WO2016131351A1

WO2016131351A1 - Medical device for treating cardiac arrhythmia

Info

Publication number: WO2016131351A1
Application number: PCT/CN2016/070514
Authority: WO
Inventors: 熊建劬; 黎贵玲; 黄敏; 陈欣欣
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2015-02-17
Filing date: 2016-01-08
Publication date: 2016-08-25
Also published as: CN104623809A; CN104623809B

Abstract

Provided is a medical device for treating cardiac arrhythmia, comprising: a microprocessor (8) and a digital/analog module (9); the microprocessor (8) comprises a main control unit (1) and a time control unit (2); the digital/analog module (9) comprises a pacing control/generation unit (5) and a sensing control/amplification unit (6); the time control unit (2) comprises a first timing unit (11) and a second timing unit (12); the main control unit (1) sets a medical device to an ADI(R) operating mode, the ADI(R) operating mode comprising: a signal of a sensing control/amplification unit (6) sensing a ventricular event is received, then the main control unit (1) sets a PVANP interval and sends a signal to a time control unit (2), and controls a first timing unit (11) to enter a timing mode, the duration being a PVANP interval; if the anticipated atrial pacing escape occurs outside the PVANP interval, then the main control unit (1) sends to the pacing control/generation unit (5) and the time control unit (2) a signal to notify the pacing control/generation unit (5) to issue a pacing pulse, and controls the second timing unit (12) to set the subsequent atrial pacing escape interval; if the anticipated atrial pacing escape occurs within the PVANP interval, then the main control unit (1) sends a signal to the time control unit (2), and controls the second timing unit (12) to set the subsequent atrial pacing escape interval.

Description

Medical device for treating arrhythmia

Technical field

The present invention relates to the field of medical device technology, and in particular to a medical device for treating arrhythmia.

Background technique

Implantable cardiac pacemakers are effective medical devices for the treatment of bradycardia. They can deliver pulsed currents of a certain frequency to stimulate the heart to complete the pumping function. Cardiac pacemakers have multiple modes of operation, such as AAI (atrial pacing, atrial perception), VVI (ventricular pacing, ventricular sensing, no atrial synchronization), DDD (dual chamber pacing, dual chamber sensing, atrial synchronization), ADI (atrial pacing, dual chamber sensing) and so on. The AAI mode refers to an atrial pacing atrial sensing-suppressed working mode, and both sensing and pacing are only for the atrium, and are usually used for patients with atrial dysfunction but with atrioventricular conduction function. The ADI mode is a dual-chamber sensing mode of atrial pacing, ADI can sense ventricular events, and the rest of the functions are the same as AAI mode. ADI's ventricular sensing capabilities provide data only for diagnosis and do not affect atrial pacing.

In the classic AAI mode, general ventricular activity is not perceived, but in the traditional ADI mode, although there is ventricular perception, but only as diagnostic data does not affect the pacing timing. So when the patient develops ventricular premature contraction (PVC, Premature Ventricular Contraction), if the AAI pacing mode, just when the atrial pacing pulse is issued, if it happens to be the time of PVC, then the atrial ventricle two chambers At the same time contraction, the atrioventricular valve can not be opened, the role of atrial-assisted ventricular filling disappears, and the blood volume of the heart beat will decrease; if the atrial and ventricular contraction are not coordinated, it may cause the atrioventricular valve to be incompletely closed, causing the blood in the heart to flow back into the atria. It can also cause adverse effects such as reduced stroke volume.

Summary of the invention

The object of the present invention is to provide a medical device for treating arrhythmia, which solves the problem that the two chambers of the central ventricle of the prior art are simultaneously contracted, resulting in a decrease in the blood volume of the heartbeat.

In order to solve the above technical problems, the present invention provides a medical device for treating arrhythmia, comprising: a microprocessor and a digital/analog module coupled to the microprocessor; the microprocessor includes a main control unit and a time control unit; the digital/analog module includes a pacing control/generation unit and a sensing control/amplifying unit ;among them,

The main control unit sets the medical device for treating arrhythmia in an ADI(R) mode of operation, the ADI(R) mode of operation comprising:

After receiving the signal that the sensing control/amplification unit senses a ventricular event, the main control unit sets a heart pacing suppression interval after the ventricular sensing event, and sends a signal to the time control unit to control the first timing. The unit enters a timing mode for the atrial pacing suppression interval after the ventricular sensing event; if the expected atrial pacing escape occurs during the atrial pacing suppression interval after the ventricular sensing event, the primary control The unit sends a signal to the pacing control/generating unit and the time control unit, notifying the pacing control/generating unit to issue a pacing pulse, and controlling the second timing unit to set a next atrial pacing escape interval; The atrial pacing escape will occur during the atrial pacing suppression interval after the ventricular sensing event, the main control unit sends a signal to the time control unit, and the second timing unit is controlled to set the next atrial pacing escape Interphase.

Further, in the medical device for treating arrhythmia, after receiving the signal that the sensing control/amplifying unit senses a ventricular event, the main control unit acquires atrial pacing suppression interval function after the ventricular sensing event Whether to set the information to be on, if enabled, enable the atrial pacing suppression interval after the ventricular sensing event.

Further, in the medical device for treating arrhythmia, if the signal that the perceptual control/amplification unit perceives a ventricular event is received again during the atrial pacing suppression interval after the ventricular sensing event, The main control unit sends a signal to the time control unit to control the first timing unit to restart timing, and the duration is an atrial pacing suppression interval after the ventricular sensing event. .

Further, in the medical device for treating arrhythmia, the start time of the atrial pacing suppression interval after the ventricular sensing event is a time at which a ventricular event is perceived.

Further, in the medical device for treating arrhythmia, when the main control unit sets an atrial pacing suppression interval after a ventricular sensing event, the type flag of the interval is simultaneously set.

Further, in the medical device for treating arrhythmia, the main control unit clears the type flag of the interval when the atrial pacing suppression interval expires after the ventricular sensing event.

Further, in the medical device for treating arrhythmia, if the type flag of the interval is set, it indicates that the atrial pacing suppression period is after the ventricular sensing event; otherwise, it indicates that after the ventricular sensing event Atrial pacing is suppressed outside the interval.

Further, in the medical device for treating arrhythmia, if the atrial pacing escape interval expires during the atrial pacing suppression interval after the ventricular sensing event, the main control unit marks A virtual atrial pacing event inhibits an expected atrial pacing; if the atrial pacing escape interval expires after the ventricular pacing suppression interval, the primary control unit marks a true Atrial pacing events allow for expected atrial pacing.

Further, in the medical device for treating arrhythmia, when marked as a virtual atrial event, the main control unit sets a next atrial pacing escape interval starting from a virtual atrial pacing event.

Further, in the medical device for treating arrhythmia, when marked as a real atrial pacing event, the main control unit sets a next atrial pacing escape interval starting from a real atrial pacing event.

The medical device for treating arrhythmia provided by the invention has the following beneficial effects: the digital/analog module of the invention notifies the microprocessor to set a PVANP atrial pacing suppression interval after sensing a ventricular event, and can avoid the atrioventricular compartment The phenomenon of synchronous contraction has a good effect on defibrillators and pacemakers.

DRAWINGS

1 is a schematic structural view of a medical device for treating arrhythmia according to a preferred embodiment of the present invention;

2 is a flow chart showing the operation of a medical device for treating arrhythmia according to a preferred embodiment of the present invention;

3 is a functional timing diagram of a medical device for treating arrhythmia in accordance with a preferred embodiment of the present invention.

detailed description

The medical device for treating arrhythmia proposed by the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. Advantages and features of the present invention will be apparent from the description and appended claims. It should be noted that the drawings are in a very simplified form and all use non-precise proportions, and are only for convenience and clarity to assist the purpose of the embodiments of the present invention.

Please refer to FIG. 1, which is a schematic structural view of a medical device according to a preferred embodiment of the present invention. The present invention can be effectively applied thereto, and the figure should be regarded as an example of the type of device embodying the present invention, and is not limited.

As shown in Figure 1, the present invention provides a medical device for treating arrhythmia comprising a microprocessor 8 and a digital/analog module 9 coupled thereto, the perception of the atrial ventricle being always open, regardless of the mode. This makes it easy to open an atrial fibrillation period after the ventricular event and avoid the simultaneous contraction of the atrioventricular compartment. 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.

Further, the microprocessor 8 includes a main control unit 1, a time control unit 2, and a data/information interaction interface 3. The time control unit 2 includes at least a first timing unit 11 and a second timing unit 12. The main control unit 1 implements reception, processing, and control of events that occur from the digital/analog module 9 in which an event occurs. The main control unit 1 can select, through the time control unit 2, a time-related control function such as timing, timing, etc., for example, the time control unit 2 can capture and record the time when the event occurs, and can also control the event to be generated. Accurate time, etc. For example, after receiving the signal of a ventricular event, the main control unit 1 sets an atrial pacing suppression interval after the ventricular sensing event, and sends a signal to the time control unit 2 to set the first timing unit 11 as a timer operation. Mode, the time duration is the atrial pacing suppression interval after ventricular perception events. For another example, a second timing unit 12 functioning as a timer is an atrial pacing escape interval for providing an accurate time for the occurrence of an atrial pacing event. The data/information interface 3 implements interaction of data or information between the microprocessor 8 and other modules of the device. The data/information The inter-interface 3 can be a normal I/O interface or a serial or parallel data transmission module. In this embodiment, the data/information interface 3 can receive the perceived event information, issue a pacing event request, serial data interaction, clock data interaction, and the like. In addition, the device of the present invention may have other units, for example, the main control unit 10 further includes a control unit 10 (referred to as PVANP control unit 10) for controlling the atrial pacing suppression interval function after the ventricular sensing event, when receiving a ventricular event. After the signal, the main control unit 1 acquires a signal that the PVANP control unit 10 has been turned on, and if turned on, the main control unit 1 sets a heart pacing suppression interval after a ventricular sensing event, and to the time control unit 2 The signal is sent to control the first timing unit 11 to enter a timing mode for a period of atrial pacing suppression after the ventricular sensing event.

Further, the digital/analog module 9 includes a data/information interaction interface 4, a pacing control/generation unit 5, a perceptual control/amplification unit 6, and a program control unit 7. The data/information interface 4 can interact with the corresponding data/information interface 3, although the implementation may be the same or different. The pacing control/generating unit 5 receives the pacing request of the microprocessor 8 and generates a signal of the required intensity to act on the outside, and the strength, type, and the like of the signal differ depending on the difference of the affected object. The perceptual control/amplification unit 6 is capable of capturing and distinguishing external real signals, such as cardiac signals, and notifying the microprocessor 8. The program control unit 7 is capable of information interaction with the outside world, such as a user.

As shown in FIG. 2, the main control unit 1 of the microprocessor sets a medical device for treating arrhythmia in an ADI(R) mode of operation to provide a perceptual function of a ventricular event: the perceptual control/amplification unit 6 senses a ventricle Immediately after the event, a signal is sent to the main control unit 1. After receiving the signal, the main control unit 1 acquires the opening and closing information of the PVANP function from the PVANP control unit 10. If the current PVANP control unit 10 turns on the PVANP (Atrial Pacing Restraining Interval after Ventricular Perception Event) function, the main control unit 1 immediately Set a PVANP atrial pacing suppression interval, otherwise the main control unit 1 may not do any treatment; if the expected atrial pacing escape will occur during the PVANP interval, the main control unit 1 suppresses the expected atrial pacing, That is, the main control unit 1 does not send a signal to the pacing control/generating unit 5 to issue an atrial pacing pulse, but sends a signal to the time control unit 2 to control the second timing unit 12 to set the next atrial pacing escape. Period; if expected atrial pacing will Occurring outside the PVANP interval, the main control unit 1 sends a signal to the pacing control/generating unit 5 and the time control unit 2, informing the pacing control/generating unit 5 to issue a pacing pulse, and controlling the second timing. Unit 12 sets the next atrial pacing escape interval. During the PVANP interval, if the signal that the perceptual control/amplification unit 6 senses a ventricular event is received again, the main control unit 1 sends a signal to the time control unit 2 to control the first timing unit 11 to restart. Timing, duration is the atrial pacing suppression interval after ventricular perception events.

Further, please refer to FIG. 3, which is a timing diagram of a medical device for treating arrhythmia according to the present invention. As shown in Figure 3,

At 1 sequence, atrial and ventricular perception is normal, regardless of the specific heartbeat pacing pattern. The hardware of the medical device described in various modes has a perceptual function for both atrial events and ventricular events, regardless of the specific pacing mode.

At the 2 sequence time, the lower limit frequency (LRI) expires and is not in the PVANP interval, and the main control unit 1 notifies the pacing control/generating unit to issue the pulse pacing atrium.

At the 3rd sequence moment, when a PVC (ventricular premature contraction) event occurs, the main control unit 1 opens a ventricular chamber pacing phase (PVANP, Post Ventricular Atrial None Pacing); the interval between the setting period is PVANP The start time of the interval is the time when the ventricular event, that is, the PVC, is perceived. The embodiment is preferably set to 30 to 80 ms; and the PVANP interval type flag is marked; in particular, the present invention is not limited to the PVC event. The rest of the general ventricular events can also be applied.

When the ventricular event is detected, the main control unit 1 obtains information from the PVANP control unit 10 whether the PVANP function is currently turned on. The ADI(R) has the PVANP function only when the function bit is turned on, otherwise the ADI(R) only provides diagnostic information for the ventricle. When the PVANP function is turned on, the ventricular event will enter the ventricular after atrial pacing suppression interval, including: setting the PVANP interval type flag of the main control unit 1; when the ventricle senses the atrial pacing suppression interval Upon expiration, the main control unit 1 clears the type flag of the PVANP interval.

At the 4th sequence, the lower limit frequency (LRI) expires, if not in the posterior ventricular pacing suppression During the period, the main control unit 1 normally informs the pacing control/generating unit 5 to issue a pulse pacing atrium, marks a real atrial pacing event at the expiration time, and sets the next atrium from the real atrial pacing event. Stroke escape interval LRI. That is, when the atrial pacing escape interval expires, the atrial pacing is only issued when the PVANP interval type flag is cleared, and the next atrial pacing escape interval is calculated.

At the time of the 5 sequence, when a PVC (ventricular premature contraction) event occurs, a post-ventricular atrial pacing suppression interval (PVANP) is initiated, which is the same as the 3 sequence moment.

At the 6th sequence time, the lower limit frequency (LRI) expires. If it is still in the non-pacing interval of the posterior atrial, then the atrial can not be beaten, and a virtual atrial pacing event is marked at this expiration time. The escape interval LRI of the pulse that is pulsed to the atrium is calculated next time. That is, when the atrial pacing escape interval expires, when the PVANP interval type flag is set, the main control unit 1 sends a signal only to the time control unit 2, and the second timing unit 12 is controlled to set the next atrial pacing escape. During the interval, the pacing control/generating unit 5 is not notified to issue a pacing pulse.

At the 7th sequence time, the lower limit frequency (LRI) expires and the atrial is normal.

Based on this, the digital/analog module of the present invention sends a signal to the microprocessor to set a PVANP atrial pacing suppression interval after sensing a ventricular event, thereby avoiding the problem of synchronous contraction of the atrioventricular.

The above description is only for the description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes and modifications made by those skilled in the art in light of the above disclosure are all within the scope of the appended claims.

Claims

A medical device for treating arrhythmia, comprising: a microprocessor and a digital/analog module connected to the microprocessor; the microprocessor comprising a main control unit and a time control unit; The simulation module includes a pacing control/generating unit that issues a pulse and a sensing control/amplifying unit that senses the ventricle and the atrial event; the time control unit includes at least a first timing unit and a second timing unit;

The main control unit sets the medical device for treating arrhythmia in an ADI(R) mode of operation, the ADI(R) mode of operation comprising:

After receiving the signal that the sensing control/amplification unit senses a ventricular event, the main control unit sets a heart pacing suppression interval after the ventricular sensing event, and sends a signal to the time control unit to control the first timing. The unit enters a timing mode for the atrial pacing suppression interval after the ventricular sensing event; if the expected atrial pacing escape occurs during the atrial pacing suppression interval after the ventricular sensing event, the primary control The unit sends a signal to the pacing control/generating unit and the time control unit, notifying the pacing control/generating unit to issue a pacing pulse, and controlling the second timing unit to set a next atrial pacing escape interval; The atrial pacing escape will occur during the atrial pacing suppression interval after the ventricular sensing event, the main control unit sends a signal to the time control unit, and the second timing unit is controlled to set the next atrial pacing escape Interphase.
The medical device for treating arrhythmia according to claim 1, wherein after receiving the signal that the perceptual control/amplification unit senses a ventricular event, the main control unit acquires atrial pacing suppression after a ventricular sensing event Whether the interval function is set to open information, if enabled, the main control unit sets a heart pacing suppression interval after the ventricular sensing event, and sends a signal to the time control unit to control the first timing unit to enter the timing mode, the duration Atrial pacing suppression interval after the ventricular perception event.
The medical device for treating arrhythmia according to claim 1, wherein said sensing control/amplifying unit is received again during an atrial pacing suppression interval after said ventricular sensing event A signal of a ventricular event is sensed, the main control unit sends a signal to the time control unit to control the first timing unit to restart timing, the duration being an atrial pacing suppression interval after the ventricular sensing event.
The medical device for treating arrhythmia according to claim 1, wherein a start time of the atrial pacing suppression interval after the ventricular sensing event is a time at which the sensing control/amplifying unit senses a ventricular event.
The medical device for treating arrhythmia according to claim 1, wherein when the main control unit sets the atrial pacing suppression interval after the ventricular sensing event, the type flag of the interval is simultaneously set.
The medical device for treating arrhythmia according to claim 5, wherein said main control unit clears the type flag of the interval when the atrial pacing suppression interval expires after said ventricular sensing event.
A medical device for treating arrhythmia according to claim 5, wherein if the type flag of said interval is set, it marks a period of atrial pacing suppression after a ventricular sensing event; otherwise, it indicates that it is in the ventricle After atrial events, atrial pacing is suppressed outside the interval.
The medical device for treating arrhythmia according to claim 1, wherein said main pacing escape interval expires after said ventricular pacing suppression period, said atrial pacing escape interval expires The control unit marks a virtual atrial pacing event to inhibit the expected atrial pacing; if the atrial pacing escape interval expires after the ventricular pacing suppression interval, the primary control The unit marks a real atrial pacing event to allow for the expected atrial pacing.
The medical device for treating arrhythmia according to claim 8, wherein when marked as a virtual atrial event, said main control unit sets a next atrial pacing escape interval starting from a virtual atrial pacing event.
The medical device for treating arrhythmia according to claim 8, wherein when marked as a real atrial pacing event, said main control unit sets a next atrial pacing escape between the real atrial pacing event as a starting point. period.