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WO2019001478A1 - Method for realizing double-chamber demand pacing - Google Patents

Method for realizing double-chamber demand pacing Download PDF

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Publication number
WO2019001478A1
WO2019001478A1 PCT/CN2018/093158 CN2018093158W WO2019001478A1 WO 2019001478 A1 WO2019001478 A1 WO 2019001478A1 CN 2018093158 W CN2018093158 W CN 2018093158W WO 2019001478 A1 WO2019001478 A1 WO 2019001478A1
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WIPO (PCT)
Prior art keywords
ventricular
atrial
pacing
control unit
event
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Ceased
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PCT/CN2018/093158
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French (fr)
Chinese (zh)
Inventor
熊建劬
黎贵玲
黄敏
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Micro Port Sorin Crm (shanghai) Co Ltd
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Micro Port Sorin Crm (shanghai) Co Ltd
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Publication of WO2019001478A1 publication Critical patent/WO2019001478A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/3621Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3622Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36592Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by the heart rate variability
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3684Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3688Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions configured for switching the pacing mode, e.g. from AAI to DDD
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/3702Physiological parameters

Definitions

  • the invention relates to a method for controlling a pacemaker, in particular to a double-cavity on-demand pacing implementation method.
  • Cardiac pacemaker is an electronic therapeutic device implanted in the body.
  • the pulse generator distributes the electric pulse that is powered by the battery.
  • the myocardial contacted by the electrode is stimulated, and the heart is excited and contracted. In order to achieve the purpose of treating cardiac dysfunction caused by certain arrhythmias.
  • a dual-chamber pacemaker is one of the most clinically installed pacemakers.
  • the English abbreviation is DDD.
  • the first D represents a double heart chamber that can be pacing, including the atria and ventricle.
  • the second D represents two (double) heart chambers that can be perceived, including an atrium and a ventricle.
  • the third D represents After the heartbeat senses its own heart, it can be reflected in two ways (double), one is suppression and the other is trigger, so it is also represented by D.
  • the dual-chamber pacemaker has two electrodes that are placed in the two chambers of the heart to sense and pace the atria and ventricles. Generally, one electrode is placed in the right atrium and one is placed in the apex of the right ventricle.
  • the pacemaker itself sets a time limit for the conduction of the ventricle from the atrium (the systole of the ventricle after the atrium), for example 0.20 seconds. If the atrial contraction, after 0.20 seconds, the ventricle does not shrink, then it starts from The beater sends impulses to the electrodes of the right ventricle, stimulating the myocardium and creating ventricular contractions.
  • Dual-chamber pacemakers typically operate in dual-chamber pacing modes such as DDD, DDI, DOO, ODO, and DVI, depending on user settings.
  • the various modes can be automatically converted as needed, when the atrial rate is lower than the lower limit frequency set by the pacemaker, and the PR interval (perceived interventricular interval) is greater than the AV interval set by the pacemaker (pacing) During the interventricular period, the ventricular pacing is presented.
  • the other modes of the dual-chamber pacemaker appear to suppress the release of ventricular impulses and reform the pacing frequency.
  • the DDI mode is a dual-chamber on-demand pacing mode, equivalent to AAI+VVI, suitable for patients with sick sinus with atrioventricular block, especially with paroxysmal atrial tachyarrhythmia.
  • Dual-cavity pacemakers currently on the market which operate in DDI pacing mode, are typically switched from DDD pacing mode (or other currently operating mode of operation) to DDI pacing mode.
  • DDD pacing mode or other currently operating mode of operation
  • DDI pacing mode When a pacemaker is operating in DDI mode: When an atrial event outside the refractory period is detected, the expected atrial pacing is cancelled. However, a new interventricular interval is initiated when atrial pacing is expected, and ventricular pacing is delivered at the end of the interventricular interval.
  • the technical problem to be solved by the present invention is to provide a dual-cavity on-demand pacing implementation method, which can not only improve the convenience, reliability and direct verifiability of implementing the on-demand DDI mode, but also greatly reduce the workload of verification, and Since the substantial mode conversion is not required, the mode switching is fast and smooth, physiologically good, and the patient's discomfort is reduced.
  • the technical solution adopted by the present invention to solve the above technical problem is to provide a dual-cavity on-demand pacing implementation method, comprising the steps of: setting an upper limit tracking frequency of a dual-chamber pacemaker to be equal to a lower limit frequency in advance;
  • the cavity pacemaker works according to the DDD mode.
  • the atrial pulse After sensing the atrial event, the atrial pulse is suppressed, the interventricular phase is opened, and the ventricular pacing is delivered at the end of the interventricular interval until the ventricular rate exceeds the upper limit tracking frequency; After the upper limit tracking frequency is exceeded, the atrial event is continued to be perceived; and after detecting the atrial sensing event outside the refractory period, the trigger of the atrial pulse is suppressed, and the ventricular pulse is issued to achieve the DDI mode at the end of the lower limit frequency interval.
  • the dual-chamber pacemaker comprises a microprocessor and a digital/analog module connected thereto, the microprocessor and the digital/analog module interacting through data/information The interfaces are connected.
  • the dual-cavity on-demand pacing implementation method wherein the control unit of the microprocessor acquires user setting information through the data/information interaction interface, and sets an upper limit tracking frequency interval UTRI to a lower frequency interval LRI is consistent.
  • the microprocessor comprises a main control unit and a time control unit, the digital/analog module comprising a pacing control/generation unit, a perceptual control/amplification unit, and a program control unit
  • the perceptual control/amplification unit of the digital/analog module detects an atrial sensing event, and when the main control unit of the microprocessor determines that the event is a ventricular refractory period, the dual-chamber type is controlled
  • the beater continues to operate in accordance with the mode of operation of the DDD mode, and the main control unit of the microprocessor controls the time control unit to set the atrial-aware post-ventricular pacing interval.
  • the dual-cavity on-demand pacing implementation method wherein the sensing/amplifying unit of the digital/analog module detects the atrial sensing event As and the ventricular sensing event Vs in real time, first determining the UTRI and the starting point of the above ventricular event The current atrial perception event As is the starting time of the atrial perception of the interventricular interval AsVI timing overflow sequence. If the AsVI first timed out, the atrial perception post-ventricular escape interval is overflowed at the end of UTRI; if UTRI is one step ahead Timed overflow, then set the atrial perception after the ventricular escape interval is overflowed at the end of AsVI.
  • the main control unit of the microprocessor controls the pacing control/generation unit to deliver a ventricular pacing pulse when the atrial sensing post-ventricular ventricular interval timeout occurs Vp, and controlling the time control unit to set atrial ventricular refractory period PVARP, ventricular refractory period VRP, upper limit tracking frequency interval UTRI and ventricular chamber atrial escape interval AEI.
  • the dual-chamber on-demand pacing implementation method described above wherein the perceptual control/amplification unit of the digital/analog module does not perceive any atrial or ventricular event if the atrial escape interval AEI is timed out after the ventricular event
  • the atrial pacing event is issued when the AEI is timed out; at the same time, the main control unit of the microprocessor controls the time control unit to set the ventricular escape interval ApVI after atrial pacing.
  • the above-described dual-chamber on-demand pacing implementation method wherein the atrial sensing post-interventricular interval AsVI, ventricular retroatrial refractory period PVARP, ventricular refractory period VRP and upper limit tracking frequency interval UTRI and atrial pacing
  • the dual-cavity on-demand pacing implementation method described above wherein the sensing/amplifying unit of the digital/analog module senses a ventricular event before the ApVI timing overflow, and inhibits ventricular pacing; meanwhile, the microprocessing
  • the main control unit of the device controls the time control unit to set a post-ventricular atrial refractory period PVARP, a ventricular refractory period VRP and an upper limit tracking frequency interval UTRI.
  • the invention also provides a dual-chamber type pacemaker, comprising: a microprocessor comprising a main control unit and a time control unit, the main control unit being configured to acquire user setting information through a data/information interaction interface, and to track the upper limit The frequency interval UTRI is set to be consistent with the lower limit frequency interval LRI;
  • the digital/analog module is connected to the microprocessor through a data/information interface;
  • the digital/analog module includes: a perceptual control/amplification unit, and pacing control/generation The unit;
  • the sensing control/amplifying unit is configured to detect an atrial event, and the pacing control/generating unit is configured to issue or suppress a pacing pulse;
  • the main control unit is further configured to: when the dual chamber type pacemaker operates in the DDD mode, by sensing The control/amplification unit detects the atrial event, and after detecting the atrial event, controls the pacing control/generating unit to suppress the triggering of the atrial pacing pulse, and controls
  • the sensing control/amplifying unit is further configured to detect the atrial sensing event As and the ventricular sensing event Vs in real time, and the main control unit is further configured to determine the UTRI of the previous ventricular event as the starting point and the atrium starting from the current atrial sensing event As Perceive the timed outflow sequence of the interventricular interventricular period AsVI. If the AsVI first timed out, set the atrial perception after the ventricular escape interval is overflowed at the end of UTRI. If the UTRI first timed out, set the atrial perception after ventricular escape. The blog interval overflows at the end of AsVI.
  • the main control unit is further configured to: when the ventricular sensation is delayed, the pacing control/generation unit issues a ventricular pacing pulse, and controls the time control unit to set a post-ventricular atrial refractory period PVARP, Ventricular refractory period VRP, upper limit tracking frequency interval UTRI and ventricular escape interval AEI.
  • the main control unit is further configured to: before the ventricular escape interval AEI timing overflow, if the self-atrial or ventricular event is not sensed by the sensing control/amplification unit, then the control occurs when the AEI timing overflows
  • the beat control/generation unit issues an atrial pacing pulse and controls the time control unit to set the ventricular escape interval ApVI after atrial pacing.
  • the digital/analog module further includes a program control unit, atrial-aware posterior atrioventricular phase AsVI, post-ventricular atrial refractory period PVARP, ventricular refractory period VRP, upper-rate tracking frequency interval UTRI, and atrial pacing after ventricular escape.
  • the main control unit is further configured to: after the ApVI timing overflows, the pacing control unit generates the ventricular pacing pulse, and controls the pacing control/generation unit to suppress the ventricular pacing pulse, and controls the time control unit to set the ventricular chamber Atrial refractory period PVARP, ventricular refractory period VRP and upper limit tracking frequency interval UTRI.
  • the dual-cavity on-demand pacing implementation method provided by the present invention has the same UTRI and LRI values, and does not need to perform any special operation and state machine setting for the DDI working mode.
  • the DDI mode can be implemented according to the DDD mode, which not only improves the convenience, reliability and direct verifiability of the implementation, but also greatly reduces the workload of verification.
  • mode conversion between DDD mode and DDI mode such as room speed may be performed
  • no special mode switching operation is required, which makes the mode conversion fast, smooth, physiological, and reduces patient discomfort.
  • FIG. 1 is a schematic diagram showing a mode control flow of a dual-chamber pacemaker according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of timing control of a dual-chamber pacemaker in DDD mode according to an embodiment of the present invention
  • FIG. 3 is a schematic diagram of timing control of a dual-cavity pacemaker implementing a DDI mode in a DDD mode according to an embodiment of the present invention
  • FIG. 4 is a schematic structural view of a dual-chamber pacemaker used in an embodiment of the present invention.
  • FIG. 1 is a schematic diagram of a mode control flow of a dual-chamber pacemaker according to an embodiment of the present invention.
  • a method for implementing a dual-chamber on-demand pacing includes the following steps:
  • Step S1 setting an upper limit tracking frequency of the dual chamber type pacemaker to be equal to a lower limit frequency
  • Step S2 Control the dual-chamber pacemaker to work in DDD mode, after atrial events, suppress atrial pulse, and simultaneously open the interventricular phase (atrial perception post-interventricular interval, AsVI), and in the interventricular phase (AsVI) At the end of the ventricular pacing, until the ventricular rate exceeds the upper limit tracking frequency;
  • Step S3 After the ventricular rate exceeds the upper limit tracking frequency, continue to sense the atrial event; and after detecting the atrial sensing event outside the refractory period, suppress the trigger of the atrial pulse until the end of the lower limit frequency interval to release the ventricular pulse to implement the DDI mode.
  • the upper limit tracking frequency the lower limit frequency.
  • ventricular pacing will be issued at the end of the interventricular interval; if the ventricular rate exceeds the upper limit tracking frequency, it will end at the upper tracking frequency interval (UTRI) (also equivalent to the lower limit frequency) At the end of the interval LRI, a ventricular pulse (also called a ventricular pacing) is issued.
  • UTRI upper tracking frequency interval
  • the dual-chamber pacemaker of the embodiment of the present invention When the dual-chamber pacemaker of the embodiment of the present invention operates in the DDI mode, the atrium and the ventricle can be sensed or paced.
  • the working mode is the same as the DDD mode.
  • the user or system automatically sets the UTRI (upper limit tracking frequency interval) and LRI (lower limit frequency interval) values to be consistent on the DDD mode. It can be understood that the values of UTRI and LRI are the same, which is equivalent to setting the upper limit tracking frequency equal to the lower limit frequency.
  • the embodiment of the present invention has the same UTRI and LRI values, and does not need to perform any special operation and state machine setting for the DDI working mode, and can implement the DDI mode according to the DDD mode, thereby improving the convenience of the implementation manner. , reliability and direct verifiability, reducing the amount of verification work.
  • mode conversion between DDD mode and DDI mode such as room speed may be performed
  • no special mode switching operation is required, which makes the mode conversion fast, smooth, physiological, and reduces patient discomfort.
  • the operation of the two modes of the dual chamber pacemaker of the present invention is given below.
  • DDD pacing mode synchronous dual-chamber pacing mode
  • the atrium and the ventricle can be sensed or pacing, and the ventricular pacing can follow the atrial event after the interventricular interval, thereby achieving the synchronization of the atrioventricular, as shown in FIG. 2
  • the specific timing is as follows:
  • the ventricular pacing time point set for the escape interval is shorter than the upper limit tracking frequency interval (previous ventricular time point, 3 sequence time), that is, 4 sequences
  • the AsVI at the beginning of the time expires before the UTRI starting at the 3rd sequence (AsVI expires at the 5th sequence, and UTRI expires at the 6th sequence). Therefore, the upper limit tracking interval (3 sequence time) is used to adjust the most recent Vp occurrence time and count into the ventricular pacing escape counter, and the pacing chamber is set as the ventricle.
  • Ventricular pacing Vp (6 sequence time) is issued when the ventricular pacing escape counter expires (also UTRI expires).
  • DDI pacing mode dual cavity on-demand pacing mode
  • the dual-chamber pacemaker of the embodiment of the present invention operates in the DDI mode, the atrium and the ventricle can be sensed or paced.
  • the working mode is the same as the DDD mode. Only the DDD mode needs to be set by the user or the system to automatically match the values of UTRI and LRI (lower frequency interval). Therefore, UTRI in Figure 3 can be regarded as Equivalent to LRI. As shown in Figure 3, the specific timing control is as follows:
  • Vp Ventricular pacing Vp (2 sequence moment) when the interventricular interval is equal to LRI.
  • Atrial pacing (3 sequence moments) after AEI expires.
  • AEI LRI–ApVI (ApVI is the atrioventricular phase after atrial pacing).
  • Vp appears (6 sequence time).
  • a dual-chamber pacemaker includes a microprocessor 8 and a digital/analog module 9 connected thereto, and the perception of the atrial ventricle is always on, in any mode.
  • the selection and implementation manner of the microprocessor 8 and the like are not limited.
  • the digital/analog module 9 needs to realize the perception of external signals, needs to be able to issue signals to the outside, and needs to be able to interact with external data information.
  • the microprocessor 8 includes a main control unit 1, a time control unit 2, and a data/information interaction interface 3.
  • the main control unit 1 controls the occurrence of an event, an event to be generated, and the like.
  • the main control unit 1 can select, through the time control unit 2, a time-related control function such as timing, timing, etc., for example, the time control unit 2 can capture and record the time when the event occurs, and can also control the event to be generated. Accurate time, etc.
  • the data/information interface 3 implements interaction of data or information between the device and other modules.
  • the data/information interface 3 can be a normal I/O interface or a serial or parallel data transmission module. In this embodiment, the data/information interface 3 can receive the perceived event information, issue a pacing event request, serial data interaction, clock data interaction, and the like.
  • the digital/analog module 9 includes a data/information interaction interface 4, a pacing control/generation unit 5, a perceptual control/amplification unit 6, and a program control unit 7.
  • the data/information interface 4 can interact with the corresponding data/information interface 3, although its implementation can be different.
  • the pacing control/generating unit 5 receives the pacing request of the microprocessor 8 and generates a signal of required intensity to act on the outside, and at the same time bears a small part of the control function, depending on the difference of the affected object, the strength and type of the signal, etc. The difference.
  • the perceptual control/amplification unit 6 is capable of capturing and distinguishing external real signals and notifying the microprocessor 8, such as a heart signal, and the need to be able to amplify the signal according to user settings.
  • the program control unit 7 is capable of information interaction with the outside world, such as a user.
  • the user transmits DDI working mode information to the pacemaker through the program control unit, and the main control unit of the microprocessor acquires user setting information through the data/information interaction interface, and UTRI (upper limit tracking)
  • the frequency interval is set to be consistent with the LRI.
  • the sensing control/amplification unit 6 of the digital/analog module 9 continues to operate in the DDD mode when the ventricle is not expected to be outside the atrial sensing event, the main body of the microprocessor 8.
  • the control unit 1 controls the time control unit 2 to set the atrial-aware post-ventricular pacing interval:
  • the main control unit of the microprocessor controls the pacing control/generation unit to issue the ventricular pacing Vp, and controls the time control unit to set the PVARP, the ventricle, when the ventricular systolic interval is timed out.
  • the refractory period VRP, the upper limit tracking frequency interval UTRI and the ventricular escape interval AEI as shown in Figure 3, the above-mentioned PVARP, VRP, UTRI and AEI.
  • Atrial pacing is dispensed when the AEI timing overflow occurs if the perceptual control/amplification unit of the digital/analog module does not perceive any atrial or ventricular events before the ventricular escape interval (AEI) timeout
  • the event Ap is as shown in the sequence of 3 sequences in FIG.
  • the main control unit 1 of the microprocessor 8 controls the time control unit 2 to set the ventricular escape interval (ApVI) after atrial pacing.
  • the ApVI is programmed by the user through the program control unit.
  • the perceptual control/amplification unit of the digital/analog module senses its own ventricular event and ventricular pacing is suppressed.
  • the main control unit of the microprocessor controls the time control unit to set a post-ventricular atrial refractory period PVARP, a ventricular refractory period VRP and an upper limit tracking frequency interval UTRI. As shown in the sequence of 4 in Figure 3.
  • the DDI mode can be implemented according to the DDD mode, which not only improves the convenience of the implementation mode, but also is reliable. Sexuality and direct verifiability, and greatly reduce the amount of verification work.

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Abstract

本发明公开了一种双腔按需型起搏实现方法,包括如下步骤:预先将双腔型起搏器的上限跟踪频率设置为等于下限频率;控制双腔型起搏器按DDD模式工作,感知心房事件后,抑制心房脉冲,同时开启房室间期,并在房室间期结束时发放心室起搏,直至心室率超过上限跟踪频率;当心室率超过上限跟踪频率后,继续感知心房事件;并在检测到不应期外心房感知事件后,抑制心房脉冲的触发,直至下限频率间期结束时发放心室脉冲实现DDI模式。本发明设置UTRI与LRI的值一致,按照DDD模式实现DDI模式,不但提高实现DDI模式的便捷性,可靠性和直接可验证性,大大减少验证的工作量,并且由于无需进行实质模式转换,使得模式转换快速流畅,生理性好,减少患者不适。The invention discloses a dual-cavity on-demand pacing implementation method, comprising the steps of: setting an upper limit tracking frequency of a dual-chamber pacemaker to be equal to a lower limit frequency in advance; controlling a dual-chamber pacemaker to operate in a DDD mode, After sensing the atrial event, the atrial pulse is suppressed, and the interventricular phase is opened, and ventricular pacing is delivered at the end of the interventricular interval until the ventricular rate exceeds the upper limit tracking frequency; when the ventricular rate exceeds the upper limit tracking frequency, the atrial event continues to be perceived. And after detecting the atrial sensing event outside the refractory period, suppress the trigger of the atrial pulse until the end of the lower limit frequency interval to release the ventricular pulse to achieve the DDI mode. The present invention sets the UTRI and LRI values consistently, and implements the DDI mode according to the DDD mode, which not only improves the convenience, reliability and direct verifiability of implementing the DDI mode, greatly reduces the workload of verification, and does not require substantial mode conversion. Mode conversion is fast and smooth, physiologically good, and reduces patient discomfort.

Description

一种双腔按需型起搏实现方法Double-cavity on-demand pacing implementation method 技术领域Technical field

本发明涉及一种心脏起搏器的控制方法,尤其涉及一种双腔按需型起搏实现方法。The invention relates to a method for controlling a pacemaker, in particular to a double-cavity on-demand pacing implementation method.

背景技术Background technique

心脏起搏器(cardiac pacemaker)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。Cardiac pacemaker is an electronic therapeutic device implanted in the body. The pulse generator distributes the electric pulse that is powered by the battery. Through the conduction of the wire electrode, the myocardial contacted by the electrode is stimulated, and the heart is excited and contracted. In order to achieve the purpose of treating cardiac dysfunction caused by certain arrhythmias.

双腔起搏器是临床上安装最多的一种起搏器,英文缩写叫DDD。第一个D代表双(double)心腔都可以起搏,包括心房和心室,第二个D代表两个(double)心腔都可以感知,包括一个心房和一个心室,第三个D代表起搏器感知自身心脏激动后可以使用两种方式(double)反映,一种是抑制,一种是触发,所以也用D来表示。双腔型起搏器有两根电极,分别放在心脏的两个腔里,能对心房和心室进行感知和起搏。一般来说,是一根电极放在右心房,一根放在右心室心尖部。起搏器自己设定了一个从心房传导心室的时限(先心房后心室的心脏收缩顺序),例如0.20秒,如果心房收缩后,经过这0.20秒,自己的心室还不收缩,那就由起搏器发送冲动到右心室的电极,刺激心肌,产生心室收缩。A dual-chamber pacemaker is one of the most clinically installed pacemakers. The English abbreviation is DDD. The first D represents a double heart chamber that can be pacing, including the atria and ventricle. The second D represents two (double) heart chambers that can be perceived, including an atrium and a ventricle. The third D represents After the heartbeat senses its own heart, it can be reflected in two ways (double), one is suppression and the other is trigger, so it is also represented by D. The dual-chamber pacemaker has two electrodes that are placed in the two chambers of the heart to sense and pace the atria and ventricles. Generally, one electrode is placed in the right atrium and one is placed in the apex of the right ventricle. The pacemaker itself sets a time limit for the conduction of the ventricle from the atrium (the systole of the ventricle after the atrium), for example 0.20 seconds. If the atrial contraction, after 0.20 seconds, the ventricle does not shrink, then it starts from The beater sends impulses to the electrodes of the right ventricle, stimulating the myocardium and creating ventricular contractions.

双腔型起搏器一般可根据用户设置工作在DDD,DDI,DOO,ODO,DVI等双腔起搏模式。各种模式根据需要可自动转换,当自身心房率低于起搏器所设置的低限频率,而PR间期(感知的房室间期)又大于起搏器设置的AV间期(起搏的房室间期)时,呈现房室顺序起搏。当出现自身心室事件时,除了VAT模式外,双腔起搏器的其它模式均表现为抑制心室脉冲的发放,重整起搏频率。其中DDI模式是一种双腔按需型起搏模式,相当于AAI+VVI,适用于病窦伴房室阻滞的患者,尤其伴阵发性房性快速心律失常者。Dual-chamber pacemakers typically operate in dual-chamber pacing modes such as DDD, DDI, DOO, ODO, and DVI, depending on user settings. The various modes can be automatically converted as needed, when the atrial rate is lower than the lower limit frequency set by the pacemaker, and the PR interval (perceived interventricular interval) is greater than the AV interval set by the pacemaker (pacing) During the interventricular period, the ventricular pacing is presented. When a ventricular event occurs, in addition to the VAT mode, the other modes of the dual-chamber pacemaker appear to suppress the release of ventricular impulses and reform the pacing frequency. The DDI mode is a dual-chamber on-demand pacing mode, equivalent to AAI+VVI, suitable for patients with sick sinus with atrioventricular block, especially with paroxysmal atrial tachyarrhythmia.

目前市场上的双腔型起搏器,其工作在DDI起搏模式,通常是起搏器由DDD起搏模式(或其它当前运行的工作模式)切换到DDI起搏模式。一种起搏器工作在DDI模式时:当检测到不应期外的心房事件时,预期发生的心房起搏被取消。但在预期发生心房起搏时开启新的房室间期,并在房室间期结束时发放心室起搏。Dual-cavity pacemakers currently on the market, which operate in DDI pacing mode, are typically switched from DDD pacing mode (or other currently operating mode of operation) to DDI pacing mode. When a pacemaker is operating in DDI mode: When an atrial event outside the refractory period is detected, the expected atrial pacing is cancelled. However, a new interventricular interval is initiated when atrial pacing is expected, and ventricular pacing is delivered at the end of the interventricular interval.

发明内容Summary of the invention

本发明所要解决的技术问题是提供一种双腔按需型起搏实现方法,不但能够提高实现按需型DDI模式的便捷性,可靠性和直接可验证性,大大减少验证的工作量,并且由于无需进行实质模式转换,使得模式转换快速流畅,生理性好,减少患者不适。The technical problem to be solved by the present invention is to provide a dual-cavity on-demand pacing implementation method, which can not only improve the convenience, reliability and direct verifiability of implementing the on-demand DDI mode, but also greatly reduce the workload of verification, and Since the substantial mode conversion is not required, the mode switching is fast and smooth, physiologically good, and the patient's discomfort is reduced.

本发明为解决上述技术问题而采用的技术方案是提供一种双腔按需型起搏实现方法,包括如下步骤:预先将双腔型起搏器的上限跟踪频率设置为等于下限频率;控制双腔型起搏器按DDD模式工作,感知心房事件后,抑制心房脉冲,同时开启房室间期,并在房室间期结束时发放心室起搏,直至心室率超过上限跟踪频率;当心室率超过上限跟踪频率后,继续感知心房事件;并在检测到不应期外心房感知事件后,抑制心房脉冲的触发,直至下限频率间期结束时发放心室脉冲实现DDI模式。The technical solution adopted by the present invention to solve the above technical problem is to provide a dual-cavity on-demand pacing implementation method, comprising the steps of: setting an upper limit tracking frequency of a dual-chamber pacemaker to be equal to a lower limit frequency in advance; The cavity pacemaker works according to the DDD mode. After sensing the atrial event, the atrial pulse is suppressed, the interventricular phase is opened, and the ventricular pacing is delivered at the end of the interventricular interval until the ventricular rate exceeds the upper limit tracking frequency; After the upper limit tracking frequency is exceeded, the atrial event is continued to be perceived; and after detecting the atrial sensing event outside the refractory period, the trigger of the atrial pulse is suppressed, and the ventricular pulse is issued to achieve the DDI mode at the end of the lower limit frequency interval.

上述的双腔按需型起搏实现方法,其中,所述双腔型起搏器包括微处理器及与其连接的数字/模拟模块,所述微处理器和数字/模拟模块通过数据/信息交互接口相连。The dual-chamber on-demand pacing implementation method described above, wherein the dual-chamber pacemaker comprises a microprocessor and a digital/analog module connected thereto, the microprocessor and the digital/analog module interacting through data/information The interfaces are connected.

上述的双腔按需型起搏实现方法,其中,所述微处理器的控制单元通过所述数据/信息交互接口获取用户设置信息,并将上限跟踪频率间期UTRI设置为与下限频率间期LRI一致。The dual-cavity on-demand pacing implementation method, wherein the control unit of the microprocessor acquires user setting information through the data/information interaction interface, and sets an upper limit tracking frequency interval UTRI to a lower frequency interval LRI is consistent.

上述的双腔按需型起搏实现方法,其中,所述微处理器包括主控制单元和时间控制单元,所述数字/模拟模块包括起搏控制/产生单元、感知控制/放大单元和程控单元;所述数字/模拟模块的感知控制/放大单元检测到心房感知事件,且当所述微处理器的主控制单元判断该事件为心室后不应期外心房感知事件时,控制双腔型起搏器继续按照DDD模式的工作方式工作,所述微处理器的主控制单元控制所述时间控制单元设置心房感知后心室起搏间期。The dual-cavity on-demand pacing implementation method described above, wherein the microprocessor comprises a main control unit and a time control unit, the digital/analog module comprising a pacing control/generation unit, a perceptual control/amplification unit, and a program control unit The perceptual control/amplification unit of the digital/analog module detects an atrial sensing event, and when the main control unit of the microprocessor determines that the event is a ventricular refractory period, the dual-chamber type is controlled The beater continues to operate in accordance with the mode of operation of the DDD mode, and the main control unit of the microprocessor controls the time control unit to set the atrial-aware post-ventricular pacing interval.

上述的双腔按需型起搏实现方法,其中,所述数字/模拟模块的感知控制/放大单元实时检测心房感知事件As和心室感知事件Vs,首先判断以上一心室事件为起点的UTRI和以当前的心房感知事件As为起点的心房感知后房室间期AsVI的定时溢出顺序,如果AsVI先一步定时溢出,则设置心房感知后心室逸博间期为在UTRI结束时溢出;如果UTRI先一步定时溢出,则设置心房感知后心室逸博间期为在AsVI结束时溢出。The dual-cavity on-demand pacing implementation method, wherein the sensing/amplifying unit of the digital/analog module detects the atrial sensing event As and the ventricular sensing event Vs in real time, first determining the UTRI and the starting point of the above ventricular event The current atrial perception event As is the starting time of the atrial perception of the interventricular interval AsVI timing overflow sequence. If the AsVI first timed out, the atrial perception post-ventricular escape interval is overflowed at the end of UTRI; if UTRI is one step ahead Timed overflow, then set the atrial perception after the ventricular escape interval is overflowed at the end of AsVI.

上述的双腔按需型起搏实现方法,其中,当心房感知后心室逸博间期定时溢出 时,所述微处理器的主控制单元控制所述起搏控制/发生单元发放心室起搏脉冲Vp,并控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心室事件后心房逸搏间期AEI。The above-described dual-chamber on-demand pacing implementation method, wherein the main control unit of the microprocessor controls the pacing control/generation unit to deliver a ventricular pacing pulse when the atrial sensing post-ventricular ventricular interval timeout occurs Vp, and controlling the time control unit to set atrial ventricular refractory period PVARP, ventricular refractory period VRP, upper limit tracking frequency interval UTRI and ventricular chamber atrial escape interval AEI.

上述的双腔按需型起搏实现方法,其中,在心室事件后心房逸搏间期AEI定时溢出之前,若所述数字/模拟模块的感知控制/放大单元未感知到任何自身心房或心室事件,则在AEI定时溢出时,发放心房起搏事件;同时,所述微处理器的主控制单元控制所述时间控制单元设置心房起搏后心室逸搏间期ApVI。The dual-chamber on-demand pacing implementation method described above, wherein the perceptual control/amplification unit of the digital/analog module does not perceive any atrial or ventricular event if the atrial escape interval AEI is timed out after the ventricular event The atrial pacing event is issued when the AEI is timed out; at the same time, the main control unit of the microprocessor controls the time control unit to set the ventricular escape interval ApVI after atrial pacing.

上述的双腔按需型起搏实现方法,其中,所述心房感知后房室间期AsVI,心室后心房不应期PVARP,心室不应期VRP和上限跟踪频率间期UTRI和心房起搏后心室逸搏间期ApVI由用户通过所述程控单元程控设置,并且AEI=LRI-ApVI。The above-described dual-chamber on-demand pacing implementation method, wherein the atrial sensing post-interventricular interval AsVI, ventricular retroatrial refractory period PVARP, ventricular refractory period VRP and upper limit tracking frequency interval UTRI and atrial pacing The ventricular escape interval ApVI is programmed by the user through the programmed unit, and AEI=LRI-ApVI.

上述的双腔按需型起搏实现方法,其中,在ApVI定时溢出之前,所述数字/模拟模块的感知控制/放大单元感知到自身心室事件,则抑制心室起搏;同时,所述微处理器的主控制单元控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP及上限跟踪频率间期UTRI。The dual-cavity on-demand pacing implementation method described above, wherein the sensing/amplifying unit of the digital/analog module senses a ventricular event before the ApVI timing overflow, and inhibits ventricular pacing; meanwhile, the microprocessing The main control unit of the device controls the time control unit to set a post-ventricular atrial refractory period PVARP, a ventricular refractory period VRP and an upper limit tracking frequency interval UTRI.

上述的双腔按需型起搏实现方法,其中,所述微处理器的主控制单元还控制所述时间控制单元设置AEI=LRI-ApVI-前一房室间期中ApVI或者AsVI的剩余时间段。The dual-cavity on-demand pacing implementation method described above, wherein the main control unit of the microprocessor further controls the time control unit to set AEI=LRI-ApVI-the remaining time period of ApVI or AsVI in the previous interventricular period .

本发明还提供了一种双腔型起搏器,包括:微处理器,其包括主控制单元和时间控制单元,主控制单元配置为通过数据/信息交互接口获取用户设置信息,并将上限跟踪频率间期UTRI设置为与下限频率间期LRI一致;数字/模拟模块,其通过数据/信息交互接口相连至微处理器;数字/模拟模块包括:感知控制/放大单元,和起搏控制/产生单元;感知控制/放大单元配置为检测心房事件,起搏控制/产生单元用于发放或抑制起搏脉冲;主控制单元还配置为:当双腔型起搏器按DDD模式工作时,通过感知控制/放大单元检测心房事件,在检测到心房事件后,控制起搏控制/产生单元抑制心房起搏脉冲的触发,并控制时间控制单元开启房室间期,以及控制起搏控制/产生单元在房室间期结束后发放心室起搏脉冲;直至检测到心室率超过上限跟踪频率后,继续通过感知控制/放大单元检测心房事件,判断检测到的心房事件是不应期外心房感知事件后,控制起搏控制/产生单元抑制心房起搏脉冲的触发,直至下限频率间期结束时,使起搏控制/产生单元发放心室起搏脉冲,以实现DDI模式。The invention also provides a dual-chamber type pacemaker, comprising: a microprocessor comprising a main control unit and a time control unit, the main control unit being configured to acquire user setting information through a data/information interaction interface, and to track the upper limit The frequency interval UTRI is set to be consistent with the lower limit frequency interval LRI; the digital/analog module is connected to the microprocessor through a data/information interface; the digital/analog module includes: a perceptual control/amplification unit, and pacing control/generation The unit; the sensing control/amplifying unit is configured to detect an atrial event, and the pacing control/generating unit is configured to issue or suppress a pacing pulse; the main control unit is further configured to: when the dual chamber type pacemaker operates in the DDD mode, by sensing The control/amplification unit detects the atrial event, and after detecting the atrial event, controls the pacing control/generating unit to suppress the triggering of the atrial pacing pulse, and controls the time control unit to open the interventricular interval, and controls the pacing control/generating unit to The ventricular pacing pulse is delivered after the interventricular interval; until the ventricular rate is detected to exceed the upper limit tracking frequency, continue to pass the perceptual control / The amplifying unit detects the atrial event, determines that the detected atrial event is an ectopic atrial sensing event, and controls the pacing control/generating unit to suppress the trigger of the atrial pacing pulse until the end of the lower limit frequency interval, so that the pacing control/ The generating unit issues a ventricular pacing pulse to implement the DDI mode.

进一步地,感知控制/放大单元还配置为实时检测心房感知事件As和心室感知 事件Vs,主控制单元还配置为判断以上一心室事件为起点的UTRI和以当前的心房感知事件As为起点的心房感知后房室间期AsVI的定时溢出顺序,如果AsVI先一步定时溢出,则设置心房感知后心室逸博间期为在UTRI结束时溢出,如果UTRI先一步定时溢出,则设置心房感知后心室逸博间期为在AsVI结束时溢出。Further, the sensing control/amplifying unit is further configured to detect the atrial sensing event As and the ventricular sensing event Vs in real time, and the main control unit is further configured to determine the UTRI of the previous ventricular event as the starting point and the atrium starting from the current atrial sensing event As Perceive the timed outflow sequence of the interventricular interventricular period AsVI. If the AsVI first timed out, set the atrial perception after the ventricular escape interval is overflowed at the end of UTRI. If the UTRI first timed out, set the atrial perception after ventricular escape. The blog interval overflows at the end of AsVI.

进一步地,主控制单元还配置为:当心房感知后心室逸博间期定时溢出时,控制起搏控制/发生单元发放心室起搏脉冲,并控制时间控制单元设置心室后心房不应期PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心室事件后心房逸搏间期AEI。Further, the main control unit is further configured to: when the ventricular sensation is delayed, the pacing control/generation unit issues a ventricular pacing pulse, and controls the time control unit to set a post-ventricular atrial refractory period PVARP, Ventricular refractory period VRP, upper limit tracking frequency interval UTRI and ventricular escape interval AEI.

进一步地,主控制单元还配置为:在心室事件后心房逸搏间期AEI定时溢出之前,若通过感知控制/放大单元未感知到任何自身心房或心室事件,则在AEI定时溢出时,控制起搏控制/发生单元发放心房起搏脉冲,并控制时间控制单元设置心房起搏后心室逸搏间期ApVI。Further, the main control unit is further configured to: before the ventricular escape interval AEI timing overflow, if the self-atrial or ventricular event is not sensed by the sensing control/amplification unit, then the control occurs when the AEI timing overflows The beat control/generation unit issues an atrial pacing pulse and controls the time control unit to set the ventricular escape interval ApVI after atrial pacing.

进一步地,数字/模拟模块还包括程控单元,心房感知后房室间期AsVI、心室后心房不应期PVARP、心室不应期VRP、上限跟踪频率间期UTRI和心房起搏后心室逸搏间期ApVI由程控单元程控时间控制单元设置,心室事件后心房逸搏间期AEI=LRI-ApVI。Further, the digital/analog module further includes a program control unit, atrial-aware posterior atrioventricular phase AsVI, post-ventricular atrial refractory period PVARP, ventricular refractory period VRP, upper-rate tracking frequency interval UTRI, and atrial pacing after ventricular escape. The ApVI is set by the program control unit programmed time control unit, and the atrial escape interval after the ventricular event is AEI=LRI-ApVI.

进一步地,主控制单元还配置成:在ApVI定时溢出之前,通过感知控制/放大单元感知到自身心室事件,则控制起搏控制/发生单元抑制心室起搏脉冲,并控制时间控制单元设置心室后心房不应期PVARP,心室不应期VRP及上限跟踪频率间期UTRI。Further, the main control unit is further configured to: after the ApVI timing overflows, the pacing control unit generates the ventricular pacing pulse, and controls the pacing control/generation unit to suppress the ventricular pacing pulse, and controls the time control unit to set the ventricular chamber Atrial refractory period PVARP, ventricular refractory period VRP and upper limit tracking frequency interval UTRI.

进一步地,主控制单元还控制时间控制单元设置AEI=LRI-ApVI-前一房室间期中ApVI或者AsVI的剩余时间段。Further, the main control unit further controls the time control unit to set AEI=LRI-ApVI-the remaining time period of the ApVI or AsVI in the previous interventricular period.

本发明对比现有技术有如下的有益效果:本发明提供的双腔按需型起搏实现方法,通过设置UTRI与LRI的值一致,无需为DDI工作模式进行任何特殊的操作和状态机设置,即可按照DDD模式实现DDI模式,不但提高了实现方式的便捷性,可靠性和直接可验证性,并且大大减少验证的工作量。此外,DDD模式与DDI模式之间进行模式转换时(例如房速时可能会进行此转换),无需进行专门的模式切换操作,使得模式转换快速,并且流畅,生理性好,减少患者不适。Compared with the prior art, the present invention has the following beneficial effects: the dual-cavity on-demand pacing implementation method provided by the present invention has the same UTRI and LRI values, and does not need to perform any special operation and state machine setting for the DDI working mode. The DDI mode can be implemented according to the DDD mode, which not only improves the convenience, reliability and direct verifiability of the implementation, but also greatly reduces the workload of verification. In addition, when mode conversion between DDD mode and DDI mode (such as room speed may be performed), no special mode switching operation is required, which makes the mode conversion fast, smooth, physiological, and reduces patient discomfort.

附图说明DRAWINGS

图1为本发明实施例的双腔型起搏器的模式控制流程示意图;1 is a schematic diagram showing a mode control flow of a dual-chamber pacemaker according to an embodiment of the present invention;

图2为本发明实施例的双腔型起搏器在DDD模式下的时序控制示意图;2 is a schematic diagram of timing control of a dual-chamber pacemaker in DDD mode according to an embodiment of the present invention;

图3为本发明实施例的双腔型起搏器沿用DDD模式实现DDI模式的时序控制示意图;3 is a schematic diagram of timing control of a dual-cavity pacemaker implementing a DDI mode in a DDD mode according to an embodiment of the present invention;

图4为本发明实施例的使用的双腔型起搏器的架构示意图。4 is a schematic structural view of a dual-chamber pacemaker used in an embodiment of the present invention.

具体实施方式Detailed ways

下面结合附图和实施例对本发明作进一步的描述。The invention will now be further described with reference to the drawings and embodiments.

图1为本发明实施例的双腔型起搏器的模式控制流程示意图。FIG. 1 is a schematic diagram of a mode control flow of a dual-chamber pacemaker according to an embodiment of the present invention.

请参见图1,本发明实施例提供的双腔按需型起搏实现方法,包括如下步骤:Referring to FIG. 1 , a method for implementing a dual-chamber on-demand pacing according to an embodiment of the present invention includes the following steps:

步骤S1:预先将双腔型起搏器的上限跟踪频率设置为等于下限频率;Step S1: setting an upper limit tracking frequency of the dual chamber type pacemaker to be equal to a lower limit frequency;

步骤S2:控制双腔型起搏器按DDD模式工作,感知心房事件后,抑制心房脉冲,同时开启房室间期(心房感知后房室间期,AsVI),并在房室间期(AsVI)结束时发放心室起搏,直至心室率超过上限跟踪频率;Step S2: Control the dual-chamber pacemaker to work in DDD mode, after atrial events, suppress atrial pulse, and simultaneously open the interventricular phase (atrial perception post-interventricular interval, AsVI), and in the interventricular phase (AsVI) At the end of the ventricular pacing, until the ventricular rate exceeds the upper limit tracking frequency;

步骤S3:当心室率超过上限跟踪频率后,继续感知心房事件;并在检测到不应期外心房感知事件后,抑制心房脉冲的触发,直至下限频率间期结束时发放心室脉冲实现DDI模式。在该DDI模式下,上限跟踪频率=下限频率。Step S3: After the ventricular rate exceeds the upper limit tracking frequency, continue to sense the atrial event; and after detecting the atrial sensing event outside the refractory period, suppress the trigger of the atrial pulse until the end of the lower limit frequency interval to release the ventricular pulse to implement the DDI mode. In this DDI mode, the upper limit tracking frequency = the lower limit frequency.

可以理解,如果心室率未达到上限跟踪频率,将在房室间期结束时发放心室起搏;如果心室率超过上限跟踪频率,将在上限跟踪频率间期(UTRI)结束(也相当于下限频率间期LRI结束)时发放心室脉冲(也可以称为发放心室起搏)。It can be understood that if the ventricular rate does not reach the upper limit tracking frequency, ventricular pacing will be issued at the end of the interventricular interval; if the ventricular rate exceeds the upper limit tracking frequency, it will end at the upper tracking frequency interval (UTRI) (also equivalent to the lower limit frequency) At the end of the interval LRI, a ventricular pulse (also called a ventricular pacing) is issued.

本发明实施例的双腔型起搏器工作在DDI模式时,可以感知或起搏心房和心室。其工作模式与DDD模式的实现方式一致,仅需要在DDD模式的基础上,由用户或系统自动将UTRI(上限跟踪频率间期)与LRI(下限频率间期)的值设置为一致。可以理解,UTRI和LRI的值一致,相当于将上限跟踪频率设置为等于下限频率。When the dual-chamber pacemaker of the embodiment of the present invention operates in the DDI mode, the atrium and the ventricle can be sensed or paced. The working mode is the same as the DDD mode. The user or system automatically sets the UTRI (upper limit tracking frequency interval) and LRI (lower limit frequency interval) values to be consistent on the DDD mode. It can be understood that the values of UTRI and LRI are the same, which is equivalent to setting the upper limit tracking frequency equal to the lower limit frequency.

本发明实施例与传统方法相比,通过设置UTRI与LRI的值一致,无需为DDI工作模式进行任何特殊的操作和状态机设置,即可按照DDD模式实现DDI模式,提高了实现方式的便捷性,可靠性和直接可验证性,减少验证的工作量。此外,DDD模式与DDI模式之间进行模式转换时(例如房速时可能会进行此转换),无需进行专门的模式切换操作,使得模式转换快速,并且流畅,生理性好,减少患者不适。下面给出本发明双腔型起搏器的两种模式的工作过程。Compared with the traditional method, the embodiment of the present invention has the same UTRI and LRI values, and does not need to perform any special operation and state machine setting for the DDI working mode, and can implement the DDI mode according to the DDD mode, thereby improving the convenience of the implementation manner. , reliability and direct verifiability, reducing the amount of verification work. In addition, when mode conversion between DDD mode and DDI mode (such as room speed may be performed), no special mode switching operation is required, which makes the mode conversion fast, smooth, physiological, and reduces patient discomfort. The operation of the two modes of the dual chamber pacemaker of the present invention is given below.

一、DDD起搏模式(同步型双腔起搏模式)First, DDD pacing mode (synchronous dual-chamber pacing mode)

本发明实施例的双腔型起搏器工作在DDD模式时,可以感知或起搏心房和心室,同时心室起搏会以房室间期跟随心房事件之后,从而实现房室同步,如图2所示,具体时序如下:When the dual-chamber pacemaker of the embodiment of the present invention works in the DDD mode, the atrium and the ventricle can be sensed or pacing, and the ventricular pacing can follow the atrial event after the interventricular interval, thereby achieving the synchronization of the atrioventricular, as shown in FIG. 2 As shown, the specific timing is as follows:

1.PVARP(心室后心房不应期)内感知到的一心房事件Ar(①序列时刻,不应期内心房感知事件)。1. An atrial event perceived in PVARP (post-ventricular atrial refractory period) Ar (1 sequence moment, atrial perception event during refractory period).

2.As(不应期外心房感知事件)位于PVARP(前一Vp后的心室后心房不应期)外AEI(前一Vp后的心室后心房逸搏间期AEI)期满前,以As(②序列时刻)为基准使用AsVI(心房感知后房室间期)为逸搏间期,投射的心室起搏时间点较以UTRI(上限跟踪频率)投射者为长(以前一心室时间点为基准),也即AsVI比UTRI后期满。因此,AsVI被计入心室起搏逸搏计数器,并将起搏腔设置为心室。2.As (not expected outside atrial perception events) located before PVARP (post-Vp post-ventricular atrial refractory period) AEI (AEI after ventricular re-ventricular atrial escape interval AEI) before the expiration of As (2 sequence time) is based on AsVI (Atrial Perceptual Posterior Interventricular Phase) as the escape interval, and the projected ventricular pacing time is longer than the UTRI (upper tracking frequency) projection (previous ventricular time point is Benchmark), that is, AsVI is later than UTRI. Therefore, AsVI is counted in the ventricular pacing escape counter and the pacing chamber is set to the ventricle.

3.在心室起搏逸搏间期期满前无心室感知,发出心室起搏脉冲Vp(③序列时刻)。3. No ventricular perception before the ventricular pacing escape interval expires, issuing a ventricular pacing pulse Vp (3 sequence moment).

4.PVARP外感知到的心房事件As(④序列时刻)。4. Atrial event As perceived by PVARP (4 sequence moment).

5.使用AsVI(④序列时刻)为逸搏间期设定的心室起搏时间点较以上限跟踪频率间期(以前一心室时点为基准,③序列时刻)投射者短,也即④序列时刻开始的AsVI比③序列时刻开始的UTRI先期满(AsVI在⑤序列时刻期满,UTRI在⑥序列时刻期满)。因此,使用上限追踪间期(③序列时刻)来调节最近的Vp发生时间并计入心室起搏逸搏计数器,并将起搏腔被设置为心室。5. Using AsVI (4 sequence time), the ventricular pacing time point set for the escape interval is shorter than the upper limit tracking frequency interval (previous ventricular time point, 3 sequence time), that is, 4 sequences The AsVI at the beginning of the time expires before the UTRI starting at the 3rd sequence (AsVI expires at the 5th sequence, and UTRI expires at the 6th sequence). Therefore, the upper limit tracking interval (3 sequence time) is used to adjust the most recent Vp occurrence time and count into the ventricular pacing escape counter, and the pacing chamber is set as the ventricle.

6.心室起搏Vp(⑥序列时刻)在心室起搏逸搏计数器期满(也是UTRI期满)时发出。6. Ventricular pacing Vp (6 sequence time) is issued when the ventricular pacing escape counter expires (also UTRI expires).

二、DDI起搏模式(双腔按需型起搏模式)Second, DDI pacing mode (dual cavity on-demand pacing mode)

本发明实施例的双腔型起搏器工作在DDI模式时,可以感知或起搏心房和心室。其工作模式与DDD模式的实现方式一致,仅需要在DDD模式的基础上,由用户或系统自动将UTRI与LRI(下限频率间期)的值设置为一致,因此图3中UTRI可被视为等同于LRI。如图3所示,具体时序控制如下:When the dual-chamber pacemaker of the embodiment of the present invention operates in the DDI mode, the atrium and the ventricle can be sensed or paced. The working mode is the same as the DDD mode. Only the DDD mode needs to be set by the user or the system to automatically match the values of UTRI and LRI (lower frequency interval). Therefore, UTRI in Figure 3 can be regarded as Equivalent to LRI. As shown in Figure 3, the specific timing control is as follows:

1.PVARP(②序列时刻)外的As(①序列时刻),在UTRI与LRI相等时跟踪心房活动。1. As (1 sequence time) outside PVARP (2 sequence time), track atrial activity when UTRI is equal to LRI.

2.当室室间期与LRI相等时发出心室起搏Vp(②序列时刻)。2. Ventricular pacing Vp (2 sequence moment) when the interventricular interval is equal to LRI.

3.AEI期满后发出心房起搏(③序列时刻)。AEI=LRI–ApVI(ApVI为心房起搏 后房室间期)。3. Atrial pacing (3 sequence moments) after AEI expires. AEI=LRI–ApVI (ApVI is the atrioventricular phase after atrial pacing).

4.Vs(④序列时刻)在ApVI期满前发生,其中,AEI=LRI–ApVI。但根据投射的Vp(心室起搏)点来调整,AEI从ApVI结束开始,但UTRI从Vs(不应期外心室感知事件)点处开始,且值等于LRI。4.Vs (4 sequence moments) occurs before the ApVI expires, where AEI = LRI - ApVI. However, depending on the projected Vp (ventricular pacing) point, AEI begins at the end of ApVI, but UTRI begins at the Vs (out of ventricular sensation event) point and has a value equal to LRI.

5.②序列时刻开始的UTRI期满后,在AEI期满前发生As(⑤序列时刻)。投射的Vp时间(⑥序列时刻)即是AsVI期满时。5.2 After the UTRI expiration from the beginning of the sequence time, As (5 sequence time) occurs before the AEI expires. The projected Vp time (6 sequence time) is when the AsVI expires.

6.⑤序列时刻开始的AsVI期满时,Vp出现(⑥序列时刻)。6.5 When the AsVI expires at the beginning of the sequence, Vp appears (6 sequence time).

由上文可知,DDD模式与DDI模式的区别在于,DDI模式的LRI=UTRI,下限频率LRL=上限跟踪频率URL。As can be seen from the above, the DDD mode differs from the DDI mode in that the DDI mode has LRI=UTRI and the lower limit frequency LRL=upper limit tracking frequency URL.

请继续参见图4,本发明实施例提供的双腔型起搏器,包括微处理器8及与其连接的数字/模拟模块9,心房心室的感知是一直开启的,不论在任何模式。所述微处理器8的选择及实现方式等不限制。所述数字/模拟模块9需要实现对外部信号的感知,需要能够发放信号作用于外部,需要能够与外部进行数据信息交互。Referring to FIG. 4, a dual-chamber pacemaker according to an embodiment of the present invention includes a microprocessor 8 and a digital/analog module 9 connected thereto, and the perception of the atrial ventricle is always on, in any mode. The selection and implementation manner of the microprocessor 8 and the like are not limited. The digital/analog module 9 needs to realize the perception of external signals, needs to be able to issue signals to the outside, and needs to be able to interact with external data information.

进一步的,所述微处理器8包括主控制单元1、时间控制单元2及数据/信息交互接口3。所述主控制单元1实现对发生事件及需发生事件等的控制。所述主控制单元1可以选择通过所述时间控制单元2来实现定时、计时等时间相关的控制功能,比如所述时间控制单元2可以捕获及记录事件发生的时间,也可以控制需发生事件的准确发生时间等。所述数据/信息交互接口3实现装置与其他模块间的数据或信息等的交互。所述数据/信息交互接口3可以是普通的I/O接口,也可以是串行或并行的数据传输模块。在本实施例中,所述数据/信息交互接口3能够接收感知事件信息,发放起搏事件请求,串行数据交互,时钟数据交互等。Further, the microprocessor 8 includes a main control unit 1, a time control unit 2, and a data/information interaction interface 3. The main control unit 1 controls the occurrence of an event, an event to be generated, and the like. The main control unit 1 can select, through the time control unit 2, a time-related control function such as timing, timing, etc., for example, the time control unit 2 can capture and record the time when the event occurs, and can also control the event to be generated. Accurate time, etc. The data/information interface 3 implements interaction of data or information between the device and other modules. The data/information interface 3 can be a normal I/O interface or a serial or parallel data transmission module. In this embodiment, the data/information interface 3 can receive the perceived event information, issue a pacing event request, serial data interaction, clock data interaction, and the like.

进一步的,所述数字/模拟模块9包括数据/信息交互接口4、起搏控制/产生单元5、感知控制/放大单元6及程控单元7。所述数据/信息交互接口4能够与相应的数据/信息交互接口3进行交互,当然其实现方式可以与其不同。所述起搏控制/产生单元5接受微处理器8的起搏请求并产生要求强度的信号作用于外部,同时承担少部分的控制功能,根据受作用对象的差异,信号的强度,类型等有所差别。所述感知控制/放大单元6能够捕获及区分外部真实的信号并将其通知微处理器8,如心脏信号,并需要能够对信号根据用户设置进行放大。所述程控单元7能够与外界,如用户,进行信息交互。Further, the digital/analog module 9 includes a data/information interaction interface 4, a pacing control/generation unit 5, a perceptual control/amplification unit 6, and a program control unit 7. The data/information interface 4 can interact with the corresponding data/information interface 3, although its implementation can be different. The pacing control/generating unit 5 receives the pacing request of the microprocessor 8 and generates a signal of required intensity to act on the outside, and at the same time bears a small part of the control function, depending on the difference of the affected object, the strength and type of the signal, etc. The difference. The perceptual control/amplification unit 6 is capable of capturing and distinguishing external real signals and notifying the microprocessor 8, such as a heart signal, and the need to be able to amplify the signal according to user settings. The program control unit 7 is capable of information interaction with the outside world, such as a user.

如图4所示,用户通过所述程控单元将DDI工作模式信息传输到起搏器,所述微处理器的主控制单元通过所述数据/信息交互接口获取用户设置信息,将UTRI(上限跟踪频率间期)设置为与LRI一致。As shown in FIG. 4, the user transmits DDI working mode information to the pacemaker through the program control unit, and the main control unit of the microprocessor acquires user setting information through the data/information interaction interface, and UTRI (upper limit tracking) The frequency interval is set to be consistent with the LRI.

如图3所示,所述数字/模拟模块9的感知控制/放大单元6感知到心室后不应期外心房感知事件时,继续按照DDD模式的工作方式工作,所述微处理器8的主控制单元1控制所述时间控制单元2设置心房感知后心室起搏间期:As shown in FIG. 3, the sensing control/amplification unit 6 of the digital/analog module 9 continues to operate in the DDD mode when the ventricle is not expected to be outside the atrial sensing event, the main body of the microprocessor 8. The control unit 1 controls the time control unit 2 to set the atrial-aware post-ventricular pacing interval:

首先判断以上一心室事件(上一心动周期中的心室起搏Vp,或者感知到的心室事件Vs)为起点的UTRI和以当前心房事件As为起点的心房感知后房室间期AsVI的定时溢出顺序,如果AsVI先一步定时溢出,则设置心房感知后心室逸博间期为在UTRI结束时溢出,如图3中①②序列时刻所示;如果UTRI先一步定时溢出,则设置心房感知后心室逸博间期为在AsVI结束时溢出,如图3中⑤⑥序列时刻所示。First, determine the UTRI of the above ventricular event (ventricular pacing Vp in the last cardiac cycle, or perceived ventricular event Vs) as the starting point and the timing of the atrioventricular interphase AVI with the current atrial event As as the starting point. Sequence, if AsVI first timed out, set the atrial perception post-ventricular escape interval to overflow at the end of UTRI, as shown in the sequence of 12 in Figure 3; if UTRI first timed out, set the atrial perception of ventricular escape The blog interval overflows at the end of AsVI, as shown in the 56 sequence moment in Figure 3.

进一步地,心房感知后心室逸博间期定时溢出时,所述微处理器的主控制单元控制所述起搏控制/发生单元发放心室起搏Vp,并控制所述时间控制单元设置PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心室事件后心房逸搏间期AEI,如图3中②⑥序列时刻时开启的上述的PVARP、VRP、UTRI和AEI。Further, the main control unit of the microprocessor controls the pacing control/generation unit to issue the ventricular pacing Vp, and controls the time control unit to set the PVARP, the ventricle, when the ventricular systolic interval is timed out. The refractory period VRP, the upper limit tracking frequency interval UTRI and the ventricular escape interval AEI, as shown in Figure 3, the above-mentioned PVARP, VRP, UTRI and AEI.

进一步地,心房感知后房室间期AsVI,心室后心房不应期PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心房起搏后心室逸搏间期ApVI由用户通过所述程控单元程控设置,AEI=LRI–ApVI。Further, atrial perception of posterior atrioventricular phase AsVI, post-ventricular atrial refractory period PVARP, ventricular refractory period VRP, upper-order tracking frequency interval UTRI and atrial pacing ventricular escape interval ApVI are passed by the user through the program control unit Program control settings, AEI=LRI–ApVI.

在心室事件后心房逸搏间期(AEI)定时溢出之前,若所述数字/模拟模块的感知控制/放大单元未感知到任何自身心房或心室事件,则在AEI定时溢出时,发放心房起搏事件Ap,如图3中③序列时刻所示。同时,所述微处理器8的主控制单元1控制所述时间控制单元2设置心房起搏后心室逸搏间期(ApVI)。Atrial pacing is dispensed when the AEI timing overflow occurs if the perceptual control/amplification unit of the digital/analog module does not perceive any atrial or ventricular events before the ventricular escape interval (AEI) timeout The event Ap is as shown in the sequence of 3 sequences in FIG. At the same time, the main control unit 1 of the microprocessor 8 controls the time control unit 2 to set the ventricular escape interval (ApVI) after atrial pacing.

进一步地,ApVI由用户通过所述程控单元程控设置。Further, the ApVI is programmed by the user through the program control unit.

在ApVI定时溢出之前,所述数字/模拟模块的感知控制/放大单元感知到自身心室事件,心室起搏被抑制。同时,所述微处理器的主控制单元控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP及上限跟踪频率间期UTRI。如图3中④序列时刻所示。Prior to the ApVI timing overflow, the perceptual control/amplification unit of the digital/analog module senses its own ventricular event and ventricular pacing is suppressed. At the same time, the main control unit of the microprocessor controls the time control unit to set a post-ventricular atrial refractory period PVARP, a ventricular refractory period VRP and an upper limit tracking frequency interval UTRI. As shown in the sequence of 4 in Figure 3.

进一步地,所述微处理器的主控制单元控制所述时间控制单元可设置AEI=LRI-ApVI-③序列时刻设置的ApVI的剩余时间段,以此保持房房间期的稳定性。Further, the main control unit of the microprocessor controls the time control unit to set the remaining time period of the ApVI set by the AEI=LRI-ApVI-3 sequence time, thereby maintaining the stability of the room period.

基此,本发明实施例通过设置UTRI与LRI的值一致,无需为DDI工作模式进行 任何特殊的操作和状态机设置,即可按照DDD模式实现DDI模式,不但提高了实现方式的便捷性,可靠性和直接可验证性,并且大大减少验证的工作量。Therefore, in the embodiment of the present invention, by setting the values of UTRI and LRI, it is not necessary to perform any special operation and state machine setting for the DDI working mode, and the DDI mode can be implemented according to the DDD mode, which not only improves the convenience of the implementation mode, but also is reliable. Sexuality and direct verifiability, and greatly reduce the amount of verification work.

虽然本发明已以较佳实施例揭示如上,然其并非用以限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,当可作些许的修改和完善,因此本发明的保护范围当以权利要求书所界定的为准。While the present invention has been described in its preferred embodiments, the present invention is not intended to be limited thereto, and the present invention may be modified and improved without departing from the spirit and scope of the invention. The scope of protection is defined by the terms of the claims.

Claims (17)

一种双腔按需型起搏实现方法,其特征在于,包括如下步骤:A dual-cavity on-demand pacing implementation method, comprising the steps of: 预先将双腔型起搏器的上限跟踪频率设置为等于下限频率;The upper limit tracking frequency of the dual chamber type pacemaker is set to be equal to the lower limit frequency in advance; 控制双腔型起搏器按DDD模式工作,感知心房事件后,抑制心房脉冲,同时开启房室间期,并在房室间期结束时发放心室起搏,直至心室率超过上限跟踪频率;The dual-chamber pacemaker is controlled to operate in DDD mode. After sensing the atrial event, the atrial pulse is suppressed, and the interventricular interval is opened, and ventricular pacing is delivered at the end of the interventricular interval until the ventricular rate exceeds the upper limit tracking frequency; 当心室率超过上限跟踪频率后,继续感知心房事件;并在检测到不应期外心房感知事件后,抑制心房脉冲的触发,直至下限频率间期结束时发放心室脉冲实现DDI模式。After the ventricular rate exceeds the upper limit tracking frequency, the atrial event continues to be perceived; and after detecting the atrial sensing event outside the refractory period, the trigger of the atrial pulse is suppressed until the ventricular pulse is delivered at the end of the lower limit frequency interval to implement the DDI mode. 如权利要求1所述的双腔按需型起搏实现方法,其特征在于,所述双腔型起搏器包括微处理器及与其连接的数字/模拟模块,所述微处理器和数字/模拟模块通过数据/信息交互接口相连。The dual-chamber on-demand pacing method of claim 1 wherein said dual chamber pacemaker comprises a microprocessor and a digital/analog module coupled thereto, said microprocessor and digital/ The analog modules are connected via a data/information interface. 如权利要求2所述的双腔按需型起搏实现方法,其特征在于,所述微处理器的控制单元通过所述数据/信息交互接口获取用户设置信息,并将上限跟踪频率间期UTRI设置为与下限频率间期LRI一致。The dual-cavity on-demand pacing implementation method according to claim 2, wherein the control unit of the microprocessor acquires user setting information through the data/information interaction interface, and the upper limit tracking frequency interval UTRI Set to match the lower limit frequency interval LRI. 如权利要求2所述的双腔按需型起搏实现方法,其特征在于,所述微处理器包括主控制单元和时间控制单元,所述数字/模拟模块包括起搏控制/产生单元、感知控制/放大单元和程控单元;所述数字/模拟模块的感知控制/放大单元检测到心房感知事件,且当所述微处理器的主控制单元判断该事件为心室后不应期外心房感知事件时,控制双腔型起搏器继续按照DDD模式的工作方式工作,所述微处理器的主控制单元控制所述时间控制单元设置心房感知后心室起搏间期。The dual-cavity on-demand pacing implementation method according to claim 2, wherein said microprocessor comprises a main control unit and a time control unit, said digital/analog module comprising pacing control/generation unit, sensing a control/amplification unit and a program control unit; the sensing/amplifying unit of the digital/analog module detects an atrial sensing event, and when the main control unit of the microprocessor determines that the event is a ventricular refractory period At this time, the dual-chamber pacemaker is controlled to continue to operate in the DDD mode, and the main control unit of the microprocessor controls the time control unit to set the atrial-aware post-ventricular pacing interval. 如权利要求4所述的双腔按需型起搏实现方法,其特征在于,所述数字/模拟模块的感知控制/放大单元实时检测心房感知事件As和心室感知事件Vs,首先判断以上一心室事件为起点的UTRI和以当前的心房感知事件As为起点的心房感知后房室间期AsVI的定时溢出顺序,如果AsVI先一步定时溢出,则设置心房感知后心室逸博间期为在UTRI结束时溢出;如果UTRI先一步定时溢出,则设置心房感知后心室逸博间期为在AsVI结束时溢出。The dual-cavity on-demand pacing implementation method according to claim 4, wherein the sensing/amplifying unit of the digital/analog module detects the atrial sensing event As and the ventricular sensing event Vs in real time, and first determines the upper ventricle The event is the starting point of the UTRI and the current atrial sensing event As as the starting point for the atrial sensing of the interventricular interventricular period AsVI timing overflow sequence. If the AsVI first timed out of time, then the atrial perception post-ventricular ventricular interval is set at the end of UTRI Time overflow; if UTRI first timed out, set the atrial perception post-ventricular escape interval to overflow at the end of AsVI. 如权利要求5所述的双腔按需型起搏实现方法,其特征在于,当心房感知后心室逸博间期定时溢出时,所述微处理器的主控制单元控制所述起搏控制/发生单元发放心室起搏脉冲,并控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心室事件后心房逸搏间期AEI。The dual-chamber on-demand pacing implementation method according to claim 5, wherein the main control unit of the microprocessor controls the pacing control when the atrial sensing post-ventricular ventricular interval timeout occurs The generating unit issues a ventricular pacing pulse, and controls the time control unit to set a post-ventricular atrial refractory period PVARP, a ventricular refractory period VRP, an upper limit tracking frequency interval UTRI, and a post-ventricular atrial escape interval AEI. 如权利要求6所述的双腔按需型起搏实现方法,其特征在于,在心室事件后心房逸搏间期AEI定时溢出之前,若所述数字/模拟模块的感知控制/放大单元未感知到任何自身心房或心室事件,则在AEI定时溢出时,发放心房起搏事件;同时,所述微处理器的主控制单元控制所述时间控制单元设置心房起搏后心室逸搏间期ApVI。The dual-chamber on-demand pacing implementation method according to claim 6, wherein the sensing/amplifying unit of the digital/analog module is not perceived before the atrial escape interval AEI timing overflows after the ventricular event To any of the atrial or ventricular events, the atrial pacing event is issued when the AEI is timed out; at the same time, the main control unit of the microprocessor controls the time control unit to set the ventricular escape interval ApVI after atrial pacing. 如权利要求6或7所述的双腔按需型起搏器的模式控制实现方法,其特征在于,所述心房感知后房室间期AsVI、心室后心房不应期PVARP、心室不应期VRP、上限跟踪频率间期UTRI和心房起搏后心室逸搏间期ApVI由用户通过所述程控单元程控设置,并且AEI=LRI-ApVI。The method for implementing a mode control of a dual-chamber on-demand pacemaker according to claim 6 or 7, wherein the atrial sensing post-interventricular interval AsVI, ventricular retroatrial refractory period PVARP, ventricular refractory period VRP, upper limit tracking frequency interval UTRI and atrial pacing ventricular escape interval ApVI are programmed by the user through the program control unit, and AEI=LRI-ApVI. 如权利要求7所述的双腔按需型起搏实现方法,其特征在于,在ApVI定时溢出之前,所述数字/模拟模块的感知控制/放大单元感知到自身心室事件,则抑制心室起搏;同时,所述微处理器的主控制单元控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP及上限跟踪频率间期UTRI。The dual-chamber on-demand pacing implementation method according to claim 7, wherein the perceptual control/amplification unit of the digital/analog module senses a ventricular event and suppresses ventricular pacing before the ApVI timeout occurs. At the same time, the main control unit of the microprocessor controls the time control unit to set the post-ventricular atrial refractory period PVARP, the ventricular refractory period VRP and the upper limit tracking frequency interval UTRI. 如权利要求9所述的双腔按需型起搏实现方法,其特征在于,所述微处理器的主控制单元还控制所述时间控制单元设置AEI=LRI-ApVI-前一房室间期中ApVI或者AsVI的剩余时间段。The dual-chamber on-demand pacing implementation method according to claim 9, wherein the main control unit of the microprocessor further controls the time control unit to set AEI=LRI-ApVI-in the first interventricular period The remaining time period of ApVI or AsVI. 一种双腔型起搏器,其特征在于,包括:A dual-chamber pacemaker characterized by comprising: 微处理器,其包括主控制单元和时间控制单元,所述主控制单元配置为通过数据/信息交互接口获取用户设置信息,并将上限跟踪频率间期UTRI设置为与下限频率间期LRI一致;a microprocessor comprising a main control unit and a time control unit, the main control unit configured to acquire user setting information through a data/information interaction interface, and set an upper limit tracking frequency interval UTRI to be consistent with a lower limit frequency interval LRI; 数字/模拟模块,其通过所述数据/信息交互接口相连至所述微处理器;所述数字/模拟模块包括:感知控制/放大单元,和起搏控制/产生单元;所述感知控制/放大单元配置为检测心房事件,所述起搏控制/产生单元用于发放或抑制起搏脉冲;a digital/analog module connected to the microprocessor via the data/information interface; the digital/analog module comprising: a perceptual control/amplification unit, and a pacing control/generation unit; the perceptual control/amplification The unit is configured to detect an atrial event, the pacing control/generating unit for dispensing or suppressing a pacing pulse; 所述主控制单元还配置为:The main control unit is further configured to: 当所述双腔型起搏器按DDD模式工作时,通过所述感知控制/放大单元检测心房事件,在检测到心房事件后,控制所述起搏控制/产生单元抑制心房起搏脉冲的触发,并控制所述时间控制单元开启房室间期,以及控制所述起搏控制/产生单元在房室间期结束后发放心室起搏脉冲;直至检测到心室率超过上限跟踪频率后,继续通过所述感知控制/放大单元检测心房事件,判断检测到的心房事件是不应期外心房感知事件后,控制所述起搏控制/产生单元抑制心房起搏脉冲的触发,直至下限频率间 期结束时,使所述起搏控制/产生单元发放心室起搏脉冲,以实现DDI模式。When the dual-chamber pacemaker operates in the DDD mode, the atrial event is detected by the sensing control/amplifying unit, and after detecting the atrial event, the pacing control/generating unit is controlled to suppress the triggering of the atrial pacing pulse And controlling the time control unit to open the interventricular interval, and controlling the pacing control/generating unit to issue a ventricular pacing pulse after the end of the interventricular interval; until the ventricular rate is detected to exceed the upper limit tracking frequency, continue to pass The sensing control/amplification unit detects an atrial event, and determines that the detected atrial event is an refractory atrial sensing event, and controls the pacing control/generating unit to suppress triggering of the atrial pacing pulse until the lower frequency interval ends The pacing control/generating unit is caused to dispense a ventricular pacing pulse to achieve a DDI mode. 如权利要求11所述的双腔型起搏器,其特征在于,所述感知控制/放大单元还配置为实时检测心房感知事件As和心室感知事件Vs,所述主控制单元还配置为判断以上一心室事件为起点的UTRI和以当前的心房感知事件As为起点的心房感知后房室间期AsVI的定时溢出顺序,如果AsVI先一步定时溢出,则设置心房感知后心室逸博间期为在UTRI结束时溢出,如果UTRI先一步定时溢出,则设置心房感知后心室逸博间期为在AsVI结束时溢出。The dual-chamber pacemaker according to claim 11, wherein the sensing control/amplifying unit is further configured to detect the atrial sensing event As and the ventricular sensing event Vs in real time, and the main control unit is further configured to determine the above The UTRI of the ventricular event as the starting point and the atrial perceptual interventricular interphase AsVI with the current atrial sensing event As as the starting point. If the AsVI first overflows in a step, the ventricular ventricular interval is set after the atrial perception. UTRI overflows at the end. If UTRI first overflows in one step, then the atrial perception is set and the ventricular escape interval is overflowed at the end of AsVI. 如权利要求12所述的双腔型起搏器,其特征在于,所述主控制单元还配置为:当心房感知后心室逸博间期定时溢出时,控制所述起搏控制/发生单元发放心室起搏脉冲,并控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP,上限跟踪频率间期UTRI和心室事件后心房逸搏间期AEI。The dual-chamber pacemaker according to claim 12, wherein said main control unit is further configured to: control said pacing control/generation unit to be dispensed when atrial sensation ventricular ventricular interval timeout occurs Ventricular pacing pulse, and control the time control unit to set the ventricular ventricular refractory period PVARP, ventricular refractory period VRP, upper limit tracking frequency interval UTRI and ventricular event after atrial escape interval AEI. 如权利要求13所述的双腔型起搏器,其特征在于,所述主控制单元还配置为:在心室事件后心房逸搏间期AEI定时溢出之前,若通过所述感知控制/放大单元未感知到任何自身心房或心室事件,则在AEI定时溢出时,控制所述起搏控制/发生单元发放心房起搏脉冲,并控制所述时间控制单元设置心房起搏后心室逸搏间期ApVI。The dual-chamber pacemaker according to claim 13, wherein said main control unit is further configured to: pass through said sensing control/amplification unit before an atrial escape interval AEI timing overflow after a ventricular event If no atrial or ventricular events are sensed, the pacing control/generation unit is controlled to issue an atrial pacing pulse when the AEI is timed out, and the time control unit is set to set the ventricular escape interval ApVI after atrial pacing . 如权利要求13所述的双腔型起搏器,其特征在于,所述数字/模拟模块还包括程控单元,所述心房感知后房室间期AsVI、心室后心房不应期PVARP、心室不应期VRP、上限跟踪频率间期UTRI和心房起搏后心室逸搏间期ApVI由所述程控单元程控所述时间控制单元设置,所述心室事件后心房逸搏间期AEI=LRI-ApVI。The dual-chamber pacemaker according to claim 13, wherein said digital/analog module further comprises a program control unit, said atrial sensing post-interventricular interval AsVI, ventricular retroatrial refractory period PVARP, ventricular refractory The scheduled period VRP, the upper limit tracking frequency interval UTRI and the atrial pacing ventricular escape interval ApVI are programmed by the programmed unit to control the time control unit, and the atrial escape interval after the ventricular event AEI=LRI-ApVI. 如权利要求14所述的双腔型起搏器,其特征在于,所述主控制单元还配置成:在ApVI定时溢出之前,通过所述感知控制/放大单元感知到自身心室事件,则控制所述起搏控制/发生单元抑制心室起搏脉冲,并控制所述时间控制单元设置心室后心房不应期PVARP,心室不应期VRP及上限跟踪频率间期UTRI。The dual-chamber pacemaker according to claim 14, wherein said main control unit is further configured to: sense the ventricular event by said perceptual control/amplification unit before said ApVI timing overflow, then control the The pacing control/generating unit suppresses the ventricular pacing pulse, and controls the time control unit to set the post-ventricular atrial refractory period PVARP, the ventricular refractory period VRP and the upper limit tracking frequency interval UTRI. 如权利要求16所述的双腔型起搏器,其特征在于,所述主控制单元还控制所述时间控制单元设置AEI=LRI-ApVI-前一房室间期中ApVI或者AsVI的剩余时间段。The dual-chamber pacemaker according to claim 16, wherein said main control unit further controls said time control unit to set AEI=LRI-ApVI-the remaining time period of ApVI or AsVI in the previous interventricular interval .
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