The content of invention
Because the excitement of neuron and fiber thereof needs constantly to obtain the energy from blood circulation with conduction, intracranial pressure (ICP) causes neuron and fiber hypoxic-ischemic and dysbolismus when raising, and nerve conduction can block, the conduct velocity of the signal of telecommunication in brain.Conduction velocity and intracranial are pressed with corresponding relation, and according to the flash visual evoked potential principle: human eye is sent standard light to stimulate, and picks up from head F
PZ, F
Z, O
1, O
2The flash visual evoked potential signal, thereby learn the intracranial pressure value by detecting the conduction velocity of this signal of telecommunication in brain.
According to above-mentioned principle, the mathematical function that the present invention is constructed between intracranial pressure and the measured signal closes
System: ICP=f (Latency) (I)
ICP is that intracranial pressure value, L are that incubation period (Latency), Δ L are hardware system response time-delay (for constant) in the formula (I).Detect patient and obtain L
i, simultaneously with there being wound method (opening the cranium art) to record this patient's true intracranial pressure value ICP
i, by n to measurement data [(L
1-Δ L), ICP
1]; [(L
2-Δ L), ICP
2]; [(L
3-Δ L), ICP
3 [(L
n-Δ L), ICP
n] back returns and to obtain functional relationship ICP=f (L-Δ L).This relational expression is enrolled analysis software, calculate automatically, and generate relevant characteristic curve by computer.
One of technical problem to be solved by this invention is: the characteristic curve based on above-mentioned principle and formula (I) provides a kind of Noninvasive intracranial pressure monitoring method.
Two of technical problem to be solved by this invention is: a kind of Noninvasive intracranial pressure monitoring device based on the flash visual evoked potential principle is provided.
The present invention one of solve the problems of the technologies described above adopt technical scheme be: adopt the flash of light eyeshade that human eye is sent the standard light stimulus signal; After Retinal impression, convert the signal of telecommunication → detecting electrode to and pick up the signal of telecommunication and process → import the wave crest delitescence value of computer → demonstrations flash visual evoked potential-incubation period (FlashVisual Evoked Potential--IIILatency) indicatrix → determine III ripple → applications intracranial pressure and preclinical functional relation ICP=f in III wave-wave peak (IIILatency) through amplifier, bear and put a corresponding intracranial pressure value namely demonstrating on the flash visual evoked potential-incubation period curve III wave-wave peak on the display screen.
According to technique scheme, the Noninvasive intracranial pressure monitoring method based on the flash visual evoked potential principle of indication of the present invention may further comprise the steps:
1. the controllable pulse formula flash signal that stimulates human eye is set, constitutes the pumping signal of bringing out current potential by it; Flashing rate, flash pulse width, guide number, and brightness values be respectively:
0.75Hz~1.0Hz, 5.33ms~7.33ms, 50~60 times, 20000cd/m
2~25000cd/m
2
Brightness is quantitatively controlled, and keep suitable, stablize constant flash stimulation intensity, with adaptability and the concordance that guarantees that Noninvasive intracranial pressure detects.
2, adopt non-invasive electrode to pick up from measured's head F
PZ, F
Z, O
1, O
2The flash visual evoked potential signal.
3, the flash visual evoked potential signal that picks up is amplified the back, is converted to digital signal input computer through A/D by amplifier, by computer flash visual evoked potential-incubation period waveform is carried out dynamic clustering stack, intercept method digital filtering and the fairing of sliding translation method, show to have high credibility, high fidelity and to be easy to identification blink visual evoked potential-incubation period characteristic curve, the crest place of III ripple is defined as incubation period (IIILatency);
4, according to the functional relationship (unit: IIILatency ms, ICP mmH of intracranial pressure ICP and III wave-wave peak IIILatency incubation period
2O), determine the intracranial pressure value, promptly
(1). determine acute intracranial hypertension according to formula ICP=a * IIILatency+b, wherein the span of a is 4.732 * (1 ± 5%), and the span of b is-326.17 * (1 ± 5%);
Or (2). according to formula ICP=α * EXP (β * IIILatency) determine non-acute intracranial hypertension and normal intracranial pressure, wherein the span of α is 9.3356 * (1 ± 5%), the span of β is 0.0199 * (1 ± 5%).
Promptly demonstrating the pairing intracranial pressure value of the negative point in III wave-wave peak on the flash visual evoked potential-incubation period curve on the display screen.
Two technical schemes that adopted that the present invention solves the problems of the technologies described above are such, and promptly a kind of Noninvasive intracranial pressure monitoring device based on the flash visual evoked potential principle is characterized in that:
1, comprises signal and data handling machine, this computer finish the filtering of detection sampling that the intracranial nerve brings out the current potential clock signal, characteristic curve and list or monitored record list were calculated, detected to fairing processing, intracranial pressure generation with printing, detect data file management, guarantee that optical flare triggers and detect the accurate timing of sampling and synchronous;
2, comprise eyeshield formula flasher and luminous body, this flasher is a pulsed, triggers control by computer, and luminous body is made of light emitting diode matrix, and is arranged in a pair of eyeshield;
3, comprise the light intensity detector of quantitatively controlling light intensity by computer;
4, comprise electrode, be connected with the ultramicro signal amplifier in;
5, ultramicro signal amplifier, it comprises two multistage band elimination filters and a circuit such as low frequency bandpass filter, in order to eliminate extraneous useless interfering signal, therefrom extract required flash visual evoked potential signal and amplify, this amplifier special frequency channel: OHz~30Hz.
Described ultramicro signal amplifier, eyeshield formula flasher are accepted the control of computer by controlling conversion and adjusting module circuit and data collecting card and input/output control module.Light intensity detector and ultramicro signal amplifier by data collecting card and input/output control module to computer input signal.
Monitoring intracranial pressure method based on the flash visual evoked potential principle of the present invention, having overcome traditional method has shortcomings such as wound, complicated operation, the scope of application be little, has realized accurate, quick, easy monitoring intracranial pressure.Compare with existing intracranial pressure testing product, also increased intracranial and divided functions such as cavity pressure detection, real-time monitoring, data readback, avoided having danger and patient suffering that wound detects, reduced diagnostic fees usefulness.The present invention has high stability ultramicro signal amplifying circuit, light intensity quantitatively control reaches ICP=f (Latency) functional relationship accurately, device adopts modularity, intellectuality, Chinesizing design fully, feature richness, simple to operate, safeguard easily, also be convenient to function expansion, product up-gradation.
Average relative measurement error of the present invention is lower than except other pressure testing method beyond the cranium pressure measurement.About 3 minutes of a pressure measurement deadline of the present invention is far fewer than other pressure testing method
The specific embodiment
Said method of the present invention and device can further specify by the embodiment that concrete accompanying drawing provides.
According to the present invention, the step of method comprises:
1, the flash of light eyeshield sends the standard light stimulus signal to human eye, converts the signal of telecommunication to through retinal photoreceptor:
Light source in the eyeshield is a pulsed, triggers control by computer, has constituted the pumping signal of bringing out current potential.
Flashing rate, flash pulse width, guide number, and brightness adopt the optimum combination value:
1.0Hz, 5.997ms, 60 times, 22000cd/m
2
Described brightness needs quantitatively control, and keep suitable, stablize constant flash stimulation intensity, can guarantee adaptability and concordance that Noninvasive intracranial pressure detects.
The characteristics of this light source are:
(1) adopts the fast opto-electronic conversion of speed, no hysteresis effect;
(2) adopt yellow light sources, desaturation is good, is difficult for bringing out the retina retarded potential---and this current potential is an interfering signal to this detection system;
(3) low-voltage, little current drives are luminous, long service life;
(4) the emission light beam is that directional light and brightness are even, pupil is that the big visual field is subjected to light, and eyeball rotates measuring influence very little;
(5) light intensity is moderate---and not only surpassed and produced the needed threshold value of flash visual evoked potential, but also interference such as unlikely generation retina retarded potential;
(6) but the self check of flash of light eyeshield luminosity, and can adjust to required numerical value at any time, thereby photostimulation deviation and the intracranial pressure measurement error that can avoid light decay to cause.
1, adopts and to touch little, the Non-Invasive sunflower shape of impedance electrode and pick up from F
PZ, F
Z, O
1, O
2The flash visual evoked potential signal.The disclosed technical pattern of wherein Non-Invasive sunflower shape electrode patent No. ZL00244894.7
3, the flash visual evoked potential signal amplifies, is converted to digital signal input computer through data collecting card (6) again by amplifier (10~17), sees Fig. 2.
(1) computer carries out showing after the Mathematical treatment to flash visual evoked potential-incubation period characteristic curve, sees Fig. 2, Fig. 3.
Computer carries out dynamic clustering stack, intercept method digital filtering and the fairing of sliding translation method to flash visual evoked potential-incubation period waveform, makes it have high credibility, high fidelity and is easy to identification.
1. dynamic clustering stack: be exactly that N time (50~60) detection sampling curve is superposeed and on average, after cluster analysis, reject n (N * 10%) unusual sample again, so that final flash visual evoked potential-incubation period characteristic curve have high credibility, wherein N represents guide number;
2. intercept method digital filtering: comprise low-pass digital filter, the filtering of power frequency cut-off frequency, the filtering of myoelectricity cut-off frequency, it is characterized in that adopting intercept method---eliminate " end effect " of digital filtering, make flash visual evoked potential-characteristic curve distortion incubation period minimum;
Intercept method: as shown in Figure 4, if the flash visual evoked potential of desiring to take-incubation period characteristic curve length is L (from moment t2~moment t3), the section that then extracts length in advance and be 2L (from moment t1~moment t4) carries out digital filtering to be handled, pinch a 1/2L (from the moment t1~moment t2) 1/2L that truncates (from moment t3~moment t4) then, finally only take required interlude L (from moment t2~moment t3).
3. sliding translation method fairing: after flash visual evoked potential-incubation period characteristic curve fairing processing, can make waveform be easy to discern and be convenient to the crest location of III ripple.
(2) moving cursor to the crest of III ripple is sentenced and is determined its incubation period (IIILatency), sees Fig. 2.
(3) use intracranial pressure and the preclinical functional relation in III wave-wave peak 1. or formula 2., computer is extrapolated the intracranial pressure value automatically.
The formula 1. acute intracranial hypertension of ICP=a * IIILatency+b is suitable for;
Formula 1. according to acute intracranial hypertension patient's III wave-wave peak hide time value with open cranium pressure measurement value and obtain through mathematical regression.
Formula 2. ICP=α * EXP (non-acute intracranial hypertension of β * IIILatency) and normal intracranial pressure are suitable for.
Formula 2. according to non-acute intracranial hypertension patient and normal person's III wave-wave peak hide time value with open cranium pressure measurement value and obtain through mathematical regression.
Annotate: a, b, α, β are constant, IIILatency unit: ms, ICP unit: mmH
2O.The preferable value of a, b, α, β is as follows:
1. the acute intracranial hypertension of formula ICP=4.732 * IIILatency-326.17 is suitable for;
2. (0.0199 * IIILatency) non-acute intracranial hypertension and normal intracranial pressure are suitable for formula ICP=9.3356 * EXP.
4, promptly demonstrate the pairing intracranial pressure value of the negative point in III wave-wave peak on the flash visual evoked potential-incubation period curve on the display screen.See Fig. 2.
Referring to Figure 22,23, and subordinate list 1,2, detect data and 56 routine acute intracranial hypertension detection data by the non-acute intracranial hypertension of 48 examples, illustrate the acquisition of ICP=f (Latency) functional relationship, its error is in the scope of clinical permission.In fact, the functional relationship that provides of the present invention returns through thousands of routine measured datas and obtains.
Among the embodiment of apparatus of the present invention, mainly by constituting with lower member:
(1) signal and data handling machine.This computer is finished the detection sampling that the intracranial nerve brings out the current potential clock signal, the filtering of characteristic curve and the generation and printing, detection data file management that list or monitored record list were calculated, detected to fairing processing, intracranial pressure.Control corresponding software moves under MS-DOS operation system, triggers and detect the accurate timing of sampling with synchronously to guarantee optical flare.
(2) flasher.This flasher is a pulsed, triggers control by computer.Luminous body 20 is made of light emitting diode matrix, and is arranged among a pair of MK11 type eyeshield 21, so that Fig. 7~9 are seen in clinical use.Described MK11 type eyeshield 21 is produced by Suzhou Semiconductor General Factory.Its parameter is:
1. luminous body: light emitting diode, brightness 9000cd/m
2± 5%, 15 ° of wavelength 590 ± 5nm (gold-tinted) angles of departure, (constant pressure source is 2.0V) forward current 21.5mA ± 7%;
2. arrangement mode: dot matrix gathers in the ellipse area of a=29.8mm, b=25.0mm, sees Fig. 8; Its circuit is made of voltage stabilizing integrator SCA015 and light emitting diode, sees Figure 10;
(3) light intensity detector.In the present embodiment, adopt VL-C590 type high accuracy brightness detection probe, this probe is produced by a distant place, Hangzhou company.Referring to Figure 11~15.
VL-C590 type brightness probe is made of light probe 22 and cone 23, and wherein cone 23 is enclosed within on the luminous body 20 of flash of light eyeshield 21.Be applicable to the brightness of measuring λ=590 ± 5nm LED array (eyeshield formula profile).The brightness probe is converted to the brightness signal of input the d. c. voltage signal of corresponding proportion, export data collecting card 6 to and convert digital signal to and import computer again, control the flash luminance of flash of light eyeshield luminous body 20 again by computer according to the brightness requirement of enrolling software in advance automatically.
VL-C590 type brightness probe major parameter and performance indications:
1. probe measurement range: 67500cd/m
2, maximum input: the 100000cd/m that allows
2
2. specified output area: DC0V~5V pops one's head in;
3. the no-load voltage ratio of popping one's head in coefficient: K=13500cd/m
2/ V;
4. linear: 0.5%;
5. zero-bit: ± 0.1% range;
6. accuracy: one-level;
7. the output impedance of popping one's head in: 1k Ω;
8. working condition: a. working power: ± 12V~15V; B. ambient temperature: 0 ℃~40 ℃; C. ambient humidity: 55 ± 15R.H.
(4) electrode.In the present embodiment, electrode adopts SEF-1 type sunflower shape electrode, referring to patent ZL00244894.7, is the pick-up of flash visual evoked potential signal.Electrode also can be selected needle electrode for use.
(5) amplifier.This amplifier be for the normal amplification of the ultra micro flash visual evoked potential signal of realizing special frequency channel custom-designed; it is by conversion switch 10; input stage holding circuit 11; preamplifier 12; mid-amplifier 13; 14,17 and low frequency bandpass filters 16 of 15, two function wave traps of isolated amplifier combine, and see Fig. 6.
Wherein: conversion switch 10 is formed the received signal circuit by optical relay; Preamplifier 12 is made of the micro-signal difference amplifier; Mid-amplifier 13 is made of the micro-signal amplifier; Function wave trap 14,17 is made of active function type band resistance amplifying circuit; Isolated amplifier 15 is made of an output, input, the isolated amplifier of power supply three ends; Low frequency bandpass filter 16 is made of the oval low pass active filter circuit in five rank.The flash visual evoked potential signal is connected with preamplifier by the input of two signal line by preamplifier 12 respectively through conversion switch 10, be connected by the input of outfan again with mid-amplifier 13, outfan by mid-amplifier is connected with the input of first order function wave trap 14 again, outfan by first order function wave trap is connected with the input of isolated amplifier 15 again, outfan by isolated amplifier is connected with the input of low frequency bandpass filter 16 again, outfan by low frequency bandpass filter is connected with the input of second level function wave trap 17 again, last outfan by second level function wave trap again exports data card 6 to, sees Fig. 6.
Its key technical indexes: amplification 〉=2.8 * 10
5Signal input range: 0.01 μ V~10.00 μ V; Signal frequency range: 0Hz~30Hz; Common mode rejection ratio 〉=60dB; Amplitude-frequency characteristic: the output signal amplitude of variation is no more than 1V in 10Hz~30Hz scope; Stopband characteristic: during 50Hz, output voltage is not more than 0.08V (no input signal).
In the amplifier architecture,, can suppress to eliminate extraneous useless interfering signal, from the special frequency channel of input signal, extract the flash visual evoked potential signal of required detection, see Fig. 6 because each element circuit has adopted above-mentioned connected mode.
The amplifier workflow is as shown in Figure 6: after the flash visual evoked potential signal enters input stage holding circuit 11 by electrode input change-over switch module 10; successively by behind the full frequency band signal processing of preamplifier 12 mid-amplifiers 13; entering the first order has source function wave trap 14 to carry out the Filtering Processing of interference band signal, again by isolating enter large-signal after micro-signal amplifier 15 is isolated the processing stage.Have source function wave trap 17 to extract the useful signal of flash visual evoked potential signal place frequency ranges again through low frequency bandpass filter 16 and the second level, input data collecting card 6 offer again computer carry out operational analysis and with the result show, record.
In specific embodiment:
1. referring to Figure 16: circuit is by optical relay U8 among the figure, U9, U10, U18 forms the signaling switch ALT-CH alternate channel, and by buffering driver U13 and resistance R 3, R48-R51 forms control circuit, by capacitor C 43, C44, resistance R 52-R56 forms the attenuation input circuit, and micro-signal picks up the passage modular converter 10 that enters high sensitivity ultramicro signal amplifier by the sunflower electrode.It is characterized in that described circuit input end receives from Fpz, Fz, O
1, O
24 flash visual evoked potential signal (referring to accompanying drawing 6), change-over switch module is formed switch arrays, the real-time Transmission measured signal by noninductive Low ESR high-speed light relay.
2. referring to Figure 17: among the figure circuit by capacitor C 33-C36, resistance R 42, R43 forms input stage filtering and circuit is eliminated in self-excitation, can control the self-excitation of eliminating circuit by the cut-off signals path.By both-end difference input amplification circuit U7, resistance R 41, capacitor C 31, the preposition input stage that C32 forms, by integrated circuit U6A, U6B, capacitor C 2, C27-C30, resistance R 36 is formed mid-amplifying circuit.By its three amplifier amplification systems that constitute low noise, low drift, improved the ability of system's detection weak signal greatly, also improved the degree of balance between the dual pathways simultaneously, reduced of the interference of external interference signal to preamplifier state.
3. referring to Figure 18: the first function wave trap among the figure is by integrated circuit U1A, U1B, resistance R 4, R19, R22, R25-R29, R32, R33, potentiometer W6-W8, capacitor C 1, C11-C13, C15, C16, C19, C20, C23 forms, and utilize mid-amplifier and first order function wave trap to form the one-level combinational circuit, this kind combination effectively is amplified into first order function wave trap with measured signal with the onesize human body body interfering signal of measured signal, makes that the latter is more effective to suppress processing at interfering signal
The distortion circuit structure of function wave trap has logical preferably stopband characteristic.The interfering signal that is used to suppress useless and the interference of power supply clutter.
4. referring to Figure 19: circuit is by isolating amplification circuit U5, resistance R 11, R44-R47, capacitor C 24 among the figure, C25, C37-C42 forms isolating amplifier circuit, by the U14 photoisolator, coil T2, resistance R 59, R60, capacitor C 47-C49 form power supply and supply with and testing circuit.Realize isolating the electrical isolation of micro-signal amplifier stage and sample stage by it, to reach the safety of system.And provide high-quality working power to forward and backward level.
5. referring to Figure 20: among the figure circuit by amplification circuit U2, U3, U4, resistance R 2, R6, R8-R12, R14-R18, R20, R21, R23, R24, R61, R62, R65, capacitor C 1-C3, C5, C6, C17, C18, C21, C22, C50, C55, C60, C61 form five rank elliptic function low pass active filter circuits, and low frequency bandpass filter is characterized in that, can extract special frequency channel flash visual evoked potential signal by low frequency bandpass filter.Special frequency channel is 0Hz~30Hz.
6. the structure of second level function wave trap is identical with the structure of first order function wave trap, but there is difference in the value of relevant components and parts.
Second level function wave trap, employing be single-frequency stopband filter circuit (50Hz).Being used to eliminate the power frequency that comes from computer system disturbs.
Whole amplification system adopts the module preferred arrangement, installs multiple shielding additional, isolates various interference sources.Amplifier has good capacity of resisting disturbance and weak signal high-fidelity amplifying power, has very high stability, reliability.
(6) data collecting card and input and output control.See Fig. 5,6: data collecting card and input/output control circuit are made of 16 A/D of high-speed, high precision, be responsible for amplifying with Filtering Processing after FlashVisual Evoked Potential conversion of signals be digital signal so that the processing of computer.The signal source that also can produce standard is used for testing oneself of whole system and adjustment automatically.
(7) printer.Slightly.
(8) display.Slightly.
(9) control conversion and adjusting module.See Figure 21: among the figure circuit by reflective diode (led) driver (MK10A) U30, U31, optical relay U32, U33, digital regulation resistance U34, U35 forms.Be implemented under the computer control by it and produce pulse control signal by optical relay to be used for the flicker of eyeshield luminous, and utilize reflective diode (led) driver (MK10A) and digital regulation resistance that the luminous intensity of eyeshield is adjusted automatically.
According to model machine in Medical University Of Chongqing's second hospital clinical evidence, acute intracranial hypertension 29 examples of being done, in the non-acute intracranial hypertension 22 routine demonstration tests, there is wound relevant with the Noninvasive intracranial pressure detected value, consistent, average relative error is lower than 11.1%, within the scope of clinical permission, prove that both have interchangeability, intracranial monitor clinical practice of the present invention is effective.