CN217472580U - Pulse stimulation device and medical equipment - Google Patents

Abstract

The utility model discloses a pulse stimulation device and medical equipment. An R-wave sensing module in the device is used for acquiring a body surface electrocardiogram and/or acquiring a myocardial electrocardiogram, and acquiring the R-wave sensing time at which the R-wave appears to determine each preset. Set the pulse delivery time of the stimulation position, and the pulse delivery time corresponds to the time from sensing the R wave to triggering the cardiac stimulation pulse delivery; the cardiac stimulation pulse generator is used to deliver the cardiac stimulation pulse to the control electrode according to the pulse delivery time; the time update module is used to update Pulse delivery time. The utility model realizes the multi-site electrical stimulation of the left and right ventricles to provide cardiac circulatory support, and more effectively improves the overall contractility of the left and right ventricles of the patient's heart compared with the existing method of simply stimulating the right ventricle ventricular septum. patients with acute and/or short-term markedly decreased ventricular function.

Description

Pulse stimulation device and medical equipment

This application claims the priority of Chinese patent application 2021218275150 with an application date of 2021/8/5. This application cites the full text of the above Chinese patent application.

technical field

The utility model relates to the technical field of medical equipment, in particular to a pulse stimulation device and medical equipment.

Background technique

The CCM (contractility modulation) device currently on the market is a self-contained, implantable, complex and expensive device that is basically used in chronic heart failure patients. Among them, two bipolar leads are implanted in the right ventricular septum, which are used to sense the potential of the local myocardium and release cardiac stimulation pulses within a certain time after sensing (absolute refractory period) to increase myocardial contractility. At this time, myocardial stimulation does not directly act on the left ventricle, which is the ventricle most in need of increased contractility. Although CCM applied to the right ventricular septum has a global effect on cardiac contractility and cardiac function (including left ventricular contractility), studies have shown that this global effect is not direct, but rather occurs through local stimulation of the right ventricular septum the effect on the local myocardium.

The current CCM stimulation is only used for implantable devices in patients with chronic heart failure, by stimulating a single part of the right ventricular septum to achieve long-term treatment of patients with chronic heart failure; however, when the patient's cardiac function deteriorates rapidly, blood pressure drops When the patient does not need or has no long-term use of an implantable device (such as an acute heart failure episode), or only requires a relatively short period of support for cardiac function until the cause is resolved and/or cardiac function is restored, the existing implantable CCM and its single-site stimulation cannot provide acute and/or short-term support (time and extent of cardiac/circulatory support), while providing acute and short-term (days) cardiac/circulatory support is critical to patient survival (eg, acute exacerbation of heart failure) Important, or resuscitating patients in emergency situations, such as emergency rooms or ambulances, any little extra (other than medication) cardiac circulatory support can mean "life or death" for the patient.

Utility model content

The technical problem to be solved by the present invention is to overcome the fact that the existing implantable CCM stimulation method in the prior art is only suitable for patients with chronic heart failure, cannot meet acute and/or short-term requirements, and the electrical stimulation of a single site may not meet the needs of the heart A pulse stimulation device and medical equipment are provided for the deficiencies of the use requirements of patients with circulatory support.

The utility model solves the above-mentioned technical problems through the following technical solutions:

The utility model provides a pulse stimulation device, which comprises an R-wave sensing module, a cardiac stimulation pulse generator, a pulse control module, a time update module and at least two control electrodes, and the different control electrodes are used for implantation different said preset stimulation positions of the patient's left ventricular myocardium and/or right ventricular myocardium;

The control electrodes are respectively electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator, and the R-wave sensing module, the pulse control module, the time update module and the cardiac stimulation pulse generate device communication connection;

The R-wave sensing module is used to acquire a body surface electrocardiogram and/or collect an electrocardiogram based on the control electrodes to acquire a myocardial electrocardiogram, and obtain the corresponding R-wave occurrence according to the body surface electrocardiogram and/or the myocardial electrocardiogram. R-wave sensing time, and determining the pulse delivery time corresponding to each of the preset stimulation positions according to the R-wave sensing time;

The pulse control module is used to generate a pulse delivery pattern and send it to the cardiac stimulation pulse generator;

The cardiac stimulation pulse generator is configured to, when an R wave appears in the body surface electrocardiogram and/or the myocardial electrocardiogram, based on the pulse discharge pattern and each of the pulse discharge times, send a heart stimulation pulse to each corresponding pulse. the control electrode;

The time update module is used to update the pulse release time regularly or irregularly;

The cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to each of the corresponding control electrodes according to the updated pulse delivery time.

In this solution, based on the surface electrocardiogram and/or myocardial electrocardiogram, the R wave sensing time of the corresponding R wave is obtained to determine the pulse discharge time corresponding to the preset stimulation position, so as to meet the requirements of acute and/or short-term, single-site electrical stimulation The use requirements of patients who may not meet the circulatory support required by the heart can ensure the timeliness and reliability of the cardiac stimulation pulse triggering, thereby effectively ensuring the safety of the patients.

By setting at least two control electrodes to stimulate multiple different positions in the myocardium of the left ventricle and/or the myocardium of the right ventricle, compared with the existing method of simply stimulating the right ventricular septum, it can more effectively improve the patient experience. The overall contractility of the heart, especially the left ventricle. For patients with acute heart failure and/or significant short-term ventricular function decline, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function.

By presetting different pulse delivery modes in the pulse control module, in the actual pulse delivery scenario, the pulse delivery mode can be determined according to the operator's manual selection, preset a certain fixed pulse mode or random selection, etc., so as to automatically realize the pulse delivery mode. Pulse firing to different preset stimulus locations. Of course, the pulse delivery mode can also be dynamically adjusted according to actual needs.

Optionally, the pulse delivery mode includes, based on the surface electrocardiogram and/or the R wave in the myocardial electrocardiogram, synchronizing, according to a set or random order, to the control corresponding to each of the preset stimulation positions. The electrodes deliver cardiac stimulation pulses.

In this scheme, pulses can be delivered in synchronization, set or random order, etc., to meet various pulse delivery requirements as much as possible, to meet more pulse stimulation scenarios, and to ensure the effectiveness of pulse stimulation for patients at the same time. , improving the patient experience.

Optionally, the pulse control module is further configured to generate stimulation combinations corresponding to different preset stimulation positions by adopting a set construction rule or a random combination method based on a set number of the preset stimulation positions;

Wherein, the stimulation combination 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 pulse delivery;

The pulse firing mode includes, based on the R wave in the body surface electrocardiogram and/or the myocardial electrocardiogram, according to a set or random sequence and the stimulation combination, to the control electrode corresponding to the preset stimulation position. Cardiac stimulation pulses are delivered.

In this scheme, each preset stimulation position is no longer considered separately, but different stimulation combinations are formed based on multiple preset stimulation positions. Pulse stimulation is carried out in a set or random sequence of pulse delivery to meet the needs of more pulse stimulation scenarios and further ensure the safety of patients.

Optionally, in a set or random order, the cardiac stimulation pulses are continuously sent to the corresponding preset stimulation positions to achieve a preset number of heartbeats.

In this solution, control electrodes are placed in multiple parts of the left and right ventricles to provide simultaneous or sequential cardiac electrical stimulation (CCM) to multiple parts to achieve Electrical Circulatory Support (ECS). Compared with the method of simply stimulating the right ventricular septum in the prior art, it can more effectively improve the overall contractility of the patient's heart, especially the left ventricle. For patients with acute heart failure and/or significant short-term ventricular function decline, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function.

Optionally, the preset stimulation positions include the inner wall of the interventricular septum of the left and right ventricles, the interventricular groove of the outer wall of the ventricle, the outer wall of the left ventricle, the anterior and lateral walls of the left ventricle, the posterolateral wall of the left ventricle, the inner wall of the right ventricular free wall, and the right ventricle. At least one of the free wall epicardial wall, the apex of the right ventricle, and the apex of the left ventricle.

In this solution, control electrodes are respectively set in the above-listed positions of the left and right ventricles, or control electrodes are set at some positions according to actual stimulation requirements, so as to ensure the reliability of cardiac pulse stimulation as much as possible.

Optionally, the R-wave sensing module is used to obtain a body surface electrocardiogram and a myocardial electrocardiogram based on the control electrodes, and to obtain the first R-wave sensing time and the The surface electrocardiogram obtains the second R wave sensing time when the R wave appears;

The R-wave sensing module is further configured to determine the first pulse release time corresponding to each of the preset stimulation positions according to the first R-wave sensing time;

The R-wave sensing module is further configured to determine a second pulse delivery time corresponding to each of the preset stimulation positions according to the first R-wave sensing time and the second R-wave sensing time.

The cardiac stimulation pulse generator is configured to deliver cardiac stimulation pulses to each of the corresponding control electrodes according to the first pulse delivery time and/or the second pulse delivery time.

In this solution, the first R wave sensing time when the R wave appears in the myocardial electrocardiogram is obtained, and the first pulse discharge time corresponding to the preset stimulation position is determined; the second R wave sensing time when the R wave appears in the body surface electrocardiogram is obtained, The second pulse delivery time corresponding to the preset stimulation position is determined according to the first R-wave sensing time and the second R-wave sensing time, and then pulses are performed based on the first pulse delivery time and/or the second pulse delivery time Dispatch, that is to say, a scheme is proposed to determine the pulse dispatch time based on the R wave in the myocardial ECG and the R wave in the body surface ECG, which effectively ensures the timeliness and reliability of the pulse stimulation.

Optionally, the R-wave sensing module is further configured to use the first R-wave sensing time as a reference zero point, and determine the first pulse delivery time corresponding to each of the preset stimulation positions according to a preset duration;

The R-wave sensing module is further configured to determine a first time difference between the second R-wave sensing time and the first R-wave sensing time at each of the preset stimulation positions, and use The second R-wave sensing time is a reference zero point, and the second pulse delivery time corresponding to each of the preset stimulation positions is determined according to the first time difference and the preset duration.

Optionally, the cardiac stimulation pulse generator is configured to maintain the first time difference after obtaining the second pulse delivery time, so as to maintain the cardiac stimulation pulse to the corresponding the control electrode.

Optionally, the time update module is configured to update the first time difference regularly or irregularly, so as to update the second pulse release time based on the updated first time difference;

The cardiac stimulation pulse generator is configured to deliver cardiac stimulation pulses to the corresponding control electrodes according to the updated second pulse delivery time.

In this solution, the second pulse release time can be updated regularly or irregularly according to actual needs (the myocardial electrical stimulation can be continued or stopped at this time), and then the myocardial electrical stimulation can be continued according to the updated trigger time to achieve more flexible electrical stimulation. Stimulation effect to meet the needs of more pulsed electrical stimulation scenarios.

Optionally, the R wave sensing module is also used to acquire the myocardial electrocardiogram corresponding to all other remaining preset stimulation positions when pacing is performed at a preset stimulation position, and obtain the R wave in the myocardial electrocardiogram. The new first R-wave sensing time that appears and the new second R-wave sensing time that the R wave appears in the body surface electrocardiogram;

The R-wave sensing module is further configured to determine a new first pulse release time corresponding to each of the preset stimulation positions based on the new first R-wave sensing time and a preset duration;

The R-wave sensing module is further configured to determine a new first R-wave sensing time between the new second R-wave sensing time and the new first R-wave sensing time at each of the preset stimulation positions. time difference value, and taking the new second R-wave sensing time as the reference zero point, according to the new first time difference value and the preset duration to determine the new corresponding to each of the preset stimulation positions the second pulse release time.

In this solution, when pacing is performed by a control electrode, in this pulse stimulation scenario, it is necessary to re-determine the R wave in the new myocardial ECG and the R wave sensing time in the R wave in the body surface ECG, and then determine the corresponding R wave respectively. The first pulse release time and the second pulse release time are set to realize the timely release of the pulse stimulation in this scenario.

Optionally, the R-wave sensing module is configured to acquire multiple first R-wave sensing times corresponding to R-waves appearing in the myocardial electrocardiogram at multiple preset stimulation positions, and select a first R-wave sensing time. The measurement time is taken as the reference zero point, the second difference between each first R-wave sensing time after the reference zero point and the reference zero point is determined, and each time difference is determined according to the second difference value and the preset duration each of the first pulse delivery times corresponding to the preset stimulation positions.

In this scheme, a first R-wave sensing time (LS) is arbitrarily selected as the reference zero point, and the release time of the stimulation position at the later time is based on this. The pulse delivery time of each pulse stimulation position is obtained, so that the timely and effective pulse delivery can be completed only based on the myocardial ECG without relying on the surface ECG, which makes the control process of the pulse stimulation more flexible and can be adapted to more use scenarios. .

Optionally, the R-wave sensing module is configured to randomly select a first R-wave sensing time from the occurrence times of multiple first R-wave sensing times, or select the first R-wave sensing time with the earliest occurrence time. The measured time is taken as the reference zero point.

Optionally, the first R wave sensing time at which the R wave appears from the myocardial electrocardiogram is obtained, and the second R wave sensing time at which the R wave appears from the body surface electrocardiogram is corresponding to the same heartbeat.

In this scheme, in order to ensure the effectiveness of pulse stimulation, all R waves (ie R waves in the myocardial ECG and R waves in the body surface ECG) are sensed under the same heartbeat; that is, the R waves obtained from the myocardial ECG The first R-wave sensing time that appears and the second R-wave sensing time that the R-wave appears in the body surface ECG acquisition, the time difference between the two R-wave sensing times must be less than a certain value, so that there is pulse stimulation. Practical significance, otherwise the reliability of pulse stimulation cannot be guaranteed.

Optionally, the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator using a monopolar wire or a bipolar wire.

The present invention also provides a medical device, which includes the above-mentioned pulse stimulation device.

On the basis of common knowledge in the field, the preferred conditions can be combined arbitrarily to obtain preferred embodiments of the present invention.

The positive progressive effect of the present utility model is:

(1) Place control electrodes (eg, corresponding to stimulation and/or pacing functions) in multiple parts of the left and right ventricles to provide simultaneous or sequential cardiac electrical stimulation (CCM) to multiple parts to provide cardiac circulatory support; compared with existing The simple way of stimulating the right ventricular septum can more effectively improve the overall contractility of the patient's heart, especially the left ventricle. For patients with acute heart failure and/or significant short-term ventricular function decline, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function. For example, for a patient who has just undergone cardiac surgery, the leads are implanted at different locations in the left and right ventricular myocardium (such as the anterior/posterior lateral view of the left ventricle on the epicardial surface, the interventricular sulcus, the right ventricular free wall, etc.) . In other patients, leads may be placed transvenously in the right ventricle (eg, in the interventricular septum, apex, or free wall) and/or in the left ventricle (eg, in the interventricular septum, apex, or free wall), transseptal or arterial, or in the left ventricle Wires etc. are placed on the epicardial surface (through electrodes placed in coronary veins or arteries).

(2) Cardiac electrical stimulation (CCM) method (mechanism, time, etc.): a. The stimulation mechanism is the mechanism of multiple cardiac electrical stimulation (synchronous or sequential), such as triggering stimulation of all electrode sites in a cardiac cycle (synchronized stimulation) ), or trigger stimulation (sequential stimulation) of each electrode site in a set or random order in multiple cardiac cycles; b. The trigger mechanism is R-wave sensing and/or representative of local ventricular myoelectric activity The time of R-wave sensing of global ventricular EMG activity is the trigger point. In the latter case, the temporal relationship between the global and local ventricular EMG R waves becomes part of the trigger time. The stimulation method (mechanism, time, etc.) can be dynamically adjusted according to the actual situation to adapt to the patient's changing heart rate and overall cardiac condition, that is, it can be adapted and adjusted according to the dynamic state of each patient's own heart, so as to effectively improve cardiac function. Effect.

(3) CCM transmission can be achieved through a simple monopolar wire, instead of having to use two monopolar wires or bipolar wires at one heart location, thereby simplifying the system structure and reducing the cost.

Description of drawings

FIG. 1 is a schematic structural diagram of a pulse stimulation device according to Embodiment 1 of the present invention.

2 is a schematic diagram of R-wave triggering corresponding to ECG and EGMs during CCM transmission according to Embodiment 1 of the present invention.

FIG. 3 is a schematic diagram of R-wave triggering corresponding to ECG and EGMs during CCM sequential transmission according to Embodiment 1 of the present invention.

Detailed ways

The present invention is further described below by way of examples, but the present invention is not limited to the scope of the described examples.

Example 1

As shown in FIG. 1 , the pulse stimulation device of this embodiment includes an R-wave sensing module 1 , a cardiac stimulation pulse generator 2 and at least one control electrode 3 , and the control electrode 3 is connected to the R-wave sensing module 1 and the heart through wires 4 respectively. The stimulation pulse generator 2 is electrically connected, and the R wave sensing module 1 and the cardiac stimulation pulse generator 2 are connected in communication.

Preferably, the device comprises at least two control electrodes, different control electrodes for implanting different preset stimulation positions of the left ventricular myocardium and/or right ventricular myocardium of the patient.

By setting at least two control electrodes to stimulate multiple different positions in the myocardium of the left ventricle and/or the myocardium of the right ventricle, compared with the existing method of simply stimulating the right ventricular septum, it can more effectively improve the patient experience. The overall contractility of the heart, especially the left ventricle. For patients with acute heart failure and/or significant short-term ventricular function decline, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function. Of course, the number of control electrodes can be reset and adjusted according to actual scene requirements.

Specifically, the different preset stimulation positions include, but are not limited to, the inner wall of the interventricular septum of the left and right ventricles, the interventricular sulcus of the outer wall of the ventricle, the outer wall of the left ventricle, the anterior and lateral walls of the left ventricle, the posterolateral wall of the left ventricle, the inner wall of the right ventricular free wall, The epicardial wall of the right ventricular free wall, the apex of the right ventricle, and the apex of the left ventricle.

Control electrodes are respectively arranged in the above-mentioned positions of the left and right ventricles, or control electrodes are arranged at some positions according to actual stimulation requirements, so as to ensure the reliability of cardiac pulse stimulation as much as possible.

The R-wave sensing module 1 is used to acquire a body surface electrocardiogram (ECG) and/or acquire an electrocardiogram (ECG) signal based on the control electrode 3 to acquire a myocardial electrocardiogram (EGM). (EGM) covers signals from the ventricular cavity or the outer wall of the ventricle.

Specifically, the R-wave sensing module 1 is configured to acquire the R-wave sensing time at which the R-wave appears according to the body surface electrocardiogram and/or the myocardial electrocardiogram, and determine the cardiac stimulation pulse corresponding to each preset stimulation position according to the R-wave sensing time (or CCM electrical stimulation) release time, the pulse release time corresponds to the time from sensing the R wave to triggering the release of the cardiac stimulation pulse, and the transmission of CCM at each position or site is induced by the R wave of the regional myocardial ECG EGM or the global surface ECG ECG R-wave induction trigger.

The cardiac stimulation pulse generator 2 is used for delivering cardiac stimulation pulses to each corresponding control electrode 3 according to each pulse delivery time.

In an implementable solution, the R-wave sensing module is used to acquire a body surface electrocardiogram and/or a myocardial electrocardiogram based on the control electrodes, and obtain the first R wave sensing time and the body surface electrocardiogram when the R wave appears according to the myocardial electrocardiogram, respectively. Obtain the second R wave sensing time when the R wave appears;

It should be noted that in this embodiment, the first R wave sensing time when the R wave appears in the myocardial electrocardiogram is obtained, and the second R wave sensing time when the R wave appears in the body surface electrocardiogram is corresponding to the same heartbeat.

The pulse stimulation device of this embodiment further includes a time update module 5 for regularly or irregularly updating the pulse delivery time;

The cardiac stimulation pulse generator 2 is used for delivering cardiac stimulation pulses to each corresponding control electrode according to the updated pulse delivery time.

In order to ensure the effectiveness of pulse stimulation, all R waves (ie R waves in the myocardial ECG and R waves in the body surface ECG) are sensed under the same heartbeat; The R-wave sensing time and the second R-wave sensing time when the R-wave appears from the surface electrocardiogram are obtained. The time difference between the two R-wave sensing times must be less than a certain value, so that the pulse stimulation has practical significance. Otherwise, The reliability of pulsed stimulation cannot be guaranteed. The R-wave sensing module is also used for the first R-wave sensing time to determine the first pulse delivery time corresponding to each preset stimulation position; wherein, once the first R-wave sensing time is determined, the corresponding first pulse delivery time It is also determined (that is, the preset time) and will not change.

The R-wave sensing module is further configured to determine the second pulse delivery time corresponding to each preset stimulation position according to the first R-wave sensing time and the second R-wave sensing time.

Wherein, in this embodiment, an adder or other hardware device may be used to determine the pulse delivery time according to the R-wave sensing time.

The cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to the control electrodes according to the first pulse delivery time and/or the second pulse delivery time.

In the pulse stimulation process in this embodiment, (1) the heart stimulation pulse can be issued mainly by the R wave in the surface electrocardiogram, that is, the time when each electrode is stimulated takes the R wave sensing time of the surface electrocardiogram as the trigger time. Zero point; (2) Cardiac stimulation pulses can be issued mainly based on the R wave in the myocardial ECG, that is, the time when each electrode is stimulated is the zero point of the trigger time based on the R wave of the myocardial ECG; (3) Based on the R wave in the surface ECG Wave and R wave in the myocardial electrocardiogram are used to send cardiac stimulation pulses; specific use of a specific trigger mechanism among these three can be selected or adjusted in real time according to the actual electrical stimulation needs.

In addition, in order to further improve the control effect of cardiac stimulation pulse triggering, when the body surface ECG perception is poor, it can be directly switched to EGM-based triggering; In order to prevent continuous pulse stimulation due to special conditions such as misperception or poor perception, the therapy can be continued in a timely and effective manner.

In an implementable solution, the R-wave sensing module 1 is configured to determine the first pulse delivery time corresponding to each preset stimulation position according to the first R-wave sensing time and the preset duration.

For the myocardial electrocardiogram (EGM) collected by electrode 3, the first pulse release time is the preset duration (LPD) of the R-wave induction moment of the EGM as the reference zero point (or trigger point), and the preset duration is usually 40ms by default. , and the duration value can be adjusted according to actual needs. The LPD (ie, the first pulse delivery time) of each location or location is used to trigger the time of CCM transmission at the location or location relative to the R-wave sensing moment of the myocardial electrocardiogram.

The R-wave sensing module 1 is further configured to determine a first time difference between the second R-wave sensing time and the first R-wave sensing time, and to determine each pulse delivery time according to the first time difference and the preset duration pulse release time. Each preset stimulation position corresponds to the second pulse release time with the second R-wave sensing time as the reference zero point (or trigger point).

Obtain the first R wave sensing time when the R wave appears in the myocardial electrocardiogram, and calculate the first pulse discharge time corresponding to the preset stimulation position; obtain the second R wave sensing time when the R wave appears in the body surface electrocardiogram. The wave sensing time and the second R-wave sensing time determine the second pulse delivery time corresponding to the preset stimulation position, and then perform pulse delivery based on the first pulse delivery time and/or the second pulse delivery time. The R wave and the R wave in the body surface electrocardiogram determine the pulse delivery time scheme, which effectively ensures the timeliness and reliability of the pulse stimulation.

That is to say, for the CCM triggered by the EGM R wave, the duration from the R wave to the sending of each stimulus location is fixed (for example, the preset duration is 40ms). For CCM triggered by ECG R wave, the duration of each stimulation position is not fixed and different (that is, it is determined by the fixed preset duration of 40ms and the time difference according to the position change).

Referring to Figure 2, when the patient is in sinus rhythm, for the body surface ECG ECG, first calculate the time difference (GLSD) between the time corresponding to the sensed R wave of the surface ECG ECG and the corresponding time of the sensed R wave of the regional myocardial ECG EGM. ), the time difference represents the time-sensitive value of the myocardial electrical activity of the corresponding myocardial part/position relative to the electrical activity of the whole heart; the pulse delivery time (GPD) triggered by the sensing R wave of the surface electrocardiogram ECG will be the corresponding time GLSD and The myocardial electrocardiogram pulse discharge time LPD is added, that is, GPD=GLSD+LPD. In addition, the GLSD and GPD corresponding to each part can be measured and averaged over several self-beats (default is 5 consecutive self-beats, ranging from 3 to 12). The GPD (ie, the second pulse delivery time) of each site or location is used to trigger the time of CCM transmission at the site or location relative to the R-wave sensing moment of the ECG on the body surface. In this embodiment, this step is called a set-up period.

In an embodiment of the solution, the cardiac stimulation pulse generator is configured to maintain the first time difference after obtaining the second pulse delivery time at each position, so as to maintain the cardiac stimulation pulse to the corresponding pulse according to the second pulse delivery time. control electrode.

That is, in this embodiment, after the second pulse delivery time is determined, there is no need to recalculate before each electrical stimulation output, and the electrical stimulation output time can be directly triggered by the surface electrocardiogram, without the need to sense the myocardial electrocardiogram every time. Therefore, while achieving the effect of cardiac electrical stimulation, the time-consuming of data processing is effectively shortened, and the control efficiency of cardiac stimulation pulse triggering is improved.

In an embodiment of the solution, the time update module is configured to update the first time difference regularly or irregularly, so as to update the second pulse release time based on the updated first time difference;

The cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to the corresponding control electrodes according to the updated second pulse delivery time.

That is, in this embodiment, the second pulse release time can be updated regularly or irregularly according to actual needs (the myocardial electrical stimulation can be continued or stopped at this time), and then the myocardial electrical stimulation can be continued according to the updated trigger time, so as to achieve more flexibility. The electric stimulation effect can meet the needs of more pulsed electric stimulation scenarios.

In this embodiment, the effect of strengthening or maximizing the circulatory support to the heart is achieved through the setting of the stimulation position and the stimulation mechanism.

Of course, the control scheme of CCM stimulation in this embodiment needs to be automatically suspended in some special cases, for example, when it is detected that the patient's heart rate is too fast (for example, higher than 120 beats/min), there is PVC (premature ventricular contraction), etc., To ensure the safety of the patient's cardiac stimulation support.

Place control electrodes (such as corresponding stimulation and/or pacing functions) in multiple parts of the left and right ventricles to provide cardiac electrical stimulation CCM to multiple parts; Improves the overall contractility of the patient's heart, especially the left ventricle. For patients with acute heart failure and/or significant short-term ventricular function decline, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function.

The pulse stimulation device of this embodiment further includes a pulse control module 6 , and the pulse control module 6 is connected in communication with the cardiac stimulation pulse generator 2 .

The pulse control module 6 is used to generate a pulse delivery pattern and send it to the cardiac stimulation pulse generator 2 .

The cardiac stimulation pulse generator 2 is used to deliver cardiac stimulation pulses to each corresponding control electrode 3 based on the pulse delivery mode and pulse delivery time when R waves appear in the body surface electrocardiogram or myocardial electrocardiogram.

By presetting different pulse delivery modes in the pulse control module, in the actual pulse delivery scenario, the pulse delivery mode can be determined according to the operator's manual selection, preset a certain fixed pulse mode or random selection, etc., so as to automatically realize the pulse delivery mode. Pulse firing to different preset stimulus locations. Of course, the pulse delivery mode can also be dynamically adjusted according to actual needs.

In an implementable solution, the pulse delivery mode includes sending cardiac stimulation pulses to control electrodes corresponding to each preset stimulation position synchronously, in a set or random order, based on R waves in the body surface ECG and/or myocardial ECG.

In a set or random order, the cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions to achieve the preset number of heartbeats.

The pulse delivery mode is triggered by the global (global) R wave of the surface electrocardiogram or the local (local) R wave of each part. The delivery mechanism is to deliver cardiac stimulation pulses to each preset stimulation location synchronously and in a set or random order. , or a set-up period, that is, the measurement and calculation of the GLSD corresponding to each electrode position, etc.

By synchronizing, setting or random order, etc., pulse delivery can meet various pulse delivery requirements as much as possible to meet more pulse stimulation scenarios, which not only ensures the effectiveness of pulse stimulation for patients, but also improves the patient's quality of life. Use experience.

CCM stimulation to a location or site can be triggered and delivered (called synchronization) at the corresponding time of each site after the same R wave (ie, in the same cardiac cycle), or at multiple sites on multiple R waves. Sequential delivery, etc.; when transmitted in the set order, CCM stimulation is triggered at one site after the R wave at the corresponding time of the site, and then delivered at the next site after the next R wave, and so on, until all sites are covered transmission. After the same R wave, there may be one or more parts with CCM stimulation at the corresponding time of each part (but not all parts, otherwise it is synchronous). In addition, the sequence of specific parts receiving CCM stimulation can be specially designed (programmed by a doctor and other relevant authorized staff), or it can be random. During sequential delivery, the stimulation times of each preset part can be one or more times (for example, 6 times, that is, six cardiac cycles), and then go to the next preset part for stimulation, and so on.

In an implementable solution, the pulse control module is further configured to generate stimulation combinations corresponding to different preset stimulation positions by adopting a set construction rule or a random combination method based on a set number of preset stimulation positions;

Wherein, the stimulation combination includes at least two stimulation units, and at least one stimulation unit corresponds to two or more preset stimulation positions for synchronously executing pulse delivery;

The pulse delivery mode includes sending cardiac stimulation pulses to control electrodes corresponding to preset stimulation positions based on R waves in the body surface electrocardiogram and/or myocardial electrocardiogram, according to a set or random sequence and stimulation combination.

In a set or random order, the cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions to achieve the preset number of heartbeats.

Each preset stimulation position is no longer considered separately, but different stimulation combinations are formed based on multiple preset stimulation positions. For different preset stimulation positions corresponding to the same stimulation combination, pulses are released synchronously. Pulse stimulation is performed in a random sequence of pulse delivery to meet the needs of more pulse stimulation scenarios, further ensuring the safety of patients.

In addition, in a possible embodiment, the pulse stimulation device corresponds to two leads 4, and the electrodes of one lead are located in the right ventricular septum (right ventricular septum as an endocardial location) or located in/near the ventricle or posterior to the ventricle Interventricular sulcus (as epicardial location); the other is located on the anterolateral wall of the left ventricle (either epicardial or endocardial location).

In a possible embodiment, the pulse stimulation device corresponds to three wires 4, and one electrode is located in the right ventricular septum (the right ventricular septum is the endocardial position) or located in/near the anterior or posterior ventricular sulcus ( as an epicardial location); one on the posterolateral wall of the left ventricle (epicardial or endocardial location) and the other on the anterolateral wall of the left ventricle (in epicardial or endocardial location).

Of course, the number of wires 4 and the preset implantation position can also be re-planned according to different patients' conditions, cardiac-related surgical conditions, needs for circulatory support, and needs for CCM stimulation.

In an embodiment, the lead 4 in this embodiment includes a monopolar lead or a bipolar lead, and the cardiac stimulation pulse is transmitted to the corresponding part through the lead 4 . (1) When a single monopolar lead is used, CCM is delivered between the monopolar electrode in contact with the myocardium and the electrode elsewhere in the patient's body. At this time, the monopolar electrode can be an electrode on the cardiac cavity or other electrode leads in the blood vessel, a body surface ECG electrode or a body surface patch electrode for external defibrillation; or an electrode implanted under the skin (such as S-ICD) ) or electrodes implanted in the heart, etc. Alternatively, it can be obtained with other specially designed electrodes. (2) When multiple monopolar leads are used, CCM can be delivered between two monopolar electrodes in contact with the myocardium, one of which is the cathode and the other is the anode. (3) If a bipolar lead is used and only one electrode is in continuous contact with the myocardium (such as the right ventricular septal lead 4), CCM can be delivered between the two electrodes or as a monopolar lead (the electrode in contact with the myocardium) , similar to the unipolar setup. (4) Such as left ventricular epicardial electrodes, CCM can be delivered between two electrodes or as two monopolar leads respectively. (5) Unipolar wires and bipolar wires can be used at the same time, so there are many possible combinations, and the specific combination can be determined and adjusted according to actual needs.

The working principle of the pulse stimulation device of this embodiment will be specifically described below with reference to an example:

(1) On the epicardial surface of patients who have just undergone thoracotomy, specifically in the interventricular sulcus (near the interventricular sulcus area), the posterolateral wall of the left ventricle, and the anterior and lateral walls of the left ventricle in the anterior or posterior epicardial wall. Three bipolar leads 4 are inserted; meanwhile, the body surface electrocardiogram of the current patient is provided; these three leads are connected together with the body surface electrocardiogram to the external electrical circulation support device, that is, the R wave sensing module 1 of the pulse stimulation device;

(2) In a preset period (set-up 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 time of the EGMs of the myocardial electrocardiogram, respectively. LS (LS1, LS2, LS3), see Figure 2 for details; GLSD and GPD (GLSD1 and GPD1, GLSD2 and GPD2, GLSD31 and GPD3) of each part are calculated according to GS, LS (LS1, LS2, LS3) and LPD, Wherein GLSD=LS-GS, GPD=GLSD+LPD;

(3) Cardiac stimulation pulse delivery pattern (triggered R-wave source, synchronous or sequential, and specific order or random in the sequence, programmable by all physicians), generated for one or more sites based on the cardiac stimulation pulse delivery pattern, LPD and GPD Cardiac stimulation pulses, as shown in Figure 3;

(4) Once connected the device will go through a setup process including sensing R-waves (GS & LS) and calculating the GLSD & GPD of each part (where each of the three wires is located), in this GLSDn & GPDn, n=1, 2 and 3. It is best performed during sinus rhythm with no CCM delivery. Then, if it is the R-wave trigger mode of the surface ECG, the CCM will follow the corresponding GPD at each location in a synchronous mode (in the same heartbeat (R-wave)) or sequential mode (such as CCM after sensing the R-wave of the surface ECG) Delivered 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 random order to deliver/trigger CCM.

Similarly, CCM can be triggered by local R-waves at each site, either synchronously or sequentially (local/local R-wave patterns).

Additionally, after a CCM has been delivered for a specific number of beats or duration (default 3600 beats or 60 minutes, programmable), the setup process will start again to accommodate changes due to heart rate and/or patient conditions (such as after medication) Potential changes in parameters (such as GLSD, etc.) caused by changes. In addition, CCM transmission may also continue according to the updated parameters.

With the support of the control method triggered by the above-mentioned cardiac stimulation pulses, it can meet the needs of patients with acute and/or short-term, and single-site electrical stimulation can achieve the circulatory support required by the heart, especially for patients with weak cardiac function (such as low cardiac output). Low) patients who are unsuitable or uneasy for heart surgery, etc., can effectively strengthen postoperative cardiac function, enable patients to recover faster, and provide timely and effective support for patients' cardiac needs; at the same time, with the support of this technology, it also helps patients and the doctor’s confidence in performing related operations; in addition, the existing methods of enhancing cardiac contractility based on drugs often have side effects (such as arrhythmia, increased myocardial oxygen consumption, etc., and may increase mortality), while the cardiac stimulation of this embodiment The pulse-triggered control method basically has no related side effects (heart rate and oxygen consumption are basically unchanged), and can achieve more timely and effective electrical stimulation and better improve cardiac contractility.

In this embodiment, control electrodes (eg, corresponding to stimulation and/or pacing functions) are placed in multiple parts of the left and right ventricles to provide synchronous or sequential cardiac electrical stimulation CCM to multiple parts; the triggering mechanism of CCM stimulation is determined by the local cardiac electrical activity The timing of R wave induction and/or the R wave induction of the overall cardiac electrical activity is determined, and the triggering method can be dynamically adjusted according to the actual situation to adapt to the patient's changing heart rate and overall cardiac condition, that is, it can follow each patient's own heart. Dynamically changing state to adapt and adjust to effectively improve the control effect of CCM stimulation, achieve better cardiac contractility, better meet acute and/or short-term, and single-site electrical stimulation can achieve the use of patients with circulatory support required by the heart need.

Example 2

The pulse stimulation device of this embodiment is a further improvement to Embodiment 1. This embodiment considers a CCM stimulation scenario in which a control electrode performs a pacing operation, specifically:

For the CCM stimulation scene during pacing, there are two situations as follows: a) pacing is delivered by an independent electrode, and the control principle triggered by the cardiac stimulation pulse at this time is consistent with the above description and will not be affected; b) pacing When the CCM stimulation electrode is released, the electrode that provides CCM stimulation must also provide pacing (it is identified as the electrode position corresponding to LS1 during pacing), and the working principle of other remaining electrode positions (only CCM stimulation is provided) is the same as the above. The content is consistent. For the CCM stimulation electrodes that provide pacing, LS1 during pacing is the pacing pulse delivery time, and the preset duration needs to be extended to 40-100ms, preferably 60-80ms (also programmable). In both cases, the preset period requires two measurements, one measurement time to detect own heart rate (sinus rate) and another measurement time to pace.

Specifically, the R wave sensing module is further configured to acquire myocardial electrocardiograms corresponding to all other remaining preset stimulation positions when pacing is performed at a preset stimulation position, and acquire the new first R wave in which R waves appear in the myocardial electrocardiogram The wave sensing time and the new second R wave sensing time when the R wave appears in the body surface ECG;

The R-wave sensing module is further configured to determine a new first pulse release time corresponding to each preset stimulation position based on the new first R-wave sensing time and the preset duration;

The R-wave sensing module is further configured to determine 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 use the new The second R-wave sensing time is the reference zero point, and a new second pulse release time corresponding to each preset stimulation position is determined according to the new first time difference and the preset duration.

In this embodiment, when pacing is performed by a control electrode, in the pulse stimulation scenario, it is necessary to recalculate the R wave in the new myocardial ECG and the R wave sensing time in the R wave in the body surface ECG, and then calculate respectively The corresponding first pulse release time and the second pulse release time are used to realize the timely release of the pulse stimulation in this scenario.

Example 3

The pulse stimulation device of this embodiment is a further improvement to Embodiment 1, specifically:

The R-wave sensing module is used to obtain multiple first R-wave sensing times corresponding to R-waves appearing in the myocardial ECG at multiple preset stimulation positions, select a first R-wave sensing time as the reference zero point, and determine at the reference zero point Each subsequent first R wave senses the second difference between the time and the reference zero point, and determines the first pulse delivery time corresponding to each preset stimulation position according to the second difference and the preset duration.

The R-wave sensing module is used to randomly select a first R-wave sensing time from the occurrence times of a plurality of first R-wave sensing times, or select the first R-wave sensing time with the earliest occurrence time as a reference zero. According to practical experience, generally the first R-wave sensing time with the earliest occurrence time is preferably selected as the reference zero point.

In this embodiment, the first R-wave sensing time (LS) with the earliest occurrence time is selected as the reference zero point, and the release time of the stimulation positions at other times later is based on this, and the difference is calculated and the preset duration is added. , the pulse delivery time of each pulse stimulation position can be obtained, so that the timely and effective pulse delivery can be completed only based on the myocardial ECG without relying on the body surface ECG, which makes the control process of the pulse stimulation more flexible and can be adapted to more usage scenarios.

Example 4

The medical device in this embodiment includes the pulse stimulation device in any one of Embodiments 1-3.

Medical devices can include only pulse stimulation devices for various lead configurations; can also be integrated into or as accessories to other systems. Such medical devices may include, but are not limited to, the following:

(1) Temporary pacing system: ECS functionality can be added to the temporary pacing system that is commonly used to provide bradycardia pacing in the patient population described above. ECS can use the control electrodes for pacing as part of the CCM stimulation electrodes, or it can be independent of the CCM stimulation electrodes, with minimal impact on clinical practice, but can provide additional clinical benefit, or in the need for better CCM induced The retraction improves the location using an additional wire.

(2) Partial or full implantable devices that provide acute/short-term or chronic (long-term) mechanical circulatory support: Appropriate leads and/or myocardial electrodes (at desired locations) can be added to such systems to provide ECS as well as other Features such as bradycardia pacing, ATP, and defibrillation.

(3) External defibrillator systems: such as wearable defibrillators, AEDs, or defibrillators used in emergency rooms and/or ambulances. CCM may be provided via skin electrodes (eg, defibrillation electrodes) after sensing the R-wave of the body surface ECG. Only the ECS circuit may need to be added to an existing equipment design or for this purpose a separate ECS unit can be connected to the current equipment. When the patient is in severe bradycardia or cardiac arrest after shock or in electromechanical dissociation (EMD), the ECS function may provide a more effective aid to the recovery of the patient's cardiac function.

(4) S-ICD system: R-wave sensing can be achieved by ECG of non-myocardial contact electrodes (such as right ventricular sub-Q electrode pair) or right ventricular EGM of S-ICD with right ventricular leadless pacemaker, This triggers CCM stimulation in the S-ICD and delivers it via subQ defib electrodes and/or leadless pacemaker electrodes. When the patient is in severe bradycardia or cardiac arrest after shock or in electromechanical dissociation, this feature may provide a more effective aid to the recovery of the patient's cardiac function.

The medical device of this embodiment includes the above-mentioned pulse stimulation device, which realizes the provision of cardiac electrical stimulation CCM to multiple parts, which more effectively improves the overall contractility of the patient's heart compared with the existing method of simply stimulating the right ventricular septum. In particular, the left ventricle can be well applied to patients with acute and/or short-term ventricular function decline, which greatly improves the overall product performance of the medical device.

Although the specific embodiments of the present invention are described above, those skilled in the art should understand that this is only an example, and the protection scope of the present invention is defined by the appended claims. Those skilled in the art can make various changes or modifications to these embodiments without departing from the principle and essence of the present invention, but these changes and modifications all fall within the protection scope of the present invention.

Claims (15)

1. a pulse stimulation device, is characterized in that, described device comprises R wave sensing module, cardiac stimulation pulse generator, pulse control module, time update module and at least two control electrodes, different described control electrodes are used for Implantation of the patient's left ventricular myocardium and/or right ventricular myocardium at different preset stimulation locations; The control electrodes are respectively electrically connected with the R-wave sensing module and the cardiac stimulation pulse generator, and the R-wave sensing module, the pulse control module, the time update module and the cardiac stimulation pulse generate device communication connection; The R-wave sensing module is used to acquire a body surface electrocardiogram and/or collect an electrocardiogram based on the control electrodes to acquire a myocardial electrocardiogram, and obtain the corresponding R-wave occurrence according to the body surface electrocardiogram and/or the myocardial electrocardiogram. R-wave sensing time, and determining the pulse delivery time corresponding to each of the preset stimulation positions according to the R-wave sensing time; The pulse control module is used to generate a pulse delivery pattern and send it to the cardiac stimulation pulse generator; The cardiac stimulation pulse generator is configured to, when an R wave appears in the body surface electrocardiogram and/or the myocardial electrocardiogram, based on the pulse discharge pattern and each of the pulse discharge times, send a heart stimulation pulse to each corresponding pulse. the control electrode; The time update module is used to update the pulse release time regularly or irregularly; The cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to each of the corresponding control electrodes according to the updated pulse delivery time. 2 . The pulse stimulation device according to claim 1 , wherein the pulse delivery mode comprises synchronizing, setting or random order based on the R wave in the body surface electrocardiogram and/or the myocardial electrocardiogram. 3 . The control electrodes corresponding to each of the preset stimulation positions emit cardiac stimulation pulses. 3 . The pulse stimulation device according to claim 1 , wherein the pulse control module is further configured to generate different stimulators based on a preset number of preset stimulation positions, using a set construction rule or a random combination method. 4 . the stimulation combination corresponding to the preset stimulation position; Wherein, the stimulation combination 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 pulse delivery; The pulse firing mode includes, based on the R wave in the body surface electrocardiogram and/or the myocardial electrocardiogram, according to a set or random sequence and the stimulation combination, to the control electrode corresponding to the preset stimulation position. Cardiac stimulation pulses are delivered. 4. The pulse stimulation device according to claim 2 or 3, characterized in that, under a set or random sequence, cardiac stimulation pulses are continuously sent to the corresponding preset stimulation positions to achieve a preset number of heartbeats. 5 . The pulse stimulation device according to claim 1 , wherein the preset stimulation positions comprise the inner wall of the interventricular septum of the left and right ventricles, the interventricular sulcus of the outer wall of the ventricle, the lateral wall of the left ventricle, the anterior and lateral walls of the left ventricle, the left At least one of the posterolateral wall of the ventricle, the inner wall of the right ventricle free wall, the outer wall of the right ventricle free wall, the apex of the right ventricle, and the apex of the left ventricle. 6 . The pulse stimulation device according to claim 1 , wherein the R-wave sensing module is used to obtain a body surface electrocardiogram and a myocardial electrocardiogram based on the control electrodes, and obtain an R wave according to the myocardial electrocardiogram respectively. 7 . The first R-wave sensing time that occurs and the second R-wave sensing time that the R wave appears from the body surface electrocardiogram; The R-wave sensing module is further configured to determine the first pulse release time corresponding to each of the preset stimulation positions according to the first R-wave sensing time; The R-wave sensing module is further configured to determine the second pulse release time corresponding to each of the preset stimulation positions according to the first R-wave sensing time and the second R-wave sensing time; The cardiac stimulation pulse generator is configured to deliver cardiac stimulation pulses to each of the corresponding control electrodes according to the first pulse delivery time and/or the second pulse delivery time. 7. The pulse stimulation device according to claim 6, wherein the R-wave sensing module is further configured to take the first R-wave sensing time as a reference zero point, and determine each of the The first pulse release time corresponding to the preset stimulation position; The R-wave sensing module is further configured to determine a first time difference between the second R-wave sensing time and the first R-wave sensing time at each of the preset stimulation positions, and use The second R-wave sensing time is a reference zero point, and the second pulse delivery time corresponding to each of the preset stimulation positions is determined according to the first time difference and the preset duration. 8 . The pulse stimulation device according to claim 7 , wherein the cardiac stimulation pulse generator is configured to maintain the first time difference after obtaining the second pulse discharge time, so as to maintain the first time difference according to the The second pulse delivery time delivers cardiac stimulation pulses to the corresponding control electrodes. 9. The pulse stimulation device of claim 7, wherein The time update module is configured to update the first time difference regularly or irregularly, so as to update the second pulse release time based on the updated first time difference; The cardiac stimulation pulse generator is configured to deliver cardiac stimulation pulses to the corresponding control electrodes according to the updated second pulse delivery time. 10 . The pulse stimulation device according to claim 6 , wherein the R-wave sensing module is further configured to acquire all other remaining preset stimulation positions corresponding to all other preset stimulation positions when pacing is performed at one preset stimulation position. 11 . The myocardial electrocardiogram is obtained, and a new first R wave sensing time when the R wave appears in the myocardial electrocardiogram and a new second R wave sensing time when the R wave appears in the body surface electrocardiogram is obtained; The R-wave sensing module is further configured to determine a new first pulse release time corresponding to each of the preset stimulation positions based on the new first R-wave sensing time and a preset duration; The R-wave sensing module is further configured to determine a new first R-wave sensing time between the new second R-wave sensing time and the new first R-wave sensing time at each of the preset stimulation positions. time difference value, and taking the new second R-wave sensing time as the reference zero point, according to the new first time difference value and the preset duration to determine a new corresponding to each of the preset stimulation positions the second pulse release time. 11 . The pulse stimulation device according to claim 1 , wherein the R-wave sensing module is configured to acquire a plurality of first corresponding to R waves appearing in the myocardial electrocardiogram at a plurality of the preset stimulation positions. 12 . R-wave sensing time, selecting a first R-wave sensing time as a reference zero point, determining a second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and The first pulse release time corresponding to each of the preset stimulation positions is determined according to the second difference and the preset duration. 12 . The pulse stimulation device according to claim 11 , wherein the R-wave sensing module is used to randomly select a first R-wave sensing time from the occurrence time of a plurality of first R-wave sensing times. 13 . time, or select the first R-wave sensing time with the earliest occurrence time as the reference zero point. 13. The pulse stimulation device according to any one of claims 6-11, wherein the myocardial electrocardiogram obtains the first R wave sensing time when the R wave appears, and the body surface electrocardiogram obtains the R wave appearance The second R-wave sensing time corresponds to the same heartbeat. 14 . The pulse stimulation device according to claim 1 , wherein the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator by a monopolar wire or a bipolar wire. 15 . 15. A medical device, characterized in that, the medical device comprises the pulse stimulation device of any one of claims 1-14.

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