CN103735261B - Eeg monitoring sedation depth closed-loop control syringe pump apparatus - Google Patents
Eeg monitoring sedation depth closed-loop control syringe pump apparatus Download PDFInfo
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- CN103735261B CN103735261B CN201410001522.3A CN201410001522A CN103735261B CN 103735261 B CN103735261 B CN 103735261B CN 201410001522 A CN201410001522 A CN 201410001522A CN 103735261 B CN103735261 B CN 103735261B
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Abstract
The present invention relates to a kind of eeg monitoring sedation depth closed-loop control syringe pump apparatus, including: integrated brain electric data collecting module in the same apparatus and injection module main frame；Described brain electric data collecting module is for gathering the original EEG signals of human body and be translated into can be with the quantized data index of sedation depth monitoring；Described injection module main frame is connected with described brain electric data collecting module, for determining downern medication administration parameters information according to described quantized data index, carries out downern injection dose according to described medication administration parameters information and controls.Present invention achieves eeg monitoring technology and syringe pump technology is integrated, and uses eeg monitoring sedation depth to carry out closed-loop control.This invention achieves individual administration, accurate medication, it is to avoid the mistake of anesthesia (calm) degree of depth is deep or crosses the clinical of shallow generation and endangers；Avoid dose excessive or the too small negative interaction brought to patient.
Description
Technical field
The present invention relates to a kind of anesthesia (calm) medical intravenous injection (or infusion) and automatically control dress
Put, be specifically related to a kind of eeg monitoring sedation depth closed-loop control syringe pump apparatus, belong to anesthesiology
Technical field.
Background technology
Applying downern to implement anesthesia the most more accurately is that clinical vein anaesthetizes problems faced.
In recent years, such as BIS Propofol-targeted (Bispectral Index, BIS), and brainstem auditory evoked electricity
Position index (Auditory Evoked Potential Index, AEPindex, AEPI),
NCT (Narcotren index anesthesia/brain electricity depth of consciousness monitoring system), anesthesia entropy (EEG
Spectral entropy), CSI(cerebral State Index) brain mind composition can be reacted refer to
Leading and preferably use the custodial care facility of downern more and more in clinical practice, doctor is according to brain
Electricity index manually regulates the dosage of syringe pump.
Because syringe pump and patient monitor are all independent products, and the most approved logical
The brain electricity patient monitor (such as BIS) crossing U.S. FDA certification is all external product.Because this
The Technical comparing of the general index of brain electricity double frequency is complicated, exploitation exists certain difficulty, so, current state
Nei You syringe pump producer, utilizing third party's patient monitor is the reserved communication interface of other designated equipment,
Monitoring data is received in the syringe pump oneself produced, by extracting from numerous monitoring data
BIS Propofol-targeted on data, and as leading indicator control syringe pump automatically to
Medicine, realizes closed-loop delivery injection with this.
But, above-mentioned syringe pump prior art is not a complete product.Can only say it is syringe pump
On with a data communication interface.If user wants to use closed loop drug administration by injection function, it is necessary to
Possesses the condition having patient monitor.Additionally, technology is applied there is very big clinical risk: anesthesia monitor
Be all multi-parameter monitoring equipment, not only there are one data of BIS Propofol-targeted, also have many its
Its monitoring data, such as: heart rate, blood pressure, pulse oxygen etc..Patient monitor is that other appointment sets
Standby reserved communication interface, its data being not used to non-designated third party device uses connect
Mouthful, the data of transmission also can carry out different technical finesses for its different designated equipment, monitoring
Instrument manufacturer will not ensure its data accuracy on non-designated third party device, if receiving these
Data the Main Basis being administered as equipment or index, then be more likely to produce error are so-called
" least bit leading to great error of difference ", severe patient then can cause malpractice, because narcotics is all
Belong to the great medicine of harmfulness, overdose dangerous.
Summary of the invention
Brief overview about the present invention given below, in order to provide about some of the present invention
The basic comprehension of aspect.Should be appreciated that this general introduction is not that the exhaustive about the present invention is summarized.
It is not intended to determine the key of the present invention or pith, is not the intended limitation present invention
Scope.Its purpose is only to provide some concept in simplified form, in this, as discuss after a while
Preamble in greater detail.
The present invention provides a kind of eeg monitoring sedation depth closed-loop control syringe pump apparatus, in order to realize
The automatic chemical feeding closed-loop control of downern, reduces and is administered risk.
A kind of eeg monitoring sedation depth closed-loop control syringe pump apparatus that the present invention provides, including:
Integrated brain electric data collecting module in the same apparatus and injection module main frame；
Described brain electric data collecting module is used for gathering the original EEG signals of human body and being translated into
Can be with the quantized data index of sedation depth monitoring；
Described injection module main frame is connected with described brain electric data collecting module, for according to described amount
Change data target and determine downern medication administration parameters information, carry out town according to described medication administration parameters information
Quiet drug injection dose controls.
The eeg monitoring sedation depth closed-loop control syringe pump apparatus that the present invention provides, device self collects
Become to have brain electric data collecting module and injection module main frame, be have downern automatically to
A complete product facility of medicine closed loop control function, it is achieved that by eeg monitoring technology and injection
Pump technology integrated, and use eeg monitoring sedation depth to carry out closed-loop control.Due to device
Middle injection module main frame carries out the brain of downern injection dose automatic chemical feeding closed-loop control institute foundation
Electricity data, are directly to be gathered by the brain electric data collecting module that same device is integrated, thus be excluded that
Because the human body initial data that third party device is to gathering disturbs the error caused, reduce administration
Risk, it is achieved that individual administration, accurate medication, it is to avoid anesthesia (calm) degree of depth the deepest
Or cross the clinical harm of shallow generation, and avoid that dose is excessive or the too small negative work brought to patient
With.
Accompanying drawing explanation
In order to be illustrated more clearly that the embodiment of the present invention or technical scheme of the prior art, below will
The accompanying drawing used required in embodiment or description of the prior art is briefly described, it is clear that
Ground, the accompanying drawing in describing below is only some embodiments of the present invention, skill common for this area
From the point of view of art personnel, on the premise of not paying creative work, it is also possible to obtain according to these accompanying drawings
Other accompanying drawing.
The eeg monitoring sedation depth closed-loop control syringe pump dress that Fig. 1 provides for the embodiment of the present invention
One of theory diagram put；
The eeg monitoring sedation depth closed-loop control syringe pump dress that Fig. 2 provides for the embodiment of the present invention
The two of the theory diagram put；
Fig. 3 is the eeg monitoring sedation depth closed-loop control syringe pump providing the embodiment of the present invention
The control method schematic diagram of device.
Detailed description of the invention
For making the purpose of the embodiment of the present invention, technical scheme and advantage clearer, below in conjunction with
Accompanying drawing in the embodiment of the present invention, carries out clear, complete to the technical scheme in the embodiment of the present invention
Ground describes, it is clear that described embodiment is a part of embodiment of the present invention rather than whole
Embodiment.Element and feature described in the accompanying drawing of the present invention or a kind of embodiment are permissible
Combine with the element shown in one or more other accompanying drawing or embodiment and feature.Should
Note, for purposes of clarity, accompanying drawing and explanation eliminate unrelated to the invention, this area
Parts known to those of ordinary skill and the expression of process and description.Based on the enforcement in the present invention
Example, it is all that those of ordinary skill in the art are obtained on the premise of not paying creative work
Other embodiments, broadly fall into the scope of protection of the invention.
Common anesthesia is the body weight with patient, age rough estimate sedative dosage, and in art
Judge to anaesthetize the depth of (calm) by blood pressure, heart rate, and blood pressure, heart rate are stung by operation
The impact swashed, can not accurately reflect the degree of depth of anesthesia (calm), therefore, the anaesthesia process traditional Chinese medical science
Raw experience has played decisive action to a great extent.And due to individual difference, the one-tenth of same body weight
Year people, the reaction to the same anesthetic and sedative drugs thing of Isodose is likely to vary, even if warp
Testing abundant doctor also cannot make different patients reach preferable depth of anesthesia, thus the use that has been born
Instrument and equipment in special monitoring anesthesia (calm) degree of depth.
The instrument monitoring of anesthesia (calm) degree of depth experienced by be studied widely and attempts, as volume is retouched
Note figure, frontalis electricity, dermatopolyneuritis, lower esophageal contractility, HRV, original electroencephalogram
With Evoked ptential etc..By continuous clinical verification, above-mentioned most methods is due to cannot be well
Reflection anesthesia (calm) degree of depth or disturbing factor are too much, and be gradually eliminated (or needing the most perfect).
Only according to the derivation index BIS Propofol-targeted of original electroencephalogram (Bispectral Index,
BIS), and AEPI (Auditory Evoked Potential Index,
AEPindex, AEPI), NCT (Narcotren index anesthesia/brain electricity depth of consciousness monitoring system
System), anesthesia entropy (EEG spectral entropy), CSI(cerebral State Index) become
For the application index more likely of Monitored anesthesia (calm) degree of depth, the most gradually obtain wide
General application.
BIS Propofol-targeted (Bispectral Index, BIS), refers to measure electroencephalogram linear components
(frequency and power), the non-linear relation being parsed into again between partial wave (position phase and harmonic wave), energy
The various EEG signals representing different level of sedation are picked out, and are standardized and at digitlization
Reason, is finally translated into a kind of simple quantizating index.The size of BIS Propofol-targeted value with calm,
Consciousness, memory height correlation, not only closely related with normal physiological sleep, moreover it is possible to monitor well
Sedation degree in depth of anesthesia, has higher specificity and sensitivity.At present, this index is made
For detecting the index of sedation depth of anaesthesia, extensively apply in clinic.Coordinate Intravenous Anesthesia defeated simultaneously
Note equipment (such as syringe pump), manual control calmness dosage, the anesthesia that can reach good is calm
Effect.
During surgery anesthesia, medical personnel only can not accomplish in Real Time Observation by manpower
While BIS Propofol-targeted fluctuation, dosage can be manually adjusted by real-time carrying out again；Therefore,
Medical personnel need one both can detect BIS Propofol-targeted in real time, again can be according to brain electricity double frequency
The fluctuation of index automatically controls the infusion apparatus (syringe pump) of dosage.
But, because directly obtain the Technical comparing complexity of BIS Propofol-targeted by human body, exist
Certain difficulty；So, some infusion apparatus (such as syringe pump) producer at present, in a disguised form utilize
Tripartite's anesthesia monitor is the communication interface that other designated equipment is reserved, is received by monitoring data certainly
In the syringe pump that oneself produces, by extracting BIS Propofol-targeted from numerous monitoring data, and make
Control syringe pump automatic chemical feeding for leading indicator, realize the purpose of closed-loop delivery with this.
But, because anesthesia monitor belongs to comprehensive anesthesia monitoring equipment, BIS Propofol-targeted
Simply one of its numerous monitoring data, patient monitor is the communication interface that other designated equipment is reserved, its
Effect is not data-interface open, that use to non-designated third party device, the data of transmission
Also different technical finesses can be carried out for different designated equipments；Anesthesia monitor manufacturer will not protect
Demonstrate,prove its data accuracy on non-designated third party device, if receiving these data and as setting
The standby Main Basis being administered or index, then be more likely to produce error, the so-called " least bit of difference
Leading to great error ", severe patient then can cause malpractice.
As mentioned above, although BIS Propofol-targeted (BIS) index is as detection anesthesia calmness
The index of the degree of depth, can the sedation depth in Depth of Anesthesia well, and by extensively in clinic
Application；But improper owing to gathering the approach obtained or mode, not only can not accomplish to close accurately
Ring is administered, and also can produce serious problem, even jeopardize the life of patient.
The present invention is in order to overcome drawbacks described above, it is provided that one be integrated with brain electric data collecting module and
The complete product equipment of injection module main frame, i.e. eeg monitoring sedation depth closed-loop control syringe pump dress
Put.Due in device injection module main frame carry out downern injection dose be administered closed-loop control depended on
According to eeg data, be directly to be gathered by the brain electric data collecting module that same device is integrated, because of
This eliminates because the third party device human body initial data to gathering disturbs the error caused, and reduces
Administration risk.Below in conjunction with the accompanying drawings technical scheme is described in detail.
The eeg monitoring sedation depth closed-loop control syringe pump dress that Fig. 1 provides for the embodiment of the present invention
The theory diagram put.As it is shown in figure 1, the eeg monitoring sedation depth closed loop control that the present embodiment provides
Syringe pump apparatus 1 processed includes: brain electric data collecting module 11 and injection module main frame 12.
Brain electric data collecting module 11 is used for gathering the human body original brain telecommunications of human body (such as patient)
Number and be translated into can be with the quantized data index of sedation depth monitoring.Wherein, human body is original
EEG signals abundant information, it may include but be not limited to one or more of: brain wave spectrum, frequency,
Power, the frontalis signal of telecommunication, human body impedance；Can be able to wrap with the quantized data index of sedation depth monitoring
Include but be not limited to one or more of: BIS(Bispectral Index, BIS Propofol-targeted),
(Auditory Evoked Potential Index, AEPindex, auditory evoked potential refers to AEPI
Number), NCT (Narcotren index anesthesia/brain electricity depth of consciousness monitoring system), anaesthetize entropy
(EEG spectral entropy), CSI(cerebral State Index) quantitatively
EEG (quantitative EEG), edge spectrum (SpectralEdge Frequency), middle position
Frequency spectrum (mean power frequency) etc. come from brain electricity, for Monitored anesthesia sedation depth
The quantized data index of (depth of consciousness).It is analyzed original for above-mentioned human body EEG signals calculating
Be converted into one of the above or multiple can with the technology of the quantized data index of sedation depth monitoring, for
Prior art, the present invention does not repeats them here.
Injection module main frame 12 is connected with brain electric data collecting module 11, for according to eeg data
The described quantized data index of acquisition module 11 output determines downern medication administration parameters information, root
Carry out downern injection dose according to described medication administration parameters information to control.Injection module main frame of the present invention
Implementation very flexible, such as: injection module main frame can come according to described medication administration parameters information
Regulation is injected the speed of medicine and injects with this speed constant speed after adjustment.Or, injection module master
Machine can also regulate target level (i.e. target blood concentration) according to described medication administration parameters information, logical
Overregulate the target level of injection medicine to maintain target blood concentration constant.Medication administration parameters information can be wrapped
Include but be not limited to one or more of: dosage, injection speed, TCI target level.
The eeg monitoring sedation depth closed-loop control syringe pump apparatus that the present embodiment provides is integrated with brain
Electric data collecting module and injection module main frame, it is original that brain electric data collecting module directly gathers human body
EEG signals are also converted into the quantized data index that can monitor sedation depth, are referred to by this quantized data
Mark is sent to injection module main frame, the situation of change of this quantized data index of injection module host supervision
And carry out downern injection dose control according to testing result, thus using this eeg monitoring town
During quiet degree of depth closed-loop control syringe pump apparatus carries out eeg monitoring to human body, calmness can be realized
The automatic chemical feeding closed-loop control of medicine, it is to avoid the mistake of anesthesia (calm) degree of depth is deep or the shallow generation of mistake
Clinical harm；Avoid the excessive negative interaction brought to patient of dose, it is achieved individual administration, essence
Really it is administered, and the quantized data index of automatic chemical feeding closed-loop control institute foundation is integrated by same device
Brain electric data collecting module provide, therefore, eliminate because third party device to gather human body
Original EEG signals disturb the error caused, and reduce administration risk.
(1) in technique scheme, optional structure such as Fig. 2 institute of brain electric data collecting module 11
Show, including: the brain electric transducer 111 that is sequentially connected with, human body cable 112, data conversion module
113 and host cable 114, concrete:
Brain electric transducer 111 is connected with human body cable 112, is used for gathering the original EEG signals of human body.
Brain electric transducer can be but be not limited to brain electrode sheet, and during use, brain electrode sheet is attached to human body brain,
The primitive organism signal of telecommunication (i.e. human body original brain telecommunications produced by human body brain is gathered by electrode points
Number).
Human body cable 112 is connected with brain electric transducer 111 and data conversion module 113 respectively, uses
It is sent to data conversion module in the original EEG signals of the human body gathered by brain electric transducer 111
113。
Data conversion module 113 is connected with human body cable 112 and host cable 114 respectively, is used for
The original EEG Processing of human body sent by human body cable 112 is converted into can monitor calmness
The quantized data index of the degree of depth, and described quantized data index is sent to host cable 114.Data
The process of modular converter 113 EEG signals original to human body may include but be not limited to: to human body brain
The filtering of primitive organism signal, amplification, computing etc. process, and can monitor obtaining one or more
The quantized data index of sedation depth.
Host cable 114 is connected with injection module main frame 12, for by data conversion module 113
What transmission came can be sent to injection module main frame 12 with the quantized data index of sedation depth monitoring.
Using this technical scheme, injection module main frame can be from the integrated brain electric data collecting module of device
Directly obtain the original EEG signals of human body, the informative of the original EEG signals of human body, can meet
The administration demand for control of injection module main frame.This technical scheme without by third party device obtain to
Medicine control needed for information, thereby eliminating because of third party device to gather human body original brain telecommunications
Number error that interference causes, reduces administration risk.
(2) in technique scheme, the optional structure of injection module main frame 12 as in figure 2 it is shown,
Including: data monitoring analyzes module 121 and drug administration by injection control module 122, concrete:
Data monitoring is analyzed module 121 and is connected with brain electric data collecting module 11, is used for monitoring brain
The situation of change of the described quantized data index that electric data collecting module 11 sends, according to monitoring knot
Fruit adjusts downern medication administration parameters information.
Drug administration by injection control module 122 is analyzed module 121 with data monitoring and is connected, for according to institute
State downern medication administration parameters information and carry out the administration control of downern.
Further, injection module main frame 12 may also include man-machine interaction display module 123.People
Machine interactive display module 123 analyzes module and described drug administration by injection control with described data monitoring respectively
Molding block connects, and is used for using figure and/or written form display one or more of information,
The original EEG signals of described human body, described quantized data index, described downern medication administration parameters are believed
Breath.
(21) in an optional implementation, data monitoring is analyzed module 121 and can be wrapped further
Include: analyze submodule 1211, monitoring submodule 1212 and output sub-module 1213.
Described monitoring submodule 1212 is connected with described brain electric data collecting module 11, is used for monitoring
The situation of change of the quantizating index data of described brain electric data collecting module 11 output.
Described analysis submodule 1211 respectively with described monitoring submodule 1212 and described output submodule
Block 1213 connects, and adjusts downern for the monitoring result according to described monitoring submodule 1212
Medication administration parameters information also exports to described output sub-module 1213.
Described output sub-module 1213 respectively with described analysis submodule 1211 and described drug administration by injection
Control module 122 connects, and is administered for described downern medication administration parameters information processing is become corresponding
Information is also sent to described drug administration by injection control module 122.
In technique scheme, described quantized data index include one or more of: BIS,
AEPI, NCT, anesthesia entropy, CSI, quantitative EEG, edge spectrum.Described analysis submodule
Block 1211 can adjust downern according to the monitoring result of one or more quantized data indexs above-mentioned
Medication administration parameters information also exports to described output sub-module 1213.Such as: monitoring submodule 1212
Change for the described quantized data index (such as BIS) of monitoring in real time.Analyze submodule 1211
By (predetermined with predetermined upper limit value or predetermined lower bound value for the value of described quantized data index (such as BIS)
Threshold values) compare analysis to adjust downern medication administration parameters information.Such as: when BIS is calm
Change in depth, higher than when setting upper limit threshold values, illustrates that current sedation depth is inadequate, it should increase dose；
When sedation depth change is less than lower limit threshold values, illustrate that current sedation depth is the deepest, it should reduce and give
Dose.Meanwhile, according to the changing value of sedation depth association BIS value, special algorithm is used to calculate
The final of downern increases dose or subtracts dose, and according to result of calculation output increase and decrease medicine instruction, example
As: when BIS exceedes predetermined upper limit value, increase medicine instruction to output sub-module 1213 output；When
When BIS exceedes predetermined lower bound value, subtract medicine instruction to output sub-module 1213 output.
Preferably, analyze submodule 1211 and can be additionally used according to the original EEG signals of described human body true
Fixed original electroencephalogram (EEG) data and/or electromyogram (EMG) data, comprehensive described quantization number
According to the monitoring result of index situation of change and described original EEG data and/or electromyogram number
According to, adjust downern medication administration parameters information.Such as: in the technical program, when brain electricity double frequency
When index (BIS) reaches pre-set threshold value, analyzing submodule 1211 can be in combination with current EMG
The vibration frequency of relative strength index and/or EEG curve carries out comprehensive analysis, determines that BIS value becomes
The degree of accuracy changed, thus reach correctly to judge the purpose of current human's sedation depth.Specifically,
Human body is extremely complex physiological system, and BIS change there may be interference, in order to avoid merely
BIS change causes the erroneous judgement of administration, BIS is combined EEG, EMG and judges, first
Judge whether BIS exceedes pre-set threshold value, if it does, then combine EMG relative strength index and/
Or the vibration frequency of EEG curve determines whether, thus see that whether the change of BIS is by frontalis electricity
Movable or human body causes when the interference of forebrain consciousness situation.Generally speaking, EMG index is the lowest
Showing that frontalis electrical activity is the most weak, the interference to BIS is the least；Index is the highest shows frontalis electrical activity more
By force, the interference to BIS is the biggest；EEG curve frequencies fluctuation explanation the soonest is realized more when forebrain
Clear-headed, the interference to BIS is the biggest；Frequency fluctuation illustrates when forebrain consciousness is the fuzzyyest the most gently,
Interference to BIS is the least.BIS combines EEG, EMG and carries out the step of comprehensive descision, can
By operative site, medical worker judges, to this, data monitoring of the present invention is analyzed module and also can be wrapped
Include alarm control unit (not shown), this alarm control unit and brain electric data collecting module
Connecting, for monitoring the change of described BIS Propofol-targeted, the value at described BIS Propofol-targeted surpasses
When crossing predetermined threshold (predetermined upper limit value or predetermined lower bound value), output warning message also interrupts described
Drug administration by injection control module is administered control.Described drug administration by injection control module is in interruption of reporting to the police
Between the control instruction of acceptable medical worker determine as increased medicine, subtracting actual administrations the such as medicine and control.Enter
One step, can not get feedback for a long time in order to avoid described drug administration by injection control module and be delayed administration
Controlling, affect operation and be smoothed out, data monitoring of the present invention is analyzed module and is also included time delay control
Unit (not shown) processed.Delays time to control unit respectively with described alarm unit and described injection
Administration control module connects, for when described alarm unit output warning message, starting calculating and prolong
Time, if being not received by the external command adjusting medication administration parameters and being administered in during time delay,
Then after time delay terminates, control described drug administration by injection control module and recover according to former setting medication administration parameters
It is administered.
Described output sub-module 1213 respectively with analyze submodule 1211 and drug administration by injection control module
122 connect, for becoming corresponding drug administration information concurrent described downern medication administration parameters information processing
Give drug administration by injection control module 122.Might as well illustrate as a example by target control is injected: output submodule
Block 1213 is for according to increasing, subtract medicine instruction, according to the changing value of sedation depth of anaesthesia, to medicine
Parameter calculates, and determines the target level finally increasing, subtracting downern, and exports drug administration by injection
Control module.
(22) in an optional implementation, drug administration by injection control module 122 includes: injection
Device pushing means 1221 and step motor control module 1222.
Step motor control module 1222 analyzes module 121 with data monitoring respectively and syringe pushes away
Dynamic device 1221 connects, for according to data monitoring analyze downern that module 121 sends to
Medicine parameter information drives syringe pushing means 1221.Such as: medication administration parameters information can include but
It is not limited to dosage and/or injection speed；Step motor control module 1222 includes stepper motor
And control circuit, realized the accurate speed governing of stepper motor by control circuit, be used for controlling syringe pump
Actual injection speed and dosage.
Syringe pushing means 1221 is for carrying out the injection of downern.Such as: syringe pushes away
Dynamic device is for sending stepper motor action to syringe, it is achieved the true administration to human body.
(23) in an optional implementation, man-machine interaction display module 123 includes: liquid crystal
Display module 1231 and the touch-control module 1232 being connected with LCD MODULE 1231.
LCD MODULE 1231 is used for showing that the original EEG signals of human body, described quantized data refer to
Mark (such as BIS value), downern medication administration parameters information, electroencephalogram (EEG), electromyogram (EMG)
Etc. critical data, figure (including various graphical function button) etc..
LCD MODULE 1231 is controlled by touch-control module 1232 according to the touch information received
System.Such as: touch-control module 1232 in response screen graphical function button tap operation,
Complete the various functions being pre-designed, it is achieved the simplest man-machine interaction mode.
Fig. 3 is the eeg monitoring sedation depth closed-loop control syringe pump providing the embodiment of the present invention
The control method schematic diagram of device.As it is shown on figure 3, eeg monitoring sedation depth closed-loop control injection
The control method of pump installation includes: brain electric data collecting module gathers the human body original brain telecommunications of patient
Number and be translated into can be with the quantized data index of sedation depth monitoring, and by described quantization number
Injection module main frame is sent to according to index；Injection module main frame carries out reality to described quantized data index
Time monitoring and analyze, according to monitoring and analysis result control downern injection dose, with realize
To the automatic drug administration by injection of human body (such as patient) closed loop.In Fig. 3, solid line loop is closed loop and is administered to
The route signal of medicine, concrete, such as:
Brain electric data collecting module obtains the original EEG signals of human body of patient by brain electric transducer.
Such as: directly gather human body original brain electricity by the brain electric transducer of BIS Propofol-targeted acquisition module
Signal, and be filtered through data conversion module, amplify and after computing etc. processes, obtain permissible
The crucial eeg data of the quantized data index (such as BIS value etc.) of sedation depth monitoring.
Data monitoring analyzes the situation of change of quantized data index described in module monitors, according to monitoring knot
Fruit adjusts downern medication administration parameters information.Such as: data monitoring submodule is by monitoring submodule
The situation of change of described quantized data index is monitored in real time, by analyzing submodule to described
Quantized data index is analyzed, by the described quantized data index real-time monitored and predetermined threshold
(upper and lower critical value) carries out synchronizing comparative analysis, is up to shortly or exceedes preset upper lower critical
Carry out alarm during value, and determine whether to carry out increasing, subtracting administration according to comparative analysis result, with
Adjust the medication administration parameters information of downern.Data monitoring is analyzed module and is shown also by man-machine interaction
Show module, by original for described human body EEG signals, described quantized data index, described downern
The information such as medication administration parameters information are graphically shown to the aobvious of man-machine interaction display module with textual form
In display screen, it is possible to by touch interface, data parameters is operated.
Drug administration by injection control module analyzes the dosage after module adjusts, administration according to data monitoring
The medication administration parameters information such as speed, the actual administration carrying out downern controls.
The technical scheme that the present invention provides, by being attached to the brain electric transducer collection people of human body brain
The original EEG signals of body, directly obtain such as brains such as BIS Propofol-targeted based on the original EEG signals of human body
Electricity data, eliminate because initial data is disturbed the error caused by third party device；And can be effective
Monitoring operation in the sedation depth of anaesthesia of patient, and automatically control according to the change of sedation depth of anaesthesia
The consumption of downern processed, solves because different individual patient differences are administered inaccurate problem.Further
, the present invention also can by described quantized data index (such as BIS) combine based on as described in human body original
Original electroencephalogram (EEG) and/or electromyogram (EMG) that EEG signals determine comprehensively are analyzed,
Determine and the change of Monitored anesthesia sedation depth, accurately calculate and control dosage, reach closed loop certainly
The dynamic purpose being administered；Thus change usual surgery anesthesia relies on and manually cannot accurately judge patient
The situation of individual difference, improves the security in anaesthesia process, has good society and application
It is worth.
In the various embodiments described above of the present invention, sequence number and/or the sequencing of embodiment are merely convenient of
Describe, do not represent the quality of embodiment.Description to each embodiment all emphasizes particularly on different fields, and certain is real
Execute the part not having to describe in detail in example, may refer to the associated description of other embodiments.
One of ordinary skill in the art will appreciate that: realize all or part of of said method embodiment
Step can be completed by the hardware that programmed instruction is relevant, and aforesaid program can be stored in a meter
In calculation machine read/write memory medium, this program upon execution, performs to include said method embodiment
Step；And aforesaid storage medium includes: read-only storage (Read-Only Memory, letter
Claim ROM), random access memory (Random Access Memory, be called for short RAM),
The various medium that can store program code such as magnetic disc or CD.
In the embodiments such as apparatus and method of the present invention, it is clear that each parts or each step are permissible
Decompose, combine and/or decompose after reconfigure.These decompose and/or reconfigure and should be regarded as this
The equivalents of invention.Meanwhile, in description to the specific embodiment of the invention above, for one
Kind of embodiment describes and/or the feature that illustrates can in same or similar mode at one or more
Other embodiments multiple use, combined with the feature in other embodiment, or substitute it
Feature in its embodiment.
It should be emphasized that term " includes/comprises " referring to when using feature, key element, step herein
Or the existence of assembly, but it is not precluded from one or more further feature, key element, step or assembly
Existence or additional.
Although last it is noted that the present invention and advantage thereof have been described in detail above, but
It is to be understood that without departing from the spirit and scope of the present invention being defined by the claims appended hereto
In the case of can carry out various change, substitute and convert.And, the scope of the present invention is not limited only to
Process described by specification, equipment, means, the specific embodiment of method and steps.This area
Interior those of ordinary skill will readily appreciate that from the disclosure, can make according to the present invention
With performing the function essentially identical to corresponding embodiment described herein or obtaining phase basic with it
Same result, existing and the most to be developed process, equipment, means, method or step.
Therefore, appended claim is directed in the range of them including such process, equipment, hand
Section, method or step.
Claims (7)
1. an eeg monitoring sedation depth closed-loop control syringe pump apparatus, it is characterised in that including:
Integrated brain electric data collecting module in the same apparatus and injection module main frame；
Described brain electric data collecting module is used for gathering the original EEG signals of human body and being translated into permissible
The quantized data index of sedation depth monitoring；
Described injection module main frame is connected with described brain electric data collecting module, for according to described quantization number
Determine downern medication administration parameters information according to index, carry out downern note according to described medication administration parameters information
Penetrate dose control；
Described injection module main frame includes:
Data monitoring analyzes module, is connected with described brain electric data collecting module, be used for monitoring described in
The situation of change of quantized data index, adjusts downern medication administration parameters information according to monitoring result；
Drug administration by injection control module, analyzes module with described data monitoring and is connected, for according to described
Downern medication administration parameters information carries out the administration of downern and controls；
Described data monitoring is analyzed module and is connected with described brain electric data collecting module, is additionally operable to basis
The original EEG signals of described human body determine original EEG data and/or electromyographic data, comprehensive described amount
Change the monitoring result of data target situation of change and described original EEG data and/or electromyogram number
According to, adjust downern medication administration parameters information；
Described data monitoring is analyzed module and is included:
Alarm control unit, is connected with described brain electric data collecting module, is used for monitoring described quantized data
The change of index, when described quantized data refers to that target value exceedes predetermined threshold, output warning message and in
Disconnected described drug administration by injection control module is administered control；
Delays time to control unit, is connected with described alarm unit and described drug administration by injection control module respectively, uses
When at described alarm unit output warning message, start computation delay, if do not connect in during time delay
Receive the external command adjusting medication administration parameters and being administered, then, after time delay terminates, control described injection
It is administered control module to recover to be administered according to former setting medication administration parameters.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 1, its
It is characterised by,
Described brain electric data collecting module includes: the brain electric transducer that is sequentially connected with, human body cable, data
Modular converter and host cable；
Described human body cable is for being sent to the original EEG signals of human body of described brain electric transducer collection
Described data conversion module；
Described data conversion module is for being converted into can monitor original for described human body EEG Processing
The quantized data index of sedation depth, and described quantized data index is sent to described through described host cable
Injection module main frame.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 1 and 2,
It is characterized in that, described data monitoring is analyzed module and is included: monitoring submodule, analysis submodule and output
Submodule；
Described monitoring submodule is connected with described brain electric data collecting module, is used for monitoring described eeg data
The situation of change of the quantizating index data of acquisition module output；
Described analysis submodule is connected, for root with described monitoring submodule and described output sub-module respectively
Adjust downern medication administration parameters information according to the monitoring result of described monitoring submodule and export to described defeated
Go out submodule；
Described output sub-module is connected with described analysis submodule and described drug administration by injection control module respectively,
For described downern medication administration parameters information processing is become corresponding drug administration information and is sent to described injection
It is administered control module.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 1 and 2,
It is characterized in that, described drug administration by injection control module includes: syringe pushing means and step motor control
Module；Described syringe pushing means is for carrying out the injection of downern；
Described step motor control module analyzes module with described data monitoring respectively and described syringe pushes away
Dynamic device connects, for promoting dress according to syringe described in described downern medication administration parameters information-driven
Put.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 1 and 2,
It is characterized in that, also include: man-machine interaction display module；
Described man-machine interaction display module analyzes module and described drug administration by injection with described data monitoring respectively
Control module connects, and is used for using figure and/or written form display one or more of information: institute
State the original EEG signals of human body, described quantized data index, described downern medication administration parameters information.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 5, its
Be characterised by, described man-machine interaction display module include LCD MODULE and with described LCD MODULE
The touch-control module connected.
Eeg monitoring sedation depth closed-loop control syringe pump apparatus the most according to claim 1 and 2,
It is characterized in that,
The original EEG signals of described human body include one or more of: brain wave spectrum, frequency, power,
The frontalis signal of telecommunication, human body impedance；And/or,
Described quantized data index includes one or more of: BIS, AEPI, NCT, anesthesia
Entropy, CSI, quantitative EEG, edge spectrum.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410001522.3A CN103735261B (en) | 2013-12-05 | 2014-01-02 | Eeg monitoring sedation depth closed-loop control syringe pump apparatus |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310654039 | 2013-12-05 | ||
| CN2013106540390 | 2013-12-05 | ||
| CN201310654039.0 | 2013-12-05 | ||
| CN201410001522.3A CN103735261B (en) | 2013-12-05 | 2014-01-02 | Eeg monitoring sedation depth closed-loop control syringe pump apparatus |
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| CN103735261A CN103735261A (en) | 2014-04-23 |
| CN103735261B true CN103735261B (en) | 2016-08-24 |
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| CN201410001522.3A Active CN103735261B (en) | 2013-12-05 | 2014-01-02 | Eeg monitoring sedation depth closed-loop control syringe pump apparatus |
| CN201420001961.XU Expired - Lifetime CN203749411U (en) | 2013-12-05 | 2014-01-02 | Closed-loop control injection pump device for electroencephalogram monitoring sedation depth |
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| CN201420001961.XU Expired - Lifetime CN203749411U (en) | 2013-12-05 | 2014-01-02 | Closed-loop control injection pump device for electroencephalogram monitoring sedation depth |
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Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014173558A1 (en) | 2013-04-24 | 2014-10-30 | Fresenius Kabi Deutschland Gmbh | Method of operating a control device for controlling an infusion device |
| CN103735261B (en) * | 2013-12-05 | 2016-08-24 | 北京思路高医疗科技有限公司 | Eeg monitoring sedation depth closed-loop control syringe pump apparatus |
| CN104307069B (en) * | 2014-10-17 | 2017-05-31 | ***广州总医院 | Target controlled infusion control device is anaesthetized using the binary channels of Propofol and sufentanil |
| CN104606746A (en) * | 2015-01-29 | 2015-05-13 | 张海青 | Painless automatic anesthesia device |
| CN104784784B (en) * | 2015-04-24 | 2019-04-09 | 江苏人先医疗科技有限公司 | A kind of analgesia apparatus for controlling pump that realizing intelligent transfusion and equipment |
| CN104887225B (en) * | 2015-06-04 | 2017-10-10 | 卞汉道 | Anaesthetize precision monitor and method |
| CN105056344A (en) * | 2015-09-21 | 2015-11-18 | 鑫麦源创时代医疗科技(苏州)有限公司 | Digital anesthesia control system |
| CN106730110A (en) * | 2016-12-01 | 2017-05-31 | 谢言虎 | A kind of patient-controlled sedation target-controlled infusion system based on anesthesia depth monitoring |
| CN106902421B (en) * | 2017-01-17 | 2020-03-31 | 燕山大学 | Individual anesthesia closed-loop control system |
| CN106964014B (en) * | 2017-02-13 | 2020-03-10 | 深圳麦科田生物医疗技术有限公司 | Infusion management method and system |
| WO2019127557A1 (en) * | 2017-12-29 | 2019-07-04 | 深圳迈瑞生物医疗电子股份有限公司 | Method for identifying anesthetic drug, and method and device for processing anesthesia electroencephalography signal |
| CN112309539B (en) * | 2020-11-12 | 2024-03-22 | 智谷医疗科技（广州）有限公司 | Intelligent correction method and equipment for liquid output parameters applied to injection system |
| CN112870480B (en) * | 2021-01-22 | 2021-12-14 | 燕山大学 | Fuzzy control remote control anesthetic drug infusion pump system |
| CN113440690A (en) * | 2021-08-03 | 2021-09-28 | 复旦大学 | Intelligent quantitative drug administration electric needle injection device based on electromyographic signal feedback |
| CN114224292A (en) * | 2021-12-22 | 2022-03-25 | 宁波大学 | Anesthesia depth early warning monitoring method and system, electronic device and storage medium |
| CN117797359A (en) * | 2024-01-12 | 2024-04-02 | 江苏朗沁科技有限公司 | Injection pump control system for transdermal administration |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE20005004U1 (en) * | 2000-03-17 | 2000-06-08 | Braun Melsungen Ag | Anesthetic regulator |
| CN2620531Y (en) * | 2003-04-18 | 2004-06-16 | 吴一兵 | Multifunctional anaesthetic depth monitor |
| US20060009733A1 (en) * | 2004-07-07 | 2006-01-12 | Martin James F | Bis closed loop anesthetic delivery |
| FR2940912B1 (en) * | 2009-01-15 | 2013-08-16 | Hopital Foch | SYSTEM FOR CONTROLLING MEANS FOR INJECTING AGENTS OF ANESTHESIA OR SEDATION IN ORDER TO INDUCE THEM |
| CN101816576A (en) * | 2010-04-08 | 2010-09-01 | 广西威利方舟科技有限公司 | Closed loop muscle relaxation iatrical effect monitoring and injecting method and closed loop muscle relaxation injecting device |
| CN102793534A (en) * | 2012-07-11 | 2012-11-28 | 广西威利方舟科技有限公司 | Anesthesia depth monitoring device and method |
| CN103735261B (en) * | 2013-12-05 | 2016-08-24 | 北京思路高医疗科技有限公司 | Eeg monitoring sedation depth closed-loop control syringe pump apparatus |
-
2014
- 2014-01-02 CN CN201410001522.3A patent/CN103735261B/en active Active
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| CN103735261A (en) | 2014-04-23 |
| CN203749411U (en) | 2014-08-06 |
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