WO2023011641A1 - 脉冲刺激装置、方法及医疗设备 - Google Patents

脉冲刺激装置、方法及医疗设备 Download PDF

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WO2023011641A1
WO2023011641A1 PCT/CN2022/110614 CN2022110614W WO2023011641A1 WO 2023011641 A1 WO2023011641 A1 WO 2023011641A1 CN 2022110614 W CN2022110614 W CN 2022110614W WO 2023011641 A1 WO2023011641 A1 WO 2023011641A1
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stimulation
pulse
time
wave sensing
wave
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French (fr)
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王励
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United Innomed Shanghai Ltd
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United Innomed Shanghai Ltd
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Priority to JP2024506832A priority Critical patent/JP7849458B2/ja
Priority to EP22852352.8A priority patent/EP4382162A4/en
Publication of WO2023011641A1 publication Critical patent/WO2023011641A1/zh
Priority to US18/431,995 priority patent/US20240173554A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
    • A61N1/36843—Bi-ventricular stimulation

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a pulse stimulation device, method and medical equipment.
  • the CCM (cardiac contraction modulation) device currently on the market is an independent, implanted, complicated and expensive device, which is basically used for patients with chronic heart failure.
  • two bipolar wires are implanted in the right ventricular septum, which are used to sense the potential of the local myocardium and send cardiac stimulation pulses within a certain period of time after sensing (absolute refractory period) to increase myocardial contractility.
  • myocardial stimulation does not directly act on the left ventricle, which is the ventricle most in need of increased contractility.
  • CCMs administered to the RV septum have a global effect on cardiac contractility and cardiac function (including LV contractility), studies have shown that this global effect is not direct but occurs through local stimulation of the RV septum Driven by the impact on the local myocardium.
  • the current CCM stimulation is only used for implantable devices for patients with chronic heart failure, and the long-term treatment of patients with chronic heart failure can be achieved by stimulating a single site of the right ventricular septum; however, when the patient's heart function deteriorates sharply, blood pressure drops
  • patients do not need or do not use implanted devices for a long time, or only need support for cardiac function for a relatively short period of time until the cause is eliminated and/or cardiac function is restored
  • the existing implantable CCM And its single-site stimulation cannot meet acute and/or short-term support (time and degree of cardiac/circulatory support), while providing acute and short-term (days) cardiac/circulatory support is critical to patient survival (such as acute heart failure attack)
  • any additional (other than medication) cardiocirculatory support can mean "life or death" for the patient.
  • the technical problem to be solved by the present invention is to overcome the problem that the existing implanted CCM stimulation method in the prior art is only suitable for patients with chronic heart failure, and cannot meet the acute and/or short-term needs, and the electrical stimulation of a single site may not meet the needs of the heart.
  • the invention provides a pulse stimulation device, method and medical equipment for the deficiencies in the use requirements of patients with circulatory support.
  • the present invention provides a pulse stimulation device, which includes an R-wave sensing module, a cardiac stimulation pulse generator and at least one control electrode, each of which corresponds to a different preset stimulation position;
  • 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 and the cardiac stimulation pulse generator are connected in communication;
  • the R-wave sensing module is used to acquire a body surface electrocardiogram and/or collect electrocardiographic signals based on the control electrodes to acquire a myocardial electrocardiogram, and acquire corresponding R-wave occurrences 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 cardiac stimulation pulse generator is used to deliver cardiac stimulation pulses to each corresponding control electrode according to each pulse delivery time.
  • the R wave sensing time of the corresponding R wave is obtained to determine the pulse delivery time corresponding to the preset stimulation position, so as to meet the requirements of acute and/or short-term, single-site electrical stimulation.
  • the device includes at least two control electrodes, and different control electrodes are used to be implanted in different preset stimulation positions of left and right ventricular myocardium of the patient.
  • At least two control electrodes are set to stimulate multiple different positions in the left and right ventricular myocardium.
  • it can more effectively improve the patient's heart rate.
  • multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function.
  • the device further includes a pulse control module, and the pulse control module is communicatively connected with the cardiac stimulation pulse generator;
  • 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 used for issuing cardiac stimulation pulses to each corresponding pulse emission mode and each pulse emission time when an R wave appears in the body surface electrocardiogram and/or the myocardial electrocardiogram. the control electrode.
  • the pulse emission mode can be determined according to the manual selection of the operator, a preset fixed pulse pattern or random selection, etc. In order to automatically realize the pulse delivery to different preset stimulation positions.
  • the pulse distribution mode can also be dynamically adjusted according to actual needs.
  • the pulse delivery mode includes the control corresponding to each of the preset stimulation positions synchronously, according to a set or random order based on the R wave in the body surface electrocardiogram and/or the myocardial electrocardiogram.
  • the electrodes deliver cardiac stimulation pulses.
  • pulses can be delivered synchronously, in accordance with settings or in random order, so as to meet various pulse delivery requirements as much as possible to meet more pulse stimulation scenarios, while ensuring the effectiveness of pulse stimulation for patients , improving the patient experience.
  • the pulse control module is further configured to generate different stimulation combinations corresponding to the preset stimulation positions based on a set number of the preset stimulation positions by using a set construction rule or a random combination method;
  • the stimulation combination includes at least two stimulation units, and at least one of the stimulation units corresponds to two or more preset stimulation positions where pulses are issued synchronously;
  • the pulse delivery mode includes sending pulses to the control electrode corresponding to the preset stimulation position based on the R wave in the body surface electrocardiogram and/or the myocardial electrocardiogram according to a set or random order and the stimulation combination. Deliver cardiac stimulation pulses.
  • each preset stimulation position is no longer considered separately, but different stimulation combinations are formed based on multiple preset stimulation positions.
  • pulses are issued synchronously. Different stimulation combinations Pulse stimulation is performed 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.
  • cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions to reach the preset number of heartbeats.
  • 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).
  • CCM cardiac electrical stimulation
  • ECS electrical circulatory support
  • 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 and lateral walls of the left ventricle, the anterolateral wall of the left ventricle, the posterolateral wall of the left ventricle, the inner wall of the free wall of the right ventricle, and the inner wall of the right ventricle. At least one of the outer wall of the free wall, the apex of the right ventricle, and the apex of the left ventricle.
  • control electrodes are respectively set at the above-mentioned positions of the left and right ventricles, or control electrodes are set at some positions according to the actual stimulation requirements, so as to ensure the reliability of cardiac pulse stimulation as much as possible.
  • the R wave sensing module is used to acquire body surface electrocardiogram and myocardial electrocardiogram based on the control electrodes, and obtain the first R wave sensing time of R wave appearance and the body electrocardiogram respectively according to the myocardial electrocardiogram.
  • the electrocardiogram obtains the second R wave sensing time when the R wave appears;
  • the R-wave sensing module is also used to calculate the first pulse delivery time corresponding to each preset stimulation position according to the first R-wave sensing time;
  • the R-wave sensing module is also used to calculate the second pulse release 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 cardiac stimulation pulses to each corresponding control electrode according to the first pulse delivery time and/or the second pulse delivery time.
  • the first R-wave sensing time when the R-wave appears in the myocardial electrocardiogram is obtained, and the first pulse delivery time corresponding to the preset stimulation position is calculated;
  • the second R-wave sensing time when the R-wave appears in the body surface electrocardiogram is obtained, Calculate the second pulse delivery time corresponding to the preset stimulation position according to the first R wave sensing time and the second R wave sensing time, and then proceed based on the first pulse delivery time and/or the second pulse delivery time
  • Pulse delivery that is, a scheme to determine the pulse delivery time based on the R wave in the myocardial electrocardiogram and the R wave in the body surface electrocardiogram is proposed, which effectively ensures the timeliness and reliability of the pulse stimulation.
  • the R-wave sensing module is further configured to use the first R-wave sensing time as a reference zero point to calculate the first pulse delivery time corresponding to each of the preset stimulation positions according to the preset duration;
  • the R-wave sensing module is further configured to calculate 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 Taking the second R-wave sensing time as a reference zero point, the second pulse delivery time corresponding to each preset stimulation position is calculated according to the first time difference and the preset duration.
  • the cardiac stimulation pulse generator is configured to maintain the first time difference after obtaining the second pulse delivery time, so as to keep delivering cardiac stimulation pulses to the corresponding pulses according to the second pulse delivery time. the control electrode.
  • the device also includes a time update module
  • the time update module is used to regularly or irregularly update the first time difference, so as to update the second pulse emission 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.
  • the second pulse delivery time can be updated regularly or irregularly according to actual needs (at this time, myocardial electrical stimulation can be continued or stopped), and then 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 pulse electrical stimulation scenarios.
  • 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 one preset stimulation position, and acquire the R wave in the myocardial electrocardiogram a new first R-wave sensing time of occurrence and a new second R-wave sensing time of R-wave occurrence in the body surface ECG;
  • the R-wave sensing module is also used to calculate a new first pulse delivery time corresponding to each preset stimulation position based on the new first R-wave sensing time and preset duration;
  • the R-wave sensing module is also used to calculate 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.
  • a time difference, with the new second R-wave sensing time as the reference zero point, calculated according to the new first time difference and the preset duration to obtain the corresponding stimulation position for each preset stimulation position The new second pulse emission time.
  • the R-wave sensing module is used to acquire a plurality of first R-wave sensing times corresponding to R-waves appearing in the myocardial electrocardiogram at a plurality of preset stimulation positions, and select a first R-wave sensing time measure time as a reference zero point, calculate the second difference between each first R-wave sensing time after the reference zero point and the reference zero point, and calculate according to the second difference and the preset duration
  • the first pulse emission time corresponding to each preset stimulation position is obtained.
  • a first R-wave sensing time (LS) is arbitrarily selected as the reference zero point, and the release time of other stimulation positions at a later time is based on this, and the difference is calculated and added to the preset duration.
  • the pulse release time of each pulse stimulation position is obtained, so as to achieve timely and effective pulse release based only on the myocardial ECG, independent of the body surface ECG, making the pulse stimulation control process more flexible and adaptable to more usage scenarios .
  • the R-wave sensing module is used to randomly select a first R-wave sensing time from among multiple first R-wave sensing times, or select the first R-wave sensing time with the earliest appearance time. measured time as the reference zero point.
  • the first R-wave sensing time at which the R-wave is obtained from the myocardial electrocardiogram and the second R-wave sensing time at which the R-wave is obtained from the body surface electrocardiogram correspond to the same heartbeat.
  • control electrode is electrically connected to the R-wave sensing module and the cardiac stimulation pulse generator by using a monopolar wire or a bipolar wire.
  • the present invention also provides a pulse stimulation method, which is realized by using the above pulse stimulation device, and the method includes:
  • a cardiac stimulation pulse is delivered to each corresponding control electrode according to each pulse delivery time.
  • the present invention also provides a medical device, which includes the above pulse stimulation device.
  • control electrodes such as corresponding stimulation and/or pacing functions
  • CCM cardiac electrical stimulation
  • guide wires are implanted at different locations in the left and right ventricular myocardium (such as the left ventricle anterior/posterior side on the epicardial surface, interventricular groove, right ventricular free wall, etc.) .
  • leads can be placed transvenously in the right ventricle (eg, at the septum, apex, or free wall) and/or transseptal or arterial or LV in the endocardium of the left ventricle (eg, at the septum, apex, or free wall) Leads etc. are placed on the epicardial surface (via electrodes placed in the coronary veins or arteries).
  • Cardiac electrical stimulation (CCM) method (mechanism, time, etc.): a.
  • the stimulation mechanism is the mechanism of electrical stimulation of multiple parts of the heart (synchronous or sequential), such as all electrode sites trigger stimulation in one cardiac cycle (synchronous stimulation ), or complete the trigger stimulation of each electrode site according to a set or random sequence in multiple cardiac cycles (sequential stimulation); b.
  • the trigger mechanism is sensed and/or represented by R waves representing local ventricular myoelectric activity
  • the timing of R-wave sensing of the overall ventricular myoelectric activity is the trigger point. In the latter case, the temporal relationship of global and local ventricular EMG R waves becomes part of the trigger timing.
  • 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 heart condition, that is, it can be adapted and adjusted to each patient's own heart dynamic state to effectively improve heart function. Effect.
  • CCM transmission can be realized by a simple monopolar wire, instead of having to use two monopolar wires or bipolar wires at one cardiac location, thereby simplifying the system structure and reducing the cost.
  • FIG. 1 is a schematic structural diagram of a pulse stimulation device 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 structural diagram of a pulse stimulation device according to Example 2 of the present invention.
  • FIG. 4 is a schematic diagram of R-wave triggering corresponding to ECG and EGMs during sequential CCM transmission according to Embodiment 2 of the present invention.
  • Fig. 5 is a flow chart of the pulse stimulation method according to Embodiment 3 of the present invention.
  • the pulse stimulation device of the present embodiment comprises R wave sensing module 1, cardiac stimulation pulse generator 2 and at least one control electrode 3, and control electrode 3 is connected with R wave sensing module 1 and heart respectively by wire 4.
  • 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.
  • the device includes at least two control electrodes, and different control electrodes are implanted in different preset stimulation positions of left and right ventricular myocardium of the patient.
  • control electrodes By arranging at least two control electrodes to achieve stimulation of multiple different positions in the left and right ventricular myocardium, compared with the existing method of simply stimulating the right ventricular septum, 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 short-term significant decline in ventricular function, multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function. Of course, the number setting of the control electrodes can be reset and adjusted according to actual scene requirements.
  • different preset stimulation locations include but not limited to 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 and lateral walls of the left ventricle, the anterolateral wall of the left ventricle, the posterolateral wall of the left ventricle, the inner wall of the free wall of the right ventricle, The outer wall of the right ventricular free wall, the apex of the right ventricle, and the apex of the left ventricle.
  • Control electrodes are respectively set at the above-mentioned 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.
  • the R wave sensing module 1 is used to obtain body surface electrocardiogram (ECG) and/or collect electrocardiogram based on control electrode 3 to obtain myocardial electrocardiogram (EGM).
  • ECG body surface electrocardiogram
  • EMG electrocardiogram
  • EMG electrocardiogram
  • EMG myocardial electrocardiogram
  • ECM covers signals originating from the ventricular cavity or from the ventricular wall.
  • the R-wave sensing module 1 is used to obtain the R-wave sensing time when the R-wave occurs according to the body surface electrocardiogram and/or 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 period from sensing the R wave to triggering the cardiac stimulation pulse release, and the transmission of CCM at various positions or parts is induced by the R wave of the local myocardial electrocardiogram EGM or the global body surface electrocardiogram ECG The R-wave induction triggers.
  • Cardiac stimulation pulse generator 2 is used for sending cardiac stimulation pulses to each corresponding control electrode 3 according to each pulse sending time.
  • the R wave sensing module is used to acquire body surface electrocardiogram and/or acquire myocardial electrocardiogram based on control electrodes, and acquire the first R wave sensing time and body surface electrocardiogram when R wave appears according to myocardial electrocardiogram Obtain the second R-wave sensing time when the R-wave occurs;
  • the first R-wave sensing time when the R-wave is acquired by the myocardial electrocardiogram and the second R-wave sensing time when the R-wave is acquired by the body surface electrocardiogram correspond to the same heartbeat.
  • R waves i.e. R waves in myocardial ECG and R waves in body surface ECG
  • the R wave sensing time and the second R wave sensing time when the R wave is obtained from the body surface electrocardiogram the time difference between the two R wave sensing times must be less than a certain value, so that there is a practical meaning of pulse stimulation, otherwise The reliability of pulse stimulation cannot be guaranteed.
  • the R wave sensing module is also used to calculate the first R wave sensing time to obtain 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 The time is also determined (that is, the preset time) and will not change.
  • the R-wave sensing module is also used to calculate 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.
  • 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.
  • the heart stimulation pulse can be issued mainly based on the R wave in the body surface electrocardiogram, that is, the time for sending out each electrode stimulation takes the R wave sensing time of the body surface electrocardiogram as the trigger time Zero point;
  • Cardiac stimulation pulses can be issued mainly based on the R wave in the myocardial ECG, that is, the R wave of each electrode stimulation is the zero point of the trigger time;
  • at the same time based on the R wave in the body surface ECG Cardiac stimulation pulses are issued by the R wave and the R wave in the myocardial electrocardiogram; the specific use of a specific trigger mechanism among these three can be selected or adjusted in real time according to the actual electrical stimulation requirements.
  • ECG pulse triggering when the body surface ECG perception is poor, it can be directly transferred to EGM-based triggering; In order to prevent continuous pulse stimulation due to special conditions such as misperception or poor perception, it can ensure the continuation of therapy in a timely and effective manner.
  • the R-wave sensing module 1 is used to calculate the first pulse delivery time corresponding to each preset stimulation position according to the first R-wave sensing time and the preset duration.
  • the first pulse release time is the preset duration (LPD) of the R-wave sensing moment of the myocardial EGM 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.
  • LPD preset duration
  • the LPD i.e., first pulse delivery time
  • the LPD for each site or location is used to trigger the timing of CCM delivery at that site or location relative to the moment of perception of the R-wave of the myocardial ECG.
  • the R wave sensing module 1 is also used to calculate the first time difference between the second R wave sensing time and the first R wave sensing time, and calculate according to the first time difference and the pulse emission time of the preset duration Obtain the second pulse delivery time corresponding to each preset stimulation position with the second R-wave sensing time as the reference zero point (or trigger point).
  • the wave sensing time and the second R wave sensing time are calculated to obtain the second pulse delivery time corresponding to the preset stimulation position, and then the pulse delivery is performed based on the first pulse delivery time and/or the second pulse delivery time, that is, the proposed method based on the myocardial electrocardiogram
  • the scheme of determining the pulse release time by the middle R wave and the R wave in the surface ECG effectively ensures the timeliness and reliability of the pulse stimulation.
  • the duration from R wave to sending of each stimulation position is fixed (for example, the preset duration is 40ms).
  • 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).
  • the time difference characterizes the time-sensitive value of the myocardial electrical activity corresponding to the myocardial site/position relative to the electrical activity of the whole heart;
  • the GLSD and GPD corresponding to each part can be measured and averaged over several self-heartbeats (the default is 5 consecutive self-heartbeats, ranging from 3 to 12).
  • the GPD that is, the second pulse delivery time) of each site or position is used to trigger the CCM sending time at the site or position relative to the R wave perception moment of the body surface ECG. This step in this embodiment is called a set-up period.
  • the cardiac stimulation pulse generator is used to maintain the first time difference after obtaining the second pulse delivery time of each position, so as to keep sending the cardiac stimulation pulse to the corresponding position according to the second pulse delivery time. control electrodes.
  • the electrical stimulation output time can be directly triggered by the body surface electrocardiogram instead of sensing the myocardial pulse each time.
  • the R wave of the electrocardiogram is used to trigger, thereby achieving the effect of electrocardiographic stimulation, effectively shortening the time-consuming data processing, and improving the control efficiency of cardiac stimulation pulse triggering.
  • the device of this embodiment further includes a time updating module.
  • the time update module is used to regularly or irregularly update the first time difference, so as to update the second pulse emission time based on the updated first time difference;
  • the heart stimulation pulse generator is used for sending heart stimulation pulses to corresponding control electrodes according to the updated second pulse sending time.
  • the second pulse delivery time can be updated regularly or irregularly according to actual needs (at this time, myocardial electrical stimulation can be continued or stopped), and then myocardial electrical stimulation can be continued according to the updated trigger time to achieve more flexible
  • the electrical stimulation effect meets the needs of more pulse electrical stimulation scenarios.
  • the effect of strengthening or maximizing the circulatory support for the heart is achieved by setting the stimulation position and the stimulation mechanism.
  • control scheme of CCM stimulation in this embodiment needs to be automatically suspended in some special cases, for example, when the patient's heart rate is detected too fast (for example, higher than 120 beats/min), there is PVC (ventricular premature beat), etc. To ensure the safety of cardiac stimulation support for patients.
  • control electrodes (such as corresponding stimulation and/or pacing functions) are placed in multiple parts of the left and right ventricle, so as to provide cardiac electrical stimulation CCM to multiple parts; , can more effectively improve the overall contractility of the patient's heart, especially the left ventricle.
  • multi-site stimulation can better enhance cardiac contractility and improve cardiac ejection function.
  • the pulse stimulation device of this embodiment is a further improvement on Embodiment 1, specifically:
  • the pulse stimulation device in this embodiment further includes a pulse control module 5 , which is connected to the cardiac stimulation pulse generator 2 in communication.
  • the pulse control module 5 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 firing mode and pulse firing time when an R wave appears in the body surface electrocardiogram or myocardial electrocardiogram.
  • the pulse release mode can be determined according to the operator's artificial selection, preset a fixed pulse mode, or random selection, so as to automatically realize Pulse delivery to different preset stimulation locations.
  • the pulse distribution mode can also be dynamically adjusted according to actual needs.
  • the pulse delivery mode includes sending cardiac stimulation pulses to the control electrodes corresponding to each preset stimulation position synchronously, according to a preset or random sequence based on the R wave in the body surface electrocardiogram and/or myocardial electrocardiogram.
  • cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions to reach the preset number of heartbeats.
  • the pulse delivery mode is triggered by the overall (global) R wave of the body surface ECG or the local (local) R wave of each part.
  • the delivery mechanism is to send cardiac stimulation pulses to each preset stimulation position synchronously and in accordance with a set or random order , or the preset period (set-up period), that is, the measurement and calculation of the GLSD corresponding to each electrode position, etc.
  • the CCM stimulation to a location or location can trigger transmission (called synchronization) at the same time according to the corresponding time of each location (that is, in the same cardiac cycle) after the same R wave, or at multiple locations on multiple R waves Sequential transmission, etc.; when transmitted in a set order, the CCM stimulus triggers transmission at a site after the R wave, and then transmits at the next site after the next R wave, and so on, until all sites are covered transmission.
  • the sequence of specific parts receiving CCM stimulation can be specially designed (programmed by doctors and other staff with relevant authority), or it can be random.
  • the number of times of stimulation for each preset site can be one or more times (for example, 6 times, that is, six cardiac cycles), and then transfer to the next preset site for stimulation, and so on.
  • the pulse control module is also used to generate stimulation combinations corresponding to different preset stimulation positions based on a set number of preset stimulation positions, using a set construction rule or a random combination method;
  • the stimulation combination includes at least two stimulation units, and at least one stimulation unit corresponds to two or more preset stimulation positions where pulses are issued synchronously;
  • the pulse delivery mode includes sending cardiac stimulation pulses to control electrodes corresponding to preset stimulation positions based on the R wave in the body surface electrocardiogram and/or myocardial electrocardiogram according to a set or random order and stimulation combination.
  • cardiac stimulation pulses are continuously delivered to the corresponding preset stimulation positions to reach 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 sent out synchronously. Different stimulation combinations adopt the setting or Pulse stimulation is performed in a random sequence of pulse delivery to meet the needs of more pulse stimulation scenarios and further ensure the safety of patients.
  • the pulse stimulation device corresponds to two wires 4, and the electrode of one wire is located in the right ventricle septum (the right ventricle septum is used as the endocardial position) or is located/close to the front of the ventricle or behind the ventricle.
  • the interventricular groove (as an epicardial location); the other is located on the anterolateral wall of the left ventricle (either epicardial or endocardial location).
  • the pulse stimulation device corresponds to three lead wires 4, and the electrode of one is located in the right ventricle interventricular septum (the right ventricle interventricular septum is the endocardial position) or is located in/close to the anterior or posterior interventricular groove of the ventricle ( as the epicardial site); one on the posterolateral wall of the left ventricle (epicardial or endocardial site) and the other on the anterolateral wall of the left ventricle (epicardial or endocardial site).
  • the number of guide wires 4 and the preset implantation position can also be re-planned according to different patients' conditions, heart-related surgery conditions, demand for circulatory support and demand for CCM stimulation.
  • the lead wire 4 of this embodiment includes a monopolar lead wire or a bipolar lead wire, and cardiac stimulation pulses are transmitted to corresponding parts through the lead wire 4 .
  • the CCM is delivered between the monopolar electrode in contact with the myocardium and electrodes elsewhere on the patient's body.
  • the monopolar electrode can be an electrode on another electrode lead in a cardiac chamber or a blood vessel, a surface ECG electrode or a surface patch electrode for external defibrillation; or an electrode implanted under the skin (such as S-ICD ) or electrodes implanted in the heart, etc.
  • other specially designed electrodes are available.
  • 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.
  • CCM can be delivered between the two electrodes or as a monopolar lead (electrode in contact with the myocardium) , similar to the unipolar setup.
  • a bipolar lead is used and only one electrode is in continuous contact with the myocardium (e.g. RV septal lead 4)
  • CCM can be delivered between the two electrodes or as a monopolar lead (electrode in contact with the myocardium) , similar to the unipolar setup.
  • Such as LV epicardial electrodes CCM can be delivered between the two electrodes or separately as two monopolar leads.
  • Unipolar wires and bipolar wires can be used at the same time, so that there are many possible combinations, and the specific combination can be determined and adjusted according to actual needs.
  • Cardiac stimulation pulse delivery mode (triggered R wave source, synchronous or sequential, and specific sequence or random in the sequence, all doctors can be programmed), based on cardiac stimulation pulse delivery mode, LPD and GPD for one or more parts generated Cardiac stimulation pulse, as shown in Figure 4;
  • CCM can be triggered by the local R-wave at each site, either synchronously or sequentially (local/local R-wave mode).
  • CCM transmission may continue according to the updated parameters.
  • the support of the control mode triggered by the above-mentioned cardiac stimulation pulse can meet the needs of patients with acute and/or short-term and single-site electrical stimulation that can achieve the circulatory support required by the heart, especially for patients with weak heart function (such as low cardiac output) Low) Patients who are not suitable or worried about undergoing cardiac surgery can effectively enhance postoperative cardiac function, enabling patients to recover faster, and provide timely and effective support to patients with cardiac needs; at the same time, with the support of this technology, it can also help patients And the doctor’s confidence in related operations has been improved; 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), and 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 achieve a better effect of improving cardiac contractility.
  • control electrodes (such as corresponding stimulation and/or pacing functions) are placed in multiple parts of the left and right ventricles, so as to provide synchronous or sequential cardiac electrical stimulation CCM to multiple parts; the trigger mechanism of CCM stimulation is determined by local cardiac electrical activity The timing of the R wave induction and/or the R wave induction of the overall cardiac electrical activity is determined, and the trigger mode can be dynamically adjusted according to the actual situation to adapt to the patient's changing heart rate and overall heart condition, that is, it can follow each patient's own heart The dynamic change state is adapted and adjusted to effectively improve the control effect of CCM stimulation, achieve better cardiac contractility, and better meet the acute and/or short-term needs, as well as the use of patients whose single-site electrical stimulation can achieve the circulatory support needed by the heart need.
  • the pulse stimulation device of this embodiment is a further improvement on Embodiment 2.
  • This embodiment considers a CCM stimulation scenario in which a control electrode performs a pacing operation, specifically:
  • pacing is delivered by an independent electrode, and the control principle of cardiac stimulation pulse triggering at this time is consistent with the above statement and will not be affected; b) pacing
  • the electrode that provides CCM stimulation is mainly used to provide pacing (the electrode position that is identified as corresponding to LS1 during pacing), and the working principle of other remaining electrode positions (only CCM stimulation) is the same as above The expressions are consistent.
  • LS1 during pacing is the pacing pulse delivery time, and the preset duration needs to be extended to 40-100ms, preferably 60-80ms (programmable adjustment is also possible). In both cases, the preset period needs to be measured twice, one time when the intrinsic heart rate (sinus rate) is detected, and the other time when the pacing is performed.
  • the R wave sensing module is also used to obtain the myocardial electrocardiograms corresponding to all other remaining preset stimulation positions when pacing is performed at a preset stimulation position, and obtain the myocardial electrocardiogram The new first R wave sensing time for the middle R wave and the new second R wave sensing time for the R wave appearance in the body surface ECG;
  • the R-wave sensing module is also used to calculate a new first pulse delivery time corresponding to each preset stimulation position based on the new first R-wave sensing time and preset duration;
  • the R-wave sensing module is also used to calculate 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 position, and use the new The second R-wave sensing time is the reference zero point, and the new second pulse delivery time corresponding to each preset stimulation position is calculated according to the new first time difference and the preset duration.
  • the pulse stimulation device of this embodiment is a further improvement to Embodiment 2, specifically:
  • the R-wave sensing module is used to obtain a plurality of first R-wave sensing times corresponding to the R-wave in the myocardial electrocardiogram at multiple preset stimulation positions, select a first R-wave sensing time as a reference zero point, and calculate the The second difference between each first R-wave sensing time after the zero point and the reference zero point is calculated according to the second difference and the preset duration to obtain the first pulse emission time corresponding to each preset stimulation position.
  • the R-wave sensing module is used to randomly select a first R-wave sensing time from among multiple first R-wave sensing times, or select the earliest first R-wave sensing time as a reference zero.
  • the first R-wave sensing time with the earliest appearance time is preferably selected as the reference zero point.
  • the first R-wave sensing time (LS) with the earliest appearance time is selected as the reference zero point, and the release time of other stimulation positions later in time is based on this, and the difference with it is calculated and the preset duration is added.
  • the pulse release time of each pulse stimulation position can be obtained, so that the timely and effective pulse release can be completed only based on the myocardial ECG, independent of the body surface ECG, making the control process of pulse stimulation more flexible and adaptable to more usage scenarios.
  • the pulse stimulation method of this embodiment is realized by using the pulse stimulation device of Embodiment 1.
  • the pulse stimulation method of the present embodiment includes:
  • S104 Send cardiac stimulation pulses to each corresponding control electrode according to each pulse sending time.
  • the implementation principle corresponding to the pulse stimulation method in this embodiment corresponds to the working principle corresponding to the pulse stimulation device in any one of the embodiments 1-4, so it will not be repeated here.
  • the support of the control mode triggered by the above-mentioned cardiac stimulation pulse can meet the needs of patients with acute and/or short-term and single-site electrical stimulation that can achieve the circulatory support required by the heart, especially for patients with weak heart function (such as low cardiac output) Low) Patients who are not suitable or worried about undergoing cardiac surgery can effectively enhance postoperative cardiac function, enabling patients to recover faster, and provide timely and effective support to patients with cardiac needs; at the same time, with the support of this technology, it can also help patients And the doctor's confidence in related operations has been improved; in addition, the existing methods of enhancing cardiac contractility based on drugs often have side effects (such as arrhythmia, increased heart rate, increased myocardial oxygen consumption, etc., and may increase mortality), and this embodiment
  • the heart stimulation pulse triggering 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 achieve a better effect of improving cardiac contractility.
  • the medical equipment of this embodiment includes the pulse stimulation device in any one of the embodiments 1-4.
  • Medical equipment can include pulse stimulation devices only, for various lead configurations; can also be integrated into or as an accessory to other systems.
  • Such medical equipment may include, but is not limited to, the following:
  • ECS functionality can be added to temporary pacing systems, which are commonly used to provide bradycardia pacing in the above patient population.
  • ECS can use control electrodes for pacing as part of the CCM stimulation electrodes, or it can be independent of the CCM stimulation electrodes, which has minimal impact on clinical practice, but can provide additional clinical benefits, or when a better CCM is required. The retraction improves the position using additional wires.
  • Partial or total 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 functions such as bradycardia pacing, ATP and defibrillation.
  • 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.
  • skin electrodes eg, defibrillation electrodes
  • ECS electromechanical dissociation
  • R wave sensing can be achieved by ECG with non-myocardial contact electrodes (such as right ventricular sub-Q electrode pair) or right ventricular EGM with S-ICD with right ventricular leadless pacemaker, This triggers CCM stimulation in the S-ICD and is delivered via subQ defib electrodes and/or leadless pacemaker electrodes.
  • this function may provide more effective help for the recovery of the patient's cardiac function.
  • the medical equipment of this embodiment includes the above-mentioned pulse stimulation device to provide cardiac electrical stimulation CCM to multiple parts. Compared with the existing method of simply stimulating the right ventricular septum, it more effectively improves the overall contractility of the patient's heart. Especially the left ventricle, so it can be well applied to patients with acute and/or short-term ventricular function decline, which greatly improves the overall product performance of medical equipment.

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Abstract

一种脉冲刺激装置、方法及医疗设备，该装置包括R波感测模块（1）、心脏刺激脉冲发生器（2）和至少一个控制电极（3），每个控制电极（3）用于植入患者心肌的不同的预设刺激位置；R波感测模块（1）用于获取体表心电图和/或获取心肌心电图，获取R波出现的R波感测时间以确定每个预设刺激位置的脉冲发放时间，脉冲发放时间对应感测到R波至触发心脏刺激脉冲发放的时长；心脏刺激脉冲发生器（2）用于根据脉冲发放时间发放心脏刺激脉冲至控制电极（3）。由此实现对左右心室的多部位电刺激以提供心脏循环支持，相比现有的单纯对右心室室间隔刺激方式，更有效地提升了患者心脏的左右心室整体收缩力，从而能够很好地支持急性和/或短期心室功能明显下降的患者。

Description

脉冲刺激装置、方法及医疗设备
本申请要求申请日为2021/8/5的中国专利申请2021108979710的优先权。本申请引用上述中国专利申请的全文。
技术领域
本发明涉及医疗器械技术领域，特别涉及一种脉冲刺激装置、方法及医疗设备。
背景技术
现有市场上的CCM(心肌收缩调节)装置是一种独立、植入的、结构复杂且昂贵的设备，基本用于慢性心衰患者。其中采用两个双极导线植入部位为右心室室间隔，用于感知局部心肌的电位和在感知后的一定时间(绝对不应期内)发放心脏刺激脉冲，以增加心肌收缩力。此时心肌刺激不是直接作用在左心室，而左心室是最需要增加收缩力的心室。尽管用于右心室室间隔的CCM对心脏收缩力和心功能有整体影响(包括左心室收缩力)，但研究表明这种整体影响不是直接的，而是通过对右心室室间隔的局部刺激产生的对局部心肌造成的影响带动来的。
目前的CCM刺激仅用于针对慢性心力衰竭患者的植入式设备，通过对右心室室间隔的单一部位刺激以达到对慢性心衰病人的长期治疗；然而当患者的心功能急剧恶化，血压下降时(如急性心衰发作)，患者不需要或没有长期使用植入式装置，或只需要相对较短时间对心脏功能支持直至病因消除和/或心功能恢复，则现有的植入式CCM以及其单一部位刺激无法满足急性和/或短期支持(对心脏/循环支持的时间和程度)，而提供急性和短期(天)心脏/循环支持对患者的生存(如心衰急性发作)至关重要，或在急诊情况下复苏的患者，如急诊室或救护车中，任何一点额外(药物以外的)的心脏循环支持对患者都可能意味着“生或死”。
发明内容
本发明要解决的技术问题是为了克服现有技术中现有植入式CCM刺激方式仅适用于慢性心力衰竭患者，无法满足急性和/或短期，以及单一部位电刺激可能达不到心脏需要的循环支持的患者的使用需求的缺陷，提供一种脉冲刺激装置、方法及医疗设备。
本发明是通过下述技术方案来解决上述技术问题：
本发明提供一种脉冲刺激装置，所述装置包括R波感测模块、心脏刺激脉冲发生器和至少一个控制电极，每个所述控制电极对应不同的预设刺激位置；
所述控制电极分别与所述R波感测模块和所述心脏刺激脉冲发生器电连接，所述R波感测模块和所述心脏刺激脉冲发生器通信连接；
所述R波感测模块用于获取体表心电图和/或基于所述控制电极采集心电信号以获取心肌心电图，根据所述体表心电图和/或所述心肌心电图获取对应的R波出现的R波感测时间，并根据所述R波感测时间确定每个所述预设刺激位置对应的脉冲发放时间；
所述心脏刺激脉冲发生器用于根据每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
本方案中，基于体表心电图和/或心肌心电图，获取对应的R波出现的R波感测时间，以确定预设刺激位置对应脉冲发放时间，达到满足急性和/或短期，单一部位电刺激可能达不到心脏需要的循环支持的患者的使用需求，保证了心脏刺激脉冲触发的及时性和可靠性，从而有效地保障了患者的安全性。
可选地，所述装置包括至少两个所述控制电极，不同的所述控制电极用于植入患者左右心室心肌的不同的所述预设刺激位置。
本方案中，通过设置至少两个控制电极，以实现对左右心室心肌中多个不同位置的刺激，相比现有的单纯对右心室室间隔刺激的方式，能更有效地提升对患者心脏的整体收缩力，尤其是左心室。针对急性心衰和/或短期心室功能明显下降的患者，多部位刺激能够更好地增强心脏收缩力，改善心脏射血功能。
可选地，所述装置还包括脉冲控制模块，所述脉冲控制模块与所述心脏刺激脉冲发生器通信连接；
所述脉冲控制模块用于生成脉冲发放模式并发送至所述心脏刺激脉冲发生器；
所述心脏刺激脉冲发生器用于在所述体表心电图和/或所述心肌心电图中出现R波时，基于所述脉冲发放模式和每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
本方案中，通过在脉冲控制模块中预先设置不同的脉冲发放模式，在实际脉冲发放场景中，可以根据操作人员人为选取、预设某一固定的脉冲模式或者随机选取等方式确定脉冲发放模式，以自动地实现对不同的预设刺激位置的脉冲发放。当然还可以根据实际需求对脉冲发放模式进行动态调整。
可选地，所述脉冲发放模式包括基于所述体表心电图和/或所述心肌心电图中的R波，同步、按照设定或随机顺序向每个所述预设刺激位置对应的所述控制电极发放心脏刺激脉冲。
本方案中，可以采用同步、按照设定或随机顺序等方式进行脉冲发放，达到尽可能 满足各种脉冲发放需求，以满足更多脉冲刺激场景，在保证了对患者脉冲刺激的有效性的同时，提升了患者的使用体验。
可选地，所述脉冲控制模块还用于基于设定数量的所述预设刺激位置，采用设定构建规则或者随机组合方式，生成不同的所述预设刺激位置对应的刺激组合；
其中，所述刺激组合包括至少两个刺激单元，且至少一个所述刺激单元对应两个及以上同步执行脉冲发放的所述预设刺激位置；
所述脉冲发放模式包括基于所述体表心电图和/或所述心肌心电图中的R波，根据设定或随机顺序以及所述刺激组合，向对应的所述预设刺激位置的所述控制电极发放心脏刺激脉冲。
本方案中，不再将每个预设刺激位置单独考虑，而是基于多个预设刺激位置形成不同的刺激组合，对于同一刺激组合对应的不同预设刺激位置同步发放脉冲，不同的刺激组合采用设定或随机顺序的脉冲发放方式进行脉冲刺激，以满足更多的脉冲刺激场景需求，进一步地保障了患者的安全性。
可选地，在设定或随机顺序下，向对应的所述预设刺激位置处连续发放心脏刺激脉冲以达到预设心跳次数。
本方案中，在左右心室多个部位放置控制电极，实现对多部位提供同时或顺序的心脏电刺激(CCM)，以实现心脏循环支持(Electrical Circulatory Support，ECS)。相比现有技术中单纯对右心室室间隔刺激的方式，能更有效地提升对患者心脏的整体收缩力，尤其是左心室。针对急性心衰和/或短期心室功能明显下降的患者，多部位刺激能够更好地增强心脏收缩力，改善心脏射血功能。
可选地，所述预设刺激位置包括左右心室的室间隔内壁、心室外壁的室间沟、左心室外侧壁、左心室前外侧壁、左心室后外侧壁、右心室游离壁内壁、右心室游离壁心外壁、右心室心尖部位、左心室心尖部位中的至少一个部位。
本方案中，在左右心室的上述列举的位置中分别设置控制电极，或者根据实际刺激需求在部分位置处设置控制电极，以尽可能保障心脏脉冲刺激的可靠性。
可选地，所述R波感测模块用于获取体表心电图和基于所述控制电极获取心肌心电图，并分别根据所述心肌心电图获取R波出现的第一R波感测时间以及所述体表心电图获取R波出现的第二R波感测时间；
所述R波感测模块还用于根据所述第一R波感测时间计算得到每个所述预设刺激位置对应的第一脉冲发放时间；
所述R波感测模块还用于根据所述第一R波感测时间和所述第二R波感测时间计算 得到每个所述预设刺激位置对应的第二脉冲发放时间。
所述心脏刺激脉冲发生器用于根据所述第一脉冲发放时间和/或所述第二脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
本方案中，获取心肌心电图中R波出现的第一R波感测时间，计算预设刺激位置对应的第一脉冲发放时间；获取体表心电图中R波出现的第二R波感测时间，根据所述第一R波感测时间和所述第二R波感测时间计算得到预设刺激位置对应的第二脉冲发放时间，进而基于第一脉冲发放时间和/或第二脉冲发放时间进行脉冲发放，即提出基于心肌心电图中R波、体表心电图中R波确定脉冲发放时间的方案，有效地保证了脉冲刺激的及时性和可靠性。
可选地，所述R波感测模块还用于以所述第一R波感测时间为参考零点，根据预设时长计算得到每个所述预设刺激位置对应的第一脉冲发放时间；
所述R波感测模块还用于计算得到所述第二R波感测时间和每个所述预设刺激位置的所述第一R波感测时间之间的第一时间差值，并以所述第二R波感测时间为参考零点，根据所述第一时间差值和所述预设时长计算得到每个所述预设刺激位置对应的所述第二脉冲发放时间。
可选地，所述心脏刺激脉冲发生器用于在得到所述第二脉冲发放时间后，保持所述第一时间差值，以保持根据所述第二脉冲发放时间发放心脏刺激脉冲至对应的所述控制电极。
可选地，所述装置还包括时间更新模块；
所述时间更新模块用于定期或者不定期的更新所述第一时间差值，以基于更新后的所述第一时间差值更新所述第二脉冲发放时间；
所述心脏刺激脉冲发生器用于根据更新后的所述第二脉冲发放时间发放心脏刺激脉冲至对应的所述控制电极。
本方案中，可以根据实际需求定期或不定期的更新第二脉冲发放时间(此时可以继续或停止心肌电刺激)，然后根据更新后的触发时间继续进行心肌电刺激，以实现更灵活的电刺激效果，满足更多的脉冲电刺激场景需求。
可选地，所述R波感测模块还用于在一个预设刺激位置进行起搏时，获取其他所有剩余的预设刺激位置对应的所述心肌心电图，并获取所述心肌心电图中R波出现的新的第一R波感测时间以及所述体表心电图中R波出现的新的第二R波感测时间；
所述R波感测模块还用于基于新的第一R波感测时间和预设时长计算得到每个所述预设刺激位置对应的新的第一脉冲发放时间；
所述R波感测模块还用于计算得到新的所述第二R波感测时间和每个所述预设刺激位置的新的所述第一R波感测时间之间的新的第一时间差值，并以新的所述第二R波感测时间为参考零点，根据新的所述第一时间差值和所述预设时长计算得到每个所述预设刺激位置对应的新的所述第二脉冲发放时间。
本方案中，在通过一个控制电极执行起搏时，在该脉冲刺激场景下，需要重新计算新的心肌心电图中R波以及体表心电图中R波中的R波感测时间，继而分别计算对应的第一脉冲发放时间以及第二脉冲发放时间，以实现该场景下的脉冲刺激的及时发放。
可选地，所述R波感测模块用于在多个所述预设刺激位置获取所述心肌心电图中出现R波对应的多个第一R波感测时间，选取一个第一R波感测时间作为参考零点，计算得到在所述参考零点之后的每个第一R波感测时间与所述参考零点之间的第二差值，并根据所述第二差值和预设时长计算得到每个所述预设刺激位置对应的第一脉冲发放时间。
本方案中，任意选取一个第一R波感测时间(LS)作为参考零点，其他时间靠后的刺激位置的发放时间以此为基础，计算与其的差值并加上预设时长，就可以得到每个脉冲刺激位置的脉冲发放时间，从而达到不依赖于体表心电图，仅基于心肌心电图即可完成脉冲的及时有效发放，使得脉冲刺激的控制过程更加灵活，能够适应于更多的使用场景。
可选地，所述R波感测模块用于从多个第一R波感测时间中出现时间中随机选取出一个第一R波感测时间，或选取出现时间最早的第一R波感测时间作为所述参考零点。
可选地，所述心肌心电图获取R波出现的第一R波感测时间，和所述体表心电图获取R波出现的第二R波感测时间对应同一心跳。
本方案中，为了保证脉冲刺激的有效性，所有R波(即心肌心电图中的R波和体表心电图中的R波)都是在同一心跳下感知到的；也即，心肌心电图获取R波出现的第一R波感测时间和体表心电图获取R波出现的第二R波感测时间，两个R波感测时间之间的时间差值必须小于一定值，这样才有脉冲刺激的实际意义，否则无法保证脉冲刺激的可靠性。
可选地，所述控制电极采用单极导线或双极导线与所述R波感测模块和所述心脏刺激脉冲发生器电连接。
本发明还提供一种脉冲刺激方法，所述方法采用上述的脉冲刺激装置实现，所述方法包括：
获取体表心电图和/或基于所述控制电极采集心电信号以获取心肌心电图；
根据所述体表心电图和/或所述心肌心电图获取R波出现的R波感测时间；
根据所述R波感测时间确定每个所述预设刺激位置对应的脉冲发放时间；
根据每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
本发明还提供一种医疗设备，所述医疗设备包括上述的脉冲刺激装置。
在符合本领域常识的基础上，所述各优选条件，可任意组合，即得本发明各较佳实施例。
本发明的积极进步效果在于：
(1)在左右心室多个部位放置控制电极(如对应刺激和/或起搏功能)，实现对多部位提供同时或顺序的心脏电刺激(CCM)，以提供心脏循环支持；相比现有的单纯对右心室室间隔刺激的方式，能更有效地提升对患者心脏的整体收缩力，尤其是左心室。针对急性心衰和/或短期心室功能明显下降的患者，多部位刺激能够更好地增强心脏收缩力，改善心脏射血功能。比如，对于刚接收心脏外科手术的病人，通过在其左、右心室心肌中不同位置(如心外膜表面的左心室前/后侧位、室间沟、右心室游离壁等)植入导线。在其他病人，可在右心室内(如在室间隔，心尖或游离壁)内经静脉放置导线和/或在左心室内膜(如室间隔、心尖或游离壁)经房间隔或动脉或左心室心外膜表面(通过放置在冠状静脉或动脉中的电极)放置导线等。
(2)心脏电刺激(CCM)方式(机制，时间等)：a.刺激机制为多部位心脏电刺激的机制(同步或顺序)，如在一个心动周期里全部电极部位都触发刺激(同步刺激)，或在多个心动周期里按照设定或随机顺序完成对每个电极部位的触发刺激(顺序刺激)；b.触发机制为由代表局部心室肌电活动的R波感测和/或代表整体心室肌电活动的R波感测的时间为触发点。当为后者时，整体和局部心室肌电R波的时间关系成为触发时间中的一部分。刺激方式(机制，时间等)可以根据实际情况进行动态调节以适应患者不断变化的心率和整体心脏状况，即能够跟随每个患者自身的心脏动态变化状态进行适配调整，以有效提高心脏功能提高的效果。
(3)CCM传输可以通过简单的单极导线实现，而不是必需在一个心脏位置使用两个单极导线或双极导线，从而简化了系统结构，降低了成本。
附图说明
图1为本发明实施例1的脉冲刺激装置的结构示意图。
图2为本发明实施例1的CCM传输时ECG和EGMs对应的R波触发示意图。
图3为本发明实施例2的脉冲刺激装置的结构示意图。
图4为本发明实施例2的CCM顺序传输时ECG和EGMs对应的R波触发示意图。
图5为本发明实施例3的脉冲刺激方法的流程图。
具体实施方式
下面通过实施例的方式进一步说明本发明，但并不因此将本发明限制在所述的实施例范围之中。
实施例1
如图1所示，本实施例的脉冲刺激装置包括R波感测模块1、心脏刺激脉冲发生器2和至少一个控制电极3，控制电极3通过导线4分别与R波感测模块1和心脏刺激脉冲发生器2电连接，R波感测模块1和心脏刺激脉冲发生器2通信连接。
优选地，装置包括至少两个控制电极，不同的控制电极用于植入患者左右心室心肌的不同的预设刺激位置。
通过设置至少两个控制电极，以实现对左右心室心肌中多个不同位置的刺激，相比现有的单纯对右心室室间隔刺激的方式，能更有效地提升对患者心脏的整体收缩力，尤其是左心室。针对急性心衰和/或短期心室功能明显下降的患者，多部位刺激能够更好地增强心脏收缩力，改善心脏射血功能。当然，控制电极的数量设置可以根据实际场景需求进行重新设置与调整。
具体地，不同的预设刺激位置包括但不限于左右心室的室间隔内壁、心室外壁的室间沟、左心室外侧壁、左心室前外侧壁、左心室后外侧壁、右心室游离壁内壁、右心室游离壁心外壁、右心室心尖部位、左心室心尖部位。
在左右心室的上述列举的位置中分别设置控制电极，或者根据实际刺激需求在部分位置处设置控制电极，以尽可能保障心脏脉冲刺激的可靠性。
R波感测模块1用于获取体表心电图(ECG)和/或基于控制电极3采集心电信号以获取心肌心电图(EGM)，由于控制电极可以位于心室内膜或心室外膜，因此心肌心电图(EGM)涵盖来自于心室腔内或心室外壁的信号。
具体地，R波感测模块1用于根据体表心电图和/或心肌心电图获取R波出现的R波感测时间，并根据R波感测时间确定每个预设刺激位置对应的心脏刺激脉冲(或CCM电刺激)发放时间，脉冲发放时间对应感测到R波至触发心脏刺激脉冲发放的时长，CCM在各个位置或部位的传递由局部心肌心电图EGM的R波感应或全局体表心电图ECG的R波感应触发。
心脏刺激脉冲发生器2用于根据每个脉冲发放时间发放心脏刺激脉冲至每个对应的控制电极3。
在一可实施的方案中，R波感测模块用于获取体表心电图和/或基于控制电极获取心肌心电图，并分别根据心肌心电图获取R波出现的第一R波感测时间以及体表心电图获取R波出现的第二R波感测时间；
需要说明的是，本实施例心肌心电图获取R波出现的第一R波感测时间，和体表心电图获取R波出现的第二R波感测时间对应同一心跳。
为了保证脉冲刺激的有效性，所有R波(即心肌心电图中的R波和体表心电图中的R波)都是在同一心跳下感知到的；也即，心肌心电图获取R波出现的第一R波感测时间和体表心电图获取R波出现的第二R波感测时间，两个R波感测时间之间的时间差值必须小于一定值，这样才有脉冲刺激的实际意义，否则无法保证脉冲刺激的可靠性。R波感测模块还用于第一R波感测时间计算得到每个预设刺激位置对应的第一脉冲发放时间；其中，一旦第一R波感测时间确定后，对应的第一脉冲发放时间也就确定(即是预设的时间)，不会发生变化。
R波感测模块还用于根据第一R波感测时间和第二R波感测时间计算得到每个预设刺激位置对应的第二脉冲发放时间。
心脏刺激脉冲发生器用于根据第一脉冲发放时间和/或第二脉冲发放时间发放心脏刺激脉冲至控制电极。
本实施例中的脉冲刺激过程中，(1)可以以体表心电图中R波为主进行心脏刺激脉冲发放，即每个电极刺激发出时间以体表心电图的R波感测时间为触发时间的零点；(2)可以以心肌心电图中R波为主进行心脏刺激脉冲发放，即每个电极刺激发出时间以其心肌心电图的R波为触发时间的零点；(3)同时基于体表心电图中R波和心肌心电图中R波进行心脏刺激脉冲发放；具体采用这三种中的具体某种触发机制可以根据实际电刺激需求进行选择或实时调整。
另外，为了进一步地提高心脏刺激脉冲触发的控制效果，当体表ECG感知不良时可以直接转到基于EGM触发；或，当有一个位置的EGM感知不良时可以直接转到基于ECG触发，即避免了因误感知或者感知不良等特殊状况造成无法持续脉冲刺激，及时有效地保证了疗法持续进行。
在一可实施的方案中，R波感测模块1用于根据第一R波感测时间和预设时长计算得到每个预设刺激位置对应的第一脉冲发放时间。
对于电极3采集的心肌心电图(EGM)，第一脉冲发放时间为心肌心电图EGM的R波感应时刻作为参考零点(或称触发点)的预设时长(LPD)，该预设时长通常默认为40ms，且该时长值可以根据实际需求调整。每个部位或位置的LPD(即第一脉冲发放时间)用 于在该部位或位置相对心肌心电图R波感知时刻触发CCM发送的时间。
R波感测模块1还用于计算得到第二R波感测时间和第一R波感测时间之间的第一时间差值，并根据第一时间差值和预设时长脉冲发放时间计算得到每个预设刺激位置对应的以第二R波感测时间作为参考零点(或称触发点)的第二脉冲发放时间。
获取心肌心电图中R波出现的第一R波感测时间，计算预设刺激位置对应的第一脉冲发放时间；获取体表心电图中R波出现的第二R波感测时间，根据第一R波感测时间和第二R波感测时间计算得到预设刺激位置对应的第二脉冲发放时间，进而基于第一脉冲发放时间和/或第二脉冲发放时间进行脉冲发放，即提出基于心肌心电图中R波、体表心电图中R波确定脉冲发放时间的方案，有效地保证了脉冲刺激的及时性和可靠性。
也就是说，以EGM R波触发的CCM，每个刺激位置从R波到发送的时长是固定的(如预设时长40ms)。以ECG R波触发的CCM，每个刺激位置的时长是不固定,不一样的(即由固定的预设时长40ms、根据位置变化的时间差值决定)。
参见图2所示，在病人窦性心律时，对于体表心电图ECG，首先计算体表心电图ECG的感测R波对应时刻和局部心肌心电图EGM的感测R波对应时刻之间的时间差(GLSD)，该时间差表征对应心肌部位/位置的心肌电活动相对整个心脏电活动的时间敏感值；以体表心电图ECG的感测R波时刻为触发的脉冲发放时间(GPD)将为对应时刻GLSD和心肌心电图脉冲发放时间LPD相加，即GPD＝GLSD+LPD。另外，每个部位对应的GLSD和GPD可在几个自身心跳时测量并平均得到(默认为5个连续自身心跳，范围从3到12)。每个部位或位置的GPD(即第二脉冲发放时间)用于在该部位或位置相对体表心电图R波感知时刻触发CCM发送的时间。本实施例中该步骤称为预设期(set-up period)。
在一可实施例的方案中，心脏刺激脉冲发生器用于在得到每个位置的第二脉冲发放时间后，保持第一时间差值，以保持根据第二脉冲发放时间发放心脏刺激脉冲至对应的控制电极。
即本实施例中，在计算得到第二脉冲发放时间后，无需每次电刺激输出前都再次计算，可以由体表心电图来直接触发电刺激输出时间，而不需要每次都通过感测心肌心电图的R波来触发，从而在达到心电刺激效果的同时，有效地缩短了数据处理耗时，提高了心脏刺激脉冲触发的控制效率。
在一可实施例的方案中，本实施例的装置还包括时间更新模块。
时间更新模块用于定期或者不定期的更新第一时间差值，以基于更新后的第一时间差值更新第二脉冲发放时间；
心脏刺激脉冲发生器用于根据更新后的第二脉冲发放时间发放心脏刺激脉冲至对应 的控制电极。
即本实施例中，可以根据实际需求定期或不定期的更新第二脉冲发放时间(此时可以继续或停止心肌电刺激)，然后根据更新后的触发时间继续进行心肌电刺激，以实现更灵活的电刺激效果，满足更多的脉冲电刺激场景需求。
本实施例中通过刺激位置以及刺激机制的设置，达到加强或最大化对心脏的循环支持的效果。
当然，本实施例中CCM刺激的控制方案在某些特殊情况下需要自动暂停实施，例如在检测到患者的心率过快时(比如高于120次/分钟)，有PVC(心室早搏)等，以保障患者的心脏刺激支持的安全性。
本实施例中，在左右心室多个部位放置控制电极(如对应刺激和/或起搏功能)，实现对多部位提供心脏电刺激CCM；相比现有的单纯对右心室室间隔刺激的方式，能更有效地提升对患者心脏的整体收缩力，尤其是左心室。针对急性心衰和/或短期心室功能明显下降的患者，多部位刺激能够更好地增强心脏收缩力，改善心脏射血功能。
实施例2
如图3所示，本实施例的脉冲刺激装置是对实施例1的进一步改进，具体地：
本实施例的脉冲刺激装置还包括脉冲控制模块5，脉冲控制模块5与心脏刺激脉冲发生器2通信连接。
脉冲控制模块5用于生成脉冲发放模式并发送至心脏刺激脉冲发生器2。
心脏刺激脉冲发生器2用于在体表心电图或心肌心电图中出现R波时，基于脉冲发放模式和脉冲发放时间发放心脏刺激脉冲至每个对应的控制电极3。
通过在脉冲控制模块中预先设置不同的脉冲发放模式，在实际脉冲发放场景中，可以根据操作人员人为选取、预设某一固定的脉冲模式或者随机选取等方式确定脉冲发放模式，以自动地实现对不同的预设刺激位置的脉冲发放。当然还可以根据实际需求对脉冲发放模式进行动态调整。
在一可实施的方案中，脉冲发放模式包括基于体表心电图和/或心肌心电图中的R波，同步、按照设定或随机顺序向每个预设刺激位置对应的控制电极发放心脏刺激脉冲。
在设定或随机顺序下，向对应的预设刺激位置处连续发放心脏刺激脉冲以达到预设心跳次数。
脉冲发放模式由体表心电图的整体(global)R波还是各部位的本地(local)R波来触发，发放机制，即同步、按照设定或随机顺序向每个预设刺激位置发放心脏刺激脉冲，或预设期(set-up period)，即对于每个电极位置对应的GLSD的测量和计算等。
通过同步、按照设定或随机顺序等方式进行脉冲发放，达到尽可能满足各种脉冲发放需求，以满足更多脉冲刺激场景，在保证了对患者脉冲刺激的有效性的同时，提升了患者的使用体验。
对位置或部位的CCM刺激可以在同一R波后的按照每个部位相应时间“同时”(即同一心动周期里)触发传递(称为同步)，也可以在多个R波上的多个部位依次传递等；按照设定顺序传输时，CCM刺激在R波后在一个部位按照该部位相应时间后触发传递，然后在下一个R波后在下一个部位传递，依此类推，直到所有部位都被覆盖传输。在同一R波后，可能有1个或多个部位按照每个部位相应时间出现CCM刺激(但不是所有部位，否则是同步)。另外，接收CCM刺激的特定部位序列可以是专门设计(可由医生等相关权限工作人员程控)，也可以是随机的。在顺序传递时，每个预设部位的刺激次数可为一次或多次(比如6次，即六个心动周期)，然后再转到下个预设部位刺激，以此类推。
在一可实施的方案中，脉冲控制模块还用于基于设定数量的预设刺激位置，采用设定构建规则或者随机组合方式，生成不同的预设刺激位置对应的刺激组合；
其中，刺激组合包括至少两个刺激单元，且至少一个刺激单元对应两个及以上同步执行脉冲发放的预设刺激位置；
脉冲发放模式包括基于体表心电图和/或心肌心电图中的R波，根据设定或随机顺序以及刺激组合，向对应的预设刺激位置的控制电极发放心脏刺激脉冲。
在设定或随机顺序下，向对应的预设刺激位置处连续发放心脏刺激脉冲以达到预设心跳次数。
不再将每个预设刺激位置单独考虑，而是基于多个预设刺激位置形成不同的刺激组合，对于同一刺激组合对应的不同预设刺激位置同步发放脉冲，不同的刺激组合采用设定或随机顺序的脉冲发放方式进行脉冲刺激，以满足更多的脉冲刺激场景需求，进一步地保障了患者的安全性。
另外，在一可实施例的方案中，脉冲刺激装置对应两根导线4，一根导线的电极位于右心室室间隔(右心室室间隔作为心内膜位置)或位于/靠近心室前或心室后室间沟(作为心外膜位置)；另一根位于左心室前外侧壁(心外膜或心内膜位置)。
在一可实施例的方案中，脉冲刺激装置对应三根导线4，一根的电极位于右心室室间隔(右心室室间隔为心内膜位置)或位于/靠近心室前或心室后室间沟(作为心外膜位置)；一根位于左心室后外侧壁(心外膜或心内膜位置)，另一根位于左心室前外侧壁(心外膜或心内膜位置)。
当然，还可以根据不同的患者的病情，心脏相关手术情况，对循环支持的需求及对CCM刺激需求重新规划导线4的数量以及预设植入位置。
在一可实施例的方案中，本实施例的导线4包括单极导线或双极导线，心脏刺激脉冲通过导线4传输至对应部位。(1)当使用单个单极导线时，CCM在与心肌接触的单极电极和患者身体其他地方的电极之间进行传递。此时，单极电极可为心腔或血管内其他电极导线上的电极，体表ECG电极或用于外部除颤的体表贴片电极；或是植入皮肤下的电极(如S-ICD)或植入心脏的电极等。或者，可通过其他特殊设计的电极来获得。(2)若使用多个单极导线时，CCM可以在两个与心肌接触的单极电极之间传递，其中一个是阴极，另一个是阳极。(3)若使用双极导线时，只有一个电极与心肌持续接触(如右心室室间隔导线4)，CCM可在两个电极之间传递或作为单极导线(与心肌接触的电极)形式传递，类似于单极设置。(4)比如左心室心外膜电极，CCM可以在两个电极之间或分别作为两个单极导线传递。(5)可以同时使用单极导线和双极导线，这样就存在多种可能性组合，具体如何组合可以根据实际需求进行确定与调整。
下面结合实例具体说明本实施例的脉冲刺激装置的工作原理：
(1)在刚接受开胸心脏手术的病人的心外膜表面，具体在心外前或后壁的室间沟(靠近心室室间沟区)、左心室后外侧壁和左心室前外侧壁植入三根双极导线4；同时提供当前患者的体表心电图；这三根导线与体表心电图一起连接到外部电循环支持设备，即脉冲刺激装置的R波感测模块1；
(2)在预设期(set-up period)，R波感测模块1分别用于感测体表心电图(ECG)的R波感测时间(GS)和心肌心电图EGMs的R波感测时间LS(LS1、LS2、LS3)，具体参见图2；根据GS、LS(LS1、LS2、LS3)和LPD计算出每个部位的GLSD和GPD(GLSD1和GPD1、GLSD2和GPD2、GLSD31和GPD3)，其中GLSD＝LS-GS，GPD＝GLSD+LPD；
(3)心脏刺激脉冲发放模式(触发R波来源，同步或顺序，以及顺序中的特定顺序或随机，所有医生可程控)，基于心脏刺激脉冲发放模式、LPD和GPD为一个或多个部位生成心脏刺激脉冲，如图4所示；
(4)一旦连接设备将经历一个设置过程，包括感测R波(GS&LS)和计算每个部位(三根导线中的每根导线所在的位置)的GLSD&GPD，在此GLSDn&GPDn中，n＝1、2和3。最好在窦性心律期间进行，同时无CCM发送。然后，如果是体表ECG的R波触发模式，CCM将在感测到表面ECG的R波后按照每个位置相应的GPD以同步模式(在同一心跳(R波))或顺序模式(例如CCM在R波1后传递到部位1，在R波2后 传递到部位2，在R波3后传递到部位3(一个接一个)或以随机顺序传递/触发CCM。
类似地，CCM可以由每个部位的本地R波来触发，同步或顺序地进行(局部/本地R波模式)。
另外，在CCM的发送持续了特定的跳动次数或持续时间(默认为3600次跳动或60分钟，可编程)后，设置过程将再次启动，以适应由于心率和/或患者状况(比如用药后)变化引起的参数(比如GLSD等)的潜在变化。另外，CCM发送也可以根据更新的参数继续。
通过上述心脏刺激脉冲触发的控制方式的支持，可以满足急性和/或短期，以及单一部位电刺激能够达到心脏需要的循环支持的患者的使用需求，特别对于心功能较弱(比如心排量较低)不适合或不放心做心脏手术的病人等，能够有效加强术后心功能，使得患者能够更快恢复，对患者进行及时有效地心脏需求支持；同时在该技术的支持下，也帮助患者以及医生做相关手术提升了信心；另外，现有基于药物增强心脏收缩力的方式往往存在副作用(比如心律失常，心肌氧耗量增加等，并可能增加死亡率)，而本实施例的心脏刺激脉冲触发的控制方式基本没有相关副作用(心率，氧耗量基本不变)，且能够达到电刺激更及时有效、实现更好地提高心脏收缩力的效果。
本实施例中，在左右心室多个部位放置控制电极(如对应刺激和/或起搏功能)，实现对多部位提供同步或顺序的心脏电刺激CCM；CCM刺激的触发机制由局部心电活动的R波感应和/或整体心电活动的R波感应的时间决定，且触发方式可以根据实际情况进行动态调节以适应患者不断变化的心率和整体心脏状况，即能够跟随每个患者自身的心脏动态变化状态进行适配调整，以有效提高CCM刺激控制效果，实现更好的心脏收缩力，更好地满足急性和/或短期，以及单一部位电刺激能够达到心脏需要的循环支持的患者的使用需求。
实施例3
本实施例的脉冲刺激装置是对实施例2的进一步改进，本实施例为考虑一个控制电极执行起搏操作的CCM刺激场景，具体地：
对于起搏时的CCM刺激场景，存在如下两种情况：a)起搏是由独立电极发放的，此时心脏刺激脉冲触发的控制原理与上述表述内容一致，不会受到影响；b)起搏是由CCM刺激电极发放时，主要针对提供CCM刺激的电极又要提供起搏(起搏时被认定为对应LS1的电极位置)，而其他剩余电极位置(只提供CCM刺激)的工作原理与上述表述内容一致。对于提供起搏的CCM刺激电极，起搏时的LS1就是起搏脉冲发放时间，预设时长需要延长到40-100ms，优选60-80ms(也可程控调节)。在这两种情况下，预 设期都需要测量二次，一次测量时间是检测自身心率(窦率)时，另一次测量时间是起搏时。
具体地，在一个控制电极执行起搏操作时，R波感测模块还用于在一个预设刺激位置进行起搏时，获取其他所有剩余的预设刺激位置对应的心肌心电图，并获取心肌心电图中R波出现的新的第一R波感测时间以及体表心电图中R波出现的新的第二R波感测时间；
R波感测模块还用于基于新的第一R波感测时间和预设时长计算得到每个预设刺激位置对应的新的第一脉冲发放时间；
R波感测模块还用于计算得到新的第二R波感测时间和每个预设刺激位置的新的第一R波感测时间之间的新的第一时间差值，并以新的第二R波感测时间为参考零点，根据新的第一时间差值和预设时长计算得到每个预设刺激位置对应的新的第二脉冲发放时间。
本实施例中，在通过一个控制电极执行起搏时，在该脉冲刺激场景下，需要重新计算新的心肌心电图中R波以及体表心电图中R波中的R波感测时间，继而分别计算对应的第一脉冲发放时间以及第二脉冲发放时间，以实现该场景下的脉冲刺激的及时发放。
实施例4
本实施例的脉冲刺激装置是对实施例2的进一步改进，具体地：
R波感测模块用于在多个预设刺激位置获取心肌心电图中出现R波对应的多个第一R波感测时间，选取一个第一R波感测时间作为参考零点，计算得到在参考零点之后的每个第一R波感测时间与参考零点之间的第二差值，并根据第二差值和预设时长计算得到每个预设刺激位置对应的第一脉冲发放时间。
其中，R波感测模块用于从多个第一R波感测时间中出现时间中随机选取出一个第一R波感测时间，或选取出现时间最早的第一R波感测时间作为参考零点。根据实际经验，一般优先选取出现时间最早的第一R波感测时间作为参考零点。
本实施例中，选取出现时间最早的第一R波感测时间(LS)作为参考零点，其他时间靠后的刺激位置的发放时间以此为基础，计算与其的差值并加上预设时长，就可以得到每个脉冲刺激位置的脉冲发放时间，从而达到不依赖于体表心电图，仅基于心肌心电图即可完成脉冲的及时有效发放，使得脉冲刺激的控制过程更加灵活，能够适应于更多的使用场景。
实施例5
本实施例的脉冲刺激方法采用实施例1的脉冲刺激装置实现。
如图5所示，本实施例的脉冲刺激方法包括：
S101、获取体表心电图和/或基于控制电极采集心电信号以获取心肌心电图；
S102、根据体表心电图和/或心肌心电图获取对应的R波出现的R波感测时间；
S103、根据R波感测时间确定每个预设刺激位置对应的脉冲发放时间；
S104、根据每个脉冲发放时间发放心脏刺激脉冲至每个对应的控制电极。
本实施例的脉冲刺激方法对应的实现原理与实施例1-4中任意一个实施例的脉冲刺激装置对应的工作原理对应，因此在此就不再赘述。
通过上述心脏刺激脉冲触发的控制方式的支持，可以满足急性和/或短期，以及单一部位电刺激能够达到心脏需要的循环支持的患者的使用需求，特别对于心功能较弱(比如心排量较低)不适合或不放心做心脏手术的病人等，能够有效加强术后心功能，使得患者能够更快恢复，对患者进行及时有效地心脏需求支持；同时在该技术的支持下，也帮助患者以及医生做相关手术提升了信心；另外，现有基于药物增强心脏收缩力的方式往往存在副作用(比如心律失常，心率加快，心肌氧耗量增加等，并可能增加死亡率)，而本实施例的心脏刺激脉冲触发的控制方式基本没有相关副作用(心率，氧耗量基本不变)，且能够达到电刺激更及时有效、实现更好地提高心脏收缩力的效果。
实施例6
本实施例的医疗设备包括实施例1-4中任意一个实施例中的脉冲刺激装置。
医疗设备可以仅包括脉冲刺激装置，用于各种导线配置；还可以集成到或作为其他系统的附件。这样的医疗设备可以包括但不限于以下内容：
(1)临时起搏系统：ECS功能可添加到临时起搏系统中，该系统通常用于在上述患者群体中提供心动过缓起搏。ECS可以将用于起搏的控制电极作为CCM刺激电极的一部分，也可独立于CCM的刺激电极，这样对临床实践的影响最小，但可以提供额外的临床益处，或者在需要更好的CCM引起的收缩改善的位置使用额外的导线。
(2)提供急性/短期或慢性(长期)机械循环支持的部分或全部植入式装置：可将适当的导线和/或心肌电极(在所需位置)添加到此类系统以提供ECS以及其他功能，例如心动过缓起搏、ATP和除颤。
(3)外部除颤器系统：如可穿戴式除颤器、AED或用于急诊室和/或救护车的除颤器。CCM可以在感测到体表ECG的R波之后经由皮肤电极(例如除颤电极)来提供。只有ECS电路可能需要添加到现有设备设计中或者出于这种目的，可以将单独的ECS单元与当前设备连接。当患者处于电击后严重心动过缓或心脏停搏时或处于机电分离(EMD)时，ECS功能可能会对病人心脏功能恢复提供更有效的帮助。
(4)S-ICD系统：R波感测可通过非心肌接触电极(如右心室sub-Q电极对)的ECG或具有右心室无导线起搏器的S-ICD的右心室EGM来实现，从而触发S-ICD里的CCM刺激并经subQ defib电极和/或无导线起搏器电极来传递。当患者处于电击后严重心动过缓或心脏停搏时或处于机电分离时，此功能可能会对病人心脏功能恢复提供更有效的帮助。
本实施例的医疗设备包含上述的脉冲刺激装置，实现对多部位提供心脏电刺激CCM，相比现有的单纯对右心室室间隔刺激的方式，更有效地提升了患者心脏的整体收缩力，尤其是左心室，从而能够很好地适用于急性和/或短期心室功能明显下降的患者，大大地提升了医疗设备的整体产品性能。
虽然以上描述了本发明的具体实施方式，但是本领域的技术人员应当理解，这些仅是举例说明，在不背离本发明的原理和实质的前提下，可以对这些实施方式做出多种变更或修改。因此，本发明的保护范围由所附权利要求书限定。

Claims (18)

  1. 一种脉冲刺激装置，其特征在于，所述装置包括R波感测模块、心脏刺激脉冲发生器和至少一个控制电极，每个所述控制电极对应不同的预设刺激位置；
    所述控制电极分别与所述R波感测模块和所述心脏刺激脉冲发生器电连接，所述R波感测模块和所述心脏刺激脉冲发生器通信连接；
    所述R波感测模块用于获取体表心电图和/或基于所述控制电极采集心电信号以获取心肌心电图，根据所述体表心电图和/或所述心肌心电图获取对应的R波出现的R波感测时间，并根据所述R波感测时间确定每个所述预设刺激位置对应的脉冲发放时间；
    所述心脏刺激脉冲发生器用于根据每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
  2. 如权利要求1所述的脉冲刺激装置，其特征在于，所述装置包括至少两个所述控制电极，不同的所述控制电极用于植入患者左右心室心肌的不同的所述预设刺激位置。
  3. 如权利要求1或2所述的脉冲刺激装置，其特征在于，所述装置还包括脉冲控制模块，所述脉冲控制模块与所述心脏刺激脉冲发生器通信连接；
    所述脉冲控制模块用于生成脉冲发放模式并发送至所述心脏刺激脉冲发生器；
    所述心脏刺激脉冲发生器用于在所述体表心电图和/或所述心肌心电图中出现R波时，基于所述脉冲发放模式和每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
  4. 如权利要求3所述的脉冲刺激装置，其特征在于，所述脉冲发放模式包括基于所述体表心电图和/或所述心肌心电图中的R波，同步、按照设定或随机顺序向每个所述预设刺激位置对应的所述控制电极发放心脏刺激脉冲。
  5. 如权利要求3所述的脉冲刺激装置，其特征在于，所述脉冲控制模块还用于基于设定数量的所述预设刺激位置，采用设定构建规则或者随机组合方式，生成不同的所述预设刺激位置对应的刺激组合；
    其中，所述刺激组合包括至少两个刺激单元，且至少一个所述刺激单元对应两个及以上同步执行脉冲发放的所述预设刺激位置；
    所述脉冲发放模式包括基于所述体表心电图和/或所述心肌心电图中的R波，根据设定或随机顺序以及所述刺激组合，向对应的所述预设刺激位置的所述控制电极发放心脏刺激脉冲。
  6. 如权利要求4或5所述的脉冲刺激装置，其特征在于，在设定或随机顺序下，向 对应的所述预设刺激位置处连续发放心脏刺激脉冲以达到预设心跳次数。
  7. 如权利要求1-6中至少一项所述的脉冲刺激装置，其特征在于，所述预设刺激位置包括左右心室的室间隔内壁、心室外壁的室间沟、左心室外侧壁、左心室前外侧壁、左心室后外侧壁、右心室游离壁内壁、右心室游离壁心外壁、右心室心尖部位、左心室心尖部位中的至少一个部位。
  8. 如权利要求1-7中至少一项所述的脉冲刺激装置，其特征在于，所述R波感测模块用于获取体表心电图和基于所述控制电极获取心肌心电图，并分别根据所述心肌心电图获取R波出现的第一R波感测时间以及所述体表心电图获取R波出现的第二R波感测时间；
    所述R波感测模块还用于根据所述第一R波感测时间计算得到每个所述预设刺激位置对应的第一脉冲发放时间；
    所述R波感测模块还用于根据所述第一R波感测时间和所述第二R波感测时间计算得到每个所述预设刺激位置对应的第二脉冲发放时间；
    所述心脏刺激脉冲发生器用于根据所述第一脉冲发放时间和/或所述第二脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
  9. 如权利要求8所述的脉冲刺激装置，其特征在于，所述R波感测模块还用于以所述第一R波感测时间为参考零点，根据预设时长计算得到每个所述预设刺激位置对应的第一脉冲发放时间；
    所述R波感测模块还用于计算得到所述第二R波感测时间和每个所述预设刺激位置的所述第一R波感测时间之间的第一时间差值，并以所述第二R波感测时间为参考零点，根据所述第一时间差值和所述预设时长计算得到每个所述预设刺激位置对应的所述第二脉冲发放时间。
  10. 如权利要求9所述的脉冲刺激装置，其特征在于，所述心脏刺激脉冲发生器用于在得到所述第二脉冲发放时间后，保持所述第一时间差值，以保持根据所述第二脉冲发放时间发放心脏刺激脉冲至对应的所述控制电极。
  11. 如权利要求9或10所述的脉冲刺激装置，其特征在于，所述装置还包括时间更新模块；
    所述时间更新模块用于定期或者不定期的更新所述第一时间差值，以基于更新后的所述第一时间差值更新所述第二脉冲发放时间；
    所述心脏刺激脉冲发生器用于根据更新后的所述第二脉冲发放时间发放心脏刺激脉冲至对应的所述控制电极。
  12. 如权利要求8-11中至少一项所述的脉冲刺激装置，其特征在于，所述R波感测模块还用于在一个预设刺激位置进行起搏时，获取其他所有剩余的预设刺激位置对应的所述心肌心电图，并获取所述心肌心电图中R波出现的新的第一R波感测时间以及所述体表心电图中R波出现的新的第二R波感测时间；
    所述R波感测模块还用于基于新的第一R波感测时间和预设时长计算得到每个所述预设刺激位置对应的新的第一脉冲发放时间；
    所述R波感测模块还用于计算得到新的所述第二R波感测时间和每个所述预设刺激位置的新的所述第一R波感测时间之间的新的第一时间差值，并以新的所述第二R波感测时间为参考零点，根据新的所述第一时间差值和所述预设时长计算得到每个所述预设刺激位置对应的新的所述第二脉冲发放时间。
  13. 如权利要求1所述的脉冲刺激装置，其特征在于，所述R波感测模块用于在多个所述预设刺激位置获取所述心肌心电图中出现R波对应的多个第一R波感测时间，选取一个第一R波感测时间作为参考零点，计算得到在所述参考零点之后的每个第一R波感测时间与所述参考零点之间的第二差值，并根据所述第二差值和预设时长计算得到每个所述预设刺激位置对应的第一脉冲发放时间。
  14. 如权利要求13所述的脉冲刺激装置，其特征在于，所述R波感测模块用于从多个第一R波感测时间中出现时间中随机选取出一个第一R波感测时间，或选取出现时间最早的第一R波感测时间作为所述参考零点。
  15. 如权利要求8-13中任一项所述的脉冲刺激装置，其特征在于，所述心肌心电图获取R波出现的第一R波感测时间，和所述体表心电图获取R波出现的第二R波感测时间对应同一心跳。
  16. 如权利要求1所述的脉冲刺激装置，其特征在于，所述控制电极采用单极导线或双极导线与所述R波感测模块和所述心脏刺激脉冲发生器电连接。
  17. 一种脉冲刺激方法，其特征在于，所述方法采用权利要求1-16中任一项所述的脉冲刺激装置实现，所述方法包括：
    获取体表心电图和/或基于所述控制电极采集心电信号以获取心肌心电图；
    根据所述体表心电图和/或所述心肌心电图获取R波出现的R波感测时间；
    根据所述R波感测时间确定每个所述预设刺激位置对应的脉冲发放时间；
    根据每个所述脉冲发放时间发放心脏刺激脉冲至每个对应的所述控制电极。
  18. 一种医疗设备，其特征在于，所述医疗设备包括权利要求1-16中任一项所述的脉冲刺激装置。
PCT/CN2022/110614 2021-08-05 2022-08-05 脉冲刺激装置、方法及医疗设备 Ceased WO2023011641A1 (zh)

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