Pulse stimulation control method, device, medical system, electronic device, and medium

Abstract

The present invention discloses a pulse stimulation control method, device, medical system, electronic device and medium, the method includes the steps of obtaining a first sensing time of an R wave in a preset electrocardiogram, determining a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position and its second sensing time, and if the second sensing time does not meet the first preset condition, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling not to send the corresponding pulse stimulation. The present invention ensures that the cardiac pulse stimulation is not sent in an incorrect case, effectively avoiding the risk of inducing VT or VF, sends the pulse stimulation only when it is determined to be an R wave, and ensures that it is sent within the sendable period corresponding to the R wave in the preset electrocardiogram, guaranteeing the reliability, safety, timeliness and effectiveness of the pulse stimulation to the patient's heart, and better guaranteeing the safety, effectiveness and therapeutic effect of the pulse stimulation to the patient.

Description

[Technical field]

[0001] <CROSS REFERENCE TO RELATED APPLICATIONS> This application claims priority to a Chinese patent application having a filing date of January 30, 2022 and application number 2022101141302. The entire contents of the above Chinese patent application are incorporated herein by reference.

[0002] The present invention relates to the field of medical mechanical technology, and in particular to pulse stimulation control methods, devices, medical systems, electronic devices and media. [Background technology]

[0003] Currently available medical devices with CCM (cardiac contraction modulation) function are basically used for patients with chronic heart failure, and are generally implanted in the right ventricular septum using two bipolar leads to sense the local myocardial potential and deliver a pulse stimulus at a certain time after the sensing to enhance ventricular myocardial contractility. The two bipolar electrodes are used to sense the local myocardial electrical activity and the time sequence of the electrical activity, and both electrodes can be used to trigger a pulse stimulus (also called CCM stimulus) by the local cardiac electrical activity within the local myocardial delivery period (also called the safe period, corresponding to the absolute refractory period of the local myocardium), and the pulse stimulus is delivered only with the ventricular beat (electrical activity) initiated by the atrium, and is not delivered under the ventricular extrasystole or beat initiated by the other ventricle.

[0004] The pulse stimulation is effective when delivered within the period when the local myocardium can be delivered, and does not cause re-depolarization of the local myocardium. However, the energy of the pulse stimulation is quite large, and such high-energy electrical stimulation may affect far-field myocardium other than the local myocardium in contact with the stimulation electrode, and the degree of this effect varies depending on the design (e.g., shape) of the stimulation electrodes located in the local myocardium and the distance between the electrodes. Under the same energy, the greater the distance between the stimulation electrodes or the larger the effective area of ​​the stimulation electrodes, the greater the degree and / or range of the possible effect on the far-field myocardium. If the local pulse stimulation occurs at a site where myocardial repolarization (within the absolute refractory period) is slow, the delivery time of the pulse stimulation may be after the period when the action potential of the far-field myocardium that has depolarized early (relative to the local myocardium) can be delivered, which increases the possibility of re-depolarization by the myocardium in this area, and there is a risk of causing malignant ventricular arrhythmia (VT / VF, ventricular tachycardia or ventricular fibrillation). The existing pulse stimulation method is to deliver the pulse at the ventricular septum. The atrium's down-conduction activates the ventricular muscle in this region earlier than the ventricular muscle in other regions, such as the lateral wall of the left ventricle. This reduces or avoids the risk that the pulse delivered at the ventricular septum will not be delivered after the delivery period of other regions, and the myocardium in these regions will be triggered to ventricular arrhythmia. However, when the ventricular excitation is not due to the electrical activity delivered down-conduction to the atrium but due to the ventricular's own electrical activity, such as premature contraction, ventricular pacing, etc., the electrical activity of the ventricular muscle in the ventricular septum is not necessarily the earliest in the ventricular muscle, and in this case, the pulse electrical stimulation delivered on the ventricular septum may be delivered after the delivery period of the myocardium in other regions, thereby increasing the risk that the myocardium in that region will be electrically stimulated by the pulse and induce arrhythmia. Therefore, existing pulse stimulation devices do not deliver pulse stimulation unless the ventricular excitation is due to the atrium (ventricular ectopic excitation). However, the incidence of premature ventricular contractions is high in patients with heart failure, and some patients with heart failure are dependent on ventricular pacing for the long term, including some patients who take beta-receptor blockers for the long term to slow their heart rate, patients with single-ventricular ICDs, and patients with CRT (cardiac resynchronization therapy).This may significantly reduce the positive effect of pulse stimulation on the myocardium in these patients.Placement of myocardial stimulation electrodes in other parts of the ventricle (e.g., other than the interventricular septum) may result in a higher incidence of risks similar to those described above.

[0005] In the existing pulse stimulation method, when a sensing event occurs in a local myocardial electrocardiogram at a certain myocardial position, after a certain time, it can directly control the pulse stimulation to be sent to the stimulation electrode at the current myocardial position; however, if erroneous sensing occurs in the local myocardial electrocardiogram at a certain myocardial position, the sensing event is a T wave or other event (e.g., an interference signal), and the pulse stimulation is performed after the T wave, which significantly increases the risk of inducing malignant ventricular arrhythmia VT or VF, thereby increasing the risk to the patient's life and causing the patient extra painful stimulation. Summary of the Invention [Problem to be solved by the invention]

[0006] The technical problem that the present invention aims to solve is that in the existing technology, when there is a sensing event in a local myocardial electrocardiogram based on a certain myocardial position, it is determined that a pulse stimulation is to be sent to the corresponding myocardium, and if there is an erroneous sensing, there is a risk of inducing malignant ventricular arrhythmia such as VT or VF, and there are defects in the pulse stimulation method, such as not being able to send a pulse with ventricular electrical activity caused by the ventricle itself, and only being able to send a pulse stimulation at the atrial septum when the ventricle has electrical activity transmitted downward to the atrium. The purpose of the present invention is to provide a pulse stimulation control method, device, medical system, electronic device and medium, which can better enhance the effect on cardiac contractility and ensure that the risk of inducing ventricular arrhythmia in this process is kept to a very small extent, and can effectively guarantee the safety and therapeutic effect of pulse stimulation for patients, by placing pulse stimulation electrodes at different positions (e.g., the left ventricular wall) or multiple positions of the ventricle. [Means for solving the problem]

[0007] The present invention solves the above technical problems by the following technical solutions.

[0008] The present invention provides a method for controlling pulse stimulation, the method comprising: Obtaining a first sensing time of an R wave in a preset electrocardiogram; determining a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position based on the first sensing time, and acquiring a second sensing time corresponding to the sensing event; If the second sensing time does not satisfy a first preset condition, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling not to deliver a pulse stimulation to a stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.

[0009] Preferably, when the second sensing time does not satisfy a first preset condition, the step of determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram and controlling not to transmit a pulse stimulation to the stimulation electrode at the set myocardial position includes: obtaining a sensing time window corresponding to an R wave in the preset electrocardiogram; If the second sensing time does not fall within the sensing time window, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling so as not to deliver pulse stimulation to the stimulation electrode at the set myocardial position.

[0010] Preferably, the step of determining a sensed event in a local myocardial electrocardiogram corresponding to a set myocardial location based on the first sensed time includes: The first sensing time is a first time point, and a time point corresponding to a first set duration before the first time point is a time reference starting point; and acquiring a sensing event in a local myocardial electrocardiogram corresponding to the set myocardial location based on the time reference starting point.

[0011] Preferably, the method comprises the steps of: The method further includes determining that the sensed event is an R wave if the second sensed time falls within the sensing time window.

[0012] Preferably, the pulse stimulation control method includes: After the sensing event is an R wave, determining a pulse delivery time corresponding to a stimulation electrode at the set myocardial position based on the second sensing time of an R wave in the local myocardial electrocardiogram; The method further includes a step of determining whether the pulse delivery time satisfies a second preset condition, and if so, deciding to deliver a pulse stimulation to a stimulation electrode at the set myocardial position, and if not, deciding not to deliver a pulse stimulation to the stimulation electrode at the set myocardial position.

[0013] Preferably, the step of determining whether the pulse delivery time satisfies a second preset condition, determining to deliver a pulse stimulus to a stimulation electrode at the set myocardial position if the second preset condition is satisfied, and determining not to deliver a pulse stimulus to a stimulation electrode at the set myocardial position if the second preset condition is not satisfied, obtaining a pulse transmittable time window corresponding to an R wave in the preset electrocardiogram; setting the pulse transmittable time window corresponding to the sensing time window; When the pulse delivery time falls within the pulse delivery possible time window, a control step is performed so that a pulse stimulus is delivered to a stimulation electrode at the set myocardial position during the pulse delivery time; and controlling so as not to deliver a pulse stimulus to the stimulation electrode at the set myocardial position if the pulse delivery time is not within the pulse delivery possible time window.

[0014] Preferably, in the case of a plurality of set myocardial locations, the method further comprises: A step of sequentially determining whether the corresponding second sensing time falls within the sensing time window according to the second sensing time order in which the sensing events in each of the local myocardial electrocardiograms occurred, The method further includes determining the sensing time window according to the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event that occurs first.

[0015] Preferably, in the case of a plurality of set myocardial locations, the method further comprises: Presetting configurations of sensing parameters corresponding to sensing times at different configurations of myocardial locations, The predetermined sensing parameters include predetermined sensing times and / or predetermined sensing occurrence sequences; or If the first sensing event in the local myocardial electrocardiogram is an R wave, setting all remaining sensing events in the local myocardial electrocardiogram to be R waves; or The method further includes a step of setting, when the last sensed event in the local myocardial electrocardiogram is an R wave, all the remaining sensed events in the local myocardial electrocardiograms to be R waves.

[0016] Preferably, the preset electrocardiograms include a surface electrocardiogram and / or an internal far-field myocardial electrocardiogram; and / or The pulse deliverable time window and the sensing time window are determined based on the preset electrocardiogram.

[0017] Preferably, the step of determining a pulse transmission time corresponding to a stimulation electrode at the set myocardial position based on the second sensing time of an R wave in the local myocardial electrocardiogram includes: Calculating the pulse delivery time corresponding to the stimulation electrode at the set myocardial position according to the second sensing time of the R wave in the local myocardial electrocardiogram and a preset duration, Or, Calculating a time difference value between the first sensing time corresponding to an R wave in the preset electrocardiogram and the second sensing time at the set myocardial position; The method includes a step of calculating the pulse transmission time corresponding to the set myocardial position according to the time difference value and a preset duration, using the first sensing time as a reference zero point.

[0018] Preferably, the pulse stimulus is a CCM stimulus; Here, the CCM stimulus is The pulse is delivered during at least one of ventricular electrical activity: a sinus beat, a ventricular beat resulting from atrial subconduction, a ventricular beat resulting from a ventricular ventricle, and a ventricular paced beat.

[0019] The present invention further provides a pulse stimulation control device, the device comprising: a first sensing time acquisition module for acquiring a first sensing time of an R wave in a preset electrocardiogram; a sensed event determination module for determining a sensed event in a local myocardial electrocardiogram corresponding to a preset myocardial location based on the first sensed time; a second sensing time acquisition module for acquiring a second sensing time corresponding to the sensing event; a first judgment module for determining that the sensed event is not an R wave signal corresponding to an R wave in the preset electrocardiogram when the second sensing time does not satisfy a first preset condition, and for controlling not to deliver a pulse stimulation to a stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.

[0020] The present invention further provides a medical system including the above-described pulse stimulation control device.

[0021] The present invention further provides an electronic device including a memory, a processor, and a computer program stored in the memory and executed on the processor, wherein when the computer program is executed by the processor, the above-mentioned pulse stimulation control method is realized.

[0022] The present invention further provides a computer-readable storage medium having a computer program stored thereon, which, when executed by a processor, realizes the above-mentioned pulse stimulation control method.

[0023] Based on common knowledge in the art, the above preferred conditions can be arbitrarily combined to obtain preferred embodiments of the present invention. Effect of the Invention

[0024] The positive and improved effects of the present invention are as follows: (1) Regarding only the pulse stimulation sent after the R wave, the present invention can perform analysis processing on the sensing event in the local myocardial electrocardiogram of the myocardium in a timely manner, automatically and accurately screen the erroneous sensing event, and determine that it belongs to an interference signal such as a T wave, not an R wave signal corresponding to the R wave in the preset electrocardiogram. At this time, control is performed so that the pulse stimulation is not sent to the corresponding myocardial position, and ensure that the pulse stimulation is not sent in the case of an error, effectively reducing or avoiding the risk of inducing VT or VF, and thus avoiding causing unnecessary pain to the patient and even safety concerns, ensuring the safety of the patient, improving the reliability of the pulse stimulation control, and also ensuring that the pulse stimulation is sent in a timely manner when it is determined to be an R wave, that is, that the pulse stimulation is sent only when it is correct. (2) Pulse stimulation is delivered only within the ventricular deliverable period. By confirming that the pulse stimulation delivery time falls within the deliverable period corresponding to the cardiac electrical activity (R wave) of the entire ventricle reflected by the body surface electrocardiogram or the internal far-field myocardial electrocardiogram, the timeliness, safety, and effectiveness of the pulse stimulation to the patient's heart are guaranteed. Here, obtaining deliverable period information of ventricular cardiac electrical activity by the body surface electrocardiogram or the far-field myocardial electrocardiogram in order to ensure the safety of the pulse stimulation delivery time also means active improvement of the pulse stimulation technology, and further guarantees the safety, effectiveness, and therapeutic effect of the pulse stimulation to the patient. [Brief description of the drawings]

[0025] [Figure 1] 2 is a flowchart of a pulse stimulation control method according to the first embodiment of the present invention. [Diagram 2] 11 is a first flowchart of a pulse stimulation control method according to Example 2 of the present invention. [Diagram 3] 2 is a second flowchart of the pulse stimulation control method according to the second embodiment of the present invention. [Figure 4] 11 is a third flowchart of the pulse stimulation control method according to the second embodiment of the present invention. [Diagram 5]4 is a fourth flowchart of the pulse stimulation control method according to the second embodiment of the present invention. [Figure 6] 5 is a fifth flowchart of the pulse stimulation control method according to the second embodiment of the present invention. [Figure 7] 11 is a schematic electrocardiogram corresponding to R wave sensing when using a single electrode lead according to the second embodiment of the present invention. FIG. [Figure 8] 11 is a schematic electrocardiogram corresponding to R wave sensing when multiple electrode leads are used in Example 2 of the present invention. FIG. [Figure 9] FIG. 11 is a schematic diagram of a module of a pulse stimulation control system according to a third embodiment of the present invention. [Figure 10] FIG. 11 is a schematic diagram of a module of a pulse stimulation control system according to a fourth embodiment of the present invention. [Figure 11] FIG. 11 is a schematic structural diagram of an electronic device for implementing the pulse stimulation control method according to the fifth embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] The present invention will be further described below by way of examples, but the present invention is not limited to the scope of the above examples.

[0027] In the present invention, stimulation electrodes are pre-installed at different myocardial locations of a patient (the myocardial locations at which the electrodes are installed can be determined or adjusted according to actual requirements), and each stimulation electrode is implanted via a lead and / or electrically connected to an external pulse stimulation device to realize control operations such as collecting electrocardiographic signals for different myocardial locations and sending pulse stimulation to different myocardial locations.

[0028] The pulse stimulation method of the present invention may be for the case of pulse stimulation of a single electrode lead or for the case of pulse stimulation of multiple electrode leads, such as an ECS (Electrical Circulatory Support) system, and by providing pulse stimulation to multiple myocardial sites, it is possible to cover one or more ventricles that are most in need of local and global support, while providing pulse stimulation to them and better ensuring the timeliness, safety, and efficacy of the pulse stimulation provided by the system.

[0029] Example 1 As shown in FIG. 1, the pulse stimulation control method of this embodiment includes S101 to S103.

[0030] In S101, a first sensing time of an R wave in a preset electrocardiogram is obtained; Here, the preset electrocardiograms include, but are not limited to, a surface electrocardiogram (ECG) and an internal far-field myocardial electrocardiogram (also called a Far-Field Electrogram (FF-EGM)), and the first sensing time is also called GS (Global Sense, far-field sensing).

[0031] In S102, a sensing event in a local myocardial electrocardiogram corresponding to the set myocardial position is determined based on the first sensing time, and a second sensing time corresponding to the sensing event is obtained; Here, the second sensing time corresponding to a sensing event in a local myocardial electrocardiogram is also called LS (Local Sense).

[0032] The sensing event in the local myocardial electrocardiogram is a sensing event that corresponds to the R wave of the preset electrocardiogram.

[0033] In S103, if the second sensing time does not satisfy the first preset condition, it is determined that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and control is performed so as not to transmit a pulse stimulation to the stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to a sensing event.

[0034] In one possible implementation, as shown in FIG. 2, step S103 includes S1031 and S1032.

[0035] In S1031, a sensing time window corresponding to an R wave in a preset electrocardiogram is obtained; Here, the method of acquiring the sensing time window includes, but is not limited to, acquiring the sensing time window based on a pre-installed sensing circuit, and acquiring the sensing time window by inputting the sensing time window from an external device and directly receiving the sensing time window.

[0036] Surface electrocardiogram ECG: The corresponding signal is from a control electrode attached to the skin, where the control electrode can be a general surface electrocardiogram electrode, but is not limited to a specially designed electrode.

[0037] The far-field myocardial electrocardiogram (FF-EGM) represents (or reflects) the signal of the whole heart's electrical activity and is similar to a body surface electrocardiogram. The signal corresponding to the far-field myocardial electrocardiogram is from a combination of multiple types of control electrodes, including, but not limited to, electrodes with a large surface area that directly contacts the myocardium (i.e., significantly larger than the surface area of ​​electrodes for conventional myocardial electrical stimulation), electrodes that do not directly contact the myocardium but are closer to or farther from the ventricular myocardium, or electrodes with a large relative surface area that are located subcutaneously.

[0038] For example, the different electrode combinations correspond to any combination of different electrodes, such as defibrillation electrodes placed in a blood vessel or ventricle, epicardially placed defibrillation electrodes, subcutaneous defibrillation electrodes of a sub-Q ICD, or defibrillation electrodes of an external defibrillator (e.g., an AED), and specifically, how these different electrodes are combined and placed can be determined or adjusted according to the needs of the actual usage scenario.

[0039] Based on the R-waves in the single or multiple induced body surface electrocardiograms and / or one or more far-field myocardial electrocardiograms, a sensing time and a corresponding sensing time window are obtained, which represents a period of time during which a part or all of the depolarizing electrical activity of the entire ventricular myocardium is present, thereby obtaining a pulse delivery possible time window. By improving the control mechanism for whether or not to deliver at the stimulation site and the delivery time, the accuracy of the pulse stimulation delivery decision is further improved and safety is improved.

[0040] In S1032, if the second sensing time does not fall within the sensing time window, it is determined that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and control is performed so as not to deliver pulse stimulation to the stimulation electrode at the set myocardial position.

[0041] Here, the non-R wave signal corresponding to the sensing event LS in the local myocardial electrocardiogram includes a T wave signal or other interference signals, etc. Specifically, the pulse stimulation is a CCM stimulation, and the realization of the pulse stimulation can be performed in different ventricular electrical activity situations, thereby improving the usable range of the pulse stimulation and greatly improving the overall effectiveness of the pulse stimulation control.

[0042] CCM stimulation occurs during ventricular electrical activity such as sinus beats, ventricular beats caused by atrial subconduction, ventricular beats caused by the ventricle (ventricular ectopic activation), and ventricular-paced beats.

[0043] By verifying that the local sensing event is the R wave, it can better ensure that the CCM stimulation is not triggered by other signals (such as T waves, electromyography, or other non-myocardial electrical activity) but is triggered by the local R wave, effectively eliminating the occurrence of false triggering. The design of this crucial step can effectively improve the safety and efficacy of pulse stimulation.

[0044] In order to effectively improve the accuracy of confirming whether LS is R wave sensing in a local myocardial electrocardiogram, in this embodiment, far field sensing (GS) and local sensing (LS) of the same heartbeat are considered simultaneously, and the judgment result is determined using both far field sensing (GS) and local sensing (LS) of the same heartbeat, which greatly reduces the probability of occurrence of a situation in which pulse stimulation is erroneously triggered due to the high possibility of misjudgment when only one sensing, i.e., far field sensing (GS) or local sensing (LS), is considered, thereby effectively improving the confirmation accuracy of the sensing event (LS), more effectively avoiding pulse stimulation being sent in an erroneous case, and greatly improving the safety of pulse stimulation for the patient.

[0045] The pulse stimulation is ensured to be delivered not only within the period of transmission of local myocardial R waves (those sensed by the electrodes at this myocardial site), but also within the period of transmission of far-field myocardial R waves (electrical activity generated by the entire ventricular myocardium), thereby maximally reducing, and even eliminating, the risk of the ventricular myocardium being unexpectedly activated and depolarized by the pulse stimulation.

[0046] In this embodiment, the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed in a timely manner, and the erroneous sensing events can be automatically and accurately screened to determine that they are not R wave signals corresponding to the R waves in the preset electrocardiogram but interference signals such as T waves. At this time, the pulse stimulation is controlled not to be sent to the corresponding myocardial position, and pulse stimulation is ensured not to be sent in the case of an error, effectively avoiding the risk of inducing VT or VF, and avoiding causing unnecessary pain to the patient and even safety concerns, ensuring the safety of the patient, improving the reliability of the pulse stimulation control, and ensuring the safety, efficacy and therapeutic effect of the pulse stimulation for the patient.

[0047] Example 2 The pulse stimulation control method of this embodiment is a further improvement of the first embodiment. Specifically, In one possible implementation, as shown in FIG. 3, step S102 includes: S1021, a first sensing time is a first time point, and a time point corresponding to a first setting duration before the first time point is a time reference starting point; and acquiring a sensing event in a local myocardial electrocardiogram corresponding to the set myocardial location based on a time reference starting point (S1022).

[0048] In one possible solution, as shown in FIG. 4, after step S102, If the second sensed time falls within the sensed time window, S104 includes determining that the sensed event is an R wave.

[0049] In one possible implementation, as shown in FIG. 5, the pulse stimulation control method of this embodiment further includes S105 and S106.

[0050] In S105, after the sensing event is an R wave, a pulse delivery time corresponding to the stimulation electrode at the set myocardial position is determined based on a second sensing time of the R wave in the local myocardial electrocardiogram.

[0051] In this embodiment, the method for determining whether a sensing event is an R wave is to directly acquire the R wave by transmitting the R wave from an external device, or to determine whether the R wave falls within a sensing time window.

[0052] In S106, it is determined whether the pulse delivery time satisfies the second preset condition, and if so, it is decided to deliver a pulse stimulation to the stimulation electrode at the set myocardial position, and if not, it is decided not to deliver a pulse stimulation to the stimulation electrode at the set myocardial position.

[0053] A sensing event whose local myocardial sensing time is within a sensing time window corresponding to an R wave in a preset electrocardiogram is determined to belong to an R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram, and it is only when it is determined to be an R wave that a pulse stimulus is delivered in a timely manner, thereby ensuring the timeliness, safety and effectiveness of the pulse stimulus to the patient's heart.

[0054] The pulse stimulation is ensured to be delivered not only within the period during which local myocardial R waves (sensed by the electrodes at this myocardial site) can be delivered, but also within the period during which far-field myocardial R waves (electrical activity generated by the entire ventricular myocardium) can be delivered, thereby minimizing the risk that myocardium in other parts of the ventricle will be activated and polarized by the pulse stimulation, and ultimately eliminating this risk, greatly ensuring the safety of the pulse stimulation for the patient and minimizing the need to cause unnecessary treatment risks and pain to the patient.

[0055] In other words, the pulse stimulation control of this embodiment allows pulse stimulation to be delivered only when necessary, regardless of where the stimulation electrode is located in the myocardium, i.e., within the deliverable period of the entire ventricular myocardium, rather than only within the deliverable period of the local myocardium, thereby better ensuring the safety and effectiveness of the pulse stimulation, which also makes it possible to deliver pulse stimulation under various heart rates (including atrially conducted ventricular heart rate, ventricular self-induced heart rate, e.g. PVCs, ventricular pacing heart rate, etc.) if necessary, thereby meeting to a large extent the patient's demand for enhanced myocardial contractility.

[0056] In one possible embodiment, step S105 includes: Calculating a pulse delivery time corresponding to the stimulation electrode at the set myocardial position according to a second sensing time of an R wave in a local myocardial electrocardiogram and a preset duration; Or, Calculating a time difference between a first sensing time (GS) corresponding to an R wave in a preset electrocardiogram and a second sensing time at a preset myocardial position; The method includes a step of calculating a pulse delivery time corresponding to a set myocardial position according to the time difference value and the preset duration, using the first sensing time as a reference zero point.

[0057] The above two steps for calculating the pulse transmission time of the R wave in the local myocardial electrocardiogram will now be described in detail.

[0058] (1) The second sensing time at which an R wave appears on the local myocardial electrocardiogram is obtained in a timely manner, and the second sensing time is set as the reference zero point (or trigger point). Based on this, a preset duration (LPD) is added to obtain the pulse transmission time corresponding to the stimulating electrode at the corresponding myocardial position.

[0059] (2) Based on the second sensing time and the first sensing time at which an R wave appears in the surface electrocardiogram ECG and / or the far-field myocardial electrocardiogram FF-EGM, a time difference value (GLSD) between the second sensing time and the first sensing time is calculated, and then the first sensing time is set as the reference zero point. Based on this, the time difference value GLSD and the preset duration LPD are added to calculate the pulse transmission time GPD corresponding to each set myocardial position with the first sensing time as the trigger point (reference point), i.e., GPD = GLSD + LPD.

[0060] After obtaining the pulse sending time GPD for each set myocardial position, it is also possible to maintain the time difference value as it is, and maintain the cardiac pulse stimulation to be sent to the corresponding control electrode according to the pulse sending time GPD, without the need to re-calculate every time before outputting the electrical stimulation. At this time, after sensing of the R wave of the local myocardial electrocardiogram occurs, the output time of the electrical stimulation can be directly determined according to the GPD, without the need to calculate the sending time of the pulse stimulation far-field myocardial electrocardiogram every time according to the first sensing time, thereby achieving the cardiac electrical stimulation effect, effectively shortening the data processing time, and improving the control efficiency of the trigger by the cardiac pulse stimulation.

[0061] In addition, according to actual requirements, the pulse delivery time GPD (at this time, myocardial electrical stimulation may be continued or stopped) can be updated periodically or irregularly, and then myocardial electrical stimulation can be continued according to the updated trigger time, thereby achieving a more flexible electrical stimulation effect and meeting the needs of more pulse electrical stimulation scenes.

[0062] The pulse stimulation triggered by the R wave (second sensing time) of the local myocardial electrocardiogram has a constant R-wave-to-transmission duration (LPD) at each stimulation position (e.g., preset duration 40 ms). The pulse stimulation triggered by the R wave in the surface electrocardiogram ECG and / or the far-field myocardial electrocardiogram FF-EGM has a different GPD at each stimulation position (i.e., determined according to the time difference value of the position change from a constant preset duration of 40 ms). Here, the preset duration is usually set to 40 ms by default, and the duration value can be fine-tuned or updated (i.e., programmable adjustment) according to actual requirements.

[0063] In addition, the GLSD and GPD corresponding to each set myocardial site can be obtained by averaging several intrinsic heartbeats measured during a preset period (default is 5 consecutive intrinsic heartbeats, range is 3 to 12). It can also be obtained according to the actual measured duration at each heartbeat. The GPD of each set myocardial site or position is used to trigger the time of pulse stimulation transmission with respect to the preset electrocardiogram R wave sensing time at that site or position. The pulse transmission time corresponds to the duration from sensing the R wave to triggering the cardiac pulse stimulation transmission, and the delivery of the pulse stimulation at each site or position is triggered by the R wave sensing of the body surface electrocardiogram ECG or the R wave sensing of the far-field myocardial electrocardiogram FF-EGM, and then the cardiac pulse stimulation is transmitted to each corresponding control electrode according to the pulse transmission time. To ensure the effectiveness of the pulse stimulation, all R waves (i.e., the R wave in the far-field myocardial electrocardiogram FF-EGM and the R wave in the body surface electrocardiogram ECG) are both sensed under the same heartbeat. Based on the above pulse delivery time acquisition method, the timeliness and reliability of pulse stimulation can be effectively guaranteed.

[0064] In addition, according to actual requirements, different ventricular electrical activities can be preset with corresponding parameters such as GLSD, for example, sinus (SR) ventricular electrical activity, and then, in the actual working period, the corresponding parameters set in the preset period during sinus rhythm can be directly called, so as to ensure the timeliness and effectiveness of pulse stimulation control while reducing the calculation requirements for each heartbeat; In order to further improve the timeliness and effectiveness of pulse stimulation control, and thus further ensure the safety and therapeutic effect of pulse stimulation for patients, it is also possible to perform dynamic calculations based on data and parameters sensed from real-time cardiac electrical activity directly during the operating period, rather than relying on parameters obtained during preset periods such as GLSD, to obtain GLSD and other parameters corresponding to the current actual ventricular electrical activity.

[0065] In one possible implementation, as shown in FIG. 6, step S106 includes S1061 and S1062.

[0066] In S1061, a pulse transmittable time window corresponding to an R wave in a preset electrocardiogram is obtained; Here, the start time and window duration corresponding to the two time windows, the pulse transmittable time window and the sensing time window, may be the same or different, that is, the two time windows, the pulse transmittable time window and the sensing time window, may be set independently and may not have any correlation or dependency with each other.

[0067] Specifically, the pulse transmittable time window and the sensing time window are determined based on a preset electrocardiogram, and the specific settings are adaptively adjusted according to factors such as the actual R wave sensing situation and the condition of the myocardium, thereby covering or meeting the needs of most pulse stimulation scenes.

[0068] In S1062, when the pulse delivery time falls within the pulse delivery possible time window, control is performed so that a pulse stimulation is delivered to a stimulation electrode at a set myocardial position within the pulse delivery time; If the pulse delivery time does not fall within the pulse delivery possible time window, control is performed so that the pulse stimulation is not delivered to the stimulation electrode at the set myocardial position.

[0069] The present solution ensures that CCM stimulation occurs within the local myocardial depolarization (R-wave) and the internal far-field myocardial depolarization (R-wave) window, where the pulse delivery window corresponds to a safe period, which corresponds to the entire ventricular delivery window. Both the start and end of the pulse delivery window are adjustable, with the goal that the start corresponds roughly to the depolarization area and the end is earlier than or equal to the end of the delivery window.

[0070] In one possible implementation, when there are multiple myocardial positions to be set, the pulse stimulation control method of this embodiment further comprises: The method includes a step of executing steps S102 to S106 one by one for sensing events LS in a local myocardial electrocardiogram corresponding to each myocardial position, thereby delivering pulse stimulation to each myocardial position in a timely and effective manner, thereby ensuring safety, effectiveness and reliability of treating the patient.

[0071] Here, the sensing time window is determined according to a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to the sensing event that occurs first.

[0072] For example, one pulse stimulation electrode is installed at each of three different settings of myocardial positions (A, B, C) of a patient in advance as an example, and the settings of myocardial positions A, B, C correspond to stimulation electrode pairs E1, E2, E3, respectively, and the second sensing times of the corresponding sensing events are LS1, LS2, LS3, respectively, where the occurrence times corresponding to LS1, LS2, LS3 move sequentially (i.e., the sensing event LS1 occurs earliest, and other sensing events occur sequentially at subsequent times). Here, the configuration of each electrode pair may be two types of electrode combination settings: a monopolar electrode and a monopolar electrode, a bipolar electrode and a bipolar electrode lead, a monopolar electrode and a monopolar electrode, and a bipolar electrode and a bipolar electrode lead, and other types of electrodes, specifically, which types of electrode pairs and which combination settings are used, may be determined or adjusted according to the needs of the actual scene.

[0073] Specifically, when acquiring a sensing event LS1 in a local myocardial electrocardiogram corresponding to a preset myocardial position A based on the electrode pair E1 at the myocardial position A, a second sensing time corresponding to the sensing event LS1 is acquired, and it is determined whether the second sensing time falls within a sensing time window corresponding to an R wave in the preset electrocardiogram. If the second sensing time does not fall within the sensing time window, it is determined that the sensing event LS1 is not an R wave signal corresponding to an R wave in the preset electrocardiogram, but is another interference signal such as a T wave, and control is performed so as not to send a pulse stimulation to the stimulation electrode pair E1 at the preset myocardial position A. If the second sensing time falls within the sensing time window, it is determined that the sensing event LS1 is not an R wave signal corresponding to an R wave in the preset electrocardiogram, but is another interference signal such as a T wave. It is then determined that the sensing event LS1 is an R wave signal of a local myocardium corresponding to the R wave in the set electrocardiogram, and then a pulse sending time corresponding to the stimulating electrode corresponding to the set myocardial position A is calculated in a timely and accurate manner at the second sensing time corresponding to the sensing event LS1. It then determines whether the pulse sending time falls within a pulse sending possible time window corresponding to the R wave in the preset electrocardiogram, and if it does, it controls so that a pulse stimulation is sent to the stimulating electrode at the set myocardial position A at the pulse sending time, and if it does not, it determines that a pulse stimulation will not be sent to the stimulating electrode at the set myocardial position A, thereby completing one pulse stimulation control at the set myocardial position A.

[0074] By analogy, the pulse stimulation control process for the set myocardial positions B and C is similar to the pulse stimulation control process for the set myocardial position A, so a detailed description thereof will be omitted here.

[0075] Furthermore, the pulse stimulation control processes at different set myocardial positions are independent of each other and do not interfere with or affect each other. For example, while a pulse stimulation control process is being performed at set myocardial position A, or when pulse stimulation control at set myocardial position A has already been completed, if a sensing event LS2 appears on the local myocardial electrocardiogram corresponding to set myocardial position B, the above pulse stimulation control process can be performed independently to finally complete pulse stimulation control at all set myocardial positions, making the control operation orderly and very effectively ensuring the safety and reliability of pulse stimulation for patients.

[0076] In one possible implementation, when the sensing times corresponding to the sensing events of the multiple local myocardial electrocardiograms occur very compactly (i.e., the time intervals are small), the pulse stimulation control method of this embodiment further comprises: a step of acquiring a second sensing time corresponding to a sensing event LS in a local myocardial electrocardiogram corresponding to each local myocardial electrocardiogram, acquiring a sensing event having the earliest occurrence time as a first sensing event LS1, acquiring a second sensing time corresponding to the first sensing event LS1, determining whether the first sensing event LS1 falls within a sensing time window corresponding to an R wave in a preset electrocardiogram, and if so, determining that the sensing event is a local myocardial R wave signal corresponding to an R wave in the preset electrocardiogram; and determining whether a second sensing time corresponding to the sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions falls within the sensing time window, and if so, determining that the first sensing event is an R-wave signal corresponding to an R-wave in the preset electrocardiogram, then directly determining that the sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions are also R-wave signals corresponding to R-waves in the preset electrocardiogram, thereby achieving an accurate determination without the need to determine and analyze the sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions one by one, greatly simplifying the data analysis processing process, effectively shortening the data processing time, and reducing the requirements for the computing power of the device, and further ensuring the timeliness, accuracy and effectiveness of the pulse stimulation control for the patient.

[0077] In addition, the specific method used to determine whether the sensing events of multiple local myocardial electrocardiograms are R waves can be selected as a single implementation method or a combination of multiple methods according to the needs of actual scenes, which meets the more demanding electrocardiac ventricular conduction scenes, greatly improves the practicability of pulse stimulation control, and greatly improves the safety and efficacy of patient treatment.

[0078] In addition, when there are a plurality of set myocardial positions, the pulse stimulation control method of this embodiment further includes: (1) presetting sensing parameters corresponding to R waves at different myocardial locations, The set of sensing parameters includes a set of sensing times and / or a set of sensing occurrence order; (2) if the first sensing event in the local myocardial electrocardiogram is an R wave, setting all the remaining sensing events in the local myocardial electrocardiogram to be R waves, or (3) A step of setting, when the last sensed event in the local myocardial electrocardiogram is an R wave, all sensed events in the remaining local myocardial electrocardiograms to be R waves.

[0079] Of course, the above setting contents may be further adjusted or more setting contents may be added according to the needs of the actual scene.

[0080] Hereinafter, a concrete description will be given of the realization principle of determining whether or not a sensing event in a local myocardial electrocardiogram is an R wave.

[0081] The step of determining whether the sensed event LS is an R-wave or not involves two stages: a set-up period and an operational period.

[0082] The pulse stimulation system for a single myocardial point electrode has a preset electrocardiogram (e.g., ECG) and one electrode lead connected to the ventricle, which is used for sensing R-waves and for delivering pulse stimulation to the myocardium. The following parameters need to be measured during a preset period:

[0083] Set-up period: (11) ECG Sensing (GS) = the time when ECG (R wave) sensing occurred (total sensing), Here, the ventricular electrical activity (electrical activity of the entire ventricle) of the R wave in the electrocardiogram ECG is preset, and the R wave sensing reflects a relatively early time of the ventricular electrical activity. (12) EGM sensing (LS) = the time when EGM (R wave) sensing occurred (local sensing), Here, LS is the first sensed local electrocardiogram sensing event after the reference time start point corresponding to GS (GS-X, X=60 ms, programmable, the range includes but is not limited to 30 ms to 200 ms). (13) GLSD=LS-GS, the time delay between GS and LS; (14) LPD = time delay from LS to pulse stimulation, (15) GPD = GLSD + LPD, the time delay from GS to pulse stimulation; (16) GVT is the sensing time window (programmably set and adjusted) of the corresponding GS, LSVT is the sensing time window corresponding to the LS, Specifically, the start time of GVT is GVT -S and the time window duration is B, a1) GVT -S =GS-A, GLSD>0 (i.e. LS is slower than GS), GVT -S =GS+GLSD-A, GLSD≦0 (i.e., LS is earlier than GS or is simultaneous with GS), where the default value of A is 20 ms, and A is programmable (including 0 ms). At this time, GVT -S must be obtained using time parameters corresponding to GS and LS. b1) For sinus rhythm, B includes, but is not limited to, a range of 30 ms to 130 ms (programmable). c1) For ventricular ectopic activation, e.g., PVCs, ventricular pacing, etc., B includes, but is not limited to, a range of 30 ms to 250 ms (programmable). LSVT -S =LS-A, LSVT-B=B-(LSVT -S -GVT -S ), Note that LSVT is used only when there are electrodes in multiple local myocardium, and the LS is LS1, which corresponds to the sensing event that occurs earliest in all myocardial regions. 17) As shown in FIG. 7, GPT is the pulse transmission time window of the corresponding GS, and LSPT is the pulse transmission time window of the corresponding LS (programmably set and adjusted); Specifically, the GPT start time GPT -S =GVT -SThe window duration specifically includes, but is not limited to, a range of 20 ms to 200 ms (programmable) (default is 130 ms). LSPT start time LSPT -S =LSVT -S , the window duration is the GPT window duration minus GLSD. In addition, GVT -S Presets for ECG Far Field Sensing GS Scene, LSVT -S As described above, the scene includes the scene of the local sensing LS in the local myocardial electrocardiogram corresponding to A (ie, when A=0 ms). It should be noted that all of the above parameters should be calculated by averaging over several cardiac cycles (e.g., six cardiac cycles, or programmable, other number of cardiac cycles), and the preset periods should be taken over periods of sinus cardiac electrical activity, ventricular escape electrical activity, and ventricular pacing, etc. As shown in FIG. 7, for a single-electrode lead stimulation system, LSPT is the pulse delivery time window of the corresponding LS, and the start of the window is LSVT -S and its window duration is the GPT window duration (B) minus GLSD, both of which are pulse emission time windows with LS as the trigger point (reference point) for pulse stimulation emission. Note that LSPT is used only when there are electrodes in multiple local myocardium, and LS is LS1, that is, it corresponds to the sensing event with the earliest occurrence time in all myocardial regions. In this case, the starting point of GPT must also be obtained using the time parameter corresponding to LS. Moreover, the time windows such as GVT, GPT, LSVT and LSPT in this embodiment are all described by these two parameters, which are the corresponding window start point and window duration.

[0084] Operational period: (18) LS is a real-time local R-wave sensing system that satisfies the following conditions: a2) There are two preset sensing events: ECG (GS) and local EGM (LS). where LS is the second sensing time of the first sensed local electrocardiogram sensing event after the reference time start point corresponding to GS (GS-X, X=60 ms, programmable, the range includes but is not limited to 30 to 200 ms); b2) The LS falls within the GVT (i.e., the sensing time window). (19) Whether pulse stimulation time is an appropriate criterion; a3) The pulse stimulation time falls within the GPT (pulse transmission time window). Here, GVT and GPT are derived from corresponding ventricular cardiac electrical activity during a preset period, such as sinus cardiac electrical activity, ventricular escape electrical activity, or ventricular pacing. For a multi-electrode pulse stimulation system, a preset electrocardiogram and multiple leads are connected to multiple ventricular muscle sites in the pulse stimulation system to sense R-waves and deliver pulse stimulation to local myocardium. The following parameters need to be measured during a preset period:

[0085] Set-up period: (21) Similar to (11)-(19) above, where all parameters corresponding to each stimulation electrode are measured and obtained (as some program-controlled numbers further include achieving all parameters together with the measurement numbers). (22) Pre-form a template corresponding to LSn (which is local R-wave sensing), which includes information such as the time of LSn (n=1, 2, 3, ...) relative to LS1, and the order in which sensing occurred at each electrode.

[0086] Operational period: (23) During the operation period, GS and LSn are obtained in real time. (24) Using the rules in step (18) above, check for true R waves for LSn. Alternatively, if LS1 is confirmed to be a true R-wave in step (18) above, then LSn (n=2, 3, ...) is assumed to be a true R-wave (if LSn occurs within the GVT window). Alternatively, if LS1 is confirmed as a true R wave in step (18) above, and LSn (n=2, 3, ...) matches a preset template, then LSn (n=2, 3, ...) is confirmed independently as a true R sensing. Or, when LS1 is used as a reference, the sensing time window is LSVT, and it is determined whether LSn (n=2, 3, . . . ) is within the LSVT time window.

[0087] As shown in FIG. 8, for the multiple electrode lead stimulation system to be in a set period, when LS1 is used as a reference, the pulse delivery time window is LSPT. During the operating period, after each LS is determined to be R-wave sensing, the corresponding pulse emission time should be within the GPT window, and when LS1 is used as the trigger point (reference point) of the pulse emission time window, the emission time of LSn (n>1) is within the LSPT window.

[0088] In addition, in single-electrode and multi-electrode pulse stimulation systems, the delivery time of each myocardial site pulse stimulation is after the local myocardial sensing time, for example, 40 ms later. GPT or LSPT is a new requirement for the pulse stimulation delivery time, especially for the situation where pulse stimulation is delivered at multiple stimulation sites, and the delivery time of each stimulation site must be within the GPT or LSPT time window, that is, within the delivery possible period of the entire ventricle of the same heartbeat (ventricular excitation) (not only the delivery possible period of the local ventricular muscle at the electrode site).

[0089] GVT / LSVT is the R-wave sensing time window of "whole ventricle" or "far-field ventricle" to determine whether LS is the R-wave sensing of local ventricular depolarization corresponding to GS (i.e., corresponding to the R-wave sensing of "whole ventricle" or "far-field" of ventricular depolarization). GPT / LSPT is the pulse delivery possible time window (delivery possible period corresponding to the whole ventricular muscle ("whole ventricle" or "far-field ventricle") as the safe area of ​​stimulation delivery), and is used to determine whether the pulse stimulation delivery time corresponding to LS is safe. GPT and GVT are independent, and the two parameters can be programmed respectively to meet the configuration requirements of the actual parameters. Of course, to reduce the complexity of the program control, the doctor may select similar values ​​(if appropriate) for both. Also, the system can directly pre-give similar values ​​to the two parameters, but it is necessary to maintain the function of programming the two parameters respectively. These two steps may be used together or separately.

[0090] In addition, instead of first setting the preset period and then setting the operating period (i.e., specifically executing and using the operating period depending on the numbers obtained in the preset period), the above parameters can be directly obtained and used each time ventricular myoelectrical activity occurs during the operating period (each cardiac cycle), without having to rely on the preset period, thereby greatly improving the flexibility and efficiency of the pulse stimulation control process.

[0091] In this embodiment, the pulse stimulation is sent only after the R wave, and the analysis processing can be performed on the sensing event in the local myocardial electrocardiogram of the myocardium in a timely manner, and the erroneous sensing event is automatically and accurately screened and determined to belong to an interference signal such as a T wave, not an R wave signal corresponding to the R wave in the preset electrocardiogram, and at this time, the pulse stimulation is controlled not to be sent to the corresponding myocardial position, ensuring that the pulse stimulation is not sent in the case of an error, effectively avoiding the risk of inducing VT or VF, and thus avoiding causing unnecessary pain to the patient and even safety concerns, ensuring the safety of the patient, improving the reliability of the pulse stimulation control, and also ensuring that the pulse stimulation is sent in a timely manner when it is determined to be an R wave, that is, the pulse stimulation is sent only when it is correct.

[0092] In addition, the timeliness, safety, and effectiveness of the pulse stimulation to the patient's heart are guaranteed by transmitting pulse stimulation only within the ventricular transmittable period and by confirming that the pulse stimulation transmission time falls within the pulse transmission window corresponding to the cardiac electrical activity (R wave) of the entire ventricle in the body surface electrocardiogram or the internal far-field myocardial electrocardiogram. Here, for the safety of the pulse stimulation transmission time, obtaining transmittable period information of the ventricular cardiac electrical activity in the body surface electrocardiogram or the far-field myocardial electrocardiogram also means active improvement of the pulse stimulation technology, and further guarantees the safety, effectiveness, and therapeutic effect of the pulse stimulation to the patient.

[0093] Example 3 As shown in FIG. 9, the pulse stimulation control device of this embodiment includes: A first sensing time acquisition module 1 for acquiring a first sensing time of an R wave in a preset electrocardiogram, The preset electrocardiogram includes, but is not limited to, a body surface electrocardiogram ECG, an internal far-field myocardial electrocardiogram Far-Field Electrogram, and the first sensing time is also called GS; a sensed event determination module 2 for determining a sensed event in a local myocardial electrocardiogram corresponding to the set myocardial location based on the first sensed time; a second sensing time acquisition module 3 for acquiring a second sensing time corresponding to the sensing event; Here, the second sensing time corresponding to the sensing event in the local myocardial electrocardiogram is also referred to as LS.

[0094] The sensing event in the local myocardial electrocardiogram is a sensing event that corresponds to the R wave of the preset electrocardiogram.

[0095] the first judgment module 4 is used to determine that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram when the second sensing time does not satisfy the first preset condition, and to call the control module 5; The control module 5 is used to control not to send pulse stimulation to the stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to a sensing event.

[0096] In one possible implementation, the first judgment module 4 is further used to obtain a sensing time window corresponding to an R wave in the preset electrocardiogram, and the first judgment module 4 is further used to determine that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram if the second sensing time does not fall within the sensing time window.

[0097] Here, the method of acquiring the sensing time window includes, but is not limited to, acquiring the sensing time window based on a pre-installed sensing circuit and acquiring the sensing time window by inputting the sensing time window from an external device and directly receiving the sensing time window.

[0098] The non-R wave signal corresponding to the sensing event LS in the local myocardial electrocardiogram includes a T wave signal or other interference signals, etc. Specifically, the pulse stimulation is a CCM stimulation, and the realization of the pulse stimulation can be performed in the context of different ventricular electrical activity, which improves the usable range of the pulse stimulation and greatly improves the overall effectiveness of the pulse stimulation control.

[0099] CCM stimulation occurs during ventricular electrical activity such as sinus beats, ventricular beats caused by atrial subconduction, ventricular beats caused by the ventricle (ventricular ectopic activation), and ventricular-paced beats.

[0100] By verifying that the local sensing event is an R wave, it can better ensure that CCM stimulation is triggered by the local R wave rather than being triggered by other signals (e.g., T waves, electromyography, or other non-myocardial depolarization electrical activity), effectively eliminating the occurrence of false triggering situations; this key part of the design can effectively improve the safety and efficacy of pulse stimulation.

[0101] The principle of realizing the pulse stimulus control device of this embodiment is similar to the pulse stimulus control method of the first embodiment, so a detailed description thereof will be omitted here.

[0102] In this embodiment, analysis processing can be performed in a timely manner on the sensing events in the local myocardial electrocardiogram of each heartbeat, and the erroneous sensing events can be automatically and accurately screened to determine that they belong to an interference signal, such as a T wave, rather than an R wave signal corresponding to the R wave in the preset electrocardiogram. At this time, control is performed to prevent pulse stimulation from being sent to the corresponding myocardial position, ensuring that pulse stimulation is not sent in an erroneous case, effectively avoiding the risk of inducing VT or VF, avoiding causing unnecessary pain to the patient and even safety concerns, ensuring the safety of the patient, improving the reliability of the pulse stimulation control, and ensuring the safety, effectiveness and therapeutic effect of pulse stimulation for the patient.

[0103] Example 4 As shown in FIG. 10, the pulse stimulation control system of this embodiment is a further improvement of the third embodiment. Specifically, In one possible implementation, the sensing event determination module 2 of this embodiment includes: a time reference start point obtaining unit 6 for taking the first sensing time as a first time point and taking a time point corresponding to a first setting duration before the first time point as a time reference start point; a sensed event determining unit 7 for obtaining a sensed event in a local myocardial electrocardiogram corresponding to the set myocardial location based on the time reference starting point.

[0104] In one possible implementation, the first judgment module 4 is further used to determine that the sensing event is an R wave when the second sensing time falls within the sensing time window.

[0105] In one possible embodiment, the pulse stimulation control system of this embodiment further comprises: and a pulse delivery time determination module 8 for determining a pulse delivery time corresponding to a stimulation electrode at a set myocardial position based on a second sensing time of the R wave in the local myocardial electrocardiogram after the sensing event is an R wave.

[0106] In this embodiment, the method for determining that a sensing event is an R wave is to directly acquire the information by transmitting the information from an external device, or to determine that the information falls within a sensing time window.

[0107] Specifically, the pulse delivery time determination module 8 is used to calculate the pulse delivery time corresponding to the stimulation electrode at the set myocardial position according to the second sensing time of the R wave in the local myocardial electrocardiogram and the preset duration.

[0108] Alternatively, the pulse delivery time determination module 8 is used to obtain a first sensing time corresponding to an R wave in a preset electrocardiogram, calculate a time difference value between the first sensing time and a second sensing time of a set myocardial position, and calculate a pulse delivery time corresponding to the set myocardial position according to the time difference value and the preset duration, with the first sensing time as the reference zero point.

[0109] The second judgment module 9 is used to judge whether the pulse delivery time satisfies a second preset condition, and if so, to call the decision module to decide to deliver a pulse stimulation to the stimulation electrode at the set myocardial position, and if not, to call the decision module to decide not to deliver a pulse stimulation to the stimulation electrode at the set myocardial position.

[0110] A sensing event whose local myocardial sensing time is within a sensing time window corresponding to an R wave in a preset electrocardiogram is determined to belong to a local myocardial R wave signal corresponding to an R wave in a preset electrocardiogram, and only when determined as an R wave, a pulse stimulus is ensured to be delivered in a timely manner, thereby ensuring the timeliness, safety and effectiveness of the pulse stimulus to the patient's heart.

[0111] In one possible embodiment, the second judgment module 9 of this embodiment includes: to obtain a pulse delivery window corresponding to an R wave in a preset electrocardiogram; Here, the pulse transmittable time window is set corresponding to the sensing time window by a pulse time window acquisition unit 10; a judgment unit 11 for calling the control module 5 when the pulse delivery time falls within the pulse delivery possible time window, and controlling the pulse stimulation to be delivered to the stimulation electrode at the set myocardial position within the pulse delivery time; The judgment unit 11 is further used to call the control module 5 and control not to deliver the pulse stimulation to the stimulation electrode at the set myocardial position if the pulse delivery time does not fall within the pulse delivery possible time window.

[0112] In one possible solution, when there are multiple set myocardial positions, the control module 5 of this embodiment is used to control the first judgment module 4 according to the second sensing time sequence of the occurrence of sensing events in each local myocardial electrocardiogram to sequentially judge whether the corresponding second sensing time falls within the sensing time window.

[0113] Here, the sensing time window is determined according to a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to a first occurring sensing event.

[0114] In one possible implementation, when there are multiple preset myocardial locations, the control module 5 of this embodiment is used to preset preset sensing parameters corresponding to R waves at different preset myocardial locations; wherein the set of sensing parameters includes a set of sensing times and / or a set of sensing occurrence sequences; Or, If the first sensing event in the local myocardial electrocardiogram is an R wave, all the remaining sensing events in the local myocardial electrocardiograms are set to be R waves; Or, If the last sensing event in the local myocardial electrocardiogram is an R wave, all the remaining sensing events in the local myocardial electrocardiograms are set to be R waves.

[0115] The operating principle of the pulse stimulus control device of this embodiment is similar to the realization principle of the pulse stimulus control in the second embodiment, so a detailed description thereof will be omitted here.

[0116] In this embodiment, the pulse stimulation is sent only after the R wave, and the analysis processing can be performed on the sensing event in the local myocardial electrocardiogram of the myocardium in a timely manner, and the erroneous sensing event is automatically and accurately screened and determined to belong to an interference signal such as a T wave, not an R wave signal corresponding to the R wave in the preset electrocardiogram, and at this time, the pulse stimulation is controlled not to be sent to the corresponding myocardial position, ensuring that the pulse stimulation is not sent in the case of an error, effectively avoiding the risk of inducing VT or VF, and thus avoiding causing unnecessary pain to the patient and even safety concerns, ensuring the safety of the patient, improving the reliability of the pulse stimulation control, and also ensuring that the pulse stimulation is sent in a timely manner when it is determined to be an R wave, that is, the pulse stimulation is sent only when it is correct.

[0117] In addition, the timeliness, safety, and effectiveness of the pulse stimulation to the patient's heart are guaranteed by transmitting pulse stimulation only within the ventricular transmittable period and by confirming that the pulse stimulation transmission time falls within the pulse transmission window corresponding to the cardiac electrical activity (R wave) of the entire ventricle in the body surface electrocardiogram or the internal far-field myocardial electrocardiogram. Here, for the safety of the pulse stimulation transmission time, obtaining transmittable period information of the ventricular cardiac electrical activity in the body surface electrocardiogram or the far-field myocardial electrocardiogram also means active improvement of the pulse stimulation technology, and further guarantees the safety, effectiveness, and therapeutic effect of the pulse stimulation to the patient.

[0118] Example 5 The medical system ECS of this embodiment is the pulse stimulation control device in the third or fourth embodiment.

[0119] The myocardial global depolarization (R-wave and corresponding GS) includes, but is not limited to, that derived from a surface ECG (surface ECG electrodes attached on the skin) or a far-field ECG (FF-EGM, electrodes close to the heart or electrodes on internal tissues or organs far from the heart but subcutaneously located). This allows the ECS system to be used in many machines or devices provided for cardiac treatment, such as AED, MCS (mechanical circulatory support), subQ-ICD, implantable CRM (cardiac rhythm management) machines, etc. Also, the ECS can be not only an acute support machine (where the surface ECG can be one of the input signals) but also a chronic heart failure treatment machine, but the surface ECG cannot always be used as an input for the machine. This allows the ECS system to provide treatment to more patients in more scenes, and more patients will benefit. The medical system of the present embodiment allows pulse stimulation to be delivered during sinus rhythm, atrially transmitted ventricular rhythm, or other ventricular ectopic rhythm, which is a breakthrough or improvement over the current limitation that pulse stimulation cannot be delivered in the situations of non-normal cardiac conduction system rhythms, such as sinus rhythms, ventricular rhythms caused by atrial subconduction, ventricular rhythms caused by ventricular ectopic activation, and ventricular paced rhythms, etc. This provides more support opportunities for the heart, especially when the patient needs such support the most.

[0120] The above-mentioned pulse stimulation control device is integrated and installed in the medical system of this embodiment, which helps to prevent pulse stimulation from being sent out in an incorrect case and sends out pulse stimulation only when it is correct, and sends out pulse stimulation within the sendable period corresponding to the R wave in the body surface electrocardiogram and the body far-field myocardial electrocardiogram, thereby ensuring the timeliness and effectiveness of the pulse stimulation to the patient's heart, ensuring the safety, efficacy and therapeutic effect of the pulse stimulation to the patient, and effectively improving the overall product performance of the existing medical system.

[0121] Example 6 Fig. 11 is a schematic structural diagram of an electronic device provided in Example 6 of the present invention. The electronic device includes a memory, a processor, and a computer program stored in the memory and executed on the processor, and when the program is executed by the processor, the pulse stimulation control method in Example 1 or 2 is realized. The electronic device 30 shown in Fig. 11 is merely one example and does not limit the functions and scope of use of the embodiments of the present invention.

[0122] 11, the electronic device 30 may be embodied in the form of a general-purpose computing device, for example, a server device. The components of the electronic device 30 may include, but are not limited to, at least one processor 31 as described above, at least one memory 32 as described above, and a bus 33 that couples different system components (including the memory 32 and the processor 31).

[0123] The bus 33 includes a data bus, an address bus, and a control bus.

[0124] The memory 32 may include volatile memory, such as random access memory (RAM) 321 and / or cache memory 322 , and may further include read only memory (ROM) 323 .

[0125] The memory 32 may further include a program / utilities 325 having a set (at least one) of program modules 324, including, but not limited to, an operating system, one or more application programs, other program modules, and program data, each of which, or some combination thereof, in examples, may include implementing a network environment.

[0126] The processor 31 executes a computer program stored in the memory 32 to apply each function and process data, for example, the pulse stimulation control method in the first or second embodiment of the present invention.

[0127] The electronic device 30 may also communicate with one or more external devices 34 (e.g., keyboard, pointing device, etc.). Such communication may occur via an input / output (I / O) interface 35. The model generating device 30 may then further communicate with one or more networks (e.g., a local area network (LAN), a wide area network (WAN), and / or a public network such as the Internet) via a network adapter 36. As shown in FIG. 11, the network adapter 36 communicates with other modules of the model generating device 30 via a bus 33. Although not shown, it will be understood that other hardware and / or software modules may be used in combination with the model generating device 30, including, but not limited to, microcode, device drivers, redundant processors, external disk drive arrays, RAID (disk array) systems, tape drives, and data backup storage systems.

[0128] It should be noted that although the above detailed description refers to several units / modules or sub-units / modules of an electronic device, such division is merely exemplary and not mandatory. Indeed, depending on the embodiment of the present invention, features and functions of two or more units / modules described above may be embodied in one unit / module. Conversely, features and functions of one unit / module described above may be further divided to be embodied by multiple units / modules.

[0129] Example 7 This embodiment provides a computer-readable storage medium having a computer program stored thereon. When the program is executed by a processor, the steps of the pulse stimulation control method in the first or second embodiment are realized.

[0130] Here, the readable storage medium may more specifically include, but is not limited to, a portable disk, a hard disk, a random access memory, a read-only memory, an erasable programmable read-only memory, an optical storage device, a magnetic storage device, or any suitable combination of the above.

[0131] In a possible embodiment, the present invention may be implemented in the form of a program product including program code, and when the program product is executed on a terminal device, the program code is used to cause the terminal device to perform the implementation of the steps of the pulse stimulation control method in Example 1 or 2.

[0132] Here, program code for carrying out the invention may be written in any combination of one or more program design languages, and the program code may run entirely on the user equipment, partially on the user equipment, as a single separate software package, partially on the user equipment and partially on the remote equipment, or entirely on the remote equipment.

[0133] Although the specific embodiments of the present invention have been described above, those skilled in the art will understand that these are merely examples, and the scope of protection of the present invention is subject to the scope of the accompanying claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principle and essence of the present invention, and all such changes and modifications fall within the scope of protection of the present invention.

Claims

1. Obtaining a first sensing time of an R wave in a preset electrocardiogram; determining a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position based on the first sensing time, and acquiring a second sensing time corresponding to the sensing event; If the second sensing time does not satisfy a first preset condition, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling not to deliver a pulse stimulation to a stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event. A pulse stimulation control method comprising:

2. When the second sensing time does not satisfy a first preset condition, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling not to transmit a pulse stimulation to a stimulation electrode at the set myocardial position, obtaining a sensing time window corresponding to an R wave in the preset electrocardiogram; If the second sensing time does not fall within the sensing time window, determining that the sensing event is not an R wave signal corresponding to an R wave in the preset electrocardiogram, and controlling not to deliver a pulse stimulation to a stimulation electrode at the preset myocardial position.

2. The pulse stimulation control method according to claim 1 .

3. The step of determining a sensed event in a local myocardial electrocardiogram corresponding to a set myocardial location based on the first sensed time includes: determining the first sensing time as a first time point and a time point corresponding to a first set duration before the first time point as a time reference starting point; and acquiring a sensing event in a local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point.

3. The pulse stimulation control method according to claim 1 or 2.

4. The method comprises: determining that the sensed event is an R wave when the second sensed time falls within the sensing time window. A pulse stimulation control method according to at least one of claims 1 to 3.

5. The pulse stimulation control method includes: After the sensing event is an R wave, determining a pulse delivery time corresponding to a stimulation electrode at the set myocardial position based on the second sensing time of an R wave in the local myocardial electrocardiogram; The method further includes the steps of: determining whether the pulse delivery time satisfies a second preset condition; if so, determining to deliver a pulse stimulus to a stimulation electrode at the set myocardial position; and if not, determining not to deliver a pulse stimulus to a stimulation electrode at the set myocardial position. A pulse stimulation control method according to at least one of claims 1 to 4.

6. The step of determining whether the pulse delivery time satisfies a second preset condition, and if so, determining to deliver a pulse stimulus to a stimulation electrode at the set myocardial position, and if not, determining not to deliver a pulse stimulus to a stimulation electrode at the set myocardial position, Obtaining a pulse transmittable time window corresponding to an R wave in the preset electrocardiogram; wherein the pulse transmittable time window is set corresponding to the sensing time window; When the pulse delivery time falls within the pulse delivery possible time window, a control step is performed so that a pulse stimulus is delivered to a stimulation electrode at the set myocardial position during the pulse delivery time; and controlling not to deliver a pulse stimulus to a stimulation electrode at the set myocardial position if the pulse delivery time does not fall within the pulse delivery possible time window.

6. The pulse stimulation control method according to claim 5.

7. In the case of multiple set myocardial locations, the method further comprises: The method further includes a step of sequentially determining whether the corresponding second sensing time falls within the sensing time window according to an order of the second sensing times at which the sensing events occur in each of the local myocardial electrocardiograms; Here, the sensing time window is determined according to the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event that occurs first. A pulse stimulation control method according to at least one of claims 2 to 6.

8. In the case of multiple set myocardial locations, the method further comprises: Presetting sensing parameters of different sets corresponding to sensing times at different sets of myocardial locations; wherein the set sensing parameters include set sensing times and / or set sensing occurrence sequences; or A step of setting, when a first sensed event in the local myocardial electrocardiogram is an R wave, all other sensed events in the remaining local myocardial electrocardiograms are R waves; or and further comprising a step of setting, when the last-appearing sensing event in the local myocardial electrocardiogram is an R wave, all remaining sensing events in the local myocardial electrocardiogram are R waves. A pulse stimulation control method according to at least one of claims 1 to 7.

9. the preset electrocardiograms include a surface electrocardiogram and / or an internal far-field myocardial electrocardiogram; and / or the pulse transmittable time window and the sensing time window are determined based on the preset electrocardiogram.

8. The pulse stimulation control method according to claim 6 or 7.

10. The step of determining a pulse transmission time corresponding to a stimulation electrode at the set myocardial position based on the second sensing time of an R wave in the local myocardial electrocardiogram includes: calculating the pulse delivery time corresponding to the stimulation electrode at the set myocardial position according to the second sensing time of an R wave in the local myocardial electrocardiogram and a preset duration; Or, calculating a time difference value between the first sensing time corresponding to an R wave in the preset electrocardiogram and the second sensing time at the set myocardial position; and calculating the pulse delivery time corresponding to the set myocardial position according to the time difference value and a preset duration, using the first sensing time as a reference zero point.

6. The pulse stimulation control method according to claim 5.

11. The pulse stimulus is a CCM stimulus, Here, the CCM stimulus is delivered during at least one of ventricular electrical activity including sinus beats, ventricular beats resulting from atrial subconduction, ventricular beats resulting from a ventricular pacing beat, and ventricular electrical activity including at least one of ventricular subconduction, ventricular beats resulting from a ventricular pacing beat, A pulse stimulation control method according to at least one of claims 1 to 10.

12. A first sensing time acquisition module for acquiring a first sensing time of an R wave in a preset electrocardiogram; a sensed event determination module for determining a sensed event in a local myocardial electrocardiogram corresponding to a preset myocardial location based on the first sensed time; a second sensing time obtaining module for obtaining a second sensing time corresponding to the sensing event; a first judgment module for determining that the sensed event is not an R wave signal corresponding to an R wave in the preset electrocardiogram when the second sensing time does not satisfy a first preset condition, and for controlling not to deliver a pulse stimulation to a stimulation electrode at the set myocardial position; Here, the first preset condition is determined based on the first sensing time of an R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event. A pulse stimulation control device comprising:

13. A pulse stimulation control device comprising the pulse stimulation control device according to claim 12. A medical system characterized by:

14. 1. An electronic device including a memory, a processor, and a computer program stored in the memory and executed on the processor, When the computer program is executed by the processor, the pulse stimulation control method according to any one of claims 1 to 11 is realized.

1. An electronic device comprising:

15. A computer-readable storage medium having a computer program stored thereon, When the computer program is executed by a processor, the pulse stimulation control method according to any one of claims 1 to 11 is realized. A computer-readable storage medium comprising:

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