicates between devices through communication pulses; Keith P. Miley's publication number is CN107073273A The Chinese invention patent describes that the pacemaker uses the sensor to sense the parameters related to the myocardial contractility of the heart, obtains the electrical activity of the heart, and manages the power of the sensor according to the sensed electrical activity signal of the heart, so as to achieve the purpose of low power consumption.
发明内容SUMMARY OF THE INVENTION
本发明为一种多腔室无导线起搏器系统的感知起搏方法，配置为在心脏任意腔室的起搏器，通过其处理模块接收到的力学传感器感测的机械事件及心电感知模块感知的电事件，判断心脏搏动状况及心电状况，以此达到感测心脏活动、精准调控心脏起搏的目的。The present invention is a sensing and pacing method for a multi-chamber leadless pacemaker system, which is configured as a pacemaker in any chamber of the heart, and receives mechanical events and electrocardiogram sensing by a mechanical sensor received by its processing module. The electrical events sensed by the module can be used to determine the heartbeat status and electrocardiographic status, so as to achieve the purpose of sensing heart activity and accurately regulating heart pacing.
系统中的无导线起搏器均包括力学感测模块，心电感知模块，处理模块，通信模块，起搏模块，供电模块，存储器；以及起搏器可受体外程控装置控制。The leadless pacemakers in the system all include a mechanical sensing module, an ECG sensing module, a processing module, a communication module, a pacing module, a power supply module, and a memory; and the pacemaker can be controlled by an external programming device.
所述力学感测模块中力学传感器可感测心脏心肌细胞扭转力，从而检测所植入腔室的机械事件。The mechanical sensor in the mechanical sensing module can sense the torsional force of cardiac cardiomyocytes to detect mechanical events in the implanted chamber.
所述心电感知模块则通过电极感测所处腔室的心电信号。The ECG sensing module senses the ECG signal of the chamber where it is located through the electrodes.
所述处理模块通过处理力学感测模块感测到的心脏机械事件及心电感知模块感知到的心电信号，确定心脏活动状况，根据设定的参数确定心脏起搏指令。The processing module determines the cardiac activity status by processing the cardiac mechanical events sensed by the mechanical sensing module and the electrocardiographic signal sensed by the electrocardiographic sensing module, and determines the cardiac pacing instruction according to the set parameters.
所述通信模块可与体外程控装置之间进行通讯，主要是将起搏器运行状况传输给体外程控装置，且接收体外程控装置的相关指令。The communication module can communicate with the external program-controlled device, and mainly transmits the operation status of the pacemaker to the external program-controlled device, and receives the relevant instructions from the external program-controlled device.
所述起搏模块接收处理模块发出的起搏指令，并进行起搏。The pacing module receives the pacing instruction sent by the processing module, and performs pacing.
所述供电模块为起搏器各模块的活动供电。The power supply module supplies power for the activities of each module of the pacemaker.
所述存储器负责存储起搏器的运行数据。The memory is responsible for storing pacemaker operating data.
本发明创新点Innovation point of the present invention
本发明一种多腔室无导线起搏器系统的感知起搏方法，心脏可根据需要安装一个或多个起搏器，起搏器根据所在位置，设定感知、起搏参数，不同起搏器之间可独立工作，通过感知到的心脏活动建立关联。该发明将心脏的机械信号与心电信号相结合，不同腔室的起搏器可通过这两种信号相互感应，体外程控系统也可以将不同的起搏器建立联系，使得不同腔室起搏器的起搏活动能够统一，多腔室起搏器系统的运转也更加安全、有效。The present invention is a sensing and pacing method for a multi-chamber leadless pacemaker system. One or more pacemakers can be installed in the heart according to the needs. The pacemaker can set sensing and pacing parameters according to its location. The devices can work independently and establish an association through the sensed cardiac activity. The invention combines the mechanical signal of the heart with the ECG signal. The pacemakers in different chambers can sense each other through these two signals, and the external program control system can also establish a connection between the different pacemakers, so that the different chambers can be paced. The pacing activity of the device can be unified, and the operation of the multi-chamber pacemaker system is safer and more effective.
附图说明Description of drawings
下列附图用以说明本发明涉及的特定实施例及方法，且因此并不限制本发明的范围。结合下列详细描述中的解释，附图未按照比例（除非如此规定）且以使用为目的。结合附图，以数字表示元件，本发明涉及的方法将在下文中进行描述，以及：The following drawings illustrate specific embodiments and methods to which the present invention relates, and therefore do not limit the scope of the present invention. In conjunction with the explanations in the following detailed description, the drawings are not to scale (unless so specified) and are intended for use. In conjunction with the accompanying drawings, elements are represented numerically, and the method to which the present invention relates will be described hereinafter, and:
图1a示出能够感测心脏电信号、心脏机械事件，并将起搏治疗提供给患者心脏的心内起搏系统示意图。Figure 1a shows a schematic diagram of an intracardiac pacing system capable of sensing cardiac electrical signals, cardiac mechanical events, and delivering pacing therapy to a patient's heart.
图1b是一个示例的起搏器植入后力学传感器与心肌细胞的相对位置。Figure 1b is an example of the relative position of the mechanical sensor to the cardiomyocytes after pacemaker implantation.
图2是图1的心内起搏器其中一个实施例的概念图。FIG. 2 is a conceptual diagram of one embodiment of the intracardiac pacemaker of FIG. 1 .
图3是图1的起搏器示例配置的示意图。FIG. 3 is a schematic diagram of an example configuration of the pacemaker of FIG. 1 .
图4是根据一个示例的心房内起搏器起搏方法的流程图。4 is a flow diagram of an intra-atrial pacemaker pacing method according to one example.
图5是根据一个示例的用于递送心房同步的心室起搏方法的流程图。5 is a flowchart of a ventricular pacing method for delivering atrial synchronization, according to one example.
图6是本发明测得的不同腔室心电信号、机械信号之间相关关系的示图。FIG. 6 is a diagram showing the correlation between ECG signals and mechanical signals in different chambers measured by the present invention.
具体实施方式Detailed ways
图1是一个示例可用于感测心脏电信号和由心肌扭转引起的心肌扭转力，并将起搏治疗提供给患者心脏100的多腔室无导线起搏系统101的概念图。多腔室无导线起搏系统101，一些示例中可包括右心室（RV）心内起搏器200，右心房（RA）心内起搏器300，或其他不同腔室起搏器的组合。起搏器均为经导管心内起搏器，其可被适配用于完全植入在心脏100的腔室内，例如，完全在RV内，完全在左心室（LV）内，完全在RA内或完全在左心房（LA）内。在图1的示例中，起搏器300沿着RA的心内膜（例如沿着RA侧壁或RA隔膜）被定位。起搏器200沿着RV的心内膜壁被定位（例如RV心尖）。然而，本文公开的技术不限于图1的示例中所示的起搏器位置和数量，并且其他位置和彼此相对位置是可能的。在一些示例中，心室心内起搏器200被定位在RV中，用于使用本文公开的技术递送心房同步的心室起搏。FIG. 1 is a conceptual diagram of an example multi-chamber leadless pacing system 101 that may be used to sense cardiac electrical signals and myocardial torsional forces caused by myocardial torsion, and provide pacing therapy to a patient's heart 100 . The multi-chamber leadless pacing system 101, in some examples, may include a right ventricular (RV) intracardiac pacemaker 200, a right atrial (RA) intracardiac pacemaker 300, or a combination of other different chamber pacemakers. The pacemakers are all transcatheter intracardiac pacemakers that can be adapted for implantation entirely within a chamber of the heart 100, eg, entirely within the RV, entirely within the left ventricle (LV), entirely within the RA or completely within the left atrium (LA). In the example of FIG. 1, the pacemaker 300 is positioned along the endocardium of the RA (eg, along the RA sidewall or the RA septum). The pacemaker 200 is positioned along the endocardial wall of the RV (eg, the RV apex). However, the techniques disclosed herein are not limited to the pacemaker positions and numbers shown in the example of FIG. 1, and other positions and positions relative to each other are possible. In some examples, a ventricular intracardiac pacemaker 200 is positioned in the RV for delivering atrial synchronized ventricular pacing using the techniques disclosed herein.
起搏器200和300与皮下植入的起搏器相比在尺寸上被减小，并且在形状上可通常是圆柱形，以实现经由递送导管的经静脉植入。在其他示例中，起搏器200和300可被定位在心脏100里面的任何其他位置处。例如起搏器300可被定位在右心房和左心房的外面或之内，以提供相应的右心房或左心房起搏。起搏器300可被定位在右心室或左心室内，以提供相应的右心室或左心室起搏，并用于通过心室腔内的力学传感器感测心脏搏动情况。Pacemakers 200 and 300 are reduced in size compared to subcutaneously implanted pacemakers, and may be generally cylindrical in shape to enable transvenous implantation via a delivery catheter. In other examples, pacemakers 200 and 300 may be positioned at any other location within heart 100 . For example, pacemaker 300 may be positioned outside or within the right and left atria to provide corresponding right or left atrial pacing. The pacemaker 300 may be positioned within the right ventricle or the left ventricle to provide corresponding right or left ventricular pacing and for sensing cardiac beating conditions via mechanical sensors within the ventricular cavity.
起搏器200和300能够独立产生经由起搏器外部壳体上的一个或多个电极被递送到心脏100的电刺激脉冲，例如，起搏脉冲。RA起搏器300被配置为感测RA内的心电信号，其可以用于转化为RA心内电描记图信号（EGM）。用于递送RA起搏脉冲的基于壳体的电极也可以用于感测RA心电信号。RV起搏器200配置成使用基于壳体的电极来递送RV起搏脉冲并感测RV心电信号。Pacemakers 200 and 300 are capable of independently generating electrical stimulation pulses, eg, pacing pulses, that are delivered to heart 100 via one or more electrodes on the pacemaker's outer housing. The RA pacemaker 300 is configured to sense electrocardiographic signals within the RA, which can be used to convert into RA intracardiographic electrogram signals (EGM). Housing-based electrodes used to deliver RA pacing pulses can also be used to sense RA ECG signals. The RV pacemaker 200 is configured to deliver RV pacing pulses and sense RV ECG signals using housing-based electrodes.
在一些示例中，患者可能仅需要RV起搏器200用于递送心室起搏。在其他示例中，取决于个体患者需要，可能需要RA起搏器300用于心房起搏。RV起搏器200被配置成用以促进RA激活和RV激活之间的同步（例如，通过维持心房事件和心室起搏脉冲之间的目标房室（AV）间期）的方式控制将心室起搏脉冲递送到RV。也就是说，RV起搏器200控制RV起搏脉冲递送以维持对应于心房收缩的心房激活（固有的或起搏诱发的）与被递送以致心室去极化的心室起搏脉冲之间的期望AV间期。根据本公开描述的技术，RV起搏器通过获取的力学传感器信号判断心脏搏动情况，该力学传感器信号源于心脏搏动时产生的心肌扭转力。例如RV起搏器200，根据力学传感器感测到的心室内心肌细胞在心脏搏动时产生的心肌扭转力，获取心脏机械活动信号。In some examples, the patient may only need the RV pacemaker 200 for delivering ventricular pacing. In other examples, RA pacemaker 300 may be required for atrial pacing depending on individual patient needs. RV pacemaker 200 is configured to control ventricular pacing in a manner that facilitates synchronization between RA activation and RV activation (eg, by maintaining a target atrioventricular (AV) interval between atrial events and ventricular pacing pulses). beat pulses are delivered to the RV. That is, the RV pacemaker 200 controls RV pacing pulse delivery to maintain a desired between atrial activation (either intrinsic or pace-induced) corresponding to atrial contraction and a ventricular pacing pulse delivered to depolarize the ventricle AV interval. According to the technology described in the present disclosure, the RV pacemaker judges the cardiac beating condition by the acquired mechanical sensor signal, the mechanical sensor signal originating from the myocardial torsion force generated during the beating of the heart. For example, the RV pacemaker 200 acquires the mechanical activity signal of the heart according to the myocardial torsion force generated by the cardiac muscle cells in the ventricle when the heart beats sensed by the mechanical sensor.
目标AV间期可以是由临床医生选择的编程值，并且是从检测到心房事件直到递送心室起搏脉冲的时间间期。在一些示例中，目标AV间期可以从基于力学传感器信号检测到的心房事件的时间开始，或者力学传感器信号被表示的基准点开始。可以基于从由RV起搏器200接收到的心电信号和由RV起搏器200接收到的力学传感器信号所表示出的电事件和心肌扭转力相关事件的相对定时，确定目标AV间期是最佳的。The target AV interval may be a programmed value selected by the clinician and is the time interval from detection of an atrial event until delivery of a ventricular pacing pulse. In some examples, the target AV interval may begin at the time of the atrial event detected based on the mechanics sensor signal, or a reference point at which the mechanics sensor signal is represented. The target AV interval can be determined to be based on the relative timing of electrical events and myocardial torsion-related events represented by the ECG signal received by the RV pacemaker 200 and the mechanics sensor signal received by the RV pacemaker 200. The best.
起搏器200和起搏器300均能够与外部的程控装置进行双向无线通信，以用于对AV间期以及其他力学传感器感知参数和起搏控制参数进行编程。Both pacemaker 200 and pacemaker 300 are capable of two-way wireless communication with an external programming device for programming the AV interval and other mechanical sensor sensing parameters and pacing control parameters.
如图2所示的心内RV起搏器的概念图。RV起搏器200包括沿着起搏器200的壳体204间隔开的用于感测心电信号和递送起搏脉冲的电极211和212。电极212被示为位于起搏器200固定端201的尖端电极，并且电极211被示为沿着壳体204的中部的环形电极。A conceptual diagram of the intracardiac RV pacemaker shown in Figure 2. The RV pacemaker 200 includes electrodes 211 and 212 spaced along the housing 204 of the pacemaker 200 for sensing ECG signals and delivering pacing pulses. Electrode 212 is shown as a tip electrode at fixed end 201 of pacemaker 200 , and electrode 211 is shown as a ring electrode along the middle of housing 204 .
电极211和212形成阳极和阴极对，以用于双极心脏起搏与感知。在替代的实施例中，起搏器200可包括两个或多个电极对，电极也可以位于壳体204其他位置。电极211和212可以是但不限于铂、钛、铱或其合金，并且可以包括低偏振涂层，例如氮化钛、氧化铱、氧化钌、铂黑等。Electrodes 211 and 212 form an anode and cathode pair for bipolar cardiac pacing and sensing. In alternative embodiments, the pacemaker 200 may include two or more electrode pairs, and the electrodes may also be located elsewhere in the housing 204 . Electrodes 211 and 212 may be, but are not limited to, platinum, titanium, iridium, or alloys thereof, and may include low-polarization coatings such as titanium nitride, iridium oxide, ruthenium oxide, platinum black, and the like.
壳体204由生物相容性材料（例如，不锈钢或钛合金）形成。在一些示例中，壳体204可包括绝缘涂层。绝缘涂层的示例包括聚对二甲苯、聚氨酯、PEEK或聚酰亚胺等。壳体204的整体可以是绝缘的，但是仅电极211和212是未绝缘的。电极212可以用作阴极电极并且经由跨壳体204的电馈通耦合到被壳体所封围的内部电路，例如，起搏脉冲发生器和心电信号感测电路。Housing 204 is formed from a biocompatible material (eg, stainless steel or titanium alloy). In some examples, the housing 204 may include an insulating coating. Examples of insulating coatings include parylene, polyurethane, PEEK, or polyimide, among others. The entirety of housing 204 may be insulated, but only electrodes 211 and 212 are uninsulated. Electrode 212 may function as a cathode electrode and be coupled via electrical feedthroughs across housing 204 to internal circuitry enclosed by the housing, eg, pacing pulse generators and electrocardiographic signal sensing circuitry.
壳体204包括控制电子组件203，其用于感知心脏电信号、产生起搏脉冲并控制治疗递送以及如下面结合图3描述的起搏器200的其他功能的电子器件。Housing 204 includes control electronics 203 for sensing cardiac electrical signals, generating pacing pulses, and controlling therapy delivery, among other functions of pacemaker 200 as described below in connection with FIG. 3 .
壳体进一步包括供电模块270，该供电模块包括电池组件，将电力提供给控制电子组件。电池可为生物自供能电池、可充电电池、氟化碳电池、锂电池等。The housing further includes a power supply module 270 that includes a battery assembly that provides power to the control electronics assembly. The battery may be a biological self-powered battery, a rechargeable battery, a fluorocarbon battery, a lithium battery, or the like.
起搏器200可包括固定器205，固定器205可为示例中的尖齿状，在一些示例中，固定器205可为螺旋状、倒钩状等，可以是由金属（注入，不锈钢或钛合金）形成。The pacemaker 200 may include a retainer 205, which may be in the shape of tines in the example, in some examples, the retainer 205 may be helical, barb-shaped, etc., and may be made of metal (injected, stainless steel, or titanium). alloy) formed.
在一些示例中，力学传感器213可被安装在固定器上。固定器固定在心肌细胞后，力学传感器镶嵌在心肌细胞中，以感知心肌扭转力的变化。In some examples, the force sensor 213 may be mounted on the fixture. After the fixator is fixed in the cardiomyocytes, the mechanical sensors are embedded in the cardiomyocytes to sense the changes of myocardial torsion force.
图3是图1所示的起搏器200的示例配置的示意图。起搏器200包括力学感测模块210、起搏模块220、处理模块230、通信模块240、心电感知模块250、存储器260、供电模块270。力学感测模块210被实现在下面结合图4-6描述的示例中的力学传感器并且在本文中也被称为“力学传感器213”。力学传感器213不限于压电传感器和微机电系统，并且其他材料的传感器可以在起搏器200中被成功地予以利用来根据本文描述的技术来检测心脏机械事件。力学传感器213可以是多轴传感器（例如。二维或三维传感器），每个轴可以单独或组合分析以用于检测心脏机械事件的信号。图3中被表示的各种电路可以组合在一个或者多个集成电路板上，该一个或多个集成电路包括专用集成电路、电子电路、执行一个或多个软件或固定程序的处理器（共享的、专用的、或组）和存储器、组合逻辑电路、状态机、或提供所描述的功能的其他合适的组件。FIG. 3 is a schematic diagram of an example configuration of the pacemaker 200 shown in FIG. 1 . The pacemaker 200 includes a mechanical sensing module 210 , a pacing module 220 , a processing module 230 , a communication module 240 , an electrocardiogram sensing module 250 , a memory 260 , and a power supply module 270 . The force sensing module 210 is implemented as a force sensor in the examples described below in connection with FIGS. 4-6 and is also referred to herein as "mechanical sensor 213". Mechanical sensors 213 are not limited to piezoelectric sensors and microelectromechanical systems, and sensors of other materials may be successfully utilized in pacemaker 200 to detect cardiac mechanical events in accordance with the techniques described herein. The mechanical sensor 213 may be a multi-axis sensor (eg, a two-dimensional or three-dimensional sensor), and each axis may be analyzed individually or in combination to detect signals of cardiac mechanical events. The various circuits represented in Figure 3 may be combined on one or more integrated circuit boards including application specific integrated circuits, electronic circuits, processors (shared) executing one or more software or fixed programs dedicated, dedicated, or group) and memory, combinational logic, state machines, or other suitable components that provide the described functionality.
心电感知模块250被配置为通过前置滤波器251经由电极211和212接收心电信号。前置滤波器251可以进一步包括放大器，以放大被传递到整流器和放大器电路252的“原始”心电信号。整流器和放大器电路252将信号传递给心电信号检测器和模数转换器253。模数转换器253可以将多位数字电描记图信号传递到起搏器处理模块230的起搏控制电路231，以用于由心脏运行检测电路233使用来表示心脏电事件。The ECG sensing module 250 is configured to receive ECG signals via the electrodes 211 and 212 through the pre-filter 251 . The pre-filter 251 may further include an amplifier to amplify the "raw" ECG signal passed to the rectifier and amplifier circuit 252 . The rectifier and amplifier circuit 252 passes the signal to the ECG signal detector and analog-to-digital converter 253 . The analog-to-digital converter 253 may pass the multi-bit digital electrogram signal to the pacing control circuit 231 of the pacemaker processing module 230 for use by the cardiac performance detection circuit 233 to represent cardiac electrical events.
处理模块230包括心脏运行检测电路231、起搏控制电路232和处理器233。心脏运行检测电路231被配置为从力学感测模块210接收到的信号中检测心脏机械事件。力学感测模块210包括力学传感器213，其可以是压电晶体或微机电系统设备，当心肌细胞运动时，产生与力学传感器213（和起搏器200）的运动相关的电信号。The processing module 230 includes a heart operation detection circuit 231 , a pacing control circuit 232 and a processor 233 . The cardiac performance detection circuit 231 is configured to detect cardiac mechanical events from signals received by the mechanical sensing module 210 . The mechanics sensing module 210 includes a mechanics sensor 213, which may be a piezoelectric crystal or a microelectromechanical system device, which generates electrical signals related to the movement of the mechanics sensor 213 (and pacemaker 200) when the cardiomyocytes move.
心脏运行检测电路231可以从心电感知模块250接收心电信号和/或数字EGM信号，以用于与力学感测模块210检测到的心脏机械事件作对照，增加起搏器200对心脏运动状态判断的准确率。心脏运行检测电路231将得到的心脏运行信息传递给处理器233，对心脏运行情况进行判断，并做出是否发送起搏脉冲的指令。The cardiac operation detection circuit 231 may receive the ECG signal and/or the digital EGM signal from the ECG sensing module 250 for comparison with the cardiac mechanical events detected by the mechanical sensing module 210, so as to increase the pacemaker 200's response to the cardiac movement state. Judgment accuracy. The heart operation detection circuit 231 transmits the obtained heart operation information to the processor 233, judges the heart operation condition, and makes an instruction whether to send a pacing pulse.
本文归因于起搏器200的功能可以被体现为一个或多个处理器、控制器、硬件、固件、软件或其任何组合。将不同的特征描绘为具有电路旨在突出不同的功能方面并且不一定暗示这种功能必须由单独的硬件、固件或软件组件或任何特定架构来实现。The functions attributed herein to pacemaker 200 may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof. Depiction of different features as having circuitry is intended to highlight different functional aspects and does not necessarily imply that such functionality must be implemented by separate hardware, firmware or software components or any particular architecture.
起搏模块220接收到处理模块230下达的发放起搏脉冲的指令后，该起搏脉冲经由电极211和212被递送至患者心脏的起搏部位。起搏模块可以包括充电电路221、开关222和输出电路223。充电电路221包括电容器原件。开关222在接到起搏指令后电路成为通路。输出电路223，将脉冲输送到电极211和212。After the pacing module 220 receives the instruction to issue a pacing pulse from the processing module 230 , the pacing pulse is delivered to the pacing site of the patient's heart via the electrodes 211 and 212 . The pacing module may include a charging circuit 221 , a switch 222 and an output circuit 223 . The charging circuit 221 includes capacitor elements. Switch 222 is turned on when a pacing command is received. An output circuit 223 delivers pulses to electrodes 211 and 212.
存储器260可以包括程控装置400的可读指令，以及心电感知模块250及力学感测模块210采集的心脏相关事件的数据。The memory 260 may include readable instructions of the programming device 400 , and data of cardiac-related events collected by the electrocardiogram sensing module 250 and the mechanics sensing module 210 .
供电模块270根据需要向起搏器200的其他电路组件提供电力。供电模块270可执行处理模块230下达的供电指令。供电模块可包括一个或多个能量存储设备，例如一个或多个可充电电池或不可充电电池。The power supply module 270 provides power to other circuit components of the pacemaker 200 as needed. The power supply module 270 can execute the power supply instruction issued by the processing module 230 . The power supply module may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries.
通信模块240可将起搏器200的运行状况传输给体外程控装置。体外程控装置的指令也可以通过通信模块240传输如起搏器200中。The communication module 240 may transmit the operating status of the pacemaker 200 to the external programming device. The commands of the external programming device can also be transmitted through the communication module 240 , such as in the pacemaker 200 .
图4是根据一个示例的心脏运行检测电路231的示意图。在该示例中，心电感知模块250、力学感测模块210搜集到的心脏力学运行信息传输给心脏运行检测电路231，心脏运行检测电路231根据起搏器固有信息（该固有信息可以是医生根据患者病情、起搏器安装位置进行设置的起搏器固有程序），对心脏运行情况进行判断，并做出是否发放起搏脉冲的判断。FIG. 4 is a schematic diagram of a cardiac performance detection circuit 231 according to one example. In this example, the cardiac mechanical operation information collected by the electrocardiogram sensing module 250 and the mechanical sensing module 210 is transmitted to the heart operation detection circuit 231, and the cardiac operation detection circuit 231 is based on the inherent information of the pacemaker (the inherent information can be The patient's condition and the pacemaker's inherent program to set the pacemaker's installation location), to judge the heart's operation, and to make a judgment on whether to issue pacing pulses.
图5是根据一个示例的用于由起搏器200递送心房同步起搏方法的流程图。通过力学传感器获得心脏心肌扭转力信号，获得的心肌扭转力信号后通过与心脏腔室机械事件的标准值进行对比，结合心电感知模块接收到的心电信号共同验证心脏的运动状态，以判断是否检测到心脏运行的特征事件。若力学感测模块未感测到心脏的心房事件，心脏可能处于某个起搏间期，因此，需要一直处于检测模式；当接收到心房事件时，根据设置的AV起搏间期，若心电感知模块能够感知到R波，则说明心脏未发生房室阻滞，心脏运行正常；若心电感知模块未感知到R波，则说明心脏发生房室阻滞，需要起搏器进行起搏脉冲的发放。5 is a flowchart of a method for delivering atrial synchronized pacing by pacemaker 200, according to one example. The cardiac myocardial torsion force signal is obtained through the mechanical sensor, and the obtained myocardial torsion force signal is compared with the standard value of the mechanical events of the cardiac chamber, and the ECG signal received by the ECG sensing module is combined to verify the heart's motion state to judge Whether or not an event characteristic of heart operation is detected. If the mechanical sensing module does not sense atrial events of the heart, the heart may be in a certain pacing interval, so it needs to be in the detection mode all the time; when an atrial event is received, according to the set AV pacing interval, if the heart If the electrical sensing module can sense the R wave, it means that the heart does not have atrioventricular block and the heart is running normally; if the ECG sensing module does not sense the R wave, it means that the heart has atrioventricular block and needs a pacemaker for pacing Pulse delivery.
图6是根据一个示例描述的不同植入位置的起搏器的心肌力与心脏内心电信号及心脏运行状态的对比示意图。如图所示，心室内起搏器测试到的心室心肌力与相应的心室容积及心电信号相对应，心房内起搏器检测到的心房心肌力与相应的心房容积及心电信号相对应，以此，心脏内起搏器能够在互相无通信且无干扰的情况下做出对心脏运行状态的判断。FIG. 6 is a schematic diagram illustrating the comparison of the myocardial force of the pacemaker in different implanted positions, the electrical signal in the heart, and the running state of the heart, according to an example. As shown in the figure, the ventricular myocardial force detected by the intraventricular pacemaker corresponds to the corresponding ventricular volume and ECG signal, and the atrial myocardial force detected by the intraventricular pacemaker corresponds to the corresponding atrial volume and ECG signal , in this way, the intracardiac pacemaker can make a judgment on the operation state of the heart under the condition of no communication and no interference with each other.
已参照说明性实施例提供了本公开，并且本公开不旨在以限制的意思进行解释。如先前所述，本领域的技术人员将认识到除在本文中描述和设想的特定示例之外，可以以各种形式来表明本公开。The present disclosure has been provided with reference to illustrative embodiments and is not intended to be construed in a limiting sense. As previously described, those skilled in the art will recognize that the present disclosure may be embodied in various forms other than the specific examples described and contemplated herein.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910254542.4ACN109966643A (en) | 2019-03-31 | 2019-03-31 | A sensory pacing method for a multi-chamber leadless pacemaker system |
| Application Number | Priority Date | Filing Date | Title |
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| CN201910254542.4ACN109966643A (en) | 2019-03-31 | 2019-03-31 | A sensory pacing method for a multi-chamber leadless pacemaker system |
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| CN201910254542.4APendingCN109966643A (en) | 2019-03-31 | 2019-03-31 | A sensory pacing method for a multi-chamber leadless pacemaker system |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115197903A (en)* | 2022-07-19 | 2022-10-18 | 北京智源人工智能研究院 | Cardiac biological pacemaker, computational model construction method, simulation method and device |
| CN117339107A (en)* | 2023-08-24 | 2024-01-05 | 中国人民解放军海军军医大学第一附属医院 | Biventricular synchronous leadless pacing device and pacing system |
| CN117339108A (en)* | 2023-12-04 | 2024-01-05 | 山东瑞安泰医疗技术有限公司 | Leadless cardiac pacemaker system capable of reducing pacing threshold and accurately positioning |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060287685A1 (en)* | 2005-06-21 | 2006-12-21 | Meyer Scott A | Multi-chamber cardiac capture detection using cross chamber sensing |
| CN106535988A (en)* | 2014-07-17 | 2017-03-22 | 美敦力公司 | Multi-chamber intracardiac pacing system |
| CN106535987A (en)* | 2014-07-25 | 2017-03-22 | 美敦力公司 | Atrial contraction detection by a ventricular leadless pacing device for atrial-synchronized ventricular pacing |
| CN107073273A (en)* | 2014-08-22 | 2017-08-18 | 心脏起搏器股份公司 | Possess the leadless cardiac pacemaker of the sensor with compared with low power mode |
| CN107405492A (en)* | 2015-02-26 | 2017-11-28 | 美敦力公司 | Pace crosstalk detection |
| CN109663210A (en)* | 2018-12-06 | 2019-04-23 | 张海军 | Self synchronous radio cardiac pacemaker system and its stimulating method |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060287685A1 (en)* | 2005-06-21 | 2006-12-21 | Meyer Scott A | Multi-chamber cardiac capture detection using cross chamber sensing |
| CN106535988A (en)* | 2014-07-17 | 2017-03-22 | 美敦力公司 | Multi-chamber intracardiac pacing system |
| CN106535987A (en)* | 2014-07-25 | 2017-03-22 | 美敦力公司 | Atrial contraction detection by a ventricular leadless pacing device for atrial-synchronized ventricular pacing |
| CN107073273A (en)* | 2014-08-22 | 2017-08-18 | 心脏起搏器股份公司 | Possess the leadless cardiac pacemaker of the sensor with compared with low power mode |
| CN107405492A (en)* | 2015-02-26 | 2017-11-28 | 美敦力公司 | Pace crosstalk detection |
| CN109663210A (en)* | 2018-12-06 | 2019-04-23 | 张海军 | Self synchronous radio cardiac pacemaker system and its stimulating method |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115197903A (en)* | 2022-07-19 | 2022-10-18 | 北京智源人工智能研究院 | Cardiac biological pacemaker, computational model construction method, simulation method and device |
| CN115197903B (en)* | 2022-07-19 | 2023-11-14 | 北京智源人工智能研究院 | Cardiac biological pacemaker, computational model construction method, simulation method and device |
| CN117339107A (en)* | 2023-08-24 | 2024-01-05 | 中国人民解放军海军军医大学第一附属医院 | Biventricular synchronous leadless pacing device and pacing system |
| CN117339108A (en)* | 2023-12-04 | 2024-01-05 | 山东瑞安泰医疗技术有限公司 | Leadless cardiac pacemaker system capable of reducing pacing threshold and accurately positioning |
| CN117339108B (en)* | 2023-12-04 | 2024-02-13 | 山东瑞安泰医疗技术有限公司 | Leadless cardiac pacemaker system capable of reducing pacing threshold |
| Publication | Publication Date | Title |
|---|---|---|
| US7873410B2 (en) | Implantable medical device with electromechanical delay measurement for lead position and ventricular | |
| EP2782638B1 (en) | Apparatus for adaptive cardiac resynchronization therapy employing a multipolar left ventricular lead | |
| US8380308B2 (en) | Systems and methods for optimizing ventricular pacing based on left atrial electromechanical activation detected by an AV groove electrode | |
| JP5210882B2 (en) | Method and apparatus for improving cardiac efficiency based on myocardial oxygen consumption | |
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| WO2004050179A1 (en) | Determining relative depolarization at multiple cardiac sites | |
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| EP1957159B1 (en) | Implantable cardiac stimulator for monitoring the heart cycle in a human heart | |
| US20150134023A1 (en) | Method and system for selecting lv pacing site in a multipolar lv lead | |
| US9675805B2 (en) | Method and system for localizing left ventricular conduction non-uniformity | |
| US9044615B2 (en) | Method and system for validating local capture in multisite pacing delivery | |
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| US20230148931A1 (en) | Implantable medical devices including transseptal lead | |
| WO2024226852A1 (en) | Heart failure risk using mechanical activity |
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