Pulse stimulators and medical devices

Abstract

A pulse stimulation apparatus, method and medical 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 be implanted in a different preset stimulation position of a patient's myocardium, the R-wave sensing module (1) is used to acquire a surface electrocardiogram and / or a myocardial electrocardiogram, and to acquire an R-wave sensing time at which an R-wave appears to determine a pulse transmission time for each preset stimulation position, the pulse transmission time corresponding to a duration from the sensing of an R-wave to a trigger of a cardiac stimulation pulse transmission, and the cardiac stimulation pulse generator (2) is used to transmit a cardiac stimulation pulse to the control electrode (3) based on the pulse transmission time, thereby realizing the provision of cardiac circulatory support by providing electrical stimulation to multiple sites of the left and right ventricles, and more effectively improving the overall contractile force of the left and right ventricles of the patient's heart compared with the conventional method of simply stimulating the right ventricular septum, thereby providing good support to patients with significant acute and / or short-term ventricular dysfunction.

Description

Technical Field

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

Background Art

[0002] Currently commercially available CCM (Cardiac Contractility Modulation) devices are independent implantable devices with a complex and expensive structure, 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 transmits a cardiac stimulation pulse within a predetermined period (during 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 is shown by research to be brought about through the influence on the local myocardium caused by local stimulation of the right ventricular septum.

[0003] 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 deteriorates rapidly 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 needs cardiac function support for a relatively short period until the cause is removed and / or cardiac function is restored. 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). 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.

Summary of the Invention

[0004] The technical problem that the present invention aims to solve is to overcome 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, by providing a pulsed stimulator. Reach The objective is to provide medical devices. [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. before The control electrode is, P A pulse stimulator is provided that corresponds to the reset 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 This is used to determine the first pulse transmission time corresponding to the preset stimulus position based on the first R-wave sensing time, and / or the second pulse transmission time corresponding to the preset stimulus position based on the second R-wave sensing time.

[0009] The cardiac stimulation pulse generator is, before Note first Pulse transmission time and / or the second pulse transmission time Based on the corresponding before Record control electrodes on the heart electricity stimulation (CCM) It is used to transmit pulses.

[0010] In this embodiment, the R-wave detection time at which the corresponding R-wave appears is obtained based on the surface electrocardiogram and / or myocardial electrocardiogram, and the pulse transmission time corresponding to the preset stimulation position is determined. This meets the needs of patients with acute and / or short-term conditions, and patients for whom single-site electrical stimulation may not provide the necessary circulatory support to the heart, 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 used to generate a pulse transmission mode and transmit it to the cardiac stimulation pulse generator.

[0015] The cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to the corresponding control electrodes based on the pulse transmission mode and each pulse transmission time when an R wave appears in the surface electrocardiogram and / or the myocardial electrocardiogram.

[0016] In this embodiment, by pre-setting different pulse transmission modes in the pulse control module, the pulse transmission mode can be determined in actual pulse transmission scenarios based on methods such as manual selection by the operator, pre-setting of predetermined fixed pulse modes, or random selection, thereby automatically achieving pulse transmission to different preset stimulation locations. Of course, the pulse transmission mode can also be dynamically adjusted according to actual needs.

[0017] Optionally, the pulse transmission mode includes transmitting cardiac stimulation pulses to the control electrodes corresponding to each of the preset stimulation positions synchronously, in a set order or random order, based on the R wave in the surface electrocardiogram and / or the myocardial electrocardiogram.

[0018] In this embodiment, pulses are transmitted synchronously in a set order or random order, thereby meeting as many different pulse transmission needs as possible, accommodating a wider range of pulse stimulation scenarios, ensuring the effectiveness of pulse stimulation for the patient, and simultaneously improving the patient's user experience.

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

[0020] Here, the combination of stimuli includes at least two stimulation units, and at least one of the stimulation units corresponds to two or more of the preset stimulation positions that synchronously perform pulse transmission.

[0021] The pulse transmission mode includes transmitting cardiac stimulation pulses to the control electrodes at the corresponding preset stimulation locations according to a set or random order and combination of stimulations based on the R waves in the surface electrocardiogram and / or the myocardial electrocardiogram.

[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 transmitted synchronously to different preset stimulation positions corresponding to the same combination of stimuli. The different combinations of stimuli perform pulse stimulation using a pulse transmission method in a set order or a random order, so as to meet the needs of more pulse stimulation scenarios and further ensure patient safety.

[0023] Optionally, by continuously transmitting cardiac stimulation pulses to the corresponding preset stimulation positions in a set order or a random order, a preset heart rate is reached.

[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 realize electrical circulatory support (ECS). Compared with the prior art method of simply stimulating 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 position includes at least one of the inner wall of the left and right ventricular septum, the interventricular groove on the outer wall of the ventricle, the outer wall of the left ventricle, the anterior outer wall of the left ventricle, the posterior outer wall of the left ventricle, the inner wall of the free wall of the right ventricle, the outer wall of the free wall of the right ventricle, 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 respectively provided at the above-listed positions of the left and right ventricles, or control electrodes are provided at some positions according to actual stimulation needs.

[0027] Optionally, the R-wave sensing module acquires a surface electrocardiogram and a myocardial electrocardiogram based on the control electrodes, and the R-wave appears based on the myocardial electrocardiogram. The aforementioned The first R wave detection time and the appearance of the R wave based on the surface electrocardiogram. The aforementioned It is used to obtain the second R-wave detection time.

[0028] The R-wave sensing module is further used to calculate the first pulse transmission time corresponding to each of the preset stimulus positions based on the first R-wave sensing time.

[0029] The R-wave sensing module is further used to calculate a second pulse transmission time corresponding to each of the preset stimulus positions, based on the first R-wave sensing time and the second R-wave sensing time.

[0030] The cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to each of the corresponding control electrodes based on the first pulse transmission time and / or the second pulse transmission time.

[0031] In this embodiment, the first R wave detection time, when an R wave appears on the electrocardiogram, is acquired, and the first pulse transmission time corresponding to the preset stimulation position is calculated. death The system acquires the second R-wave detection time at which the R-wave appears on the surface electrocardiogram, and calculates the second pulse transmission time corresponding to the preset stimulation position based on the first R-wave detection time and the second R-wave detection time. Based on this, pulse transmission is performed based on the first pulse transmission time and / or the second pulse transmission time. In other words, by proposing a scheme to determine the pulse transmission time based on the R-wave of the myocardial electrocardiogram and the R-wave of the surface electrocardiogram, the timeliness and reliability of pulse stimulation are effectively ensured.

[0032] Optionally, the R-wave sensing module is further used to calculate the first pulse transmission time corresponding to each of the preset stimulus positions, based on the preset duration, with the first R-wave sensing time as the reference zero point.

[0033] 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 for each of the preset stimulation positions, and to calculate the second pulse transmission time corresponding to each of the preset stimulation positions based on the first time difference and the preset duration, with the second R-wave sensing time as the reference zero point.

[0034] Optionally, the cardiac stimulation pulse generator is used to maintain the first time difference after obtaining the second pulse transmission time, and to transmit cardiac stimulation pulses to the corresponding control electrodes based on the second pulse transmission time.

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

[0036] The time update module is used to update the first time difference periodically or irregularly, and to update the second pulse transmission time based on the updated first time difference.

[0037] The cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to the corresponding control electrodes based on the updated second pulse transmission time.

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

[0039] Optionally, the R-wave sensing module may further be used to use the pacing pulse transmission time as the first R-wave sensing time corresponding to the control electrode providing pacing when pacing is performed at one preset stimulation position, the preset duration being 60-80 ms.

[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 is further used to calculate a new first pulse transmission time corresponding to each of the preset stimulus positions, based on the new first R-wave sensing time and the preset duration.

[0042] The R-wave sensing module is further used to calculate 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 to calculate a new second pulse transmission time corresponding to each of the preset stimulation positions based on the new first time difference and the preset duration, with the new second R-wave sensing time as the reference zero point.

[0043] In this embodiment, when pacing is performed via a single control electrode, the pulse stimulation scenario requires recalculating the R-wave detection time in the new myocardial electrocardiogram and the R-wave of the surface electrocardiogram, and then calculating the corresponding first pulse transmission time and second pulse transmission time, thereby achieving timely transmission of pulse stimulation in the scenario.

[0044] Optionally, the R-wave sensing module provides a plurality of preset stimulation positions corresponding to the appearance of the R wave in the electrocardiogram. The aforementioned This system is used to obtain the first R-wave detection time, select one first R-wave detection time as a reference zero point, calculate the second difference between each first R-wave detection time after the reference zero point and the reference zero point, and calculate the first pulse transmission time corresponding to each of the preset stimulation positions based on the second difference and the preset duration.

[0045] In this embodiment, by arbitrarily selecting one first R-wave sensing time (LS) as the reference zero point, and calculating the difference between this and the transmission time of the stimulation position at other times thereafter, and adding the preset duration, the pulse transmission time for each pulse stimulation position can be obtained. This enables timely and effective pulse transmission based solely on the electrocardiogram, without relying on the surface electrocardiogram, making the pulse stimulation control process more flexible and adaptable to a wider range of usage scenarios.

[0046] Optionally, the R-wave sensing module may have multiple The aforementioned From the generation time of the first R wave detection time, The aforementioned The first R-wave detection time is randomly selected, or the earliest occurrence time is selected. The aforementioned The first R-wave detection time is used to select the reference zero point.

[0047] Optionally, the electrocardiogram of the myocardial ECG based on The acquired R wave appears. The aforementioned The first R wave detection time, and the surface electrocardiogram based on The acquired R wave appears. The aforementioned The detection time for the second R wave corresponds 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 is used to acquire a first R-wave detection time at which an R-wave appears based on the myocardial electrocardiogram, and to determine a first pulse transmission time corresponding to the preset stimulation position based on the first R-wave detection time. If the myocardial electrocardiogram is poorly perceived, the R-wave sensing module is used to acquire a second R-wave detection time at which an R-wave appears based on the surface electrocardiogram, and to determine a second pulse transmission time corresponding to the preset stimulation position based on the second R-wave detection 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 transmission does not require the use of two unipolar or bipolar leads at a single cardiac location and can be implemented with a simple unipolar lead, thus simplifying the system structure and reducing costs. [Brief explanation of the drawing]

[0057] [Figure 1] This is a schematic diagram of the structure of a pulse stimulation device according to Embodiment 1 of the present invention. [Figure 2] This is a schematic diagram of the R-wave trigger corresponding to the ECG and EGMs during CCM transmission according to Embodiment 1 of the present invention. [Figure 3] This is a schematic diagram of the structure of a pulse stimulation device according to Embodiment 2 of the present invention. [Figure 4] This is a schematic diagram of the R-wave trigger corresponding to the ECG and EGMs during sequential transmission of CCM according to Embodiment 2 of the present invention. [Figure 5] This is a flowchart of the pulse stimulation method according to Embodiment 3 of the present invention. [Modes for carrying out the invention]

[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 in the listed locations on the left and right ventricles, respectively, or in 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 is used to determine the transmission time of the cardiac stimulation pulse (or CCM electrical stimulation) corresponding to each preset stimulation location based on the R-wave sensing time. The pulse transmission time corresponds to the duration from R-wave sensing to the trigger of cardiac stimulation pulse transmission, and the transmission of CCM at each location or site is triggered by R-wave sensing in the local myocardial electrocardiogram (EGM) or R-wave sensing in the whole surface electrocardiogram (ECG).

[0066] The cardiac stimulation pulse generator 2 is used to transmit cardiac stimulation pulses to each corresponding control electrode 3 based on the duration of each pulse transmission.

[0067] In one feasible 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 captures the first R wave detection time Based This is used to obtain the first pulse transmission time corresponding to each preset stimulation position, where, once the first R-wave sensing time is determined, the corresponding first pulse transmission time is also determined. ru .

[0070] The R-wave sensing module is further used to calculate the second pulse transmission time corresponding to each preset stimulus position, based on the first R-wave sensing time and the second R-wave sensing time.

[0071] A cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to a control electrode based on the first pulse transmission time and / or the second pulse transmission time.

[0072] In the pulse stimulation process of this embodiment, (1) cardiac stimulation pulses can be transmitted mainly using the R wave of the surface electrocardiogram. That is, the stimulation transmission time of each electrode is set to the R wave detection time of the surface electrocardiogram as the trigger time. standard (2) The R wave of the electrocardiogram is used to transmit cardiac stimulation pulses. That is, the stimulation transmission time of each electrode is determined by the R wave of the electrocardiogram. standard (3) Set the zero point. Simultaneously, transmit cardiac stimulation pulses based on the R wave of the surface electrocardiogram and the R wave of the myocardial electrocardiogram. Specifically, one of the three trigger mechanisms can be used, 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 is used to calculate the first pulse transmission time corresponding to each preset stimulus position, based on the first R-wave sensing time and the preset duration.

[0075] In the case of an electrocardiogram (EGM) acquired by electrode 3, the first pulse transmission time is set with the R wave detection time of the EGM as the reference zero point (or trigger point). Use it as follows: Preset duration (LPD) Time calculated based on The duration is typically 40ms by default, and the value of this duration can be adjusted according to actual needs. First pulse transmission time This refers to the CCM at the site or location in relation to the R wave detection time of the electrocardiogram. pulse Send trigger time That is .

[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 the first time difference and the preset duration. to Based on this, the second R-wave detection time is used as the reference zero point (or trigger point) to calculate the second pulse transmission time corresponding to each preset stimulus position.

[0077] The first R-wave detection time, when the R-wave appears on the electrocardiogram (ECG), is obtained, and the first pulse transmission time corresponding to the preset stimulation position is calculated. The second R-wave detection time, when the R-wave appears on the electrocardiogram (ECG), is obtained, and the second pulse transmission time corresponding to the preset stimulation position is calculated based on the first and second R-wave detection times. Pulse transmission is then performed based on the first and / or second pulse transmission times. In other words, by proposing a scheme to determine the pulse transmission time based on the R-wave of the ECG and the ECG, the timeliness and reliability of pulse stimulation are effectively ensured.

[0078] In other words, CCM is triggered by the R wave of the EGM. pulse In this case, from the R wave CCM pulse The duration of each stimulus location is fixed until transmission (for example, the preset duration is 40ms). CCM is triggered by the R wave of the ECG. pulse in the case of, From R-wave to CCM pulse transmission 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 the patient is in sinus rhythm, for the surface electrocardiogram (ECG), first, the corresponding time of R wave detection in the surface electrocardiogram (ECG) (Second R wave detection time) and the corresponding time of R wave detection in local myocardial electrocardiogram (EGM). (First R wave detection time) The time difference (GLSD) between the time point and the time point is calculated, and 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 the R wave detection time of the surface electrocardiogram (ECG). Using as the reference zero point (or trigger point) Triggered second Pulse transmission time teeth ,handle Time difference ( GLSD ) and It is obtained by adding the preset duration (LPD). That is to say The duration from the R wave detection time to the second pulse transmission time in a surface electrocardiogram (ECG) is the GPD (Ground Percentage Distance). GPD = GLSD + LPD. Furthermore, GLSD and GPD corresponding to each body part can be measured over multiple intrinsic heartbeats and averaged (by default, this is 5 consecutive intrinsic heartbeats in the range of 3 to 12). Second pulse transmission timeThis refers to the trigger time for CCM transmission at the site or location relative to the R-wave detection time of the surface electrocardiogram. That is In this example, this step is referred to as the setup period.

[0080] In one feasible embodiment, a cardiac stimulation pulse generator is used to maintain the first time difference after obtaining the second pulse transmission time at each position, and to maintain the transmission of cardiac stimulation pulses to the corresponding control electrodes based on the second pulse transmission time.

[0081] In other words, in this embodiment, after calculating the second pulse transmission time, there is no need to recalculate it each time before outputting electrical stimulation. 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 shortens data processing time and improves the control efficiency of cardiac stimulation pulse triggering while achieving the 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 is used to periodically or irregularly update the first time difference and update the second pulse transmission time based on the updated first time difference.

[0084] The cardiac stimulation pulse generator is used to transmit cardiac stimulation pulses to the corresponding control electrodes based on the updated second pulse transmission time.

[0085] In other words, in this embodiment, in order to achieve a more flexible electrical stimulation effect and meet the needs of a wider range of pulsed electrical stimulation scenarios, the second pulse transmission time (at which point myocardial electrical stimulation can be continued or stopped) can be updated periodically or irregularly according to the actual needs, and then myocardial electrical stimulation is continued based on the 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 used to generate a pulse transmission mode and transmit it to the cardiac stimulation pulse generator 2.

[0091] The cardiac stimulation pulse generator 2 is used to transmit cardiac stimulation pulses to the corresponding control electrodes 3 based on the pulse transmission mode and pulse transmission time when an R wave appears in the surface electrocardiogram or myocardial electrocardiogram.

[0092] By pre-setting different pulse transmission modes in the pulse control module, the pulse transmission mode can be determined in actual pulse transmission scenarios based on methods such as operator selection, pre-setting of predetermined fixed pulse modes, or random selection, enabling automatic pulse transmission to different preset stimulation locations. Of course, the pulse transmission mode can also be dynamically adjusted according to actual needs.

[0093] In one implementable embodiment, the pulse transmission mode includes synchronously transmitting cardiac stimulation pulses to 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.

[0094] By continuously transmitting cardiac stimulation pulses to the corresponding preset stimulation locations in a set or random order, the system reaches a preset heart rate.

[0095] The pulse transmission mode is a transmission mechanism triggered by the global R wave of the surface electrocardiogram, or the local R wave of each site, i.e., synchronously, in a set order or random order, sending cardiac stimulation pulses to each preset stimulation location, or a setup period, i.e., measurement and calculation of GLSD corresponding to each electrode location.

[0096] By transmitting pulses synchronously, in a set order, or in a random order, the system aims to meet as many different pulse transmission needs as possible, accommodate a wider range of pulse stimulation scenarios, ensure the effectiveness of pulse stimulation for patients, and improve the patient's experience.

[0097] CCM stimulation to a location or site can be triggered and transmitted "simultaneously" (i.e., in the same cardiac cycle) after the same R wave at the corresponding time for each site (called synchronous), or it can be transmitted sequentially to multiple sites over multiple R waves. When transmitted in a set order, CCM stimulation is triggered and transmitted at one site after the R wave at its corresponding time, then transmitted at the next site after the next R wave, and so on, until all sites are covered by the transmission. After the same R wave, CCM stimulation may appear at one or more sites according to the corresponding time for each site (but not all sites; otherwise, it is synchronous). Furthermore, the order in which specific sites receive CCM stimulation may be specially designed (programmable by staff with relevant authority, such as a physician) or random. When transmitted sequentially, the number of times each preset site is stimulated may be one or more (e.g., six times, i.e., six cardiac cycles), after which the stimulation of the next preset site is initiated, and so on.

[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 random combination based on a set number of preset stimulus locations.

[0099] Here, the stimulus combination includes at least two stimulus units, and at least one stimulus unit corresponds to two or more preset stimulus positions that synchronously transmit pulses.

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

[0101] By continuously transmitting cardiac stimulation pulses to the corresponding preset stimulation locations in a set or random order, the system reaches a preset heart rate.

[0102] Without considering each preset stimulation position individually, different stimulation combinations are formed based on multiple preset stimulation positions, pulses are synchronously sent to different preset stimulation positions corresponding to the same stimulation combination, and different stimulation combinations perform pulse stimulation using a pulse transmission method in a set order or a random order to meet the needs of more pulse 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 interventricular septum (the right interventricular septum being in the endocardial position) or near the anterior or posterior interventricular groove (being in the epicardial position), and the other lead electrodes It is located on the anterolateral wall of the left ventricle (either epicardial or endocardial position).

[0104] In one feasible embodiment, the pulse stimulator corresponds to three leads 4, and one Lead The electrode is located either in the right interventricular septum (the right ventricular septum is in the endocardial position) or near the anterior or posterior interventricular groove (in the epicardial position), one Lead electrodes It is located on the posterolateral wall of the left ventricle (epidermal or endocardial position), and is another lead. electrodes It is located on the anterolateral wall of the left ventricle (either epicardial or endocardial position).

[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, lead 4 of this embodiment includes a unipolar lead or a bipolar lead, and cardiac stimulation pulses are transmitted through lead 4 to the corresponding site. (1) When a single unipolar lead is used, the CCM is transmitted between the unipolar electrode in contact with the myocardium and an electrode at another part of the patient's body. In this case, the unipolar electrode may be an electrode on another electrode lead in a 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 multiple unipolar leads are used, the CCM can be transmitted between two unipolar electrodes in contact with the myocardium (one cathode, the other anode). (3) When a bipolar lead is used, only one electrode is in continuous contact with the myocardium (e.g., right ventricular septal lead 4), and the CCM can be transmitted between the two electrodes or as a unipolar lead (the electrode in contact with the myocardium), similar to a unipolar setup. (4) For example, in the case of an epicardial electrode in the left ventricle, the CCM can be transmitted between the two electrodes or as two unipolar leads each. (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 the 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) Based on the cardiac stimulation pulse transmission mode (the trigger source of the R wave, whether it is synchronous or sequential, and whether it is a specific or random sequence within the sequence, all of which can be programmed by the physician), LPD, and GPD, cardiac stimulation pulses are generated for one or more sites as shown in Figure 4.

[0111] (4) When connected, the device will use R wave (GS and It senses LS and GLSD at each site (where each of the three leads is located). and After going through the setup process to calculate GPD, this GLSDn and In GPDn, n=1, 2, and 3. It is best performed during sinus rhythm when CCM is not being transmitted. Next, in the R-wave trigger mode of the surface ECG, after sensing the R-wave of the surface ECG, the CCM is transmitted / triggered in synchronous mode (on the same heartbeat (R-wave)), sequential mode (for example, the CCM is transmitted to site 1 after R-wave 1, to site 2 after R-wave 2, to site 3 after R-wave 3 (one by one)), or in a random order according to the corresponding GPD at each location.

[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, after the CCM is transmitted at a specific heart rate or duration (default is 3600 beats or 60 minutes, programmable), the setup process is restarted to accommodate potential changes in parameters (e.g., GLSD) due to changes in heart rate and / or patient condition (e.g., after medication). Additionally, transmission of the CCM can continue based on the updated parameters.

[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 over 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 cardiac stimulation pulse triggering is consistent with the above and unaffected; b) When pacing is generated by a CCM stimulation electrode, the electrode that primarily provides CCM stimulation also needs to provide pacing (during pacing). First R-wave detection time ( LS1 ) (The corresponding electrode position is recognized) while the operating principle of the other remaining electrode positions (which provide only CCM stimulation) is consistent with the above. In the case of the CCM stimulation electrode that provides pacing, during pacing... First R-wave detection time ( LS1 ) is the pacing pulse transmission time, and the preset duration needs to be extended to 40-100 ms, preferably 60-80 ms (this can also be adjusted in the program). In either case, two measurements are required during the preset period: one measurement to detect your own heart rate (sinus rhythm) and the other measurement 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 is further used to calculate a new first pulse transmission time corresponding to each preset stimulus position, based on the new first R-wave sensing time and the preset duration.

[0119] The R-wave sensing module is further used to calculate a new first time difference between the new second R-wave sensing time and the new first R-wave sensing time at each preset stimulus location, and to calculate a new second pulse transmission time corresponding to each preset stimulus location based on the new first time difference and the preset duration, with the new second R-wave sensing time as the reference zero point.

[0120] In this embodiment, when pacing is performed via a single control electrode, the pulse stimulation scenario requires recalculating the R-wave detection time in the new myocardial electrocardiogram and the R-wave of the surface electrocardiogram, and then calculating the corresponding first pulse transmission time and second pulse transmission time, thereby achieving timely transmission of pulse stimulation in this scenario.

[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 is used to acquire multiple first R-wave sensing times corresponding to the appearance of the R wave in the electrocardiogram at multiple preset stimulation locations, select one first R-wave sensing time as the reference zero point, calculate the second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and calculate the first pulse transmission time corresponding to each preset stimulation location based on the second difference and the preset duration.

[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 occurs earliest, is selected as the reference zero point. Based on this, the transmission times of the stimulation positions at other times are calculated, and the difference is added to the preset duration. This allows the pulse transmission time for each pulse stimulation position to be obtained, thereby achieving timely and effective pulse transmission based solely on the electrocardiogram without relying on the surface electrocardiogram. This makes the pulse stimulation control process 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, a step of determining the pulse transmission time corresponding to each preset stimulation position based on the R-wave sensing time, S104 includes the step of sending cardiac stimulation pulses to each corresponding control electrode based on each pulse transmission time.

[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 non-myocardial contact electrodes (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, which is transmitted via the subQ defib electrode and / or leadless pacemaker electrode. If the patient is in severe bradycardia or cardiac arrest after electric shock, or in the event of electrical device disconnection, this function may provide more effective assistance in restoring the patient's cardiac function.

[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, a cardiac stimulation pulse generator, and at least one control electrode, The control electrode corresponds to a preset stimulation position, 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 and the cardiac stimulation pulse generator are connected in a communication manner. The R-wave sensing module acquires a surface electrocardiogram, collects electrocardiogram signals based on the control electrodes to acquire a myocardial electrocardiogram, acquires the first R-wave detection time at which the R wave appears based on the myocardial electrocardiogram, acquires the second R-wave detection time at which the R wave appears based on the surface electrocardiogram, and Based on the first R-wave detection time and the second R-wave detection time, the first time difference between the second R-wave detection time and the first R-wave detection time at the preset stimulation position is calculated, and the second pulse transmission time corresponding to the preset stimulation position is determined based on the first time difference and the preset duration, with the second R-wave detection time as the reference zero point. Here, the preset duration is a preset time calculated in combination with the first time difference when calculating the second pulse transmission time corresponding to the preset stimulation position. The cardiac stimulation pulse generator is, The method is characterized by transmitting a cardiac stimulation pulse to the control electrode to adjust myocardial contractility based on the second pulse transmission time. Pulse stimulator.

2. The pulse stimulation device includes at least two control electrodes, The pulse stimulator according to claim 1, characterized in that the different control electrodes are used to implant the patient's left and right ventricular myocardium at different preset stimulation locations.

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 a pulse transmission mode and transmit it to the cardiac stimulation pulse generator. The cardiac stimulation pulse generator transmits cardiac stimulation pulses to the corresponding control electrodes based on the pulse transmission mode and the second pulse transmission time when an R wave appears in the surface electrocardiogram. The pulse stimulation device according to claim 1, characterized in that

4. The pulse stimulator includes at least two control electrodes, each of which corresponds to a different preset stimulation position, The pulse transmission mode calculates the second pulse transmission time corresponding to each of the preset stimulation positions based on the R wave in the surface electrocardiogram, Within the same heartbeat cycle, the cardiac stimulation pulse is transmitted synchronously to the control electrode corresponding to the preset stimulation position, or Over multiple heart cycles, the cardiac stimulation pulses are sequentially transmitted 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 transmitting 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 transmission mode based on a set or random combination of the preset stimulation positions, and transmits 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 transmission mode includes reaching a preset heart rate by continuously transmitting 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 pulse stimulator according to at least one of claims 1 to 7, further characterized in that the R-wave sensing module uses the first R-wave sensing time as a reference zero point and calculates the first pulse transmission time corresponding to each of the preset stimulation positions based on the preset duration.

9. After acquiring the second pulse transmission time, the cardiac stimulation pulse generator Used to maintain the aforementioned first time difference and to maintain the transmission of cardiac stimulation pulses. The pulse stimulation device according to claim 8, characterized in that

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 transmission time based on the updated first time difference. The cardiac stimulation pulse generator transmits a cardiac stimulation pulse to the corresponding control electrode based on the updated second pulse transmission 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 transmission 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 transmission time is calculated. The pulse stimulation device according to claim 8, characterized in that

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 transmission 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 transmission 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 transmission 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. A medical device characterized by including the pulse stimulation device described in claim 1.

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