CN107281641B

CN107281641B - Physiological mode switching control method of cardiac treatment equipment

Info

Publication number: CN107281641B
Application number: CN201710497488.7A
Authority: CN
Inventors: 黄敏; 黎贵玲; 熊建劬
Original assignee: Microport Sorin CRM Shanghai Co Ltd
Current assignee: Microport Sorin CRM Shanghai Co Ltd
Priority date: 2017-06-27
Filing date: 2017-06-27
Publication date: 2020-07-07
Anticipated expiration: 2037-06-27
Also published as: CN107281641A; WO2019001479A1

Abstract

The invention discloses a physiological mode switching control method of cardiac treatment equipment, which comprises the following steps: s1: the same functional module is adopted to realize mode switching and different working modes of the heart treatment equipment are set in a bit combination mode; s2: starting a mode switching process after receiving a mode switching request, detecting an effective cardiac event in the switching process, and determining the time for mode switching and time sequence setting according to the type of the effective cardiac event and the types of the modes before and after conversion; s3: and determining a time sequence interval set in the mode switching process according to the effective cardiac event type and the converted mode type, and controlling the mode switching process to be completed in one cardiac cycle. The invention can give consideration to AV conductivity, heart rate stability and time sequence stability, and has the characteristics of high response speed, flexible operation and simple and clear behavior; the problems that the response speed of the existing mode switching is low, long intermittence possibly occurs in the mode switching, A, V time sequences are asynchronous, and the heart rate is unstable are solved.

Description

Physiological mode switching control method of cardiac treatment equipment

Technical Field

The present invention relates to a control method for a cardiac therapy apparatus, and more particularly, to a physiological mode switching control method for a cardiac therapy apparatus.

Background

Medical devices for treating heart diseases, such as IPGs (pacemakers, ICDs, CRTs, etc.), can generally provide multi-parameter programmable functions, wherein the operation mode is a key adjustable parameter. Taking a pacemaker as an example, a doctor can set the pacemaker in a proper pacing mode through a program controller to achieve the best treatment effect aiming at different symptoms of different patients. While some test measurement activity is required during patient follow-up, these operations may require a temporary working mode switch. If the pacemaker turns on certain advanced functions, it may be necessary to actively make a temporary or long mode switch while the functions are running. However, because different pacing modes work differently, when the pacemaker switches between the two modes, the pacing timing sequence inevitably changes suddenly, and if the pacing timing sequence changes unreasonably, the patient may have long intermittent timing, too fast timing, AV asynchronism and the like, which causes discomfort to the patient and even induces arrhythmia.

Currently, there is a mode switching method that completely restarts a pacing mode immediately after receiving a switching command without considering the influence of the previous operation mode. This approach is a simple and crude method, prone to long intermittent timing sequences, and causes discomfort to the patient. Yet another mode switching method is to switch modes on the premise of ensuring a stable ventricular rate, which is more physiological than the former one, but it is less physiological than the former one in consideration of AV conductivity. In addition, if the instructions for mode switching are issued by the programmer, the time is not synchronized with the cardiac events. Sometimes between the AVs and sometimes between the VA. Such switching from the initial operating mode of the pacemaker to the target mode is often quite complicated and can be annoying to the user.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a physiologic mode switching control method of cardiac treatment equipment, which can give consideration to AV conductivity, heart rate stability and time sequence stability, and has the characteristics of physiology, high response speed, flexible operation and simple and clear behavior.

The invention provides a physiological mode switching control method of a heart treatment device, which solves the technical problem and comprises the following steps: s1: the same functional module is adopted to realize mode switching and different working modes of the heart treatment equipment are set in a bit combination mode; s2: starting a mode switching process after receiving a mode switching request, detecting an effective cardiac event in the switching process, and determining the time for mode switching and time sequence setting according to the type of the effective cardiac event and the types of the modes before and after conversion; s3: and determining a time sequence interval set in the mode switching process according to the effective cardiac event type and the converted mode type, and controlling the mode switching process to be completed in one cardiac cycle.

In the above physiological mode switching control method of the cardiac therapy apparatus, the cardiac therapy apparatus has a plurality of different operation modes, and can switch the operation modes according to the switching request.

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

In the above physiological mode switching control method of the cardiac treatment apparatus, the timing of mode switching in step S2 may include any one of the following modes: s21: setting the pacing interval follows the mode before switching, and immediately switching the mode after the pacing interval is set; s22: the pacing interval setting follows the switched mode and the mode switching is performed before the pacing interval setting; s23: the pacing interval is set to a new transition interval and a mode switch is made prior to the pacing interval setting.

In the physiologic mode switching control method of the cardiac treatment device, the valid cardiac events occurring in steps S2 and S3 include an atrial pacing event AP event, a ventricular pacing event VP event, an atrial sensing event AS event outside the refractory period, and a ventricular sensing event VS event;

if an atrial event occurs during the switching, the step S3 includes the steps of: i) if the target mode is without pacing function, switching mode immediately at the atrial event and not interval setting, otherwise ii) if the target mode has atrial pacing and is a single chamber mode, switching mode to the target mode at the atrial event and setting the next pacing interval to pace the atrium for the currently operating base pacing interval, otherwise iii) switching mode to the target mode at the atrial event and setting the next pacing interval to pace the ventricle for the currently operating atrioventricular pacing interval;

if a ventricular event occurs during the switching process, the step S3 includes the following steps: i) if the target mode is without pacing functionality, the mode is switched immediately at the ventricular event and no interval setting is done, otherwise ii) if the target mode has ventricular pacing and is a single chamber mode, the mode is switched to the target mode at the ventricular event and the next pacing interval is set to pace the ventricle for the currently running base pacing interval, otherwise iii) the mode is switched to the target mode at the ventricular event and the next pacing interval is set to pace the atrium for the currently running ventricular pacing interval.

The physiologic mode switching control method of the cardiac treatment device, wherein if an atrial pacing event AP event occurs during the switching, the step S3 comprises the following steps: s31) if the target mode is a single chamber a pacing mode that does not include an OAO, switching the mode to the target mode at the AP event and setting the next pacing interval to eff _ lrl, pacing the atrium; s32) if the target mode is a non-single chamber a pacing mode that does not include OXO, switching the mode to the target mode at the AP event and setting the next pacing interval to eff _ pavi, pacing the ventricle; s33) if the target mode is OXO, the mode is switched immediately at the AP event and no interval setting is made.

In the above physiological mode switching control method of a cardiac therapy apparatus, if a ventricular pacing event VP event occurs during the switching process, the step S3 includes the following steps: s31) if the target mode is the single chamber V pacing mode not including OVO, switching the mode to the target mode at the VP event and setting the next pacing interval to eff _ lrl, pacing the ventricle; s32) if the target mode is a non-single chamber V pacing mode that does not include OXO, switching the mode to the target mode at the VP event and setting the next pacing interval to eff _ lrl-eff _ pavi, pacing the atrium; s33) if the target mode is OXO, the mode is switched immediately at the VP event and no interval setting is done.

The physiologic mode switching control method of the cardiac treatment device, wherein if an atrial sensing event AS event occurs during switching, the step S3 comprises the following steps: s31) if the target mode is a single chamber a pacing mode that does not include an OAO, switching the mode to the target mode at the AS event and setting the next pacing interval to eff _ lrl, pacing the atrium; s32) if the target mode is a non-single chamber a pacing mode that does not include OXO, switching the mode to the target mode at an AS event and setting the next pacing interval to eff _ savi, pacing the ventricle; s33) if the target mode is OXO, the mode is switched immediately upon the AS event and no interval setting is made.

The physiologic mode switching control method of the cardiac treatment device, wherein if a ventricular sense event VS event occurs during the switching process, the step S3 includes the following steps: s31) if the target mode is a single chamber V pacing mode not including OVO, switching the mode to the target mode at the VS event and setting the next pacing interval to eff _ lrl, pacing the ventricle; s32) if the target mode is a non-single chamber V pacing mode that does not include OXO, switching the mode to the target mode at the time of the VS event and setting the next pacing interval to eff _ lrl-eff _ pavi, pacing the atrium; s33) if the target mode is OXO, the mode is switched immediately upon the VS event and no interval setting is made.

In the physiologic mode switching control method of the cardiac therapy device, the specific values of Eff _ lrl, Eff _ savi, and Eff _ pavi follow the current mode or the target mode or take programmed values according to the selected timing in step S2.

The physiologic mode switching control method of the cardiac therapy device is characterized in that the cardiac therapy device is a pacemaker, an ICD, a CRT-D, PSA or a TPG device.

Compared with the prior art, the invention has the following beneficial effects: the physiologic mode switching control method of the cardiac treatment equipment can give consideration to AV conductivity, ventricular rate stability and time sequence stability, and has the characteristics of being physiologic and fast in response speed; the problems that the response speed of the existing mode switching is low, long intermittence possibly occurs in the mode switching, A, V time sequences are asynchronous, and the heart rate is unstable are effectively solved.

Drawings

FIG. 1 is a schematic diagram of a physiological mode switching control flow of the cardiac treatment apparatus of the present invention;

FIG. 2 is a diagram illustrating the timing of the occurrence of an atrial pacing event during a switching event in accordance with the present invention;

FIG. 3 is a diagram illustrating the timing of the occurrence of a ventricular pacing event during a switching process in accordance with the present invention;

FIG. 4 is a timing diagram illustrating the occurrence of atrial sensed events during a handoff process in accordance with the present invention;

FIG. 5 is a diagram illustrating the timing of the occurrence of ventricular sense events during a handoff process in accordance with the present invention;

FIG. 6 is a schematic diagram of a system architecture of the cardiac treatment apparatus of the present invention;

FIG. 7 is a timing diagram illustrating the switching from DDD mode to AAI mode according to the present invention;

FIG. 8 is a timing diagram illustrating the switching from the AAI mode to the VVI mode according to the present invention;

FIG. 9 is a timing diagram illustrating the switching from the VVI mode to the DDD mode according to the present invention;

FIG. 10 is a timing diagram for switching the DDD mode to the DDI mode according to the present invention.

Detailed Description

The invention is further described below with reference to the figures and examples.

Fig. 1 is a schematic diagram of a physiological mode switching control flow of the cardiac treatment apparatus of the present invention.

Referring to fig. 1, the physiological mode switching control method of the cardiac therapy device provided by the invention comprises the following steps:

s1: the same functional module is adopted to realize mode switching and different working modes of the heart treatment equipment are set in a bit combination mode;

s2: starting a mode switching process after receiving a mode switching request, detecting an effective cardiac event in the switching process, and determining the time for mode switching and time sequence setting according to the type of the effective cardiac event and the types of the modes before and after conversion;

s3: and determining a time sequence interval set in the mode switching process according to the effective cardiac event type and the converted mode type, and controlling the mode switching process to be completed in one cardiac cycle.

The mode switching operation may be performed at any time while the system is operating. Factors for triggering may include: mode switching commands in the program control process, temporary mode switching in the test measurement process, active mode switching operation after system functions are operated and the like. Once the trigger factors occur, the system starts the mode switching process, the mode switching process of the invention is completed in at most one cardiac cycle, and the specific longest time depends on the basic pacing frequency of the current system, thereby ensuring the fastest and physiological mode switching process. The actual transition of the mode is made during the active cardiac event that occurs during the mode switching process. Among the cardiac events that are effective are atrial pacing, ventricular pacing, atrial sensing outside the refractory period, and ventricular sensing. When different effective cardiac events occur, a new time sequence or a proper transition time sequence is set according to different modes before and after conversion, and the specific time for switching the modes is determined, wherein the time sequence maximally ensures the heart rate stability and the AV conductivity.

The invention adopts a uniform function module in each different working mode, namely the same function module is adopted in the operation of all the modes, and different working modes are realized by a bit pattern coded combination mode, for example, the bit pattern coded can be as follows, and the following schemes such as sequencing and naming are not limited uniquely:

wherein:

AS: whether the current mode has an atrial sensing function, 0 is absent and 1 is present;

VS: whether the current mode has a ventricular sensing function or not, wherein 0 is absent and 1 is present;

and (2) DS: whether the current mode is a double-cavity mode or not, wherein 0 is a single cavity and 1 is a double cavity;

AP: whether the current mode has an atrial pacing function, 0 is absent, and 1 is present;

VP: whether the current mode has a ventricular pacing function or not, wherein 0 is absent and 1 is present;

I/T: the current mode has a trigger function, 0 is absent, and 1 is present;

for example, the bit pattern of AAI is 00001001, which means that AAI mode has atrial sensing and atrial pacing, and other modes have similar analytic meaning of bit pattern. The mode switching of uninterrupted time sequence can be realized under the unified functional module architecture, the time point of the mode switching can be accurately controlled, and the application range of the modes before and after the switching can be very flexible. For example, when the AAI is converted into the VVI, the bit pattern is only required to be converted from 00001001 to 00010010, the AV conduction interval is started after the next atrial event to trigger the first ventricular pacing after the mode conversion, and the pacing timing does not need to be reset in the whole conversion process, so that the mode conversion of the uninterrupted timing is realized; the mode switching time point is controlled after the current time sequence is set, and the mode switching is flexible and physiological through a transitional AV time sequence.

In effective cardiac event processing, it is desirable to make a reasonable choice of timing for the mode switching and interval setting. Any one of the following modes can be selected during the specific mode switching: 1. the setting of the interval follows the mode before switching, if necessary, also influenced by its advanced functions, at which point the interval setting completes the mode switching immediately. DDD- > VVI switching in AP; 2. the mode of the interval setting following the switching is simultaneously influenced by its advanced functions if necessary, in which case the mode switching takes place before the interval setting. Such as AAI- > DDD handover in AP; 3. if neither of the two previous approaches is appropriate, the interval is set to a new transition interval and the mode switch is performed prior to the interval setting. Such as the switching of AAI- > VVI in the AP.

FIG. 2 is a diagram illustrating the timing of the occurrence of an atrial pacing event during a switching event in accordance with the present invention.

Referring to fig. 2, when an atrial pacing event occurs during a switching event, the present invention sets the pacing interval according to the target mode as follows.

1) If the target mode is single chamber a pacing mode (excluding OAO), as in fig. 2A, switching the mode to the target mode at the AP event and setting the next pacing interval to eff _ lrl, achieves fast switching while ensuring heart rate stabilization;

2) if the target mode is a non-single chamber a pacing mode (excluding OXO), as shown in fig. 2B, the mode is switched to the target mode at the AP event, and the next pacing interval is set to eff _ pavi, so that AV conductivity and heart rate stability are ensured while fast switching is achieved;

3) if the target mode is OXO, switching the mode immediately upon an AP event without interval setting;

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 to be executed following the current mode or the target mode, or to take program control values.

FIG. 3 is a diagram illustrating the timing of the occurrence of a ventricular pacing event during a switching process in accordance with the present invention.

With continued reference to fig. 3, when a ventricular pacing event occurs during a handover, the present invention sets the pacing interval according to the target mode as follows.

1) If the target mode is single chamber V pacing mode (excluding OVO), as in fig. 3A, switching the mode to the target mode at VP event and setting the next pacing interval to eff _ lrl (eff is active, lrl is the base frequency interval), achieving fast switching while ensuring heart rate stabilization;

2) if the target mode is a non-single chamber V pacing mode (excluding OXO), as in fig. 3B, the mode is switched to the target mode at the VP event and the next pacing interval is set to eff _ lrl-eff _ pavi (pavi is the post atrial-paced AV interval), achieving fast switching while ensuring heart rate stabilization;

3) if the target mode is OXO, the mode is switched immediately at the VP event without interval setting;

FIG. 4 is a timing diagram illustrating the occurrence of atrial sensed events during the switching process of the present invention.

With continued reference to fig. 4, when an atrial sensed event occurs during a switch, the pacing interval is set according to the target mode as follows.

1) If the target mode is single chamber a pacing mode (excluding OAO), AS in fig. 4A, switching the mode to the target mode at the AS event and setting the next pacing interval to eff _ lrl, achieves fast switching while ensuring heart rate stabilization;

2) if the target mode is a non-single chamber a pacing mode (excluding OXO), AS shown in fig. 4B, switching the mode to the target mode at the AS event, and setting the next pacing interval to eff _ savi (savi is AV interval after atrial sensing), so AS to ensure AV conductivity and heart rate stability while realizing fast switching;

3) if the target mode is OXO, switching the mode immediately at the AS event without interval setting;

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 to execute in following the current mode or in following the target mode, or to take program control values.

FIG. 5 is a diagram illustrating the timing of the occurrence of ventricular sensed events during the switching process of the present invention.

With continued reference to fig. 5, when a ventricular sense event occurs during a switch, the pacing interval is set according to the target mode as follows.

1) If the target mode is the single chamber V pacing mode (excluding OVO), as in fig. 5A, switching the mode to the target mode at the VS event and setting the next pacing interval to eff _ lrl, achieves fast switching while ensuring heart rate stabilization;

2) if the target mode is a non-single chamber V pacing mode (excluding OXO), as shown in fig. 5B, the mode is switched to the target mode at the time of the VS event, and the next pacing interval is set to eff _ lrl-eff _ pavi, so that the heart rate is guaranteed to be stable while fast switching is realized;

3) if the target mode is OXO, switching the mode immediately at VS event without interval setting;

The system architecture of the heart treatment device of the invention is shown in fig. 6, which comprises a microprocessor 8 and a digital/analog module 9 connected thereto, the sensing of the atrioventricular chambers being always on, regardless of the model. The selection and implementation of the microprocessor 8 are not limited. The digital/analog module 9 needs to realize the perception of external signals, needs to be able to send signals to act on the outside, and needs to be able to perform data information interaction with the outside.

The microprocessor 8 comprises a main control unit 1, a time control unit 2 and a data/information interaction interface 3. The main control unit 1 controls events and events to be generated, and can record and count the events. The main control unit 1 can select the time control unit 2 to realize the time-related control functions of timing, timing and the like. The data/information interaction interface 3 realizes the interaction of data or information and the like with other modules of the device. The data/information interaction interface 3 can be a common I/O interface, and can also be a serial or parallel data transmission module, and the communication between the main control unit and the corresponding control/generation unit is realized through I/O lines for the pacing signals and the sensing signals.

The digital/analog module 9 comprises a data/information interaction interface 4, a pacing control/generation unit 5, a sensing control/amplification unit 6 and a program control unit 7. The data/information interaction interface 4 can interact with the corresponding data/information interaction interface 3, although the implementation manner may be different from that. The pacing control/generation unit 5 receives a pacing request from the microprocessor 8 and generates a signal of a required intensity to be applied to the outside. The sensing control/amplification unit 6 is able to capture and distinguish external real signals and inform the microprocessor 8 of them, such as cardiac signals. The program control unit 7 can perform information interaction with the outside, such as a user, for example, receive a user mode switching operation request, transmit the request information to the main control unit 1 through the data/information interaction interfaces 4 and 3, and the main control unit 1 controls to realize mode switching.

The single chamber pacing mode of operation of conventional cardiac therapy devices is as follows:

1. AAI mode this mode operates by atrial pacing, atrial sensing, and inhibiting the delivery of pacemaker pulses after sensing atrial intrinsic electrical activity. In this mode, ventricular signals are not sensed.

2. The mode of the VVI mode is referred to as ventricular pacing, ventricular sensing, and delivery of a pacemaker pulse inhibited after sensing ventricular intrinsic electrical activity, which is also referred to as R-wave inhibited ventricular pacing or ventricular-on-demand pacing. In this mode, atrial signals are not sensed. VVI pulses the ventricle only when "needed" and the resulting paced rhythm is actually an escape rhythm.

The commonly used dual chamber pacing mode of operation is as follows:

1. the DDD mode is also called atrioventricular full-function pacing, which is a physiological pacing mode with atrioventricular dual-chamber sequential pacing, atrioventricular dual sensing, triggering and suppression of dual responses.

2. The VDD mode is also called an atrial synchronous ventricular inhibited pacemaker. Both the atria and ventricles have sensing functions, but only the ventricles have pacing functions. Proper sensing of P-waves is critical to their proper functioning throughout the VDD pacing system.

3. DDI mode both atrial and ventricular have sensing and pacing functions, inhibiting atrial pacing after P-wave sensing (similar to DDD), but without triggering atrioventricular intervals, i.e. ventricular tracking does not occur. If the patient has normal atrioventricular conduction, substantially similar to AAI; it does not operate as a single pacing mode but only as a mode-switched mode of operation for ddd (r).

The operating modes of the cardiac treatment device of the present invention include all commonly used single and dual chamber modes, such AS DDD, DDI, DVI, VDD, DOO, ODO, AAI, AAT, AOO, OAO, VVI, VVT, VOO and/or OVO modes, with the different operating modes being set and switched by a combination of AS, VS, DS, AP, VP and I/T bits. A typical detailed switching procedure for the different operating modes of the cardiac therapy device of the present invention is given below.

DDD- > AAI as shown in FIG. 7:

receiving a mode switch command at time t1 as shown in FIG. 7A, initiating a mode switch process; an atrial pacing event occurs at time t2, and in atrial pacing event processing, the current mode is first switched to the AAI mode, and then the next atrial pacing interval is set to the current lower limit frequency according to the atrial pacing event processing mode in the AAI mode, completing the mode switching process. Operating fully in AAI mode after time t2 achieves a steady atrial rate during mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 7B, initiating a mode switch process; a ventricular pacing event occurs at time t2, and in ventricular pacing event processing, the next atrial pacing interval is first set to the current lower limit frequency minus the current pavi according to the DDD mode central chamber pacing event processing mode, and then the current mode is switched to the AAI mode, completing the mode switching process. And the room sequence and the heart rate are kept stable in the mode switching process by completely operating in the AAI mode after the time t 2.

Receiving a mode switch command at time t1 as shown in FIG. 7C, initiating a mode switch process; an atrial sense event occurs at time t2, and in atrial sense event processing, the current mode is first switched to the AAI mode, and then the next atrial escape interval is set to the current lower limit frequency according to the AAI mode atrial sense event processing mode (if single-chamber hysteresis is turned on in the AAI mode again, the interval is set according to the single-chamber hysteresis function), and the mode switching process is completed. Operating fully in AAI mode after time t2 achieves a steady atrial rate during mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 7D, initiating a mode switch process; a ventricular sense event occurs at time t2, and in ventricular sense event processing, the mode switching process is completed by first setting the next atrial pacing interval to the current lower limit frequency minus the current pavi plus the remaining time of the previous AV interval according to the DDD mode ventricular sense event processing mode, and then switching the current mode to the AAI mode. And the room sequence and the heart rate are kept stable in the mode switching process by completely operating in the AAI mode after the time t 2.

Receiving a mode switch command at time t1 as shown in FIG. 7E, initiating a mode switch process; a ventricular premature event occurs at time t2, and in ventricular premature event processing, the next atrial pacing interval is first set to the current lower limit frequency minus the current pavi according to the DDD mode ventricular premature event processing mode, and then the current mode is switched to the AAI mode, completing the mode switching process. And the room sequence and the heart rate are kept stable in the mode switching process by completely operating in the AAI mode after the time t 2.

AAI- > VVI: as shown in fig. 8:

receiving a mode switch command at time t1 as shown in FIG. 8A, initiating a mode switch process; an atrial pacing event occurs at time t2, in the processing of the atrial pacing event, the current mode is first switched to the VVI mode, since the current mode is switched from AAI to VVI, the effective cardiac events included in the two modes are respectively the a event and the V event, and the two modes have no AV sequence, a transition interval, namely an AV interval (in this case, a default AV interval), needs to be set when the interval is set, and the mode switching process is completed. After time t2, the operation is completely in the AAI mode, and the use of the transition interval ensures that the heart rate is stable on the basis of this AV conductivity.

Receiving a mode switch command at time t1 as shown in FIG. 8B, initiating a mode switch process; an atrial sensed event occurs at time t2, in the processing of the atrial sensed event, the current mode is first switched to the VVI mode, since the current mode is switched from AAI to VVI, the effective cardiac events included in the two modes are the a event and the V event respectively, and the two modes have no AV sequence, a transition interval, namely an AV interval (in this case, a default AV interval), needs to be set when the interval is set, and the mode switching process is completed. After time t2, the operation is completely in the AAI mode, and the use of the transition interval ensures that the heart rate is stable on the basis of this AV conductivity.

VVI- > DDD: as shown in fig. 9:

receiving a mode switch command at time t1 as shown in fig. 9A, starting a mode switching process; a ventricular pacing event occurs at time t2, and in ventricular pacing event processing, the current mode is first switched to DDD mode, and then the next atrial pacing interval is set to the current lower limit frequency minus the current pavi according to the DDD mode-centric pacing event processing, completing the mode switching process. Operating in DDD mode completely after time t2, it is achieved that the ventricular order and heart rate are kept stable during the mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 9B, initiating a mode switch process; a ventricular sense event occurs at time t2, and in ventricular pacing event processing, the current mode is first switched to DDD mode, and then the next atrial pacing interval is set to the current lower limit frequency minus the current pavi according to the DDD mode ventricular premature event processing mode, completing the mode switching process. Operating in DDD mode completely after time t2, it is achieved that the ventricular order and heart rate are kept stable during the mode switching.

DDD- > DDI: as shown in fig. 10:

receiving a mode switch command at time t1 as shown in FIG. 10A, initiating a mode switch process; an atrial pacing event occurs at time t2, and in atrial pacing event processing, the current mode is first switched to the DDI mode, and then the next ventricular pacing interval is set to the current pavi according to the atrial pacing event processing mode in the DDI mode, completing the mode switching process. Operating in DDI mode entirely after time t2 achieves a stable atrial rate during mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 10B, initiating a mode switch process; a ventricular pacing event occurs at time t2, and in ventricular pacing event processing, the current mode is first switched to DDI mode, and then the next atrial pacing interval is set to the current lower limit frequency minus the current pavi according to DDI mode-centric pacing event processing, completing the mode switching process. Operating in DDI mode completely after time t2, it is achieved that the ventricular order and heart rate are kept stable during the mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 10C, initiating a mode switch process; an atrial sense event occurs at time t2, and in the processing of the atrial sense event, the next ventricular escape interval is first set to the current savi according to the processing mode of the atrial sense event in the DDD mode (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, completing the mode switching process. Operating in DDI mode entirely after time t2 achieves a stable atrial rate during mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 10D, initiating a mode switch process; a ventricular sense event occurs at time t2, and in ventricular sense event processing, the next atrial pacing interval is first set to the current lower limit frequency minus the current pavi plus the remaining time of the previous AV interval according to the DDD mode ventricular sense event processing mode, and then the current mode is switched to DDI mode, completing the mode switching process. Operating in DDI mode completely after time t2, it is achieved that the ventricular order and heart rate are kept stable during the mode switching.

Receiving a mode switch command at time t1 as shown in FIG. 10E, initiating a mode switch process; a ventricular premature event occurs at time t2, and in ventricular premature event processing, the next atrial pacing interval is first set to the current lower limit frequency minus the current pavi according to the ventricular premature event processing mode in DDD mode, and then the current mode is switched to DDI mode, completing the mode switching process. Operating in DDI mode completely after time t2, it is achieved that the ventricular order and heart rate are kept stable during the mode switching.

In summary, the physiologic mode switching control method of the cardiac therapy device provided by the invention can give consideration to AV conductivity, heart rate stability and timing stability, and has the following specific advantages: 1) the invention can realize fast mode switching; quick response to the enabling of a reasonable mode of operation; 2) physiological switching time sequences can be provided, inappropriate switching time sequences such as long intermittence and asynchronous AV can be avoided, and more comfortable experience of patients can be provided; 3) can provide more stable atrial rate and ventricular rate during mode switching, and bring better experience to patients; 4) the actual action interval can be flexibly adjusted according to actual needs, and the optimal switching operation can be flexibly realized for equipment with complex advanced functions. 5) Meanwhile, the complex phenomenon of pacing behaviors caused by different timings of the AV or VA in the cardiac cycle under the instruction of the program controller is eliminated.

Although the present invention has been described with respect to the preferred embodiments, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A physiological mode switching control method of a cardiac treatment apparatus, characterized by comprising the steps of:

s3: determining a time sequence interval set in the mode switching process according to the effective cardiac event type and the converted mode type, and controlling the mode switching process to be completed in one cardiac cycle;

the occurrence of valid cardiac events in steps S2 and S3 includes an atrial pacing event AP event, a ventricular pacing event VP event, an atrial sense event AS event outside the refractory period, and a ventricular sense event VS event;

if an atrial event occurs during the switching, the step S3 includes the steps of:

i) if the target mode is pacing-free, the mode is switched immediately upon an atrial event and no interval setting is performed, otherwise

ii) if the target mode has atrial pacing and is the single chamber mode, switching the mode to the target mode at the atrial event and setting the next pacing interval to pace the atrium for the currently running base pacing interval, otherwise

iii) switching mode to target mode at atrial event and setting next pacing interval to pace ventricle for currently running atrioventricular pacing interval;

if a ventricular event occurs during the switching process, the step S3 includes the following steps:

i) if the target mode is pacing-free, the mode is switched immediately upon a ventricular event and no interval setting is made, otherwise

ii) if the target mode has ventricular pacing and is the single chamber mode, switch the mode to the target mode at a ventricular event and set the next pacing interval to pace the ventricle for the currently running base pacing interval, otherwise

iii) switching the mode to the target mode at a ventricular event and setting the next pacing interval to pace the atrium for the currently running ventricular pacing interval.

2.A physiological mode switching control method of a cardiac treatment apparatus according to claim 1, wherein the cardiac treatment apparatus has a plurality of different operation modes and can perform mode switching according to a switching request.

3. The physiological mode switching control method of a cardiac treatment device according to claim 2, wherein the operation modes of the cardiac treatment device include a DDD mode, a DDI mode, a DVI mode, a VDD mode, a DOO mode, an ODO mode, an AAI mode, an AAT mode, an AOO mode, an OAO mode, a VVI mode, a VVT mode, a VOO mode, and/or an OVO mode, and different operation modes are set and switched by a combination of an AS bit, a VS bit, a DS bit, an AP bit, a VP bit, and an I/T bit.

4. The physiological mode switching control method of cardiac treatment equipment according to claim 1, wherein the timing of mode switching in step S2 includes any one of:

s21: setting the pacing interval follows the mode before switching, and immediately switching the mode after the pacing interval is set;

s22: the pacing interval setting follows the switched mode and the mode switching is performed before the pacing interval setting;

s23: the pacing interval is set to a new transition interval and a mode switch is made prior to the pacing interval setting.

5. The physiological mode switching control method of a cardiac treatment device according to claim 1, wherein if an atrial pacing event AP event occurs during switching, said step S3 includes the steps of:

s31) if the target mode is a single chamber a pacing mode that does not include an OAO, switching the mode to the target mode at the AP event and setting the next pacing interval to eff _ lrl, pacing the atrium;

s32) if the target mode is a non-single chamber a pacing mode that does not include OXO, switching the mode to the target mode at the AP event and setting the next pacing interval to eff _ pavi, pacing the ventricle;

s33) if the target mode is OXO, the mode is switched immediately at the AP event and no interval setting is made.

6. The physiological mode switching control method of a cardiac treatment device according to claim 1, wherein if a ventricular pacing event VP event occurs during switching, said step S3 includes the steps of:

s31) if the target mode is the single chamber V pacing mode not including OVO, switching the mode to the target mode at the VP event and setting the next pacing interval to eff _ lrl, pacing the ventricle;

s32) if the target mode is a non-single chamber V pacing mode that does not include OXO, switching the mode to the target mode at the VP event and setting the next pacing interval to eff _ lrl-eff _ pavi, pacing the atrium;

s33) if the target mode is OXO, the mode is switched immediately at the VP event and no interval setting is done.

7. The physiological mode switching control method of cardiac treatment equipment according to claim 1, wherein if an atrial sense event AS event occurs during switching, said step S3 includes the steps of:

s31) if the target mode is a single chamber a pacing mode that does not include an OAO, switching the mode to the target mode at the AS event and setting the next pacing interval to eff _ lrl, pacing the atrium;

s32) if the target mode is a non-single chamber a pacing mode that does not include OXO, switching the mode to the target mode at an AS event and setting the next pacing interval to eff _ savi, pacing the ventricle;

s33) if the target mode is OXO, the mode is switched immediately upon the AS event and no interval setting is made.

8. The physiological mode switching control method of cardiac treatment apparatus according to claim 1, wherein if a ventricular sense event VS event occurs during switching, said step S3 includes the steps of:

s31) if the target mode is a single chamber V pacing mode not including OVO, switching the mode to the target mode at the VS event and setting the next pacing interval to eff _ lrl, pacing the ventricle;

s32) if the target mode is a non-single chamber V pacing mode that does not include OXO, switching the mode to the target mode at the time of the VS event and setting the next pacing interval to eff _ lrl-eff _ pavi, pacing the atrium;

s33) if the target mode is OXO, the mode is switched immediately upon the VS event and no interval setting is made.

9. The physiologic mode switching control method of cardiac therapy device according to any one of claims 5-8, wherein the specific values of eff _ lrl, eff _ savi and eff _ pavi follow the current mode or the target mode or take programmed values according to the selection timing of step S2.

10. The physiological mode switching control method of a cardiac treatment device according to any one of claims 1 to 8, wherein the cardiac treatment device is a pacemaker, an ICD, a CRT-D, PSA, or a TPG device.