CN105148403B

CN105148403B - One kind being based on itself Atrioventricular Conduction following cardiac resynchronization therapy system

Info

Publication number: CN105148403B
Application number: CN201510489207.4A
Authority: CN
Inventors: 吴强; 俞杉; 范寿年; 蒋晨曦
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-08-11
Filing date: 2015-08-11
Publication date: 2018-08-17
Anticipated expiration: 2035-08-11
Also published as: CN105148403A

Abstract

The present invention relates to a kind of following cardiac resynchronization therapy methods based on itself Atrioventricular Conduction, contain following steps：Right room endocardial electrode and left room epicardial electrode are implanted into the patient of CRT indications；Electrode is connect with impulse generator；The intelligent pulse generator parameters of setting；Execute the scanning search program of acquisition heart real time signal and the pace-making order of left room；Time one-point measurement is carried out to the resource of scanning search by impulse generator and logical algorithm is analyzed, to find the phase between the AS/AP VP that the most narrow QRS time limits occur；And with the phase between this AS/AP VP, timing property CRT is executed by impulse generator.After the above process, impulse generator returns to ecg signal acquiring and pace-making scanning search, finds the phase between the AS/AP VP that the most narrow QRS time limits occur again；And timing property CRT is executed with the phase between this AS/AP VP；Such repetitive cycling.The present invention is high with intelligence degree, widely used, easy to operate and use cost is low.

Description

One kind being based on itself Atrioventricular Conduction following cardiac resynchronization therapy system

Technical field

The present invention relates to a kind of cardiac pacing therapy heart failure (CHF) scope of medicine and hygiene fields more particularly to one Following cardiac resynchronization therapy (CRT) method of kind based on itself Atrioventricular Conduction.

Background technology

CHF is one of pernicious home to return to of all angiocardiopathies.Although as etiological treatment and Angiotensin-Converting The drug therapies such as inhibitor, beta-blocker are constantly progressive, the hospital mortality of CHF patient and admission rate is dropped again It is low, but the incidence of CHF is still high, seriously affects life quality and the prognosis of cardiovascular patient.1994, method State doctor Cazeau etc. is reported first implements four to 1 male's CHF patient with complete left bundle branch block (LBBB) Chamber (diplocardia room, biventricular) pacing therapy, hence it is evident that improve its clinical symptoms, opened from this for the new treatment of CRT this CHF Prelude.Clinical research finds that the about QRS time limits of 1/3CHF patient are more than 120ms, are common in LBBB.The CHF patient of companion LBBB Left ventricle (LV) excitement is obviously later than right ventricle (RV), and LV internal membrane of heart excitements betide after interventricular septum from right to left excitement, Interventricular septum can not support LV to penetrate blood, and LV loses the spherical contractile function of coordination；After exciting site is typically LV side walls, side the latest Wall is being shunk late period, and LV sidewall shrinks, intraventricular pressure rises rapidly, and interventricular septum is protruded to the right by pressure influence, generates contradiction fortune It is dynamic, and then to penetrating blood before reducing；The LV inner region mechanical delays caused with indoor electric conduction delay between room, cause functional Mitral reflux, LV contractile functions reduce.CRT restores the synchronism of interventricular septum and LV sidewall shrinks by pacing biventricular, carries High LV mechanical functions increase the diastolic filling time, paradoxical movement and the mitral regurgitation of interventricular septum are reduced, to reduce CHF The death rate of patient, readmission are led, and improve patient symptom and quality of life.MIRALE、CARE-HF、COMPANION、PATH- Study of evidence based medicine crucial CHF and MUSTIC-SR etc. several specifies that CRT improves the work of CHF patient symptoms of heart failure and prognosis With, on this basis, American Society of Cardiology/American Heart Association, European Society of Cardiology, Chinese Medical Association's cardiovascular disease point Meeting/cardiac electrophysiology has been recommended CRT as the I class idicatios for the treatment of CHF patient with pace-making branch.Now with CRT In clinical extensive use, for CRT impulse generators and the performance design of pacing electrode wire, implantation auxiliary tool and related Technology is just experiencing unprecedented fast development, becomes the clinical therapeutics of CHF, the research heat in medical bioengineering field Point.

Currently, CRT uses atrium dextrum (RA) and left and right double-ventricle pacemaker pattern substantially in clinical practice, by being arranged Phase (phase between LV-RV/RV-LV), perceptual performance, pace-making between fighting between the individuation atrioventricular interval (A-V Interval) of impulse generator, room The parameters such as performance, rate response, perception response, pace/sense polarity strive that realization ECG-QRS Wave is most narrow, and Atrioventricular sequence is most It is good, echocardiogram ventricular synchronous index (E-A, VTI, MR, LVEDD, LVEF, IVMD and SPWMD etc.) optimal, patient symptom Most light and complication is minimum, to reach the therapeutic purposes for improving CHF patient symptom and prognosis.Although CRT is to lock-out The treatment of CHF patient achieves the achievement to attract people's attention, but part CHF patient reactionless perplexs to CRT low reactions or even still Patients and clinicians.Clinical studies show at present, the preoperative QRS wave of idicatio patient is wider, after implantation CRT when QRS wave Limit is narrower, and patient is higher to the reactivity of CRT；And Candidacy selection it is improper (as implantation opportunity too late), LV electrodes positioning it is bad Or the factors such as dislocation, the non-dynamic optimization of CRT parameters, drug therapy and the improper, complication of psychological intervention lead to nearly one third CHF patient is reactionless to CRT treatments, wherein the influence factor to make number one is exactly inappropriate A-V Interval.In order to obtain 100% double-ventricle pacemaker generally requires that shorter A-V Interval is arranged, but when too short A-V Interval can shorten ventricular diastole Between, lead to ventricle premature contraction, two/premature tricuspid closure, not only reduce cardiac output, impairs atrium " auxiliary pump " Function.Independent LV pace-makings can extend the right ventricular filling time, increase pulmonary artery flow, reduce venous system extravasated blood, increase indirectly Patient's oxygen content of blood and left heart blood back reduce atrioventricular valve and backflow, and delay even to reverse chamber enlargement.Due to most CHF Patient is sinus rhythm, function of atrial-ventricular node Non Apparent Abnormality, and the risk at a specified future date that atrioventricular block occurs is relatively low, therefore simple LV Pace-making rather than double-ventricle pacemaker, if the interest that ventricular synchronous causes educational circles may be restored.

EATER-EARTH registration studies and the smaller non-pessimum clinical research of some sample sizes are found, for (the left rooms LVEF Ejection fraction)≤35%, merge the patient of LBBB (QRS width >=130ms), it is single by follow-up observation in 6~12 months by a definite date Pure LV pace-makings are close to the improvement degree and double-ventricle pacemaker of the indexs such as patient clinical situation, exercise tolerance, LV internal diameters and function. Meta-analysis has also further affirmed that simple LV pace-makings merge the diastolic dysfunction of ventricle mechanical movement lock-out in treatment Status.

Based on above-mentioned theory, we are directed to the normal LBBB patient of function of atrial-ventricular node, design unique impulse generator, In the case of only implementing LV pace-makings merely, A-V Interval is arranged by automatic dynamic, so that the conduction of its own atrioventricular node is participated in ventricle and swashs It is dynamic, most narrow QRS is triggered to realize CRT curative effects.

Invention content

In view of the shortcomings of the prior art, the present invention provide with the high and low power consumption of intelligence degree, it is widely used, One kind easy to operate and low use cost is based on itself Atrioventricular Conduction following cardiac resynchronization therapy system.

To achieve the goals above, the present invention is to realize by following technical solution：One kind being based on itself Atrioventricular Conduction Following cardiac resynchronization therapy system, which is characterized in that include the following steps：

Right room endocardial pacing electricity is implanted into the patient of the following cardiac resynchronization therapy indication based on itself Atrioventricular Conduction Pole and left room epicardial electrode；

By the mouth connection corresponding with impulse generator respectively of right room endocardial lead and left room epicardial electrode；

By connecting program control instrument, impulse generator initial parameter is set；

Impulse generator acquires heart real time signal, and independently execute pace-making scanning by being reliably connected with pacing electrode Search measures；

The data that acquisition obtains is measured to executing pace-making scanning search by impulse generator, carries out time one-point measurement meter It calculates；

Module logic Algorithm Analysis is carried out to survey calculation result by impulse generator, when most narrow QRS occurring to find Phase between the AS/AP-VP of limit, and with the phase between this AS/AP-VP, timing property CRT is executed by impulse generator, it is based on itself to realize Left and right ventricles harmony diastole under Atrioventricular Conduction state and contraction；Impulse generator returns again after executing the secondary timing CRT To ecg signal acquiring and pace-making scanning search program, and by module logic Algorithm Analysis, find hair during scanning search Phase between the AS/AP-VP in raw most narrow QRS time limits；And timing property CRT is executed with the phase between new AS/AP-VP again, so recycle.

Further：The impulse generator is acquired, detected and deposited to the electrocardiosignal by pacing electrode Storage starts simultaneously at execution pace-making scanning search and measures phase program between AS/AP-VS；The scanning search of phase, arteries and veins between AS/AP-VS Generator is rushed by initial setting up, determines its positive or negative sense scan mode；Dynamic AS/AP-VP scanning room phase ranges, which are arranged, is 70~300ms, step value are ± 5ms or ± 10ms or ± 15ms or ± 20ms.

Further：Between the dynamic AS/AP-VP in the scanning of phase negativity and positivity scanning process, automatic measurement is needed It is sought each time by the phase between scanning search AS/AP-VS by QRS (VP) the wave time limit of phase between the dynamic AS/AP-VP of change step Look for the phase between the AS/AP-VP for triggering the most narrow QRS time limits.

Further：Between the AS/AP-VP for triggering the most narrow QRS time limits after the phase, impulse generator working procedure is turned to this Phase between AS/AP-VP, by impulse generator to patient execute initial setting up fix pace-making the time be：With 6,12,24,36,48, 60,72 hours 7 grades of alternative time sets carry out being based on itself Atrioventricular Conduction cardiac resynchronization pacing therapy for refractory heart failure, in CRT After the timing pace-making time, impulse generator executes dynamic AS/AP-VP pace-making scanning search programs again, finds and touches again Phase between the AS/AP-VP in hair most narrow QRS time limits, and with the phase between this AS/AP-VP, fix CRT by initial setting up and pace the time, execute Itself Atrioventricular Conduction following cardiac resynchronization therapy so recycles, until patient carries out the follow-up of CRT pacemakers to hospital and changes arteries and veins Rush generator initial setting up.

Further：In the time-histories that above-mentioned CRT treats pace-making LV, the phase is lasting between impulse generator detects AS-AS Change absolute value >=200ms of 10 minutes more last scanning radixes, auto-steering are executed with AS/AP-VP as 70-300ms models Enclose it is negative sweep or just sweep, the phase between the AS/AP-VP to re-search for the most narrow QRS time limits, with establish the new set time (6,12, 24,36,48,60,72 hours it is available) CRT pacing therapy processes, such repetitive cycling.

Further：The pace-making operating mode provides AAI/AAIR, VVI/VVIR, VAT and DDD/DDDR by program Module, after intracavitary electrocardiosignal inputs computer A/D, two-way monopole or bipolar analog electrocardiogram signal are rapidly converted into digital letter Number, and bulk intelligent processing is carried out to the signal, including signal display pretreatment and external program control instrument communication process, monopole And/or signal identification and time phase processing in the bipolar chambers of the heart, selectivity is bipolar or unipolar signal originates and terminates identification, time Measurement processing etc., is the formation base of logical algorithm of the present invention, and impulse generator is according to the parameter and pace-making work of initial setting up Operation mode is converted, and is measured by pacing to scan and search for, the time limit of atrium and ventricle excitement is calculated, when to atrium and ventricle waveform Between phase difference be identified, finally the phase between the AS/AP-VP most narrow QRS time limits occur, execute CRT pacing therapy functions.

Further：Processor logical algorithm implements at digital module the electrocardiosignal for having been subjected to A/D conversions Reason, including:4 grades of digital bandpass filterings, 50/60Hz numbers fall into filtering, electrocardiosignal automatic growth control, real-time wave mode initially/ Greatest gradient variation in end calculates and pinpoints timing, automatic baseline correction eventually.

Further：The impulse generator includes ecg amplifier and two-way impulse generator in the two-way chambers of the heart, described Two-way intracavitary ecg amplifier using intracavitary monopolar regime signal acquisition when, intend linking pacing electrode catheter remote electrode and Circuit is constituted with the metal layer of impulse generator, two electrodes of the pacing electrode catheter generate intracavitary two pole analysis signal Source, the boost pulse form of formation have positive, negative sense with it is two-way optional, default configuration is negative sense.

Further：Ecg amplifier includes that two-way amplifies with bipolar/monopole intracavitary electrocardiosignal in the two-way chambers of the heart Device, two-way ecg signal amplifier gain fix in 50-100 times of biological amplifier, 50/60Hz trap circuits, 4 grades of Ingeborg Bachmanns Bandpass filter, frequency bandwidth 5-200Hz；Unipolar electrogram hardware module gain also fixes at 50-100 times, 4 grades of Ingeborg Bachmanns Bandpass filter, frequency 5-200Hz.

Further：The pulse width 0.1-1.0ms, stepping ± 0.1ms, 10 grades optional, boost pulse voltage range 1-10V, stepping ± 1.0V, 10 grades available.

Compared to the prior art, it is of the invention based on itself Atrioventricular Conduction following cardiac resynchronization therapy method have it is following excellent Point：The following cardiac resynchronization therapy method and impulse generator based on itself Atrioventricular Conduction are arranged and rise according to initial parameter Pattern of fighting implements automatic conversion；It is independent that atrium, ventricle and the atrioventricular conduction time of entirely searching for measurement period are identified, surveyed Amount, analysis and judgement；Impulse generator is program-controlled individually by the stepping of its logical algorithm, and the most narrow QRS time limits occurs in automatic search AS/AP-VP between the phase, and timing CRT treatment is executed with the phase between this AS/AP-VP, utilizes itself Atrioventricular Conduction in room to greatest extent Property fusion wave formed in participation, there are the high and low power consumption of intelligence degree, the spies such as widely used, easy to operate, use cost is low Point.

Description of the drawings

The following describes the present invention in detail with reference to the accompanying drawings and specific embodiments；

Fig. 1 is the impulse generator pacemaker hardware basic structure schematic diagram of the present invention.

Fig. 2 is that the impulse generator of the present invention searches for AS/AP-VP software logic figures automatically based on itself Atrioventricular Conduction.

Fig. 3 is the automatic searching and detecting program of impulse generator and CRT pacing therapy work flow diagrams of the present invention.

Fig. 4 searches for AS-VP schematic diagrames automatically for the present invention's based on itself Atrioventricular Conduction.

Specific implementation mode

To make the technical means, the creative features, the aims and the efficiencies achieved by the present invention be easy to understand, with reference to Specific implementation mode, the present invention is further explained.

As shown in Figures 1 to 4, it illustrates one kind of the present invention being based on itself Atrioventricular Conduction following cardiac resynchronization therapy system System, includes the following steps：Impulse generator is set；To the trouble of the following cardiac resynchronization therapy indication based on itself Atrioventricular Conduction Person is implanted into RA endocardial leads and LV epicardial electrodes；Connection impulse generator is detected and sweeps to electrocardiosignal Search is retouched to measure；Time one-point measurement calculating and analysis are carried out by impulse generator；Pace-making work(is carried out by impulse generator It can module logic algorithm；The programmable following cardiac resynchronization therapy based on itself Atrioventricular Conduction is established by impulse generator to rise It fights program；It realizes and is synchronized based on the biventricular under itself Atrioventricular Conduction state.

One kind being based on itself Atrioventricular Conduction following cardiac resynchronization therapy system, which is characterized in that including as follows

Step：

By the mouth connection corresponding with impulse generator of above-mentioned pacing electrode；

By external related program control instrument, impulse generator initial parameter is set；

Impulse generator acquires heart real time signal by pacing electrode, and executes pace-making scanning search and measure；

The data that acquisition obtains is measured to executing pace-making scanning search by impulse generator, and carries out time fixed point in real time Survey calculation；

Modularization logical algorithm analysis is carried out to survey calculation result by impulse generator, most narrow QRS occurs to find Phase between the AS/AP-VP in time limit, and with the phase between this AS/AP-VP, timing property CRT is executed by impulse generator, to realize based on certainly Left and right ventricles harmony diastole under body Atrioventricular Conduction state and contraction；Impulse generator is after executing the secondary timing CRT, again Ecg signal acquiring and pace-making scanning search program are returned to, and by module logic Algorithm Analysis, finds scanning search again The phase between the AS/AP-VP in most narrow QRS time limits occurs in journey；And timing property CRT is executed with the phase between new AS/AP-VP again.

Impulse generator is acquired, detected and stored to the electrocardiosignal by pacing electrode, starts simultaneously at execution Pace-making scanning search simultaneously measures phase program between AS/AP-VS.The scanning search of phase between AS/AP-VS, impulse generator is by initial Setting determines its positive or negative sense scan mode；The present invention be arranged dynamic AS/AP-VP scanning room phase ranges be 70~ 300ms, i.e. dynamic AS/AP-VP scanning rooms phase minimum value are 70ms, and dynamic AS/AP-VP scanning room phase maximum values are 300ms；Step It is into value：± 5ms, ± 10ms, ± 15ms and ± 20ms.

Between the dynamic AS/AP-VP phase negativity scanning or positivity scanning process in, need automatic measurement each time by step Into QRS (VP) the wave time limit of phase between the dynamic AS/AP-VP of change, it is therefore an objective to by the phase between scanning search AS/AP-VS, find and touch Phase between the AS/AP-VP in hair most narrow QRS time limits.

Between the AS/AP-VP for clearly triggering the most narrow QRS time limits after the phase, impulse generator working procedure is turned to this AS/ Phase between AP-VP, by impulse generator to patient execute initial setting up fix pace-making the time be：With 6,12,24,36,48,60, 72 hours 7 grades of alternative time sets carry out being based on itself Atrioventricular Conduction cardiac resynchronization pacing therapy for refractory heart failure.It is fixed in CRT When the pace-making time after, impulse generator executes dynamic AS/AP-VP pace-making scanning search program again, finds triggering again Phase between the AS/AP-VP in most narrow QRS time limits, and with the phase between this AS/AP-VP, fix CRT by initial setting up and pace the time, execute certainly Body Atrioventricular Conduction following cardiac resynchronization therapy.So cycle, until patient carries out the follow-up of CRT pacemakers to hospital and changes pulse Generator initial setting up.

In view of receiving CRT treatment patients arrhythmia cordis is likely to occur in executing CRT pace-makings, the factors such as heart murmur, There is frequency adaptivity scan pattern to work as impulse generator that is, in the time-histories that above-mentioned CRT treats pace-making LV for present invention design Detect that phase between AS-AS continues change absolute value >=200ms of 10 minutes more last scanning radixes, auto-steering execute with AS/AP-VP is that the negative of 70-300ms ranges sweeps or just sweep, the phase between the AS/AP-VP to re-search for the most narrow QRS time limits, to establish The CRT pacing therapy processes ... of new set time (6,12,24,36,48,60,72 hours available) so repeat to follow Ring.

It paces operating mode and provides AAI/AAIR, VVI/VVIR, VAT and DDD/DDDR submodule by impulse generator program Block.After intracavitary electrocardiosignal inputs computer A/D, two-way monopole or bipolar analog electrocardiogram signal are rapidly converted into digital signal, And bulk intelligent processing is carried out to the signal, comprising signal display pretreatment and outside program control instrument communication process, monopole and/ Or signal identification and time phase processing in the bipolar chambers of the heart, selectivity is bipolar or unipolar signal starting is surveyed with termination identification, time Amount processing etc., is the formation base of logical algorithm of the present invention.Impulse generator is according to the parameter of initial setting up and pace-making Working mould Formula is converted, and is measured by pacing to scan and search for, the time limit of atrium and ventricle excitement is calculated, to atrium and ventricle waveform time phase Potential difference is identified, and finally the phase between the AS/AP-VP the most narrow QRS time limits occur, executes CRT pacing therapy functions.

CRT relevant devices, i.e. impulse generator, hardware include ecg amplifier and two-way pulse generation in the two-way chambers of the heart Device, two-way intracavitary ecg amplifier intend the distal end electricity of linking pacing electrode catheter when using intracavitary monopolar regime signal acquisition Pole and with the metal layer of impulse generator constitute circuit；The two-way intracavitary ecg amplifier is using the bipolar status signal of intracavitary When acquisition, two electrodes for intending linking pacing electrode catheter constitute circuit.The boost pulse form of the two-way pulse follower With positive, negative sense with it is two-way optional, default configuration is negative sense.In the two-way chambers of the heart ecg amplifier include two-way with it is bipolar/mono- Pole intracavitary ecg signal amplifier, two-way ecg signal amplifier gain fix in 50-100 times of biological amplifier, 50/60Hz Trap circuit, 4 grades of Ingeborg Bachmann bandpass filters, frequency bandwidth 5-200Hz；Unipolar electrogram hardware module gain, also fixes 50-100 times, 4 grades of Ingeborg Bachmann bandpass filters, frequency 5-200Hz.Pulse width 0.1-1.0ms, stepping ± 0.1ms, 10 grades Optional, boost pulse voltage range 1-10V, stepping ± 1.0V, 10 grades available.Processor software inside impulse generator Logical algorithm implements digital module processing to the electrocardiosignal converted by A/D, including:4 grades of digital band pass filters Wave, 50/60Hz numbers fall into filtering, electrocardiosignal automatic growth control, real-time waveform it is initial/eventually last greatest gradient variation calculating and Pinpoint timing, automatic baseline correction.

The present invention is by sending out following cardiac resynchronization therapy (CRT) pulse based on itself Atrioventricular Conduction voluntarily researched and developed Pacing mode, logical algorithm, chambers of the heart heart electric signal measurement and the digitlization real-time synchronization of raw device (hereafter instead of with CRT-GZ1) It calculates and the foundation of clinical method, the foundation for having studied complete set is new under CHF patient itself Atrioventricular Conduction state Type CRT technologies.

1. the implantation of pacing electrode catheter and CRT-GZ1 impulse generators and operation principle summary

CRT generate optimal blood dynamics not only rely on LV electrodes placement position, also with most suitable A-V Interval, The phase is closely related between LV-RV/RV-LV.The present invention designs a kind of novel CRT scheme based on itself Atrioventricular Conduction：First, facing The I class eligible patients being implanted on bed to meeting CRT, using the method for the RA electrodes and LV electrodes for being conventionally implanted into CRT, part fiber crops It is liquor-saturated lower through subclavian vein approach, RA endocardial leads conduit and LV epicardial electrode conduits are only implanted into (through coronal Venous sinus, which drives in the wrong direction, is placed in coronary vein category branch)；Secondly, after the parameter testing for completing pacing electrode catheter, respectively by RA electrodes Connect with LV electrodes and atrium and ventricle input/outlet of the CRT-GZ1 with Atrioventricular sequence dual chamber pacing (DDD/DDDR) function It connects, it is subcutaneous that electrode with impulse generator is embedded in upper breast；Atrial sense (AS)-ventricular senses of the CRT-GZ1 to patient (VS), four kinds of A-V Intervals such as auricular pacemaking (AP)-VS, AP- ventricular pacemakings (VP), AS-VP and its corresponding intracavitary QRS time limits It carries out automatic search to measure, and the phase between the AS/AP-VP for triggering the most narrow QRS time limits is set automatically, paced with double pole mode. It is emphasized that CRT pattern of the system of the present invention based on patient itself Atrioventricular Conduction, i.e., by being searched automatically to AS/AP-VS Rope measures, and then the phase between the AS/AP-VP of impulse generator is arranged automatically, to execute CRT treatments.Therefore, CRT-GZ1 is not generally Do not have definite 1 suitable for II~III ° of atrioventricular block, auricular flutter, auricular fibrillation etc.:The arrhythmia cordis of 1 atrioventricular relationship Patient.

The physical facility of 2.CRT-GZ1

(1) hardware of CRT-GZ1 includes：

1. the electrically amplified module of two-way chambers of the heart heart：Relate generally to two-way, bipolar/monopole intracavitary ecg signal amplifier.It is double Road intracavitary ecg amplifier, i.e. RA electric signals and LV electric signals all have monopole or amplification mode may be selected in bipolar acquisition.Make When with intracavitary monopolar regime signal acquisition, intend the remote electrode of linking pacing electrode catheter, and constitute with the metal layer of CRT-GZ1 Circuit.Intracavitary two pole analysis signal source is then derived from two electrodes of pacing electrode catheter completely.Its hardware module includes：Gain is fixed Biological amplifier of the lattice at 50-100 times；50/60Hz trap circuits；4 grades of Ingeborg Bachmann bandpass filters, frequency bandwidth 5- 200Hz.Intracavitary Unipolar electrogram hardware module gain also fixes at 50-100 times, 4 grades of Ingeborg Bachmann bandpass filters, frequency 5- 200Hz.Signal is after hardware handles in the chambers of the heart, into A/D conversion process at digital signal, by the programmed logic of cpu controller Algorithm carries out the signal processing such as digital signal amplitude, filtering, trap, phase calculation, the analysis of X-axis waveform inflection point slope again, The required data of CRT pacing functions are executed to provide.

2. two-way impulse generator：The boost pulse form of the present invention has forward direction/negative sense/two-way optional, default configuration Negative sense.Pulse width 0.1-1.0ms, stepping ± 0.1ms, 10 grades optional.Boost pulse voltage range 1-10V, stepping ± 1.0V, 10 grades optional.Setting is selected between basic boost pulse TS1S1=2000-400ms (30-150PPM).

(2) in the chambers of the heart ecg signal acquiring special technique

Whether the reliability for identifying and measuring to RA and LV intracavitary electrograms is to be related to entire CRT to treat successfully most One of big influence factor.Traditional cardiac electrophysiology system is all based on signal in the chambers of the heart to the processing method of electrocardiosignal in the chambers of the heart Relatively high, the unordered higher hamonic wave of the main component of frequency spectrum, i.e. frequency, therefore common cardiac electrophysiology equipment is to electric in the chambers of the heart Relating to for signal takes, and mainly amplifies its high end frequency signal source, and the figure of acquisition is usually to provide qualitative point of clinical cardiac electrophysiology Analysis and manual measurement time use.Acquisition of traditional implanted pacemaker to atrium in the chambers of the heart or ventricular cardiac signal, does not also relate to And the time shaft of signal source is measured and calculated, mostly it is that signal in the collected chambers of the heart is passed through into comparative degree circuit, is converted into Transistor-Transistor Logic level is transmitted to CPU control centres, is used as calculating heart rate and perceiving.

The impulse generator CRT-GZ1 of the present invention is designed on DDD/DDDR pacing pulse generator platforms, is risen Workflow of fighting provides AAI/AAIR, VVI/VVIR, VVT, VAT and DDD/DDDR Pattern completion by program software.The present invention's One of feature is processing of the CRT-GZ1 to electrocardiosignal in the chambers of the heart, i.e. the specific identification and measuring technique of RA and LV electrographs.This hair It is bright to propose, to electric signal in the chambers of the heart, the i.e. acquisition of AS, AP, VS or VP, to focus on the low middle-end frequency range of its signal source first, I.e. in 5-100HZ bandwidth, it is therefore an objective to be easy to implement more accurate simulation to the starting point of AS, AP, VS or VP excitement and end of the final point Change and digitized processing.By hardware circuit and software programming, the multiple unordered higher hamonic wave of electric signal in the chambers of the heart is filtered out, is retained Firmly AS, AP, VS or VP starting point and the end of the final point clearly low middle-end frequency content of signal source relatively, in order to which logical algorithm is easy It by the inflection point slope variation of waveform, calculated, analyzed and is judged, the AS/AP for more accurately measuring X-axis time arrow is initial Point and VS/VP initial points and destination node.After taking care intracavitary analog signal input computer A/D, software is by two-way monopole or bipolar Analog electrocardiogram signal is rapidly converted into digital signal, and carries out batch intelligent processing to the signal, including digital band pass filtering, 50/60Hz numbers fall into filtering, the automatic zoom gain of electrocardiosignal controls, initial/whole last slope variation of real-time wave mode calculates With fixed point timing, automatic baseline correction；Signal shows pretreatment and related program control instrument communication process etc..Wherein monopole or bipolar Signal identification and time phase processing in the chambers of the heart, selectivity is bipolar or unipolar signal originates and terminates identification, time measurement processing It is the important foundation of logical algorithm of the present invention.Monopole amplification mode or double is used in addition, handling RA and LV intracavitary electrical picture signals Pole amplification mode, selection and combination are voluntarily arranged by clinician, and initial default state is double pole mode.

Phase scanning, the setting of pacing mode and parameter between 3.CRT-GZ1

The present invention carries the normal CHF patient of itself Atrioventricular Conduction on the platform of DDD/DDDR pacing pulse generators Novel CRT scheme is gone out：Measurement method is searched for automatically in relation to phase between AS/AP-VS and QRS time limits to establish；Related AS/AP-VP Between the phase interrelated logic algorithm and automatic setting.

Under the premise of CRT-GZ1 and relevant RA electrodes and LV electrodes are reliably connected, coordinate by CRT-GZ1 and with it Program control instrument communication, pacemaker working condition and pacing parameter are set.According to the real-time performance of patient's rhythm of the heart, heart rate, it is arranged It fights parameter, including basic pacing frequency, impulse stimulation intensity (1.5-2.5 times that is higher than pacing threshold), pulse width (default value 0.2ms, 0.1-1.0ms may be selected), perceptual sensitivity (default value atrium is 0.1-1.0mv, ventricle 0.5-5.0mv) etc..Base The phase between AP/AS-VS/VP maximum scans, and the QRS time limits closely related therewith determination, be realize CRT-GZ1 execute Therefore the basis of CRT before search automatically measures and CRT pace-making work does not start, sets and judges AP/AS-VS/VP maximums The scanning room phase is the critically important work of CRT-GZ1.The scanning screening of our phases between the AS/AP-VP of CRT treatments is divided into fixed negative To automatically scanning and fixed positive automatically scanning two types, set according to patient's states by clinician.No matter negative sweep or just It sweeps, automatic search sweep range is fixed at the Inner of 70-300ms, i.e., negative to sweep since 300ms, is swept to by stepping is negative 70ms；Just sweeping by 70ms, 300ms is just swept to by stepping.Scanning stepping is divided into 4 grades：5,10,15,20ms, sets itself. It is emphasized that ensure the synchronism of atrioventricular excitation sequence, we are to the negative minimums for sweeping state pace-making of design CRT-GZ1 The phase is not less than 70ms between AP/AS-VP, and the phase is not higher than 300ms between just sweeping the maximum AP/AS-VP of state pace-making.Automatic search measures Content include following components.

(1) phase and the QRS time limits of VS/VP measure between phase, AS/AP-VS/VP between AS-AS

Basic parameter measures the independent measurement containing real-time AS, AP, VS and/or VP intracavitary electrograph time limit.According to the X axis time The AS/AP initial points and VS/VP initial points of measurement, to obtain the phase between AS-VS, AP-VS, AS-VP and AP-VP；When according to X axis Between the VS/VP initial points and destination node that measure, to obtain the QRS time limits of VS/VP.All real-time AS, AP, VS and/or VP intracavitary The independent of electrograph time limit measures, and becomes all in accordance with the initial and/or whole maximum inflection point slope function in end for obtaining signal waveform in the chambers of the heart Change, handled and obtained by the logical algorithm of CRT-GZ1, and enters phase data library and preserve.It is emphasized that CRT-GZ1 with Under its program control instrument communications status coordinated, the data transfer that nearest CRT-GZ1 searches for measurement period process automatically is can also be achieved, And data storage, playback display, post-processing, including the background works such as edit, print.

(2) between therapeutic AS/AP-VP the phase automatic foundation

This part is core of the invention technology.Between searching for measurement automatically and obtaining AS/AP-VS on the basis of the phase, lead to The automatic pace-making scanning for spending the phase between dynamic AS/AP-VP, measures with caused by the phase between the dynamic AS/AP-VP of step change in real time The QRS time limits of serial LV, and screening go out to trigger the QRS wave time limit it is most narrow when AS/AP-VP between the phase.Thereafter, the logic of CRT-GZ1 Algorithm will be in 5~10 seconds, and automatic establish treats pacemaker impulse with the CRT that the phase between the AS/AP-VP provides, and realizes LV pace-makings Excitement is merged with the true property of the intrinsic ventricular excitement passed down through atrioventricular node, is resynchronized to reach between chamber, between LV and RV The therapeutic purposes of change.

(3) the CRT pacing modes of scanning are repeated

Under the conditions of different physiology, pathology and pharmacology, dynamic change (its between patient itself AS/AP-VS present in the phase The phase is proportional between middle heart rate speed and AS/AP-VS), participate in the CRT treatments that LV is paced to ensure to maximally utilize itself Atrioventricular Conduction Effect, we design CRT-GZ1 can realize above-mentioned automatic measurement, the function of setting pace-making repeatedly：

1. definite-time scan pattern, i.e., automatic by between the AS/AP-VP for triggering the most narrow QRS time limits according to the setting of program After the CRT pacing therapies of time (6,12,24,36,48,60,72 hours available) are fixed in phase, re-execute again AS/AP-VP is the negative scanning of 70-300ms ranges or positive scanning search, to find the new AS/AP-VP of CRT pacing therapies next time Between the phase, i.e., automatically by AS/AP-VP be 70-300ms ranges, between negativity or the AS/AP-VP in positivity scanning search most narrow QRS time limits Phase, the CRT pacing therapy processes ... of time (6,12,24,36,48,60,72 hours are available) are fixed, so Repetitive cycling.

2. frequency adaptivity scan pattern, in the time-histories that above-mentioned CRT treats pace-making LV, when the phase continues 10 between AS-AS Change absolute value >=200ms of minute more last scanning radix, it is 70- that CRT-GY1 auto-steerings, which are executed with AS/AP-VP, The negative of 300ms ranges sweeps or just sweeps, the phase between the AS/AP-VP to re-search for the most narrow QRS time limits, with establish new timing (6, 12,24,36,48,60,72 hours it is available) CRT pacing therapy processes ..., such repetitive cycling.

As shown in fig. 1, human body signal is handled by the intracardiac signal imitation in 2 tunnels, after A/D is converted, becomes digital signal Into MCU.MCU passes through the information such as program control instrument system acquisition parameters setting.MCU controls power management by battery management system. MCU adjusts system to control the boost pulse that 2 tunnels export human body by pulse generating system, laser pulse forming system, pulse parameter.

In Fig. 2 N be setting each scan period single step into pace-making number (1,2,4,8 fourth gear may be selected), n is scanning week Interim remaining pace-making number；T is the scanning step (5,10,15,20 fourth gear may be selected) of setting, unit ms；T is AS/AP-VP Value, unit ms；X is positive and negative scanning times, initial value 0；Tx is AS/AP-VP values when x: th scans；Q is that QRS wave is long Degree, unit ms；Qn is QRS wave length when each scan period n-th paces, and Qx is that average QRS wave when x: th scans is long Degree, unit is ms.Since program sweep judgement N is assigned to n, by positive and negative；Each period pace-making number cycle；Whether Surmount automatic search range to judge；Qx is averaged and waits and etc., finally chooses minimum value in a series of QX values, then calculates Go out corresponding AS/AP-VP values, the AS/AP-VP values as needed, EP (end of program).

The flow of automatic searching and detecting program and the work of CRT pacing therapies is simply described in Fig. 3.From parameter setting, peace Load receiving electrode starts, and then automatic searching and detecting program, obtains AS/AP-VP numerical value, and long-range CRT treatments are carried out with this numerical value Pace-making when such as occurring the more apparent change of generation of patient itself heart rate during pace-making, stops CRT treatment pace-making work, lays equal stress on The new automatic search measurement portion division of labor of beginning is made；Or work until completing predetermined C RT pacing therapies, it is searched automatically into next stage afterwards Rope process of measurement.

The search process of measurement of CRT-GY1 is set for forward scan, stepping 10ms, single step paces number into fixed in Fig. 4 It is 1.First forward scan period, AS-VP=70ms is paced 1 time；Second forward scan period, AS-VP= 80ms is paced 1 time；In the third forward scan period, AS-VP=90ms is paced 1 time ... ....When forward scan to AS-VP When >=160ms (the 10th cardiac cycle), there is AS-VS (i.e. atrial impulses pass down exciting ventricle through itself atrioventricular node).This time When the phase is 130ms between AS-VP in search sweep (the 7th cardiac cycle), the QRS wave time limit is most narrow (130ms).

The present invention depends on patient itself Atrioventricular Conduction state, in the state that function of atrial-ventricular node is substantially without exception, Automatic execution AS/AP-VP sweeps search for just sweeping or bearing for 70-300ms ranges, and searches for automatically in the process and detect AS/ Phase and QRS time limits between AP-VP, i.e. between AS/AP-VP the phase press preset stepping, the phase is (between AS/AP-VP between dynamic changes AS/AP-VP Phase ± stepping between phase=AS/AP-VS), carry out/incremental search formula scanning the pace-making that successively decreases, while real-time automatic measuring AS/AP-VP Between phase and VP the QRS time limits.The purpose is to the dynamic scan carried out by the phase between AS/AP-VP pace-makings, search for VP ventricular fusion beats Reach the phase between the AS/AP-VP in most narrow time limit.Then it is with the phase between the AS/AP-VP corresponding to most narrow QRS wave time limit for searching Pacing parameter executes relatively long fixation and carries out resynchronization CRT pacing therapies to patient.Below according to patient itself heart rate Whether speed, two specific embodiments of CRT-GZ1 pace-makings RA and non-pacing RA modes are provided.

1. embodiment 1：Non-pacing RA modes

(1) implementation condition

Patient is sinus rhythm, no apparent cardiac arrhythmia, average ventricular rate>50~60bpm, electrocardiogram show P waves and QRS Wave is 1：1 related fixed relationship.

(2) pacing electrode catheter is implanted into and is connect with CRT-GZ1

Under local anesthesia using routine techniques, through subclavian vein approach implantation RA electrodes and LV electrodes, (LV electrodes are set The vein after the lateral vein of coronary vein or side), after the parameter testing for completing pacing electrode catheter, respectively by RA electrodes and LV The atrium and ventricle of electrode and CRT-GZ1 input/outlet are reliably connected, and electrode and CRT-GZ1 are fixed, are embedded in upper breast Subcutaneously.

(3) parameter setting

CRT-GZ1 pacing modes are atrial synchronous ventricular pacing type (VAT)；Basic pacing frequency for patient is set (phase between TS1S1) may be selected less than itself average heart rate 5,10,15,20Bpm (beat/min, for itself beat), design parameter；If Set negative sense and/or forward scan stepping (5,10,15,20ms), AS-VP minimum and maximum values be fixed to 70ms and 300ms. No matter bear and sweep or just sweep, it is 70-300ms that automatic search sweep range, which is fixedly installed, negative to sweep as since 300ms, is pressed Stepping is negative to be swept to 70ms and terminates；Just sweeping i.e. be by 70ms, 300ms is just being swept to by stepping and is being terminated.The phase sets between each AS-VP It sets single step to may be selected for 1,2,4,8 fourth gear into fixed pace-making number, design default value is 2.In addition, for each therapeutic AP-VP Between the fixed CRT treatment time-histories (6,12,24,36,48,60,72 hours available, default values 12 hours) of phase setting.

(4) between the acquisition and AS-VS of intracavitary electrocardiosignal the phase scanning

After CRT-GZ1 pacemakers are started to work, collect from pacing electrode catheter it is bipolar/the intracavitary electrogram mould of monopole Quasi- signal inputs computer A/D immediately first by hardware enhanced processing, and simulation intracavitary electrogram is rapidly converted into number Signal, CPU control under with CRT-GY1 logical algorithms to the signal carry out batch intellectualizing system processing, comprising pass through pair Identification, calculating and the fixed point of digital signal waveform inflection point slope variation, measure the AS initial points of X axis, VS/VP initial points and Phase between destination node and AS-VS.

(5) between the therapeutic AS-VP of CRT the phase screening and foundation

It is reliably connected, under stationary state in RA electrodes and the atrium and ventricle of LV electrodes and CRT-GZ1 input/outlet, CRT-GZ1 pacemakers commence work without delay, and the phase (70-300ms) between the AS-VP of CRT-GZ1 settings are executed, using negative sense or forward direction VAT pace-making scannings.For example, when the search process of measurement of CRT-GY1 programs setting scans for negative sense, stepping 10ms, single step is into admittedly Surely pace-making number is 2, then in first negative sense scan period, AS-VP=300ms, continuous pace-making 2 times；It is swept in second negative sense It retouches the period, AS-VP=290ms, continuous pace-making 2 times；In the third negative sense scan period, AS-VP=280ms continuously paces 2 It is secondary ... ....When negative sense is scanned to AS-VP≤70ms, search process of measurement is automatically stopped, and notifies CRT-GZ1 automatically, is inquired This time search measures in scanning process, and the phase, the QRS wave time limit was most narrow, and at 5-10 seconds in the state that is worth between AS-VP Interior, CRT-GZ1 sets the phase between the AS-VP for triggering most narrow QRS wave time limit to the phase between the therapeutic AS-VP of CRT automatically, immediately enters The CRT pacing therapies of the VAT modes of relatively long time-histories.In another example when the search process of measurement of CRT-GY1 programs setting is just To scanning, stepping 5ms, single step is 3 into fixed pace-making number, then first forward scan period, AS-VP=70ms paces 3 It is secondary；Second forward scan period, AS-VP=75ms is paced 3 times；In the third forward scan period, AS-VP=80ms, Pace-making 3 times ... ....When forward scan is to AS-VP >=300ms, search process of measurement is automatically stopped, and notifies CRT- automatically What value GZ1 inquire in this search sweep between AS-VP the phase in the state of, and the QRS wave time limit is most narrow, and in 5-10 seconds, CRT-GZ1 sets the phase between the AS-VP for triggering most narrow QRS wave time limit to the phase between the therapeutic AS-VP of CRT automatically, immediately enters phase To the CRT pacing therapies of the VAT modes of longer time-histories.

(6) repetition of phase is screened and is established between therapeutic AS-VP

The fixation time-histories that CRT treatment pace-makings are carried out with the phase between therapeutic AS-VP (6,12,24,36,48,60,72 hours can It is selective, give tacit consent to 6 hours) after, search is re-executed again measures phase, automatic positivity or negativity scanning search between AS-VP Phase between AS-VP, the time is fixed with the phase between the AP-VP in triggering most narrow QRS time limits (6,12,24,36,48,60,72 hours can It is selective, give tacit consent to 6 hours) VAT patterns CRT pacing therapy processes ..., such repetitive cycling.

During carrying out CRT pace-makings with the phase between therapeutic AS-VP, when more apparent change occurs for patient itself heart rate When (phase between AS-AS that is preset as continues change absolute value >=200ms of radix when more last scanning in 10 minutes), i.e., restart automatically Search measures the phase between AS-VS, i.e., the phase between negativity or positivity scanning survey AS-VP, most narrow to seek within the scope of 70-300ms Phase between the AS-VP in QRS time limits, and CRT pace-making LV treatments are re-executed with VAT patterns.

2. embodiment 2：Pace RA modes

(1) implementation condition

There are apparent sinus bradycardia, sinoatrial block or sinus arrest, average ventricular rates by patient<50bpm.

(2) connection of pacing electrode catheter and CRT-GZ1

Under local anesthesia using routine techniques, through subclavian vein approach implantation RA electrodes and LV electrodes, (LV electrodes are set The vein after the lateral vein of coronary vein or side), after the parameter testing for completing pacing electrode catheter, respectively by RA electrodes and LV The atrium and ventricle of electrode and CRT-GZ1 input/outlet are reliably connected, fix, and electrode and CRT-GZ1 are fixed, are embedded in Chest is subcutaneous.

(3) parameter setting

CRT-GZ1 pacing modes are DDD/DDDR；The basic pacing frequency (phase between TS1S1) being arranged for patient is higher than certainly Body average heart rate 5,10,15,20bpm, design parameter may be selected；Setting is positive and/or negative sense scanning stepping (5,10,15, 20ms), phase (phase=AP-VS between dynamic AP-VP is arranged between dynamic AP-VP in minimum or maximum AP-VP values (range 70-300ms) Between phase ± stepping, stepping 5,10,15,20ms it is optional, design default value be 10ms).The phase scan setting list between each AP-VP Stepping is fixed pace-making number and be may be selected for 1,2,4,8 fourth gear, and design default value is 2.In addition, the phase between each therapeutic AP-VP The fixed CRT treatment time-histories (6,12,24,36,48,60,72 hours available, default values 12 hours) of setting.

(4) between the acquisition and AP-VS of intracavitary electrocardiosignal the phase scanning

Acquire pacing electrode catheter it is bipolar/the intracavitary electrogram simulation signal generator of monopole, first by hardware enhanced processing, Computer A/D is inputted immediately, simulation intracavitary electrogram is rapidly converted into digital signal, with CRT-GY1 logics under CPU controls Algorithm carries out the processing of batch intellectualizing system to the signal, including identification, meter to digital signal waveform inflection point slope variation It calculates and pinpoints, measure the phase between the AS/AP initial points, VS/VP initial points and destination node and AS/AP-VP of X axis.

(5) between the therapeutic AP-VP of CRT the phase screening and foundation

According to the phase between default dynamic AP-VP, using negative sense and forward direction DDD/DDDR pace-making scannings.In RA electrodes and LV electrodes Atrium and ventricle input/outlet with CRT-GZ1 is reliably connected, under stationary state, and CRT-GZ1 pacemakers are started to work, by just To or negative sense pace-making scanning, execute CRT-GZ1 setting AP-VP between the phase (70-300ms).For example, being swept when program is set as negative sense It retouches, stepping 10ms, single step is 4 into fixed pace-making number, then in first negative sense scan period, AP-VP=300ms is continuous to rise It fights 4 times；In second negative sense scan period, AP-VP=290ms, continuous pace-making 4 times；In the third negative sense scan period, AP- VP=280ms, continuous pace-making 4 times ... ....When negative sense is scanned to AP-VP≤70ms, search process of measurement is automatically stopped, and What value automatic notice CRT-GZ1 inquire during this search sweep between AP-VP the phase in the state of, and the QRS wave time limit is most It is narrow, and in 5-10 seconds, CRT-GZ1 sets the phase between the AP-VP for triggering the most narrow QRS wave time limit to the therapeutic AP- of CRT automatically Phase between VP immediately enters the CRT pacing therapies of the DDD/DDDR modes of relatively long time-histories.In another example when CRT-GY1 programs are set It is set to forward scan, stepping 20ms, single step is 2 into pace-making number is fixed, then in first forward scan period, AP-VP= 70ms, continuous pace-making 2 times；Second forward scan period, AP-VP=90ms, continuous pace-making 2 times；It is swept in third forward direction It retouches the period, AP-VP=110ms, continuous pace-making 2 times ... ....When forward scan is to AP-VP >=300ms, process of measurement is searched for It is automatically stopped, and notifies CRT-GZ1 automatically, inquire during this search sweep between AS-VP the phase in the state of what value, The QRS wave time limit is most narrow, and in 5-10 seconds, and CRT-GZ1 automatically sets the phase between the AP-VP for triggering the most narrow QRS wave time limit to Phase between the therapeutic AP-VP of CRT immediately enters the CRT pacing therapies of the DDD/DDDR modes of relatively long time-histories.

(6) repetition of phase is screened and is established between therapeutic AP-VP

The fixation time-histories that CRT treatment pace-makings are carried out with the phase between therapeutic AP-VP (6,12,24,36,48,60,72 hours can It is selective, give tacit consent to 6 hours) after, search is re-executed again measures phase, automatic negativity or positivity scanning search between AP-VS Phase between AP-VP, the time is fixed with the phase between the AP-VP in triggering most narrow QRS time limits (6,12,24,36,48,60,72 hours can It is selective, give tacit consent to 6 hours) DDD pacing therapy processes ..., such repetitive cycling.

During carrying out CRT pace-makings with the phase between therapeutic AP-VP, when more apparent change occurs for patient itself heart rate When (phase between AS-AS that is preset as continues variation >=200ms of radix when more last scanning in 10 minutes), i.e., increased heart rate or subtract Slowly, the ventricular rate period averagely shortens or increases above 200ms or more, and CRT-GY1 restarts negativity or positivity scanning survey AS- automatically Phase between VP, phase between the AS/AP-VP to seek the most narrow QRS time limits again execute CRT pace-making LV treatments.

It is worth illustrating, although the present invention contains above-mentioned non-pacing RA and pace-making RA, two kinds of search measure work The pattern of work, but in actual clinical in use, CRT-GY1 executes the operation scope that algorithm software is a total tune.For example, It is faster in itself sinus frequency, non-pacing RA modes (i.e. phase between AS-VP) are executed, and work as patient itself sinus frequency Relatively low or there are when sinus node dysfunction, the DDD/DDDR operating modes of CRT-GZ1 can be in preset pacing parameter item Under part, i.e., between basic boost pulse TS1S1 in the phase, auto-steering executes pace-making RA modes (i.e. phase between AP-VP).Then dynamic Phase scanning search measures function between executing AS/AP-VP, and by negative sense or forward scan, finds and trigger the most narrow QRS wave time limit Phase between therapeutic AS/AP-VP.

By the workflow of above-mentioned 2 embodiments, show that the CRT-GY1 impulse generators of the present invention are the masters of its structure Want core.The main overall operation for including ecg amplifier, two-way boost pulse, microprocessor (MCU) composition in the two-way chambers of the heart Control centre.Impulse generator is connected to by the right room electrode being positioned in the chambers of the heart and left room electrode with human heart, and CRT is provided Pulse and the electricity physiological signal for receiving cardiac muscle.Ecg amplifier is acquiring and is handling atrium and ventricle electro physiology letter in the two-way chambers of the heart Number when, can two-chamber simultaneously use double pole mode, also can two-chamber simultaneously use unipolar lead pattern；Also can a chamber use monopole, separately One chamber uses bipolar lead pattern.Ecg amplifier hardware gain is 50-100 times in the two-way chambers of the heart, 50/60Hz trap circuits, Crest frequency is optional；Simultaneously by 4 grades of Ingeborg Bachmann filters, realization amplifier band logical frequency is 5-200Hz.Two-way chambers of the heart heart Electric amplifier, into the modulus processor (A/D conversions) of MCU, uses 12 times of SAR after original electro-cardiologic signals hardware handles Structure.Two-way impulse generator, pulse width 0.1-1.0ms is adjustable (stepping ± 0.1ms)；Boost pulse voltage range 1- 10V is adjustable (stepping ± 1.0V)；Boost pulse waveform forward direction, negative sense and two-way optional, acquiescence negative sense.Pacemaker microprocessor (MCU), after electrocardial analog signal being changed into digital signal by its A/D converter, after being digitized immediately to the signal Processing, includes the amplitude controlling to signal, 50/60Hz trap high q-factor advanced treatings, digital 4 grades of bandpass filterings, at bandwidth optimization Reason cutting (5-150Hz ranges).Electrocardiosignal bandwidth optimization is handled, and refers to the program sent out by the MCU of impulse generator, i.e., Automatically the generated serial electrocardiosignal of search implements whole logical algorithm processing to AS/AP-VS, and the content of processing covers each Real-time AS/AP-VS information, i.e. AS/AP starting point coordinates, VS starting points and end of the final point coordinate, and calculate between AS/AP-VS Phase.Coordinate data is stored in database, by cured logical algorithm program, final determine occurs what most narrow VS was realized Phase between AS/AP-VS.Logical algorithm program determines that phase, MCU press setting immediately between the AS/AP-VS that the most narrow QRS wave time limit occurs CRT treats timing, executes and is treated with the CRT of phase between AS/AP-VS.When the CRT treatments that MCU is executed are the timings with setting Between limited, CRT treatment timing be fixed as to set for 6/12/24/36/48/72 hour.It is treated once this CRT It completes, MCU starts to repeat the automatic search programs of new AS/AP-VS.Scanning with forward program and negative sense program scanning Selection setting function.Design parameter further includes forward direction/negative sense scanning stepping setting, is divided into 5/10/15/20ms4 grades of optional, negative senses Programmed state is swept, the phase is not less than 70ms between minimum AP/AS-VP；The phase is not more than between forward direction sweeps programmed state maximum AP/AS-VP 300ms。

It is described above to show CRT-GZ1 operating modes and its impulse generator, it is significantly different with existing CRT designs, The former not only reduces the adjustment setting of phase between the implantation and LV-RV/RV-LV of a RV pacing electrode catheter, and can realize The regular follow-up that complete independently largely needs artificial and program-controlled equipment postoperative to implantation CRT patient.Simultaneously as CRT-GZ1 Within the time that can be arranged, automatically repeatedly execute AS/AP-VS/VP search measure, with seek at any time to have itself Atrioventricular Conduction ginseng The possibility that the phase between the AS/AP-VP in most narrow QRS time limits is triggered with, LV pace-making greatly improves, and further improves the adaptive of CRT Property response rate.Therefore, CRT-GZ1 implements automatic conversion according to initial parameter setting and pacing mode, independent to entirely searching for survey Atrium, ventricle and the atrioventricular conduction time in amount period be identified, measure, analyze and judge, and it is automatic, repeat dynamic most The CRT pace-makings of phase between good AS/AP-VP, the participation using itself Atrioventricular Conduction in ventricular fusion beats are formed to greatest extent is this Invent most crucial basis.

It is of the invention a kind of based on itself Atrioventricular Conduction following cardiac resynchronization therapy system, at least there is following advantages：It is described Following cardiac resynchronization therapy method and impulse generator based on itself Atrioventricular Conduction are arranged according to initial parameter and pacing mode Implement automatic conversion, it is independent that atrium, ventricle and the atrioventricular conduction time of entirely searching for measurement period are identified, measured, is divided Analysis and judge, and it is automatic, repeat the best AS/AP-VP of dynamic between the phase pace, utilize itself Atrioventricular Conduction in room to greatest extent Property fusion wave formed in participation, there are the high and low power consumption of intelligence degree, the spies such as widely used, easy to operate, use cost is low Point.

The basic principles and main features and advantages of the present invention of the present invention have been shown and described above.The industry For technical staff it should be appreciated that the present invention is not limited to the above embodiments, what is described in the above embodiment and the description is only say Bright the principle of the present invention, without departing from the spirit and scope of the present invention, various changes and improvements may be made to the invention, this A little changes and improvements all fall within the protetion scope of the claimed invention.The claimed scope of the invention is by appended claims And its equivalent thereof.

Claims

1. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction, it is characterised in that：Including：

Right room endocardial lead, the patient for being implanted into the following cardiac resynchronization therapy indication based on itself Atrioventricular Conduction Atrium dextrum；

Left room epicardial electrode, the patient for being implanted into the following cardiac resynchronization therapy indication based on itself Atrioventricular Conduction Left ventricle；

Mouth corresponding with impulse generator connects respectively for impulse generator, right room endocardial lead and left room epicardial electrode It connects；

Program control instrument, for impulse generator initial parameter to be arranged；

The data that acquisition obtains is measured to executing pace-making scanning search by impulse generator, carries out time one-point measurement calculating；

Modularization logical algorithm analysis is carried out to survey calculation result by impulse generator, the most narrow QRS time limits occur to find AS/AP-VP between the phase, and with the phase between this AS/AP-VP, timing CRT programs are executed by impulse generator, itself are based on to realize Left and right ventricles harmony diastole under Atrioventricular Conduction state and contraction；Impulse generator returns again after executing the secondary timing CRT It measures to ecg signal acquiring and pace-making scanning search, and is analyzed by modularization logical algorithm, during searching scanning search Phase between the AS/AP-VP in generation most narrow QRS time limits；And timing CRT is executed with the phase between new AS/AP-VP again, so recycle；

Wherein, impulse generator includes ecg amplifier and two-way pulse follower, the two-way chambers of the heart heart in the two-way chambers of the heart Electric amplifier intends the remote electrode of linking pacing electrode catheter and and pulse generation when using intracavitary monopolar regime signal acquisition The metal layer of device constitutes circuit；Ecg amplifier intends rank in state signal collecting bipolar using intracavitary in the two-way chambers of the heart Two electrodes for connecing pacing electrode catheter constitute circuit, and the boost pulse form of the two-way pulse follower is with positive, negative To with two-way choice, default configuration is negative sense.

2. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as described in claim 1, it is characterised in that： The impulse generator is acquired, detected and stored to the electrocardiosignal, started simultaneously at and execute pace-making by pacing electrode Scanning search, and the phase between AS/AP-VS is measured in scanning search one by one；The scanning search of phase, impulse generator between AS/AP-VS By initial setting up, determine that its scanning search is positive or negative sense scan mode；Dynamic AS/AP-VP scanning room phase ranges are 70 ~300ms, step value are ± 5ms or ± 10ms or ± 15ms or ± 20ms.

3. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as claimed in claim 2, it is characterised in that： During described its scanning search of decision is positive or negative sense scan mode, need automatic measurement each time by change step Dynamic AS/AP-VP between the phase the QRS wave time limit, and be loaded into database, this time scanning search terminates, and passes through impulse generator number According to library array logic algorithm, the phase between the AS/AP-VP for triggering the most narrow QRS time limits is searched out.

4. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as claimed in claim 3, it is characterised in that： Between the AS/AP-VP for searching the most narrow QRS time limits after the phase, the CRT working procedures of impulse generator are turned to between this AS/AP-VP Phase, to patient execute initial setting up fix pace-making the time be：With 7 grades of selective timings in 6,12,24,36,48,60,72 hours Setting carries out being based on itself Atrioventricular Conduction cardiac resynchronization pacing therapy for refractory heart failure, after timing CRT paces the time, pulse hair Raw device executes dynamic AS/AP-VP pace-making scanning search programs again, again between the AS/AP-VP in searching triggering most narrow QRS time limits Phase, and itself Atrioventricular Conduction heart is executed again by the timing of initial setting up CRT pace-makings with the phase between this new AS/AP-VP Synchronization therapy so recycles, until patient carries out CRT pacemaker follow-ups to hospital, doctor passes through external program-controlled change pulse Generator initial parameter is arranged.

5. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as claimed in claim 3, it is characterised in that： It is turned to the phase between this AS/AP-VP in the CRT working procedures of impulse generator, the phase is lasting between impulse generator detects AS-AS Change absolute value >=200ms of 10 minutes more last scanning radixes, auto-steering are executed with AS/AP-VP as 70-300ms models The forward direction or negative sense scan mode enclosed, phase between the AS/AP-VP to re-search for the most narrow QRS time limits, when establishing new fixation Between, the CRT pacing therapy processes of set time 6,12,24,36,48,60 or 72 hours, such repetitive cycling.

6. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as described in claim 1, it is characterised in that： The modularization logical algorithm analysis provides AAI/AAIR, VVI/VVIR, VAT and DDD/DDDR submodule, the intracavitary heart by program After electric signal inputs computer A/D, two-way monopole or bipolar analog electrocardiogram signal are converted into digital signal, and are carried out to the signal Bulk intelligent processing, including signal display pretreatment and external program control instrument communication process, monopole and/or the interior letter of the bipolar chambers of the heart Number identification and time phase processing, select bipolar or unipolar signal starting and terminate identification, time measurement processing, pulse generation Device is measured by pacing to scan and search for according to the parameter and pace-making working mode change of initial setting up, calculates atrium and ventricle In the time limit of excitement, atrium and ventricle waveform time phase difference is identified, finally the AS/AP-VP in most narrow QRS time limits occurs Between the phase, execute CRT pacing therapy functions.

7. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as claimed in claim 6, it is characterised in that： The electrocardiosignal converted to having been subjected to A/D implements digital module processing, including:4 grades of digital bandpass filterings, 50/60Hz numbers are fallen into Initial/whole last greatest gradient variation of filtering, electrocardiosignal automatic growth control, real-time wave mode calculates and fixed point timing, automatic base Line corrects.

8. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as described in claim 1, it is characterised in that： Ecg amplifier includes two-way and bipolar/monopole intracavitary ecg signal amplifier in the two-way chambers of the heart, and two-way electrocardiosignal is put Big biological amplifier of the device gain at 50-100 times, 50/60Hz trap circuits, 4 grades of Ingeborg Bachmann bandpass filters, frequency bandwidth are 5-200Hz；The gain of Unipolar electrogram hardware module, also at 50-100 times, 4 grades of Ingeborg Bachmann bandpass filters, frequency 5- 200Hz。

9. a kind of following cardiac resynchronization therapy system based on itself Atrioventricular Conduction as described in claim 1, it is characterised in that： The pulse width of the impulse generator is 0.1-1.0ms, and stepping is ± 0.1ms, and 10 grades selective, boost pulse voltage range For 1-10V, stepping is ± 1.0V, and 10 grades selective.