Analgesic drug delivery control system
By combining EEG signals and uterine contraction detection modules, the injection amount of analgesic drugs is dynamically adjusted, and the problem of inability to finely adjust the dose of drugs in the existing technology is solved, and the fine matching and pain relief for the mother's pain is achieved, which improves childbirth Analgesic effect.
Patent Information
- Application Number
- CN202410471008.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-04-18
- Publication Date
- 2025-01-10
- Estimated Expiration
- 2044-04-18
AI Technical Summary
The existing delivery analgesic system cannot dynamically adjust the amount of analgesic drugs injection, and cannot finely match the dynamic pain changes in the mother, resulting in poor pain relief effect, especially when the intensity of uterine contraction changes, the drug dosage cannot be adjusted in time.
The combination of EEG signal detection module and uterine contraction detection module is used to dynamically adjust the amount of analgesic drugs through the bioelectric potential signals related to uterine muscle contraction, and adjust the type and amount of drug injection according to the uterine contraction rhythm and peak period to achieve the drug Instant updates and adjustments to injection volumes.
The amount of analgesic drugs can be adjusted in detail according to the dynamic pain and uterine contraction state of the mother, which improves the effect of childbirth analgesics, reduces the pain in the mother, and improves the painless childbirth experience.
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Figure CN118178785B_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of drug injection pumps, and in particular to an analgesic drug administration control system. Background Art
[0002] With the shift of the medical model to "comfort medicine", labor analgesia has gradually become a trend. In 2012, the Evidence-Based Medicine Database conducted a comprehensive analysis of 310 related studies and concluded that epidural anesthesia, combined spinal anesthesia and inhalation analgesia have clear effects on labor analgesia. Currently, the most effective method of labor analgesia is epidural analgesia. The method of epidural analgesia is continuous infusion combined with maternal controlled epidural analgesia (PCEA), that is, the analgesia pump continuously infuses drugs into the epidural space at a certain speed. When the mother feels pain, she can press the pump to add a certain amount of additional dose. The results of a study involving 9658 parturients showed that the pain intensity of parturients who received epidural anesthesia in the first and second stages of labor was significantly reduced. Compared with parturients who did not receive labor analgesia, the second stage of labor in the epidural anesthesia group was prolonged by 13.66 minutes and the rate of vaginal delivery was increased [16.96% (675 / 3981) vs. 12.37% (489 / 3954)].
[0003] In the prior art, there are many studies on analgesic methods and related equipment for painless delivery. The Chinese patent with publication number CN104707204A discloses a method for using an epidural pulse delivery analgesia pump, which generates a corresponding dynamic delivery method through the design of drug distribution. However, combined with this delivery method, medical staff are required to stay by the parturient's side at all times and pay attention to changes in the parturient's physiological indicators. This adjustment method requires medical staff to guard the parturient one-to-one or even one-to-many, and the adjustment efficiency is low, and it tests the medical staff's grasp of the parturient's condition. The results of a survey conducted by the Obstetrics Group of the Anesthesiology Branch of the Chinese Medical Association on the current status of labor analgesia in 2018 showed that the popularity of painless delivery in China is very low, especially in the southwest region, where it is only 7.56%. The reduced selectivity of labor analgesia caused by the shortage of human resources for anesthesiologists is one of the main factors.
[0004] With the popularization of intelligent equipment, designs for providing the amount and type of analgesic drugs to parturients based on their physiological state and emotional changes are gradually being used. The Chinese patent with publication number CN115006678A discloses a labor analgesia method and device with adjustable drug concentration. The device measures the pain level of parturients by placing a hand-held pressure sensor component and a sound collection component in the hands of parturients, and also detects the uterine contraction pressure by placing a uterine contraction monitoring component on the abdomen of parturients, and combines multiple parameters to judge the switching of multiple drug delivery modes. Or as disclosed in the Chinese patent with publication number CN111671505A, the intelligent injection system and method adjust the injection volume gear by the size of the cervix and the pain level. In this application, the VAS score is used to assess the pain perception of parturients. The VAS scoring standard is the pain level scoring standard, which uses a visual simulation method to judge the severity of pain. The scoring standard is divided into 10 equal parts using a ruler, 0 is no pain, 1~3 is mild pain, 4~6 is moderate pain, and 7~10 is severe pain. A ruler divided into 10 equal parts was used to ask the patient to say which scale they were on using a visual analog pain rating scale. However, due to the lack of control, parturients often cannot distinguish the specific pain level when the pain level reaches level 5 or above, and they randomly choose the pain level or report a high pain level.
[0005] The above-mentioned public documents all adopt multiple parameters to adjust the drug delivery mode, but in the disclosed technical solutions, these parameters have the following disadvantages:
[0006] The evaluation logic is relatively independent (each parameter is used to independently judge an indicator);
[0007] When parturients request additional analgesics, the amount of additional medication is judged using highly subjective parameters, which results in bias in the estimated amount of additional medication.
[0008] It is impossible to finely adjust the amount of analgesics according to the dynamic changes in the pain sensation of the parturient (the largest division is the first stage of labor and the second stage of labor). Parturients with high pain sensitivity have a high baseline of pain relief confirmed in the early stage, which causes parturients whose pain deepens with the deepening of uterine contractions to be unable to perceive obvious changes in pain relief in the later stage.
[0009] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the applicant studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background technology. Summary of the invention
[0010] The prior art has already developed a technical solution for adjusting the dosage of different types of drugs through a variety of prenatal examination monitoring indicators. For example, the patent document with publication number CN115006678A discloses a labor analgesia method and device with adjustable drug concentration, which includes a hand-held pressure sensor component, a uterine contraction monitoring component, a sound collection component, a control component and an injection component. This technical solution measures the pain level of the parturient through a hand-held pressure sensor component and a sound collection component placed in the parturient's hand, detects the uterine contraction pressure through a uterine contraction monitoring component placed on the parturient's abdomen, sets up a medicine bin to store different types of drugs, and controls the opening or closing of the valves set on each medicine bin according to the measurement results, thereby obtaining mixed drugs of different concentrations. This technical solution can adjust the concentration of the mixed drug and the amount of drug infusion according to the pain level of the parturient and the uterine contraction pressure, thereby improving the effect of labor analgesia. However, the purpose of the pressure data and / or sound decibel data detection involved in this technical solution is to determine different pain levels, and different pain levels correspond to different preferred drugs. The matching result of this setting method can only determine a single dosing regimen, in which the different detection data are only for obtaining a unique dosing regimen. Once the dosing regimen is determined, if the above-mentioned detection data of the parturient changes and the preset dosing regimen needs to be adjusted, it is necessary to re-determine a new dosing regimen in combination with a variety of different detection data, and it is impossible to achieve instant updating and adjustment of the dosing regimen to match the actual physiological pain of the parturient.
[0011] The present application provides an analgesic drug administration control system. The system comprises a handgrip strengthener provided with a patient request unit, an analgesic drug delivery device connected to the handgrip strengthener for providing drug delivery to a parturient when the patient request unit transmits a request signal, and an information processing unit for generating a signal for controlling the injection amount of the drug output by the analgesic drug delivery device based on received information related to the parturient.
[0012] The system is also provided with a uterine contraction detection module for collecting data reflecting the pain rhythm of the parturient and an electroencephalogram signal detection module for collecting data reflecting the pain state of the parturient. When receiving the request signal sent by the patient request unit, the information processing unit generates a drug injection amount corresponding to the brain information based on the brain information presented by the electroencephalogram signal detection module. The drug injection amount adjusted based on the brain information is adjusted within the division range that matches the uterine contraction rhythm reflected by the original biopotential signal, limited by the original biopotential signal related to uterine muscle contraction presented by the uterine contraction detection module.
[0013] Compared with the above-mentioned prior art, the present invention can generate an initial drug injection amount that matches the brain information presented by the EEG signal detection module, and can dynamically adjust the initial drug injection amount according to the original biopotential signal related to uterine muscle contraction presented by the uterine contraction detection module. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to dynamically adjust the injection amount of analgesics according to the different periods of the uterine contraction rhythm of the patient during childbirth, so as to finely adjust the amount of analgesics according to the dynamically changing pain of the parturient. Specifically, the rhythm of uterine contractions during delivery includes an interval period and a peak period, and the intensity of the contraction reaction gradually increases with the arrival of the labor time, thereby causing the patient to feel different degrees of pain. Therefore, the injection amount of analgesics should also be dynamically adjusted according to the patient's production progress. Beneficial effects of this technical solution:
[0014] The prior art disclosed in the publication number CN111671505A discloses an intelligent injection system that uses the pain level and cervical size fed back by the feedback parameter receiving module to divide the injection mode and injection parameters. Different from the intelligent injection system disclosed in the prior art, the present application uses the uterine contraction state as an objective reference factor of the parturient's body to generate an injection control signal including the injection type and injection amount, and adjusts the point value within the injection amount range based on the subjective factor with the parturient's pressure as the main reference information.
[0015] The objective factors of the parturient's body are standard values that reflect the parturient's pain state. The changes in this state can be predicted by medical staff and corresponding analgesic measures can be given based on the process changes. Therefore, the present application reflects the pain rhythm based on the parturient's uterine contraction rhythm, and at the same time enables the analgesic drug delivery device to accompany the rhythm and provide the parturient with corresponding drug delivery according to preset rules.
[0016] Furthermore, the subjective factors of the parturient (or the pain perception) are affected by individual differences and show differences. When the parturient requests analgesics based on pain, individuals with more obvious pain require higher doses of analgesics to relieve their pain. The VAS scoring method is used in the comparative document to adjust the drug injection mode. However, the VAS scoring method requires parturients to judge their perception with pain, which cannot eliminate the deviation caused by subjectivity. In particular, parturients in a state of pain stimulated by progesterone have low mental clarity, and the credibility of the scores given in this state is low. This also makes the assessment of the pain level under the VAS scoring method unable to effectively adjust the device to a dose that can relieve the pain of the parturient, or increase the dose at a single time (because the large dose lowers the baseline value of pain, subsequent parturients will only need a higher dose to achieve changes in perceived pain relief. This will reduce the experience of painless delivery for parturients with greater uterine contractions and higher pain in the later stages).
[0017] At the same time, different from the comparative documents that use the evaluation parameters of cervical size, this application uses the detection information of uterine contraction rhythm as the basis to evaluate the injection type and injection amount of analgesics. Since the changes in the cervical ostium of the parturient gradually open to more than ten centimeters over a long period of time (for example, 6 to 18 hours), and the amplitude of the changes in the early stage is small, using the changes in the cervical ostium as reference data will reduce the mobility of the evaluation, making the amplitude of the changes in the evaluation results smaller, and unable to match the changes in the actual pain of the parturient. This application uses the uterine contraction rhythm of the parturient as a reference indicator, and the uterine contraction rhythm is also the main basis for directly reflecting the pain rhythm of the parturient. With the changes in the uterine contraction rhythm, the injection type and injection amount of analgesics can be adjusted at the peak or interval of each or several contractions. In particular, the pain caused by the interval period of uterine contractions will be less than the peak period of uterine contractions. Therefore, the timing of drug injection will affect the analgesic feeling of the parturient.
[0018] According to a preferred embodiment, the brain information at least includes a waveform curve collected by the EEG detection electrodes of the EEG signal detection module, which conforms to the EEG characteristics of brain activity, wherein the time domain and frequency domain of the EEG signal representing the EEG characteristics of brain activity are used to match the drug injection amount adjusted based on the brain information in a manner that represents the stress state of the parturient.
[0019] According to a preferred embodiment, the information processing unit is configured as follows:
[0020] Based on the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module, a regular waveform curve is formed. When the regular waveform curve has the characteristics of the peak period of uterine contraction, the preset injection amount range is used to provide the parturient with drug injection, wherein the preset injection amount range is modified based on the generation time node of the regular waveform curve that meets the characteristics of the peak period of uterine contraction as the driving basis for increasing / decreasing the injection amount of the preset increase value. The prior art has already appeared a technical solution for detecting uterine contraction state data to realize the judgment of the parturient state. For example, the patent document with the publication number CN113018618A discloses a device for auxiliary anesthesia in the clinical department of anesthesiology, including breathing, blood oxygen, fetal movement, and uterine contraction pressure sensors, which are used to monitor the physiological state of the parturient and the fetus. The main control unit receives all signals and analyzes and judges the state of the parturient. Based on different states, the main control unit controls the ventilator to perform different modes of ventilation, deliver anesthetic gas, inject oxytocin, or enter the anesthetic drug preparation state. The technical solution calculates the uterine contraction pressure value through the uterine contraction pressure signal obtained by the uterine contraction pressure sensor, and executes the corresponding treatment plan regulation by monitoring the change of the uterine contraction pressure signal. However, the uterine contraction pressure data obtained in this technical solution is limited to controlling a single ventilator working mode, and cannot be superimposed on other detection data to perform refined analgesic drug injection adjustment. Furthermore, the uterine contraction pressure value detected and obtained in this technical solution can only be used to reflect the node parameters under the current state, and cannot be used to achieve continuous periodic treatment plan regulation, and thus it is impossible to dynamically adjust the analgesic drug injection amount according to the patient's physiological state data at different uterine contraction periods. Compared with the above-mentioned prior art, the information processing unit of the present invention can form a regular waveform curve based on the original biopotential signal collected by the uterine contraction detection module, and can increase the injection amount at the generation time node of the regular waveform curve that meets the characteristics of the uterine contraction peak period. Based on the above-mentioned distinguishing technical features, the problems to be solved by the present invention may include: how to dynamically adjust the analgesic drug injection amount according to the different uterine contraction peak period characteristics of the patient. Specifically, the cyclical administration in the present application is divided into a first dose of medicine and a mixed drug. When the parturient enters a uterine contraction state and has the first regular uterine contraction, the first dose of medicine is injected into the parturient at the peak period of the contraction. When the parturient has the second or perhaps regular uterine contraction, the mixed drug is injected into the parturient at the peak period of the contraction. The injection volume increases by a preset injection volume as the number of contractions increases, thereby achieving dynamic matching of the analgesic drug injection volume with the parturient's uterine contraction state to reduce her pain.
[0021] According to a preferred embodiment, the analgesic drug delivery device comprises a first drug liquid box and a second drug liquid box driven by a driving module, wherein the first drug liquid box and the second drug liquid box respectively contain drugs of different categories.
[0022] According to a preferred embodiment, based on the first appearance of a regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the contraction detection module that conforms to the characteristics of the peak period of uterine contraction, the information processing unit controls the driving module of the analgesic drug delivery device to drive the second drug liquid box to inject the first dose of drug into the parturient with a preset content, wherein, controlled by the request signal sent by the patient request unit and the brain information characterizing the stress state of the parturient, the information processing unit sends a drug delivery signal to the analgesic drug delivery device with an adjusted injection volume to control the second drug liquid box and the first drug liquid box to supply drugs in a preset ratio.
[0023] Preferably, the first and second medicine boxes of the analgesic drug delivery device are respectively filled with ropivacaine and sufentanil, wherein, when a regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the contraction detection module and conforming to the characteristics of the peak period of uterine contraction first appears, the information processing unit controls the driving module of the analgesic drug delivery device to drive the second medicine box containing sufentanil to inject the first dose of the drug into the parturient with a preset content, wherein, controlled by the request signal sent by the patient request unit and the brain information characterizing the stress state of the parturient, the information processing unit sends a drug delivery signal to the analgesic drug delivery device with an adjusted injection volume to control the second medicine box containing sufentanil and the first medicine box containing ropivacaine to supply drugs in a preset ratio.
[0024] According to a preferred embodiment, based on the fact that the regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the contraction detection module and meeting the characteristics of the peak period of uterine contraction is not the first appearance, the information processing unit controls the driving module of the analgesic drug delivery device to drive the second drug liquid box and the first drug liquid box to inject drugs in the contraction cycle to the parturient in a preset ratio, wherein the injection volume of the drug mixture generated by the second drug liquid box and the first drug liquid box in a preset ratio is increased by a preset increase value based on the generation time node of the regular waveform curve meeting the characteristics of the peak period of uterine contraction as the driving basis.
[0025] Preferably, based on the fact that the regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module and meeting the characteristics of the peak period of uterine contraction does not appear for the first time, the information processing unit is configured as follows:
[0026] The driving module of the analgesic drug delivery device is controlled to drive the second drug solution box containing sufentanil and the first drug solution box containing ropivacaine to inject drugs in a preset ratio during the uterine contraction cycle into the parturient.
[0027] According to a preferred embodiment, based on the fact that the regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module that meets the characteristics of the peak period of uterine contraction does not appear for the first time, the information processing unit is configured as follows:
[0028] Controlled by the request signal sent by the patient request unit and the brain information representing the stress state of the parturient, the injection volume of the drug solution in the first drug solution box or the second drug solution box is increased according to a preset increase value.
[0029] Preferably, based on the fact that the regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module and meeting the characteristics of the peak period of uterine contraction does not appear for the first time, the information processing unit is configured as follows:
[0030] Controlled by the request signal sent by the patient request unit and the brain information representing the stress state of the parturient, the injection amount of the liquid medicine in the first liquid medicine box or the second liquid medicine box is increased according to a preset increase value, such as Figure 1 shown.
[0031] According to a preferred embodiment, the hand gripper includes an elastic shell, at least two elastic support rods cross-arranged inside the elastic shell, and a pressure sensor arranged at the intersection center of the elastic support rods and capable of sensing the pressure value of the corresponding elastic support rod, wherein when the pressure value transmitted by the pressure sensor exceeds a preset threshold value, a spring compressor arranged at one end of the elastic support rod for adjusting the spring compression range of the elastic support rod is controlled by an information processing unit to decompress the spring so that the mother's fingers stretch as the elastic shell expands.
[0032] According to a preferred embodiment, the patient request unit comprises a vibration sensor to recognize a tapping action sent by the parturient in a conscious state for sending a request signal to the analgesic drug delivery device.
[0033] According to a preferred embodiment, at least one finger sleeve is provided on the surface of the elastic shell, wherein the area corresponding to the at least one finger sleeve is provided with a vibration sensor capable of sensing the tapping behavior generated in the area corresponding to the at least one finger sleeve. BRIEF DESCRIPTION OF THE DRAWINGS
[0034] Figure 1 A diagram of the use state of a pregnant woman in a lying position provided by the present invention;
[0035] Figure 2 A diagram showing a pregnant woman in a sitting position supporting a wall provided by the present invention;
[0036] Figure 3 A functional structure diagram of the guide module provided by the present invention;
[0037] Figure 4 A functional structure diagram of a guide module in another embodiment of the present invention;
[0038] Figure 5 A three-dimensional diagram of the handgrip provided by the present invention;
[0039] Figure 6 A three-dimensional diagram of another embodiment of the handgrip provided by the present invention;
[0040] Figure 7 A diagram showing the internal structure of the handgrip provided by the present invention;
[0041] Figure 8 The system flow chart provided by the present invention.
[0042] Reference numerals list
[0043] 100: analgesic drug delivery device; 110: driving module; 120: first drug liquid box; 130: second drug liquid box; 200: handgripper; 210: patient request unit; 211: vibration sensor; 220: pressure assembly; 221: elastic support rod; 222: spring compressor; 223: pressure sensor; 230: emotion information acquisition unit; 231: speech recognizer; 232: player; 240: elastic shell; 250: rebound wrist rope; 251: button; 252: ring; 260: finger sleeve; 300: EEG signal detection module; 310: EEG detection electrode; 320: first filter amplifier circuit; 400: uterine contraction detection module; 410: potential signal acquisition unit; 500: information processing unit; 600: physiological parameter detection module. DETAILED DESCRIPTION
[0044] The following is a detailed description with reference to the accompanying drawings.
[0045] In the description of the present invention, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance. In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "provided with", "connected", etc. should be understood in a broad sense. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal connection of two elements. "Several" means two or more, unless otherwise clearly and specifically limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. Example 1
[0046] This embodiment provides a system for calming labor pain caused by uterine contractions during childbirth, regulating the administration of different drug doses and types to reduce the pain felt by the parturient.
[0047] One aspect of the present application relates to an analgesic modulation system. Figure 3 , 4The functional structure diagram of the system is shown. In the application, the handgrip 200, the EEG signal detection module 300, the analgesic drug delivery device 100 and the uterine contraction detection module 400 can establish a communication connection, such as data, signals and / or control signals, through a wireless network (such as Bluetooth, WIFI, Zigbee, etc.).
[0048] Another aspect of the present application relates to an analgesic drug delivery device 100. The analgesic drug delivery device 100 can establish a drug delivery relationship with a parturient through puncture or other means. Preferably, the analgesic drug delivery device 100 can deliver at least one anesthetic drug to the parturient through an epidural catheter placed in the intervertebral space.
[0049] Specifically, Figure 1 and 3 As shown, the analgesic drug delivery device 100 includes a first drug liquid box 120, a second drug liquid box 130, a communication module and a driving module 110. The communication module can receive a drug liquid delivery signal sent by the information processing unit 500. The driving module 110 can drive the flow of the drug liquid in the first drug liquid box 120 and the second drug liquid box 130 at the same time, and it can also drive the flow of the drug liquid in the first drug liquid box 120 or the second drug liquid box 130 alone, such as a PCA pump (analgesic pump).
[0050] Preferably, the first drug solution box 120 and the second drug solution box 130 respectively contain drugs of different categories, for example, the first drug solution box 120 contains ropivacaine, and the second drug solution box 130 contains sufentanil.
[0051] Another aspect of the present application relates to a uterine contraction detection module 400. The uterine contraction detection module 400 includes a potential signal acquisition unit 410 and a power supply unit for supplying power to the potential signal acquisition unit 410. Preferably, Figure 1 , Figure 2 As shown, during the painless delivery of the parturient, the potential signal acquisition unit 410 is attached to the upper abdomen of the parturient in the form of an electrode sheet to collect the myoelectric signal of the uterus, such as EMG. The uterine contraction detection module 400 can transmit the collected signal to the information processing unit 500 to obtain the fluctuation state of the uterus during the contraction.
[0052] Specifically, the waveform formed by the signal characterizing the state of uterine contraction collected by the potential signal acquisition unit 410 includes a regular waveform and an irregular waveform. The system involved in the present application can distinguish whether the parturient has entered the state of waiting for delivery based on the regularity of the waveform, that is, distinguish the authenticity of the state of uterine contraction. Since false contractions belong to the phenomenon of false labor of parturients, in the current common sense of pregnancy and childbirth, in order to prevent parturients from losing their perception of real contractions, the injection of analgesics, especially the injection method of intrathecal labor analgesia, should be avoided as much as possible. Since parturients before delivery (especially first-time parturients) have the probability of experiencing false contractions before real contractions occur, it becomes a necessary step to distinguish the timing of the first injection of analgesics through waveforms.
[0053] The rhythm of uterine contraction includes an interval and a peak period, and the intensity of uterine contraction gradually increases with the arrival of labor. Therefore, the injection volume of analgesics should not be fixed.
[0054] In the present application, the information processing unit 500 is driven by the generation time node of the regular waveform curve that meets the characteristics of the peak period of uterine contraction. The later the uterine contraction state is, the greater the injection amount will be. Preferably, each time a regular waveform curve that meets the characteristics of the peak period of uterine contraction is generated, the injection amount will be increased once according to the preset increase amount. Preferably, since the injection amounts of different drugs are different, the increase in the injection amount (preset increase value) involved in the present application can include the increase in the injection amount of a single drug.
[0055] At the same time, the rhythm of uterine contractions, that is, the interval and peak period, also need to be paid attention to. The drug administration methods in labor analgesia generally include cyclical administration and request administration, that is, based on the rhythm of uterine contractions, the drugs are injected into the parturient according to the preset injection volume and drug category at the peak period of uterine contractions. Since uterine contractions are a regular change state with a gradually increasing peak value, this type of drug administration is called cyclical administration.
[0056] In the present application, the applicant divides cyclical administration into the first dose of drugs and mixed drugs based on many years of experience in obstetric anesthesia. When the parturient has the first regular uterine contraction, 5 μg of sufentanil is injected into the parturient at the peak of the contraction. At the same time, an injection volume of 0.3 μg / mL of sufentanil + 0.1% ropivacaine is provided to provide drug delivery to the parturient at the injection volume determined by the information processing unit 500 when the parturient requests an injection. When the parturient has the second or perhaps regular uterine contraction, a drug mixture of 0.3 μg / mL of sufentanil + 0.1% ropivacaine is injected into the parturient at the peak of the contraction, and the injection volume increases by a preset injection volume as the number of contractions increases, and a single drug delivery is provided to the parturient at the injection volume determined by the information processing unit 500 when the parturient requests an injection.
[0057] It should be noted that in order to ensure the stability of the blood concentration of anesthetic drugs in parturients, the injection volume of 0.3 μg / mL of sufentanil + 0.1% ropivacaine should not exceed 5 mL every 20 to 30 minutes from the start of regular uterine contractions.
[0058] Another aspect of the present application relates to an EEG signal detection module 300. The EEG signal detection module 300 comprises an EEG detection electrode 310, a first filter amplifier circuit 320 and a power supply unit. Figure 3 , 4 As shown. The EEG signal detection module 300 can be configured as a wearable device, and transmits signals to the information processing unit 500 in a wireless connection. When the parturient enters labor, the EEG signal detection module 300 worn on the parturient's head does not affect the medical staff's auxiliary operations during labor, nor does it affect the parturient's behavior when exercising out of bed to relieve the pain of uterine contractions, such as Figure 2 When the EEG detection electrode 310 collects brain wave signals such as EEG, the EEG signal detection module 300 sends the collected signals to the information processing unit 500 through screening and adjustment by the first filter amplifier circuit 320 to generate information for judging the stress state of the parturient. Preferably, the EEG signal detection module 300 is an electroencephalogram (EEG) device published in a Chinese application with publication number CN107690308A.
[0059] Another aspect of the present application relates to an information processing unit 500. The information processing unit 500 can be configured as an integrated device, which is integrated into the handgrip 200 or the analgesic drug delivery device 100, or it can be configured as an independent device. Preferably, the information processing unit 500 can be a smart phone, a smart watch or other wearable device, a tablet computer, a computer, a cloud server or other smart device with a CPU and a communication module. The CPU receives the detection signal sent by the EEG signal detection module 300, the uterine contraction detection module 400, the handgrip 200 or the physiological parameter detection module 600 with blood oxygen, blood pressure, and heart rate detection functions through the communication module, and converts the detection signal into processable data for further generating a signal for controlling the analgesic drug delivery device 100.
[0060] Another aspect of the present application relates to a handgrip strengthener 200 . The handgrip strengthener 200 comprises an elastic shell 240 , a patient request unit 210 , a power supply unit and a pressure assembly 220 .
[0061] Specifically, Figure 7As shown, the pressure assembly 220 includes at least two elastic support rods 221 arranged crosswise inside the elastic housing 240 and a pressure sensor 223 arranged at the intersection center of the elastic support rods 221 and capable of sensing the pressure value of the corresponding elastic support rods 221. The elastic support rods 221 are connected to the elastic housing 240 via a spring compressor 222. Based on a preset pressure value, the spring compressor 222 adjusts the elastic force of the elastic support rods 221 so that the gripper 200 matches the gripping force of the parturient.
[0062] As the degree of uterine contraction of the parturient increases (or the degree of pain increases), the parturient's grip strength will gradually increase. When the pressure value transmitted by the pressure sensor 223 exceeds the preset threshold value, the spring compressor 222 provided at one end of the elastic support rod 221 for adjusting the spring compression range of the elastic support rod 221 is controlled by the information processing unit 500 to decompress the spring. The spring is sleeved on the elastic support rod 221. After the spring is decompressed, it increases the length of the elastic support rod 221, that is, the decompressed spring elastic shell 240 expands, and the curvature of the fingers of the parturient holding the gripper 200 in a gripping posture will decrease. At this time, the fingers of the parturient stretch as the elastic shell 240 expands.
[0063] The handgrip 200 is also provided with a vibration sensor 211. Since the mother in pain cannot control herself, her hand will unconsciously apply pressure to the object in the palm. The analgesic pump controller in the prior art is basically set as a thumb-pressing device, which also causes the mother in pain to press repeatedly unconsciously, so that the analgesic pump basically provides analgesics to the mother at the maximum output, and the drug regulation effect based on the mother's state is not obvious. Therefore, the present application sets the patient request unit 210 as a component of the tapping signal sending mode, that is, the patient request unit 210 includes a vibration sensor 211 to identify the tapping behavior sent by the mother in the awake state for sending a request signal to the analgesic drug delivery device 100, such as Figure 6 shown.
[0064] In order to accurately locate the tapping area, the elastic shell 240 of the present application adds one of the following two structures on the surface.
[0065] At least one finger sleeve 260 is disposed on the surface of the elastic shell 240, wherein a vibration sensor 211 capable of sensing the tapping behavior generated in the corresponding area is disposed in the area corresponding to the at least one finger sleeve 260. Figure 5 shown.
[0066] A resilient wrist connecting rope 250 is disposed on the surface of the elastic housing 240. An adjustment unit including a spring and a locking assembly is disposed at one end of the resilient wrist connecting rope 250, and a ring 252 that is sleeved on the parturient's wrist is disposed at the other end. Preferably, the structure of the adjustment unit can be the same as the telescopic structure of a retractable traction rope, or the same as the automatic telescopic structure of a measuring tape. When the parturient needs to leave the bed to relieve the pain of uterine contraction, the parturient can release the handgrip 200, and the handgrip 200 is suspended in the air, such as Figure 2 As shown, the mother can use her palms to support the wall and complete the relevant movements.
[0067] After returning to bed, the handgrip 200 is rebounded into the hand by pressing the button 251, and the control of the analgesic drug delivery device 100 is restored. Preferably, the button 251 can be arranged on the ring 252 or on the surface of the elastic shell 240.
[0068] According to a preferred embodiment, the analgesia regulation system involved in the present application is located in the clinical information system (Clinical Information System) of the hospital and can be connected to the hospital information system (Hospital Information System).
[0069] Specifically, when a pregnant woman enters the hospital in an emergency or is judged to be in labor in the ward, based on the occurrence of the pregnant woman entering the delivery room, the obstetrician's smart device (such as the obstetrician's mobile phone) in the clinical information system is connected to the analgesia adjustment system. The obstetrician can remotely send instructions to the information processing unit 500 through the communication module in the obstetrician's smart device when the obstetrician has not yet reached the delivery room but the midwife has arrived, and adjust the initial dosage value of the analgesic drug delivery device 100 in the delivery room based on the pregnant woman's historical medical history.
[0070] During this process, since the use of analgesics is monitored (for example, supervision of dosage and recycling of used analgesic bottles), the information processing unit 500 can record the dosage of analgesics used by the analgesic delivery device 100 and send it to the hospital information system to verify whether the amount of analgesics recovered is correct. Example 2
[0071] This embodiment provides a method for regulating analgesic medication for parturients under stress. In this embodiment, the CPU is integrated into the handgrip 200 as an example. Figure 3 As shown, except that the information processing unit 500 controls the analgesic drug delivery device 100 in a different manner, other hardware is the same as the previous embodiment.
[0072] The potential signal acquisition unit 410 of the contraction detection module 400 collects the original biopotential signal of the parturient from the abdomen of the parturient. After receiving the signal sent by the contraction detection module 400, the information processing unit 500 of the handgrip 200 analyzes the contraction state of the parturient using a model disclosed in the Chinese patent publication number CN109875556A. When the waveform curve formed by the original biopotential signal of the parturient shows regular fluctuations for the first time, the information processing unit 500 of the handgrip 200 generates an instruction to control the analgesic drug delivery device 100 to inject 5 μg of sufentanil into the parturient at the peak of the contraction. Subsequently, during the contraction time period of this contraction or several cycles, when the parturient taps the handgrip 200 to cause the vibration sensor 211 of the handgrip 200 to generate a request signal sent to the information processing unit 500, the information processing unit 500 analyzes the calibration index α of the EEG signal collected by the EEG signal detection module 300, such as Figure 8 As shown. The calibration index contains data that characterizes the amplitude of changes in the EEG signal and is used to show changes in the emotions of the mother. For example: the calibration index contains the time domain or frequency domain of the EEG signal. The time domain refers to the analysis of the time series of the EEG signal to extract the information it contains. Common time domain features include: average amplitude, variance, slope, peak time, maximum and minimum values, etc. Frequency domain features refer to the extraction of frequency feature information contained in the EEG signal by performing frequency analysis on the EEG signal. Common frequency domain features include: wave frequency, power spectral density, energy spectrum, absolute / relative normalized power, spectrum bandwidth, etc.
[0073] Taking the wave frequency of the EEG signal as an example, when the calibration index α is lower than the preset threshold, the information processing unit 500 controls the analgesic drug delivery device 100 to provide the parturient with a first preset injection amount of 0.3 μg / mL of sufentanil + 0.1% ropivacaine.
[0074] When the calibration index α is higher than the preset threshold, the information processing unit 500 controls the analgesic drug delivery device 100 to provide the parturient with a second preset injection volume of 0.3 μg / mL of sufentanil+0.1% ropivacaine.
[0075] Preferably, the first preset injection volume is smaller than the second preset injection volume.
[0076] Compared with the VAS score generated based on the mother's own feelings, this application uses objective parameters (such as physiological parameters) to judge the mother's subjective feelings (pain feelings), avoiding the situation where the mother is unable to distinguish the specific pain level when the pain level reaches level 5 or above due to lack of control. Example 3
[0077] This embodiment provides a method for analgesia. In this embodiment, a CPU is integrated in an analgesic drug delivery device 100 as an example. Figure 4As shown, except that the information processing unit 500 controls the analgesic drug delivery device 100 in a different manner, other hardware is the same as the previous embodiment.
[0078] Another aspect of the present application relates to a physiological parameter detection module 600. The physiological parameter detection module 600 includes a blood oxygen detection unit, a blood pressure detection unit and / or a heart rate detection unit. The physiological parameter detection module 600 also includes a power supply unit for supplying power to the above detection units.
[0079] The physiological parameter detection module 600 can be configured as a smart bracelet worn on the wrist of the parturient. The physiological parameter detection module 600 can replace the ring 252 disposed at one end of the rebound wrist connecting rope 250 in the handgrip 200.
[0080] The handgrip 200 is provided with an emotion information collection unit 230 including a voice recognizer 231 and a player 232. The emotion information collection unit 230 can collect the voice of the parturient. When the physiological parameters of the parturient (such as blood pressure, blood oxygen, heart rate) are in a range that does not meet the normal physical signs of the parturient, the information processing unit 500 controls the analgesic drug delivery device 100 to stop delivering analgesics to the parturient, and issues a voice prompt through the emotion information collection unit 230. When the medical staff confirms that the physiological parameters of the parturient are not affected, based on the secondary confirmation of the medical staff through their handheld device or other means (i.e., the signal for secondary confirmation sent to the information processing unit 500 through their handheld device or other means), the information processing unit 500 controls the analgesic drug delivery device 100 to resume work, and continues the above-mentioned drug administration method after restoring the historical data. The historical data includes all the data generated by the parturient during this delivery before the analgesic drug delivery device 100 is controlled to stop delivering analgesics to the parturient.
[0081] For example, when the second regular uterine contraction is in the intermittent period, the blood oxygen of the parturient is lower than the preset threshold, and the information processing unit 500 controls the analgesic drug delivery device 100 to stop delivering analgesics to the parturient. At the same time, based on the voice exceeding the preset decibel collected by the voice recognizer 231 of the emotional information collection unit 230 for more than the preset time, the information processing unit 500 sends a prompt containing the blood oxygen information of the parturient and the sound information of the parturient's voice exceeding the preset decibel for more than the preset time to the medical staff through the player 232. After the medical staff sends a second confirmation signal through the restore button 251 set on the analgesic drug delivery device 100, the information processing unit 500 obtains the signal collected by the uterine contraction detection module 400 that has not stopped collecting work, and controls the analgesic drug delivery device 100 to provide analgesics to the parturient according to the current uterine contraction state of the parturient.
[0082] It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the present invention specification and its drawings are illustrative and do not constitute a limitation of the claims. The scope of protection of the present invention is defined by the claims and their equivalents. The present invention specification contains multiple inventive concepts, such as "preferably", "according to a preferred embodiment" or "specifically", all of which indicate that the corresponding paragraph discloses an independent concept, and the applicant reserves the right to file a divisional application based on each inventive concept. Throughout the text, the features guided by "preferably" are only an optional method and should not be understood as being required. Therefore, the applicant reserves the right to abandon or delete the relevant preferred features at any time.
Claims
1. An analgesic drug administration control system, comprising a handgrip (200) provided with a patient request unit (210) with a tapping signal sending mode, an analgesic drug delivery device (100) connected to the handgrip (200) for providing analgesic drug delivery to the patient when the patient request unit (210) transmits a request signal, and an information processing unit (500) for generating a signal for controlling the analgesic drug delivery device (100) to output an injection amount of analgesic drugs based on received patient-related information, characterized in that: The system is also provided with a uterine contraction detection module (400) for collecting information reflecting the pain rhythm of the parturient and an electroencephalogram signal detection module (300) for collecting information reflecting the pain state of the parturient. When the patient taps the handgrip (200) to cause the vibration sensor (211) of the handgrip (200) to generate a request signal to be sent to the information processing unit (500), the information processing unit (500) analyzes the calibration index α of the electroencephalogram signal collected by the electroencephalogram signal detection module (300), wherein: Upon receiving the request signal sent by the patient request unit (210), the information processing unit (500) generates an analgesic drug injection amount corresponding to the brain information based on the brain information presented by the electroencephalogram signal detection module (300), wherein, limited by the original biopotential signal related to uterine muscle contraction presented by the uterine contraction detection module (400), the analgesic drug injection amount adjusted based on the brain information is adjusted within the division range matched with the uterine contraction rhythm reflected by the original biopotential signal, The information processing unit (500) forms a regular waveform curve based on the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module (400), and provides analgesic drug injection to the parturient within a preset injection volume range when the regular waveform curve has characteristics consistent with the peak period of uterine contraction, wherein the preset injection volume range increases the injection volume by a preset increase value based on the generation time node of the regular waveform curve that meets the characteristics of the peak period of uterine contraction as the driving basis for modifying the injection volume range.
2. The analgesic drug delivery control system according to claim 1, characterized in that: The brain information at least includes a waveform curve collected by the EEG detection electrodes of the EEG signal detection module (300) that conforms to the EEG characteristics representing brain activity, wherein the time domain and frequency domain of the EEG signal representing the EEG characteristics representing brain activity are used to match the analgesic drug injection amount adjusted based on the brain information in a manner that represents the stress state of the parturient.
3. The analgesic drug delivery control system according to claim 1, characterized in that: The analgesic drug delivery device (100) comprises a first drug liquid box (120) and a second drug liquid box (130) driven by a driving module (110), wherein the first drug liquid box (120) and the second drug liquid box (130) respectively contain analgesics of different categories.
4. The analgesic drug delivery control system according to claim 3, characterized in that: Based on the first appearance of a regular waveform curve formed by the original biopotential signal related to uterine muscle contraction collected by the uterine contraction detection module (400) that meets the characteristics of the peak period of uterine contraction, the information processing unit (500) controls the driving module (110) of the analgesic drug delivery device (100) to drive the second liquid medicine box (130) to inject the first dose of analgesic drugs to the parturient at a preset content, wherein, controlled by the request signal sent by the patient request unit (210) and the brain information representing the stress state of the parturient, the information processing unit (500) sends an analgesic drug delivery signal to the analgesic drug delivery device (100) with an adjusted injection volume to control the second liquid medicine box (130) and the first liquid medicine box (120) to supply drugs at a preset ratio.
5. The analgesic drug delivery control system according to claim 4, characterized in that: Based on the fact that the regular waveform curve formed by the original bioelectric potential signal related to uterine muscle contraction collected by the uterine contraction detection module (400) that meets the characteristics of the peak period of uterine contraction is not the first appearance, the information processing unit (500) controls the driving module (110) of the analgesic drug delivery device (100) to drive the second drug liquid box (130) and the first drug liquid box (120) to inject analgesic drugs in the process of uterine contraction cycle into the parturient at a preset ratio, wherein: The injection volume of the liquid medicine mixture generated by the second liquid medicine box (130) and the first liquid medicine box (120) in a preset ratio is increased by a preset increase value based on the generation time node of the regular waveform curve that conforms to the characteristics of the peak period of uterine contraction as the driving basis for modifying the injection volume range.
6. The analgesic drug delivery control system according to claim 5, characterized in that: Based on the fact that the regular waveform curve formed by the original bioelectric potential signal related to uterine muscle contraction collected by the uterine contraction detection module (400) that meets the characteristics of the peak period of uterine contraction does not appear for the first time, the information processing unit (500) is configured as follows: Controlled by a request signal sent by a patient request unit (210) and brain information representing the stress state of the parturient, the injection volume of the drug solution in the first drug solution box (120) or the second drug solution box (130) is increased according to a preset increase value.
7. The analgesic drug delivery control system according to claim 1, characterized in that: The gripper (200) comprises an elastic shell (240), at least two elastic support rods (221) arranged crosswise inside the elastic shell (240), and a pressure sensor (223) arranged at the intersection center of the elastic support rods (221) and capable of sensing the corresponding pressure value of the elastic support rod (221), wherein when the pressure value transmitted by the pressure sensor (223) exceeds a preset threshold value, a spring compressor (222) arranged at one end of the elastic support rod (221) for adjusting the spring compression range of the elastic support rod (221) is controlled by the information processing unit (500) to decompress the spring, so that the parturient's fingers extend as the elastic shell (240) expands.
8. The analgesic drug delivery control system according to claim 7, characterized in that: The patient request unit (210) includes a vibration sensor (211) to identify a tapping behavior sent by a parturient in a waking state to send a request signal to the analgesic drug delivery device (100).
9. The analgesic drug delivery control system according to claim 8, characterized in that: At least one finger sleeve (260) is arranged on the surface of the elastic shell (240), wherein the area corresponding to the at least one finger sleeve (260) is provided with the vibration sensor (211) capable of sensing the tapping behavior generated in the area corresponding to the at least one finger sleeve (260).
Citation Information
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