Extracorporeal blood multi-parameter monitoring device

Abstract

This application discloses a multi-parameter monitoring device for extracorporeal circulation blood. The device includes: a blood monitoring device, a controller, a printed circuit board, and a flow cell. The blood monitoring device includes at least two of the following: a flow monitoring device, a blood oxygen monitoring device, a pressure monitoring device, and a temperature monitoring device. The blood monitoring device and the controller are integrated on the printed circuit board. The flow cell includes an outer tube and an inner tube, and the printed circuit board is disposed between the outer and inner tubes of the flow cell. The flow cell is connected to a blood circulation pipeline. The controller is connected to a host computer via a serial communication line. The controller sends the data collected by the blood monitoring device to the host computer. The controller also sends the device's digital address to the host computer, so that the host computer can determine the installation location of the device based on the digital address. This device can integrate multiple monitoring devices into one monitoring device. The monitoring device is integrated into the blood circulation pipeline, resulting in low cost, simple piping, and high safety and reliability.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a multi-parameter monitoring device for extracorporeal circulating blood. Background Technology

[0002] In clinical applications such as extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass (CPB), multi-parameter monitoring is a key technology to assist medical staff in decision-making and improve patient condition. Related technologies often involve multi-parameter monitoring systems with multiple monitoring devices. Some devices, such as pressure sensors, require independent tubing, pressure bags, signal cables, and other accessories, making the system highly complex. Setting up and maintaining such a system requires matching sensors to individual tubing and cables, which is extremely inconvenient.

[0003] Furthermore, some existing monitoring devices, such as temperature monitoring devices, employ invasive designs, directly monitoring the blood inside the blood tubing. This means the monitoring device comes into direct contact with the blood, placing high demands on its manufacturing process. In addition, interference with blood flow by the monitoring device can not only lead to CPB system malfunctions but also pose health risks to patients. Summary of the Invention

[0004] In view of this, this application provides an extracorporeal circulation blood multi-parameter monitoring device that can integrate multiple monitoring devices into one monitoring device. The monitoring device is integrated into the blood circulation pipeline, and the monitoring device has low cost, simple pipeline, and high safety and reliability.

[0005] To solve the above problems, the technical solution provided in this application is as follows:

[0006] In a first aspect of this application, an extracorporeal circulation blood multi-parameter monitoring device is provided, the device comprising: a blood monitoring device, a controller, a printed circuit board, and a flow cell;

[0007] Blood monitoring devices include at least two of the following: flow monitoring devices, blood oxygen monitoring devices, pressure monitoring devices, and temperature monitoring devices; blood monitoring devices are used to monitor blood parameters.

[0008] The blood monitoring device and controller are integrated on a printed circuit board. The flow cell includes an outer tube and an inner tube. The printed circuit board is located between the outer tube and the inner tube of the flow cell. The inside of the inner tube is used for blood flow. The flow cell is used to connect to the blood circulation pipeline.

[0009] The controller is used to connect to the host via a serial communication line and to send the data collected by the blood monitoring device to the host.

[0010] The controller is also used to send the device's digital address to the host so that the host can determine the device's installation location based on the digital address.

[0011] In one possible implementation, where the blood monitoring device includes a pressure monitoring device, the pressure monitoring device includes a pressure sensor, a pressure plate, and a gel protective structure.

[0012] The pressure sensor is integrated inside the printed circuit board, which is the side closest to the inner tube; the pressure sensing surface of the pressure plate is in contact with the blood, and the pressure sensor is isolated from the blood by a gel protective structure.

[0013] The pressure plate is used to convert blood pressure into a mechanical signal, and the pressure sensor is used to convert the mechanical signal into a first electrical signal and send the amplified first electrical signal to the controller;

[0014] A pressure monitoring device for monitoring at least one of the following: pre-membrane pressure of blood, post-membrane pressure of blood, negative pressure drainage pressure of blood in extracorporeal membrane oxygenation mode, and mean arterial pressure of blood in extracorporeal circulation mode.

[0015] In one possible implementation, where the blood monitoring device includes a temperature monitoring device, the temperature monitoring device includes a temperature sensor;

[0016] The temperature sensor is integrated inside the printed circuit board, which is the side closest to the inner tube.

[0017] The temperature sensor is used to convert the infrared radiation signal of the blood into a fifth electrical signal and send the fifth electrical signal to the controller;

[0018] Temperature monitoring devices are used to monitor at least one of the venous temperature and the arterial temperature of blood.

[0019] In one possible implementation, where the blood monitoring device includes a flow monitoring device, the flow monitoring device includes a first ultrasonic transducer and a second ultrasonic transducer.

[0020] The first and second ultrasonic transducers are connected to the printed circuit board via connectors integrated on the printed circuit board. The first and second ultrasonic transducers are attached to the outside of the outer tube at a preset angle and are symmetrically distributed with the axis of the inner tube as the center.

[0021] The first ultrasonic transducer is used to convert the second electrical signal from the controller into an ultrasonic signal and send the ultrasonic signal to the second ultrasonic transducer; the second ultrasonic transducer is used to convert the ultrasonic signal passing through the blood into a third electrical signal and send the third electrical signal to the controller.

[0022] A flow monitoring device for monitoring at least one of blood flow and air bubbles in a tubing.

[0023] In one possible implementation, where the blood monitoring device includes a blood oxygen monitoring device, the blood oxygen monitoring device includes a transmitter and a blood oxygen sensor;

[0024] The transmitter and blood oxygen sensor are integrated on the inside of the printed circuit board, which is the side closest to the inner tube.

[0025] The transmitter is used to emit light signals, and the blood oxygen sensor is used to convert the light signals passing through the blood into a fourth electrical signal, and send the fourth electrical signal to the controller.

[0026] The blood oxygen monitoring device is used to monitor at least one of the following: venous blood oxygen saturation, arterial blood oxygen saturation, hematocrit, and hemoglobin.

[0027] The extracorporeal circulation blood multi-parameter monitoring device provided in this application integrates at least two of the following devices—flow monitoring, blood oxygen monitoring, pressure monitoring, and temperature monitoring—on a printed circuit board. The controller connects to the host computer via a serial communication line, allowing multiple monitoring devices to transmit monitoring data to the host computer through the same line. This simplifies the device's structure, significantly reducing the number of tubing lines and mitigating the risks associated with tubing failures. Furthermore, the printed circuit board is positioned between the outer and inner tubes of the flow cell, ensuring that the sensors in the monitoring devices do not directly contact the blood inside the inner tube, thus preventing interference with blood flow. This reduces the probability of monitoring device failure and ensures patient safety. Additionally, the host computer can determine the installation location of the monitoring devices based on digital addresses. Therefore, when multiple monitoring devices are used simultaneously, there is no need to distinguish signal paths, enhancing usability and improving operational efficiency. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of a multi-parameter monitoring system for extracorporeal blood circulation in related technologies;

[0029] Figure 2 A schematic diagram of an extracorporeal circulation blood multi-parameter monitoring device provided in an embodiment of this application;

[0030] Figure 3 A schematic diagram of an extracorporeal circulation blood multi-parameter monitoring system provided in an embodiment of this application;

[0031] Figure 4 A schematic diagram of a pressure monitoring device provided in an embodiment of this application;

[0032] Figure 5 A schematic diagram of a temperature monitoring device provided in an embodiment of this application;

[0033] Figure 6 A schematic diagram of a flow monitoring device provided in an embodiment of this application;

[0034] Figure 7 A schematic diagram of a blood oxygen monitoring device provided in an embodiment of this application;

[0035] Figure 8 A flowchart of an extracorporeal circulation blood monitoring method provided in an embodiment of this application. Detailed Implementation

[0036] To make the above-mentioned objectives, features and advantages of this application more apparent and understandable, the embodiments of this application will be further described in detail below with reference to the accompanying drawings and specific implementation methods.

[0037] In related technologies, extracorporeal circulation blood multi-parameter monitoring systems typically employ multiple sensors that are distributed within the extracorporeal circulation system via clamping or intrusion methods. Each sensor is connected to the main unit through corresponding tubing and signal cables. Specifically, for pressure sensors, three or more pressure sensors are usually required to monitor simultaneously, and each pressure sensor requires a pressure bag, saline bag, independent tubing, and signal cables.

[0038] See Figure 1 The figure is a schematic diagram of a multi-parameter monitoring system for extracorporeal blood circulation in the related technology.

[0039] Figure 1 The monitoring system shown includes a first pressure sensor P1, a second pressure sensor P2, and a third pressure sensor P3. Each pressure sensor is connected to the blood circulation pipeline. Each pressure sensor is connected to the heparin saline bag D1 and the pressurization device D2 through the corresponding fluid pipeline, and sends the collected electrical signals to the host through the corresponding electrical signal cable. Figure 1 Other sensors in the system include a flow bubble sensor T1, a venous temperature sensor T2, a venous blood oxygen sensor T3, an arterial temperature sensor T4, and an arterial blood oxygen sensor T5, and each sensor is connected to the host via a corresponding electrical signal cable.

[0040] Figure 1 In the monitoring system shown, when multiple parameters need to be measured, the use of different types of sensors results in a large number of pipelines, which can easily lead to blockages, knots, or leaks during use. Furthermore, the construction and maintenance of these pipelines require distinguishing the correspondence between different pipeline locations and signal cables, increasing the complexity of operation. Moreover, the pressure sensor's fluid lines require pre-filling with saline solution, resulting in a prolonged preparation time for the overall extracorporeal circulation system and extending the patient's resuscitation time.

[0041] Furthermore, some existing monitoring devices, such as temperature monitoring devices, employ invasive designs, directly monitoring the blood inside the blood tubing. This means the monitoring device comes into direct contact with the blood, placing high demands on its manufacturing process. In addition, interference with blood flow by the monitoring device could not only lead to malfunctions in the extracorporeal circulation system but also pose health risks to the patient.

[0042] To reduce the complexity of the monitoring system, decrease the number of pipelines, and improve the reliability and ease of use of the monitoring system, this application proposes a multi-parameter monitoring device for extracorporeal blood circulation.

[0043] See Figure 2 The figure is a schematic diagram of an extracorporeal circulation blood multi-parameter monitoring device provided in an embodiment of this application.

[0044] Figure 2 The extracorporeal circulation blood multi-parameter monitoring device shown includes a blood monitoring device, a controller 200, a printed circuit board 300, and a flow cell 400.

[0045] The blood monitoring device includes at least two of the following: a flow monitoring device 101, a blood oxygen monitoring device 102, a pressure monitoring device 103, and a temperature monitoring device 104. To enable those skilled in the art to better understand the structure of the blood monitoring device, Figure 2 The following description uses a blood monitoring device that simultaneously includes a flow monitoring device 101, a blood oxygen monitoring device 102, a pressure monitoring device 103, and a temperature monitoring device 104 as an example. The blood monitoring device is used to monitor blood parameters.

[0046] The blood monitoring device and controller 200 are integrated on a printed circuit board 300, which is disposed between the outer tube To and the inner tube Ti of the flow cell 400, with the inner tube Ti used for blood flow. The flow cell 400 is connected to the blood circulation tubing. In one possible implementation, the flow cell 400 can employ a quick-connect or seamless integrated design to reduce the risk of leakage between the blood circulation tubing and the flow cell 400.

[0047] The controller 200 is used to connect to the host computer via a serial communication line to send the data collected by the blood monitoring device 100 to the host computer. This application does not specifically limit the type of serial communication line. For example, in this embodiment, the controller 200 can connect to an RS485 transceiver driver chip via a USART2 interface to transmit processed blood oxygenation data and other blood parameters to the host computer via an RS485 bus, thus achieving communication with the host computer. One possible implementation is to convert a 5V power supply to 3.3V via a linearly regulated power supply to power the controller 200.

[0048] The controller 200 is also used to send the digital address of the monitoring device to the host, so that the host can determine the installation location of the monitoring device based on the digital address. Specifically, the controller 200 may include a digital address, and there is a mapping relationship between the digital address and the installation location of the monitoring device, so that the host can determine the installation location of the monitoring device (e.g., "front end of blood pump", "back end of oxygenator", "between blood pump and oxygenator", etc.) based on the digital address of the monitoring device. Since the host can determine the installation location of the monitoring device based on the digital address, the operator does not need to distinguish the signal path when multiple monitoring devices are used simultaneously.

[0049] See Figure 3 The figure is a schematic diagram of an extracorporeal circulation blood multi-parameter monitoring system provided in an embodiment of this application.

[0050] Figure 3 The monitoring system shown includes three monitoring devices: a first monitoring device 10, a second monitoring device 20, and a third monitoring device 30. The first monitoring device 10 is located in the blood circulation pipeline at the first end of the blood pump 40, the second monitoring device 20 is located in the blood circulation pipeline between the second end of the blood pump 40 and the first end of the oxygenator 50, and the third monitoring device 30 is located in the blood circulation pipeline at the second end of the oxygenator 50.

[0051] The host's serial communication line is divided into three lines to connect the first monitoring device 10, the second monitoring device 20, and the third monitoring device 30. Since the first monitoring device 10, the second monitoring device 20, and the third monitoring device 30 correspond to different digital addresses, there is no need to distinguish the correspondence between the serial communication line and the monitoring device. The three serial communication lines can be connected to the three monitoring devices arbitrarily, thereby further reducing the number of communication cables and making the monitoring system simpler.

[0052] This application does not specifically limit the type of numeric address. The numeric address can be an 8-bit binary code, a 16-bit binary code, or an ASCII code, etc.

[0053] The extracorporeal circulation blood multi-parameter monitoring device provided in this application integrates at least two of the following devices—flow monitoring, blood oxygen monitoring, pressure monitoring, and temperature monitoring—on a printed circuit board. The controller connects to the host computer via a serial communication line, allowing multiple monitoring devices to transmit monitoring data to the host computer through the same line. This results in a simple device structure, significantly reducing the number of tubing lines and mitigating the risks associated with tubing failures. Furthermore, the printed circuit board is positioned between the outer and inner tubing of the blood circulation system, ensuring that the sensors in the monitoring devices do not directly contact the blood inside the inner tubing, thus preventing interference with blood flow. This reduces the probability of monitoring device failure and ensures patient safety. Additionally, the host computer can determine the installation location of the monitoring devices based on digital addresses. Therefore, when multiple monitoring devices are used simultaneously, there is no need to distinguish signal paths, enhancing usability and improving operational efficiency.

[0054] To enable those skilled in the art to fully understand the monitoring principle of the monitoring device provided in the embodiments of this application, the monitoring devices in the monitoring device will be further described below.

[0055] See Figure 4 The figure is a schematic diagram of a pressure monitoring device provided in an embodiment of this application.

[0056] The pressure monitoring device 103 includes a pressure sensor 1031, a pressure plate 1032, and a gel protective structure 1033.

[0057] The pressure sensor 1031 is integrated on the inside of a printed circuit board, with the inside of the circuit board being the side closest to the inner tube Ti. The pressure sensing surface of the pressure plate 1032 is in contact with the blood, while the pressure sensor 1031 is isolated from the blood by a gel protective structure 1033. The pressure plate 1032 is used to convert the blood pressure into a mechanical signal, and the pressure sensor 1031 is used to convert the mechanical signal into a first electrical signal and send the amplified first electrical signal to the controller.

[0058] The pressure monitoring device 103 is used to monitor at least one of the following: pre-membrane pressure of blood, post-membrane pressure of blood, negative pressure drainage pressure of blood in extracorporeal membrane oxygenation mode, and mean arterial pressure of blood in extracorporeal circulation mode.

[0059] Specifically, the pressure sensing surface of the pressure plate 1032 deforms due to the pressure of the blood, generating a mechanical signal. The pressure sensing surface of the pressure plate 1032 comes into contact with the blood, enabling precise measurement of blood pressure.

[0060] The pressure sensor 1031 converts the mechanical signal into a first electrical signal, amplifies and calibrates the first electrical signal, and sends the amplified and calibrated first electrical signal to the controller. The first electrical signal is proportional to the pressure, and the controller can determine the blood pressure at the location of the pressure monitoring device 103 based on the magnitude of the first electrical signal. The pressure sensor 1031 is isolated from the blood by a gel protective structure 1033, which protects the pressure sensor 1031 from blood corrosion.

[0061] In one possible implementation, the magnitude of the first electrical signal varies depending on the magnitude of the pressure sensor input voltage. For example, if the input voltage is 5V, the magnitude of the first electrical signal = input voltage * 5uV / V / mmHg = 25mV.

[0062] In one possible implementation, the pressure sensor can be integrated with the temperature compensation circuit and the gel protection structure into the same small package, for example, the package size can be 4.85mm*4.85mm.

[0063] The monitoring device provided in this application, when including a pressure monitoring device, comprises a pressure sensor, a pressure plate, and a gel protective structure. The pressure sensing surface of the pressure plate is in contact with blood, enabling accurate measurement of blood pressure; the pressure sensor is isolated from blood by the gel protective structure, protecting it from blood corrosion. The pressure monitoring device is used to monitor at least one of the following: pre-membrane pressure of blood, post-membrane pressure of blood, negative pressure drainage pressure of blood in extracorporeal membrane oxygenation (ECMO) mode, and mean arterial pressure of blood in extracorporeal circulation mode.

[0064] See Figure 5 The figure is a schematic diagram of a temperature monitoring device provided in an embodiment of this application.

[0065] Temperature monitoring device 104 includes temperature sensor 1041. Temperature sensor 1041 is integrated on the inside of a printed circuit board and is used to convert the infrared radiation signal of blood into a fifth electrical signal and send the fifth electrical signal to controller 200.

[0066] The temperature monitoring device 104 is used to monitor at least one of the venous temperature and the arterial temperature of blood. The venous temperature is the liquid temperature at the outlet of the blood pump, used to simulate the venous blood temperature of a human body. The arterial temperature is the liquid temperature at the outlet of the oxygenator, used to simulate the arterial blood temperature of a human body.

[0067] Specifically, the temperature sensor 1041 receives infrared radiation of a specific wavelength emitted by the blood through the temperature measurement window on the inner tube Ti, converts the infrared radiation signal into a fifth electrical signal, and sends the fifth electrical signal to the controller 200.

[0068] This application does not specifically limit the communication method between the temperature sensor and the controller. One possible implementation, for example, in the embodiments of this application, is that the temperature sensor can be connected to the controller's I2C1 bus through an Inter-Integrated Circuit (IIC) interface. The controller can read the raw temperature data in the register and send the processed temperature data to the host via an RS485 bus.

[0069] The monitoring device provided in this application, when including a temperature monitoring device, comprises a temperature sensor. The temperature sensor is integrated on the inside of a printed circuit board and is used to convert infrared radiation signals of a specific wavelength from blood into electrical signals. A controller receives the electrical signals and acquires the blood temperature parameters based on the infrared radiation signals. The temperature monitoring device is used to monitor at least one of the venous temperature and the arterial temperature of blood.

[0070] See Figure 6 The figure is a schematic diagram of a flow monitoring device provided in an embodiment of this application.

[0071] The flow monitoring device 101 includes a first ultrasonic transducer 1011 and a second ultrasonic transducer 1012. The first ultrasonic transducer 1011 and the second ultrasonic transducer 1012 are connected to the printed circuit board via a connector C integrated on the printed circuit board. The first ultrasonic transducer 1011 and the second ultrasonic transducer 1012 are attached to the outside of the outer tube To at a preset tilt angle. The first ultrasonic transducer 1011 and the second ultrasonic transducer 1012 are symmetrically distributed with the axis of the inner tube Ti as the center.

[0072] The first ultrasonic transducer 1011 is used to convert the second electrical signal from the controller 200 into an ultrasonic signal and send the ultrasonic signal to the second ultrasonic transducer 1012; the second ultrasonic transducer 1012 is used to convert the ultrasonic signal passing through the blood into a third electrical signal and send the third electrical signal to the controller 200.

[0073] Specifically, the controller 200 sends an ultrasonic frequency pulse electrical signal to the first ultrasonic transducer 1011. The first ultrasonic transducer 1011 converts the received ultrasonic frequency pulse electrical signal into ultrasound waves, which are then transmitted through the blood in the inner tube to the second ultrasonic transducer 1012. The second ultrasonic transducer 1012 converts the received ultrasound waves into piezoelectric signals and sends the piezoelectric signals to the controller 200. The controller 200 amplifies the piezoelectric signals to obtain a clear and processable signal.

[0074] This application does not specifically limit the size of the preset tilt angle; an appropriate tilt angle can be set according to the actual situation.

[0075] Flow monitoring device 101 is used to monitor at least one of blood flow and air bubbles in a tubing.

[0076] In one possible implementation, the controller may include a multiplexer and a Time-to-Digital Converter (TDC) chip. The multiplexer is used to switch between different signal sources to achieve scanning at multiple measurement points. The TDC chip is used to accurately measure the time difference between the transmission time of ultrasound from the first ultrasonic transducer to the reception time of the second ultrasonic transducer, and sends the time difference data to the host computer. Based on the time difference, the controller calculates the blood flow rate in conjunction with parameters such as blood temperature, and further calculates the flow rate by combining the structural parameters of the tubing.

[0077] In one possible implementation, the controller is also used to analyze the intensity of the piezoelectric signal. Specifically, since air bubbles in the blood can alter the propagation characteristics of ultrasound, the intensity of the ultrasound signal received by the second ultrasonic transducer will fluctuate abnormally when air bubbles are present in the blood, leading to abnormal fluctuations in the intensity of the piezoelectric signal. By analyzing the signal intensity of each measurement, the controller can determine whether air bubbles are present in the pipeline and their size.

[0078] In one possible implementation, the flow monitoring device can employ a dual-beam design. For example, the flow monitoring device further includes a third and a fourth ultrasonic transducer, the mounting positions of which are the same as those of the first and second ultrasonic transducers, and will not be elaborated further here. This flow monitoring device can improve measurement accuracy while enhancing stability and reliability through redundant backup design.

[0079] The monitoring device provided in this application embodiment, when including a flow monitoring device, comprises a first ultrasonic transducer and a second ultrasonic transducer. The first and second ultrasonic transducers are symmetrically distributed along the axis of the inner tube on the outer side of the inner tube. The controller obtains the blood flow parameters based on the ultrasonic signals transmitted by the first ultrasonic transducer and the ultrasonic signals received by the second ultrasonic transducer. The flow monitoring device is used to monitor at least one of the following: blood flow rate and air bubbles in the pipeline.

[0080] See Figure 7 The figure is a schematic diagram of a blood oxygen monitoring device provided in an embodiment of this application.

[0081] The blood oxygen monitoring device 102 includes a transmitter 1021 and a blood oxygen sensor 1022, which are integrated on the inside of a printed circuit board.

[0082] The transmitter 1021 is used to transmit light signals, and the blood oxygen sensor 1022 is used to convert the light signals passing through the blood into a fourth electrical signal and send the fourth electrical signal to the controller 200.

[0083] The blood oxygen monitoring device 102 is used to monitor at least one of the following: venous blood oxygen saturation, arterial blood oxygen saturation, hematocrit, and hemoglobin. Venous blood oxygen saturation is the blood saturation before oxygenation, used to assess the oxygen-carrying status of the blood before oxygenation; arterial blood oxygen saturation is the blood saturation after oxygenation, used to assess the gas exchange efficiency of the oxygenator.

[0084] Specifically, transmitter 1021 emits light of a specific wavelength through the blood oxygen measurement window on the inner tube Ti. After reflection or transmission through the blood, the light returns to blood oxygen sensor 1022. Blood oxygen sensor 1022 converts the received specific wavelength light into a fourth electrical signal and sends the fourth electrical signal to controller 200. Because oxyhemoglobin and deoxyhemoglobin in the blood have different absorption characteristics for specific wavelength light, controller 200 can monitor blood oxygen parameters based on the specific wavelength light emitted by transmitter 1021 and the specific wavelength light received by blood oxygen sensor 1022.

[0085] One possible implementation, to ensure the modularity and maintainability of the pulse oximetry monitoring device, can employ a layered design. For example, the device may include a peripheral driver layer, a module abstraction layer, a scheduling layer, and a communication layer. The peripheral driver layer can be used for external controller settings and bus driving; the module abstraction layer can be used to manage the optical analog front-end and protocol parsing; the scheduling layer can be used to manage interrupts and task polling; and the communication layer can be used for host protocol processing. Non-high real-time tasks such as algorithm calculations and timing control can be treated as the main polling task, divided into multiple time slices for execution. User communication and optical analog front-end interrupts are set to high priority, with the first half of the interrupt responding quickly and the second half handling events registered through the main polling, balancing real-time performance and task efficiency.

[0086] This application does not specifically limit the structure of the transmitter. One possible implementation, such as in this embodiment, is that the transmitter may include an infrared LED and a constant current driving circuit. The infrared LED can be powered by a 5V cable with a shielded mesh. The constant current driving circuit includes a precision operational amplifier and a high-precision resistor. The precision operational amplifier and the high-precision resistor form a negative feedback circuit, which ensures that the driving current remains stable during each exposure, preventing fluctuations in light intensity from affecting the measurement results. The driving current of the infrared LED can be flexibly configured by the processor through a digital-to-analog converter and a multiplexer, thereby adapting to the emission requirements of different wavelengths of light.

[0087] This application does not specifically limit the structure of the blood oxygen sensor. One possible implementation, such as in the embodiments of this application, is that the blood oxygen sensor may include a photodiode. The photodiode operates in photovoltaic mode and can receive light of a specific wavelength after reflection or transmission through blood. It converts the light intensity signal into a weak current signal. This current signal is then converted into a small voltage signal by a transimpedance amplifier composed of a precision operational amplifier and resistors, and further amplified by a single-supply instrumentation amplifier. The controller's analog-to-digital converter receives the amplified voltage signal, realizing digital sampling of blood oxygen data.

[0088] The monitoring device provided in this application, when including a blood oxygen monitoring device, comprises a transmitter and a blood oxygen sensor, which are integrated on the inner side of a printed circuit board. The controller obtains blood oxygen parameters based on light of a specific wavelength emitted by the transmitter and light of a specific wavelength received by the blood oxygen sensor. The blood oxygen monitoring device monitors at least one of venous blood oxygen saturation, arterial blood oxygen saturation, hematocrit, and hemoglobin.

[0089] Based on the extracorporeal circulation monitoring device provided in the above embodiments, this application also provides an extracorporeal circulation monitoring method. The extracorporeal circulation monitoring method provided in this application is applied to the extracorporeal circulation monitoring device provided in the above embodiments.

[0090] See Figure 8 The figure is a flowchart of an extracorporeal circulation blood monitoring method provided in an embodiment of this application.

[0091] The method includes:

[0092] S801: A blood monitoring device located on a printed circuit board between the outer and inner tubes of a blood circulation pipeline monitors parameters of the blood flowing in the inner tube; the blood monitoring device includes at least two of the following: a flow monitoring device, a blood oxygen monitoring device, a pressure monitoring device, and a temperature monitoring device.

[0093] For example, the controller uses a blood monitoring device on a printed circuit board located between the outer and inner tubes of the blood circulation tubing to monitor parameters of the blood flowing in the inner tube.

[0094] S802: Sends the data collected by the blood monitoring device to the host.

[0095] For example, the controller sends the data collected by the blood monitoring device to the host computer.

[0096] S803: Sends the device's digital address to the host so that the host can determine the device's installation location based on the digital address.

[0097] For example, the controller sends the device's digital address to the host so that the host can determine the device's installation location based on the digital address.

[0098] In the above method, there is no distinction in the order of steps S802 and S803.

[0099] The extracorporeal circulation blood multi-parameter monitoring method provided in this application allows the controller to be connected to the host via a serial communication line. This enables multiple monitoring devices to send monitoring data to the host through the same serial communication line, significantly reducing the number of tubing lines and mitigating the risks associated with tubing failures. Furthermore, the host can determine the installation location of the monitoring device based on its digital address. Therefore, when multiple monitoring devices are used simultaneously, there is no need to distinguish signal paths, resulting in high usability and improved operational efficiency.

[0100] In one possible implementation, where the blood monitoring device includes a pressure monitoring device, the pressure monitoring device includes a pressure sensor, a pressure plate, and a gel protective structure; the pressure sensor is integrated inside the printed circuit board, the pressure sensing surface of the pressure plate is in contact with the blood, and the pressure sensor is isolated from the blood by the gel protective structure;

[0101] The parameters of blood flowing within the inner tube that are monitored using a blood monitoring device include:

[0102] The pressure plate converts the blood pressure into a first electrical signal, which is received and amplified by the pressure sensor; the amplified first electrical signal is then received.

[0103] The pressure monitoring device is used to monitor at least one of the following: pre-membrane pressure of blood, post-membrane pressure of blood, negative pressure drainage pressure of blood in extracorporeal membrane oxygenation mode, and mean arterial pressure of blood in extracorporeal circulation mode.

[0104] In one possible implementation, where the blood monitoring device includes a temperature monitoring device, the temperature monitoring device includes a temperature sensor; the temperature sensor is integrated on the inside of a printed circuit board, the inside of which is the side closest to the inner tube.

[0105] The parameters of blood flowing within the inner tube that are monitored using a blood monitoring device include:

[0106] The temperature sensor converts the infrared radiation signal from the blood into a fifth electrical signal; it receives the fifth electrical signal.

[0107] The temperature monitoring device is used to monitor at least one of the venous temperature and the arterial temperature of the blood.

[0108] In one possible implementation, when the blood monitoring device includes a flow monitoring device, the flow monitoring device includes a first ultrasonic transducer and a second ultrasonic transducer; the first ultrasonic transducer and the second ultrasonic transducer are connected to the printed circuit board via a connector integrated on the printed circuit board, the first ultrasonic transducer and the second ultrasonic transducer are attached to the outside of the outer tube at a preset tilt angle, and the first ultrasonic transducer and the second ultrasonic transducer are symmetrically distributed about the axis of the inner tube.

[0109] The parameters of blood flowing within the inner tube that are monitored using a blood monitoring device include:

[0110] The first ultrasonic transducer converts the second electrical signal into an ultrasonic signal and sends the ultrasonic signal to the second ultrasonic transducer; the second ultrasonic transducer converts the ultrasonic signal passing through the blood into a third electrical signal and receives the third electrical signal;

[0111] The flow rate of blood and the presence of air bubbles in the blood circulation tubing are monitored using a flow monitoring device.

[0112] In one possible implementation, when the blood monitoring device includes a blood oxygen monitoring device, the blood oxygen monitoring device includes a first transmitter and a blood oxygen sensor; the first transmitter and the blood oxygen sensor are integrated on the inside of a printed circuit board, the inside of which is the side closer to the inner tube.

[0113] The parameters of blood flowing within the inner tube that are monitored using a blood monitoring device include:

[0114] The first transmitter emits a light signal, and the blood oxygen sensor converts the light signal passing through the blood into a fourth electrical signal; it then receives the fourth electrical signal.

[0115] The blood oxygenation device is used to monitor at least one of the following: venous blood oxygen saturation, arterial blood oxygen saturation, hematocrit, and hemoglobin.

[0116] The controller provided in this application embodiment may include software to implement the control methods described above. Alternatively, the controller provided in this application embodiment may include hardware to implement the control methods described above. Or, the controller provided in this application embodiment may include both software and hardware, using a combination of software and hardware to execute the control methods described above.

[0117] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0118] The above description of the disclosed embodiments enables those skilled in the art to make or use this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A multi-parameter monitoring device for extracorporeal circulating blood, characterized in that, The device includes: a blood monitoring device, a controller, a printed circuit board, and a flow cell; The blood monitoring device includes at least two of the following: a flow monitoring device, a blood oxygen monitoring device, a pressure monitoring device, and a temperature monitoring device; the blood monitoring device is used to monitor blood parameters. The blood monitoring device and the controller are integrated on the printed circuit board. The flow cell includes an outer tube and an inner tube. The printed circuit board is disposed between the outer tube and the inner tube of the flow cell. The interior of the inner tube is used for the flow of blood. The flow cell is used to connect to a blood circulation pipeline. The controller is used to connect to the host via a serial communication line, and the controller is used to send the data collected by the blood monitoring device to the host. The controller is further configured to send the digital address of the device to the host, so that the host can determine the installation location of the device based on the digital address.

2. The apparatus according to claim 1, characterized in that, In the case where the blood monitoring device includes the pressure monitoring device, the pressure monitoring device includes a pressure sensor, a pressure plate, and a gel protective structure; The pressure sensor is integrated inside the printed circuit board, which is the side closest to the inner tube; the pressure sensing surface of the pressure plate is in contact with the blood, and the pressure sensor is isolated from the blood by the gel protective structure. The pressure plate is used to convert the pressure of the blood into a mechanical signal, and the pressure sensor is used to convert the mechanical signal into a first electrical signal and send the amplified first electrical signal to the controller; The pressure monitoring device is used to monitor at least one of the following: pre-membrane pressure of the blood, post-membrane pressure of the blood, negative pressure drainage pressure of the blood in extracorporeal membrane oxygenation mode, and mean arterial pressure of the blood in extracorporeal circulation mode.

3. The apparatus according to claim 1, characterized in that, In the case where the blood monitoring device includes the temperature monitoring device, the temperature monitoring device includes a temperature sensor; The temperature sensor is integrated on the inside of the printed circuit board, and the inside of the printed circuit board is the side closest to the inner tube. The temperature sensor is used to convert the infrared radiation signal of the blood into a fifth electrical signal and send the fifth electrical signal to the controller; The temperature monitoring device is used to monitor at least one of the venous temperature and the arterial temperature of the blood.

4. The apparatus according to claim 1, characterized in that, In the case where the blood monitoring device includes the flow monitoring device, the flow monitoring device includes a first ultrasonic transducer and a second ultrasonic transducer; The first ultrasonic transducer and the second ultrasonic transducer are connected to the printed circuit board via connectors integrated on the printed circuit board. The first ultrasonic transducer and the second ultrasonic transducer are attached to the outside of the outer tube at a preset angle. The first ultrasonic transducer and the second ultrasonic transducer are symmetrically distributed with the axis of the inner tube as the center. The first ultrasonic transducer is used to convert the second electrical signal from the controller into an ultrasonic signal and send the ultrasonic signal to the second ultrasonic transducer; the second ultrasonic transducer is used to convert the ultrasonic signal passing through the blood into a third electrical signal and send the third electrical signal to the controller. The flow monitoring device is used to monitor at least one of the blood flow rate and air bubbles in the pipeline.

5. The apparatus according to claim 1, characterized in that, In the case where the blood monitoring device includes the blood oxygen monitoring device, the blood oxygen monitoring device includes a transmitter and a blood oxygen sensor; The transmitter and the blood oxygen sensor are integrated on the inside of the printed circuit board, which is the side closest to the inner tube. The transmitter is used to transmit light signals, and the blood oxygen sensor is used to convert the light signals passing through the blood into a fourth electrical signal and send the fourth electrical signal to the controller; The blood oxygen monitoring device is used to monitor at least one of the following: venous blood oxygen saturation, arterial blood oxygen saturation, hematocrit, and hemoglobin.

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