CN217472580U

CN217472580U - Pulse stimulation device and medical equipment

Info

Publication number: CN217472580U
Application number: CN202121888237.XU
Authority: CN
Inventors: 王励
Original assignee: Heyuan Medical Device Shanghai Co ltd
Current assignee: Heyuan Medical Device Shanghai Co ltd
Priority date: 2021-08-05
Filing date: 2021-08-12
Publication date: 2022-09-23
Anticipated expiration: 2031-08-12

Abstract

The utility model discloses a pulse stimulation device and medical equipment, wherein an R wave sensing module in the device is used for acquiring a body surface electrocardiogram and/or a cardiac electrocardiogram, acquiring R wave sensing time appearing in the R wave to determine pulse distribution time of each preset stimulation position, and the pulse distribution time corresponds to the time length of sensing the R wave to triggering the distribution of heart stimulation pulses; the cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to the control electrode according to the pulse delivery time; the time updating module is used for updating the pulse sending time. The utility model discloses the realization is to controlling the multi-section position electro photoluminescence of ventricle in order to provide the heart circulation support, compares current simplex to right ventricle ventricular interval stimulation mode, has promoted the whole contractility of ventricle about patient's heart more effectively to can support the patient that acute and/or short-term ventricle function obviously descends well.

Description

Pulse stimulation device and medical equipment

This application claims priority from chinese patent application 2021218275150, filed as 2021/8/5. The present application refers to the above-mentioned chinese patent application in its entirety.

Technical Field

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

Background

The CCM (myocardial contraction modulation) device on the market today is a stand-alone, implanted, structurally complex and expensive device, primarily for patients with chronic heart failure. The implantation position of two bipolar leads is right ventricular septum, which is used for sensing local myocardial electric potential and sending out heart stimulation pulse in a certain time (within absolute refractory period) after sensing so as to increase myocardial contractility. In this case, the myocardial stimulation is not directed to the left ventricle, which is the ventricle most in need of increased contractility. Although CCMs for the right ventricular septum have an overall effect on cardiac contractility and cardiac function (including left ventricular contractility), studies have shown that this overall effect is not direct, but is driven by the effects on the local myocardium resulting from local stimulation of the right ventricular septum.

The CCM stimulation is only used for implantable devices for patients with chronic heart failure, and long-term treatment of the patients with the chronic heart failure is achieved by stimulating a single part of the right ventricular septum; however, when a patient's cardiac function is severely impaired, blood pressure is reduced (e.g., an acute heart failure episode), the patient may not require or may not have long-term use of an implantable device, or may require relatively short-term support of cardiac function until etiology is eliminated and/or cardiac function is restored, and existing implantable CCMs and single site stimulation thereof may not satisfy acute and/or short-term support (time and degree of cardiac/circulatory support), while providing acute and short-term (day) cardiac/circulatory support may be critical to the patient's survival (e.g., an acute heart failure episode), or any additional (beyond drug) cardiac circulatory support may mean "life or death" to the patient in an emergency situation, such as an emergency room or ambulance on which the patient is resuscitated.

SUMMERY OF THE UTILITY MODEL

The to-be-solved technical problem of the utility model is to provide a pulse stimulation device and medical equipment in order to overcome the current implanted CCM stimulation mode among the prior art and only be applicable to chronic heart failure patient, can't satisfy acutely and/or short-term to and single position electro photoluminescence probably can not reach the defect of the patient's user demand of circulation support that the heart needs.

The utility model discloses an above-mentioned technical problem is solved through following technical scheme:

the utility model provides a pulse stimulation device, which comprises an R wave sensing module, a heart stimulation pulse generator, a pulse control module, a time updating module and at least two control electrodes, wherein different control electrodes are used for being implanted into different preset stimulation positions of left ventricular myocardium and/or right ventricular myocardium of a patient;

the control electrode is respectively and 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 updating module and the cardiac stimulation pulse generator are in communication connection;

the R wave sensing module is used for acquiring a body surface electrocardiogram and/or acquiring electrocardiosignals based on the control electrode to acquire a cardiac electrocardiogram, acquiring R wave sensing time of the corresponding R wave according to the body surface electrocardiogram and/or the cardiac electrocardiogram, and determining pulse sending time corresponding to each preset stimulation position according to the R wave sensing time;

the pulse control module is used for generating a pulse delivery mode and sending the pulse delivery mode to the cardiac stimulation pulse generator;

the cardiac stimulation pulse generator is used for delivering cardiac stimulation pulses to each corresponding control electrode based on the pulse delivery mode and each pulse delivery time when R waves appear in the body surface electrocardiogram and/or the cardiac electrocardiogram;

the time updating module is used for updating the pulse sending time regularly or irregularly;

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

In the scheme, based on the body surface electrocardiogram and/or the cardiac electrocardiogram, the R wave sensing time of the corresponding R wave is obtained to determine the pulse sending time corresponding to the preset stimulation position, so that the use requirement of the patient who can not meet the circulation support required by the heart in acute and/or short-term electrical stimulation of a single part is met, the timeliness and the reliability of triggering the cardiac stimulation pulse are ensured, and the safety of the patient is effectively guaranteed.

Through setting up two at least control electrodes to realize the stimulation to a plurality of different positions in left ventricle cardiac muscle and/or the right ventricle cardiac muscle, compare the mode of the pure right ventricle ventricular interval stimulation of current, can promote the whole contractility to patient's heart more effectively, especially left ventricle. Aiming at patients with acute heart failure and/or short-term ventricular function obvious decline, multi-part stimulation can better enhance the cardiac contractility and improve the cardiac ejection function.

Different pulse sending modes are preset in the pulse control module, and in an actual pulse sending scene, the pulse sending modes can be determined according to the modes of manual selection, preset of a certain fixed pulse mode or random selection of an operator and the like, so that pulse sending of different preset stimulation positions is automatically realized. Of course, the pulse delivery mode can be dynamically adjusted according to actual requirements.

Optionally, the pulse delivery mode includes delivering heart stimulation pulses to the control electrodes corresponding to each of the preset stimulation positions synchronously, in a set or random order based on the body surface electrocardiogram and/or the R-wave in the cardiac electrocardiogram.

In the scheme, the pulse can be issued synchronously and in a set or random sequence mode, various pulse issuing requirements can be met as far as possible, more pulse stimulation scenes can be met, and the use experience of a patient is improved while the effectiveness of pulse stimulation of the patient is guaranteed.

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

the stimulation combination comprises 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 comprises delivering heart stimulation pulses to the control electrodes of the corresponding preset stimulation positions according to a set or random sequence and the stimulation combination based on the body surface electrocardiogram and/or the R wave in the cardiac electrocardiogram.

In the scheme, each preset stimulation position is not considered independently, different stimulation combinations are formed based on the plurality of preset stimulation positions, pulses are synchronously sent to different preset stimulation positions corresponding to the same stimulation combination, and different stimulation combinations are subjected to pulse stimulation in a set or random sequence pulse sending mode so as to meet the requirements of more pulse stimulation scenes and further ensure the safety of patients.

Optionally, the cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions in a set or random sequence to reach a preset heartbeat number.

In the scheme, control electrodes are placed at a plurality of positions of left and right ventricles, so that the simultaneous or sequential cardiac Electrical stimulation (CCM) is provided for the plurality of positions to realize the cardiac circulation Support (ECS). Compared with the mode of stimulating the right ventricle ventricular septum in the prior art, the method can more effectively improve the whole contractility of the heart of the patient, particularly the left ventricle. Aiming at patients with acute heart failure and/or obvious decline of short-term ventricular function, the multi-part stimulation can better enhance the heart contractility and improve the heart ejection function.

Optionally, the preset stimulation position includes at least one of an inner ventricular septal wall, an interventricular sulcus, an outer left ventricular wall, an outer left ventricular front lateral wall, an outer left ventricular rear lateral wall, an inner right ventricular free wall, an outer right ventricular free wall, an apex of a right ventricle, and an apex of a left ventricle.

In the scheme, control electrodes are respectively arranged in the enumerated positions of the left ventricle and the right ventricle, or the control electrodes are arranged at partial positions according to the actual stimulation requirement, so that the reliability of the heart pulse stimulation is guaranteed as much as possible.

Optionally, the R-wave sensing module is configured to acquire a body surface electrocardiogram and a cardiac electrocardiogram based on the control electrode, and acquire a first R-wave sensing time when an R-wave occurs and a second R-wave sensing time when an R-wave occurs according to the cardiac electrocardiogram and the body surface electrocardiogram, respectively;

the R wave sensing module is further used for determining first pulse emitting time corresponding to each preset stimulation position according to the first R wave sensing time;

the R wave sensing module is further used for determining second pulse emitting time corresponding to each preset stimulation position 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 corresponding control electrode according to the first pulse delivery time and/or the second pulse delivery time.

In the scheme, first R wave sensing time of R waves in a myocardial electrocardiogram is obtained, and first pulse sending time corresponding to a preset stimulation position is determined; and acquiring second R wave sensing time when the R wave appears in the body surface electrocardiogram, determining second pulse sending time corresponding to the preset stimulation position according to the first R wave sensing time and the second R wave sensing time, and then sending pulses based on the first pulse sending time and/or the second pulse sending time, namely, providing a scheme for determining the pulse sending time based on the R wave in the cardiac electrocardiogram and the R wave in the body surface electrocardiogram, and effectively ensuring the timeliness and reliability of pulse stimulation.

Optionally, the R-wave sensing module is further configured to determine, according to a preset duration, a first pulse emitting time corresponding to each preset stimulation position, with the first R-wave sensing time as a reference zero point;

the R-wave sensing module is further used for determining a first time difference value between the second R-wave sensing time and the first R-wave sensing time of each preset stimulation position, and determining second pulse sending time corresponding to each preset stimulation position according to the first time difference value and the preset duration by taking the second R-wave sensing time as a reference zero point.

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

Optionally, the time updating module is configured to update the first time difference periodically or aperiodically, so as to update the second pulse issuance time based on the updated first time difference;

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

In the scheme, the second pulse sending time can be updated regularly or irregularly according to actual requirements (the myocardial electrostimulation can be continued or stopped at the moment), and then the myocardial electrostimulation is continued according to the updated trigger time, so that a more flexible electrostimulation effect is realized, and more pulse electrostimulation scene requirements are met.

Optionally, the R-wave sensing module is further configured to, when pacing is performed at one preset stimulation location, obtain the cardiac electrocardiogram corresponding to all other remaining preset stimulation locations, and obtain a new first R-wave sensing time when an R-wave appears in the cardiac electrocardiogram and a new second R-wave sensing time when an R-wave appears in the body surface electrocardiogram;

the R wave sensing module is further used for determining a new first pulse emitting time corresponding to each preset stimulation position based on a new first R wave sensing time and a 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 of each preset stimulation location, and determine a new second pulse issuing time corresponding to each preset stimulation location according to the new first time difference and the preset duration with the new second R-wave sensing time as a reference zero point.

In the scheme, when pacing is performed through one control electrode, in the pulse stimulation scene, the sensing time of the R wave in the new cardiac electrocardiogram and the sensing time of the R wave in the body surface electrocardiogram need to be determined again, and then the corresponding first pulse delivery time and the corresponding second pulse delivery time are determined respectively, so that the pulse stimulation in the scene is delivered in time.

Optionally, the R-wave sensing module is configured to obtain a plurality of first R-wave sensing times corresponding to R-waves appearing in the electrocardiogram at a plurality of preset stimulation locations, select one first R-wave sensing time as a reference zero point, determine a second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and determine a first pulse delivery time corresponding to each preset stimulation location according to the second difference and a preset duration.

In the scheme, a first R wave sensing time (LS) is selected as a reference zero point at will, the pulse issuing time of each pulse stimulation position can be obtained by determining the difference value of the first R wave sensing time (LS) and the preset time length on the basis of the issuing time of the stimulation positions at the later time, so that the aim of timely and effectively issuing pulses can be achieved only on the basis of the cardiac electrocardiogram without depending on the body surface electrocardiogram, the control process of pulse stimulation is more flexible, and the method and the device can be suitable for more use scenes.

Optionally, the R-wave sensing module is configured to randomly select one first R-wave sensing time from the occurrence times of the plurality of first R-wave sensing times, or select the first R-wave sensing time with the earliest occurrence time as the reference zero point.

Optionally, a first R-wave sensing time at which the myocardial electrocardiogram acquires R-waves and a second R-wave sensing time at which the body-surface electrocardiogram acquires R-waves correspond to the same heartbeat.

In the scheme, in order to ensure the effectiveness of pulse stimulation, all R waves (namely R waves in a cardiac electrocardiogram and R waves in a body surface electrocardiogram) are sensed under the same heartbeat; that is, the first R-wave sensing time for the myocardial electrocardiogram to acquire the R-waves and the second R-wave sensing time for the body-surface electrocardiogram to acquire the R-waves, the time difference between the two R-wave sensing times must be less than a certain value, so that the actual significance of the pulse stimulation is achieved, otherwise the reliability of the pulse stimulation cannot be ensured.

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

The utility model also provides a medical equipment, medical equipment includes foretell pulse stimulation device.

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

The utility model discloses an actively advance the effect and lie in:

(1) control electrodes are placed at multiple positions of the left ventricle and the right ventricle (such as corresponding stimulation and/or pacing functions), so that the simultaneous or sequential cardiac electrical stimulation (CCM) is provided for the multiple positions to provide the cardiac circulation support; compared with the existing mode of stimulating the right ventricle in the ventricular septal mode, the method can more effectively improve the whole contractility of the heart of the patient, particularly the left ventricle. Aiming at patients with acute heart failure and/or obvious decline of short-term ventricular function, the multi-part stimulation can better enhance the heart contractility and improve the heart ejection function. For example, for a patient who has just received cardiac surgery, the lead may be implanted at a different location in the myocardium of his left and right ventricles (e.g., anterior/posterior left ventricular locations on the epicardial surface, the interventricular sulcus, the free wall of the right ventricle, etc.). In other patients, the lead may be placed intravenously in the right ventricle (e.g., in the interventricular septum, apex, or free wall) and/or placed on the left ventricular intima (e.g., interventricular septum, apex, or free wall) via the atrial septum or artery or the left ventricular epicardial surface (via electrodes placed in the coronary veins or arteries), etc.

(2) Electrical cardiac stimulation (CCM) modality (mechanism, time, etc.): a. the stimulation mechanism is a multi-position cardiac electrical stimulation mechanism (synchronous or sequential), for example, all electrode positions trigger stimulation in one cardiac cycle (synchronous stimulation), or the triggering stimulation to each electrode position is completed in a set or random sequence in a plurality of cardiac cycles (sequential stimulation); b. the trigger mechanism is the trigger point that is sensed by an R-wave representative of local ventricular myoelectrical activity and/or the time of R-wave representative of global ventricular myoelectrical activity. In the latter case, the time relationship between the global and local ventricular myoelectric R-waves becomes a part of the trigger time. The stimulation mode (mechanism, time and the like) can be dynamically adjusted according to the actual situation to adapt to the continuously changing heart rate and the overall heart condition of the patient, namely, the stimulation mode can be adapted and adjusted along with the dynamic change state of the heart of each patient, so that the effect of improving the heart function is effectively improved.

(3) CCM transmission can be achieved with a simple unipolar wire rather than having to use two unipolar or bipolar wires at a cardiac site, thereby simplifying system architecture and reducing cost.

Drawings

Fig. 1 is a schematic structural diagram of a pulse stimulation apparatus according to embodiment 1 of the present invention.

Fig. 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 Description

The present invention is further illustrated by way of the following examples, which are not intended to limit the scope of the invention.

Example 1

As shown in fig. 1, the pulse stimulation apparatus of the present 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 through a lead 4, and the R-wave sensing module 1 is in communication connection with the cardiac stimulation pulse generator 2.

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

Through setting up two at least control electrodes to realize the stimulation to a plurality of different positions in left ventricle cardiac muscle and/or the right ventricle cardiac muscle, compare the mode of the pure right ventricle ventricular interval stimulation of current, can promote the whole contractility to patient's heart more effectively, especially left ventricle. Aiming at patients with acute heart failure and/or obvious decline of short-term ventricular function, the multi-part stimulation can better enhance the heart contractility and improve the heart ejection function. Of course, the number of the control electrodes can be reset and adjusted according to the actual scene requirements.

Specifically, the different preset stimulation locations include, but are not limited to, the interatrial wall of the left and right ventricles, the interventricular sulcus of the outer ventricular wall, the outer lateral left ventricular wall, 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.

Control electrodes are arranged in the enumerated positions of the left ventricle and the right ventricle respectively, or are arranged at partial positions according to actual stimulation requirements, so that the reliability of heart pulse stimulation is guaranteed as much as possible.

The R-wave sensing module 1 is used to acquire a body surface Electrocardiogram (ECG) and/or acquire an electrocardiogram signal based on the control electrodes 3 to acquire a cardiac Electrocardiogram (EGM), which covers signals from inside or outside of the ventricle because the control electrodes may be located on the endocardium or epicardium.

Specifically, the R-wave sensing module 1 is configured to obtain R-wave sensing time when an R-wave appears according to a body surface electrocardiogram and/or a cardiac electrocardiogram, and determine cardiac stimulation pulse (or CCM electrical stimulation) delivery time corresponding to each preset stimulation position according to the R-wave sensing time, where the pulse delivery time corresponds to a time period from sensing of the R-wave to triggering of delivery of the cardiac stimulation pulse, and transmission of the CCM at each position or location is triggered by R-wave sensing of a local cardiac electrocardiogram EGM or R-wave sensing of a global body surface ECG.

The cardiac stimulation pulse generator 2 is adapted to deliver cardiac stimulation pulses to each corresponding control electrode 3 according to each pulse delivery time.

In an implementation scheme, the R-wave sensing module is configured to acquire a body surface electrocardiogram and/or acquire a cardiac electrocardiogram based on the control electrodes, and acquire a first R-wave sensing time when an R-wave occurs and a second R-wave sensing time when an R-wave occurs according to the cardiac electrocardiogram and the body surface electrocardiogram, respectively;

it should be noted that the first R-wave sensing time for acquiring R-waves by the electrocardiograph of the myocardium and the second R-wave sensing time for acquiring R-waves by the electrocardiograph of the body surface correspond to the same heart beat.

The pulse stimulation device of the embodiment further comprises a time updating module 5 for updating the pulse delivery time periodically or aperiodically;

the cardiac stimulation pulse generator 2 is configured to deliver cardiac stimulation pulses to each corresponding control electrode according to the updated pulse delivery times.

In order to ensure the effectiveness of the pulse stimulation, all R waves (namely R waves in the electrocardiogram of the myocardium and R waves in the electrocardiogram of the body surface) are sensed under the same heartbeat; that is, the first R-wave sensing time for the myocardial electrocardiogram to acquire the R-waves and the second R-wave sensing time for the body-surface electrocardiogram to acquire the R-waves, the time difference between the two R-wave sensing times must be less than a certain value, so that the actual significance of the pulse stimulation is achieved, otherwise the reliability of the pulse stimulation cannot be ensured. The R wave sensing module is also used for determining first pulse emitting time corresponding to each preset stimulation position according to the first R wave sensing time; once the first R-wave sensing time is determined, the corresponding first pulse emitting time is also determined (i.e. is a preset time), and will not change.

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

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

In the pulse stimulation process in the embodiment, (1) the heart stimulation pulse can be delivered mainly by taking the R wave in the body surface electrocardiogram, that is, the stimulation emitting time of each electrode takes the R wave sensing time of the body surface electrocardiogram as the zero point of the trigger time; (2) the heart stimulation pulse can be delivered by taking the R wave in the electrocardiogram of the heart muscle as the main part, namely the stimulation emitting time of each electrode takes the R wave of the electrocardiogram of the heart muscle as the zero point of the trigger time; (3) simultaneously, heart stimulation pulse distribution is carried out based on R waves in the body surface electrocardiogram and R waves in the cardiac electrocardiogram; the specific trigger mechanism of the three types can be selected or adjusted in real time according to the actual electrical stimulation requirement.

In addition, in order to further improve the control effect of the cardiac stimulation pulse trigger, the EGM-based trigger can be directly switched to when the body surface ECG senses badly; or, when the EGM at one position has poor perception, the EGM can be directly switched to ECG-based triggering, so that the problem that continuous pulse stimulation cannot be performed due to special conditions such as misperception or poor perception is avoided, and the continuous therapy is timely and effectively ensured.

In an implementation scheme, the R-wave sensing module 1 is configured to determine a first pulse emitting time corresponding to each preset stimulation location according to the first R-wave sensing time and a preset duration.

For a cardiac Electrocardiogram (EGM) acquired by the electrodes 3, the first pulse sending time is a preset time period (LPD) taking an R-wave sensing time of the cardiac Electrocardiogram (EGM) as a reference zero point (or trigger point), the preset time period is usually defaulted to 40ms, and the value of the time period can be adjusted according to actual requirements. The LPD (i.e., the first pulse delivery time) for each site or location is the time at which the site or location triggers CCM transmission relative to the moment of electrocardiographic R-wave sensing.

The R-wave sensing module 1 is further configured to determine a first time difference between a second R-wave sensing time and the first R-wave sensing time, and determine, according to the first time difference and a preset duration pulse emitting time, a second pulse emitting time corresponding to each preset stimulation location and using the second R-wave sensing time as a reference zero point (or trigger point).

Acquiring first R wave sensing time of the occurrence of R waves in the electrocardiogram of the myocardium, and calculating first pulse sending time corresponding to a preset stimulation position; and acquiring second R wave sensing time when the R wave appears in the body surface electrocardiogram, determining second pulse sending time corresponding to the preset stimulation position according to the first R wave sensing time and the second R wave sensing time, and then sending pulses based on the first pulse sending time and/or the second pulse sending time, namely, providing a scheme for determining the pulse sending time based on the R wave in the cardiac electrocardiogram and the R wave in the body surface electrocardiogram, and effectively ensuring the timeliness and reliability of pulse stimulation.

That is, in the CCM triggered by the EGM R-wave, the duration from the R-wave to the delivery is fixed for each stimulation location (e.g., 40 ms). CCM triggered by ECG R-wave, the duration of each stimulation site is not fixed, but varied (i.e. determined by a fixed preset duration of 40ms, time difference depending on site variation).

Referring to fig. 2, in the case of sinus rhythm of a patient, for a body surface electrocardiogram ECG, a time difference (GLSD) between a time corresponding to a sensed R-wave of the body surface electrocardiogram ECG and a time corresponding to a sensed R-wave of a local myocardial electrocardiogram EGM is first calculated, which represents a time sensitive value of myocardial electrical activity corresponding to a myocardial region/location with respect to the overall cardiac electrical activity; the pulse delivery time (GPD) triggered by the sensing R-wave time of the body surface electrocardiogram ECG will be added to the corresponding time GLSD and the electrocardiographic pulse delivery time LPD, i.e. GPD GLSD + LPD. In addition, the GLSD and GPD for each site can be measured and averaged over several self-heartbeats (default is 5 consecutive self-heartbeats, ranging from 3 to 12). The GPD (i.e., second pulse delivery time) for each site or location is the time at which CCM transmission is triggered at that site or location relative to the time of R-wave perception of the body surface electrocardiogram. This step is referred to in this embodiment as a set-up period.

In one embodiment, the cardiac stimulation pulse generator is configured to maintain the first time difference after obtaining the second pulse delivery time for each location to maintain delivery of the cardiac stimulation pulses to the corresponding control electrodes according to the second pulse delivery time.

That is, in this embodiment, after the second pulse delivery time is determined, it is not necessary to perform recalculation before electrical stimulation is output each time, the electrical stimulation output time may be directly triggered by the body surface electrocardiogram, and it is not necessary to trigger by sensing the R wave of the myocardial electrocardiogram each time, so that the time consumed for data processing is effectively shortened while the effect of cardiac electrical stimulation is achieved, and the control efficiency of cardiac stimulation pulse triggering is improved.

In an embodiment, the time updating module is configured to update the first time difference periodically or aperiodically, so as to update the second pulse emitting time based on the updated first time difference;

That is, in this embodiment, the second pulse delivery time may be updated periodically or aperiodically according to actual requirements (at this time, the electrical stimulation of the myocardium may be continued or stopped), and then the electrical stimulation of the myocardium may be continued according to the updated trigger time, so as to achieve a more flexible electrical stimulation effect, and meet more requirements of the pulse electrical stimulation scene.

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

Of course, the CCM stimulation control scheme of the present embodiment may need to automatically suspend implementation in some special cases, for example, when the heart rate of the patient is detected to be too fast (e.g. higher than 120 beats/minute), PVC (ventricular premature beat) is present, etc., so as to ensure the safety of the cardiac stimulation support of the patient.

Control electrodes (such as corresponding stimulation and/or pacing functions) are placed at a plurality of positions of the left ventricle and the right ventricle, so that the CCM (continuous current machine) for providing electrical stimulation to the plurality of positions is realized; compared with the existing mode of stimulating the right ventricle ventricular septum, the method can more effectively improve the whole contractility of the heart of a patient, particularly the left ventricle. Aiming at patients with acute heart failure and/or obvious decline of short-term ventricular function, the multi-part stimulation can better enhance the heart contractility and improve the heart ejection function.

The pulse stimulation device of the present embodiment further comprises 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 and send a pulse delivery pattern 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 pattern and pulse delivery time when R-waves appear in a body surface electrocardiogram or a cardiac electrocardiogram.

In an implementation, the pulse delivery mode includes delivering the cardiac stimulation pulses to the control electrodes corresponding to each of the predetermined stimulation locations synchronously, in a set or random order based on the R-wave in the body surface electrocardiogram and/or the cardiac electrocardiogram.

Under the set or random sequence, the heart stimulation pulses are continuously sent to the corresponding preset stimulation positions to reach the preset heartbeat times.

The pulse delivery mode is triggered by a global (global) R wave of a body surface electrocardiogram or a local (local) R wave of each part, and the delivery mechanism is to deliver heart stimulation pulses to each preset stimulation position synchronously and in a set-up order, or to deliver a set-up period (set-up period), i.e. to measure and calculate the GLSD corresponding to each electrode position.

The pulse is issued in a synchronous mode or a set or random sequence mode, various pulse issuing requirements are met as far as possible, more pulse stimulation scenes are met, effectiveness of pulse stimulation on patients is guaranteed, and use experience of the patients is improved.

CCM stimulation of a location or site may be delivered "simultaneously" (i.e., within the same cardiac cycle) at the same time for each site after the same R-wave (referred to as synchronization), or sequentially at multiple sites on multiple R-waves, etc.; when delivered in a set sequence, the CCM stimulus triggers delivery at one location after a corresponding time for that location after the R wave, then at the next location after the next R wave, and so on until all locations are over-delivered. After the same R wave, there may be 1 or more sites where CCM stimulation occurs at the corresponding time for each site (but not all sites, otherwise synchronous). In addition, the specific part sequence for receiving CCM stimulation can be specially designed (can be programmed by related authority staff such as doctors) or can be random. In sequential delivery, the number of stimulations at each preset site may be one or more (e.g., 6, six cardiac cycles), and then go to the next preset site for stimulation, and so on.

In an implementable scheme, 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 mode based on a set number of preset stimulation positions;

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

the pulse delivery mode includes delivering cardiac stimulation pulses to the control electrodes at the corresponding preset stimulation locations according to a set or random order and stimulation combinations based on R-waves in the body surface electrocardiogram and/or the cardiac electrocardiogram.

Each preset stimulation position is not considered independently, different stimulation combinations are formed based on the plurality of preset stimulation positions, pulses are synchronously sent to different preset stimulation positions corresponding to the same stimulation combination, and different stimulation combinations are subjected to pulse stimulation in a set or random sequence pulse sending mode, so that more pulse stimulation scene requirements are met, and the safety of patients is further guaranteed.

In addition, in one embodiment, the impulse stimulation device corresponds to two leads 4, one with its electrodes located in the right ventricular septum (right ventricular septum as the endocardial location) or in/near the ventricular anterior or ventricular posterior interventricular sulcus (as the epicardial location); the other is located on the antero-lateral left ventricular wall (epicardial or endocardial location).

In one embodiment, the pulse stimulation device is associated with three leads 4, one electrode being located in the right ventricular septum (the right ventricular septum being the endocardial location) or in/near the ventricular anterior or ventricular posterior interventricular sulcus (being the 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 (epicardial or endocardial location).

Of course, the number of leads 4 and the preset implant locations may also be reprogrammed based on the condition of the patient, the heart related surgery, the need for circulatory support and the need for CCM stimulation.

In one embodiment, the lead 4 of the present embodiment comprises a monopolar lead or a bipolar lead, and the cardiac stimulation pulses are transmitted to the corresponding site through the lead 4. (1) When a single unipolar lead is used, the CCM is communicated between the unipolar electrode in contact with the myocardium and the electrode elsewhere in the patient's body. In this case, the unipolar electrode may be an electrode on the heart chamber or other electrode leads within the blood vessel, a body surface ECG electrode or a body surface patch electrode for external defibrillation; or an electrode implanted under the skin (e.g., S-ICD) or an electrode implanted in the heart, etc. Alternatively, it may be achieved by other specially designed electrodes. (2) If multiple unipolar leads are used, the CCM may be passed between two unipolar electrodes in contact with the myocardium, one being the cathode and the other being the anode. (3) If a bipolar lead is used, with only one electrode in continuous contact with the myocardium (e.g., the right ventricular septal lead 4), the CCM may be delivered between the two electrodes or as a monopolar lead (an electrode in contact with the myocardium), similar to a monopolar arrangement. (4) Such as a left ventricular epicardial electrode, the CCM may be delivered between the two electrodes or as two unipolar leads, respectively. (5) Both monopolar and bipolar leads can be used, so that there are many possible combinations, and how the combination can be determined and adjusted according to actual needs.

The working principle of the pulse stimulation device of the present embodiment is specifically described below with reference to examples:

(1) three bipolar leads 4 are implanted on the epicardial surface of a patient who just receives the thoracotomy operation, particularly on the ventricular sulcus (close to the ventricular interventricular sulcus region) of the extraventricular front wall or the extraventricular back wall, the left ventricular back outer side wall and the left ventricular front outer side wall; simultaneously providing a body surface electrocardiogram of the current patient; these three leads are connected to an external electrical circulation support device, i.e., an R-wave sensing module 1 of the pulse stimulation apparatus, together with the body surface electrocardiogram;

(2) in a preset period (set-up period), the R-wave sensing module 1 is used for sensing R-wave sensing time (GS) of a body surface Electrocardiogram (ECG) and R-wave sensing time LS (LS1, LS2, LS3) of the cardiac electrocardiogram EGMs, respectively, see fig. 2 specifically; calculating GLSD and GPD (GLSD1 and GPD1, GLSD2 and GPD2, GLSD31 and GPD3) for each site from GS, LS (LS1, LS2, LS3) and LPD, where GLSD is LS-GS and GPD is GLSD + LPD;

(3) a cardiac stimulation pulse delivery pattern (trigger R-wave source, synchronization or sequence, and specific or random in sequence, all physician programmable) that generates cardiac stimulation pulses for one or more sites based on the cardiac stimulation pulse delivery pattern, LPD, and GPD, as shown in fig. 3;

(4) once the connection device is going through a setup procedure, including sensing the R-wave (GS & LS) and calculating GLSD & GPD for each site (where each of the three wires is located), where n is 1, 2 and 3. Preferably during sinus rhythm, without CCM delivery. Then, if it is the R-wave triggered mode of the surface ECG, the CCMs will deliver/trigger the CCMs in either synchronous mode (at the same heartbeat (R-wave)) or sequential mode (e.g., CCMs deliver to site 1 after R-wave 1, site 2 after R-wave 2, site 3 after R-wave 3 (one after the other) or in random order according to the GPD corresponding to each location after sensing the R-wave of the surface ECG.

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

In addition, after CCM delivery continues for a certain number or duration of beats (default 3600 beats or 60 minutes, programmable), the setup process will start again to accommodate potential changes in parameters (such as GLSD, etc.) due to changes in heart rate and/or patient condition (such as post-medication). In addition, CCM transmission may also continue according to the updated parameters.

By the support of the control mode triggered by the cardiac stimulation pulse, the use requirements of a patient on acute and/or short-term and cyclic support required by the heart by single-part electrical stimulation can be met, and particularly for patients with weak cardiac functions (such as low cardiac output) who are not suitable for cardiac surgery or who are not relieved of heart surgery and the like, the postoperative cardiac function can be effectively strengthened, so that the patient can recover more quickly, and the timely and effective cardiac demand support can be performed on the patient; meanwhile, the support of the technology also helps patients and doctors to do relevant operations, so that the confidence is improved; in addition, the existing mode of enhancing the heart contractility based on drugs often has side effects (such as arrhythmia, increase of myocardial oxygen consumption and the like, and possibly increase of death rate), while the control mode triggered by the heart stimulation pulses of the embodiment basically has no related side effects (heart rate and oxygen consumption are basically unchanged), and can achieve the effects of more timely and effective electrical stimulation and better improvement of the heart contractility.

In the embodiment, control electrodes (such as corresponding stimulation and/or pacing functions) are placed at multiple positions of the left ventricle and the right ventricle, so that synchronous or sequential cardiac electrical stimulation CCM is provided for the multiple positions; the triggering mechanism of CCM stimulation is determined by the R wave induction of local electrocardio activity and/or the R wave induction of whole electrocardio activity, and the triggering mode can be dynamically adjusted according to actual conditions to adapt to the constantly changing heart rate and the whole heart condition of a patient, namely, the triggering mode can be adjusted in an adaptive manner along with the heart dynamic change state of each patient, so that the CCM stimulation control effect is effectively improved, better heart contractility is realized, the acute and/or short-term conditions are better met, and the electrical stimulation of a single part can meet the use requirements of the patient supported by the circulation of the heart.

Example 2

The pulse stimulation apparatus of this embodiment is a further improvement of embodiment 1, and this embodiment is a CCM stimulation scenario in which one control electrode performs a pacing operation, specifically:

for CCM stimulation scenarios at pacing, there are two cases: a) pacing is delivered by an independent electrode, and the control principle of the triggering of the cardiac stimulation pulse is consistent with the content of the expression and cannot be influenced; b) pacing is delivered by a CCM stimulation electrode, primarily for the electrode providing CCM stimulation, but also for pacing (pacing is identified as the electrode location corresponding to LS 1), while the other remaining electrode locations (providing only CCM stimulation) operate in accordance with the above statements. For CCM stimulation electrodes that provide pacing, LS1 at pacing is the pacing pulse delivery time, and the preset duration needs to be extended to 40-100ms, preferably 60-80ms (also programmable adjustment). In both cases, the predetermined period requires two measurements, one at the time of detecting the heart rate (sinus rate) and the other at the time of pacing.

Specifically, the R-wave sensing module is further configured to, when pacing is performed at a preset stimulation position, obtain a cardiac electrocardiogram corresponding to all other remaining preset stimulation positions, and obtain a new first R-wave sensing time when an R-wave appears in the cardiac electrocardiogram and a new second R-wave sensing time when an R-wave appears in the body surface electrocardiogram;

the R wave sensing module is also used for determining new first pulse sending 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 used for determining a new first time difference value between a new second R wave sensing time and a new first R wave sensing time of each preset stimulation position, and determining a new second pulse issuing time corresponding to each preset stimulation position according to the new first time difference value and the preset time length by taking the new second R wave sensing time as a reference zero point.

In this embodiment, when pacing is performed through one control electrode, in the pulse stimulation scenario, it is necessary to recalculate the R-wave sensing time in the new cardiac electrocardiogram and the R-wave sensing time in the R-wave in the body surface electrocardiogram, and then calculate the corresponding first pulse delivery time and second pulse delivery time, respectively, so as to implement the timely delivery of pulse stimulation in the scenario.

Example 3

The pulse stimulation device of the present embodiment is a further improvement of embodiment 1, specifically:

the R-wave sensing module is used for acquiring a plurality of first R-wave sensing times corresponding to the occurrence of R-waves in the myocardial electrocardiogram at a plurality of preset stimulation positions, selecting one first R-wave sensing time as a reference zero point, determining a second difference value between each first R-wave sensing time after the reference zero point and the reference zero point, and determining a first pulse sending time corresponding to each preset stimulation position according to the second difference value and preset duration.

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

In the embodiment, the first R wave sensing time (LS) with the earliest occurrence time is selected as a reference zero point, the pulse release time of each pulse stimulation position can be obtained by calculating the difference value of the first R wave sensing time (LS) with the first R wave sensing time and the release time of the stimulation positions at the later time on the basis of the first R wave sensing time (LS) and the preset time length, so that the pulse release time of each pulse stimulation position can be obtained only based on the cardiac electrocardiogram without depending on the body surface electrocardiogram, the pulse can be timely and effectively released, the control process of the pulse stimulation is more flexible, and the pulse stimulation control method can be suitable for more use scenes.

Example 4

The medical apparatus of this embodiment comprises the pulse stimulation device of any of embodiments 1-3.

The medical device may include only the pulse stimulation means for various lead configurations; and may also be integrated into or as an accessory 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 temporary pacing systems that are typically used to provide bradycardia pacing in the patient population described above. The ECS may have the control electrode for pacing as part of the CCM stimulation electrode, or may be independent of the CCM stimulation electrode, thus having minimal impact on clinical practice, but may provide additional clinical benefits, or use additional leads where better CCM-induced contraction improvement is desired.

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

(3) External defibrillator system: such as a wearable defibrillator, AED, or defibrillator for emergency rooms and/or ambulances. The CCM may be provided via a skin electrode (e.g., a defibrillation electrode) after sensing an R-wave of the body surface ECG. Only the ECS circuit may need to be added to the existing device design or for this purpose a separate ECS cell may be connected to the current device. ECS function may provide more effective assistance in the restoration of a patient's cardiac function when the patient is in severe bradycardia or cardiac arrest following a shock or in electro-mechanical separation (EMD).

(4) S-ICD system: r-wave sensing can be achieved by ECG with non-myocardial contact electrodes (e.g., right ventricular sub-Q electrode pair) or right ventricular EGM of an S-ICD with a right ventricular leadless pacemaker, triggering CCM stimulation in the S-ICD and delivered via subQ defib electrodes and/or leadless pacemaker electrodes. This function may provide a more effective aid to the patient's restoration of cardiac function when the patient is in severe bradycardia or cardiac arrest following a shock or in electromechanical disassociation.

The medical equipment of the embodiment comprises the pulse stimulation device, realizes the electrical stimulation CCM for the heart to multiple parts, and more effectively improves the whole contractility of the heart of a patient, especially the left ventricle compared with the existing mode of simply stimulating the right ventricle at intervals, thereby being well suitable for the patient with acute and/or short-term ventricular function obviously reduced and greatly improving the whole product performance of the medical equipment.

Although specific embodiments of the present invention have been described above, it will be understood by those skilled in the art that this is by way of example only, and that the scope of the invention is defined by the appended claims. Various changes and modifications to these embodiments may be made by those skilled in the art without departing from the spirit and the principles of the present invention, and these changes and modifications are all within the scope of the present invention.

Claims

1. A pulse stimulation device, characterized in that the device 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, different ones of said control electrodes being intended to be implanted in different preset stimulation positions of the left and/or right ventricular myocardium of a patient;

the R wave sensing module is used for acquiring a body surface electrocardiogram and/or acquiring an electrocardiosignal based on the control electrode to acquire a cardiac electrocardiogram, acquiring R wave sensing time of the corresponding R wave according to the body surface electrocardiogram and/or the cardiac electrocardiogram, and determining pulse sending time corresponding to each preset stimulation position according to the R wave sensing time;

2. The pulse stimulation apparatus according to claim 1, wherein the pulse delivery pattern comprises delivering cardiac stimulation pulses to the control electrodes corresponding to each of the preset stimulation locations in a set or random order based on R-waves in the body-surface electrocardiogram and/or the myocardial electrocardiogram.

3. The impulse stimulation device according to claim 1, wherein the impulse control module is further configured to generate stimulation combinations corresponding to different preset stimulation positions based on a set number of the preset stimulation positions by using a set construction rule or a random combination manner;

4. The pulse stimulation device according to claim 2 or 3, wherein the cardiac stimulation pulses are delivered continuously to the corresponding predetermined stimulation locations in a set or random order to reach a predetermined number of heart beats.

5. The impulse stimulation device of claim 1, wherein the predetermined stimulation site comprises at least one of an inner ventricular septum wall of the left and right ventricles, an interventricular sulcus of an outer ventricular wall, an outer left ventricular sidewall, an anterior and lateral left ventricular wall, a posterior and lateral left ventricular wall, an inner right ventricular free wall, an outer right ventricular free wall, an apex of the right ventricle, and an apex of the left ventricle.

6. The pulse stimulation device according to claim 1, wherein the R-wave sensing module is configured to acquire a body-surface electrocardiogram and a cardiac electrocardiogram based on the control electrodes, and acquire a first R-wave sensing time of occurrence of an R-wave and a second R-wave sensing time of occurrence of an R-wave from the cardiac electrocardiogram and the body-surface electrocardiogram, respectively;

the R wave sensing module is further used for determining second pulse emitting time corresponding to each preset stimulation position according to the first R wave sensing time and the second R wave sensing time;

the cardiac stimulation pulse generator is used for delivering a cardiac stimulation pulse to each corresponding control electrode according to the first pulse delivery time and/or the second pulse delivery time.

7. The impulse stimulation device according to claim 6, wherein the R-wave sensing module is further configured to determine a first pulse emitting time corresponding to each of the preset stimulation locations according to a preset duration with the first R-wave sensing time as a reference zero point;

the R wave sensing module is further configured to determine a first time difference value between the second R wave sensing time and the first R wave sensing time of each preset stimulation location, and determine the second pulse emitting time corresponding to each preset stimulation location according to the first time difference value and the preset duration by using the second R wave sensing time as a reference zero point.

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 delivery time to maintain delivery of cardiac stimulation pulses to the corresponding control electrode according to the second pulse delivery time.

9. The impulse stimulation device of claim 7,

the time updating module is used for updating the first time difference value periodically or aperiodically so as to update the second pulse issuing time based on the updated first time difference value;

the heart stimulation pulse generator is used for sending the heart stimulation pulse to the corresponding control electrode according to the updated second pulse sending time.

10. The pulse stimulation device according to claim 6, wherein the R-wave sensing module is further configured to, during pacing at one preset stimulation location, obtain the cardiac electrocardiograms corresponding to all other remaining preset stimulation locations, and obtain a new first R-wave sensing time when an R-wave appears in the cardiac electrocardiograms and a new second R-wave sensing time when an R-wave appears in the body surface electrocardiograms;

11. The impulse stimulation device according to claim 1, wherein the R-wave sensing module is configured to obtain a plurality of first R-wave sensing times corresponding to R-waves appearing in the electrocardiogram at a plurality of the preset stimulation locations, select one of the first R-wave sensing times as a reference zero point, determine a second difference between each of the first R-wave sensing times after the reference zero point and the reference zero point, and determine a first pulse emitting time corresponding to each of the preset stimulation locations according to the second difference and a preset duration.

12. The pulse stimulation device according to claim 11, wherein the R-wave sensing module is configured to randomly select one of the first R-wave sensing times from the plurality of first R-wave sensing times, or select the first R-wave sensing time with the earliest occurrence time as the reference zero point.

13. The pulse stimulation apparatus according to any one of claims 6-11, wherein a first R-wave sensing time at which the myocardial electrocardiogram acquires R-waves and a second R-wave sensing time at which the body-surface electrocardiogram acquires R-waves correspond to the same heartbeat.

14. The impulse stimulation device of claim 1, wherein the control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator using either a monopolar lead or a bipolar lead.

15. A medical device, characterized in that it comprises a pulse stimulation apparatus according to any of claims 1-14.