CN205019592U - Therapeutical impulse generator of heart resynchronizeization based on conduction of self room - Google Patents

Abstract

The utility model relates to a therapeutical impulse generator of heart resynchronizeization in the conduction of self room. It includes double - circuit monopole / bipolar chambers of the heart heart electric amplifier, double - circuit impulse generator and computer control center, and pulse amplifier passes through pacing electrode and links up with left room and left room, realizes the ASAP -VS automatic search to the amazing pulse of the programme -controlled granting of developments ASAP -VP interphase, and by the QRS ripples time limit during the pulse amplifier automated inspection search. The rule of developments ASAP -VP interphase changes to be accomplished according to specific step by step proper motion based on impulse generator, the utility model discloses an impulse generator has the independent characteristics of reliably carrying out CRT work, current CRT cost has not only been reduced, significantly reduced following up a case by regular visits to of CRT patient and the complicated operation of medical treatment of its nimble unique CRT mode moreover.

Description

Based on the pulse generator of the following cardiac resynchronization therapy of self Atrioventricular Conduction

Technical field

This utility model relates to a kind of cardiac pacing therapy heart failure category of medicine and hygiene fields, particularly relates to a kind of pulse generator of the following cardiac resynchronization therapy based on self Atrioventricular Conduction.

Background technology

CHF is one of pernicious home to return to of all cardiovascular disease.Although along with the continuous progress of etiological treatment and the Drug therapy such as angiotensin converting enzyme inhibitor, beta-blocker, the hospital mortality of CHF patient and again admission rate decrease, but the sickness rate of CHF still remains high, have a strong impact on life quality and the prognosis of cardiovascular patient.1994, first Charles Robert Richet Cazeau etc. reports and implements four chambeies (diplocardia room, biventricular) pacing therapy to 1 example with the male CHF patient of complete left bundle branch block (LBBB), significantly improve its clinical symptoms, from then on for the new therapy of this CHF of CRT has opened prelude.Clinical research finds, about the QRS time limit of 1/3CHF patient is more than 120ms, is common in LBBB; Left ventricle (LV) excitement of the CHF patient of companion LBBB is obviously later than right ventricle (RV), the excitement of LV endocardium betides after interventricular septum from right to left excitement, interventricular septum cannot support that LV penetrates blood, and LV loses the spherical contractile function of coordination; Exciting site normally LV sidewall, rear flank wall the latest, shrinking late period, LV sidewall shrink, intraventricular pressure rises rapidly, and interventricular septum is stressed to affect and protrudes to the right, produces paradoxical movement, and then minimizing forward direction penetrates blood; The LV inner region mechanical delay caused with indoor electric conduction delay between room, causes functional mitral reflux, LV contractile function to reduce.CRT passes through the synchronicity of pace-making biventricular recovery room interval and LV sidewall shrink, improve LV mechanical function, increase the diastolic filling time, reduce paradoxical movement and the mitral incompetence of interventricular septum, thus reduce the mortality rate of CHF patient, readmission leads, and improves patients symptomatic and quality of life.The crucial Study of evidence based medicine of MIRALE, CARE-HF, COMPANION, PATH-CHF and MUSTIC-SR etc. several specify that CRT improves the effect of CHF patient's symptoms of heart failure and prognosis, on this basis, CRT recommends as the I class indication for the treatment of CHF patient by ACC/American Heart Association, ESC, Chinese Medical Association cardiovascular diseases branch/cardiac electrophysiology and pace-making branch all.At present along with CRT is in clinical extensive use, for CRT pulse generator and pacing electrode wire performance design, implant aid and correlation technique is just experiencing unprecedented fast development, become the study hotspot in the clinical therapeutics of CHF, medical bioengineering field.

Current CRT adopts right atrium (RA) and double-ventricle pacemaker pattern in clinical practice substantially, by arranging the individuation atrioventricular interval (A-V Interval) of pacing pulse generator, interval (LV-RV/RV-LV interval) between room, perceptual performance, pace-making performance, rate response, perception responds, the parameters such as pace-making/perception polarity, strive realizing ECG-QRS Wave the narrowest, Atrioventricular sequence is best, ultrasoundcardiogram ventricular synchronous index (E-A, VTI, MR, LVEDD, LVEF, IVMD and SPWMD etc.) optimum, patients symptomatic is the lightest and complication is minimum, thus reach the therapeutic purposes improving CHF patients symptomatic and prognosis.Although the treatment of CRT to the CHF patient of lock-out achieves the achievement attracted people's attention, part CHF patient, to CRT low reaction, even reactionlessly still annoyings patient and clinician.Current clinical studies show, the QRS ripple before indication operation in patients is wider, implant CRT after the QRS ripple time limit narrower, the response rate of patient to CRT is higher; And the factor such as Candidacy selection improper (as excessively late in implanted opportunity), LV positioning of electrode not good or dislocation, the non-dynamic optimization of CRT parameter, Drug therapy and psychological intervention is improper, complication causes the CHF patient of nearly 1/3rd to treat reactionless to CRT, the influence factor wherein made number one is exactly inappropriate A-V Interval.In order to obtain the double-ventricle pacemaker of 100%, often need to arrange shorter A-V Interval, but too short A-V Interval can shorten the ventricular diastole time, cause ventricle premature contraction, two/premature tricuspid closure, not only reduce cardiac output, impair the function of atrium " donkey pump ".Independent LV pace-making can extend the right ventricular filling time, increases PBF, reduces Venous system congestion, indirectly adds patient's oxygen content and left heart blood back, reduces atrioventricular valves (A V valves) and backflows, delay even to reverse chamber enlargement.Because most CHF patient is sinus rhythm, function of atrial-ventricular node Non Apparent Abnormality, and the risk of generation atrioventricular block at a specified future date is lower, therefore simple LV pace-making, but not double-ventricle pacemaker, whether may recover the interest that ventricular synchronous causes educational circles.

EATER-EARTH registration studies and the smaller non-pessimum clinical research of some sample sizes find, for LVEF (Left Ventricular Ejection Fraction)≤35%, the patient merging LBBB (QRS width >=130ms), through the follow-up observation of 6 ~ 12 months by a definite date, the improvement degree of simple LV pace-making to indexs such as patient clinical situation, exercise tolerance, LV internal diameter and functions was close with double-ventricle pacemaker.Meta-analysis has also affirmed that simple LV pace-making merges the status of the diastolic dysfunction of ventricle mechanical movement lock-out in treatment further.

Based on above-mentioned theory, we suppose for the normal LBBB patient of function of atrial-ventricular node, the pulse generator that design is unique, when only implementing merely LV pace-making, A-V Interval is set by automatic dynamic, himself atrioventricular node is conducted and participates in ventricular activation, trigger the narrowest QRS to realize CRT curative effect.

Utility model content

For the deficiency that prior art exists, this utility model provides a kind of and has the high and low power consumption of intelligence degree, of many uses, the easy and simple to handle and pulse generator of the following cardiac resynchronization therapy based on self Atrioventricular Conduction that use cost is low.

To achieve these goals, this utility model realizes by the following technical solutions: a kind of following cardiac resynchronization therapy pulse generator based on self Atrioventricular Conduction, comprise the overall operation control centre of ecg amplifier and two-way pulse generator and microprocessor formation in the two-way chambers of the heart, described pulse generator is communicated with human heart with left room electrode by the right room electrode be positioned in the chambers of the heart, provides the following cardiac resynchronization therapy pulse based on self Atrioventricular Conduction and accepts myocardium electricity physiological signal.

Further: ecg amplifier in the described two-way chambers of the heart, when accepting and process atrium and ventricular electrophysiology signal, double pole mode can be adopted by two-chamber simultaneously, also can adopt unipolar lead pattern by two-chamber simultaneously, also can adopt one pole in a chamber, another chamber adopts bipolar lead pattern.

Further: in the described two-way chambers of the heart, ecg amplifier hardware gain is 50-100 times, 50/60Hz trap circuit, crest frequency is optional and by 4 grades of Ingeborg Bachmann wave filter, realizing amplifier band passband rate is 5-200Hz.

Further: in the described two-way chambers of the heart, ecg amplifier is by after original electro-cardiologic signals hardware handles, enter the modulus processor (A/D conversion) of MCU, adopt 12 times of SAR structures.

Further: described two-way pulse generator pulse width is 0.1-1.0ms, stepping ± 0.1ms, and boost pulse voltage range is 1-10V, stepping ± 1.0V, boost pulse waveform forward, negative sense and two-way optional, acquiescence negative sense.

Further: after described microprocessor changes ECG simulator signal into digital signal by its A/D converter, digitized post processing is carried out to this signal, comprise the amplitude controlling to signal, 50/60Hz trap high q-factor advanced treating, numeral level Four high pass and low-pass filtering, the bandwidth optimization processing cutting of 5-150Hz scope.

Further: described electrocardiosignal bandwidth optimization process, refer to the program sent by the MCU of pulse generator, namely the serial electrocardiosignal that AS/AP-VS automatic search produces implements omnidistance logical algorithm process, the content of process contains each real-time AS/AP-VS information, i.e. AS/AP starting point coordinate, VS starting point and swollen point coordinates, and calculate AS/AP-VS interval, coordinate data is stored in data base, rely on the logical algorithm program of fixed line, finally determine the AS/AP-VS interval that the narrowest VS realization occurs.

Compared to prior art, at least there is following advantage in the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction that this utility model provides: the pulse generator of the described following cardiac resynchronization therapy based on self Atrioventricular Conduction is to the signal of telecommunication in the chambers of the heart, i.e. AS, AP, the collection of VS or VP, focus on the low middle-end frequency range of its signal source, namely in 5-100HZ bandwidth, object is easy to AS, AP, simulated and digitized processing is more accurately implemented in the starting point of VS or VP excitement and end of the final point, by hardware circuit and software programming, the multiple unordered higher hamonic wave of the signal of telecommunication in the filtering chambers of the heart, retain AS, AP, the low middle-end frequency content of VS or VP starting point clearly signal source relative to end of the final point, so that logical algorithm is easily by the flex point slope variation of waveform, calculate, analyze and judge, more accurately measure the AS/AP initial point of X-axis time arrow and VS/VP initial point and destination node.

Accompanying drawing explanation

This utility model is described in detail below in conjunction with the drawings and specific embodiments;

Fig. 1 is pulse generator pacemaker hardware basic structure schematic diagram of the present utility model.

Fig. 2 is that pulse generator of the present utility model is based on self Atrioventricular Conduction automatic search AS/AP-VP software logic figure.

Fig. 3 is pulse generator automatic search trace routine of the present utility model and CRT pacing therapy workflow diagram.

Fig. 4 is of the present utility model based on self Atrioventricular Conduction automatic search AS-VP schematic diagram.

Detailed description of the invention

The technological means realized for making this utility model, creation characteristic, reaching object and effect is easy to understand, below in conjunction with detailed description of the invention, setting forth this utility model further.

As shown in Figures 1 to 4, it illustrates of the present utility model by calculating pacing mode, logical algorithm, chambers of the heart heart electric signal measurement and the real-time synchronization of the following cardiac resynchronization therapy based on self Atrioventricular Conduction researched and developed voluntarily (CRT) pulse generator (hereafter with CRT-GZ1 for it), and the foundation of clinical method, have studied the novel CRT technology under CHF patient self the Atrioventricular Conduction state that is based upon of complete set.

1, the implantation of pacing electrode catheter and CRT-GZ1 pulse generator and operation principle summary

The optimal blood kinetics that CRT produces not only relies on the position of LV electrode arrangement, also closely related with optimal A-V Interval, LV-RV/RV-LV interval.A kind of novel CRT scheme based on self Atrioventricular Conduction of this utility model design: first, clinically to the I class eligible patients meeting CRT implantation, application is conventional implants the RA electrode of CRT and the method for LV electrode, through subclavian vein approach under local anesthesia, only implant RA endocardial lead conduit and LV epicardial lead conduit (drive in the wrong direction through coronary sinus vein and be placed in Coronary vein genus); Secondly, after the parameter testing completing pacing electrode catheter, respectively RA electrode and LV electrode are inputted with the atrium of CRT-GZ1 and ventricle with Atrioventricular sequence dual chamber pacing (DDD/DDDR) function/export and be connected, electrode and pulse generator are embedded in upper breast subcutaneous; CRT-GZ1 carries out automatic search measurement to four kinds of A-V Intervals such as atrial sense (AS)-ventricular sense (VS), auricular pacemaking (AP)-VS, AP-ventricular pacemaking (VP), AS-VP of patient and corresponding intracavity QRS time limit thereof, and Lookup protocol triggers the AS/AP-VP interval in the narrowest QRS time limit, carries out pace-making with double pole mode.It is emphasized that this utility model system is based on the CRT pattern of patient self Atrioventricular Conduction, namely by carrying out automatic search measurement to AS/AP-VS, and then the AS/AP-VP interval of Lookup protocol pulse generator, to perform CRT treatment.Therefore, CRT-GZ1 is not generally suitable for the patients with arrhythmia that II ~ III ° of atrioventricular block, atrial flutter, atrial fibrillation etc. do not possess definite 1:1 atrioventricular relationship.

2, the physical facility of CRT-GZ1

(1) hardware of CRT-GZ1 comprises:

1. two-way chambers of the heart heart electricity amplification module: relate generally to two-way, bipolar/one pole intracavity ecg signal amplifier.Two-way intracavity ecg amplifier, namely the RA signal of telecommunication and the LV signal of telecommunication all have one pole or bipolar collection can select amplification mode.When using intracavity monopolar regime signals collecting, intending the remote electrode being connected pacing electrode catheter, forming loop with the metal level of CRT-GZ1.Intracavity two pole analysis signal source then takes from two electrodes of pacing electrode catheter completely.Its hardware module comprises: gain fixes at 50-100 biological amplifier doubly; 50/60Hz trap circuit; 4 grades of Ingeborg Bachmann band filters, frequency bandwidth is 5-200Hz.The gain of intracavity Unipolar electrogram hardware module, also fix at 50-100 doubly, 4 grades of Ingeborg Bachmann band filters, frequency is 5-200Hz.In the chambers of the heart, signal is after hardware handles, enter A/D conversion process and become digital signal, by the programmed logic algorithm of cpu controller, this signal is carried out again to the process such as digital signal amplitude, filtering, trap, phase calculation, the analysis of X-axis waveform flex point slope, to provide the data performed required for CRT pacing function.

2. two-way pulse generator: boost pulse form of the present utility model has forward/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.Select between basis boost pulse TS1S1=2000-400ms (30-150PPM) to arrange.

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

To the reliability of the identification of RA and LV intracavitary electrogram and measurement, be related to whole CRT to treat whether successfully one of maximum effect factor.Tradition cardiac electrophysiology system is to the processing method of electrocardiosignal in the chambers of the heart, all the main components based on signal spectrum in the chambers of the heart, i.e. relatively high, the unordered higher hamonic wave of frequency, therefore common cardiac electrophysiology equipment is got relating to of the signal of telecommunication in the chambers of the heart, mainly amplify its high end frequency signal source, the figure of acquisition normally provides clinical cardiac electrophysiology qualitative analysis and manual measurement time to use.Tradition implanted heart pacemaker is to the collection of atrium in the chambers of the heart or ventricular cardiac signal, the time shaft measurements and calculations to signal source are not related to yet, be mostly by signal in the chambers of the heart that collects through comparative degree circuit, be converted into Transistor-Transistor Logic level and pass to CPU control centre, use as calculating heart rate and perception.

Pulse generator CRT-GZ1 of the present utility model designs on DDD/DDDR pacing pulse generator platform, and its pace-making workflow provides AAI/AAIR, VVI/VVIR, VVT, VAT and DDD/DDDR Pattern completion by program software.One of feature of the present utility model is the process of CRT-GZ1 to electrocardiosignal in the chambers of the heart, i.e. the specific identification of RA and LV electrograph and measuring technique.First this utility model proposes the signal of telecommunication in the chambers of the heart, the i.e. collection of AS, AP, VS or VP, focus on the low middle-end frequency range of its signal source, namely, in 5-100HZ bandwidth, object is easy to implement simulated and digitized processing more accurately to the starting point of AS, AP, VS or VP excitement and end of the final point.By hardware circuit and software programming, the multiple unordered higher hamonic wave of the signal of telecommunication in the filtering chambers of the heart, retain the low middle-end frequency content of AS, AP, VS or VP starting point clearly signal source relative to end of the final point, so that logical algorithm is easily by the flex point slope variation of waveform, carry out calculating, analyze and judging, more accurately measure the AS/AP initial point of X-axis time arrow and VS/VP initial point and destination node.After taking care intracavity analogue signal input computer A/D, two-way one pole or bipolar analog electrocardiogram signal are rapidly converted into digital signal by software, and batch intelligent processing method is carried out to this signal, comprise digital band pass filtering, the digital sunken filtering of 50Hz, initial/whole last slope variation calculating of electrocardiosignal automatic Scalable gain control, in real time wave mode and fix a point timing, automatic baseline correction; Signal aspects pretreatment and relevant program control instrument communication process etc.Wherein Signal analysis and process time phase in one pole or the bipolar chambers of the heart, the bipolar or initial important foundation with stopping identifying, measure of time process is this utility model logical algorithm of unipolar signal of selectivity.In addition, adopt one pole amplification mode or bipolar amplification mode to the process of RA and LV intracavity electrical picture signal, arranged voluntarily by clinician and select and combination, initial default state is double pole mode.

3, the interval scanning of CRT-GZ1, the setting of pacing mode and parameter

This utility model is on the platform of common DDD/DDDR pacing pulse generator, and to self Atrioventricular Conduction, normal CHF patient proposes novel CRT scheme: about AS/AP-VS interval and QRS time limit automatic search measuring method are set up; About interrelated logic algorithm and the Lookup protocol of AS/AP-VP interval.

Under the prerequisite that CRT-GZ1 and relevant RA electrode and LV electrode reliably connect, communicated with the program control instrument be mated by CRT-GZ1, pacemaker duty and pacing parameter are set.According to the real-time performance of patient's rhythm of the heart, heart rate, pacing parameter is set, comprise basic pacing frequency, impulse stimulation intensity (1.5-2.5 times higher than pacing threshold), pulse width (default value 0.2ms, 0.1-1.0ms can select), (default value atrium is 0.1-1.0mv to perceptual sensitivity, ventricle is 0.5-5.0mv), AP/AS-VS maximum scan interval etc.Based on AP/AS-VS/VP maximum scan interval, and the determination in closely-related QRS time limit with it, realize the basis that CRT-GZ1 performs CRT, therefore, before automatic search is measured and the work of CRT pace-making do not start, set and judge that AP/AS-VS/VP maximum scan interval is the very important work of CRT-GZ1.We are divided into fixing negative sense automatic scam and fixing forward automatic scam two type to the scanning screening of the AS/AP-VP interval of CRT treatment, are set according to patient's states by clinician.No matter bear and sweep or just sweep, the scanning of its automatic search is all fixedly installed on the scope Inner of 70-300ms, namely bears and sweeps from 300ms, is swept to 70ms by stepping is negative; Just sweeping by 70ms, be just swept to 300ms by stepping.Scanning stepping is divided into 4 grades: 5,10,15,20ms, sets itself.It is emphasized that the synchronicity for guaranteeing atrioventricular excitation order, we are not less than 70ms to the negative minimum AP/AS-VP interval of sweeping state pace-making of design CRT-GZ1, and the maximum AP/AS-VP interval of just sweeping state pace-making is not more than 300ms.The time setting that automatic search is measured is completed by following components respectively.

(1) the QRS time limit of AS-AS interval, AS/AP-VS/VP interval and VS/VP measures

Basic parameter is measured and is measured containing the independence in real-time AS, AP, VS and/or VP intracavity electrograph time limit.According to AS/AP initial point and the VS/VP initial point of X axis measure of time, to obtain AS-VS, AP-VS, AS-VP and AP-VP interval; According to VS/VP initial point and the destination node of X axis measure of time, to obtain the QRS time limit of VS/VP.The independence measurement in all real-time AS, AP, VS and/or VP intracavity electrograph time limits, all according to the initial and/or last maximum flex point slope function change eventually obtaining signal waveform in the chambers of the heart, is obtained by the logical algorithm process of CRT-GZ1, and enters the preservation of phase data storehouse.It is emphasized that under the program control instrument communications status be mated at CRT-GZ1, the data transfer of nearest CRT-GZ1 automatic search process measuring period also can be realized, and data storage, playback shows, and post processing, comprises the background work such as editor, printing.

(2) the automatic foundation of therapeutic AS/AP-VP interval

This part is core technology of the present utility model.Measure at automatic search and obtain on the basis of AS/AP-VS interval, by the automatic pace-making scanning of dynamic AS/AP-VP interval, the QRS time limit of the serial LV that real-time measurement produced with the dynamic AS/AP-VP interval of step change, and examination go out to trigger the QRS ripple time limit the narrowest time AS/AP-VP interval.Thereafter, the logical algorithm of CRT-GZ1 will within 5 ~ 10 seconds, the CRT that automatic foundation was provided with this AS/AP-VP interval treats pacemaker impulse, the true property realizing the exciting intrinsic ventricular excitement with passing down through atrioventricular node of LV pace-making merges, thus reaches the therapeutic purposes of resynchronization between chamber, between LV and RV.

(3) can the CRT pacing mode of multiple scanning

In view of under different physiology, pathology and pharmacology condition, dynamic change existing for patient self AS/AP-VS interval (wherein heart rate speed and AS/AP-VS interval proportional), for guaranteeing that maximum using self Atrioventricular Conduction participates in the CRT curative effect of LV pace-making, we design CRT-GZ1 and repeatedly can realize above-mentioned automatic measurement, arrange the function of pace-making:

1. definite-time scan pattern, namely according to the setting of program, automatically the time (6 is fixed by the AS/AP-VP interval triggering the narrowest QRS time limit, 12, 24, 36, 48, 60, 72 hours are available) CRT pacing therapy after, again re-execute negative scanning or positive scanning search that AS/AP-VP is 70-300ms scope, to find next CRT pacing therapy new AS/AP-VP interval, namely automatic is 70-300ms scope by AS/AP-VP, the AS/AP-VP interval in negativity or positivity scanning search the narrowest QRS time limit, to be fixed the time (6, 12, 24, 36, 48, 60, 72 hours are available) CRT pacing therapy process repetitive cycling like this.

2. frequency self-adaption scan pattern, treat in the time-histories of pace-making LV at above-mentioned CRT, change absolute value >=the 200ms of 10 minutes more last scanning radixes is continued when AS-AS interval, it is that the negative of 70-300ms scope is swept or just sweep that CRT-GY1 automatically performs with AS/AP-VP, again to search for the AS/AP-VP interval in the narrowest QRS time limit, to set up the CRT pacing therapy process of new set time (6,12,24,36,48,60,72 hours available) ..., repetitive cycling like this.

As shown in fig. 1, human body signal, by the 2 intracardiac signal imitation process in tunnel, after A/D conversion, becomes digital signal and enters MCU.MCU is by information such as program control instrument system acquisition parameters are arranged.MCU controls power management by battery management system.MCU controls by pulse generating system, laser pulse forming system, pulse parameter adjustment system the boost pulse that 2 tunnels export human body.

In Fig. 2, N is that pace-making number (1,2,4,8 fourth gear can be selected) is entered in each scan period single step arranged, and n is remaining pace-making number of times in the scan period; T is the scanning step (5,10,15,20 fourth gear can be selected) arranged, unit ms; T is AS/AP-VP value, unit ms; X is positive and negative scanning times, and initial value is 0; AS/AP-VP value when Tx is xth time scanning; Q is QRS wavelength degree, unit ms; QRS wavelength degree when Qn is each scan period n-th pace-making, average QRS wavelength degree when Qx is xth time scanning, unit is ms.Program from by N assignment to n, sweep judgement through positive and negative; Each cycle pace-making number circulation; Whether surmount automatic search scope to judge; Qx to average etc. step, finally in a series of QX value, chooses minima, then calculates corresponding AS/AP-VP value, be the AS/AP-VP value of needs, EP (end of program).

The flow process of automatic search trace routine and the work of CRT pacing therapy is simply described in Fig. 3.From optimum configurations, installation connection electrode, then automatic search trace routine, draw AS/AP-VP numerical value, carry out long-range CRT with this numerical value and treat pace-making, time in pace-making process as occurred that patient self heart rate occurs more obviously to change, stop CRT treating pace-making work, and restart the work of automatic search measure portion; Or until complete the work of predetermined C RT pacing therapy, after enter next stage automatic search process of measurement.

The search process of measurement arranging CRT-GY1 in Fig. 4 is forward scan, stepping 10ms, and it is 1 that fixing pace-making number is entered in single step.First forward scan cycle, AS-VP=70ms, pace-making 1 time; Second forward scan cycle, AS-VP=80ms, pace-making 1 time; The 3rd forward scan cycle, AS-VP=90ms, pace-making 1 time ...When forward scan is to (the 10th cardiac cycle) during AS-VP >=160ms, there is AS-VS (namely atrial impulses passes exciting ventricle under self atrioventricular node).When in this time search sweep, AS-VP interval is 130ms (the 7th cardiac cycle), the QRS ripple time limit the narrowest (130ms).

This utility model depends on patient self Atrioventricular Conduction state, under the substantially N/R state of function of atrial-ventricular node, to automatically perform AS/AP-VP be just sweeping of 70-300ms scope or negative sweep search, and automatic search detect AS/AP-VP interval and QRS time limit in the process, namely AS/AP-VP interval, is by the stepping preset, dynamic change AS/AP-VP interval (AS/AP-VP interval=AS/AP-VS interval ± stepping), carry out the search type scanning pace-making that successively decreases/increase progressively, the QRS time limit of real-time automatic measuring AS/AP-VP interval and VP simultaneously.Its objective is the dynamic scan pace-making undertaken by AS/AP-VP interval, search VP ventricular fusion beat reaches the AS/AP-VP interval in the narrowest time limit.Then with the AS/AP-VP interval corresponding to the narrowest QRS ripple time limit searched for pacing parameter, perform and relatively long-time fixing resynchronization CRT pacing therapy carried out to patient.Following according to patient self heart rate speed whether, two specific embodiments of CRT-GZ1 pace-making RA and non-pacing RA mode are provided.

Embodiment 1: non-pacing RA mode

(1) implementation condition

Patient is sinus rhythm, is the relevant fixed relationship of 1:1 without obvious arrhythmia, average Ventricular Rate >50 ~ 60bpm, electrocardiogram display P ripple to QRS ripple.

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

Application routine techniques under local anesthesia, RA electrode and LV electrode (LV electrode is placed in lateral vein or the rear flank vein of Coronary vein) is implanted through subclavian vein approach, after the parameter testing completing pacing electrode catheter, respectively the atrium of RA electrode and LV electrode and CRT-GZ1 and ventricle are inputted/export and be reliably connected, and electrode and CRT-GZ1 are fixed, to be embedded in upper breast subcutaneous.

(3) optimum configurations

CRT-GZ1 pacing mode is atrial synchronous ventricular pacing type (VAT); Arrange for patient basic pacing frequency (TS1S1 interval) lower than self average heart rate 5,10,15,20bpm, design parameter can be selected; Arrange negative sense and/or forward scan stepping (5,10,15,20ms), the minimum and maximum of AS-VP is fixed as 70ms and 300ms respectively.No matter negative sweep or just sweep, its automatic search sweep limits is all fixedly installed as 70-300ms, and negative sweeping is from 300ms, is swept to 70ms terminates by stepping is negative; Just sweeping namely for by 70ms, be just swept to 300ms by stepping and terminating.Each AS-VP interval arranges single step, and to enter fixing pace-making number be that 1,2,4,8 fourth gear can be selected, and design default value is 2.In addition, time-histories (6,12,24,36,48,60,72 hours available, default value 12 hours) is treated for each therapeutic AP-VP interval arranges fixation of C RT.

(4) collection of intracavity electrocardiosignal and the scanning of AS-VS interval

After CRT-GZ1 pacemaker is started working, collect be derived from pacing electrode catheter bipolar/the intracavitary electrogram analogue signal of one pole, first by hardware processing and amplifying, input computer A/D immediately, simulation intracavitary electrogram is rapidly converted into digital signal, under CPU controls, with CRT-GY1 logical algorithm, the process of batch intellectualizing system is carried out to this signal, comprise by the identification to digital signal waveform flex point slope variation, calculating and fixed point, measure the AS initial point of X axis, VS/VP initial point and destination node and AS-VS interval.

(5) Establishment and screening of CRT therapeutic AS-VP interval

Input in the atrium of RA electrode and LV electrode and CRT-GZ1 and ventricle/export and be reliably connected, under stationary state, CRT-GZ1 pacemaker commences work without delay, perform the AS-VP interval (70-300ms) of CRT-GZ1 setting, adopt negative sense or the scanning of forward VAT pace-making.Such as, when the search process of measurement of CRT-GY1 programming is negative sense scanning, stepping 10ms, it is 2 that fixing pace-making number is entered in single step, then first negative sense scan period, AS-VP=300ms, continuous pace-making 2 times; Second negative sense scan period, AS-VP=290ms, continuous pace-making 2 times; The 3rd negative sense scan period, AS-VP=280ms, continuous pace-making 2 times ...When negative sense is scanned up to AS-VP≤70ms, search process of measurement stops automatically, and automatically notify CRT-GZ1, inquiry this time search is measured in scanning process, under the state what AS-VP interval be worth at, the QRS ripple time limit is the narrowest, and within 5-10 second, the AS-VP interval triggering the narrowest QRS ripple time limit, is set to CRT therapeutic AS-VP interval by CRT-GZ1 automatically, enters the CRT pacing therapy of the VAT mode of relatively long time-histories immediately.Again such as, when the search process of measurement of CRT-GY1 programming is forward scan, stepping 5ms, it is 3 that fixing pace-making number is entered in single step, then first forward scan cycle, AS-VP=70ms, pace-making 3 times; Second forward scan cycle, AS-VP=75ms, pace-making 3 times; The 3rd forward scan cycle, AS-VP=80ms, pace-making 3 times ...When forward scan is to AS-VP >=300ms, search process of measurement stops automatically, and automatically notify CRT-GZ1, to inquire about in this search sweep AS-VP interval under the state of what value, the QRS ripple time limit is the narrowest, and within 5-10 second, the AS-VP interval triggering the narrowest QRS ripple time limit, is set to CRT therapeutic AS-VP interval by CRT-GZ1 automatically, enters the CRT pacing therapy of the VAT mode of relatively long time-histories immediately.

(6) the repetition Establishment and screening of therapeutic AS-VP interval

Carry out CRT with therapeutic AS-VP interval to treat the fixing time-histories of pace-making (6,12,24,36,48,60,72 hours available, give tacit consent to 6 hours) terminate after, again re-execute search and measure AS-VP interval, automatic positivity or negativity scanning search AS-VP interval, (6,12,24,36,48,60,72 hours available to be fixed the time with the AP-VP interval triggering the narrowest QRS time limit, give tacit consent to 6 hours) the CRT pacing therapy process of VAT pattern ..., repetitive cycling like this.

Carrying out in the process of CRT pace-making with therapeutic AS-VP interval, when patient self heart rate occur more obviously change (be preset as AS-AS interval continue 10 minutes more last scanning time radix change absolute value >=200ms) time, namely AS-VS interval, is measured in autoboot search, namely within the scope of 70-300ms, negativity or positivity scanning survey AS-VP interval, to seek the AS-VP interval in the narrowest QRS time limit, and re-execute CRT pace-making LV with VAT pattern and treat.

Embodiment 2: pace-making RA mode

(1) implementation condition

There is obvious sinus bradycardia, sinoatrial block or sinus arrest in patient, average Ventricular Rate <50bpm.

(2) connection of pacing electrode catheter and CRT-GZ1, implantation, application routine techniques are under local anesthesia, RA electrode and LV electrode (LV electrode is placed in lateral vein or the rear flank vein of Coronary vein) is implanted through subclavian vein approach, after the parameter testing completing pacing electrode catheter, respectively the atrium of RA electrode and LV electrode and CRT-GZ1 and ventricle are inputted/export reliably be connected, fixing, electrode and CRT-GZ1 are fixed, to be embedded in upper breast subcutaneous.

(3) optimum configurations

CRT-GZ1 pacing mode is DDD/DDDR; Arrange for patient basic pacing frequency (TS1S1 interval) higher than self average heart rate 5,10,15,20bpm, design parameter can be selected; Arrange forward and/or negative sense scanning stepping (5,10,15,20ms), minimum or maximum AP-VP value (scope 70-300ms), arrange dynamic AP-VP interval (dynamic AP-VP interval=AP-VS interval ± stepping, stepping 5,10,15,20ms is optional, design default value is 10ms).Entering fixing pace-making number for each AP-VP interval scan setting single step is that 1,2,4,8 fourth gear can be selected, and design default value is 2.In addition, time-histories (6,12,24,36,48,60,72 hours available, default value 12 hours) is treated for each therapeutic AP-VP interval arranges fixation of C RT.

(4) collection of intracavity electrocardiosignal and the scanning of AP-VS interval

Gather pacing electrode catheter bipolar/the intracavitary electrogram simulation signal generator of one pole, first by hardware processing and amplifying, input computer A/D immediately, simulation intracavitary electrogram is rapidly converted into digital signal, under CPU controls, with CRT-GY1 logical algorithm, the process of batch intellectualizing system is carried out to this signal, comprise the identification to digital signal waveform flex point slope variation, calculating and fixed point, measure the AS/AP initial point of X axis, VS/VP initial point and destination node and AS/AP-VP interval.

(5) Establishment and screening of CRT therapeutic AP-VP interval

According to default dynamic AP-VP interval, adopt negative sense and the scanning of forward DDD/DDDR pace-making.Input in the atrium of RA electrode and LV electrode and CRT-GZ1 and ventricle/export reliably be connected, under stationary state, CRT-GZ1 pacemaker is started working, and by forward or the scanning of negative sense pace-making, performs the AP-VP interval (70-300ms) of CRT-GZ1 setting.Such as, when programming is negative sense scanning, stepping 10ms, it is 4 that fixing pace-making number is entered in single step, then first negative sense scan period, AP-VP=300ms, continuous pace-making 4 times; Second negative sense scan period, AP-VP=290ms, continuous pace-making 4 times; The 3rd negative sense scan period, AP-VP=280ms, continuous pace-making 4 times ...When negative sense is scanned up to AP-VP≤70ms, search process of measurement stops automatically, and automatically notify CRT-GZ1, to inquire about in this search sweep process AP-VP interval under the state of what value, the QRS ripple time limit is the narrowest, and within 5-10 second, the AP-VP interval triggering the narrowest QRS ripple time limit, is set to CRT therapeutic AP-VP interval by CRT-GZ1 automatically, enters the CRT pacing therapy of the DDD/DDDR mode of relatively long time-histories immediately.Again such as, when CRT-GY1 programming is forward scan, stepping 20ms, it is 2 that fixing pace-making number is entered in single step, then first forward scan cycle, AP-VP=70ms, continuous pace-making 2 times; Second forward scan cycle, AP-VP=90ms, continuous pace-making 2 times; The 3rd forward scan cycle, AP-VP=110ms, continuous pace-making 2 times ...When forward scan is to AP-VP >=300ms, search process of measurement stops automatically, and automatically notify CRT-GZ1, to inquire about in this search sweep process AS-VP interval under the state of what value, the QRS ripple time limit is the narrowest, and within 5-10 second, the AP-VP interval triggering the narrowest QRS ripple time limit, is set to CRT therapeutic AP-VP interval by CRT-GZ1 automatically, enters the CRT pacing therapy of the DDD/DDDR mode of relatively long time-histories immediately.

(6) the repetition Establishment and screening of therapeutic AP-VP interval

Carry out CRT with therapeutic AP-VP interval to treat the fixing time-histories of pace-making (6,12,24,36,48,60,72 hours available, give tacit consent to 6 hours) terminate after, again re-execute search and measure AP-VS interval, automatic negativity or positivity scanning search AP-VP interval, (6,12,24,36,48,60,72 hours available to be fixed the time with the AP-VP interval triggering the narrowest QRS time limit, give tacit consent to 6 hours) DDD pacing therapy process ..., repetitive cycling like this.

Carrying out in the process of CRT pace-making with therapeutic AP-VP interval, when patient self heart rate occur more obviously change (be preset as AS-AS interval continue 10 minutes more last scanning time radix change >=200ms) time, i.e. increased heart rate or slow down, Ventricular Rate cycle shorten in average or increase above more than 200ms, CRT-GY1 autoboot negativity or positivity scanning survey AS-VP interval, again to seek the AS/AP-VP interval in the narrowest QRS time limit, perform CRT pace-making LV treatment.

Be worth special instruction, although this utility model contains the pattern that above-mentioned non-pacing RA and pace-making RA two kinds searches for surveying work, in actual clinical uses, CRT-GY1 execution algorithm software is the operation category of a total tune.Such as, under self sinus frequency faster situation, perform non-pacing RA mode (i.e. AS-VP interval), and when patient self sinus frequency is lower or when there is sinus node dysfunction, the DDD/DDDR mode of operation of CRT-GZ1 can under the pacing parameter condition preset, namely, within basic boost pulse TS1S1 interval, auto-steering performs pace-making RA mode (i.e. AP-VP interval).Then Dynamic Execution AS/AP-VP interval scanning search measurement function, and by negative sense or forward scan, find the therapeutic AS/AP-VP interval triggering the narrowest QRS ripple time limit.

More than describe and show, CRT-GZ1 mode of operation and existing CRT design obviously different, the former not only reduces the implantation of a RV pacing electrode catheter and the adjustment of LV-RV/RV-LV interval is arranged, and can realize complete independently and need artificial and program-controlled equipment to follow up a case by regular visits to regular after implantation CRT operation in patients in a large number.Simultaneously, because CRT-GZ1 is within the time that can arrange, automatically repeatedly perform AS/AP-VS/VP search to measure, to seek at any time, self Atrioventricular Conduction participates in, LV pace-making triggers the probability of the AS/AP-VP interval in the narrowest QRS time limit and greatly improves, and improves the self adaptive response rate of CRT further.Therefore, CRT-GZ1 is arranged according to initial parameter and pacing mode implements conversion automatically, the independent atrium to whole search measuring period, ventricle and atrioventricular conduction time identify, measure, analyze and judge, and automatically, repeat dynamic best AS/AP-VP interval pace-making, utilizing the participation of self Atrioventricular Conduction in ventricular fusion beats is formed to greatest extent, is key foundation of the present utility model.

Pulse generator based on the following cardiac resynchronization therapy of self Atrioventricular Conduction comprises ecg amplifier and two-way pulse generator in the two-way chambers of the heart, and the overall operation control centre that microprocessor (MCU) is formed.Pulse generator is communicated with human heart with left room electrode by the right room electrode be positioned in the chambers of the heart, provides CRT pulse and accepts myocardium electricity physiological signal.Ecg amplifier in the two-way chambers of the heart, when accepting and process atrium and ventricular electrophysiology signal, can adopt double pole mode by two-chamber simultaneously, also can adopt unipolar lead pattern by two-chamber simultaneously; Also can adopt one pole in a chamber, another chamber adopts bipolar lead pattern.In the two-way chambers of the heart, ecg amplifier hardware gain is 50-100 times, 50/60Hz trap circuit, and crest frequency is optional; Simultaneously by 4 grades of Ingeborg Bachmann wave filter, realizing amplifier band passband rate is 5-200Hz.Ecg amplifier in the two-way chambers of the heart, after original electro-cardiologic signals hardware handles, enter the modulus processor (A/D conversion) of MCU, it adopts 12 times of SAR structures.Two-way pulse generator, its 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, negative sense and two-way optional, acquiescence negative sense.Pacemaker microprocessor (MCU), after changing ECG simulator signal into digital signal by its A/D converter, immediately digitized post processing is carried out to this signal, comprise the amplitude controlling to signal, 50/60Hz trap high q-factor advanced treating, numeral level Four high pass and low-pass filtering, bandwidth optimization processing cutting (5-150Hz scope).Electrocardiosignal bandwidth optimization process, refer to the program sent by the MCU of pulse generator, namely the serial electrocardiosignal that AS/AP-VS automatic search produces implements omnidistance logical algorithm process, the content of process contains each real-time AS/AP-VS information, i.e. AS/AP starting point coordinate, VS starting point and end of the final point coordinate, and calculate AS/AP-VS interval.Coordinate data is stored in data base, the logical algorithm program of dependenceization words, finally determines the AS/AP-VS interval that the narrowest VS realization occurs.Logical algorithm program has determined the AS/AP-VS interval that the narrowest VS (QRS ripple) time limit occurs, and MCU treats timing by the CRT arranged immediately, performs and treats with the CRT of AS/AP-VS interval.The CRT treatment that MCU performs is that the timing arranged limits, and the timing of CRT treatment is fixed as 6/12/24/36/48/72 hour and can sets.Treated once this CRT, MCU starts to repeat new AS/AP-VS automatic search program.Scanning and the negative sense program scanning with forward program are selected to arrange function.Design parameter also comprises forward/negative sense scanning stepping and arranges, and be divided into 5/10/15/20ms4 shelves optional, sweep programmed state to negative, minimum AP/AS-VP interval is not less than 70ms; Align and sweep programmed state maximum AP/AS-VP interval and be not more than 300ms.

Based on the pulse generator of the following cardiac resynchronization therapy of self Atrioventricular Conduction to the signal of telecommunication in the chambers of the heart, i.e. AS, AP, the collection of VS or VP, focus on the low middle-end frequency range of its signal source, namely in 5-100HZ bandwidth, object is easy to AS, AP, simulated and digitized processing is more accurately implemented in the starting point of VS or VP excitement and end of the final point, by hardware circuit and software programming, the multiple unordered higher hamonic wave of the signal of telecommunication in the filtering chambers of the heart, retain AS, AP, the low middle-end frequency content of VS or VP starting point clearly signal source relative to end of the final point, so that logical algorithm is easily by the flex point slope variation of waveform, calculate, analyze and judge, more accurately measure the AS/AP initial point of X-axis time arrow and VS/VP initial point and destination node.

More than show and describe ultimate principle of the present utility model and principal character and advantage of the present utility model.The technical staff of the industry should understand; this utility model is not restricted to the described embodiments; what describe in above-described embodiment and description just illustrates principle of the present utility model; under the prerequisite not departing from this utility model spirit and scope; this utility model also has various changes and modifications, and these changes and improvements all fall within the scope of claimed this utility model.The claimed scope of this utility model is defined by appending claims and equivalent thereof.

Claims (7)

1. based on a following cardiac resynchronization therapy pulse generator for self Atrioventricular Conduction, it is characterized in that: comprise the overall operation control centre that ecg amplifier in the two-way chambers of the heart, two-way pulse output and microprocessor are formed.Described pulse generator is communicated with human heart with left room electrode by the right room electrode be positioned in the chambers of the heart, provides the following cardiac resynchronization therapy pulse based on self Atrioventricular Conduction and accepts myocardium electricity physiological signal.

2. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 1, it is characterized in that: ecg amplifier in the described two-way chambers of the heart, when accepting and process atrium and ventricular electrophysiology signal, double pole mode can be adopted by two-chamber simultaneously, also can adopt unipolar lead pattern by two-chamber simultaneously, also can adopt one pole in a chamber, another chamber adopts bipolar lead pattern.

3. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 2, it is characterized in that: in the described two-way chambers of the heart, ecg amplifier hardware gain is 50-100 times, 50/60Hz trap circuit, crest frequency is optional and by 4 grades of Ingeborg Bachmann wave filter, realizing amplifier band passband rate is 5-200Hz.

4. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 3, it is characterized in that: in the described two-way chambers of the heart, ecg amplifier is by after original electro-cardiologic signals hardware handles, enter the modulus processor (A/D conversion) of MCU, adopt 12 times of SAR structures.

5. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 4, it is characterized in that: described two-way pulse generator pulse width is 0.1-1.0ms, stepping ± 0.1ms, boost pulse voltage range is 1-10V, stepping ± 1.0V, boost pulse waveform forward, negative sense and two-way optional, acquiescence negative sense.

6. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 1, it is characterized in that: after described microprocessor changes ECG simulator signal into digital signal by its A/D converter, digitized post processing is carried out to this signal, comprise the amplitude controlling to signal, 50/60Hz trap high q-factor advanced treating, numeral level Four high pass and low-pass filtering, the bandwidth optimization processing cutting of 5-150Hz scope.

7. the pulse generator of a kind of following cardiac resynchronization therapy based on self Atrioventricular Conduction as claimed in claim 6, it is characterized in that: described electrocardiosignal bandwidth optimization process, refer to the program sent by the MCU of pulse generator, namely the serial electrocardiosignal that AS/AP-VS automatic search produces implements omnidistance logical algorithm process, the content of process contains each real-time AS/AP-VS information, i.e. AS/AP starting point coordinate, VS starting point and end of the final point coordinate, and calculate AS/AP-VS interval, coordinate data is stored in data base, rely on the logical algorithm program of solidification, finally determine the AS/AP-VS interval that the narrowest VS realization occurs.