CN102485171A

CN102485171A - Non-invasive attached telemetering electrocardiographic recording method and system having ultra-long record period and ultra-high storage capacity

Info

Publication number: CN102485171A
Application number: CN2010105796565A
Authority: CN
Inventors: 涂权; 罗章源; 张文赞
Original assignee: JIESHENG BIOTECHNOLOGY (SHANGHAI) Co Ltd
Current assignee: JIESHENG BIOTECHNOLOGY (SHANGHAI) Co Ltd
Priority date: 2010-12-01
Filing date: 2010-12-01
Publication date: 2012-06-06

Abstract

The invention relates to a non-invasive attached telemetering electrocardiographic recording method having an ultra-long record period and an ultra-high storage capacity. By using the method, characteristic values of electrocardiographic waves can be safely, stably and clearly acquired under the natural physiological state of a human body within a long period (more than 15 days), microvolt-level measurements of T-wave alternans can be acquired, and the collection, processing and high-capacity storage of electrocardiographic waves can be completed; and multiple electrocardiographic recording pasters can be used to realize the simultaneous recording of multi-channel body surface electrocardiograms, and a computer data processing and analysis system can complete the data monitoring and analysis, image display, data storage and printing and output of the recorded signals and realize the networking transmission of the electrocardiosignals. The clinical indications of the device include: symptoms related to suspected arrhythmia; determination of arrhythmia property, and completion of reasonably evaluating anti-arrhythmia treatment and monitoring myocardial ischemia; evaluation of anemic heart disease treatment measures; instructions to acute myocardial infarction patients before leaving hospital and during convalescence; and installation, detection and function assessment of sudden cardiac death and heart pacemakers.

Description

The method and system of the sticking type remote measurement electrocardiographic recording of noinvasive overlength record vast capacity storage

Affiliated technical field

The present technique invention relates to the method and system of the sticking type remote measurement electrocardiographic recording of noinvasive overlength record vast capacity storage; Can measure electrocardiosignal more than 15 days in safety, stable attaching under the human body physiological state of nature; The microvolt level that obtains the eigenvalue of ecg wave form clearly and obtain T ripple electrical alternations is measured; And accomplish collection, processing, the long-time high capacity storage of ecg wave form and realize networked medical information transmission, and carry out cardiac electrical event analysis, early warning diagnosis; Belong to biomedical engineering field and Clinical Medical Engineering.

Background technology

At present, known electrocardiosignal obtain manner has monitor monitoring, electrocardiograph measurement, dynamic ecg monitoring, the monitoring of portable cardiac monitor; But existing ECG monitor, its measuring system is huge, and patient activity is seriously limited; Electrocardiograph also exists patient activity range limited, and the Measuring Time weak point cannot more obtain ecg information more; Though dynamic electrocardiogram and portable cardiac monitoring extend to 72 hours with Measuring Time, reality does not break through non-volatile recording and carries still inconvenient; And heart disease prevention, diagnosis, treatment all press for and obtain more electrocardiogram (ECG) data; Obtain more electrocardiogram (ECG) data eigenvalue; Particularly suspect symptom, the clear and definite ARR character relevant with arrhythmia; To the monitoring of antiarrhythmic therapy rational evaluation and myocardial ischemia,, leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients to the evaluation of ischemic heart desease treatment measure; All there are not well to solve this scheme and way in installation, detection and the assessment of function to sudden cardiac death, cardiac pacemaker; Along with the develop rapidly of micro sensing technology, the developing rapidly of semiconductor components and devices, integrated chip is powerful and perfect, and also the sticking type remote measurement electrocardiographic recording method and system design for the advanced overlength vast capacity writing time storage of invention provides technical guarantee.

Summary of the invention

The present technique invention relates to the sticking type remote measurement electrocardiographic recording method and system of overlength vast capacity writing time storage; The miniature sticking type remote measurement electrocardiographic recording of ultra-long time (more than 15 days) noinvasive body surface dynamic electrocardiographic recording especially can be provided; A plurality of electrocardiographic recorder pasters are united use, can write down multichannel noinvasive body surface ecg simultaneously.The clinical indication of this device has covered the scope of dynamic electrocardiographic recording Holter and implanted elecrocardiogram recorder, promptly comprises: suspect the symptom relevant with arrhythmia cordis; Clear and definite ARR character, and can be to the monitoring of antiarrhythmic therapy rational evaluation and myocardial ischemia; Evaluation to ischemic heart disease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; Installation, detection and assessment of function to sudden cardiac death, pacemaker; This system and method mainly comprises the electrocardiosignal prime acquisition process of super low-power consumption; Circuit realizes comprising prime amplification, filtering, baseline drift, the anti-high-tension circuit of low-power consumption three amplifiers, A/D conversion and MCU control circuit that particular form is used, flash storage; System switching control and abnormal signal are reported to the police; Powerful signal embeds the identification handling procedure, and the encapsulant of special material satisfies biocompatibility and skin specificity; Can be attached to skin surface for a long time and not have the allergy of infection; And the ability waterproof reaches and does not come off more than 15 days in the body surface well attached, and the profile of particular design has reduced interference and error that the electrocardio lead produces, guarantees the true of biological electrocardiosignal and stablizes; Storage of patient's ecg information and network transmitting software; The computer system install software but this software patient stays at home; Obtain the electrocardiogram (ECG) data above the TF card and support the networking of data to transmit; And can show ecg wave form, early warning sign on computers, can support the quick return visit and the convenient inquiry of ecg wave form; The work station electrocardio signal analytical system can directly obtain TF card data or obtain the electrocardiogram (ECG) data of king's transmission; And the playback of completion electrocardiosignal; Analyze, and, analyze electrocardiosignal and abnormal marking based on identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; The diagnosis cardiac electrical event, effectively the symptom relevant with arrhythmia cordis suspected in record; Clear and definite ARR character, and can be to the antiarrhythmic therapy rational evaluation; Realize the monitoring of myocardial ischemia; Evaluation to ischemic heart disease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; To installation, detection and the assessment of function of sudden cardiac death, pacemaker, all testing results are being transferred to patient with report form, and draw corresponding clinical diagnosis report based on testing result, and foundation are provided for clinical treatment.The present technique invention provides the sticking type remote measurement electrocardiographic recording method and system of overlength vast capacity writing time storage; Can be under the human body physiological state of nature long-term, safe, stable direct measurement electrocardiosignal; The microvolt level that obtains the eigenvalue of ecg wave form clearly and obtain T ripple electrical alternations is measured, and accomplishes collection, processing, the long-time high capacity storage of ecg wave form; Present technique invention comprises that ultra-micro power consumption ultra-small volume body implants the miniature applicator system of signals collecting and processing, external Computer signal Data Management Analysis system; The miniature applicator system of body surface of present technique invention utilization ultra-micro power consumption ultra-small volume body signals collecting and processing is accomplished the conduction to electrocardiosignal, the collection of the signal of super low-power consumption, special-purpose low-power consumption high capacity storage; Computer signal Data Management Analysis system accomplishes special-purpose software data monitoring and the analysis to tracer signal, and data image shows, data storage, and printout, and realize electrocardiosignal networking transmission.

The present technique invention solves the technical scheme that its technical problem adopted: electrocardiosignal is conducted to the signal condition processing module by physiological signal sensing extraction module has the storage of low-power consumption high capacity after nursing one's health processing; Computer signal Data Management Analysis system realizes electrocardiosignal networking transmission; Completion is to the special-purpose software data monitoring and the analysis of tracer signal; Data image shows, data storage, printout.The miniature applicator system that ultra-micro power consumption ultra-small volume body is implanted signals collecting and processing is a flat package; Whole applicator system length is 44mm, and wide is 20mm, and diameter is 7mm; Big capacity button cell, electrocardiogram acquisition and sensing extraction module, signal condition and processing capacity module, micro-power consumption high-capacity signal storage module, special electrode extract point; Special shell is formed, and this system bulk is little, simple in structure, dependable performance, accomplishes the power supply supply of system in vivo in the implant system; Electrocardiosignal sensing extraction module comprises prime amplification, filtering, baseline drift, the anti-high-tension circuit of low-power consumption three amplifiers, and the high accuracy appearance is with amplifying, and the A/D that particular form is used changes and the MCU control circuit; Big capacity flash storage; System switching control and abnormal signal are reported to the police, and powerful signal embeds identification handling procedure, the encapsulant of special material; Satisfy biocompatibility and skin specificity, can be attached to skin surface does not for a long time have the allergy of infection; External signal data Treatment Analysis system is by computer, data-interface, special-purpose software, output equipment, PRN device; Web-transporting device is formed, and this system accomplishes the playback of electrocardiosignal, analyzes; And based on identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; Analyze electrocardiosignal and show tags, accomplish the network transmission of electrocardiosignal, the electrocardiogram (ECG) data that is write down to doctor workstation and hospital system analysis through the network terminal; The diagnosis cardiac electrical event, effectively the symptom relevant with arrhythmia cordis suspected in record; Clear and definite ARR character, and can be to the antiarrhythmic therapy rational evaluation; Realize the monitoring of myocardial ischemia; Evaluation to ischemic heart disease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; Installation, detection and assessment of function to sudden cardiac death, pacemaker.

The invention has the beneficial effects as follows: this system is under natural Physiological Psychology state, and body surface sticking type monitoring long-term effectively and record cardiac electrical event were directly measured electrocardiosignal more than 15 days; The microvolt level that obtains the characteristic value of ecg wave form clearly and obtain T ripple electrical alternations is measured; And accomplish collection, processing, the long-time big capacity storage of ecg wave form, and realize the playback of electrocardiosignal, analyze; And based on identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; Analyze electrocardiosignal and show tags, accomplish the network transmission of electrocardiosignal, the electrocardiogram (ECG) data that is write down to doctor workstation and hospital system analysis through the network terminal; The diagnosis cardiac electrical event, effectively the symptom relevant with arrhythmia cordis suspected in record; Clear and definite ARR character, and can be to the antiarrhythmic therapy rational evaluation; Realize the monitoring of myocardial ischemia; Evaluation to ischemic heart disease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; Installation, detection and assessment of function to sudden cardiac death, pacemaker.

Description of drawings

Below in conjunction with accompanying drawing and embodiment the present invention is further specified

Fig. 1 is the inner schematic diagram of miniature applicator system that ultra-micro power consumption ultra-small volume body is implanted signals collecting and processing:

Its inside of the inner schematic diagram of miniature applicator system that this ultra-micro power consumption ultra-small volume body is implanted signals collecting and processing comprises (1) electrocardio prestage amplification (low-power consumption three amplifiers), and (2) signal strips is handled and level promotes, and (3) are main amplifies; (4) with the low-power consumption MCU of 12 A/D, (5) TF card high capacity stores, (6) battery; (7) power switch button; (8) electric power starting display lamp, (9) abnormal signal shift knob, (10) abnormal signal testing circuit; (11) abnormal signal alarm lamp; (1) electrocardio prestage amplifying circuit is selected little power consumption three amplifier chips for use among the figure, and its operating current is 40uA, and amplification is chosen as 10 times, and CMRR is 90dB and high input impedance; (2) signal processing and level promote and comprise high pass, low pass filter among the figure, and notch filter, level lifting circuit are realized rising to positive signal to electrocardiosignal so that A/D transforms among the MCU of rear end; (3) main amplifier adopts the low-power consumption instrument to amplify among the figure, and several microamperes operating current and high CMRR and input impedance are only arranged; The all functions that the MCU completion system that (4) transform with 12 A/D among the figure controls comprise the A/D sampling, the signal software processes; Signal read-write and storing, system can be under low-power consumption and park mode switch operating, the system works electric current is at 50uA; (5) are between the TF card storage life among the figure; Comprise cutting ferrule and TF card, cutting ferrule is of a size of 15mm*15mm, adopts special storing mode to make the power consumption of writing data inside the past TF card of MCU at 300uA; The control and the indication of battery and system realized in (6) (7) (8) among the figure, realizes truly electrical isolation and shutoff; Battery is selected the high capacity button cell for use, satisfies system's power supply and dimensional requirement fully.(9) (10) (11) realize that abnormal signal detects among the figure, pass through to open shift knob to testing circuit identification and early warning through the signal after amplifying.

Fig. 2 is that this system of miniature applicator system sketch map that ultra-micro power consumption ultra-small volume body is implanted signals collecting and processing is a flat package, and whole implant length is 44mm, and wide is 20mm, and diameter is 7mm, comprising button cell; Circuit board section, shift knob, signal is strong and weak to be shown and warning, among the figure 1,2; 3,4,5 form front elevation, 1 expression shell encapsulation among the figure; It satisfies sealing, antiseep, and flexibility especially can effectively touch control in button and warning control zone; 2 is circuit board section among the figure, and this circuit board is realized the extraction of electrocardiosignal, handles and system's control; Realize system's all functions fully; System power dissipation is at 500uA, and shape effectively combines with battery part 5 fully, and 3 are system's unlatching button and input abnormality detection button among the figure; This button is realized complete electrical isolation and the instrument normal mounting and the effectively detection of monitoring of system, and 4 real-world piece is to realize the strong and weak and unusual detection of signal among the cooperation figure; Fig. 5 is a button cell, and this battery is selected 2450 model 3V buttons power supplies for use, among the figure 6; 7 is the stereoscopic figure of device; 6 diameters that are expressed as part in system's body are 44mm among this figure, and 7 is 7mm highly among the t figure, and face is semicircle about system; And circular arc is arranged at each face, so that better adapt to the good adhesion with skin; Among the figure 8,9th, this face sketch map, wherein Fig. 8 is expressed as the riding position and the structure of tf card; This card size is 1.5mm*1.5mm; Capacity is 2G, can realize uninterrupted storages in 15 days of electrocardiogram (ECG) data, and Fig. 9 is a pair of electrocardioelectrode; This electrode spacing is 40mm, effectively measures electrocardiosignal and adapts with shell.

Fig. 3 is the system works principle schematic

(1) is human body among the figure; (2) black part branch is expressed as the miniature applicator system that ultra-micro power consumption ultra-small volume body is implanted signals collecting and processing among its figure; It connects by the good biadhesive colloid of biocompatibility; This colloid can breathe freely and can particular design the discharge of suitable sweat secretion thing, and do not produce specific reaction and the rejection of nontoxic nothing with skin, can effectively produce the undistorted noiseless conduction electrocardiosignal of ion exchange; It is 40mm that electrode effectively obtains ISI, realizes that the high capacity of ecg information stores; (3) are patient's electrocardiogram (ECG) data reading displayed and network transmitting software system among the figure: comprise the software that it is special that department of computer science unifies; Patient opens applicator system; Take out storage TF card; Use conventional special F card reader with the data upload computer and can demonstration, playback, search fast, mark unusually, and support printout, institute's data that obtain can be carried out network and transmitted and phone transmission in the TF card.Figure (4) is web-transporting device and phone transmission equipment, and figure (5) doctor workstation system is transferred to the hospital doctor work station through phone and network transmission or patient follow-up's pattern with electrocardiosignal; Accomplish the playback of electrocardiosignal, analyze, and according to identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; Analyze electrocardiosignal and abnormal marking, the recovery of diagnosis cardiac electrical event electrocardiosignal, the software processes of electrocardiosignal and analysis; The R-R interval, HRV, T ripple electrical alternations and time domain frequency-domain analysis; Waveform shows, the software identification of playback and unusual waveforms; All testing results are being transferred to patient with report form, and draw corresponding clinical diagnosis report according to testing result, and foundation are provided for clinical treatment.

The specific embodiment

Step 1: according to clinical demand, it is to think explanation and training on operation that the patient that needs are worn this device does Related product each item; Utilize surface electrocardiogram to select suitable attach area (guaranteeing electrocardiosignal amplitude, waveform); With the sticking portion cleaning and sterilizing, adopt special two-sided attaching sticker at body surface, this colloid has two-way viscosity; And ability waterproof and breathable, very ionic conductivity; The body surface applicator system is taken out from special-purpose sterilization wrap box, and power-on button and electrocardiosignal recognition button check that this system whether can operate as normal, and the inspection shutdown system that finishes will have the fine silver electrode towards patient's sticking position, be attached on the double faced adhesive tape; And have gentle hands light press 15 minutes, guarantee to attach and surely lean on.

Step 2: will open the power knob of applicator system, whether the viewing system display lamp is normal; Start signal button, observation signal indicate whether normally, if please check whether attaching is correct unusually.

Step 3: open miniature applicator system according to patient's needs, this system's ability waterproof and breathable, and can stop record at any time according to patient; And can press the signal recognition button at any time, to guarantee that signals collecting is normal, refined approval is accomplished signals collecting and was caught 15 days; After accomplishing signals collecting; Patient can take off applicator system, and tears double faced adhesive tape, and the skin clean processing is done in suggestion.

Step 4; Patient's computer is installed signal storage and software for display; Patient opens applicator system, takes out storage TF card, use conventional special F card reader with the data upload computer and can demonstration, playback, search fast, mark unusually; And the support printout, institute's data that obtain can be carried out network and transmitted and phone transmission in the TF card.

Step 5: through phone and network transmission or patient follow-up's pattern; Electrocardiosignal is transferred to the hospital doctor work station, and workstation computer signal data Treatment Analysis system accomplishes the playback of electrocardiosignal, analyzes; And according to identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; Analyze electrocardiosignal and abnormal marking, the diagnosis cardiac electrical event, effectively the symptom relevant with arrhythmia suspected in record; Clear and definite ARR character, and can be to the antiarrhythmic therapy rational evaluation; Realize the monitoring of myocardial ischemia; Evaluation to ischemic heart desease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; To installation, detection and the assessment of function of sudden cardiac death, cardiac pacemaker, all testing results are being transferred to patient with report form, and draw corresponding clinical diagnosis report according to testing result, and foundation are provided for clinical treatment.

Claims

The method and system of the sticking type remote measurement electrocardiographic recording of noinvasive overlength record vast capacity storage, comprise the miniature applicator system of body surface among Fig. 3; Patient's electrocardiosignal reads, demonstration and network transmitting software system; Doctor workstation patient electrocardiogram (ECG) data obtains, cardiac electrical event analysis, early warning and diagnostic system; Realize the signals collecting of ultra-micro power consumption superminiature body surface applicator system completion, special-purpose low-power consumption high capacity storage to electrocardiosignal conduction, super low-power consumption; Realize electrocardiosignal networking transmission, Computer signal Data Management Analysis system accomplishes special-purpose software data monitoring and the analysis to tracer signal, early warning and diagnosis, and data image shows, data storage, printout.
2. ultra-micro power consumption superminiature body surface applicator system according to claim 1; It is characterized in that overall dimensions is length 44mm, wide 20mm, diameter 7mm; System realizes that body surface attaches also waterproof and breathable, no infection, rejection, allergy, and reliable and stable attaching is more than 15 days.
3. ultra-micro power consumption superminiature body surface applicator system according to claim 1; Long-term, safe, stable direct measurement electrocardiosignal under the human body physiological state of ability nature; The microvolt level that obtains the eigenvalue of ecg wave form clearly and obtain T ripple electrical alternations is measured; The miniature sticking type remote measurement electrocardiographic recording of ultra-long time (more than 15 days) noinvasive body surface dynamic electrocardiographic recording especially can be provided; A plurality of electrocardiographic recorder pasters are united use, and write down multichannel noinvasive body surface ecg simultaneously, realize the storage of the cardiac electrical TF card of multichannel body surface high capacity.
4. patient's electrocardiosignal according to claim 1 reads, demonstration and network transmitting software system; It is characterized in that using conventional special F card reader with the data upload computer and can demonstration, playback, search fast, mark unusually; And the support printout, institute's data that obtain can be carried out network and transmitted and phone transmission in the TF card.
5. doctor workstation patient electrocardiogram (ECG) data according to claim 1 obtains, cardiac electrical event analysis, early warning and diagnostic system; It is characterized in that through phone and network transmission or patient follow-up's pattern; Electrocardiosignal is transferred to the hospital doctor work station, and workstation computer signal data Treatment Analysis system accomplishes the playback of electrocardiosignal, analyzes; And according to identification abnormal electrocardiogram signals such as the waveform of electrocardiosignal, form, amplitudes; Analyze electrocardiosignal and abnormal marking, the diagnosis cardiac electrical event, effectively the symptom relevant with arrhythmia suspected in record; Clear and definite ARR character, and can be to the antiarrhythmic therapy rational evaluation; Realize the monitoring of myocardial ischemia; Evaluation to ischemic heart desease treatment measure; Leave hospital preceding and the convalescence guidance to Acute Myocardial Infarction Patients; To installation, detection and the assessment of function of sudden cardiac death, cardiac pacemaker, all testing results are being transferred to patient with report form, and draw corresponding clinical diagnosis report according to testing result, and foundation are provided for clinical treatment.