WO2014161457A1 - Anesthesia pain monitoring system and method - Google Patents
Anesthesia pain monitoring system and method Download PDFInfo
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- WO2014161457A1 WO2014161457A1 PCT/CN2014/074470 CN2014074470W WO2014161457A1 WO 2014161457 A1 WO2014161457 A1 WO 2014161457A1 CN 2014074470 W CN2014074470 W CN 2014074470W WO 2014161457 A1 WO2014161457 A1 WO 2014161457A1
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- pain
- main control
- monitoring system
- anesthesia
- collector
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- 208000002193 Pain Diseases 0.000 title claims abstract description 79
- 230000036407 pain Effects 0.000 title claims abstract description 79
- 238000012544 monitoring process Methods 0.000 title claims abstract description 48
- 206010002091 Anaesthesia Diseases 0.000 title claims abstract description 32
- 230000037005 anaesthesia Effects 0.000 title claims abstract description 32
- 238000000034 method Methods 0.000 title claims abstract description 21
- 230000000763 evoking effect Effects 0.000 claims abstract description 34
- 230000004936 stimulating effect Effects 0.000 claims abstract description 11
- 230000008569 process Effects 0.000 claims abstract description 3
- 238000012545 processing Methods 0.000 claims abstract description 3
- 230000000638 stimulation Effects 0.000 claims description 25
- 230000002457 bidirectional effect Effects 0.000 claims description 7
- 238000001356 surgical procedure Methods 0.000 claims description 6
- 238000012360 testing method Methods 0.000 claims description 6
- 230000003993 interaction Effects 0.000 claims description 5
- 230000001054 cortical effect Effects 0.000 claims description 4
- 230000003238 somatosensory effect Effects 0.000 claims description 4
- 230000008058 pain sensation Effects 0.000 claims description 2
- 238000002695 general anesthesia Methods 0.000 abstract description 7
- 229940035674 anesthetics Drugs 0.000 abstract 1
- 239000003193 general anesthetic agent Substances 0.000 abstract 1
- 230000003444 anaesthetic effect Effects 0.000 description 7
- 238000010586 diagram Methods 0.000 description 5
- 230000000202 analgesic effect Effects 0.000 description 3
- 239000000730 antalgic agent Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 206010021118 Hypotonia Diseases 0.000 description 2
- 230000036592 analgesia Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000036640 muscle relaxation Effects 0.000 description 2
- 230000001953 sensory effect Effects 0.000 description 2
- 210000001364 upper extremity Anatomy 0.000 description 2
- 208000000114 Pain Threshold Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000007177 brain activity Effects 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000037324 pain perception Effects 0.000 description 1
- 230000037040 pain threshold Effects 0.000 description 1
- 238000004886 process control Methods 0.000 description 1
- 238000011155 quantitative monitoring Methods 0.000 description 1
- 238000013139 quantization Methods 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 210000003625 skull Anatomy 0.000 description 1
- 210000004092 somatosensory cortex Anatomy 0.000 description 1
- 238000013024 troubleshooting Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/377—Electroencephalography [EEG] using evoked responses
- A61B5/383—Somatosensory stimuli, e.g. electric stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4821—Determining level or depth of anaesthesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/369—Electroencephalography [EEG]
- A61B5/377—Electroencephalography [EEG] using evoked responses
Definitions
- the invention relates to the field of medicine, veterinary medicine or hygiene, in particular to a pain monitoring system and a monitoring method dedicated to real-time dynamic detection of anesthesia.
- General anesthesia includes three aspects: calming, analgesia and muscle relaxation. Among them, there is already a bispectral index (Bis) technique to monitor brain activity, and muscle relaxation can be combined with a series of stimulation (Train of Four, TOF). Response monitoring, but monitoring of analgesia does not have a complete system. In the course of surgery or treatment, the degree of pain perception of the patient allows the doctor to master and adjust the anesthetic dose. In the prior art, doctors generally understand the analgesic dose through observation and experience. Therefore, how to provide a pain monitoring system that monitors the pain of a patient in real time during general anesthesia is an urgent problem to be solved in the industry.
- the present invention provides a pain monitoring system and a monitoring method for anesthesia, which can detect the pain of a patient in general anesthesia in real time, so as to facilitate the doctor to adjust the anesthetic dose.
- Step 4 Input the slowly changing waveform from the stimulation position through the pain stimulator to stimulate the monitoring object, the collector picks up the pain evoked potential from the collection position, and the main control panel compares the acquired pain evoked potential with the baseline data;
- Step 6 Determine whether the surgery is over. If not, return to step 4 for continuous monitoring. If it is over, the monitoring ends.
- Figure 1 is a schematic diagram of the principle of the present invention
- FIG. 2 is a structural block diagram of a pain stimulator of the present invention
- FIG. 3 is a structural block diagram of a collector of the present invention.
- FIG. 4 is a structural block diagram of a main control board of the present invention.
- Figure 5 is a flow chart of the anesthesia monitoring method of the present invention.
- FIG. 1 is a schematic illustration of an embodiment of the invention.
- the pain monitoring system for anesthesia is described by taking a human body as an example.
- the system's solution includes a pain stimulator that generates a pain evoked potential in the human body, a collector that collects and records the pain evoked potential generated by the human body, and a main control panel that controls the pain stimulator, controls and analyzes the output signal of the collector.
- the main control board is connected to external devices such as a keyboard, a touch screen, and a display.
- the stimulating electrode stimulates the part of the human body
- any part of the body surface that is prone to pain can be selected as the stimulation position, and a plurality of different parts can be tried during the actual operation.
- the polarity reversal module can also perform the necessary polarity inversion at any time by the waveform of the current signal.
- the voltage-to-current module requires a power module to supply a high voltage to the current source. The purpose is to prevent the output impedance of the current source from being cut off when the body impedance is increased.
- the output voltage of the power module should be guaranteed up to 100V to ensure the dynamic change between the electrode and the human body between 500 and 10,000 ohms, and will not cause inaccurate output of the waveform.
- the circuit part of the pain stimulator that applies current to the human body needs to be completely isolated from the mains. Therefore, the pain stimulator can be powered in two ways. One is to use the battery as the power module to supply power, and the other is to use the battery as the power module for power supply. One is that the power module is connected to the mains supply through a low frequency transformer.
- analog-to-digital conversion requires an analog-to-digital converter with high precision and high sampling rate.
- An isolators are also provided between the programmable amplifier and the analog-to-digital converter to isolate the collector from the main control board circuit. Prevent damage to the main control board from the high-voltage electric knife pulse introduced from the acquisition circuit, or leakage current from the main control board to the human body. It is also possible to replace the isolator with a photocoupler to achieve the same effect.
- the bidirectional data interface also has a loop-to-analog converter, a program-controlled amplifier, and a preamplifier, so that the main control board transmits control signals to the acquisition board through the bidirectional data interface.
- These signals include the gain of the preamplifier, the gain of the programmable amplifier, and the configuration of the analog to digital converter.
- the main control board after receiving the signal transmitted from the bidirectional data interface of the collector, the main control board performs digital signal processing through a field programmable gate array (FPGA) or a digital signal processor (DSP), and the processed signal can be processed.
- FPGA field programmable gate array
- DSP digital signal processor
- the processed signal can also be a value of 0-100, or a text or letter as the obvious knowledge information.
- the main control board may further include a microprocessor and a data memory, and independently serve as an embedded module, and the microprocessor generates a UI interface, and the information result in the FPGA is synthesized and displayed on the display.
- Figure 5 is a flow chart of a method of monitoring anesthesia of the present invention, and a method of monitoring an anesthetized patient of the present invention is described in detail below.
- Step 4 After anesthesia, the patient is continuously monitored by the pain monitoring system, and the painful stimulator inputs a slowly changing waveform from the stimulation position to stimulate the monitoring object, and the collector picks up the pain evoked potential from the collection position, and the main control board pairs the collected
- the pain evoked potential was compared to the baseline for data comparison.
- the pain evoked potential is in a state of inhibition due to the application of an anesthetic, and its amplitude and latency are significantly different from the baseline state. For example, when the amplitude and latency of the acquired pain evoked potential are similar to those recorded at baseline, the degree is reached to some extent. At the time, it indicates that the anesthesia effect is poor; when the amplitude and latency of the acquired pain evoked potential are significantly different from the baseline records, the anesthesia is too deep;
- Step 5 The collector determines whether the pain evoked potential after the collection deviates from the normal range. If it deviates, the display screen of the main control board prompts correspondingly, waits for the doctor to adjust the anesthesia, and continues to return to step 4 for continuous monitoring, according to the doctor. Prompt information, combined with judgments on other factors, such as troubleshooting machine failure, current surgery requirements for anesthesia, determine whether the anesthetic or analgesic dose is sufficient, if the dose is insufficient, adjust the corresponding anesthetic dose until the expected anesthesia is achieved effect. If the pain evoked potential collected by the collector does not deviate from the normal range, no prompt is given and the next step is continued;
- Step 6 Determine whether the surgery is over. If it is not over, return to step 4 for continuous monitoring until the end of the operation and stop monitoring.
Abstract
An anesthesia pain monitoring system and method. The monitoring system includes a pain stimulator, a collector and a main control panel, wherein the pain stimulator is used for stimulating a monitored object to produce pain evoked potentials; the collector is used for collecting and recording the pain evoked potentials and translating the pain evoked potentials into signal output, and the main control panel is connected with the pain stimulator and the collector. The main control panel controls the pain stimulator and carries out digital signal processing on the signals output from the collector. The monitoring method corresponding to the monitoring system enables anesthetists to monitor the pain condition of a patient at any time in a general anesthesia process and control the dose of anesthetics.
Description
本发明涉及医学、兽医学或卫生学领域，尤其涉及一种专用于麻醉的实时动态检测的痛觉监护系统及监护方法。 The invention relates to the field of medicine, veterinary medicine or hygiene, in particular to a pain monitoring system and a monitoring method dedicated to real-time dynamic detection of anesthesia.
在某些手术过程中，需要对病人进行全身麻醉，而全身麻醉存在用药过量或用药不足的风险。而这两种情况都会对病人的麻醉效果或临床结果造成不良的后果。因此对全麻病人进行客观量化的监护，是一个重要课题。
In some surgical procedures, general anesthesia is required for the patient, and general anesthesia is at risk of overdose or underdosing. Both of these conditions can have adverse consequences on the patient's anesthetic effect or clinical outcome. Therefore, objective quantitative monitoring of patients with general anesthesia is an important issue.
全身麻醉包括镇定、镇痛、肌松三个方面，其中镇定目前已有脑电双频指数（Bis）技术监测脑活跃程度，肌松可用成串刺激（Train of Four,
TOF）的复合肌电响应监测，但是对镇痛的监测却没有一个完整的系统。在手术或治疗过程中，对病人的痛觉程度的判定，可以让医生掌握并调整麻醉剂量。现有技术中，医生一般是通过观察和经验来了解镇痛剂剂量。因此，如何提供一种在全身麻醉中实时地监控病人痛觉的痛觉监护系统是业界亟待解决的问题。
General anesthesia includes three aspects: calming, analgesia and muscle relaxation. Among them, there is already a bispectral index (Bis) technique to monitor brain activity, and muscle relaxation can be combined with a series of stimulation (Train of Four, TOF). Response monitoring, but monitoring of analgesia does not have a complete system. In the course of surgery or treatment, the degree of pain perception of the patient allows the doctor to master and adjust the anesthetic dose. In the prior art, doctors generally understand the analgesic dose through observation and experience. Therefore, how to provide a pain monitoring system that monitors the pain of a patient in real time during general anesthesia is an urgent problem to be solved in the industry.
本发明为了解决上述问题，提出一种用于麻醉的痛觉监护系统及监护方法，可以实时检测病人在全身麻醉中的痛感，以方便医生调整麻醉剂量。
In order to solve the above problems, the present invention provides a pain monitoring system and a monitoring method for anesthesia, which can detect the pain of a patient in general anesthesia in real time, so as to facilitate the doctor to adjust the anesthetic dose.
本发明所提出的用于麻醉的痛觉监护系统，痛觉刺激器，用于刺激监护对象产生痛觉诱发电位；采集器，用于采集并记录所述痛觉诱发电位；与所述痛觉刺激器、采集器相连接的主控板，所述主控板控制痛觉刺激器和采集器，并将采集器输出的信号进行处理。
The pain monitoring system for anesthesia proposed by the present invention, the pain stimulator for stimulating the monitoring object to generate a pain evoked potential; the collector for collecting and recording the pain evoked potential; and the pain stimulator and the collector A connected main control board that controls the pain stimulator and the collector and processes the signals output by the collector.
本发明所提出的用于麻醉的痛觉监护系统的监护方法，主要包括如下步骤： The monitoring method for the pain monitoring system for anesthesia proposed by the present invention mainly includes the following steps:
步骤1.将采集电极和刺激电极分别放置到相应的采集位置和刺激位置，并且刺激位置与采集位置根据躯体感觉皮层定位关系和10-20系统法相对应；
Step 1. Place the collecting electrode and the stimulating electrode respectively to the corresponding collecting position and the stimulating position, and the stimulating position and the collecting position correspond to the somatosensory cortical positioning relationship and the 10-20 system method;
步骤2.进行痛觉诱发电位的基线测试，获取监护对象的痛觉阈值对应的诱发电位信息作为基线，包括诱发电位幅值与潜伏期；
Step 2. Perform a baseline test of the pain evoked potential, and obtain evoked potential information corresponding to the pain threshold of the monitored subject as a baseline, including the evoked potential amplitude and the latency;
步骤3.实施麻醉； Step 3. Perform anesthesia;
步骤4.通过痛觉刺激器从刺激位置输入缓慢变化的波形刺激监护对象，采集器从采集位置拾取痛觉诱发电位，主控板对采集后的痛觉诱发电位和基线进行数据对比；
Step 4. Input the slowly changing waveform from the stimulation position through the pain stimulator to stimulate the monitoring object, the collector picks up the pain evoked potential from the collection position, and the main control panel compares the acquired pain evoked potential with the baseline data;
步骤5.判断采集后的痛觉诱发电位是否偏离正常范围，若偏离，主控板的显示屏进行相应的提示，等待医生对麻醉进行调整，并继续返回步骤4进行持续的监控；若没有偏离正常范围，则继续下一步；
Step 5. Determine whether the pain evoked potential after the collection deviates from the normal range. If it deviates, the display screen of the main control board prompts accordingly, wait for the doctor to adjust the anesthesia, and continue to return to step 4 for continuous monitoring; if not deviation from normal Range, continue to the next step;
步骤6.判断手术是否结束，若没有结束，返回步骤4进行持续的监控，若结束，则监控结束。 Step 6. Determine whether the surgery is over. If not, return to step 4 for continuous monitoring. If it is over, the monitoring ends.
本发明通过采集和分析痛觉诱发电位的幅值和潜伏期，来监测镇痛剂在人体中产生的镇痛效果的变化，应用在麻醉方面，可以指导麻醉师根据监护结果及时调整镇痛剂的用量，避免了病人在手术或治疗过程中镇痛药物的不足引发痛苦的情况。
The invention monitors the change of the analgesic effect of the analgesic agent in the human body by collecting and analyzing the amplitude and the latency of the pain evoked potential, and applies the anesthesia to guide the anesthesiologist to adjust the dosage of the analgesic agent according to the monitoring result. To avoid the painful situation caused by the lack of analgesic drugs during the operation or treatment of the patient.
图1为本发明的原理示意图； Figure 1 is a schematic diagram of the principle of the present invention;
图2为本发明痛觉刺激器的结构框图； 2 is a structural block diagram of a pain stimulator of the present invention;
图3为本发明采集器的结构框图； 3 is a structural block diagram of a collector of the present invention;
图4为本发明主控板的结构框图； 4 is a structural block diagram of a main control board of the present invention;
图5为本发明的麻醉监护方法的流程图。
Figure 5 is a flow chart of the anesthesia monitoring method of the present invention.
图1是本发明一实施例的示意图。该实施例中，用于麻醉的痛觉监护系统以人体为例来进行说明。该系统的方案包括一个使人体产生痛觉诱发电位的痛觉刺激器、采集并记录人体产生的痛觉诱发电位的采集器，以及控制痛觉刺激器、控制并分析采集器输出信号的主控板。该主控板与键盘、触摸屏、显示器等外接设备连接。
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of an embodiment of the invention. In this embodiment, the pain monitoring system for anesthesia is described by taking a human body as an example. The system's solution includes a pain stimulator that generates a pain evoked potential in the human body, a collector that collects and records the pain evoked potential generated by the human body, and a main control panel that controls the pain stimulator, controls and analyzes the output signal of the collector. The main control board is connected to external devices such as a keyboard, a touch screen, and a display.
图2是痛觉刺激器的结构框图，痛觉刺激器主要是用于产生刺激波形施加于人体。目前可以通过用模拟电路滤除方波高频成分的方法，产生正弦波作为刺激波形，也可以控制电平上升/下降时间，来拟合三角波或指数波作为刺激波形，这些方法产生的波形都比较单一，并且电路较复杂。本发明的痛觉刺激器与前两者不同，可以通过编程产生任意刺激波形。并且更易于操作。本发明的痛觉刺激器包括一个人机交互界面，该交互界面可以是分立的键盘和显示屏，或者是一个带触摸功能的显示屏，用户通过这个交互界面输入刺激波形、刺激频率、刺激幅度、刺激脉宽等参数；一个与主控板相连接的控制接口，用户可以通过此接口由主控板输入参数控制痛觉刺激器；波形生成模块，该模块根据输入的参数，产生任意的低频缓慢变化的波形数据，这些波形数据包括但不仅限于正弦波、三角波或指数波，可以根据需要利用该痛觉刺激器产生任意合适的波形；数模转换器，接收波形数据并将数字信号转换成模拟信号；电压转电流模块，将数模转换器输出的电压信号转换为电流信号；刺激电极，用于将输出的电流信号通过刺激电极施加到被检测的人体。其中刺激电极刺激人体的部位，可以选择在躯体体表上任意容易产生痛觉的部分作为刺激位置，并且在实际操作过程中可以尝试多个不同的部位。电流信号输出之前，还可以通过极性反转模块使电流信号的波形在任意时刻进行必要的极性反转。电压转电流模块需要一个电源模块，用于提供高压给电流源，目的是为了防止在应用时，人体阻抗变大而造成电流源的输出波形截断。如，为了保证10mA的电流输出，电源模块输出的电压应该保证最高可达100V，以保证电极与人体间阻抗在500～10,000欧姆之间的动态变化，不会引起波形的不准确输出。根据医学设备安全标准的规定，痛觉刺激器中施加电流到人体的电路部分需要和市电完全隔离，因此痛觉刺激器可以采用两种方式进行供电，一种是采用电池作为电源模块进行供电，另一种是电源模块通过低频变压器连接到市电供电。
2 is a structural block diagram of a pain stimulator, which is mainly used to generate a stimulation waveform applied to a human body. At present, a sine wave can be generated as a stimulus waveform by filtering a square wave high-frequency component by an analog circuit, and a level rise/fall time can also be controlled to fit a triangular wave or an exponential wave as a stimulus waveform, and the waveforms generated by these methods are all It is relatively simple and the circuit is more complicated. Unlike the first two, the pain stimulator of the present invention can be programmed to generate an arbitrary stimulation waveform. And easier to operate. The pain stimulator of the present invention comprises a human-computer interaction interface, which may be a separate keyboard and display screen, or a display screen with a touch function, through which the user inputs stimulation waveforms, stimulation frequencies, stimulation amplitudes, Stimulation pulse width and other parameters; a control interface connected to the main control board, through which the user can input the parameters of the main control board to control the pain stimulator; the waveform generation module, which generates arbitrary low frequency slowly changes according to the input parameters Waveform data, including but not limited to sine waves, triangular waves or exponential waves, can be generated by the pain stimulator as needed; the digital-to-analog converter receives the waveform data and converts the digital signal into an analog signal; The voltage-to-current module converts the voltage signal output by the digital-to-analog converter into a current signal; and the stimulation electrode is configured to apply the output current signal to the detected human body through the stimulation electrode. Where the stimulating electrode stimulates the part of the human body, any part of the body surface that is prone to pain can be selected as the stimulation position, and a plurality of different parts can be tried during the actual operation. Before the current signal is output, the polarity reversal module can also perform the necessary polarity inversion at any time by the waveform of the current signal. The voltage-to-current module requires a power module to supply a high voltage to the current source. The purpose is to prevent the output impedance of the current source from being cut off when the body impedance is increased. For example, in order to ensure the current output of 10mA, the output voltage of the power module should be guaranteed up to 100V to ensure the dynamic change between the electrode and the human body between 500 and 10,000 ohms, and will not cause inaccurate output of the waveform. According to the medical equipment safety standards, the circuit part of the pain stimulator that applies current to the human body needs to be completely isolated from the mains. Therefore, the pain stimulator can be powered in two ways. One is to use the battery as the power module to supply power, and the other is to use the battery as the power module for power supply. One is that the power module is connected to the mains supply through a low frequency transformer.
如图3所示，采集器通过采集电极采集人体产生的痛觉诱发电位，采集电极数目不限，种类可以选择为针电极，或者为加了导电膏的电极帽，亦或者是经过特殊处理的干电极。采集输入方式为差分输入，根据需要选择合适的两个电极构成差分电极对。差分电极放置于人体上的采集位置应与刺激位置相对应，例如刺激左上肢，应将差分电极通过躯体感觉皮层定位的关系置于颅骨右侧上C2，C4的位置，具体的C2、C4定位可以10-20系统法得出，以便重点记录右脑躯体初级感觉皮层S1和躯体次级感觉皮层S2对应左上肢刺激产生的痛觉诱发电位。采集电极通过过压保护电路连接到前置放大器，前置放大器对采集的痛觉诱发电位进行信号拾取，带通滤波器去除信号的直流漂移和高频噪声，然后通过程控放大器对信号的幅值进行进一步增强，以避免模数转换器转换时量化噪声淹没信号，然后经模数转换器转换后的信号再通过双向数据接口输出至主控板。本实施例中，模数转换需采用高精度、高采样率的模数转换器。程控放大器与模数转换器之间还设有隔离器，将采集器与主控板电路隔离，目的在于
防止从采集电路引入的高压电刀脉冲对主控板的损坏，或主控板上电流对人体的漏电。也可以将隔离器换作光电耦合器，达到相同的效果。
As shown in Fig. 3, the collector collects the pain evoked potential generated by the human body through the collecting electrode, and the number of collecting electrodes is not limited. The type can be selected as a needle electrode, or an electrode cap with a conductive paste, or a specially treated dry electrode. electrode. The acquisition input mode is a differential input, and the appropriate two electrodes are selected as needed to form a differential electrode pair. The position where the differential electrode is placed on the human body should correspond to the stimulation position. For example, the left upper limb should be stimulated. The relationship between the differential electrode and the somatosensory cortex should be placed on the right side of the skull on the right side of C2, C4, and the specific C2 and C4 positions. It can be obtained by the 10-20 system method, in order to record the pain evoked potentials generated by the left upper limb stimulation of the right brain body primary sensory cortex S1 and the body secondary sensory cortex S2. The collecting electrode is connected to the preamplifier through an overvoltage protection circuit. The preamplifier picks up the acquired pain evoked potential, the bandpass filter removes the DC drift and high frequency noise of the signal, and then passes the amplitude of the signal through the process control amplifier. Further enhancement is made to avoid the quantization noise flooding signal during the conversion of the analog-to-digital converter, and then the signal converted by the analog-to-digital converter is output to the main control board through the bidirectional data interface. In this embodiment, analog-to-digital conversion requires an analog-to-digital converter with high precision and high sampling rate. An isolators are also provided between the programmable amplifier and the analog-to-digital converter to isolate the collector from the main control board circuit.
Prevent damage to the main control board from the high-voltage electric knife pulse introduced from the acquisition circuit, or leakage current from the main control board to the human body. It is also possible to replace the isolator with a photocoupler to achieve the same effect.
双向数据接口还设有回路至模数转换器、程控放大器、前置放大器，以便于主控板通过双向数据接口传输控制信号给采集板。这些信号包括前置放大器的增益，程控放大器的增益，和对模数转换器的配置等。
The bidirectional data interface also has a loop-to-analog converter, a program-controlled amplifier, and a preamplifier, so that the main control board transmits control signals to the acquisition board through the bidirectional data interface. These signals include the gain of the preamplifier, the gain of the programmable amplifier, and the configuration of the analog to digital converter.
如图4所示，主控板收到从采集器双向数据接口传来的信号后，通过现场可编程门阵列（FPGA）或数字信号处理器（DSP）进行数字信号处理，处理后的信号可以通过数据交互接口，例如USB2.0连接至电脑上，并通过用户接口（UI）界面显示采集到的波形进行分析。处理后的信号也可以是0-100的数值，或者以文字或字母作为明显的知识信息。此外主控板还可以包括微处理器、数据存储器，独立作为一个嵌入式模块，由微处理器生成UI界面，与FPGA中的信息结果合成显示到显示器上。
As shown in FIG. 4, after receiving the signal transmitted from the bidirectional data interface of the collector, the main control board performs digital signal processing through a field programmable gate array (FPGA) or a digital signal processor (DSP), and the processed signal can be processed. Connect to the computer through a data interaction interface, such as USB2.0, and display the acquired waveform through the user interface (UI) interface for analysis. The processed signal can also be a value of 0-100, or a text or letter as the obvious knowledge information. In addition, the main control board may further include a microprocessor and a data memory, and independently serve as an embedded module, and the microprocessor generates a UI interface, and the information result in the FPGA is synthesized and displayed on the display.
图5是本发明的用于麻醉的监护方法的流程图，下面详细描述本发明对麻醉病人进行监控的方法。 Figure 5 is a flow chart of a method of monitoring anesthesia of the present invention, and a method of monitoring an anesthetized patient of the present invention is described in detail below.
步骤1.首先在病人准备好后，将刺激电极和采集电极都放置到病人身体相应的刺激位置和采集位置上，刺激位置可以在人体易产生痛感的体表处多次试验，选择最合适的刺激位置，然后根据躯体感觉皮层定位的关系选择与刺激位置相对应的采集位置；
Step 1. First, after the patient is ready, place the stimulation electrode and the collection electrode on the corresponding stimulation position and collection position of the patient's body. The stimulation position can be tested multiple times on the body surface where the human body is prone to pain, and the most suitable one is selected. Stimulating the position, and then selecting a collection position corresponding to the stimulation position according to the relationship of the somatosensory cortical positioning;
步骤2.在麻醉未施加前，做一次痛觉诱发电位的基线测试。基线测试下病人保持清醒并未加任何麻醉药物，通过慢慢加大电流强度，直到病人有明确的痛觉感觉为止，此时记录病人痛觉诱发电位的幅值和潜伏期，作为基线；
Step 2. Perform a baseline test of pain evoked potentials before anesthesia is applied. Under baseline test, the patient remained awake without any anesthetic, and the current intensity was gradually increased until the patient had a clear pain sensation. At this time, the amplitude and latency of the pain evoked potential were recorded as a baseline;
步骤3.做完基线测试后进行麻醉； Step 3. Perform anesthesia after the baseline test;
步骤4.麻醉后，通过痛觉监护系统对病人进行持续的监护，通过痛觉刺激器从刺激位置输入缓慢变化的波形刺激监护对象，采集器从采集位置拾取痛觉诱发电位，主控板对采集后的痛觉诱发电位和基线进行数据对比。此时痛觉诱发电位因为麻醉药的施加，处于一种抑制状态，其幅值、潜伏期与基线状态明显不同，例如当被采集的痛觉诱发电位的波幅和潜伏期与基线的记录的相似达到某一程度时，则表示麻醉效果不良；当被采集的痛觉诱发电位的波幅和潜伏期与基线的记录相差较大，则表示麻醉过深；
Step 4. After anesthesia, the patient is continuously monitored by the pain monitoring system, and the painful stimulator inputs a slowly changing waveform from the stimulation position to stimulate the monitoring object, and the collector picks up the pain evoked potential from the collection position, and the main control board pairs the collected The pain evoked potential was compared to the baseline for data comparison. At this time, the pain evoked potential is in a state of inhibition due to the application of an anesthetic, and its amplitude and latency are significantly different from the baseline state. For example, when the amplitude and latency of the acquired pain evoked potential are similar to those recorded at baseline, the degree is reached to some extent. At the time, it indicates that the anesthesia effect is poor; when the amplitude and latency of the acquired pain evoked potential are significantly different from the baseline records, the anesthesia is too deep;
步骤5.采集器判断采集后的痛觉诱发电位是否偏离正常范围，若偏离，主控板的显示屏进行相应的提示，等待医生对麻醉进行调整，并且继续返回步骤4进行持续的监控，医生根据提示信息，并结合对其他因素的判断，例如排除机器故障，当前手术对麻醉的需求，判断麻醉药或镇痛剂剂量是否充足，若剂量不足，则调整相应的麻醉剂量，直至达到预期的麻醉效果。若采集器采集的痛觉诱发电位没有偏离正常范围，则不进行提示，并继续下一步；
Step 5. The collector determines whether the pain evoked potential after the collection deviates from the normal range. If it deviates, the display screen of the main control board prompts correspondingly, waits for the doctor to adjust the anesthesia, and continues to return to step 4 for continuous monitoring, according to the doctor. Prompt information, combined with judgments on other factors, such as troubleshooting machine failure, current surgery requirements for anesthesia, determine whether the anesthetic or analgesic dose is sufficient, if the dose is insufficient, adjust the corresponding anesthetic dose until the expected anesthesia is achieved effect. If the pain evoked potential collected by the collector does not deviate from the normal range, no prompt is given and the next step is continued;
步骤6.判断手术是否结束，若没有结束，还是返回步骤4进行持续的监控，直至手术结束，停止监护。 Step 6. Determine whether the surgery is over. If it is not over, return to step 4 for continuous monitoring until the end of the operation and stop monitoring.
以上具体实施例仅用以举例说明本发明的结构，本领域的普通技术人员在本发明的构思下可以做出多种变形和变化，这些变形和变化均包括在本发明的保护范围之内。
The above specific embodiments are only intended to exemplify the structure of the present invention, and those skilled in the art can make various modifications and changes within the scope of the present invention.
Claims (10)
- 一种用于麻醉的痛觉监护系统，其特征在于包括：痛觉刺激器，用于刺激监护对象产生痛觉诱发电位；采集器，用于采集并记录所述痛觉诱发电位；与所述痛觉刺激器、采集器相连接的主控板，所述主控板控制痛觉刺激器和采集器，并将采集器输出的信号进行处理。 A pain monitoring system for anesthesia, comprising: a pain stimulator for stimulating a monitoring object to generate a pain evoked potential; a collector for collecting and recording the pain evoked potential; and the pain stimulator, A main control board connected to the collector, the main control board controls the pain stimulator and the collector, and processes the signal output by the collector.
- 如权利要求1所述的用于麻醉的痛觉监护系统，其特征在于，所述痛觉刺激器通过控制接口与主控板连接，并包括依次连接的波形生成模块、数模转换器、电压转电流模块、极性反转模块、刺激电极，以及与所述电压转电流模块连接的电源模块，和与波形生成模块连接的交互界面，所述交互界面用于输入产生波形的数据参数，所述数模转换器用于将波形数据转换为模拟电压信号，通过电压转电流模块将模拟电压信号转为电流信号，然后由刺激电极施加于刺激位置。 The pain monitoring system for anesthesia according to claim 1, wherein the pain stimulator is connected to the main control board through a control interface, and includes a waveform generation module, a digital-to-analog converter, and a voltage-converting current that are sequentially connected. a module, a polarity inversion module, a stimulation electrode, and a power module connected to the voltage to current module, and an interaction interface connected to the waveform generation module, the interaction interface is configured to input a data parameter that generates a waveform, the number The analog-to-analog converter is used to convert the waveform data into an analog voltage signal, and the analog voltage signal is converted into a current signal by a voltage-to-current module, and then applied to the stimulation position by the stimulation electrode.
- 如权利要求2所述的用于麻醉的痛觉监护系统，其特征在于，所述电源模块采用电池供电，或者通过低频变压器连接到市电供电。 A pain monitoring system for anesthesia according to claim 2, wherein said power module is powered by a battery or connected to a mains supply via a low frequency transformer.
- 如权利要求1所述的用于麻醉的痛觉监护系统，其特征在于， 所述采集器包括采集电极、与采集电极依次连接的过压保护电路、前置放大器、带通滤波器、程控放大器、模数转换器、双向数据接口，双向数据接口分别设有回路至模数转换器、程控放大器、前置放大器，采集电极在采集位置采集痛觉诱发电位信号，并将该信号放大、滤波、数模转换，然后由双向数据接口输出至主控板。 The pain monitoring system for anesthesia according to claim 1, wherein The collector includes an acquisition electrode, an overvoltage protection circuit sequentially connected to the collection electrode, a preamplifier, a band pass filter, a program control amplifier, an analog to digital converter, and a bidirectional data interface, and the bidirectional data interface is respectively provided with a loop to a modulus The converter, the program-controlled amplifier, the preamplifier, the acquisition electrode collects the pain evoked potential signal at the acquisition position, and amplifies, filters, and digital-analogs the signal, and then outputs the signal to the main control board through the bidirectional data interface.
- 如权利要求4所述的用于麻醉的痛觉监护系统，其特征在于，所述程控放大器与数模转换器之间还设有隔离器或光电耦合器，将采集器与主控板电路隔离。 The pain monitoring system for anesthesia according to claim 4, wherein an isolator or a photocoupler is further disposed between the programmable amplifier and the digital to analog converter to isolate the collector from the main control board circuit.
- 如权利要求2和4所述的用于麻醉的痛觉监护系统，其特征在于，所述刺激位置与采集位置根据躯体感觉皮层定位关系和10-20系统法相对应。 The pain monitoring system for anesthesia according to claims 2 and 4, wherein the stimulation position and the collection position correspond to a somatosensory cortical positioning relationship and a 10-20 system method.
- 如权利要求1所述的用于麻醉的痛觉监护系统，其特征在于，所述主控板包括：现场可编程门阵列，用于对数据进行处理；数据交互接口，用于传送数据。 The pain monitoring system for anesthesia according to claim 1, wherein the main control board comprises: a field programmable gate array for processing data; and a data interaction interface for transmitting data.
- 如权利要求1所述的用于麻醉的痛觉监护系统，其特征在于，所述主控板还包括：微处理器、数字信号处理器、数据存储器和显示屏。 The pain monitoring system for anesthesia according to claim 1, wherein the main control board further comprises: a microprocessor, a digital signal processor, a data memory, and a display screen.
- 一种用于麻醉的痛觉监护系统的监护方法，其特征在于，包括如下步骤：A method for monitoring a pain monitoring system for anesthesia, comprising the steps of:步骤1.将采集电极和刺激电极分别放置到相应的采集位置和刺激位置，并且刺激位置与采集位置根据躯体感觉皮层定位关系和10-20系统法相对应；Step 1. Place the collecting electrode and the stimulating electrode respectively to the corresponding collecting position and the stimulating position, and the stimulating position and the collecting position correspond to the somatosensory cortical positioning relationship and the 10-20 system method;步骤2.进行痛觉诱发电位的基线测试，获取监护对象的基线，包括幅值与潜伏期；Step 2. Perform a baseline test of pain evoked potentials to obtain a baseline of the monitored subject, including amplitude and latency;步骤3.实施麻醉；Step 3. Perform anesthesia;步骤4.通过痛觉刺激器从刺激位置输入缓慢变化的波形刺激监护对象，采集器从采集位置采集痛觉诱发电位，主控板对采集后的痛觉诱发电位和基线进行数据对比；Step 4. Input the slowly changing waveform from the stimulation position through the pain stimulator to stimulate the monitoring object, the collector collects the pain evoked potential from the collection position, and the main control panel compares the acquired pain evoked potential with the baseline data;步骤5.判断采集后的痛觉诱发电位是否偏离正常范围，若偏离，主控板的显示屏进行相应的提示，等待医生对麻醉进行调整，并继续返回步骤4进行持续的监控；若没有偏离正常范围，则继续下一步；Step 5. Determine whether the pain evoked potential after the collection deviates from the normal range. If it deviates, the display screen of the main control board prompts accordingly, wait for the doctor to adjust the anesthesia, and continue to return to step 4 for continuous monitoring; if not deviation from normal Range, continue to the next step;步骤6.判断手术是否结束，若没有结束，返回步骤4进行持续的监控，若结束，则监控结束。Step 6. Determine whether the surgery is over. If not, return to step 4 for continuous monitoring. If it is over, the monitoring ends.
- 如权利要求1所述的用于麻醉的痛觉监护系统的监护方法，其特征在于，所述步骤2中基线测试包括如下步骤：通过刺激电极将施加于刺激位置的电流信号强度慢慢加大，直到监护对象有明确的痛觉感觉为止，此时记录监护对象的痛觉诱发电位的幅值和潜伏期，作为基线。 The method of monitoring a pain monitoring system for anesthesia according to claim 1, wherein the baseline test in the step 2 comprises the step of gradually increasing the intensity of the current signal applied to the stimulation position by the stimulation electrode. Until the monitoring object has a clear pain sensation, the amplitude and latency of the pain evoked potential of the monitored subject are recorded as a baseline.
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| CN201310112754.1A CN103169466B (en) | 2013-04-01 | 2013-04-01 | Algesia monitoring system and monitoring method for anesthesia |
| CN201310112754.1 | 2013-04-01 |
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| WO2014161457A1 true WO2014161457A1 (en) | 2014-10-09 |
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| PCT/CN2014/074470 WO2014161457A1 (en) | 2013-04-01 | 2014-04-01 | Anesthesia pain monitoring system and method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103169466B (en) * | 2013-04-01 | 2015-07-22 | 张宇奇 | Algesia monitoring system and monitoring method for anesthesia |
| CN104138257A (en) * | 2014-07-17 | 2014-11-12 | 南宁市锋威科技有限公司 | Surgical anesthesia pain perception monitor |
| CN105536094A (en) * | 2016-02-02 | 2016-05-04 | 钱浩 | Intelligent monitoring type operative anesthesia system |
| CN107551377B (en) * | 2017-09-20 | 2021-01-05 | 王胜钢 | Limb anesthesia strength detection device |
| CN109330564B (en) * | 2018-10-11 | 2023-04-11 | 杨松 | Method and device for judging falling asleep |
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| CN103169466A (en) | 2013-06-26 |
| CN103169466B (en) | 2015-07-22 |
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