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CN109420254A - A kind of pacemaker and cardiac pacing system for realizing CRT treatment based on single electrode - Google Patents

A kind of pacemaker and cardiac pacing system for realizing CRT treatment based on single electrode Download PDF

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Publication number
CN109420254A
CN109420254A CN201710774566.3A CN201710774566A CN109420254A CN 109420254 A CN109420254 A CN 109420254A CN 201710774566 A CN201710774566 A CN 201710774566A CN 109420254 A CN109420254 A CN 109420254A
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crt
electrode
signal
impulse generator
pacing
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吴强
俞杉
范寿年
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36507Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by gradient or slope of the heart potential
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Physiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention discloses a kind of pacemakers and cardiac pacing system that CRT treatment is realized based on single electrode, the cardiac pacing system includes pacemaker and the program control instrument for controlling pacemaker, the pacemaker includes impulse generator and a pacing catheter, the impulse generator includes shell and the pulse generating system in shell, and the shell includes metal upper shell body, metal lower shell body and the dielectric isolation layer between metal upper shell body and metal lower shell body.The present invention abandons the separating treatment status that tradition CRT individually receives right room, right ventricle and left room signal by more electrodes, realize that impulse generator shell and left room epicardial lead construct bipolar symmetrical expression AV signal unipath and acquire, A wave, V wave and the processing of AV conformability are realized, to provide EGC parameter necessary to whole CRT technology.Clinical manipulation of the present invention is more easy, and production cost and price are more cheap, and intelligence degree is higher.

Description

A kind of pacemaker and cardiac pacing system for realizing CRT treatment based on single electrode
Technical field
The invention belongs to field of medical technology, and in particular to a kind of pacemaker that CRT treatment is realized based on single electrode And cardiac pacing system.
Background technique
Currently, routine clinical CRT technology is in clinical application, mostly using implantation each of three electrodes conduit, implantation is right respectively Room apex, right Fang Xiner, left room.Wherein left room electrode catheter is by after coronary sinus, into the vein after left room side wall, Realize Epicardial pacing.It specifically, is exactly vein in left ventricle, each of three electrodes altogether are placed in right ventricular apex, atrium dextrum, with Realize atrium dextrum (RA) and left and right double-ventricle pacemaker mode.By the individuation atrioventricular interval (A-V that pacing pulse generator is arranged Interphase), indoor conduction intervals (LV-RV/RV-LV interphase), perceptual performance, pace-making performance, rate response, perception response, pace-making/ The parameters such as polarity are perceived, strive realizing that ECG-QRS Wave is most narrow, Atrioventricular sequence is best, echocardiogram ventricular synchronous index (E-A, VTI, MR, LVEDD, LVEF, IVMD and SPWMD etc.) is optimal, and patient symptom is most light and complication is minimum, changes to reach The therapeutic purposes of kind CHF patient symptom and prognosis.Although CRT achieves the treatment of the CHF patient of lock-out and attracts people's attention Achievement, but part CHF patient reactionless annoyings to CRT low reaction or even still patients and clinicians.
Clinical studies show at present, the preoperative QRS wave of idicatio patient is wider, the QRS wave time limit is narrower after implantation CRT, suffers from Person is higher to the reactivity of CRT;And Candidacy selection improper (too late such as implantation opportunity), LV electrode position bad or dislocation, CRT The non-dynamic optimization of parameter, drug therapy and psychological intervention are improper and with factors such as other complication, then may cause nearly three points One of CHF patient, to CRT treat it is reactionless, wherein the influence factor to make number one is exactly inappropriate A-V Interval.For The double-ventricle pacemaker for obtaining 100% generally requires that shorter A-V Interval is arranged, but too short A-V Interval can shorten ventricle and relax Time phase is opened, leads to ventricle premature contraction, two/premature tricuspid closure, not only reduces cardiac output, it is " auxiliary to impair atrium Help pump " function.Independent LV pace-making can extend the right ventricular filling time, increase pulmonary artery flow, reduce venous system extravasated blood, It connects and increases patient's oxygen content of blood and left heart blood back, reduce atrioventricular valve and backflow, delay even to reverse chamber enlargement.Due to absolutely mostly Number CHF patients are sinus rhythm, function of atrial-ventricular node Non Apparent Abnormality, and the at a specified future date risk that atrioventricular block occurs is lower, therefore Simple LV pace-making, rather than double-ventricle pacemaker, if ventricular synchronous may be restored, cause the interest of educational circles.
EATER-EARTH registration studies and some sample sizes it is smaller non-pessimum clinical research discovery, with CRT pace-making pair LVEF (Left Ventricular Ejection Fraction)≤35%, merge complete left bundle branch block, the i.e. trouble of LBBB (QRS width >=130ms) Person has found the CRT treatment of simple LV pace-making by follow-up observation in 6~12 months by a definite date, resistance to patient clinical situation, movement The improvement degree of the indexs such as amount, LV internal diameter and function is close with the CRT therapeutic effect of left and right double-ventricle pacemaker.Meta-analysis The CRT treatment for further having affirmed simple LV pace-making, in the status of the diastolic dysfunction of ventricle mechanical movement lock-out.
Based on the status analyzed and current CRT technology develops above in relation to this working principle of CRT base, for atrioventricular node (AV) it is normally passed down with 1:1, and the not LBBB patient of severe bradyarrhythmia, if being suitable for executing CRT through clinical diagnosis Pacing therapy then can not consider the pace-making in right room, to save an electrode catheter.It can be to give up right room electrode, it is right For CRT treatment technology, will imply that can not obtain atrium dextrum (RA) information, can not more crucially be obtained by hardware and software Take AS-VS/VP interphase so that AS-VP automatic search sweep program necessary to CRT is treated can not be executed, can not seek to It is found necessary to CRT treatment by scanning search process and most narrow VP occurs, be also impossible to necessary to discovery CRT treatment certainly The corresponding AS-VP interphase of most narrow VP (QRS).
Summary of the invention
Realize that the impulse generator of CRT treatment makes pulse by unitary electrode based on single electrode the present invention provides a kind of Generator obtains the AS-VS information under quiescent condition, and based on AS-VS interphase, and it is corresponding to find the most narrow V wave of generation AS-VP interphase.
The technical solution of the present invention is as follows: it is a kind of based on single electrode realize CRT treatment impulse generator, including shell and Pulse generating system in shell, the shell include metal upper shell body, metal lower shell body and be located at metal upper shell body Dielectric isolation layer between metal lower shell body.
The present invention is according to the principle of human body electrocardio volume conduction and section electrocardio current potential, and clinical places embedded heart The human dissection position of pacemaker directly puts into the metal shell of the CRT impulse generator of human body, with the pace-making for being implanted into left room The current potential that the electrocardio volume electric field constructed between electrode causes implements amplification and acquisition.Just because of routine clinical placement is embedded Under the right clavicle of human body or left clavicle, no matter the region of anatomy faces away from right room or left room relative close for the position of pacemaker Bed placement CRT impulse generator is implantation human body right subclavian or left clavicle lower portion, can be led due to human body electrocardio volume The atrial electrical activity that electricity induces exists, although this current potential is comparatively small (microvolt grade).Fortunately, CRT impulse generator The pouch position of placement is subcutaneous, rather than on skin.Note that the metal shell of CRT impulse generator is placed in subcutaneous impedance, phase Than being placed on skin, the impedance contrast ratio of the two is 1:100 or more.In addition, the pacing electrode for being implanted into left room is directly attached to the left room heart Outer membrane, current potential can be bigger.Illustrate the CRT impulse generator metal shell and implantation left ventricular pacing electrode by merging human body Between chamber electrocardio potential difference, AV signal can be got, and ensure by the bipolar symmetrical electrocardio biological amplifier of single channel The hardware design of A-V Interval necessary to CRT treatment technology is feasible.Cannot dash forward depending on the problem of be tradition merging human body Implanted pacemaker, also includes CRT impulse generator now, conventional ophthalmic design be pacemaker it is extremely important and Indispensable zero potential electrode, it is subcutaneous by human body is integrally placed at.We it can make now as the anode for receiving AV signal With, then the zero potential electrode of implanted pacemaker namely CRT impulse generator this how to exist? in order to realize single channel Bipolar symmetrical expression electrocardio biological amplifier (anode, cathode, null electrode) is to AV signal acquisition, also for the left room of CRT bipolar pacing (needing ground electrode, i.e., be total to null electrode with preposition biological amplifier) pulse granting, null electrode (ground electrode) also there must be.
It therefore, is the principle of capacitance-resistance antibody according to human body, we are by (including the CRT pulse of traditional implanted pacemaker Generator) metal monolithic case gold as metal upper shell body, metal lower shell body and is located at its thick side position one dividing into three Belong to the dielectric isolation layer between upper housing and metal lower shell body, metal upper shell body constitutes impulse generator null electrode;Metal lower shell The anode of body composition impulse generator AV signal acquisition;Center portion (dielectric isolation layer) is high insulating polyimide separation layer, will Above-mentioned 2 electrode separates up and down.I.e. using be placed in the CRT impulse generator outer casing underpart (metal lower shell body) of pouch under left clavicle as Anode, shell upper layer (the metal upper shell body) of AV acquisition are used as null electrode, are implanted into left room epicardial electrode (if such as pace-making When conduit is quadrupole, two of them electrode conduction), as the cathode of AV acquisition, electrocardio life is led with by external program control instrument more Recorder is managed, can recorde experimental AV signal, so that impulse generator is obtained the AS-VS information under quiescent condition, and with AS- Based on VS interphase, finds and the corresponding AS-VP interphase of most narrow V wave occurs.
Wherein, impulse generator, equally can be in the case where completing all working state after its placement, and is also that must lead to Extra pulse generator shell electrode and the electrode for being placed in left room, separate records to the bipolar symmetrical electrocardio biology of single channel AS-VS/VP Amplified signal, to realize CRT patient in the state of leaving hospital, CRT-GY2 impulse generator can be according to doctor to CRT base This parameter setting, it is automatic to carry out AS-VP scanning search, it finds and AS-VP interphase corresponding to most narrow VP occurs, and it is fixed to start execution When property CRT pacing therapy program.
In the present invention material of dielectric isolation layer can use a variety of existing insulating materials, preferably, it is described insulation every Absciss layer is made of polyurethane material.
Preferably, the height of the metal upper shell body is 6~8mm, the height of the metal lower shell body is 6~8mm, institute The height for stating dielectric isolation layer is 3~5mm.
As further preferred, the height of the metal upper shell body is 7mm, and the height of the metal lower shell body is 7mm, institute The height for stating dielectric isolation layer is 4mm.
Existing CRT paces technology, provides pacemaker impulse by RA electrode and receives RA signal;It is risen by RV electrode granting It fights and pulse and receives RV signal.It simultaneously by collected RA and RV independent body electrocardiosignal, is synthesized, is constructed by computer software AS/AP-VS/VP interphase.Cause 2 road ecg amplifiers in its structure and deposit, the hardware and softwares such as two-way A/D acquisition it is cumbersome, Designer has to that the necessary extensive work of CRT technology and numerous functional modules are transferred to the relevant program control instrument of CRT and have been gone At;And CRT impulse generator itself does not have the function of the signal of autonomous intelligenceization processing A wave, V wave and AS-VS, also more It has no way of executing AS/AP-VS/VP interphase automatically scanning search program.It can only be led to by hospital's dedicated doctor and medical engineering persons Its relevant program control instrument is crossed, the search of AS/AP-VS/VP interphase automatically scanning is executed, AS/ corresponding to most narrow V wave occurs to find AP-VS/VP interphase, and by this interphase, parameter is executed as CRT, CRT impulse generator is sent to by program control instrument, then again Order CRT impulse generator with this AS/AP-VS/VP interphase, the CRT pace-making for carrying out sustained fixed AS-VP mode is controlled It treats, until next CRT patient changes CRT impulse generator running parameter to hospital, then row.Here it is present CRT patient is necessary The main cause of hospital's follow-up is periodically arrived at any time.Therefore, CRT external now paces technological system, only sends out with regard to current CRT pulse Function that raw device itself has, structure design, intelligence degree, clinical practice apply and clinically CRT patient because of pathology For all various aspects such as the CRT technological adaptability that physiological parameter changes, many queries are still had, are also studied to continue deeper into With exploitation CRT technology, provide can developing deeply potentiality space.
Preferably, the pulse generating system includes:
Electrocardiosignal pre-amplification circuit acquires the A-V signal of CRT patient and amplifies A-V signal;
A/D conversion module, for the amplified A-V signal of the electrocardiosignal pre-amplification circuit to be converted to digital letter Number;
MCU controller, for receiving the digital signal of A/D conversion module conveying, and based on the received, digital signal is calculated Obtain pacing parameter;
Pacing pulse generator is controlled by MCU controller, is believed according to the control signal pulsing that MCU controller issues Number;
Pacemaker impulse controller, for receiving the pacing parameter of MCU controller sending, and pacing parameter control based on the received The pulse signal parameter of impulse generator output processed;
Power supply, for providing electric energy for impulse generator.
The initial parameter that impulse generator works in the present invention is controlled by its matched program control instrument, is put before electrocardiosignal The collected weak A-V signal of big circuit, and after electrocardiosignal pre-amplification circuit enhanced processing, at A/D conversion module Digital signal is managed into, by series of programs logical algorithm in MCU controller, carries out the processing of digital signal amplitude, height again to the signal The processing such as logical and low-pass digital filter, 50/60Hz digital notch, phase calculation, X-axis A-V waveform inflection point slope discrete analysis, with The data of AS-VS/VP interphase and VS/VP time limit required for executing CRT pacing function are provided.
By the MCU controller designated port of impulse generator, positive TTL pulse is issued by program, excitation boost pulse is put Electrode ports of the big circuit to impulse generator, output CRT treatment boost pulse.Boost pulse form of the invention can have just To/negative sense/two-way optional, default configuration negative sense.0.1~1.0ms of pulse width, stepping ± 0.1ms, 10 grades optional.Stimulate arteries and veins 1~10V of voltage range is rushed, stepping ± 1.0V, 10 grades optional.Basic boost pulse TS1S1=2000~400ms (30~ Setting is selected between 150PPM).
Whether the reliability for identifying and measuring to RA and LV intracavitary electrogram 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, abandons its low end frequency signal source;The figure of acquisition is usually to mention It is used for clinical cardiac electrophysiology qualitative analysis and manual measurement time.Traditional implanted pacemaker is to atrium in the chambers of the heart or the heart The acquisition of room signal is not related to the time shaft measurement to signal source yet and calculates, is mostly to pass through signal in the collected chambers of the heart Comparative degree circuit is crossed, Transistor-Transistor Logic level is converted into and is transmitted to CPU control centre, is used as calculating heart rate and perceiving.
Impulse generator of the invention is designed on DDD/DDDR pacing pulse generator platform, and workflow is paced Journey provides AAI/AAIR, VVI/VVIR, VVT, VAT and DDD/DDDR Pattern completion by program software.The most crucial spy of the present invention Point first is that: impulse generator (CRT implanted pacemakers shell electricity outer to (signal electrode for being placed in LV) in the chambers of the heart and the chambers of the heart Pole) " fuzzy " processing of A-V electrocardiosignal of joint mapping collects CRT trouble that is, by single channel A-V signal electrocardio amplification module Person's A-V single signal, using the software and hardware and MCU controller Intelligent treatment inside CRT-GZ2, realization must to CRT technology The time limit of palpus and the acquisition of VS/VP timing information.Finally by the MCU controller of CRT-GZ2 impulse generator, determination is swept in pace-making After retouching search program, AS-VS/VP interphase corresponding to the most narrow VS/VP time limit during this will occur in, as CRT The fixed pacing parameter for the treatment of technology executes timing property CRT pace-making.
Therefore, the specific identification to A-V electrocardiogram and measuring technique become pith of the invention.The present invention mentions first Out: with CRT-GZ2 impulse generator to (signal electrode for being placed in LV) in the chambers of the heart and outer (the CRT implanted pacemakers shell of the chambers of the heart Electrode) joint mapping single channel A-V, by its signal component implement decompose and it is whole and, to obtain the acquisition of AS, AP, VS or VP.Its Between one of emphasis, be by collected signal, it is main to retain wherein low end frequency range, i.e., in 1-150HZ bandwidth, it is therefore an objective to It is easy to implement the starting point of AS, AP, VS or VP excitement and end of the final point more accurate simulated and digitized processing.Pass through hardware Circuit and software programming filter out the multiple unordered higher hamonic wave of electric signal in the chambers of the heart, retain AS, AP, VS or VP starting point and Clearly low middle-end frequency content carries out in order to which logical algorithm is easy the inflection point slope variation by waveform relatively for end of the final point It calculates, analysis and judgement, more accurately measures the AS/AP initial point and VS/VP initial point and destination node of X-axis time arrow.When In the chambers of the heart after analog signal input computer A/D, bipolar analog electrocardiogram signal is rapidly converted into digital signal by software, and to this Signal carries out batch intelligent processing, including digital band pass filtering, 50/60Hz number fall into filtering, electrocardiosignal amplification/contracting automatically Small gain control, real-time wave mode be initial/and terminal slope variation calculates and fixed point timing, automatic baseline correction;Signal shows pre- place Reason is to related program control instrument communication process etc..Therefore, the bipolar hybrid heart is outer and the chambers of the heart in signal identification and at time phase Reason, the bipolar electrocardiosignal starting of selectivity and termination identification, time measurement processing, are the important foundations of logical algorithm of the present invention.
Preferably, the gain that the electrocardiosignal pre-amplification circuit includes successively signal connection fixes 50~300 Biological amplifier, 50/60Hz trap circuit and 4 grades of Ingeborg Bachmann bandpass filters again, 4 grades of Ingeborg Bachmann bandpass filters Frequency bandwidth be 1~150Hz.
Preferably, the MCU controller includes MCU database information module, MCU message processing module and MCU control Molding block.
Preferably, the power supply includes power module, battery, battery protection system and isolated power supply.
Preferably, being equipped with for exporting power module between the power module and the pacing pulse generator The raised pulse power boost module of voltage.
The present invention also provides it is a kind of based on single electrode realize CRT treatment pacemaker, including impulse generator with And a pacing catheter, the impulse generator are above-mentioned impulse generator.
To CRT patient implement left room Epicardial pacing (4 pole) electrode normally dispose, the determination of bipolar pacing electrode position, Initial pacing threshold voltage tester terminates, program control instrument prerun CRT treatment procedure is successful, impulse generator is communicated with program control instrument again, And be implanted into the patient from program control instrument to the serial basic parameter of impulse generator transmission CRT treatment, again by impulse generator, and The left room epicardial electrode tail end for being implanted into CRT patient's body is reliably connected with impulse generator corresponding interface, upper After stating work completion, impulse generator formally enters the substantive work stage of its CRT treatment.
Firstly, impulse generator before starting its life's work, first automatically into self-check program, determines its operation again Required basic running parameter, comprising:
1. CRT pacemaker impulse width;
2. CRT pacemaker impulse form;
CRT pacemaker impulse voltage;
3. the left room epicardial electrode position (1-2,1-3,1-4,2-3,2-4) of CRT bipolar pacing pulse choice;
4. the cathode of AV collection of simulant signal, i.e., remaining in the left room epicardial lead for having been used for CRT bipolar pacing pulse One of two electrodes determined by position;
5. scanning search program is just scanning or negative scanning mode;
6. scanning search program executes stepping (default 10ms);
7. maximum (300ms) or minimum (70ms) AS-VP time that scanning search program executes;
8. CRT pacing therapy timing.
CRT-GY2 impulse generator is delayed 5 seconds after process of self-test;Start 10 seconds adaptive states, main work Work is to start to detect the atrium (A) under tranquillization, ventricle (V) and AV interphase.The preposition electrocardio biosimulation of impulse generator is amplified Device start directly to acquire the anode acquired as AV by CRT-GY2 impulse generator shell lower layer, shell upper layer as null electrode, It is implanted into the cathode that left room epicardial electrode is acquired as AV, AV analog signal is recorded in the loop combination constituted, and will This simulation AV electrocardiosignal becomes digital signal, into computer directly by the A/D digital analog converter in impulse generator Digital signal processing module enters computer waveform logic algorithm thereafter and analyzes program, parses A wave starting inflection point, the starting of V wave With terminal inflection point, and according to A wave and V wave starting inflection point calculate AV interphase.
Impulse generator is by the initial parameter received, with aforementioned calculated AV interphase, starts to execute pace-making scanning search Program.For example, the AV interphase that impulse generator has calculated that is 280ms, pace-making scanning search program initial setting up, which is negative, sweeps shape State, and bear and sweep stepping -10ms, then scanning search program is paced first after perceiving A wave with AS-VP=280ms for the first time, this A wave caused by secondary pace-making process, V wave is (produced by the ventricular activation that really QRS wave of patient itself and left room pace-making cause Ventricular fusion beat) and AV information, the anode acquired by impulse generator shell lower layer as AV, shell upper layer are as zero The cathode that electrode, the left room epicardial electrode of implantation are acquired as AV, the circuit constituted has recorded, and is sent into pulse The computer system of generator is calculated AS-VP=280ms pace-making scanning and is searched by serial waveform logic algorithm analysis module The V wave time limit of strand state, and stored and search for V wave database with related scans.Immediately pace-making scanning next time, AS-VP= 270ms, similarly not only impulse generator computer system but also obtain AS-VP=270ms pace-making scanning search state the V wave time limit, It is stored again and searches for V wave database with related scans.Until this pace-making is swept when pace-making scanning goes to AS-VP=70ms Retouching search program terminates.
Further: impulse generator computer system immediately will after discovery this time pace-making scanning search EP (end of program) Be stored in related scans search V wave database in serial V wave width data array (for example, with negative scanning mode from 280 to 70ms, stepping -10ms amount to 21 V wave width data of acquisition) it is sorted from small to large.Finally determine the smallest V wave AS-VP interphase corresponding to (time limit most narrow QRS wave) data is the result of this pace-making scanning search program.
Further: the computer system of impulse generator is wide to pace the most narrow V wave of scanning search program acquisition immediately The corresponding AS-VP interphase of degree, as the set time of CRT treatment pace-making, and inquire CRT treatment regular time parameter (such as It is 48 hours), CRT pacemaker impulse width (for example, 0.5ms);CRT pacemaker impulse form (for example, negative sense);CRT paces arteries and veins Rush voltage (for example, 1V);The left room epicardial electrode position (for example, pole 1-2) of CRT bipolar pacing pulse choice, it is quasi- It is standby to start to carry out CRT pacing therapy to patient.
Further: impulse generator start by CRT treat regular time parameter, with VAT (atrial sense, ventricular stimulation, Triggering type) based on pacing mode, to patient's being timed property CRT pacing therapy.CRT treatment timing terminates, this CRT Pacing therapy is accused and is completed.At this point, the computer system of impulse generator immediately to be stored in related scans search V wave database In serial V wave data array reset, while removing generated whole real time datas in executing last time CRT treatment.
Further: impulse generator returns to its initial self-test, starts 10 seconds adaptive states, intends preparing next time Pace-making scanning search program and CRT pacing therapy process.Such repetitive cycling.
Preferably, the pacing catheter is 2~4 pole pacing catheters.
Preferably, the pacing catheter is 4 pole pacing catheters, the electrode on the pacing catheter of 4 pole is by distal end to closely End respectively is first electrode, second electrode, third electrode and the 4th electrode, and the first electrode and the 4th electrode are led Logical, composition receives the cathode of AS-VS/VP physiological ecg signal, and constitutes AS-VS/VP cardiac electrophysiology with the impulse generator Signal anode, the second electrode are pacemaker impulse cathode, and the third electrode is pacemaker impulse anode.
Using the design standard of a left 4 pole pacing catheter of room, in order to realize bipolar left room pace-making and the bipolarity AS-VS heart Electricity physiological signal receives, in conjunction with above-mentioned impulse generator.To the 4 pole electrode pacing catheters for being placed in left room, electrode tip merging is suffered from The left room external membrane of heart of person, tail end (connecting pin) is before the installation of CRT implanted pacemakers for the first time, first journey matched with impulse generator Control the connection of instrument corresponding interface;It will be put into the corresponding interface of two electrode of impulse generator shell of patient's pouch simultaneously, passed through spy The connecting wire of system, is reliably connected with program control instrument.
Thereafter, start to be executed automatically by the matched program control instrument of impulse generator to the 4 pole electrodes for being placed in left room, be risen It fights threshold value determination, and the logical series judgement of corresponding pacing electrode position optimization selective screening.Content of parameter includes electrode Between between impedance detection (200~2000 ohm of range), electrode pace-making vector variation prediction it is program-controlled provide (0.5~4.0V of range, step Into+0.5V.From low to high with pace-making vector, until continuing three ventricular captures stops electrode combination pace-making vector survey Examination);Bipolar left room pacing electrode test selecting sequence is by electrode label 1-2 (first electrode to second electrode), 1-3 (the first electricity Best third electrode), 1-4 (first electrode to the 4th electrode), 2-3 (second electrode to third electrode), (second electrode is extremely by 2-4 4th electrode), 3-4 (third electrode to the 4th electrode) automatically carry out.All detection data and relational graph, by pulse Database storage and processing in the matched program control instrument of generator, and can show and call in a tabular form.
After left room bipolar pacing determines optimum electrode combination, the electrode number information column of related program control instrument display panel Respective electrode number flashes (orange) automatically.With example: if electrode 2-3 combination is selected, the flashing of 2 and 3 signal lamp positions continues 3 Second 2 and 3 signal lamp positions become constant orange illuminating state.Meanwhile remaining 1 and 4 electrode number light start therewith in green And flash, also clock for 3 seconds, when 1 and 4 signal lamp positions become constant green illuminating state, show 1 to 4 electrodes in related journey Control instrument Inner Constitution on state.Continue with example, the final conduit for being placed in Left Ventricular, 4 electrodes are (by distal end to proximal end point Be not defined as first electrode, second electrode, third electrode, the 4th electrode) function distribution are as follows: second electrode is negative for pacemaker impulse Pole;Third electrode is pacemaker impulse anode;First electrode and the 4th electrode conduction collectively constitute and receive AS-VS/VP cardiac electrophysiology The cathode of signal, and the AS-VS/VP physiological ecg signal anode constituted with Virtual pulse generator outer casing underpart, form weak life Signal electrical circuit is managed, ECG preamplifier inside related program control instrument is input to, to acquire AS-VS signal.At this point, in related journey The information of reality AS-VS, operates program control instrument panel, to obtain the work in relation to ECG preamplifier when control instrument CED screen display goes out Make parameter and saves it.
The left room pacing catheter being placed in patient's chambers of the heart, first electrode, second electrode, third electrode, the 4th electrode Combination, be switched on and off state, be that a switching circuit and two either-or switch are selected by four four inside related program control instrument Circuit and relevant logic control circuit are constituted.Each four select being switched on and off for a switch and either-or switch circuit, The instruction control issued by program control instrument inner computer by its port I/O.The timing of I/O port command is in original state (original state here refers to that left ventricular catheter has been placed in patient's chambers of the heart, left room electrode tail end is reliably held in the mouth with impulse generator Connect, impulse generator and the communication of related program control instrument) complete in the case where, program control instrument master controller passes through the port I/O and two first A switch module, it is preferential to carry out left ventricular catheter compound electrode resistance value detection, then start to execute compound electrode pacing threshold survey It is fixed.Thereafter, program control instrument master controller is handled according to the data of acquisition through automatic Synthesis analysis, determines best pacing electrode combination Position.Under the premise of herein, instruction is assigned by other another switch module in the port I/O, executes remaining to left room pacing catheter Two electrodes execute turn-on action, to realize the cathode port for receiving AS-VS electrocardiosignal.
After the completion of above-mentioned task, the parameters in series that related program control instrument is obtained is transmitted to CRT-GY2 pulse by wireless telecommunications Generator, parameter include pacing the electrode position volume of left room electrode position coding, pace-making vector, 2 poles conducting reception AS-VS signal Code, AS-VS/VP physiological ecg signal amplifier operation bandwidth frequency, amplification factor etc..It is only for CRT-GY2 impulse generator The parameter that basis is established in vertical work prepares.
The present invention also provides a kind of cardiac pacing systems that CRT treatment is realized based on single electrode, including pacemaker And the program control instrument for controlling pacemaker, the pacemaker are above-mentioned pacemaker.
For the present invention with the CRT standard pacing catheter of a clinical tradition application at present, conduit number is 2~4 poles, for example, 4 When pole, wherein 2 poles, using bipolar lead mode, for acquiring atrium and ventricle analog signal;Other 2 pole, using mono-/bis-pole Pacing stimulation mode is paced for left room (LV).More it is essential that the clinical method established according to the present invention, Yi Jiben The pacing pulse generator main structure of invention automatically analyzes and identifies the heart, it can be achieved that by pacing pulse generator independent acquisition Room electrograph initial slope converts inflection point, electroventriculogram starting and terminal initial slope and converts inflection point, and calculates P-R interphase with this (AS-VS/AS-VP) and the QRS time limit (VS/VP).It can be achieved to execute AS-VP pace-making scanning search automatically by pacing pulse generator Program, and scanning search data are paced according to AS-VP, when automatically analyzing, finding generation most narrow QRS (VP) during scanning search Limit corresponding AS-VP interphase;Finally to occur the P-R interphase in most narrow QRS (VP) time limit during scanning search, i.e. between AS-VP Phase executes timing property CRT pacing therapy.
Preferably, further include CRT dummy electrodes, can fixed placement planning to place the impulse generator with clinic In the tissue of position, the tail end of CRT dummy electrodes is connect with the program control instrument signal.
By the test board of CRT test fixture (CRT dummy electrodes), it is placed on and plans CRT-GY2 pulse to be placed with clinic In the tissue of generator position (pouch), and fixed, tail end jack connection corresponding with mating program control instrument.It is tested with CRT The position of fixture is AV signal anode, and the implantation remaining electrode of Left Ventricular epicardial electrode is AV signal cathode, the two The electrical circuit of composition, to acquire AV electrocardiosignal, and real-time display is in program control instrument LED screen.If pacing electrode is 4 poles, due to Two electrodes in left 4 pole pacing electrode of the room external membrane of heart are occupied by left room pacing function, therefore, participate in AV signal acquisition circuit Left room epicardial electrode can only be just its remaining two electrode, using this remaining two electrode as AV information collection Cathode use.After program control instrument starts AV collection of simulant signal, by carrying out analog signal amplification to AV electrocardiosignal, and implement Second order voltage controlled voltage source Butterworth low pass and high-pass filtering, 50/60HZ trap, level adjustment;Thereafter AV analog signal is held Row analog/digital (A/V) conversion.Digital filtering, wavelet discrete processing and the automatic increasing of number are executed to AV digital signal by computer again Benefit reason, and by the logical operation module of CPU, obtains that A wave is initial, V wave initially and time origin for changing of terminal greatest gradient, To seek the time limit of A-V (AS-VS) interphase and V wave under patient at rest's state.
The data that program control instrument is obtained by above procedure, final automatic or manual synthetic time series CRT operational parameter value, goes forward side by side Enter the preservation of program control instrument initial CRT running parameter library.Its fundamental includes: can the CRT pace-making vector of manual intervention, pacemaker impulse Kenel (positive, negative sense or two-way), pacemaker impulse width, CRT treatment timing, pace-making scanning search positive negative sweep mode, with And the parameters such as scanning search stepping.
CRT dummy electrodes are split out from patient pulse's generator presetting bit (pouch), 4 poles for being placed in Left Ventricular are risen It fights electrode tail end, is extracted from the corresponding port of program control instrument, then the left room socket of reliable insertion impulse generator, and lock.It will CRT-GY2 impulse generator is placed in pouch, and is communicated with matched program control instrument, and the two is shaken hands success.Program control instrument will execute Whole parameters of CRT pacing therapy are sent to impulse generator, and the latter starts the serial important parameter issued by program control instrument, prepare Independent operating CRT working procedure.
It is subcutaneous by routine clinical merging patient in impulse generator, and the CRT for being placed in the left room external membrane of heart is paced into electricity Pole tail end after being reliably connected with corresponding ports, issues from program control instrument to impulse generator and starts self-checking command, and impulse generator is certainly After inspection, detection patient AV electrocardiosignal is executed, about 20-30 seconds behind, impulse generator formally started.At this point, Cardiac electrophysiology recorder can be led by the electrocardiograph that connect with patient or mostly, monitoring is placed in the patient impulse generator Specific works state.
So far, clinical instrumentation, implantation 4 pole of the Left Ventricular external membrane of heart pace-making of CRT treatment are realized with single 4 pole electrode Electrode constructs best to the bipolar acquisition mode of CRT patient's AV signal, automatic external membrane of heart bipolar pacing electrode with impulse generator The selection of combination pacing threshold is basically completed the serial process of impulse generator input series of tasks parameter.Thereafter, pulse generation Device independently executes CRT scanning search program by the CRT running parameter being arranged, and after scanning search EP (end of program), automatically The AS-VP interphase that the most narrow VP time limit occurs for scanning process is found, and with this AS-VP interphase, starts timing CRT pacing therapy.
Compared with prior art, the beneficial effects of the present invention are embodied in:
(1) present invention abandons the separating treatment that tradition CRT individually receives right room, right ventricle and left room signal by more electrodes Status realizes that impulse generator shell and left room epicardial lead construct bipolar symmetrical expression AV signal unipath and acquire, realizes A Wave, V wave and the processing of AV conformability, to provide EGC parameter necessary to whole CRT technology.For the first time from hardware point of view, it is real The novel concept of existing single electrode CRT pacing therapy.Brand-new design is implemented to structure in CRT impulse generator for the first time.Pulse generation The pioneering all processes for independently integrating CRT technology of device design singly to lead electrocardio amplification while acquire AV signal inside it, and enter Waveform logic algorithm analyzes program and storage number library, and parsing A wave starting inflection point, the starting of V wave and terminal inflection point calculate AV interphase. By pulse generation itself, independent operating CRT scanning search program, there is the AS-VP interphase in most narrow QRS time limit in automatic search, And timing property CRT treatment is executed with this AS-VP interphase, to greatest extent using itself Atrioventricular Conduction in ventricular fusion beats are formed It participates in.Therefore, have the characteristics that the high and low power consumption of intelligence degree, widely used, easy to operate, use cost is low.
(2) impulse generator voluntarily establishes a kind of completely new CRT working method in the present invention, most with its independent automatic search The AS-VP interphase in narrow QRS time limit, it is independent to implement timing CRT treatment, and independently carry out new CRT automatically again in the short time and sweep Search program is retouched, patient is made it is raw can to obtain optimal pathology in the best AS-VP interphase for generating the most narrow QRS time limit at any time Manage CRT therapeutic effect.Changing traditional CRT patient must be executed by Cardiologists by program control instrument periodically to hospital's follow-up CRT scanning search program finds the AS-VP interphase for the most narrow QRS time limit occur again, and fixedly with this AS-VP interphase CRT treatment is executed, until next follow-up.Therefore, impulse generator structure design no matter succinct from its special single electrode, still Its CRT therapy theory and actual clinical efficacy more have issuable during follow-up of patients interval (average is 60 days) Non-scientific CRT pacing therapy caused by pathophysiological change is angularly examined closely, equal implied meaning impulse generator as a kind of New CRT operating mode not only more improves the theory and technology of existing CRT design, the more allomeric function and knot of CRT equipment Structure updates and CRT clinical therapeutic efficacy, opens the beginning integrally innovated.For compared with the existing technology, the present invention is clinical Operation is more easy, and production cost and price are more cheap, and intelligence degree is higher.
Detailed description of the invention
Fig. 1 be paced by coronary sinus implantation for left room and the quadrupole conduit that records to the left room external membrane of heart schematic diagram.
Fig. 2 is the structural schematic diagram of quadrupole pacing catheter in the present invention (only drawing quadrupole electrode, other structures are not drawn).
Fig. 3 be through the invention in program control instrument be recorded surface electrocardiogram (1ch), left room electrode pace-making mark (2ch) and The two pole analysis (3ch) of CRT pacing electrode and the building of impulse generator shell.
Fig. 4 is that double pole mode records AS-VP signal processing figure point location and time critical data schematic diagram in the present invention.
Fig. 5 is CRT-GY2 impulse generator contour structures and electrode arrangement figure in the present invention.
Fig. 6 is the control design case figure that program control instrument distributes left room quadrupole electrode applications in the present invention.
Fig. 7 is impulse generator hardware block diagram in the present invention.
Fig. 8 is the modular structure that impulse generator handles analog signal in the present invention.
Fig. 9 is that impulse generator MCU executes CRT pace-making work flow diagram in the present invention.
Specific embodiment
1.CRT-GY2 pulse generator system base frame and design object
Technology is paced from existing CRT, it is not difficult to find out that atrium (A) and ventricle (V) signal are for CRT technology, being can not Physiological parameter such as is lacked, the AS-VS interphase constructed by both A wave and V wave is the basis that CRT pace-making technology executes treatment running. However, existing CRT technological system, is in the state of establishing communication with CRT impulse generator, in addition the body surface ecg of connection Electrode under artificial operation, is executed scanning AS/AP-VS/VP interphase search program, finds and occur most by matched program control instrument The corresponding AS/AP-VS/VP interphase of narrow V wave, and CRT pacing therapy is executed with this interphase.
And Design Thinking of the invention is: firstly, can normally be passed down with 1:1 only for chamber (AV) knot, and without serious The LBBB patient of slow arrhythmia executes CRT treatment, and right room (RA) pace-making can not considered, and can save atrium electricity Pole;Secondly because CRT treatment is built upon the Working mould for the following cardiac resynchronization therapy that patient itself Atrioventricular Conduction 1:1 is passed down Formula, so right ventricle (RV) pace-making is not considered yet, to save RV electrode.Remainder only has left room (LV) pacing electrode, You Qifa The excitement of LV caused by the boost pulse put is conducted the ventricular activation passed down self by atrioventricular node with CRT patient, is collectively formed Ventricular fusion beat.And the ventricular fusion beat time limit constructed by CRT pacing therapy technical requirements the two is as short as possible that (i.e. V wave is most It is narrow), therefore, before executing CRT pacing therapy to patient, it is necessary to first carry out the relevant program-controlled pace-making of CRT, that is, pass through scanning To find AS/AP-VS/VP interphase corresponding to most narrow V wave occurs for the search of AS/AP-VS/VP interphase.
Just because of CRT of the invention is treated, it is to be based on passing following cardiac resynchronization therapy base under patient itself Atrioventricular Conduction 1:1 Operating mode on plinth.Therefore, scanning search program, which is only limitted to find, occurs the corresponding AS-VP interphase of most narrow V wave.That , how by unitary electrode, impulse generator is made to obtain the AS-VS information under quiescent condition;As how AS-VS interphase is base Program-controlled AS-VP interphase scanning search program is arranged in plinth, finds and the corresponding AS-VP interphase of most narrow V wave occurs;Such as how this AS- VP interphase is implemented to treat based on itself Atrioventricular Conduction cardiac resynchronization timing property CRT;How in period CRT treatment end Afterwards, then by impulse generator new CRT scanning search program is independently carried out automatically, make patient in controllable space-time unique, most Maximum probability executes CRT pace-making with the best AS-VP interphase in most narrow QRS time limit, to reach optimal physiological CRT curative effect;Most A set of single electrode CRT pacing system based on patient 1:1 itself Atrioventricular Conduction following cardiac resynchronization therapy is established eventually, is the present invention Basic target.
The implementation of 2.CRT-GY2 impulse generator contour structures
Existing CRT paces technology, provides pacemaker impulse by RA electrode and receives RA signal;It is risen by RV electrode granting It fights and pulse and receives RV signal.It simultaneously by collected RA and RV independent body electrocardiosignal, is synthesized, is constructed by computer software AS/AP-VS/VP interphase.Cause 2 road ecg amplifiers in its structure and deposit, the hardware and softwares such as two-way A/D acquisition it is cumbersome, Designer has to that the necessary extensive work of CRT technology and numerous functional modules are transferred to the relevant program control instrument of CRT and have been gone At;And CRT impulse generator itself does not have the function of the signal of autonomous intelligenceization processing A wave, V wave and AS-VS, also more It has no way of executing AS/AP-VS/VP interphase automatically scanning search program.It can only be led to by hospital's dedicated doctor and medical engineering persons Its relevant program control instrument is crossed, the search of AS/AP-VS/VP interphase automatically scanning is executed, AS/ corresponding to most narrow V wave occurs to find AP-VS/VP interphase, and by this interphase, parameter is executed as CRT, CRT impulse generator is sent to by program control instrument, then again Order CRT impulse generator with this AS/AP-VS/VP interphase, the CRT pace-making for carrying out sustained fixed AS-VP mode is controlled It treats, until next CRT patient changes CRT impulse generator running parameter to hospital, then row.Here it is present CRT patient is necessary The main cause of hospital's follow-up is periodically arrived at any time.Therefore, CRT external now paces technological system, only sends out with regard to current CRT pulse Function that raw device itself has, structure design, intelligence degree, clinical practice apply and clinically CRT patient because of pathology For all various aspects such as the CRT technological adaptability that physiological parameter changes, many queries are still had, are also studied to continue deeper into With exploitation CRT technology, provide can developing deeply potentiality space.
CRT technology of the invention, RA and RV electrode lack into the state of, in order to which the signal of A wave, V wave and AS-VP is adopted Collection considers to start with from the external structure for changing tradition CRT impulse generator first.Since embedded impulse generator clinic disposes Position be generally located under patient's left or right clavicle, anatomical position is with respect to atrial signal source more close to if the position It has been placed between the pacing electrode of LV with clinic and has built electric potential signal amplification acquisition, it can be achieved that amplifying by single channel electrocardio, together When get existing A wave signal, have V wave signal again, there are also A-V Interval.Therefore, with the metal shell of implanted pacemaker As the anode of acquisition AV signal, become the first choice of our designs.But cannot dash forward depending on the problem of be: be placed in the embedded heart of human body Dirty pacemaker, conventional ophthalmic is zero potential electrode necessary to pacemaker works normally, subcutaneous by human body is integrally placed at.But As receive AV signal anode use, then the zero potential electrode of implanted pacemaker this how to handle?
Be realize the bipolar symmetrical electrocardio biological amplifier (anode, cathode, null electrode) of single channel to AV signal acquisition, also for The left room of CRT bipolar pacing (needing ground electrode, i.e., be total to null electrode with preposition biological amplifier) pulse granting, null electrode (it is electric Pole) also there must be, be the principle of capacitance-resistance antibody according to human body, we by the metal whole-house of implanted pacemaker, From its side position, equalization is divided into two parts, i.e. metal upper shell body 1a, metal lower shell body 2a and is located at metal upper shell body 1a and gold Dielectric isolation layer 3a between subordinate's shell 2a, is configured to two electrodes (see Fig. 5), and metal upper shell body 1a constitutes CRT-GY2 arteries and veins Generator null electrode is rushed, metal lower shell body 2a constitutes the anode of CRT-GY2 impulse generator AV signal acquisition, with 5.0mm thickness High insulating polyimide class material separation layer, this two electrode is separated, and in addition the height of metal upper shell body 1a is 7mm, metal lower shell The height of body 2a is 7mm.
3.CRT-GY2 the foundation and control technology of left 4 pole electrode of the room connection distribution of system
The CRT-GY2 impulse generator of base in this present embodiment is limited to The bipolar left room pace-making of realization and bipolarity AS-VS physiological ecg signal receive, we are to the mating journey of CRT-GY2 impulse generator The electrocardiogram acquisition front end that control instrument is adopted, with the design of Fig. 6.
As seen from Figure 6, to 4 pole electrodes (first electrode 1, second electrode 2, the third electrode the 3, the 4th for being placed in left room Electrode 4), electrode tip is placed in the Left Ventricular external membrane of heart;Its tail end (connecting pin) CRT implanted pacemakers for the first time installation before, First program control instrument corresponding interface matched with CRT-GY2 impulse generator is connect;It will be put into the CRT-GY2 arteries and veins of patient's pouch simultaneously The corresponding interface of two electrode of generator shell is rushed to be reliably connected by special connecting wire with program control instrument.Thereafter, it opens Begin to be executed automatically by the matched program control instrument of CRT-GY2 impulse generator to carry out pacing threshold survey to the 4 pole electrodes for being placed in left room It is fixed, and the logical series judgement of corresponding pacing electrode position optimization selective screening.Content of parameter includes inter-electrode impedance inspection Survey program-controlled granting (the range 0.5-4.0V, stepping+0.5V of pace-making vector variation prediction between (200-2000 ohm of range), electrode.With Pace-making vector is tested from low to high, until continuing three ventricular captures and stopping the electrode combination pace-making vector);Bipolar left room Pacing electrode tests selecting sequence by electrode label 1-2 (first electrode to second electrode), 1-3 (first electrode to third electricity Pole), 1-4 (first electrode to the 4th electrode), 2-3 (second electrode to third electrode), 2-4 (second electrode to the 4th electrode), 3-4 (third electrode to the 4th electrode) is carried out automatically.All detection data and relational graph are sent out by CRT-GY2 pulse Database storage and processing in the matched program control instrument of life device, and can show and call in a tabular form.
After left room bipolar pacing determines optimum electrode combination, the electrode number information column of related program control instrument display panel Respective electrode number flashes (orange) automatically.With example: if electrode 2-3 combination is selected, the flashing of 2 and 3 signal lamp positions continues 3 Second 2 and 3 signal lamp positions become constant orange illuminating state.Meanwhile remaining 1 and 4 electrode number light start therewith in green And flash, also clock for 3 seconds, when 1 and 4 signal lamp positions become constant green illuminating state, show 1 to 4 electrodes in related journey Control instrument Inner Constitution on state.Continue with example, the final conduit for being placed in Left Ventricular, 4 electrodes are (by distal end to proximal end point Be not defined as 1 electrode (first electrode), 2 electrodes (second electrode), 3 electrodes (third electrode), 4 electrodes (the 4th electrode)) function It can distribute are as follows: 2 electrodes are pacemaker impulse cathode;3 electrodes are pacemaker impulse anode.1 electrode and 4 electrode conductions, collectively constitute and connect Receive the cathode of AS-VS/VP physiological ecg signal, and the AS-VS/VP cardiac electrophysiology constituted with Virtual pulse generator outer casing underpart Signal anode, forms weak physiological signal electrical circuit, ECG preamplifier inside related program control instrument is input to, to acquire AS-VS Signal.At this point, when related program control instrument CED screen display goes out reality AS-VS information, operate program control instrument panel, it is related to obtain The running parameter of ECG preamplifier simultaneously saves it.
As shown in fig. 6, it has been placed in the left room pacing catheter in patient's chambers of the heart, first electrode 1, second electrode 2, third electricity Pole 3, the 4th electrode 4 combination, be switched on and off state, be to select a switching circuit and two by four four inside related program control instrument A either-or switch circuit and relevant logic control circuit are constituted.Each four select a switch and either-or switch circuit It is switched on and off, is controlled by program control instrument inner computer by the instruction that its port I/O issues.The timing of I/O port command Be original state (original state here refer to left ventricular catheter be placed in patient's chambers of the heart, left room electrode tail end and pulse Generator is reliably connected, impulse generator and related program control instrument communication) complete in the case where, program control instrument master controller passes through first The port I/O and C and D switch module shown in fig. 6, it is preferential to carry out left ventricular catheter compound electrode resistance value detection, then start to group Composite electrode executes pacing threshold measurement.Thereafter, program control instrument master controller is handled according to the data of acquisition through automatic Synthesis analysis, Determine best pacing electrode combination position.Under the premise of herein, the port I/O is by assigning finger to A and B switch module shown in fig. 6 It enables, executes two electrodes remaining to left ventricular catheter and execute turn-on action, to realize the negative pole end for receiving AS-VS electrocardiosignal Mouthful.
After the completion of above-mentioned task, the parameters in series that related program control instrument is obtained is transmitted to CRT-GY2 pulse by wireless telecommunications Generator, parameter include pacing the electrode position volume of left room electrode position coding, pace-making vector, 2 poles conducting reception AS-VS signal Code, AS-VS/VP physiological ecg signal amplifier operation bandwidth frequency, amplification factor etc..It is only for CRT-GY2 impulse generator The parameter that basis is established in vertical work prepares.
4.CRT-GY2 system pulse generator function module design
As shown in fig. 7, pulse generating system includes: in the present invention
Electrocardiosignal pre-amplification circuit 5 acquires the A-V signal of CRT patient and amplifies A-V signal;
A/D conversion module 6, for the amplified A-V signal of the electrocardiosignal pre-amplification circuit to be converted to number Signal;
MCU controller 7, for receiving the digital signal of A/D conversion module conveying, and based on the received, digital signal is calculated Obtain pacing parameter;
Pacing pulse generator 8 is controlled by MCU controller, is believed according to the control signal pulsing that MCU controller issues Number;
Pacemaker impulse controller 9, for receiving the pacing parameter of MCU controller sending, and pacing parameter based on the received Control the pulse signal parameter of impulse generator output;
Power supply 10, for providing electric energy for impulse generator.
Wherein MCU controller 7 includes that MCU database information module 71, MCU message processing module 72 and MCU control mould Block 73.Power supply 10 includes power module 101, battery 102, battery protection system 103 and isolated power supply 104.Power module 104 The raised pulse power boost module 11 of voltage for exporting power module 101 is equipped between pacing pulse generator 8.
Built-in (electrocardiosignal pre-amplification circuit 5) electrocardiosignal pre-amplification circuit single channel A-V signal electrocardio amplifies mould Block (see Fig. 8): merging CRT patient 4 pole electrode of left room, have determined that complete wherein 2 poles for bipolar LV pace, and remainder 2 poles constituted conducting after, that is, constitute receive AS-VS/VP physiological ecg signal cathode;By CRT-GY2 impulse generator The AS-VS/VP physiological ecg signal anode that metal lower shell body 2a is constituted;Zero potential is constituted by impulse generator metal upper shell body 1a Electrode.The Differential Input mode of three's building send weak A-V signal to A-V signal electrocardio inside CRT-GY2 impulse generator Preamplifier, to acquire AS-VS signal, final realize is believed by the A-V of CRT-GY2 impulse generator independent acquisition CRT patient Number.Its electrocardiosignal pre-amplification circuit 5 includes: that gain fixes in 50-300 times of biological amplifier;50/60Hz trap electricity Road;4 grades of Ingeborg Bachmann bandpass filters, frequency bandwidth 1-150Hz.It is worth noting that, above-mentioned CRT-GY2 impulse generator work The initial parameter of work is controlled by its matched program control instrument.In the collected weak A-V signal of hardware parameter, put through electrocardiosignal is preposition After big circuit 5 is handled, it is processed into digital signal into A/D conversion module 6, it is right by 7 series of programs logical algorithm of MCU controller The signal carries out the processing of digital signal amplitude, high pass and low-pass digital filter, 50/60Hz digital notch, phase calculation, X-axis again The processing such as A-V waveform inflection point slope discrete analysis, to provide AS-VS/VP interphase and VS/ required for executing CRT pacing function The data in VP time limit.By the CPU designated port of CRT-GY2 impulse generator, positive TTL pulse, excitation stimulation are issued by program Electrode ports of the pulse amplifying circuit to CRT-GY2 impulse generator, output CRT treatment boost pulse.Stimulation arteries and veins of the invention Form is rushed with forward direction/negative sense/two-way optional, default configuration negative sense.Pulse width 0.1-1.0ms, stepping ± 0.1ms, 10 grades It is optional.Boost pulse voltage range 1-10V, stepping ± 1.0V, 10 grades optional.Basic boost pulse TS1S1=2000-400ms Setting is selected between (30-150PPM).
As shown in figure 9, the reliability for identifying and measuring to RA and LV intracavitary electrogram, is to be related to entire CRT treatment to be One of no successful biggest impact factor.Traditional cardiac electrophysiology system is all based on the processing method of electrocardiosignal in the chambers of the heart The main component of signal spectrum in the chambers of the heart, i.e. relatively high, the unordered higher hamonic wave of frequency.Therefore common cardiac electrophysiology equipment Relating to for electric signal in the chambers of the heart is taken, its high end frequency signal source is mainly amplified, abandons its low end frequency signal source;The figure of acquisition Shape is usually to provide clinical cardiac electrophysiology qualitative analysis and the manual measurement time uses.Traditional implanted pacemaker is to the chambers of the heart The acquisition of interior atrium or ventricular cardiac signal is not related to the time shaft measurement to signal source yet and calculates, is mostly by the collected heart Intracavitary signal passes through comparative degree circuit, is converted into Transistor-Transistor Logic level and is transmitted to CPU control centre, uses as calculating heart rate and perceiving.
Impulse generator CRT-GZ2 of the invention is designed on DDD/DDDR pacing pulse generator platform, is risen Workflow of fighting provides AAI/AAIR, VVI/VVIR, VVT, VAT and DDD/DDDR Pattern completion by program software.The present invention is most The characteristics of core first is that: CRT-GZ2 impulse generator is outer to (signal electrode for being placed in LV) in the chambers of the heart and the chambers of the heart, and (CRT is buried Formula pacemaker housing electrode) joint mapping A-V electrocardiosignal it is " fuzzy " processing, i.e., by single channel A-V signal electrocardio amplify mould Block collects CRT patient's A-V single signal, using the software and hardware and CPU Intelligent treatment inside CRT-GZ2, realizes to CRT The acquisition in time limit necessary to technology and VS/VP timing information.Finally by the CPU of CRT-GZ2 impulse generator, determination is being paced After scanning search EP (end of program), AS-VS/VP interphase corresponding to the most narrow VS/VP time limit during this will occur in, as The fixed pacing parameter of CRT treatment technology executes timing property CRT pace-making.
Therefore, the specific identification to A-V electrocardiogram and measuring technique become pith of the invention.The present invention mentions first Out: with CRT-GZ2 impulse generator to (signal electrode for being placed in LV) in the chambers of the heart and outer (the CRT implanted pacemakers shell of the chambers of the heart Electrode) joint mapping single channel A-V, by its signal component implement decompose and it is whole and, to obtain the acquisition of AS, AP, VS or VP.Its Between one of emphasis, be by collected signal, it is main to retain wherein low end frequency range, i.e., in 1-150HZ bandwidth, it is therefore an objective to It is easy to implement the starting point of AS, AP, VS or VP excitement and end of the final point more accurate simulated and digitized processing.Pass through hardware Circuit and software programming filter out the multiple unordered higher hamonic wave of electric signal in the chambers of the heart, retain AS, AP, VS or VP starting point and Clearly low middle-end frequency content carries out in order to which logical algorithm is easy the inflection point slope variation by waveform relatively for end of the final point It calculates, analysis and judgement, more accurately measures the AS/AP initial point and VS/VP initial point and destination node of X-axis time arrow.When In the chambers of the heart after analog signal input computer A/D, bipolar analog electrocardiogram signal is rapidly converted into digital signal by software, and to this Signal carries out batch intelligent processing, including digital band pass filtering, 50/60Hz number fall into filtering, electrocardiosignal amplification/contracting automatically Small gain control, real-time wave mode be initial/and terminal slope variation calculates and fixed point timing, automatic baseline correction;Signal shows pre- place Reason is to related program control instrument communication process etc..Therefore, the bipolar hybrid heart is outer and the chambers of the heart in signal identification and at time phase Reason, the bipolar electrocardiosignal starting of selectivity and termination identification, time measurement processing, are the important foundations of logical algorithm of the present invention.
Processing of the 5.CRT-GY2 impulse generator to arrhythmia cordis occurs
CRT-GY2 impulse generator of the invention, clinical use can normally be passed down with 1:1 mainly for atrioventricular node, not had There is the LBBB patient of severe bradyarrhythmia;And the operating mode of CRT is built upon patient itself Atrioventricular Conduction heart again On the basis of synchronization therapy.But we are in CRT-GY2 impulse generator whole design, still with unobvious increase pulse generation Under the premise of device workload, especially hardware, software and Overall Power Consumption, initiates design CRT-GY2 impulse generator and treated in CRT In the process, if patient may occur it is obvious slowly and/or tachy-arrhythmia, CRT-GY2 impulse generator how to cope with processing, The arrhythmia cordis how about to happen suddenly for patient, interim intelligent change CRT-GY2 impulse generator working condition.
(1) CRT-GY2 impulse generator is in executing CRT therapeutic process, if between the sudden A wave of A-V signal detection appearance Break or continuously lacks such as.At this point, therefore timing CRT pacing therapy will be disturbed with the workflow of AS-VP, VP pace-making also can not It realizes.When CRT-GY2 impulse generator perceived in 2 seconds because A wave interruption or it is continuous lack such as, until make average ventricular rate≤ 40BPM, CRT-GY2 impulse generator are by automatically with the frequency of stimulation of 60PPM, with VVI pacing mode, the left room of temporary cardiac pacing.When CRT-GY2 impulse generator detects A wave, V wave and AV interphase again, then stops the left room pace-making of VVI pacing mode, CRT- GY2 impulse generator will continue to re-execute CRT pacing therapy program when being terminated by burst arrhythmia cordis.
(2) CRT-GY2 impulse generator is in executing CRT therapeutic process, if after AS wave occurs in A-V signal detection process The sudden random broadening and/or sudden duration of V (QRS wave) wave is broadening, it is more likely that and I °/II ° of this CRT patient generation/ III ° of atrioventricular block (A-VB).At this point, LV electrode will be by the fixation AS-VP that CRT-GY2 impulse generator has determined Interphase executes VAT (atrial sense, ventricular stimulation, triggering type) mode pacing mode.When CRT-GY2 pulse generation is thought highly of Newly detect that the V wave time limit restores to scan the most narrow V wave width that the search of AS/AP-VS/VP interphase searches out, CRT- to by CRT GY2 impulse generator will continue to re-execute the timing CRT pacing therapy program being terminated.
(3) CRT-GY2 impulse generator is in executing CRT therapeutic process, if AS frequency (the i.e. heart occurs in A-V signal detection Room excitation frequency) >=150BPM, it is possible to paroxysmal auricular tachycardia occurs for CRT patient or paroxysmal is supraventricular aroused in interest It overruns, if continuing >=5 seconds, CRT treatment terminates operation immediately.Up to again AS frequency < 150BPM, CRT-GY2 impulse generator will Immediately continue with the CRT pacing therapy program re-executed when being terminated by burst arrhythmia cordis.
(4) CRT-GY2 impulse generator is during executing CRT pacing therapy, if A-V signal detection occur AS frequency >= 250BPM, it is possible to which paroxysmal auricular flutter (AF) or paroxysmal rapid atrial fibrillation (Af) occur for CRT patient, if continuing >=5 Second, CRT treatment terminates operation immediately.Until AS frequency < 150BPM, CRT-GY2 impulse generator continue to re-execute and be terminated Timing CRT pacing therapy program.

Claims (10)

1. a kind of impulse generator for realizing CRT treatment based on single electrode, the pulse generation including shell and in shell System, which is characterized in that the shell include metal upper shell body, metal lower shell body and be located at metal upper shell body and metal lower shell Dielectric isolation layer between body.
2. the impulse generator of CRT treatment is realized based on single electrode as described in claim 1, which is characterized in that the insulation Separation layer is made of polyurethane material.
3. the impulse generator of CRT treatment is realized based on single electrode as claimed in claim 1 or 2, which is characterized in that the gold The height for belonging to upper housing is 6~8mm, and the height of the metal lower shell body is 6~8mm, the height of the dielectric isolation layer is 3~ 5mm。
4. the impulse generator of CRT treatment is realized based on single electrode as claimed in claim 3, which is characterized in that the pulse Generating system includes:
Electrocardiosignal pre-amplification circuit acquires the A-V signal of CRT patient and amplifies A-V signal;
A/D conversion module, for the amplified A-V signal of the electrocardiosignal pre-amplification circuit to be converted to digital signal;
MCU controller, for receiving the digital signal of A/D conversion module conveying, and digital signal is calculated based on the received Pacing parameter;
Pacing pulse generator is controlled by MCU controller, the control signal pulsing signal issued according to MCU controller;
Pacemaker impulse controller, for receiving the pacing parameter of MCU controller sending, and based on the received, pacing parameter controls arteries and veins Rush the pulse signal parameter of generator output;
Power supply, for providing electric energy for impulse generator.
5. the impulse generator of CRT treatment is realized based on single electrode as claimed in claim 4, which is characterized in that the electrocardio Signal pre-amplification circuit includes biological amplifier, the 50/60Hz trap that the gain of successively signal connection fixes at 50~300 times Circuit and 4 grades of Ingeborg Bachmann bandpass filters, the frequency bandwidth of 4 grades of Ingeborg Bachmann bandpass filters are 1~150Hz.
6. a kind of pacemaker that CRT treatment is realized based on single electrode, including impulse generator and a pacing catheter, It is characterized in that, the impulse generator is any impulse generator of Claims 1 to 5.
7. the pacemaker of CRT treatment is realized based on single electrode as claimed in claim 6, which is characterized in that the pace-making Conduit is 2~4 pole pacing catheters.
8. the pacemaker of CRT treatment is realized based on single electrode as claimed in claim 7, which is characterized in that the pace-making Conduit is 4 pole pacing catheters, and the electrode on the pacing catheter of 4 pole respectively is first electrode, second by distal-to-proximal Electrode, third electrode and the 4th electrode, the first electrode and the 4th electrode conduction, composition receive AS-VS/VP cardiac electrophysiology The cathode of signal, and AS-VS/VP physiological ecg signal anode is constituted with the impulse generator, the second electrode is pace-making Pulse cathode, the third electrode are pacemaker impulse anode.
9. a kind of cardiac pacing system for realizing CRT treatment based on single electrode, including pacemaker and for controlling heart The program control instrument of pacemaker, which is characterized in that the pacemaker is any pacemaker of claim 6~8.
10. the cardiac pacing system of CRT treatment is realized based on single electrode as claimed in claim 9, which is characterized in that further include CRT dummy electrodes, can fixed placement plan in the tissue that place the impulse generator position with clinic, CRT is empty The tail end of quasi- electrode is connect with the program control instrument signal.
CN201710774566.3A 2017-08-31 2017-08-31 A kind of pacemaker and cardiac pacing system for realizing CRT treatment based on single electrode Pending CN109420254A (en)

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Application publication date: 20190305