WO2023143602A1 - 脉冲刺激控制方法、装置、医疗系统、电子设备及介质 - Google Patents

脉冲刺激控制方法、装置、医疗系统、电子设备及介质 Download PDF

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WO2023143602A1
WO2023143602A1 PCT/CN2023/073806 CN2023073806W WO2023143602A1 WO 2023143602 A1 WO2023143602 A1 WO 2023143602A1 CN 2023073806 W CN2023073806 W CN 2023073806W WO 2023143602 A1 WO2023143602 A1 WO 2023143602A1
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Prior art keywords
sensing
time
myocardial
pulse
wave
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English (en)
French (fr)
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王励
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United Innomed Shanghai Ltd
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United Innomed Shanghai Ltd
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Priority to CN202380019534.6A priority Critical patent/CN118591406A/zh
Priority to JP2024545033A priority patent/JP2025504046A/ja
Priority to EP23746479.7A priority patent/EP4470601A4/en
Publication of WO2023143602A1 publication Critical patent/WO2023143602A1/zh
Priority to US18/786,707 priority patent/US20240382763A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3706—Pacemaker parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods

Definitions

  • the invention relates to the technical field of medical devices, in particular to a pulse stimulation control method, device, medical system, electronic equipment and media.
  • the medical devices with CCM cardiac contraction modulation
  • CCM cardiac contraction modulation
  • two bipolar wires are implanted into the right ventricular septum to sense the potential of the local myocardium and after sensing Pulse stimulation is issued for a certain period of time to increase the contractility of the ventricular myocardium.
  • These two bipolar electrodes are used to perceive the electrical activity of the local myocardium and the time sequence of the electrical activity. Both electric levels can be used to monitor the resusceptible period of the local myocardium (also known as the safe period, which corresponds to the absolutely unresponsive period of the local myocardium).
  • pulse stimulation or CCM stimulation
  • Pulse stimulation will only be delivered under the ventricular heartbeat (electrical activity) initiated by the atrium, and will not be issued under the heartbeat initiated by the premature ventricular or other ventricles.
  • the pulse stimulation is delivered within the rechargeable period of the local myocardium so as to be effective without causing re-depolarization of the local myocardium.
  • the energy of pulse stimulation is quite large, and such a large-energy electrical stimulation may affect the far-field myocardium other than the local myocardium that the stimulating electrode contacts, and the degree of influence varies with the design (such as shape) of the stimulating electrode located in the local myocardium.
  • the greater the distance between the stimulating electrodes, or the larger the effective area of the stimulating electrodes the greater the degree and/or scope of the possible influence on the far-field myocardium.
  • the local pulse stimulation occurs at a later site of myocardial repolarization (absolute refractory period), there may be a possibility that the pulse stimulation time falls on the action potential of the far-field myocardium that depolarizes earlier (relative to the local myocardium). After the burst period, this increases the risk of re-depolarization of this part of the myocardium, which could lead to malignant ventricular arrhythmias (VT/VF, VT or VF).
  • Existing pulse stimulation protocols deliver pulses in the interventricular septum. Atrial descent activates the ventricular muscle in this area earlier than that in other areas, such as the left ventricular side wall.
  • the pulses delivered in the interventricular septum will not fall behind the available periods in other regions, thereby reducing or avoiding the risk of triggering ventricular arrhythmias in the myocardium in these regions.
  • the excitation of the ventricle is not caused by the electrical activity transmitted from the atrium, but is caused by the electrical activity of the ventricle itself, such as premature beats, ventricular pacing, etc., then the ventricular myoelectric activity of the ventricular septum is not necessarily the ventricular myocardium.
  • the existing pulse stimulation device does not emit pulse stimulation when the ventricle is excited (ventricular ectopic excitation) caused by the non-atrial chamber.
  • the incidence of premature ventricle in heart failure patients is very high.
  • Some heart failure patients rely on ventricular pacing for a long time, including some patients who have been taking beta-blockers for a long time and their heart rate is reduced, patients with single-chamber ICD, and CRT (cardiac resynchronization therapy) patients.
  • the positive effect of pulse stimulation on the myocardium may thus be substantially reduced in these patients.
  • myocardial stimulation electrodes placed in other parts of the ventricle such as places other than the interventricular septum
  • the incidence of similar risks to the above-described scenarios may be higher.
  • the pulse stimulation sent to the stimulating electrode at the current myocardial position can be directly controlled after a certain period of time; however, if a certain myocardial position Misperception of the local myocardial ECG at the location, the perceived event is a T wave or other events (such as interference signals), and the pulse stimulation is performed after the T wave, which will significantly increase the risk of inducing malignant ventricular arrhythmia VT or VF, thereby increasing the risk of patients life-threatening and cause additional pain stimulation to the patient.
  • the technical problem to be solved by the present invention is to overcome the existence of the pulse stimulation scheme in the prior art and determine the delivery of pulse stimulation to the corresponding myocardium directly based on the local myocardial electrocardiogram of a certain myocardial position.
  • Risks such as ventricular arrhythmia VT or VF, and only send pulse stimulation in the atrial septum when the ventricular electrical activity is transmitted from the atrium, but cannot send pulses in the ventricular electrical activity caused by the ventricle itself
  • the purpose is to provide a pulse stimulation
  • the control method, device, medical system, electronic equipment and medium can place the pulse stimulating electrodes at different positions of the ventricle (such as the left ventricle wall) or multiple positions, so as to achieve a better effect of enhancing the contraction force of the heart, and at the same time In this process, the risk of inducing ventricular arrhythmia is ensured to be reduced to a minimum, which effectively guarantees the safety and therapeutic effect of pulse stimulation to patients.
  • the invention provides a pulse stimulation control method, the method comprising:
  • the sensing event is not an R wave signal corresponding to the R wave in the preset ECG, and the control does not set the myocardial position
  • the stimulating electrode at the place emits pulse stimulation
  • the first preset condition is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.
  • the control does not control the Set the stimulation electrodes at the location of the myocardium to deliver pulse stimulation, including:
  • the control does not Stimulating electrodes at a certain location of the myocardium emit pulse stimulation.
  • determining the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position includes:
  • a sensing event in a local myocardial electrocardiogram corresponding to the set myocardial position is acquired.
  • the method also includes:
  • the sensing event is an R wave.
  • the pulse stimulation control method also includes:
  • the sensing event is an R wave
  • the pulse time window that can be issued is set corresponding to the sensing time window
  • the control does not deliver pulse stimulation to the stimulation electrode at the set myocardial position.
  • said method when there are multiple said set myocardial positions, said method also includes:
  • the sensing time window is determined according to the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event that occurs first.
  • said method when there are multiple said set myocardial positions, said method also includes:
  • said setting the sensing parameters includes setting the sensing time and/or setting the sensing occurrence sequence; or,
  • the preset electrocardiogram includes body surface electrocardiogram and/or in vivo far-field myocardial electrocardiogram;
  • the dispensable pulse time window and the sensing time window are determined based on the preset electrocardiogram.
  • the determining the pulse emission time corresponding to the stimulating electrode at the set myocardial position based on the second sensing time of the R wave in the local myocardial electrocardiogram includes:
  • the pulse delivery time corresponding to the set myocardial position is calculated according to the time difference and the preset duration.
  • the pulse stimulation is CCM stimulation
  • the CCM stimulation can be released during at least one of the following ventricular electrical activities:
  • Sinus beats ventricular beats from atrial origin, ventricular beats from ventricles, and ventricular paced beats.
  • the present invention also provides a pulse stimulation control device, said device comprising:
  • the first sensing time acquisition module is used to acquire the first sensing time of the R wave in the preset electrocardiogram
  • a sensing event determination module configured to determine a sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the first sensing time
  • a second sensing time acquisition module configured to acquire a second sensing time corresponding to the sensing event
  • a first judging module configured to determine that the sensing event is not an R-wave signal corresponding to an R-wave in the preset ECG when the second sensing time does not meet the first preset condition, and control Not sending pulse stimulation to the stimulation electrodes at the set myocardial position;
  • the first preset condition is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.
  • the present invention also provides a medical system, which includes the above pulse stimulation control device.
  • the present invention also provides an electronic device, which includes a memory, a processor, and a computer program stored in the memory and operable on the processor.
  • the processor implements the above pulse stimulation control method when executing the computer program.
  • the present invention also provides a computer-readable storage medium, on which a computer program is stored, and when the computer program is executed by a processor, the above pulse stimulation control method is realized.
  • the sensing events in the local myocardial ECG of the myocardium can be analyzed and processed in time, and the mis-sensing events can be automatically and accurately checked out, and it is determined that it is not consistent with the preset
  • the R wave signal corresponding to the R wave in the electrocardiogram belongs to the interference signal such as T wave.
  • the control does not send pulse stimulation to the corresponding myocardial position, so as to ensure that pulse stimulation is not issued under wrong circumstances, effectively reducing or avoiding the induction of VT or VF
  • the control does not send pulse stimulation to the corresponding myocardial position, so as to ensure that pulse stimulation is not issued under wrong circumstances, effectively reducing or avoiding the induction of VT or VF
  • the control does not send pulse stimulation to the corresponding myocardial position, so as to ensure that pulse stimulation is not issued under wrong circumstances, effectively reducing or avoiding the induction of VT or VF
  • R wave that is, only when Pulse stimulation is delivered only under correct conditions.
  • FIG. 1 is a flow chart of a pulse stimulation control method according to Embodiment 1 of the present invention.
  • FIG. 2 is a first flowchart of the pulse stimulation control method according to Embodiment 2 of the present invention.
  • FIG. 3 is a second flow chart of the pulse stimulation control method according to Embodiment 2 of the present invention.
  • FIG. 4 is a third flowchart of the pulse stimulation control method according to Embodiment 2 of the present invention.
  • FIG. 5 is a fourth flowchart of the pulse stimulation control method according to Embodiment 2 of the present invention.
  • FIG. 6 is a fifth flow chart of the pulse stimulation control method according to Embodiment 2 of the present invention.
  • FIG. 7 is a schematic diagram of an electrocardiogram corresponding to R wave sensing when a single electrode lead is used in Embodiment 2 of the present invention.
  • FIG. 8 is a schematic diagram of an electrocardiogram corresponding to R wave sensing when there are multiple electrode leads in Embodiment 2 of the present invention.
  • Fig. 9 is a block diagram of a pulse stimulation control system according to Embodiment 3 of the present invention.
  • Fig. 10 is a block diagram of a pulse stimulation control system according to Embodiment 4 of the present invention.
  • FIG. 11 is a schematic structural diagram of an electronic device implementing a pulse stimulation control method according to Embodiment 5 of the present invention.
  • stimulating electrodes are set in different myocardial positions of the patient in advance (the myocardial positions where the electrodes are set can be determined or adjusted according to actual needs), and each stimulating electrode is electrically connected to implantation and/or external pulse stimulating equipment via wires to Realize control operations such as the collection of ECG signals at different myocardial positions, and the issuance of pulse stimulation to different myocardial positions.
  • the pulse stimulation scheme of the present invention can be aimed at the pulse stimulation situation of a single electrode wire, and can also be aimed at the pulse stimulation situation of multiple electrode wires, such as the ECS (Electrical Circulatory Support, electrical stimulation circulatory support) system, which provides pulse stimulation for multiple myocardial parts. Stimulation, so as to cover one or more heart chambers that most need local and overall support; while providing pulse stimulation, it can better ensure the timeliness, safety and effectiveness of the pulse stimulation provided by the system.
  • ECS Electro Circulatory Support, electrical stimulation circulatory support
  • the pulse stimulation control method of the present embodiment includes:
  • the preset electrocardiogram includes but not limited to body surface electrocardiogram ECG, in vivo far-field myocardial electrocardiogram Far-Field Electrogram (also known as FF-EGM); the first sensing time is also called GS (Global Sense, far-field sensing).
  • ECG body surface electrocardiogram
  • Far-Field Electrogram also known as FF-EGM
  • GS Global Sense, far-field sensing
  • the second sensing time corresponding to the sensing event in the local local myocardial electrocardiogram is also called LS (Local Sense, near-field sensing).
  • the sensing event in the local myocardial electrocardiogram is the sensing event corresponding to the R wave of the preset electrocardiogram.
  • the first preset condition is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.
  • step S103 includes:
  • the manner of obtaining the sensing time window includes but is not limited to: obtaining based on a preset sensing circuit, and obtaining by inputting or receiving directly through an external device.
  • Body surface electrocardiogram ECG the corresponding signal comes from the control electrodes attached to the skin; the control electrodes here are not limited to the commonly used body surface electrocardiogram electrodes and specially designed electrodes.
  • Far-field myocardial electrocardiogram FF-EGM which represents (or reflects) the signal of the electrical activity of the whole heart, is similar to the body surface electrocardiogram.
  • the signal corresponding to the far-field myocardial electrocardiogram comes from a variety of control electrode combinations, including but not limited to electrodes that directly contact the myocardium with a large surface area (that is, significantly larger than the surface area of conventional electrodes used for myocardial electrical stimulation); electrodes that do not directly contact the myocardium but are close to the myocardium Or an electrode far away from the ventricular myocardium; or an electrode with a relatively large surface area located subcutaneously.
  • different electrode combinations correspond to: intravascular or cardiac chambers, epicardial defibrillation electrodes, subcutaneous defibrillation electrodes for a sub-Q ICD, or defibrillation electrodes for an external defibrillator such as an AED Any combination of different electrodes, etc., how these different electrodes are combined and set can be determined or adjusted according to the needs of actual use scenarios.
  • the sensing time and the corresponding sensing time window can be obtained based on single or multiple lead surface ECG, and/or one or more far-field myocardial ECG R waves, which represent the overall ventricular myocardial depolarization electrical activity.
  • the time window for distributable pulses is obtained by using part or all of the time periods.
  • 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.
  • the pulse stimulation is CCM stimulation; the pulse stimulation can be performed under different conditions of ventricular electrical activity, which improves the usable range of pulse stimulation and greatly improves the overall effectiveness of pulse stimulation control.
  • CCM stimulation occurs during the following ventricular electrical activity: sinus beat, ventricular beat from atrial origin, ventricular beat from ventricle (ectopic ventricular activation), and ventricular paced beat.
  • the locally sensed event is the R wave
  • the far-field sensing (GS) and near-field sensing (LS) of the same heartbeat are considered at the same time in this embodiment, and the far-field sensing (LS) under the same heartbeat (GS) and near-field perception (LS) to jointly determine the judgment result, which greatly reduces the possibility of misjudgment when only one kind of perception is considered, that is, far-field perception (GS) or near-field perception (LS), which leads to misjudgment.
  • the probability of triggering the pulse stimulation can effectively improve the confirmation accuracy of the sensing event (LS), further effectively avoid the pulse stimulation being issued in the wrong situation, and greatly improve the pulse stimulation of the patient. security.
  • the pulse stimulation is delivered not only during the dischargeable period of the local myocardial R wave (sensed by electrodes at this myocardial site), but also within the dischargeable period of the far-field myocardial R wave (electrical activity generated by the whole ventricular myocardium). During the delivery period, the risk of depolarization of the ventricular myocardium due to accidental activation of the pulse stimulus can be minimized or even eliminated.
  • the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in time, and the mis-sensing event can be automatically and accurately checked out, and it can be determined that it is not the R wave corresponding to the R wave in the preset electrocardiogram Signals, which belong to interference signals such as T waves, are controlled not to issue pulse stimulation to the corresponding myocardial position at this time, so as to ensure that pulse stimulation is not issued under wrong circumstances, effectively avoiding the risk of inducing VT or VF, and avoiding unnecessary harm to patients. Pain even causes safety hazards to ensure the safety of patients, improve the reliability of pulse stimulation control, and ensure the safety, effectiveness and therapeutic effect of pulse stimulation for patients.
  • the pulse stimulation control method of this embodiment is a further improvement on Embodiment 1, specifically:
  • step S102 includes:
  • step S102 it also includes:
  • the pulse stimulation control method of this implementation also includes:
  • the method of obtaining the sensing event as the R wave can be obtained directly through external device transmission, or determined based on a method such as judging that the event falls within the sensing time window.
  • S106 Determine whether the pulse delivery time satisfies the second preset condition, and if so, determine to deliver pulse stimulation to the stimulation electrode at the set myocardial position; otherwise, determine not to deliver pulse stimulation to the stimulation electrode at the set myocardial position.
  • the sensing event of the local myocardial sensing time is within the sensing time window corresponding to the R wave in the preset electrocardiogram, which belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram, and then ensures that when it is determined as the R wave
  • the pulse stimulation is issued in time only when the pulse is waved, so as to ensure the timeliness, safety and effectiveness of the pulse stimulation to the patient's heart.
  • pulse stimulation is delivered not only during the dispensable period of the local myocardial R-wave (sensed by the electrodes at this myocardium site), but also during the dispensable period of the far-field myocardial R-wave (generated by the electrical activity of the whole ventricular myocardium). It is released during the delivery period, which can minimize or even eliminate the risk of polarization of other parts of the ventricle due to the activation of pulse stimulation, which greatly guarantees the safety of pulse stimulation for patients and avoids harm to patients to the greatest extent. Unnecessary treatment risk and suffering.
  • the pulse stimulation control in this embodiment makes no matter where the stimulating electrode is in the myocardium, only in the correct situation, that is, not only the local myocardium, but also the entire ventricular myocardium, the pulse stimulation is issued, and more Ensure the safety and effectiveness of pulse stimulation; this also allows pulse stimulation to be delivered under various heartbeats when needed (including atrial-conducted ventricular heartbeats, heartbeats induced by the ventricles themselves, such as PVCs, ventricular pacing heartbeats, etc.) , to a greater extent meet the patient's demand for myocardial contractility enhancement.
  • step S105 includes:
  • the second sensing time and the preset duration of the R wave in the local myocardial electrocardiogram calculate and obtain the pulse emission time corresponding to the stimulating electrode at the set myocardial position
  • the pulse emission time corresponding to the set myocardial position is calculated according to the time difference and the preset duration.
  • the pulse delivery time GPD can be updated regularly or irregularly according to actual needs (at this time, myocardial electrical stimulation can be continued or stopped), and then myocardial electrical stimulation can be continued according to the updated trigger time to achieve a more flexible electrical stimulation effect , to meet the needs of more pulse electrical stimulation scenarios.
  • the preset duration is usually 40 ms by default, and the duration value can be fine-tuned and other update settings (ie, programmable adjustment) according to actual needs.
  • the GLSD and GPD corresponding to each set myocardial site can be measured and averaged at several self-heartbeats during the preset period (the default is 5 consecutive self-heartbeats, ranging from 3 to 12). It can also be obtained according to the measured duration of each heartbeat.
  • the GPD for each set myocardial site or position is used to trigger the timing of pulse stimulation transmission at this site or position relative to the preset electrocardiogram R-wave sensing moment.
  • the pulse release time corresponds to the time between sensing the R wave and triggering the heart pulse stimulation.
  • the transmission of the pulse stimulation at various positions or parts is triggered by the R wave induction of the body surface ECG ECG or the R wave induction of the far-field myocardial electrocardiogram FF-EGM. Then, cardiac pulse stimulation is delivered to each corresponding control electrode according to the pulse delivery time. In order to ensure the effectiveness of pulse stimulation, all R waves (i.e., R waves in far-field myocardial electrocardiogram FF-EGM and R waves in body surface electrocardiogram ECG) are perceived under the same heartbeat. Based on the above scheme for acquiring the pulse delivery time, the timeliness and reliability of the pulse stimulation can be effectively guaranteed.
  • parameters such as GLSD can be preset for different ventricular electrical activities, such as sinus (SR) ventricular electrical activity, and then in the actual operation period, the preset function can be directly called in sinus rhythm.
  • SR sinus
  • the corresponding parameters can be set regularly, so as to reduce the calculation requirements required for each heartbeat, and at the same time ensure the timeliness and effectiveness of pulse stimulation control;
  • step S106 includes:
  • the starting time points and the window durations corresponding to the two time windows of the distributable pulse time window and the sensing time window can be the same or different; that is, the two time windows of the distributable pulse time window and the sensing time window can be Set up independently, there can be no interrelationships and dependencies between each other.
  • the distributable pulse time window and the sensing time window are determined based on the preset electrocardiogram, and how to set it is adaptively adjusted according to factors such as the actual R wave sensing situation and the condition of the myocardium, so that most pulse stimulation scenarios can be covered or satisfied Just need it.
  • the control does not send pulse stimulation to the stimulation electrode at the set myocardial position.
  • the CCM stimulation must be within the release period of the local myocardial depolarization (R wave) and the release period of the far-field myocardial depolarization (R wave) in the body.
  • the pulse delivery time window corresponds to a safety period
  • the safety period corresponds to the delivery period of the whole ventricle.
  • Both the starting point and the ending point of the time window for releasing pulses are adjustable, and the target is that the starting point approximately corresponds to the depolarization zone, and the ending point is earlier than or equal to the ending point of the emitting period.
  • the pulse stimulation control method of this embodiment further includes the following steps:
  • steps S102 to S106 For the sensing event LS in the local (Local) local myocardial electrocardiogram corresponding to each myocardial position, execute steps S102 to S106 one by one, so as to timely and effectively issue pulse stimulation to each myocardial position to ensure the safety of patient treatment, Effectiveness and reliability.
  • the sensing time window is determined according to the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event that occurs first.
  • each electrode pair can be: a single-stage electrode and a single-stage electrode, a bipolar electrode and a bipolar electrode wire, a monopolar electrode and a single-stage electrode and a bipolar electrode, and a bipolar electrode wire.
  • the configuration can also be made of other types of electrodes, and what kind of electrode pair to use and how to combine the configuration can be determined or adjusted according to actual scene requirements.
  • the local myocardial heart rate corresponding to the myocardial position is obtained.
  • sensing event LS1 in the electrocardiogram obtain the second sensing time corresponding to the sensing event LS1, and judge that the second sensing time falls within the sensing time window corresponding to the R wave in the preset electrocardiogram, and When it falls, it is determined that the sensing event LS1 is not the R wave signal corresponding to the R wave in the preset ECG, but other interference signals such as T wave, and the stimulation electrode pair E1 at the myocardial position A is controlled not to be set.
  • Distribute pulse stimulation when it falls, then determine the local myocardial R wave signal corresponding to the sensing event LS1 and the preset R wave in the electrocardiogram, and then at the second sensing time corresponding to the sensing event LS1 in time and Accurately calculate the pulse release time corresponding to the stimulating electrode corresponding to the set myocardial position A; and then continue to judge whether the pulse release time falls within the pulse release time window corresponding to the R wave in the preset ECG, and if it falls, control it at Pulse delivery time Send pulse stimulation to the stimulation electrode at the set myocardial position A, otherwise it is determined not to send pulse stimulation to the stimulation electrode at the set myocardial position A, so as to complete a pulse stimulation control on the set myocardial position A.
  • the pulse stimulation control process for setting myocardial positions B and C is similar to the pulse stimulation control process for setting myocardial position A, so details will not be repeated here.
  • the different pulse stimulation control processes for setting the myocardial position are independent of each other and will not cause mutual interference or influence;
  • the pulse stimulation control at a fixed myocardial position A as long as the sensing event LS2 appears in the local myocardial ECG corresponding to the set myocardial position B, the above pulse stimulation control process can be performed separately, and finally the control of all the set myocardial positions is completed.
  • Pulse stimulation control the control operation is orderly, which effectively guarantees the safety and reliability of pulse stimulation to patients.
  • the pulse stimulation control method of this embodiment further includes the following steps:
  • the sensing events in the local myocardial electrocardiograms corresponding to the remaining myocardial positions it is judged whether the second sensing time corresponding to these sensing events falls within the above-mentioned sensing time window, if so, then after determining that the first sensing event is When the R wave signal corresponding to the R wave in the preset electrocardiogram is used, it is directly determined that the sensing event in the local myocardial electrocardiogram corresponding to the remaining myocardial position is also the R wave signal corresponding to the R wave in the preset electrocardiogram; at this time, There is no need to judge and analyze the sensing events in the local myocardial ECG corresponding to the remaining myocardial positions one by one. While achieving accurate judgment, it greatly simplifies the data analysis and processing process, effectively shortens the time-consuming data processing, and also reduces Computing power for the device Requirements, to further ensure the timeliness, accuracy and effectiveness of pulse stimulation control for patients.
  • the pulse stimulation control method of this embodiment also includes:
  • setting the sensing parameters includes setting the sensing time and/or setting the sensing occurrence sequence.
  • setting content can also be adjusted or more setting content can be added according to actual scene requirements.
  • Determining whether the sensing event LS is an R-wave involves two phases: a set-up period and an operational period.
  • ECG ECG
  • R wave R wave
  • ECG perception (GS) time when ECG (R wave) perception occurs (overall perception);
  • the ventricular electrical activity of the R wave in the electrocardiogram ECG (the overall electrical activity of the ventricle) is preset, and the perception of the R wave reflects the relatively early time of the ventricular electrical activity.
  • EGM perception (LS) time when EGM (R wave) perception occurs (local perception);
  • LPD time delay between LS and pulse stimulation
  • GPD GLSD + LPD, which is the time delay between GS and pulse stimulation
  • GVT is the sensing time window of the corresponding GS (programmable setting and adjustment);
  • LSVT is the corresponding LS The sensing time window of ;
  • the start time of GVT is GVT-s, and the time window duration is B;
  • GVT-s GS-A, GLSD>0 (that is, LS is later than GS);
  • GVT-s GS+GLSD-A, GLSD ⁇ 0 (that is, LS is earlier than GS or at the same time);
  • the default value of A is 20ms, and A is programmable setting and adjustment (including 0ms);
  • GVT-s needs to be obtained using the corresponding time parameters of GS and LS.
  • B is in the range including but not limited to, 30ms-130ms (programmable);
  • B For ventricular ectopic activation, such as PVC, ventricular pacing, etc., B includes but is not limited to, within the range of 30ms-250ms (programmable).
  • LSVT is used only when multiple local myocardium has electrodes; and LS is LS1, which corresponds to the earliest sensing event in all myocardial parts.
  • GPT is the pulse release time window of the corresponding GS
  • LSPT is the pulse release event window of the corresponding LS (programmable setting and adjustment);
  • the GPT start time GPT-s GVT-s; the window duration specifically includes, but is not limited to, the range of 20ms-200ms (programmable) (the default is 130ms).
  • the start time of LSPT LSPT-s LSVT-s, and the window duration is the window duration of GPT minus GLSD.
  • GVT-s corresponds to far-field sensing GS in the preset ECG
  • LSPT is the pulse release time window of the corresponding LS
  • the starting point of the window is LSVT-s
  • its window duration is the window duration (B) of GPT minus GLSD
  • both is the pulse release time window with LS as the trigger point (reference point) of pulse stimulation release.
  • LSPT is used only when multiple local myocardium has electrodes; and LS is LS1, which corresponds to the earliest sensing event among all myocardial parts. At this time, the starting point of GPT also needs to be obtained by using the corresponding time parameters of LS.
  • time windows such as GVT, GPT, LSVT, and LSPT in this embodiment are all described by two parameters corresponding to the starting point of the window and the length of the window.
  • LS falls within GVT (ie, sensing time window).
  • the GVT and GPT are obtained from the corresponding ventricular electrical activity in the preset period, such as sinus electrical activity, ventricular different pulse electrical activity, or ventricular pacing.
  • this pulse stimulation system there will be a preset ECG and multiple wires connected to multiple ventricular muscle sites for sensing R waves and delivering pulse stimulation to local myocardium.
  • the following parameters need to be measured during the preset period:
  • the pulse delivery time window is LSPT.
  • the corresponding pulse release time should be within the GPT window; if LS1 is used as the trigger point (reference point) of the pulse release time window, the release of LSn (n>1) Time is within the LSPT window.
  • the pulse stimulation release time relative to the respective myocardial positions is after the local myocardial sensing time, for example, 40 ms after the release.
  • GPT or LSPT is a new requirement for the timing of pulse stimulation, especially in the case of multiple stimulation sites, the timing of each stimulation site must fall within the time window of GPT or LSPT, that is, within the same heartbeat (Ventricular excitation) in the release period of the whole ventricle (not only the release period of the local ventricular muscle at the electrode site).
  • GVT/LSVT as a "whole ventricle” or "far field ventricular” R wave sensing time window, is used to judge whether the LS is corresponding to the GS (i.e. corresponding to the "whole ventricle” or "far field” of ventricular depolarization R-wave perception of local ventricular depolarization.
  • GPT/LSPT which is the time window for the release of pulses (as a safe area for stimulation release, corresponding to the release period of the whole ventricular muscle ("whole ventricle” or "far-field ventricle”)), is used to judge the pulse corresponding to LS Whether the stimulus delivery time is safe.
  • GPT and GVT are independent, and these two parameters can be programmed separately to meet the actual parameter configuration requirements.
  • the doctor can choose the same value for both (when appropriate).
  • the system can directly assign the same value to these two parameters in advance, but it is necessary to maintain the function of separate program control of these two parameters.
  • the preset period in addition to the above, set the preset period first, and then do the running period (that is, the running period depends on the number obtained during the preset period for specific execution and use).
  • the above parameters can also be obtained and used directly at each ventricular myoelectric activity (each cardiac cycle) during the running period without relying on the preset period, thereby greatly improving the flexibility and efficiency of the pulse stimulation control process.
  • pulse stimulation is only sent after the R wave, and the sensing events in the local myocardial electrocardiogram can be analyzed and processed in time, and the mis-sensing event can be automatically and accurately checked out, and it is determined that it is not consistent with the preset electrocardiogram.
  • the R wave signal corresponding to the R wave belongs to the interference signal such as the T wave.
  • pulse stimulation it is controlled not to issue pulse stimulation to the corresponding myocardial position, so as to ensure that the pulse stimulation is not issued under the wrong situation, and effectively avoid the risk of inducing VT or VF, and then Avoid causing unnecessary pain to patients or even cause safety hazards to ensure the safety of patients and improve the reliability of pulse stimulation control; at the same time, ensure that pulse stimulation is issued in time when it is determined to be an R wave, that is, only under correct conditions pulse stimulation is issued;
  • the pulse stimulation is only sent during the release period of the ventricle: by confirming that the release time of the pulse stimulation falls within the pulse release window corresponding to the overall ventricular electrical activity (R wave) of the body surface ECG or the in vivo far-field myocardial ECG, to ensure the patient’s
  • the timeliness, safety and effectiveness of pulse stimulation of the heart are important to ensure the safety of pulse stimulation transmission time. Among them, in order to ensure the safety of pulse stimulation transmission time, obtaining the release period information of ventricular electrocardiographic activity by body surface ECG or far-field myocardial Safety, efficacy and therapeutic effects of stimuli.
  • the pulse stimulation control device of this embodiment includes:
  • the first sensing time acquisition module 1 is used to acquire the first sensing time of the R wave in the preset electrocardiogram
  • the preset electrocardiogram includes but not limited to body surface electrocardiogram ECG, in vivo far-field myocardial electrocardiogram Far-Field Electrogram; the first sensing time is also called GS.
  • the sensing event determination module 2 is configured to determine the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the first sensing time;
  • a second sensing time acquisition module 3 configured to acquire a second sensing time corresponding to the sensing event
  • the second sensing time corresponding to the sensing event in the local local myocardial electrocardiogram is also called LS.
  • the sensing event in the local myocardial electrocardiogram is the sensing event corresponding to the R wave of the preset electrocardiogram.
  • the first judging module 4 is used to determine that the sensing event is not an R wave signal corresponding to the R wave in the preset electrocardiogram when the second sensing time does not meet the first preset condition, and call the control module 5;
  • the control module 5 is used to control not to issue pulse stimulation to the stimulation electrode at the set myocardial position
  • the first preset condition is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.
  • the first judging module 4 is also used to obtain the sensing time window corresponding to the R wave in the preset electrocardiogram; When it is within the window, it is determined that the sensing event is not an R-wave signal corresponding to an R-wave in a preset electrocardiogram.
  • the manner of obtaining the sensing time window includes but is not limited to: obtaining based on a preset sensing circuit, and obtaining by inputting or receiving directly through an external device.
  • 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.
  • the pulse stimulation is CCM stimulation; the pulse stimulation can be performed under different conditions of ventricular electrical activity, which improves the usable range of pulse stimulation and greatly improves the overall effectiveness of pulse stimulation control.
  • CCM stimulation occurs during the following ventricular electrical activity: sinus beat, ventricular beat from atrial origin, ventricular beat from ventricle (ectopic ventricular activation), and ventricular paced beat.
  • the locally sensed event is the R wave
  • the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in time, and the mis-sensing event can be automatically and accurately checked out, and it can be determined that it is not the R wave corresponding to the R wave in the preset electrocardiogram Signal, It belongs to interference signals such as T waves.
  • the control does not issue pulse stimulation to the corresponding myocardial position, so as to ensure that pulse stimulation is not issued under wrong circumstances, effectively avoiding the risk of inducing VT or VF, and avoiding unnecessary pain to the patient. Even cause safety hazards to ensure the safety of patients, improve the reliability of pulse stimulation control, and ensure the safety, effectiveness and therapeutic effect of pulse stimulation to patients.
  • the pulse stimulation control system of this embodiment is a further improvement on Embodiment 3, specifically:
  • the sensing event determination module 2 of this embodiment includes:
  • a time reference starting point acquisition unit 6 configured to use the first sensing time as the first time point, and use the time point corresponding to the first set duration before the first time point as the time reference starting point;
  • the sensing event determining unit 7 is configured to acquire the sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point.
  • the first judging module 4 is further configured to determine that the sensing event is an R wave when the second sensing time falls within the sensing time window.
  • the pulse stimulation control system of this embodiment also includes:
  • the pulse delivery time determination module 8 is used to determine the pulse delivery time corresponding to the stimulating electrode for setting the myocardial position based on the second sensing time of the R wave in the local myocardial electrocardiogram after the sensing event is an R wave;
  • the method of obtaining the sensing event as the R wave can be obtained directly through external device transmission, or determined based on a method such as judging that the event falls within the sensing time window.
  • the pulse delivery time determination module 8 is used to calculate the pulse delivery time corresponding to the stimulating electrode at the set myocardial position according to the second sensing time and preset duration of the R wave in the local myocardial electrocardiogram.
  • the pulse release time determination module 8 is used to obtain the first sensing time corresponding to the R wave in the preset electrocardiogram; calculate the time difference between the first sensing time and the second sensing time of the set myocardial position; Taking the first sensing time as a reference zero point, the pulse emission time corresponding to the set myocardial position is calculated according to the time difference and the preset duration.
  • the second judging module 9 is used to judge whether the pulse delivery time satisfies the second preset condition, if so, call the determination module to determine to send pulse stimulation to the stimulation electrode at the set myocardial position; otherwise, call the determination module to determine not to The stimulating electrodes at the position of the myocardium are set to deliver pulse stimulation.
  • the sensing event of the local myocardial sensing time is within the sensing time window corresponding to the R wave in the preset electrocardiogram, which belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram, and then ensures that when it is determined as the R wave
  • the pulse stimulation is issued in time only when the pulse is waved, so as to ensure the timeliness, safety and effectiveness of the pulse stimulation to the patient's heart.
  • the second judging module 9 of this embodiment includes:
  • the pulse time window acquisition unit 10 is used to acquire the pulse time window corresponding to the R wave in the preset electrocardiogram;
  • the pulse time window that can be issued is set corresponding to the sensing time window
  • the judging unit 11 is used to call the control module 5 to control the pulse stimulation to be delivered to the stimulation electrode at the set myocardial position at the pulse delivery time when the pulse delivery time falls within the pulse delivery time window;
  • the judging unit 11 is also used to call the control module 5 to control not to deliver pulse stimulation to the stimulation electrode at the set myocardial position when the pulse delivery time does not fall within the pulse delivery time window.
  • control module 5 of this embodiment is used to control the The first judging module 4 sequentially judges whether the corresponding second sensing time falls within the sensing time window.
  • the sensing time window is determined according to the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the first sensing event that occurs.
  • control module 5 of this embodiment when there are multiple set myocardial positions, the control module 5 of this embodiment is used to preset the set sensing parameters corresponding to the R waves at different set myocardial positions;
  • setting the sensing parameters includes setting the sensing time and/or setting the sensing occurrence sequence
  • the sensing event in the first local myocardial electrocardiogram is an R wave
  • the sensing events in other remaining local myocardial electrocardiograms are R waves
  • pulse stimulation is only sent after the R wave, and the sensing events in the local myocardial electrocardiogram can be analyzed and processed in time, and the mis-sensing event can be automatically and accurately checked out, and it is determined that it is not consistent with the preset electrocardiogram.
  • the R wave signal corresponding to the R wave belongs to the interference signal such as the T wave.
  • pulse stimulation it is controlled not to issue pulse stimulation to the corresponding myocardial position, so as to ensure that the pulse stimulation is not issued under the wrong situation, and effectively avoid the risk of inducing VT or VF, and then Avoid causing unnecessary pain to patients or even cause safety hazards to ensure the safety of patients and improve the reliability of pulse stimulation control; at the same time, ensure that pulse stimulation is issued in time when it is determined to be an R wave, that is, only under correct conditions pulse stimulation is issued;
  • the pulse stimulation is only sent during the release period of the ventricle: by confirming that the release time of the pulse stimulation falls within the pulse release window corresponding to the overall ventricular electrical activity (R wave) of the body surface ECG or the in vivo far-field myocardial ECG, to ensure the patient’s
  • the timeliness, safety and effectiveness of pulse stimulation of the heart are important to ensure that the release time of the pulse stimulation falls within the pulse release window corresponding to the overall ventricular electrical activity (R wave) of the body surface ECG or the in vivo far-field myocardial ECG, to ensure the patient’s
  • the timeliness, safety and effectiveness of pulse stimulation of the heart for the safety of pulse stimulation sending time
  • Obtaining the releasable period information of ventricular electrical activity by body surface electrocardiogram or far-field myocardial electrocardiogram also represents a positive improvement on pulse stimulation technology, which further guarantees the safety, effectiveness and treatment of pulse stimulation for patients Effect.
  • the pulse stimulation control device in Embodiment 3 or 4 of the medical system ECS of this embodiment is not limited.
  • Global myocardial depolarization can be derived from including but not limited to surface ECG (from surface ECG electrodes attached to the skin), or far-field myocardial ECG (FF-EGM, from close The electrode of the heart or the electrode of the tissue or organ in the body that is far away from the heart but located under the skin).
  • FF-EGM far-field myocardial ECG
  • ECS acute support device
  • ECG can be used as one of the input signals
  • the surface ECG cannot always be used as the input of the device.
  • the medical system of this embodiment enables pulse stimulation to be delivered during sinus rhythm, atrial-derived ventricular rhythm (beat), or other ventricular ectopic rhythm (beat).
  • the medical system of this embodiment is integrated with the above-mentioned pulse stimulation control device, which can support pulse stimulation not being issued under wrong conditions, but only under correct conditions.
  • the pulse stimulation can be issued within the period corresponding to the R wave to ensure the timeliness and effectiveness of the pulse stimulation to the patient's heart, ensure the safety, effectiveness and therapeutic effect of the pulse stimulation to the patient, and effectively improve the existing The overall product performance of the medical system.
  • FIG. 11 is a schematic structural diagram of an electronic device provided by Embodiment 6 of the present invention.
  • the electronic device includes a memory, a processor, and a computer program stored on the memory and operable on the processor.
  • the processor implements the pulse stimulation control method in Embodiment 1 or 2 when executing the program.
  • the electronic device 30 shown in FIG. 11 is only an example, and should not limit the functions and scope of use of this embodiment of the present invention.
  • the electronic device 30 may be in the form of a general-purpose computing device, for example, it may be a server device.
  • Components of the electronic device 30 may include, but are not limited to: at least one processor 31 , at least one memory 32 , and a bus 33 connecting different system components (including the memory 32 and the processor 31 ).
  • the bus 33 includes a data bus, an address bus, and a control bus.
  • the memory 32 may include a volatile memory, such as a random access memory (RAM) 321 and/or a cache memory 322 , and may further include a read only memory (ROM) 323 .
  • RAM random access memory
  • ROM read only memory
  • Memory 32 may also include a program/utility tool 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, which Each or some combination of the examples may include the implementation of a network environment.
  • program/utility tool 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, which Each or some combination of the examples may include the implementation of a network environment.
  • the processor 31 executes various functional applications and data processing by running the computer program stored in the memory 32, such as the pulse stimulation control method in Embodiment 1 or 2 of the present invention.
  • Electronic device 30 may also communicate with one or more external devices 34 (eg, keyboards, pointing devices, etc.). Such communication may occur through input/output (I/O) interface 35 .
  • the model generation device 30 can also communicate with one or more networks (eg, a local area network (LAN), a wide area network (WAN) and/or a public network, such as the Internet) via a network adapter 36 .
  • network adapter 36 communicates with other modules of model generation device 30 via bus 33 .
  • model generating device 30 may be used in conjunction 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.
  • This embodiment provides a computer-readable storage medium, on which a computer program is stored.
  • the program is executed by a processor, the steps in the pulse stimulation control method in Embodiment 1 or 2 are realized.
  • the readable storage medium may more specifically include but not limited to: portable disk, hard disk, random access memory, read-only memory, erasable programmable read-only memory, optical storage device, magnetic storage device or any of the above-mentioned the right combination.
  • the present invention can also be implemented in the form of a program product, which includes program code, and when the program product runs on the terminal device, the program code is used to make the terminal device execute the implementation of the embodiment 1 or 2. Steps in the Pulse Stimulation Control Method.
  • program code for executing the present invention can be written in any combination of one or more programming languages, and the program code can be completely executed on the user equipment, partially executed on the user equipment, as an independent software package execute, partly on the user device and partly on the remote device, or entirely on the remote device.

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Abstract

本发明公开了一种脉冲刺激控制方法、装置、医疗系统、电子设备及介质，该方法包括：获取预设心电图中R波的第一感测时间；确定设定心肌位置对应的局部心肌心电图中的感测事件及其第二感测时间；在第二感测时间不满足第一预设条件时，确定感测事件不是与预设心电图中R波相对应的R波信号，并控制不对应发放脉冲刺激。本发明保证了不在错误的情况下发放心脏的脉冲刺激，有效地避免诱发VT或VF的风险；保证了只有在确定为R波时才发放脉冲刺激，且在预设心电图中R波对应的可发放期内发放，保证了脉冲刺激对患者心脏的可靠性、安全性、及时性和有效性，更好地保障了对患者的脉冲刺激的安全性、有效性和治疗效果。

Description

脉冲刺激控制方法、装置、医疗系统、电子设备及介质
本申请要求申请日为2022/1/30的中国专利申请2022101141302的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及医疗器械技术领域，特别涉及一种脉冲刺激控制方法、装置、医疗系统、电子设备及介质。
背景技术
现有市场上的具有CCM(心肌收缩调节)功能的医疗装置，基本用于慢性心衰患者，一般采用两个双极导线植入右心室室间隔，用于感知局部心肌的电位和在感知后的一定时间发放脉冲刺激，以增加心室心肌收缩力。这二根双极的电极，用来感知局部心肌的电活动以及电活动的时间顺序，两个电级都可用来对局部心肌的可发放期(又称安全期，对应局部心肌的绝对不应期)内通过局部心电活动来触发脉冲刺激(或称CCM刺激)，脉冲刺激只会在心房发起的心室心跳(电活动)下发放，不会在室早或其他心室发起的心跳下发放。
脉冲刺激是在本地心肌的可发放期内发放，从而有效，同时不会引起本地心肌的再次除极。但是，脉冲刺激的能量是相当大的，如此大能量的电刺激可能会影响到刺激电极接触的本地心肌以外的远场心肌，且该影响程度随着位于本地心肌的刺激电极设计(如形状)和电极之间的距离而变化，在同样的能量下，刺激电极之间的距离越大，或刺激电极的有效面积越大，对远场心肌可能的影响程度和/或范围可能也越大。如果本地脉冲刺激是发生在心肌复极(绝对不应期内)较晚的部位，就有可能发生脉冲刺激发送时间落在较早除极(相对本地心肌)的远场心肌的动作电位的可发放期之后，这样就会增加这部分心肌产生再次除极可能而可能引起恶性室性心律失常(VT/VF，室速或室颤)的风险。现有的脉冲刺激方案是在室间隔进行脉冲发放。心房下传较早激活此区域的心室肌，早于其他区域的心室肌，比如左心室侧壁等。这样在室间隔发放的脉冲不会落在其他区域的可发放期之后，而较少或避免这些区域的心肌被触发室性心律失常的风险。但是，如果心室的激动不是由于心房下传的电活动引起的，而是由于心室自身电活动引起的，比如早搏，心室起搏等，这时室间隔的心室肌电活动就不一定是心室肌中最早的了；该情况下在室间隔上发送的脉冲电刺激有可能会落在其他区域心肌的可发放期之后，从而增加 该区域心肌被脉冲电刺激诱发出心律失常的风险。所以现有脉冲刺激装置在非心房引起的心室激动(心室异位激动)时是不发放脉冲刺激的。但是，心衰病人的室早发生率是很高的，有些心衰病人长期依赖心室起搏，其中包括有些长期服用β受体阻断剂而心率降低的病人，单腔ICD的病人，以及CRT(心脏再同步治疗)的病人。脉冲刺激在这些病人中对心肌产生的正向影响可能会因此而大幅度减少。对于心肌刺激电极放在心室其他部位(比如室间隔以外的部位)，以上描述的情景类似的风险发生率可能会更高。
现有的脉冲刺激方案中只要检测到某一心肌位置的局部心肌心电图有感知事件发生，则可以直接控制在一定时间后向当前心肌位置出的刺激电极发放的脉冲刺激；然而，如若某一心肌位置的局部心肌心电图发生误感知，感知事件是T波或其他事件(如干扰信号)，脉冲刺激在T波后进行，这样会显著增加诱发恶性室性心律失常VT或VF的风险，从而增加患者的生命危险性，且给患者造成额外的疼痛刺激。
发明内容
本发明要解决的技术问题是为了克服现有技术中从脉冲刺激方案存在直接基于某一心肌位置的局部心肌心电图有感知事件就确定发放脉冲刺激至对应心肌，在误感知时有可能导致诱发恶性室性心律失常VT或VF等风险，且只在心房下传的心室电活动时在房间隔发送脉冲刺激，而不能在心室自身引起的心室电活动发送脉冲等缺陷，目的在于提供一种脉冲刺激控制方法、装置、医疗系统、电子设备及介质，可以将脉冲刺激电极放在心室不同位置(比如左侧心室壁)或多个位置，以达到能够更好地增强对心脏收缩力的效果，同时在此过程中确保将诱发心室心律失常的风险降低降低到很小，有效地保障了对患者的脉冲刺激的安全性和治疗效果。
本发明是通过下述技术方案来解决上述技术问题：
本发明提供一种脉冲刺激控制方法，所述方法包括：
获取预设心电图中R波的第一感测时间；
基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件，并获取所述感测事件对应的第二感测时间；
在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激；
其中，所述第一预设条件基于所述预设心电图中R波的所述第一感测时间和所述感测事件对应的所述第二感测时间确定。
较佳地，在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激，包括：
获取所述预设心电图中R波对应的感测时间窗；
在所述第二感测时间未落入所述感测时间窗内时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激。
较佳地，所述基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件，包括：
将所述第一感测时间作为第一时间点，并将所述第一时间点之前的第一设定时长对应的时间点作为时间参考起点；
基于所述时间参考起点，获取所述设定心肌位置对应的局部心肌心电图中的感测事件。
较佳地，所述方法还包括：
在所述第二感测时间落入所述感测时间窗内时，则确定所述感测事件为R波。
较佳地，所述脉冲刺激控制方法，还包括：
在所述感测事件为R波后，基于所述局部心肌心电图中R波的所述第二感测时间，确定所述设定心肌位置的刺激电极对应的脉冲发放时间；
判断所述脉冲发放时间是否满足第二预设条件，若是，则确定向所述设定心肌位置处的刺激电极发放脉冲刺激；否则，确定不向所述设定心肌位置处的刺激电极发放脉冲刺激。
较佳地，所述判断所述脉冲发放时间是否满足第二预设条件，若是，则确定向所述设定心肌位置处的刺激电极发放脉冲刺激；否则，确定不向所述设定心肌位置处的刺激电极发放脉冲刺激，包括：
获取所述预设心电图中R波对应的可发放脉冲时间窗；
其中，所述可发放脉冲时间窗与所述感测时间窗相对应设置；
在所述脉冲发放时间落入所述可发放脉冲时间窗时，则控制在所述脉冲发放时间将脉冲刺激发放至所述设定心肌位置处的刺激电极；
在所述脉冲发放时间未落入所述可发放脉冲时间窗时，则控制不对所述设定心肌位置处的刺激电极发放脉冲刺激。
较佳地，当有多个所述设定心肌位置时，所述方法还包括：
按照每个所述局部心肌心电图中的所述感测事件发生的所述第二感测时间顺序，依次判断对应的所述第二感测时间是否落入所述感测时间窗内；
其中，所述感测时间窗根据所述预设心电图中R波的所述第一感测时间和第一个发生的所述感测事件对应的所述第二感测时间确定。
较佳地，当有多个所述设定心肌位置时，所述方法还包括：
预设不同的所述设定心肌位置处感测时间对应的设定感测参数；
其中，所述设定感测参数包括设定感测时间和/或设定感测发生顺序；或，
当第一个出现的所述局部心肌心电图中感测事件为R波时，则设置其他剩余的所述局部心肌心电图中感测事件均为R波；或，
当最后一个出现的所述局部心肌心电图中感测事件为R波时，则设置其他剩余的所述局部心肌心电图中感测事件均为R波。
较佳地，所述预设心电图包括体表心电图和/或体内远场心肌心电图；
和/或，
所述可发放脉冲时间窗与所述感测时间窗基于所述预设心电图确定。
较佳地，所述基于所述局部心肌心电图中R波的所述第二感测时间，确定所述设定心肌位置的刺激电极对应的脉冲发放时间，包括：
根据所述局部心肌心电图中R波的所述第二感测时间和预设时长，计算得到所述设定心肌位置的刺激电极对应的所述脉冲发放时间；
或，
计算得到所述预设心电图中R波对应的所述第一感测时间和所述设定心肌位置的所述第二感测时间之间的时间差值；
以所述第一感测时间为参考零点，根据所述时间差值和预设时长计算得到所述设定心肌位置对应的所述脉冲发放时间。
较佳地，所述脉冲刺激为CCM刺激；
其中，所述CCM刺激可以在如下至少一种心室电活动时发放：
窦性心跳、源于心房下传引起的心室心跳、源于心室的心室心跳，和心室起搏心跳。
本发明还提供一种脉冲刺激控制装置，所述装置包括：
第一感测时间获取模块，用于获取预设心电图中R波的第一感测时间；
感测事件确定模块，用于基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件；
第二感测时间获取模块，用于获取所述感测事件对应的第二感测时间；
第一判断模块，用于在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激；
其中，所述第一预设条件基于所述预设心电图中R波的所述第一感测时间和所述感测事件对应的所述第二感测时间确定。
本发明还提供一种医疗系统，所述医疗系统包括上述的脉冲刺激控制装置。
本发明还提供一种电子设备，包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序，所述处理器执行计算机程序时实现上述的脉冲刺激控制方法。
本发明还提供一种计算机可读存储介质，其上存储有计算机程序，所述计算机程序被处理器执行时实现上述的脉冲刺激控制方法。
在符合本领域常识的基础上，所述各优选条件，可任意组合，即得本发明各较佳实施例。
本发明的积极进步效果在于：
(1)只针对R波后发送脉冲刺激：本发明中，能够及时对心肌的局部心肌心电图中的感测事件进行解析处理，自动且准确排查出误感知事件，将之确定为不是与预设心电图中R波相对应的R波信号，而属于T波等干扰信号，此时控制不对相应心肌位置发放脉冲刺激，保证了不在错误的情况下发放脉冲刺激，有效地降低或避免诱发VT或VF的风险，继而避免对患者造成不必要的疼痛感甚至造成安全隐患，以确保患者的安全性，提高了脉冲刺激控制的可靠性；同时保证在确定为R波时及时发放脉冲刺激，即只有在正确的情况下才发放脉冲刺激。
(2)只在心室可发放期内发送脉冲刺激：通过确认脉冲刺激发放时间落在体表心电图或体内远场心肌心电图反映整体心室心电活动(R波)对应的可发放期内，以保证对患者心脏的脉冲刺激的及时性、安全性和有效性。其中，为了确保脉冲刺激发送时间的安全性，以体表心电图或远场心肌心电图来获得心室心电活动的可发放期信息也代表了对于脉冲刺激技术的积极改进，进一步地保障了对患者的脉冲刺激的安全性、有效性和治疗效果。
附图说明
图1为本发明实施例1的脉冲刺激控制方法的流程图。
图2为本发明实施例2的脉冲刺激控制方法的第一流程图。
图3为本发明实施例2的脉冲刺激控制方法的第二流程图。
图4为本发明实施例2的脉冲刺激控制方法的第三流程图。
图5为本发明实施例2的脉冲刺激控制方法的第四流程图。
图6为本发明实施例2的脉冲刺激控制方法的第五流程图。
图7为本发明实施例2的单个电极导线时R波感知对应的心电示意图。
图8为本发明实施例2的多个电极导线时R波感知对应的心电示意图。
图9为本发明实施例3的脉冲刺激控制系统的模块示意图。
图10为本发明实施例4的脉冲刺激控制系统的模块示意图。
图11为本发明实施例5的实现脉冲刺激控制方法的电子设备的结构示意图。
具体实施方式
下面通过实施例的方式进一步说明本发明，但并不因此将本发明限制在所述的实施例范围之中。
本发明中，预先在患者的不同心肌位置设置刺激电极(设置电极的心肌位置可以根据实际需求进行确定或调整)，每个刺激电极经由导线与植入和/或外部脉冲刺激设备电连接，以实现对不同心肌位置的心电信号的采集、向不同心肌位置发放脉冲刺激等控制操作。
本发明的脉冲刺激方案可以针对单一电极导线的脉冲刺激情况，还可以是针对多个电极导线的脉冲刺激情况，如ECS(Electrical Circulatory Support，电刺激循环支持)系统，对于多个心肌部位提供脉冲刺激，从而得以覆盖最需要本地和整体支持的一个或多个心腔；能在提供脉冲刺激同时，更好地确保该系统提供的脉冲刺激的及时性、安全性和有效性。
实施例1
如图1所示，本实施例的脉冲刺激控制方法包括：
S101、获取预设心电图中R波的第一感测时间；
其中，预设心电图包括但不限于体表心电图ECG、体内远场心肌心电图Far-Field Electrogram(又称FF-EGM)；第一感测时间又称GS(Global Sense，远场感知)。
S102、基于第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件，并获取感测事件对应的第二感测时间；
其中，对应于本地局部心肌心电图中的感测事件的第二感测时间又称LS(Local Sense，近场感知)。
局部心肌心电图中的感测事件为对应于预设心电图的R波的感测事件。
S103、在第二感测时间不满足第一预设条件时，则确定感测事件不是与预设心电图中R波相对应的R波信号，并控制不对设定心肌位置处的刺激电极发放脉冲刺激；
其中，第一预设条件基于预设心电图中R波的第一感测时间和感测事件对应的第二感测时间确定。
在一可实施的方案中，如图2所示，步骤S103包括：
S1031、获取预设心电图中R波对应的感测时间窗；
其中，获取感测时间窗的方式包括但不限于：基于预先设置的感知电路得到、通过外部设备输入以直接接收得到。
体表心电图ECG：对应的信号来自于贴在皮肤上的控制电极；此处的控制电极但不限于采用常用的体表心电图电极、特殊设计的电极。
远场心肌心电图FF-EGM，代表(或反映)整个心脏电活动的信号，类似于体表心电图。远场心肌心电图对应的信号来自于多种控制电极组合，包括但不限于直接接触心肌的表面积较大(即明显大于常规用于心肌电刺激的电极的表面积)的电极；不直接接触心肌但靠近或远离心室心肌的电极；或位于皮下的相对表面积较大的电极。
例如，不同的电极组合对应：放在血管或心腔内的、放在心外膜的除颤电极、sub-Q ICD的皮下除颤电极，或者是体外除颤器(如AED)的除颤电极等的不同电极的任意组合，具体这些不同电极如何组合设置可以根据实际使用场景的需求进行确定或调整。
可以基于单一或多个导联的体表心电图，和/或一个或多个远场心肌心电图中R波，获取感知时间和相应的感测时间窗，以其代表整体心室心肌除极电活动的部分或全部时间段而获得可发放脉冲时间窗。通过对于在刺激部位是否发放和发放时间的控制机制的改进，进一步提高脉冲刺激发放确定的准确度，并提高其安全性。
S1032、在第二感测时间未落入感测时间窗内时，则确定感测事件不是与预设心电图中R波相对应的R波信号，并控制不对设定心肌位置处的刺激电极发放脉冲刺激。
其中，局部心肌心电图中的感测事件LS对应的非R波信号包括T波信号或其他干扰信号等。具体地，脉冲刺激为CCM刺激；实现脉冲刺激能在不同心室电活动情况下进行，提高了脉冲刺激的可使用范围，大大地提升了脉冲刺激控制的整体有效性。
CCM刺激在如下心室电活动时发生：窦性心跳、源于心房下传引起的心室心跳、源于心室的心室心跳(心室异位激动)，和心室起搏心跳等。
通过确认局部感知的事件是R波，更好确保CCM刺激是由本地R波触发，而不是其他(如T波、肌电、或其他非心肌去极化电活动等)信号触发，有效地排除误触发情况发生，通过这一关键环节的设计，能够有效地提高脉冲刺激的安全性和有效性。
为了有效提高局部心肌心电图中LS是否为R波感知的确认精度，本实施例中同时考虑同一个心跳的远场感知(GS)和近场感知(LS)，由同一个心跳下的远场感知(GS)和近场感知(LS)来共同确定判断结果，大大地降低了只考虑一种感知即远场感知(GS)或近场感知(LS)时很有可能发生误判，而导致误触发脉冲刺激的情况的发生概率，从而有效地提高了对感测事件(LS)的确认准确度，进一步有效地避免了脉冲刺激在错误的情况下发放，极大程度上提高了对患者脉冲刺激的安全性。
确保脉冲刺激是不仅是在本地心肌R波(由在此心肌部位的电极感知到的)的可发放期内发放的，也是在远场心肌R波(由心室心肌整体产生的电活动)的可发放期内发放的，这样可以最大程度上的减少心室心肌由于脉冲刺激意外被激活而去极化的风险，甚至可以消除此风险。
本实施例中，能够及时对每次心跳的局部心肌心电图中的感测事件进行解析处理，自动且准确排查出误感知事件，将之确定为不是与预设心电图中R波相对应的R波信号，而属于比如T波等干扰信号，此时控制不对相应心肌位置发放脉冲刺激，保证了不在错误的情况下发放脉冲刺激，有效地避免诱发VT或VF的风险，避免对患者造成不必要的疼痛感甚至造成安全隐患，以确保患者的安全性，提高了脉冲刺激控制的可靠性，保障了对患者的脉冲刺激的安全性、有效性和治疗效果。
实施例2
本实施例的脉冲刺激控制方法是对实施例1的进一步改进，具体地：
在一可实施的方案中，如图3所示，步骤S102包括：
S1021、将第一感测时间作为第一时间点，并将第一时间点之前的第一设定时长对应的时间点作为时间参考起点；
S1022、基于时间参考起点，获取设定心肌位置对应的局部心肌心电图中的感测事件。
在一可实施的方案中，如图4所示，步骤S102之后还包括：
S104、在第二感测时间落入感测时间窗内时，则确定感测事件为R波。
在一可实施的方案中，如图5所示，本实施的脉冲刺激控制方法还包括：
S105、在感测事件为R波后，基于局部心肌心电图中R波的第二感测时间，确定设定心肌位置的刺激电极对应的脉冲发放时间；
需要说明的是，本实施例中的获取感测事件为R波的方式可以通过外部设备传输的方式直接获取，或者基于判断落入感测时间窗等方式进行确定。
S106、判断脉冲发放时间是否满足第二预设条件，若是，则确定向设定心肌位置处的刺激电极发放脉冲刺激；否则，确定不向设定心肌位置处的刺激电极发放脉冲刺激。
确定局部心肌感测时间在预设心电图中R波对应的感测时间窗内的感测事件，其属于与预设心电图中R波相对应的局部心肌的R波信号，进而保证在确定为R波时才及时发放脉冲刺激，以保证对患者心脏的脉冲刺激的及时性、安全性和有效性。
确保脉冲刺激是不仅是在本地心肌R波(由在此心肌部位的电极感知到的)的可发放期内发放的，也是在远场心肌R波(由整体心室心肌产生的电活动)的可发放期内发放的，这样可以最大程度上的减少甚至消除心室其他部位心肌由于脉冲刺激被激活而被极化的风险，极大程度上保障了患者脉冲刺激的安全性，最大程度上避免对患者造成不必要的治疗风险和痛苦。
也就是说，本实施例的脉冲刺激控制使得无论刺激电极在心肌何处，只在正确的情况下，即不光是本地心肌的，也是整个心室心肌的可发放期内，才发放脉冲刺激，更好地保证脉冲刺激的安全性和有效性；这也使得脉冲刺激可在需要时在各种心跳下发放(包括心房传导的心室心跳，心室自身引发的心跳，如PVCs，心室起搏心跳等)，更大程度满足病人对心肌收缩力加强的需求。
在一可实施的方案中，步骤S105包括：
根据局部心肌心电图中R波的第二感测时间和预设时长，计算得到设定心肌位置的刺激电极对应的脉冲发放时间；
或，
计算得到预设心电图中R波对应的第一感测时间(GS)和设定心肌位置的第二感测时间之间的时间差值；
以第一感测时间为参考零点，根据时间差值和预设时长计算得到设定心肌位置对应的脉冲发放时间。
具体说明上述两种计算得到局部心肌心电图中R波的脉冲发放时间的过程：
(1)及时获取局部心肌心电图中R波出现的第二感测时间，则以第二感测时间作为参考零点(或称触发点)，在此基础上加上预设时长(LPD)以得到对应心肌位置的刺激电极对应的脉冲发放时间。
(2)基于第二感测时间，以及体表心电图ECG和/或远场心肌心电图FF-EGM中R波出现的第一感测时间，计算得到第二感测时间与第一感测时间之间的时间差值(GLSD)；然后，以第一感测时间作为参考零点，在此基础上加上时间差值GLSD和预设时长LPD，以计算得到以第一感测时间为触发点(参考点)的每个设定心肌位置对应的脉冲发放时间GPD，即GPD＝GLSD+LPD。
还可以在得到每个设定心肌位置的脉冲发放时间GPD后，保持时间差值不变，以实 现保持根据脉冲发放时间GPD发放心脏脉冲刺激至对应的控制电极；无需每次电刺激输出前都再次计算，此时可以在发生局部心肌心电图R波感知后，根据GPD直接确定电刺激输出时间，而不需要每次都通过第一和第一感测时间来计算脉冲刺激远场心肌心电图发放时间，从而在达到心电刺激效果的同时，有效地缩短了数据处理耗时，提高了心脏脉冲刺激触发的控制效率。
另外，还可以根据实际需求定期或不定期的更新脉冲发放时间GPD(此时可以继续或停止心肌电刺激)，然后根据更新后的触发时间继续进行心肌电刺激，以实现更灵活的电刺激效果，满足更多的脉冲电刺激场景需求。
以局部心肌心电图R波(第二感测时间)触发的脉冲刺激，每个刺激位置从R波到发送的时长(LPD)是固定的(如预设时长40ms)。以体表心电图ECG和/或远场心肌心电图FF-EGM中R波触发的脉冲刺激，每个刺激位置的时长(GPD是不固定，不一样的(即由固定的预设时长40ms、根据位置变化的时间差值决定)。其中，该预设时长通常默认为40ms，且该时长值可以根据实际需求进行微调等更新设置(即可编程调整)。
需要说明的是，每个设定心肌部位对应的GLSD和GPD在预设期时可在几个自身心跳时测量并平均得到(默认为5个连续自身心跳，范围从3到12)。也可是根据每个心跳下的实测时长得到。每个设定心肌部位或位置的GPD用于在该部位或位置相对预设心电图R波感知时刻触发脉冲刺激发送的时间。脉冲发放时间对应感测到R波至触发心脏脉冲刺激发放的时长，脉冲刺激在各个位置或部位的传递由体表心电图ECG的R波感应或远场心肌心电图FF-EGM的R波感应触发，继而根据脉冲发放时间发放心脏脉冲刺激至每个对应的控制电极。为了保证脉冲刺激的有效性，所有R波(即远场心肌心电图FF-EGM中的R波和体表心电图ECG中的R波)都是在同一心跳下感知到的。基于上述的脉冲发放时间的获取方案，能够有效地保证脉冲刺激的及时性和可靠性。
另外，可以根据实际需求，针对不同的心室电活动预先设置与之相适配的GLSD等参数，例如窦性(SR)的心室电活动，然后在实际运行期时，在窦律时直接调用预设期设置的对应参数即可，以减少每次心跳所需的计算要求，同时保证脉冲刺激控制的及时性和有效性；
还可以不依赖于预设期中获得参数，如GLSD等，而是直接基于运行期过程中，基于实时心电活动感测的数据以及参数进行动态计算得到与当前实际的心室电活动相对应的GLSD以及其它参数，以进一步提高脉冲刺激控制的及时性和有效性，继而进一步保障了对患者的脉冲刺激的安全性和疗效。
在一可实施的方案中，如图6所示，步骤S106包括：
S1061、获取预设心电图中R波对应的可发放脉冲时间窗；
其中，可发放脉冲时间窗和感测时间窗这两个时间窗对应的起始时间点以及窗口时长均可以相同或者不同；也即可发放脉冲时间窗和感测时间窗这两个时间窗可以进行独立设置，相互之间可以没有相互关联性和依赖关系。
具体地，可发放脉冲时间窗与感测时间窗基于预设心电图确定，具体如何设置根据实际R波感知情况和心肌的情况等因素进行适应性调整，使得能够覆盖或满足绝大部分脉冲刺激场景需求即可。
S1062、在脉冲发放时间落入可发放脉冲时间窗时，则控制在脉冲发放时间将脉冲刺激发放至设定心肌位置处的刺激电极；
在脉冲发放时间未落入可发放脉冲时间窗时，则控制不对设定心肌位置处的刺激电极发放脉冲刺激。
本方案，保证CCM刺激必须在本地心肌除极(R波)的可发放期内、和体内远场心肌除极(R波)的可发放期内。其中，可发放脉冲时间窗对应的是一个安全期，此安全期对应整体心室的可发放期。可发放脉冲时间窗的起点和终点均是可调节的，目标是其起点约对应于除极区，其终点早于或等于可发放期终点。
在一可实施的方案中，当有多个所述设定心肌位置时，本实施例的脉冲刺激控制方法还包括如下步骤：
对于每个心肌位置对应的本地(Local)局部心肌心电图中的感测事件LS，逐一执行步骤S102至S106，以及时且有效地向每个心肌位置发放脉冲刺激，保证对患者治疗的安全性、有效性和可靠性。
其中，感测时间窗根据预设心电图中R波的第一感测时间和第一个发生的所述感测事件对应的第二感测时间确定。
例如，以预先在患者的3个不同设定心肌位置(A、B、C)处分别设置一个脉冲刺激电极为例进行说明，设定心肌位置A、B、C处分别对应刺激电极对E1、E2、E3，对应的感测事件的第二感测时间分别为LS1、LS2、LS3；其中，LS1、LS2、LS3对应的发生时间依次推移(即感测事件LS1最早发生，其他感测事件依次在后续时间发生)。其中，每个电极对的构成可以为：单级电极以及单级电极、双极电极以及双极电极导线、单极电极以及单级电极和双极电极以及双极电极导线两种类型的电极组合设置，还可以由其他类型的电极，具体采用何种电极对以及如何组合设置可以根据实际场景需求进行确定或调整。
具体地，在基于设定心肌位置A处的电极对E1获取该心肌位置对应的局部心肌心 电图中的感测事件LS1时，获取该感测事件LS1对应的第二感测时间，并判断该第二感测时间落入预设心电图中R波对应的感测时间窗，在其未落入时，则确定该感测事件LS1不是与预设心电图中R波相对应的R波信号，而是T波等其他的干扰信号，并控制不对设定心肌位置A处的刺激电极对E1发放脉冲刺激；在其落入时，则确定该感测事件LS1与预设心电图中R波相对应的局部心肌的R波信号，然后在该感测事件LS1对应的第二感测时间及时且准确计算得到设定心肌位置A对应的刺激电极对应的脉冲发放时间；进而继续判断脉冲发放时间是否落入预设心电图中R波对应的可发放脉冲时间窗，若其落入时，则控制在脉冲发放时间将脉冲刺激发放至设定心肌位置A处的刺激电极，否则确定不向设定心肌位置A处的刺激电极发放脉冲刺激，以完成对设定心肌位置A处的一次脉冲刺激控制。
依次类推，对于设定心肌位置B、C的脉冲刺激控制过程与设定心肌位置A的脉冲刺激控制过程类似，因此在此就不再赘述。
需要说明的是，不同的设定心肌位置的脉冲刺激控制过程相互独立，彼此不会造成相互干扰或影响；例如，在对设定心肌位置A处正在进行脉冲刺激控制过程中，或者已经完成设定心肌位置A处的脉冲刺激控制，只要设定心肌位置B对应的局部心肌心电图中出现感测事件LS2，则就可以单独执行上述的脉冲刺激控制过程，最终完成对所有设定心肌位置处的脉冲刺激控制，控制操作井然有序，非常有效地保障了对患者的脉冲刺激的安全性和可靠性。
在一可实施的方案中，当多个局部心肌心电图的感测事件对应的感测时间发生非常紧凑(即时间跨度较小)时，本实施例的脉冲刺激控制方法还包括如下步骤：
获取每个局部心肌心电图对应的本地(Local)局部心肌心电图中的感测事件LS对应的第二感测时间，以获取发生时间最早的感测事件为第一个感测事件LS1；获取第一个感测事件LS1对应的第二感测时间，并判断该第一感测事件LS1是否落入预设心电图中R波对应的感测时间窗，并在其落入时确定该感测事件为与预设心电图中R波相对应的本地心肌R波信号；
对于剩余的心肌位置对应的局部心肌心电图中的感测事件，判断这些感测事件对应的第二感测时间是否落入上述感测时间窗内，若是，则在确定第一个感测事件为与预设心电图中R波相对应的R波信号时，则直接确定剩余的心肌位置对应的局部心肌心电图中的感测事件也是与预设心电图中R波相对应的R波信号；此时，无需对剩余的心肌位置对应的局部心肌心电图中的感测事件进行逐一判断分析，在达到能够准确判断的同时，大大地简化了数据分析处理过程，有效地缩短了数据处理耗时，也降低了对设备的算力 要求，进一步地保证了对患者的脉冲刺激控制的及时性、准确性和有效性。
需要说明的是，具体采用何种方式对多个局部心肌心电图的感测事件是否为R波进行判断，可以根据实际场景需求选择单一的执行方案或者将多种执行方案进行组合，以满足更高要求的心电心室传导场景，大大地提高了脉冲刺激控制的实用性，非常大地程度上提高了对患者治疗的安全性和效果。
另外，有多个所述设定心肌位置时，本实施例的脉冲刺激控制方法还包括：
(1)预设不同的设定心肌位置处R波对应的设定感测参数；
其中，设定感测参数包括设定感测时间和/或设定感测发生顺序。
(2)当第一个出现的局部心肌心电图中感测事件为R波时，则设置其他剩余的局部心肌心电图中感测事件均为R波；或，
(3)当最后一个出现的局部心肌心电图中感测事件为R波时，则设置其他剩余的局部心肌心电图中感测事件均为R波。
当然，还可以根据实际场景需求，对上述设置内容进行调整或者增设更多的设置内容。
下面具体说明确定局部心肌心电图中的感测事件是否为R波的实现原理：
确定感测事件LS是否为R波涉及两个阶段：建立期/预设期(set-up period)和运行期(operational period)。
对于单一心肌点的电极的脉冲刺激系统，在该脉冲刺激系统中，将有预设心电(如ECG)和一根电极导线连接到心室的心肌以用于感知R波，并用于将脉冲刺激传递至心肌。在预设期需要对如下参数进行测量：
预设期(set-up period)：
(11)ECG感知(GS)＝ECG(R波)感知发生的时间(整体感知)；
其中，预设心电图ECG中R波的心室电活动(心室整体电活动)，R波感知反映了心室电活动相对早期的时间。
(12)EGM感知(LS)＝EGM(R波)感知发生的时间(局部感知)；
其中，LS是GS对应参考时间起点(GS-X，X＝60ms，可程控，范围包括但不限于30ms到200ms)后第一个感测到的局部心电图的感测事件；
(13)GLSD＝LS-GS，为GS和LS之间的时间延迟；
(14)LPD＝LS到脉冲刺激之间的时间延迟；
(15)GPD＝GLSD+LPD，是GS到脉冲刺激之间的时间延迟；
(16)GVT是相应GS的感测时间窗口(可编程设置与调整的)；LSVT是对应LS 的感测时间窗口；
具体地，GVT的开始时间为GVT-s，时间窗口持续时间为B；
a1)GVT-s＝GS-A，GLSD＞0(即LS晚于GS)；
GVT-s＝GS+GLSD-A，GLSD≤0(即LS早于GS或同时)；
其中，A的默认值为20ms，且A为可编程设置与调整的(包括0ms)；
此时，GVT-s均需要使用GS和LS相应的时间参数来获得。
b1)对于窦性心律，B在包括但不限于，30ms-130ms(可编程)范围内；
c1)对于室性异位激动，如PVC、心室起搏等，B包括但不限于，30ms-250ms(可编程)范围内。
LSVT-s＝LS-A；LSVT-B＝B-(LSVT-s-GVT-s)；
需要说明的是，LSVT只有在多个局部心肌有电极时才使用；而且LS为LS1，即对应所有心肌部位中发生时间最早的感测事件。
17)如图7所示，GPT是相应GS的脉冲发放时间窗口；LSPT是相应LS的脉冲发放事件窗口(可编程设置与调整的)；
具体地，GPT的开始时间GPT-s＝GVT-s；窗口持续时间具体地包括但不限于，20ms-200ms(可编程)范围(default为130ms)。
LSPT的开始时间LSPT-s＝LSVT-s，窗口持续时间为GPT的窗口持续时间减去GLSD。
需要说明的是，以上描述是包括GVT-s对应预设心电图中远场感知GS的场景，LSVT-s对应局部心肌心电图中近场感知LS的场景(即A＝0ms时)。
需要说明的是，上述参数都是在几个心动周期下平均计算得到(比如6个心动周期，可编程，还可以为其他数量次数下的心动周期)；另外，预设期应分别在窦性心电活动，心室异博电活动，和心室起搏等期间分别进行。
如图7所示，对于单一电极导线刺激系统，LSPT为相应LS的脉冲发放时间窗，窗口的起点为LSVT-s，其窗口持续时间为GPT的窗口持续时间(B)减去GLSD，二者是作为以LS作为脉冲刺激发放的触发点(参考点)的脉冲发放时间窗。
需要说明的是，LSPT只有在多个局部心肌有电极时才使用；而且LS为LS1，即对应所有心肌部位中发生时间最早的感测事件。此时，GPT的起点也需要使用LS相应的时间参数来获得。
另外，本实施例中的GVT、GPT、LSVT和LSPT等时间窗口，均由对应窗口起点和窗口时长这两个参数来描述。
运行期(operational period)
(18)LS为实时本地的R波感知需满足以下条件：
a2)有两个感知事件：预设ECG(GS)和局部EGM(LS)；
其中，LS是GS对应参考时间起点(GS-X，X＝60ms，可程控，范围包括但不限于30到200ms)后第一个感测到的局部心电图的感测事件的第二感测时间；
b2)LS落在GVT(即感测时间窗口)内。
(19)脉冲刺激时间是否合适的判断标准：
a3)脉冲刺激时间落在GPT(脉冲发放时间窗口)里。
其中GVT和GPT来自于预设期中相应的心室心电活动中获得的，比如窦性心电活动，心室异博电活动，或心室起搏等。
对于多电极的脉冲刺激系统，在该脉冲刺激系统中，将有预设心电图和多个导线连接到多个心室肌部位，用于感知R波，并将脉冲刺激传递至局部心肌。在预设期需要测量如下参数：
预设期(set-up period)：
(21)类似上述(11)-(19)，其中测量和获取(因为还包括一些程控的数字同测量数字一起达到所有参数)每个刺激电极对应的所有参数；
(22)预先形成LSn(为本地的R波感知)对应的模板，该模板包括LSn(n＝1，2，3，…)相对于LS1的时间，以及在每个电极发生感知时的顺序等信息；
运行期(operational period)：
(23)在运行期间，实时获取GS和LSn；
(24)使用与上述步骤(18)中的规则，对LSn分别进行确是否为真正的R波；
或者，如果在上述步骤(18)中，LS1被确认为真正的R波，则LSn(n＝2，3，…)被假定为真正的R波(如果LSn在GVT窗口内发生)。
或者，如果上述步骤(18)中LS1被确认为真正的R波，且LSn(n＝2，3，…)符合预设模板，则LSn(n＝2，3，…)被单独确认为真实R感测；
或者，如果使用LS1作为参考，则感测时间窗口将为LSVT，判断LSn(n＝2，3，…)是否在LSVT时间窗内。
如图8所示，对于多电极导线刺激系统在设置期间：如果使用LS1作为参考，脉冲发放时间窗为LSPT。
运行期间：在确定每个LS为R波感知后，相应的脉冲发放时间应在GPT窗口内；如果使用LS1作为脉冲发放时间窗的触发点(参考点)，则LSn(n>1)的发放时间在LSPT窗口内。
需要说明的是：对于单电极和多电极的脉冲刺激系统中，相对于各自心肌位置的脉冲刺激的发放时间是在局部心肌感知时间后，比如40ms后发放。GPT或LSPT是针对脉冲刺激发放时间的新的要求，特别是对多个刺激部位有脉冲刺激发放的情况，各个刺激部位的发放时间都需要落在GPT或LSPT的时间窗口里，即在同一心跳(心室激动)的整体心室的可发放期里(不光是电极部位的局部心室肌的可发放期)。
GVT/LSVT，作为一个“全心室“或”远场心室“R波感知时间窗，是用于判断LS是否是对应于GS(即对应于心室去极化的“全心室“或”远场“的R波感知)的局部心室去极化的R波感知。GPT/LSPT，为脉冲可发放时间窗(作为刺激发放的安全区，对应于心室肌整体(“全心室“或”远场心室“)的可发放期)，是用于判断对应于LS的脉冲刺激发放时间是否安全。GPT和GVT为独立的，可分别程控的这两个参数，以满足实际的参数配置需求。当然，为了减少程控复杂度，医生可以对于二者选择同样的数值(合适时)。或者，系统可以直接预先赋予这两个参数同样的数值，但需保持这两个参数分别程控的功能。这两个步骤可以共同使用，也可各自单独使用。
另外，除了上述先设置预设期，再做运行期(即运行期依赖于预设期获得的数字来具体执行使用)。还可以通过将以上参数直接在运行期中每次心室肌电活动(每个心动周期)时获得并使用，无需依赖预设期，从而大大地提升了脉冲刺激控制过程的灵活性和效率。
本实施例中，只针对R波后发送脉冲刺激，能够及时对心肌的局部心肌心电图中的感测事件进行解析处理，自动且准确排查出误感知事件，将之确定为不是与预设心电图中R波相对应的R波信号，而属于T波等干扰信号，此时控制不对相应心肌位置发放脉冲刺激，保证了不在错误的情况下发放脉冲刺激，有效地避免诱发VT或VF的风险，继而避免对患者造成不必要的疼痛感甚至造成安全隐患，以确保患者的安全性，提高了脉冲刺激控制的可靠性；同时保证在确定为R波时及时发放脉冲刺激，即只有在正确的情况下才发放脉冲刺激；
另外，只在心室可发放期内发送脉冲刺激：通过确认脉冲刺激发放时间落在体表心电图或体内远场心肌心电图整体心室心电活动(R波)对应的脉冲发放窗口内，以保证对患者心脏的脉冲刺激的及时性、安全性和有效性。其中，为了脉冲刺激发送时间的安全性，以体表心电图或远场心肌心电图来获得心室心电活动的可发放期信息也代表了对于脉冲刺激技术的积极改进，进一步地保障了对患者的脉冲刺激的安全性、有效性和治疗效果。
实施例3
如图9所示，本实施例的脉冲刺激控制装置包括：
第一感测时间获取模块1，用于获取预设心电图中R波的第一感测时间；
其中，预设心电图包括但不限于体表心电图ECG、体内远场心肌心电图Far-Field Electrogram；第一感测时间又称GS。
感测事件确定模块2，用于基于第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件；
第二感测时间获取模块3，用于获取感测事件对应的第二感测时间；
其中，对应于本地局部心肌心电图中的感测事件的第二感测时间又称LS。
局部心肌心电图中的感测事件为对应于预设心电图的R波的感测事件。
第一判断模块4，用于在第二感测时间不满足第一预设条件时，则确定感测事件不是与预设心电图中R波相对应的R波信号，并调用控制模块5；
控制模块5用于控制不对设定心肌位置处的刺激电极发放脉冲刺激；
其中，其中，第一预设条件基于预设心电图中R波的第一感测时间和感测事件对应的第二感测时间确定。
在一可实施的方案中，第一判断模块4还用于获取预设心电图中R波对应的感测时间窗；第一判断模块4还用于在第二感测时间未落入感测时间窗内时，则确定感测事件不是与预设心电图中R波相对应的R波信号。
其中，获取感测时间窗的方式包括但不限于：基于预先设置的感知电路得到、通过外部设备输入以直接接收得到。
局部心肌心电图中的感测事件LS对应的非R波信号包括T波信号或其他干扰信号等。具体地，脉冲刺激为CCM刺激；实现脉冲刺激能在不同心室电活动情况下进行，提高了脉冲刺激的可使用范围，大大地提升了脉冲刺激控制的整体有效性。
CCM刺激在如下心室电活动时发生：窦性心跳、源于心房下传引起的心室心跳、源于心室的心室心跳(心室异位激动)，和心室起搏心跳等。
通过确认局部感知的事件是R波，更好确保CCM刺激是由本地R波触发，而不是其他(如T波、肌电、或其他非心肌去极化电活动等)信号触发，有效地排除误触发情况发生，通过这一关键环节的设计，能够有效地提高脉冲刺激的安全性和有效性。
需要说明的是，本实施例的脉冲刺激控制装置的实现原理与实施例1的脉冲刺激控制方法类似，因此在此就不再赘述。
本实施例中，能够及时对每次心跳的局部心肌心电图中的感测事件进行解析处理，自动且准确排查出误感知事件，将之确定为不是与预设心电图中R波相对应的R波信号， 而属于比如T波等干扰信号，此时控制不对相应心肌位置发放脉冲刺激，保证了不在错误的情况下发放脉冲刺激，有效地避免诱发VT或VF的风险，避免对患者造成不必要的疼痛感甚至造成安全隐患，以确保患者的安全性，提高了脉冲刺激控制的可靠性，保障了对患者的脉冲刺激的安全性、有效性和治疗效果。
实施例4
如图10所示，本实施例的脉冲刺激控制系统是对实施例3的进一步改进，具体地：
在一可实施的方案中，本实施例的感测事件确定模块2包括：
时间参考起点获取单元6，用于将第一感测时间作为第一时间点，并将第一时间点之前的第一设定时长对应的时间点作为时间参考起点；
感测事件确定单元7，用于基于时间参考起点，获取设定心肌位置对应的局部心肌心电图中的感测事件。
在一可实施的方案中，第一判断模块4还用于在第二感测时间落入感测时间窗内时，则确定感测事件为R波。
在一可实施的方案中，本实施例的脉冲刺激控制系统还包括：
脉冲发放时间确定模块8，用于在感测事件为R波后，基于局部心肌心电图中R波的第二感测时间，确定设定心肌位置的刺激电极对应的脉冲发放时间；
需要说明的是，本实施例中的获取感测事件为R波的方式可以通过外部设备传输的方式直接获取，或者基于判断落入感测时间窗等方式进行确定。
具体地，脉冲发放时间确定模块8用于根据局部心肌心电图中R波的第二感测时间和预设时长，计算得到设定心肌位置的刺激电极对应的脉冲发放时间。
或，脉冲发放时间确定模块8用于获取预设心电图中R波对应的第一感测时间；计算得到第一感测时间和设定心肌位置的第二感测时间之间的时间差值；以第一感测时间为参考零点，根据时间差值和预设时长计算得到设定心肌位置对应的脉冲发放时间。
第二判断模块9，用于判断脉冲发放时间是否满足第二预设条件，若是，则调用确定模块以确定向设定心肌位置处的刺激电极发放脉冲刺激；否则，调用确定模块以确定不向设定心肌位置处的刺激电极发放脉冲刺激。
确定局部心肌感测时间在预设心电图中R波对应的感测时间窗内的感测事件，其属于与预设心电图中R波相对应的局部心肌的R波信号，进而保证在确定为R波时才及时发放脉冲刺激，以保证对患者心脏的脉冲刺激的及时性、安全性和有效性。
在一可实施的方案中，本实施例的第二判断模块9包括：
脉冲时间窗获取单元10，用于获取预设心电图中R波对应的可发放脉冲时间窗；
其中，可发放脉冲时间窗与感测时间窗相对应设置；
判断单元11，用于在脉冲发放时间落入可发放脉冲时间窗时，则调用控制模块5以控制在脉冲发放时间将脉冲刺激发放至设定心肌位置处的刺激电极；
判断单元11还用于在脉冲发放时间未落入可发放脉冲时间窗时，则调用控制模块5以控制不对设定心肌位置处的刺激电极发放脉冲刺激。
在一可实施的方案中，当有多个所述设定心肌位置时，本实施例的控制模块5用于按照每个局部心肌心电图中的感测事件发生的第二感测时间顺序，控制第一判断模块4依次判断对应的第二感测时间是否落入感测时间窗内。
其中，感测时间窗根据预设心电图中R波的第一感测时间和第一个发生的感测事件对应的第二感测时间确定。
在一可实施的方案中，当有多个所述设定心肌位置时，本实施例的控制模块5用于预设不同的设定心肌位置处R波对应的设定感测参数；
其中，设定感测参数包括设定感测时间和/或设定感测发生顺序；
或，
当第一个出现的局部心肌心电图中感测事件为R波时，则设置其他剩余的局部心肌心电图中感测事件均为R波；
或，
当最后一个出现的局部心肌心电图中感测事件为R波时，则设置其他剩余的局部心肌心电图中感测事件均为R波。
需要说明的是，本实施的脉冲刺激控制装置的工作原理与实施例2中的脉冲刺激控制的实现原理类似，因此在此就不再赘述。
本实施例中，只针对R波后发送脉冲刺激，能够及时对心肌的局部心肌心电图中的感测事件进行解析处理，自动且准确排查出误感知事件，将之确定为不是与预设心电图中R波相对应的R波信号，而属于T波等干扰信号，此时控制不对相应心肌位置发放脉冲刺激，保证了不在错误的情况下发放脉冲刺激，有效地避免诱发VT或VF的风险，继而避免对患者造成不必要的疼痛感甚至造成安全隐患，以确保患者的安全性，提高了脉冲刺激控制的可靠性；同时保证在确定为R波时及时发放脉冲刺激，即只有在正确的情况下才发放脉冲刺激；
另外，只在心室可发放期内发送脉冲刺激：通过确认脉冲刺激发放时间落在体表心电图或体内远场心肌心电图整体心室心电活动(R波)对应的脉冲发放窗口内，以保证对患者心脏的脉冲刺激的及时性、安全性和有效性。其中，为了脉冲刺激发送时间的安全 性，以体表心电图或远场心肌心电图来获得心室心电活动的可发放期信息也代表了对于脉冲刺激技术的积极改进，进一步地保障了对患者的脉冲刺激的安全性、有效性和治疗效果。
实施例5
本实施例的医疗系统ECS实施例3或4中的脉冲刺激控制装置。
整体心肌去极化(R波以及相应的GS)可以来自于包括但不限于体表心电图(来自于贴在皮肤上的体表心电图电极)，或远场心肌心电图(FF-EGM，来自于靠近心脏的电极或远离心脏但是位于皮下的，体内的组织或脏器的电极)。这样可以使这个ECS系统被用于很多对心脏提供治疗的器械或设备，比如AED、MCS(机械循环支持)、subQ-ICD、植入式CRM(心脏节律管理)器械，等等。同时，这也能使ECS不仅可以作为急性支持器械(体表心电图ECG可以作为输入信号之一)，也可作为慢性心衰治疗器械，但体表心电图不能一直可以作为该器械的输入。这样，ECS系统可以为更多的病人，在更多的场景提供治疗，使更多病人获益。本实施例的医疗系统能使脉冲刺激在窦性心律，心房传到的室性心律(跳)，或其他心室异位心律(跳)时发放。这是对目前对脉冲刺激发放不能在非心脏正常传导系统下的心跳，如在窦性心跳、源于心房下传引起的心室心跳、源于心室的心室心跳(心室异位激动)，和心室起搏心跳等情况下发放的限制条件的一种突破或改进。这将为心脏提供更多的支持的机会，特别在病人可能最需要这类支持的情况下。
本实施例的医疗系统中集成设置有上述脉冲刺激控制装置，能够支持不在错误的情况下发放脉冲刺激，只在正确的情况下才发放脉冲刺激，且在体表心电图、体内远场心肌心电图中R波对应的可发放期内发放脉冲刺激，以保证对患者心脏的脉冲刺激的及时性和有效性，保障了对患者的脉冲刺激的安全性、有效性和治疗效果，有效地提高了现有的医疗系统的整体产品性能。
实施例6
图11为本发明实施例6提供的一种电子设备的结构示意图。电子设备包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序，处理器执行程序时实现实施例1或2中的脉冲刺激控制方法。图11显示的电子设备30仅仅是一个示例，不应对本发明实施例的功能和使用范围带来任何限制。
如图11所示，电子设备30可以通用计算设备的形式表现，例如其可以为服务器设备。电子设备30的组件可以包括但不限于：上述至少一个处理器31、上述至少一个存储器32、连接不同系统组件(包括存储器32和处理器31)的总线33。
总线33包括数据总线、地址总线和控制总线。
存储器32可以包括易失性存储器，例如随机存取存储器(RAM)321和/或高速缓存存储器322，还可以进一步包括只读存储器(ROM)323。
存储器32还可以包括具有一组(至少一个)程序模块324的程序/实用工具325，这样的程序模块324包括但不限于：操作系统、一个或者多个应用程序、其它程序模块以及程序数据，这些示例中的每一个或某种组合中可能包括网络环境的实现。
处理器31通过运行存储在存储器32中的计算机程序，从而执行各种功能应用以及数据处理，例如本发明实施例1或2中的脉冲刺激控制方法。
电子设备30也可以与一个或多个外部设备34(例如键盘、指向设备等)通信。这种通信可以通过输入/输出(I/O)接口35进行。并且，模型生成的设备30还可以通过网络适配器36与一个或者多个网络(例如局域网(LAN)，广域网(WAN)和/或公共网络，例如因特网)通信。如图11所示，网络适配器36通过总线33与模型生成的设备30的其它模块通信。应当明白，尽管图中未示出，可以结合模型生成的设备30使用其它硬件和/或软件模块，包括但不限于：微代码、设备驱动器、冗余处理器、外部磁盘驱动阵列、RAID(磁盘阵列)系统、磁带驱动器以及数据备份存储系统等。
应当注意，尽管在上文详细描述中提及了电子设备的若干单元/模块或子单元/模块，但是这种划分仅仅是示例性的并非强制性的。实际上，根据本发明的实施方式，上文描述的两个或更多单元/模块的特征和功能可以在一个单元/模块中具体化。反之，上文描述的一个单元/模块的特征和功能可以进一步划分为由多个单元/模块来具体化。
实施例7
本实施例提供了一种计算机可读存储介质，其上存储有计算机程序，程序被处理器执行时实现实施例1或2中的脉冲刺激控制方法中的步骤。
其中，可读存储介质可以采用的更具体可以包括但不限于：便携式盘、硬盘、随机存取存储器、只读存储器、可擦拭可编程只读存储器、光存储器件、磁存储器件或上述的任意合适的组合。
在可能的实施方式中，本发明还可以实现为一种程序产品的形式，其包括程序代码，当程序产品在终端设备上运行时，程序代码用于使终端设备执行实现实施例1或2中的脉冲刺激控制方法中的步骤。
其中，可以一种或多种程序设计语言的任意组合来编写用于执行本发明的程序代码，程序代码可以完全地在用户设备上执行、部分地在用户设备上执行、作为一个独立的软件包执行、部分在用户设备上部分在远程设备上执行或完全在远程设备上执行。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这仅是举例说明，本发明的保护范围是由所附权利要求书限定的。本领域的技术人员在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改，但这些变更和修改均落入本发明的保护范围。

Claims (15)

  1. 一种脉冲刺激控制方法，其特征在于，所述方法包括：
    获取预设心电图中R波的第一感测时间；
    基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件，并获取所述感测事件对应的第二感测时间；
    在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激；
    其中，所述第一预设条件基于所述预设心电图中R波的所述第一感测时间和所述感测事件对应的所述第二感测时间确定。
  2. 如权利要求1所述的脉冲刺激控制方法，其特征在于，在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激，包括：
    获取所述预设心电图中R波对应的感测时间窗；
    在所述第二感测时间未落入所述感测时间窗内时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激。
  3. 如权利要求1或2所述的脉冲刺激控制方法，其特征在于，所述基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件，包括：
    将所述第一感测时间作为第一时间点，并将所述第一时间点之前的第一设定时长对应的时间点作为时间参考起点；
    基于所述时间参考起点，获取所述设定心肌位置对应的局部心肌心电图中的感测事件。
  4. 如权利要求1-3中至少一项所述的脉冲刺激控制方法，其特征在于，所述方法还包括：
    在所述第二感测时间落入所述感测时间窗内时，则确定所述感测事件为R波。
  5. 如权利要求1-4中至少一项所述的脉冲刺激控制方法，其特征在于，所述脉冲刺激控制方法，还包括：
    在所述感测事件为R波后，基于所述局部心肌心电图中R波的所述第二感测时间，确定所述设定心肌位置的刺激电极对应的脉冲发放时间；
    判断所述脉冲发放时间是否满足第二预设条件，若是，则确定向所述设定心肌位置处的刺激电极发放脉冲刺激；否则，确定不向所述设定心肌位置处的刺激电极发放脉冲刺激。
  6. 如权利要求5所述的脉冲刺激控制方法，其特征在于，所述判断所述脉冲发放时间是否满足第二预设条件，若是，则确定向所述设定心肌位置处的刺激电极发放脉冲刺激；否则，确定不向所述设定心肌位置处的刺激电极发放脉冲刺激，包括：
    获取所述预设心电图中R波对应的可发放脉冲时间窗；
    其中，所述可发放脉冲时间窗与所述感测时间窗相对应设置；
    在所述脉冲发放时间落入所述可发放脉冲时间窗时，则控制在所述脉冲发放时间将脉冲刺激发放至所述设定心肌位置处的刺激电极；
    在所述脉冲发放时间未落入所述可发放脉冲时间窗时，则控制不对所述设定心肌位置处的刺激电极发放脉冲刺激。
  7. 如权利要求2-6中至少一项所述的脉冲刺激控制方法，其特征在于，当有多个所述设定心肌位置时，所述方法还包括：
    按照每个所述局部心肌心电图中的所述感测事件发生的所述第二感测时间顺序，依次判断对应的所述第二感测时间是否落入所述感测时间窗内；
    其中，所述感测时间窗根据所述预设心电图中R波的所述第一感测时间和第一个发生的所述感测事件对应的所述第二感测时间确定。
  8. 如权利要求1-7中至少一项所述的脉冲刺激控制方法，其特征在于，当有多个所述设定心肌位置时，所述方法还包括：
    预设不同的所述设定心肌位置处感测时间对应的设定感测参数；
    其中，所述设定感测参数包括设定感测时间和/或设定感测发生顺序；或，
    当第一个出现的所述局部心肌心电图中感测事件为R波时，则设置其他剩余的所述局部心肌心电图中感测事件均为R波；或，
    当最后一个出现的所述局部心肌心电图中感测事件为R波时，则设置其他剩余的所述局部心肌心电图中感测事件均为R波。
  9. 如权利要求6或7所述的脉冲刺激控制方法，其特征在于，所述预设心电图包括体表心电图和/或体内远场心肌心电图；
    和/或，
    所述可发放脉冲时间窗与所述感测时间窗基于所述预设心电图确定。
  10. 如权利要求5所述的脉冲刺激控制方法，其特征在于，所述基于所述局部心肌 心电图中R波的所述第二感测时间，确定所述设定心肌位置的刺激电极对应的脉冲发放时间，包括：
    根据所述局部心肌心电图中R波的所述第二感测时间和预设时长，计算得到所述设定心肌位置的刺激电极对应的所述脉冲发放时间；
    或，
    计算得到所述预设心电图中R波对应的所述第一感测时间和所述设定心肌位置的所述第二感测时间之间的时间差值；
    以所述第一感测时间为参考零点，根据所述时间差值和预设时长计算得到所述设定心肌位置对应的所述脉冲发放时间。
  11. 如权利要求1-10中至少一项所述的脉冲刺激控制方法，其特征在于，所述脉冲刺激为CCM刺激；
    其中，所述CCM刺激可以在如下至少一种心室电活动时发放：
    窦性心跳、源于心房下传引起的心室心跳、源于心室的心室心跳，和心室起搏心跳。
  12. 一种脉冲刺激控制装置，其特征在于，所述装置包括：
    第一感测时间获取模块，用于获取预设心电图中R波的第一感测时间；
    感测事件确定模块，用于基于所述第一感测时间，确定设定心肌位置对应的局部心肌心电图中的感测事件；
    第二感测时间获取模块，用于获取所述感测事件对应的第二感测时间；
    第一判断模块，用于在所述第二感测时间不满足第一预设条件时，则确定所述感测事件不是与所述预设心电图中R波相对应的R波信号，并控制不对所述设定心肌位置处的刺激电极发放脉冲刺激；
    其中，所述第一预设条件基于所述预设心电图中R波的所述第一感测时间和所述感测事件对应的所述第二感测时间确定。
  13. 一种医疗系统，其特征在于，所述医疗系统包括权利要求12所述的脉冲刺激控制装置。
  14. 一种电子设备，包括存储器、处理器及存储在存储器上并可在处理器上运行的计算机程序，其特征在于，所述处理器执行计算机程序时实现权利要求1-11中任一项所述的脉冲刺激控制方法。
  15. 一种计算机可读存储介质，其上存储有计算机程序，其特征在于，所述计算机程序被处理器执行时实现权利要求1-11中任一项所述的脉冲刺激控制方法。
PCT/CN2023/073806 2022-01-30 2023-01-30 脉冲刺激控制方法、装置、医疗系统、电子设备及介质 Ceased WO2023143602A1 (zh)

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