CN109966643A - A kind of perception pacing method of the multi-chamber without conducting wire pacemaker system - Google Patents

A kind of perception pacing method of the multi-chamber without conducting wire pacemaker system Download PDF

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Publication number
CN109966643A
CN109966643A CN201910254542.4A CN201910254542A CN109966643A CN 109966643 A CN109966643 A CN 109966643A CN 201910254542 A CN201910254542 A CN 201910254542A CN 109966643 A CN109966643 A CN 109966643A
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China
Prior art keywords
pacemaker
conducting wire
chamber
module
heart
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CN201910254542.4A
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Chinese (zh)
Inventor
张海军
周文秀
侯文博
王燕
李建文
房艺
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Individual
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Individual
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Priority to CN201910254542.4A priority Critical patent/CN109966643A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36585Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by two or more physical parameters

Abstract

A kind of perception pacing method the invention discloses multi-chamber without conducting wire pacemaker system, multi-chamber are configured as the pacemaker of one or more implantation human bodies without conducting wire pacemaker.Pacemaker includes mechanics sensing module, electrocardio sensing module, processing module, communication module, pacing module, power supply module, memory etc..Pacemaker judges cardiomotility situation and electrocardio situation according to the received cardiac mechanical event of processing module and cardiac electric event, achievees the purpose that precisely to pace with this, regulates and controls cardiomotility.Wherein, mechanics sensor perceives the mechanical event of heart by related myocardiums cell twisting resistances such as sensing mycardial contractility, Diastolic Forces.Multi-chamber between conducting wire pacemaker system difference pacemaker by the cardiac mechanical event perceived and/or cardiac electric event establishment without being contacted, to cooperate.

Description

A kind of perception pacing method of the multi-chamber without conducting wire pacemaker system
Technical field
The invention belongs to medical instruments fields, and in particular to a kind of perception pace-making side of the multi-chamber without conducting wire pacemaker system Method.
Background technique
Pacemaker is that one kind is implanted in intracorporal electronic therapeutic instrument, is provided by impulse generator granting by battery The electric pulse of energy, by the conduction of lead electrode, the cardiac muscle that stimulating electrode is contacted makes heart excitement and shrinks, to reach To treatment due to the purpose of certain arrhythmia caused heart dysfunctions.Pacing system is other than above-mentioned pacing function, also There can be the perceptional function that heart itself electrocardio-activity is back to impulse generator.
In some instances, a kind of no conducting wire pacemaker can plant patient's ventricle, on its housing include one or more Electrode, to provide pacemaker impulse and/or perception cardiac electrical activity.Although the sensing and pacing function without conducting wire pacemaker can solve The certainly patient's condition such as bradyarrhythmia, but the patient's condition such as sinus node dysfunction, atrioventricular block may need it is more Chamber synchronous pacing, to maintain the heart rate of rule.
Utilize Chinese patent database, Chinese Journal Full-text Database (CNKI), PubMed, United States Patent (USP) trade mark (USPTO), discovery is consulted with the presence of similar to patent of the invention by EUROPEAN PATENT OFFICE (EPO) etc..Similarity it is higher for example, The United States Patent (USP) of Matthew D. Bonner et al. Patent No. US2014/0121720 A1, describes through the electrodes sense heart (accelerometer perceives acceleration or pressure sensor in atrium for room electric signal and/or utilization sensor perception ventricle mechanical signal Perception atrial pressure) method that synchronizes pace-making;The Chinese invention of assorted et al. the Publication No. CN108883281A of S dagger-axe is special Benefit, the method for describing intracardiac ventricular pace maker and detecting atrial event using motion sensor and carrying out synchronous pacing;Jie Fu In E Shi Taman Publication No. CN106132478A Chinese invention patent, describe by communication pulse carry out device it Between the multicell that communicates without lead pacemaker system;Base thinks the Chinese invention patent that P steps Lay Publication No. CN107073273A, It describes pacemaker and parameter related with the myocardial contractive power of heart is sensed by sensor, cardiac electrical activity is obtained, according to sense The cardiac electrical activity signal measured carries out electrical management to sensor, achievees the purpose that low-power consumption.
Summary of the invention
The present invention is a kind of perception pacing method of multi-chamber without conducting wire pacemaker system, is configured in any chamber of heart Pacemaker, the mechanical event of the mechanics sensor sensing received by its processing module and the electricity of electrocardio sensing module perception Event judges heartbeat situation and electrocardio situation, achievees the purpose that sense cardiomotility, control accurate cardiac pacing with this.
In system includes mechanics sensing module, electrocardio sensing module, processing module, communication mould without conducting wire pacemaker Block, pacing module, power supply module, memory;And pacemaker can be controlled by external program control device.
Mechanics sensor can sense cardiac myocytes twisting resistance in the mechanics sensing module, to detect institute's implant cavity The mechanical event of room.
The electrocardio sensing module then passes through the electrocardiosignal of chamber locating for electrode senses.
The cardiac mechanical event and electrocardio sensing module sense that the processing module is sensed by handling mechanics sensing module The electrocardiosignal known determines cardiomotility situation, determines that cardiac pacing instructs according to the parameter of setting.
The communication module can be communicated between vitro program controlled device, mainly be transferred to pacemaker operation conditions Vitro program controlled device, and the dependent instruction of the outer program control device of receiving body.
The pace-making instruction that the pacing module receiving processing module issues, and paced.
The power supply module is the activity power supply of each module of pacemaker.
The memory is responsible for storing the operation data of pacemaker.
Innovative point of the present invention
A kind of perception pacing method of the multi-chamber without conducting wire pacemaker system of the present invention, heart can install one or more as needed A pacemaker, pacemaker set perception, pacing parameter, can work independently between different pacemakers, pass through sense according to position Association is established in the cardiomotility known.The invention combines the mechanical signal of heart with electrocardiosignal, the pace-making of different chamber Device can be by both signal mutual inductions, and different pacemakers can also be established and be contacted by vitro program controlled system, so that different The pacemaker activity of chamber pacemaker can be unified, and the operating of multi-chamber pacemaker system is also more safely, effectively.
Detailed description of the invention
Therefore following drawings is not intended to limit model of the invention to illustrate specific embodiment of the present invention and method It encloses.In conjunction with the explanation in the following detailed description, attached drawing is not drawn on (except the regulation that is far from it) and for the purpose of use.In conjunction with attached Figure, numerically element, method of the present invention will hereinafter be described, and:
Fig. 1 a, which is shown, can sense cardiac electric signals, cardiac mechanical event, and pacing therapy is supplied to the intracardiac of patient's heart Pacing system schematic diagram.
Fig. 1 b is the relative position of mechanics sensor and cardiac muscle cell after an exemplary Pacemaker implantation.
Fig. 2 is the concept map of the one of embodiment of intracardiac pacemaker of Fig. 1.
Fig. 3 is the schematic diagram of the pacemaker example arrangement of Fig. 1.
Fig. 4 is the flow chart according to an exemplary intra-atrial pacing device pacing method.
Fig. 5 is exemplary for delivering the flow chart of the synchronous ventricular pacemaking method in atrium according to one.
Fig. 6 be the present invention measure different chamber electrocardiosignal, between mechanical signal correlativity diagram.
Specific embodiment
Fig. 1 is myocardium twisting resistance caused by an example can be used for sensing cardiac electric signals and be reversed by cardiac muscle, and will be risen Treatment of fighting is supplied to the multi-chamber of patient's heart 100 without the concept map of conducting wire pacing system 101.Multi-chamber is without conducting wire pacing system 101, may include right ventricle (RV) intracardiac pacemaker 200 in some examples, atrium dextrum (RA) intracardiac pacemaker 300 or other not With the combination of chamber pacemaker.Pacemaker is that can be adapted to be fully implanted in heart 100 through conduit intracardiac pacemaker Chamber in, for example, completely in RV, completely in left ventricle (LV), completely in RA or completely in atrium sinistrum (LA).? In the example of Fig. 1, pacemaker 300 is positioned along the internal membrane of heart (such as along RA side wall or RA diaphragm) of RA.200 edge of pacemaker The endocardial wall of RV positioned (such as RV apex of the heart).However, presently disclosed technology is not limited to rise shown in the example of Fig. 1 It fights device position and quantity, and other positions and position relative to each other are possible.In some instances, ventricle intracardiac pacemaker 200 are positioned in RV, the ventricular pacemaking for using presently disclosed technology delivering atrium synchronous.
Pacemaker 200 and 300 is dimensionally reduced compared with the pacemaker being subcutaneously implanted, and in shape can be usual It is cylinder, to realize being implanted into through vein via delivery catheter.In other examples, pacemaker 200 and 300 can be positioned in At any other position of 100 the inside of heart.Such as pacemaker 300 can be positioned in atrium dextrum and atrium sinistrum outside or it It is interior, to provide corresponding atrium dextrum or Left atrium pacing.Pacemaker 300 can be positioned in right ventricle or left ventricle, to provide Corresponding right ventricle or left ventricular pacing, and for sensing heartbeat situation by the mechanics sensor in ventricular chamber.
Pacemaker 200 and 300 can be generated independently to be delivered via one or more electrodes on pacemaker external shell To the electric stimulation pulse of heart 100, for example, pacemaker impulse.RA pacemaker 300 is configured as the electrocardiosignal in sensing RA, It can be used for being converted into RA intra-cardiac electrograms signal (EGM).The electrode based on shell for delivering RA pacemaker impulse can also For sensing RA electrocardiosignal.RV pacemaker 200 is configured to using being delivered RV pacemaker impulse based on the electrode of shell and felt Survey RV electrocardiosignal.
In some instances, patient may only need RV pacemaker 200 for delivering ventricular pacemaking.In other examples, It is needed depending on individual patient, it may be necessary to which RA pacemaker 300 is used for auricular pacemaking.RV pacemaker 200 is configured to promote Into the synchronization between RA activation and RV activation (for example, by maintaining the target chamber between atrial event and ventricular pace pulse (AV) interphase) mode control ventricular pace pulse be delivered to RV.That is, RV pacemaker 200 controls RV pacemaker impulse Delivering is to maintain the atrial activation (intrinsic or that pace-making induces) for corresponding to atrial contraction and be delivered so that ventricular depolarization Ventricular pace pulse between expectation AV interphase.According to the technology that the disclosure describes, RV pacemaker is passed by the mechanics obtained Sensor signal judges heartbeat situation, which is derived from the myocardium twisting resistance generated when heartbeat.Such as RV pacemaker 200, the myocardium twisting resistance that the intra-ventricle cardiac muscle cell sensed according to mechanics sensor generates in heartbeat, Obtain mechanical activity signal.
Target AV interphase can be by clinician select programming value, and be from detect atrial event until delivering The Time Intervals of ventricular pace pulse.In some instances, target AV interphase can from based on mechanics sensor signal detection to Atrial event time or the datum mark that is expressed of mechanics sensor signal start.It can be based on pacing from by RV Electric event represented by electrocardiosignal that device 200 receives and the mechanics sensor signal received as RV pacemaker 200 and The relative timing of myocardium twisting resistance dependent event determines that target AV interphase is optimal.
Pacemaker 200 and pacemaker 300 can carry out two-way wireless communication with external program control device, for AV Interphase and other mechanics sensor perceptual parameters and pace-making control parameter are programmed.
The concept map of intracardiac RV pacemaker as shown in Figure 2.RV pacemaker 200 includes the shell 204 along pacemaker 200 Electrode 211 and 212 for sensing electrocardiosignal and delivering pacemaker impulse spaced apart.Electrode 212 is shown located on pacemaker The point electrode of 200 fixing ends 201, and electrode 211 is illustrated as the annular electrode at the middle part along shell 204.
Electrode 211 and 212 forms anode and cathode pair, for bipolar cardiac pacing and perception.In alternative embodiment In, pacemaker 200 may include two or more electrodes pair, and electrode can also be located at 204 other positions of shell.Electrode 211 and 212 It can be but not limited to platinum, titanium, iridium or its alloy, and may include low polarizing coating, such as titanium nitride, yttrium oxide, oxidation Ruthenium, platinum black etc..
Shell 204 is formed by biocompatible materials (for example, stainless steel or titanium alloy).In some instances, shell 204 It may include insulating coating.The example of insulating coating includes Parylene, polyurethane, PEEK or polyimides etc..Shell 204 Entirety can be insulation, but only electrode 211 and 212 is uninsulated.Electrode 212 may be used as cathode electrode and via The internal circuit fenced by shell is coupled in electric feedthrough across shell 204, for example, pacing pulse generator and electrocardiosignal sense Slowdown monitoring circuit.
Shell 204 includes control electronic building brick 203, is used to perceive cardiac electric signals, generates pacemaker impulse and control and control Treat delivering and such as the electronic device of the other function below with reference to the pacemaker 200 described in Fig. 3.
Shell further comprises power supply module 270, which includes battery component, provides power to control electronics Component.Battery can be biological self energizing battery, rechargeable battery, fluorination carbon battery, lithium battery etc..
Pacemaker 200 may include fixator 205, and fixator 205 can be the sharp tooth in example, in some instances, Gu Determining device 205 can be helical form, barb-like etc., can be and formed by metal (injection, stainless steel or titanium alloy).
In some instances, mechanics sensor 213 may be mounted to that on fixator.After fixator is fixed on cardiac muscle cell, Mechanics sensor is embedded in cardiac muscle cell, to perceive the variation of myocardium twisting resistance.
Fig. 3 is the schematic diagram of the example arrangement of pacemaker 200 shown in FIG. 1.Pacemaker 200 includes mechanics sensing module 210, pacing module 220, processing module 230, communication module 240, electrocardio sensing module 250, memory 260, power supply module 270.Mechanics sensing module 210 be implemented in below with reference to Fig. 4-6 describe example in mechanics sensor and herein Also referred to as " mechanics sensor 213 ".Mechanics sensor 213 is not limited to piezoelectric transducer and MEMS, and other materials The sensor of material can be successfully utilized in pacemaker 200 to detect cardiac mechanical according to technique described herein Event.Mechanics sensor 213 can be multi-axial sensor (such as.Two dimension or three-dimension sensor), each axis can independent or group Analysis is closed with the signal for detecting cardiac mechanical event.The various circuits being expressed in Fig. 3 can combine at one or more On a integrated circuit board, the one or more integrated circuit include specific integrated circuit, electronic circuit, execute it is one or more soft Part or the processor (shared, dedicated or group) and memory of fixed routine, combinational logic circuit, state machine or offer institute Other suitable components of the function of description.
Electrocardio sensing module 250 is configured as receiving electrocardiosignal via electrode 211 and 212 by prefilter 251. Prefilter 251 may further include amplifier, to amplify " original " that is passed to rectifier and amplifier circuit 252 Electrocardiosignal.Signal is passed to ECG signal sampling device and analog-digital converter 253 by rectifier and amplifier circuit 252.Modulus Long number electrogram signal can be transmitted to the pace-making control circuit 231 of pacemaker processing module 230 by converter 253, With for by heart operation detecting circuit 233 using indicating cardiac electric event.
Processing module 230 includes heart operation detecting circuit 231, pace-making control circuit 232 and processor 233.Heart fortune Row detection circuit 231 is configured as detecting cardiac mechanical event from the signal that mechanics sensing module 210 receives.Mechanics sensing Module 210 includes mechanics sensor 213, can be piezo-electric crystal or MEMS device, when cardiac muscle cells move, is produced Raw and mechanics sensor 213(and pacemaker 200) the relevant electric signal of movement.
Heart operation detecting circuit 231 can receive electrocardiosignal and/or number EGM signal from electrocardio sensing module 250, It is compared with the cardiac mechanical event for being detected with mechanics sensing module 210, increases pacemaker 200 to cardiac motion state The accuracy rate of judgement.Obtained heart operation information is passed to processor 233 by heart operation detecting circuit 231, is transported to heart Market condition is judged, and is made whether to send the instruction of pacemaker impulse.
Herein due to the function of pacemaker 200 can be embodied as one or more processors, controller, hardware, consolidate Part, software or any combination thereof.Different features is portrayed as have the function of circuit be intended to protrude it is different aspect and it is different Surely imply that this function must be realized by individual hardware, firmware or software component or any certain architectures.
After pacing module 220 receives the instruction for the granting pacemaker impulse that processing module 230 assigns, the pacemaker impulse via Electrode 211 and 212 is delivered to the pacing site of patient's heart.Pacing module may include charging circuit 221,222 and of switch Output circuit 223.Charging circuit 221 includes capacitor original part.The circuit after being connected to pace-making instruction of switch 222 becomes access.It is defeated Pulse is transported to electrode 211 and 212 by circuit 223 out.
Memory 260 may include program control device 400 readable instruction and electrocardio sensing module 250 and mechanics sensing The data for the heart dependent event that module 210 acquires.
Power supply module 270 provides electric power to other circuit units of pacemaker 200 as needed.Power supply module 270 can be held The power supply instruction that row processing module 230 is assigned.Power supply module may include one or more energy storage devices, such as one or more A rechargeable battery or non-rechargeable battery.
The operation conditions of pacemaker 200 can be transferred to vitro program controlled device by communication module 240.The finger of vitro program controlled device Enabling can also be transmitted by communication module 240 as in pacemaker 200.
Fig. 4 is the schematic diagram according to an exemplary heart operation detecting circuit 231.In this example, electrocardio perceives mould The cardiac mechanics operation information that block 250, mechanics sensing module 210 were collected is transferred to heart operation detecting circuit 231, heart fortune According to pacemaker intrinsic information, (intrinsic information can be doctor according to conditions of patients, pacemaker installation position to row detection circuit 231 Set the intrinsic program of the pacemaker being configured), heart operating condition is judged, and be made whether to provide sentencing for pacemaker impulse It is disconnected.
Fig. 5 is exemplary for delivering the flow chart of atrial triggered ventricular pacing method by pacemaker 200 according to one.Pass through power Learn sensor obtain cardiac myocytes reverse force signal, acquisition cardiac muscle torsion force signal after by with heart chamber mechanical event Standard value compares, in conjunction with the motion state for the electrocardiosignal mutual authentication heart that electrocardio sensing module receives, with judgement Whether the characteristic event of heart operation is detected.If mechanics sensing module does not sense the atrial event of heart, heart may be located In some pacing interval, therefore, it is necessary to be constantly in detection pattern;When receiving atrial event, paced according to the AV of setting Interphase illustrates that atrioventricular block, heart normal operation do not occur for heart if electrocardio sensing module can perceive R wave;If electrocardio Sensing module does not perceive R wave, then illustrates that atrioventricular block occurs for heart, pacemaker is needed to carry out the granting of pacemaker impulse.
Fig. 6 be according to an example description different implantation positions pacemaker myocardium power and heart in electrocardiosignal and The contrast schematic diagram of heart operating status.As shown, the myocardium of ventricle power tested of intraventricular pacing device and corresponding ventricle Volume and electrocardiosignal are corresponding, the myocardium of atrium power that intra-atrial pacing device detects and corresponding atrial volume and electrocardiosignal Corresponding, with this, pacemaker can be made under mutually without communication and glitch-free situation to heart operating status in heart Judgement.
The disclosure is provided with reference to illustrative embodiments, and the disclosure is not intended to and is explained with the meaning of limitation. It, can be with as it was earlier mentioned, those skilled in the art will recognize that in addition to the particular example for being described herein and imagining Various forms shows the disclosure.

Claims (12)

1. a kind of perception pacing method of multi-chamber without conducting wire pacemaker system, is configured as:
One or more for be implanted in heart without conducting wire pacemaker, the no conducting wire pacemaker be configured to perception heart Intrinsic cardiac cycle, and pacemaker impulse is sent to place chamber in the specific time;
Further, the no conducting wire pacemaker includes mechanics sensing module, electrocardio sensing module, processing module, communication module, Pacing module, power supply module, memory;And pacemaker can be controlled by external program control device.
2. no conducting wire pacemaker system according to claim 1, wherein mechanics sensing module includes mechanics sensor, can be felt The related myocardiums cell twisting resistance such as intimate dirty mycardial contractility, Diastolic Force.
3. no conducting wire pacemaker system according to claim 2, wherein mechanics sensor can be configured to piezoelectric material, pressure Sensing element etc..
4. no conducting wire pacemaker system according to claim 1, wherein electrocardio sensing module is configured as through pace-making electricity Electrocardiosignal extremely to sense locating chamber.
5. no conducting wire pacemaker system according to claim 1, wherein processing module is configured as can receive the mechanics Cardiac muscle cell's twisting resistance of sensor perception;
The cardiac muscle cell's twisting resistance that can be configured to perceive from the mechanics sensor detects the machinery of be implanted into chamber Event;
Processing module passes through the chamber mechanical event detected compared with standard mechanical event, confirms the mechanical thing of the chamber Part.
6. no conducting wire pacemaker system according to claim 1, wherein processing module is configured as can receive the electrocardio The electrocardiosignal for the chamber that sensing module senses;
Processing module compares the chamber electrocardiosignal with standard cardioelectric signal, confirms the electric event of the chamber.
7. according to claim 1 without conducting wire pacemaker system described in -6, it is characterised in that processing module can be further configured For the signal rule for analyzing the chamber electricity event and mechanical event, heart working state is judged, to determine that the work of pacemaker refers to It enables.
8. according to claim 1 without conducting wire pacemaker system described in -7, which is characterized in that the pacemaker between different chamber, It can judge the working condition of entire heart by itself perception to cardiac mechanical event and cardiac electrical event, be established not with this With the working relation between sensor;
Further, the pacemaker of different chamber can be contacted by communication module and the foundation of vitro program controlled device, can be by looking into It sees program control device, understands heart of patient working condition, doctor can also reset the work of the pacemaker in patient body by program control device Make parameter.
9. the pacemaker further comprises according to claim 1 without conducting wire pacemaker system described in -8:
Shell at least encapsulates the processing module, communication module, power supply module, and pacing module, electrocardio sense in the shell Module is surveyed to be attached on shell;
Fixing piece, the fixing piece are coupled on shell, for pacemaker to be anchored on implant site;The mechanics sensor It is embedded on fixing piece, is located at fixing piece and is inserted into cardia, convenient for being bonded with cardiac muscle cell;
The mechanics sensor can be one or more.
10. no conducting wire pacemaker system according to claim 9, the mechanics sensor can sense cardiac muscle cell's fortune The twisting resistance of all directions in dynamic.
11. according to claim 1 without conducting wire pacemaker system described in -10, which is characterized in that the pacing module provides pulse It is realized with electrocardio sensing module sensing electrocardiosignal by electrode, electrode can be one or more.
12. wherein pacemaker independent can be placed on the heart according to claim 1 without conducting wire pacemaker system described in -11 In dirty any required chamber, one or more pacemakers can be placed in heart, can work independently between pacemaker and not do mutually It disturbs or communicates, pacemaker passes through the cardiac event perceived and judges cardiomotility.
CN201910254542.4A 2019-03-31 2019-03-31 A kind of perception pacing method of the multi-chamber without conducting wire pacemaker system Pending CN109966643A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115197903A (en) * 2022-07-19 2022-10-18 北京智源人工智能研究院 Cardiac biological pacemaker, calculation model construction method, simulation method and device
CN117339108A (en) * 2023-12-04 2024-01-05 山东瑞安泰医疗技术有限公司 Leadless cardiac pacemaker system capable of reducing pacing threshold and accurately positioning

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115197903A (en) * 2022-07-19 2022-10-18 北京智源人工智能研究院 Cardiac biological pacemaker, calculation model construction method, simulation method and device
CN115197903B (en) * 2022-07-19 2023-11-14 北京智源人工智能研究院 Cardiac biological pacemaker, calculation model construction method, simulation method and device
CN117339108A (en) * 2023-12-04 2024-01-05 山东瑞安泰医疗技术有限公司 Leadless cardiac pacemaker system capable of reducing pacing threshold and accurately positioning
CN117339108B (en) * 2023-12-04 2024-02-13 山东瑞安泰医疗技术有限公司 Leadless cardiac pacemaker system capable of reducing pacing threshold

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