Implantable heart failure treatment device

Abstract

The invention relates to an implantable heart failure treatment device. The implantable heart failure treatment device comprises a shell; an anchoring member connected to the housing and fixing the housing to the heart; a pair of stimulation electrodes coupled to the housing and configured to contact a predetermined stimulation location of the heart and configured to apply a stimulation electrical pulse enhancing myocardial contractility at the predetermined stimulation location; a pulse generation module accommodated in the housing and electrically coupled to the stimulation electrode, and configured to generate a stimulation electrical pulse; and a control module housed in the housing and electrically coupled to the stimulation electrode and the pulse generation module, and configured to receive a far-field detection signal indicative of an overall excitation event of the patient's heart and a local detection signal indicative of a local excitation event of a local location of the patient's heart, and determining whether a local excitation event at a local location of the patient's heart corresponds to a specific overall excitation event based at least on the far-field detection signal and the local detection signal, and transmitting a stimulation electrical pulse to the stimulation electrode during an absolutely non-stress period of the local excitation event.

Description

Implantable heart failure devices Technical Field

[0001] The present application relates to the field of heart failure treatment, and more specifically, to an implantable heart failure treatment device and a method for treating heart failure based on the device. Background Art

[0002] Cardiac contractility modulation (CCM) is a unique and innovative therapy for the treatment of patients with chronic heart failure. It enhances the contractility of the myocardium by sending electrical stimulation to the myocardium, thereby achieving the therapeutic purpose. Unlike traditional pacemakers or cardiac resynchronization therapy devices, the electrical stimulation sent by the CCM device is sent during the absolute refractory period and does not affect the heart rate or action potential distribution. The CCM devices currently on the market usually include a host device implanted outside the heart and two bipolar leads extending through the ventricular septum of the ventricle to sense the electrical activity of the local myocardium and the temporal sequence of the electrical activity, and then determine the time period in which electrical pulse stimulation can be sent to the myocardium, and apply electrical pulse stimulation to the local myocardial cells during the time period in order to enhance the contractility of the myocardium.

[0003] However, the two bipolar leads implanted in the body of the existing CCM device not only affect the normal blood flow in the blood vessels and the right heart, and the closure of the tricuspid valve, but may also fall off, and there is also infection (including the pocket, electrode wires, etc.), which leads to additional safety risks. At the same time, the existing CCM device determines the time when the electrical pulse stimulation can be delivered based on the electrical signal at the local myocardial position, so it may cause misjudgment of the time when the electrical pulse stimulation can be delivered. For example, if the CCM device confirms that the electrical signal at the local myocardial position corresponds to the R wave of the cardiac cycle, but in fact the signal corresponds to the T wave or other events (such as interference signals), then the electrical pulse stimulation applied by the CCM device will act on the myocardium during the T wave phase, which will significantly increase the risk of inducing malignant ventricular arrhythmias ventricular tachycardia (VT) or ventricular fibrillation (VF).

[0004] Furthermore, at the same energy level, the greater the distance between stimulating electrodes or the larger the effective area of ​​the stimulating electrodes, the greater the potential degree and / or range of impact on the far-field myocardium. If local pulse stimulation occurs at a location where myocardial cells depolarize relatively late, the timing of application of the electrical pulse stimulation may coincide with the abnormal duration of the action potential of myocardial cells in a location that depolarizes earlier, potentially causing re-depolarization in this portion of the myocardium. To avoid this problem, existing CCM devices require the stimulating electrodes to be located in the ventricular septum, making them unsuitable for other locations of the myocardium where enhanced contractility may be required. Furthermore, to avoid this risk, the control strategy of existing CCM devices is to uniformly withhold electrical pulse stimulation when myocardial potential changes are not caused by the atria (ventricular ectopic activation). However, the incidence of premature ventricular contractions is high in patients with heart failure, and some patients with heart failure rely on ventricular pacing for a long time, especially those taking long-term beta-blockers, those with single-chamber ICDs, and those receiving cardiac resynchronization therapy (CRT). Therefore, the therapeutic effectiveness of existing CCM devices for these patients is significantly reduced.

[0005] In summary, it is necessary to provide a new heart failure treatment device and method to solve at least one problem existing in the prior art.

[0006] Summary of the Invention

[0007] One object of the present application is to provide an implantable heart failure treatment device and a method for treating heart failure based on the device.

[0008] In a first aspect of the present application, an implantable heart failure treatment device is provided, the device comprising: a housing; an anchoring member connected to the housing and configured to fix the housing to the patient's heart; a pair of stimulation electrodes coupled to the housing and constructed to contact a predetermined stimulation position of the patient's heart, the pair of stimulation electrodes being configured to detect a local detection signal generated by discharge of myocardial cells at the predetermined stimulation position, and to apply a stimulation electric pulse for enhancing the contractility of myocardial cells of the patient's heart to the predetermined stimulation position; a pulse generating module, the pulse generating module being housed in the housing and electrically coupled to the pair of stimulation electrodes. electrodes, the pulse generating module being configured to generate the stimulation electrical pulses; and a control module being housed in the housing and electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart, and to determine whether a local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific overall excitation event based at least on the far-field detection signal and the local detection signal, and when it is determined that the local excitation event corresponds to a specific overall excitation event, to transmit the stimulation electrical pulses to the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0009] In a second aspect of the present application, an implantable heart failure treatment device is also provided, the device comprising: a shell; an anchoring member, the anchoring member being connected to the shell and being configured to fix the shell to the patient's heart; a pair of stimulation electrodes, the pair of stimulation electrodes being coupled to the shell and being constructed for contacting a predetermined stimulation position of the patient's heart, the pair of stimulation electrodes being configured to apply stimulation electric pulses for enhancing the contractility of the myocardial cells of the patient's heart and pacing electric pulses for adjusting the heart rate of the patient's heart to the predetermined stimulation position; a pulse generating module, the pulse generating module being housed in the shell and being electrically coupled to the pair of stimulation electrodes, the pulse generating module Configured to generate the stimulation electrical pulses and the pacing electrical pulses; and a control module, which is accommodated in the shell and electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart, and to determine whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific overall excitation event based at least on the far-field detection signal and the applied pacing electrical pulses, and when it is determined that the local excitation event corresponds to the specific overall excitation event, transmit the stimulation electrical pulses to the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0010] In a third aspect of the present application, an implantable heart failure treatment device is also provided, the device comprising: a shell; an anchoring member, the anchoring member being connected to the shell and configured to fix the shell to the patient's heart; a pair of stimulation electrodes, the pair of stimulation electrodes being coupled to the shell and being constructed for contacting a predetermined stimulation position of the patient's heart, the pair of stimulation electrodes being configured to apply stimulation electric pulses to the predetermined stimulation position for enhancing the contractility of the myocardial cells of the patient's heart; a pulse generating module, the pulse generating module being accommodated in the shell and electrically coupled to the pair of stimulation electrodes, the pulse generating module being configured to generate the stimulation electric pulses; and a control module, the control module being accommodated in the shell and electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart, and to determine a pulse emission time and a pulse-emittable time window based at least on the far-field detection signal and the local detection signal, and to transmit the stimulation electric pulse to the pair of stimulation electrodes when the pulse emission time falls within the pulse-emittable time window.

[0011] In a fourth aspect of the present application, an implantable heart failure treatment device is also provided, the device comprising: a shell; an anchoring member connected to the shell and configured to fix the shell to the patient's heart; a pair of stimulation electrodes, the pair of stimulation electrodes being coupled to the shell and constructed for contacting a predetermined stimulation position of the patient's heart, the pair of stimulation electrodes being configured to apply a stimulation electric pulse for enhancing the contractility of the myocardial cells of the patient's heart to the predetermined stimulation position; a pulse generating module, the pulse generating module being housed in the shell and electrically coupled to the pair of stimulation electrodes, the pulse generating module being configured to generate the stimulation electric pulse; and a control A control module is housed in the shell and is electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart and a local detection signal indicating a local excitation event at a local position of the patient's heart, and to determine whether the local excitation event at the local position of the patient's heart corresponds to a specific overall excitation event based at least on the far-field detection signal and the local detection signal, and when it is determined that the local excitation event corresponds to the specific overall excitation event, transmit a stimulation electric pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0012] In the fifth aspect of the present application, a method for treating heart failure based on an implantable device is also provided, wherein the implantable device includes a shell, which is fixed to the patient's heart by an anchoring member thereon, and includes a pair of stimulation electrodes constructed to contact a predetermined stimulation position of the patient's heart; wherein the method includes: detecting a local detection signal generated by the discharge of myocardial cells at the predetermined stimulation position by the pair of stimulation electrodes; receiving a far-field detection signal indicating an overall excitation event of the patient's heart; determining whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific overall excitation event based on at least the far-field detection signal and the local detection signal; and, when it is determined that the local excitation event corresponds to the specific overall excitation event, applying the stimulation electric pulse to the predetermined stimulation position using the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0013] In the sixth aspect of the present application, a method for treating heart failure based on an implantable device is also provided, wherein the implantable device includes a shell, which is fixed to the patient's heart by an anchoring member thereon, and includes a pair of stimulation electrodes constructed to contact a predetermined stimulation position of the patient's heart; wherein the method includes: applying a pacing electric pulse for adjusting the patient's heart rate to the predetermined stimulation position of the patient's heart by the pair of stimulation electrodes; determining the capture of the patient's heart; after determining the capture, determining whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific overall excitation event based on the acquired far-field detection signal indicating the overall excitation event of the patient's heart and the pacing electric pulse; and when it is determined that the local excitation event corresponds to the specific overall excitation event, using the pair of stimulation electrodes to apply the stimulation electric pulse to the predetermined stimulation position during the absolute refractory period of the local excitation event.

[0014] In the seventh aspect of the present application, a non-volatile computer-readable storage medium is further provided, on which a computer program is stored. When the computer program is executed by a processor, the steps of the method described in any one of the fifth and sixth aspects of the present application are implemented.

[0015] The above is a summary of this application, which may contain simplifications, generalizations, and omissions of details. Therefore, those skilled in the art should recognize that this section is illustrative only and is not intended to limit the scope of this application in any way. This summary is neither intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The above and other features of the present application will be more fully understood through the following description and the appended claims, taken in conjunction with the accompanying drawings. It should be understood that these drawings only depict several embodiments of the present application and, therefore, should not be construed as limiting the scope of the present application. The present application will be more clearly and fully illustrated by the accompanying drawings.

[0017] FIG1 is a schematic diagram showing an implantable heart failure treatment device fixed to a ventricle according to one embodiment of the present application;

[0018] 2A to 2C are schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application;

[0019] 3A to 3C are schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application;

[0020] 4A to 4C are schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application;

[0021] 5A and 5B are schematic diagrams of implantable heart failure treatment devices according to two different embodiments of the present application;

[0022] FIG6 is a flow chart showing a control method of an implantable heart failure treatment device according to an embodiment of the present application;

[0023] FIG7 shows a schematic diagram of the workflow of an implantable device in pacing mode according to one embodiment of the present application;

[0024] FIG8 shows a module schematic diagram of a control system of an implantable heart failure treatment device according to an embodiment of the present application;

[0025] FIG9 is a flow chart of the pulse stimulation control method according to Example 1 of the present invention;

[0026] FIG10 is a first flow chart of the pulse stimulation control method according to Example 2 of the present invention;

[0027] FIG11 is a second flow chart of the pulse stimulation control method according to Example 2 of the present invention;

[0028] FIG12 is a third flow chart of the pulse stimulation control method according to Example 2 of the present invention;

[0029] FIG13 is a fourth flow chart of the pulse stimulation control method according to Example 2 of the present invention;

[0030] FIG14 is a fifth flow chart of the pulse stimulation control method according to Example 2 of the present invention;

[0031] FIG15 is a schematic diagram of an electrocardiogram corresponding to R wave sensing when a single electrode lead is used in Example 2 of the present invention;

[0032] FIG16 is a schematic diagram of an electrocardiogram corresponding to R wave sensing when multiple electrode leads are used in Example 2 of the present invention;

[0033] FIG17 is a module diagram of a pulse stimulation control system according to Example 3 of the present invention;

[0034] FIG18 is a schematic diagram of modules of a pulse stimulation control system according to Example 4 of the present invention;

[0035] FIG19 is a schematic structural diagram of an electronic device for implementing the pulse stimulation control method according to Example 5 of the present invention. DETAILED DESCRIPTION

[0036] In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols generally indicate similar components, unless the context indicates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be employed, and other changes may be made, without departing from the spirit or scope of the subject matter of the present application. It is understood that various configurations, substitutions, combinations, and designs of the various aspects of the present application generally described herein and illustrated in the accompanying drawings may be made, all of which are expressly intended to form a part of the present application.

[0037] Figure 1 shows a schematic diagram of an implantable heart failure treatment device 100 fixed to a ventricle according to an embodiment of the present application. The implantable heart failure treatment device 100 can be implanted in the body in various suitable ways, such as through the apex or through the blood vessels.

[0038] As shown in FIG1 , an implantable heart failure treatment device 100 includes a housing 101 and an anchoring member 102 connected to the housing 101. The anchoring member 102 is used to secure the housing 100 to a specific location in the patient's heart. Although not specifically shown in the figure, the anchoring member 102 may include various suitable mechanical components, such as a pin, a nail, a screw, a hook, a thread, a spiral, a serrated tooth, a clamp, and / or other similar structures, to secure it to the heart tissue. In some embodiments, one or more anchoring members 102 may have a hook-shaped portion that can pierce the heart tissue and be at least partially lodged therein. In other embodiments, one or more anchoring members 102 may have an auger structure similar to a wine corkscrew, enabling it to drill into the heart tissue and achieve fixation. In still other embodiments, one or more anchoring members 102 may have a screw portion that can achieve a tight engagement with the heart tissue through helical rotation. Those skilled in the art will appreciate that the aforementioned structures of the anchoring members 102 are merely exemplary and not limiting.

[0039] Although FIG1 illustrates a single anchoring member 102, the implantable heart failure treatment device 100 may include any suitable number of anchoring members 102 to secure the housing 101 to the cardiac tissue. For example, the device 100 may include one, two, three, four, five, six, seven, eight, or more anchoring members 102. Furthermore, the implantable heart failure treatment device 100 may also utilize a combination of the aforementioned anchoring members to achieve a more stable fixation effect.

[0040] Continuing with reference to Figure 1, the implantable heart failure treatment device 100 also includes a pair of stimulation electrodes coupled to the housing 100, consisting of electrodes 103 and 104. The electrodes 103 or 104 may include one or more biocompatible conductive materials, such as various metals or alloys that are known to be safely implanted in the human body. The pair of stimulation electrodes is exposed to the surrounding tissue and / or blood it contacts, so that electrical signals can be sent to the surrounding tissue and / or blood, or received from the surrounding tissue and / or blood. The electrical signals can be conducted via cardiac tissue and / or blood. In some embodiments, the stimulation electrode pair 103 and 104 is configured to be capable of detecting a local detection (Local Sense, hereinafter referred to as LS) signal generated by the discharge of myocardial cells at a predetermined stimulation position, and applying a stimulation electrical pulse at the predetermined stimulation position for enhancing the contractility of the myocardial cells of the patient's heart.

[0041] Because the anchoring member 102 shown in FIG1 is implanted at the interventricular septum, the stimulating electrode pair 103 and 104 can apply electrical stimulation to the nearby interventricular septum. However, depending on the location of the anchoring member 102, the predetermined stimulation location at which the stimulating electrode pair 103 and 104 is located can be any other cardiac location where stimulating electrical pulses are desired to enhance myocardial cell contractility. For example, the predetermined stimulation location can be the endocardium within a patient's cardiac chamber, or a location on the epicardium of the patient's heart. In some embodiments, the predetermined stimulation location corresponds to a portion of ventricular tissue, while in other embodiments, the predetermined stimulation location can also be a portion of atrial tissue. In some embodiments, the housing 101 of the device 100 is configured to be positioned within a venous vessel outside the patient's heart (e.g., having a capsule-like structure), and the predetermined stimulation location is the epicardial tissue adjacent to the venous vessel. In this case, the anchoring member 102 is also configured as a suitable structure. For example, the anchoring member 102 can be a stent, balloon, support arm, or similar expandable structure, or the anchoring member 102 can be a spike or hook extending from the housing 101 and contacting the venous vessel wall. In some other embodiments, the anchoring member 102 may be formed by a portion of the housing 101 , the cross-sectional diameter of which is configured to engage a relatively narrow section of a vein wall, thereby securing the housing 101 in the blood vessel.

[0042] As shown in FIG1 , the implantable heart failure treatment device 100 also has a pulse generating module 105 and a control module 106 disposed in the housing 101 and electrically coupled to the stimulation electrode pair 103 and 104. Although the electrodes 103 and 104 are shown as being located on the anchoring member 102, they may also be any structure that is electrically coupled to the pulse generating module 105 and the control module 106 in the housing 101 and exposed to tissue and / or blood outside the housing 101. For example, at least one of the electrode pairs 103 and 104 is not disposed on the anchoring member 102. In some embodiments, the electrodes 103 and / or 104 may be formed on the outer surface of the housing or arranged on other components extending from the housing. When the anchoring member 102 is fixed to the heart or vascular tissue, the electrodes 103 and / or 104 remain in contact with the heart or vascular tissue. For example, the anchoring member 102 may have a hook-shaped structure as described above, and the electrodes 103 and / or 104 may be located on a protrusion extending from the housing and adjacent to the anchoring member 102. When the hook-shaped portion of the anchoring member 102 penetrates the cardiac tissue and is at least partially lodged in the cardiac tissue, the protrusion on which the electrodes 103 and / or 104 are located contacts the cardiac tissue. In other embodiments, the electrodes 103 and / or 104 may be disposed on the anchoring member 102 or constituted by the entirety or a portion of the anchoring member 102, and may be inserted into the cardiac or vascular tissue along with the anchoring member 102. For example, the anchoring member 102 may have an auger structure similar to a wine corkscrew as described above, wherein a portion or all of the auger constitutes the electrodes 103 and / or 104, and the electrodes 103 and / or 104 at least partially penetrate the cardiac tissue.

[0043] In some embodiments, the stimulation electrode pair 103 and 104 may also adopt any electrode structure used by conventional leadless pacemakers to apply pacing pulses. In some embodiments, the electrodes 103 and / or 104 may be defined by a portion of the housing 101, for example, the surface of the housing 101 includes an insulating material, and the portion not covered by the insulating material constitutes the electrodes 103 and / or 104, wherein the electrodes 103 and / or 104 may be formed by an area of ​​any shape smaller than the surface area of ​​the housing, such as a circular, rectangular, annular, semi-annular, fan-shaped, and arched area. In some embodiments, the electrodes 103 and / or 104 are configured such that a portion is located within the housing 101 and another portion is exposed from the surface of the housing 101. In other embodiments, the electrodes 103 and / or 104 are disposed on other members extending from the housing 101 and are spaced apart from the housing 101 and / or the anchoring member 102. It should be emphasized that the above description is not intended to limit the specific position or construction of electrodes 103 and / or 104. Electrodes 103 and 104 can adopt any combination of the above-mentioned electrode position and construction features, or adopt any feasible position arrangement or construction form that can achieve their functions.

[0044] As shown in FIG1 , electrode 103 of the stimulation electrode pair is used to contact or electrically connect with a predetermined stimulation location of the myocardial tissue (the interventricular septum location in the figure). Electrodes 103 and / or 104 themselves can have various available sizes and / or shapes. In some embodiments, the surface area of ​​electrode 103 used for contacting the predetermined stimulation location is 1 to 10 mm. 2 , preferably 1.5, 2, 3, 4, 5 mm 2 In the stimulation electrode pair, the electrode 103 and the electrode 104 are separated from each other. In some embodiments, the distance between the two electrodes is 2 to 20 mm, preferably 5 to 10 mm.

[0045] Continuing with reference to FIG1 , in addition to detecting the local electrical signals generated by the discharge of myocardial cells at a predetermined stimulation location, the implantable heart failure treatment device 100 may also include a far-field excitation detection module, which is used to detect overall excitation events of the patient's heart, such as the P wave that characterizes the time and potential changes of the depolarization of the atrial muscle group as a whole, the QRS complex that characterizes the time and potential changes of the depolarization of the ventricular muscle group as a whole, and the T wave that characterizes the time and potential changes of the repolarization of the ventricular muscle group as a whole. After acquiring the far-field detection (Global Sense, hereinafter referred to as GS) signal associated with the overall excitation event, the far-field excitation detection module provides the corresponding far-field detection signal to the control module 106 of the implantable heart failure treatment device 100, so that the control module 106 can further determine the specific release time of the stimulation pulse based on the far-field detection signal and the local detection signal.

[0046] As shown in Figure 1, the far-field excitement detection module includes a detection electrode pair consisting of detection electrodes 107 and 108, which are coupled to the housing 101 and are constructed to realize the detection of the far-field electrical signals involved in the above-mentioned overall excitement event. It should be noted that, although the electrodes 107 and 108 as shown in Figure 1 are arranged on the outer surface of the housing 101, they can also have any structure that realizes electrical coupling with the control module 106 and is exposed to the tissue and / or blood outside the housing 101. In other words, the detection electrodes 107 and 108 can adopt any combination of the electrode materials and structural form features adopted by the stimulation electrodes 103 and 104 as described above, or any feasible position arrangement or structural form that can realize its function. In some embodiments, the surface area of ​​the detection electrodes 107 and / or 108 is greater than that of the stimulation electrodes 103 and / or 104. In some embodiments, the electrodes 107 and / or 108 are limited by a portion of the housing 101, and their surface area occupies one-quarter to one-third of the overall surface area of ​​the housing. In some embodiments, the stimulation electrode pair and the detection electrode pair may also share a common electrode, for example, the detection electrode 107 and the stimulation electrode 104 may be combined into a single electrode. The specific arrangement of the detection electrodes and the stimulation electrodes will be described in detail below.

[0047] Although not shown in the figures, in some embodiments, the far-field excitation detection module may also be arranged outside the housing 101 and be communicatively connected to the control module 106. For example, the far-field excitation detection module may be constructed in another implantable device independent of the implantable heart failure treatment device 100, and be communicatively connected to the implantable heart failure treatment device 100 in a wireless or wired manner. The far-field excitation detection module arranged in the other implantable device may take the form of the detection electrode pair 107 and 108 as described above, obtain the far-field detection signal and send the far-field detection signal or the processing result of the far-field detection signal to the control module 106 of the implantable heart failure treatment device 100. The other implantable device may be any available implantable device having the function of detecting and / or processing the far-field detection signal.

[0048] In some embodiments, two or more implantable heart failure treatment devices can together constitute a heart failure treatment system, and at least one of the implantable heart failure treatment devices does not have a far-field excitation detection module, but instead obtains the far-field detection signal of the far-field excitation detection module of the other implantable heart failure treatment devices through a wired or wireless method. In some embodiments, the aforementioned heart failure treatment system includes an implantable heart failure treatment device 100 as shown in Figure 1, which is arranged in the right ventricle, and another implantable heart failure treatment device arranged in the coronary vein of the heart and connected to the device 100 for communication. Compared with the device 100, the implantable heart failure treatment device in the coronary vein may not have the detection electrode pair 107 and 108, and its control module is configured to detect the local detection signal generated by the discharge of the myocardial cells at the predetermined stimulation location through the stimulation electrode, and send the local detection signal and / or its processing result to the device 100. Subsequently, the device 100 determines the specific time to apply the stimulation electric pulse based on the above-mentioned local detection signal combined with the far-field detection signal obtained by itself, and sends the instruction to apply the stimulation electric pulse to the device in the coronary vein. After receiving the instruction, the device applies electrical stimulation at the predetermined stimulation location. In other embodiments, the device in the coronary vein may be configured to only receive the far-field detection signal indicating an overall excitation event in the patient's heart from device 100, and then determine the specific time to apply the stimulation pulse based on the far-field detection signal and the local detection signal. The specific method for determining the time to apply the stimulation pulse based on the far-field detection signal and the local detection signal will be described in detail below.

[0049] In other embodiments, the far-field excitation detection module may include a pair of detection electrode patches, which are constructed to contact the patient's body surface to detect the patient's surface electrocardiogram signal as a far-field detection signal, and transmit it to the control module 106 of the implantable heart failure treatment device 100 fixed to the heart in a wireless or wired manner. Since the far-field detection signal reflects the far-field characteristics of the patient's heart activity, sharing the far-field detection signal can effectively reduce the manufacturing cost of the device. Of course, in some embodiments, the far-field detection signal indicating the overall excitation event of the patient's heart received by the control module 106 of the implantable heart failure treatment device 100 can also come from any other device that is communicatively connected to the control module 106 and has the function of detecting and / or processing far-field detection signals. These devices can be any other type of implanted device arranged in the patient's body, or any type of device arranged on the body surface or outside the body.

[0050] In the housing 101, a pulse generation module 105 is electrically coupled to the stimulation electrode pairs 103 and 104 and is configured to generate stimulation electrical pulses. A control module 106 is electrically coupled to the stimulation electrode pairs 103 and 104 and the pulse generation module 105, and is configured to receive local detection signals generated by the discharge of myocardial cells at a predetermined stimulation location acquired by the stimulation electrode pairs 103 and 104, as well as far-field detection signals indicating an overall excitation event of the patient's heart. At the same time, the control module 106 also determines, based at least on the far-field detection signals and the local detection signals, whether the local excitation event of the myocardial cells at the predetermined stimulation location corresponds to a specific overall excitation event, for example, determining whether the electrical signal generated by the action potential of the myocardial cell group at and near the predetermined stimulation location corresponds to a specific far-field electrocardiogram change. When it is determined that the local excitation event corresponds to a specific overall excitation event, during the absolute refractory period of the local excitation event, the control module 106 will control the pulse generation module 105 to transmit the stimulation electrical pulse to the stimulation electrode pairs 103 and 104, thereby enhancing the myocardial cell contractility of the myocardial cells during the local excitation event to treat heart failure. The specific manner in which the control module 106 determines the instruction to transmit the stimulation electrical pulse based on the above-mentioned signals will be described in detail below. FIG. 2A to FIG. 2C are schematic diagrams of implantable heart failure treatment devices 200 a, 200 b, and 200 c, respectively, according to different embodiments of the present application, schematically illustrating alternative arrangements of the detection electrode pairs and the stimulation electrode pairs relative to the housing.

[0051] As shown in Figure 2A , electrode 203a of the stimulation electrode pair of device 200a is located at the end of the anchoring member 202a away from the housing 201a, while the other electrode 204a is disposed on the housing 201a at an end adjacent to the anchoring member 202a. The detection electrode pair 207a and 208a of device 200a are sequentially disposed on the housing 201a in a direction away from electrode 204a. The arrangement of the detection electrode pair and the stimulation electrode pair of device 200b shown in Figure 2B is substantially the same as that of the embodiment shown in Figure 2A , differing only in that stimulation electrode 204b is disposed on the anchoring member 202b rather than on the housing 201b. Furthermore, the detection electrodes 207a and 207b of device 200b are disposed at opposite ends of the housing 201b. The implantable heart failure treatment device 200c shown in FIG2C differs from the implantable heart failure treatment device 200b shown in FIG2B only in that the device 200c eliminates the stimulation electrode 204b provided on the anchoring member 202b. Instead, the device 200c utilizes the electrode 207c located on the end of the housing 201c adjacent to the anchoring member 202c as the common reference electrode for both the detection and stimulation electrode pairs. In other words, in device 200c, the detection electrode pair consists of electrodes 207c and 208c, while the stimulation electrode pair consists of electrodes 203c and 207c.

[0052] 3A to 3C respectively show schematic diagrams of implantable heart failure treatment devices 300a, 300b and 300c according to different embodiments of the present application, which schematically illustrate the positional arrangement of the detection electrode pair and the stimulation electrode pair relative to the shell. The implantable heart failure treatment device 300a shown in FIG3A is substantially the same in structure as the implantable heart failure treatment device 200a shown in FIG2A , with the only difference being the arrangement direction of the electrodes in the detection electrode pair. If the arrangement direction of the detection electrodes 207a and 208a shown in FIG2A is defined as the long axis direction of the shell, the detection electrode pair 307a and 308a shown in FIG3A are arranged in a direction substantially perpendicular to the long axis direction. Similarly, the implantable heart failure treatment device 300b shown in FIG3B is substantially the same in structure as the implantable heart failure treatment device 200b shown in FIG2B , with the difference being that the detection electrode pair 307b and 308b are also arranged along the shell 301b in a direction substantially perpendicular to the long axis direction. The implantable heart failure treatment device 300c shown in FIG3C has substantially the same structure as the implantable heart failure treatment device 200c shown in FIG2C , except that the detection electrode pair 307c and 308c are also arranged along the shell 301c in a direction substantially perpendicular to the long axis direction.

[0053] In some embodiments, the detection electrodes of a detection electrode pair are arranged to be relatively far apart. For example, the detection electrodes are arranged at both ends of the long axis of the housing, on two surfaces farther away from the short axis, or on two surfaces at both ends of the long axis. This allows for better collection of electrical activity from the entire heart, particularly the entire ventricular myocardium. Specifically, in some embodiments, if one electrode of a stimulation electrode pair is located on the housing and the far-field detection electrode pair does not share this stimulation electrode, the areas covered by the stimulation electrode pair and the detection electrode pair do not overlap. Assuming the detection electrode pair includes electrodes A and B, and the stimulation electrode pair includes electrodes C and D, where D is the electrode in contact with the myocardium, the order of arrangement of the electrodes is A, B, C, and D. In some instances, an insulator is placed between electrodes B and C to maintain a certain distance between the two electrodes and minimize the impact of the pulse stimulation delivered by the stimulation electrode on the electrical activity measured by the detection electrode. Those skilled in the art will understand that, regardless of the arrangement, any two of electrodes A, B, C, and D must be insulated from each other.

[0054] 4A to 4C respectively show schematic diagrams of implantable heart failure treatment devices 400a, 400b and 400c according to different embodiments of the present application, each of which has multiple pairs of stimulation electrodes. The implantable heart failure treatment device 400a shown in FIG4A is substantially the same in structure as the implantable heart failure treatment device 200b shown in FIG2B , the only difference being that the device 400a also has another anchoring member 409a, and the anchoring member 409a is provided with another set of stimulation electrode pairs 410a and 411a. The two pairs of stimulation electrode pairs are arranged to contact different predetermined stimulation positions of the endocardium or the epicardium, respectively. These stimulation electrode pairs can detect the local detection (LS) signal generated by the action potential of the myocardial cells at the predetermined stimulation positions to which they correspond, and can also apply stimulation electrical pulses for enhancing the contractility of the myocardial cells of the patient's heart at the corresponding predetermined stimulation positions.

[0055] In some embodiments, it is assumed that electrode 403a of the stimulation electrode pair 403a and 404a contacts position A of the ventricular lumen, while electrode 410a of the stimulation electrode pair 410a and 411a contacts position B of the ventricular lumen, which is different from position A. The two electrode pairs respectively detect local detection signals generated by changes in the membrane potential of the myocardial cells at positions A and B, and when the local detection signals at positions A and B meet certain preset conditions, the stimulation electrode pairs apply stimulation electrical pulses to positions A and B, respectively, to enhance the contractility of the myocardium. For example, the control module of device 400a can determine whether the electrical activity of the myocardial cells at positions A and B corresponds to the depolarization transmission process of the ventricle based on the intensity and / or time sequence of the local detection signals at positions A and B, and if the determination result is yes, apply stimulation electrical pulses to the myocardial tissue at positions A and / or B.

[0056] The implantable heart failure treatment device 400b in the embodiment shown in FIG4B is substantially the same as the implantable heart failure treatment device 300a in FIG3A , except that device 400b further comprises another anchoring member 409b and another stimulation electrode 410b disposed on the anchoring member 409b, wherein electrode 404b, which is formed from a portion of the housing 401b, forms two stimulation electrode pairs with electrodes 403b and 410b, respectively. The structure of device 400c shown in FIG4C is substantially the same as device 200a shown in FIG2A , except that device 400c further comprises another anchoring member 409c, and electrode 404c, which is formed from a portion of the housing 401c, forms two stimulation electrode pairs with electrodes 403c and 410c, respectively. Similar to the description of device 400a in FIG4A , devices 400b and 400c can also be configured to detect and process local detection signals at different locations of the heart and to deliver stimulation electrical pulses separately through their two stimulation electrode pairs, which will not be described in detail here.

[0057] 5A to 5B respectively show schematic diagrams of implantable heart failure treatment devices 500a and 500b according to different embodiments of the present application, which schematically illustrate the positional arrangement of the stimulation electrode pair relative to the shell. As shown in FIG5A , the device 500 includes a shell 501a and a stimulation electrode pair consisting of electrodes 503a and 504a attached to the shell 501a. As previously described, the device 500 is designed to be suitable for placement in a venous vessel outside the patient's heart, and its predetermined stimulation position is the epicardial myocardial tissue near the venous vessel. The stimulation electrode pair is configured to detect the local detection (LS) signal generated by the discharge of myocardial cells at a specific position of its epicardium, and can also apply a stimulation electric pulse for enhancing the contractility of the myocardial cells of the patient's heart at the corresponding position. The shell 501a shown in the figure and the stimulation electrode pair attached to the shell surface are constructed to be able to engage with the venous vessel wall outside the heart to fix the device 500a in the blood vessel, and at least one electrode in the stimulation electrode pair is configured to abut against the side of the vessel wall adjacent to the epicardium.

[0058] In addition, in some embodiments, the device 500a may also have an anchoring member composed of a stent, a balloon, a support arm, or a similar expandable structure, or an anchoring member composed of an anchor barb or a hook structure, so that it can engage with the wall of the venous vessel to fix the device 500. In other embodiments, the size of at least a portion of the shell 501a is set to be able to be fixed in a relatively narrow section of the venous vessel outside the heart, so that the shell 501a is fixed in the venous vessel. The implantable heart failure treatment device 500b shown in Figure 5B is substantially the same as the device 500a in Figure 5A, the difference being that the structure of the single electrode 504b in the stimulation electrode pair is replaced with a portion of the shell 501a, for example, an annular area on the shell 501a that is not covered by the insulating material. In some embodiments, the single electrode 504b may also be a local area in the annular area facing the myocardium, such as a semi-annular area facing the myocardium, or an arc that is smaller or larger than a semi-annular area. As described above, two or more implantable heart failure treatment devices disclosed in the present application can together constitute a heart failure treatment system, and at least one of the implantable heart failure treatment devices may not have far-field excitation detection electrodes and detection modules, but may obtain far-field detection signals and / or signal processing results of far-field excitation detection modules of other implantable heart failure treatment devices in a wired or wireless manner. In order to minimize the volume so as to facilitate placement in the venous vessels outside the heart, the implantable heart failure treatment devices 500a and 500b shown in Figures 5A or 5B may not have a far-field excitation detection module, but may receive far-field detection signals indicating overall excitation events of the patient's heart from other external devices or other implanted devices having far-field excitation detection modules, and determine by its own control module whether the local excitation event of the myocardial cells at the corresponding predetermined stimulation position corresponds to a specific overall excitation event based on the local detection signal detected by its stimulation electrode pair. In this way, when the local excitation event meets the preset conditions, the implantable heart failure treatment device can instruct the stimulation electrode pair to apply pulsed electrical stimulation at the predetermined stimulation position. In some embodiments, the implantable heart failure treatment devices 500a and 500b may be constructed so as not to perform the above-mentioned judgment steps based on the far-field detection signal and the local detection signal, and they are connected to other implanted devices or external devices in the system to communicate with each other so as to send the local detection signal or detection result obtained by the stimulation electrode pair to other implanted devices or external devices in the system. In this way, other implanted devices or external devices can make judgments based on the far-field detection signal and the local detection signal, and send instructions to the implantable heart failure treatment device 500a or 500b to deliver pulsed electrical stimulation at appropriate times. Subsequently, the device 500a or 500b controls the stimulation electrode pair to apply electrical pulse stimulation to the predetermined stimulation position (epicomyocardium) that it contacts or corresponds to based on the received instructions, so as to enhance the contractility of its myocardium.

[0059] It should be emphasized that the embodiments shown in Figures 2A to 5B are intended to schematically illustrate possible positional arrangements of stimulation electrode pairs and / or detection electrode pairs. The materials, structural shapes, etc. of the stimulation electrode pairs and / or detection electrode pairs in the figure can adopt any of the technical features and combinations thereof described in the electrodes 103, 104, 107 and 108 described in the embodiment shown in Figure 1, or adopt any other feasible positional arrangements or structural forms that can achieve their functions, which will not be repeated here. In addition, for the sake of simplifying the views, some views do not specifically draw the insulating material or structure between the electrodes, but it is obvious that an insulating structure or material is provided between the electrodes. For example, for multiple electrodes provided on the housing, isolation can be achieved by insulating material coating or covering the electrodes. For another example, the housing of the device can be made of an insulating material as a whole, and two or more electrodes extend from the housing and are connected to the circuit module in the housing. Those skilled in the art will obviously understand that the insulation arrangement between these electrodes can adopt any feasible method, which will not be repeated here.

[0060] FIG6 shows a flow chart of a control method 600 for an implantable device according to an embodiment of the present application. The steps of the method shown in the figure will be exemplarily described below with reference to the device 100 shown in FIG1 .

[0061] In step 602, the control module 106 determines whether a local excitation event of a cardiomyocyte at a predetermined stimulation location corresponds to a specific global excitation event based on at least the acquired far-field detection signal and the acquired local detection signal. In some embodiments, step 602 may include: acquiring a specific event time window corresponding to the specific global excitation event; and determining that the local excitation event corresponds to the specific global excitation event if the time at which the local excitation event is sensed falls within the specific event time window.

[0062] The specific event time window refers to a time period associated with a specific event of the cardiac cycle, determined based on a far-field detection signal (also referred to herein as a GS signal) and / or a local detection signal (also referred to herein as a LS signal). For example, a time period associated with a specific event of the cardiac cycle (such as an R wave or a QRS complex, etc.) can be determined based on a far-field electrocardiogram detected by one or more detection electrodes of an in vivo implanted device or a surface electrocardiogram detected by one or more external devices. In some embodiments, when the implantable heart failure treatment device has multiple stimulation electrode pairs, the specific event time window can also be determined based on multiple LS signals provided by stimulation monopole pairs at different predetermined stimulation positions.

[0063] Specifically, the starting point of the specific event time window can be determined by the GS signal and / or the LS signal. In some embodiments, the starting point of the specific event time window can be determined based on the time point when the specific event is sensed in the far-field detection signal (hereinafter referred to as the "GS sensing time") and / or the time point when the local detection signal generated by the discharge of the myocardial cell at the predetermined stimulation location is detected (hereinafter referred to as the "LS sensing time").

[0064] In an embodiment of a heart failure treatment device implanted in the right ventricle as shown in FIG1 , the starting point of the specific event time window (abbreviated as GVT-s in the following formula) can be set as follows:

[0065] When the LS sensing time is later than the GS sensing time, that is, the difference between the LS sensing time and the GS sensing time (abbreviated as GLSD in the following formula) is greater than 0, GVT-s is set to the time before the preset time length (abbreviated as A in the following formula) of the GS sensing time (abbreviated as GS in the following formula). The specific formula is as follows:

[0066] When GLSD>0, GVT-s=GS-A;

[0067] On the contrary, when the LS sensing time is earlier than or equal to the GS sensing time, GVT-s can be set to a time before the preset time length of the LS sensing time (abbreviated as LS in the following formula), and the specific formula is as follows:

[0068] When H≤GLSD≤0, GVT-s=LS-A, which can also be transformed into GVT-s=GS+GLSD-A. Where H<0, preferably, -120ms≤H≤-20ms. When actually sensing the ECG signal, the GS sensing time may lag behind the actual time node due to the delay in capturing the ECG signal, or the LS sensing time may be slightly earlier than the GS sensing time due to other reasons. By using LS as the starting time, this situation can be better handled and the correspondence between local excitation events and overall excitation events can be more accurately judged.

[0069] The above settings can be implemented in real time during each cardiac cycle.

[0070] It should also be noted that the implantable heart failure treatment device can also monitor the LS signal and the GS signal during the preset parameter period to determine a reference time difference B between the LS sensing time and the GS sensing time when the LS sensing time is later than the GS sensing time, and a reference time difference C between the LS sensing time and the GS sensing time when the LS sensing time is earlier than or equal to the GS sensing time. During subsequent operation, the setting of GVT-s can be determined based on the above reference time difference and the LS sensing time or the GS sensing time, using the following formula:

[0071] When GLSD>0, GVT-s=LS-BA;

[0072] When H≤GLSD≤0, GVT-s=GS-CA; H<0. Preferably, -120ms≤H≤-20ms.

[0073] It should be noted that the above specific calculation method is merely an example, and the starting point of the specific event time window may also be determined using other methods or based on other parameters. In the above embodiment, the preset time lengths A, B, and C can all be adjustable preset values, where A can be selected from 0 to 40 ms, preferably 20 ms. In some embodiments, the preset time lengths B and C can use the same preset value.

[0074] The length of the specific event time window can be a preset time length, which is generally related to the specific type of the specific event. Taking the specific event as an R wave as an example, for an R wave caused by a spontaneous electrical impulse at the atrial location (e.g., generated by the sinoatrial node), the length of the specific event time window (or R wave time window) can be set to 30 to 130 ms, preferably 90 ms; while for an R wave caused by spontaneous electrical activity at the ventricular location (e.g., premature ventricular contractions) or external electrical stimulation of ventricular tissue, the length of the R wave time window can be set to 30 to 250 ms, preferably 150 ms.

[0075] In other examples, the duration of the ventricular spontaneous electrical activity and the ventricular electrical activity induced by pacing can be set separately by the doctor according to actual conditions. Different ventricular premature beats can also be set with different durations by the doctor according to specific conditions.

[0076] 6 , at step 604 , when the control module 106 determines that the local excitation event corresponds to a specific global excitation event, the control module 106 transmits a stimulation electrical pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0077] In some embodiments, step 604 specifically includes: the control module 106 determines the pulse emission time based on the local detection signal and / or the far-field detection signal; determines a pulse-emittable time window suitable for sending a stimulation electrical pulse based on the local detection signal and / or the far-field detection signal; and, when the pulse emission time falls within the pulse-emittable time window, transmits the stimulation electrical pulse to the stimulation electrode pair 103 and 104, thereby enhancing the contractility of the patient's myocardium.

[0078] In this application, pulse delivery time (also abbreviated herein as CSDT) refers to the time point at which the stimulation electrode pair delivers the stimulation pulse based on the obtained GS signal and / or LS signal. The pulse delivery time can be determined in various ways. The CSDT setting ensures that the pulse delivery time is within the absolute refractory period of the local excitation event.

[0079] In some embodiments, the pulse emission time may be determined according to the LS sensing time. For example, the pulse emission time may be a moment after a preset time length of the LS sensing time. The specific formula is as follows: CSDT=LS+D;

[0080] In other embodiments, the pulse emission time is determined based on the GS sensing time combined with the GLSD. For example, the pulse emission time may be the sum of the GS sensing time, the GLSD and a preset time length. The specific formula is as follows: CSDT=GS+GLSD+D.

[0081] As previously described, a reference time difference E between the LS sensing time and the GS sensing time can be determined by detecting the LS signal and the GS signal within a preset period. When the LS sensing time is later than the GS sensing time, and when the LS sensing time is earlier than or equal to the GS sensing time, a reference time difference F between the LS sensing time and the GS sensing time can be determined. During subsequent operation, the CSDT can be determined based on the aforementioned reference time difference and the LS sensing time or the GS sensing time. The specific formula is as follows:

[0082] When GLSD>0, CSDT=GS+E+D;

[0083] When H ≤ GLSD ≤ 0, GSDT = GS - F + D; where H < 0, preferably -120 ≤ H ≤ -20. When actually sensing ECG signals, delays in signal capture may cause the GS sensing time to lag behind the actual time node, or other reasons may cause the LS sensing time to be slightly earlier than the GS sensing time. Using the LS as the starting time can better address such situations and more accurately determine the correspondence between local excitation events and global excitation events.

[0084] The above determination of E and F can be performed in real time during each cardiac cycle, or can be determined as preset values ​​during a setup period.

[0085] It should be noted that the above specific calculation method is only an example, and the pulse emission time can also be determined by other methods or based on other parameters. In the above embodiment, the preset time length D can be selected from 10 to 80 ms, preferably 40 ms.

[0086] The pulse-deliverable time window refers to a time period suitable for delivering stimulating electrical pulses. During this period, the delivery of stimulating electrical pulses to the predetermined stimulation site via the stimulating electrode will not or will hardly cause a re-depolarization event at the predetermined stimulation site and other myocardial tissues that the stimulating electrical pulses can affect. By setting the pulse-deliverable time window as a judgment condition, the implantable heart failure treatment device can ensure that the delivered stimulating electrical pulses fall at the stimulation site and at an appropriate time within the absolute refractory period of the myocardium that the stimulating pulses can affect, thereby achieving the effect of enhancing myocardial contractility while avoiding the risk of inducing malignant ventricular arrhythmias such as ventricular tachycardia (VT) or ventricular fibrillation (VF).

[0087] In some embodiments, the starting point of the pulse-issuable time window can be determined in the same manner as the starting point of the specific event time window described above, which will not be described in detail here. In some embodiments, the starting points of the specific event time window and the pulse-issuable time window can also be determined in any other feasible manner. For example, in the case where an implantable heart failure treatment device has multiple stimulation electrode pairs, such as implanted devices in the right ventricle and the left ventricle, the specific event time window and the pulse-issuable time window can also be determined based on the GS and the LS signal of the stimulation electrode pair that first senses the local excitation event in one cardiac cycle. Of course, the pulse-issuable time window can also be determined based on a comprehensive consideration of the LS signal, the GS signal and the various factors mentioned above.

[0088] Similar to the length setting of the specific event time window, the length of the pulse-issuable time window can be a preset time length, which is generally related to the specific type of specific event. For example, for an R wave caused by a spontaneous electrical impulse in the atria (e.g., generated by the sinoatrial node), the length of the pulse-issuable time window (or R-wave pulse-issuable time window) can be set to 30 to 250 ms, preferably 130 ms. For an R wave caused by spontaneous electrical activity in the ventricles or external electrical stimulation of ventricular tissue, the length of the pulse-issuable time window can also be set to 30 to 250 ms, preferably 200 ms.

[0089] In other examples, the length of the pulse-emittable time window for ventricular electrical activity caused by ventricular spontaneous electrical activity and ventricular pacing can be set separately by the doctor according to actual conditions. Different ventricular premature beats can also be set with different time lengths according to specific circumstances.

[0090] It should be noted that the starting time points corresponding to the pulse-issuable time window and the specific event time window (also referred to as the "sensing time window" in some descriptions herein) can be the same or different. In other words, the pulse-issuable time window and the specific event time window can be set independently and may have no mutual correlation or dependency relationship. Specifically, the pulse-issuable time window and the specific event time window can be determined based on far-field ECG signals and can be adaptively adjusted based on factors such as the specific circumstances of the sensed specific event (e.g., R wave) and the specific location of the myocardium, so that they can cover or meet the requirements of most pulse stimulation scenarios. The specific method for determining the pulse-issuable time window and the specific event time window will be described in detail below in conjunction with the accompanying drawings and specific embodiments. Optionally, method 600 may also include step 601 before step 602. In step 601, the source of the electrical signal that triggers the local excitation event is determined. The source of the electrical signal may include spontaneous electrical impulses from the atrial location, spontaneous ventricular electrical activity from the ventricular location, or ventricular electrical activity caused by electrical stimulation from outside the heart. In some embodiments, the specific type of the electrical signal source can be determined by the far-field detection signal. Subsequently, based on the source of the electrical signal determined in step 601, parameters such as the specific event time window, the pulse-issuable time window, and the pulse issuance time can be adjusted accordingly in steps 602 and 604. The specific adjustment methods can be referred to the descriptions of steps 602 and 604. For situations where the source of the electrical signal is external cardiac electrical stimulation (e.g., pacing pulses), reference can be made to the description of the control method for an implantable heart failure treatment device with a pacing pulse function described below.

[0091] FIG8 shows a module schematic diagram of a control system of an implantable heart failure treatment device 800 according to an embodiment of the present application. As shown in FIG8 , the device 800 includes a sensing and analysis module 801, which is used to sense and receive local detection signals (indicated as LS in FIG8 ) and far-field detection signals (indicated as GS in FIG8 ) acquired at the stimulation electrode pair (indicated as S1 and S2 in FIG8 ) and the detection electrode pair (indicated as E1 and E2 in FIG8 ) of the device 800, and transmit them to a reference time window determination module 802 and a pulse emission time determination module 804. In some embodiments, the far-field detection signal (GS) includes a far-field electrocardiogram (ECG) signal of the patient's heart detected by the detection electrode pair. The reference time window determination module 802 determines a specific event (e.g., R-wave) time window (R-wave time window is indicated as RTW in the figure) and / or a pulse emission time window (SSW) corresponding to a specific event in the far-field ECG signal based on the obtained GS signal and / or LS signal.

[0092] Continuing with FIG8 , the sensing and analysis module 801 of the apparatus 800 can also be configured to acquire a signal (denoted as BC in FIG8 ) indicating the source of the electrical activity that triggered the local excitation event and transmit the signal to the reference time window determination module 802 and the pulse discharge time determination module 804. The reference time window determination module 802 is configured to determine whether the local excitation event of the myocardial cells at the predetermined stimulation location corresponds to a specific global excitation event based on the received BC signal, LS signal, and GS signal. Taking the specific event as an R wave as an example, if the BC signal indicates that the source of the electrical activity is, for example, spontaneous electrical activity from the atrial location, spontaneous ventricular electrical activity from the ventricular location, or ventricular electrical activity induced by external electrical stimulation of the ventricle, the reference time window determination module 802 will accordingly set the specific event time window RTW and the pulse discharge time window SSW, and transmit them to the comparison and analysis module 803. Similarly, if the BC signal indicates that the source of the electrical signal is spontaneous electrical impulses from the atrial location, spontaneous electrical impulses from the ventricular location, or electrical stimulation from outside the heart, the pulse discharge time determination module 804 will accordingly determine the pulse discharge time CSDT. Based on the above information, the comparison and analysis module 803 determines whether to apply a stimulating electric pulse to a predetermined stimulation position of the patient's heart through the stimulation electrode. In some embodiments, the comparison and analysis module 803 first determines whether the time of the local excitation event sensed in the LS signal falls within the RTW. If the answer is yes, it is determined that the local electrical excitation event at the predetermined stimulation position is an R wave event corresponding to the event caused thereby, and the stimulating electric pulse can be transmitted to a pair of stimulating electrodes S1 and S2 during the absolute refractory period of the local electrical excitation event. Further, after the comparison and analysis module 803 determines that the time of the local excitation event sensed in the LS signal falls within the RTW, it is determined whether the pulse discharge time CSDT falls within the pulse discharge time window SSW, and only when it falls within the SSW, the stimulating electric pulse is transmitted to a pair of stimulating electrodes S1 and S2.

[0093] As shown in FIG8 , the device 800 may also include a pacing operation module 805, which is configured to provide a signal to the sensing and analysis module 801 indicating whether a pacing pulse has been delivered. After receiving the signal that a pacing pulse has been delivered, the sensing and analysis module 801 determines whether cardiac capture has been achieved. If cardiac capture has been achieved, the BC signal type is pacing (e.g., ventricular pacing). The time window determination module 802 sets the specific event time window (RTW) and the pulse-issuable time window (SSW) accordingly. The pulse discharge time determination module 804 also determines the pulse discharge time (CSDT). These signals are then sent to the comparison and analysis module 803. Based on the acquired information, the comparison and analysis module 803 first determines whether the application time of the pacing pulse falls within the RTW. If so, the local electrical excitation event at the predetermined stimulation location is determined to correspond to the resulting ventricular myocardial electrical activity and subsequent contraction event. A stimulation pulse may then be delivered to the pair of stimulation electrodes S1 and S2 during the absolute refractory period of the local electrical excitation event. Furthermore, after determining that the application time of the pacing electrical pulse falls within the RTW, the comparison and analysis module 803 can further determine whether the pulse discharge time CSDT falls within the pulse dischargeable time window SSW, and only if it falls within the SSW, the stimulation electrical pulse is transmitted to the pair of stimulation electrodes. Of course, in the case where it is determined that cardiac capture is achieved after the pacing pulse is delivered, it is usually also possible to directly determine the correspondence between the delivery of the pacing pulse and the specific overall excitation event (e.g., R wave) reflected by the far-field detection signal. Therefore, in some embodiments, in the case of pacing pulse delivery, it is also possible to directly determine whether the local excitation event at the predetermined stimulation position as described above corresponds to the specific overall excitation event based on whether capture occurs.

[0094] It should be noted that the division of modules in the embodiment of FIG. 8 above is based on functions or execution steps, rather than on the division of specific physical modules. In practice, one or more modules may be combined into a single module, or each module may be further divided. Furthermore, the steps and functions performed by each module are not necessarily in the order shown in FIG. 8 . For example, in some embodiments, the reference time window determination module 802 may first determine whether the occurrence time of the local excitation event sensed in the LS signal falls within the RTW, and only when it falls within the RTW is the pulse discharge time CSDT determined to be within the pulse discharge time window SSW to determine whether the stimulation pulse can be discharged. The various modules in the device shown in FIG. 8 may be implemented by hardware, software, firmware, or a combination of hardware and software / firmware. Furthermore, one or more of the GS and LS signals in the device 800 shown in FIG. 8 may also come from other implanted devices or external devices, rather than just from the detection electrode pair E1 and E2 and the stimulation electrode pair S1 and S2.

[0095] In the embodiment described above, the local detection signal generated by the discharge of the myocardial cells at the predetermined stimulation position is used as the local detection signal indicating the local excitation event at the local position of the patient's heart, and further based on the far-field detection signal indicating the overall excitation event of the patient's heart and the local detection signal indicating the local excitation event at the local position of the patient's heart, it is determined whether the local excitation event of the myocardial cells at the predetermined stimulation position of the patient's heart corresponds to a specific overall excitation event. It should be noted that in some embodiments, the control module 106 of the device 100 in Figure 1 may not obtain the local detection signal generated by the discharge of the myocardial cells at the predetermined stimulation position through the stimulation electrode pair 103 and 104, but may obtain the local detection signal (also referred to as other LS signal) generated by the discharge of the myocardial cells at other local positions of the heart through other electrodes coupled to the shell and in contact with the heart tissue or blood vessels. The other local position may be, but is not limited to, adjacent to the predetermined stimulation position. In other embodiments, the control module 106 may also obtain other LS signals from other devices that are communicatively connected to it and can obtain the electrical signals of the myocardial cells at other local positions of the patient's heart. Subsequently, the control module 106 can determine whether the local excitation event at other local locations of the patient's heart corresponds to a specific overall excitation event of the patient's heart based on the GS signal and the LS signal, and when it is determined that the local excitation event corresponds to a specific overall excitation event, transmit the stimulation electrical pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event. It should be noted that in some embodiments, the so-called "step of transmitting the stimulation electrical pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event" herein may only consider the absolute refractory period of the local excitation event. In other embodiments, the above steps can also be further limited to considering the absolute refractory period of the local excitation event and the absolute refractory period of the ventricular myocardium as a whole at the same time, specifically as the steps and methods described in step 604. In some embodiments, the control module 106 can take steps similar to those of method 600, except that the LS signal is replaced by the other LS signals mentioned above. In other embodiments, the control module 106 can also adaptively adjust the specific steps and parameters while considering factors such as the positional relationship between the predetermined stimulation position and other local locations.

[0096] Figures 9 to 19 mainly relate to a number of specific embodiments of the present application, and further describe the specific details of the implantable heart failure treatment device involved in the present application from different aspects. Among them, Example 1 and Example 2 relate to the pulse stimulation control method adopted by the implantable heart failure treatment device of the present application. Examples 3 and 4 mainly relate to the pulse stimulation control system of the implantable heart failure treatment device. Example 5 mainly relates to the pulse stimulation control device of the pulse stimulation control system. Example 6 relates to an electronic device for implementing the pulse stimulation control method, and Example 7 relates to a computer-readable storage medium storing a computer program for implementing the pulse stimulation control method in Example 1 or 2. The specific details of the implantable heart failure treatment device will be further described below in conjunction with Figures 9 to 19 and the above-mentioned specific embodiments. It should be noted that these embodiments are only illustrative descriptions of the specific implementation methods of the implantable heart failure treatment device, and are not intended to limit the scope of the present application in any way.

[0097] Example 1

[0098] As shown in FIG9 , the pulse stimulation control method of this embodiment includes:

[0099] S101, obtaining a first sensing time of an R wave in a preset electrocardiogram;

[0100] The preset electrocardiogram includes but is not limited to a surface electrocardiogram (ECG) and an in-vivo far-field myocardial electrocardiogram (Far-Field Electrogram) (also known as FF-EGM); the first sensing time is also known as a far-field sensing time or a GS sensing time.

[0101] S102, determining a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position based on the first sensing time, and obtaining a second sensing time corresponding to the sensing event;

[0102] The second sensing time corresponding to the sensing event in the local myocardial electrocardiogram is also called the local sensing time or the LS sensing time.

[0103] The sensing events in the regional myocardial electrocardiogram are sensing events corresponding to the R wave of the preset electrocardiogram.

[0104] S103. When the first preset condition is not satisfied during the second sensing time, determining that the sensing event is not an R wave signal corresponding to an R wave in a preset electrocardiogram, and controlling not to deliver pulse stimulation to the stimulation electrode at the set myocardial position;

[0105] The first preset condition is determined based on a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to a sensing event.

[0106] In one feasible solution, as shown in FIG10 , step S103 includes:

[0107] S1031, obtaining a sensing time window corresponding to an R wave in a preset electrocardiogram;

[0108] The manner of obtaining the sensing time window includes, but is not limited to: obtaining it based on a pre-set sensing circuit, and obtaining it by directly receiving input from an external device.

[0109] Surface electrocardiogram (ECG): The corresponding signal comes from control electrodes attached to the skin; however, the control electrodes here are not limited to commonly used surface electrocardiogram electrodes or specially designed electrodes.

[0110] Far-field myocardial electrocardiogram (FF-EGM) is a signal that represents (or reflects) the electrical activity of the entire heart, similar to a surface electrocardiogram (ECG). The signals corresponding to the FF-EGM come from a variety of control electrode combinations, including but not limited to electrodes with a large surface area that directly contacts the myocardium (i.e., significantly larger than the surface area of ​​electrodes conventionally used for myocardial electrical stimulation); electrodes that do not directly contact the myocardium but are close to or far from the ventricular myocardium; or electrodes with a relatively large surface area located subcutaneously.

[0111] For example, different electrode combinations correspond to any combination of different electrodes, such as defibrillation electrodes placed in blood vessels or cardiac cavities, placed on the epicardium, subcutaneous defibrillation electrodes of a sub-Q ICD, or defibrillation electrodes of an external defibrillator (such as an AED). The specific combination of these different electrodes can be determined or adjusted according to the needs of the actual usage scenario.

[0112] Based on single-lead or multi-lead surface electrocardiograms and / or R waves from one or more far-field myocardial electrocardiograms, the sensing time and corresponding sensing time window can be obtained. This time window represents part or all of the time period for overall ventricular myocardial depolarization electrical activity, thereby determining the pulse delivery time window. By improving the control mechanism for whether to deliver and when to deliver at the stimulation site, the accuracy of pulse delivery determination and its safety can be further improved.

[0113] S1032: When the second sensing time does not fall within the sensing time window, it is determined that the sensing event is not an R wave signal corresponding to the R wave in the preset electrocardiogram, and pulse stimulation is not issued to the stimulation electrode at the set myocardial position.

[0114] The non-R wave signals corresponding to the sensing event LS in the local myocardial electrocardiogram include T wave signals or other interfering signals. Specifically, the pulse stimulation is CCM stimulation; this allows pulse stimulation to be performed under different ventricular electrical activity conditions, expanding the applicable range of pulse stimulation and significantly improving the overall effectiveness of pulse stimulation control.

[0115] CCM stimulation occurs during the following ventricular electrical activity: sinus beat, ventricular beat caused by conduction from the atria, ventricular beat originating from the ventricles (ventricular ectopic activation), and ventricular paced beat.

[0116] By confirming that the locally sensed event is the R wave, we can better ensure that CCM stimulation is triggered by the local R wave rather than other signals (such as T waves, electromyography, or other non-myocardial depolarization electrical activities), effectively eliminating the occurrence of false triggering. Through the design of this key link, the safety and effectiveness of pulse stimulation can be effectively improved.

[0117] In order to effectively improve the accuracy of confirming whether LS in the local myocardial electrocardiogram is R wave perception, the far-field detection signal and the local detection signal of the same heartbeat are considered simultaneously in this embodiment, and the judgment result is jointly determined by the far-field detection signal and the local detection signal under the same heartbeat, which greatly reduces the probability of misjudgment when only considering one perception, namely the far-field detection signal or the local detection signal (LS), and leads to the occurrence of false triggering of pulse stimulation, thereby effectively improving the accuracy of confirmation of sensing events, further effectively avoiding the issuance of pulse stimulation under incorrect circumstances, and greatly improving the safety of pulse stimulation for patients.

[0118] Ensuring that the pulse stimulation is delivered not only within the releasable period of the local myocardial R wave (sensed by the electrodes at this myocardial site), but also within the releasable period of the far-field myocardial R wave (the electrical activity generated by the entire ventricular myocardium) can minimize the risk of ventricular myocardium being accidentally activated and depolarized due to pulse stimulation, or even eliminate this risk.

[0119] In this embodiment, the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in a timely manner, and the mis-sensed events 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 preset electrocardiogram, but an interference signal such as a T wave. At this time, the control is not to issue pulse stimulation to the corresponding myocardial position, ensuring that pulse stimulation is not issued under erroneous circumstances, effectively avoiding the risk of inducing VT or VF, avoiding unnecessary pain to the patient and even causing safety hazards, thereby ensuring the safety of the patient, improving the reliability of pulse stimulation control, and ensuring the safety, effectiveness and therapeutic effect of pulse stimulation for the patient.

[0120] Example 2

[0121] The pulse stimulation control method of this embodiment is a further improvement of the embodiment 1. Specifically, in one feasible solution, as shown in FIG11 , step S102 includes:

[0122] S1021: Use the first sensing time as a first time point, and use a time point corresponding to a first set time length before the first time point as a time reference starting point;

[0123] S1022: Based on the time reference starting point, obtain a sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position.

[0124] In one feasible solution, as shown in FIG12 , after step S102, the following steps are further included:

[0125] S104: When the second sensing time falls within the sensing time window, the sensing event is determined to be an R wave. In one feasible solution, as shown in FIG13 , the pulse stimulation control method of this embodiment further includes:

[0126] S105, after the sensing event is an R wave, determining a pulse delivery time corresponding to the stimulation electrode at the set myocardial position based on a second sensing time of the R wave in the local myocardial electrocardiogram;

[0127] It should be noted that the method of obtaining the sensing event as the R wave in this embodiment can be directly obtained through transmission from an external device, or determined based on methods such as judging whether it falls within a sensing time window.

[0128] S106. Determine whether the pulse emission time satisfies a second preset condition. If so, determine to emit pulse stimulation to the stimulation electrode at the set myocardial position; otherwise, determine not to emit pulse stimulation to the stimulation electrode at the set myocardial position.

[0129] Determine the sensing event whose local myocardial sensing time is within the sensing time window corresponding to the R wave in the preset electrocardiogram, which belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram, and then ensure that pulse stimulation is delivered in time when it is determined to be an R wave, so as to ensure the timeliness, safety and effectiveness of the pulse stimulation to the patient's heart.

[0130] Ensure that the pulse stimulation is delivered not only within the releasable period of the local myocardial R wave (sense by the electrodes at this myocardial site), but also within the releasable period of the far-field myocardial R wave (electrical activity generated by the entire ventricular myocardium). This can minimize or even eliminate the risk of myocardium in other parts of the ventricle being polarized due to activation of the pulse stimulation, greatly ensure the safety of the patient's pulse stimulation, and avoid unnecessary treatment risks and pain to the patient.

[0131] That is to say, the pulse stimulation control of this embodiment ensures that no matter where the stimulation electrode is in the myocardium, pulse stimulation is only delivered under the correct circumstances, that is, not only within the releasable period of the local myocardium, but also within the entire ventricular myocardium, thereby better ensuring the safety and effectiveness of the pulse stimulation; this also allows pulse stimulation to be delivered under various heartbeats when needed (including ventricular heartbeats conducted by the atria, heartbeats initiated by the ventricles themselves, such as PVCs, ventricular pacing heartbeats, etc.), thereby meeting the patient's needs for enhanced myocardial contractility to a greater extent.

[0132] In one feasible solution, step S105 includes:

[0133] Calculate the pulse emission time corresponding to the stimulation electrode at the set myocardial position based on the second sensing time and the preset duration of the R wave in the local myocardial electrocardiogram; or

[0134] Calculate the time difference between a first sensing time (GS sensing time) corresponding to an R wave in a preset electrocardiogram and a second sensing time of a set myocardial position;

[0135] Taking the first sensing time as the reference zero point, the pulse emission time corresponding to the set myocardial position is calculated according to the time difference and the preset duration.

[0136] Specifically explain the above two calculation processes for obtaining the pulse emission time of the R wave in the local myocardial electrocardiogram:

[0137] (1) The second sensing time of the R wave in the local myocardial electrocardiogram is obtained in a timely manner. The second sensing time is used as the reference zero point (or trigger point), and the preset time length (LPD) is added to this to obtain the pulse emission time corresponding to the stimulation electrode at the corresponding myocardial position.

[0138] (2) Based on the second sensing time and the first sensing time of the appearance of the R wave in the surface electrocardiogram ECG and / or the far-field myocardial electrocardiogram FF-EGM, the time difference (GLSD) between the second sensing time and the first sensing time is calculated; then, with the first sensing time as the reference zero point, the time difference GLSD and the preset time length LPD are added to this to calculate the pulse emission time GPD corresponding to each set myocardial position with the first sensing time as the trigger point (reference point), that is, GPD = GLSD + LPD.

[0139] It is also possible to keep the time difference unchanged after obtaining the pulse emission time GPD of each set myocardial position, so as to realize the maintenance of releasing cardiac pulse stimulation to the corresponding control electrode according to the pulse emission time GPD; there is no need to calculate again before each electrical stimulation output. At this time, after the local myocardial electrocardiogram R wave perception occurs, the electrical stimulation output time can be directly determined according to the GPD, without the need to calculate the pulse stimulation far-field myocardial electrocardiogram emission time through the first and second sensing times each time, thereby achieving the electrocardiographic stimulation effect while effectively shortening the data processing time and improving the control efficiency of the cardiac pulse stimulation triggering.

[0140] 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.

[0141] For pulse stimulation triggered by the R wave of the local myocardial electrocardiogram (second sensing time), the duration (LPD) from the R wave to the transmission of each stimulation position is fixed (such as a preset duration of 40ms). For pulse stimulation triggered by the R wave in the surface electrocardiogram ECG and / or the far-field myocardial electrocardiogram FF-EGM, the duration (GPD) of each stimulation position is not fixed and is different (i.e., it is determined by a fixed preset duration of 40ms and the time difference according to the position change). Among them, the preset duration is usually 40ms by default, and the duration value can be fine-tuned and updated according to actual needs (i.e., programmable adjustment).

[0142] It should be noted that the GLSD and GPD corresponding to each set myocardial site can be measured and averaged over several autologous heartbeats during a preset period (the default is 5 consecutive autologous heartbeats, ranging from 3 to 12). It can also be obtained based on the actual measured duration of each heartbeat. The GPD of each set myocardial site or position is used to trigger the time of pulse stimulation delivery at that site or position relative to the preset electrocardiogram R wave sensing moment. The pulse delivery time corresponds to the time from sensing the R wave to triggering the delivery of the cardiac pulse stimulation. The delivery of the pulse stimulation at each site or position is triggered by the R wave sensing of the surface electrocardiogram (ECG) or the R wave sensing of the far-field myocardial electrocardiogram (FF-EGM). The cardiac pulse stimulation is then delivered to each corresponding control electrode according to the pulse delivery time. To ensure the effectiveness of the pulse stimulation, all R waves (i.e., the R wave in the far-field myocardial electrocardiogram (FF-EGM) and the R wave in the surface electrocardiogram (ECG)) are sensed in the same heartbeat. Based on the above-mentioned pulse delivery time acquisition scheme, the timeliness and reliability of the pulse stimulation can be effectively guaranteed.

[0143] In addition, according to actual needs, parameters such as GLSD that are adapted to different ventricular electrical activities can be pre-set, such as sinus (SR) ventricular electrical activity. Then, during the actual operation period, the corresponding parameters set in the pre-set period can be directly called during sinus rhythm, thereby reducing the calculation requirements required for each heartbeat and ensuring the timeliness and effectiveness of pulse stimulation control.

[0144] It is also possible to obtain GLSD and other parameters corresponding to the current actual ventricular electrical activity directly based on the data and parameters of real-time ECG activity sensing without relying on the parameters obtained in the preset period, so as to further improve the timeliness and effectiveness of pulse stimulation control, and further ensure the safety and efficacy of pulse stimulation for patients.

[0145] In one feasible solution, as shown in FIG14 , step S106 includes:

[0146] S1061, obtaining a pulse-issuable time window corresponding to the R wave in a preset electrocardiogram;

[0147] The starting time points and window durations of the two time windows, the pulse delivery window and the sensing time window, can be the same or different; that is, the pulse delivery window and the sensing time window can be set independently, without any correlation or dependency between them. Specifically, the pulse delivery window and the sensing time window are determined based on a preset electrocardiogram. The specific settings are adaptively adjusted based on factors such as actual R-wave perception and myocardial conditions, so as to cover or meet the needs of most pulse stimulation scenarios.

[0148] S1062, when the pulse delivery time falls within the pulse delivery time window, controlling the delivery of the pulse stimulation to the stimulation electrode at the set myocardial position at the pulse delivery time;

[0149] When the pulse emission time does not fall within the pulse emission time window, the control is to not emit pulse stimulation to the stimulation electrode at the set myocardial position.

[0150] This protocol ensures that CCM stimulation occurs within the releasable period of local myocardial depolarization (R wave) and the releasable period of far-field myocardial depolarization (R wave) in vivo. The releasable pulse window corresponds to a safe period, which corresponds to the releasable period of the entire ventricle. Both the start and end points of the releasable pulse window are adjustable, with the goal of having the start point approximately corresponding to the depolarization zone and the end point prior to or equal to the end point of the releasable period.

[0151] In an practicable solution, when there are multiple set myocardial positions, the pulse stimulation control method of this embodiment further includes the following steps:

[0152] For each sensing event LS in the local myocardial electrocardiogram corresponding to each myocardial position, steps S102 to S106 are executed one by one to deliver pulse stimulation to each myocardial position in a timely and effective manner, thereby ensuring the safety, effectiveness and reliability of the patient's treatment.

[0153] The sensing time window is determined according to a first sensing time of an R wave in a preset electrocardiogram and a second sensing time corresponding to the first sensing event that occurs.

[0154] For example, a pulse stimulation electrode is set at three different set myocardial positions (A, B, C) of the patient in advance. The myocardial positions A, B, and C are set to correspond to stimulation electrode pairs E1, E2, and E3, respectively, and the second sensing times of the corresponding sensing events are LS1, LS2, and LS3, respectively; wherein, the occurrence times corresponding to LS1, LS2, and LS3 are shifted in sequence (i.e., sensing event LS1 occurs first, and other sensing events occur in sequence at subsequent times). Each electrode pair can be composed of: a monopolar electrode and a monopolar electrode, a bipolar electrode and a bipolar electrode wire, a monopolar electrode and a combination of two types of electrodes, a monopolar electrode and a bipolar electrode and a bipolar electrode wire, or other types of electrodes. The specific electrode pair to be used and how to combine them can be determined or adjusted according to the actual scenario requirements.

[0155] Specifically, when a sensing event LS1 in a local myocardial electrocardiogram corresponding to a set myocardial position A is obtained based on the electrode pair E1 at the set myocardial position, a second sensing time corresponding to the sensing event LS1 is obtained, and it is determined that the second sensing time falls within the sensing time window corresponding to the R wave in the preset electrocardiogram. If it does not fall within the sensing time window, it is determined that the sensing event LS1 is not an R wave signal corresponding to the R wave in the preset electrocardiogram, but other interference signals such as a T wave, and the stimulation electrode pair E1 at the set myocardial position A is controlled not to be stimulated by pulse stimulation; if it falls within the sensing time window, the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram is determined, and then the pulse emission time corresponding to the stimulation electrode corresponding to the set myocardial position A is timely and accurately calculated at the second sensing time corresponding to the sensing event LS1; and then it is further determined whether the pulse emission time falls within the pulse-emittable time window corresponding to the R wave in the preset electrocardiogram. If it falls within the pulse-emittable time window, 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 that the pulse stimulation is not emitted to the stimulation electrode at the set myocardial position A, thereby completing a single pulse stimulation control at the set myocardial position A.

[0156] 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.

[0157] It should be noted that the pulse stimulation control processes for different set myocardial positions are independent of each other and will not interfere with or affect each other; for example, while the pulse stimulation control process is being carried out at the set myocardial position A, or the pulse stimulation control at the set myocardial position A has been completed, as long as the sensing event LS2 appears in the local 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 at all set myocardial positions is completed. The control operation is in order, which effectively ensures the safety and reliability of the patient's pulse stimulation.

[0158] In one feasible solution, when the sensing events corresponding to the multiple local myocardial electrocardiograms occur very closely (i.e., the time span is small), the pulse stimulation control method of this embodiment further includes the following steps:

[0159] Obtaining the second sensing time corresponding to the sensing event LS in the local (Local) local myocardial electrocardiogram corresponding to each local myocardial electrocardiogram, so as to obtain the sensing event with the earliest occurrence time as the first sensing event LS1; obtaining the second sensing time corresponding to the first sensing event LS1, and determining whether the first sensing event LS1 falls within the sensing time window corresponding to the R wave in the preset electrocardiogram, and if so, determining that the sensing event is a local myocardial R wave signal corresponding to the R wave in the preset electrocardiogram;

[0160] For the sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions, it is determined whether the second sensing times corresponding to these sensing events fall within the above-mentioned sensing time window. If so, when the first sensing event is determined to be an R wave signal corresponding to the R wave in the preset electrocardiogram, it is directly determined that the sensing events in the local myocardial electrocardiogram corresponding to the remaining myocardial positions are also R wave signals corresponding to the R wave in the preset electrocardiogram; at this time, there is no need to judge and analyze the sensing events in the local myocardial 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. It should be noted that the specific method used to judge whether the sensing events of multiple local myocardial electrocardiograms are R waves can be selected according to the actual scenario requirements. A single execution scheme or a combination of multiple execution schemes can be selected to meet the more demanding electrocardiographic ventricular conduction scenarios, greatly improving the practicality of pulse stimulation control and greatly improving the safety and effectiveness of patient treatment. In addition, when there are multiple set myocardial positions, the pulse stimulation control method of this embodiment further includes:

[0161] (1) Preset sensing parameters corresponding to R waves at different myocardial locations;

[0162] The setting of the sensing parameters includes setting the sensing time and / or setting the sensing sequence.

[0163] (2) when the first detected event in the local myocardial electrocardiogram is an R wave, all the detected events in the remaining local myocardial electrocardiograms are set to be R waves; or

[0164] (3) When the last sensing event in the local myocardial electrocardiogram is an R wave, all the sensing events in the remaining local myocardial electrocardiograms are set to be R waves.

[0165] Of course, the above settings can be adjusted or more settings can be added according to actual scene requirements.

[0166] The following specifically describes the implementation principle of determining whether a sensed event in a local myocardial electrocardiogram is an R wave:

[0167] Determining whether a sensed event LS is an R-wave involves two phases: a set-up period and an operational period.

[0168] For a pulse stimulation system with electrodes at a single myocardial point, a preset electrocardiogram (such as an ECG) and an electrode lead are connected to the ventricular myocardium to sense the R wave and deliver pulse stimulation to the myocardium. The following parameters need to be measured during the preset period:

[0169] Set-up period:

[0170] (11) ECG perception (GS sensing time) = time when ECG (R wave) perception occurs (overall perception);

[0171] Among them, the ventricular electrical activity (overall ventricular electrical activity) of the R wave in the electrocardiogram ECG is preset, and the R wave perception reflects the relatively early time of the ventricular electrical activity.

[0172] (12) EGM perception (LS sensing time) = the time when EGM (R wave) perception occurs (local perception); where LS is the first local electrocardiogram sensing event after the GS corresponding reference time starting point (GS-X, X = 60 ms, programmable, ranging from but not limited to 30 ms to 200 ms);

[0173] (13) GLSD = LS - GS, which is the time delay between GS and LS;

[0174] (14) LPD = time delay between LS and pulse stimulation;

[0175] (15) GPD = GLSD + LPD, which is the time delay between GS and pulse stimulation;

[0176] (16) GVT is the sensing time window of the corresponding GS (programmable and adjustable); LSVT is the sensing time window of the corresponding LS;

[0177] Specifically, the start time of GVT is GVT-s, and the time window duration is B;

[0178] a1) GVT-s = GS-A, GLSD > 0 (i.e., LS is later than GS);

[0179] GVT-s=GS+GLSD-A, H≤GLSD≤0 (i.e., LS is earlier than or simultaneous with GS); H<0. Preferably, -120ms≤H≤-20ms.

[0180] The default value of A is 20 ms, and A is programmable and adjustable (including 0 ms). In this case, GVT-s needs to be obtained using the corresponding time parameters of GS and LS.

[0181] b1) For sinus rhythm, B is within the range of, but not limited to, 30 ms to 130 ms (programmable);

[0182] c1) For ventricular ectopic excitation, such as PVC, ventricular pacing, etc., B includes but is not limited to the range of 30ms-250ms (programmable).

[0183] LSVT-s=LS-A; LSVT-B=B-(LSVT-s-GVT-s);

[0184] It should be noted that LSVT is only used when there are electrodes in multiple local myocardiums; and LS is LS1, which corresponds to the earliest sensing event in all myocardial locations.

[0185] 17) As shown in Figure 7, GPT is the pulse emission time window of the corresponding GS; LSPT is the pulse emission event window of the corresponding LS (programmable and adjustable);

[0186] Specifically, the start time of GPT GPT-s=GVT-s; the window duration specifically includes but is not limited to a range of 20ms-200ms (programmable) (the default is 130ms).

[0187] The start time of LSPT LSPT-s=LSVT-s, and the window duration is the window duration of GPT minus GLSD.

[0188] It should be noted that the above description includes the scenario where GVT-s corresponds to far-field GS detection in the preset ECG, and LSVT-s corresponds to the scenario where LS is detected locally in the regional myocardial ECG (i.e., when A = 0 ms). It should be noted that the above parameters are calculated by averaging over several cardiac cycles (for example, 6 cardiac cycles, which can also be programmed to other numbers of cardiac cycles); in addition, the preset period should be calculated during sinus activity, ventricular ectopic activity, and ventricular pacing.

[0189] As shown in Figure 15, for a single-electrode wire stimulation system, LSPT is the pulse emission time window of the corresponding LS. The starting point of the window is LSVT-s, and its window duration is the window duration of GPT (B) minus GLSD. Both are the pulse emission times that serve as the trigger point (reference point) for pulse stimulation emission with LS as the trigger point.

[0190] It should be noted that LSPT is only used when multiple myocardial regions have electrodes, and when LS is LS1, which corresponds to the earliest sensing event among all myocardial regions. In this case, the starting point of GPT also needs to be determined using the time parameters corresponding to LS.

[0191] In addition, the time windows such as GVT, GPT, LSVT and LSPT in this embodiment are all described by two parameters: the corresponding window start point and the window duration.

[0192] operational period

[0193] (18) LS is a real-time local R-wave sensing that must meet the following conditions:

[0194] a2) There are two sensing events: preset ECG (GS) and local EGM (LS);

[0195] Wherein, LS is the second sensing time of the first sensing event of the local electrocardiogram sensed after the GS corresponding reference time starting point (GS-X, X=60ms, programmable, ranging from but not limited to 30 to 200ms);

[0196] b2) LS falls within the GVT (ie, sensing time window).

[0197] (19) Criteria for judging whether the pulse stimulation time is appropriate:

[0198] a3) The pulse stimulation time falls within the GPT (Gate of Pulse Time).

[0199] GVT and GPT are obtained from the corresponding ventricular electrical activity during the preset period, such as sinus electrical activity, ventricular ectopic electrical activity, or ventricular pacing.

[0200] For a multi-electrode pulse stimulation system, there is a preset electrocardiogram and multiple leads connected to multiple ventricular myocardial sites to sense the R wave and deliver pulse stimulation to the local myocardium. The following parameters need to be measured during the preset period:

[0201] Set-up period:

[0202] (21) Similar to the above (11)-(19), wherein all parameters corresponding to each stimulation electrode are measured and acquired (because some programmed numbers are also included together with the measured numbers to achieve all parameters);

[0203] (22) Pre-form a template corresponding to LSn (for local R wave perception), which includes information such as the time of LSn (n = 1, 2, 3, ...) relative to LS1 and the order in which perception occurs at each electrode;

[0204] Operational period:

[0205] (23) During operation, GS and LSn are obtained in real time;

[0206] (24) Using the same rules as in step (18), confirm whether LSn is a true R wave;

[0207] Alternatively, if LS1 is confirmed as a true R wave in the above step (18), LSn (n=2, 3, ...) is assumed to be a true R wave (if LSn occurs within the GVT window).

[0208] Alternatively, if LS1 is confirmed as a true R wave in the above step (18), and LSn (n=2, 3, ...) conforms to the preset template, then LSn (n=2, 3, ...) is individually confirmed as a true R sensing;

[0209] Alternatively, if LS1 is used as a reference, the sensing time window will be LSVT, and it is determined whether LSn (n=2, 3, ...) is within the LSVT time window.

[0210] As shown in Figure 16, for a multi-electrode lead stimulation system during setup: if LS1 is used as a reference, the pulse delivery time is LSPT.

[0211] During operation: After determining that each LS is R-wave sensing, the corresponding pulse emission time should be within the GPT window; if LS1 is used as the trigger point (reference point) for the pulse emission time, the emission time of LSn (n>1) is within the LSPT window.

[0212] It should be noted that for both single-electrode and multi-electrode pulse stimulation systems, pulse delivery to each myocardial location is timed after the local myocardial perception time, for example, 40ms. GPT or LSPT are new requirements for pulse delivery timing, particularly when delivering pulses to multiple stimulation sites. The delivery time of each stimulation site must fall within the GPT or LSPT time window, meaning it falls within the overall ventricular discharge period (not just the local ventricular discharge period at the electrode site) during the same heartbeat (ventricular excitation).

[0213] GVT / LSVT, as a "whole-ventricle" or "far-field ventricular" R-wave perception time window, is used to determine whether the LS corresponds to the R-wave perception of local ventricular depolarization (GS) (i.e., the "whole-ventricle" or "far-field ventricular" R-wave perception of ventricular depolarization). GPT / LSPT, as a pulse-dispensable time window (a safe zone for stimulus delivery, corresponding to the dispenseable period of the entire ventricular myocardium ("whole-ventricle" or "far-field ventricular")), is used to determine whether the timing of pulse stimulation delivery corresponding to the LS is safe. GPT and GVT are independent, separately programmable parameters to meet actual parameter configuration requirements. Of course, to reduce programming complexity, the physician can select the same value for both (if appropriate). Alternatively, the system can directly pre-assign the same value to these two parameters, while maintaining the ability to program them separately. These two steps can be used together or separately.

[0214] In addition, in addition to setting the preset period first and then performing the running period (i.e., the running period depends on the numbers obtained in the preset period for specific execution and use), the above parameters can also be directly obtained and used at each ventricular myoelectric activity (each cardiac cycle) during the running period, without relying on the preset period, thereby greatly improving the flexibility and efficiency of the pulse stimulation control process.

[0215] In this embodiment, pulse stimulation is only sent after the R wave, which can timely analyze and process the sensing events in the local myocardial electrocardiogram of the myocardium, automatically and accurately identify the erroneous sensing events, and determine that they are not R wave signals corresponding to the R wave in the preset electrocardiogram, but interference signals such as T waves. At this time, the pulse stimulation is controlled not to be sent to the corresponding myocardial position, ensuring that the pulse stimulation is not sent under the wrong circumstances, effectively 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 the pulse stimulation control; at the same time, it is ensured that the pulse stimulation is sent in time when it is determined to be an R wave, that is, the pulse stimulation is sent only under the correct circumstances;

[0216] In addition, pulse stimulation is only delivered during the ventricular releasable period: by confirming that the pulse stimulation delivery time falls within the pulse delivery window corresponding to the overall ventricular electrical activity (R wave) of the surface electrocardiogram or the in vivo far-field myocardial electrocardiogram, the timeliness, safety and effectiveness of the pulse stimulation of the patient's heart are guaranteed. Among them, in order to ensure the safety of the pulse stimulation delivery time, obtaining the releasable period information of the ventricular electrical activity by the surface electrocardiogram or the far-field myocardial electrocardiogram also represents a positive improvement to the pulse stimulation technology.

[0217] The safety, effectiveness and therapeutic effect of the pulse stimulation for patients are further guaranteed.

[0218] Example 3

[0219] As shown in FIG17 , the pulse stimulation control device of this embodiment includes:

[0220] The first sensing time acquisition module 1 is used to obtain the first sensing time of the R wave in a preset electrocardiogram; wherein the preset electrocardiogram includes but is not limited to the surface electrocardiogram ECG and the far-field myocardial electrocardiogram in the body; the first sensing time is also abbreviated as GS.

[0221] a sensing event determination module 2, configured to determine a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position based on the first sensing time;

[0222] A second sensing time acquisition module 3, configured to acquire a second sensing time corresponding to a sensing event;

[0223] The second sensing time corresponding to the sensing event in the local regional myocardial electrocardiogram is also abbreviated as LS.

[0224] The sensing event in the local myocardial electrocardiogram is a sensing event corresponding to the R wave of the preset electrocardiogram. The first judgment module 4 is configured to determine, when the second sensing time does not meet a first preset condition, that the sensing event is not an R wave signal corresponding to the R wave in the preset electrocardiogram, and to call the control module 5; the control module 5 is configured to control the stimulation electrode at the set myocardial location from being stimulated by a pulse; wherein the first preset condition is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the sensing event.

[0225] In an implementable solution, the first judgment module 4 is further used to obtain a sensing time window corresponding to the R wave in a preset electrocardiogram; the first judgment module 4 is further used to determine that the sensing event is not an R wave signal corresponding to the R wave in the preset electrocardiogram when the second sensing time does not fall within the sensing time window.

[0226] The manner of obtaining the sensing time window includes, but is not limited to: obtaining it based on a pre-set sensing circuit, and obtaining it by directly receiving input from an external device.

[0227] Non-R wave signals corresponding to the LS sensing event in the regional myocardial electrocardiogram include T wave signals or other interfering signals. Specifically, the pulse stimulation is CCM stimulation; this allows pulse stimulation to be performed under different ventricular electrical activity conditions, expanding the applicable range of pulse stimulation and significantly improving the overall effectiveness of pulse stimulation control.

[0228] CCM stimulation occurs during the following ventricular electrical activity: sinus beat, ventricular beat caused by conduction from the atria, ventricular beat originating from the ventricles (ventricular ectopic activation), and ventricular paced beat.

[0229] By confirming that the locally sensed event is the R wave, we can better ensure that CCM stimulation is triggered by the local R wave rather than other signals (such as T waves, electromyography, or other non-myocardial depolarization electrical activities), effectively eliminating the occurrence of false triggering. Through the design of this key link, the safety and effectiveness of pulse stimulation can be effectively improved.

[0230] It should be noted that the implementation principle of the pulse stimulation control device of this embodiment is similar to the pulse stimulation control method of Example 1, so it will not be described in detail here.

[0231] In this embodiment, the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in a timely manner, and the mis-sensed events 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 preset electrocardiogram, but an interference signal such as a T wave. At this time, the control is not to issue pulse stimulation to the corresponding myocardial position, ensuring that pulse stimulation is not issued under erroneous circumstances, effectively avoiding the risk of inducing VT or VF, avoiding unnecessary pain to the patient and even causing safety hazards, thereby ensuring the safety of the patient, improving the reliability of pulse stimulation control, and ensuring the safety, effectiveness and therapeutic effect of pulse stimulation for the patient.

[0232] Example 4

[0233] As shown in FIG18 , the pulse stimulation control system of this embodiment is a further improvement of the embodiment 3. Specifically:

[0234] In one practicable solution, the sensing event determination module 2 of this embodiment includes:

[0235] a time reference starting point acquiring unit 6, configured to use the first sensing time as a first time point, and use a time point corresponding to a first set time length before the first time point as a time reference starting point;

[0236] The sensing event determining unit 7 is configured to obtain a sensing event in a local myocardial electrocardiogram corresponding to a set myocardial position based on a time reference starting point.

[0237] In an implementable solution, the first judgment module 4 is further configured to determine that the sensed event is an R wave when the second sensing time falls within the sensing time window.

[0238] In one feasible solution, the pulse stimulation control system of this embodiment further includes:

[0239] a pulse emission time determination module 8 for determining, after the sensing event is an R wave, a pulse emission time corresponding to the stimulation electrode at the set myocardial position based on a second sensing time of the R wave in the local myocardial electrocardiogram;

[0240] It should be noted that in this embodiment, the method of obtaining the sensing event as an R wave can be directly obtained through transmission from an external device, or determined based on whether it falls within a sensing time window. Specifically, the pulse emission time determination module 8 is used to calculate the pulse emission time corresponding to the stimulation electrode at a set myocardial position based on the second sensing time and the preset duration of the R wave in the local myocardial electrocardiogram.

[0241] Alternatively, the pulse emission time determination module 8 is used to obtain a first sensing time corresponding to the R wave in a preset electrocardiogram; calculate the time difference between the first sensing time and the second sensing time of a set myocardial position; and use the first sensing time as a reference zero point to calculate the pulse emission time corresponding to the set myocardial position based on the time difference and the preset duration.

[0242] The second judgment module 9 is used to judge whether the pulse issuance time meets the second preset condition. If so, the determination module is called to determine whether the pulse stimulation is issued to the stimulation electrode at the set myocardial position; otherwise, the determination module is called to determine not to issue the pulse stimulation to the stimulation electrode at the set myocardial position.

[0243] Determine the sensing event whose local myocardial sensing time is within the sensing time window corresponding to the R wave in the preset electrocardiogram, which belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram, and then ensure that pulse stimulation is delivered in time when it is determined to be an R wave, so as to ensure the timeliness, safety and effectiveness of the pulse stimulation to the patient's heart.

[0244] In one feasible solution, the second determination module 9 of this embodiment includes:

[0245] The pulse time window acquisition unit 10 is used to obtain a pulse-issuable time window corresponding to an R wave in a preset electrocardiogram;

[0246] The pulse issuing time window and the sensing time window are set correspondingly;

[0247] The judgment unit 11 is configured to call the control module 5 to control the delivery of pulse stimulation to the stimulation electrode at the set myocardial position at the pulse delivery time when the pulse delivery time falls within the pulse delivery time window;

[0248] The judgment unit 11 is further configured to call the control module 5 to control not to issue pulse stimulation to the stimulation electrode at the set myocardial position when the pulse issuance time does not fall within the pulse issuance time window.

[0249] In one practicable embodiment, when there are multiple predetermined myocardial locations, the control module 5 of this embodiment is configured to control the first determination module 4 to sequentially determine whether the corresponding second sensing times fall within a sensing time window, based on the order of the second sensing times of the sensing events occurring in the electrocardiogram of each local myocardium. The sensing time window is determined based on the first sensing time of the R wave in the preset electrocardiogram and the second sensing time corresponding to the first sensing event occurring.

[0250] In an practicable solution, when there are multiple set myocardial positions, the control module 5 of this embodiment is used to preset set sensing parameters corresponding to R waves at different set myocardial positions;

[0251] Wherein, setting the sensing parameters includes setting the sensing time and / or setting the sensing sequence; or,

[0252] When the first sensing event in the local myocardial electrocardiogram is an R wave, the sensing events in the remaining local myocardial electrocardiograms are all set to be R waves;

[0253] or,

[0254] When the last sensing event in the local myocardial electrocardiogram is an R wave, all the sensing events in the remaining local myocardial electrocardiograms are set to be R waves.

[0255] It should be noted that the working principle of the pulse stimulation control device of this embodiment is similar to the implementation principle of the pulse stimulation control in Example 2, so it will not be repeated here.

[0256] In this embodiment, pulse stimulation is only sent after the R wave, which can timely analyze and process the sensing events in the local myocardial electrocardiogram of the myocardium, automatically and accurately identify the erroneous sensing events, and determine that they are not R wave signals corresponding to the R wave in the preset electrocardiogram, but interference signals such as T waves. At this time, the pulse stimulation is controlled not to be sent to the corresponding myocardial position, ensuring that the pulse stimulation is not sent under the wrong circumstances, effectively 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 the pulse stimulation control; at the same time, it is ensured that the pulse stimulation is sent in time when it is determined to be an R wave, that is, the pulse stimulation is sent only under the correct circumstances;

[0257] Furthermore, pulse stimulation is delivered only during the ventricular releasable period: 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, this ensures the timeliness, safety, and effectiveness of the pulse stimulation to the patient's heart. To ensure the safety of pulse stimulation delivery time, obtaining information on the releasable period of ventricular electrical activity from the surface electrocardiogram or the far-field myocardial electrocardiogram also represents a positive improvement in pulse stimulation technology, further ensuring the safety, effectiveness, and therapeutic effects of pulse stimulation for patients.

[0258] Example 5

[0259] The pulse stimulation control device in the medical system ECS embodiment 3 or 4 of this embodiment.

[0260] Global myocardial depolarization (R wave and corresponding GS) can be derived from, but not limited to, a surface ECG (from surface ECG electrodes attached to the skin) or a far-field myocardial ECG (FF-EGM, derived from electrodes close to the heart or electrodes located subcutaneously, in tissues or organs within the body, away from the heart). This allows the ECS system to be used in a wide range of devices or equipment that provide cardiac therapy, such as AEDs, MCS (mechanical circulatory support), subQ-ICDs, implantable CRM (cardiac rhythm management) devices, and so on. Furthermore, this allows the ECS to be used not only as an acute support device (where surface ECG can be used as one of the input signals) but also as a chronic heart failure treatment device, although surface ECG cannot always be used as an input for this device. This allows the ECS system to provide treatment for more patients in more scenarios, benefiting more patients. The medical system of this embodiment enables pulse stimulation to be delivered during sinus rhythm, ventricular heart rate (beat) transmitted from the atria, or other ventricular ectopic heart rates (beats). This is a breakthrough or improvement in the current limitation that pulse stimulation cannot be delivered in heartbeats that are not in the normal conduction system of the heart, such as sinus beats, ventricular beats caused by atrium conduction, ventricular beats originating from the ventricles (ventricular ectopy), and ventricular paced beats. This will provide more opportunities for support to the heart, especially in the cases where the patient may need this kind of support the most.

[0261] The medical system of this embodiment is integrated with the above-mentioned pulse stimulation control device, which can support the issuance of pulse stimulation not in error but only in correct circumstances, and issue pulse stimulation within the issuable period corresponding to the R wave in the surface electrocardiogram and the in vivo far-field myocardial electrocardiogram, so as to ensure the timeliness and effectiveness of the pulse stimulation to the patient's heart, thereby ensuring the safety, effectiveness and therapeutic effect of the pulse stimulation to the patient, and effectively improving the overall product performance of the existing medical system.

[0262] Example 6

[0263] Figure 19 is a schematic diagram of the structure of an electronic device provided in Example 6 of the present invention. The electronic device includes a memory, a processor, and a computer program stored in the memory and executable on the processor. When the processor executes the program, the pulse stimulation control method of Example 1 or 2 is implemented. The electronic device 30 shown in Figure 19 is merely an example and should not limit the functionality or scope of use of the embodiments of the present invention.

[0264] As shown in FIG19 , electronic device 30 may be implemented as a general-purpose computing device, such as a server device. Components of electronic device 30 may include, but are not limited to, the at least one processor 31 described above, the at least one memory 32 described above, and a bus 33 connecting various system components (including memory 32 and processor 31). Bus 33 includes a data bus, an address bus, and a control bus. Memory 32 may include volatile memory, such as random access memory (RAM) 321 and / or cache memory 322, and may further include read-only memory (ROM) 323. Memory 32 may also include a program / utility 325 comprising a set (at least one) of program modules 324. Such program modules 324 may include, but are not limited to, an operating system, one or more application programs, other program modules, and program data. Each or some combination of these examples may include an implementation of a network environment. Processor 31 executes computer programs stored in memory 32 to perform various functional applications and data processing, such as the pulse stimulation control method described in Examples 1 or 2 of the present invention. Electronic device 30 may also communicate with one or more external devices 34 (e.g., a keyboard, pointing device, etc.). Such communication can be performed through an input / output (I / O) interface 35. In addition, the model generating device 30 can also communicate with one or more networks (such as a local area network (LAN), a wide area network (WAN) and / or a public network such as the Internet) through a network adapter 36.

[0265] 19 , the network adapter 36 communicates with the other modules of the model-generated device 30 via the bus 33. It should be understood that, although not shown, other hardware and / or software modules may be used in conjunction with the model-generated device 30, including but not limited to microcode, device drivers, redundant processors, external disk drive arrays, RAID (RAID) systems, tape drives, and data backup storage systems.

[0266] It should be noted that although several units / modules or sub-units / modules of the electronic device are mentioned in the detailed description above, this division is merely exemplary and not mandatory. In fact, according to embodiments of the present invention, the features and functions of two or more units / modules described above may be embodied in a single unit / module. Conversely, the features and functions of a single unit / module described above may be further divided and embodied by multiple units / modules.

[0267] Example 7

[0268] This embodiment provides a computer-readable storage medium having a computer program stored thereon. When the program is executed by a processor, the steps in the pulse stimulation control method in embodiment 1 or 2 are implemented.

[0269] The readable storage medium may include, but is not limited to, a portable disk, a hard disk, a random access memory, a read-only memory, an erasable programmable read-only memory, an optical storage device, a magnetic storage device, or any suitable combination thereof.

[0270] In a possible implementation, the present invention can also be implemented in the form of a program product, which includes program code. When the program product runs on a terminal device, the program code is used to enable the terminal device to execute the steps in the pulse stimulation control method in Example 1 or 2.

[0271] The program code for executing the present invention may be written in any combination of one or more programming languages, and the program code may be executed entirely on the user device, partially on the user device, as an independent software package, partially on the user device and partially on a remote device, or entirely on the remote device.

[0272] It should be noted that although the implantable heart failure treatment device and several steps or modules for heart failure treatment based thereon are mentioned in the above detailed description, this division is merely exemplary and not mandatory. In fact, according to an embodiment of the present application, the features and functions of two or more modules described above can be concretized in one module. Conversely, the features and functions of one module described above can be further divided to be concretized by multiple modules.

[0273] Those skilled in the art will understand and implement other variations to the disclosed embodiments by studying the specification, disclosure, drawings, and appended claims. In the claims, the word "comprising" does not exclude other elements or steps, and the words "a" or "an" do not exclude plural reference. In the practice of this application, a single component may perform the functions of multiple technical features cited in the claims. Any reference signs in the claims should not be construed as limiting the scope.

Claims

1. An implantable heart failure treatment device, characterized in that: The device comprises: case; an anchoring member coupled to the housing and configured to secure the housing to the patient's heart; a pair of stimulation electrodes coupled to the housing and configured to contact predetermined stimulation locations of the patient's heart and to apply stimulation electrical pulses to the predetermined stimulation locations for enhancing the contractility of cardiomyocytes of the patient's heart; a pulse generating module housed in the housing and electrically coupled to the pair of stimulation electrodes, the pulse generating module being configured to generate the stimulation electrical pulses; and A control module is housed in the housing and electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart and a local detection signal indicating a local excitation event at a local position of the patient's heart, and to determine whether the local excitation event at the local position of the patient's heart corresponds to a specific overall excitation event based at least on the far-field detection signal and the local detection signal, and when it is determined that the local excitation event corresponds to a specific overall excitation event, transmit a stimulation electrical pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

2. The implantable heart failure treatment device according to claim 1, characterized in that: The pair of stimulation electrodes are configured to detect local detection signals generated by the discharge of myocardial cells at the predetermined stimulation position, and the local detection signal indicating a local excitation event at a local position of the patient's heart includes the local detection signal generated by the discharge of myocardial cells at the predetermined stimulation position detected by the pair of stimulation electrodes.

3. The implantable heart failure treatment device according to claim 1, wherein: The housing is configured to be received within a chamber of a patient's heart, and the predetermined stimulation location includes the endocardium.

4. The implantable heart failure treatment device according to claim 1, wherein: The housing is configured to be received within a vein on an outer surface of a patient's heart, and the predetermined stimulation location includes the epicardium.

5. The implantable heart failure treatment device according to claim 1, characterized in that: The apparatus further includes a far-field excitement detection module configured to detect a global excitement event of the patient's heart and provide a far-field detection signal indicative of the global excitement event to the control module.

6. The implantable heart failure treatment device according to claim 5, characterized in that: The far-field excitation detection module includes a pair of detection electrodes, which are coupled to the shell and configured to detect a far-field detection signal indicative of an overall excitation event of the patient's heart and provide the far-field detection signal to the control module.

7. The implantable heart failure treatment device according to claim 6, characterized in that: The surface area of ​​the detection electrode is larger than that of the stimulation electrode.

8. The implantable heart failure treatment device according to claim 6, characterized in that: The pair of detection electrodes and the pair of stimulation electrodes share one electrode, and the common electrode serves as a reference potential electrode.

9. The implantable heart failure treatment device according to claim 1, characterized in that: The control module determines, based on at least the far-field detection signal and the local detection signal, whether a local excitement event at a local location of the patient's heart corresponds to a specific global excitement event, including: Obtaining a specific event time window corresponding to the specific overall excitement event; If the time when the local excitement event is sensed falls within the specific event time window, it is determined that the local excitement event corresponds to the specific overall excitement event.

10. The implantable heart failure treatment device according to claim 1, characterized in that: The step of transmitting a stimulation electrical pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event comprises: determining the pulse emission time based on the local detection signal and / or the far-field detection signal; Determining a pulse-dispensable time window suitable for delivering the stimulation electrical pulse based on the local detection signal and / or the far-field detection signal; and When the pulse emission time falls within the pulse emission time window, a stimulation electrical pulse is transmitted to the pair of stimulation electrodes.

11. The implantable heart failure treatment device according to claim 1, characterized in that: The specific global excitation event corresponds to an R wave or a QRS complex in a far-field electrocardiogram, and the local excitation event corresponds to an R wave or a QRS complex in a local myocardial electrocardiogram.

12. The implantable heart failure treatment device according to claim 1, wherein: The control module is further configured to determine the source of the electrical signal that triggers the local excitation event, and determine whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to the specific overall excitation event based at least on the source of the electrical signal, the local detection signal and the far-field detection signal.

13. The implantable heart failure treatment device according to claim 12, characterized in that: The step of determining whether the local excitation event of the myocardial cell at the predetermined stimulation position corresponds to the specific overall excitation event based on at least the electrical signal source, the local detection signal, and the far-field detection signal comprises: The length of the specific event time window is determined according to the source of the electrical signal.

14. The implantable heart failure treatment device according to claim 12, wherein: During the absolute refractory period of the local excitation event, delivering a stimulation electrical pulse to the pair of stimulation electrodes comprises: Based on the source of the electrical signal, further combining the local detection signal and / or the far-field detection signal, determining the pulse emission time; Based on the source of the electrical signal, further combining the local detection signal and / or the far-field detection signal, determining a pulse-dispensable time window suitable for transmitting the stimulation electrical pulse; and When the pulse emission time falls within the pulse emission time window, a stimulation electrical pulse is transmitted to the pair of stimulation electrodes.

15. The implantable heart failure treatment device according to claim 12, characterized in that: The sources of the electrical signals that trigger local excitation events include spontaneous electrical impulses from the atria, spontaneous electrical impulses from the ventricles, or external electrical stimulation applied to the heart.

16. The implantable heart failure treatment device according to claim 6, characterized in that: At least one of the pair of stimulation electrodes is placed on the anchoring member, and the pair of detection electrodes are placed on the housing and exposed from a surface of the housing.

17. The implantable heart failure treatment device according to claim 6, characterized in that: The far-field excitement detection module is disposed outside the housing and is communicatively coupled to the control module.

18. The implantable heart failure treatment device according to claim 1, characterized in that: The far-field detection signal indicative of an overall excitation event of the patient's heart received by the control module originates from another implantable device in communication with the control module or from a non-implantable device in communication with the control module.

19. The implantable heart failure treatment device according to claim 1, wherein: The device also includes another pair or more pairs of stimulation electrodes, which are coupled to the shell and constructed to contact one or more other predetermined stimulation locations of the patient's heart. Each of the other pair or more pairs of stimulation electrodes is configured to respectively detect local detection signals generated by the discharge of myocardial cells at another predetermined stimulation location and apply stimulation electrical pulses to the other predetermined stimulation location.

20. The implantable heart failure treatment device according to claim 1, characterized in that The pair of stimulation electrodes are also configured to selectively apply pacing electrical pulses to the predetermined stimulation position for adjusting the patient's heart rate, and the control module is further configured to determine whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to the specific overall excitation event based at least on the far-field detection signal and the pacing electrical pulses.

21. The implantable heart failure treatment device according to claim 20, characterized in that: The control module is further configured to receive a mode selection signal and control the implantable heart failure treatment device to be in a pacing mode or a non-pacing mode according to the mode selection signal; wherein, in the non-pacing mode, the control module determines whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to the specific overall excitation event based at least on the far-field detection signal and the local detection signal, and in the pacing mode, the control module determines whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to the specific overall excitation event based at least on the far-field detection signal and the pacing electrical pulse.

22. The implantable heart failure treatment device according to claim 21, characterized in that: In the pacing mode, the control module is configured to determine capture of the patient's heart and determine a starting point of a local excitation event of a myocardial cell at the predetermined stimulation location based on a timing of applying the pacing electrical pulse after the capture.

23. The implantable heart failure treatment device according to claim 22, characterized in that: The control module is configured to determine capture of the patient's heart based on the far-field detection signal.

24. The implantable heart failure treatment device according to claim 1, characterized in that The device is a leadless device, the device further comprising: a first power source and a second power source housed within the housing, wherein the first power source is configured to supply power to the pulse generation module and the control module; and A pacing pulse generation module is housed in the housing and electrically coupled to the second power source to be powered thereby, the pacing pulse generation module being configured to generate the pacing electrical pulse.

25. An implantable heart failure treatment device, characterized in that: The device comprises: case; an anchoring member coupled to the housing and configured to secure the housing to the patient's heart; a pair of stimulation electrodes coupled to the housing and configured to contact predetermined stimulation locations of the patient's heart, the pair of stimulation electrodes being configured to apply stimulation electrical pulses for enhancing the contractility of cardiomyocytes of the patient's heart and pacing electrical pulses for adjusting the heart rate of the patient's heart to the predetermined stimulation locations; a pulse generation module housed in the housing and electrically coupled to the pair of stimulation electrodes, the pulse generation module being configured to generate the stimulation electrical pulse and the pacing electrical pulse; and A control module is housed in the housing and electrically coupled to the pair of stimulation electrodes and the pulse generating module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart, and to determine whether a local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific overall excitation event based at least on the far-field detection signal and the applied pacing electrical pulse, and when it is determined that the local excitation event corresponds to the specific overall excitation event, transmit a stimulation electrical pulse to the pair of stimulation electrodes during an absolute refractory period of the local excitation event.

26. The implantable heart failure treatment device according to claim 25, characterized in that The determining whether the local excitation event of the myocardial cell at the predetermined stimulation position corresponds to a specific global excitation event at least based on the far-field detection signal and the applied pacing electrical pulse comprises: Obtaining a specific event time window corresponding to the specific overall excitement event; If the application time of the pacing electric pulse falls within the specific event time window, it is determined that the local excitation event is Should be in accordance with the specific overall excitement event.

27. The implantable heart failure treatment device according to claim 25, characterized in that The determining whether the local excitation event of the myocardial cell at the predetermined stimulation position corresponds to a specific global excitation event at least based on the far-field detection signal and the applied pacing electrical pulse comprises: After the pair of stimulation electrodes applies a pacing electrical pulse for adjusting the heart rate of the patient to a predetermined stimulation position of the patient's heart, detecting and determining capture of the patient's heart; After detecting capture of the patient's heart, it is determined that a local excitation event of a cardiomyocyte at the predetermined stimulation location corresponds to the specific global excitation event.

28. An implantable heart failure treatment device, characterized in that: The device comprises: case; an anchoring member coupled to the housing and configured to secure the housing to the patient's heart; a pair of stimulation electrodes, the pair of stimulation electrodes being coupled to the housing and configured to contact predetermined stimulation locations of the patient's heart, the pair of stimulation electrodes being configured to detect local detection signals generated by discharges of cardiomyocytes at the predetermined stimulation locations, and to apply stimulation electrical pulses for enhancing the contractility of the cardiomyocytes of the patient's heart to the predetermined stimulation locations; a pulse generating module housed in the housing and electrically coupled to the pair of stimulation electrodes, the pulse generating module being configured to generate the stimulation electrical pulses; and A control module is housed in the shell and is electrically coupled to the pair of stimulation electrodes and the pulse generation module, the control module being configured to receive a far-field detection signal indicating an overall excitation event of the patient's heart, and to determine a pulse emission time and a pulse-emittable time window based at least on the far-field detection signal and the local detection signal, and to transmit a stimulation electrical pulse to the pair of stimulation electrodes when the pulse emission time falls within the pulse-emittable time window.

29. A non-volatile computer-readable storage medium having a computer program stored thereon, characterized in that: The computer program is executed by a processor to control an implantable device to perform a heart failure treatment method, wherein the implantable device includes a pair of stimulation electrodes configured to contact predetermined stimulation locations of a patient's heart; and the method includes: The pair of stimulation electrodes detects a local detection signal generated by discharge of myocardial cells at the predetermined stimulation position; receiving a far-field detection signal indicative of a global excitation event in the patient's heart; determining whether a local excitation event of a myocardial cell at the predetermined stimulation location corresponds to a specific global excitation event based at least on the far-field detection signal and the local detection signal; and When it is determined that the local excitement event corresponds to the specific overall excitement event, During the absolute refractory period of the local excitation event, the stimulation electrical pulse is applied to the predetermined stimulation location using the pair of stimulation electrodes.

30. A non-volatile computer-readable storage medium having a computer program stored thereon, characterized in that: The computer program is executed by a processor to control an implantable device to perform a heart failure treatment method, wherein the implantable device includes a pair of stimulation electrodes configured to contact predetermined stimulation locations of a patient's heart; wherein the method comprises: Applying pacing electrical pulses for adjusting the heart rate of the patient to a predetermined stimulation location of the patient's heart by the pair of stimulation electrodes; determining capture of the patient's heart; After determining the capture, determining whether the local excitation event of the myocardial cell at the predetermined stimulation position corresponds to a specific global excitation event based on the acquired far-field detection signal indicating the global excitation event of the patient's heart and the pacing electrical pulse; and When it is determined that the local excitation event corresponds to the specific global excitation event, the stimulation electrical pulse is applied to the predetermined stimulation position using the pair of stimulation electrodes during the absolute refractory period of the local excitation event.

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