Pulse stimulators and medical devices

Abstract

We provide pulse stimulation devices and medical devices. [Solution] The device includes an R-wave sensing module (1), a cardiac stimulation pulse generator (2), and at least one control electrode (3), each of which is used to implant in different preset stimulation locations on the patient's myocardium. The R-wave sensing module is used to acquire a surface electrocardiogram and / or myocardial electrocardiogram, to acquire the R-wave sensing time at which the R wave appears, and to determine the pulse transmission time for each preset stimulation location. The pulse transmission time corresponds to the duration from R-wave sensing to the trigger for cardiac stimulation pulse transmission. The cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to the control electrodes based on the pulse transmission time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a pulse stimulation device and a medical device.

Background Art

[0002] Currently commercially available CCM (Cardiac Contractility Modulation) devices are independent implantable devices that are structurally complex and expensive, and are basically used for patients with chronic heart failure. It uses two bipolar leads, is implanted in the right ventricular septum, senses the potential of the local myocardium, and delivers a cardiac stimulation pulse within a predetermined period (within the absolute refractory period) after sensing to increase myocardial contractility. At this time, myocardial stimulation does not directly act on the left ventricle, which is the ventricle most necessary for increasing contractility. The CCM used in the right ventricular septum has an overall effect on cardiac contractility and cardiac function (including the contractility of the left ventricle), but this overall effect is not direct and has been shown by research to be brought about through the effect on the local myocardium resulting from local stimulation of the right ventricular septum. Delivery The current CCM stimulation is only used in implantable equipment for patients with chronic heart failure, and realizes long-term treatment of patients with chronic heart failure by stimulating a single site in the right ventricular septum. However, when the patient's cardiac function rapidly deteriorates and blood pressure drops (for example, in an episode of acute heart failure), the patient may not need an implantable device, or may not use it for a long time, or only requires cardiac function support for a relatively short period until the cause is removed and / or the cardiac function recovers. Existing implantable CCMs and their single-site stimulation do not meet acute and / or short-term support (the period and scope of cardiac / circulatory support), and providing acute and short-term (for several days) cardiac / circulatory support is essential for the survival of the patient (for example, in an acute episode of heart failure). For a patient resuscitated in an emergency situation such as an emergency room or an ambulance, any additional (other than drugs) cardiac circulatory support may mean "life or death" for the patient.

[0003]

Summary of the Invention

Problems to be Solved by the Invention

[0004] The technical problem that the present invention aims to solve is to provide a pulse stimulator and medical device that overcomes the shortcomings of the prior art, namely that existing implantable CCM stimulation methods are only suitable for patients with chronic heart failure and cannot meet the needs of patients with acute and / or short-term conditions, as well as patients for whom single-site electrical stimulation may not provide the necessary circulatory support to the heart. [Means for solving the problem]

[0005] The present invention solves the above technical problems through the following technical solution.

[0006] The present invention includes an R-wave sensing module, a cardiac stimulation pulse generator, and at least one control electrode, wherein the control electrode provides a pulse stimulation device corresponding to a preset stimulation position.

[0007] The control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator, respectively, and the R-wave sensing module is communicatively connected to the cardiac stimulation pulse generator.

[0008] The R-wave sensing module acquires a surface electrocardiogram and / or collects electrocardiogram signals based on the control electrodes to acquire a myocardial electrocardiogram. Based on the myocardial electrocardiogram, the first R wave detection time at which the R wave appears, and / or based on the surface electrocardiogram, the second R wave detection time at which the R wave appears, are obtained, and Based on the first R-wave sensing time, the first pulse corresponding to the preset stimulation position Delivery A second pulse corresponding to the preset stimulation position based on time and / or the second R-wave sensing time. Delivery Used to determine the time.

[0009] The cardiac stimulation pulse generator generates the first pulse Delivery Time and / or the second pulse DeliveryBased on time, cardiac electrical stimulation (CCM) pulses are applied to the corresponding control electrodes. Delivery It is used for that purpose.

[0010] In this embodiment, based on the surface electrocardiogram and / or myocardial electrocardiogram, the R-wave detection time at which the corresponding R wave appears is obtained, and a pulse corresponding to the preset stimulation position is obtained. Delivery By determining the timing, the use needs of acute and / or short-term patients, and patients in whom single-site electrical stimulation may not provide the necessary circulatory support to the heart, are met, ensuring the timeliness and reliability of the triggering of cardiac stimulation pulses, thereby effectively protecting patient safety.

[0011] Optionally, the device includes at least two control electrodes, each of which is used to implant different preset stimulation locations in the left and right ventricular myocardium of the patient.

[0012] In this embodiment, by providing at least two control electrodes to stimulate multiple different locations within the myocardium of the left and right ventricles, it is possible to more effectively improve the contractility of the patient's entire heart, particularly the contractility of the left ventricle, compared to conventional methods that simply stimulate the right interventricular septum. In patients with acute heart failure and / or significant short-term ventricular dysfunction, multi-site stimulation can further improve cardiac contractility and cardiac ejection function.

[0013] Optionally, the apparatus further includes a pulse control module that is communicatively connected to the cardiac stimulation pulse generator.

[0014] The pulse control module is pulse Delivery A mode is generated, and the cardiac stimulation pulse generator Delivery It is used for that purpose.

[0015] The cardiac stimulation pulse generator generates the pulse when an R wave appears in the surface electrocardiogram and / or myocardial electrocardiogram. Delivery Mode and each of the pulses DeliveryBased on time, cardiac stimulation pulses are applied to each of the corresponding control electrodes. Delivery It is used for this purpose.

[0016] In this embodiment, by presetting different pulse Delivery modes in the pulse control module, in the actual pulse Delivery scenario, the pulse Delivery mode is determined based on methods such as manual selection by the operator, presetting of a predetermined fixed pulse mode, or random selection, and pulses can be automatically applied to different preset stimulation positions. Delivery Of course, the pulse Delivery mode can also be dynamically adjusted according to actual needs.

[0017] Optionally, the pulse Delivery mode includes applying cardiac stimulation pulses to the control electrodes corresponding to each of the preset stimulation positions in a synchronous manner, in a set order or a random order, based on the R wave in the surface electrocardiogram and / or the myocardial electrocardiogram. Delivery It includes doing this.

[0018] In this embodiment, pulses are applied in a method such as a set order or a random order synchronously, Delivery meeting various pulse Delivery needs as much as possible, satisfying more pulse stimulation scenarios, ensuring the effectiveness of pulse stimulation for the patient, and at the same time improving the patient's usage experience.

[0019] Optionally, the pulse control module is further used to generate combinations of stimulations corresponding to different preset stimulation positions using a set construction rule or a random combination method based on a set number of the preset stimulation positions.

[0020] Here, the combination of stimulations includes at least two stimulation units, and at least one of the stimulation units corresponds to two or more of the preset stimulation positions for synchronously executing pulses. Delivery It corresponds to this.

[0021] the pulse Delivery The mode is based on the R wave in the surface electrocardiogram and / or the myocardial electrocardiogram, and according to the set order or random order and the combination of the stimuli, a cardiac stimulation pulse is applied to the control electrode at the corresponding preset stimulation position Delivery including doing so.

[0022] In this embodiment, without considering each preset stimulation position individually, different combinations of stimuli are formed based on a plurality of preset stimulation positions, and pulses are applied synchronously to different preset stimulation positions corresponding to the same combination of stimuli Delivery and the different combinations of stimuli are pulse Delivery The pulse stimulation is performed using a method to meet the needs of more pulse stimulation scenarios and further ensure patient safety.

[0023] Optionally, a cardiac stimulation pulse is continuously applied to the corresponding preset stimulation position in a set order or a random order Delivery to reach a preset heart rate.

[0024] In this embodiment, control electrodes are arranged at multiple sites in the left and right ventricles, and cardiac electrical stimulation (CCM) is provided to these multiple sites synchronously or sequentially to achieve electrical circulatory support (ECS). Compared with the method in the prior art that simply stimulates the right ventricular septum, the contractility of the patient's entire heart, especially the contractility of the left ventricle, can be more effectively improved. In the case of patients with severe acute heart failure and / or short-term ventricular dysfunction, multi-site stimulation can further improve the contractility of the heart and improve the cardiac ejection function.

[0025] Optionally, the preset stimulation location includes at least one of the following: the medial wall of the left and right interventricular septum, the interventricular groove of the ventricular lateral wall, the lateral wall of the left ventricle, the anterolateral wall of the left ventricle, the posterolateral wall of the left ventricle, the medial wall of the right ventricular free wall, the extracardiac wall of the right ventricular free wall, the apex of the right ventricle, and the apex of the left ventricle.

[0026] In this embodiment, in order to ensure the reliability of cardiac pulse stimulation as much as possible, control electrodes are provided at the above-listed positions in the left and right ventricles, respectively, or control electrodes are provided at several positions depending on the actual stimulation needs.

[0027] Optionally, the R-wave sensing module is used to acquire a surface electrocardiogram, acquire a cardiac electrocardiogram based on the control electrodes, and acquire the first R-wave sensing time at which the R-wave appears based on the cardiac electrocardiogram, and the second R-wave sensing time at which the R-wave appears based on the surface electrocardiogram.

[0028] The R-wave sensing module further generates a first pulse corresponding to each of the preset stimulation positions based on the first R-wave sensing time. Delivery Used to calculate time.

[0029] The R-wave sensing module further generates a second pulse corresponding to each of the preset stimulation positions based on the first R-wave sensing time and the second R-wave sensing time. Delivery Used to calculate time.

[0030] The cardiac stimulation pulse generator generates the first pulse Delivery Time and / or the second pulse Delivery Based on time, cardiac stimulation pulses are applied to each of the corresponding control electrodes. Delivery It is used for that purpose.

[0031] In this embodiment, the first R wave detection time at which the R wave appears in the electrocardiogram is acquired, and the first pulse corresponding to the preset stimulation position is obtained. DeliveryThe time is calculated, the second R wave detection time at which the R wave appears on the surface electrocardiogram is obtained, and based on the first R wave detection time and the second R wave detection time, a second pulse corresponding to the preset stimulation position is generated. Delivery By calculating the time, the first pulse Delivery Time and / or second pulse Delivery Pulses based on time Delivery This is done by pulsing based on the R wave of the myocardial electrocardiogram and the R wave of the surface electrocardiogram. Delivery By proposing a scheme for determining the timing, we effectively ensure the timeliness and reliability of pulsed stimulation.

[0032] Optionally, the R-wave sensing module further uses the first R-wave sensing time as a reference zero point and, based on the preset duration, generates a first pulse corresponding to each preset stimulation position. Delivery Used to calculate time.

[0033] The R-wave sensing module further calculates a first time difference between the second R-wave sensing time and the first R-wave sensing time for each of the preset stimulation positions, and, using the second R-wave sensing time as the reference zero point, calculates the second pulse corresponding to each of the preset stimulation positions based on the first time difference and the preset duration. Delivery Used to calculate time.

[0034] Optionally, the cardiac stimulation pulse generator may use the second pulse Delivery After acquiring the time, the first time difference is maintained, and the second pulse Delivery Based on time, cardiac stimulation pulses are applied to the corresponding control electrodes. Delivery It is used to maintain the action.

[0035] The device optionally further includes a time update module.

[0036] The time update module updates the first time difference periodically or irregularly, and based on the updated first time difference, the second pulse Delivery Used to update the time.

[0037] The cardiac stimulation pulse generator updates the second pulse Delivery Based on time, cardiac stimulation pulses are applied to the corresponding control electrodes. Delivery It is used for that purpose.

[0038] In this embodiment, in order to achieve a more flexible electrical stimulation effect and meet the needs of more pulsed electrical stimulation scenarios, a second pulse is introduced according to the actual needs. Delivery The time (at which point myocardial electrical stimulation can be continued or stopped) can be updated periodically or irregularly, and myocardial electrical stimulation is then continued based on the next updated trigger time.

[0039] Optionally, the R-wave sensing module further provides a pacing pulse as the first R-wave sensing time corresponding to the control electrode providing pacing when pacing is performed at one preset stimulation position. Delivery It is used to utilize time, and the preset duration is 60-80ms.

[0040] Optionally, the R-wave sensing module is further used to acquire the electrocardiogram corresponding to all other remaining preset stimulation locations when pacing is performed at one preset stimulation location, and to acquire a new first R-wave sensing time at which the R wave appears in the electrocardiogram, and a new second R-wave sensing time at which the R wave appears in the electrocardiogram.

[0041] The R-wave sensing module further generates a new first pulse corresponding to each of the preset stimulation positions, based on the new first R-wave sensing time and preset duration. Delivery Used to calculate time.

[0042] The R-wave sensing module further calculates a new first time difference between the new second R-wave sensing time and the new first R-wave sensing time for each of the preset stimulation positions, and, using the new second R-wave sensing time as the reference zero point, calculates a new second pulse corresponding to each of the preset stimulation positions based on the new first time difference and the preset duration. Delivery Used to calculate time.

[0043] In this embodiment, when pacing is performed via a single control electrode, the pulse stimulation scenario recalculates the R-wave sensing time in the new myocardial electrocardiogram R-wave and the surface electrocardiogram R-wave, and then the corresponding first pulse Delivery Time and second pulse Delivery Each time needs to be calculated, which ensures timely pulse stimulation in that scenario. Delivery To achieve this.

[0044] Optionally, the R-wave sensing module acquires multiple first R-wave sensing times corresponding to the appearance of R waves in the electrocardiogram at multiple preset stimulation locations, selects one first R-wave sensing time as a reference zero point, calculates a second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and generates a first pulse corresponding to each preset stimulation location based on the second difference and the preset duration. Delivery Used to calculate time.

[0045] In this embodiment, one first R-wave detection time (LS) is arbitrarily selected as the reference zero point, and the stimulus position at other times thereafter is... Delivery Based on this, the difference is calculated and the preset duration is added, resulting in the pulse at each pulse stimulation position. Delivery This allows for time acquisition, enabling timely and effective pulses based solely on the electrocardiogram, without relying on the surface electrocardiogram. Delivery This achieves the goal of making the control process of pulsed stimulation more flexible and adaptable to a wider range of usage scenarios.

[0046] Optionally, the R-wave sensing module is used to randomly select one of the occurrence times of multiple first R-wave sensing times, or to select the first R-wave sensing time with the earliest occurrence time as the reference zero point.

[0047] Optionally, the first R-wave detection time at which the R-wave acquired based on the myocardial electrocardiogram appears, and the second R-wave detection time at which the R-wave acquired based on the surface electrocardiogram appears, correspond to the same heartbeat.

[0048] In this embodiment, in order to ensure the effectiveness of pulse stimulation, all R waves (i.e., R waves in the myocardial electrocardiogram and R waves in the surface electrocardiogram) are detected at the same heartbeat. That is, the myocardial electrocardiogram acquires the detection time of the first R wave when the R wave appears, and the surface electrocardiogram acquires the detection time of the second R wave when the R wave appears. The time difference between the two R wave detection times must be within a predetermined value, otherwise the pulse stimulation has substantial meaning, and the reliability of the pulse stimulation cannot be ensured.

[0049] Optionally, the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator using a unipolar or bipolar lead.

[0050] Optionally, the R-wave sensing module is used to acquire the surface electrocardiogram and the myocardial electrocardiogram. If the surface electrocardiogram is poorly perceived, the R-wave sensing module acquires the first R-wave detection time at which the R wave appears based on the myocardial electrocardiogram, and based on the first R-wave detection time, it generates a first pulse corresponding to the preset stimulation position. Delivery Used to determine the time, if the perception of the myocardial electrocardiogram is poor, the R-wave sensing module obtains a second R-wave sensing time in which the R wave appears based on the surface electrocardiogram, and based on the second R-wave sensing time, a second pulse corresponding to the preset stimulation position Delivery Used to determine the time.

[0051] The present invention further provides a medical device including the pulse stimulation device described above.

[0052] Based on common sense in the art, each preferred embodiment of the present invention can be obtained by arbitrarily combining each of the above preferred conditions.

[0053] The positive advancements and effects of this invention are as follows:

[0054] (1) By placing control electrodes (e.g., corresponding stimulating and / or pacing functions) at multiple locations in the left and right ventricles and providing cardiac electrical stimulation (CCM) to multiple locations synchronously or sequentially, cardiac circulatory support can be provided, and the contractility of the patient's entire heart, especially the contractility of the left ventricle, can be improved more effectively compared to conventional methods that simply stimulate the right interventricular septum. In patients with acute heart failure and / or significant short-term ventricular dysfunction, multi-site stimulation can further improve cardiac contractility and cardiac ejection function. For example, in patients who have recently undergone cardiac surgery, leads can be implanted at different locations in the myocardium of the left and right ventricles (e.g., anterior / posterior positions of the left ventricle on the epicardial surface, interventricular groove, right ventricular free wall, etc.). In other patients, leads may be placed via veins within the right ventricle (e.g., interventricular septum, apex, or free wall), and / or via interventricular septa or arteries into the endocardium of the left ventricle (e.g., interventricular septum, apex, or free wall), or via electrodes placed on the epicardial surface of the left ventricle (e.g., via electrodes placed in coronary veins or arteries).

[0055] (2) Cardiac electrical stimulation (CCM) method (mechanism, timing, etc.): a. The stimulation mechanism is a multi-site cardiac electrical stimulation mechanism (synchronous or sequential), for example, all electrode sites are triggered in one cardiac cycle (synchronous stimulation), or trigger stimulation (sequential stimulation) of each electrode site is completed in a set order or random order over multiple cardiac cycles. b. The trigger mechanism uses the timing of R-wave detection representing local ventricular electromyographic activity and / or R-wave detection representing global ventricular electromyographic activity as the trigger point. In the latter case, the temporal relationship between the global ventricular electromyographic R wave and the local ventricular electromyographic R wave becomes part of the trigger time. The stimulation method (mechanism, timing, etc.) can be dynamically adjusted according to the actual situation in order to adapt to the patient's constantly changing heart rate and overall cardiac condition. That is, it can be adapted and adjusted according to the dynamic changes in each patient's own heart in order to effectively enhance the effect of improving cardiac function.

[0056] (3) CCM Delivery This eliminates the need to use two unipolar or bipolar leads at a single cardiac location, as it can be implemented with a simple unipolar lead, thus simplifying the system structure and reducing costs. [Brief explanation of the drawing]

[0057]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

[0058] The present invention will be further described below through examples, but the present invention is not limited thereto to the scope of the above examples.

[0059] <Example 1> As shown in Figure 1, the pulse stimulator of this embodiment includes an R-wave sensing module 1, a cardiac stimulation pulse generator 2, and at least one control electrode 3. The control electrode 3 is electrically connected to the R-wave sensing module 1 and the cardiac stimulation pulse generator 2, respectively, via leads 4, and the R-wave sensing module 1 is communicatively connected to the cardiac stimulation pulse generator 2.

[0060] Preferably, the device includes at least two control electrodes, the different control electrodes being used to implant different preset stimulation locations in the left and right ventricular myocardium of the patient.

[0061] By providing at least two control electrodes to stimulate multiple different locations within the myocardium of the left and right ventricles, the contractility of the patient's entire heart, particularly the contractility of the left ventricle, can be more effectively improved compared to conventional methods that simply stimulate the right interventricular septum. In patients with acute heart failure and / or significant short-term ventricular dysfunction, multi-site stimulation can further improve cardiac contractility and cardiac ejection function. Of course, the number of control electrodes can be reset and adjusted according to the needs of the actual scenario.

[0062] Specifically, different preset stimulation locations include, but are not limited to, the medial walls of the left and right interventricular septa, the interventricular grooves of the ventricular lateral walls, the lateral wall of the left ventricle, the anterolateral wall of the left ventricle, the posterolateral wall of the left ventricle, the medial wall of the right ventricular free wall, the extracardiac wall of the right ventricular free wall, the apex of the right ventricle, and the apex of the left ventricle.

[0063] To ensure the reliability of cardiac pulse stimulation as much as possible, control electrodes should be placed at the listed locations in the left and right ventricles, respectively, or at several locations depending on the actual stimulation needs.

[0064] The R-wave sensing module 1 is used to acquire a surface electrocardiogram (ECG) and / or to acquire an electrocardiogram (EGM) by collecting electrocardiogram signals based on the control electrode 3, and since the control electrode can be placed in the ventricular or epiventricular lining, the EGM covers signals from within the ventricular cavity or from the ventricular wall.

[0065] Specifically, the R-wave sensing module 1 acquires the R-wave sensing time at which the R-wave appears based on the surface electrocardiogram and / or myocardial electrocardiogram, and based on the R-wave sensing time, determines the cardiac stimulation pulse (or CCM electrical stimulation) corresponding to each preset stimulation position. Delivery Used to determine time, pulse Delivery The time is measured from the detection of the R wave to the cardiac stimulation pulse. Delivery Corresponding to the duration until trigger, CCM at each location or site Delivery This is triggered by R-wave detection in a local electrocardiogram (EGM) or a whole-body electrocardiogram (ECG).

[0066] The cardiac stimulation pulse generator 2 generates each pulse Delivery Based on time, cardiac stimulation pulses are applied to each corresponding control electrode 3. Delivery It is used for that purpose.

[0067] In one implementable embodiment, the R-wave sensing module is used to acquire a surface electrocardiogram and / or a cardiac electrocardiogram based on control electrodes, and to acquire a first R-wave sensing time at which an R wave appears based on the cardiac electrocardiogram and a second R-wave sensing time at which an R wave appears based on the surface electrocardiogram, respectively.

[0068] In this embodiment, the first R-wave detection time, when the R-wave appears as obtained by the myocardial electrocardiogram, and the second R-wave detection time, when the R-wave appears as obtained by the surface electrocardiogram, correspond to the same heartbeat.

[0069] To ensure the effectiveness of pulse stimulation, all R waves (i.e., R waves in the myocardial electrocardiogram and R waves in the surface electrocardiogram) are detected at the same heartbeat. That is, the myocardial electrocardiogram captures the detection time of the first R wave when the R wave appears, and the surface electrocardiogram captures the detection time of the second R wave when the R wave appears. The time difference between the two R wave detection times must be within a predetermined value, otherwise the pulse stimulation has substantial meaning, and the reliability of the pulse stimulation cannot be ensured. The R wave detection module further generates a first pulse corresponding to each preset stimulation position based on the first R wave detection time. Delivery Used to obtain time, where the first R-wave sensing time is determined, and the corresponding first pulse Delivery The time will also be determined.

[0070] The R-wave sensing module further generates a second pulse corresponding to each preset stimulation position based on the first and second R-wave sensing times. Delivery Used to calculate time.

[0071] The cardiac stimulation pulse generator produces the first pulse. Delivery Time and / or second pulse Delivery Based on time, cardiac stimulation pulses are applied to the control electrode. Delivery It is used for that purpose.

[0072] In the pulse stimulation process in this embodiment, (1) the R wave of the surface electrocardiogram is mainly used as the cardiac stimulation pulse. Delivery This can be performed. That is, stimulation of each electrode Delivery The trigger time is set to the R wave detection time of the surface electrocardiogram as the reference zero point. (2) The cardiac stimulation pulse is mainly based on the R wave of the myocardial electrocardiogram. Delivery This can be performed. That is, stimulation of each electrode Delivery The time is set with the R wave of the electrocardiogram as the reference zero point for the trigger time. (3) Simultaneously, the cardiac stimulation pulse is calculated based on the R wave of the surface electrocardiogram and the R wave of the electrocardiogram. Delivery This is performed. Specifically, one of the three trigger mechanisms can be used, which can be selected or adjusted in real time according to the actual needs of the electrical stimulation.

[0073] Furthermore, to further improve the control effect of cardiac stimulation pulse triggers, if the perception of the body surface ECG is poor, it can be directly switched to an EGM-based trigger, or if the perception of the EGM at a certain location is poor, it can be directly switched to an ECG-based trigger. In other words, it avoids situations where pulse stimulation cannot be continued due to special circumstances such as misrecognition or poor perception, and ensures that treatment can be continued in a timely and effective manner.

[0074] In one feasible embodiment, the R-wave sensing module 1 generates a first pulse corresponding to each preset stimulus position based on the first R-wave sensing time and preset duration. Delivery Used to calculate time.

[0075] In the case of an electrocardiogram (EGM) collected by electrode 3, the first pulse Delivery The time is calculated based on a preset duration (LPD), using the R-wave detection time of the myocardial electrocardiogram (EGM) as the reference zero point (or trigger point). This duration is typically 40 ms by default, and the value of this duration can be adjusted according to actual needs. First pulse at each site or location. Delivery The time is the time of R wave detection in the electrocardiogram relative to the CCM pulse at that site or location. Delivery This is the trigger time.

[0076] The R-wave sensing module 1 further calculates the first time difference between the second R-wave sensing time and the first R-wave sensing time, and based on the first time difference and the preset duration, sets the second R-wave sensing time as the reference zero point (or trigger point) and generates a second pulse corresponding to each preset stimulation position. Delivery Used to calculate time.

[0077] The first R wave detection time, when the R wave appears on the electrocardiogram, is acquired, and the first pulse corresponding to the preset stimulation position is generated. Delivery The time is calculated, the second R wave detection time at which the R wave appears on the surface electrocardiogram is obtained, and based on the first and second R wave detection times, a second pulse corresponding to the preset stimulation position is generated.Delivery By calculating the time, the first pulse Delivery Time and / or second pulse Delivery Pulses based on time Delivery This is done by pulsing based on the R wave of the myocardial electrocardiogram and the R wave of the surface electrocardiogram. Delivery By proposing a scheme for determining the timing, we effectively ensure the timeliness and reliability of pulsed stimulation.

[0078] In other words, in the case of a CCM pulse triggered by the R wave of an EGM, the CCM pulse starts from the R wave. Delivery The duration of each stimulation position is fixed until (for example, the preset duration is 40ms). In the case of a CCM pulse triggered by the R wave of the ECG, the CCM pulse starts from the R wave. Delivery The duration of each stimulation location is not fixed but varies (i.e., determined by a fixed preset duration of 40ms and the time difference based on the change in location).

[0079] As shown in Figure 2, when a patient is in sinus rhythm, for the surface electrocardiogram (ECG), first, the time difference (GLSD) between the corresponding time of R wave detection in the surface ECG (second R wave detection time) and the corresponding time of R wave detection in the focal myocardial electrocardiogram (EGM) (first R wave detection time) is calculated. This time difference characterizes the time sensitivity of the myocardial electrical activity of the corresponding myocardial portion / location to the overall cardiac electrical activity, and a second pulse is triggered using the R wave detection time of the surface ECG as the reference zero point (or trigger point). Delivery The time is obtained by adding the corresponding time difference (GLSD) and preset duration (LPD), i.e., from the time of R wave detection in the surface electrocardiogram (ECG) to the second pulse. Delivery The duration up to a certain time is GPD, where GPD = GLSD + LPD. Furthermore, the GLSD and GPD corresponding to each site can be measured over multiple intrinsic heartbeats and averaged (by default, five consecutive intrinsic heartbeats in the range of 3 to 12). The second pulse for each site or location. Delivery The time is the time of R wave detection in the surface electrocardiogram relative to the CCM at the site or location. DeliveryThis is the trigger time. In this example, this step is called the setup period.

[0080] In one feasible embodiment, the cardiac stimulation pulse generator generates a second pulse at each position. Delivery After obtaining the time, maintain the first time difference and then the second pulse Delivery Cardiac stimulation pulses are applied to the corresponding control electrodes based on time. Delivery It is used to maintain the action.

[0081] That is, in this embodiment, the second pulse Delivery After calculating the time, there is no need to recalculate before each electrical stimulation output. The electrical stimulation output time can be directly triggered by the surface electrocardiogram, eliminating the need to sense and trigger the R wave of the myocardial electrocardiogram each time. This effectively reduces data processing time and improves the control efficiency of cardiac stimulation pulse triggering while achieving the desired effect of cardiac electrical stimulation.

[0082] In one feasible embodiment, the apparatus of this embodiment further includes a time update module.

[0083] The time update module updates the first time difference periodically or irregularly, and then pulses a second pulse based on the updated first time difference. Delivery Used to update the time.

[0084] The cardiac stimulation pulse generator has been updated with a second pulse. Delivery Based on time, cardiac stimulation pulses are applied to the corresponding control electrodes. Delivery It is used for that purpose.

[0085] In other words, in this embodiment, in order to achieve a more flexible electrical stimulation effect and meet the needs of more pulsed electrical stimulation scenarios, a second pulse is added according to the actual needs. Delivery The time (at which point myocardial electrical stimulation can be continued or stopped) can be updated periodically or irregularly, and myocardial electrical stimulation is then continued based on the next updated trigger time.

[0086] In this embodiment, the effect of enhancing or maximizing circulatory support to the heart is achieved by setting the stimulation location and stimulation mechanism.

[0087] Of course, the CCM stimulation control scheme in this embodiment needs to be automatically interrupted under certain special circumstances, such as when the patient's heart rate is too fast (e.g., exceeding 120 beats / minute) or when PVCs (premature ventricular contractions) are detected, in order to ensure the safety of supporting the patient's cardiac stimulation.

[0088] In this embodiment, control electrodes (e.g., corresponding stimulation and / or pacing functions) are placed at multiple sites in the left and right ventricles, and cardiac electrical stimulation (CCM) is provided to multiple sites. Compared to conventional methods that simply stimulate the right interventricular septum, this method can more effectively improve the contractility of the patient's entire heart, particularly the contractility of the left ventricle. In patients with acute heart failure and / or significant short-term ventricular dysfunction, multi-site stimulation can further improve cardiac contractility and cardiac ejection function.

[0089] <Example 2> As shown in Figure 3, the pulse stimulation device of this embodiment is a further improvement over the one in Embodiment 1, and specifically, The pulse stimulator of this embodiment further includes a pulse control module 5 that is communicatively connected to the cardiac stimulation pulse generator 2.

[0090] The pulse control module 5 is pulse Delivery A mode is generated, and the cardiac stimulation pulse generator 2 Delivery It is used for that purpose.

[0091] The cardiac stimulation pulse generator 2 generates a pulse when an R wave appears on the surface electrocardiogram or myocardial electrocardiogram. Delivery Mode and pulse Delivery Based on time, cardiac stimulation pulses are applied to each corresponding control electrode 3. Delivery It is used for that purpose.

[0092] Different pulses in the pulse control moduleDelivery By pre-setting the mode, the actual pulse Delivery In the scenario, pulses are generated based on methods such as operator selection, pre-setting of a predetermined fixed pulse mode, or random selection. Delivery Determine the mode and pulse to different preset stimulation locations. Delivery This can be achieved automatically. Of course, pulses can be applied according to actual needs. Delivery The mode can also be adjusted dynamically.

[0093] In one feasible embodiment, pulse [[ID=1L17]]Delivery The mode synchronously applies cardiac stimulation pulses to the control electrodes corresponding to each preset stimulation position in a set or random order, based on the R wave in the surface electrocardiogram and / or myocardial electrocardiogram. Delivery This includes doing so.

[0094] Cardiac stimulation pulses are delivered sequentially to the corresponding preset stimulation locations in a set or random order. Delivery This will cause the heart rate to reach a preset level.

[0095] pulse Delivery The mode is triggered by the global R wave in the surface electrocardiogram, or by the local R wave in each area. Delivery The mechanism involves delivering cardiac stimulation pulses to each preset stimulation location synchronously, in a set or random order. Delivery Alternatively, this may involve a setup period, i.e., measurements and calculations for GLSD corresponding to each electrode position.

[0096] Pulses are transmitted synchronously in a set order or random order. Delivery By doing so, various pulses Delivery To meet as many needs as possible, accommodate a wider range of pulsed stimulation scenarios, ensure the effectiveness of pulsed stimulation for patients, and improve the patient experience.

[0097] CCM stimulation to a location or site is triggered "simultaneously" (i.e., in the same cardiac cycle) at the corresponding time for each site after the same R wave. Delivery It can also be done (called synchronization), or sequentially to multiple sites in multiple R waves. Delivery It can also be done in the set order. Delivery If so, CCM stimulation is triggered in one site after the R wave, after the corresponding time interval for that site. Delivery Then, after the next R wave, at the next site Delivery In this way, all parts Delivery This continues until covered by the CCM. After the same R wave, CCM stimulation may appear in one or more sites according to the corresponding time for each site (but not all sites, otherwise they are synchronized). Furthermore, the order in which specific sites receive CCM stimulation may be specially designed (which can be programmed by staff with relevant authority, such as a physician) or randomized. Sequentially Delivery When this is done, the number of times each preset site is stimulated may be one or more times (for example, six times, i.e., six cardiac cycles), after which the stimulation of the next preset site is moved on to, and the process is carried out by analogy.

[0098] In one feasible embodiment, the pulse control module is further used to generate combinations of stimuli corresponding to different preset stimulus locations, using a set construction rule or a random combination based on a set number of preset stimulus locations.

[0099] Here, the combination of stimuli includes at least two stimuli units, and at least one of the stimuli units is pulsed. Delivery It corresponds to two or more preset stimulus positions that execute synchronously.

[0100] pulse Delivery The mode applies cardiac stimulation pulses to control electrodes corresponding to preset stimulation positions, based on the R wave in the surface electrocardiogram and / or myocardial electrocardiogram, according to a set or random order and combination of stimulations. Delivery This includes doing so.

[0101] Cardiac stimulation pulses are delivered sequentially to the corresponding preset stimulation locations in a set or random order. Delivery This will cause the heart rate to reach a preset level.

[0102] Instead of considering each preset stimulus position individually, different stimulus combinations are formed based on multiple preset stimulus positions, and pulses are synchronously applied to different preset stimulus positions corresponding to the same stimulus combination. Delivery The combination of different stimuli is a pulse in a set order or a random order. Delivery This method uses pulsed stimulation to meet the needs of a wider range of pulsed stimulation scenarios and further ensure patient safety.

[0103] Furthermore, in one feasible embodiment, the pulse stimulator corresponds to two leads 4, with the electrode of one lead located near the right ventricular septum (the right ventricular septum being in an endocardial position) or the anterior or posterior interventricular groove (in an epicardial position), and the electrode of the other lead located on the anterolateral wall of the left ventricle (in an epicardial or endocardial position).

[0104] In one feasible embodiment, the pulse stimulator corresponds to three leads 4, with the electrode of one lead located near the right interventricular septum (which is an endocardial location) or anterior or posterior interventricular groove (which is an epicardial location), the electrode of one lead located near the posterolateral wall of the left ventricle (which is an epicardial or endocardial location), and the electrode of the other lead located near the anterolateral wall of the left ventricle (which is an epicardial or endocardial location).

[0105] Of course, the number of leads 4 and the pre-set implantation locations can also be replanned depending on the different patient conditions, the status of cardiac-related surgery, the circulatory support needs, and the CCM stimulation needs.

[0106] In one feasible embodiment, the lead 4 of this embodiment includes a unipolar lead or a bipolar lead, and the cardiac stimulation pulse is transmitted through the lead 4 to the corresponding site. Delivery(1) When using a single unipolar lead, the CCM will be placed between the unipolar electrode in contact with the myocardium and the electrodes on other parts of the patient's body. Delivery In this case, the unipolar electrode may be an electrode on another electrode lead in the cardiac chamber or blood vessel, a surface ECG electrode or a surface patch electrode for extracorporeal defibrillation; or an electrode implanted subcutaneously (e.g., S-ICD) or an electrode implanted in the heart. Alternatively, it may be obtained using other specially designed electrodes. (2) When using multiple unipolar leads, the CCM is placed between two unipolar electrodes in contact with the myocardium (one cathode, the other anode) Delivery (3) When using bipolar leads, only one electrode is in continuous contact with the myocardium (e.g., right ventricular septal lead 4), and the CCM is between the two electrodes. Delivery This can also be done as a single-electrode lead (an electrode in contact with the myocardium). Delivery It is also possible to do so, similar to a unipolar setup. (4) For example, in the case of an epicardial electrode of the left ventricle, the CCM can be between the two electrodes, or each as two unipolar leads. Delivery (5) Since unipolar and bipolar leads can be used simultaneously, many combinations are possible, and how they are combined can be determined and adjusted according to actual needs.

[0107] The operating principle of the pulse stimulation device of this embodiment will be explained in detail below with reference to practical examples.

[0108] (1) Three bipolar leads 4 are implanted in the epicardial surface of a patient who has just undergone open-heart cardiac surgery, specifically in the interventricular groove (near the interventricular groove of the ventricle) of the anterior or posterior epicardial wall, the posterolateral wall of the left ventricle, and the anterolateral wall of the left ventricle. Simultaneously, the patient's current surface electrocardiogram is provided. These three leads, along with the surface electrocardiogram, are connected to an external electrical circulatory support device, i.e., the R-wave sensing module 1 of a pulse stimulator.

[0109] (2) During the setup period, the R-wave sensing module 1 is used to sense the R-wave sensing time (GS) of the surface electrocardiogram (ECG) and the R-wave sensing times LS (LS1, LS2, LS3) of the myocardial electrocardiogram (EGMs), as shown in Figure 2. Based on GS, LS (LS1, LS2, LS3) and LPD, the GLSD and GPD (GLSD1 and GPD1, GLSD2 and GPD2, GLSD31 and GPD3) of each site are calculated, where GLSD = LS - GS and GPD = GLSD + LPD.

[0110] (3) Cardiac stimulation pulse Delivery Mode (R-wave trigger source, synchronous or sequential, and specific or random order within the sequence can all be programmed by the physician), cardiac stimulation pulse Delivery Based on the mode, LPD, and GPD, cardiac stimulation pulses are generated for one or more sites, as shown in Figure 4.

[0111] (4) Once connected, the device goes through a setup process to sense the R wave (GS and LS) and calculate the GLSD and GPD for each part (where each of the three leads is located), where n=1, 2, and 3 in the GLSDn and GPDn. Delivery It is best performed during sinus rhythm when it is not being performed. Next, in the case of R-wave trigger mode for surface ECG, after sensing the R wave of the surface ECG, the CCM will operate according to the corresponding GPD at each location in either synchronous mode (with the same heartbeat (R wave)) or sequential mode (for example, the CCM will go to site 1 after R wave 1, site 2 after R wave 2, site 3 after R wave 3 (one by one)). Delivery (to be done), or CCM in a random order Delivery / Trigger.

[0112] Similarly, CCM can be triggered by local R-waves in each site and can be performed synchronously or sequentially (local / local R-wave mode).

[0113] Furthermore, the CCM can set a specific heart rate or duration (default is 3600 beats or 60 minutes, programmable).Delivery Afterward, the setup process is restarted to accommodate potential changes in parameters (e.g., GLSD, etc.) due to changes in heart rate and / or patient condition (e.g., after medication). Furthermore, the CCM is adjusted based on the updated parameters. Delivery You can also continue with it.

[0114] The control method for cardiac stimulation pulse triggers described above can meet the needs of acute and / or short-term patients, and patients for whom single-site electrical stimulation can achieve the necessary circulatory support for the heart. In particular, for patients with weak cardiac function (e.g., relatively low cardiac output) who are unsuitable for or anxious about undergoing cardiac surgery, it can effectively enhance postoperative cardiac function, accelerate patient recovery, and provide timely and effective support for the patient's cardiac needs. At the same time, this technology can help increase the confidence of both patients and physicians when performing the relevant surgery. Furthermore, while existing methods of increasing cardiac contractility based on drugs often have side effects (e.g., arrhythmias, increased myocardial oxygen consumption, etc., which can increase mortality), the control method for cardiac stimulation pulse triggers in this embodiment has virtually no associated side effects (heart rate and oxygen consumption do not fundamentally change) and can achieve a better effect in increasing cardiac contractility by achieving electrical stimulation more timely and effectively.

[0115] In this embodiment, control electrodes are placed at multiple locations in the left and right ventricles (for example, for stimulation and / or pacing functions) to provide synchronous or sequential cardiac electrical stimulation (CCM) to multiple locations. The trigger mechanism for CCM stimulation is determined by the timing of R-wave detection of local electrocardiogram activity and / or R-wave detection of global electrocardiogram activity. The trigger method is dynamically adjusted according to the actual situation to adapt to the patient's constantly changing heart rate and overall cardiac condition. That is, by adapting and adjusting according to the dynamic changes in each patient's own heart, the control effect of CCM stimulation is effectively improved, better cardiac contractility is achieved, and the needs of acute and / or short-term patients, as well as patients for whom single-site electrical stimulation can achieve the necessary circulatory support for the heart, can be better met.

[0116] <Example 3> The pulse stimulation device of this embodiment is a further improvement of Embodiment 2, and this embodiment takes into account a CCM stimulation scenario in which the control electrode performs pacing operations, specifically, Regarding the CCM stimulation scenario during pacing, there are two situations: a) Pacing is generated by an independent electrode, in which case the control principle of the cardiac stimulation pulse trigger is consistent with the above and unaffected; b) When pacing is generated by a CCM stimulation electrode, the electrode that primarily provides CCM stimulation must also provide pacing (recognized as the electrode position corresponding to the first R-wave sensing time (LS1) during pacing), while the operating principle of the other remaining electrode positions (which provide only CCM stimulation) is consistent with the above. In the case of a CCM stimulation electrode that provides pacing, the first R-wave sensing time (LS1) during pacing corresponds to the pacing pulse. Delivery This is a time interval, and the preset duration needs to be extended to 40-100ms, preferably 60-80ms (this can also be adjusted in the program). In either case, two measurements are required within the preset period: one measurement to detect your heart rate (sinus rhythm) and the other during pacing.

[0117] Specifically, when the control electrode performs a pacing action, the R-wave sensing module is further used to acquire the electrocardiogram (ECG) corresponding to all other remaining preset stimulation locations when pacing is performed at one preset stimulation location, and to acquire a new first R-wave sensing time at which the R wave appears in the ECG, and a new second R-wave sensing time at which the R wave appears in the surface ECG.

[0118] The R-wave sensing module further generates a new first pulse corresponding to each preset stimulation location, based on the new first R-wave sensing time and preset duration. Delivery Used to calculate time.

[0119] The R-wave sensing module further calculates a new first time difference between the new second R-wave sensing time and the new first R-wave sensing time at each preset stimulation location, and, using the new second R-wave sensing time as the reference zero point, calculates a new second pulse corresponding to each preset stimulation location based on the new first time difference and the preset duration. Delivery Used to calculate time.

[0120] In this embodiment, when pacing is performed via a single control electrode, the pulse stimulation scenario recalculates the R-wave sensing time in the new myocardial electrocardiogram and the R-wave of the surface electrocardiogram, and then the corresponding first pulse Delivery Time and second pulse Delivery Each time needs to be calculated, which ensures timely pulse stimulation in that scenario. Delivery To achieve this.

[0121] <Example 4> The pulse stimulation device of this embodiment is a further improvement over that of Embodiment 2, and specifically, The R-wave sensing module acquires multiple first R-wave sensing times corresponding to the appearance of the R wave in the electrocardiogram at multiple preset stimulation locations, selects one first R-wave sensing time as the reference zero point, calculates the second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and calculates the first pulse corresponding to each preset stimulation location based on the second difference and the preset duration. Delivery Used to calculate time.

[0122] Here, the R-wave sensing module is used to randomly select one first R-wave sensing time from multiple occurrence times, or to select the first R-wave sensing time with the earliest occurrence time as the reference zero point. Based on practical experience, it is generally preferable to select the first R-wave sensing time with the earliest occurrence time as the reference zero point.

[0123] In this embodiment, the first R-wave detection time (LS), which is the earliest occurrence time, is selected as the reference zero point, and the stimulus position at other times thereafter is used. DeliveryBased on this, the difference is calculated and the preset duration is added, resulting in the pulse at each pulse stimulation position. Delivery This allows for time acquisition, enabling timely and effective pulses based solely on the electrocardiogram, without relying on the surface electrocardiogram. Delivery This achieves the goal of making the control process of pulsed stimulation more flexible and adaptable to a wider range of usage scenarios.

[0124] <Example 5> The pulse stimulation method in this embodiment is implemented using the pulse stimulation device of Embodiment 1.

[0125] As shown in Figure 5, the pulse stimulation method of this embodiment is S101, a step of acquiring a surface electrocardiogram and / or acquiring a myocardial electrocardiogram by collecting electrocardiogram signals based on control electrodes, S102, a step of obtaining the R wave detection time at which the corresponding R wave appears based on the surface electrocardiogram and / or myocardial electrocardiogram, S103, based on the R-wave detection time, pulses corresponding to each preset stimulation position. [[ID=L61]]Delivery The step of determining the time, S104, each pulse Delivery Based on time, cardiac stimulation pulses are applied to each corresponding control electrode. Delivery The steps include,

[0126] The implementation principle corresponding to the pulse stimulation method in this embodiment corresponds to the operating principle of the pulse stimulation device in any one of the embodiments from Examples 1 to 4, and therefore will not be explained further here.

[0127] The control method for cardiac stimulation pulse triggers described above can meet the needs of acute and / or short-term patients, and patients for whom single-site electrical stimulation can achieve the necessary circulatory support for the heart. In particular, for patients with weak cardiac function (e.g., relatively low cardiac output) who are unsuitable for or anxious about undergoing cardiac surgery, it can effectively enhance postoperative cardiac function, accelerate patient recovery, and provide patients with timely and effective support for their cardiac needs. At the same time, this technology can help increase the confidence of both patients and physicians when performing the relevant surgery. Furthermore, while existing methods of increasing cardiac contractility based on drugs often have side effects (e.g., arrhythmias, increased heart rate, increased myocardial oxygen consumption, etc., which can increase mortality), the control method for cardiac stimulation pulse triggers in this embodiment has virtually no associated side effects (heart rate and oxygen consumption do not change fundamentally) and can achieve a better effect in increasing cardiac contractility by achieving electrical stimulation more timely and effectively.

[0128] <Example 6> The medical device of this embodiment includes a pulse stimulator according to any one of the embodiments of Examples 1 to 4.

[0129] Medical devices may include only pulse stimulators used for various lead placements, but may also be integrated into other systems or used as accessories to other systems. Such medical devices include, but are not limited to, the following:

[0130] (1) Temporary pacing system: ECS functionality can be added to temporary pacing systems commonly used to provide bradycardia pacing to the patient groups described above. The ECS may use a control electrode used for pacing as part of the CCM stimulating electrode, or it may be used independently of the CCM stimulating electrode, with minimal impact on clinical practice but providing additional clinical benefits, or additional leads may be used where better CCM-mediated contraction improvement is needed.

[0131] (2) Partially or fully implantable devices that provide acute / short-term or chronic (long-term) mechanical circulatory support: Appropriate leads and / or myocardial electrodes (in the required location) can be added to such systems to provide ECS and other functions, such as bradycardia pacing, ATP, and defibrillation.

[0132] (3) External defibrillator systems: e.g., wearable defibrillators, AEDs, or defibrillators used in emergency rooms and / or ambulances. CCM can be delivered via skin electrodes (e.g., defibrillation electrodes) after sensing the R wave of a surface ECG. It may be necessary to add only the ECS circuit to an existing device design, or a separate ECS unit can be connected to the current equipment for such purposes. If the patient is in severe bradycardia or cardiac arrest after an electric shock, or in electromechanical dissociation (EMD), the ECS function may provide more effective assistance in restoring the patient's cardiac function.

[0133] (4) S-ICD system: R wave sensing can be achieved by ECG of a non-myocardial contact electrode (e.g., right ventricular sub-Q electrode pair) or by right ventricular EGM of an S-ICD equipped with a right ventricular leadless pacemaker, thereby triggering CCM stimulation of the S-ICD via the subQ defib electrode and / or leadless pacemaker electrode Delivery This function may provide more effective support in restoring the patient's cardiac function if the patient is in a state of severe bradycardia or cardiac arrest after an electric shock, or if the electrical device is disconnected.

[0134] The medical device of this embodiment includes the pulse stimulator described above and provides cardiac electrical stimulation (CCM) to multiple sites. Compared to conventional methods that simply stimulate the right interventricular septum, it more effectively improves the contractility of the patient's entire heart, particularly the contractility of the left ventricle. This makes it suitable for use in patients with acute and / or short-term ventricular dysfunction and significantly improves the overall product performance of the medical device.

[0135] Although specific embodiments of the present invention have been described above, these are merely illustrative examples, and those skilled in the art should understand that various changes or modifications can be made to these embodiments without departing from the principles and substance of the present invention. Accordingly, the scope of protection of the present invention is limited by the appended claims.

Claims

1. A pulse stimulator comprising an R-wave sensing module and a cardiac stimulation pulse generator, The R-wave sensing module and the cardiac stimulation pulse generator are connected in a communicative manner. The R-wave sensing module and the cardiac stimulation pulse generator are each electrically connected to one control electrode, the control electrode corresponds to a preset stimulation position, the R-wave sensing module acquires a surface electrocardiogram, collects electrocardiogram signals based on the control electrode to acquire a myocardial electrocardiogram, acquires the first R-wave detection time at which the R wave appears based on the myocardial electrocardiogram, and acquires the second R-wave detection time at which the R wave appears based on the surface electrocardiogram. The R-wave sensing module is further used to determine a first pulse delivery time corresponding to the preset stimulus position based on the first R-wave sensing time, and / or to determine a second pulse delivery time corresponding to the preset stimulus position based on the second R-wave sensing time. A pulse stimulator characterized in that the cardiac stimulation pulse generator is used to deliver cardiac stimulation pulses to the control electrode based on the first pulse delivery time and / or the second pulse delivery time.

2. The pulse stimulator according to claim 1, wherein the R-wave sensing module and the cardiac stimulation pulse generator are each electrically connected to at least two control electrodes, and the at least two control electrodes are used to implant at different preset stimulation locations in the myocardium of the left and right ventricles of the patient.

3. The pulse stimulator further includes a pulse control module that is communicably connected to the cardiac stimulation pulse generator, The pulse control module is used to generate pulse delivery modes and deliver them to the cardiac stimulation pulse generator. The cardiac stimulation pulse generator is used to deliver cardiac stimulation pulses to the corresponding control electrodes based on the pulse delivery mode and each of the first pulse delivery times when an R wave appears in the electrocardiogram, or The cardiac stimulation pulse generator delivers cardiac stimulation pulses to the corresponding control electrodes based on the pulse delivery mode and the delivery time of each second pulse when an R wave appears in the surface electrocardiogram. The pulse stimulation device according to claim 2, characterized in that

4. The pulse delivery mode is determined after calculating the first pulse delivery time corresponding to each preset stimulation position based on the R wave in the electrocardiogram, or after calculating the second pulse delivery time corresponding to each preset stimulation position based on the R wave in the electrocardiogram. Within the same heartbeat cycle, the cardiac stimulation pulse is synchronously delivered to the control electrode corresponding to the preset stimulation position, or, Over multiple heart cycles, the cardiac stimulation pulses are sequentially delivered in a set order to the control electrodes corresponding to each of the preset stimulation positions. The pulse stimulator according to claim 3, characterized in that it includes delivering the cardiac stimulation pulses to the control electrodes corresponding to each of the preset stimulation positions in a random order.

5. The pulse control module further, The pulse stimulator according to claim 3, characterized in that it sets the pulse delivery mode based on a set or random combination of the preset stimulation positions, and delivers cardiac stimulation pulses to the control electrodes of each of the preset stimulation positions corresponding to the combination.

6. The pulse stimulation device according to claim 4, characterized in that the pulse delivery mode includes reaching a preset heart rate by continuously delivering cardiac stimulation pulses to the corresponding preset stimulation positions in a set order or a random order.

7. The pulse stimulator according to claim 1, characterized in that the preset stimulation location includes at least one of the following locations: the inner wall of the left and right interventricular septum, the interventricular groove of the outer wall of the ventricles, the lateral wall of the left ventricle, the anterolateral wall of the left ventricle, the posterolateral wall of the left ventricle, the inner wall of the free wall of the right ventricle, the extracardiac wall of the free wall of the right ventricle, the apex of the right ventricle, and the apex of the left ventricle.

8. The R-wave sensing module further uses the first R-wave sensing time as a reference zero point and calculates the first pulse delivery time corresponding to each of the preset stimulation positions based on the preset duration. The R-wave sensing module is further used to calculate a first time difference between the second R-wave sensing time and the first R-wave sensing time at the preset stimulation position, based on the first R-wave sensing time and the second R-wave sensing time, and to determine the second pulse delivery time corresponding to the preset stimulation position based on the first time difference and the preset duration, with the second R-wave sensing time as the reference zero point. The pulse stimulator according to claim 1, characterized in that the preset duration is a preset time calculated in combination with the first time difference when calculating the second pulse delivery time corresponding to the preset stimulation position.

9. After obtaining the second pulse delivery time, the cardiac stimulation pulse generator The pulse stimulator according to claim 8, characterized in that it is used to maintain the first time difference and to maintain the delivery of cardiac stimulation pulses.

10. The pulse stimulation device further includes a time update module, The time update module is used to update the first time difference periodically or irregularly, and to update the second pulse delivery time based on the updated first time difference. The cardiac stimulation pulse generator delivers cardiac stimulation pulses to the corresponding control electrodes based on the updated second pulse delivery time. The pulse stimulation device according to claim 1, characterized in that

11. The R-wave sensing module further, The pulse stimulator according to claim 1, characterized in that when pacing is performed at one preset stimulation position, the pacing pulse delivery time is used as the first R-wave sensing time corresponding to the control electrode providing pacing, and the preset duration is 60 to 80 ms.

12. The R-wave sensing module further, When pacing is performed at one preset stimulation location, an electrocardiogram is obtained for all other remaining preset stimulation locations. Furthermore, the new first R-wave detection time at which the R wave appears in the myocardial electrocardiogram and the new second R-wave detection time at which the R wave appears in the surface electrocardiogram are obtained, and the new second pulse delivery time is calculated. The pulse stimulator according to claim 8, further characterized in that the R-wave sensing module is used to calculate a new first pulse delivery time corresponding to each of the preset stimulation positions based on a new first R-wave sensing time and a preset duration.

13. The pulse stimulation device includes at least two control electrodes, each of which corresponds to a different preset stimulation position. The R-wave sensing module acquires multiple electrocardiograms based on at least two of the control electrodes, and when an R wave appears in the multiple electrocardiograms corresponding to the multiple preset stimulation positions, it acquires multiple first R-wave sensing times. Randomly, one of the first R-wave detection times or the earliest occurrence time is selected as the reference zero point. The second difference between each first R-wave detection time after the aforementioned reference zero point and the reference zero point is calculated. Furthermore, the first pulse delivery time corresponding to each preset stimulation position is calculated by combining the second difference and the preset duration. The pulse stimulation device according to claim 1, characterized in that

14. The pulse stimulator according to claim 8, characterized in that the first R wave detection time, in which an R wave acquired based on the myocardial electrocardiogram appears, and the second R wave detection time, in which an R wave acquired based on the surface electrocardiogram appears, correspond to the same heartbeat.

15. The R-wave sensing module is used to collect electrocardiogram signals based on the control electrodes to obtain a myocardial electrocardiogram, and if the perception of the surface electrocardiogram is poor, it determines the first pulse delivery time corresponding to the preset stimulation position based on the first R-wave sensing time based on the myocardial electrocardiogram. If the perception of the myocardial electrocardiogram is poor, the second pulse delivery time corresponding to the preset stimulation position is determined based on the second R wave detection time based on the surface electrocardiogram. The pulse stimulation device according to claim 1, characterized in that

16. The R-wave sensing module is further used to obtain the second pulse delivery time by calculating a first time difference between the second R-wave sensing time and the first R-wave sensing time at the preset stimulation position based on the first R-wave sensing time and the second R-wave sensing time during the setup period, and by calculating the duration from the sensing of the R-wave of the surface electrocardiogram to the trigger of cardiac stimulation pulse delivery based on the first time difference and the preset duration. The pulse stimulator according to claim 1, characterized in that the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator using a unipolar or bipolar lead, and the cardiac stimulation pulse is used to adjust myocardial contractility.

17. A medical device characterized by including a pulse stimulator according to any one of claims 1 to 16.

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