Method and circuit for adaptively adjusting alertness period and implantable cardiac contractility regulator

Abstract

The invention discloses a method and a circuit for adaptively adjusting an alertness period and an implantable cardiac contractility regulator. The invention relates to the field of implantable cardiac contractility regulators, and aims to solve the problem that treatment pulses cannot be correctly emitted due to the position of an alertness period. Perceptual event information is stored through the perceptual storage unit; the sensing comparison recognition unit is used for screening out R wave sensing events of the local sensing channel by taking the ventricle sensing event as a reference, recording time and judging whether the R wave sensing time of the local sensing channel is stable or not; the alertness period adjusting unit adaptively adjusts the position of the alertness period according to the time of the local sensing channel sensing the R wave under the condition that the time of the local sensing channel sensing the R wave is stable; and the pulse control unit generates a pulse issuing instruction according to the alertness period position adjustment result. According to the circuit and the method, the position of the alertness period window can be automatically adjusted, it is guaranteed that treatment pulses can be normally emitted, and the treatment rate of CCM is increased.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of implantable cardiac contractility modulator, and particularly relates to a method and circuit for adaptively adjusting a vigilance period and an implantable cardiac contractility modulator. BACKGROUND

[0002] Cardiac contractility modulation (CCM) is an implantable pulse generator for treating heart failure, which works by applying electrical stimulation to the ventricular muscle in the absolute refractory period to enhance the contractility of the ventricular muscle and improve the cardiac function and clinical symptoms of the patient with heart failure. Generally, CCM has two electrodes or three electrodes, two of which are placed in the right ventricle, one of which can be referred to as a ventricular channel, and the other of which can be referred to as a local sensing channel. One is placed in the right atrium and can be referred to as an atrial channel. The electrode can be implanted or not implanted. The implanted atrial electrode senses P waves to determine the heart rate, and the two electrodes implanted in the ventricle sense QRS waves of the ventricle, and a bidirectional therapy pulse is emitted in the absolute refractory period of the myocardial contraction.

[0003] When CCM is working, it can be programmed by a matching external programmer. In the existing cardiac contractility modulation therapy scheme, the vigilance period is set on the local sensing channel based on the ventricular channel sensing event. In the vigilance period, the local sensing channel detects a sensing event, which triggers a therapy pulse. Outside the vigilance period, the sensing event of the local sensing channel does not trigger a therapy pulse.

[0004] However, since the position of the vigilance period is a programmable parameter, if the value programmed by the operator is not very reasonable, the interval that could trigger a pulse will not be treated; there can also be a situation where the vigilance period is programmed reasonably during implantation, but as the implantation time increases, the time relationship of the R waves sensed by the ventricular channel and the local sensing channel electrodes changes, which can also cause the sensing on the local sensing channel to fall outside the vigilance period, so that a therapy pulse cannot be triggered. In addition, CCM is often implanted in combination with a pacemaker in clinical use. As the implantation time of CCM increases, the actual therapy pulse electrical signal conduction can also change, and it is very likely that the local sensing originally in the vigilance period will shift to outside the vigilance period. The existing programmed vigilance period position is no longer suitable for the sensing event after the change. Even if the sensing of the ventricle and the local sensing channel meets the triggering conditions, the pulse that should be emitted is not triggered due to a slight deviation from the vigilance period position, thereby reducing the therapy rate of the modulator. SUMMARY

[0005] The present application aims to provide a method and circuit for adaptively adjusting a vigilance period and an implantable cardiac contractility modulator to solve the problem that the therapy pulse cannot be correctly emitted due to the position of the vigilance period in the prior art.

[0006] In a first aspect, the present invention provides a circuit for adaptively adjusting the alert period, comprising: a sensing filter amplification module, a sensing threshold comparison module, a microcontroller, and a bidirectional pulse delivery module;

[0007] The sensing, filtering, and amplifying module senses the electrical signals of the human heart through the ventricular sensing channel and the local sensing channel, and then filters and amplifies the electrical signals.

[0008] The sensing threshold comparison module compares the electrical signal with a preset sensing sensitivity threshold and outputs sensing event information.

[0009] The microcontroller includes a sensing storage unit, a sensing comparison and recognition unit, an alertness period adjustment unit, and a pulse control unit, which generates a pulse firing command based on the sensing event information.

[0010] The bidirectional pulse delivery module, according to the pulse delivery command, delivers bidirectional pulses to the human heart through the ventricular sensing channel and the local sensing channel.

[0011] Secondly, the present invention provides a method for adaptively adjusting the alert period, applied to a microcontroller of the aforementioned adaptively adjusting alert period circuit, the method comprising the following steps:

[0012] The sensing storage unit stores sensing event information, which includes the sensing event type and the occurrence time of the sensing event. The sensing event type includes ventricular sensing events and local sensing events. The ventricular sensing event is the event in which the ventricular sensing channel senses the R wave, and the local sensing event is the sensing event of the local sensing channel within a preset time period before and after the sensing event of the ventricular sensing channel.

[0013] The perception comparison and recognition unit uses ventricular sensing events as a benchmark to filter out events in which the local sensing channel senses R waves, records the time, and determines whether the time of R wave sensing by the local sensing channel is stable.

[0014] When the time for R-wave perception by the local sensing channel is stable, the alertness period adjustment unit adjusts the alertness period position according to the time for R-wave perception by the local sensing channel.

[0015] The pulse control unit generates a pulse firing command based on the position adjustment results during the alert period.

[0016] Furthermore, the perception comparison and recognition unit takes the perception events of the local perception channel within a preset time period before and after the perception event of the ventricular perception channel as potential local perception events; based on the potential local perception events, it filters out the events in which the local perception channel perceives the R wave.

[0017] Furthermore, the sensing comparison and recognition unit continuously monitors the most recent preset intervals. Within each of the consecutive preset intervals, there are events where the local sensing channel senses the R-wave, and the occurrence time of the R-wave events sensed by the local sensing channel meets a predetermined discreteness standard, thus determining that the time of R-wave sensing by the local sensing channel is stable.

[0018] Furthermore, when the time for the local sensing channel to perceive the R-wave is stable, the alert period adjustment unit adjusts the position of the alert period according to the time for the local sensing channel to perceive the R-wave. The adjustment principle is: by adjusting the start time of the alert period, the time for the local sensing channel to perceive the R-wave is at the middle position of the alert period.

[0019] Thirdly, the present invention provides an implantable cardiac contractility modulator, including the circuit described above for adaptively adjusting the alert period.

[0020] This invention offers the following advantages: The method, circuit, and implantable cardiac contractility modulator for adaptively adjusting the alert period effectively solve the problem of existing implantable cardiac contractility modulators where local sensing events fall outside the alert period due to unreasonable alert period position programming, electrode sensing time deviation, or changes in conduction sequence when implanted in conjunction with a pacemaker. This leads to suppression of treatment pulse delivery and reduced treatment rates. Based on a circuit composed of sensing filtering amplification, threshold comparison, a microcontroller, and a bidirectional pulse delivery module, this invention can monitor the real-time relationship between the ventricle and the local sensing channel's R-wave sensing. By identifying potential local sensing events, the local sensing channel's R-wave sensing time, and judging the stability of adjacent interval sensing times, it automatically adjusts the alert period start time, ensuring the local sensing R-wave time is in the middle of the alert period. This ensures normal triggering of treatment pulses and avoids pulse suppression caused by time interval changes, thereby significantly improving the treatment rate of implantable cardiac contractility modulators and ensuring continuous and effective treatment for patients with heart failure. Attached Figure Description

[0021] To more clearly illustrate the technical solution of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, those skilled in the art can obtain other drawings based on these drawings without creative effort.

[0022] Figure 1 Circuit diagram for adaptive adjustment of alert period;

[0023] Figure 2 This is a microcontroller architecture diagram;

[0024] Figure 3 A diagram illustrating the basic timing parameters of CCM in existing technologies;

[0025] Figure 4A basic timing diagram of pulse delivery and pulse suppression in existing CCM technology;

[0026] Figure 5 A diagram illustrating the time information stored in the sensing storage unit;

[0027] Figure 6 A schematic diagram for confirming the location of the R-wave sensed by the local sensing channel, where (a) is a schematic diagram of application example 1 and (b) is a schematic diagram of application example 2;

[0028] Figure 7 A schematic diagram illustrating the stability assessment of R-wave time sensing by local sensing channels between two adjacent intervals;

[0029] Figure 8 The diagram shows the monitoring process for 10 consecutive intervals. (a) shows the situation where the local sensing channel fails to sense the R wave during the interval, resulting in the count being reset to zero. (b) shows the situation where the local sensing channel senses the R wave at an unstable time for 2 consecutive intervals, resulting in the count being reset to zero.

[0030] Figure 9 A diagram illustrating the automatic adjustment of the alertness period position;

[0031] Figure 10 Main flowchart for the adaptive adjustment of alert period position method;

[0032] Figure 11 A flowchart for determining the time stability of R-wave sensing through local sensing channels between adjacent intervals. Detailed Implementation

[0033] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention. The technical solutions provided by various embodiments of this invention will be described in detail below with reference to the accompanying drawings.

[0034] Cardiac contractility modulation therapy (CCM) delivers therapeutic pulses during the absolute refractory period of the ventricular myocardium to increase its contractility. If, during the interval between therapeutic pulse deliveries, no sensory event occurs on the local sensory channel within the programmed alert window, or if a sensory event occurs outside the alert window, CCM will suppress the next N intervals of therapeutic pulses. The circuit and method proposed in this invention, applied to cardiac contractility modulation therapy, can automatically adjust the position of the alert window based on the patient's real-time sensory status, ensuring that therapeutic pulses are delivered normally and improving the treatment rate of CCM.

[0035] Please see Figure 1 First, this invention provides a circuit for adaptively adjusting the alert period, comprising: a sensing filter amplification module, a sensing threshold comparison module, a microcontroller, and a bidirectional pulse firing module. The sensing filter amplification module is connected to the sensing threshold comparison module, which is connected to the microcontroller, and the microcontroller is connected to the bidirectional pulse firing module. Both the sensing filter amplification module and the bidirectional pulse firing module are connected to ventricular electrodes and local sensing electrodes. If atrial electrodes are provided, the sensing filter amplification module is also connected to the atrial electrodes. The atrial electrodes, ventricular electrodes, and local sensing electrodes are connected to human heart tissue.

[0036] The sensing, filtering, and amplification module includes filters and amplifiers, used to sense electrical signals from the human heart through atrial, ventricular, and local sensing channels, and to filter and amplify these signals. The sensing threshold comparison module compares the analog signal output from the sensing, filtering, and amplification module with a preset sensing sensitivity threshold, transmitting the sensing result (sensing event information) to the microcontroller. The microcontroller generates pulse delivery commands based on the sensing event information. The bidirectional pulse delivery module is the core circuit for generating bidirectional therapeutic pulses. It receives pulse delivery commands from the microcontroller and, based on these commands, delivers bidirectional pulses to the human heart through the ventricular and local sensing channels.

[0037] Secondly, this invention also provides a method for adaptively adjusting the alert period. When the time intervals between the ventricular electrode sensing the R-wave and the local sensing electrode sensing the R-wave change, the local sensing R-wave time may shift outside the alert period window. This method allows the CCM to automatically adjust the position of the alert period, bringing the local sensing R-wave time back within the alert period window. This avoids the phenomenon where the CCM fails to trigger a treatment pulse due to the aforementioned time interval changes, thereby improving the treatment rate of the CCM.

[0038] Please see Figure 2 This invention provides a method for adaptively adjusting the alert period, applied to a microcontroller in a circuit for adaptively adjusting the alert period. The microcontroller includes a sensing storage unit, a sensing comparison and recognition unit, an alert period adjustment unit, and a pulse control unit. The method includes the following steps:

[0039] The sensing storage unit stores sensing event information, including the type of sensing event and the time of occurrence of the sensing event. The sensing event types include atrial sensing events (AS), ventricular sensing events (VS), and local sensing events (LS). Among them, ventricular sensing events are events in which the ventricular sensing channel senses the R wave, and local sensing events are sensing events in the local sensing channel within preset time periods before and after the ventricular sensing channel's sensing event.

[0040] The perception comparison and recognition unit uses ventricular perception events as a benchmark to filter out events in which the local perception channel senses R waves, records the time of events in which the local perception channel senses R waves, and determines whether the time of R wave sensing by the local perception channel is stable based on whether the local perception channel senses R wave events exist in consecutive preset intervals and whether the occurrence time of the local perception channel senses R wave events meets a predetermined discreteness standard.

[0041] When the time for R-wave perception by the local sensing channel is stable, the alert period adjustment unit adjusts the alert period position according to the time for R-wave perception by the local sensing channel.

[0042] The pulse control unit generates a pulse firing command based on the position adjustment results during the alert period.

[0043] In this application, the perception comparison and identification unit considers the perception events of the local perception channel within preset time intervals before and after the ventricular perception channel's perception event as potential local perception events. Based on these potential local perception events, events in which the local perception channel perceives the R wave are selected. For example, if the perception occurs within 50ms before and after the ventricular perception event, it can be considered that the local perception channel perceived the R wave, and is thus considered a potential local perception event, requiring further judgment. If the local perception event occurs outside of 50ms, it is directly considered a false perception. If a potential local perception event exists within an interval, it is necessary to further determine whether it is an event in which the local perception channel perceives the R wave based on its temporal relationship with the ventricular perception event. Once a false perception occurs, the CCM will suppress the treatment pulse, which is outside the scope of this application and therefore will not be described in detail here.

[0044] Within one interval, events that sense the R wave through the local sensing channel are selected within 50ms before and after a ventricular sensing event. This application proposes two application examples based on the different number of events sensed by the local sensing channel. In practical applications, either Application Example 1 or Application Example 2 can be selected. Application Example 1: If there is only one LS (Last Stop) within 50ms before and after the ventricle, it is considered that the local channel sensed the R wave. If there are two LS within 50ms before and after the ventricle, neither of these two LS is considered an R wave sensing event. Application Example 2: If there is only one LS within 50ms before and after the ventricle, it is considered that the local channel sensed the R wave. If there are two LS within 50ms before and after the ventricle, the LS closer to the ventricular event is selected as the R wave sensing event.

[0045] In this application, the sensing comparison and recognition unit continuously monitors the most recent preset intervals. If, within each consecutive preset interval, an event occurs where the local sensing channel senses an R-wave, and the occurrence time of this event meets a predetermined discreteness standard, the time at which the local sensing channel senses the R-wave is determined to be stable. For example, if events where the local sensing channel senses an R-wave are identified in two adjacent intervals, and the difference in sensing time is less than 10 ms, then the local sensing channel is considered to be stably sensing the R-wave in these two intervals. If the local sensing channel can stably sense the R-wave for 10 consecutive intervals, the alert period position is automatically adjusted based on the average time of R-wave sensing by the local sensing channel.

[0046] In existing technologies, during the treatment pulse delivery phase, the treatment pulse is only triggered if a local sensing event occurs within the alert period. Assuming the sensing sensitivity of the CCM ventricle and local sensing channels is properly programmed, based on the time it takes for the ventricle to sense the R wave, the local sensing channel will inevitably sense the R wave within a certain timeframe before and after. Because the implantation positions of the two ventricular electrodes differ among patients, the time interval between ventricular R wave sensing and local sensing channel R wave sensing varies, and even for the same patient, this time interval may change slightly as the electrode implantation time progresses. This application automatically adjusts the alert period position based on the patient's actual sensing time relationship, ensuring that the CCM can continuously deliver treatment pulses.

[0047] In this application, the alert period adjustment unit adjusts the position of the alert period according to the time when the local sensing channel senses the R wave, provided that the time when the local sensing channel senses the R wave is stable. The adjustment principle is to adjust the start time of the alert period so that the time when the local sensing channel senses the R wave is in the middle of the alert period.

[0048] In this application, after confirming the time when the R-wave is sensed on the local sensing channel, the position of the alert period can be automatically adjusted according to this time, so that the time when the local sensing channel senses the R-wave is in the middle of the alert period. Adjusting the position of the alert period is achieved by adjusting the alert period initiation parameter. This ensures that the LS event when the local sensing channel senses the R-wave is within the alert period, thereby triggering the treatment pulse. Assuming that the local sensing channel can stably sense the R-wave, changing the alert period initiation parameter so that the time when the local sensing channel senses the R-wave is in the middle of the alert period window ensures that the CCM can trigger the treatment pulse to the greatest extent. The specific values ​​mentioned in this application, such as 50ms, 10 intervals, and 10ms, are only illustrative examples and are not specified as fixed values.

[0049] The present application will now be described in further detail with reference to the accompanying drawings:

[0050] Figure 3This application describes the basic timing parameters of the CCM involved in the prior art. Specifically, in the atrial channel, an atrial refractory period is set starting from a ventricular sensing event, during which no sensing events occur in the atrium, to avoid false sensing in the atrial channel. Similarly, in the ventricular channel, a ventricular refractory period is set starting from a ventricular sensing event, during which no ventricular sensing events occur, to avoid false sensing in the ventricular channel. The local sensing channel also has a refractory period during which no local sensing events occur. An alert period is set in the local sensing channel. If a sensing event occurs outside the refractory period in the local channel during the alert period, the CCM will be triggered to deliver a treatment pulse. If a sensing event occurs outside the refractory period outside the alert period, the delivery of the treatment pulse will be inhibited. After a sensing event occurs in the local sensing channel, there is a local post-sensing refractory period, mainly to prevent the same event from being sensed twice and affecting the timing. The post-pulse refractory period begins with the treatment pulse and ends simultaneously with the ventricular refractory period, mainly to avoid the influence of the treatment pulse on the local sensing channel, thus ensuring the normal delivery of the treatment pulse.

[0051] Figure 4 This application addresses the basic timing of the firing and suppression pulses involved in existing CCM technologies. The local sensing channel is equipped with an alert period, which is a time window. Figure 4 Event LS1, where the local sensing channel senses the R-wave, occurs within the alert period window and can trigger the delivery of a treatment pulse; event LS2, where the local sensing channel senses the R-wave, occurs outside the alert period window, does not trigger a treatment pulse, and simultaneously suppresses subsequent treatment pulses over multiple intervals. This application addresses... Figure 4 The phenomenon of LS2 inhibiting the treatment pulse is automatically adjusted according to the real-time situation of the R wave perceived by the local sensing channel. This ensures that the R wave sensing event occurs within the alert period, which can trigger the treatment pulse to the greatest extent.

[0052] Figure 5 This application describes the time information stored in the sensing storage unit. When a sensing event occurs in the ventricular channel and the local sensing channel, the type of the sensing event and the time of occurrence are stored in the sensing storage unit. For example... Figure 5 The LS sensing time of the sensing storage unit is based on VS. LS1 that occurs before VS is stored as a negative value for sensing time t1, and LS2 that occurs after VS is stored as a positive value for sensing time t2.

[0053] Figure 6 This is a schematic diagram illustrating the location of the R-wave sensed by the local sensing channel in this application. This application first needs to correctly identify the time when the local sensing channel senses the R-wave in order to adjust the alertness period position based on this time. Considering... Figure 3In the timing sequence, there is a local sensing refractory period after LS. At most, only two LS events will occur within a 50ms interval before and after the ventricle. Based on the presence of one or two potential local sensing events within a single interval, this application describes two application examples to analyze how to correctly identify R-wave events sensed by the local sensing channel. In practical applications, either application example 1 or application example 2 can be selected.

[0054] Figure 6 (a) is a schematic diagram of application example 1. When identifying events where the local sensing channel senses an R wave, only the case where there is one potential local sensing event within one interval is considered. In the diagram, there is only one LS within 50ms before and after the ventricle in interval ①. It is considered that LS is the event where the local sensing channel senses an R wave. The sensing time is t. In interval ②, there are only two LS (LS1 and LS2) within 50ms before and after the ventricle. To prevent interference from being misjudged as R wave sensing, it is considered that neither LS1 nor LS2 is the event where the local sensing channel senses an R wave.

[0055] Figure 6 (b) is a schematic diagram of application example 2. When identifying events where the local sensing channel senses the R wave, it considers the possibility of one or two potential local sensing events within a single interval. In interval ①, there is only one LS within 50ms before and after the ventricle. This LS is considered to be the event where the local sensing channel senses the R wave, with a sensing time of t. In interval ②, there are two sensing events, LS1 and LS2, within 50ms before and after the ventricle. LS1 occurs before the VS, with a time record of t1 (t1 < 0), and LS2 occurs after the VS, with a time record of t2 (t2 > 0). By comparison, |t1| > |t2|, it is considered that the event where the local sensing channel senses the R wave within this interval is LS2, which is closer to the VS, with a sensing time of t2.

[0056] In this application, it is required that the local sensing channel can detect the R wave within 50ms before and after the VS (Vibration State) for 10 consecutive intervals, and the time for the local sensing channel to detect the R wave must meet a certain dispersion standard, i.e., the time for the local sensing channel to detect the R wave must be stable, before the alert period position can be adjusted. During CCM treatment, although the time for the local sensing channel electrode to detect the R wave may vary, it will not show a particularly large difference within two consecutive intervals. This application stipulates that the upper limit of the time difference for the local sensing channel to detect the R wave within two consecutive intervals is 10ms. Once this upper limit of 10ms is exceeded, this application cannot consider the local sensing to be stable, and the alert period position cannot be easily adjusted in this case. The 10ms mentioned above is only an example here, and this application does not specify it as a certain fixed value.

[0057] Figure 7This diagram illustrates the stability assessment of R-wave sensing time between two adjacent intervals using a local sensing channel. The diagram shows events LS1, LS2, and LS3, where the local sensing channel has confirmed R-wave sensing for three consecutive intervals. The sensing times are denoted as t1, t2, and t3, respectively. The stability of R-wave sensing time between two adjacent intervals is assessed. If the interval between t1 and t2 is greater than 10 ms, the sensing times of LS1 and LS2 are considered unstable. If the time difference between t2 and t3 is less than 10 ms, the sensing times of LS2 and LS3 are considered stable.

[0058] Figure 8 This is a schematic diagram of the monitoring process over 10 consecutive intervals.

[0059] Figure 8 (a) A situation that would cause the count to be reset to zero during the 10-interval counting process of this application: the local sensing channel does not sense the R wave during the current interval. As shown in the figure, there is no LS 50ms before and after VS in intervals ① and ②. It is assumed that the local sensing channel does not sense the R wave, so the original count num is reset to zero until LS3 is confirmed as an event in which the local sensing channel senses the R wave, at which point num will start counting again.

[0060] Figure 8 (b) A second scenario where the counting process of this application over 10 intervals would result in the count being reset to zero: the local sensing channel experiences instability in sensing the R-wave time for two consecutive intervals. For example... Figure 8 As shown in (b), three consecutive intervals have passed. Figure 6 The method confirmed that LS1, LS2, and LS3 were events that sensed R waves during the current interval, with sensing times of t1, t2, and t3. Figure 7 After the method is used to determine the stability of the sensing time, the sensing times of LS1 and LS2 are unstable, so the original count num needs to be cleared until LS3, when the sensing times of LS2 and LS3 are stable, and num starts counting again.

[0061] Once localized R-wave events are confirmed within 10 consecutive intervals and the perception time is stable, the position of the alert period can be adjusted.

[0062] Figure 9 This is a schematic diagram illustrating the automatic adjustment of the alert period position in this application. When the consecutive interval count reaches 10, this application automatically adjusts the alert period position based on the time the local sensing channel senses the R wave within the most recent 10 intervals. Figure 9 As shown, the CCM has stored 10 consecutive intervals of sensory events (all of which have been processed). Figure 6 and Figure 7 The method confirmed that the event was a stable R-wave sensing event, with a sensing time of t1......t. 10The alert period parameters t_start and t_width determine the start time and width of the alert period, respectively. These two parameters determine the position of the alert period window. The position of the alert period is adjusted at the end of the 10th interval. This adjustment is achieved by adjusting the start time t_start, where t_start = (t1 + t2 + ... + t...). 10 ) / 10-t_width / 2, ensuring that LS is in the middle of the alert period, can maximize the probability of triggering the healing pulse.

[0063] Figure 10 This is the main flowchart of the automatic adjustment of the alert period position method of this application. In this application, the time stability of the R-wave sensing by the local sensing channel between adjacent intervals is first determined. Within each interval, Figure 2 The sensory storage unit in the middle records the time of ventricular sensing and regional sensing, after Figure 2 The sensing comparison and recognition unit in the middle determines the time when the local sensing channel senses the R wave, according to the above. Figure 6 and Figure 7 The mentioned method determines the stability of R-wave perception in two adjacent interval local sensing channels until the timing of R-wave perception in two adjacent interval local sensing channels is stable. Then, continuous monitoring is required until the timing of R-wave perception in 10 consecutive interval local sensing channels remains stable, at which point the alert period position is adjusted. The adjustment of the alert period position is determined by… Figure 2 The alert period adjustment unit is now complete. The alert period position is determined by two parameters: alert period start time and alert period width. When adjusting the alert period position, only the alert period start time is adjusted, which is equivalent to moving the alert period window. The adjustment principle is: the average time of LS events in the previous 10 consecutive intervals should be in the middle of the alert period window. After this adjustment, all LS events that sense R waves will be within the alert period, maximizing the triggering of therapeutic pulses and improving the treatment rate of CCM.

[0064] Figure 11 for Figure 10 The flowchart describes the process for determining the stability of R-wave sensing time in local sensing channels between adjacent intervals. First, within 50ms before and after a ventricular sensing event, the local sensing event closest to the ventricular sensing event is selected and considered the R-wave sensing event LS, with its sensing time t recorded. Then, stability is assessed. If the difference in sensing time between LS over two consecutive intervals is less than 10ms, the local sensing channel is considered to be stably sensing the R-wave without false sensing, and the stability assessment process continues. If the R-wave sensing time cannot be determined in a certain interval, or if the R-wave sensing time is unstable between two consecutive intervals, the stability assessment restarts.

[0065] This invention also provides an implantable cardiac contractility modulator, including the above-mentioned adaptive adjustment of alertness period circuitry.

[0066] The embodiments of the present invention described above do not constitute a limitation on the scope of protection of the present invention.

Claims

1. A circuit for adaptively adjusting alertness period, characterized in that, include: The system includes a sensing filter amplification module, a sensing threshold comparison module, a microcontroller, and a bidirectional pulse delivery module. The sensing, filtering, and amplifying module senses the electrical signals of the human heart through the ventricular sensing channel and the local sensing channel, and then filters and amplifies the electrical signals. The sensing threshold comparison module compares the electrical signal with a preset sensing sensitivity threshold and outputs sensing event information. The microcontroller includes a sensing storage unit, a sensing comparison and recognition unit, an alertness period adjustment unit, and a pulse control unit, which generates a pulse firing command based on the sensing event information. The bidirectional pulse delivery module, according to the pulse delivery command, delivers bidirectional pulses to the human heart through the ventricular sensing channel and the local sensing channel.

2. A method for adaptively adjusting the alert period, applied to a microcontroller of the circuit for adaptively adjusting the alert period as described in claim 1, the method comprising the following steps: The sensing storage unit stores sensing event information, including the type of sensing event and the time of occurrence of the sensing event. The sensing event types include ventricular sensing events and regional sensing events. The ventricular sensing event is the event in which the ventricular sensing channel senses the R wave, and the local sensing event is the sensing event of the local sensing channel within a preset time period before and after the ventricular sensing channel's sensing event. The perception comparison and recognition unit uses ventricular sensing events as a benchmark to filter out events in which the local sensing channel senses R waves, records the time, and determines whether the time of R wave sensing by the local sensing channel is stable. When the time for R-wave perception by the local sensing channel is stable, the alertness period adjustment unit adjusts the alertness period position according to the time for R-wave perception by the local sensing channel. The pulse control unit generates a pulse firing command based on the position adjustment results during the alert period.

3. The method for adaptively adjusting the alert period as described in claim 2, characterized in that, The perception comparison and recognition unit takes the perception events of the local perception channel within a preset time period before and after the perception event of the ventricular perception channel as potential local perception events; based on the potential local perception events, it filters out the events in which the local perception channel perceives the R wave.

4. The method for adaptively adjusting the alert period as described in claim 3, characterized in that, The sensing comparison and recognition unit continuously monitors the most recent preset intervals. Within each of the consecutive preset intervals, there are events where the local sensing channel senses the R-wave, and the occurrence time of the R-wave events sensed by the local sensing channel meets a predetermined discreteness standard, thus determining that the time of R-wave sensing by the local sensing channel is stable.

5. The method for adaptively adjusting the alert period as described in claim 4, characterized in that, When the time for the local sensing channel to perceive the R-wave is stable, the alert period adjustment unit adjusts the position of the alert period according to the time for the local sensing channel to perceive the R-wave. The adjustment principle is: by adjusting the start time of the alert period, the time for the local sensing channel to perceive the R-wave is in the middle of the alert period.

6. An implantable cardiac contractility modulator, characterized in that, Includes the circuit for adaptively adjusting the alert period as described in claim 1.

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