Medical device for delivering pulse stimulation

Abstract

The present invention discloses a medical device for delivering pulse stimuli, including at least one ventricular electrode lead configured to be placed at a myocardial location, and a control device configured to execute a pulse stimulation control method, the pulse stimulation control method including the steps of acquiring a far-field electrocardiogram and an in-vivo near-field myocardial electrocardiogram corresponding to the myocardial location, and determining whether to deliver CCM pulse stimuli to the myocardial location according to R waves in the far-field electrocardiogram and R waves in the in-vivo near-field myocardial electrocardiogram. The medical device for delivering pulse stimuli provided by the present invention can ensure the timeliness, safety, and effectiveness of CCM pulse stimuli to a patient's heart.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is This is the national phase of international application number PCT / CN2023 / 110350, filed on July 31, 2023. Priority is claimed to Chinese patent application CN202210944885.5, filed on August 8, 2022, and Chinese patent application CN202210944820.0, filed on August 8, 2022. The entire contents of the above Chinese patent applications are incorporated herein by reference.

[0002] The present invention relates to the field of medical devices, and more particularly to medical devices for delivering pulsed stimulation. [Background technology]

[0003] Currently available medical devices with cardiac contractility modulation (CCM) functions are primarily used for patients with chronic heart failure. Generally, two bipolar electrode leads are implanted in the right ventricular septum to sense local myocardial potentials and deliver pulse stimulation at a specific time after sensing to increase ventricular myocardial contractility.

[0004] Additionally, while this medical device currently only provides CCM therapy, a significant portion of patients with CCM indications (EF < 35%) also require primary prevention of sudden cardiac death (SCD) and therefore require ICD (implantable cardioverter-defibrillator) implantation. Currently, these heart failure patients simultaneously receive two implantable devices: one CCM device and one ICD (implantable cardioverter-defibrillator). Conversely, many patients currently receiving ICD therapy also have indications for CCM therapy and could benefit from CCM therapy because it can improve heart failure symptoms and hemodynamics. Currently, most ICD patients benefit from SCD prevention after ICD implantation but do not receive heart failure treatment with CCM. Furthermore, CCM devices currently do not provide pacing therapy for bradycardia, which may be a therapy required by some CCM patients.

[0005] One reason for this is that current CCM systems (devices plus at least two ventricular electrode leads) are relatively complex. The system relies on two bipolar ventricular electrode leads in the right ventricular septum to sense local myocardial activation and a time sequence of two sensed events to ensure that ventricular activation is from the atrium and not from the ventricle itself (including ventricular pacing). Here, one or both of the electrode leads is also used to deliver CCM pulses during the absolute refractory period of the local myocardium. Although CCM stimulation is not delivered directly to the left ventricular (LV) myocardium, the LV is typically the chamber most in need of enhanced contractility. While CCM has been shown to have global effects on cardiac contractility and cardiac function, studies suggest that these effects originate at the stimulation site but affect, in part, global cardiac contractility or the LV.

[0006] Among currently available transvenous ICD systems, i.e., conventional ICD systems, single-chamber ICDs have only one right ventricular (RV) lead, dual-chamber ICDs have only two leads (one in the RA right atrium and one in the RV right ventricle), and CRT-D (cardiac resynchronization defibrillator) devices have three leads (one in the RA right atrium, one in the RV right ventricle, and one on the epicardial surface of the left ventricle). These three systems have the following in common: 1) Unlike CCM devices, which have two leads, there is only one RV lead; 2) The RV lead contains the ICD housing and a defibrillation coil electrode that forms the defibrillation circuit. Sometimes, there is a second defibrillation coil electrode at the location corresponding to the SVC (superior vena cava); both are on the RV lead. Currently, ICDs themselves cannot provide CCM therapy, partly because there is no certainty that CCM is absolutely safe for local myocardial stimulation and will not induce malignant ventricular arrhythmias. Although CCM devices currently cannot provide pacing therapy, some heart failure patients can benefit from pacing to increase their heart rate. Summary of the Invention [Problem to be solved by the invention]

[0007] The technical problem that the present invention aims to solve is to overcome three limitations of the prior art: CCM pulse stimuli can only be delivered when ventricular electrical activity is transmitted from the atrium; electrode pairs on two ventricular electrode leads must be used to sense local excitation of the right ventricular septum myocardium and the time series of two sensed events in order to determine whether pulse stimuli can be delivered; and pulse stimuli are delivered only from the right ventricular septum. In order to overcome these three limitations, the prior art must provide a medical device that can ensure the delivery of CCM pulse stimuli within the period when ventricular delivery is possible and that does not have the above limitations.

[0008] Another technical problem that the present invention aims to solve is to provide a medical device for delivering pulse stimulation that can achieve the function of CCM therapy using one's own ventricular electrode lead.

[0009] Another technical problem that the present invention aims to solve is to provide a medical device for delivering pulse stimulation to overcome problems such as the inability of existing CCM devices to provide ICD therapy to patients requiring SCD prevention, and the need to implant both a CCM and an ICD medical device into the patient's body, which increases surgical and / or post-surgical risks (such as infection), or limits the choice of only one of the therapies due to financial burden.This solution allows heart failure patients to receive the necessary therapy (to alleviate heart failure and prevent sudden death), reduces the complexity of surgery and the financial burden on patients, and significantly improves the cost-effectiveness of implanted devices.

[0010] Another technical problem that the present invention aims to solve is to provide a safer and more reliable pulse stimulation control method to overcome the problem in the prior art of delivering CCM pulse stimulation in erroneous cases due to erroneous sensing of R waves in a far-field electrocardiogram or an in-vivo near-field electrocardiogram. [Means for solving the problem]

[0011] The present invention solves the above technical problems by the following technical solutions.

[0012] The present invention provides a medical device for delivering pulsed stimulation, including at least one ventricular electrode lead configured to be placed at a myocardial location in a ventricle, and a controller configured to implement a pulsed stimulation control method, the pulsed stimulation control method comprising: acquiring a far-field electrocardiogram and an in-body near-field myocardial electrocardiogram corresponding to the myocardial location; and determining whether to deliver a CCM pulse stimulus to the myocardial location via the ventricular electrode lead in response to an R wave in the far-field electrocardiogram and an R wave in the internal near-field myocardial electrocardiogram.

[0013] Optionally, the medical device further includes a first electrode pair for sensing and a second electrode pair for sensing and stimulating, the second electrode pair being disposed on the ventricular electrode lead and including a tip electrode positioned at a myocardial location in the ventricle, and the control device is configured to acquire the far-field electrocardiogram based on the first electrode pair and acquire the in-body near-field myocardial electrocardiogram based on the second electrode pair.

[0014] Optionally, the second electrode pair is both disposed on the ventricular electrode lead, and the medical device is used to provide cardiac pacing and / or defibrillation therapy functions via the ventricular electrode lead; or The first electrode pair is configured as an electrode placed on the ventricular electrode lead, or as an additional electrode placed in a blood vessel, a cardiac cavity, the epicardium, a thoracic cavity other than the heart, or subcutaneously, and the far-field electrocardiogram is an internal far-field myocardial electrocardiogram, or the first electrode pair is configured as a body surface electrode to be attached to the skin, and the far-field electrocardiogram is a body surface electrocardiogram.

[0015] The step of selectively determining whether to deliver a CCM pulse stimulus to the myocardial location in response to an R wave in the far-field electrocardiogram and an R wave in the internal near-field myocardial electrocardiogram specifically includes: obtaining a first detection time of an R wave in the far-field electrocardiogram, a second detection time of an R wave in the internal near-field electrocardiogram corresponding to the R wave in the far-field electrocardiogram, and a pulse transmittable time window, which is a CCM stimulation safety window, corresponding to the R wave in the internal near-field electrocardiogram; determining a pulse transmission start time according to the first detection time or the second detection time; and determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window.

[0016] The step of selectively determining a pulse transmission start time depending on the first detection time or the second detection time specifically includes: The method includes the steps of: obtaining a pulse transmission start time according to the second detection time and a duration of a second preset, using the second detection time as a reference zero point; or calculating a time difference between the second detection time and the first detection time; and calculating a pulse transmission time according to the first detection time, the time difference, and a duration of a third preset, which is equal to the duration of the second preset, using the first detection time as a reference zero point.

[0017] Optionally, the pulse stimulation control method further includes a setup period and an operating period. Steps to install and during the setup period, a duration of a first preset is calculated according to a difference between the first detection time and the second detection time and a duration of a third preset, and during the operation period, the first detection time is set as a reference zero point and a transmission start time of the pulse is obtained according to the first detection time and the duration of the first preset.

[0018] Optionally, the second preset has a duration of at least 15 ms and at most 80 ms.

[0019] The step of selectively obtaining a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram specifically includes: acquiring a first sensed event in the far-field electrocardiogram and a second sensed event in the far-field electrocardiogram, wherein at least one of the first sensed event and the second sensed event is an R wave; determining that the first sensed event in the far-field electrocardiogram corresponds to the second sensed event in the internal near-field electrocardiogram when an absolute value of a difference between a first detection time of the first sensed event in the far-field electrocardiogram and a second detection time of the second sensed event in the internal near-field electrocardiogram is within a preset range, and the first sensed event and the second sensed event are both R waves; The preset range is from 0 ms to 120 ms if the first sensed event in the far-field electrocardiogram is due to ventricular activation of an atrial conduction, and from 0 ms to 250 ms if the R wave in the far-field electrocardiogram is due to ventricular activation of a ventricle or a ventricular pacing pulse.

[0020] The step of selectively obtaining a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram specifically further includes: a step of taking the first detection time as a first time point and a time point corresponding to a first preset duration before the first time point as a time reference zero point, and acquiring a second detection event in the internal near-field myocardial electrocardiogram located after the time reference zero point, wherein the duration of the first preset is between 10 ms and 120 ms; Or, the second detection time is set as a second time point, and a time point corresponding to a second preset duration before the second time point is set as a time reference zero point, and a first detection event in the far-field electrocardiogram located after the time reference zero point is acquired; No. 2 The preset includes steps with a duration of at least 30 ms and no more than 120 ms.

[0021] Optionally, the step of obtaining a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further includes: obtaining a sensed time window corresponding to the first sensed event in the far-field electrocardiogram; determining whether the second detection time or the first detection time falls within the detection time window; If so, determining that the first sensed event in the far-field electrocardiogram corresponds to a second sensed event in the internal near-field electrocardiogram, and the first sensed event and the second sensed event are both R waves; otherwise, the first sensed event in the far-field electrocardiogram does not correspond to a second sensed event in the internal near-field electrocardiogram, and one of the first sensed event and the second sensed event is not an R wave, and the control device is configured not to deliver a CCM pulse stimulus to the myocardial location.

[0022] Optionally, when the first detection time is the first time point, the first detection event is an R wave, and determining whether the second detection time or the first detection time falls within the detection time window includes determining whether the second detection time falls within the detection time window; When the second detection time is the second time point, the second detection event is an R wave, and the step of determining whether the second detection time or the first detection time falls within the detection time window includes the step of determining whether the first detection time falls within the detection time window.

[0023] Optionally, when the first sensed event in the far-field electrocardiogram is a ventricular activation caused by non-ventricular pacing, if the first sensed time is earlier than the second sensed time, a start point of a sensed time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on the first sensed time, and if the second sensed time is earlier than the first sensed time, a start point of a sensed time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on the second sensed time; If the first sensed event in the far-field electrocardiogram occurs due to a ventricular pacing pulse, the start of a sensing time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on the delivery time of the pacing pulse received by the ventricle, and the delivery time of the pacing pulse is considered to be the first sensed time.

[0024] Optionally, the start time of the detection time window has a fourth preset duration that is earlier than or equal to the first detection time or the second detection time, and the pulse transmittable time window has a second preset length, the detection time window has a first preset length, and the second preset length is longer than the first preset length, and the fourth preset duration is greater than or equal to 0 ms and less than or equal to 50 ms.

[0025] Optionally, the detection time window has a first preset length, and when the R wave in the far-field electrocardiogram is a beat generated by ventricular activation due to atrial conduction, the first preset length ranges from 60 m to 100 m. s and the R wave in the far-field electrocardiogram is due to ventricular activation of a ventricle or due to a ventricular pacing pulse, the first preset length is 160 ms or more and less than 120 ms. s The first preset length is greater than or equal to 250 ms and less than or equal to 250 ms, or the first preset length is determined by program control.

[0026] Optionally, the ventricular electrode leads are multiple and are provided at multiple different ventricular myocardial locations, the internal near-field myocardial electrocardiogram and the second sensed event are multiple, and the control device further comprises: presetting preset sensing parameters corresponding to R waves at different myocardial locations, including preset sensing times and / or preset sensing occurrence sequences; If the second sensed event that first falls within the sensed time window is an R wave, setting all remaining second sensed events to R waves; or If the last second sensed event that falls within the sensing time window is an R wave, the step of setting all remaining second sensed events to R waves is performed.

[0027] The step of selectively determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window specifically includes: If the pulse delivery start time falls within the pulse delivery window, delivering a CCM pulse stimulus to the myocardial region; otherwise, not delivering a CCM pulse stimulus to the myocardial region.

[0028] Optionally, the ventricular electrode leads are multiple and are provided at multiple different myocardial locations, the internal near-field myocardial electrocardiogram and the second sensed event are multiple, and the control device further The device is configured to execute the steps of setting a transmission order of pulse stimuli corresponding to R waves at different myocardial positions, and transmitting CCM pulse stimuli to the different myocardial positions according to the transmission order of the pulse stimuli.

[0029] Optionally, when the R wave in the far-field electrocardiogram is a ventricular activation caused by non-ventricular pacing, a start point of the pulse delivery time window is determined based on a first detection time of the R wave in the far-field electrocardiogram, or a second detection time of a corresponding R wave in the internal near-field electrocardiogram determined in response to the first detection time; If the R wave in the far-field electrocardiogram is caused by a ventricular pacing pulse, the start of the pulse delivery window is determined based on the delivery time of the pacing pulse received by the ventricle, and the delivery time of the pacing pulse is considered to be the first sensing time.

[0030] Optionally, the pulse delivery time window has a second preset length, the second preset length ranging from 150 ms to 300 ms, or the second preset length is determined by program control, and the start of the pulse delivery time window is earlier than the first detection time or the second detection time by a fourth preset duration, the fourth preset duration being from 0 ms to 50 ms.

[0031] Optionally, the controller further comprises: When the second detection time is earlier than the first detection time, determining a start point of a time window in which a pulse can be transmitted corresponding to the R wave in the internal near-field myocardial electrocardiogram according to the second detection time, and determining a transmission start time of the pulse according to the first detection time or the second detection time; If the second detection time is later than the first detection time, determining a start point of a time window in which a pulse can be transmitted corresponding to the R wave in the internal near-field myocardial electrocardiogram according to the first detection time, and determining a transmission start time of the pulse according to the first detection time or the second detection time.

[0032] The step of selectively determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window specifically includes: determining a pulse transmission stop time according to the pulse transmission start time; If the pulse delivery start time and the pulse delivery stop time both fall within the pulse delivery window, delivering a CCM pulse stimulus to the myocardial location, and if not, not delivering a CCM pulse stimulus to the myocardial location.

[0033] The step of selectively determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window specifically includes: determining a start time for the pulse and a stop time for the pulse according to preset pulse parameters; If the pulse delivery start time falls within the pulse delivery available time window and the pulse delivery stop time does not fall within the pulse delivery available time window, redetermine the pulse parameters so that the pulse delivery start time and the pulse delivery stop time both fall within the pulse delivery available time window, and deliver a CCM pulse stimulus to the myocardial location according to the redetermined pulse parameters; and not delivering a CCM pulse stimulus to the myocardial location if the pulse delivery start time does not fall within the pulse delivery window.

[0034] The step of selectively determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window specifically includes: If the pulse transmission start time falls within the pulse transmission available time window, determining a pulse transmission stop time according to the pulse transmission start time and preset pulse parameters; determining whether the pulse transmission stop time falls within the pulse transmission possible time window; If so, delivering a CCM pulse stimulus; Otherwise, the method includes a step of not delivering a CCM pulse stimulus, or redetermining the pulse parameters so that the pulse delivery stop time falls within the pulse delivery possible time window, and delivering a CCM pulse stimulus according to the redetermined pulse parameters.

[0035] Optionally, the controller: determining whether a ventricular chamber has been captured if it is determined that a pacing pulse has already been delivered to the myocardial location; If so, determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery window, wherein the pulse delivery window corresponding to the R wave in the internal near-field myocardial electrocardiogram is determined based on the delivery time of a pacing pulse received by the ventricle; Otherwise, the device is configured to execute a step of determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window, wherein the pulse delivery available time window corresponding to the R wave in the internal near-field electrocardiogram is determined based on a first detection time of the R wave in the far-field electrocardiogram or a second detection time of the R wave in the internal near-field electrocardiogram.

[0036] Optionally, determining whether a ventricle has been captured specifically includes determining whether a ventricle has been captured based on the far-field electrocardiogram.

[0037] Optionally, the step of delivering a CCM pulse stimulus to the myocardial location specifically comprises: If a step is detected in which the current heart rate parameter is within a preset range, delivering a CCM pulse stimulus to the myocardial location is included.

[0038] Optionally, the CCM pulse stimulus comprises: It is delivered during at least one of the following ventricular electrical activity events: a sinus beat, a ventricular beat resulting from an atrial downbeat, a ventricular beat resulting from a ventricular downbeat, or a ventricular beat resulting from ventricular pacing.

[0039] Any combination of the above options consistent with common knowledge in the art may be used to obtain embodiments of the present invention. [Effects of the Invention]

[0040] The positive and inventive effects of the present invention are as follows:

[0041] Delivering CCM pulse stimulation within the ventricular deliverable period. By verifying that the delivery time of CCM pulse stimulation falls within the deliverable period corresponding to the cardiac electrical activity (R wave) of the entire ventricle reflected in the far-field electrocardiogram, the timeliness, safety, and effectiveness of CCM pulse stimulation for the patient's heart are ensured. Here, obtaining information on the deliverable period of ventricular cardiac electrical activity using the far-field electrocardiogram to ensure the safety of the delivery time of CCM pulse stimulation also represents a positive improvement to CCM pulse stimulation technology, further ensuring the safety, effectiveness, and therapeutic effects of CCM pulse stimulation for patients.

[0042] The system transmits pulse stimuli only for R waves afterward. It automatically and accurately detects false sensed events by analyzing and processing detected events in the far-field electrocardiogram or the internal near-field electrocardiogram in a timely manner, and determines that the false sensed events are not R-wave signals but rather interference signals such as T waves. In this case, it controls not to transmit CCM pulse stimuli to the corresponding myocardial location, ensuring that CCM pulse stimuli are not transmitted in erroneous cases, effectively reducing or avoiding the risk of inducing VT or VF, avoiding unnecessary pain to the patient and even safety risks, ensuring patient safety, and improving the reliability of pulse stimuli control. Furthermore, it ensures that CCM pulse stimuli are transmitted in a timely manner when an R wave is determined, and only transmits CCM pulse stimuli if the R wave is correct.

[0043] A first electrode pair arranged on at least one ventricular electrode lead in the medical device acquires an in-vivo far-field myocardial electrocardiogram, and a second electrode pair arranged on at least one ventricular electrode lead in the medical device acquires an in-vivo near-field myocardial electrocardiogram, and the R waves in the in-vivo far-field myocardial electrocardiogram and the R waves in the in-vivo near-field myocardial electrocardiogram are combined to determine whether to deliver a CCM pulse stimulus to a myocardial location, thereby realizing a CCM therapy function.

[0044] Furthermore, compared to existing medical devices, by using the at least one ventricular electrode lead, not only can the CCM therapy function be realized, but also the functions of the original conventional device (including the cardiac pacing function and / or the defibrillation therapy function). Therefore, the medical device provided by the present invention can provide patients with ICD therapy and CCM therapy, and patients who need SCD prevention and heart failure treatment do not need to have two types of medical devices implanted, but can simply have the medical device provided by the present invention implanted in their bodies. [Brief explanation of the drawings]

[0045] [Figure 1] 1 is a schematic diagram showing a first electrode pair and a second electrode pair arranged on a right ventricular electrode lead in a medical device provided in an embodiment of the present invention. [Figure 2] FIG. 10 is another schematic diagram showing a first electrode pair and a second electrode pair arranged on a right ventricular electrode lead in a medical device provided in an embodiment of the present invention. [Figure 3] FIG. 10 is yet another schematic diagram showing a first electrode pair and a second electrode pair arranged on a right ventricular electrode lead in a medical device provided in an embodiment of the present invention. [Figure 4] 1 is a flowchart of a method for controlling a medical device provided in an embodiment of the present invention. [Figure 5] 1 is a flowchart of step S2 provided in an embodiment of the present invention. [Figure 6] 1 is a flowchart of step S3 provided in an embodiment of the present invention. [Figure 7] 10 is another flowchart of step S3 provided in an embodiment of the present invention. [Figure 8] 10 is yet another flowchart of step S3 provided in an embodiment of the present invention. [Figure 9] 1 is a partial flowchart of a control method for a medical device provided in an embodiment of the present invention. [Figure 10] 10 is another flowchart of step S2 provided in an embodiment of the present invention. [Figure 11]1 is a schematic electrocardiogram diagram corresponding to R wave sensing in an embodiment of the present invention. FIG. [Figure 12] 10 is an electrocardiogram diagram corresponding to another R wave sensing in an embodiment of the present invention. FIG. [Figure 13] FIG. 10 is a schematic electrocardiogram diagram corresponding to still another R wave sensing in an embodiment of the present invention. [Figure 14] FIG. 10 is a schematic electrocardiogram diagram corresponding to still another R wave sensing in an embodiment of the present invention. [Figure 15] 1 is a flowchart of steps S7 and S8 provided in an embodiment of the present invention. [Figure 16] 1 is a flowchart of steps S9 to S11 provided in an embodiment of the present invention. [Figure 17] FIG. 10 is a schematic diagram of steps S1003 and S1004 provided in an embodiment of the present invention. [Figure 18] 1 is a flowchart of steps S1005 to S1008 provided in an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0046] The present invention will be further described below by way of examples, but the present invention is not limited to the scope of the examples.

[0047] The term "comprises" and variations thereof as used herein should be understood to be an open inclusion, i.e., "including but not limited to." The term "depending on" means "depending at least in part on," and the term "plurality" means "two and more than two."

[0048] Although terms such as "first," "second," "third," and "fourth" are used to describe various elements in the present invention, it should be understood that these elements are not limited to these terms and that these terms are merely used to distinguish one element from another.

[0049] Example 1 In this embodiment, the medical device for delivering pulse stimulation includes at least one ventricular electrode lead and a control device. The at least one ventricular electrode lead has a first electrode pair for sensing and a second electrode pair for sensing and stimulating, and at least one electrode of the second electrode pair is located at a myocardial location in a ventricle. The first electrode pair and the second electrode pair may be located on the same ventricular electrode lead, or the first electrode pair and the second electrode pair may be located on different ventricular electrode leads.

[0050] The medical device for delivering pulse stimuli provided in this embodiment can provide a CCM therapy function by delivering CCM pulse stimuli to the myocardial location. Here, the CCM pulse stimuli refer to pulse stimuli for adjusting the cardiac contractility.

[0051] Optionally, the medical device is used to provide cardiac pacing and / or defibrillation therapy functions through the at least one ventricular electrode lead. In a specific implementation, the medical device may be a single-chamber ICD or a dual-chamber ICD, and its right ventricular electrode lead can provide not only cardiac pacing and / or defibrillation therapy functions but also CCM therapy functions. The medical device may also be a CRT-D (cardiac resynchronization therapy defibrillator), and its right ventricular electrode lead or left ventricular electrode lead can provide not only cardiac pacing and / or defibrillation therapy functions but also CCM therapy functions. The above medical device may also be a cardiac resynchronization therapy pacemaker (CRT-P), which can not only achieve cardiac pacing through its right ventricular electrode lead and / or left ventricular electrode lead, but also achieve CCM therapy by providing a defibrillation electrode on the right ventricular electrode lead to acquire a far-field myocardial electrocardiogram (FEM). In specific implementations, since a pacing electrode pair and at least one defibrillation electrode are provided on the right ventricular electrode lead of a conventional ICD, single-chamber pacemakers, dual-chamber pacemakers, and CRT-Ps can achieve CCM therapy using the right ventricular electrode lead in an ICD. With this configuration, the right ventricular electrode lead of a CRT device (including a CRT-P and a CRT-D) can provide CCM therapy in the right ventricle in addition to providing pacing therapy.

[0052] FIGS. 1 to 3 are used to illustrate schematic diagrams of a first electrode pair and a second electrode pair disposed on a right ventricular (RV) lead in a medical device, respectively. As shown in FIGS. 1 to 3, the first electrode pair includes an E1 electrode and an E2 electrode for sensing, and the second electrode pair includes an S1 electrode and an S2 electrode for sensing and stimulating. Specifically, as shown in FIG. 1, the E1 electrode is a spiral defibrillation electrode, the S2 electrode is a ring electrode, and the S1 electrode is a tip electrode, and the E2 electrode is disposed on a medical device control device 100. As shown in FIG. 2, the E1 electrode and the E2 electrode are both spiral defibrillation electrodes, the S2 electrode is a ring electrode, and the S1 electrode is a tip electrode. As shown in FIG. 3, the E2 electrode is disposed on a medical device control device 100, the E1 electrode and the S2 electrode are spiral defibrillation electrodes, and the S1 electrode is a tip electrode. Here, the S1 electrode in FIGS. 1 to 3 is disposed at the myocardial position of the ventricle.

[0053] The specific arrangement of the first electrode pair and the second electrode pair in the ventricular electrode lead is not limited to the forms shown in FIGS. 1 to 3, and other forms may be used.

[0054] FIG. 4 is a schematic flowchart of a control method for a medical device provided in this embodiment, which may be executed by a control device of the medical device for delivering pulse stimulation, and the control device may be implemented in the form of software and / or hardware, and the control device may be part of the medical device.

[0055] As shown in FIG. 4, the method for controlling a medical device provided in this embodiment may include the following steps S1 to S2.

[0056] In step S1, an in-vivo far-field myocardial electrocardiogram is obtained based on the first electrode pair, and an in-vivo near-field myocardial electrocardiogram is obtained based on the second electrode pair.

[0057] Here, the in-vivo far-field myocardial electrogram is also called FF-EGM (Far-Field Electrogram), and the in-vivo near-field myocardial electrogram is also called L-EGM (Local Electrogram, sometimes called Near-field Electrogram).

[0058] In step S2, it is determined whether to transmit a CCM pulse stimulus to the myocardial position according to the R wave in the internal far-field electrocardiogram and the R wave in the internal near-field electrocardiogram.

[0059] It should be noted that the R wave in the internal far-field electrocardiogram and the R wave in the internal near-field electrocardiogram correspond to the same beat.

[0060] In this embodiment, a first electrode pair arranged on at least one ventricular electrode lead of the medical device acquires an in-vivo far-field myocardial electrocardiogram, and a second electrode pair arranged on at least one ventricular electrode lead of the medical device acquires an in-vivo near-field myocardial electrocardiogram. The R waves in the in-vivo far-field myocardial electrocardiogram and the R waves in the in-vivo near-field myocardial electrocardiogram are combined to determine whether to send a CCM pulse stimulus to a myocardial location, thereby realizing the CCM therapy function.

[0061] Furthermore, compared to existing medical devices, the use of the at least one ventricular electrode lead not only enables the CCM therapy function to be realized, but also the functions of the original conventional device (including the cardiac pacing function and / or the defibrillation therapy function). Therefore, the medical device provided in this embodiment can provide ICD therapy and CCM therapy to a patient, and patients who need SCD prevention and heart failure treatment do not need to have two types of medical devices implanted, but can simply have the medical device provided in this embodiment implanted in their bodies.

[0062] Similarly, single-chamber pacemakers, dual-chamber pacemakers and CRT-Ps can achieve CCM therapy functions using the right ventricular electrode lead in a conventional ICD, and can also provide corresponding pacing therapy functions to the patient.

[0063] In a specific implementation, the pulse stimulation is a CCM stimulation and is delivered during at least one of the following ventricular electrical activity events: a sinus beat, a ventricular beat caused by an atrial downbeat, a ventricular beat caused by a ventricular pacing. Current CCM devices go a step further than providing CCM pulse therapy solely during a ventricular beat caused by an atrial downbeat.

[0064] In an alternative embodiment, as shown in FIG. 5, the above step S2 includes the following steps S21 to S23.

[0065] In step S21, a first detection time of an R wave in the internal far-field myocardial electrocardiogram, a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram, and a time window in which a pulse can be sent, which is a CCM stimulation safety window, corresponding to the R wave in the internal near-field myocardial electrocardiogram are obtained.

[0066] Here, the first sensing time may be referred to as a global sense (GS), and the pulse delivery window may be referred to as a CCM stimulation safety window (SSW). Here, the pulse delivery window corresponds to a safety period, which corresponds to a period during which a CCM pulse can be delivered throughout the entire ventricle, and aims to cover the absolute refractory period of the entire ventricular myocardium. Specifically, the pulse delivery window is determined according to an in-vivo far-field myocardial electrocardiogram, and both its start and end points are adjustable. The start point corresponds approximately to the "earliest" depolarization zone throughout the ventricular myocardium, and the end point corresponds to the end point of the absolute refractory period of the ventricular myocardium or slightly earlier than this point.

[0067] In one specific implementation example, if the R wave in the current internal far-field myocardial electrocardiogram is generated by a beat (e.g., an autonomous beat) caused by non-ventricular pacing, the start point of the time window in which the pulse can be sent can be determined according to the first detection time GS.

[0068] In a general case, the start point of the pulse delivery window corresponding to the R wave in the internal near-field electrocardiogram is determined based on the first detection time GS of the first detection event in the internal far-field electrocardiogram, thereby corresponding to the CCM pulse delivery period for the entire ventricle, where the first detection event is the R wave.

[0069] In a special case, a second detection time of a second sensed event in the near-field electrocardiogram corresponding to the first sensed event can also be determined. The second detection time may also be referred to as LS (Local Sense). Then, the start point of the time window in which a pulse can be delivered is determined according to the second detection time LS. In this case, the first detection time GS may be later than the true time node due to a delay in the acquisition of the electrocardiogram signal, or the second detection time LS of the second sensed event in the near-field electrocardiogram may be slightly earlier than the first detection time GS of the first sensed event due to other reasons. In this case, the second detection time LS is used as the counting start time, so that the correspondence between the local excitation event and the global excitation event can be more accurately determined. Therefore, the time window in which a pulse can be delivered corresponding to an R wave in the near-field electrocardiogram can be determined based on the second detection time LS of the R wave in the near-field electrocardiogram, and can correspond to the period in which a CCM pulse can be delivered throughout the entire ventricle.

[0070] The pulse delivery window corresponding to the R wave in the internal near-field myocardial electrocardiogram may further be determined by the delivery time of the pacing pulse.

[0071] In another specific example of implementation, if the R wave in the far-field electrocardiogram is generated due to a ventricular pacing pulse, the starting point of the pulse delivery window is the delivery time of the pacing pulse, which is considered to be the first sensing time in each embodiment of the present invention.

[0072] Specifically, the second preset length of the pulse delivery window may be preset to 200 ms, and the selectable range includes, but is not limited to, 150 ms to 300 ms, as long as the end point of the pulse delivery window does not exceed the absolute refractory period of the entire ventricular myocardium. Specifically, the second preset length can be adaptively adjusted depending on factors such as the patient's condition (e.g., whether or not an antiarrhythmic drug such as amiodarone is used, which may extend the absolute refractory period of the myocardium), the actual R-wave sensing situation (the first detection time GS and / or the second detection time LS), etc.

[0073] In step S22, the pulse transmission start time is determined according to the first detection time GS or the second detection time LS.

[0074] In an alternative embodiment of step S22, the pulse transmission start time is determined based solely on the first detection time GS. Specifically, the first detection time GS is used as a reference zero point, and the first preset duration is added to this to obtain the pulse transmission start time. The first preset duration may be determined based on calculating the time difference between the first detection time GS and the second detection time LS during a setup period before the actual operating period. The reference zero point here represents the time start point.

[0075] In an optional embodiment of step S22, a second detection time LS corresponding to a second detection event in the internal near-field myocardial electrocardiogram is determined according to the first detection time GS, and a pulse transmission start time is determined according to the second detection time.

[0076] In a specific example, the pulse transmission start time is determined based only on the second detection time, for example, the second detection time is set as the reference zero point, and based on this, the second preset duration is added to obtain the pulse transmission start time.

[0077] In another specific example, the pulse transmission start time is determined according to the first detection time and the second detection time. For example, the time difference between the second detection time and the first detection time is calculated, and then the first detection time is taken as the reference zero point. Based on this, the time difference and the third preset duration are added to obtain the pulse transmission start time.

[0078] Setting the pulse delivery start time ensures that the delivery time of the pulse stimulus is within the absolute refractory period of the myocardial excitation event contacted by the electrode delivering the pulse.

[0079] In step S23, it is determined whether or not to transmit a CCM pulse stimulus to the myocardial position, depending on the pulse transmission start time and the time window during which the pulse can be transmitted.

[0080] In an alternative embodiment, whether to transmit a CCM pulse stimulus is determined depending on whether the pulse transmission start time falls within a time window in which the pulse can be transmitted. Specifically, as shown in FIG. 6, step S23 includes the following steps S231a to S231c.

[0081] In step S231a, it is determined whether the pulse transmission start time falls within the pulse transmission possible time window, and if so, step S231b is executed, and if not, step S231c is executed.

[0082] In step S231b, a CCM pulse stimulus is transmitted to the myocardial position. Specifically, at the pulse transmission start time, a CCM pulse stimulus is transmitted to the myocardial position where the distal electrode S1 of the second electrode pair is located.

[0083] In step S231c, no CCM pulse stimulation is delivered to the myocardial position.

[0084] In this embodiment, by delivering a CCM pulse stimulus to a myocardial location only when the pulse delivery start time falls within the pulse delivery window, the CCM pulse stimulus is always delivered within the absolute refractory period of the entire ventricular myocardium, thereby ensuring the safety and reliability of patient treatment.

[0085] In another alternative embodiment, whether to deliver a CCM pulse stimulus is determined depending on whether the pulse delivery start time and pulse delivery stop time both fall within a time window in which the pulse can be delivered. Specifically, as shown in Fig. 7, step S23 includes the following steps S232a to S232d.

[0086] In step S232a, the pulse transmission stop time is determined according to the pulse transmission start time.

[0087] In step S232b, it is determined whether the pulse transmission start time and the pulse transmission stop time are both within the pulse transmission possible time window, and if so, step S232c is executed, and if not, step S232d is executed.

[0088] In step S232c, CCM pulse stimuli are transmitted to the myocardial location. Specifically, transmission of CCM pulse stimuli to the myocardial location starts at the pulse transmission start time, and transmission of CCM pulse stimuli to the myocardial location stops at the pulse transmission stop time.

[0089] In step S232d, no CCM pulse stimulus is delivered to the myocardial location.

[0090] In this embodiment, by delivering CCM pulse stimuli to a myocardial location only when the pulse delivery start time and pulse delivery stop time are both within the pulse delivery window, all CCM pulse stimuli are guaranteed to be within the absolute refractory period of the entire ventricular myocardium, thereby fully ensuring the safety and reliability of patient treatment.

[0091] In yet another alternative embodiment of step S23, whether to transmit a CCM pulse stimulus is determined depending on whether the pulse transmission start time and pulse transmission stop time fall within a time window in which the pulse can be transmitted. Specifically, as shown in Fig. 8, step S23 includes the following steps S233a to S233d.

[0092] In step S233a, the pulse transmission stop time is determined according to the pulse transmission start time and preset pulse parameters, where the pulse parameters include the number of pulses transmitted, pulse width, etc.

[0093] In step S233b, it is determined whether the pulse transmission start time falls within the pulse transmission possible time window, and if so, step S233c is executed, and if not, step S233f is executed.

[0094] In step S233c, it is determined whether the pulse transmission stop time falls within the pulse transmission possible time window, and if so, step S233e is executed, and if not, step S233d is executed.

[0095] In step S233d, the pulse parameters are re-determined so that the pulse transmission stop time falls within the pulse transmission available time window. In a specific implementation, the pulse transmission stop time can be made to fall within the pulse transmission available time window by reducing the pulse transmission number, the pulse transmission stop time can be made to fall within the pulse transmission available time window by reducing the pulse transmission width, or the pulse transmission stop time can be made to fall within the pulse transmission available time window by reducing the pulse transmission number and the pulse width.

[0096] In step S233e, a CCM pulse stimulus is transmitted to the myocardial position. Specifically, transmission of the CCM pulse stimulus to the myocardial position starts at the pulse transmission start time and stops at the pulse transmission stop time.

[0097] In one specific implementation example, if the pulse transmission start time falls within the pulse transmission possible time window and the pulse transmission stop time does not fall within the pulse transmission possible time window, the pulse parameters need to be re-determined so that the pulse transmission start time and the pulse transmission stop time both fall within the pulse transmission possible time window, and a CCM pulse stimulus is delivered to the myocardial location according to the re-determined pulse parameters.

[0098] In another example of specific implementation, if the pulse transmission start time and the pulse transmission stop time are both within the pulse transmittable time window, a CCM pulse stimulus is transmitted to the myocardial location according to preset pulse parameters.

[0099] In step S233f, no CCM pulse stimulus is sent to the myocardial position.

[0100] In this embodiment, if the pulse transmission start time falls within the pulse transmission possible time window and the pulse transmission stop time does not fall within the pulse transmission possible time window, the pulse parameters are re-determined so that CCM pulse stimulation is transmitted to the myocardial position only when the pulse transmission start time and the pulse transmission stop time both fall within the pulse transmission possible time window, thereby ensuring that all CCM pulse stimulations are within the absolute refractory period of the entire ventricular myocardium, thereby fully ensuring the safety and reliability of patient treatment and providing the patient with the maximum possible CCM therapy.

[0101] In yet another alternative embodiment, step S23 includes the following steps S234a to S234b.

[0102] In step S234a, if the pulse transmission start time falls within the pulse transmission possible time window, the pulse transmission stop time is determined.

[0103] In step S234b, it is determined whether or not to transmit a CCM pulse stimulus depending on the pulse transmission stop time and the time window during which the pulse can be transmitted.

[0104] In the medical device provided in this embodiment, if the pulse transmission start time falls within the pulse transmission window, the pulse transmission stop time is further determined, and finally, whether to transmit a CCM pulse stimulus is determined depending on whether the pulse transmission stop time falls within the pulse transmission window, thereby effectively avoiding the situation where a CCM pulse stimulus is transmitted outside the absolute refractory period of the entire myocardium. The medical device provided in this embodiment can improve the safety, effectiveness, and reliability of patient treatment compared to existing cardiac contractility modulation devices.

[0105] In an optional embodiment of step S234b, it is determined whether the pulse delivery stop time falls within the pulse delivery time window, and if so, a CCM pulse stimulus is delivered, and if not, a CCM pulse stimulus is not delivered.

[0106] In another alternative embodiment, step S234a specifically includes a step of determining a pulse delivery stop time according to the pulse delivery start time and preset pulse parameters, and step S234b specifically includes a step of determining whether the pulse delivery stop time falls within the pulse delivery possible time window, and if so, delivering a CCM pulse stimulus, and if not, redetermining the pulse parameters so that the pulse delivery stop time falls within the pulse delivery possible time window, and delivering a CCM pulse stimulus according to the redetermined pulse parameters.

[0107] In an optional embodiment, the step of delivering a CCM pulse stimulus to the myocardial location, e.g., steps S231b, S232c, and S233e, specifically delivers a CCM pulse stimulus to the myocardial location when it is determined that a second sensed event in the internal near-field myocardial electrocardiogram is an R wave corresponding to an R wave in the internal far-field myocardial electrocardiogram.

[0108] In this embodiment, by determining that the second sensed event in the internal near-field myocardial electrocardiogram is an R wave, the CCM stimulation is not triggered by other signals (e.g., T waves, myoelectricity, or other non-myocardial depolarizing electrical activity, etc.), but is triggered by the near-field R wave, thereby effectively eliminating the occurrence of false triggering situations. This important design effectively improves the safety and efficacy of CCM pulse stimulation.

[0109] In an alternative embodiment, as shown in FIG. 9, the above control method further includes the following steps S3 to S6.

[0110] In step S3, a detection time window corresponding to an R wave in the body far-field myocardial electrocardiogram is obtained.

[0111] Here, the detection time window may also be referred to as an R-wave time window (RTW). Specifically, the detection time window can be obtained according to the first detection time and / or the second detection time. First, the start point of the detection time window is determined according to the first detection time and / or the second detection time. Then, the first preset length of the detection time window can be determined according to the type of current ventricular activation. In a specific example, if the type of current activation is atrial-conducted ventricular activation, the width of the R wave in the internal far-field electrocardiogram is normal, typically between 60 ms and 120 ms. For example, the first preset length of the detection time window may be determined to be 100 ms. In another specific example, if the type of current activation is ventricular activation caused by the ventricle, the width of the R wave in the internal far-field electrocardiogram is wider than the normal width, typically between 160 ms and 250 ms. For example, the first preset length of the detection time window may be determined to be 200 ms. In another specific example, if the type of current excitation is ventricular pacing excitation, the R wave in the far-field electrocardiogram is wide, typically between 160 and 250 ms, and the first preset length of the detection time window can be determined to be 200 ms. Here, the type of ventricular excitation can be determined by a conventional method, such as detecting PVC (premature ventricular contraction).

[0112] Alternatively, the first preset length of the detection time window can be obtained in other ways, such as by a physician directly programming the length of the time window through an external device (e.g., a programmable controller) to modify the preset value. Here, the starting points of the pulse delivery time window and the detection time window may be the same or different, and the second preset length of the pulse delivery time window and the first preset length of the detection time window may be the same or different. That is, the pulse delivery time window and the detection time window may be set in the same way or independently of each other, with no correlation or dependency between them, for example, by setting different window lengths and setting different preset durations after the first and second detection times. Preferably, when the pulse delivery time window and the detection time window starting points are the same, the second preset length of the pulse delivery time window is greater than the first preset length of the detection time window.

[0113] In step S4, it is determined whether the second detection time falls within the detection time window, and if so, step S5 is executed; if not, step S6 is executed.

[0114] In step S5, the second sensed event is determined to be an R wave corresponding to an R wave in the internal far-field myocardial electrocardiogram.

[0115] In step S6, it is determined that the second sensed event is not an R wave corresponding to an R wave in the internal far-field electrocardiogram. Specifically, if the second sensed event is not an R wave corresponding to an R wave in the internal far-field electrocardiogram, it is possible that the second sensed event is a T wave or other interference signal.

[0116] In general, the R wave sensing in the far-field electrocardiogram reflects a relatively early time of ventricular electrical activity, and the second sensing time LS in the internal near-field electrocardiogram is usually located after the first sensing time GS. Therefore, a sensing time window is obtained at the first sensing time GS to determine whether the second sensing time falls within the sensing time window. In special cases, due to possible delayed sensing, the first sensing time GS may be slightly later than the second sensing time LS, and the difference between the two is within a predetermined range (e.g., 20 ms to 120 ms). In order to more accurately determine the correspondence between the R wave in the far-field electrocardiogram and the second sensing event in the internal near-field electrocardiogram, the sensing time window can be obtained using the second sensing time LS. In this case, the second sensing time LS necessarily falls within the sensing time window, and it can be directly determined that the second sensing event in the internal near-field electrocardiogram is the R wave corresponding to the R wave in the far-field electrocardiogram.

[0117] As shown in FIG. 10, the method for controlling a medical device provided in this embodiment may include the following steps S301 to S304.

[0118] In step S301, it is determined whether a pacing pulse is to be delivered to the myocardial position. If so, step S302 is executed; if not, step S303 is executed.

[0119] In step S302, it is determined whether the ventricle has been captured. If not, step S303 is executed; if yes, step S304 is executed. In a specific implementation, there are several ways to determine whether the ventricle has been captured, for example, it can be determined whether the ventricle has been captured based on the in-vivo far-field myocardial electrocardiogram. Of course, if the pacing pulse width is sufficiently high and / or the pulse width is sufficiently long, capture can be considered definitive, and no special determination is required to determine capture, and step S304 can be directly executed.

[0120] In step S303, determine whether the second sensed event in the internal near-field electrocardiogram is an R wave corresponding to an R wave in the internal far-field electrocardiogram; if so, execute step S304; if not, end the flow.

[0121] In step 304, whether to deliver a CCM pulse stimulus to the myocardial region is determined according to the pulse delivery start time and the pulse delivery available time window. In a specific implementation, a first detection time of an R wave in the intracorporeal far-field electrocardiogram and a pulse delivery available time window corresponding to the R wave in the intracorporeal near-field electrocardiogram are obtained, and a pulse delivery start time is determined according to the first detection time. The step of determining whether to deliver a CCM pulse stimulus to the myocardial region according to the pulse delivery start time and the pulse delivery available time window is similar to step S23 above.

[0122] In this embodiment, if it is determined that a pacing pulse is to be delivered to the myocardial location, the medical device provides a pacing function, and it is necessary to further determine whether the ventricle has been captured. If it is determined that the ventricle has not been captured, it is necessary to further determine whether the second sensed event in the internal near-field myocardial electrocardiogram is a corresponding R wave. If it is an R wave, it is determined whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window. If it is determined that the ventricle has been captured, the pacing pulse time is set to 0. First detection time As a result, whether or not to deliver a CCM pulse stimulus to the myocardial position is directly determined according to the pulse delivery start time and the time window during which the pulse can be delivered.

[0123] In an alternative embodiment, the step of delivering CCM pulse stimulation to the myocardial location, e.g., the above steps S231b, S232c, and S233e, specifically includes a step of delivering CCM pulse stimulation to the myocardial location if it is detected that the current heart rate parameter is within a preset range. Here, if the current heart rate parameter is not within the preset range, it is explained that the patient's current heart rate parameter is abnormal, and in this case, CCM pulse stimulation is not delivered to the myocardial location.

[0124] Specifically, two adjacent R waves can be used to determine whether the current heart rate parameter is within a preset range, which can be set according to the patient's actual condition, for example, [40 beats / min, 120 beats / min]. If the current heart rate parameter is less than 40 beats / min or greater than 120 beats / min, it can be determined that the current heart rate parameter is abnormal.

[0125] In this embodiment, only when the current heart rate parameter is within the preset range, i.e., when the current heart rate parameter is normal, can CCM pulse stimulation be delivered to the patient's myocardial location where the second electrode pair is installed, further ensuring the safety and reliability of treatment for the patient.

[0126] Example 2 Example 2 is similar to Example 1, and the same points will not be described in detail here, but will focus on the differences between the two. In this example, the first electrode pair is not placed on a ventricular electrode lead, but is configured as an additional electrode placed intravascularly, intracardiacly, epicardially, intrathoracically outside the heart, or subcutaneously, such as a subcutaneous defibrillation electrode for a sub-Q ICD, and these electrodes can similarly acquire an in-vivo far-field myocardial electrocardiogram. It should be understood that any of the various methods described in Example 1 can be applied to the situation in Example 2.

[0127] Example 3 Example 3 is similar to Example 1, and the same points will not be described in detail here, focusing instead on the differences between the two. In this example, the first electrode pair is not arranged on a ventricular electrode lead, but is configured as a body surface electrode for attachment to the skin, such as a commonly used body surface electrocardiogram electrode, a specially designed electrode, or a defibrillation electrode of an external defibrillator (such as an AED). Therefore, based on the first electrode pair, a body surface electrocardiogram is acquired instead of the far-field myocardial electrocardiogram in Example 1, and the first detection time of an R wave in the body surface electrocardiogram is obtained. The pulse delivery start time is determined according to the first detection time, and whether the pulse delivery start time falls within the pulse delivery window is determined. It should be understood that the various methods described in Example 1 can all be applied to the situation in Example 3.

[0128] In the present invention, the body surface electrocardiogram and the far-field myocardial electrocardiogram in Examples 1, 2, and 3 can be collectively referred to as a far-field electrocardiogram. Those skilled in the art will understand that the R wave referred to in the present invention includes a QRS complex and an individual R wave.

[0129] In summary, the present invention actually provides a medical device for delivering pulse stimulation, including at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be placed at a myocardial location in a ventricle, and the control device is configured to execute a pulse stimulation control method, as shown in FIG. 15 : Step S7 of acquiring a far-field electrocardiogram and an in-body near-field myocardial electrocardiogram corresponding to the myocardial location; and step S8, determining whether to deliver a CCM pulse stimulus to the myocardial location via the ventricular electrode lead in response to an R wave in the far-field electrocardiogram and an R wave in the internal near-field myocardial electrocardiogram.

[0130] Hereinafter, the pulse stimulation control method according to the embodiment of the present invention will be described in more detail, taking an electrocardiogram corresponding to R wave sensing as an example.

[0131] Optionally, the first detection time GS is taken as the first time point, and a time point corresponding to a preset duration (programmable, the range includes but is not limited to 10 ms to 200 ms, preferably 30 ms to 120 ms, e.g., 60 ms) before the first time point is taken as the time reference zero point (starting point), and a second detection time LS of the R wave of the internal near-field myocardial electrocardiogram is obtained based on the time reference zero point.

[0132] In one embodiment, the global pulse time (GPT) is a time window during which a pulse can be delivered, determined based on a first detection time GS of a first sensed event in a far-field electrocardiogram (which may be a body surface electrocardiogram or an internal far-field electrocardiogram), and has a first preset length. The first sensed event is an R wave. As shown in FIG. 11 , the control device first obtains a first detection time GS of an R wave in the far-field electrocardiogram, and generates a time window during which a pulse can be delivered based on the first detection time GS and the first preset length. The control device then obtains a second detection time LS of an R wave in the near-field electrocardiogram corresponding to the R wave, where the second detection time LS is later than the first detection time GS. The second detection time LS is set as the reference zero point, and the pulse transmission start time T is obtained according to the second detection time LS and the second preset duration LPD. Since the pulse transmission start time T falls within the time window GPT in which the pulse can be transmitted, it is decided to transmit a CCM pulse stimulus to the second electrode pair (i.e., after the second detection time LS, the second preset duration is waited for, and when the pulse transmission start time T arrives, the CCM pulse stimulus is transmitted).

[0133] The pulse transmission start time may be determined by the first detection time GS. Specifically, the first detection time GS is used as the reference zero point, and the pulse transmission start time T is obtained according to the difference GLSD (in this case, a positive number) between the second detection time LS and the first detection time GS and the third preset duration (here, equal to the second preset duration LPD, which may range from 15 ms to 80 ms, and is generally defaulted to 30 ms) (that is, after the first detection time GS, the CCM pulse stimulation is transmitted when the pulse transmission start time T is reached after the total time length of the difference GLSD and the third preset duration).

[0134] To prevent misdetection of an R wave in an in-vivo near-field electrocardiogram (e.g., to prevent a T wave from being mistaken for an R wave), a first detection time GS can be used as a reference zero point to determine the start point of a detection time window corresponding to an R wave in a far-field electrocardiogram. The first preset length of the detection time window can be equal to or shorter than a second preset length of the pulse transmission window GPT. A second detection time LS is further determined to fall within the detection time window. If the second detection time LS falls within the detection time window, it is determined that the detected event is an R wave in an in-vivo near-field electrocardiogram corresponding to an R wave in a far-field electrocardiogram. If the second detection time LS does not fall within the detection time window, it is determined that the detected event is not an R wave in an in-vivo near-field electrocardiogram corresponding to an R wave in a far-field electrocardiogram, but is a different detected event. In this case, no CCM pulse stimulation is transmitted.

[0135] In another embodiment, as shown in Figure 12, the control device first detects the second detection time LS of the R wave in the in-vivo near-field electrocardiogram, and then detects the first detection time GS of the R wave in the far-field electrocardiogram. If the second detection time LS occurs slightly earlier than the first detection time GS, this may be due to a bias caused by a delay in R-wave sensing. In this case, a local sense pulse time LSPT is determined. The LSPT (Local Sense Pulse Time) is a time window in which a pulse can be delivered, determined based on the second detection time LS of the R wave in the in-vivo near-field electrocardiogram, and has a preset window length. Furthermore, the second detection time LS is set as the reference zero point, and the pulse transmission start time T is obtained according to the second detection time LS and the second preset duration LPD. In this case, when the pulse transmission start time T falls within the LSPT, it is determined that a CCM pulse stimulus is to be transmitted to the myocardial position where the second electrode is located (i.e., after the second detection time LS, the second preset duration is waited for, and when the pulse transmission start time T arrives, the CCM pulse stimulus is transmitted).

[0136] Furthermore, the first detection time GS is set as the reference zero point, and the pulse transmission start time T can be obtained according to the difference GLSD (which is a negative number in this case) between the second detection time LS and the first detection time GS and the duration of the third preset (here, equal to the duration LPD of the second preset) (that is, after the first detection time GS, the CCM pulse stimulation is transmitted when the pulse transmission start time T arrives after the total time length of the difference GLSD and the duration of the third preset has elapsed).

[0137] To prevent false detection of the R wave of the in-vivo near-field electrocardiogram, the second detection time LS can be used as a reference zero point to determine the start point of a detection time window corresponding to the R wave of the far-field electrocardiogram, and the first preset length of the detection time window can be equal to or shorter than the second preset length of the pulse transmittable time window LSPT. It is further determined whether the second detection time LS falls within the detection time window. Since the second detection time LS falls within the detection time window, it can be confirmed that the detected R wave is the R wave of the in-vivo near-field electrocardiogram corresponding to the R wave of the far-field electrocardiogram.

[0138] Example 4 Regarding the above-mentioned Examples 1, 2, and 3, the method of delivering pulse stimulation can be further divided into two stages: a setup period and an operational period.

[0139] For a single myocardial point electrode pulse stimulation system, the following parameters need to be measured during the setup period:

[0140] Referring to FIG. 11 or 12, the second detection time LS is the second detection event of the local electrocardiogram that is detected for the first time after the time reference zero point determined from the first detection time GS.

[0141] GLSD is the difference between the second detection time LS and the first detection time GS, and if the second detection time LS is later than the first detection time GS, the difference GLSD is a positive number, and if the second detection time LS is earlier than the first detection time GS, the difference GLSD is a negative number. The second preset duration LPD is the length of time between the second detection time LS and the pulse transmission start time T, and as in the above embodiment, the length of time GPD between the first detection time GS and the pulse transmission start time T can be calculated from the difference GLSD and the second preset duration LPD. That is, GPD = GLSD + LPD.

[0142] During the operation period, the GPD calculated during the setup period is set as the first preset duration, and a CCM pulse stimulus can be delivered to the corresponding myocardial position according to the first detection time GS and the first preset duration GPD. In this case, after an R wave of the local myocardial electrocardiogram is sensed, the pulse stimulus is delivered according to the first detection time GS and the second detection time LS. intense The electrical stimulation output time can be directly determined according to the first preset duration GPD without needing to calculate the delivery time of the first preset duration GPD, thereby achieving the stimulation effect while effectively shortening the time required for data processing and improving the control efficiency of cardiac pulse stimulation triggers.

[0143] Also, according to actual requirements, the pulse delivery time GPD (at this time, myocardial electrical stimulation may continue or stop) is updated periodically or irregularly, and then, myocardial electrical stimulation is continuously performed according to the updated trigger time to achieve a more flexible electrical stimulation effect and meet the needs of more pulse electrical stimulation scenarios.

[0144] Preferably, all the above parameters are averaged over several cardiac cycles (for example, 6 cardiac cycles, programmable, and other numbers of cardiac cycles may also be used), and the setup period should be performed during the periods of sinus cardiac electrical activity, ventricular compensatory electrical activity, and ventricular pacing, respectively.

[0145] In another embodiment, as shown in FIG. 13, the start time of the pulse deliverable time window GPT / LSPT may be different from the first detection time GS or the second detection time LS, and is earlier than the first detection time GS or the second detection time LS - the duration A of the fourth preset. By setting the duration A of the fourth preset, the error due to detection delay can be corrected, and the accuracy of R-wave determination and the safety of pulse stimulation delivery can be further improved.

[0146] Specifically, when the start time of the pulse deliverable time window GPT / LSPT is GPT-s / LSPT-s, GPT-s = GS - A, GLSD > 0 (that is, LS is later than GS), LSPT-s = GS + GLSD - A, GLSD ≤ 0 (that is, LS is earlier than GS or the same as GS), Here, 0ms < A ≤ 50ms. For example, the default value of A is 20ms, and A is programmably set and adjusted.

[0147] In other embodiments, the second detection time LS may be equal to the first detection time GS, and the difference between the first detection time and the second detection time is equal to 0ms, that is GLSD=0 ms. In this case, the first detection time GS may be set as the reference zero point, or the second detection time LS may be set as the reference zero point, and the first preset time, the second preset time, and the third preset time are all equal.

[0148] Example 5 The difference between this embodiment and the above embodiments is that the medical device includes multiple ventricular electrode leads that are respectively placed at multiple different myocardial locations, and multiple second electrodes contact the tissue at these myocardial locations. According to the control device described in embodiments 1, 2, and 3, CCM pulse stimulation is delivered to each myocardial location in a timely and effective manner, ensuring the safety, effectiveness, and reliability of treatment for the patient.

[0149] Here, the detection time window is determined according to a first detection time of an R wave in a far-field electrocardiogram and a second detection time corresponding to the closest second detection event.

[0150] For example, as shown in Figure 14, taking the example of pre-installing pulse stimulation electrodes at three different predetermined myocardial positions (A, B, C) of a patient, the predetermined myocardial positions A, B, and C correspond to stimulation electrode pairs E1, E2, and E3, respectively, and the second detection times of the corresponding second detection events are LS1, LS2, and LS3, respectively, where the occurrence times corresponding to LS1, LS2, and LS3 progress sequentially (i.e., the first second detection event occurs earliest and is therefore closest to the first detection time, and the other second detection events occur at subsequent times).

[0151] Specifically, when a second detected event in the internal near-field myocardial electrocardiogram corresponding to a set myocardial position A is acquired based on the electrode pair E1 at the set myocardial position A, a second detection time LS1 corresponding to the second detected event is acquired, and it is determined whether or not the second detection time LS1 falls within a detection time window corresponding to an R wave in the far-field electrocardiogram. If the second detection time LS1 does not fall within the detection time window, the second detected event is determined to be not an R wave signal corresponding to an R wave in the far-field electrocardiogram but another interference signal such as a T wave, and control is performed so as not to send a CCM pulse stimulation to the stimulation electrode pair E1 at the set myocardial position A. If the second detected event falls within the detection time window, the second detected event is determined to be not an R wave signal corresponding to an R wave in the far-field electrocardiogram. Then, within the second detection time corresponding to the second detection event, the pulse delivery time corresponding to the stimulating electrode corresponding to the set myocardial position A is calculated in a timely and accurate manner. Then, the pulse delivery time is determined to be within the pulse delivery window GPT corresponding to the R wave in the far-field electrocardiogram. If it is within the pulse delivery window GPT, the pulse stimulation is controlled to be delivered to the stimulating electrode at the set myocardial position A within the pulse delivery time. If not, the CCM pulse stimulation is determined not to be delivered to the stimulating electrode at the set myocardial position A, and one pulse stimulation control at the set myocardial position A is completed.

[0152] 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, and therefore a detailed description thereof will be omitted here.

[0153] After determining that each second detection event is an R wave detection, if the pulse transmission time calculated according to the second detection time corresponding to the second detection event falls within the pulse transmission time window GPT corresponding to the R wave in the far-field electrocardiogram, the second detection time LS1 corresponding to the first second detection event can be used as the trigger point (reference zero point) of the pulse transmission time window LSPT, and the pulse transmission times of subsequent LSn (n>1, for example, LS2 and LS3) can be ensured to be within the LSPT window.

[0154] Furthermore, the pulse stimulation control processes for different designated myocardial locations can be independent of each other and do not interfere with or affect each other. For example, when a pulse stimulation control process for designated myocardial location A is in progress or has been completed, if a second sensed event LS2 appears on the near-field electrocardiogram corresponding to designated myocardial location B, the above pulse stimulation control process can be independently performed, ultimately completing pulse stimulation control for all designated myocardial locations. The control operations are performed in an orderly manner, effectively ensuring the safety and reliability of CCM pulse stimulation for patients. Different pulse stimulation delivery sequences can be set for different designated myocardial locations. For example, within three consecutive time periods, each ventricular electrode lead can stimulate myocardial locations A, B, and C, respectively. Alternatively, for example, pulse stimulation can be performed only to designated myocardial location A during one time period and only to designated myocardial locations B and C during another time period, thereby achieving both safety and efficacy.

[0155] In a possible solution, when the detection times corresponding to the second detection events of the multiple internal near-field myocardial electrocardiograms are very tight (i.e., the time intervals are small), the pulse stimulation control method of this embodiment further comprises: acquiring a second detection time LS corresponding to a second detected event in the in-vivo near-field electrocardiogram corresponding to each in-vivo electrocardiogram, acquiring the second detected event with the earliest occurrence time as the first second detected event, acquiring a second detection time LS1 corresponding to the first second detected event, determining whether the second detection time LS1 falls within a detection time window corresponding to an R wave in the far-field electrocardiogram, and if so, determining that the second detected event is a local myocardial R wave signal corresponding to an R wave in the far-field electrocardiogram; and determining whether the second detection times corresponding to the second sensed events in the local myocardial electrocardiogram corresponding to the remaining myocardial locations are within the detection time window. If so, if it is determined that the first second sensed event is an R-wave signal corresponding to an R-wave in the far-field electrocardiogram, then directly determining that the second sensed event in the in-body near-field myocardial electrocardiogram corresponding to the remaining myocardial locations is also an R-wave signal corresponding to an R-wave in the far-field electrocardiogram, thereby eliminating the need to determine and analyze the second sensed events in the local myocardial electrocardiogram corresponding to the remaining myocardial locations one by one and achieving accurate determination. This greatly simplifies the data analysis process, effectively shortens the data processing time, reduces the requirements for the computing power of the device, and further ensures the timeliness, accuracy, and effectiveness of pulse stimulation control for the patient.

[0156] Furthermore, which method is used to determine whether the second detected event of multiple regional myocardial electrocardiograms is an R wave can be selected based on the needs of the actual scene, either as a single implementation plan or a combination of multiple implementation plans, which can meet the more demanding electrocardiographic ventricular conduction scenes, greatly improving the practicality of pulse stimulation control and greatly improving the safety and efficacy of treatment for patients.

[0157] Therefore, when there are a plurality of set myocardial positions, the pulse stimulation control method of this embodiment further includes: A step (1) of presetting set sensing parameters corresponding to R waves at different set myocardial locations, wherein the set detection parameters include a set detection time and / or a set detection occurrence order; (2) when the second detection event in the internal near-field myocardial electrocardiogram that first appears corresponding to the detection time window is an R wave, setting all the second detection events in the remaining local myocardial electrocardiograms to be R waves; or The method includes a step (3) of setting all remaining second detection events in the local myocardial electrocardiograms to be R waves when the second detection event in the internal near-field myocardial electrocardiogram that appears last corresponding to the detection time window is an R wave.

[0158] In both single-electrode and multi-electrode pulse stimulation systems, the delivery time of the CCM pulse stimulation at each myocardial location is after the local myocardial sensing time, for example, 40 ms.

[0159] Example 6 This embodiment is similar to Example 1, and detailed explanations of the same points will be omitted here. The difference is that the methods for obtaining the first detection time of the R wave in the far-field electrocardiogram and the second detection time of the R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram are different.

[0160] In this embodiment, the second detection time of the second sensed event in the in-vivo near-field electrocardiogram is set as the second time point, and the time point corresponding to the duration of a second preset value before the second time point is set as the zero point of the time reference, and the first sensed event in the far-field electrocardiogram located after the zero point of the time reference is obtained, and optionally the duration of the second preset value is 10 ms or more and 120 ms or less, where the second sensed event in the in-vivo near-field electrocardiogram is an R wave, and after finding the first sensed event by the above method, it can be determined whether the first sensed event in the far-field electrocardiogram is an R wave corresponding to the R wave in the in-vivo near-field electrocardiogram. Regardless of whether the first or second detection event is acquired first, one of them can be set as the first time point, and the corresponding other detection event can be acquired. By using the detection time window setting method in Examples 1 to 5, it can be determined whether the second detection event in the in-vivo near-field myocardial electrocardiogram corresponds to the first detection event in the far-field electrocardiogram. If one of them is an R wave, such correspondence can be used to determine whether the other is also an R wave, thereby ensuring that CCM pulse stimulation is not sent when false detection occurs.

[0161] As can be seen from the above Examples 1 to 6, the present invention further provides a medical device for delivering pulse stimulation, including at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be placed at a myocardial position in the ventricle, and as shown in Figure 16, the control device is configured to execute a pulse stimulation control method, which includes steps S9 to S12. In step S9, a far-field electrocardiogram and an in-body near-field myocardial electrocardiogram corresponding to the myocardial position are obtained. In step S10, it is determined whether the first sensed event in the far-field electrocardiogram and the second sensed event in the internal near-field myocardial electrocardiogram are corresponding R waves; if not, step S11 is performed; if yes, step S12 is performed. In step S11, no CCM pulse stimulus is sent to the myocardial position. In step S12, a CCM pulse stimulus is delivered to the myocardial location via the ventricular electrode lead.

[0162] Here, before step S12, the pulse transmission start time and / or pulse transmission stop time are determined based on the first detection time of the first detection event and the second detection time of the second detection event. , and the time window during which the pulse can be sent Get Pa It can be determined whether the pulse transmission start time and / or pulse transmission stop time falls within the time window in which the pulse can be transmitted. The details have already been described in detail in the first embodiment, so a detailed description will be omitted here.

[0163] Those skilled in the art will appreciate that in the prior art, signal interference can cause false sensing events, which may result in other events, such as T waves, being detected instead of R waves, significantly increasing the risk of inducing malignant ventricular arrhythmias, VT or VF, thereby increasing the risk to the patient's life and subjecting the patient to additional painful stimulation. The pulse stimulation control method provided in the present invention can effectively recognize such false sensing events and thereby prevent the delivery of inappropriate CCM pulse stimulation.

[0164] Optionally, step S10 further comprises: obtaining a first detection time GS of a first sensed event in the far-field electrocardiogram and a second detection time LS of a second sensed event in the in-body near-field electrocardiogram, wherein at least one of the first sensed event and the second sensed event is an R wave; and confirming that the first sensed event in the far-field electrocardiogram corresponds to the second sensed event in the internal near-field electrocardiogram when an absolute value of a difference between a first detection time GS of the first sensed event in the far-field electrocardiogram and a second detection time LS of the second sensed event in the internal near-field electrocardiogram is within a preset range, wherein the preset range is from 0 ms to 120 ms if the first sensed event and the second sensed event are both R waves and the first sensed event in the far-field electrocardiogram is caused by ventricular excitation of an atrial conduction, and the preset range is from 0 ms to 250 ms, preferably 100 ms, if the R wave in the far-field electrocardiogram is caused by ventricular excitation of a ventricle or a ventricular pacing pulse.

[0165] Optionally, as shown in FIG. 17, step S10 may further include: Step S1003: determining a second sensed event in the in-body near-field myocardial electrocardiogram based on the first sensed time, and obtaining a second sensed time corresponding to the second sensed event, where the first sensed time is an R wave; or The method includes step S1004: determining a first detection event in the far-field electrocardiogram based on the second detection time, and obtaining a first detection time corresponding to the first detection event, where the second detection time is an R wave.

[0166] As can be understood, when obtaining a second detection time based on the first detection time, for example when a new first detection time occurs, if the second detection time still cannot be obtained, or when obtaining a first detection time based on the second detection time, for example when a new second detection time occurs, if the first detection time still cannot be obtained, the control device is configured to start a new judgment step again.

[0167] Optionally, step S1003 further includes a step of: taking the first detection time as a first time point, and taking a time point corresponding to a first preset duration before the first time point as a time reference zero point, and acquiring a second detection event in the internal near-field myocardial electrocardiogram located after the time reference zero point, wherein the duration of the first preset is greater than or equal to 10 ms and less than or equal to 120 ms.

[0168] Optionally, step S1004 further includes a step of: taking the second detection time as a second point in time, and taking a point in time corresponding to a second preset duration before the second point in time as a time reference zero point, and acquiring a first detection event in the far-field electrocardiogram located after the time reference zero point, wherein the duration of the second preset is greater than or equal to 10 ms and less than or equal to 120 ms.

[0169] Optionally, as shown in FIG. 18, step S10 further includes steps S1005 to S1008. In step S1005, a detection time window corresponding to the first detected event in the far-field electrocardiogram is obtained. In step S1006, it is determined whether the second detection time falls within the detection time window, and if so, execute step S1007; if not, execute step S1008. In step S1007, it is determined that the first sensed event in the far-field electrocardiogram corresponds to a second sensed event in the internal near-field myocardial electrocardiogram, and both the first sensed event and the second sensed event are R waves. In step S1008, it is determined that the first sensed event in the far-field electrocardiogram does not correspond to the second sensed event in the internal near-field myocardial electrocardiogram, and one of the first sensed event and the second sensed event is not an R wave.

[0170] Steps S1005 and S1006 have already been described in detail in the first to seventh embodiments, so a detailed description thereof will be omitted here.

[0171] In each embodiment of the present invention, the pulse delivery time window is a new requirement for the delivery time of CCM pulse stimulation. In particular, when CCM pulse stimulation is delivered to multiple stimulation sites, the delivery time of each stimulation site must fall within the pulse delivery time window, i.e., within the deliverable period of the entire ventricle of the same beat (ventricular excitation) (not just the deliverable period of the local ventricular myocardium at the electrode site).

[0172] The sensing time window is used as a "whole ventricle" or "far-field ventricle" R-wave sensing time window to determine whether the acquired second sensed event is an R-wave sense corresponding to a local ventricular depolarization that corresponds to an R-wave in a far-field electrocardiogram (i.e., corresponding to an R-wave sense in the "whole ventricle" or "intracorporeal far-field" of a ventricular depolarization). The pulse delivery window (a period during which delivery of the entire ventricular myocardium ("whole ventricle" or "far-field ventricle") is possible as a safe region for stimulation delivery) is used to determine whether the pulse stimulation delivery time corresponding to the second sensing time LS is safe.

[0173] The pulse delivery time window and the detection time window are independent, and these two programmable parameters meet actual parameter setting needs. Of course, to reduce the complexity of programming, the physician may use similar values for both (if appropriate). Alternatively, the system may pre-set the same values for these two parameters, but must maintain the ability to program these two parameters separately. These two steps can be used together or separately.

[0174] In this embodiment, the CCM pulse stimulation is delivered within the ventricular deliverable period, and the delivery time of the pulse stimulation is confirmed to fall within the window for delivering a pulse corresponding to the cardiac electrical activity (R wave) of the entire ventricle on a body surface electrocardiogram or an internal far-field electrocardiogram, thereby ensuring the timeliness, safety, and effectiveness of the CCM pulse stimulation for the patient's heart. Obtaining information on the deliverable period of ventricular cardiac electrical activity from a body surface electrocardiogram or a far-field electrocardiogram for the purpose of ensuring the safety of the pulse stimulation delivery time also represents a proactive improvement in pulse stimulation technology, further ensuring the safety, effectiveness, and therapeutic effects of CCM pulse stimulation for the patient.

[0175] In addition, transmitting CCM pulse stimuli only after the R wave is detected enables timely analysis and processing of second sensed events in the in-vivo near-field myocardial electrocardiogram, automatically and accurately detects erroneous sensed events, and determines that they belong to interference signals such as T waves rather than R wave signals corresponding to R waves in the far-field electrocardiogram. In this case, control is performed to prevent CCM pulse stimuli from being transmitted to the corresponding myocardial location, ensuring that CCM pulse stimuli are not transmitted in erroneous cases, effectively avoiding the risk of inducing VT or VF, and further avoiding unnecessary pain and safety risks to the patient, ensuring patient safety, improving the reliability of pulse stimuli control, and ensuring that CCM pulse stimuli are transmitted in a timely manner when determined to be an R wave, i.e., only when accurate.

[0176] In a specific implementation, the medical device provided in this embodiment includes at least one processor and a memory communicably connected to the at least one processor, wherein the memory stores a computer program executed by the at least one processor, and when the computer program is executed by the at least one processor, the at least one processor can execute the control method provided in this embodiment, wherein the processor corresponds to the above-mentioned control device.

[0177] The above control method is also called a pulse stimulation control method.

[0178] Although specific embodiments of the present invention have been described above, those skilled in the art should understand that these are merely examples, and the scope of protection of the present invention is limited by the appended 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 will fall within the scope of protection of the present invention.

Claims

1. 1. A medical device for delivering pulse stimulation, comprising: at least one ventricular electrode lead configured to be placed at a myocardial location; and a controller, the controller configured to execute a pulse stimulation control method, the pulse stimulation control method comprising: acquiring a far-field electrocardiogram and an in-body near-field myocardial electrocardiogram corresponding to the myocardial location; determining whether to deliver a CCM pulse stimulus to the myocardial location via the ventricular electrode lead in response to an R wave in the far-field electrocardiogram and an R wave in the internal near-field myocardial electrocardiogram; A medical device for delivering pulse stimulation, characterized in that:

2. the medical device further includes a first electrode pair for sensing and a second electrode pair for sensing and stimulating, the second electrode pair being disposed on the ventricular electrode lead and including a tip electrode provided at a myocardial location in the ventricle, and the control device is configured to acquire the far-field electrocardiogram based on the first electrode pair and acquire the in-body near-field myocardial electrocardiogram based on the second electrode pair.

2. The medical device according to claim 1.

3. the second electrode pair are both disposed on the ventricular electrode lead, and the medical device is used to provide cardiac pacing and / or defibrillation therapy functions via the ventricular electrode lead; or the first electrode pair are configured as electrodes that are both placed on the ventricular electrode lead, or as electrodes that are additionally provided in a blood vessel, in a cardiac cavity, on the epicardium, in a thoracic cavity other than the heart, or subcutaneously, and the far-field electrocardiogram is an internal far-field myocardial electrocardiogram; or the first electrode pair are configured as body surface electrodes to be attached to the skin, and the far-field electrocardiogram is a body surface electrocardiogram.

3. The medical device according to claim 2.

4. Specifically, the step of determining whether to transmit a CCM pulse stimulus to the myocardial position according to the R wave in the far-field electrocardiogram and the R wave in the internal near-field myocardial electrocardiogram includes: acquiring a first detection time of an R wave in the far-field electrocardiogram, a second detection time of an R wave in the internal near-field electrocardiogram corresponding to the R wave in the far-field electrocardiogram, and a pulse transmittable time window, which is a CCM stimulation safety window, corresponding to the R wave in the internal near-field electrocardiogram; determining a pulse transmission start time in response to the first detection time or the second detection time; determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window; 2. The medical device according to claim 1.

5. Specifically, the step of determining a pulse transmission start time in accordance with the first detection time or the second detection time includes: The method includes the steps of: obtaining a pulse transmission start time according to the second detection time and a second preset duration, using the second detection time as a reference zero point; or calculating a time difference between the second detection time and the first detection time; and calculating a pulse transmission time according to the first detection time, the time difference, and a third preset duration equal to the second preset duration, using the first detection time as a reference zero point.

5. The medical device according to claim 4.

6. The pulse stimulation control method further includes a step of setting a setup period and an operation period, and within the setup period, calculating a first preset duration according to a difference between the first detection time and the second detection time and a third preset duration, and within the operation period, obtaining a pulse transmission start time according to the first detection time and the first preset duration, taking the first detection time as a reference zero point.

5. The medical device according to claim 4.

7. The duration of the second preset is between 15 ms and 80 ms.

6. The medical device according to claim 5.

8. Specifically, the step of acquiring a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram includes: acquiring a first sensed event in the far-field electrocardiogram and a second sensed event in the far-field electrocardiogram, wherein at least one of the first sensed event and the second sensed event is an R wave; determining that the first sensed event in the far-field electrocardiogram corresponds to the second sensed event in the internal near-field electrocardiogram when an absolute value of a difference between a first detection time of the first sensed event in the far-field electrocardiogram and a second detection time of the second sensed event in the internal near-field electrocardiogram is within a preset range, and the first sensed event and the second sensed event are both R waves; the preset range is from 0 ms to 120 ms if the first sensed event in the far-field electrocardiogram is due to ventricular activation of an atrial chamber, and the preset range is from 0 ms to 250 ms if the R-wave in the far-field electrocardiogram is due to ventricular activation of a ventricle or a ventricular pacing pulse.

5. The medical device according to claim 4.

9. Specifically, the step of acquiring a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further includes: a step of acquiring a second detection event in the internal near-field myocardial electrocardiogram, the second detection event being located after the time reference zero point, the first detection time being a first time point, and a time point corresponding to a first preset duration before the first time point being a first reference zero point, the second detection event being located after the time reference zero point, the first preset duration being between 10 ms and 120 ms; Or, acquiring a first detection event in the far-field electrocardiogram after the time reference zero point, the second detection time being a second time point, and a time point corresponding to a second preset duration before the second time point being a time reference zero point, the second preset duration being between 10 ms and 120 ms; 9. The medical device according to claim 8.

10. The step of acquiring a first detection time of an R wave in the far-field electrocardiogram and a second detection time of an R wave in the internal near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further comprises: obtaining a sensed time window corresponding to the first sensed event in the far-field electrocardiogram; determining whether the second detection time or the first detection time falls within the detection time window; If so, determining that the first sensed event in the far-field electrocardiogram corresponds to a second sensed event in the internal near-field electrocardiogram, and the first sensed event and the second sensed event are both R-waves; otherwise, the first sensed event in the far-field electrocardiogram does not correspond to a second sensed event in the internal near-field electrocardiogram, and one of the first sensed event and the second sensed event is not an R-wave, and the control device is configured not to deliver a CCM pulse stimulus to the myocardial location.

10. The medical device according to claim 9.

11. When the first detection time is the first time point, the first detection event is an R wave, and the step of determining whether the second detection time or the first detection time falls within the detection time window includes the step of determining whether the second detection time falls within the detection time window; When the second detection time is the second time point, the second detection event is an R wave, and the step of determining whether the second detection time or the first detection time falls within the detection time window includes the step of determining whether the first detection time falls within the detection time window.

11. The medical device according to claim 10.

12. when the first sensed event in the far-field electrocardiogram is a ventricular activation caused by non-ventricular pacing, if the first sensed time is earlier than the second sensed time, a start point of a sensed time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on the first sensed time; and if the second sensed time is earlier than the first sensed time, a start point of a sensed time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on the second sensed time; If the first sensed event in the far-field electrocardiogram occurs due to a ventricular pacing pulse, a starting point of a sensing time window corresponding to the first sensed event in the far-field electrocardiogram is determined based on a delivery time of a pacing pulse received by a ventricle, and the delivery time of the pacing pulse is considered to be the first sensed time.

11. The medical device according to claim 10.

13. a start time of the detection time window has a fourth preset duration that is earlier than or equal to the first detection time or the second detection time, and the pulse transmittable time window has a second preset length, the detection time window has a first preset length, and the second preset length is longer than the first preset length, and the fourth preset duration is between 0 ms and 50 ms.

11. The medical device according to claim 10.

14. The sensing time window has a first preset length, and when the R wave in the far-field electrocardiogram is caused by ventricular activation due to atrial conduction, the first preset length ranges from 60 ms to less than 120 ms, and when the R wave in the far-field electrocardiogram is caused by ventricular activation of a ventricle or a ventricular pacing pulse, the first preset length ranges from 160 ms to 250 ms, or the first preset length is determined by program control.

11. The medical device according to claim 10.

15. The ventricular electrode leads are multiple and are provided at multiple different ventricular myocardial positions, the internal near-field myocardial electrocardiogram and the second sensed event are multiple, and the control device further presetting preset sensing parameters corresponding to R-waves at different myocardial locations, including preset sensing times and / or preset sensing occurrence sequences; If the second sensed event that first falls within the sensing time window is an R wave, setting all remaining second sensed events to R waves; or and when the second sensed event that last falls within the sensing time window is an R wave, performing a step of setting all remaining second sensed events to R waves.

11. The medical device according to claim 10.

16. Specifically, the step of determining whether to deliver a CCM pulse stimulus to the myocardial position according to the pulse delivery start time and the pulse delivery available time window includes: If the pulse delivery start time falls within the pulse delivery window, delivering a CCM pulse stimulus to the myocardial region; otherwise, not delivering a CCM pulse stimulus to the myocardial region.

5. The medical device according to claim 4.

17. The ventricular electrode leads are multiple and are provided at multiple different myocardial positions, the internal near-field myocardial electrocardiogram and the second sensed event are multiple, and the control device further configured to execute a step of setting a delivery order of pulse stimuli corresponding to R waves at different myocardial positions, and delivering CCM pulse stimuli to the different myocardial positions according to the delivery order of the pulse stimuli.

17. The medical device of claim 16.

18. when the R wave in the far-field electrocardiogram is a ventricular activation caused by non-ventricular pacing, a start point of the pulse delivery possible time window is determined based on a first detection time of the R wave in the far-field electrocardiogram or a second detection time of a corresponding R wave in the internal near-field myocardial electrocardiogram determined in accordance with the first detection time, If the R wave in the far-field electrocardiogram is caused by a ventricular pacing pulse, the start of the pulse delivery window is determined based on a delivery time of the pacing pulse received by the ventricle, and the delivery time of the pacing pulse is considered to be the first sensed time.

17. The medical device of claim 16.

19. the pulse delivery time window has a second preset length, the second preset length being in the range of 150 ms to 300 ms, or the second preset length is determined by program control, the start point of the pulse delivery time window is earlier than the first detection time or the second detection time by a fourth preset duration, and the fourth preset duration is in the range of 0 ms to 50 ms, 19. The medical device of claim 18.

20. The control device further If the second detection time is earlier than the first detection time, determining a start point of a time window during which a pulse can be transmitted corresponding to the R wave in the internal near-field myocardial electrocardiogram according to the second detection time, and determining a transmission start time of the pulse according to the first detection time or the second detection time; If the second detection time is later than the first detection time, determining a start point of a time window during which a pulse can be transmitted corresponding to the R wave in the internal near-field myocardial electrocardiogram according to the first detection time, and determining a transmission start time of the pulse according to the first detection time or the second detection time.

19. The medical device of claim 18.

21. Specifically, the step of determining whether to deliver a CCM pulse stimulus to the myocardial position according to the pulse delivery start time and the pulse delivery available time window includes: determining a pulse transmission stop time according to the pulse transmission start time; delivering a CCM pulse stimulus to the myocardial region if the pulse delivery start time and the pulse delivery stop time both fall within the pulse delivery window, and not delivering a CCM pulse stimulus to the myocardial region otherwise.

5. The medical device according to claim 4.

22. Specifically, the step of determining whether to deliver a CCM pulse stimulus to the myocardial position according to the pulse delivery start time and the pulse delivery available time window includes: determining a start time for the pulse and a stop time for the pulse according to preset pulse parameters; If the pulse transmission start time falls within the pulse transmittable time window and the pulse transmission stop time does not fall within the pulse transmittable time window, redetermine the pulse parameters so that the pulse transmission start time and the pulse transmission stop time both fall within the pulse transmittable time window, and deliver a CCM pulse stimulus to the myocardial location according to the redetermined pulse parameters; and not delivering a CCM pulse stimulus to the myocardial location if the pulse delivery start time does not fall within the pulse delivery window.

5. The medical device according to claim 4.

23. Specifically, the step of determining whether to deliver a CCM pulse stimulus to the myocardial position according to the pulse delivery start time and the pulse delivery available time window includes: If the pulse transmission start time falls within the pulse transmission available time window, determining a pulse transmission stop time according to the pulse transmission start time and preset pulse parameters; determining whether the pulse transmission stop time falls within the pulse transmission possible time window; If so, delivering a CCM pulse stimulus; otherwise, not delivering the CCM pulse stimulus, or redetermining the pulse parameters so that the pulse delivery stop time falls within the pulse deliverable time window, and delivering the CCM pulse stimulus according to the redetermined pulse parameters.

5. The medical device according to claim 4.

24. The control device determining whether a ventricular chamber has been captured if it is determined that a pacing pulse has already been delivered to the myocardial location; If so, determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery window, wherein the pulse delivery window corresponding to the R wave in the internal near-field myocardial electrocardiogram is determined based on the delivery time of a pacing pulse received by a ventricle; otherwise, determining whether to deliver a CCM pulse stimulus to the myocardial location according to the pulse delivery start time and the pulse delivery available time window, wherein the pulse delivery available time window corresponding to the R wave in the internal near-field electrocardiogram is determined based on a first detection time of the R wave in the far-field electrocardiogram or a second detection time of the R wave in the internal near-field electrocardiogram.

5. The medical device according to claim 4.

25. The step of determining whether a ventricle has been captured specifically includes the step of determining whether a ventricle has been captured based on the far-field electrocardiogram.

25. The medical device of claim 24.

26. Specifically, the step of transmitting a CCM pulse stimulus to the myocardial location includes: delivering a CCM pulse stimulus to the myocardial location if the current heart rate parameter is detected to be within a preset range; 2. The medical device according to claim 1.

27. The CCM pulse stimulation is The pulse is delivered during at least one of ventricular electrical activity, including a sinus beat, a ventricular beat resulting from an atrial downbeat, a ventricular beat resulting from a ventricular downbeat, and a ventricular beat resulting from ventricular pacing.

2. The medical device according to claim 1.

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