Implantable heart failure treatment device

Abstract

An implantable heart failure treatment device, comprising a housing, an anchor member connected to the housing and fixing the housing to the heart, a pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the heart and apply an electrical stimulation pulse for enhancing myocardial contractility to the predetermined stimulation position, a pulse generation module housed in the housing, electrically coupled to the stimulating electrodes and configured to generate the electrical stimulation pulse, and a control module housed in the housing, electrically coupled to the stimulating electrodes and the pulse generation module, receiving a remote field sensing signal indicating a global excitation event of the patient's heart and a local sensing signal indicating a local excitation event at a local position of the patient's heart, determining whether the local excitation event at the local position of the patient's heart corresponds to a specific global excitation event based at least on the remote field sensing signal and the local sensing signal, and configured to transmit an electrical stimulation pulse to the stimulating electrodes during the absolute refractory period of the local excitation event. An implantable heart failure treatment device is provided.

Description

Technical Field

[0001] This application relates to the field of heart failure treatment, and more particularly, to an implantable heart failure treatment device and a method for treating heart failure based on such a device.

Background Art

[0002] Cardiac contractility modulation (CCM) is a unique and innovative therapy for treating patients with chronic heart failure. It enhances myocardial cell contractility by delivering electrical stimulation to the myocardium, thereby achieving the treatment goal. Different from conventional pacemakers or cardiac resynchronization therapy devices, CCM devices deliver electrical stimulation during the absolute refractory period that does not affect heart rate or action potential distribution. Existing CCM devices on the market typically include a body device implanted outside the heart and two bipolar leads that extend into the ventricular septum of the ventricle, sense the electrical activity and the time series of the electrical activity of the local myocardium, thereby determining the deliverable period for delivering electrical pulse stimulation to the myocardium, and are configured to apply electrical pulse stimulation to local myocardial cells during the deliverable period to enhance myocardial cell contractility.

[0003] However, the two bipolar leads of existing CCM devices implanted in the body 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 peel off and cause infections (including the capsule, electrode wires, etc.), resulting in additional safety risks. On the other hand, existing CCM devices determine the deliverable time of electrical pulse stimulation based on the electrical signals at the local myocardial position, which may lead to misjudgment of the deliverable time. For example, the CCM device confirms that the electrical signal at the local myocardial position corresponds to the R wave of the cardiac cycle, but actually when the signal corresponds to the T wave or another event (such as an interference signal), the electrical pulse stimulation applied by the CCM device will act on the myocardium during the T wave phase. This may significantly increase the risk of inducing malignant ventricular arrhythmias, including ventricular tachycardia (VT) or ventricular fibrillation (VF).

[0004] Furthermore, under the same energy, the longer the distance between the stimulating electrodes or the larger the effective area of each stimulating electrode, the higher the level or the wider the range of the influence that can be exerted on the remote-field myocardium. When local pulse stimulation occurs in a portion where myocardial cells depolarize relatively slowly, the timing of applying the electrical pulse stimulation may fall within the rising phase of the action potential of myocardial cells at the myocardial position that depolarizes earlier, thereby potentially causing further depolarization of this myocardial portion. To avoid the above problems, the stimulating electrodes of existing CCM devices need to be positioned on the interventricular septum and are not suitable for other myocardial positions that may require enhanced contractility. Also, to avoid the above risks, the control method of existing CCM devices does not apply electrical pulse stimulation when the non-atrial-induced (ventricular ectopic excitation) myocardial potential changes. However, premature ventricular contractions have a high incidence among heart failure patients. Some heart failure patients, especially those who have been taking beta-blockers for a long time, those who are wearing a single-chamber implantable cardioverter-defibrillator (ICD), and those who are receiving cardiac resynchronization therapy (CRT) are dependent on ventricular pacing over the long term. Therefore, the therapeutic effect provided by existing CCM devices to these patients will be significantly reduced.

[0005] In summary, there is a need to provide a novel heart failure treatment device and method to address at least one of these problems in the existing technology.

Summary of the Invention

Problems to be Solved by the Invention

[0006] One objective of the present application is to provide an implantable heart failure treatment device and a method for treating heart failure based on the device.

Means for Solving the Problems

[0007] In a first aspect of the present application, an implantable heart failure treatment device is provided. The device includes a housing, an anchor 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 configured to contact a predetermined stimulation position of the patient's heart, sense a local sensing signal generated by the discharge of cardiomyocytes at the predetermined stimulation position, and apply an electrical stimulation pulse to enhance the contractility of the cardiomyocytes of the patient's heart at the predetermined stimulation position, a pulse generation module housed within the housing, electrically coupled to the pair of stimulation electrodes and configured to generate an electrical stimulation pulse, and a control module housed within the housing, electrically coupled to the pair of stimulation electrodes and the pulse generation module, receiving a remote field sensing signal indicating a global excitation event of the patient's heart, determining whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event based at least on the remote field sensing signal and the local sensing signal, and configured to send an electrical stimulation pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event when it is determined that the local excitation event corresponds to a specific global excitation event.

[0008] In some embodiments, the device is a wireless device, and the device includes a first and a second power source housed within a housing, the first power source being configured to supply power to a pulse generation module and a control module, the first and second power sources, and a pacing pulse generation module housed within the housing, electrically coupled to the second power source, powered by the second power source, and configured to generate an electrical pacing pulse.

[0009] In a second aspect of the present application, an implantable heart failure treatment device is further provided. The device includes a housing, an anchor member connected to the housing and configured to fix the housing to the patient's heart, a pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart, and apply an electrical stimulation pulse for enhancing the contractility of myocardial cells of the patient's heart and an electrical pacing pulse for adjusting the heart rate of the patient's heart to the predetermined stimulation position, a pulse generation module housed within the housing, electrically coupled to the pair of stimulating electrodes, and configured to generate the electrical stimulation pulse and the electrical pacing pulse, and a control module housed within the housing, electrically coupled to the pair of stimulating electrodes and the pulse generation module, receiving a remote field sensing signal indicative of a global excitation event of the patient's heart, determining whether a local excitation event of myocardial cells at the predetermined stimulation position corresponds to a specific global excitation event based at least on the remote field sensing signal and the applied electrical pacing pulse, and configured to send an electrical stimulation pulse to the pair of stimulating electrodes during the absolute refractory period of the local excitation event when it is determined that the local excitation event corresponds to the specific global excitation event.

[0010] In a third aspect of the present application, an implantable heart failure treatment device is further provided. The device includes a housing, an anchor member connected to the housing and configured to fix the housing to the patient's heart, a pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart and apply an electrical stimulation pulse for enhancing the contractility of myocardial cells of the patient's heart to the predetermined stimulation position, a pulse generation module housed within the housing, electrically coupled to the pair of stimulating electrodes, and configured to generate the electrical stimulation pulse, and a control module housed within the housing, electrically coupled to the pair of stimulating electrodes and the pulse generation module, receiving a remote field sensing signal indicative of a global excitation event of the patient's heart, determining a pulse delivery time point and a pulse deliverable time window based at least on the remote field sensing signal and a local sensing signal, and configured to send an electrical stimulation pulse to the pair of stimulating electrodes when the pulse delivery time point falls within the pulse deliverable time window.

[0011] In a fourth aspect of the present application, an implantable heart failure treatment device is further provided. The device includes a housing, an anchor member connected to the housing and configured to fix the housing to the patient's heart, a pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart and apply an electrical stimulation pulse for enhancing the contractile force of the myocardial cells of the patient's heart to the predetermined stimulation position, a pulse generation module housed within the housing and electrically coupled to the pair of stimulating electrodes and configured to generate the electrical stimulation pulse, and a control module housed within the housing and electrically coupled to the pair of stimulating electrodes and the pulse generation module, which receives a remote field sensing signal indicating a global excitation event of the patient's heart and a local sensing signal indicating a local excitation event at a local position of the patient's heart, determines whether the local excitation event at the local position of the patient's heart corresponds to a specific global excitation event based at least on the remote field sensing signal and the local sensing signal, and is configured to send an electrical stimulation pulse to the pair of stimulating electrodes during the absolute refractory period of the local excitation event when it is determined that the local excitation event corresponds to the specific global excitation event.

[0012] In a fifth aspect of the present application, a method for treating heart failure based on an implantable device is provided. The implantable device includes a housing, which is fixed to the patient's heart via an anchor member on the housing, and the implantable device further includes a pair of stimulating electrodes configured to contact a predetermined stimulation position of the patient's heart. The method includes sensing, by the pair of stimulating electrodes, a local sensing signal generated by the discharge of myocardial cells at the predetermined stimulation position, receiving a remote field sensing signal indicating a global excitation event of the patient's heart, determining, based at least on the remote field sensing signal and the local sensing signal, whether the local excitation event of the myocardial cells at the predetermined stimulation position corresponds to a specific global excitation event, and applying, when it is determined that the local excitation event corresponds to the specific global excitation event, an electrical stimulation pulse to the predetermined stimulation position using the pair of stimulating electrodes during the absolute refractory period of the local excitation event.

[0013] In a sixth aspect of the present application, a method for treating heart failure based on an implantable device is further provided. The implantable device includes a housing that is fixed to a patient's heart via an anchor member on the housing, and the implantable device further includes a pair of stimulating electrodes configured to contact a predetermined stimulation position of the patient's heart. The method includes applying an electrical pacing pulse for adjusting the heart rate of the patient's heart to the predetermined stimulation position of the patient's heart by the pair of stimulating electrodes, determining capture of the patient's heart, and after capture is determined, based on an acquired remote field sensing signal indicating a global excitation event of the patient's heart and the electrical pacing pulse, determining whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event; and when it is determined that the local excitation event corresponds to a specific global excitation event, applying an electrical stimulation pulse to the predetermined stimulation position using the pair of stimulating electrodes during the absolute refractory period of the local excitation event.

[0014] In a seventh aspect, the present disclosure further provides a computer-readable storage medium storing a computer program. When the computer program is executed by a processor, it performs the steps of the method of either the fifth aspect or the sixth aspect of the present application.

[0015] The above is an overview of the present application, which may be simplified, summarized, or details may be omitted. Those skilled in the art should understand that this section is merely illustrative and is not intended to limit the scope of the present application in any way. It is not intended to identify important or essential features of the claimed subject matter, nor is it intended to serve as an aid in determining the scope of the claimed subject matter.

[0016] The above and other features of the content of this application will be more fully and clearly understood by reading the following specification and the appended claims in conjunction with the accompanying drawings. It should be understood that these accompanying drawings illustrate only some embodiments of this application and should not be considered as limiting the scope of the content of this application. The accompanying drawings are used to explain the content of this application more clearly and in detail.

Brief Description of the Drawings

[0017]

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Embodiments for Carrying Out the Invention

[0018] In the following detailed description, reference is made to the accompanying drawings, which form a part of this application. In the accompanying drawings, like reference numerals generally represent like components unless otherwise specified in the context. The exemplary implementations described in the detailed description, the accompanying drawings, and the claims are not intended to be limiting. Without departing from the spirit and scope of the subject matter of this application, other implementations may be employed and other changes may be made. Various configurations, substitutions, combinations, and designs can be made to the various aspects of the content of this application outlined herein and shown in the accompanying drawings, and all of these are to be clearly understood as constituting a part of the content of this application.

[0019] Figure 1 is a schematic diagram showing an implantable heart failure treatment device 100 fixed in the ventricle according to an embodiment of the present application. The implantable heart failure treatment device 100 can be implanted into the body by various suitable methods such as transapical or transvascular implantation.

[0020] As shown in Figure 1, the implantable heart failure treatment device 100 includes a housing 101 and an anchor member 102 connected to the housing 101. The anchor member 102 is configured to fix the housing 100 to a specific position of the patient's heart. Although not specifically shown in the drawings, the anchor member 102 may include various suitable mechanical components such as a pin portion, a nail portion, a screw portion, a hook portion, a screw-cutting portion, a spiral portion, sharp teeth, a clamping portion, and / or other similar structures for fixing the anchor member to the heart tissue. In some embodiments, one or more anchor members 102 can include a hook-shaped portion that penetrates the heart tissue and at least partially remains within the heart tissue. In other embodiments, one or more anchor members 102 may have a corkscrew drill structure similar to a wine opener so that the anchor member 102 can perforate the heart tissue and achieve fixation. In still some other embodiments, one or more anchor members 102 can have a screw portion, thereby achieving a close engagement with the heart tissue by screw rotation. Those skilled in the art will understand that the structures of the anchor member 102 described above are merely illustrative and not limiting.

[0021] Although a single anchor member 102 is shown in Figure 1, the implantable heart failure treatment device 100 may have any suitable number of anchor members 102 for fixing the housing 101 to the heart tissue. For example, the device 100 may include 1, 2, 3, 4, 5, 6, 7, 8 or more anchor members 102. On the other hand, as another method, the implantable heart failure treatment device 100 may adopt various combinations of the above anchor members to obtain a more stable fixation effect.

[0022] Referring further to FIG. 1, the implantable heart failure treatment device 100 is coupled to the housing 100 and further includes a pair of stimulating electrodes consisting of electrodes 103 and 104. The electrode 103 or 104 may include one or more biocompatible conductive materials such as various metals or alloys known to be safely implantable in the human body. The pair of stimulating electrodes is exposed to the surrounding tissue and / or blood with which the stimulating electrodes are in contact so that the stimulating electrodes can transmit electrical signals to or receive electrical signals from the surrounding tissue and / or blood. The electrical signals can be transmitted through the heart tissue and / or blood. In certain embodiments, the pair of stimulating electrodes 103 and 104 are configured to sense a local sense (LS) signal generated by the discharge of cardiomyocytes at a predetermined stimulation location and apply an electrical stimulation pulse to the predetermined stimulation location to enhance the contractility of the cardiomyocytes of the patient's heart.

[0023] Since the anchor member 102 shown in FIG. 1 is implanted at the interventricular septum position, the pair of stimulating electrodes 103 and 104 can apply an electrical stimulation to the nearby interventricular septum position. However, depending on the position of the anchor member 102, the predetermined stimulation position where the pair of stimulating electrodes 103 and 104 are arranged can be any other heart position where it is desired to apply an electrical stimulation pulse to enhance the myocardial contractility. For example, the predetermined stimulation position can be on the endocardium inside the patient's ventricle or on the epicardium of the patient's heart. In one embodiment, the predetermined stimulation position corresponds to a part of the ventricular tissue. In some other embodiments, instead, the predetermined stimulation position may be a part of the atrial tissue. In one embodiment, the housing 101 of the device 100 is configured to be positioned in a vein outside the patient's heart (for example, having a capsule-like structure), and the predetermined stimulation position is the epicardial tissue near the vein. In this case, the anchor member 102 is configured as an appropriate structure. For example, the anchor member 102 may be a stent, a balloon, a support arm or a similar expandable structure, or the anchor member 102 may be an anchor or a hook extending from the housing 101 and contacting the blood vessel wall of the vein. In a further embodiment, the anchor member 102 may be part of the housing 101. The diameter of the cross section of the anchor member 102 is set to be connected to a relatively narrow section of the blood vessel wall of the vein, thereby fixing the housing 101 in the vein.

[0024] As shown in FIG. 1, the implantable heart failure treatment device 100 further includes a pulse generation module 105 and a control module 106 that are disposed within a housing 101 and electrically coupled to a pair of stimulation electrodes 103 and 104. The positions of the electrodes 103 and 104 shown in the figure are both on the anchor member 102, but can be any structure that can be electrically coupled to the pulse generation module 105 and the control module 106 inside the housing 101 and is exposed to the tissue and / or blood outside the housing 101. For example, at least one of the pair of electrodes 103 and 104 is not disposed on the anchor member 102. In certain embodiments, the electrodes 103 and / or 104 may be formed on the outer surface of the housing or disposed on another member extending from the housing. When the anchor 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 anchor member 102 may have a hook-like structure as described above, and the electrodes 103 and / or 104 extend from the housing and are disposed on a protrusion adjacent to the anchor member 102. When the hook portion of the anchor member 102 penetrates the heart tissue and is at least partially received within the heart tissue, the protrusion on which the electrodes 103 and / or 104 are disposed contacts the heart tissue. In certain other embodiments, the electrodes 103 and / or 104 may be disposed on the anchor member 102 or formed by all or part of the anchor member 102 and inserted into the heart or vascular tissue together with the anchor member 102. For example, the anchor member 102 may have the aforementioned torsion drill structure similar to a wine opener. For example, part or all of the torsion drill constitutes the electrodes 103 and / or 104, and the electrodes 103 and / or 104 are at least partially drilled into the heart tissue.

[0025] In some embodiments, instead of the above, the pair of stimulating electrodes 103 and 104 can use any electrode configuration of a conventional leadless pacemaker for applying pacing pulses. In some embodiments, the electrodes 103 and / or 104 may be defined by a part of the housing 101. For example, the surface of the housing 101 includes an insulating material, and the portions not covered by the insulating material constitute the electrodes 103 and / or 104. The electrodes 103 and / or 104 may be formed by any shaped region having an area smaller than the surface area of the housing, such as a circular region, a rectangular region, an annular region, a semi-annular region, a sector region, and an arch region. In some embodiments, the electrodes 103 and / or 104 are configured such that a part is disposed within the housing 101 and a part is exposed outside the surface of the housing. In yet some embodiments, the electrodes 103 and / or 104 are disposed on another member extending outward from the housing 101 and are spaced apart from the housing 101 and / or the anchor member 102. It should be emphasized that the above description is not intended to limit the specific position or structure of the electrodes 103 and / or 104. The electrodes 103 and / or 104 can use any combination of the above electrode position and structural form features, or any realizable position arrangement or structural form capable of realizing its function.

[0026] As shown in FIG. 1, the electrode 103 in the pair of stimulating electrodes is configured to contact or be electrically connected to a predetermined stimulation position (the interventricular septum position in the figure) of the myocardial tissue. The electrodes 103 and / or 104 themselves may have various available sizes and / or shapes. In some embodiments, the surface area of the electrode 103 for contacting the predetermined stimulation position is 1 to 10 mm 2 , preferably 1.5 mm 2 , 2 mm 2 , 3 mm 2 , 4 mm 2 , 5 mm 2 . In the pair of electrodes, the electrodes 103 and 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.

[0027] Continuing to refer to FIG. 1, in addition to sensing local electrical signals generated by the discharge of cardiomyocytes at a predetermined stimulation position, the implantable heart failure treatment device 100 further includes a remote field excitation sensing module configured to sense global excitation events of the patient's heart, such as a P wave representing the depolarization time and potential change of the atrial global muscle group, a QRS complex representing the depolarization time and potential change of the ventricular global muscle group, and a T wave representing the repolarization time and potential change of the ventricular global muscle group. After acquiring a remote field sensing (also abbreviated as Global Sense, GS for short) signal associated with a global excitation event, the remote field excitation sensing module supplies the corresponding remote field sensing signal to the control module 106 of the implantable heart failure treatment device 100 so that the control module 106 can further determine a specific delivery time of a stimulation pulse based on the remote field sensing signal and the local sensing signal.

[0028] As shown in FIG. 1, the remote field excitation sensing module includes a pair of sensing electrodes consisting of sensing electrodes 107 and 108. The pair of sensing electrodes is coupled to the housing 101 and is configured to sense remote field electrical signals involved in the above-described global excitation events. Although the electrodes 107 and 108 shown in FIG. 1 are disposed on the outer surface of the housing 101, it should be noted that they can be electrically coupled to the control module 106 and have any structure that is exposed to tissue and / or blood outside the housing 101. In other words, the sensing electrodes 107 and 108 may use any combination of the electrode materials and structural form features used in the above-described stimulating electrodes 103 and 104, or any feasible position arrangement or structural form that can realize their functions. In certain embodiments, the surface area of the sensing electrodes 107 and / or 108 is larger than the surface area of the stimulating electrodes 103 and / or 104. In certain embodiments, the electrodes 107 and / or 108 are defined by a part of the housing 101, and the surface area of the electrodes occupies one-fourth to one-third of the entire surface area of the housing. In certain embodiments, the pair of stimulating electrodes and the pair of sensing electrodes can share one electrode. For example, the sensing electrode 107 and the stimulating electrode 104 can be combined as one electrode. The detailed arrangement of the sensing electrodes and the stimulating electrodes will be described in detail below.

[0029] Although not shown in the figure, in some embodiments, the remote field excitation sensing module may instead be disposed outside the housing 101 and communicatively connected to the control module 106. For example, the remote field excitation sensing module may be configured as a separate implantable device independent of the implantable heart failure treatment device 100 and communicatively connectable to the implantable heart failure treatment device 100 in a wireless or wired manner. The remote field excitation sensing module disposed within that separate implantable device may acquire a remote field sensing signal and use a pair of sensing electrodes 107 and 108 as described above to transmit the remote field sensing signal or the processing result of the remote field sensing signal to the control module 106 of the implantable heart failure treatment device 100. This separate implantable device may be any available implantable device having the function of sensing and / or processing a remote field sensing signal.

[0030] In one embodiment, two or more implantable heart failure treatment devices may be combined to form a heart failure treatment system, at least one of the implantable heart failure treatment devices does not have a remote field excitation sensing module, and a remote field sensing signal is obtained wirelessly or wiredly from the remote field excitation sensing module of another implantable heart failure treatment device. In one embodiment, the heart failure treatment system described above includes an implantable heart failure treatment device 100 disposed in the right ventricle as shown in FIG. 1, and another implantable heart failure treatment device disposed in the coronary vein of the heart and communicably connected to the device 100. Compared with the device 100, the implantable heart failure treatment device in the coronary vein may not have a pair of sensing electrodes 107 and 108. Further, the control module of the implantable heart failure treatment device in the coronary vein is configured to sense a local sensing signal generated by the discharge of cardiomyocytes at a predetermined stimulation position through a stimulation electrode, and transmit the local sensing signal and / or the processing result of the local sensing signal to the device 100. Then, based on the local sensing signal and the remote field sensing signal obtained by the device 100, the device 100 determines a specific time point at which to apply an electrical stimulation pulse, and transmits an instruction to apply the electrical stimulation pulse to the device in the coronary vein. After receiving the instruction, the device applies electrical stimulation to a predetermined stimulation position. In some other embodiments, the device in the coronary vein may be configured to obtain a remote field sensing signal indicating a global excitation event of the patient's heart from the device 100, and only determine a specific time point at which to apply a potential stimulation pulse based on the remote field sensing signal and the local sensing signal, and be configured to apply the electrical stimulation pulse. A detailed method for determining the time point at which to apply an electrical stimulation pulse based on the remote field sensing signal and the local sensing signal will be described in detail below.

[0031] In some other embodiments, the remote field excitation sensing module may include a pair of sensing electrode patches configured to contact the patient's body surface in order to sense the patient's body surface electrocardiogram signal as a remote field sensing signal and transmit the signal 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 remote field sensing signal reflects the remote field characteristics of the patient's heart activity, the manufacturing cost of the device can be substantially reduced by sharing the remote field sensing signal. Of course, depending on the embodiment, the remote field sensing signal indicating the global excitation event of the patient's heart received by the control module 106 of the implantable heart failure treatment device 100 may instead be a remote field sensing signal from any other device communicatively connected to the control module 106 having the function of sensing and / or processing the remote field sensing signal. These devices can be any other type of implantable device disposed inside the patient's body, or any type of device disposed on the body surface or outside the body.

[0032] In the housing 101, a pulse generation module 105 is electrically coupled to a pair of stimulation electrodes 103 and 104 and is configured to generate electrical stimulation pulses. A control module 106 is electrically coupled to the pair of stimulation electrodes 103 and 104 and the pulse generation module 105, and is configured to receive a local sensing signal generated by the discharge of cardiomyocytes at a predetermined stimulation position obtained through the pair of stimulation electrodes 103 and 104, and a remote field sensing signal indicating a global excitation event of the patient's heart. On the other hand, the control module 106 further determines whether a local excitation event of cardiomyocytes at a predetermined stimulation position corresponds to a specific global excitation event based at least on the remote field sensing signal and the local sensing signal. For example, it determines whether an electrical signal widely generated by the action potentials of a group of cardiomyocytes at and near a predetermined stimulation position corresponds to a specific remote field electrocardiogram change. When it is determined that the local excitation event corresponds to a specific global excitation event, during the absolute refractory period of the local excitation event, the control module 106 controls the pulse generation module 105 to transmit an electrical stimulation pulse to the pair of stimulation electrodes 103 and 104, thereby strengthening the myocardial contractility of the cardiomyocytes during the local excitation event to treat heart failure. The detailed method of how the control module 106 determines an instruction to transmit an electrical stimulation pulse based on the above signals will be described in detail below. FIGS. 2A to 2C show schematic diagrams of implantable heart failure treatment devices 200a, 200b, and 200c according to three different embodiments of the present application, respectively, schematically showing alternative arrangements of a pair of sensing electrodes and a pair of stimulation electrodes relative to the housing.

[0033] As shown in FIG. 2A, electrode 203a of a pair of stimulating electrodes in device 200a is located at one end of anchor member 202a away from housing 201a, and the other electrode 204a is disposed at one end of housing portion 201a close to anchor member 202a. The pair of sensing electrodes 207a and 208a of device 200a are arranged on housing 201a in order in a direction away from electrode 204a. The arrangement of the pair of sensing electrodes and the pair of stimulating electrodes of device 200b shown in FIG. 2B is generally the same as the embodiment shown in FIG. 2A, except that stimulating electrode 204b is disposed on anchor member 202b instead of housing 201b. Further, sensing electrodes 207a and 207b of device 200b are disposed at two ends of housing 201b. The only difference between the implantable heart failure treatment device 200c shown in FIG. 2C and the implantable heart failure treatment device 200b shown in FIG. 2B is that stimulating electrode 204b disposed on anchor member 202b is removed, and electrode 207c at one end of housing 201c close to anchor member 202c is used as a common reference potential electrode for the pair of sensing electrodes and the pair of stimulating electrodes. In other words, in device 200c, the pair of sensing electrodes consists of electrodes 207c and 208c, and the pair of stimulating electrodes consists of electrodes 203c and 207c.

[0034] Figures 3A through 3C schematically show the relative positional arrangements of a pair of sensing electrodes and a pair of stimulating electrodes with respect to the housing of an implantable heart failure treatment device 300a, 300b, and 300c, respectively, according to different embodiments of the present application. The structure of the implantable heart failure treatment device 300a shown in Figure 3A is generally the same as the structure of the implantable heart failure treatment device 200a shown in Figure 2A, except for the arrangement direction of the electrodes of the pair of sensing electrodes. When the arrangement direction of the sensing electrodes 207a and 208a shown in Figure 2A is defined as the long axis direction of the housing, the pair of sensing electrodes 307a and 308a shown in Figure 3A are arranged in a direction generally perpendicular to the long axis direction. Similarly, the structure of the implantable heart failure treatment device 300b shown in Figure 3B is generally the same as the structure of the implantable heart failure treatment device 200b shown in Figure 2B, except that the pair of sensing electrodes 307b and 308b are arranged along the housing 301b in a direction generally perpendicular to the long axis direction. The structure of the implantable heart failure treatment device 300c shown in Figure 3C is generally the same as the structure of the implantable heart failure treatment device 200c shown in Figure 2C, except that the pair of sensing electrodes 307c and 308c are arranged along the housing 301c in a direction generally perpendicular to the long axis direction.

[0035] In one embodiment, the distance between the sensing electrodes of a pair of sensing electrodes is set to be relatively far apart. For example, the sensing electrodes are arranged at two ends of the long axis of the housing, or on two surfaces of the short axis that are separated from each other, or on two surfaces at two ends of the long axis of the housing, whereby the electrical activity of the entire heart, particularly the electrical activity of the entire ventricular muscle, can be obtained more effectively. Specifically, in one embodiment, when one of the pair of stimulating electrodes is arranged on the housing and the pair of remote field sensing electrodes does not share this stimulating electrode, the area covered by the pair of stimulating electrodes and the area covered by one sensing electrode do not overlap. Assuming that the pair of sensing electrodes includes electrodes A and B, and the pair of stimulating electrodes includes electrodes C and D, and D is the electrode in contact with the myocardium, the arrangement order of the electrodes is A, B, C, and D. In some cases, an insulator may be provided between electrode B and electrode C to ensure the distance between the two electrodes, thereby minimizing the influence of the pulse stimulation delivered by the stimulating electrode on the electrical activity sensed by the sensing electrode. Those skilled in the art will understand that regardless of the setting, any two of the electrodes A, B, C, and D need to be insulated from each other.

[0036] Figures 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. All of these implantable heart failure treatment devices include a plurality of pairs of stimulating electrodes. The structure of the implantable heart failure treatment device 400a shown in Figure 4A is generally the same as the structure of the implantable heart failure treatment device 200b shown in Figure 2B, except that the device 400a includes another anchor member 409a. Another pair of stimulating electrodes 410a and 411a are arranged on the anchor member 409a. The two pairs of stimulating electrodes are each configured to contact different predetermined stimulation positions on the endocardium or epicardium. These pairs of stimulating electrodes can sense the local sensing (LS) signals generated by the action potentials of myocardial cells at the corresponding predetermined stimulation positions, and further, can apply electrical stimulation pulses for strengthening the myocardial contractility of the patient's heart to the corresponding predetermined stimulation positions.

[0037] In one embodiment, it is assumed that the electrode 403a of the pair of stimulation electrodes 403a and 404a contacts the position A within the ventricular cavity, and the electrode 410a of the pair of stimulation electrodes 410a and 411a contacts the position B within the ventricular cavity different from the position A. Each of the two electrodes senses a local sensing signal generated by the change in the membrane potential of cardiomyocytes at the positions A and B. When the local sensing signals at the positions A and B meet the preset conditions, electrical stimulation pulses are applied to the positions A and B via the pair of stimulation electrodes to enhance the cardiomyocyte contractility. For example, the control module of the device 400a can determine whether the electrical activity of the cardiomyocytes at the positions A and / or B corresponds to the ventricular depolarization process based on the intensity and / or chronological order of the local sensing signals at the positions A and B. When the determination result is "positive", an electrical stimulation pulse is applied to the myocardial tissue at the positions A and / or B.

[0038] The implantable heart failure treatment device 400b in the embodiment shown in FIG. 4B is generally the same as the implantable heart failure treatment device 300a shown in FIG. 3A, except that the device 400b further includes another anchor member 409b and another stimulation electrode 410b disposed on the anchor member 409b. The electrode 404b formed of a part of the housing 401b forms two pairs of stimulation electrodes each having the electrodes 403b and 410b. The structure of the device 400c shown in FIG. 4C is generally the same as the structure of the device 200a shown in FIG. 2A, except that the device 400c further includes another anchor member 409c, and the electrode 404c formed of a part of the housing 401c forms two pairs of stimulation electrodes each having the electrodes 403c and 410c. Similar to the description of the device 400a in FIG. 4A, the devices 400b and 400c can be configured to sense, process local sensing signals at different positions of the heart, and separately deliver electrical stimulation pulses via the two pairs of stimulation electrodes, which will not be elaborated here.

[0039] Figures 5A and 5B schematically show the positional arrangements of a pair of stimulating electrodes relative to a housing, and are schematic diagrams of implantable heart failure treatment devices 500a and 500b according to different embodiments of the present application, respectively. As shown in Figure 5A, device 500 includes a housing 501a and a pair of stimulating electrodes consisting of electrodes 503a and 504a mounted on housing 501a. As described above, device 500 is designed to be placed in a vein outside the patient's heart, and the predetermined stimulation position of the device is the epicardial myocardial tissue near the vein. The pair of stimulating electrodes are configured to sense local sensing (LS) signals generated by the discharge of myocardial cells at specific positions on the epicardium, and further, an electrical stimulation pulse for strengthening the myocardial contractility of the patient's heart can be applied to the corresponding position. As shown in the figure, housing 501a and the pair of stimulating electrodes mounted on the surface of the housing are configured to be connectable to the blood vessel wall of the vein outside the heart to fix device 500a in the vein, and at least one of the pair of stimulating electrodes is configured to abut on one side of the blood vessel wall close to the epicardium.

[0040] Furthermore, in certain embodiments, device 500a may further include a stent, balloon, support arm or similar expandable structure, or an anchor member including an anchor or barb structure for connecting to the vascular wall of the vein to fix device 500. In certain other embodiments, at least a portion of housing 501a is sized to be fixed to a relatively narrow portion of the vein outside the heart, thereby fixing housing 501a within the vein. Implantable heart failure treatment device 500b shown in FIG. 5B is generally the same as device 500a of FIG. 5A, except that the structure of a single electrode 504b in a pair of stimulation electrodes is replaced by a portion of housing 501a not covered by insulating material on housing 501a, such as an annular region. In certain embodiments, the single electrode 504b may be a local region in the annular region facing the myocardium, such as a semi-ring facing the myocardium, or an arc smaller or larger than the semi-ring. As described above, two or more implantable heart failure treatment devices disclosed in the present application can be combined to form a heart failure treatment system, and at least one of the implantable heart failure treatment devices does not have a remote field excitation sensing electrode and a remote field excitation sensing module. Instead, a remote field sensing signal and / or a signal processing result may be obtained from the remote field excitation sensing module of another implantable heart failure treatment device in a wireless or wired manner. Implantable heart failure treatment devices 500a and 500b shown in FIG. 5A or FIG. 5B may not have a remote field excitation sensing module so as to minimize the volume for facilitating placement within the vein outside the heart. However, the device can receive a remote field sensing signal indicating a global excitation event of the patient's heart from another extracorporeal device or another implanted device having a remote field excitation sensing module, and based on the local sensing signal sensed by a pair of stimulation electrodes of the device, the control module of the device can determine whether the local excitation event of myocardial cells at a corresponding predetermined stimulation position corresponds to a specific global excitation event.In this way, when the local excitation event satisfies a predetermined condition, the implantable heart failure treatment device can instruct a pair of stimulating electrodes to apply an electrical stimulation pulse to a predetermined stimulation position. In certain embodiments, the implantable heart failure treatment devices 500a and 500b do not perform the foregoing determination step based on the remote field sensing signal and the local sensing signal, but rather are configured to communicate with other implantable devices or extracorporeal devices within the system to transmit the local sensing signal or sensing result obtained by the pair of stimulating electrodes to the other implantable devices or extracorporeal devices within the system. In this way, another implantable device or extracorporeal device can make a determination based on the remote field sensing signal and the local sensing signal and transmit an instruction for delivering an electrical stimulation pulse to the implantable heart failure treatment device 500a or 500b at an appropriate time. Thereafter, the device 500a or 500b controls the pair of stimulating electrodes to contact the pair of stimulating electrodes so as to enhance myocardial contractility or apply an electrical stimulation pulse to the corresponding predetermined stimulation position (epicardium) based on the received instruction.

[0041] It should be emphasized that the embodiments shown in FIGS. 2A to 5B are intended to illustrate possible positional arrangements of a pair of stimulating electrodes and / or a pair of sensing electrodes. The materials, structural forms, etc. of the pair of stimulating electrodes and / or the pair of sensing electrodes in the figures can use any technical features and combinations thereof described for the electrodes 103, 104, 107, and 108 shown in the embodiment of FIG. 1, or any other realizable positional arrangement or structural form that can achieve the function. This will not be elaborated here in detail. Further, for the sake of simplicity of the figures, although some figures do not specifically illustrate the insulating material or insulating structure between the electrodes, an insulating structure or insulating material is of course arranged between the electrodes. For example, in the case of a plurality of electrodes arranged on the housing, the electrodes can be separated by an insulating material coating or insulating material wrapping. For example, the housing of the device may be entirely made of an insulating material, two or more electrodes may extend out of the housing, and two or more electrodes may be connected to a circuit module inside the housing. Those skilled in the art will clearly understand that the insulation between these electrodes can be implemented by any realizable method not elaborated here in detail.

[0042] FIG. 6 shows a flowchart 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 are exemplified below in relation to the device 100 shown in FIG. 1.

[0043] In step 602, the control module 106 determines whether a local excitation event of cardiomyocytes at a predetermined stimulation position corresponds to a specific global excitation event based at least on the acquired remote field sensing signal and the local sensing signal. In an embodiment, step 602 may include obtaining a specific event time window corresponding to a specific global excitation event, and determining that the local excitation event corresponds to the specific global excitation event if the sensing time point of the local excitation event falls within the specific event time window.

[0044] A specific event time window is a period determined based on a remote field sensing signal (also referred to as a GS signal in this specification) and / or a local sensing signal (also referred to as an LS signal in this specification), and is associated with a specific event in the cardiac cycle. For example, a period associated with a specific event in the cardiac cycle (such as an R wave or a QRS complex) can be determined based on a remote field electrocardiogram signal sensed by a sensing electrode of one or more implantable devices or a body surface electrocardiogram sensed by one or more external devices. In certain embodiments, when an implantable heart failure treatment device includes multiple pairs of stimulation electrodes, the specific event time window can be determined based on multiple LS signals supplied by those multiple pairs of stimulation electrodes at different predetermined stimulation positions.

[0045] Specifically, the start point of the specific event time window can be determined by the above-described GS signal and / or LS signal. In certain embodiments, the start point of the specific event time window may be determined based on the time point at which a specific event is sensed in the remote field sensing signal (hereinafter referred to as the "GS sensing time point") and / or the time point at which a local sensing signal generated by the discharge of cardiomyocytes at a predetermined stimulation position is sensed (hereinafter referred to as the "LS sensing time point").

[0046] In an embodiment of a heart failure treatment device implanted in the right ventricle as shown in FIG. 1, the start point of the specific event time window (abbreviated as GVT-s in the following formula) can be set as follows.

[0047] When the LS sensing time point is after the GS sensing time point, that is, when the difference between the LS sensing time point and the GS sensing time point (abbreviated as GLSD in the following formula) is greater than 0, GVT-s is set to the time point from a preset time length (abbreviated as A in the following formula) before the GS sensing time point (abbreviated as GS in the following formula), and its specific formula is as follows. When GLSD > 0, GVT-s = GS - A.

[0048] On the other hand, when the LS sensing time point is earlier than or equal to the GS sensing time point, GVT-s can be set at a time point from a preset time length before the LS sensing time point (abbreviated as LS in the following formula), and the specific formula is as follows.

[0049] When H≦GLSD≦0, GVT-s = LS - A. This formula can be rewritten as GVT-s = GS + GLSD - A, where H < 0, preferably -120ms≦H≦-20ms. During the actual sensing of the electrocardiogram signal, due to the delay in capturing the electrocardiogram signal, the GS sensing time point may be delayed compared to the real-time node, or for other reasons, the LS sensing time point may be slightly earlier than the GS sensing time point. Since LS is used as the starting point, this situation can be better handled, and the correspondence between the local excitation event and the global excitation event can be determined more accurately. The above settings can be implemented in real time for each cardiac cycle.

[0050] It should be further noted that by monitoring the LS signal and the GS signal within the preset period of the parameter, the implantable heart failure treatment device can determine the reference time difference B between the LS sensing time point and the GS sensing time point when the LS sensing time point is later than the GS sensing time point, and can determine the reference time difference C between the LS sensing time point and the GS sensing time point when the LS sensing time point is earlier than or equal to the GS sensing time point. In the subsequent operation process, GVT-s can be set based on the above reference time difference and the LS sensing time point or the GS sensing time point, and the specific formula is as follows. When GLSD > 0, GVT-s = LS - B - A, When H≦GLSD≦0, GVT-s = GS+C-A , H < 0, preferably -120ms≦H≦-20ms.

[0051] It should be noted that the above specific calculation method is only an example. Instead of the above, the starting point of the specific event time window may be determined using other methods or based on other parameters. In the above embodiment, the preset time length A, reference time differenceB and C are all adjustable preset values. A can be selected from 0 to 40 ms, preferably 20 ms. In certain embodiments, reference time difference B and C absolute value of may use the same preset value.

[0052] The length of the specific event time window can typically be a preset time length related to a specific type of specific event. Taking the R wave, which is a special event, as an example. In the case of an R wave generated by a self-generated impulse at the atrial position (for example, generated by the sinoatrial node), the length of the special event time window (or called the R wave time window) can be 3 to 130 ms, preferably 90 ms. In the case of an R wave generated by self-generated activity at the ventricular position (for example, ventricular premature contraction) or external electrical stimulation in ventricular tissue, the length of the R wave time window can be 30 to 250 ms, preferably 150 ms.

[0053] In certain other embodiments, the lengths related to ventricular self-generated electrical activity and ventricular electrical activity caused by pacing can be set separately by a physician according to the actual situation. The time length can be set to be different for each ventricular premature contraction by the physician according to the specific situation.

[0054] Referring further to FIG. 6, in step 604, when the control module 106 determines that a local excitation event corresponds to a specific global excitation event, the control module 106 transmits an electrical stimulation pulse to a pair of stimulation electrodes during the absolute refractory period of the local excitation event.

[0055] In certain embodiments, step 604 specifically includes steps of determining the pulse delivery time point by the control module 106 based on the local sensing signal and / or the remote field sensing signal, determining a pulse deliverable time window suitable for transmitting the electrical stimulation pulse based on the local sensing signal and / or the remote field sensing signal, and when the pulse delivery time point falls within the pulse deliverable time window, transmitting an electrical stimulation pulse to a pair of stimulation electrodes 103 and 104 to enhance myocardial contractility.

[0056] In this application, the pulse delivery time point (abbreviated as CSDT in this specification) means the time point when a pair of stimulating electrodes delivers an electrical stimulation pulse, and this time point is determined based on the acquired GS signal and / or LS signal. The pulse delivery time point can also be determined by different methods. By setting the CSDT, ensure that the delivery time point of the pulse stimulation falls within the absolute refractory period of the local excitation event.

[0057] In one embodiment, the pulse delivery time point can be determined based on the LS sensing time point. For example, the pulse delivery time point can be the time point from the current time duration after the LS sensing time point, and its specific formula is as follows. CSDT = LS + D.

[0058] In another embodiment, the pulse delivery time point is determined based on the combination of the GS sensing time point and GLSD. For example, the pulse delivery time point can be the sum of the GS sensing time point, GLSD, and the current time duration, and the specific formula is as follows. CSDT = GS + GLSD + D.

[0059] As described above, when the LS sensing time is later than the GS sensing time, the reference time difference E between the LS sensing time point and the GS sensing time point can be determined by sensing the LS signal and the GS signal within the preset period. When the LS sensing time point is earlier than or equal to the GS sensing time point, the reference time difference F between the LS sensing time point and the GS sensing time point can be determined. In the subsequent operation process, the CSDT can be determined based on the above reference time difference and the LS sensing time point or the GS sensing time, and its specific formula is as follows. When GLSD > 0, CSDT = GS + E + D,

[0060] When H ≤ GLSD ≤ 0, C SDT = GS +F + D, where H < 0, preferably -120 ≦ H ≦ -20. During the actual sensing of the electrocardiogram signal, the delay in capturing the electrocardiogram signal may cause the GS sensing time point to lag behind the actual time point, or for other reasons, the LS sensing time point may be slightly earlier than the GS sensing time point. Since LS is used as the starting point, this situation can be well handled, and the correspondence between local events and global events can be determined more accurately.

[0061] The above E and F can be determined in real time for each cardiac cycle or can be determined as preset values during the set period.

[0062] It should be noted that the above specific calculation method is only an example. Instead of the above, the pulse delivery time point may be determined using 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.

[0063] The pulse deliverable time window is a period suitable for delivering an electrical stimulation pulse such that the transmission of the electrical stimulation pulse to a predetermined stimulation position via the stimulating electrode does not cause or hardly causes further depolarization events in the myocardial tissue at the predetermined stimulation position and other myocardial tissues that may be affected by the electrical stimulation pulse. Since the pulse deliverable time window is set as a determination condition, the implantable heart failure treatment device can enable the electrical stimulation pulse to be sent at an appropriate time within the absolute refractory period of the myocardium at the stimulation position and the myocardium that may be affected by the stimulation pulse in order to strengthen myocardial contractility and avoid risks including malignant ventricular arrhythmias such as ventricular tachycardia (VT) or ventricular fibrillation (VF).

[0064] In certain embodiments, the start point of the pulse deliverable time window can be determined in the same manner as the start point of the above-described specific event time window, which will not be elaborated here. In certain embodiments, the start points of the specific event time window and the pulse deliverable time window may use any other feasible method. For example, when an implantable heart failure treatment device includes multiple pairs of stimulating electrodes, for example, when the device is implanted in both the right ventricle and the left ventricle, the specific event time window and the pulse deliverable time window can be determined based on the GS signal and the LS signal of a pair of stimulating electrodes that sense the earliest local excitation event in the cardiac cycle. Naturally, the pulse deliverable time window can be determined based on the LS signal, the GS signal, and the various factors described above.

[0065] Similar to the setting of the length of the specific event time window, the length of the pulse deliverable time window can usually be a preset time length related to a specific type of specific event. Taking the R wave as an example of the specific event. In the case of an R wave generated by a self-generated impulse at the atrial position (for example, generated by the sinoatrial node), the length of the pulse deliverable time window (or referred to as the R wave pulse deliverable time window) can be 3 to 250 ms, preferably 130 ms. In the case of an R wave generated by self-generated activity at the ventricular position or external electrical stimulation to the ventricular tissue, the length of the pulse deliverable time window can be 30 to 250 ms, preferably 200 ms.

[0066] In certain other embodiments, the length of the pulse deliverable time window for self-generated electrical activity at the ventricular position and ventricular electrical activity generated by a ventricular pacemaker can be set separately by a physician according to the actual situation. Different time lengths of premature ventricular contractions can be set by a physician according to specific situations.

[0067] It should be noted that the start times corresponding to the pulse deliverable time window and the specific event time window (also referred to as the "sensing time window" in some descriptions of this specification) may be the same or different. In other words, the pulse deliverable time window and the specific event time window can be set independently without any correlation or dependence on each other. Specifically, the pulse deliverable time window and the specific event time window can be determined based on the remote field electrocardiogram signal and can be adaptively adjusted according to factors such as the specific situation of the sensed specific event (such as the R wave) and the specific location of the myocardium so as to cover or meet most of the requirements of the pulse stimulation scenario. The specific determination methods of the pulse deliverable time window and the specific event time window will be described in detail below together with the accompanying drawings and embodiments. Optionally, method 600 may further include step 601 before step 602. In step 601, an electrical signal source that causes a local excitation event is determined. The electrical signal source may include self-generated impulses from the atrial position, self-generated ventricular activity from the ventricular position, or ventricular electrical activity caused by electrical stimulation from outside the heart. In one embodiment, a specific type of electrical signal source can be determined by the remote field sensing signal. Thereafter, together with the electrical signal source determined in step 601, the specific event time window, the pulse deliverable time window, the pulse delivery time, and other parameters can be adjusted correspondingly in steps 602 and 604. The specific adjustment method is described in the descriptions of steps 602 and 604. When the electrical signal source is an electrical stimulation from outside the heart (such as a pacing pulse), the specific adjustment method is described in the description of the control method of an implantable heart failure treatment device having the following pacing pulse function.

[0068] FIG. 8 is a schematic diagram showing modules of a control system for an implantable heart failure treatment device 800 according to an embodiment of the present application. As shown in FIG. 8, the device 800 includes a sensing analysis module 801 configured to sense and receive local sensing signals (LS in FIG. 8) and remote field sensing signals (GS in FIG. 8) acquired by a pair of stimulation electrodes (S1 and S2 in FIG. 8) and a pair of sensing electrodes (E1 and E2 in FIG. 8) of the device 800, and transmit those signals to a reference time window determination module 802 and a pulse delivery timing determination module 804. In certain embodiments, the remote field sensing signal (GS) includes a remote field electrocardiogram signal of the patient's heart sensed by a pair of sensing electrodes. The reference time window determination module 802 determines a specific event (e.g., R wave) time window (the R wave time window is represented by RTW in the figure) corresponding to a specific event in the remote field electrocardiogram signal, and / or a pulse deliverable time window (SSW) according to the acquired GS signal and / or LS signal.

[0069] Referring further to FIG. 8, the sensing analysis module 801 of the device 800 is further configurable to acquire a signal representing an electrical activity source that causes a local excitation event (BC in FIG. 8) and transmit the signal to a reference time window determination module 802 and a pulse delivery time determination module 804. The reference time window determination module 802 is configured to determine whether a local excitation event of cardiomyocytes at a predetermined stimulation position corresponds to a specific global excitation event based on the received BC signal, LS signal, and GS signal. Taking the R wave, which is a specific event, as an example. When the BC signal indicates, for example, that the electrical activity source is electrical activity spontaneously transmitted from the atrial position, ventricular self-generated electrical activity from the ventricular position, or ventricular electrical activity caused by external electrical stimulation, the reference time window determination module 802 sets a specific event time window RTW and a pulse deliverable time window SSW correspondingly and sends RTW and SSW to the comparison analysis module 803. Similarly, when the BC signal indicates that the electrical signal source is a self-generated impulse from the atrial position, a self-generated impulse from the ventricular position, or an electrical stimulation from outside the heart, the pulse delivery time determination module 804 determines a pulse discharge time CSDT correspondingly. Based on the above information, the comparison analysis module 803 determines whether to apply an electrical stimulation pulse to a predetermined stimulation position of the patient's heart via a pair of stimulation electrodes. In one embodiment, the comparison analysis module 803 first determines whether the sensing time of the local excitation event in the LS signal falls within the RTW. If the sensing time of the local excitation event in the LS signal falls within the RTW, it is determined that the local electrical excitation event at the predetermined stimulation position corresponds to the R wave event caused thereby, and an electrical stimulation pulse can be transmitted to a pair of stimulation electrodes S1 and S2 during the absolute refractory period of the local electrical excitation event. Also, when the comparison analysis module 803 determines that the sensing time of the local excitation event in the LS signal falls within the RTW, the comparison analysis module 803 determines whether the pulse delivery time CSDT falls within the pulse deliverable time window SSW, and transmits an electrical stimulation pulse to a pair of stimulation electrodes S1 and S2 only when CSDT falls within SSW.

[0070] As shown in FIG. 8, the device 800 can further include a pacing operation module 805 configured to supply a signal indicating whether to deliver a pacing pulse to the sensing analysis module 801. After obtaining a signal indicating that the pacing pulse has been delivered, the sensing analysis module 801 determines whether cardiac capture has been achieved. When cardiac capture is achieved and the type of the BC signal is pacing (for example, ventricular pacing), the reference time window determination module 802 correspondingly sets a specific event time window RTW and a pulse deliverable time window SSW. On the other hand, the pulse delivery time determination module 804 correspondingly determines a pulse delivery time CSDT. These signals are then sent to the comparison analysis module 803. The comparison analysis module 803 first determines whether the application time of the electrical pacing pulse falls within the RTW based on the acquired information. If the application time of the electrical pacing pulse falls within the RTW, it is determined that the local electrical excitation event at the predetermined stimulation position corresponds to the ventricular myoelectric activity and the subsequent contraction event caused thereby. Further, an electrical stimulation pulse can be transmitted to a pair of stimulation electrodes S1 and S2 during the absolute refractory period of the local electrical excitation event. Also, after determining that the application time of the pacing pulse falls within the RTW, the comparison analysis module 803 can then determine whether the pulse delivery time CSDT falls within the pulse deliverable time window SSW, and transmit an electrical stimulation pulse to a pair of stimulation electrodes only when the CSDT falls within the SSW. Naturally, when it is determined that cardiac capture is achieved after the delivery of the pacing pulse, the correspondence between the delivery of the pacing pulse and a specific global excitation event (for example, the R wave) reflected by the remote field sensing signal can usually be directly determined. Therefore, in an embodiment, in the case of delivering a pacing pulse, it is also possible to directly determine whether the local excitation event at the predetermined stimulation position as described above corresponds to a specific global excitation event according to whether capture has been performed.

[0071] In the embodiment of FIG. 8 above, it should be noted that the division of the modules is based on functions or execution steps, rather than a physical division of specific modules. In fact, one or more modules can be integrated into one overall module, or each module can 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 first determines whether the occurrence time of a locally exciting event sensed in the LS signal falls within the RTW, and then, only if the occurrence time falls within the RTW, determines whether the pulse delivery time point CSDT is within the pulse deliverable time window SSW in order to determine whether to deliver a stimulation pulse. The various modules of the device shown in FIG. 8 can be implemented by hardware, software, or firmware, or a combination of hardware and software / firmware. Furthermore, one or more of the GS signal and the LS signal in the device 800 shown in FIG. 8 may come from not only a pair of sensing electrodes E1 and E2 and a pair of stimulation electrodes S1 and S2, but also other implanted devices or extracorporeal devices.

[0072] In the above-described embodiments, a local sensing signal generated by the discharge of cardiomyocytes at a predetermined stimulation position is used as a local sensing signal indicating a local excitation event at a local position of the patient's heart, and based on a remote field sensing signal indicating a global excitation event of the patient's heart and a local sensing signal indicating a local excitation event at a local position of the patient's heart, it is further determined whether the local excitation event of cardiomyocytes at a predetermined stimulation position of the patient's heart corresponds to a specific global excitation event. In one embodiment, the control module 106 of the device 100 in FIG. 1 may acquire a local sensing signal generated by the discharge of cardiomyocytes at a predetermined stimulation position without a pair of stimulation electrodes 103 and 104. On the other hand, it should be noted that the control module 106 may acquire a local sensing signal (also referred to as another LS signal) generated by the discharge of cardiomyocytes at other local positions of the heart through other electrodes coupled to the housing and in contact with heart tissue or blood vessels. These other local positions may or may not be adjacent to the predetermined stimulation position. In another embodiment, the control module 106 may acquire other LS signals from another device communicably connected to the control module 106 and capable of acquiring electrical signals of cardiomyocytes at other local positions of the patient's heart. Then, the control module 106 can determine whether the local excitation event of cardiomyocytes at other local positions of the patient's heart corresponds to a specific global excitation event of the patient's heart based on the GS signal and the LS signal. When it is determined that the local excitation event corresponds to a specific global excitation event, an electrical stimulation pulse can be transmitted to a pair of stimulation electrodes during the absolute refractory period of the local excitation event. In some embodiments, it should be noted that the step of "transmitting an electrical stimulation pulse to a pair of stimulation electrodes during the absolute refractory period of the local excitation event" described herein can only consider the situation of the absolute refractory period of the local excitation event. In other embodiments, the above step may be further limited to considering both the absolute refractory period of the local excitation event and the entire absolute refractory period of the ventricular myocardium. This is specifically described in the steps and methods explained in step 604.In one embodiment, the control module 106 can use steps similar to those in method 600, except that the LS signal is replaced by other LS signals as described above. In some other embodiments, the control module 106 can adaptively adjust specific steps and parameters when considering factors such as the positional relationship between a predetermined stimulation position and other local positions.

[0073] Figures 9 to 19 further describe in detail the specific details of the implantable heart failure treatment device related to the present application, mainly from different aspects, which are involved in multiple embodiments of the present application. Embodiment 1 and Embodiment 2 relate to the pulse stimulation control method used in the implantable heart failure treatment device of the present application. Embodiment 3 and Embodiment 4 mainly relate to the pulse stimulation control system for the implantable heart failure treatment device. Embodiment 5 mainly relates to the pulse stimulation control device of the pulse stimulation control system. Embodiment 6 relates to an electronic device for implementing the pulse stimulation control method, and Embodiment 7 relates to a computer-readable storage medium storing a computer program configured to implement the pulse stimulation control method of Embodiment 1 or 2. These specific details of the implantable heart failure treatment device will be further described below together with Figures 9 to 19 and the above-described embodiments. It should be noted that these embodiments are only illustrative of specific embodiments of the implantable heart failure treatment device and are not intended to limit the scope of the present application in any way.

[0074] Embodiment 1 As shown in Figure 9, the pulse stimulation control method according to this embodiment includes S101, obtaining the first sensing time point of the R wave in the preset electrocardiogram, The preset electrocardiogram includes, but is not limited to, surface electrocardiogram (ECG) and in-vivo long-distance field myocardial electrocardiogram (also called far-field electrogram, FF-EGM), and the first sensing time point is also called the far-field sensing time point or the GS sensing time point. The pulse stimulation control method includes step S102 of determining a sensed event in a local myocardial electrocardiogram corresponding to a set myocardial position based on a first sensing time point and obtaining a second sensing time point corresponding to the sensed event. The second sensing time point corresponding to the sensed event in the local myocardial electrocardiogram is also called the local sensing time point or the LS sensing time point. The sensed event in the local myocardial electrocardiogram is a sensed event corresponding to the R wave in the preset electrocardiogram. The pulse stimulation control method includes step S103 of, when the second sensing time point does not meet a first preset condition, determining that the sensed event is not an R wave signal corresponding to the R wave in the preset electrocardiogram, and not delivering a pulse stimulation to the stimulation electrode at the set myocardial position. The first preset condition is determined based on the first sensing time point of the R wave in the preset electrocardiogram and the second sensing time point corresponding to the sensed event.

[0075] In one implementation form, as shown in FIG. 10, step S103 includes: S1031, including the step of obtaining a sensing time window corresponding to the R wave in the preset electrocardiogram. The method for obtaining the sensing time window includes, but is not limited to, the step of obtaining the sensing time window based on a preset sensing circuit or the step of directly receiving the sensing time window through an external device input.

[0076] Body surface electrocardiogram (ECG): The corresponding signal is derived from the control electrodes attached to the skin. In this case, the control electrodes include, but are not limited to, commonly used body surface ECG electrodes and specially designed electrodes.

[0077] Far-field electrogram of the myocardium (FF-EGM) represents (or reflects) the signal of the overall electrical activity of the heart similar to the body surface electrogram. Signals corresponding to the far-field electrogram of the myocardium come from various combinations of control electrodes including, but not limited to, electrodes in direct contact with the myocardium having a relatively large surface area (i.e., significantly larger than the surface area of conventional electrodes used for electrical stimulation of the myocardium), electrodes not in direct contact with the myocardium but positioned near or away from the ventricular myocardium, or subcutaneous electrodes having a relatively large surface area.

[0078] For example, different combinations of electrodes correspond to any combination of those placed in blood vessels or within the ventricles, defibrillation electrodes placed on the epicardium, subcutaneous defibrillation electrodes for sub-Q ICD, or defibrillation electrodes for external defibrillation (such as AEDs). The specific arrangement of these electrodes can be determined or adjusted based on the requirements of the actual usage scenario.

[0079] The sensing time point and the corresponding sensing time window can be obtained based on the R wave in the body surface electrogram via a single lead wire or multiple lead wires, and / or one or more R waves in one or more far-field electrograms of the myocardium. These represent part or all of the period of the overall electrical activity of ventricular myocardial depolarization, thereby obtaining the deliverable pulse time window. By improving the control mechanism for determining whether to deliver a stimulus at the stimulation site and the timing of delivery, the determination accuracy of pulse stimulus delivery is further improved, thereby improving safety.

[0080] Step S103 further includes step S1032 of determining that the sensing event is not an R wave signal corresponding to the R wave in the preset electrogram and not delivering a pulse stimulus to the stimulating electrode at the set myocardial position when the second sensing time point does not fall within the sensing time window.

[0081] Here, the non-R wave signal corresponding to the sensed event LS in the local myocardial electrocardiogram includes a T wave signal or other interference signals. Specifically, the pulse stimulation is CCM stimulation, and by enabling the pulse stimulation to be performed under different ventricular electrical activities, the applicability of the pulse stimulation is expanded, thereby improving the overall effectiveness of the pulse stimulation control.

[0082] CCM stimulation is performed during ventricular electrical activities such as sinus rhythm, ventricular beats transmitted from the atrium, ventricular beats originating from the ventricle (ventricular ectopic excitation), and ventricular pacing beats.

[0083] Confirming that the local sensed event is an R wave ensures that CCM stimulation is more reliably triggered by the local R wave rather than other signals (such as T waves, myoelectricity, or other non-myocardial depolarization electrical activities), thereby substantially eliminating the occurrence of false triggers. By designing this important step, the safety and effectiveness of the pulse stimulation can be effectively improved.

[0084] To effectively improve the confirmation accuracy of whether the LS in the local myocardial electrocardiogram is an R wave sensing, this embodiment simultaneously considers both the long-distance field sensing signal and the local sensing signal of the same heartbeat. By jointly determining the judgment results based on both the long-distance field sensing signal and the local sensing signal under the same heartbeat, the probability of false triggering of the pulse stimulation due to misjudgment that may occur when only one type of sensing (long-distance field sensing signal or local sensing signal (LS)) is considered is significantly reduced. Therefore, this greatly improves the confirmation accuracy of the sensed event, effectively prevents the pulse stimulation from being delivered under incorrect conditions, and thereby greatly improves the safety of the patient's pulse stimulation.

[0085] By ensuring that the pulse stimulation is reliably delivered not only during the deliverable period of the local myocardial R wave (sensed by the electrode at this myocardial site) but also during the deliverable period of the long-distance field myocardial R wave (electrical activities generated by the entire ventricular myocardium), the risk of ventricular myocardial depolarization caused by unintended activation caused by the pulse stimulation is minimized and even eliminated.

[0086] In this embodiment, the sensing events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in a timely manner. False sensing events are automatically and accurately identified and excluded, and are also determined as interference signals such as T waves instead of R wave signals corresponding to the R waves in the preset electrocardiogram. In this case, the delivery of pulse stimulation to the corresponding myocardial position is prevented, so that pulse stimulation is not delivered under incorrect conditions, effectively avoiding the risk including VT or VF, and preventing unnecessary pain or even harm to the patient. Thereby, the safety of the patient is ensured, the reliability of pulse stimulation control is improved, and the safety, effectiveness and therapeutic effect of pulse stimulation on the patient are guaranteed.

[0087] Embodiment 2 The pulse stimulation control method according to this embodiment is a further improvement of Embodiment 1, and specifically is as follows.

[0088] As shown in FIG. 11, in one embodiment, step S102 includes S1021, regarding the first sensing time point as the first time point, and taking the time point from the corresponding first set duration before the first time point as the time reference starting point; and S1022, obtaining the sensing events in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference starting point.

[0089] As shown in FIG. 12, in one implementation form, following step S102, S104 includes determining that the sensing event is an R wave when the second sensing time point falls within the sensing time window. As shown in FIG. 13, in one embodiment, the pulse stimulation control method according to this embodiment further includes S105, after the sensing event is determined to be an R wave, determining the pulse delivery time point corresponding to the stimulation electrode at the set myocardial position based on the second sensing time point of the R wave in the local myocardial electrocardiogram.

[0090] In this embodiment, it should be noted that the method of obtaining the sensed event as the R wave may be directly obtained through transmission by an external device, or may be determined based on a determination such as whether it falls within the sensing time window.

[0091] Furthermore, it includes step S106: determining whether the pulse delivery time point satisfies a second preset condition, and if affirmative, determining to deliver a pulse stimulus to the stimulating electrode at the set myocardial position, and otherwise determining not to deliver a pulse stimulus to the stimulating electrode at the set myocardial position.

[0092] By determining the sensed event such that the local myocardial sensing time point is within the sensing time window corresponding to the R wave in the preset electrocardiogram, ensure that the sensed event surely belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram. Thereby, ensure the timely delivery of the pulse stimulus only when the event is determined to be the R wave, thereby ensuring the timeliness, safety, and effectiveness of the pulse stimulus to the patient's heart.

[0093] By ensuring that the pulse stimulus is delivered not only during the deliverable period of the local myocardial R wave (sensed by the electrode at this myocardial site) but also during the deliverable period of the remote field myocardial R wave (electrical activity generated by the entire ventricular myocardium), minimize and further eliminate the risk of depolarization of other parts of the ventricular myocardium caused by the activation of the pulse stimulus. This improves the safety of the pulse stimulus for the patient and minimizes unnecessary treatment risks and pain.

[0094] In other words, the pulse stimulation control of the present embodiment ensures that, regardless of where the stimulating electrode is placed in the myocardium, the pulse stimulation is delivered only during the deliverable periods of both the local myocardium and the entire ventricular myocardium under appropriate conditions. This makes the safety and effectiveness of the pulse stimulation more reliable, thereby enabling the pulse stimulation to be delivered under various heart rates (including ventricular beats originating from the ventricle itself such as ventricular fibrillation caused by atrial conduction, PVC, and ventricular pacing beats), and thus better meeting the patient's enhanced requirement for myocardial contractility.

[0095] In one embodiment, step S105 is a step of calculating a pulse delivery time point corresponding to the stimulating electrode at the set myocardial position based on the second sensing time point of the R wave in the local myocardial electrocardiogram and the preset duration, or a step of calculating the time difference between the first sensing time point (GS sensing time point) corresponding to the R wave in the preset electrocardiogram and the second sensing time point of the set myocardial position, and a step of using the first sensing time point as the reference zero point and calculating the pulse delivery time point corresponding to the set myocardial position based on the time difference and the preset duration.

[0096] The following is a detailed description of the process for calculating the pulse delivery time point of the R wave in the local myocardial electrocardiogram by the above two methods.

[0097] (1) The second sensing time point when the R wave appears in the local myocardial electrocardiogram is timely obtained, and the second sensing time point is used as the reference zero point (or called the trigger point), and based on this, the pulse delivery time point corresponding to the stimulating electrode at the corresponding myocardial position is obtained by adding the preset duration (LPD).

[0098] (2) Based on the second sensing time point and the first sensing time point when the R wave appears in the body surface electrocardiogram (ECG) and / or the far-field electrogram of the myocardium (FF-EGM), the time difference (GLSD) between the second sensing time point and the first sensing time point is calculated. Next, using the first sensing time point as the reference zero point, based on this, the time difference (GLSD) and the preset duration (LPD) are added, that is, GPD = GLSD + LPD, and the pulse delivery time point (GPD) corresponding to each set myocardial position having the first sensing time point as the trigger point (reference point) is calculated.

[0099] After obtaining the pulse delivery time point (GPD) for each set myocardial position, this time difference can be maintained without change to deliver a cardiac pulse stimulus to the corresponding control electrode based on the pulse delivery time point (GPD). Since the electrical stimulation output time point can be directly determined based on GPD after the R wave is sensed in the local electrogram of the myocardium, there is no need to recalculate before each electrical stimulation output. By directly determining the electrical stimulation output time point based on GPD, it is not necessary to use the first and second sensing time points each time to calculate the pulse excessive excitation delivery time point, thereby substantially shortening the data processing time, myocardium and improving the efficiency of controlling the cardiac pulse stimulus trigger while achieving the stimulation effect.

[0100] Furthermore, the pulse delivery time point (GPD) can be updated periodically or irregularly based on actual needs (the myocardial electrical stimulation can be continued or stopped). Next, based on the updated trigger time point, the myocardial electrical stimulation continues to achieve a more flexible electrical stimulation effect and meet the requirements of various pulse electrical stimulation scenarios.

[0101] Regarding pulse stimulation triggered by the R wave in local myocardial electrocardiogram (at the second sensing time point), the duration from the R wave to delivery (LPD) is fixed for each stimulation location (such as a preset duration of 40 ms). Regarding pulse stimulation triggered by the R wave in surface electrocardiogram (ECG) and / or far-field myocardial electrocardiogram (FF-EGM), the duration (GPD) for each stimulation location is variable and different (i.e., determined by a fixed preset duration of 40 ms and a time difference that varies with the location). In this case, the preset duration is typically default set to 40 ms, and this duration value can be finely adjusted or updated according to actual needs (i.e., programmable adjustment).

[0102] It should be noted that the GLSD and GPD corresponding to each set myocardial site can be measured and averaged over several spontaneous beats (by default, 5 consecutive spontaneous beats, in the range of 3 to 12 beats) during the setup period. Alternatively, the GLSD and GPD can be obtained based on the measured duration under each heartbeat. The GPD of each set myocardial site or location is used to trigger the timing of pulse stimulation at that site or location relative to the instant of R wave sensing in the preset electrocardiogram. The pulse delivery time point corresponds to the duration from R wave sensing to the delivery of the cardiac pulse stimulation. The transmission of pulse stimulation at various positions or sites is triggered by R wave sensing of the surface electrocardiogram (ECG) or far-field myocardial electrocardiogram (FF-EGM), and then the cardiac pulse stimulation is delivered to the corresponding control electrodes based on the pulse delivery time point. To ensure the effectiveness of the pulse stimulation, all R waves (i.e., R waves in the far-field myocardial electrocardiogram FF-EGM and surface electrocardiogram ECG) are sensed under the same heartbeat. Based on the above method for obtaining the pulse delivery time point, it is possible to effectively ensure the timely and reliable delivery of the pulse stimulation.

[0103] Furthermore, according to actual needs, GLSD and other parameters that adapt to different ventricular electrical activities can be preset, for example, for sinus rhythm (SR) ventricular electrical activities. Next, during actual operation, the corresponding parameters set during the set period are directly called during sinus rhythm, reducing the computational requirement per heartbeat while ensuring the timeliness and effectiveness of pulse stimulation control.

[0104] Also, GLSD and other parameters corresponding to the current actual ventricular electrical activity can be dynamically calculated based on real-time cardiac electrical activity sensing data and parameters during the operation period, without relying on parameters such as GLSD obtained during the set period. This further improves the timeliness and effectiveness of pulse stimulation control, thereby more reliably ensuring the safety and efficacy of pulse stimulation for patients.

[0105] As shown in FIG. 14, in one embodiment, step S106 includes S1061: obtaining a deliverable pulse time window corresponding to the R wave in the preset electrocardiogram, The start time point and window duration corresponding to the deliverable pulse time window and the sensing time window may be the same or different, that is, the deliverable pulse time window and the sensing time window can be set independently without a correlation or dependence relationship with each other. Specifically, the deliverable pulse time window and the sensing time window can be determined based on the preset electrocardiogram, and the specific setting is adaptively adjusted based on factors such as actual R wave sensing and myocardial conditions so that most requirements of the pulse stimulation scenario are covered or satisfied.

[0106] Step S106 further includes S1062. S1062 includes controlling the pulse stimulation to be delivered to the stimulating electrode at the set myocardial position at the pulse delivery time when the pulse delivery time falls within the deliverable pulse time window, and not delivering the pulse stimulation to the stimulating electrode at the set myocardial position when the pulse delivery time does not fall within the deliverable pulse time window.

[0107] This method ensures that CCM stimulation must be reliably performed within the deliverable period of local myocardial depolarization (R wave) and the deliverable period of in-vivo long-distance field myocardial depolarization (R wave). Here, the deliverable pulse time window corresponds to a safe period corresponding to the deliverable period of the entire ventricle. Both the start point and the end point of the deliverable pulse time window can be adjusted with the goal of making the start point approximately correspond to the depolarization interval and the end point be earlier than or equal to the end point of the deliverable period.

[0108] In one implementation, when there are multiple set myocardial positions, the pulse stimulation control method according to this embodiment further includes the following steps.

[0109] For the sensed event LS in the local myocardial electrocardiogram corresponding to each myocardial position, steps S102 to S106 are executed one step at a time so as to effectively deliver pulse stimulation to each myocardial position in a timely manner, thereby ensuring the safety, effectiveness, and reliability of the patient's treatment.

[0110] Here, the sensed time window is determined based on the first sensed time point of the R wave in the preset electrocardiogram and the second sensed time point corresponding to the first occurring sensed event.

[0111] For example, an example is shown by presetting pulse stimulation electrodes at three different myocardial positions (A, B, and C) of a patient. The set myocardial positions A, B, and C correspond to the stimulation electrode pairs E1, E2, and E3 respectively, and the second sensed time points of the corresponding sensed events are LS1, LS2, and LS3 respectively, and the occurrence times of LS1, LS2, and LS3 are sequential (that is, the sensed event LS1 occurs first, and then other sensed events occur at subsequent times). Here, each electrode pair consists of a combination of a monopolar electrode with a monopolar electrode and a bipolar electrode with a bipolar electrode lead wire. Furthermore, other types of electrodes can also be used. The specific types of electrode pairs and how to combine them can be determined or adjusted based on the requirements of the actual scenario.

[0112] Specifically, when obtaining the sensed event LS1 from the local myocardial electrocardiogram corresponding to the myocardial position based on the electrode pair E1 at the set myocardial position A, the second sensing time point corresponding to the sensed event LS1 is obtained, and it is determined whether the second sensing time point falls within the sensing time window corresponding to the R wave of the preset electrocardiogram. If the second sensing time point does not fall within the window, the sensed event LS1 is determined to be not the R wave signal corresponding to the R wave in the preset electrocardiogram but other interference signals such as the T wave. Therefore, the delivery of the pulse stimulus to the stimulating electrode pair E1 at the set myocardial position A is prevented. If the second sensing time point falls within the window, the sensed event LS1 is determined to be the local myocardial R wave signal corresponding to the R wave in the preset electrocardiogram. Next, the pulse delivery time point corresponding to the stimulating electrode corresponding to the set myocardial position A is accurately calculated in a timely manner at the second sensing time point corresponding to the sensed event LS1. Next, it is determined whether the pulse delivery time point falls within the deliverable pulse time window corresponding to the R wave in the preset electrocardiogram. If it falls within the window, the pulse stimulus is controlled to be delivered to the stimulating electrode at the set myocardial position A at the pulse delivery time point. Otherwise, it is determined that the pulse stimulus is not delivered to the stimulating electrode at the set myocardial position A. Therefore, one-time stimulation control for the set myocardial position A is completed.

[0113] Similarly, the pulse stimulus control processes for the set myocardial positions B and C are similar to the pulse stimulus control process for the set myocardial position A, and therefore will not be described in detail here.

[0114] It should be noted that the pulse stimulus control processes for different set myocardial positions are independent of each other and do not cause mutual interference or interaction. For example, during the pulse stimulus control process at the set myocardial position A, or after the completion of the pulse stimulus control at the set myocardial position A, as long as the sensed event LS2 appears in the local myocardial electrocardiogram corresponding to the set myocardial position B, the above pulse stimulus control process can be executed independently, and finally the pulse stimulus control for all set myocardial positions will be completed correctly and efficiently in sequence, thereby substantially guaranteeing the safety and reliability of the patient's pulse stimulus.

[0115] In one implementation form, when the sensing time points corresponding to the sensing events of a plurality of local myocardial electrocardiograms occur extremely close to each other (i.e., within a short period of time), the pulse stimulation control method according to this embodiment includes the following steps.

[0116] To identify the earliest occurring sensing event as the first sensing event LS1, a step of obtaining a second sensing time point corresponding to the sensing event LS in the local myocardial electrocardiogram corresponding to each local myocardial electrocardiogram, obtaining the second sensing time point 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. If the sensing event falls within the window, a step of determining the sensing event as the local myocardial R wave signal corresponding to the R wave in the preset electrocardiogram, For the sensing events in the local myocardial electrocardiograms corresponding to the remaining myocardial positions, a step of determining whether the second sensing time points corresponding to these sensing events fall within the above sensing time window. If affirmative, when the first sensing event is determined to be the R wave signal corresponding to the R wave in the preset electrocardiogram, a step of directly determining that the sensing events in the local myocardial electrocardiograms corresponding to the remaining myocardial positions are also the R wave signals corresponding to the R wave in the preset electrocardiogram. In this case, there is no need for individual determination and analysis of the sensing events in the local myocardial electrocardiograms corresponding to the remaining myocardial positions, which greatly simplifies the data analysis process, substantially reduces the data processing time, reduces the required computing power of the device, and realizes accurate determination while ensuring the timeliness, accuracy, and effectiveness of the patient's pulse stimulation control. It should be noted that the specific method used to determine whether the sensing events in a plurality of local myocardial electrocardiograms are R waves can be selected based on the requirements of the actual scenario. A single execution method may be selected, or a plurality of execution methods may be combined to meet the higher requirements of the cardiac electrical ventricular conduction scenario. This greatly improves the practicality of pulse stimulation control and significantly improves the safety and effectiveness of the patient's treatment. Furthermore, when there are a plurality of preset myocardial positions, the pulse stimulation control method according to this embodiment further includes (1) a step of presetting the preset sensing parameters corresponding to the R waves at different preset myocardial positions, The set sensing parameters include the set sensing time point and / or the set sensing occurrence order. The method includes (2) when the sensed event in the first-occurring local myocardial electrocardiogram is an R wave, setting all the sensed events in the other remaining local myocardial electrocardiograms as R waves, or (3) when the sensed event in the last-occurring local myocardial electrocardiogram is an R wave, setting all the sensed events in the other remaining local myocardial electrocardiograms as R waves.

[0117] Also, based on the requirements of the actual scenario, the above settings can be adjusted, or additional settings may be added.

[0118] The implementation principle for determining whether the sensed event in the local myocardial electrocardiogram is an R wave is specified below.

[0119] The determination of whether the sensed event LS is an R wave includes two stages: the set period / pre-set period and the operation period.

[0120] In the case of a pulse stimulation system having an electrode for a single myocardial point, this pulse stimulation system has a pre-set electrocardiogram (such as an ECG) and an electrode lead wire connected to the ventricle myocardium for sensing R waves, and the system is used to deliver pulse stimulation to the myocardium. The following parameters need to be measured during the set period.

[0121] Set period: (11) ECG sensing (GS sensing time) = the time point when ECG (R wave) sensing is performed (global sensing), Here, the ventricular electrical activity of the R wave in the pre-set electrocardiogram (ECG) represents the overall ventricular electrical activity, and R wave sensing reflects a relatively early time point of the ventricular electrical activity. (12) EGM sensing (LS sensing time point) = the time point when EGM (R wave) sensing is performed (local sensing), where LS is the first local electrocardiogram sensing event sensed after the time reference start point corresponding to GS (GS-X, X = 60 ms, X is is the first set duration, This is not limited to this, but it can be controlled by a program within the range of 30 ms to 200 ms).

[0122] (13) GLSD = LS - GS, where GLSD is the time delay between GS and LS. (14) LPD = the time delay between LS and the pulse stimulation, (15) GPD = GLSD + LPD, where GPD is the time delay between GS and the pulse stimulation.

[0123] (16) GVT is the sensing time window (programmable and adjustable) of the corresponding GS, and LSVT is the sensing time window of the corresponding LS, Specifically, the start point of GVT is GVT-s, and the duration of the time window is B, a1) GVT-s = GS - A, GLSD > 0 (i.e., LS occurs after GS), GVT-s = GS + GLSD - A, H ≤ GLSD ≤ 0 (i.e., LS occurs simultaneously with or before GS), H < 0. Preferably, -120 ms ≤ H ≤ 20 ms. Here, the default value of A is 20 ms, and A is programmable and adjustable (including 0 ms). In this case, GVT-s is obtained by the corresponding time parameters of GS and LS.

[0124] b1) In the case of sinus rhythm, B is in the range of 30 ms to 130 ms (programmable), but it is not limited to this range.

[0125] c1) In the case of ventricular ectopic excitation such as PVC or ventricular pacing beats, B is in the range of 30 ms to 250 ms (programmable), but it is not limited to this range.

[0126] the start time of LSVT is LSPT-s, LSVT-s = LS - A and ; the window duration is LSVT -B and LSVT -B = B - (LSVT-s - GVT-s).

[0127] LSVT is used only when there are electrodes at multiple local myocardial positions. Further, it should be noted that LS is LS1, that is, it corresponds to the sensing event that occurs earliest among all myocardial sites.

[0128] (17) As shown in FIG. 7, GPT is the pulse delivery time window of the corresponding GS, and LSPT is the pulse delivery event window (programmable and adjustable) of the corresponding LS.

[0129] Specifically, the start point of GPT is GPT-s, and GPT-s = GVT-s. The window duration specifically includes the range of 20 ms to 200 ms (programmable), but is not limited thereto, and the default is 130 ms.

[0130] The start point of LSPT is LSPT-s, and LSPT-s = LSVT-s. The window duration of LSPT is the value obtained by subtracting GLSD from the window duration of GPT.

[0131] It should be noted that the above description includes the scenario where GVT-s corresponds to the remote field sensing GS in the preset electrocardiogram, and LSVT-s corresponds to the local sensing LS in the local myocardial electrocardiogram (that is, A = 0 ms). The above parameters are the average of several cardiac cycles (for example, 6 cardiac cycles, programmable, and may be different numbers of cycles). Further, it should be noted that the setting period needs to be performed separately during atrial electrical activity, ventricular ectopic activity, ventricular pacing, etc.

[0132] As shown in FIG. 15, in the case of a single electrode lead stimulation system, LSPT is the pulse delivery time window of the corresponding LS. The window starts at LSVT-s, and the window duration is the time obtained by subtracting GLSD from the window duration of GPT (B). Both of them are the pulse delivery time points when LS is used as the trigger point (reference point) for pulse stimulation delivery.

[0133] LSPT is only used when there are electrodes at multiple local myocardial positions. It should also be noted that LS is LS1, that is, it corresponds to the sensing event that occurs earliest among all myocardial sites. In this case, the starting point of GPT can also be obtained from the corresponding time parameter of LS.

[0134] Furthermore, in this embodiment, time windows such as GVT, GPT, LSVT, and LSPT are all represented by two parameters, namely the corresponding window starting point and window duration.

[0135] Operation period: (18) LS as real-time local R wave sensing needs to meet the following conditions.

[0136] a2) There are two sensing events, the preset ECG (GS) and the local EGM (LS). Here, LS is the second sensing time point of the local electrocardiogram sensing event that is first sensed after the time reference starting point corresponding to GS (GS-X, X = 60ms, X can be programmatically controlled within the range of 30ms to 200ms, but not limited to this). b2) LS falls within GVT (i.e., the sensing time window).

[0137] (19) Criteria for determining whether the pulse stimulation time point is appropriate: a3) The pulse stimulation time point falls within GPT (the pulse delivery time window). Here, GVT and GPT are derived from the corresponding ventricular electrical activities obtained during the set period, such as sinus electrical activity, ventricular ectopic activity, or ventricular pacing.

[0138] In the case of a pulse stimulation system having multiple electrodes, this pulse stimulation system has a preset electrocardiogram and multiple lead wires connected to multiple myocardial sites of the ventricle for sensing R waves, and the system is used to deliver pulse stimulation to the local myocardium. It is required that the following parameters be measured during the set period.

[0139] Set period: (21) Similar to the above (11) to (19), measure and obtain all parameters corresponding to each stimulating electrode (since numerical values controlled by some programs constitute all parameters together with the measured values).

[0140] (22) Prepare a template corresponding to LSn (local R-wave sensing) in advance, including the time points of LSn (n = 1, 2, 3,...) based on LS1 and information such as the order of occurrence of each electrode sensing.

[0141] Operation period: (23) Obtain GS and LSn in real time during operation.

[0142] (24) Apply the rule of step (18) above to determine whether each LSn is a true R-wave.

[0143] Alternatively, if LS1 is confirmed to be a true R-wave in step (18), (when LSn occurs within the GVT window) LSn (n = 2, 3,...) is regarded as a true R-wave.

[0144] Alternatively, if LS1 is confirmed to be a true R-wave in step (18) and LSn (n = 2, 3,...) conforms to the preset template, LSn (n = 2, 3,...) is separately confirmed to be a true R-sensing.

[0145] Alternatively, when LS1 is used as a reference, the sensing time window becomes LSVT, and it is determined whether LSn (n = 2, 3,...) falls within the LSVT time window.

[0146] As shown in FIG. 16, in the case of a multi-electrode lead wire stimulation system, during the setting period, when LS1 is used as a reference, the pulse delivery time point is LSPT.

[0147] Operation period: After each LS senses and confirms the R wave, the corresponding pulse delivery time point needs to be within the GPT window. When LS1 is used as the trigger point (reference point) for the pulse delivery time point, the delivery time point of LSn (n>1) needs to be within the LSPT window. is required 。

[0148] In the case of single electrode and multi-electrode pulse stimulation systems, it should be noted that the relative pulse stimulation delivery time point for each myocardial position is, for example, 40 ms after the local myocardial sensing time point. GPT or LSPT is a new requirement for the pulse stimulation delivery time point, especially when there is pulse stimulation delivery for multiple stimulation sites. The delivery time point for each stimulation site needs to fall not only within the deliverable period of the local ventricular myocardium at the electrode location but also within the time window of GPT or LSPT, that is, within the deliverable period of the entire ventricle of the same beat (ventricular excitation).

[0149] GVT / LSVT is used as the "global ventricular" or "remote field ventricular" R wave sensing time window to determine whether the LS is the R wave sensing of the local ventricular depolarization corresponding to the GS (i.e., corresponding to the "global ventricular" or "remote field ventricular" R wave sensing of ventricular depolarization). GPT / LSPT is used as the pulse deliverable time window (which is the safe interval for stimulus delivery corresponding to the deliverable period of the entire ventricular myocardium ("global ventricular" or "remote field ventricular")) to determine whether the pulse stimulation delivery time point corresponding to the LS is safe. GPT and GVT are independent parameters that can be separately controlled by the program to meet the actual parameter setting requirements. Also, to reduce the complexity of programming control, the physician may select the same numerical value for both parameters (if appropriate). Alternatively, the system may directly assign the same numerical value to both parameters in advance, but the function of separately controlling the two parameters by the program needs to be maintained. These two steps may be used together or separately.

[0150] Furthermore, in addition to the aforementioned method of first setting a set period and then performing an operation period (i.e., the operation period depends on the value obtained during the set period for a specific execution), the parameter may be directly obtained and used during each electrical activity (each cardiac cycle) of the ventricular myocardium during the operation period without depending on the set period. This greatly improves the flexibility and efficiency of the pulse stimulation control process.

[0151] In this embodiment, the pulse stimulation is delivered only after the R wave, thereby enabling timely analysis and processing of the sensed events in the local myocardial electrocardiogram of the myocardium. False sensing events are automatically and accurately identified and excluded, and it is also determined that they are interference signals such as T waves rather than R wave signals corresponding to the R waves in the preset electrocardiogram. In this case, the delivery of the pulse stimulation to the corresponding myocardial position is prevented, thereby ensuring that the pulse stimulation is not delivered under incorrect conditions, substantially avoiding the risk of inducing VT or VF, and thereby preventing unnecessary pain or even harm to the patient. This ensures the safety of the patient, improves the reliability of the pulse stimulation control, and further ensures that the pulse stimulation is delivered in a timely manner when the sensed event is confirmed to be an R wave, that is, the pulse stimulation is delivered only under appropriate conditions.

[0152] Furthermore, the pulse stimulation is delivered only during the ventricular deliverable period. By ensuring that the pulse stimulation delivery time point falls within the pulse delivery window corresponding to the entire ventricular electrical activity (R wave) in the body surface electrocardiogram or the in-body remote field myocardial electrocardiogram, the timeliness, safety, and effectiveness of the pulse stimulation for the patient's heart are guaranteed. Here, using the body surface electrocardiogram or the remote field myocardial electrocardiogram to obtain the deliverable period information of the ventricular electrical activity for the safety of the pulse stimulation delivery time point also represents a significant improvement in the pulse stimulation technology, thereby further ensuring the safety, effectiveness, and therapeutic effect of the pulse stimulation for the patient.

[0153] Embodiment 3 As shown in FIG. 17, the pulse stimulation control device according to this embodiment is including a first sensing time point acquisition module 1 configured to acquire a first sensing time point of an R wave in a preset electrocardiogram, the preset electrocardiogram including but not limited to a body surface electrocardiogram (ECG) and an intracorporeal long-distance field myocardial electrocardiogram (long-distance field electrocardiogram), the first sensing time point also being called GS, The apparatus includes 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 point, and a second sensing time point acquisition module 3 configured to acquire a second sensing time point corresponding to the sensing event, wherein the second sensing time point corresponding to the sensing event in the local myocardial electrocardiogram is also called LS, the sensing event in the local myocardial electrocardiogram is a sensing event corresponding to the R wave in the preset electrocardiogram, The apparatus includes a first determination module 4 configured to determine that the sensing event is not an R wave signal corresponding to the R wave in the preset electrocardiogram and call a control module 5 when the second sensing time point does not meet a first preset condition, and a control module 5 configured not to deliver a pulse stimulus to a stimulating electrode at the set myocardial position, wherein the first preset condition is determined based on the first sensing time point of the R wave in the preset electrocardiogram and the second sensing time point corresponding to the sensing event.

[0154] In one implementation form, the first determination module 4 is further configured to acquire a sensing time window corresponding to the R wave in the preset electrocardiogram, and the first determination module 4 is further configured 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 point does not fall within the sensing time window.

[0155] Here, the method of acquiring the sensing time window includes obtaining the sensing time window based on a preset sensing circuit or directly receiving the sensing time window through an external device input.

[0156] The non-R wave signals corresponding to the sensed event LS in the local myocardial electrocardiogram include T wave signals or other interference signals. Specifically, by enabling the pulse stimulation to be CCM stimulation and to be performed under different ventricular electrical activities, the applicability of the pulse stimulation is expanded, and the overall effectiveness of the pulse stimulation control is significantly improved.

[0157] CCM stimulation is performed during ventricular electrical activities such as sinus rhythm, ventricular beats resulting from atrial conduction, ventricular beats originating from the ventricle (ventricular ectopic excitation), and ventricular pacing beats.

[0158] Confirmation that the local sensed event is an R wave ensures that CCM stimulation is more reliably triggered by the local R wave rather than other signals (such as T waves, myoelectricity, or other non-myocardial depolarization electrical activities), thereby substantially eliminating the occurrence of false triggers. The design of this important step can effectively improve the safety and effectiveness of the pulse stimulation.

[0159] It should be noted that the implementation principle of the pulse stimulation control device in this embodiment is similar to that of the pulse stimulation control method in Embodiment 1, so details are not described here.

[0160] In this embodiment, the sensed events in the local myocardial electrocardiogram of each heartbeat can be analyzed and processed in a timely manner. False sensed events are automatically and accurately identified and excluded, and are also determined as interference signals such as T waves rather than R wave signals corresponding to the R waves in the preset electrocardiogram. In this case, the delivery of pulse stimulation to the corresponding myocardial position is prevented, thereby preventing the delivery of pulse signals under inappropriate conditions, effectively avoiding risks including VT or VF, and preventing unnecessary pain or even harm to the patient. This ensures the safety of the patient, improves the reliability of the pulse stimulation control, and guarantees the safety, effectiveness, and therapeutic effect of the pulse stimulation on the patient.

[0161] Embodiment 4 As shown in FIG. 18, the pulse stimulation control system according to the present embodiment is a further improvement of Embodiment 3, and specifically, it is as follows.

[0162] In one implementation form, the sensing event determination module 2 according to the present embodiment includes a time reference start point acquisition unit 6 configured to use the first sensing time point as the first time point and the time point from the corresponding first set duration before the first time point as the time reference start point, and a sensing event determination unit 7 configured to acquire a sensing event in the local myocardial electrocardiogram corresponding to the set myocardial position based on the time reference start point.

[0163] In one implementation form, the first determination module 4 is further configured to determine the sensing event as an R wave when the second sensing time point falls within the sensing time window.

[0164] In one embodiment, the pulse stimulation control system according to the present embodiment further includes a pulse delivery time point determination module 8 configured to determine the pulse delivery time point corresponding to the stimulation electrode at the set myocardial position based on the second sensing time point of the R wave in the local myocardial electrocardiogram after the sensing event is determined as the R wave.

[0165] It should be noted that in the present embodiment, the method of acquiring the sensing event as the R wave may be directly obtained by transmission by an external device, or may be determined based on a determination such as whether it falls within the sensing time window. Specifically, the pulse delivery time point determination module 8 is configured to calculate the pulse delivery time point corresponding to the stimulation electrode at the set myocardial position based on the second sensing time point of the R wave in the local myocardial electrocardiogram and the preset duration.

[0166] Alternatively, the pulse delivery timing determination module 8 obtains a first sensing timing corresponding to the R wave in the preset electrocardiogram, calculates the time difference between the first sensing timing and the second sensing timing at the set myocardial position, and uses the first sensing timing as the reference zero point to calculate the pulse delivery timing corresponding to the set myocardial position based on the time difference and the preset duration.

[0167] The second determination module 9 is configured to determine whether the pulse delivery timing satisfies a second preset condition. In the affirmative case, the determination module is required to determine to deliver a pulse stimulus to the stimulating electrode at the set myocardial position, and in other cases, the determination module is required not to deliver a pulse stimulus to the stimulating electrode at the set myocardial position.

[0168] The determination of the sensing event where the local myocardial sensing timing falls within the sensing time window corresponding to the R wave in the preset electrocardiogram ensures that the sensing event belongs to the R wave signal of the local myocardium corresponding to the R wave in the preset electrocardiogram. This ensures the timely delivery of pulse stimuli only when the event is determined to be an R wave, thereby ensuring the timely control, safety, and effectiveness of the pulse stimuli for the patient's heart.

[0169] In one implementation form, the second determination module 9 according to this embodiment includes a pulse time window acquisition unit 10 configured to acquire a deliverable pulse time window corresponding to the R wave in the preset electrocardiogram. Here, the deliverable pulse time window is set to correspond to the sensing time window. The second determination module 9 includes a determination unit 11 configured to request the control module 5 to control the delivery of a pulse stimulus to the stimulating electrode at the set myocardial position at the pulse delivery timing when the pulse delivery timing falls within the deliverable pulse time window. The determination unit 11 is further configured to request the control module 5 not to deliver a pulse stimulus to the stimulating electrode at the set myocardial position when the pulse delivery timing does not fall within the deliverable pulse time window.

[0170] In one implementation form, when there are a plurality of set myocardial positions, the control module 5 in the present embodiment is configured to control the first determination module 4 to determine whether or not the corresponding second sensing time point falls within the second time window for each of the second sensing time points of the sensed events that sequentially occur in each of the local myocardial electrocardiograms. Here, the sensing time window is determined based on the first sensing time point of the R wave in the preset electrocardiogram and the second sensing time point corresponding to the first-occurring sensed event.

[0171] In one implementation form, when there are a plurality of set myocardial positions, the control module 5 in the present embodiment is configured to preset set sensing parameters corresponding to the R waves at different set myocardial positions. Here, the set sensing parameters include a set sensing time point and / or a set sensing occurrence order. Or When the sensed event in the first-occurring local myocardial electrocardiogram is an R wave, the control module 5 sets all the sensed events in the other remaining local myocardial electrocardiograms as R waves. Or When the sensed event in the last-occurring local myocardial electrocardiogram is an R wave, the control module 5 is configured to set all the sensed events in the other remaining local electrocardiograms as R waves.

[0172] It should be noted that the implementation principle of the pulse stimulation control device in the present embodiment is similar to the implementation principle of the pulse stimulation control in Embodiment 2, and thus the details are not described here.

[0173] In this embodiment, pulse stimulation is delivered only after the R wave, thereby enabling timely analysis and processing of sensed events in the local myocardial electrocardiogram of the myocardium. False sensed events are automatically and accurately identified and excluded, and are also determined as interference signals such as T waves rather than R wave signals corresponding to the R waves in the preset electrocardiogram. In this case, pulse stimulation is prevented from being delivered to the corresponding myocardial position, thereby ensuring that pulse stimulation is not delivered under inappropriate conditions, substantially avoiding the risk including VT or VF, and preventing unnecessary pain or even harm to the patient. Thereby, the safety of the patient is ensured, the reliability of pulse stimulation control is improved, and furthermore, it is ensured that pulse stimulation is delivered when the sensed event is confirmed as an R wave, that is, pulse stimulation is delivered only under appropriate conditions.

[0174] Furthermore, the pulse stimulation is delivered only during the ventricular deliverable period. By confirming that the pulse stimulation delivery time point falls within the pulse delivery time window corresponding to the entire ventricular electrical activity (R wave) in the body surface electrocardiogram or the in-body remote field myocardial electrocardiogram, the timeliness, safety, and effectiveness of the pulse stimulation to the patient's heart are ensured. Here, using the body surface electrocardiogram or the remote field myocardial electrocardiogram to obtain the deliverable period information of the ventricular electrical activity for the safety of the pulse stimulation transmission time point also corresponds to a distinct improvement in the pulse stimulation technology, thereby further ensuring the safety, effectiveness, and therapeutic effect of the pulse stimulation to the patient.

[0175] Embodiment 5 The medical system ECS in this embodiment includes the pulse stimulation control device in Embodiment 3 or Embodiment 4.

[0176] This includes, but is not limited to, global myocardial depolarization (R wave and corresponding GS) from surface electrocardiogram (ECG) or remote field electrogram (FF-EGM) from electrodes near the heart or electrodes placed subcutaneously in the body within tissue or organs but far from the heart, from body surface ECG electrodes (from those worn on the skin). This enables the ECS system to be used in various devices or instruments that provide cardiac treatment, such as AED, MCS (Mechanical Circulatory Support), subQ-ICD, and implantable CRM (Cardiac Rhythm Management) devices. Furthermore, although body surface ECG cannot always be used as an input to the device, this allows the ECS to function not only as an emergency support device (using body surface ECG as one of the input signals) but also as a chronic heart failure treatment device. In this way, the ECS system can provide treatment to more patients in more scenarios, thereby bringing benefits to more patients. The medical system in this embodiment enables pulse stimulation to be delivered during sinus rhythm, ventricular rhythm (beat) conducted from the atrium, or other ventricular ectopic rhythms (beat). This corresponds to a breakthrough or improvement beyond the current limitations where pulse stimulation cannot be delivered during beats under abnormal cardiac conduction systems, such as sinus beat, ventricular beat resulting from atrial conduction, ventricular beat originating from the ventricle (ventricular ectopic excitation), and ventricular pacing beat. This will result in more cardiac support opportunities, especially in situations where patients may be most in need of such support.

[0177] In this embodiment, the medical system incorporates the above-described pulse stimulation control device that can ensure that the pulse stimulation is delivered only under appropriate conditions and not under inappropriate conditions. Further, this medical system delivers the pulse stimulation within the deliverable period corresponding to the R wave in the body surface electrocardiogram or the intracorporeal remote field myocardial electrocardiogram, thereby ensuring the timeliness and effectiveness of the pulse stimulation to the patient's heart. This guarantees the safety, effectiveness, and therapeutic effect of the pulse stimulation on the patient, thereby substantially improving the overall product performance of the existing medical system.

[0178] Embodiment 6 FIG. 19 is a schematic structural diagram of an electronic device provided according to Embodiment 6 of the present disclosure. This 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, it implements the pulse stimulation control method according to Embodiment 1 or 2. The electronic device 30 shown in FIG. 19 is merely an example and shall not impose any limitation on the functions and usage scope of the embodiments of the present disclosure.

[0179] As shown in FIG. 19, the electronic device 30 can take the form of a general-purpose computing device such as a server device. The components of the electronic device 30 may include, but are not limited to, at least one processor 31, at least one memory 32, and a bus 33 that connects various system components (including the memory 32 and the processor 31). The bus 33 includes a data bus, an address bus, and a control bus. The memory 32 may include volatile memory such as random access memory (RAM) 321 and / or cache memory 322, and may further include read-only memory (ROM) 323. The memory 32 may further include a program / utilities 325 having a set of (at least one) program modules 324, such as, but not limited to, an operating system, one or more application programs, other program modules, and program data included in the program module 324. Each of these embodiments or any combination thereof may include an implementation form of a network environment. The processor 31 executes various functional applications and performs processes such as the pulse stimulation control method according to Embodiment 1 or 2 of the present disclosure by executing a computer program stored in the memory 32. The electronic device 30 can also communicate with one or more external devices 34 (such as a keyboard and a pointing device). Such communication can be implemented via an input / output (I / O) interface 35. Further, the model generation device 30 may communicate with one or more networks (a local area network (LAN), a wide area network (WAN), and / or a public network such as the Internet) via a network adapter 36.

[0180] As shown in FIG. 19, network adapter 36 communicates with other modules of model generation device 30 via bus 33. Although not shown in the figure, it should be understood that other hardware and / or software modules, including but not limited to microcode, device drivers, redundant processors, external disk drive arrays, RAID (disk array) systems, tape drives, data backup storage systems, etc., can be used together with model generation device 30.

[0181] Note that in the above detailed description, some units / modules or sub-units / modules of the electronic device are mentioned, but such division is merely exemplary and not essential. In fact, the mechanisms and functions of two or more of the above-mentioned units / modules may be realized by one unit / modules according to embodiments of the present disclosure. Conversely, the mechanisms and functions of one of the above-mentioned unit / modules may be further divided to be realized by a plurality of units / modules.

[0182] Embodiment 7 This embodiment provides a computer-readable storage medium storing a computer program. When the program is executed by a processor, the processor is caused to perform the steps of the pulse stimulation control method in Embodiment 1 or 2.

[0183] Here, the readable storage medium can be more specifically adopted and can include, but is not limited to, portable disks, hard disks, random access memories, read-only memories, erasable programmable read-only memories, optical storage devices, magnetic storage devices, or any suitable combination thereof.

[0184] In one possible implementation, the present disclosure can also be implemented in the form of a program product, which includes program code used to cause a terminal device to perform the steps of the pulse stimulation control method in Embodiment 1 or 2 when the program product is executed on the terminal device.

[0185] Here, the program code used to implement the present disclosure is written in any combination of one or more programming languages, and the program code may be executed entirely on the user device, or partially on the user device, or as a stand-alone software package, or partially on the user device and partially on a remote device, or entirely on a remote device.

[0186] It should be noted that the above detailed description describes an implantable heart failure treatment device and some steps or modules for heart failure treatment based on the device, but this division is merely illustrative and not essential. In fact, according to the embodiments of the present application, the mechanisms and functions of two or more of the above-mentioned modules can be realized by one module. Conversely, the mechanisms and functions of one of the above-mentioned modules can be realized by a plurality of modules.

[0187] Those skilled in the art can understand the embodiments of the present disclosure by considering this specification, the disclosure content, the accompanying drawings and the appended claims, and can make other changes to the embodiments of the present disclosure. In the claims, the term "comprising" does not exclude other elements and steps, and the terms "a / an" and "one" do not exclude a plurality. In the actual application of the present application, one part may perform the functions of a plurality of technical mechanisms referred to in the claims. Any reference numerals in the claims should not be construed as limiting the scope.

Claims

1. An implantable heart failure treatment device, comprising: a housing; an anchor member connected to the housing and configured to fix the housing to the patient's heart; a pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart, and configured to apply an electrical stimulation pulse for strengthening the contractility of cardiomyocytes of the patient's heart to the predetermined stimulation position; a pulse generation module housed in the housing, electrically coupled to the pair of stimulating electrodes, and configured to generate the electrical stimulation pulse; a control module housed in the housing, electrically coupled to the pair of stimulating electrodes and the pulse generation module, configured to receive a remote field sensing signal indicating a global excitation event of the patient's heart and a local sensing signal indicating a local excitation event at a local position of the patient's heart, determine whether the local excitation event at the local position of the patient's heart corresponds to a specific global excitation event based on at least the remote field sensing signal and the local sensing signal, and when it is determined that the local excitation event corresponds to the specific global excitation event, transmit the electrical stimulation pulse to the pair of stimulating electrodes during the absolute refractory period of the local excitation event; An implantable heart failure treatment device comprising the above.

2. The implantable heart failure treatment device according to claim 1, wherein the pair of stimulating electrodes are configured to sense a local sensing signal generated by the discharge of cardiomyocytes at the predetermined stimulation position, and the local sensing signal indicating the local excitation event at the local position of the patient's heart is sensed by the pair of stimulating electrodes and includes the local sensing signal generated by the discharge of the cardiomyocytes at the predetermined stimulation position.

3. The implantable heart failure treatment device according to claim 1, wherein the housing is configured to be suitable for being housed in a ventricle of the patient's heart, and the predetermined stimulation position includes the endocardium.

4. The implantable heart failure treatment device according to claim 1, wherein the housing is configured to be suitable for being housed in a vein on the outer surface of the patient's heart, and the predetermined stimulation position includes the epicardium.

5. The implantable heart failure treatment device according to claim 1, further comprising a remote field excitation sensing module configured such that the device senses a global excitation event of the heart of the patient and supplies a remote field sensing signal indicating the global excitation event to the control module.

6. The implantable heart failure treatment device according to claim 5, wherein the remote field excitation sensing module includes a pair of sensing electrodes, the pair of sensing electrodes are coupled to the housing, sense a remote field sensing signal indicating a global excitation event of the heart of the patient, and are configured to supply the remote field sensing signal to the control module.

7. The implantable heart failure treatment device according to claim 6, wherein the surface area of the sensing electrode is larger than the surface area of the stimulating electrode.

8. The implantable heart failure treatment device according to claim 6, wherein the pair of sensing electrodes and the pair of stimulating electrodes share one electrode, and the common electrode functions as a reference potential electrode.

9. By the control module, based on at least the remote field sensing signal and the local sensing signal, determining whether a local excitation event at a local position of the heart of the patient corresponds to a specific global excitation event, obtaining a specific event time window corresponding to the specific global excitation event, when a time point at which the local excitation event is sensed falls within the specific event time window, determining that the local excitation event corresponds to the specific global excitation event, The implantable heart failure treatment device according to claim 1, comprising.

10. Transmitting the electrical stimulation pulse to the pair of stimulating electrodes during an absolute refractory period of the local excitation event, determining a pulse delivery time point based on the local sensing signal and / or the remote field sensing signal, determining a pulse deliverable time window suitable for transmitting the electrical stimulation pulse based on the local sensing signal and / or the remote field sensing signal, when the pulse delivery time point falls within the pulse deliverable time window, transmitting the electrical stimulation pulse to the pair of stimulating electrodes, The implantable heart failure treatment device according to claim 1, comprising.

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

12. The control module determines an electrical signal source that causes the local excitation event, and determines whether the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event based on at least the electrical signal source, the local sensing signal, and the remote field sensing signal. The implantable heart failure treatment device according to claim 1.

13. Determining whether the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event based on at least the electrical signal source, the local sensing signal, and the remote field sensing signal, includes determining the length of a specific event time window according to the electrical signal source, The implantable heart failure treatment device according to claim 12.

14. Transmitting the electrical stimulation pulse to the pair of stimulation electrodes during the absolute refractory period of the local excitation event, determining a pulse delivery time point based on the electrical signal source and further in combination with the local sensing signal and / or the remote field sensing signal, determining a pulse deliverable time window suitable for transmitting the electrical stimulation pulse based on the electrical signal source and further in combination with the local sensing signal and / or the remote field sensing signal, when the pulse delivery time point falls within the pulse deliverable time window, transmitting the electrical stimulation pulse to the pair of stimulation electrodes, The implantable heart failure treatment device according to claim 12, comprising:

15. The electrical signal source that causes the local excitation event includes an auto-generated pulse from an atrial position, an auto-generated pulse from a ventricular position, or an external electrical stimulation applied to the heart. The implantable heart failure treatment device according to claim 12.

16. At least one of the pair of stimulation electrodes is disposed on the anchor member, and the pair of sensing electrodes are disposed within the housing and exposed from the surface of the housing. The implantable heart failure treatment device according to claim 6.

17. The remote field excitation sensing module is disposed outside the housing and communicably coupled to the control module. The implantable heart failure treatment device according to claim 6.

18. The implantable heart failure treatment device according to claim 1, wherein the remote field sensing signal received by the control module and indicating the global excitation event of the patient's heart is from another implantable device communicably connected to the control module or from a non-implantable device communicably connected to the control module.

19. The device further includes another pair or pairs of stimulating electrodes, the another pair or pairs of stimulating electrodes are coupled to the housing and configured to contact one or more other predetermined stimulation positions of the patient's heart, each of the another pair or pairs of stimulating electrodes senses a local sensing signal generated by the discharge of cardiomyocytes at another predetermined stimulation position, and applies an electrical stimulation pulse to the another predetermined stimulation position. The implantable heart failure treatment device according to claim 1.

20. The pair of stimulating electrodes are further configured to selectively apply an electrical pacing pulse for adjusting the heart rate of the patient's heart to the predetermined stimulation position, and the control module is further configured to determine whether the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event based at least on the remote field sensing signal and the electrical pacing pulse. The implantable heart failure treatment device according to claim 1.

21. The control module receives a mode selection signal and controls the implantable heart failure treatment device to be in a pacemaker mode or a non-pacemaker mode according to the mode selection signal. In the non-pacemaker mode, the control module determines whether the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event based at least on the remote field sensing signal and the local sensing signal. In the pacemaker mode, the control module determines whether the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event based at least on the remote field sensing signal and the electrical pacing pulse. The implantable heart failure treatment device according to claim 20.

22. In the pacemaker mode, the control module is configured to determine capture of the patient's heart, and after the capture is established, to determine the starting point of the local excitation event of the cardiomyocytes at the predetermined stimulation position based on the application timing of the electrical pacing pulse. The implantable heart failure treatment device according to claim 21.

23. The implantable heart failure treatment device according to claim 22, wherein the control module is configured to determine capture of the patient's heart based on the remote field sensing signal.

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

25. An implantable heart failure treatment device, A housing, An anchor member connected to the housing and configured to fix the housing to the patient's heart; A pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart, and to apply an electrical stimulation pulse for strengthening the contractility of the cardiomyocytes of the patient's heart at the predetermined stimulation position and an electrical pacing pulse for adjusting the heart rate of the patient's heart; A pulse generation module housed within the housing, electrically coupled to the pair of stimulating electrodes, and configured to generate the electrical stimulation pulse and the electrical pacing pulse; Contained within the housing, electrically coupled to the pair of stimulating electrodes and the pulse generation module, receiving a remote field sensing signal indicative of a global excitation event of the patient's heart, and based at least on the remote field sensing signal and the applied electrical pacing pulse, determining whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event, and when it is determined that the local excitation event corresponds to the specific global excitation event, a control module configured to transmit the electrical stimulation pulse to the pair of stimulating electrodes during the absolute refractory period of the local excitation event. An implantable heart failure treatment device comprising the above.

26. Determining, based at least on the remote field sensing signal and the applied electrical pacing pulse, whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event, Obtaining a specific event time window corresponding to the specific global excitation event, When the application time of the electrical pacing pulse falls within the specific event time window, determining that the local excitation event corresponds to the specific global excitation event. The implantable heart failure treatment device according to claim 25, comprising the above.

27. Determining, based at least on the remote field sensing signal and the applied electrical pacing pulse, whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event, After applying the electrical pacing pulse for adjusting the heart rate of the patient's heart to the predetermined stimulation position of the patient's heart by the pair of stimulating electrodes, sensing capture of the patient's heart, After sensing capture of the patient's heart, determining that the local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to the specific global excitation event. The implantable heart failure treatment device according to claim 25, comprising the above.

28. An implantable heart failure treatment device, A housing, An anchor member connected to the housing and configured to fix the housing to the patient's heart. A pair of stimulating electrodes coupled to the housing and configured to contact a predetermined stimulation position of the patient's heart, sense a local sensing signal generated by the discharge of cardiomyocytes at the predetermined stimulation position, and apply an electrical stimulation pulse for enhancing the contractility of the cardiomyocytes of the patient's heart to the predetermined stimulation position; A pulse generation module housed within the housing, electrically coupled to the pair of stimulating electrodes, and configured to generate the electrical stimulation pulse; A control module housed within the housing, electrically coupled to the pair of stimulating electrodes and the pulse generation module, receiving a remote field sensing signal indicating a global excitation event of the patient's heart, determining a pulse delivery time point and a pulse deliverable time window based at least on the remote field sensing signal and the local sensing signal, and transmitting the electrical stimulation pulse to the pair of stimulating electrodes when the pulse delivery time point falls within the pulse deliverable time window; An implantable heart failure treatment device comprising the above.

29. A non-volatile computer-readable storage medium storing a computer program, the computer program being executed by a processor to control an implantable device to perform a heart failure treatment method, the implantable device including a pair of stimulating electrodes configured to contact a predetermined stimulation position of a patient's heart, the method comprising: Sensing, by the pair of stimulating electrodes, a local sensing signal generated by the discharge of cardiomyocytes at the predetermined stimulation position; Receiving a remote field sensing signal indicating a global excitation event of the patient's heart; Determining, based at least on the remote field sensing signal and the local sensing signal, whether a local excitation event of the cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event; When it is determined that the local excitation event corresponds to the specific global excitation event, Applying an electrical stimulation pulse to the predetermined stimulation position using the pair of stimulating electrodes during the absolute refractory period of the local excitation event; A non-volatile computer-readable storage medium comprising the above.

30. A non-volatile computer-readable storage medium storing a computer program, wherein the computer program is executed by a processor to control an implantable device to perform a heart failure treatment method, the implantable device including a pair of stimulation electrodes configured to contact a predetermined stimulation position of a patient's heart, the method comprising: applying, by the pair of stimulation electrodes, an electrical pacing pulse for adjusting a heart rate of the patient's heart to the predetermined stimulation position of the patient's heart; determining capture of the patient's heart; after the capture is determined, determining whether a local excitation event of cardiomyocytes at the predetermined stimulation position corresponds to a specific global excitation event based on a obtained remote field sensing signal indicating a global excitation event of the patient's heart and the electrical pacing pulse; when it is determined that the local excitation event corresponds to the specific global excitation event, applying an electrical stimulation pulse to the predetermined stimulation position using the pair of stimulation electrodes during an absolute refractory period of the local excitation event; A non-volatile computer-readable storage medium comprising the above.

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