Cardiac Treatment Equipment

Abstract

The present application relates to a cardiac therapy device including a subcutaneous defibrillation unit including a first control component configured to detect global cardiac excitation events, generate far-field detected signals indicative of the global excitation events, and deliver defibrillation waves to a patient when the patient experiences a malignant arrhythmia, and a leadless cardiac stimulation unit including a second control component configured to detect local myocardial excitation events at predetermined stimulation sites, generate local detected signals indicative of the local excitation events, and apply stimulating electrical pulses to the predetermined stimulation sites to enhance myocardial contractility, wherein the first control component is wirelessly coupled to the second control component, and the first control component and / or the second control component is configured to determine whether to apply stimulating electrical pulses to the predetermined stimulation sites based on at least the far-field detected signals and the local detected signals.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application relates to the field of cardiac therapy, and more particularly to implantable multifunction cardiac therapy devices. [Background technology]

[0002] Cardiac contractile modulation (CCM) is a unique and innovative treatment method for chronic heart failure patients that achieves therapeutic goals by applying electrical impulses to the myocardium to enhance myocardial contractility. Unlike conventional pacemakers and cardiac resynchronization therapy devices, CCM devices deliver electrical impulses within the absolute refractory period and do not affect heart rate or action potential distribution. Conventional CCM devices typically include a host device implanted in a location other than the heart and two bipolar leads implanted in the ventricular septum. These devices sense the electrical activity and temporal sequence of local ventricular myocardium, determine available windows for delivering electrical pulse stimuli to the myocardium, and deliver the electrical pulse stimuli to local myocardial cells during these windows to enhance myocardial contractility.

[0003] However, the two bipolar leads implanted in conventional CCM devices not only have a significant impact on normal blood circulation in blood vessels and the right heart, as well as on tricuspid valve closure, but also pose a greater safety risk due to the possibility of them becoming dislodged and becoming infected (including the pouch, electrode lead, etc.). Furthermore, conventional CCM devices determine the time when an electrical pulse stimulus can be delivered based on the electrical signal of a local myocardial region, which can lead to an incorrect determination of the delivery time. For example, if a CCM device determines that the electrical signal of a local myocardial region corresponds to the R wave of a cardiac cycle, but in fact this signal corresponds to the T wave or other events (e.g., an interference signal), the electrical pulse stimulus applied by the CCM device will act on the myocardium during the T wave phase, significantly increasing the risk of inducing malignant ventricular tachycardia (VT) or ventricular fibrillation (VF).

[0004] Furthermore, for the same energy, the greater the distance between stimulation electrodes or the larger the effective area of ​​the stimulation electrodes, the greater the degree and / or range of the potential effect on the far-field myocardium. If localized pulse stimulation occurs in a region where myocardial cells depolarize relatively slowly, the time at which the electrical pulse stimulation is applied may fall within the hyperphase of the action potential of myocardial cells in a region where myocardial cells depolarize quickly, potentially causing re-depolarization of the myocardium in that region. To avoid the above problems, conventional CCM devices require the stimulation electrode to be placed in the ventricular septum, making them inapplicable to other myocardial regions that may require enhanced contractile force. To avoid the above risks, the control policy of conventional CCM devices uniformly prevents the application of electrical pulse stimulation when myocardial potential changes due to causes other than atrial causes (ventricular ectopic activation) occur. However, the incidence of ventricular premature contractions is high in patients with heart failure, and some heart failure patients, especially those taking beta-receptor blockers for a long time, those with ICDs, and those receiving cardiac resynchronization therapy (CRT), rely on ventricular pacing for a long time. Therefore, the therapeutic effect of conventional CCM devices for these patients is somewhat reduced. Furthermore, because CCM devices currently do not provide ICD therapy, for example, due to economic reasons, many patients are forced to choose one of these two treatment methods, resulting in inadequate optimal treatment. Furthermore, implanting these two devices simultaneously increases the economic burden and risk of complications.

[0005] Currently, some patients with cardiac disease use subcutaneous implantable cardioverter-defibrillators (S-ICDs), which provide safe and effective protection against sudden cardiac arrest. However, these devices only function if the patient experiences life-threatening malignant ventricular tachycardia (VT) or ventricular fibrillation (VF). In most cases, S-ICDs provide no therapeutic value to patients.

[0006] Therefore, there is a need to provide a novel cardiac treatment device and method to overcome at least one problem existing in the prior art. Summary of the Invention

[0007] One of the objects of the present application is to provide a cardiac therapy device and a cardiac therapy method based on the cardiac therapy device.

[0008] In a first aspect of the present application, there is provided a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes, the first control component configured to detect global activation events in the patient's heart with at least some of the subcutaneous electrodes, generate far-field detection signals indicative of the global activation events, and emit defibrillation waves into the patient with at least some of the subcutaneous electrodes when the patient experiences a malignant arrhythmia; and a leadless cardiac stimulation unit configured for contact with predetermined stimulation sites in the patient's heart, the leadless cardiac stimulation unit including a second control component and a plurality of stimulation unit electrodes, the second control component configured to control the plurality of stimulation unit electrodes. and a leadless cardiac stimulation unit configured to sense local myocardial excitation events at the predetermined stimulation site with at least some of the plurality of stimulation unit electrodes and generate local sensed signals indicative of the local excitation events, and to apply stimulating electrical pulses to the predetermined stimulation site with at least some of the stimulation unit electrodes to enhance contractility of cardiomyocytes in the patient's heart, wherein the first control component is wirelessly coupled to the second control component, and the first control component and / or the second control component is configured to determine whether to apply the stimulating electrical pulses to the predetermined stimulation site based on at least the far-field sensed signals and the local sensed signals.

[0009] In a second aspect of the present application, there is provided a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes, the first control component configured to detect global activation events in the patient's heart with at least some of the subcutaneous electrodes and generate far-field detection signals indicative of the global activation events, and to emit defibrillation waves into the patient with at least some of the subcutaneous electrodes when the patient experiences a malignant arrhythmia; and a leadless cardiac stimulation unit configured for contact with a predetermined stimulation site in the patient's heart, the leadless cardiac stimulation unit including a second control component and a plurality of stimulation unit electrodes, the second control component configured to detect global activation events in the patient's heart with at least some of the stimulation unit electrodes and generate far-field detection signals indicative of the global activation events, and to emit defibrillation waves into the patient with at least some of the subcutaneous electrodes when the patient experiences a malignant arrhythmia. and a leadless cardiac stimulation unit configured to apply stimulating electrical pulses to the predetermined stimulation sites to enhance cardiomyocyte contractility of the patient's heart, and the second control component configured to apply pacing electrical pulses to the predetermined stimulation sites with at least some of the plurality of stimulation unit electrodes to regulate the patient's heart rate and generate pacing electrical pulse signals indicative of the applied pacing electrical pulses, wherein the first control component is wirelessly coupled to the second control component, and the first control component is configured to determine whether to apply the stimulating electrical pulses to the predetermined stimulation sites based on at least the far-field sensing signal and the pacing electrical pulse signals.

[0010] In a third aspect of the present application, there is provided a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes, the first control component configured to detect global activation events in the patient's heart with at least some of the subcutaneous electrodes and generate far-field detection signals indicative of the global activation events, and to emit defibrillation waves into the patient with at least some of the subcutaneous electrodes when the patient experiences a malignant arrhythmia; and a leadless cardiac stimulation unit configured for contact with a predetermined stimulation site in the patient's heart, the leadless cardiac stimulation unit including a second control component and a plurality of stimulation unit electrodes, the second control component configured to stimulate myocardial stimulation at the predetermined stimulation site with at least some of the stimulation unit electrodes. and a leadless cardiac stimulation unit configured to detect local excitation events at the predetermined stimulation sites and generate local detection signals indicative of the local excitation events and apply stimulating electrical pulses to the predetermined stimulation sites with at least some of the plurality of stimulation unit electrodes to enhance contractility of cardiomyocytes in the patient's heart, wherein the first control component is wirelessly coupled to the second control component, the first control component configured to determine whether a specific excitation event has occurred in the heart based on at least the far-field detection signals, and the first control component and / or the second control component configured to determine whether to apply the stimulating electrical pulses to the predetermined stimulation sites based on at least determining whether the specific excitation event has occurred.

[0011] In a fourth aspect of the present application, a control module wirelessly coupled to a housing configured for subcutaneous implantation in a patient, a plurality of electrodes coupled to the housing, the plurality of electrodes configured for subcutaneous implantation in a patient, and a leadless heart failure therapy device in contact with a predetermined stimulation site on the patient's heart, the control module receiving local detection signals indicative of local excitation events generated by the leadless heart failure therapy device based on detection of local excitation events in myocardium at the predetermined stimulation site, the control module detecting global excitation events in the patient's heart with at least some of the plurality of electrodes and generating far-field detection signals indicative of the global excitation events, and determining based on at least the far-field detection signals and the local detection signals that the local excitation events of cardiomyocytes at the predetermined stimulation site correspond to the specific global excitation events. a control module configured to determine whether a stimulating electrical pulse to be applied by the leadless heart failure therapy device falls within an absolute refractory period of the local activation event and / or a specific global activation event based on at least the far-field sensed signal and / or the local sensed signal and to determine whether to apply the stimulating electrical pulse to the predetermined stimulation site by the leadless heart failure therapy device; and a pulse generation module contained within the housing and electrically coupled to at least some of the multiple electrodes, the pulse generation module configured under control of the control module to deliver defibrillation waves to the patient via at least some of the multiple electrodes to treat malignant arrhythmia.

[0012] In a fifth aspect of the present application, there is further provided a method for controlling a cardiac therapy device including a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient and including a first control component and a plurality of subcutaneous electrodes; and a leadless cardiac stimulation unit configured for contact with a predetermined stimulation site on a patient's heart and including a plurality of stimulation unit electrodes and a second control component wirelessly coupled to the first control component, the method comprising: detecting, by the first control component, a global excitation event in the patient's heart with at least some of the subcutaneous electrodes and generating a far-field detection signal indicative of the global excitation event; detecting, by the second control component, a local excitation event in the myocardium at the predetermined stimulation site with at least some of the stimulation unit electrodes and generating a local detection signal indicative of the local excitation event; and determining, by the first control component and / or the second control component, whether to apply the stimulating electrical pulse to the predetermined stimulation site based on at least the far-field detection signal and the local detection signal.

[0013] In a sixth aspect of the present application, there is further provided a non-volatile computer-readable storage medium having a computer program stored thereon, the computer program, when executed by a processor, causing the steps of the method according to the fifth aspect of the present application to be realized.

[0014] It is understood that the stimulating electrical pulses of the present invention are used to enhance the contractile force of cardiac myocytes and are emitted within the absolute refractory period, whereas the pacing electrical pulses are used for cardiac pacing and are emitted outside the absolute refractory period.

[0015] Although the present application has been outlined above, those skilled in the art should understand that this is a simplified outline and may omit details, and that this is merely for illustrative purposes and is not intended to limit the scope of the present application in any way. This outline is not intended to identify key features or necessary features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. [Brief explanation of the drawings]

[0016] The above and other features of the present application will be more fully and clearly understood by referring to the following specification and the appended claims in conjunction with the drawings, which are understood to be merely illustrative of some embodiments of the present application and should not be considered to limit the scope of the present application, and which will be more clearly and in detail explained with the aid of the drawings. [Figure 1] 1 shows a schematic diagram of a cardiac treatment device according to one embodiment of the present application after implantation in a patient's body. [Figure 2A] 2A to 2C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 2B] 2A to 2C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 2C] 2A to 2C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 3A] 3A-3C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 3B] 3A-3C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 3C] 3A-3C show schematic diagrams of implantable heart failure treatment devices according to three different embodiments of the present application. [Figure 4A]4A and 4B are schematic diagrams of implantable heart failure therapy devices according to two different embodiments of the present application. [Figure 4B] 4A and 4B are schematic diagrams of implantable heart failure therapy devices according to two different embodiments of the present application. [Figure 5] 6 shows a flowchart of a method 600 for controlling a cardiac therapy device according to one embodiment of the present application. [Figure 6] Specific substeps included in step 603 of the control method 600 shown in FIG. 5 according to one embodiment are shown. [Figure 7] Specific substeps included in step 603 of the control method 600 shown in FIG. 5 according to another embodiment are shown. [Figure 8] 7 illustrates a control method 700 under pacing mode of a cardiac therapy device according to one embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0017] In the following detailed description, reference is made to the drawings, which form a part hereof. In the drawings, like numerals generally refer to like elements unless otherwise dictated by context. The illustrative embodiments set forth in the detailed description, drawings, and claims are not intended to be limiting. Other embodiments may be employed, and other changes may be made, without departing from the spirit or scope of the subject matter of this application. It is understood that various different configurations, substitutions, combinations, and designs may be made of the aspects of this application generally described herein and illustrated in the drawings, all of which expressly constitute a part of this application.

[0018] FIGURE 1 illustrates a schematic diagram of a cardiac therapy device according to one embodiment of the present disclosure after implantation in a patient. As shown in FIGURE 1, the cardiac therapy device 10 includes a subcutaneous defibrillation unit 200 and a leadless cardiac stimulation unit 100. The leadless cardiac stimulation unit 100 is configured for contact with a predetermined stimulation site on a patient's heart, and the subcutaneous defibrillation unit 200 is configured for subcutaneous implantation in a patient. The locations of the leadless cardiac stimulation unit 100 and subcutaneous defibrillation unit 200 in FIGURE 1 are shown schematically to more clearly illustrate the product architecture. The leadless cardiac stimulation unit 100 can be positioned anywhere in contact with the patient's heart, and the subcutaneous defibrillation unit 200 can be positioned subcutaneously in a location suitable for sensing the patient's cardiac electrical signals and delivering defibrillation waves to the patient when the patient experiences a malignant arrhythmia; specific locations of the two units are described in more detail below.

[0019] As shown in FIGURE 1 , the subcutaneous defibrillation unit 200 includes a first control component 206 configured to control the subcutaneous defibrillation unit 200 to detect global activation events in a patient's heart, generate far-field detection signals indicative of the global activation events, and deliver defibrillation waves to a patient when the patient experiences a malignant arrhythmia. The leadless cardiac stimulation unit 100 includes a second control component 106 wirelessly coupled to the first control component 206 configured to control the leadless cardiac stimulation unit 100 to detect local activation events in myocardium at predetermined stimulation sites, generate local detection signals indicative of the local activation events, and apply stimulating electrical pulses to the predetermined stimulation sites to enhance contractility of cardiomyocytes in the patient's heart. Note that the terms "far-field detection signal" and "local detection signal" herein may refer to any signal of related information indicative of a global or local activation event generated based on detection of the global or local activation event. In some embodiments, the "far-field detected signals" and "local detected signals" include the times at which global and local excitation events are detected, respectively.

[0020] The first control component 206 and / or the second control component 106 is configured to determine, based on at least the far-field sensed signals and the local sensed signals, whether and when to apply a stimulating electrical pulse to a given stimulation site by the leadless cardiac stimulation unit 100 to enhance the contractility of cardiomyocytes in the patient's heart. In some examples, the first control component 206 and / or the second control component 106 is configured to determine whether to apply a stimulating electrical pulse to a given stimulation site based on a result of at least one of two determining steps: i) determining, based on at least the far-field sensed signals and the local sensed signals, whether a local excitation event of the myocardium at the given stimulation site corresponds to a specific global excitation event; and ii) determining, based on at least the far-field sensed signals and / or the local sensed signals, whether a stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event.

[0021] Specifically, the first control component 206 and / or the second control component 106 may be configured to determine that a stimulating electrical pulse is applied to a predetermined stimulation site if a local excitation event (e.g., an R wave, including both a single R wave and a complex R wave having a waveform morphology similar to a QRS complex) is determined to correspond to a particular global excitation event (e.g., an R wave or a QRS complex, etc.). In some embodiments, the first control component 206 and / or the second control component 106 is configured to determine that a stimulating electrical pulse is applied to a predetermined stimulation site if a stimulating electrical pulse that needs to be applied is determined to fall within the absolute refractory period of the local excitation event and / or the particular global excitation event, regardless of whether the local excitation event corresponds to the global excitation event. Also, in some embodiments, the first control component 206 and / or the second control component 106 are configured to determine to apply a stimulating electrical pulse to a given stimulation site when it is determined that a local excitation event corresponds to a specific global excitation event and that the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event. For example, the first control component 206 may be configured to receive a local detection signal indicative of a local excitation event detected by the leadless cardiac stimulation unit 100 from the second control component 106. The first control component 206 can then determine, based on at least the far-field detection signal detected by the subcutaneous defibrillation unit 200 and the local detection signal detected by the leadless cardiac stimulation unit 100, whether the local excitation event at the given stimulation site corresponds to a specific global excitation event, e.g., whether electrical signals generated by action potentials of cardiomyocytes at and near the given stimulation site correspond to specific far-field electrocardiogram changes.If the local excitation event is determined to correspond to a specific global excitation event, the first control component 206 and / or the second control component 106 further determines, based on the far-field sensed signal and / or the local sensed signal, whether the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, and if the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, determines to apply, via the leadless cardiac stimulation unit 100, a stimulating electrical pulse to the predetermined stimulation site to enhance contractility of cardiomyocytes of the patient's heart.

[0022] In some other examples, the first control component 206 and / or the second control component 106 may be configured to determine, based at least on the far-field detection signal, whether a specific excitation event (e.g., an R wave or a QRS complex) has occurred in the heart, and, based on at least the determination of whether the specific excitation event has occurred, determine whether to apply a stimulating electrical pulse to a predetermined stimulation site. Specifically, when determining that a specific excitation event has occurred based on the far-field detection signal, the first control component 206 and / or the second control component 106 may be configured to further determine, based on the far-field detection signal and / or the local detection signal, whether a stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, and, if the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, to apply a stimulating electrical pulse to the predetermined stimulation site by the leadless cardiac stimulation unit 100 to enhance contractility of cardiomyocytes of the patient's heart. Specifically, in some embodiments, the first control component 206 determines whether a specific excitation event (e.g., an R wave or a QRS complex) has occurred based on the far-field detection signals indicative of a global excitation event detected by the first control component 206, and if the specific excitation event has occurred, sends the determination or a command to deliver a stimulating electrical pulse to the second control component 106. Upon receiving the information or command, the second control component 106 determines whether a stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event based on the far-field detection signals and / or the local detection signals, and if the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, controls the leadless cardiac stimulation unit 100 to apply a stimulating electrical pulse to a predetermined stimulation site to enhance the contractility of cardiomyocytes in the patient's heart, or does not perform the action of applying a stimulating electrical pulse otherwise. Of course, in some embodiments, upon receiving such information or command, the second control component 106 can directly control the leadless cardiac stimulation unit 100 to apply stimulating electrical pulses to predetermined stimulation sites in the patient's heart to enhance the contractility of cardiomyocytes without performing the further decision steps described above.

[0023] Specifically, in some other embodiments, the first control component 206 and / or the second control component 106 are configured to determine to apply the stimulating electrical pulse to the predetermined stimulation site if the determination result of at least one of the following two determination steps is "yes": i) determining whether a local excitation event of the myocardium at a predetermined stimulation site corresponds to a specific global excitation event based on at least the far-field detection signal and the local detection signal; and ii) determining whether the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event based on at least the far-field detection signal and / or the local detection signal.

[0024] Specific implementation forms of the above multiple determination steps will be described in detail below. Note that in this specification, "the first control component and / or the second control component are configured to...," "the first control component 206 and / or the second control component 106 are configured to...," and other similar expressions are intended to mean that the specific steps, functions, and methods described thereafter may be completed by either one of the two control components alone, or that the two control components may each perform specific substeps or subfunctions to ultimately achieve the described steps, functions, and methods. Some parameters or signals required for one control component to perform a step or substep may be obtained through communication with another control component.

[0025] Specifically, in some embodiments, if a local excitation event is determined to correspond to a specific global excitation event, the first control component 206 further determines, based on the far-field sensed signal and / or the local sensed signal, whether a stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, and commands the second control component 106 to deliver a stimulating electrical pulse if the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event. Upon receiving the command, the second control component 106 controls the leadless cardiac stimulation unit 100 to apply the stimulating electrical pulse to a predetermined stimulation site to enhance the contractility of cardiomyocytes in the patient's heart. In some other examples, if a local excitation event is determined to correspond to a specific global excitation event, the first control component 206 can transmit intermediate processed data generated in the computational process of determining whether the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event to the second control component 106, which can then perform the remaining computational steps after receiving the intermediate processed data. If a final determination is made that the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, the second control component 106 controls the leadless cardiac stimulation unit 100 to apply the stimulating electrical pulse.

[0026] Also, in some examples, if the first control component 206 determines that the local excitation event corresponds to a specific global excitation event, it may transmit only this determination to the second control component 106, which may perform a step of determining whether the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, controlling the leadless cardiac stimulation unit 100 to apply the stimulating electrical pulse if it determines that the stimulating electrical pulse to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, and not performing the action of applying the stimulating electrical pulse if it determines that the stimulating electrical pulse to be applied does not fall within or does not fall completely within the refractory period of the local excitation event. Specific methods for determining whether the local excitation event corresponds to a specific global excitation event and determining whether delivery of the stimulating electrical pulse falls within the absolute refractory period of the local excitation event and / or the specific global excitation event are described in more detail below.

[0027] The subcutaneous defibrillation unit 200 shown in FIG. 1 is a subcutaneously implantable cardiac defibrillator. The subcutaneously implantable cardiac defibrillator 200 includes a housing 201, a conductive electrode 208 disposed on the surface of the housing 201, a first control component 206 disposed within the housing, and a lead 204 extending from the housing 201, with electrodes 202, 203, and 205 attached to the lead 204. The housing 201 can be implanted under the patient's skin. In some embodiments, the housing 201 can be positioned above the chest cavity near the left axilla. The lead 204 is also implanted under the skin. In some embodiments, the lead 204 can extend under the skin from the housing 201 toward the patient's xiphoid process to the left side of the sternum, preferably parallel to and approximately 1 to 2 cm away from the left side of the sternum. Electrodes 202 and 203 are a pair of subcutaneous sensing electrodes, which, together with conductive electrode 208 on housing 201, can define a plurality of vectors for detecting global electrical activity of the heart. Using this pair of subcutaneous sensing electrodes 202 and 203 and conductive electrode 208, first control component 206 detects global excitation events of the patient's heart, such as P waves representing the depolarization time and potential changes of the global atrial muscle groups, QRS complexes representing the depolarization time and potential changes of the global ventricular muscle groups, and T waves representing the repolarization time and potential changes of the global ventricular muscle groups.

[0028] Although the illustrated electrodes 202 and 203 are cap-shaped and annular, respectively, any other feasible structure capable of detecting global activation events may be employed. Preferably, the electrodes 202 and 203 have a relatively large surface area, such as electrodes for a surface electrocardiogram. As shown in FIG. 1 , the electrode 205 is a coil electrode that forms a defibrillation electrode pair with the conductive electrode 208, thereby enabling defibrillation waves for malignant arrhythmias to be emitted between the coil electrode 205 and the conductive electrode 208 under the control of the first control component 206. In some embodiments, the first control component 206 can also detect global activation events of the heart using the electrode pair formed by the coil electrode 205 and the conductive electrode 208 on the housing 201. Note that the coil electrode 205 and the conductive electrode 208 may also have any other feasible structure. For example, the electrode 208 may be formed as part of the housing 201, and the coil electrode 205 may be positioned at a location such as the patient's left armpit or the patient's back, under the left shoulder blade.

[0029] As shown in FIG. 1 , the subcutaneously implantable cardiac defibrillator 200 further includes a pulse generating component 207, which is housed within the housing 201 and electrically coupled to the coil electrode 205. The first control component 206 is configured to emit defibrillation waves to the patient via the coil electrode 205 and the conductive electrode 208 under the control of the first control component 206 when a tachyarrhythmia is detected by a subcutaneous electrocardiogram from the detection electrodes 202, 203, and the electrode 208. Note that the subcutaneous defibrillation unit 200 shown in FIG. 1 is merely an exemplary configuration, and other configurations may be employed. For example, in some embodiments, the subcutaneous defibrillation unit 200 may include, in addition to the lead 204, one or more other leads and other electrode configurations on the other leads that are used to detect global activation events in the patient's heart and / or deliver defibrillation waves to the patient for tachyarrhythmia. In some embodiments, the sensing electrodes 203 may further include suture holes for suturing to anchorage sites in the patient's tissue during subcutaneous implantation. In some embodiments, the subcutaneous defibrillation unit 200 may be any conventional form of implantable cardioverter-defibrillator device or a combination of different parts or elements of these implantable cardioverter-defibrillator devices.

[0030] Continuing with reference to FIGURE 1 , the leadless cardiac stimulation unit 100 is an implantable heart failure therapy device. The implantable heart failure therapy device 100 includes a housing 101 and an anchoring member 102 connected to the housing 101, the anchoring member 102 being used to secure the housing 100 to a specific location in a patient's heart. Although not shown, the anchoring member 102 can include various suitable mechanical features, such as pins, nails, screws, hooks, threads, helices, prongs, clamps, and / or other similar structures, for anchoring into cardiac tissue. In some embodiments, one or more anchoring members 102 can have a hook-like portion that can penetrate and at least partially retain within cardiac tissue. In some other embodiments, one or more anchoring members 102 can have a screw structure, such as a wine corkscrew, that can be threaded into cardiac tissue for anchoring. Additionally, in some embodiments, one or more of the anchor members 102 may have threads or may be helically rotated to achieve a tight connection with cardiac tissue. Those skilled in the art will appreciate that the above-described configurations of the anchor members 102 are exemplary and not limiting. The implantable heart failure treatment device 100 can be implanted in the body in a variety of suitable ways, such as via the apex of the heart or via a blood vessel.

[0031] 1 shows one anchor member 102, the implantable heart failure treatment device 100 may have any suitable number of anchor members 102 to secure the housing 101 to cardiac tissue. For example, the device 100 may include one, two, three, four, five, six, seven, eight, or more anchor members 102. The implantable heart failure treatment device 100 may also employ a combination of the various anchor member configurations described above to achieve a more stable fixation effect.

[0032] Continuing to refer to FIG. 1 , the implantable heart failure therapy device 100 further includes a pair of stimulation electrodes, consisting of electrodes 103 and 104, coupled to the housing 100. The electrodes 103 and 104 may comprise one or more biocompatible, electrically conductive materials, such as various known metals or alloys, that can be safely implanted in the human body. The pair of stimulation electrodes are exposed to surrounding tissue and / or blood and can transmit and / or receive electrical signals from the surrounding tissue and / or blood. The electrical signals can be conducted through the cardiac tissue and / or blood. In some embodiments, the pair of stimulation electrodes 103 and 104 are positioned to detect local sense (LS) signals generated by the discharge of cardiac muscle cells at a predetermined stimulation site and to apply stimulating electrical pulses to the predetermined stimulation site to enhance the contractile force of cardiac muscle cells in the patient's heart.

[0033] 1 is implanted in, for example, the interventricular septum region, so that stimulation electrode pair 103 and 104 can apply electrical stimulation to the adjacent interventricular septum region. However, depending on the location of anchor member 102, the predetermined stimulation site at which stimulation electrode pair 103 and 104 are located may be any other cardiac site desired to receive stimulating electrical pulses that enhance cardiac muscle cell contractility. For example, the predetermined stimulation site may be the endocardium within a chamber of the patient's heart or a site on the epicardium of the patient's heart. In some embodiments, the predetermined stimulation site corresponds to a portion of ventricular tissue, while in some other embodiments, the predetermined stimulation site may be a portion of atrial tissue. In some embodiments, housing 101 of device 100 is configured (e.g., has a capsule-like structure) to be suitable for placement within a venous vessel outside the patient's heart, and the predetermined stimulation site is epicardial tissue near a coronary venous vessel. In this case, anchor member 102 may be configured in any suitable structure, for example, anchor member 102 may be a stent, balloon, support arm, or similar expandable structure, or anchor member 102 may be an anchor spike or hook-like prong that extends from housing 101 and contacts the venous vessel wall. Also, in some embodiments, anchor member 102 may be configured as a portion of housing 101, with a cross-sectional diameter that is configured to interface with a relatively narrow portion of the venous vessel wall to secure housing 101 within the vessel.

[0034] As shown in FIG. 1 , implantable heart failure therapy device 100 further includes a pulse generating component 105 and a second control component 106 disposed within housing 101 and electrically coupled to stimulation electrode pair 103 and 104. While electrodes 103 and 104 are shown located on anchor member 102, any configuration may be used as long as they are electrically coupled to pulse generating component 105 and second control component 106 within housing 101 and are exposed to tissue and / or blood outside housing 101. For example, if at least one of electrode pair 103 and 104 is not disposed on anchor member 102, the electrode not disposed on anchor member 102 can be kept out of contact with the myocardium when anchored to a predetermined stimulation site (e.g., endocardium). In some embodiments, electrodes 103 and / or 104 may be formed on the outer surface of the housing or disposed on another component extending from the housing. When anchor member 102 is secured to the cardiac or vascular tissue, electrodes 103 and / or 104 remain in contact with the cardiac or vascular tissue. For example, anchor member 102 may have the hook-like structure described above, with electrodes 103 and / or 104 located on protrusions extending from the housing and adjacent to anchor member 102. When the hook-like portions of anchor member 102 penetrate and are at least partially retained within the cardiac tissue, the protrusions on which electrodes 103 and / or 104 are located contact the cardiac tissue. In some other embodiments, electrodes 103 and / or 104 may be disposed on anchor member 102 or may be comprised entirely or partially of anchor member 102 and pierced or screwed into the cardiac or vascular tissue along with anchor member 102. For example, the anchor member 102 may have a screw structure similar to the wine corkscrew described above, with part or all of the screw constituting the electrodes 103 and / or 104, and the electrodes 103 and / or 104 being at least partially screwed into the cardiac tissue.

[0035] In some embodiments, the stimulating electrode pair 103 and 104 may employ any electrode structure for applying pacing pulses in a conventional leadless pacemaker. In some embodiments, the electrodes 103 and / or 104 may be defined by a portion of the housing 101. For example, the surface of the housing 101 may include an insulating material, and the electrodes 103 and / or 104 may be formed by a region of any shape smaller than the surface area of ​​the housing, such as a circular, rectangular, annular, semi-annular, sector-shaped, or arch-shaped region. In some embodiments, the electrodes 103 and / or 104 are configured such that a portion of the electrodes 103 and / or 104 is within the housing 101 and a portion of the electrodes 103 and / or 104 is exposed from the surface of the housing 101. In some embodiments, the electrodes 103 and / or 104 are provided on another member extending from the housing 101 and are arranged to be isolated from the housing 101 and / or the anchor member 102. It should be emphasized that the above description is not intended to limit the electrodes 103 and / or 104 to specific locations or construction methods, and that the electrodes 103 and 104 may adopt any combination of the features of the electrode locations and construction forms described above, or any feasible location arrangement or construction form that can achieve their function.

[0036] As shown in Figure 1, electrode 103 in the stimulation electrode pair is used to contact or electrically connect with a predetermined stimulation site in the myocardial tissue (illustrated as the interventricular septum site). Electrodes 103 and / or 104 themselves may have a variety of available sizes and / or shapes. In some embodiments, the surface area of ​​electrode 103 used to contact the predetermined stimulation site is between 1 and 10 mm². 2 and preferably 1.5, 2, 3, 4, 5 mm 2 In the stimulation electrode pair, the electrodes 103 and 104 are positioned to be isolated from each other, and in some embodiments, the distance between the two electrodes is 2 to 20 mm, preferably 5 to 10 mm.

[0037] In the housing 101, the pulse generating component 105 is electrically coupled to the stimulation electrode pair 103 and 104 and configured to generate a stimulating electrical pulse. The second control component 106 is electrically coupled to the stimulation electrode pair 103 and 104 and the pulse generating component 105 and configured to detect a local excitation event of the myocardium at a predetermined stimulation site by the stimulation electrode pair 103 and 104 and generate a local detection signal indicative of the local excitation event. If it is determined that the local excitation event corresponds to a specific global excitation event, the second control component 106 controls the pulse generating component 105 to deliver a stimulating electrical pulse to the stimulation electrode pair 103 and 104 within the absolute refractory period of the local excitation event and / or the specific global excitation event, thereby enhancing the contractile force of the cardiomyocytes within the period of the local excitation event and treating heart failure.

[0038] FIG. 2A-2C show schematic diagrams of implantable heart failure therapy devices or leadless cardiac stimulation units 300a, 300b, and 300c, respectively, in accordance with different embodiments of the present disclosure, illustrating alternative arrangements of stimulation electrode pairs on the housing.

[0039] As shown in Fig. 2A, electrode 303a of the stimulating electrode pair of device 300a is located at one end of anchor member 302a away from housing 301a, and another electrode 304a is provided at one end of housing 301a adjacent to anchor member 302a. The arrangement of the stimulating electrode pair of device 300b shown in Fig. 2B is substantially the same as that of the embodiment shown in Fig. 2A, except that stimulating electrode 304b is provided on anchor member 302b rather than housing 301b. The implantable heart failure treatment device 300c shown in Fig. 2C differs from the implantable heart failure treatment device 300b shown in Fig. 2B only in that stimulating electrode 304b provided on anchor member 302b is eliminated and instead provided at one end of housing 301c adjacent to anchor member 302c as 304c.

[0040] 3A to 3C are schematic diagrams of implantable heart failure treatment devices 400a, 400b, and 400c according to different embodiments of the present disclosure, each of which includes multiple stimulation electrode pairs. The implantable heart failure treatment device 400a shown in FIG. 3A has substantially the same structure as the implantable heart failure treatment device 300b shown in FIG. 2B, except that the device 400a further includes another anchoring member 409a, which is provided with another pair of stimulation electrodes 410a and 411a. These two stimulation electrode pairs are positioned to contact different predetermined stimulation sites on the endocardium or epicardium of the heart, respectively. These stimulation electrode pairs can detect local sensing (LS) signals generated by action potentials of cardiomyocytes at the corresponding predetermined stimulation sites and can apply stimulating electrical pulses to the corresponding predetermined stimulation sites to enhance the contractile force of the cardiomyocytes in the patient's heart.

[0041] In some embodiments, assume that electrode 403a of stimulation electrode pair 403a and 404a is in contact with a first location in the ventricular cavity, and electrode 410a of stimulation electrode pair 410a and 411a is in contact with a second location different from the first location in the ventricular cavity. The two electrode pairs detect local detection signals generated by membrane potential changes of cardiomyocytes at the first and second locations, respectively, and when the local detection signals at the first and second locations satisfy a predetermined preset condition, the stimulation electrode pair applies stimulating electrical pulses to the first and second locations, respectively, to enhance the contractile force of the cardiac muscle. For example, the control module of the device 400a can determine whether the electrical activity of the myocardial cells at the first site and / or the second site corresponds to a depolarization conduction process of the ventricle from the discharge intensity and / or temporal sequence of the myocardial cells indicated by the local detection signals at the first site and the second site, and if the determination result is "yes", apply a stimulating electrical pulse to the myocardial tissue at the first site and / or the second site within the absolute refractory period of the overall excitation event.

[0042] The implantable heart failure treatment device 400b in the embodiment shown in Figure 3B is substantially the same as the implantable heart failure treatment device 300c in Figure 2C, except that the device 400b further includes another anchor member 409b and another stimulation electrode 410b provided on the anchor member 409b, and an electrode 404b consisting of a part of the housing 401b forms two stimulation electrode pairs with the electrodes 403b and 410b, respectively. The structure of the device 400c shown in Figure 3C is substantially the same as the device 300a shown in Figure 2A, except that the device 400c further includes another anchor member 409c, and an electrode 404c consisting of a part of the housing 401c forms two stimulation electrode pairs with the electrodes 403c and 410c, respectively. Similar to the description of device 400a in FIG. 3A above, devices 400b and 400c may be configured to provide detection and processing of local excitation events and separate delivery of stimulating electrical pulses at different locations of the heart through their two stimulation electrode pairs, and will not be described again here.

[0043] 4A and 4B are schematic diagrams of implantable heart failure treatment devices 500a and 500b according to different embodiments of the present disclosure, respectively, illustrating the positioning of a stimulation electrode pair on a housing. As shown in FIG. 4A, device 500 includes a housing 501a and a stimulation electrode pair consisting of electrodes 503a and 504a attached to housing 501a. As described above, device 500a is designed to be placed in a venous vessel outside a patient's heart, and its predetermined stimulation site is epicardial myocardial tissue near the venous vessel. The stimulation electrode pair is configured to detect local sensing (LS) signals generated by discharge of cardiomyocytes at specific epicardial sites and apply stimulating electrical pulses to the corresponding sites to enhance the contractile force of the cardiomyocytes in the patient's heart. The housing 501a shown in FIG. 4A and the stimulation electrode pair attached to the surface of the housing are configured to be able to join with the venous blood vessel wall outside the heart so as to fix the device 500a within the blood vessel, and at least one electrode of the stimulation electrode pair is arranged to abut one side of the blood vessel wall adjacent to the epicardium.

[0044] In some embodiments, the device 500a may further include an anchoring member, such as a stent, balloon, support arm, or similar expandable structure, or an anchor spike or hook-like claw structure, to interface with the venous vessel wall and secure the device 500a. In some other embodiments, at least a portion of the housing 501a is sized to be secured to a relatively narrow portion of the venous vessel outside the heart so that the housing 501a is secured within the venous vessel. The implantable heart failure treatment device 500b shown in FIG. 4B is substantially the same as the device 500a in FIG. 4A , except that the structure of one electrode 504b of the stimulation electrode pair is replaced by a portion of the housing 501a (e.g., an annular region of the housing 501b that is not covered with insulating material). In some embodiments, the one electrode 504b may be a localized region facing the myocardium within the annular region, such as a semi-annular region facing the myocardium, or an arc-shaped region smaller or larger than a semi-annular region.

[0045] The implantable heart failure treatment device 500a or 500b shown in Figure 4A or 4B wirelessly communicates with the subcutaneously implantable cardioverter-defibrillator 200 shown in Figure 1 and transmits the acquired local detection signal and / or signal detection result to the subcutaneously implantable cardioverter-defibrillator 200. The subcutaneously implantable cardioverter-defibrillator 200 can then determine based on the far-field detection signal and / or the local detection signal and transmit a command to the implantable heart failure treatment device 500a or 500b to deliver a pulsed electrical stimulus at an appropriate timing, the command including, but not limited to, emission time and pulse parameters. Then, based on the received command, the device 500a or 500b controls the stimulation electrode pair to apply the electrical pulse stimulus to a contact or corresponding predetermined stimulation site (the epicardium of the myocardium) to enhance the contractile force of the myocardium.

[0046] It should be emphasized that the embodiments shown in FIGS. 2A to 4B are intended to schematically illustrate possible positions and arrangements of the stimulating electrode pair and the housing. The materials, structural shapes, and the like of the stimulating electrode pair in the figures may adopt any of the technical features and combinations thereof described for electrodes 103 and 104 in the embodiment shown in FIG. 1, or any other feasible positions or structural forms that can achieve the functions described therein, and will not be described again here. Also, for simplicity of the drawings, the insulating material or structure between the electrodes may not be specifically illustrated, but an insulating structure or material is clearly provided between the electrodes. For example, the housing as a whole may be electrically conductive, and a portion of the housing may be formed as an electrode by coating or covering it with an insulating material. Also, for example, the housing of the device may be made entirely of an insulating material, and one or more electrodes may extend from the housing and be connected to a circuit module within the housing.

[0047] In this application, the term "subcutaneous defibrillation unit" refers to any viable structure that has electrodes and is capable of detecting global activation events in a patient's heart, generating a global sense (GS) signal indicative of the global activation event, and delivering defibrillation waves to the patient when the patient experiences a malignant arrhythmia. For example, in some embodiments, the "subcutaneous defibrillation unit" may be a subcutaneous implantable cardioverter-defibrillator (S-ICD). In other embodiments, the "subcutaneous defibrillation unit" may have all or some of its components implanted subcutaneously and other components (including all components) implanted submuscularly. In addition, in some embodiments, the "subcutaneous defibrillation unit" may be partially or entirely external to the body, such as a wearable cardioverter-defibrillator (WCD).

[0048] 5 shows a flow chart of a method 600 for controlling a cardiac therapy device according to one embodiment of the present application. The steps of the illustrated method will now be illustratively described with reference to the cardiac therapy device shown in FIG.

[0049] In step 601, the first control component 206 of the subcutaneous defibrillation unit 200 receives from the second control component 106 of the leadless cardiac stimulation unit 100 cardiac discharge activity at a predetermined stimulation site on the heart, as sensed by the sensing electrode pair 103, 104, and generates a local sensed signal indicative of the cardiac discharge activity. Simultaneously, the first control component 206 acquires a far-field sensed signal indicative of global excitation events in the patient's heart via the sensing electrode pair 202, 203 of the subcutaneous defibrillation unit 200.

[0050] In step 602, the first control component 206 determines whether a local excitation event of cardiomyocytes at a predetermined stimulation site corresponds to a specific global excitation event based on at least the received far-field detection signal and the local detection signal. In some embodiments, step 602 may include obtaining a specific event time window corresponding to the specific global excitation event, and determining that the local excitation event corresponds to the specific global excitation event (e.g., an R wave) if the time at which the local excitation event is detected falls within the specific event time window.

[0051] A specific event time window refers to a time period associated with a specific event in a cardiac cycle, determined based on a far-field detection signal (herein abbreviated as a GS signal) and / or a local detection signal (herein abbreviated as a LS signal). For example, a time period associated with a specific event in a cardiac cycle (e.g., an R wave or a QRS complex) may be determined based on a far-field detection signal detected by the detection electrode pairs 202 and 203 of the subcutaneous defibrillation unit 200. In some examples, when the implantable heart failure therapy device 100 has multiple stimulation electrode pairs, the specific event time window may be further determined based on multiple LS signals provided by the stimulation electrode pairs at different predetermined stimulation sites.

[0052] Specifically, the start point of the specific event time window may be determined based on the GS signal and / or the LS signal. In some embodiments, the start point of the specific event time window may be determined based on the time point at which a specific event is detected in the far-field detection signal (hereinafter abbreviated as "GS detection time") and / or the time point at which a local detection signal generated by discharge of myocardial cells at a predetermined stimulation site is detected (hereinafter abbreviated as "LS detection time").

[0053] In some embodiments, the start point of a particular event time window (abbreviated as GVT-s in the following equations) may be set as follows:

[0054] If the LS detection time is later than the GS detection time, that is, if the difference between the LS detection time and the GS detection time (abbreviated as GLSD in the following formula, GLSD=LS-GS) is greater than 0, set GVT-s to the time a predetermined time length (abbreviated as A in the following formula) before the GS detection time (abbreviated as GS in the following formula), and the specific formula is as follows: If GLSD>0, GVT-s=GS-A

[0055] Conversely, if the LS detection time is earlier than or the same as the GS detection time, i.e., if the difference GLSD between the LS detection time and the GS detection time is less than or equal to 0, the GVT-s may be set to a time a predetermined time length before the LS detection time (abbreviated as LS in the following equation), and the specific equation is as follows: When GLSD≦0, GVT-s=LS-A, which can be transformed into GVT-s=GS+GLSD-A.

[0056] The above setting may be performed in real time for each cardiac cycle.

[0057] Additionally, the cardiac treatment device may monitor the LS signal and the GS signal within a predetermined period of time for the parameters to determine a reference time difference B (i.e., GLSD) between the LS detection time and the GS detection time when the LS detection time is later than the GS detection time, and a reference time difference C (i.e., GLSD) between the LS detection time and the GS detection time when the LS detection time is earlier than or the same as the GS detection time. The value A may also be confirmed within a predetermined period of time, or a more appropriate value may be obtained. In the subsequent execution process, the setting of the GVT-s may be determined based on the above-mentioned reference time difference and the LS detection time or the GS detection time. The specific formula is as follows: If GLSD>0, GVT-s=LS-BA If GLSD≦0, GVT-s=GS+CA

[0058] It should be noted that the above specific calculation method is merely exemplary, and the starting point of a specific event time window may be determined using other methods or based on other parameters. In the above embodiment, the predetermined time lengths A, B, and C may all be adjustable preset values, and A may be selected from 0 to 40 ms, preferably 20 ms. In some embodiments, the predetermined time lengths B and C may adopt similar preset values.

[0059] The length of the specific event time window may be a predetermined time length, which is typically associated with a specific type of specific event. If the source of the electrical signal is an electrical impulse from the atrium, the length of the corresponding specific event time window may be 90-120 ms. If the source of the electrical signal is an electrical impulse from the ventricle itself or an external electrical stimulus applied to the ventricle, the length of the corresponding specific event time window may be 200-250 ms. For example, if the specific event is an R wave, for an R wave due to a spontaneous electrical impulse in the atrium (e.g., generated by the sinus node), the length of the specific event time window (also referred to as an R wave time window) may be set to 30 to 130 ms, preferably 90 to 120 ms or 90 ms. For an R wave due to spontaneous electrical activity in the ventricle (e.g., a premature ventricular contraction) or an R wave due to an external electrical stimulus received by ventricular tissue, the length of the R wave time window may be set to 30 to 250 ms, preferably 200 to 250 ms, or 150 ms.

[0060] Continuing to refer to FIGURE 5 , if a local activation event is determined to correspond to a particular global activation event, the second control component 106 and / or the first control component 206 executes step 603 and determines, based on at least the far-field sensed signals and / or the local sensed signals, whether the stimulating electrical pulse to be applied falls within the absolute refractory period of the local activation event and / or the particular global activation event. If a local activation event is determined not to correspond to a particular global activation event, the first control component 206 performs no further action. If more than one leadless heart failure therapy device is present in the heart, the second control component 106 performs the above analysis and processing steps on LS from other leadless heart failure therapy devices until it has processed LS signals from all leadless heart failure therapy devices, and then continues performing the above signal analysis steps on subsequently generated far-field sensed signals and local sensed signals (corresponding to the next heart beat). For example, the leadless heart failure therapy device in FIGURES 4A and 4B can be positioned on the epicardium of a cardiac chamber, e.g., on the left or posterior left side of the left ventricle via a coronary vein, and monitor LS signals with electrode pair 503a and 504a or 504b and 504b to determine if and when to emit a stimulating electrical pulse. In some embodiments, the electrode pair can also perform cardiac pacing to achieve biventricular therapy.

[0061] Figure 6 illustrates specific substeps of step 603 of the control method 600 shown in Figure 5 in accordance with some embodiments. The steps of the illustrated method are illustratively described below with reference to the cardiac therapy device shown in Figure 1.

[0062] In step 631, the second control component 106 and / or the first control component 206 determine a pulse emission time based on the local and / or far-field detection signals.

[0063] In step 632, the second control component 106 and / or the first control component 206 determines a pulse emission window suitable for emitting a stimulating electrical pulse based on the local and / or far-field detection signals.

[0064] In step 633, the second control component 106 and / or the first control component 206 determines whether the pulse emission time falls within the time window during which the pulse can be emitted.

[0065] If the pulse emission time falls within the pulse emission possible time window, the second control component 106 performs step 634 of determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, after which, in a subsequent step, the stimulating electrode pair 103 and 104 can apply a stimulating electrical pulse to the predetermined stimulation site that enhances the patient's myocardial contractility.

[0066] If the pulse emission time is not within the pulse emission available time window, the second control component 106 executes step 635 of determining that the stimulating electrical pulse that needs to be applied is not within the absolute refractory period of the local excitation event and / or a particular global excitation event, and does not deliver the stimulating electrical pulse to the predetermined stimulation site.

[0067] In this application, the pulse emission time (sometimes abbreviated as CSDT in this specification) refers to the time point at which a stimulating electrode pair emits a stimulating electrical pulse, determined based on the obtained GS signal and / or LS signal. The pulse emission time can be determined in different ways. The setting of the CSDT ensures that the emission time of the pulse stimulation is within the absolute refractory period of a local excitation event and / or a specific global excitation event.

[0068] In some embodiments, the pulse emission time can be determined based on the LS detection time, for example, the pulse emission time can be a time after a predetermined time length of the LS detection time, and the specific formula is as follows: CSDT=LS+D If electrical activity in a given area of ​​the myocardium is due to pacing, CSDT = pacing pulse emission time + D.

[0069] In some other embodiments, the pulse emission time is determined by the GS detection time and the GLSD, for example, the pulse emission time may be the sum of the GS detection time, the GLSD, and a preset time length, and the specific formula is as follows: CSDT=GS+GLSD+D

[0070] As mentioned above, by detecting the LS signal and the GS signal within a predetermined period, a reference time difference E (i.e., GLSD) between the LS detection time and the GS detection time when the LS detection time is later than the GS detection time, and a reference time difference F (i.e., GLSD) between the LS detection time and the GS detection time when the LS detection time is earlier than or equal to the GS detection time can be determined. In the subsequent execution process, the CSDT can be determined based on the above reference time difference and the LS detection time or the GS detection time, and the specific formula is as follows: If GLSD>0, CSDT=GS+E+D If GLSD≦0, CSDT=GS+F+D

[0071] The determination of E and F above may be performed in real time for each cardiac cycle, or may be determined as preset values ​​within a predetermined period, for example by taking the mean, median, or other suitable statistical value from values ​​over a number of cardiac cycles (e.g., 16).

[0072] It should be noted that the above specific calculation method is merely illustrative, and the pulse emission time may be determined using other methods or based on other parameters. In the above embodiment, the preset time length D may be selected from the range of 10 to 80 ms, and is preferably 40 ms. In the case of electrical excitation by pacing, the preset time length D may be selected from the range of 10 to 100 ms, and is preferably 60 ms.

[0073] The pulse release window refers to a time period suitable for the release of a stimulating electrical pulse, during which delivery of a stimulating electrical pulse to a predetermined stimulation site by a stimulation electrode does not or is unlikely to cause a re-depolarization event at the predetermined stimulation site or at other myocardial tissues that may be affected by the stimulating electrical pulse. By setting the pulse release window as a judgment condition, the implantable heart failure treatment device can release a stimulating electrical pulse at an appropriate time within the absolute refractory period of the stimulation site and the myocardium that may be affected by the stimulating pulse, thereby achieving the effect of enhancing myocardial contractility and avoiding the risk of inducing malignant ventricular tachycardia (VT) or ventricular fibrillation (VF), etc.

[0074] In some embodiments, the start point of the pulse-emittable time window may be determined using a method similar to the start point of the specific event time window described above, and the description will not be repeated here. In some embodiments, the start points of the specific event time window and the pulse-emittable time window may be determined using any other feasible method. For example, if the implantable heart failure treatment device has multiple stimulation electrode pairs, for example, if devices are implanted in both the right and left ventricles, the specific event time window and the pulse-emittable time window may be further determined based on the GS signal and the LS signal of the stimulation electrode pair that detects the earliest local activation event within a cardiac cycle. Of course, the pulse-emittable time window may also be determined based on a comprehensive consideration of the LS signal, the GS signal, and the above-mentioned factors.

[0075] The length of the pulse emission window (also referred to as the R-wave pulse emission window) may be a preset time length of 100 ms to 500 ms, preferably 100 ms to 400 ms or 150 ms to 300 ms. In some embodiments, the preset time length is 200 ms. The patient's condition, for example, whether or not they are taking antiarrhythmic drugs, may affect the absolute refractory period of the myocardium (which may be prolonged by amiodarone), and the R-wave sensing conditions (GS and / or LS), for example, may also slightly affect the starting point of the time window. The specific selection should be adaptively adjusted depending on the disease state, etc.

[0076] Note that the start times corresponding to the pulse emission time window and the specific event time window (also referred to as the "detection time window" in some descriptions herein) may be the same or different. In other words, the pulse emission time window and the specific event time window may be set independently and may not have any correlation or dependency with each other. Specifically, the pulse emission time window and the specific event time window may be determined based on a far-field detection signal, and may be individually and adaptively adjusted according to factors such as the specific circumstances of the detected specific event (e.g., R wave), the specific location of the myocardium, and whether the cardiac electrical activity is spontaneous or due to pacing, so as to cover or meet the needs of most pulse stimulation scenarios. Specific methods for determining the pulse emission time window and the specific event time window will be described in detail below with reference to the drawings and specific embodiments.

[0077] 7 illustrates specific substeps of step 603 of the control method 600 shown in FIG. 5 according to some alternative embodiments. The steps of the illustrated method will now be described, by way of example, with reference to the cardiac therapy device shown in FIG.

[0078] Steps 631' and 632' shown in Figure 7 are the same as steps 631 and 632 in Figure 6 and will not be repeated here. In step 633', the first control component 206 and / or the second control component 106 determine the pulse emission end time based on the pulse emission time and the pulse emission duration.

[0079] Thereafter, in step 634', the second control component 106 and / or the first control component 206 determines whether the pulse emission time and the pulse emission end time both fall within the time window in which the pulse can be emitted.

[0080] If both the pulse emission time and the pulse emission end time fall within the pulse emission possible time window, the second control component 106 executes step 635' of determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or the specific global excitation event, and then in a subsequent step applies a stimulating electrical pulse to the predetermined stimulation site via the stimulation electrode pair 103 and 104 that enhances the patient's myocardial contractility.

[0081] If the pulse emission time and the pulse emission end time are both outside the pulse emission available time window, the second control component 106 executes step 636' of determining that the stimulating electrical pulse that needs to be applied is not within the absolute refractory period of a local excitation event and / or a particular global excitation event, and does not send the stimulating electrical pulse.

[0082] The specific method for determining the pulse emission time CSDT has been described above in detail. Once the pulse emission time is determined, if the total pulse emission time is G, the pulse emission end time (sometimes abbreviated as CSFT in this specification) can also be determined accordingly. CSFT=CSDT+G

[0083] The above G is obtained by the preset parameters of the pulse (e.g., stimulation pulse width and pulse number), and these parameters can be adjusted and selected according to different heart failure treatment needs or the specific location of a given stimulation, and whether the pulse emission end time falls within the pulse emission available time window.

[0084] Optionally, as shown in FIG. 5 , method 600 may include step 601a before step 602, in which the first control component 206 determines a source of an electrical signal causing a local excitation event. The source of the electrical signal may include a spontaneous electrical impulse from the atrium, a spontaneous electrical impulse from the ventricle, or ventricular electrical activity due to external electrical stimulation from the ventricle. In some embodiments, the source of the electrical signal may be identified by the second control component 106, and the identified source information may be sent to the first control component 206 along with the local detection signal. Also, in some embodiments, the far-field detection signal may be used to determine the specific type of source of the electrical signal. After step 601a, parameters such as a specific event time window and pulse emission time may be adjusted in steps 602 and 603 based on the source of the electrical signal determined in step 601a. For specific adjustment methods, please refer to the above-mentioned explanations of the method for determining the specific event time window and pulse emission time, and if the source of the electrical signal is electrical stimulation outside the heart (e.g., pacing pulse), please refer to the following explanation of the control method for a cardiac treatment device that also has a pacing function.

[0085] In some embodiments, the cardiac therapy device 10 can further provide pacing therapy. Specifically, the stimulating electrodes 103 and 104 of the leadless heart failure therapy device 100 shown in FIGURE 1 can further be used to apply pacing electrical pulses to the patient's heart to regulate the patient's heart rate. In some embodiments, the first control component 206 and / or the second control component 106 can further be configured to receive a mode selection signal and, based on the mode selection signal, control the cardiac therapy device into a pacing mode or a non-pacing mode. In the non-pacing mode, the first control component 206 performs corresponding operations according to a control method 600 shown in FIGURE 5 and will not be repeated here.

[0086] FIGURE 8 illustrates a method 700 for controlling the cardiac therapy device 10 in a pacing mode. The steps of the illustrated method are exemplarily described below with reference to the cardiac therapy device shown in FIGURE 1. Specifically, in the pacing mode, in step 701, the second control component 106 sends pacing electrical pulse information to the first control component 206 to control the leadless heart failure therapy device 100 to apply pacing electrical pulses to the patient's heart via the stimulating electrodes 103 and 104 to regulate the heart rate of the patient's heart, the pacing electrical pulse information including application times of the pacing electrical pulses.

[0087] Then, in step 702, the first control component 206 determines whether a local excitation event of cardiomyocytes at a predetermined stimulation site corresponds to a specific global excitation event based on at least the far-field sensing signal and the application time of the pacing electrical pulse. For a cardiac therapy device in pacing mode, the above steps are generally equivalent to the process in which the first control component 206 obtains a signal indicating the application time of a pacing pulse and then determines whether the pacing pulse achieved cardiac capture. In some examples, once it is determined that a pacing pulse achieved cardiac capture, the application time of the pacing electrical pulse can be the start time of the local excitation event of cardiomyocytes at a predetermined stimulation site and the beginning of a pulse-emittable time window and a specific event time window, or plus a delay time from the stimulus to the myocardial response.

[0088] If it is determined that the local excitation event corresponds to a specific global excitation event (i.e., it is determined that the pacing pulse achieved cardiac capture), the second control component 106 and / or the first control component 206 executes step 703 and delivers a stimulating electrical pulse to the pair of stimulating electrodes within the absolute refractory period of the local excitation event and / or the specific global excitation event. If it is determined that the local excitation event does not correspond to a specific global excitation event (i.e., it is determined that the pacing pulse did not achieve cardiac capture), the first control component 206 does not perform any further action and executes the corresponding step shown in FIG. 5 , i.e., executes according to its electrical activity mode (transition to non-pacing mode). As described above, parameters such as the CSDT in the subsequent step 703 can be adaptively adjusted based on the source of the electrical signal of the local excitation event (i.e., the pacing electrical pulse).

[0089] In some embodiments, the first control component 206 is further configured to determine the start time or detection time of a specific global excitation event based on the far-field detection signal, and send a signal indicating the start time or detection time of the specific global excitation event to the second control component 106. In this case, the second control component 106 is further configured to determine the local detection signal within a certain time interval before and after the start time or detection time of the specific global excitation event. Only if the local detection signal exists within the above time range, the second control component 106 sends the local detection signal to the first control component 206, and the first control component 206 performs further analysis based on the far-field detection signal and the local detection signal. This setting can effectively reduce the frequency of active communication and signal transmission of the second control component 106, thereby reducing its energy consumption and extending its service life.

[0090] Conversely, in some other embodiments, the second control component 106 may be further configured to transmit a local detection signal to the first control component 206 indicative of a local excitation event, the local detection signal including the time at which the local excitation event was detected. Accordingly, the first control component 206 may be further configured to determine, based on the received local detection signal, far-field detection signals within a time interval before and after the time at which the local excitation event was detected. If a corresponding far-field detection signal is detected, the first control component 206 performs a determination step to determine whether the local excitation event corresponds to a particular global excitation event. In some embodiments, the first control component 206 is further configured to determine, based on at least the far-field detection signal and the local detection signal, whether defibrillation waves for the malignant arrhythmia should be delivered to the patient by the subcutaneous defibrillation unit. Specifically, if the first control component 206 determines based on the far-field detection signal that defibrillation waves for malignant arrhythmia need to be delivered to the patient, it may further reconfirm whether the determination is correct based on the received local detection signal, and deliver defibrillation waves for malignant arrhythmia only if the reconfirmation result is correct. In this way, it is possible to effectively prevent the patient from being exposed to unnecessary electric shock currents due to an incorrect determination. In some embodiments, if the first control component 206 determines based on the far-field detection signal that defibrillation waves for malignant arrhythmia need to be delivered to the patient, it may transmit this determination result to the second control component 106, which may then complete the reconfirmation process.

[0091] In some embodiments, the second control component 106 may be further configured to determine the start time or detection time of a local excitation event based on the detected local detection signal and send a signal indicating the start time or detection time of the local excitation event to the first control component 206. The first control component 206 may be further configured to acquire far-field detection signals within a certain time interval before and after the start time or detection time of the local excitation event. When actually detecting an electrocardiogram signal, the detection time of the GS signal may be delayed compared to the actual time due to delays in capturing the electrocardiogram signal, or the detection time of the LS signal may be slightly earlier than the detection time of the GS signal due to other factors. Setting the detection time of the LS signal as the start time of a specific event time window can better address such situations and more accurately determine the correspondence between a local excitation event and a global excitation event. In this case, after determining the specific event time window using the detection time of the LS signal as the start time, it is further determined whether the detection time of the subsequent detection of a GS signal indicating a global excitation event falls within the specific event time window. If it is determined to fall within the particular event time window, then the local excitation time indicated by LS is determined to correspond to the global excitation event indicated by GS.

[0092] In some embodiments, the first control component 206 is configured to transmit the far-field detection signal to the second control component 106, which, upon receiving the far-field detection signal, determines whether defibrillation waves for the malignant arrhythmia should be delivered to the patient by the subcutaneous defibrillation unit based on at least the far-field detection signal and the local detection signal. In some other embodiments, the first control component 206 is configured to directly determine whether defibrillation waves for the malignant arrhythmia should be delivered to the patient by the subcutaneous defibrillation unit based on at least the far-field detection signal and the local detection signal.

[0093] Typically, the currents required to deliver defibrillation waves for malignant arrhythmias to a patient by a subcutaneous defibrillation unit are large and may undesirably affect the operation of the leadless defibrillation electrode unit. In some embodiments, the first control component 206 is further configured to send a signal indicative of delivery of defibrillation waves for the malignant arrhythmia to a second control component 106 of the leadless defibrillation electrode unit when the subcutaneous defibrillation unit determines that defibrillation waves for the malignant arrhythmia should be delivered to the patient. The second control component 106 is further configured to switch the leadless cardiac stimulation unit 100 to a shock-resistant mode upon receiving the signal indicative of delivery of defibrillation waves for the malignant arrhythmia, e.g., to disconnect electrical coupling between sensing elements and stimulation electrodes in the pulse generation module or control component.

[0094] In some embodiments, the step of "determining whether the stimulating electrical pulse to be applied falls within the absolute refractory period of a local activation event and / or a global activation event" in this specification may include cases where only the absolute refractory period of a specific global activation event or only the absolute refractory period of a local activation event is considered. In some other embodiments, the above step may be further limited to cases where the absolute refractory period of a local activation event and the absolute refractory period of the entire ventricular muscle are considered simultaneously. In some embodiments, if the cardiac therapy device has multiple pairs of stimulation electrodes and can acquire multiple LS signals, the first control component 206 may further adaptively adjust the specific steps and parameters of the control method 600 taking into account factors such as the positional relationship between a predetermined stimulation site and other local sites. In this specification, the term "subcutaneous" should be interpreted broader and include being placed under the muscle, being partially placed under the epidermis, or being partially placed under the muscle.

[0095] It should be noted that although the above describes in detail several components or modules of a cardiac therapy device, a subcutaneous defibrillation unit (subcutaneously implantable cardioverter-defibrillator), and a leadless cardiac stimulation unit (leadless heart failure therapy device), this division is intended to be illustrative rather than mandatory. In fact, depending on the embodiment of the present application, features and functionality of two or more of the modules described above may be implemented in a single module. Conversely, features and functionality of a single module described above may be further subdivided and implemented in multiple modules.

[0096] Those skilled in the art can understand and implement other modifications to the disclosed embodiments by studying the specification, the disclosed contents and drawings, and the appended claims. In the claims, the term "comprise" does not exclude other elements and steps, and the terms "one" and "an" do not exclude a plurality. In the actual application of this application, one element may perform the functions of multiple technical features recited in the claims. Any drawing reference signs in the claims should not be construed as limiting the scope.

Claims

1. a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes, the first control component configured to detect a global excitation event in the patient's heart with at least some of the subcutaneous electrodes, generate a far-field detection signal indicative of the global excitation event, and emit defibrillation waves to the patient with at least some of the subcutaneous electrodes when the patient develops a malignant arrhythmia; a leadless cardiac stimulation unit configured for contacting a predetermined stimulation site on a patient's heart, the leadless cardiac stimulation unit comprising a second control component and a plurality of stimulation unit electrodes, the second control component configured to sense, with at least some of the stimulation unit electrodes, local excitation events in myocardium at the predetermined stimulation site and generate local detection signals indicative of the local excitation events, and to apply, with at least some of the stimulation unit electrodes, stimulating electrical pulses to the predetermined stimulation site to enhance contractility of cardiomyocytes of the patient's heart; a first control component wirelessly coupled to the second control component, and the first control component and / or the second control component configured to determine whether to apply the stimulating electrical pulse to the predetermined stimulation site based on at least the far-field detection signal and the local detection signal.

2. The step of determining whether to apply the stimulating electrical pulse to the predetermined stimulation site based on the far-field detection signal and the local detection signal includes: determining whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to a specific global excitation event based on at least the far-field detection signal and the local detection signal; determining, based on at least the far-field and / or local detection signals, whether a stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or a particular global excitation event; 2. The cardiac treatment device according to claim 1, further comprising a step of determining whether or not to apply the stimulating electrical pulse to the predetermined stimulation site based on the determination result of at least one step.

3. The step of determining whether to apply the stimulating electrical pulse to the predetermined stimulation site based on the far-field detection signal and the local detection signal includes:

2. The cardiac therapy device according to claim 1, further comprising a step of determining to apply the stimulating electrical pulse to the predetermined stimulation site when it is determined that the local excitation event corresponds to a specific global excitation event and / or when it is determined that the stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a specific global excitation event.

4. the leadless cardiac stimulation unit a housing having an anchor member connected thereto for securing the housing to the patient's heart; a pulse generation module contained within the housing, the pulse generation module configured to generate the stimulating electrical pulses under control of the second control component; 2. The cardiac therapy device according to claim 1, wherein the plurality of stimulation unit electrodes include a pair of stimulation electrodes coupled to the housing, the pulse generation module is electrically coupled to the pair of stimulation electrodes, the pair of stimulation electrodes is configured to be used for contacting a predetermined stimulation site on a patient's heart, and the second control component is configured to detect a local excitation event of myocardium at the predetermined stimulation site using the pair of stimulation electrodes, generate a local detection signal indicative of the local excitation event, and apply the stimulation electrical pulse to the predetermined stimulation site using the pair of stimulation electrodes.

5. 5. The cardiac therapy device of claim 4 , wherein the leadless cardiac stimulation unit housing is adapted to be received within a venous vessel on the epicardial surface of a patient's heart, and the predetermined stimulation site comprises the epicardium.

6. 2. The cardiac therapy device of claim 1, wherein the local detection signal includes a time at which the local excitation event was detected.

7. determining whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to a specific global excitation event based on at least the far-field detection signal and the local detection signal, obtaining a specific event time window corresponding to the specific global excitation event, and determining that the local excitation event corresponds to the specific global excitation event if the time at which the local excitation event was detected falls within the specific event time window; or 3. The cardiac therapy device of claim 2, further comprising the step of obtaining a specific event time window corresponding to the local excitation event, and determining that the local excitation event corresponds to the specific global excitation event if a time at which the specific global excitation event is detected falls within the specific event time window.

8. determining, based on at least the far-field detection signal and / or the local detection signal, whether a stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a particular global excitation event, determining a pulse emission time of the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse release time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; and determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or a specific global excitation event if the pulse emission time falls within the pulse emission possible time window.

9. determining whether a stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a particular global excitation event based on at least the local detection signal and / or the far-field detection signal, determining a pulse emission time of the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse release time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse emission end time based on the pulse emission time and the pulse emission duration; determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or a specific global excitation event if both the pulse emission time and the pulse emission end time fall within the pulse emission possible time window.

10. The step of determining a pulse emission time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal includes: determining a start time of the pulse emission possible based on the local detection signal and / or the far-field detection signal; 10. The cardiac treatment device according to claim 8, further comprising a step of determining the time window during which the pulse can be emitted based on the start time during which the pulse can be emitted and a predetermined time length.

11. 11. The cardiac treatment device according to claim 10, wherein the predetermined time length is between 100 ms and 500 ms, or between 150 ms and 300 ms.

12. 10. The cardiac treatment device according to claim 9, wherein the first control component and the second control component are configured to adjust the pulse emission parameters, if the pulse emission end time is not within the pulse emission available time window, so that the adjusted pulse emission end time falls within the pulse emission available time window, and to apply the adjusted stimulating electrical pulse to the predetermined stimulation site.

13. The first control component is further configured to determine a start time or a detection time of the specific global arousal event based on the far-field detection signal and to send a signal indicating the start time or the detection time of the specific global arousal event to the second control component, and the second control component is further configured to obtain local detection signals within a certain time interval before and after the start time or the detection time of the specific global arousal event and to send the local detection signals to the first control component; or 2. The cardiac therapy device according to claim 1, wherein the second control component is further configured to determine a start time or a detection time of the local excitation event based on the local detection signal and to transmit a signal indicating the start time or the detection time of the local excitation event to the first control component, and the first control component is further configured to obtain a far-field detection signal within a certain time interval before and after the start time or the detection time of the local excitation event and to transmit the far-field detection signal to the second control component.

14. 2. The cardiac therapy device of claim 1, wherein the second control component is further configured to transmit the local detection signal to the first control component, or the first control component is further configured to transmit the far-field detection signal to the second control component.

15. 3. The cardiac treatment device of claim 2, wherein the specific global excitation event corresponds to an R wave or a QRS complex in a far-field electrocardiogram, and the local detection signal corresponds to an R wave in a near-field electrocardiogram.

16. 2. The cardiac treatment device according to claim 1, wherein the first control component and / or the second control component is further configured to determine whether or not defibrillation waves for treating malignant arrhythmia need to be emitted to the patient by the subcutaneous defibrillation unit based on at least the far-field detection signal and the local detection signal.

17. 2. The cardiac therapy device according to claim 1, wherein the first control component is further configured to transmit a signal indicating that defibrillation waves for treating malignant arrhythmia will be emitted to the second control component when the subcutaneous defibrillation unit determines that defibrillation waves for treating malignant arrhythmia need to be emitted to the patient.

18. 18. The cardiac therapy device of claim 17, wherein the second control component is further configured to switch the leadless cardiac stimulation unit to a shock-resistant mode upon receiving a signal indicating that a defibrillation wave for treating a malignant arrhythmia is to be emitted.

19. 3. The cardiac treatment device according to claim 2, wherein the first control component is further configured to determine a source of an electrical signal causing the global excitation event, and to determine whether a local excitation event of myocardial cells at the predetermined stimulation site corresponds to the specific global excitation event based on at least the source of the electrical signal, the local detection signal, and the far-field detection signal.

20. determining whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to the particular global excitation event based on at least the source of the electrical signal, the local detection signal, and the far-field detection signal; 20. The cardiac therapy device of claim 19, further comprising a step of determining a length of a specific event time window corresponding to the specific overall excitation event based on a source of the electrical signal, wherein if the source of the electrical signal is an electrical impulse from the atrium, the length of the specific event time window is 90 to 120 ms, and if the source of the electrical signal is an electrical impulse from the ventricle itself or an external electrical stimulus applied to the ventricle, the length of the specific event time window is 200 to 250 ms.

21. determining, based on at least the far-field detection signal and / or the local detection signal, whether a stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a particular global excitation event, determining the pulse emission time based on the source of the electrical signal and further based on the local detection signal and / or the far-field detection signal; determining a pulse release time window suitable for transmitting the stimulating electrical pulse based on a source of the electrical signal and further based on the local detection signal and / or the far-field detection signal; 20. The cardiac therapy device of claim 19, further comprising the step of transmitting a stimulating electrical pulse to the pair of stimulating electrodes when the pulse emission time falls within the pulse emission possible time window.

22. 20. The cardiac therapy device of claim 19, wherein the source of the electrical signal that causes the local excitation event includes an electrical impulse from the atrium, an electrical impulse from the ventricle itself, or an external electrical stimulus applied to the ventricle.

23. 3. The cardiac therapy device of claim 2 , wherein the second control component is also configured to control the leadless electrode unit to selectively apply pacing electrical pulses to the predetermined stimulation sites to regulate a heart rate of the patient's heart and to send application times of the pacing electrical pulses to the first control component, the first control component being further configured to determine whether a local excitation event of cardiomyocytes at the predetermined stimulation sites corresponds to the particular global excitation event based on at least the far-field sensing signal and the application times of the pacing electrical pulses.

24. 24. The cardiac therapy device of claim 23, wherein the first or second control component is further configured to receive a mode selection signal and control the cardiac therapy device to a pacing mode or a non-pacing mode based on the mode selection signal, wherein in the non-pacing mode, the first control component determines whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to the specific global excitation event based on at least the far-field detection signal and the local detection signal, and in the pacing mode, the first control component determines whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to the specific global excitation event based on at least the far-field detection signal and an application time of the pacing electrical pulse.

25. 25. The cardiac therapy device of claim 24, wherein in the pacing mode, the first control component is configured to determine capture of the patient's heart based on the far-field detection signal, and after the capture, determine a starting point of a local excitation event of cardiomyocytes at the predetermined stimulation site by an application time of the pacing electrical pulse, and the first control component and / or the second control component is configured to determine whether to apply the stimulating electrical pulse to the predetermined stimulation site based on at least the far-field detection signal and the starting point of the local excitation event.

26. a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes, the first control component configured to detect a global excitation event in the patient's heart with at least some of the subcutaneous electrodes, generate a far-field detection signal indicative of the global excitation event, and emit defibrillation waves to the patient with at least some of the subcutaneous electrodes when the patient develops a malignant arrhythmia; a leadless cardiac stimulation unit configured for contact with a predetermined stimulation site on a patient's heart, the leadless cardiac stimulation unit comprising a second control component and a plurality of stimulation unit electrodes, the second control component configured to apply stimulating electrical pulses through at least some of the stimulation unit electrodes to the predetermined stimulation site for enhancing contractility of cardiomyocytes of the patient's heart, and the second control component configured to apply pacing electrical pulses through at least some of the stimulation unit electrodes to the predetermined stimulation site for regulating a heart rate of the patient, and to generate pacing electrical pulse signals indicative of the applied pacing electrical pulses; the first control component is wirelessly coupled to the second control component, and the first control component is configured to determine whether to apply the stimulating electrical pulse to the predetermined stimulation site based on at least the far-field detection signal and the pacing electrical pulse signal.

27. 27. The cardiac therapy device of claim 26, wherein when the second control component is configured to apply pacing electrical pulses to the predetermined stimulation site by at least some of the plurality of stimulation unit electrodes to regulate the patient's heart rate, the first control component is also configured to determine capture of the patient's heart and, after the capture, determine a starting point of a local excitation event of cardiomyocytes at the predetermined stimulation site by a time of application of the pacing electrical pulses, and the first control component and / or the second control component is configured to determine whether to apply the stimulating electrical pulses to the predetermined stimulation site based on at least the far-field detection signal and the starting point of the local excitation event.

28. a housing configured for subcutaneous implantation in a patient; a plurality of electrodes coupled to the housing and configured for subcutaneous implantation in a patient; a control module wirelessly coupled to a leadless heart failure therapy device in contact with a predetermined stimulation site on the patient's heart, receiving local detection signals indicative of the local activation events generated by the leadless heart failure therapy device based on detection of local activation events of myocardium at the predetermined stimulation site, the control module configured to: sense global activation events of the patient's heart with at least some of the electrodes of the plurality of electrodes and generate far-field detection signals indicative of the global activation events; and determine based on at least the far-field detection signals and the local detection signals whether the local activation events of myocardial cells at the predetermined stimulation site correspond to a specific global activation event or based on at least the far-field detection signals and / or the local detection signals whether a stimulating electrical pulse to be applied by the leadless heart failure therapy device falls within an absolute refractory period of the local activation event and / or the specific global activation event to determine whether to apply the stimulating electrical pulse to the predetermined stimulation site by the leadless heart failure therapy device; a pulse generation module housed within the housing and electrically coupled to at least some of the plurality of electrodes, the pulse generation module being configured to emit defibrillation waves for treating malignant arrhythmia to a patient through at least some of the plurality of electrodes under the control of the control module.

29. determining whether a local excitation event of cardiomyocytes at the predetermined stimulation site corresponds to a specific global excitation event based on at least the far-field detection signal and the local detection signal, obtaining a specific event time window corresponding to the specific global excitation event, and determining that the local excitation event corresponds to the specific global excitation event if the time at which the local excitation event was detected falls within the specific event time window; or 29. The subcutaneous implantable cardioverter-defibrillator of claim 28, further comprising the step of obtaining a specific event time window corresponding to the local excitation event, and determining that the local excitation event corresponds to the specific global excitation event if a time at which the specific global excitation event is detected falls within the specific event time window.

30. 29. The subcutaneously implantable cardioverter-defibrillator of claim 28, wherein the control module and / or the leadless heart failure therapy device are further configured to, if it is determined that the local activation event corresponds to the particular global activation event, determine, based on at least the far-field sensed signal and / or the local sensed signal, whether a stimulating electrical pulse that needs to be applied falls within an absolute refractory period of the local activation event and / or the particular global activation event.

31. determining, based on at least the far-field detection signal and / or the local detection signal, whether a stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a particular global excitation event, determining a pulse emission time of the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse-emission time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; and determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or a specific global excitation event if the pulse emission time falls within the pulse emission possible time window.

32. determining, based on at least the far-field detection signal and / or the local detection signal, whether a stimulating electrical pulse to be applied falls within an absolute refractory period of the local excitation event and / or a particular global excitation event, determining a pulse emission time of the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse-emission time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal; determining a pulse emission end time based on the pulse emission duration and the time interval between the pulse emissions; determining that the stimulating electrical pulse that needs to be applied falls within the absolute refractory period of the local excitation event and / or a specific global excitation event if the pulse emission time and pulse emission end time both fall within the pulse emission possible time window.

33. The step of determining a pulse emission time window suitable for transmitting the stimulating electrical pulse based on the local detection signal and / or the far-field detection signal includes: determining a start time of the pulse emission possible based on the local detection signal and / or the far-field detection signal; and determining the time window during which the pulse can be emitted based on the start time and a predetermined time length of the pulse emission.

34. 29. The subcutaneously implantable cardioverter-defibrillator of claim 28, wherein the control module is further configured to determine a start or detected time of the specific overall activation event based on the far-field sensed signal and to send a signal indicative of the start or detected time of the specific overall activation event to the leadless heart failure therapy device.

35. 1. A method of controlling a cardiac therapy device comprising: a subcutaneous defibrillation unit configured for subcutaneous implantation in a patient, the subcutaneous defibrillation unit including a first control component and a plurality of subcutaneous electrodes; and a leadless cardiac stimulation unit configured for contacting a predetermined stimulation site on a patient's heart, the leadless cardiac stimulation unit including a plurality of stimulation unit electrodes and a second control component wirelessly coupled to the first control component, comprising: the first control component detecting a global activation event in the patient's heart with at least some of the plurality of subcutaneous electrodes and generating a far-field detection signal indicative of the global activation event; the second control component detecting a local excitation event of the myocardium at the predetermined stimulation site using at least some of the plurality of stimulation unit electrodes, and generating a local detection signal indicative of the local excitation event; and a step in which the first control component and / or the second control component determine whether or not to apply the stimulating electrical pulse to the predetermined stimulation site based on at least the far-field detection signal and the local detection signal.

36. 36. A non-volatile computer readable storage medium having a computer program stored thereon, the computer program causing the steps of the method of claim 35 to be implemented when executed by a processor.

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