Abdominal cavity drainage fluid hemoglobin real-time monitoring device and monitoring method

Abstract

The application provides an abdominal cavity drainage liquid hemoglobin real-time monitoring device and a monitoring method. The monitoring device comprises a sensing bottle, a control box and a temperature sensor. The sensing bottle is connected with the control box through an outer wall surface. The temperature sensor is connected with the control box. The control box outputs 100KHz and 500KHz sine wave voltage signals to a pair of electrodes. The two voltage signals appear alternately. The application solves three defects of traditional methods, i.e., unclear, inaccurate and slow reaction, and provides a standardized and quantitative early warning scheme for postoperative hemorrhage.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical monitoring, and particularly relates to a peritoneal cavity drainage liquid hemoglobin real-time monitoring device and a monitoring method. BACKGROUND

[0002] Drainage management after peritoneal cavity surgery is a key link in postoperative care, and its importance mainly lies in the following aspects:

[0003] Firstly, the placement of drainage tubes is crucial for postoperative recovery. After abdominal surgery such as liver resection, pancreaticoduodenectomy, or gastrointestinal surgery, drainage plays multiple roles: it not only serves as an important window for monitoring postoperative bleeding, but also effectively drains inflammatory exudates from the abdominal cavity, reducing the risk of infection. More importantly, through the drainage tube, serious complications such as anastomotic leakage, lymphatic leakage, pancreatic juice leakage, or bile leakage can be detected early, providing valuable time for clinical intervention.

[0004] However, there are significant deficiencies in the current clinical practice of monitoring drainage fluid. Traditional methods mainly rely on the naked eye observation and experience judgment of medical staff, which has obvious limitations. On the one hand, the sensitivity of naked eye observation is limited, and studies have shown that when the hemoglobin content in the drainage fluid is less than 5%, the color change is often difficult to be detected, leading to missed diagnosis of early bleeding. On the other hand, this method lacks real-time performance, and medical staff usually record the drainage volume every 4-6 hours, making it difficult to discover sudden bleeding in time.

[0005] The existing monitoring methods also have the following problems:

[0006] Strong subjectivity: different medical staff may have different judgments on the color of drainage fluid;

[0007] Difficulty in distinguishing: unable to accurately distinguish between bleeding and bile, exudate mixture;

[0008] Reaction lag: often needs to wait for a significant increase in drainage volume or the patient's clinical symptoms to discover abnormalities;

[0009] Many interference factors: blood clots, drug residues, etc. in the drainage fluid will affect the accuracy of judgment.

[0010] These defects often lead to two adverse situations in clinical practice: either overreaction, misjudging normal exudation as bleeding, or delayed diagnosis, with the patient already showing hemodynamic instability when significant bleeding is discovered. Studies have shown that in cases of postoperative bleeding after liver resection, nearly 30% of them were delayed in treatment due to inadequate monitoring of drainage fluid. SUMMARY

[0011] The present application aims to provide a peritoneal cavity drainage liquid hemoglobin real-time monitoring device and a monitoring method, which solve the above technical problems.

[0012] A peritoneal cavity drainage liquid hemoglobin real-time monitoring device, characterized in that it comprises:

[0013] A sensing bottle 3, whose liquid inlet end is connected to a liquid inlet pipe 1, and whose liquid outlet end is connected to a liquid outlet pipe 8, the liquid inlet pipe 1 is connected to the output end of a peritoneal cavity drainage tube, the liquid outlet pipe 8 is connected to the input end of a drainage device, the sensing bottle 3 comprises a side plate A extending along the Z direction, and a pair of electrodes 6 and a temperature sensor 7 are arranged on the inner wall surface of the side plate A;

[0014] A control box 12, which is connected to the outer wall surface of the sensing bottle 3, is connected to the temperature sensor 7, outputs 100KHz and 500KHz sine wave voltage signals to the pair of electrodes 6, and the two voltage signals appear alternately.

[0015] Preferably, it further comprises a guide 2, which is located in the sensing bottle 3 and is connected to the liquid inlet pipe 1, is arranged obliquely, and forms a liquid sensing area 5 between the outlet of the guide 2 and the pair of electrodes 6 and the temperature sensor 7.

[0016] The highest point of the outlet of the guide 2 is higher than the electrodes 6.

[0017] Preferably, it further comprises a pair of liquid guardrails 15, which are arranged along the Y direction and are arranged on both sides of the liquid sensing area 5; the liquid guardrails 15 are arranged on the inner wall surface of the side plate A; and along the X direction, the liquid guardrails 15 are higher than the electrodes 6.

[0018] Preferably, the control box 12 comprises:

[0019] A box body, a circuit-control module 4 and a battery 13 arranged in the box body; the box body is connected to the outer wall surface of the sensing bottle 3.

[0020] The circuit-control module 4 comprises a functional circuit and an MCU.

[0021] The temperature processing unit of the functional circuit is connected to the temperature sensor 7, the signal output unit of the functional circuit is connected to the pair of electrodes 6, the output indication unit of the functional circuit is connected to a five-state indication lamp 10, the communication unit of the functional circuit is connected to the MCU, and the power supply port of the functional circuit and the MCU is connected to the battery 13.

[0022] The signal output unit of the functional circuit outputs 100KHz and 500KHz sine wave voltage signals, and the two voltage signals appear alternately.

[0023] and a PCB board 11, disposed in the box body, on which an electrode sheet, the battery 13 and a circuit-control module 4 are arranged;

[0024] The electrode sheet is an elastic conductive body, one end of which is connected with the PCB board 11, and the other end is in contact with one electrode of the battery 13 in normal operation.

[0025] Preferably, further comprising a battery isolation sheet 14, one end of which is interposed between the battery 13 and the electrode sheet, and the other end extends out of the box body.

[0026] A method for monitoring the hemoglobin content of abdominal cavity drainage fluid, based on the cavity drainage fluid hemoglobin real-time monitoring device, comprising the following steps:

[0027] Step 1, establishing a hemoglobin content calculation model ;

[0028] The hemoglobin content calculation model is a model related to an impedance term, the impedance term comprising:

[0029] Impedance dynamic model , impedance amplitude of the drainage fluid under a 100KHz detection signal , imaginary part impedance of hemoglobin Hb under a 500KHz detection signal , imaginary part impedance of the drainage fluid under a 500KHz detection signal ;

[0030] wherein, is an empirical value of the normal body temperature of human body at 37℃;

[0031] -impedance;

[0032] -time;

[0033] -hemoglobin;

[0034] -drainage fluid;

[0035] Step 2, solving the impedance dynamic model and substituting ;

[0036] Step 3, establishing a temperature compensation model for supplementing , ;

[0037] Step 4, connecting the abdominal cavity drainage fluid hemoglobin real-time monitoring device between the abdominal cavity drainage tube and the drainage device, at this time the postoperative time t=0;

[0038] The MCU records the postoperative time t in real time; the temperature sensor monitors the drainage fluid temperature signal T in real time and transmits the signal to the MCU through the temperature processing unit and the communication unit of the functional circuit;

[0039] Step 5, calculate , ;

[0040] Step 6, apply the temperature compensation model to compensate for , ;

[0041] Step 7, bring the compensated into the bile interference detection model to determine whether there is bile interference in the drainage fluid; if not, execute step 8;

[0042] Step 8, based on the postoperative time t, the drainage fluid temperature T corresponding to the postoperative time t, the compensated , obtained in step 6, and the obtained in step 2, obtain the hemoglobin content.

[0043] Preferably, the hemoglobin content calculation model in step 1 is:

[0044] ;

[0045] The impedance dynamic model in step 2 is:

[0046] .

[0047] Preferably, the temperature compensation model in step 3 is:

[0048] ;

[0049] wherein, compensation.

[0050] Preferably, the bile interference detection model in step 7 is:

[0051] ;

[0052] = compensated .

[0053] Preferably, if it is determined that there is bile interference in step 7, the corresponding indicator light responds, and then it is confirmed by manual confirmation;

[0054] If it is judged that there is no bile interference, based on the hemoglobin content value obtained in step 8, the corresponding risk level is started according to the corresponding indicator light and clinical response of the program according to the set value of the risk level.

[0055] Compared with the prior art, the advantages of the present application are that: the cavity drainage is the "lifeline" of postoperative management, and the present application solves the three defects of "unclear, inaccurate and slow reaction" of the traditional method through impedance method φHb monitoring, i.e. hemoglobin monitoring, and provides a standardized and quantitative early warning scheme for postoperative bleeding. Specifically:

[0056] (1) Through the innovative impedance detection technology, the system can monitor the hemoglobin content in the drainage fluid in real time and quantitatively, and the sensitivity can reach 2%, which is much higher than the 5% threshold of naked eye observation.

[0057] (2) The addition of temperature compensation algorithm ensures the accuracy of the measurement results, and the five-level alarm system provides a clear basis for clinical decision-making.

[0058] (3) Compared with the traditional method, the average time of bleeding discovery is advanced by 2-4 hours, which saves a valuable time window for clinical intervention.

[0059] (4) In addition, the unique bile interference identification function of the system solves the common false alarm problem in clinical practice. When the bile mixing feature is detected, the system will start a special prompt, which not only avoids unnecessary alarms, but also reminds medical staff to pay attention to possible bile leakage complications. This intelligent discrimination ability is completely impossible for traditional naked eye observation. BRIEF DESCRIPTION OF DRAWINGS

[0060] Figure 1 It is a schematic diagram for clinical application of the hemoglobin real-time monitoring equipment for abdominal cavity drainage fluid;

[0061] Figure 2 It is a sectional view and a top view comparison diagram of the hemoglobin real-time monitoring equipment for abdominal cavity drainage fluid;

[0062] Figure 3 It is a partial view of Figure 2 ;

[0063] Figure 4 It is a schematic diagram of the installation mode of the hemoglobin real-time monitoring equipment for abdominal cavity drainage fluid in an embodiment.

[0064] Among them, 1 is a liquid inlet pipe, 2 is a guide, 3 is a sensing bottle, 4 is a circuit-control module, 5 is a liquid sensing area, 6 is an electrode, 7 is a temperature sensor, 8 is a liquid outlet pipe, 9 is a reset switch, 10 is an indicator light, 11 is a PCB board, 12 is a control box, 13 is a battery, 14 is a battery isolation sheet, and 15 is a liquid guardrail. DETAILED DESCRIPTION

[0065] The abdominal cavity drainage liquid hemoglobin real-time monitoring device and monitoring method of the present application will be described in more detail below in connection with the schematic drawings, in which the preferred embodiments of the present application are shown, and it should be understood that the present application described herein can be modified by those skilled in the art while still achieving the advantageous effects of the present application. Therefore, the following description should be understood as a broad knowledge for those skilled in the art, and not as a limitation of the present application.

[0066] As Figures 1~3 An abdominal cavity drainage liquid hemoglobin real-time monitoring device suitable for early warning of postoperative bleeding risk, comprising:

[0067] A sensing bottle 3, the inlet end of which is connected to the inlet pipe 1, and the outlet end of which is connected to the outlet pipe 8, the inlet pipe 1 is connected to the output end of the abdominal cavity drainage tube, and the outlet pipe 8 is connected to the input end of the drainage device, the sensing bottle 3 comprises a side plate A extending along the Z direction, and a pair of electrodes 6 and a temperature sensor 7 are adhered to the inner wall surface of the side plate A by epoxy resin;

[0068] In this embodiment, the inlet pipe 1 is sealingly bonded to the sensing bottle 3, and the outlet pipe 8 is sealingly bonded to the sensing bottle 3.

[0069] And a control box 12, which comprises a box body, a circuit-control module 4 and a battery 13 arranged in the box body;

[0070] The box body is connected to the outer wall surface of the sensing bottle 3. In this embodiment, the control box 12 and the sensing bottle 3 share the side plate A.

[0071] The circuit-control module 4 comprises a functional circuit and an MCU.

[0072] The temperature processing unit of the functional circuit is connected to the temperature sensor 7, the signal output unit of the functional circuit is connected to the pair of electrodes 6, the output indication unit of the functional circuit is connected to the five-state indication lamp 10, and the communication unit of the functional circuit is connected to the MCU; the power supply port of the functional circuit and the MCU is connected to the battery 13;

[0073] The signal output unit of the functional circuit outputs sinusoidal voltage signals of 100KHz and 500KHz, and the two kinds of voltage signals appear alternately.

[0074] That is, the temperature sensor 7 transmits the drainage liquid temperature signal T to the MCU through the temperature processing unit and the communication unit of the functional circuit;

[0075] The battery 13 supplies power to the MCU and the functional circuit, and the signal output unit of the functional circuit alternately outputs sinusoidal voltage signals of 100KHz and 500KHz under the control of the MCU.

[0076] In the embodiment, a guide 2 is further arranged in the sensing bottle 3 and communicates with the liquid inlet pipe 1.

[0077] The inlet liquid channel of the guide 2 communicates with the liquid inlet pipe 1, and the guide 2 is integrally formed with the liquid inlet pipe 1.

[0078] The guide 2 is arranged obliquely, and a liquid sensing area 5 is formed between the outlet of the guide 2 and the pair of electrodes 6 and the temperature sensor 7; the highest point of the outlet of the guide 2 is higher than the electrodes 6.

[0079] In the embodiment, a pair of liquid guardrails 15 are further arranged along the Y direction, and one liquid guardrail 15 is arranged on each side of the liquid sensing area 5; the liquid guardrail 15 is arranged on the inner wall surface of the side plate A; along the X direction, the liquid guardrail 15 is higher than the electrodes 6. Specifically, the liquid guardrail 15 is an integrated injection molding structure with the side plate A.

[0080] Regarding the control box 12, the control box 12 further comprises:

[0081] The PCB 11 is mounted in the box body, and the electrodes, the battery 13 and the circuit-control module 4 are arranged on the PCB 11.

[0082] Specifically, both of the two electrode pieces (electrode piece B and electrode piece C) of the battery 13 are welded on the PCB 11.

[0083] The battery 13 is fixed on the battery plastic fixing frame on the PCB 11 by a hot riveting process, conducts electricity through the two electrode pieces, and supplies power to the MCU and the functional circuit.

[0084] The circuit-control module 4 is embedded in the PCB.

[0085] The electrode piece is an elastic conductor, one end of which is connected with the PCB 11, and the other end of which is in contact with one electrode of the battery 13 during normal operation. When not in operation, the battery isolation piece is placed between the battery 13 and the electrode piece.

[0086] The battery isolation piece 14 is interposed between the battery 13 and the electrode piece (electrode piece B), and the other end of the battery isolation piece 14 extends out of the box body.

[0087] The device is connected in series in the drainage tube between the patient's abdominal cavity drainage tube and the drainage device. The drainage device can be a passive drainage container or an active drainage negative pressure aspirator, as shown in Figure 1 .

[0088] Specifically, regarding the abdominal cavity drainage liquid hemoglobin real-time monitoring device:

[0089] The liquid inlet pipe 1 is located at the upper part of the sensing bottle 3 and is connected with the patient end of the abdominal cavity drainage tube, and the inner diameter of the pipe is greater than 8 mm;

[0090] Guide 2: its upper end is communicated with the liquid inlet 1, and its lower end is opened close to the electrode 6 and the temperature sensor 7, the outlet of the guide is higher than the electrode 4-6mm, so as to ensure that the drainage of the patient can effectively flow through the electrode and the temperature sensor, especially when the drainage volume is small;

[0091] Perception bottle 3: it is a closed container, the upper end of which is connected with the liquid inlet pipe 1, and the lower end of which is connected with the liquid outlet pipe 8, a pair of gold-plated electrodes and a temperature sensor 7 are installed on the right side of the container, the volume of the whole perception bottle is greater than 100ml, and the height is greater than 80mm;

[0092] Regulation circuit and MCU (circuit-control module 4): it is installed on the PCB in the controller box 12, and is composed of a functional circuit and a MCU, which is used for waveform generation, constant current control, complex impedance extraction, output display, sound control and related mathematical operation and logical judgment;

[0093] Liquid perception area 5: the area is a narrow gap between the outlet of the guide 2 and the electrode 6 and the temperature sensor 7, the width of the narrow gap is 2-3mm, so that the flowing liquid can effectively contact the electrode and the temperature sensor, especially when the drainage volume is small;

[0094] Electrode 6: it is a pair of gold-plated electrolytic copper electrodes, the single effective size of which is not less than 6X8mm, and the temperature sensor is installed in the middle of the electrode, the electrode is installed on the shared isolation device (shared “a wall”) of the perception bottle and the controller box, and in the working state, the waveform generation circuit generates an open circuit voltage of 5V and a constant current of 100 microamperes, and the electrode is applied to the electrode pair, the frequency is 100KHz and 500KHz, and the two frequencies are alternated at an interval of 800ms.

[0095] Temperature sensor 7: the sensor is a small-volume platinum temperature sensor, and the effective surface of the temperature perception is less than 4mm 2 , so that it has as small heat capacity as possible, so that the temperature response can be realized quickly;

[0096] Liquid outlet pipe 8: the inner diameter of the pipe located at the lower part of the perception bottle is greater than 8mm, which is used for connecting the liquid guide pipe of the drainage device;

[0097] Indicator light 10: there are totally 5 LEDs from top to bottom, which are green, yellow, orange, red and blue respectively, which represent normal, mild bleeding, active bleeding, critical bleeding and bile interference respectively, and the five indicator lights are “five choices”, that is, only one is lit at a time;

[0098] PCB board 11: the circuit board in the controller box;

[0099] Control box 12: It contains battery, signal processing circuit, MCU, switch, buzzer and 5 LED indicator lights, etc. It shares an isolation device with the sensing bottle (shares a wall), and the sensing bottle side of the wall is equipped with electrodes and a temperature sensor. The temperature sensor and the electrode lead have sealing measures, which can effectively prevent the patient's drainage from leaking from the sensing bottle to the control box.

[0100] Battery 13: The device is disposable after being sterilized by ethylene oxide. It contains a non-replaceable battery with a voltage of 3.3V when it leaves the factory. The battery can maintain the device working for more than 48 hours;

[0101] Battery isolation sheet 14: A 0.5-1mm thick polymer insulating soft material gasket that serves as a switch to isolate one electrode of the battery from the circuit. When in use, the isolation sheet can be removed to turn on the power. After the battery isolation sheet is removed, it cannot be put back to ensure that the device is disposable, and also prevents battery consumption when not in use;

[0102] Liquid guardrail 15: The guardrail cooperates with the guide to ensure that the liquid drained from the patient's abdominal cavity can reliably flow through the electrode sheet and the temperature sensor. The effective height of the guardrail, i.e. the distance from the electrode surface, is 3-6mm, and the upper end of the guardrail is flush with the upper end of the upper electrode sheet. Figure 2 The liquid guardrail 15 is not shown in the cross-sectional view due to the viewing angle.

[0103] Further, in other embodiments, the abdominal drainage liquid hemoglobin real-time monitoring device can be installed according to the design as shown in Figure 4 . Figure 4 Only one electrode sheet is shown in the figure.

[0104] A method for monitoring the hemoglobin content of abdominal drainage liquid, comprising the following steps:

[0105] Step 1, establishing a hemoglobin content calculation model ;

[0106] The hemoglobin content calculation model is a model related to the impedance term, which includes:

[0107] Impedance dynamic model , impedance amplitude of the drainage liquid under 100KHz detection signal , imaginary part impedance of hemoglobin Hb under 500KHz detection signal , imaginary part impedance of the drainage liquid under 500KHz detection signal ;

[0108] Wherein, is the empirical value of the normal body temperature of human body at 37℃;

[0109] - impedance;

[0110] - time;

[0111] - hemoglobin;

[0112] - drainage fluid;

[0113] Hemoglobin content calculation model is:

[0114]

[0115] Table 1 Parameter definition table

[0116] Symbol Physical meaning 37℃ calibration value Data source Dynamic baseline Starting value 62 End value 58 Empirical value as two constants based on large data regularity extraction Impedance amplitude of mixed solution under 100KHz detection signal Need to be compensated Actual measured impedance amplitude Hemoglobin Hb imaginary impedance under 500KHz detection signal -20.5±1.5 Empirical value as a constant based on large data regularity extraction Mixed solution imaginary impedance under 500KHz detection signal Need to be compensated Actual measured impedance imaginary part T Real-time temperature of drainage fluid Compensate with this temperature Actual measurement

[0117] In this embodiment, the "mixed solution" refers to the drainage fluid.

[0118] Step 2, solving the impedance dynamic model and substituting .

[0119] The hemoglobin in the abdominal drainage fluid of a patient after surgery will gradually decrease as the patient recovers, so this baseline cannot be a constant, but a dynamic baseline model.

[0120] The dynamic baseline model is essentially a time-varying plasma baseline model This model is a function of time, with the initial point baseline impedance being the value at T = 0 and the decay end point baseline impedance being the value at T→∞,

[0121] To establish the dynamic baseline model (impedance dynamic model), the impedance values at the initial point and the decay end point need to be determined first.

[0122] Initial point impedance value: Taking the actual postoperative abdominal bleeding as a large data source, an 80 / 20 standard is extracted, i.e., by default 80% plasma composition and 20% blood composition.

[0123] The 80% plasma composition corresponds to tissue fluid exuded from the wound in the early postoperative period, and its impedance characteristics are consistent with healthy plasma ( = 55Ω), and its physiological source is the increased vascular permeability caused by surgical trauma, with plasma protein and electrolyte exudation.

[0124] The 20% blood composition corresponds to residual or early exuded whole blood during surgery, and the impedance is dominated by red blood cell membrane capacitance ( = 90Ω, 40% HCT). The physiological source is that minor blood vessel damage cannot be completely avoided during surgery. ​

[0125] 80 / 20 mixed model initial value derivation weighting formula:

[0126] ;

[0127] mix-min; - initial.

[0128] Simplified linear approximation (error < 3%):

[0129] ;

[0130] Decay end impedance value: theoretically, the composition of the drainage fluid approaches the state of pure plasma, i.e. 100% plasma composition, and is defined as the standard impedance amplitude of pure plasma at 100 kHz at 37°C, T→∞, Lim = 58Ω.

[0131] Dynamic baseline time function: the initial value is 62Ω, and as the patient gradually recovers, this baseline value will tend to 58Ω, which is the pure plasma state.

[0132] We obtained that this function is a piecewise function under big data experiments:

[0133] i.e. impedance dynamic model :

[0134] ;

[0135] Table 2 Clinical basis for dynamic adjustment

[0136] Postoperative time Adjustment strategy Physiological mechanism 0-6 hours Fixed 62Ω Wound exudation period, stable bleeding ratio 6-24 hours Linearly down to 58Ω Tissue repair reduces bleeding, plasma proportion rebounds >24 hours Fixed 58Ω (pure plasma benchmark) Drainage fluid approaches plasma when there is no active bleeding

[0137] Step 3, establish a temperature compensation model for supplementing , .

[0138] Because -20.5±1.5Ω is the average value of big data experience under the patient's body fluid at 37°C, so in actual calculation, it needs to be compensated and corrected according to the actual temperature of the patient's drainage fluid, and the corresponding value under the condition of 37°C, because the patient's body temperature will rise slightly after the operation, so the patient's drainage fluid is usually greater than 37°C, the compensation formula, i.e. temperature compensation model is as follows:

[0139] Temperature compensation model:

[0140] ;

[0141] Among them, - compensation.

[0142] Step 4: Connect the real-time monitoring device for hemoglobin in the abdominal drainage fluid in series between the abdominal drainage tube and the drainage device. At this point, the postoperative time t=0.

[0143] The MCU records the postoperative time t in real time; the temperature sensor monitors and uploads the drainage fluid temperature signal T to the MCU through the temperature processing unit and communication unit of the functional circuit.

[0144] Step 5: Calculated by the MCU , .

[0145] Step 5 is existing technology.

[0146] Step 6: Apply the temperature compensation model to , Compensation is performed to obtain the temperature-compensated value. and .

[0147] Step 7: Compensate for Input the data into the bile interference detection model to determine whether there is bile interference in the drainage fluid; if not, proceed to step 8.

[0148] Patients undergoing abdominal surgery, especially hepatobiliary surgery, often have bile mixed in their drainage fluid. Bile is an interfering factor in hemoglobin detection, and this system has a bile labeling and indication function.

[0149] The bile interference detection model, i.e., the condition for the bile marker to be true, is:

[0150] ;

[0151] =After compensation

[0152] If bile interference is detected, the corresponding indicator light will respond, and then the drainage fluid status will be manually confirmed.

[0153] Step 8: Based on postoperative time t, the drainage fluid temperature T corresponding to postoperative time t, and the compensated value obtained in Step 6. , and the results obtained in step 2 To obtain hemoglobin content.

[0154] Step 9, Press Values ​​<2%, 2-5%, 5-8%, and >8% are divided into four levels, corresponding to four risk levels: normal, mild bleeding, active bleeding, and critical bleeding.

[0155] Table 3 Risk Thresholds

[0156] Risk level Threshold value Clinical response Normal ＜2% Routine monitoring Mild bleeding 2-5% Ultrasound review Active bleeding 5-8% Emergency CT Critical bleeding ＞8% Surgical preparation Bile interference Imaginary part ratio <0.7 Manual confirmation

[0157] Table 4 Five-state indicator light and audible alert system

[0158] Risk level Threshold value Indicator light status Sound prompt status Normal ＜2% Green light always on No sound Mild bleeding 2-5% Yellow light always on Intermittent sound (1s on 1s off) Active bleeding 5-8% Orange light flickering (0.4s bright 0.4s dark) Intermittent sound and light flashing synchronization Critical bleeding ＞8% Red light always on Long sound Bile interference Imaginary part ratio <0.7 Blue light slow flashing (0.8s bright 0.8s dark) Intermittent sound (1s on 2s off)

[0159] Case 1: Post-pancreaticoduodenectomy

[0160] (1) Post-operative 18 hour data

[0161] Measured values:

[0162] Impedance magnitude ;

[0163] Impedance imaginary part ;

[0164] Temperature T = 38.1 °C

[0165] (2) Calculation steps

[0166] Temperature compensation:

[0167] ;

[0168] ;

[0169] Dynamic baseline (post-operative 18h):

[0170] ;

[0171] Bile detection:

[0172] ;

[0173] Condition not met

[0174] Hemoglobin calculation:

[0175] ;

[0176] Decision:

[0177] 2% < 3.3% < 5% -> yellow light constant (mild bleeding).

[0178] Case 2: Post-hepatectomy

[0179] (1) Post-operative 24 hour data

[0180] Measured values:

[0181] ;

[0182] ;

[0183] T = 36.4 °C

[0184] (2) Calculation step

[0185] Temperature compensation (temperature close to 37℃, compensation can be ignored)

[0186] , ;

[0187] Bile detection:

[0188] ;

[0189] Because the bile interference judgment is established, there is no need to calculate hemoglobin

[0190] Determination:

[0191] System determination for bile interference → blue light slow flashing

[0192] Case 3: after gastrectomy

[0193] (1) Postoperative 8-hour data

[0194] Measurement value:

[0195] ;

[0196] ;

[0197] T=37.8℃

[0198] (2) Calculation step

[0199] Temperature compensation:

[0200] ;

[0201] ;

[0202] Dynamic baseline (8 hours after operation):

[0203] ;

[0204] Bile detection:

[0205] ;

[0206] Hemoglobin calculation:

[0207] ;

[0208] Determination:

[0209] 11.2%>8%→ red light flashing (critical bleeding)

[0210] The above merely describes the preferred embodiments of the present application and does not limit the present application in any way. Any person skilled in the art can make any form of equivalent replacement or modification to the technical solutions and technical contents disclosed by the present application without departing from the scope of the technical solutions of the present application, and such changes still belong to the protection scope of the present application.

Claims

1. A real-time monitoring device for hemoglobin in abdominal drainage fluid, characterized in that, The application relates to a peritoneal cavity drainage liquid blood hemoglobin real-time monitoring device, which comprises the following parts: a sensing bottle (3) connected with an inlet pipe (1) at an inlet end and an outlet pipe (8) at an outlet end, the inlet pipe (1) being connected with an output end of a peritoneal cavity drainage pipe, the outlet pipe (8) being connected with an input end of a drainage device, the sensing bottle (3) comprising a side plate A extending along a Z direction, a pair of electrodes (6) and a temperature sensor (7) being arranged on an inner wall surface of the side plate A; a control box (12) connected with an outer wall surface of the sensing bottle (3), the control box (12) being connected with the temperature sensor (7), the control box (12) outputting 100KHz and 500KHz sine wave voltage signals to the pair of electrodes (6), and the two kinds of voltage signals appearing alternately.

2. The abdominal cavity draining liquid hemoglobin real-time monitoring device according to claim 1, characterized in that, further comprising a guide (2) arranged in the sensing bottle (3) and connected with the inlet pipe (1), the guide (2) being arranged in an inclined mode, a liquid sensing area (5) being formed between an outlet of the guide (2) and the pair of electrodes (6) and the temperature sensor (7); the highest point of the outlet of the guide (2) being higher than the electrodes (6).

3. The abdominal cavity draining liquid hemoglobin real-time monitoring device according to claim 2, characterized in that, further comprising a pair of liquid guardrails (15) arranged along a Y direction, one liquid guardrail (15) being arranged on each side of the liquid sensing area (5); the liquid guardrails (15) being arranged on the inner wall surface of the side plate A; and the liquid guardrails (15) being higher than the electrodes (6) along an X direction.

4. The abdominal cavity draining liquid hemoglobin real-time monitoring device according to claim 1, characterized in that, the control box (12) comprising: a box body, a circuit-control module (4) and a battery (13) arranged in the box body; the box body being connected with the outer wall surface of the sensing bottle (3); the circuit-control module (4) comprising a functional circuit and an MCU; a temperature processing unit of the functional circuit being connected with the temperature sensor (7), a signal output unit of the functional circuit being connected with the pair of electrodes (6), an output indication unit of the functional circuit being connected with five-state indication lamps (10), a communication unit of the functional circuit being connected with the MCU; and a power supply port of the functional circuit and the MCU being connected with the battery (13); the signal output unit of the functional circuit outputting 100KHz and 500KHz sine wave voltage signals, and the two kinds of voltage signals appearing alternately; and a PCB board (11) arranged in the box body, the PCB board (11) being provided with electrode pieces, the battery (13) and the circuit-control module (4); the electrode pieces being elastic conductive bodies, one end of the electrode pieces being connected with the PCB board (11), and the other end of the electrode pieces being in contact with one electrode of the battery (13) in normal operation.

5. The real-time monitoring device for blood hemoglobin in peritoneal drainage fluid according to claim 4, characterized in that, further comprising a battery isolation piece (14) arranged between the battery (13) and the electrode pieces, the other end of the battery isolation piece (14) extending out of the box body.

6. A method for monitoring the hemoglobin content of peritoneal dialysis fluid based on the real-time monitoring device for the hemoglobin content of peritoneal dialysis fluid according to any one of claims 1 to 5, characterized in that the application further comprises the following steps: Step 1, establishing a hemoglobin content calculation model ; The hemoglobin content calculation model is a model with respect to an impedance term, the impedance term including: Impedance dynamic model Impedance amplitude of the drainage fluid under 100KHz detection signal Imaginary part impedance of hemoglobin Hb under 500KHz detection signal Imaginary part impedance of the drainage fluid under 500KHz detection signal ; wherein, is an empirical value for the normal body temperature of a human being of 37°C; - impedance; - plasma; - time; - hemoglobin; - drainage fluid; Step 2, solving the impedance dynamic model and bringing in ; Step 3, establishing a temperature compensation model for supplementing the , temperature compensation model; step 4: connecting the peritoneal cavity drainage liquid blood hemoglobin real-time monitoring device between a peritoneal cavity drainage pipe and a drainage device, at this time, postoperative time t=0; the MCU recording the postoperative time t in real time; and the temperature sensor monitoring and transmitting a drainage liquid temperature signal T to the control box (12) in real time; Step 5, calculate , ; Step 6, Compensate with temperature compensation model 、 ; Step 7, the compensated into the bile interference detection model, judge whether there is bile interference in the drainage fluid; if not, step 8 is executed; Step 8, based on the postoperative time t, the drainage fluid temperature T corresponding to the postoperative time t, the compensated drainage fluid temperature T' obtained in step 6, the drainage fluid temperature T obtained in step 2, and the hemoglobin content obtained in step 7, the hemoglobin content of the patient is obtained. , , and the hemoglobin content obtained in step 7, the hemoglobin content of the patient is obtained. , the hemoglobin content of the patient is obtained. The model for calculating the hemoglobin content in step 1 is: is: ； Impedance dynamic model in step 2 is: 。 7. The method of claim 6, wherein the blood hemoglobin content of the peritoneal fluid is monitored by measuring the absorbance of the peritoneal fluid at a wavelength of 415 nm. the temperature compensation model in step 3 is: ； wherein - compensation.

8. The method of claim 6, wherein the blood hemoglobin content of the peritoneal fluid is monitored by measuring the absorbance of the peritoneal fluid at a wavelength of 415 nm. the bile interference detection model in step 7 is: ； = compensated .

9. The method of claim 6, wherein the blood hemoglobin content of the peritoneal fluid is monitored by measuring the absorbance of the peritoneal fluid at a wavelength of 415 nm. if it is judged that there is bile interference in step 7, the corresponding indication lamp responds, and then manual confirmation is carried out; if it is judged that there is no bile interference, based on the blood hemoglobin content value obtained in step 8, corresponding risk levels are set according to the program, and corresponding indication lamps and clinical responses are started according to the risk levels.

Images