Medical instrument for delivering pulse stimulation

Abstract

Disclosed is a medical instrument for delivering pulse stimulation. The medical instrument comprises at least one ventricular electrode wire and a control device. The ventricular electrode wire is configured to be arranged at a myocardial position, and the control device is configured to execute a pulse stimulation control method. The pulse stimulation control method comprises the following steps: acquiring a far-field electrocardiogram and an in-vivo near-field myocardial electrocardiogram corresponding to the myocardial position; and according to an R wave in the far-field electrocardiogram and an R wave in the in-vivo near-field myocardial electrocardiogram, determining whether CCM pulse stimulation is delivered to the myocardial position or not. The medical instrument for delivering pulse stimulation provided in the present invention can ensure the timeliness, safety and effectiveness of CCM pulse stimulation to the heart of a patient.

Description

Medical devices for delivering pulse stimulation

[0001] This application claims priority to Chinese patent application CN202210944885.5, filed on August 8, 2022, and Chinese patent application CN202210944820.0, filed on August 8, 2022. This application incorporates the entire text of the aforementioned Chinese patent application. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to a medical device for delivering pulse stimulation. Background Art

[0003] Medical devices with CCM (Cardiac Contractility Modulation) function currently on the market are basically used for patients with chronic heart failure. Generally, two bipolar electrode wires are implanted in the right ventricular septum to sense the potential of the local myocardium and deliver pulse stimulation a certain time after sensing to increase the contractility of the ventricular myocardium.

[0004] In addition, this medical device can only provide CCM therapy at present, but a considerable number of patients with CCM indications (EF < 35%) also need primary prevention of SCD (sudden cardiac death) and need to implant an ICD (implantable cardioverter defibrillator). Currently, these heart failure patients receive two implantable devices, a CCM device and an ICD (implantable cardioverter defibrillator). On the contrary, many patients currently receiving ICD treatment also have indications for CCM therapy and can benefit from CCM treatment by improving heart failure symptoms and hemodynamics through CCM devices. Today, most ICD patients benefit from SCD prevention after ICD implantation, but do not receive CCM heart failure treatment. In addition, current CCM devices do not provide pacing therapy for bradycardia, which may also be the therapy required by some CCM patients.

[0005] One reason for this is the complexity of current CCM systems (device + at least two ventricular leads). The system requires sensing of local myocardial activation based on two bipolar ventricular leads at the right ventricular septum and the temporal sequence of two sensed events to ensure that ventricular activation originates from the atria and not from the ventricles themselves (including ventricular pacing). One or both of the leads are also used to deliver CCM pulses during the absolute refractory period of the local myocardium. CCM stimulation is not delivered directly to the left ventricular (LV) myocardium, which is typically the chamber most in need of increased contractility. Although CCM has been shown to have an overall effect on cardiac contractility and function, studies have shown that this effect originates at the stimulation site and only partially affects global cardiac contractility or the LV.

[0006] Currently, the transvenous ICD systems on the market are 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 share the following features: 1) only one lead in the RV, unlike CCM devices, which have two leads; 2) the RV lead contains a defibrillation coil electrode in the RV, which forms the defibrillation circuit with the ICD housing. Sometimes, a second defibrillation coil electrode is located at the site corresponding to the SVC (superior vena cava), both of which are located on the RV lead. Currently, ICDs cannot provide CCM therapy, in part because it is not certain that local myocardial stimulation with CCM is completely safe and will not induce malignant ventricular arrhythmias. Currently, CCM devices do not provide pacing therapy, although some heart failure patients can benefit from pacing to increase their heart rate.

[0007] Summary of the Invention

[0008] One of the technical problems to be solved by the present invention is to overcome the three major limitations of the prior art, namely, that CCM pulse stimulation can only be delivered when ventricular electrical activity is transmitted from the atrium, that the electrodes on the two ventricular electrode wires must be used to sense the local activation of the right ventricular septum myocardium and the time series of the two sensing events to determine whether pulse stimulation can be delivered, and that pulse stimulation can only be sent to the right ventricular septum. The present invention provides a medical device that can ensure the delivery of CCM pulse stimulation within the ventricular septum's deliverable period without the above limitations.

[0009] Another technical problem to be solved by the present invention is to provide a medical device for delivering pulse stimulation that can achieve CCM therapy function by utilizing its own ventricular electrode wires.

[0010] Another technical problem to be solved by the present invention is to overcome the problem that the existing CCM device cannot provide ICD treatment for patients who need SCD prevention, resulting in the need to implant both CCM and ICD medical devices in the patient's body, which leads to increased surgical and / or postoperative risks (such as infection), or due to economic burden issues, only one of the therapies can be selected. A medical device for delivering pulse stimulation is provided. Through this solution, heart failure patients can obtain the required therapy (alleviate heart failure and prevent sudden death), and can reduce the comfort complexity and the economic burden of patients, greatly improving the cost-effectiveness of implanted devices.

[0011] Another technical problem to be solved by the present invention is to overcome the problem in the prior art of erroneous delivery of CCM pulse stimulation due to misperception of R waves in far-field electrocardiogram or near-field electrocardiogram in the body, and to provide a safer and more reliable pulse stimulation control method.

[0012] The present invention solves the above technical problems through the following technical solutions:

[0013] The present invention provides a medical device for delivering pulse stimulation, comprising at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be positioned at a myocardial position in a ventricle; the control device is configured to execute a pulse stimulation control method, the pulse stimulation control method comprising the following steps:

[0014] Obtaining far-field electrocardiogram and in vivo near-field myocardial electrocardiogram corresponding to myocardial location;

[0015] Determine whether to deliver CCM pulse stimulation to the myocardial position through the ventricular electrode lead based on the R wave in the far-field electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram.

[0016] Optionally, the medical device further includes a first electrode pair and a second electrode pair, the first electrode pair is used for sensing, the second electrode pair is used for sensing and stimulation, the second electrode pair includes a head end electrode, the head end electrode is configured on the ventricular electrode lead and is located at the myocardial position of the ventricle; the control device is configured to obtain the far-field electrocardiogram based on the first electrode pair, and to obtain the in vivo near-field myocardial electrocardiogram based on the second electrode pair.

[0017] Optionally, the second electrode pairs are both configured on the ventricular electrode lead, and the medical device is used to provide cardiac pacing function and / or defibrillation therapy function through the ventricular electrode lead; or,

[0018] The first electrode pairs are all configured on the ventricular electrode wires or are configured as electrodes additionally arranged in blood vessels, in cardiac chambers, on the epicardium, in the chest cavity outside the heart, or under the skin, and the far-field electrocardiogram is an in-vivo far-field myocardial electrocardiogram; or, the first electrode pairs are configured as surface electrodes for attachment to the skin, and the far-field electrocardiogram is a surface electrocardiogram.

[0019] Optionally, the step of determining whether to issue CCM pulse stimulation to the myocardial position based on the R wave in the far-field electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram specifically includes:

[0020] Obtaining a first sensing time of an R wave in the far-field electrocardiogram, a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram, and a pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram, wherein the pulse-issuable time window is a CCM stimulation safety window;

[0021] determining a pulse emission start time according to the first sensing time or the second sensing time;

[0022] Whether to issue CCM pulse stimulation to the myocardial position is determined according to the pulse start time and the pulse-issuable time window.

[0023] Optionally, the step of determining the pulse emission start time according to the first sensing time or the second sensing time specifically includes:

[0024] Taking the second sensing time as the reference zero point, the pulse start time is obtained according to the second sensing time and the second preset time length, or the time difference between the second sensing time and the first sensing time is calculated; taking the first sensing time as the reference zero point, the pulse emission time is calculated according to the first sensing time, the time difference and the third preset time length, wherein the third preset time length is equal to the second preset time length.

[0025] Optionally, the pulse stimulation control method also includes a preset period and an operating period. During the preset period, the first preset duration is calculated based on the difference between the first sensing time and the second sensing time and a third preset duration. During the operating period, the first sensing time is used as the reference zero point, and the pulse start time is obtained based on the first sensing time and the first preset duration.

[0026] Optionally, the second preset duration is greater than or equal to 15 ms and less than or equal to 80 ms.

[0027] Optionally, the step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram specifically includes:

[0028] Acquire a first sensing event in the far-field electrocardiogram and a second sensing event in the far-field electrocardiogram, wherein at least one of the first sensing event and the second sensing event is an R wave;

[0029] When the absolute value of the difference between the first sensing time of the first sensing event in the far-field electrocardiogram and the second sensing time of the second sensing event in the in vivo near-field myocardial electrocardiogram is within a preset range, it is confirmed that the first sensing event in the far-field electrocardiogram corresponds to the second sensing event in the in vivo near-field myocardial electrocardiogram, and the first sensing event and the second sensing event are both R waves; when the first sensing event in the far-field electrocardiogram is caused by ventricular activation originating from atrial conduction, the preset range is greater than or equal to 0ms and less than or equal to 120ms; when the R wave in the far-field electrocardiogram is caused by ventricular activation originating from the ventricle or by a ventricular pacing pulse, the preset range is greater than or equal to 0ms and less than or equal to 250ms.

[0030] Optionally, the step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further includes:

[0031] Taking the first sensing time as a first time point, and taking a time point corresponding to a first set time length before the first time point as a time reference zero point, obtaining a second sensing event in the in vivo near-field myocardial electrocardiogram located after the time reference zero point, wherein the first set time length is greater than or equal to 10 ms and less than or equal to 120 ms;

[0032] or,

[0033] The second sensing time is used as a second time point, and a time point corresponding to a second set time length before the second time point is used as a time reference zero point, and a first sensing event in the far-field electrocardiogram located after the time reference zero point is obtained, where the set time length is greater than or equal to 30 ms and less than or equal to 120 ms.

[0034] Optionally, the step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further includes:

[0035] Obtaining a sensing time window corresponding to the first sensing event in the far-field electrocardiogram;

[0036] determining whether the second sensing time or the first sensing time falls within the sensing time window;

[0037] If so, it is determined that the first sensing event in the far-field electrocardiogram corresponds to the second sensing event in the in vivo near-field myocardial electrocardiogram, and the first sensing event and the second sensing event are both R waves; if not, the first sensing event in the far-field electrocardiogram does not correspond to the second sensing event in the in vivo near-field myocardial electrocardiogram, and one of the first sensing event and the second sensing event is not an R wave, and the control device is configured not to issue CCM pulse stimulation to the myocardial position.

[0038] Optionally, when the first sensing time is used as the first time point, the first sensing event is an R wave; and the step of determining whether the second sensing time or the first sensing time falls within the sensing time window includes: determining whether the second sensing time falls within the sensing time window;

[0039] When the second sensing time is used as the second time point, the second sensing event is an R wave; and the step of determining whether the second sensing time or the first sensing time falls within the sensing time window includes determining whether the first sensing time falls within the sensing time window.

[0040] Optionally, when the first sensing event in the far-field electrocardiogram is ventricular activation caused by non-ventricular pacing, if the first sensing time is earlier than the second sensing time, a starting point of a sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the first sensing time; if the second sensing time is earlier than the first sensing time, a starting point of the sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the second sensing time;

[0041] When the first sensing event in the far-field electrocardiogram is caused by the generation of a ventricular pacing pulse, the starting point of the sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the release time of the pacing pulse received by the ventricle, and the release time of the pacing pulse is regarded as the first sensing time.

[0042] Optionally, the start time of the sensing time window is earlier than or equal to the first sensing time or the second sensing time by a fourth preset duration, and the pulse-issuable time window has a second preset length, the sensing time window has a first preset length, and the second preset length is greater than the first preset length, and the fourth preset duration is greater than or equal to 0ms and less than or equal to 50ms.

[0043] Optionally, the sensing time window has a first preset length. When the R wave in the far-field electrocardiogram is a heartbeat caused by atrial conduction and ventricular activation, the first preset length is greater than or equal to 60m and less than 120ms; when the R wave in the far-field electrocardiogram is ventricular activation caused by the ventricle or a ventricular pacing pulse, the first preset length is greater than or equal to 160m and less than or equal to 250ms; or, the first preset length is determined by program control.

[0044] Optionally, the number of the ventricular electrode wires is plural and they are disposed at a plurality of different ventricular myocardial positions, the number of the in vivo near-field myocardial electrocardiogram and the second sensing event is plural, and the control device is further configured to perform the following steps:

[0045] Presetting different set sensing parameters corresponding to the R waves at the myocardial positions, the set sensing parameters including set sensing time and / or set sensing occurrence order;

[0046] When the first second sensing event falling within the sensing time window is an R wave, the remaining second sensing events are all set to be R waves; or,

[0047] When the last second sensing event falling within the sensing time window is an R wave, the remaining second sensing events are all set to be R waves.

[0048] Optionally, the step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes:

[0049] If the pulse start time falls within the pulse-issuable time window, CCM pulse stimulation is issued to the myocardial position; otherwise, CCM pulse stimulation is not issued to the myocardial position.

[0050] Optionally, there are multiple ventricular electrode wires and they are disposed at multiple different myocardial locations, there are multiple in vivo near-field myocardial electrocardiograms and second sensing events, and the control device is further configured to perform the following steps:

[0051] The pulse stimulation delivery sequence corresponding to the R wave at different myocardial positions is set, and CCM pulse stimulation is delivered to different myocardial positions according to the pulse stimulation delivery sequence.

[0052] Optionally, when the R wave in the far-field electrocardiogram is ventricular activation caused by non-ventricular pacing, the starting point of the pulse issuable time window is determined based on a first sensing time of the R wave in the far-field electrocardiogram, or based on a second sensing time of a corresponding R wave in the in vivo near-field myocardial electrocardiogram determined based on the first sensing time;

[0053] When the R wave in the far-field electrocardiogram is generated by a ventricular pacing pulse, the starting point of the pulse-issuable time window is determined based on the issuance time of the pacing pulse received by the ventricle, and the issuance time of the pacing pulse is regarded as the first sensing time.

[0054] Optionally, the pulse-issuable time window has a second preset length, the range of the second preset length is greater than or equal to 150ms and less than or equal to 300ms, or the second preset length is determined by program control; the starting point of the pulse-issuable time window is earlier than the first sensing time or the second sensing time by a fourth preset time length, and the fourth preset time length is greater than or equal to 0ms and less than or equal to 50ms.

[0055] Optionally, the control device is further configured to perform the following steps:

[0056] When the second sensing time is earlier than the first sensing time, determining the starting point of the pulse-issuable time window corresponding to the R wave in the in-vivo near-field myocardial electrocardiogram according to the second sensing time, and determining the pulse start time according to the first sensing time or the second sensing time;

[0057] When the second sensing time is later than the first sensing time, the starting point of the pulse-emittable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined according to the first sensing time, and the pulse start time is determined according to the first sensing time or the second sensing time.

[0058] Optionally, the step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes:

[0059] Determining a pulse stopping time according to the pulse starting time;

[0060] If the pulse start time and the pulse stop time both fall within the pulse-issuable time window, CCM pulse stimulation is issued to the myocardial position; otherwise, CCM pulse stimulation is not issued to the myocardial position.

[0061] Optionally, the step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes:

[0062] Determining a pulse stopping time according to the pulse starting time and preset pulse parameters;

[0063] If the pulse start time falls within the pulse-issuable time window, and the pulse stop time does not fall within the pulse-issuable time window, re-determining the pulse parameters so that both the pulse start time and the pulse stop time fall within the pulse-issuable time window, and delivering a CCM pulse stimulation to the myocardial position according to the re-determined pulse parameters;

[0064] If the pulse start time does not fall within the pulse-issuable time window, no CCM pulse stimulation is issued to the myocardial location.

[0065] Optionally, the step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes:

[0066] If the pulse start time falls within the pulse issuable time window, determining the pulse stop time according to the pulse start time and preset pulse parameters;

[0067] Determining whether the pulse stopping time falls within the pulse issuing time window;

[0068] If so, a CCM pulse stimulation is delivered;

[0069] If not, no CCM pulse stimulation is issued, or the pulse parameters are re-determined so that the pulse issuance stop time falls within the pulse issuance time window; and CCM pulse stimulation is issued according to the re-determined pulse parameters.

[0070] Optionally, the control device is configured to perform the following steps:

[0071] If it is determined that a pacing pulse has been delivered to the myocardial location, determining whether the ventricle has been captured;

[0072] If so, determining whether to issue a CCM pulse stimulation to the myocardial position according to the pulse start time and the pulse-issuable time window, wherein the pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined based on the issuance time of the pacing pulse received by the ventricle;

[0073] If not, determine whether to issue CCM pulse stimulation to the myocardial position based on the pulse start time and the pulse-issuable time window, wherein the pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined based on the first sensing time of the R wave in the far-field electrocardiogram, or based on the second sensing time of the R wave in the in vivo near-field myocardial electrocardiogram.

[0074] Optionally, the step of determining whether the ventricle is captured specifically includes determining whether the ventricle is captured based on the far-field electrocardiogram.

[0075] Optionally, the step of delivering CCM pulse stimulation to the myocardial position specifically includes:

[0076] If it is detected that the current heart rate parameter is within the preset range, CCM pulse stimulation is delivered to the myocardial location.

[0077] Optionally, the CCM pulse stimulation is delivered during at least one of the following ventricular electrical activities:

[0078] Sinus heartbeat, ventricular heartbeat caused by conduction from the atria, ventricular heartbeat caused by the ventricles, and ventricular heartbeat caused by ventricular pacing.

[0079] Based on the common knowledge in this field, the optional conditions can be arbitrarily combined to obtain various embodiments of the present invention.

[0080] The positive progress effect of the present invention is:

[0081] Delivering CCM pulses only within the ventricular releasable period: By ensuring that the CCM pulse delivery time falls within the releasable period corresponding to the far-field ECG's reflection of overall ventricular electrical activity (R wave), this ensures the timeliness, safety, and effectiveness of CCM pulse stimulation for the patient's heart. To ensure the safety of CCM pulse delivery time, obtaining releasable period information for ventricular electrical activity from the far-field ECG represents a positive improvement to CCM pulse stimulation technology, further ensuring the safety, effectiveness, and therapeutic effects of CCM pulse stimulation for patients.

[0082] Only send pulse stimulation after R wave: It can timely analyze and process the sensing events in the far-field electrocardiogram or the near-field electrocardiogram in the body, automatically and accurately identify the mis-sensed events, and determine that they are not R wave signals, but interference signals such as T waves. At this time, the control does not send CCM pulse stimulation to the corresponding myocardial position, ensuring that CCM pulse stimulation is not sent under incorrect circumstances, effectively reducing or avoiding the risk of inducing VT or VF, and then avoiding unnecessary pain or even safety hazards to the patient, thereby ensuring the safety of the patient and improving the reliability of pulse stimulation control; at the same time, it ensures that CCM pulse stimulation is sent in time when it is determined to be an R wave, that is, CCM pulse stimulation is only sent under correct circumstances.

[0083] A far-field myocardial electrocardiogram in vivo is obtained by a first electrode pair configured on at least one ventricular electrode lead in the medical device, and a near-field myocardial electrocardiogram in vivo is obtained by a second electrode pair configured on at least one ventricular electrode lead in the medical device. The R wave in the far-field myocardial electrocardiogram in vivo and the R wave in the near-field myocardial electrocardiogram in vivo are combined to determine whether CCM pulse stimulation is issued to the myocardial position, thereby realizing the CCM therapy function.

[0084] Furthermore, compared to existing medical devices, the at least one ventricular electrode lead can not only achieve CCM therapy, but also achieve the functions of existing traditional devices (including cardiac pacing and / or defibrillation therapy). Therefore, the medical device provided by the present invention can provide patients with ICD therapy and CCM therapy. For patients who need SCD prevention and heart failure treatment, only the medical device provided by the present invention needs to be implanted in the patient's body, without the need to implant two medical devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0085] FIG1 is a schematic diagram of configuring a first electrode pair and a second electrode pair on a right ventricular electrode lead in a medical device provided by an embodiment of the present invention.

[0086] FIG2 is another schematic diagram of configuring a first electrode pair and a second electrode pair on a right ventricular electrode lead in the medical device provided by an embodiment of the present invention.

[0087] FIG3 is another schematic diagram of configuring a first electrode pair and a second electrode pair on a right ventricular electrode lead in the medical device provided by an embodiment of the present invention.

[0088] FIG4 is a flow chart of a method for controlling a medical device provided by an embodiment of the present invention.

[0089] FIG5 is a flow chart of step S2 provided in an embodiment of the present invention.

[0090] FIG6 is a flow chart of step S3 provided by an embodiment of the present invention.

[0091] FIG7 is another flow chart of step S3 provided in an embodiment of the present invention.

[0092] FIG8 is another flow chart of step S3 provided in an embodiment of the present invention.

[0093] FIG9 is a partial flow chart of a method for controlling a medical device provided in an embodiment of the present invention.

[0094] FIG10 is another flow chart of step S2 provided in an embodiment of the present invention.

[0095] FIG11 is a schematic diagram of an electrocardiogram corresponding to R-wave sensing according to an embodiment of the present invention.

[0096] FIG12 is another electrocardiogram corresponding to R-wave sensing according to an embodiment of the present invention.

[0097] FIG13 is a schematic diagram of an electrocardiogram corresponding to another R-wave sensing according to an embodiment of the present invention.

[0098] FIG14 is a schematic diagram of an electrocardiogram corresponding to another R-wave sensing according to an embodiment of the present invention.

[0099] FIG15 is a flowchart of steps S7 and S8 provided by an embodiment of the present invention.

[0100] FIG16 is a flowchart of steps S9 to S11 provided by an embodiment of the present invention.

[0101] FIG17 is a schematic diagram of steps S1003 and S1004 provided in an embodiment of the present invention.

[0102] FIG18 is a flowchart of steps S1005 to S1008 provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0103] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples.

[0104] It should be understood that the term "including" and its variations used in the present invention are open inclusions, i.e., "including but not limited to". The term "according to" means "at least in part according to", and the term "plurality" means "two or more".

[0105] It should be understood that although the terms "first", "second", "third", "fourth", etc. may be used in the present invention to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0106] Example 1

[0107] Figure 1 is a flow chart of a control method for a medical device provided in this embodiment. The control method can be executed by a control device of a medical device for delivering pulse stimulation. The control device can be implemented by software and / or hardware, and the control device can be a part of the medical device.

[0108] The medical device for delivering pulse stimulation in this embodiment includes at least one ventricular electrode lead and a control device. The at least one ventricular electrode lead is configured with a first electrode pair for sensing and a second electrode pair for both sensing and stimulation, with at least one electrode of the second electrode pair positioned within the ventricular myocardium. The first and second electrode pairs can be configured on the same ventricular electrode lead or on different ventricular electrode leads.

[0109] In the medical device for delivering pulse stimulation provided in this embodiment, CCM therapy function can be achieved by delivering CCM pulse stimulation to the myocardial location, wherein CCM pulse stimulation refers to pulse stimulation for regulating myocardial contraction.

[0110] Optionally, the medical device is used to provide cardiac pacing function and / or defibrillation therapy function through the at least one ventricular electrode lead. In a specific implementation, the above-mentioned medical device can be a single-chamber ICD or a dual-chamber ICD, which can realize not only cardiac pacing function and / or defibrillation therapy function through its right ventricular electrode lead, but also CCM therapy function. The above-mentioned medical device can also be a CRT-D (cardiac resynchronization therapy defibrillator), which can realize not only cardiac pacing function and / or defibrillation therapy function through its right ventricular electrode lead or left ventricular electrode lead, but also CCM therapy function. The above-mentioned medical device can also be a CRT-P (cardiac resynchronization therapy pacemaker), which can realize not only cardiac pacing function through its right ventricular electrode lead and / or left ventricular electrode lead, but also CCM therapy function by setting a defibrillation electrode in its right ventricular electrode lead to obtain a far-field myocardial electrocardiogram in the body. In specific implementations, because the right ventricular lead in a conventional ICD is equipped with a pacing electrode pair and at least one defibrillation electrode, single-chamber pacemakers, dual-chamber pacemakers, and CRT-P devices can utilize the right ventricular lead in the ICD to implement CCM therapy. With this configuration, the right ventricular lead of a CRT device (including CRT-P and CRT-D) can provide CCM therapy in the right ventricle in addition to pacing therapy.

[0111] Figures 1 to 3 are schematic diagrams illustrating the configuration of a first electrode pair and a second electrode pair on a right ventricular (RV) lead in a medical device. As shown in Figures 1-3, the first electrode pair includes an E1 electrode and an E2 electrode for sensing; the second electrode pair includes an S1 electrode and an S2 electrode for sensing and stimulation. Specifically, as shown in Figure 1, the E1 electrode is a spiral defibrillation electrode, the S2 electrode is a ring electrode, the S1 electrode is a tip electrode, and the E2 electrode is mounted on the control device 100 of the medical device. As shown in Figure 2, both the E1 electrode and the E2 electrode are spiral defibrillation electrodes, the S2 electrode is a ring electrode, and the S1 electrode is a tip electrode. As shown in Figure 3, the E2 electrode is mounted on the control device 100 of the medical device, the E1 electrode and the S2 electrode are spiral defibrillation electrodes, and the S1 electrode is a tip electrode. The S1 electrode in Figures 1-3 is positioned at the myocardium of the ventricle.

[0112] It should be noted that the specific configuration of the first electrode pair and the second electrode pair on the ventricular electrode lead is not limited to the forms shown in Figures 1-3, and may also be other forms.

[0113] As shown in FIG4 , the control method of the medical device provided in this embodiment may include the following steps S1 to S2:

[0114] Step S1: acquiring an in vivo far-field myocardial electrocardiogram based on the first electrode pair, and acquiring an in vivo near-field myocardial electrocardiogram based on the second electrode pair.

[0115] Among them, the in vivo far-field myocardial electrocardiogram is also called FF-EGM (Far-Field Electrogram), and the in vivo near-field myocardial electrocardiogram is also called L-EGM (Local Electrogram, sometimes also called Near-field Electrogram).

[0116] Step S2: Determine whether to issue CCM pulse stimulation to the myocardial position based on the R wave in the far-field myocardial electrocardiogram and the R wave in the near-field myocardial electrocardiogram.

[0117] It should be noted that the R wave in the in vivo far-field myocardial electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram correspond to the same heartbeat.

[0118] In this embodiment, a far-field myocardial electrocardiogram in vivo is obtained by a first electrode pair configured on at least one ventricular electrode lead in the medical device, and a near-field myocardial electrocardiogram in vivo is obtained by a second electrode pair configured on at least one ventricular electrode lead in the medical device. The R wave in the far-field myocardial electrocardiogram in vivo and the R wave in the near-field myocardial electrocardiogram in vivo are combined to determine whether CCM pulse stimulation is issued to the myocardial position, thereby realizing the CCM therapy function.

[0119] Furthermore, compared to existing medical devices, the at least one ventricular electrode lead can not only achieve CCM therapy, but also achieve the functions of existing traditional devices (including cardiac pacing and / or defibrillation therapy). Therefore, the medical device provided in this embodiment can provide patients with ICD therapy and CCM therapy. For patients who need SCD prevention and heart failure treatment, only the medical device provided in this embodiment needs to be implanted in the patient's body, without the need to implant two medical devices.

[0120] Similarly, single-chamber pacemakers, dual-chamber pacemakers, and CRT-Ps can use the right ventricular electrode leads in traditional ICDs to achieve CCM therapy functions and provide patients with corresponding pacing therapy functions.

[0121] In practice, the aforementioned pulse stimulation, also known as CCM stimulation, can be delivered during at least one of the following ventricular electrical activity: sinus beat, ventricular heartbeat originating from atrial conduction, ventricular heartbeat originating from the ventricles, and ventricular heartbeat originating from ventricular pacing. This represents a significant improvement over existing CCM devices, which only deliver CCM pulse therapy during ventricular heartbeats originating from atrial conduction.

[0122] In an optional embodiment, as shown in FIG5 , the above step S2 includes the following steps S21 to S23:

[0123] Step S21, obtaining the first sensing time of the R wave in the in vivo far-field myocardial electrocardiogram and the second sensing time of the R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram, as well as the pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram, wherein the pulse-issuable time window is the CCM stimulation safety window.

[0124] Among them, the first sensing time can be called GS (Global Sense), and the pulse-issuable time window can be called the CCM stimulation safety window (stimulation safety window, SSW). Among them, the pulse-issuable time window corresponds to a safe period, which corresponds to the CCM pulse-issuable period of the entire ventricle, and the goal is to cover the absolute refractory period of the entire ventricular muscle. Specifically, the pulse-issuable time window is determined based on the in vivo far-field myocardial electrocardiogram, and its starting point and end point are both adjustable. Its starting point approximately corresponds to the "earliest" depolarization area of ​​the entire ventricular muscle, and its end point corresponds to the end time point of the absolute refractory period of the ventricular muscle or slightly earlier than this point.

[0125] In a specific implementation example, when the R wave in the far-field myocardial electrocardiogram in the body is generated by a heartbeat that is not caused by ventricular pacing (such as an autonomous heartbeat), the starting point of the pulse-issuable time window can be determined according to the first sensing time GS.

[0126] Generally speaking, the starting point of the pulse-emittable time window corresponding to the R wave in the near-field myocardial electrocardiogram in the body is determined based on the first sensing time GS of the first sensing event in the far-field myocardial electrocardiogram in the body, so that it can correspond to the CCM pulse-emittable period of the entire ventricle, where the first sensing event is the R wave.

[0127] In special cases, the second sensing time of the second sensing event in the in vivo near-field myocardial electrocardiogram corresponding to the first sensing event can also be determined. The second sensing time can be called LS (Local Sense), and then the starting point of the pulse-emittable time window is determined based on the second sensing time LS. In this case, the first sensing time GS may lag behind the real time node due to the delay in capturing the ECG signal, or due to other reasons, the second sensing time LS of the second sensing event in the in vivo near-field myocardial electrocardiogram is slightly earlier than the first sensing time GS of the first sensing event. At this time, by taking the second sensing time LS as the starting time, the correspondence between the local excitation event and the overall excitation event can be more accurately judged. Therefore, the pulse-emittable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram can also be determined based on the second sensing time LS of the R wave in the in vivo near-field myocardial electrocardiogram, or it can correspond to the CCM pulse-emittable period of the overall ventricle.

[0128] The pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram may also be determined by the issuance time of the pacing pulse.

[0129] In another specific implementation example, when the R wave in the far-field electrocardiogram is generated by a ventricular pacing pulse, the starting point of the pulse-emittable time window is the time when the pacing pulse is emitted. At this time, the time when the pacing pulse is emitted is regarded as the first sensing time referred to in various embodiments of the present invention.

[0130] Specifically, the second preset length of the pulse-issuable time window can be preset to 200ms, with an optional range including but not limited to 150ms to 300ms, as long as the end time point of the pulse-issuable time window does not exceed the absolute refractory period of the entire ventricular myocardium. Adaptive adjustment can be made based on factors such as the patient's condition (e.g., whether antiarrhythmic drugs such as amiodarone are used, which may prolong the absolute refractory period of the myocardium), the actual R-wave sensing situation (the first sensing time GS and / or the second sensing time LS), and so on.

[0131] Step S22: Determine a pulse emission start time according to the first sensing time GS or the second sensing time LS.

[0132] In an optional embodiment of step S22, the pulse start time is determined based solely on the first sensing time GS. Specifically, the first sensing time GS can be used as a reference zero point, and a first preset duration can be added to this reference zero point to obtain the pulse start time. The first preset duration can be determined by calculating the time difference between the first sensing time GS and the second sensing time LS during a preset period prior to the actual operation period. The reference zero point here represents the starting point of time.

[0133] In an optional embodiment of step S22, a second sensing time LS corresponding to a second sensing event in the in vivo near-field myocardial electrocardiogram is determined according to the first sensing time GS; and a pulse emission start time is determined according to the second sensing time.

[0134] In a specific example, the pulse emission start time is determined only according to the second sensing time. For example, the second sensing time can be used as a reference zero point, and the second preset time length is added thereto to obtain the pulse emission start time.

[0135] In another specific example, the pulse start time is determined based on the first sensing time and the second sensing time. For example, the time difference between the second sensing time and the first sensing time can be calculated, and then the first sensing time is used as the reference zero point. On this basis, the time difference and the third preset time length are added to obtain the pulse start time.

[0136] The setting of the pulse start time ensures that the pulse stimulation is delivered within the absolute refractory period of the myocardial excitation event that the pulse-delivering electrode contacts.

[0137] Step S23: Determine whether to issue a CCM pulse stimulation to the myocardial position according to the pulse start time and the pulse issueable time window.

[0138] In an optional embodiment, whether to issue a CCM pulse stimulus is determined based on whether the pulse start time falls within the pulse-issuable time window. Specifically, as shown in FIG6 , step S23 includes the following steps S231a to S231c:

[0139] Step S231a, determine whether the pulse emission start time falls within the pulse emission time window, if so, execute step S231b, if not, execute step S231c.

[0140] Step S231b: delivering CCM pulse stimulation to the myocardial position. Specifically, starting at the pulse delivery start time, delivering CCM pulse stimulation to the myocardial position where the head electrode S1 of the second electrode pair is located.

[0141] Step S231c: No CCM pulse stimulation is delivered to the myocardial location.

[0142] In this embodiment, CCM pulse stimulation is only delivered to the myocardial position when the pulse start time falls within the pulse delivery time window, so that the CCM pulse stimulation must be delivered within the absolute refractory period of the entire ventricular muscle, thereby ensuring the safety and reliability of patient treatment.

[0143] In another optional embodiment, whether to issue a CCM pulse stimulation is determined based on whether the pulse start time and the pulse stop time both fall within the pulse-issuable time window. Specifically, as shown in FIG7 , step S23 includes the following steps S232a to S232d:

[0144] Step S232a: determining the pulse stopping time according to the pulse starting time.

[0145] Step S232b: determine whether the pulse start time and the pulse stop time both fall within the pulse issuable time window; if so, execute step S232c; if not, execute step S232d.

[0146] Step S232c: delivering CCM pulse stimulation to the myocardial position. Specifically, delivering CCM pulse stimulation to the myocardial position starts at the pulse delivery start time, and stops delivering CCM pulse stimulation to the myocardial position at the pulse delivery stop time.

[0147] Step S232d: No CCM pulse stimulation is delivered to the myocardial location.

[0148] In this embodiment, CCM pulse stimulation is only delivered to the myocardial position when the pulse start time and the pulse stop time both fall within the pulse delivery time window, so that all CCM pulse stimulations must be within the absolute refractory period of the entire ventricular myocardium, thereby fully ensuring the safety and reliability of patient treatment.

[0149] In another optional embodiment of step S23, whether to issue a CCM pulse stimulation is determined based on whether the pulse start time and the pulse stop time fall within the pulse issueable time window. Specifically, as shown in FIG8 , step S23 includes the following steps S233a to S233d:

[0150] Step S233a: Determine the pulse stopping time according to the pulse starting time and preset pulse parameters, wherein the pulse parameters may include the number of pulses to be emitted, pulse width, etc.

[0151] Step S233b: determine whether the pulse emission start time falls within the pulse emission time window; if so, execute step S233c; if not, execute step S233f.

[0152] Step S233c: determine whether the pulse stopping time falls within the pulse issuing time window; if so, execute step S233e; if not, execute step S233d.

[0153] Step S233d: Re-determine the pulse parameters so that the pulse cessation time falls within the pulse issuable time window. In a specific implementation, the pulse cessation time can be made to fall within the pulse issuable time window by reducing the number of pulses issued, by reducing the pulse width, or by reducing both the number of pulses issued and the pulse width.

[0154] Step S233e: delivering CCM pulse stimulation to the myocardial position. Specifically, delivering CCM pulse stimulation to the myocardial position starts at the pulse delivery start time, and stops delivering CCM pulse stimulation to the myocardial position at the pulse delivery stop time.

[0155] In a specific implementation example, if the pulse start time falls within the pulse-emittable time window, and the pulse stop time does not fall within the pulse-emittable time window, it is necessary to redetermine the pulse parameters so that the pulse start time and the pulse stop time both fall within the pulse-emittable time window, and CCM pulse stimulation is emitted to the myocardial position based on the redetermined pulse parameters.

[0156] In another specific implementation example, if the pulse start time and the pulse stop time both fall within the pulse-issuable time window, CCM pulse stimulation is delivered to the myocardial position according to preset pulse parameters.

[0157] Step S233f: No CCM pulse stimulation is delivered to the myocardial location.

[0158] In this embodiment, when the pulse start time falls within the pulse emittable time window and the pulse stop time does not fall within the pulse emittable time window, the pulse parameters are re-determined so that CCM pulse stimulation is emitted to the myocardial position only when the pulse start time and the pulse stop time both fall within the pulse emittable time window, so that all CCM pulse stimulations must be within the absolute refractory period of the entire ventricular myocardium, thereby fully ensuring the safety and reliability of the patient's treatment, and at the same time providing the patient with the maximum degree of CCM treatment.

[0159] In another optional embodiment, step S23 includes the following steps S234a-S234b:

[0160] Step S234a: If the pulse emission start time falls within the pulse emission time window, then determine the pulse emission stop time;

[0161] Step S234b: Determine whether to issue a CCM pulse stimulation according to the pulse stopping time and the pulse issuing time window.

[0162] In the medical device provided in this embodiment, when the pulse start time falls within the pulse-issuable time window, the pulse stop time is further determined. Finally, whether the pulse stop time falls within the pulse-issuable time window determines whether CCM pulse stimulation should be delivered. This effectively avoids the occurrence of CCM pulse stimulation outside the absolute refractory period of the entire myocardium. Compared with existing cardiac contractility regulators, the medical device provided in this embodiment can improve the safety, effectiveness, and reliability of patient treatment.

[0163] In an optional implementation of step S234b, it is determined whether the pulse stopping time falls within the pulse issuing time window; if so, CCM pulse stimulation is issued; if not, CCM pulse stimulation is not issued.

[0164] In another optional embodiment, step S234a specifically includes: determining the pulse stopping time based on the pulse starting time and preset pulse parameters; step S234b specifically includes: judging whether the pulse stopping time falls within the pulse issuing time window; if so, issuing CCM pulse stimulation; if not, redetermining the pulse parameters so that the pulse stopping time falls within the pulse issuing time window; and issuing CCM pulse stimulation according to the redetermined pulse parameters.

[0165] In an optional embodiment, the above-mentioned step of issuing CCM pulse stimulation to the myocardial position, such as the above-mentioned steps S231b, S232c, and S233e, specifically includes: if it is determined that the second sensing event in the in vivo near-field myocardial electrocardiogram is an R wave corresponding to the R wave in the in vivo far-field myocardial electrocardiogram, then issuing CCM pulse stimulation to the myocardial position.

[0166] In this embodiment, by determining that the second sensing event in the near-field myocardial electrocardiogram in the body is the R wave, it can be ensured that the CCM stimulation is triggered by the near-field R wave rather than other signals (such as T waves, electromyography or other non-myocardial depolarization electrical activities, etc.), thereby effectively eliminating the occurrence of false triggering. Through the design of this key link, the safety and effectiveness of CCM pulse stimulation can be effectively improved.

[0167] In an optional embodiment, as shown in FIG9 , the control method further includes the following steps S3 to S6:

[0168] Step S3: obtaining a sensing time window corresponding to an R wave in the in vivo far-field myocardial electrocardiogram.

[0169] The sensing time window may be referred to as an R-wave time window (RTW). Specifically, the sensing time window may be obtained based on the first sensing time and / or the second sensing time. First, the starting point of the sensing time window may be determined based on the first sensing time and / or the second sensing time, and then the first preset length of the sensing time window may be determined based on the type of current ventricular activation. In a specific example, if the type of current activation is atrial conduction ventricular activation, the width of the R wave in the in vivo far-field myocardial electrocardiogram is normal, typically greater than or equal to 60 ms and less than 120 ms. For example, the first preset length of the sensing time window may be determined to be 100 ms. In another specific example, if the type of current activation is ventricular activation originating from the ventricles, the width of the R wave in the in vivo far-field myocardial electrocardiogram is wider than the normal width, typically between 160 and 250 ms. For example, the first preset length of the sensing time window may be determined to be 200 ms. In another specific example, if the current activation type is ventricular pacing activation, the R wave in the in vivo far-field myocardial electrocardiogram is relatively wide, typically between 160 and 250 ms. Similarly, the first preset length of the sensing time window can be set to 200 ms. The type of ventricular myocardial activation can be determined using conventional methods, such as detecting premature contractions (PVCs).

[0170] It should be noted that the first preset length of the sensing time window can also be obtained in other ways, such as by directly programming the time window length by a physician inputting a modified preset value through an external device (such as a programmer). The starting points of the pulse-issuable time window and the sensing time window can be the same or different; the second preset length of the pulse-issuable time window and the first preset length of the sensing time window can be the same or different; that is, the pulse-issuable time window and the sensing time window can be set in the same manner or independently, and can have no correlation or dependency between them. For example, different window lengths can be set, and different preset durations can be set after the first sensing time and the second sensing time. Preferably, when the pulse-issuable time window and the sensing time window have the same starting point, the second preset length of the pulse-issuable time window is greater than the first preset length of the sensing time window.

[0171] Step S4: determine whether the second sensing time falls within the sensing time window; if so, execute step S5; if not, execute step S6.

[0172] Step S5: Determine that the second sensing event is an R wave corresponding to an R wave in the in vivo far-field myocardial electrocardiogram.

[0173] Step S6: Determine whether the second sensed event is an R wave corresponding to an R wave in the in-vivo far-field myocardial electrocardiogram. Specifically, if the second sensed event is not an R wave corresponding to an R wave in the in-vivo far-field myocardial electrocardiogram, it indicates that the second sensed event may be a T wave or other interference signal.

[0174] Under normal circumstances, the R wave perception in the far-field ECG reflects the relatively early stage of ventricular electrical activity. The second sensing time LS of the in-vivo near-field myocardial ECG typically falls after the first sensing time GS. Therefore, the first sensing time GS is used to determine the sensing time window and determine whether the second sensing time falls within the sensing time window. In special cases, due to possible sensing delays, the first sensing time GS may slightly lag behind the second sensing time LS, and the difference between the two may fall within a predetermined range (e.g., 20ms to 120ms). To more accurately determine the correspondence between the R wave in the far-field ECG and the second sensing event in the in-vivo near-field myocardial ECG, the sensing time window can be determined using the second sensing time LS. In this case, the second sensing time LS will inevitably fall within the sensing time window, directly confirming that the second sensing event in the in-vivo near-field myocardial ECG is the R wave corresponding to the R wave in the far-field ECG.

[0175] As shown in FIG10 , the control method of the medical device provided in this embodiment may include the following steps S301 to S304:

[0176] Step S301: Determine whether a pacing pulse is delivered to the myocardial position. If so, execute step S302; if not, execute step S303.

[0177] Step S302: Determine whether ventricular capture has occurred. If not, proceed to step S303; if so, proceed to step S304. In practice, there are several methods for determining whether ventricular capture has occurred, such as determining whether ventricular capture has occurred based on the in vivo far-field myocardial electrocardiogram. Of course, if the pacing pulse amplitude is sufficiently high and / or the pulse width is sufficiently long, capture can be considered confirmed, and no specific determination of capture is required; step 304 can be directly executed.

[0178] Step S303: determine whether the second sensing event in the in vivo near-field myocardial electrocardiogram is an R wave corresponding to the R wave in the in vivo far-field myocardial electrocardiogram; if so, execute step S304; if not, end the process.

[0179] Step 304: Determine whether to deliver CCM pulse stimulation to the myocardial location based on the pulse start time and the pulse-issuable time window. In a specific implementation, the first sensing time of the R wave in the in-vivo far-field myocardial electrocardiogram and the pulse-issuable time window corresponding to the R wave in the in-vivo near-field myocardial electrocardiogram are obtained, and the pulse start time is determined based on the first sensing time. The step of determining whether to deliver CCM pulse stimulation to the myocardial location based on the pulse start time and the pulse-issuable time window is similar to step S23 described above.

[0180] In this embodiment, if a pacing pulse is determined to be delivered to the myocardial location, it indicates that the medical device is currently providing a pacing function, and further determination is required as to whether the ventricle has been captured. If the ventricle has not been captured, further determination is required as to whether the second sensed event in the in vivo near-field myocardial electrocardiogram is a corresponding R wave. If it is an R wave, a determination is made as to whether a CCM pulse stimulation is delivered to the myocardial location based on the pulse delivery start time and the pulse delivery time window. If the ventricle has been captured, the pacing pulse time is used as the pulse delivery start time, and a determination is made as to whether a CCM pulse stimulation is delivered to the myocardial location based directly on the pulse delivery start time and the pulse delivery time window.

[0181] In an optional embodiment, the step of delivering CCM pulse stimulation to the myocardial location, such as steps S231b, S232c, and S233e, specifically includes delivering CCM pulse stimulation to the myocardial location if the current heart rate parameter is detected to be within a preset range. If the current heart rate parameter is not within the preset range, indicating that the patient's current heart rate parameter is abnormal, CCM pulse stimulation is not delivered to the myocardial location.

[0182] Specifically, two adjacent R waves can be used to determine whether the current heart rate parameter is within a preset range. The preset range can be set according to the patient's actual situation, for example, it can be set to [40 beats / minute, 120 beats / minute]. If the current heart rate parameter is less than 40 beats / minute or greater than 120 beats / minute, it can be determined that the current heart rate parameter is abnormal.

[0183] In this embodiment, CCM pulse stimulation will only be delivered to the myocardial position of the patient with the second electrode pair when the current heart rate parameters are within the preset range, that is, the current heart rate parameters are normal, which can further ensure the safety and reliability of the patient's treatment.

[0184] Example 2

[0185] Example 2 is similar to Example 1, and the similarities will not be repeated here. The focus will be on the differences between the two. In this example, the first electrode pair is no longer configured on the ventricular electrode lead, but is configured as an additional electrode disposed within a blood vessel, within a cardiac cavity, on the epicardium, within the chest cavity outside the heart, or subcutaneously. For example, subcutaneous defibrillation electrodes for a sub-Q ICD can also be used to obtain in vivo far-field myocardial electrocardiograms. It is understood that the various methods described in Example 1 are also applicable to the situation in Example 2.

[0186] Example 3

[0187] Example 3 is similar to Example 1. The similarities will not be repeated here, and the differences between the two will be emphasized. In this embodiment, the first electrode pair is no longer configured on the ventricular electrode lead, but is configured as a surface electrode for attachment to the skin, such as a commonly used surface electrocardiogram electrode, a specially designed electrode, or a defibrillation electrode of an external defibrillator (such as an AED). A surface electrocardiogram is obtained based on the first electrode pair, replacing the far-field myocardial electrocardiogram in Example 1. The first sensing time of the R wave in the surface electrocardiogram is obtained, the pulse start time is determined based on the first sensing time, and whether the pulse start time falls within the pulse-emittable time window is determined. It can be understood that the various methods described in Example 1 are all applicable to the situation in Example 3.

[0188] In the present invention, the surface electrocardiogram and far-field myocardial electrocardiogram in Examples 1, 2, and 3 may be collectively referred to as far-field electrocardiogram. Those skilled in the art will appreciate that the R wave referred to in the present invention includes the QRS complex and a single R wave.

[0189] In summary, the present invention provides a medical device for delivering pulse stimulation, comprising at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be positioned at a myocardial location in a ventricle; and the control device is configured to execute a pulse stimulation control method, as shown in FIG15 , comprising the following steps:

[0190] Step S7: obtaining a far-field electrocardiogram and an in vivo near-field myocardial electrocardiogram corresponding to the myocardial position;

[0191] Step S8: Determine whether to deliver CCM pulse stimulation to the myocardial position through the ventricular electrode lead based on the R wave in the far-field electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram.

[0192] The following uses the electrocardiogram corresponding to R-wave sensing as an example to further specifically introduce the pulse stimulation control method in the embodiment of the present invention.

[0193] Optionally, the first sensing time GS is used as the first time point, and the time point corresponding to the set time length before the first time point (programmable, ranging but not limited to 10ms to 200ms, preferably 30ms-120ms, for example 60ms) is used as the time reference zero point (starting point); based on the time reference zero point, the second sensing time LS of the R wave of the near-field myocardial electrocardiogram in the body is obtained.

[0194] In one embodiment, the Global Pulse Time (GPT) is a pulse-issuable time window determined based on the first sensing time GS of a first sensing event in a far-field electrocardiogram (which can be either a surface electrocardiogram or an in vivo far-field myocardial electrocardiogram), and has a first preset length. The first sensing event is an R wave. As shown in FIG11 , the control device first obtains the first sensing time GS of the R wave in the far-field electrocardiogram. Based on the first sensing time GS and the first preset length, the pulse-issuable time window GPT is generated. The control device further obtains the second sensing time LS of the R wave in the near-field myocardial electrocardiogram corresponding to this R wave, which is later than the first sensing time GS. Using the second sensing time LS as a reference zero point, the pulse start time T is determined based on the second sensing time LS and the second preset time length LPD. Since the pulse start time T falls within the pulse-issuable time window GPT, a CCM pulse stimulation is determined to be delivered to the second electrode pair (i.e., after the second sensing time LS, the second preset time length is waited until the pulse start time T is reached, and then the CCM pulse stimulation is delivered).

[0195] The pulse start time can also be determined by the first sensing time GS. Specifically, with the first sensing time GS as the reference zero point, the pulse start time T is obtained according to the difference GLSD (a positive number at this time) between the second sensing time LS and the first sensing time GS and the third preset time length (here equal to the second preset time length LPD, which can range from 15ms to 80ms, and generally defaults to 30ms) (that is, after the first sensing time GS, the time length of the sum of the difference GLSD and the third preset time length is experienced, and the CCM pulse stimulation is emitted at the pulse start time T).

[0196] To prevent misperception of the R wave of the in-vivo near-field myocardial electrocardiogram (ECG), such as mistaking a T wave for an R wave, the first sensing time GS can be used as a reference zero point to determine the starting point of the sensing time window corresponding to the R wave of the far-field ECG. The first preset length of the sensing time window can be equal to or shorter than the second preset length of the pulse-issuable time window GPT, and a further determination is made as to whether the second sensing time LS falls within the sensing time window. When the second sensing time LS falls within the sensing time window, it is confirmed that the sensed event is the R wave of the in-vivo near-field myocardial electrocardiogram corresponding to the R wave of the far-field ECG. When the second sensing time LS does not fall within the sensing time window, it is confirmed that the sensed event is not the R wave of the in-vivo near-field myocardial electrocardiogram corresponding to the R wave of the far-field ECG, but rather another sensing event. In this case, no CCM pulse stimulation is delivered.

[0197] In another embodiment, as shown in FIG12 , the control device first senses the second sensing time LS of the R wave in the near-field myocardial electrocardiogram (ECG) and then senses the first sensing time GS of the R wave in the far-field ECG. If the second sensing time LS occurs slightly earlier than the first sensing time GS, this may be due to a deviation caused by R-wave sensing delay. In this case, a pulse delivery time window LSPT is determined. The LSPT (Local Sense Pulse Time) is a pulse delivery time window determined based on the second sensing time LS of the R wave in the near-field myocardial electrocardiogram (ECG) and has a preset window length. Furthermore, using the second sensing time LS as a reference zero point, the pulse delivery start time T is determined based on the second sensing time LS and a second preset duration LPD. If the pulse delivery start time T falls within the LSPT, a CCM pulse stimulation is determined to be delivered to the myocardial location where the second electrode is located (i.e., after the second sensing time LS, the second preset duration is waited for until the pulse delivery start time T is reached, and then the CCM pulse stimulation is delivered).

[0198] The first sensing time GS can also be used as a reference zero point, and the pulse start time T can be obtained according to the difference GLSD (a negative number at this time) between the second sensing time LS and the first sensing time GS and the third preset time length (here equal to the second preset time length LPD) (that is, after the first sensing time GS, the time length of the sum of the difference GLSD and the third preset time length is experienced, and the CCM pulse stimulation is released at the pulse start time T).

[0199] To prevent misperception of the R wave of the in-vivo near-field myocardial electrocardiogram, the second sensing time LS can be used as a reference zero point to determine the starting point of a sensing time window corresponding to the R wave of the far-field electrocardiogram. The first predetermined length of the sensing time window can be equal to or shorter than the second predetermined length of the pulse-issuable time window LSPT. A further determination is then made as to whether the second sensing time LS falls within the sensing time window. Since the second sensing time LS inevitably falls within the sensing time window, it can be confirmed that the sensed R wave of the in-vivo near-field myocardial electrocardiogram corresponds to the R wave of the far-field electrocardiogram.

[0200] Example 4

[0201] With respect to the above-mentioned embodiments 1, 2, and 3, the pulse stimulation delivery method can be further divided into two phases: a setup period and an operational period.

[0202] For a pulse stimulation system with electrodes at a single myocardial point, the following parameters need to be measured during the preset period.

[0203] Please refer to FIG. 11 or FIG. 12 , the second sensing time LS is the second sensing event of the local electrocardiogram sensed first after the time reference zero point determined by the first sensing time GS.

[0204] GLSD is the difference between the second sensing time LS and the first sensing time GS. When the second sensing time LS is later than the first sensing time GS, the difference GLSD is a positive number; when the second sensing time LS is earlier than the first sensing time GS, the difference GLSD is a negative number. The second preset time length LPD is the time length between the second sensing time LS and the pulse start time T. As in the above embodiment, the time length GPD between the first sensing time GS and the pulse start time T can be calculated using the difference GLSD and the second preset time length LPD.

[0205] That is, GPD=GLSD+LPD.

[0206] During the operation period, the GPD calculated during the preset period can be used as the first preset duration, and CCM pulse stimulation can be delivered to the corresponding myocardial position according to the first sensing time GS and the first preset duration GPD; at this time, after the local myocardial electrocardiogram R wave perception occurs, the electrical stimulation output time can be directly determined according to the first preset duration GPD, without the need to calculate the pulse stimulation far-field myocardial electrocardiogram delivery time through the first sensing time GS and the second sensing time LS each time, thereby effectively shortening the data processing time while achieving the stimulation effect and improving the control efficiency of the heart pulse stimulation triggering.

[0207] In addition, the pulse release time GPD can be updated regularly or irregularly according to actual needs (myocardial electrical stimulation can be continued or stopped at this time), and then myocardial electrical stimulation can be continued according to the updated trigger time to achieve a more flexible electrical stimulation effect and meet the needs of more pulse electrical stimulation scenarios.

[0208] It should be noted that, preferably, the above parameters are calculated by averaging over several cardiac cycles (e.g., 6 cardiac cycles, which can be programmed to be other numbers of cardiac cycles); in addition, the preset periods should be performed during sinus ECG activity, ventricular ectopic electrical activity, and ventricular pacing, respectively.

[0209] In another embodiment, as shown in FIG13 , the start time of the pulse-issuable time window GPT / LSPT may be different from the first sensing time GS or the second sensing time LS, but may be earlier than the first sensing time GS or the second sensing time LS by a fourth preset duration A. By setting the fourth preset duration A, the error caused by the sensing lag may be compensated, thereby further improving the accuracy of the R-wave judgment and the safety of the pulse stimulation issuance.

[0210] Specifically, if the start time of the pulse-issuable time window GPT / LSPT is GPT-s / LSPT-s, then

[0211] GPT-s = GS-A, GLSD > 0 (i.e., LS is later than GS);

[0212] LSPT-s=GS+GLSD-A, GLSD≤0 (i.e., LS occurs earlier than GS or at the same time);

[0213] Wherein, 0ms<A≤50ms, for example, the default value of A is 20ms, and A is programmable and adjustable.

[0214] In other embodiments, the second sensing time LS can be equal to the first sensing time GS, and the difference between the first and second sensing times is 0 ms, i.e., A = 0 ms. In this case, either the first sensing time GS or the second sensing time LS can be used as the reference zero point, and the first, second, and third preset times are all equal.

[0215] Example 5

[0216] The difference between this embodiment and the above embodiments is that the medical device includes multiple ventricular electrode wires, which are respectively arranged at multiple different myocardial positions, and multiple second electrodes are in contact with the tissues of these myocardial positions. According to the control device described in Examples 1, 2 and 3, CCM pulse stimulation is delivered to each myocardial position in a timely and effective manner to ensure the safety, effectiveness and reliability of patient treatment.

[0217] The sensing time window is determined according to a first sensing time of an R wave in a far-field electrocardiogram and a second sensing time corresponding to a closest second sensing event.

[0218] For example, as shown in FIG14 , a pulse stimulation electrode is pre-set at three different set myocardial positions (A, B, and C) of the patient as an example for explanation. The set myocardial positions A, B, and C correspond to stimulation electrode pairs E1, E2, and E3, respectively, and the second sensing times of the corresponding second sensing events are LS1, LS2, and LS3, respectively; among which, the occurrence times corresponding to LS1, LS2, and LS3 progress in sequence (i.e., the first second sensing event occurs earliest, and is therefore closest to the first sensing time, and the other second sensing events occur in sequence at subsequent times).

[0219] Specifically, when obtaining the second sensing event in the in vivo near-field myocardial electrocardiogram corresponding to the myocardial position based on the electrode pair E1 at the set myocardial position A, the second sensing time LS1 corresponding to the second sensing event is obtained, and it is judged that the second sensing time LS1 falls into the sensing time window corresponding to the R wave in the far-field electrocardiogram. When it does not fall into the sensing time window, it is determined that the second sensing event is not the R wave signal corresponding to the R wave in the far-field electrocardiogram, but other interference signals such as T wave, and the stimulation electrode pair E1 at the set myocardial position A is controlled not to be stimulated by CCM pulses; when it falls ... The R wave signal of the local myocardium corresponding to the R wave in the far-field electrocardiogram is then calculated in a timely and accurate manner at the second sensing time corresponding to the second sensing event to obtain the pulse emission time corresponding to the stimulation electrode corresponding to the set myocardial position A; and then it is further determined whether the pulse emission time falls within the pulse-emittable time window GPT corresponding to the R wave in the far-field electrocardiogram. If it falls within, the pulse stimulation is controlled to be emitted to the stimulation electrode at the set myocardial position A at the pulse emission time; otherwise, it is determined not to emit the CCM pulse stimulation to the stimulation electrode at the set myocardial position A, so as to complete the one-time pulse stimulation control at the set myocardial position A.

[0220] By analogy, the pulse stimulation control process for setting the myocardial positions B and C is similar to the pulse stimulation control process for setting the myocardial position A, and therefore will not be described in detail here.

[0221] After determining that each second sensing event is R-wave perception, when the pulse emission time calculated according to the second sensing time corresponding to the second sensing event falls into the pulse emission time window GPT corresponding to the R wave in the far-field electrocardiogram, the second sensing time LS1 corresponding to the first second sensing event can also be used as the trigger point (reference zero point) of the pulse emission time window LSPT to ensure that the pulse emission time of subsequent LSn (n>1, such as LS2 and LS3) is within the LSPT window.

[0222] It should be noted that the pulse stimulation control processes for different set myocardial positions can be independent of each other and will not interfere with or affect each other. For example, when the pulse stimulation control process for the set myocardial position A is in progress, or the pulse stimulation control for the set myocardial position A has been completed, as long as the second sensing event LS2 appears in the in vivo near-field myocardial electrocardiogram corresponding to the set myocardial position B, the above-mentioned pulse stimulation control process can be executed separately, and finally the pulse stimulation control for all set myocardial positions is completed. The control operation is orderly, which effectively ensures the safety and reliability of the patient's CCM pulse stimulation. Different pulse stimulation delivery sequences can also be set for different set myocardial positions. For example, in three consecutive time periods, each ventricular electrode lead stimulates myocardial positions A, B, and C in their respective time periods. For another example, in a period of time, pulse stimulation is only performed on the set myocardial position A, and in another period of time, pulse stimulation is only performed on the set myocardial positions B and C, so as to take into account the needs of both safety and effectiveness.

[0223] In one feasible solution, when the sensing times corresponding to the second sensing events of the plurality of in-vivo near-field myocardial electrocardiograms are very close (i.e., the time span is small), the pulse stimulation control method of this embodiment further includes the following steps:

[0224] Obtaining a second sensing time LS corresponding to a second sensing event in an in-vivo near-field myocardial electrocardiogram corresponding to each in-vivo myocardial electrocardiogram, and obtaining the second sensing event with the earliest occurrence time as the first second sensing event; obtaining a second sensing time LS1 corresponding to the first second sensing event, and determining whether the second sensing time LS1 falls within a sensing time window corresponding to an R wave in the far-field electrocardiogram, and if so, determining that the second sensing event is a local myocardial R wave signal corresponding to the R wave in the far-field electrocardiogram;

[0225] For the second sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions, it is determined whether the second sensing times corresponding to these second sensing events fall within the above-mentioned sensing time window. If so, when it is determined that the first second sensing event is an R wave signal corresponding to the R wave in the far-field electrocardiogram, it is directly determined that the second sensing events in the in vivo near-field myocardial electrocardiogram corresponding to the remaining myocardial positions are also R wave signals corresponding to the R wave in the far-field electrocardiogram. At this time, there is no need to judge and analyze the second sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions one by one. While achieving accurate judgment, it greatly simplifies the data analysis and processing process, effectively shortens the data processing time, and reduces the computing power requirements of the equipment, further ensuring the timeliness, accuracy and effectiveness of the patient's pulse stimulation control.

[0226] It should be noted that the specific method used to judge whether the second sensing event of multiple local myocardial electrocardiograms is an R wave can be used to select a single execution scheme or combine multiple execution schemes according to the actual scenario requirements to meet more demanding ECG ventricular conduction scenarios, greatly improving the practicality of pulse stimulation control and greatly improving the safety and effectiveness of patient treatment.

[0227] Therefore, when there are multiple set myocardial positions, the pulse stimulation control method of this embodiment further includes:

[0228] (1) Preset sensing parameters corresponding to R waves at different myocardial locations;

[0229] The setting of the sensing parameters includes setting the sensing time and / or setting the sensing sequence.

[0230] (2) when the second sensing event in the first near-field myocardial electrocardiogram in the corresponding sensing time window is an R wave, the second sensing events in the remaining local myocardial electrocardiograms are all set to be R waves; or,

[0231] (3) When the second sensing event in the last near-field myocardial electrocardiogram in the corresponding sensing time window is an R wave, the second sensing events in the remaining local myocardial electrocardiograms are all set to be R waves.

[0232] It should be noted that: for single-electrode and multi-electrode pulse stimulation systems, the CCM pulse stimulation is delivered relative to the respective myocardial positions after the local myocardial perception time, for example, 40 ms later.

[0233] Example 6

[0234] This embodiment is similar to Example 1, and the similarities are not repeated here. The difference lies in that the methods for obtaining the first sensing time of the R wave in the far-field electrocardiogram and the second sensing time of the R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram are different.

[0235] In this embodiment, the second sensing time of the second sensing event in the in-vivo near-field myocardial electrocardiogram is used as the second time point, and the time point corresponding to the second set time length before the second time point is used as the time reference zero point to obtain the first sensing event in the far-field electrocardiogram located after the time reference zero point. Optionally, the second set time length is greater than or equal to 10 ms and less than or equal to 120 ms. The second sensing event in the in-vivo near-field myocardial electrocardiogram is an R wave. After finding the first sensing event using the above method, it is possible to determine whether the first sensing event in the far-field electrocardiogram is an R wave corresponding to the R wave in the in-vivo near-field myocardial electrocardiogram. It is understood that whether the first sensing event or the second sensing event is obtained first, either one can be used as the first time point to obtain the corresponding other. The method of establishing a sensing time window in Examples 1-5 can be used to determine whether the second sensing event in the in-vivo near-field myocardial electrocardiogram corresponds to the first sensing event in the far-field electrocardiogram. As long as one of the two is an R wave, this correspondence can be used to determine whether the other is also an R wave, thereby ensuring that CCM pulse stimulation is not delivered in the event of false perception.

[0236] As can be seen from the above-mentioned embodiments 1-6, the present invention further provides a medical device for delivering pulse stimulation, the medical device comprising at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be positioned at a myocardial location in a ventricle; as shown in FIG16 , the control device is configured to execute a pulse stimulation control method, comprising:

[0237] Step S9: obtaining a far-field electrocardiogram and an in vivo near-field myocardial electrocardiogram corresponding to the myocardial position;

[0238] Step S10: determining whether the first sensing event in the far-field electrocardiogram and the second sensing event in the in vivo near-field myocardial electrocardiogram are corresponding R waves; if not, executing step S11; if so, executing step S12;

[0239] Step S11: not issuing CCM pulse stimulation to the myocardial location;

[0240] Step S12: delivering CCM pulse stimulation to the myocardial position through the ventricular electrode wire.

[0241] Before step S12, the pulse start time and / or pulse stop time can be obtained by using the first sensing time of the first sensing event and the second sensing time of the second sensing event, as well as whether the pulse issuable time window falls within the pulse issuable time window, and it can be determined whether the pulse start time and / or pulse stop time falls within the pulse issuable time window. The details have been described in detail in Example 1 and will not be repeated here.

[0242] Those skilled in the art will appreciate that, in the prior art, signal interference can cause false perception events, resulting in the sensing of other events, such as T waves, rather than R waves. This can significantly increase the risk of inducing malignant ventricular arrhythmias (VT or VF), thereby increasing the risk to the patient's life and causing additional pain. The pulse stimulation control method provided by the present invention can effectively identify such false perceptions, thereby preventing the inappropriate delivery of CCM pulse stimulation.

[0243] Optionally, step S10 further includes:

[0244] Obtaining a first sensing time GS of a first sensing event in the far-field electrocardiogram and a second sensing time LS of a second sensing event in the in vivo near-field myocardial electrocardiogram, wherein at least one of the first sensing event and the second sensing event is an R wave; and

[0245] When the absolute value of the difference between the first sensing time GS of the first sensing event in the far-field electrocardiogram and the second sensing time LS of the second sensing event in the in vivo near-field myocardial electrocardiogram is within a preset range, it is confirmed that the first sensing event in the far-field electrocardiogram corresponds to the second sensing event in the in vivo near-field myocardial electrocardiogram, and the first sensing event and the second sensing event are both R waves. When the first sensing event in the far-field electrocardiogram is caused by ventricular activation due to atrial conduction, the preset range is greater than or equal to 0ms and less than or equal to 120ms; when the R wave in the far-field electrocardiogram is caused by ventricular activation of the ventricle or by a ventricular pacing pulse, the preset range is greater than or equal to 0ms and less than or equal to 250ms. Preferably, the preset range is 100ms.

[0246] Optionally, as shown in FIG17 , step S10 further includes:

[0247] Step S1003: determining a second sensing event in the near-field myocardial electrocardiogram in the body based on the first sensing time, and obtaining a second sensing time corresponding to the second sensing event, wherein the first sensing time is an R wave; or

[0248] Step S1004: determining a first sensing event in a far-field electrocardiogram based on the second sensing time, and acquiring a first sensing time corresponding to the first sensing event, wherein the second sensing time is an R wave.

[0249] It can be understood that when the second sensing time is obtained based on the first sensing time, if a new first sensing time appears, the second sensing time is still not obtained; or when the first sensing time is obtained based on the second sensing time, if a new second sensing time appears, the first sensing time is still not obtained, the control device is configured to restart a new round of judgment.

[0250] Optionally, step S1003 further includes: taking the first sensing time as a first time point, and taking a time point corresponding to a first set time length before the first time point as a time reference zero point, obtaining a second sensing event in the in vivo near-field myocardial electrocardiogram located after the time reference zero point, wherein the first set time length is greater than or equal to 10 ms and less than or equal to 120 ms; or,

[0251] Optionally, step S1004 also includes: taking the second sensing time as the second time point, and taking the time point corresponding to the second set time length before the second time point as the time reference zero point, obtaining the first sensing event in the far-field electrocardiogram after the time reference zero point, and the second set time length is greater than or equal to 10ms and less than or equal to 120ms.

[0252] Optionally, as shown in FIG18 , step S10 further includes:

[0253] Step S1005: obtaining a sensing time window corresponding to the first sensing event in the far-field myocardial electrocardiogram;

[0254] Step S1006: determining whether the second sensing time falls within the sensing time window; if so, executing step S1007; if not, executing step S1008;

[0255] Step S1007: Determine that the first sensing event in the far-field electrocardiogram corresponds to the second sensing event in the in vivo near-field myocardial electrocardiogram, and both the first sensing event and the second sensing event are R waves.

[0256] Step S1008: Determine that the first sensing event in the far-field electrocardiogram does not correspond to the second sensing event in the in vivo near-field myocardial electrocardiogram, and one of the first sensing event and the second sensing event is not an R wave.

[0257] Step S1005 and step S1006 have been described in detail in embodiments 1 to 7 and will not be repeated here.

[0258] In each embodiment of the present invention, the pulse emission time window is a new requirement for the CCM pulse stimulation emission time, especially when CCM pulse stimulation is emitted at multiple stimulation sites. The emission time of each stimulation site needs to fall within the pulse emission time window, that is, within the emittable period of the entire ventricle in the same heartbeat (ventricular excitation) (not just the emittable period of the local ventricular muscle at the electrode site).

[0259] The sensing time window, as a "whole-ventricle" or "far-field ventricular" R-wave perception time window, is used to determine whether the acquired second sensing event is an R-wave perception corresponding to a local ventricular depolarization in the far-field electrocardiogram (i.e., the "whole-ventricle" or "in vivo far-field" R-wave perception corresponding to ventricular depolarization). The pulse-emittable time window (as a safe zone for stimulus delivery, corresponding to the entire ventricular myocardium ("whole-ventricle" or "far-field ventricular")) is used to determine whether the pulse stimulus delivery time corresponding to the second sensing time LS is safe.

[0260] The pulse delivery time window and the sensing time window are independent, programmable parameters that can be adjusted independently to meet actual configuration requirements. To reduce programming complexity, the physician can choose the same value for both (if appropriate). Alternatively, the system can pre-assign the same value to both parameters, while maintaining the ability to program them independently. These two steps can be used together or independently.

[0261] In this embodiment, CCM pulse stimulation is delivered only during the ventricular releasable period. This ensures the timeliness, safety, and effectiveness of CCM pulse stimulation of the patient's heart by confirming that the pulse stimulation delivery time falls within the pulse delivery window corresponding to the overall ventricular electrical activity (R wave) as measured by the surface electrocardiogram or the in vivo far-field myocardial electrocardiogram. Furthermore, obtaining releasable period information for ventricular electrical activity from the surface electrocardiogram or the far-field myocardial electrocardiogram to ensure pulse stimulation delivery time safety also represents a positive improvement in pulse stimulation technology, further ensuring the safety, effectiveness, and therapeutic effects of CCM pulse stimulation for patients.

[0262] In addition, by only sending CCM pulse stimulation after the R wave, the second sensing event in the near-field myocardial electrocardiogram in the body can be analyzed and processed in time, and the mis-sensed event can be automatically and accurately detected, and it is determined that it is not the R wave signal corresponding to the R wave in the far-field electrocardiogram, but an interference signal such as the T wave. At this time, the CCM pulse stimulation is controlled not to be issued to the corresponding myocardial position, ensuring that the CCM pulse stimulation is not issued under the wrong circumstances, effectively avoiding the risk of inducing VT or VF, and then avoiding unnecessary pain to the patient or even safety hazards, so as to ensure the safety of the patient and improve the reliability of pulse stimulation control; at the same time, it is ensured that the CCM pulse stimulation is issued in time when it is determined to be an R wave, that is, the CCM pulse stimulation is only issued under the correct circumstances.

[0263] In a specific implementation, the medical device provided in this embodiment includes at least one processor and a memory in communication with the at least one processor. The memory stores a computer program executable by the at least one processor, and the computer program is executed by the at least one processor to enable the at least one processor to perform the control method provided in this embodiment. The processor corresponds to the aforementioned control device.

[0264] It should be noted that the above control method can also be called a pulse stimulation control method.

[0265] Although specific embodiments of the present invention have been described above, those skilled in the art will appreciate that these are merely illustrative and that the scope of the present invention is defined by the appended claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, and such changes and modifications are intended to fall within the scope of the present invention.

Claims

1. A medical device for delivering pulse stimulation, characterized in that: The invention comprises at least one ventricular electrode lead and a control device, wherein the ventricular electrode lead is configured to be positioned at a myocardial position; the control device is configured to execute a pulse stimulation control method, wherein the pulse stimulation control method comprises the following steps: obtaining a far-field electrocardiogram and an in vivo near-field myocardial electrocardiogram corresponding to the myocardial position; Determine whether to deliver CCM pulse stimulation to the myocardial position through the ventricular electrode lead based on the R wave in the far-field electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram.

2. The medical device according to claim 1, wherein The medical device also includes a first electrode pair and a second electrode pair, the first electrode pair is used for sensing, the second electrode pair is used for sensing and stimulation, the second electrode pair includes a head end electrode, and the head end electrode is configured on the ventricular electrode lead and is located at the myocardial position of the ventricle; the control device is configured to obtain the far-field electrocardiogram based on the first electrode pair, and to obtain the in vivo near-field myocardial electrocardiogram based on the second electrode pair.

3. The medical device according to claim 2, wherein: The second electrode pairs are both arranged on the ventricular electrode lead, and the medical device is used to provide cardiac pacing function and / or defibrillation therapy function through the ventricular electrode lead; or, The first electrode pairs are all configured on the ventricular electrode wires or are configured as electrodes additionally arranged in blood vessels, in cardiac chambers, on the epicardium, in the chest cavity outside the heart, or under the skin, and the far-field electrocardiogram is an in-vivo far-field myocardial electrocardiogram; or, the first electrode pairs are configured as surface electrodes for attachment to the skin, and the far-field electrocardiogram is a surface electrocardiogram.

4. The medical device according to claim 1, wherein The step of determining whether to issue CCM pulse stimulation to the myocardial position according to the R wave in the far-field electrocardiogram and the R wave in the in vivo near-field myocardial electrocardiogram specifically includes: Obtain the first sensing time of the R wave in the far-field electrocardiogram and the first sensing time of the R wave in the far-field electrocardiogram a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave, and a pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram, wherein the pulse-issuable time window is a CCM stimulation safety window; determining a pulse emission start time according to the first sensing time or the second sensing time; Whether to issue CCM pulse stimulation to the myocardial position is determined according to the pulse start time and the pulse-issuable time window.

5. The medical device according to claim 4, wherein: The step of determining the pulse emission start time according to the first sensing time or the second sensing time specifically includes: Taking the second sensing time as the reference zero point, the pulse start time is obtained according to the second sensing time and the second preset time length, or the time difference between the second sensing time and the first sensing time is calculated; taking the first sensing time as the reference zero point, the pulse emission time is calculated according to the first sensing time, the time difference and the third preset time length, wherein the third preset time length is equal to the second preset time length.

6. The medical device according to claim 4, wherein: The pulse stimulation control method also includes setting a preset period and an operating period. During the preset period, the first preset duration is calculated based on the difference between the first sensing time and the second sensing time and a third preset duration. During the operating period, the first sensing time is used as a reference zero point, and the pulse start time is obtained based on the first sensing time and the first preset duration.

7. The medical device according to claim 5, wherein The second preset time length is greater than or equal to 15 ms and less than or equal to 80 ms.

8. The medical device according to claim 4, wherein: The step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram specifically includes: Acquire a first sensing event in the far-field electrocardiogram and a second sensing event in the far-field electrocardiogram, wherein at least one of the first sensing event and the second sensing event is an R wave; When the first sensing time of the first sensing event in the far-field electrocardiogram is When the absolute value of the difference between the second sensing time of the second sensing event in the internal near-field myocardial electrocardiogram is within a preset range, it is confirmed that the first sensing event in the far-field electrocardiogram corresponds to the second sensing event in the internal near-field myocardial electrocardiogram, and both the first sensing event and the second sensing event are R waves; When the first sensing event in the far-field electrocardiogram is caused by ventricular activation due to atrial conduction, the preset range is greater than or equal to 0ms and less than or equal to 120ms; when the R wave in the far-field electrocardiogram is caused by ventricular activation of the ventricle or by a ventricular pacing pulse, the preset range is greater than or equal to 0ms and less than or equal to 250ms.

9. The medical device according to claim 8, wherein The step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram specifically further includes: Taking the first sensing time as a first time point, and taking a time point corresponding to a first set time length before the first time point as a time reference zero point, obtaining a second sensing event in the in vivo near-field myocardial electrocardiogram located after the time reference zero point, wherein the first set time length is greater than or equal to 10 ms and less than or equal to 120 ms; or, The second sensing time is used as a second time point, and a time point corresponding to a second set time length before the second time point is used as a time reference zero point, and a first sensing event in the far-field electrocardiogram located after the time reference zero point is obtained, where the second set time length is greater than or equal to 10 ms and less than or equal to 120 ms.

10. The medical device according to claim 9, wherein The step of obtaining a first sensing time of an R wave in the far-field electrocardiogram and a second sensing time of an R wave in the in vivo near-field myocardial electrocardiogram corresponding to the R wave in the far-field electrocardiogram further includes: Obtaining a sensing time window corresponding to the first sensing event in the far-field electrocardiogram; determining whether the second sensing time or the first sensing time falls within the sensing time window; If so, determining whether the first sensing event in the far-field electrocardiogram is related to the near-field myocardium in the body If the first sensing event corresponds to the second sensing event in the electrocardiogram, and the first sensing event and the second sensing event are both R waves; if not, the first sensing event in the far-field electrocardiogram does not correspond to the second sensing event in the in vivo near-field myocardial electrocardiogram, and one of the first sensing event and the second sensing event is not an R wave, the control device is configured not to issue CCM pulse stimulation to the myocardial position.

11. The medical device according to claim 10, wherein When the first sensing time is used as the first time point, the first sensing event is an R wave; and the step of determining whether the second sensing time or the first sensing time falls within the sensing time window includes: determining whether the second sensing time falls within the sensing time window; When the second sensing time is used as the second time point, the second sensing event is an R wave; and the step of determining whether the second sensing time or the first sensing time falls within the sensing time window includes determining whether the first sensing time falls within the sensing time window.

12. The medical device according to claim 10, wherein When the first sensing event in the far-field electrocardiogram is ventricular activation caused by non-ventricular pacing, if the first sensing time is earlier than the second sensing time, a starting point of a sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the first sensing time; If the second sensing time is earlier than the first sensing time, a starting point of a sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the second sensing time; When the first sensing event in the far-field electrocardiogram is caused by the generation of a ventricular pacing pulse, the starting point of the sensing time window corresponding to the first sensing event in the far-field electrocardiogram is determined based on the release time of the pacing pulse received by the ventricle, and the release time of the pacing pulse is regarded as the first sensing time.

13. The medical device according to claim 10, wherein: The start time of the sensing time window is earlier than or equal to the first sensing time or the second sensing time by a fourth preset duration, and the issuable pulse time window has a second preset length, the sensing time window has a first preset length, and the second preset length is greater 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.

14. The medical device according to claim 10, wherein: The sensing time window has a first preset length. When the R wave in the far-field electrocardiogram is generated by ventricular activation due to atrial conduction, the first preset length is greater than or equal to 60m and less than 120ms; when the R wave in the far-field electrocardiogram is generated by ventricular activation of the ventricle or by a ventricular pacing pulse, the first preset length is greater than or equal to 160m and less than or equal to 250ms; or, the first preset length is determined by program control.

15. The medical device according to claim 10, wherein There are multiple ventricular electrode wires and they are disposed at multiple different ventricular myocardial locations. There are multiple in vivo near-field myocardial electrocardiograms and second sensing events. The control device is further configured to perform the following steps: Presetting different set sensing parameters corresponding to the R waves at the myocardial positions, the set sensing parameters including set sensing time and / or set sensing occurrence order; When the first second sensing event falling within the sensing time window is an R wave, the remaining second sensing events are all set to be R waves; or, When the last second sensing event falling within the sensing time window is an R wave, the remaining second sensing events are all set to be R waves.

16. The medical device according to claim 4, wherein The step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes: If the pulse start time falls within the pulse-issuable time window, CCM pulse stimulation is issued to the myocardial position; otherwise, CCM pulse stimulation is not issued to the myocardial position.

17. The medical device according to claim 16, wherein There are multiple ventricular electrode wires and they are disposed at multiple different myocardial locations. There are multiple in vivo near-field myocardial electrocardiograms and second sensing events. The control device is further configured to perform the following steps: The pulse stimulation delivery sequence corresponding to the R wave at different myocardial positions is set, and CCM pulse stimulation is delivered to different myocardial positions according to the pulse stimulation delivery sequence.

18. The medical device according to claim 16, wherein When the R wave in the far-field electrocardiogram is ventricular activation caused by non-ventricular pacing, the starting point of the pulse-issuable time window is determined based on a first sensing time of the R wave in the far-field electrocardiogram, or based on a second sensing time of a corresponding R wave in the in-vivo near-field myocardial electrocardiogram determined based on the first sensing time; When the R wave in the far-field electrocardiogram is generated by a ventricular pacing pulse, the starting point of the pulse-issuable time window is determined based on the issuance time of the pacing pulse received by the ventricle, and the issuance time of the pacing pulse is regarded as the first sensing time.

19. The medical device according to claim 18, wherein The pulse-issuable time window has a second preset length, the range of the second preset length is greater than or equal to 150ms and less than or equal to 300ms, or the second preset length is determined by program control; the starting point of the pulse-issuable time window is earlier than the first sensing time or the second sensing time by a fourth preset time length, and the fourth preset time length is greater than or equal to 0ms and less than or equal to 50ms.

20. The medical device according to claim 18, wherein The control device is further configured to perform the following steps: When the second sensing time is earlier than the first sensing time, determining the starting point of the pulse-issuable time window corresponding to the R wave in the in-vivo near-field myocardial electrocardiogram according to the second sensing time, and determining the pulse start time according to the first sensing time or the second sensing time; When the second sensing time is later than the first sensing time, the starting point of the pulse-emittable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined according to the first sensing time, and the pulse start time is determined according to the first sensing time or the second sensing time.

21. The medical device according to claim 4, wherein The step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes: Determining a pulse stopping time according to the pulse starting time; If the pulse start time and the pulse stop time both fall within the pulse-issuable time window, CCM pulse stimulation is issued to the myocardial position; otherwise, CCM pulse stimulation is not issued to the myocardial position.

22. The medical device according to claim 4, wherein The step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes: Determining a pulse stopping time according to the pulse starting time and preset pulse parameters; If the pulse start time falls within the pulse-issuable time window, and the pulse stop time does not fall within the pulse-issuable time window, re-determining the pulse parameters so that both the pulse start time and the pulse stop time fall within the pulse-issuable time window, and delivering a CCM pulse stimulation to the myocardial position according to the re-determined pulse parameters; If the pulse start time does not fall within the pulse-issuable time window, no CCM pulse stimulation is issued to the myocardial location.

23. The medical device according to claim 4, wherein The step of determining whether to issue CCM pulse stimulation to the myocardial position according to the pulse issuance start time and the pulse issuance time window specifically includes: If the pulse start time falls within the pulse issuable time window, determining the pulse stop time according to the pulse start time and preset pulse parameters; Determining whether the pulse stopping time falls within the pulse issuing time window; If so, a CCM pulse stimulation is delivered; If not, no CCM pulse stimulation is issued, or the pulse parameters are re-determined so that the pulse issuance stop time falls within the pulse issuance time window; and CCM pulse stimulation is issued according to the re-determined pulse parameters.

24. The medical device according to claim 4, wherein The control device is configured to perform the following steps: If it is determined that a pacing pulse has been delivered to the myocardial location, determining whether the ventricle has been captured; If so, determining whether to issue a CCM pulse stimulation to the myocardial position according to the pulse start time and the pulse-issuable time window, wherein the pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined based on the issuance time of the pacing pulse received by the ventricle; If not, determine whether to issue CCM pulse stimulation to the myocardial position based on the pulse start time and the pulse-issuable time window, wherein the pulse-issuable time window corresponding to the R wave in the in vivo near-field myocardial electrocardiogram is determined based on the first sensing time of the R wave in the far-field electrocardiogram, or based on the second sensing time of the R wave in the in vivo near-field myocardial electrocardiogram.

25. The medical device according to claim 24, wherein The step of determining whether the ventricle is captured specifically includes: determining whether the ventricle is captured based on the far-field electrocardiogram.

26. The medical device according to claim 1, wherein The step of delivering CCM pulse stimulation to the myocardial position specifically includes: If it is detected that the current heart rate parameter is within the preset range, CCM pulse stimulation is delivered to the myocardial location.

27. The medical device according to claim 1, wherein in, The CCM pulse stimulation is delivered during at least one of the following ventricular electrical activities: Sinus heartbeat, ventricular heartbeat caused by conduction from the atria, ventricular heartbeat caused by the ventricles, and ventricular heartbeat caused by ventricular pacing.

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