WO2019001479A1

WO2019001479A1 - Physiological mode switching control method for cardiac therapy device

Info

Publication number: WO2019001479A1
Application number: PCT/CN2018/093159
Authority: WO
Inventors: 熊建劬; 黎贵玲; 黄敏
Original assignee: 创领心律管理医疗器械（上海）有限公司
Priority date: 2017-06-27
Filing date: 2018-06-27
Publication date: 2019-01-03
Also published as: CN107281641A; CN107281641B

Abstract

Disclosed is a physiological mode switching control method for a cardiac therapy device. The method comprises the following steps: S1: using a unified functional module to realize mode switching, and configuring different operating modes of the cardiac therapy device in a bit combination manner; S2: starting a mode switching process after a mode switching request has been received, detecting that a valid cardiac event exists in the switching process, and determining, according to the type of the valid cardiac event and the types of the operating mode before and after conversion, the opportunities for mode switching and timing setting; and S3: determining, according to the type of the valid cardiac event and the type of the converted operating mode, a timing interval that is set in the process of mode switching, and controlling the mode switching process to be completed within a cardiac cycle. The present invention can simultaneously take into account the AV conductivity, the heart rate stability and the timing stability, has the characteristics of fast response speed, flexible operation and simple action, and solves the problems in the existing mode switching of low response speed, long interval possibly occurring in mode switching, asynchronous A and V timings, and unstable heart rate.

Description

Physiological mode switching control method for cardiac treatment equipment

Technical field

The invention relates to a method for controlling a cardiac treatment device, in particular to a physiological mode switching control method for a cardiac treatment device.

Background technique

Medical devices for treating heart diseases, such as IPG (pacemakers, ICDs, CRTs, etc.), generally provide multi-parameter program control functions, where the working mode is a key adjustable parameter. Taking a pacemaker as an example, for different symptoms of different patients, the doctor can set the pacemaker to the appropriate pacing mode through the process controller to achieve the best therapeutic effect. At the same time, some test and measurement activities are required during the patient's follow-up, which may require temporary work mode switching. If the pacemaker is turned on with some advanced features, it may take a proactive, temporary or long-term mode switch while the feature is running. However, due to the different working modes of different pacing modes, when the pacemaker switches between the two modes, the pacing timing will inevitably change suddenly. If the pacing timing changes unreasonably, then the patient may Long intermittent timing, too fast timing, AV out of sync, etc., cause discomfort and even induce arrhythmia.

At present, there is a mode switching mode that completely restarts a pacing mode immediately after receiving a switching command, without considering the influence of the previous working mode. This method is a simple and rude method, prone to long intermittent timing, causing discomfort to the patient. There is also a mode switching method that performs mode switching on the premise of ensuring stable ventricular rate. This method is more physiological than the former one, but it is less concerned with the conductivity of AV and lacks physiologicality. In addition, if the command of the mode conversion is issued by the programmer, the time is not synchronized with the cardiac event. Sometimes it is between AV and sometimes between VA. Switching from the initial mode of operation of the pacemaker to the target mode is often quite complicated, causing confusion for the user.

Summary of the invention

The technical problem to be solved by the present invention is to provide a physiological mode switching control method for a cardiac treatment device, which can balance AV conductivity, heart rate stability and time series stability, has physiological characteristics, fast response speed, flexible operation and simple and clear behavior. specialty.

The technical solution adopted by the present invention to solve the above technical problem is to provide a physiological mode switching control method for a cardiac treatment device, comprising the following steps: S1: implementing a mode switching by using a unified functional module and setting a cardiac treatment device by a bit combination manner Different working modes; S2: the mode switching process is started after receiving the mode switching request, the effective cardiac event is detected during the switching process, and the timing of the mode switching and timing setting is determined according to the type of the effective cardiac event and the type of the working mode before and after the conversion; S3 According to the type of effective cardiac event and the type of working mode after conversion, the timing interval set in the mode switching process is determined, and the control mode switching process is completed in one cardiac cycle.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the cardiac treatment device has a plurality of different operation modes, and can perform mode switching according to a mode switching request.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the operation modes of the cardiac treatment device include DDD mode, DDI mode, DVI mode, VDD mode, DOO mode, ODO mode, AAI mode, AAT Mode, AOO mode, OAO mode, VVI mode, VVT mode, VOO mode and/or OVO mode, different working modes are set by a combination of AS bit, VS bit, DS bit, AP bit, VP bit and I/T bit And switching.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the timing of the mode switching in the step S2 includes any one of the following modes: S21: the setting of the pacing interval follows the working mode before the switching, and Mode switching is performed immediately after the pacing interval setting is completed; S22: the pacing interval setting follows the switching operation mode, and the mode switching is performed before the pacing interval setting; S23: the pacing interval is set to a new transition Interval and mode switching before pacing interval setting.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the effective cardiac events occurring in the steps S2 and S3 include an atrial event and a ventricular event, the atrial event including an AP event and a refractory period AS event, the ventricular event includes a VP event and a VS event outside the refractory period;

If an atrial event occurs during the handover, the step S3 includes the following steps: i) if the target mode has no pacing function, the mode is switched immediately at the time of the atrial event, and the interval setting is not performed, otherwise ii) if the target mode With atrial pacing function and single-cavity mode, the mode is switched to the target mode during the atrial event, and the next pacing period is set to the current pacing interval pacing atrial, otherwise iii) if the target mode has The ventricular pacing function switches the mode to the target mode during the atrial event, and sets the next pacing period to the currently operating atrioventricular pacing interval pacing ventricle;

If a ventricular event occurs during the handover, the step S3 includes the following steps: i) if the target mode has no pacing function, the mode is switched immediately at the time of the ventricular event, and the interval setting is not performed, otherwise ii) if the target mode With ventricular pacing and single-chamber mode, the mode is switched to the target mode during ventricular events, and the next pacing period is set to the current pacing interval pacing ventricle, otherwise iii) if the target mode has The atrial pacing function switches the mode to the target mode during the ventricular event, and sets the next beat period to the currently operating room pacing interval pacing atrium.

Further, the physiological mode switching control method of the cardiac treatment device, wherein if an AP event occurs during the handover, the step S3 includes the following steps: S31) if the target mode is a single cavity A that does not include OAO Pacing mode, switch mode to target mode during AP event, and set the next beat period to eff_lrl, pacing atrium; S32) If the target mode is non-single-cavity A pacing mode that does not include OXO, in AP event When the mode is switched to the target mode, and the next beat period is eff_pavi, the pacing ventricle; S33) If the target mode is OXO, the mode is switched immediately at the time of the AP event, and the interval setting is not performed.

Further, the physiological mode switching control method of the cardiac treatment device, wherein if a VP event occurs during the switching, the step S3 includes the following steps: S31) if the target mode is a single cavity V that does not include OVO Pacing mode, switch mode to target mode during VP event, and set the next beat period to eff_lrl, pacing ventricle; S32) If the target mode is non-single-chamber V pacing mode that does not include OXO, in VP event When the mode is switched to the target mode, and the next beat period is eff_lrl-eff_pavi, the pacing atrium; S33) If the target mode is OXO, the mode is switched immediately at the time of the VP event, and the interval setting is not performed.

Further, the physiological mode switching control method of the cardiac treatment device, wherein if an AS event occurs during the handover, the step S3 includes the following steps: S31) if the target mode is a single cavity A that does not include OAO Pacing mode, switch mode to target mode during AS event, and set the next beat period to eff_lrl, pacing atrium; S32) If the target mode is non-single-chamber A pacing mode that does not include OXO, in AS event Switch the mode to the target mode, and set the next beat period to eff_savi, pacing the ventricle; S33)

If the target mode is OXO, the mode is switched immediately at the time of the AS event, and the interval setting is not performed.

Further, the physiological mode switching control method of the cardiac treatment device, wherein if a VS event occurs during the switching, the step S3 includes the following steps: S31) if the target mode is a single cavity V that does not include OVO Pacing mode, switch mode to target mode during VS event, and set the next beat period to eff_lrl, pacing ventricle; S32) If the target mode is non-single-chamber V pacing mode that does not include OXO, in VS event When the mode is switched to the target mode, and the next beat period is eff_lrl-eff_pavi, the pacing atrium is set; S33) If the target mode is OXO, the mode is switched immediately at the time of the VS event, and the interval setting is not performed.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the specific value of the eff_lrl, eff_pavi follows the current mode or the target mode or the acquisition control value according to the selection timing of step S2.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the specific value of the eff_lrl, eff_savi follows the current mode or the target mode or the acquisition control value according to the selection timing of the step S2.

Further, the physiological mode switching control method of the cardiac treatment device, wherein the cardiac treatment device is a pacemaker, an ICD, a CRT, a CRT-D, a PSA, or a TPG device.

The present invention also provides a cardiac treatment device comprising: a digital/analog module configured to detect an external signal; a microprocessor connected to the digital/analog module via a data/information interface and receiving a digital/analog module to detect To the external signal, the microprocessor is configured to: switch the working mode of the cardiac treatment device through a unified function module, and set different working modes of the cardiac treatment device by bit combination; after receiving the mode switching request, the mode switching process is started, When receiving a valid cardiac event detected by the digital/analog module during the switching process, determine the type of effective cardiac event, and determine the timing of the mode switching and timing setting according to the type of the effective cardiac event and the type of the working mode before and after the conversion; according to the effective heart The event type and the converted working mode type determine the timing interval set during the mode switching, and the control mode switching process is completed in one cardiac cycle.

Further, the cardiac treatment device further includes a time control unit for setting a pacing interval, the time control unit is electrically connected to the microprocessor; and the timing of the mode switching includes any one of the following:

i) the microprocessor controls the time control unit to set the pacing interval to follow the working mode before the switching, and controls the unified function module to perform mode switching immediately after the pacing interval setting is completed;

Ii) the microprocessor controls the time control unit to set the pacing interval to follow the switched operating mode, and controls the unified functional module to perform mode switching before the pacing interval setting;

Iii) The microprocessor controls the time control unit to set the pacing interval to a new transition interval and controls the unified functional module to switch modes prior to the pacing interval setting.

Further, the digital/analog module further includes a sensing control/amplifying unit configured to detect an atrial event and a ventricular event;

If the perceptual control/amplification unit detects an atrial event during the handover, the timing interval set during the mode switching is:

i) If the target mode has no pacing function, switch the mode immediately at the time of the atrial event, and do not set the interval, otherwise

Ii) If the target mode has atrial pacing function and is in single-chamber mode, switch the mode to the target mode during the atrial event, and set the next pacing period to the current pacing interval pacing atrial, otherwise

Iii) If the target mode has a ventricular pacing function, switch the mode to the target mode at the time of the atrial event, and set the next intervening period to the currently operating atrioventricular pacing interval pacing ventricle;

If the perceptual control/amplification unit detects a ventricular event during the handover, the timing interval set during the mode switching is:

i) If the target mode has no pacing function, the mode is switched immediately during the ventricular event, and the interval setting is not performed, otherwise

Ii) If the target mode has ventricular pacing function and is in single-chamber mode, switch the mode to the target mode during the ventricular event, and set the next pacing period to the current pacing interval pacing ventricle, otherwise

Iii) If the target mode has an atrial pacing function, switch the mode to the target mode at the time of the ventricular event, and set the next pacing period to the currently operating room pacing interval pacing atrium.

Further, the working modes of the cardiac treatment device include DDD mode, DDI mode, DVI mode, VDD mode, DOO mode, ODO mode, AAI mode, AAT mode, AOO mode, OAO mode, VVI mode, VVT mode, VOO mode and/or Or OVO mode, different working modes are set and switched by the combination of AS bit, VS bit, DS bit, AP bit, VP bit and I/T bit.

Further, the cardiac treatment device is a pacemaker, ICD, CRT, CRT-D, PSA or TPG device.

Compared with the prior art, the present invention has the following beneficial effects: the physiological mode switching control method of the cardiac treatment device provided by the present invention can balance AV conductivity, ventricular rate stability and time series stability, and has physiological and fast response speed. Features; effectively solve the problem of slow response of existing mode switching, mode switching may occur long interval, A, V timing is not synchronized, heart rate is unstable.

DRAWINGS

1 is a schematic diagram of a physiological mode switching control flow of a cardiac treatment device according to an embodiment of the present invention;

2 is a timing diagram showing an atrial pacing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention;

3 is a timing diagram of a ventricular pacing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention;

4 is a timing diagram of a heart-aware event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention;

FIG. 5 is a timing diagram of a ventricular sensing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention; FIG.

6 is a schematic structural diagram of a system of a cardiac treatment device according to an embodiment of the present invention;

7 is a timing diagram of switching of a cardiac treatment device from a DDD mode to an AAI mode according to an embodiment of the present invention;

8 is a timing diagram of switching of a cardiac treatment device from an AAI mode to a VVI mode according to an embodiment of the present invention;

9 is a timing diagram of switching of a cardiac treatment device from a VVI mode to a DDD mode according to an embodiment of the present invention;

10 is a timing chart of switching of a cardiac treatment device from a DDD mode to a DDI mode according to an embodiment of the present invention.

Detailed ways

The invention will now be further described with reference to the drawings and embodiments.

1 is a schematic flow chart of a physiological mode switching control of a cardiac treatment device according to an embodiment of the present invention.

Referring to FIG. 1 , a physiological mode switching control method for a cardiac treatment device provided by the present invention includes the following steps:

S1: adopting the same function module to realize mode switching and setting different working modes of the cardiac treatment device by bit combination;

S2: After receiving the mode switching request, the mode switching process is started, and a valid cardiac event is detected during the switching process, and the timing of the mode switching and the timing setting is determined according to the type of the effective cardiac event and the type of the mode before and after the conversion;

S3: The timing interval set in the mode switching process is determined according to the type of the effective cardiac event and the type of the converted mode, and the control mode switching process is completed in one cardiac cycle.

Mode switching operations are possible at any point in the system's operation. The triggering factors may include: mode switching command during program control, temporary mode switching during test measurement, active mode switching operation after system function operation, and the like. Once the above trigger factor occurs, the system turns on the mode switching process after receiving the mode switching request to switch from the current working mode (hereinafter also referred to as the current mode) to the target working mode (hereinafter also referred to as the target mode). The mode switching process described in the embodiment of the present invention will be completed in at most one cardiac cycle, and the specific maximum time depends on the basic pacing frequency of the current system, thereby ensuring the fastest and physiological mode switching process. The actual conversion of the operating mode is performed during a valid cardiac event that occurs during the mode switching process. Among the effective cardiac events include atrial pacing events, ventricular pacing events, atrial perception events outside the refractory period, and ventricular perception events outside the refractory period. When different effective cardiac events occur, a new timing or a suitable transition timing is set according to different working modes before and after the conversion, and a specific timing for determining the mode switching, which ensures maximum heart rate stability and AV conductivity.

Different working modes of the cardiac treatment device of the embodiment of the present invention adopt a unified functional module, and it can be said that all modes operate using the same functional module, for example, by a combination of bit pattern coded. Working mode. For example, the bit pattern coded can be as follows, and the following schemes such as sorting and naming are not uniquely defined:

among them:

AS: Whether the current mode has atrial sensing function, 0 is none, 1 is yes;

VS: Does the current mode have ventricular awareness, 0 is none, 1 is yes;

DS: Whether the current mode is dual-cavity mode, 0 is a single cavity, and 1 is a double cavity;

AP: Whether the current mode has atrial pacing function, 0 is none, 1 is yes;

VP: Whether the current mode has ventricular pacing function, 0 is none, 1 is there;

I/T: Whether the current mode has a trigger function, 0 is none, 1 is yes;

For example, AAI's bit pattern is 00001001, which means that AAI mode has atrial perception and atrial pacing. The bit pattern of other modes has similar meanings. In this unified functional module architecture, mode switching of uninterrupted timing can be realized, and the time point of mode switching can be precisely controlled, and the range of application before and after the switching mode can be very flexible. For example, when converting from AAI to VVI, you only need to convert the bit pattern from 00001001 to 00010010, and start the first ventricular pacing after the AV conduction interval trigger mode conversion after the next atrial event. There is no need to reset during the whole conversion process. The pacing timing enables mode switching of uninterrupted timing; the time point control of mode switching is completed after the current timing setting is completed, and a transitional AV timing is made to make the mode switching flexible and physiological.

In the effective cardiac event processing, it is necessary to reasonably select the timing for mode switching and interval setting. In the specific mode switching, you can choose any of the following methods: 1. The setting of the interval follows the mode before the switching. If necessary, it is also affected by its advanced functions. At this time, the mode setting is completed immediately after the interval setting is completed. For example, the DDD->VVI switch in the AP event; 2. The mode after the switch is followed by the switch mode, if necessary, is also affected by its advanced function. At this time, the mode switch is performed before the interval setting. For example, the switching of AAI->DDD in the AP; 3. If the first two methods are not suitable, the interval is set to a new transition interval, and the mode switching is performed before the interval setting. Such as AP AAI->VVI switching. It should be noted that the Atrial Pace (abbreviated as AP) event, that is, the AP event refers to the atrial pacing event.

2 is a timing diagram showing an atrial pacing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention.

Referring to FIG. 2, in the cardiac treatment device of the embodiment of the present invention, an atrial pacing event AP event occurs during the handover, and the pacing interval is set as follows according to the target mode.

1) If the target mode is single-cavity A pacing mode (excluding OAO), as shown in Fig. 2A, switch the mode to the target mode at the AP event, and set the next inter-pulse period EI to eff_lrl (eff is currently valid, Lrl is the lower limit frequency interval, eff_lrl refers to the lower limit frequency interval in the current working state), and the pacing atrium realizes the stability of the heart rate while fast switching;

2) If the target mode is non-single-chamber A pacing mode (excluding OXO, for example, the target mode has ventricular pacing function), as shown in Fig. 2B, switch the mode to the target mode at the AP event, and set the next beat period. EI is eff_pavi (pavi is the AV interval after atrial pacing, eff_pavi refers to the AV interval after atrial pacing in the current working state), pacing the ventricle, achieving fast switching while ensuring AV conductivity and heart rate stability ;

3) If the target mode is OXO (no pacing function), as shown in Figure 2C, the mode is switched immediately at the AP event, and no interval setting is required;

4) The specific values of eff_lrl and eff_pavi need to be determined according to the actual current mode and its advanced functions and the target mode and its advanced functions, whether to follow the current mode, or follow the target mode, or take the program control value.

3 is a timing diagram showing a ventricular pacing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention.

Referring to FIG. 3, in the cardiac treatment device of the embodiment of the present invention, a Ventricular Pace (VP) event occurs during the handover, and the pacing interval is set as follows according to the target mode.

1) If the target mode is single-chamber V pacing mode (excluding OVO), as shown in Fig. 3A, switch the mode to the target mode at the time of the VP event, and set the next inter-pulse period EI to eff_lrl (eff is currently valid, Lrl is the lower limit frequency interval, eff_lrl has the same meaning as eff_lrl above), and the pacing ventricle realizes the rapid switching of heart rate while ensuring the stability of heart rate;

2) If the target mode is non-single-chamber V pacing mode (excluding OXO, for example, the target mode has atrial pacing function), as shown in Fig. 3B, switch the mode to the target mode at the time of the VP event, and set the next beat period. EI, EI=eff_lrl-eff_pavi (eff is currently valid, lrl is the lower frequency interval, pavi is the AV interval after atrial pacing, eff_lrl has the same meaning as above, eff_pavi has the same meaning as above), pacing atrium, Realize the stability of heart rate while fast switching;

3) If the target mode is OXO, as shown in Figure 3C, the mode is switched immediately at the time of the VP event, and no interval setting is required;

4 is a timing diagram of a heart-aware event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention.

4, in the cardiac therapy device of the embodiment of the present invention, an Atria Sense (AS) event occurs during the handover process, and the pacing interval is set as follows according to the target mode.

1) If the target mode is single-chamber A pacing mode (excluding OAO), as shown in Figure 4A, switch the mode to the target mode at the AS event, and set the next beat period to eff_lrl (eff_lrl has the same meaning as above) The pacing atrium achieves a stable heart rate while fast switching;

2) If the target mode is non-single-cavity A pacing mode (excluding OXO), as shown in Figure 4B, switch the mode to the target mode at the AS event, and set the next inter-pulse period EI to eff_savi (eff is currently valid) , savi is the AV interval after atrial perception, eff_savi refers to the AV interval after atrial perception in the current working state), pacing the ventricle, achieving fast switching while ensuring AV conductivity and heart rate stability;

3) If the target mode is OXO, as shown in Figure 4C, the mode is switched immediately at the time of the AS event, and no interval setting is required;

4) The specific values of eff_lrl and eff_savi need to be determined according to the actual current mode and its advanced functions and the target mode and its advanced functions, whether to follow the current mode, or follow the target mode, or take the program control value.

FIG. 5 is a timing diagram showing a ventricular sensing event occurring during a handover of a cardiac treatment device according to an embodiment of the present invention.

Referring to FIG. 5, in the cardiac treatment device of the embodiment of the present invention, a Ventricular Sense (VS) event occurs during the handover, and the pacing interval is set as follows according to the target mode.

1) If the target mode is single-chamber V pacing mode (excluding OVO), as shown in Fig. 5A, switch the mode to the target mode at the VS event, and set the next inter-pulse period EI to eff_lrl (eff_lrl has the same meaning as above) ), pacing the ventricle, ensuring stable heart rate while switching quickly;

2) If the target mode is non-single-cavity V pacing mode (excluding OXO), as shown in Fig. 5B, switch the mode to the target mode at the VS event, and set the next inter-pulse period EI, EI=eff_lrl-eff_pavi(eff_lrl Same as above, eff_pavi has the same meaning as above), pacing the atrium, ensuring stable heart rate while switching quickly;

3) If the target mode is OXO, as shown in Figure 5C, the mode is switched immediately at the time of the VS event, and no interval setting is required;

The system architecture of the cardiac treatment device of the embodiment of the present invention is shown in Figure 6, which includes a microprocessor 8 and a digital/analog module 9 connected thereto, the perception of the atrial ventricle being always on, regardless of the 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 implements control of occurrence events, events to be generated, and the like, and also records and statistics on occurrence events. The main control unit 1 can select to implement time-dependent control functions such as timing and timing through the time control unit 2. The data/information interface 3 implements interaction with data or information and the like between other modules of the device. The data/information interface 3 can be an ordinary I/O interface or a serial or parallel data transmission module. The pacing signal and the sensing signal are the main control unit and the corresponding control through the I/O line. Generate communication between units.

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 accepts the pacing request of the microprocessor 8 and generates a signal of the required intensity to act on the outside. 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. The program control unit 7 can perform information interaction with the outside world, such as a user, such as receiving a user mode switching operation request, and transmitting the request information to the main control unit 1 through the data/information interaction interfaces 4 and 3. The main control unit 1 controls the implementation mode. Switch.

The single-chamber pacing mode of the commonly used cardiac therapy equipment is as follows:

1. AAI mode This mode works by atrial pacing and atrial perception, and suppresses the release of pacemaker pulses after sensing the electrical activity of the atrium. In this mode, the ventricular signal is not perceived.

2, VVI mode This mode works in the ventricular pacing, ventricular perception, after sensing the ventricular self-electrical activity to inhibit the release of pacemaker pulse, also known as R wave suppression ventricular pacing or ventricular on-demand pacing. In this mode, the atrial signal is not perceived. VVI only issues a pulsed pacing ventricle when it is "needed", and the heart rhythm produced by pacing is actually an escape rhythm.

The commonly used dual chamber pacing mode is as follows:

1, DDD mode, also known as atrioventricular pacing, is a physiological pacing mode with dual-chamber sequential pacing, dual atrial ventricular pacing, triggering and inhibition.

2, VDD mode is also known as atrial synchronous ventricular suppression pacemaker. The atrium and ventricle all have a sensory function, but only the ventricle has a pacing function. In the entire VDD pacing system, the correct perception of the P wave is the key to its normal operation.

3, DDI mode atrium, ventricle have a perception and pacing function, P wave perception after suppression of atrial pacing (similar to DDD), but does not trigger the interventricular interval, that is, no ventricular tracking. If the patient has normal atrioventricular conduction, it is basically similar to AAI; it does not act as a separate pacing mode but only as a mode of operation after DDD(R) mode transition.

The mode of operation of the cardiac treatment device of the embodiment of the present invention includes all commonly used single and dual cavity modes such as DDD, DDI, DVI, VDD, DOO, ODO, AAI, AAT, AOO, OAO, VVI, VVT, VOO and/or In the OVO mode, different working modes are set and switched by a combination of AS bit, VS bit, DS bit, AP bit, VP bit, and I/T bit. A typical specific switching procedure for different modes of operation of the cardiac treatment device of an embodiment of the present invention is given below. The coding meaning of each of the above modes of operation can be found in the NASPE/BPEG pacemaker identification code, where NASPE stands for North American Pacing and Electrophysiology Society and BPEG stands for British Pacing and Electrophysiology. As mentioned above, according to the NASPE/BPEG pacemaker identification code, DDD mode, also known as atrioventricular pacing, is a physiological pacing with dual-chamber sequential pacing, atrial ventricular dual sensing, triggering and inhibition. mode.

1.DDD->AAI: as shown in Figure 7:

As shown in FIG. 7A, a mode switching command is received at time t1 to turn on the mode switching process; at time t2, an atrial pacing event AP ^* occurs (distinguished from AP events at other times), in an atrial pacing event. In the process, the current mode is first switched to the AAI mode, and then the next atrial pacing interval is set to the lower limit frequency in the current working state according to the AAI mode central room pacing event processing mode, and the mode switching process is completed. It is completely operated in the AAI mode after the time t2, and the atrial rate is kept stable during the mode switching.

As shown in FIG. 7B, a mode switching command is received at time t1 to turn on the mode switching process; a ventricular pacing event VP ^* occurs at time t2 (distinguish from VP events at other times), and in the ventricular pacing event processing, first according to The DDD mode central room pacing event processing mode sets the next atrial pacing interval to the lower limit frequency in the current working state minus the current working state, and then switches the current mode to the AAI mode to complete the mode switching process. After the time t2, it is completely operated in the AAI mode, and the room order and heart rate are kept stable during the mode switching.

As shown in FIG. 7C, the mode switching command is received at time t1, and the mode switching process is started; the atrial sensing event AS ^* occurs at time t2 (distinguished from the AS events at other times), and in the atrial sensing event processing, the current mode is firstly Switch to AAI mode, and then set the next atrial escape interval to the lower limit frequency of the current working state according to the AAI mode central room sensing event processing method (if single cavity hysteresis is turned on in AAI mode, according to single cavity hysteresis function) Set the interval) to complete the mode switching process. It is completely operated in the AAI mode after the time t2, and the atrial rate is kept stable during the mode switching.

As shown in FIG. 7D, a mode switching command is received at time t1 to turn on the mode switching process; a ventricular sensing event VS ^* occurs at time t2 (distinguish from the VS event at other times), and in the ventricular sensing event processing, first according to the DDD mode The central room sensing event processing method sets the next atrial pacing interval to the lower limit frequency in the current working state minus the current working state pavi plus the remaining time of the previous AV interval resi (resi is t3 time and t2 The difference between the moments), then switch the current mode to AAI mode to complete the mode switching process. After the time t2, it is completely operated in the AAI mode, and the room order and heart rate are kept stable during the mode switching.

As shown in FIG. 7E, the mode switching command is received at time t1, and the mode switching process is started; the ventricular premature beat event PVC ^* occurs at time t2 (distinguish from the PVC event at other times), and in the ventricular premature beat event processing, first according to the DDD mode. The central chamber premature beat event processing method sets the next atrial pacing interval to the lower limit frequency in the current working state minus the pavi in the current working state, and then switches the current mode to the AAI mode to complete the mode switching process. After the time t2, it is completely operated in the AAI mode, and the room order and heart rate are kept stable during the mode switching.

2. AAI->VVI: as shown in Figure 8:

As shown in FIG. 8A, a mode switching command is received at time t1 to turn on the mode switching process; an atrial pacing event AP ^* occurs at time t2, and in the atrial pacing event processing, the current mode is first switched to the VVI mode due to the current mode. Switch to switch from AAI to VVI. The effective cardiac events included in these two modes are A event and V event respectively. The two modes do not have AV sequence. Therefore, you need to set a transition interval when setting the interval. , that is, the AV interval (this is the default AV interval, eff_pavi, eff_pavi has the same meaning as above), and the mode switching process is completed. After the time t2, it runs completely in VVI mode, and the use of the transition period ensures the stability of the heart rate under the premise of this AV conductivity.

As shown in FIG. 8B, the mode switching command is received at time t1, and the mode switching process is started; the atrial sensing event AS ^* occurs at time t2, and in the atrial sensing event processing, the current mode is first switched to the VVI mode, because the current mode is switched to Switching from AAI to VVI, the effective cardiac events included in these two modes are A event and V event respectively. The two modes do not have AV sequence itself. Therefore, a transition interval needs to be set during the setup interval. The AV interval (in this case, the default AV interval, eff_savi, eff_savi has the same meaning as above) completes the mode switching process. After the time t2, it runs completely in VVI mode, and the use of the transition period ensures the stability of the heart rate under the premise of this AV conductivity.

3.VVI->DDD: as shown in Figure 9:

As shown in FIG. 9A, a mode switching command is received at time t1 to turn on the mode switching process; a ventricular pacing event VP ^* occurs at time t2, and in the ventricular pacing event processing, the current mode is first switched to the DDD mode, and then according to the DDD. The mode center room pacing event processing mode sets the next atrial pacing interval to the lower limit frequency in the current working state minus the pavi in the current working state, and completes the mode switching process. It is fully operated in DDD mode after time t2, which maintains the order of the room and the stability of the heart rate during the mode switching.

As shown in FIG. 9B, a mode switching command is received at time t1 to turn on the mode switching process; at time t2, a ventricular sensing event VS ^* occurs, and in the ventricular sensing event processing, the current mode is first switched to the DDD mode, and then according to the DDD mode center. The premature beat event processing method sets the next atrial pacing interval to the lower limit frequency in the current working state minus the pavi in the current working state, and completes the mode switching process. It is fully operated in DDD mode after time t2, which maintains the order of the room and the stability of the heart rate during the mode switching.

4.DDD->DDI: as shown in Figure 10:

As shown in FIG. 10A, a mode switching command is received at time t1 to turn on the mode switching process; an atrial pacing event AP ^* occurs at time t2, and in the atrial pacing event processing, the current mode is first switched to the DDI mode, and then according to the DDI. The mode center room pacing event processing method sets the next ventricular pacing interval to the pavi in the current working state, and completes the mode switching process. After running at time t2 and completely in DDI mode, it is achieved that the atrial rate is kept stable during mode switching.

As shown in FIG. 10B, a mode switching command is received at time t1 to turn on the mode switching process; a ventricular pacing event VP ^* occurs at time t2, and in the ventricular pacing event processing, the current mode is first switched to the DDI mode, and then according to the DDI. The mode center room pacing event processing mode sets the next atrial pacing interval to the lower limit frequency in the current working state minus the pavi in the current working state, and completes the mode switching process. After running at time t2 and completely in DDI mode, it is achieved that the room order and heart rate are stabilized during mode switching.

As shown in FIG. 10C, the mode switching command is received at time t1, and the mode switching process is started; the atrial sensing event AS ^* occurs at time t2, and in the atrial sensing event processing, the next ventricle is firstly processed according to the DDD mode central room sensing event processing mode. The pacing interval is set to savi in the current working state (if the AV hysteresis is turned on in the DDD mode, the interval is set according to the AV hysteresis function), and then the current mode is switched to the DDI mode to complete the mode switching process. After running at time t2 and completely in DDI mode, it is achieved that the atrial rate is kept stable during mode switching.

As shown in FIG. 10D, the mode switching command is received at time t1, and the mode switching process is started; the ventricular sensing event VS ^* occurs at time t2, and in the ventricular sensing event processing, the next atrium is firstly processed according to the DDD mode central room sensing event processing mode. The pacing interval is set to the lower limit frequency in the current working state minus the pavi in the current working state plus the remaining time resi of the previous AV interval, and then the current mode is switched to the DDI mode to complete the mode switching process. After running at time t2 and completely in DDI mode, it is achieved that the room order and heart rate are stabilized during mode switching.

As shown in FIG. 10E, the mode switching command is received at time t1, and the mode switching process is started; the ventricular premature beat event PVC ^* occurs at time t2, and in the ventricular premature beat event processing, the next atrium is firstly processed according to the DDD mode central chamber premature beat event processing mode. The pacing interval is set to the lower limit frequency in the current working state minus the pavi in the current working state, and then the current mode is switched to the DDI mode to complete the mode switching process. After running at time t2 and completely in DDI mode, it is achieved that the room order and heart rate are stabilized during mode switching.

In summary, the physiological mode switching control method of the cardiac treatment device provided by the embodiment of the present invention can balance AV conductivity, heart rate stability, and timing stability, and the specific advantages are as follows: 1) fast mode switching can be realized; Responsible for the activation of a reasonable working mode; 2) can provide physiological switching timing, avoiding inappropriate switching timings such as long pauses, AV out of sync, etc., providing a more comfortable experience for patients; 3) providing more during mode switching Stable atrial rate and ventricular rate, to bring a better experience to patients; 4) can flexibly adjust the actual interaction interval according to actual needs, and can flexibly achieve optimal switching operation for devices with complex advanced functions. ; 5) At the same time, the complicated phenomenon of pacing behavior caused by the timing of the heartbeat cycle AV or the timing of the VA is also cleared.

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

A physiological mode switching control method for a cardiac treatment device, comprising the steps of:

S1: adopting a unified function module to realize mode switching and setting different working modes of the cardiac treatment device by bit combination;

S2: After receiving the mode switching request, the mode switching process is started, and a valid cardiac event is detected during the switching process, and the timing of the mode switching and the timing setting is determined according to the type of the effective cardiac event and the type of the working mode before and after the conversion;

S3: The timing interval set in the mode switching process is determined according to the type of the effective cardiac event and the type of the working mode after the conversion, and the control mode switching process is completed in one cardiac cycle.
A physiological mode switching control method for a cardiac treatment device according to claim 1, wherein said cardiac treatment device has a plurality of different operation modes, and mode switching is performed according to a mode switching request.
The physiological mode switching control method of the cardiac treatment device according to claim 2, wherein the operation mode of the cardiac treatment device comprises DDD mode, DDI mode, DVI mode, VDD mode, DOO mode, ODO mode, AAI Mode, AAT mode, AOO mode, OAO mode, VVI mode, VVT mode, VOO mode and/or OVO mode, different working modes through AS bit, VS bit, DS bit, AP bit, VP bit and I/T bit Combine settings and switch.
The physiological mode switching control method of the cardiac treatment device according to claim 1, wherein the timing of the mode switching in the step S2 comprises any one of the following methods:

S21: the setting of the pacing interval follows the working mode before the switching, and the mode switching is performed immediately after the setting of the pacing interval is completed;

S22: the pacing interval setting follows the working mode after the switching, and performs mode switching before the pacing interval setting;

S23: The pacing interval is set to a new transition interval, and the mode is switched before the pacing interval is set.
The physiological mode switching control method of the cardiac treatment apparatus according to claim 1, wherein the effective cardiac events occurring in said steps S2 and S3 include an atrial event and a ventricular event, said atrial event including an AP event and should not Extra-stage AS events, including VP events and VS events outside the refractory period;

If an atrial event occurs during the handover, the step S3 includes the following steps:

i) If the target mode has no pacing function, switch the mode immediately at the time of the atrial event, and do not set the interval, otherwise

Ii) If the target mode has atrial pacing function and is in single-chamber mode, switch the mode to the target mode during the atrial event, and set the next pacing period to the current pacing interval pacing atrial, otherwise

Iii) If the target mode has a ventricular pacing function, switch the mode to the target mode at the time of the atrial event, and set the next pacing period to the currently operating atrioventricular pacing interval pacing ventricle;

If a ventricular event occurs during the handover, the step S3 includes the following steps:

i) If the target mode has no pacing function, the mode is switched immediately during the ventricular event, and the interval setting is not performed, otherwise

Ii) If the target mode has ventricular pacing function and is in single-chamber mode, switch the mode to the target mode during the ventricular event, and set the next pacing period to the current pacing interval pacing ventricle, otherwise

Iii) If the target mode has an atrial pacing function, switch the mode to the target mode at the time of the ventricular event, and set the next pacing period to the currently operating room pacing interval pacing atrium.
The physiological mode switching control method of the cardiac treatment device according to claim 5, wherein if an AP event occurs during the handover, the step S3 includes the following steps:

S31) If the target mode is a single-cavity A pacing mode that does not include OAO, switch the mode to the target mode at the time of the AP event, and set the next beat period to eff_lrl, the pacing atrium;

S32) If the target mode is a non-single-cavity A pacing mode that does not include OXO, switch the mode to the target mode at the AP event, and set the next beat period to eff_pavi, the pacing ventricle;

S33) If the target mode is OXO, the mode is switched immediately at the time of the AP event, and the interval setting is not performed.
The physiological mode switching control method of the cardiac treatment device according to claim 5, wherein if a VP event occurs during the handover, the step S3 comprises the following steps:

S31) If the target mode is a single-chamber V pacing mode that does not include OVO, switch the mode to the target mode at the time of the VP event, and set the next beat period to eff_lrl, the pacing ventricle;

S32) If the target mode is a non-single-cavity V pacing mode that does not include OXO, switch the mode to the target mode at the time of the VP event, and set the next beat period to eff_lrl-eff_pavi, the pacing atrium;

S33) If the target mode is OXO, the mode is switched immediately at the time of the VP event, and the interval setting is not performed.
The physiological mode switching control method of the cardiac treatment device according to claim 5, wherein if an AS event occurs during the handover, the step S3 includes the following steps:

S31) If the target mode is a single-cavity A pacing mode that does not include OAO, switch the mode to the target mode at the time of the AS event, and set the next beat period to eff_lrl, the pacing atrium;

S32) If the target mode is a non-single-cavity A pacing mode that does not include OXO, switch the mode to the target mode at the time of the AS event, and set the next beat period to eff_savi, the pacing ventricle;

S33) If the target mode is OXO, the mode is switched immediately at the time of the AS event, and the interval setting is not performed.
The physiological mode switching control method of the cardiac treatment device according to claim 5, wherein if a VS event occurs during the switching, the step S3 comprises the following steps:

S31) If the target mode is a single-chamber V pacing mode that does not include OVO, switch the mode to the target mode at the VS event, and set the next beat period to eff_lrl, the pacing ventricle;

S32) If the target mode is a non-single-cavity V pacing mode that does not include OXO, switch the mode to the target mode at the VS event, and set the next beat period to eff_lrl-eff_pavi, the pacing atrium;

S33) If the target mode is OXO, the mode is switched immediately at the time of the VS event, and the interval setting is not performed.
The physiological mode switching control method of the cardiac treatment device according to claim 6 or 7 or 9, wherein the specific value of the eff_lrl, eff_pavi follows the current mode or the target mode or the acquisition control according to the selection timing of the step S2 value.
The physiological mode switching control method of the cardiac treatment device according to claim 8, wherein the specific value of the eff_lrl, eff_savi follows the current mode or the target mode or the acquisition control value according to the selection timing of the step S2.
The physiological mode switching control method of the cardiac treatment device according to any one of claims 1 to 9, characterized in that the cardiac treatment device is a pacemaker, an ICD, a CRT, a CRT-D, a PSA or a TPG device.
A cardiac treatment device comprising:

a digital/analog module configured to detect an external signal;

a microprocessor coupled to the digital/analog module via a data/information interface and receiving an external signal detected by the digital/analog module, the microprocessor configured to:

Switching the working mode of the cardiac treatment device through a unified function module, and setting different working modes of the cardiac treatment device by bit combination;

After receiving the mode switching request, the mode switching process is started, and when the valid cardiac event detected by the digital/analog module is received during the switching process, the type of the effective cardiac event is determined, and according to the type of the effective cardiac event and the working mode before and after the conversion The type determines the timing of mode switching and timing setting;

The timing interval set in the mode switching process is determined according to the type of the effective cardiac event and the type of the working mode after the conversion, and the control mode switching process is completed in one cardiac cycle.
A cardiac treatment apparatus according to claim 13, further comprising a time control unit for setting a pacing interval, said time control unit being electrically connected to said microprocessor; said timing of said mode switching comprising Any of the following ways:

i) the microprocessor controls the time control unit to set the pacing interval to follow the working mode before the switching, and control the unified function module to perform mode switching immediately after the pacing interval setting is completed;

Ii) the microprocessor controls the time control unit to set the pacing interval to follow the switched operating mode, and control the unified functional module to perform mode switching before the pacing interval setting;

Iii) The microprocessor controls the time control unit to set the pacing interval to a new transition interval and controls the unified functional module to perform mode switching prior to the pacing interval setting.
A cardiac treatment device according to claim 13 wherein:

The digital/analog module further includes a sensing control/amplifying unit configured to detect an atrial event and a ventricular event;

If the perceptual control/amplification unit detects an atrial event during the handover, the timing interval set in the mode switching process is:

i) If the target mode has no pacing function, switch the mode immediately at the time of the atrial event, and do not set the interval, otherwise

Ii) If the target mode has atrial pacing function and is in single-chamber mode, switch the mode to the target mode during the atrial event, and set the next pacing period to the current pacing interval pacing atrial, otherwise

Iii) If the target mode has a ventricular pacing function, switch the mode to the target mode at the time of the atrial event, and set the next pacing period to the currently operating atrioventricular pacing interval pacing ventricle;

If the perceptual control/amplification unit detects a ventricular event during the handover, the timing interval set in the mode switching process is:

i) If the target mode has no pacing function, the mode is switched immediately during the ventricular event, and the interval setting is not performed, otherwise

Ii) If the target mode has ventricular pacing function and is in single-chamber mode, switch the mode to the target mode during the ventricular event, and set the next pacing period to the current pacing interval pacing ventricle, otherwise

Iii) If the target mode has an atrial pacing function, switch the mode to the target mode at the time of the ventricular event, and set the next pacing period to the currently operating room pacing interval pacing atrium.
The cardiac treatment device according to claim 13, wherein the operation mode of the cardiac treatment device comprises a DDD mode, a DDI mode, a DVI mode, a VDD mode, a DOO mode, an ODO mode, an AAI mode, an AAT mode, and an AOO mode. , OAO mode, VVI mode, VVT mode, VOO mode and / or OVO mode, different working modes are set and switched by a combination of AS bit, VS bit, DS bit, AP bit, VP bit and I/T bit.
A cardiac treatment device according to claim 13 wherein the cardiac treatment device is a pacemaker, ICD, CRT, CRT-D, PSA or TPG device.