Integrated hemodialysis and electrocardiograph monitoring all-in-one machine and using method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to an integrated hemodialysis and electrocardiograph monitoring all-in-one machine and a using method thereof.The integrated hemodialysis and electrocardiograph monitoring all-in-one machine comprises a machine body, a display screen and a controller are embedded in the machine body, and the machine body internally comprises a monitoring cavity, a dialysis cavity and an auxiliary cavity; an electrocardiogram monitoring module is arranged in the monitoring cavity, the electrocardiogram monitoring module is electrically connected with the controller, and an electrocardiogram signal collecting unit used for collecting electrocardiogram waveform signals of a patient is arranged in the monitoring cavity; a motor and a pipeline system used for blood extracorporeal circulation are arranged in the dialysis cavity, the motor is electrically connected with the controller, a control assembly used for controlling the blood flow speed during dialysis is arranged on the motor, and a power supply module is arranged in the auxiliary cavity. The electrocardiogram monitoring module is embedded into the hemodialysis machine body, the occupied space and the manufacturing cost are reduced, meanwhile, the pressure of the blood pressure cuff is controlled through the flow change of the blood pump, and the accuracy of blood pressure measurement is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an integrated hemodialysis and electrocardiogram monitoring machine and its usage method. Background Technology

[0002] Hemodialysis, commonly known as "kidney dialysis," is a treatment method that uses a machine to replace some of the kidney's functions. Its main function is to remove metabolic waste, excess water, and electrolytes that accumulate in the blood due to kidney failure in order to maintain the stability of the body's internal environment. It is a life-sustaining treatment.

[0003] During hemodialysis, the rapid and drastic changes in body fluids and electrolytes can significantly increase the burden on the heart, easily triggering acute cardiac events such as arrhythmias and myocardial ischemia. This is especially true for critically ill patients, whose cardiac function is often unstable, making them more susceptible to acute cardiac events. Therefore, in clinical practice, it is common to use a separate hemodialysis machine in conjunction with a separate electrocardiogram (ECG) monitor. For example, the Fresenius 4008 series hemodialysis machine and the Philips IntelliVue MX800 ECG monitor are used together to simultaneously perform blood purification treatment (hemodialysis) and ECG monitoring on patients.

[0004] However, while commercially available hemodialysis equipment can monitor basic parameters such as heart rate and blood volume, it generally lacks the ability to acquire and display complete electrocardiogram (ECG) waveforms. Although ECG monitoring equipment can provide standard ECGs, it cannot achieve data linkage with the dialysis process. In actual use, although real-time monitoring of the patient's heart and blood pressure with an ECG monitor can better assess the patient's condition during hemodialysis, the hemodialysis machine and the ECG monitor are two independent devices that occupy a large area in the operating room, reducing the operating space for medical staff. Furthermore, medical staff need to observe the data from both devices simultaneously during dialysis to assess the patient's condition, resulting in low operational convenience.

[0005] Therefore, this invention proposes an integrated hemodialysis and electrocardiogram monitoring device and its usage method to solve the above problems. Summary of the Invention

[0006] To address the aforementioned issues, this invention provides an integrated hemodialysis and electrocardiogram (ECG) monitoring machine. By embedding the ECG monitoring module within the hemodialysis machine, space occupancy and manufacturing costs are reduced. Simultaneously, the pressure of the blood pressure cuff is controlled by changes in the blood pump flow rate, thereby improving the accuracy of blood pressure measurement.

[0007] To achieve the above objectives, the technical solution of the present invention is as follows: An integrated hemodialysis and electrocardiogram (ECG) monitoring machine includes a body, on which a display screen and a controller are embedded. The body includes a monitoring chamber, a dialysis chamber, and an auxiliary chamber. The monitoring chamber is equipped with an ECG monitoring module, which is electrically connected to the controller. The monitoring chamber is also equipped with an ECG signal acquisition unit for acquiring ECG waveform signals from the patient. The dialysis chamber is equipped with a motor and a tubing system for supplying blood for extracorporeal circulation. The motor is electrically connected to the controller and has a control component for controlling the blood flow rate during dialysis. The auxiliary chamber is equipped with a power supply module.

[0008] The technical principle of the above solution is as follows: the ECG monitoring module collects the patient's ECG signal through the ECG signal acquisition unit and transmits it to the controller; the controller adjusts the speed of the dialysis chamber motor according to the ECG waveform signal, thereby controlling the blood pump flow; the power supply module provides a stable power supply for all electrical components (controller, motor, ECG monitoring module, etc.) to ensure the coordinated function of each chamber.

[0009] The above approach has the following beneficial effects:

[0010] 1. This solution integrates ECG monitoring and hemodialysis functions, avoiding the redundant structure of two independent devices, reducing the floor space (especially suitable for space-constrained scenarios such as ICUs and operating rooms), and lowering the overall manufacturing cost;

[0011] 2. In this solution, the controller uniformly processes ECG data and dialysis parameters (such as blood flow), and can quickly respond to changes in the patient's vital signs (such as automatically adjusting the dialysis intensity in case of arrhythmia), thereby improving treatment safety.

[0012] 3. With this solution, medical staff can monitor multi-dimensional data such as ECG, blood pressure, and blood flow through a single display screen without switching between two devices, thus improving work efficiency.

[0013] Furthermore, the ECG signal acquisition unit includes lead wires, which are electrically connected to the ECG monitoring module. The other end of the lead wires is electrically connected to several electrode pads, which are used to attach to the patient's body surface to obtain ECG waveform signals.

[0014] Beneficial effects: The electrode pads are attached to the patient's skin to collect bioelectrical signals. The leads are transmitted to the ECG monitoring module, which converts the analog signals into digital signals. The controller processes and displays the ECG waveform. The leads and electrode pads form an ECG signal acquisition circuit, transmitting the patient's surface ECG signal to the ECG monitoring module, where it is processed and displayed on the screen.

[0015] Furthermore, an air pump is fixedly installed inside the monitoring chamber, and the air pump is connected to a connecting tube. The other end of the connecting tube is connected to a blood pressure cuff, and a connecting branch tube is connected to the connecting tube. A one-way valve is installed in the connecting branch tube.

[0016] Beneficial effects: Non-invasive blood pressure measurement is achieved by inflating the blood pressure cuff with an air pump and controlling the cuff pressure with a one-way valve in the connecting tube. The one-way valve is used to maintain stable cuff pressure. When the air pump inflates, gas enters the blood pressure cuff through the connecting tube. The one-way valve in the connecting tube opens under air pressure, the cuff expands and compresses the artery. After the pressure stabilizes, the one-way valve closes to maintain cuff pressure. It integrates blood pressure measurement function, eliminating the need for an additional blood pressure monitor and enabling simultaneous monitoring of multiple parameters including ECG, blood pressure, and dialysis.

[0017] Furthermore, a pressure sensor is embedded in the blood pressure cuff, and the pressure sensor is connected to the controller signal.

[0018] Beneficial effects: The pressure sensor is embedded in the blood pressure cuff to detect changes in cuff pressure in real time and transmit the signal to the controller to calculate the blood pressure value (determining systolic and diastolic pressure through pressure fluctuations); the blood pressure data, together with ECG and blood flow data, serve as the basis for the controller to adjust dialysis parameters (such as reducing blood pump flow when there is low blood pressure).

[0019] Furthermore, the control components include a blood pump, the rotor of which is coaxially and fixedly connected to the output shaft of the motor, and the blood pump is connected to an inlet pipe and an outlet pipe.

[0020] Beneficial effects: The motor drives the blood pump to rotate through the output shaft, controlling the blood flow rate in the tubing system. The inlet and outlet tubes are connected to the patient's vascular access and the dialyzer, respectively, to achieve extracorporeal blood circulation. The motor speed is linearly related to the blood pump flow rate. The controller can precisely control the blood flow rate (e.g., 100-500 mL / min) by adjusting the motor speed to meet the dialysis needs of different patients.

[0021] Furthermore, the other end of the output pipe is connected to a T-shaped tee pipe, one side of which is connected to an outlet pipe, which is connected to the pipeline system. The top end of the T-shaped tee pipe is connected to a vertically installed connecting pipe, the bottom end of which is fixedly connected to a diaphragm, and the top of which is fixedly connected to a push rod, with the top of the push rod extending to below the valve core of the one-way valve.

[0022] Beneficial effects: When the blood pump flow rate increases, the blood pressure in the output tube rises. The increased pressure in the connecting tube at the top of the T-shaped three-way valve pushes the diaphragm upward, causing the diaphragm to move upward and the push rod to move upward. The top of the push rod extends to below the one-way valve and moves upward with the increasing blood flow until it contacts the one-way valve. It then pushes the one-way valve upward to close it, preventing the gas between the connecting tube and the blood pressure cuff from flowing to the outside. This inflates and pressurizes the blood pressure cuff, ensuring that the pressure of the blood pressure cuff on the patient's artery can block arterial blood flow when the blood flow velocity is high. This avoids interference from blood flow fluctuations during dialysis on blood pressure measurement and improves accuracy. After the blood flow stabilizes, the diaphragm pressure balances, and the diaphragm and push rod return to their original positions.

[0023] Furthermore, the piping system includes piping sections, arterial piping interfaces, venous piping interfaces, and a heparin pump. The heparin pump is signal-connected to the controller, and the arterial and venous piping interfaces are connected to the inlet and outlet pipes, respectively.

[0024] Beneficial effects: The tubing system connects to the patient's blood vessels via an arterial / venous interface. The heparin pump injects an anticoagulant (heparin) into the tubing to prevent blood from clotting during extracorporeal circulation. The controller adjusts the heparin pump injection rate according to the blood flow.

[0025] Furthermore, a flow sensor is installed within the pipeline section, and the flow sensor is connected to the controller signal.

[0026] Beneficial effects: The flow sensor is installed in the pipeline section to detect the blood flow rate in real time and transmit the signal to the controller for feedback adjustment of the blood pump speed and heparin pump dosage; real-time monitoring ensures stable blood flow (such as automatically compensating for changes in vascular access resistance during dialysis), avoiding insufficient dialysis or excessive blood dilution caused by flow fluctuations.

[0027] Furthermore, the dialysis chamber is equipped with a heater and a dehumidifier, both of which are connected to the controller signal.

[0028] Beneficial effects: The heater heats the dialysate or blood, the dehumidifier regulates the humidity of the air inside the dialysis chamber, and the controller controls the operation of both according to the set parameters (such as blood temperature 37°C) to maintain a stable dialysis environment; it prevents the return of low-temperature blood from causing hypothermia in patients (especially critically ill patients) and reduces the risk of complications such as arrhythmia.

[0029] A method for using an integrated hemodialysis and electrocardiogram monitoring device includes the following steps:

[0030] S1: Parameter initialization: Turn on the device, the controller reads the preset dialysis parameters, including target blood flow, heparin pump infusion rate, dialysate temperature, etc., and initializes monitoring components such as ECG monitoring module, flow sensor, and pressure sensor to complete device self-test;

[0031] S2: ECG signal acquisition: The electrode pads are attached to the patient's body surface, and the patient's ECG signal is transmitted to the ECG monitoring module through the lead wire. The ECG monitoring module converts the analog ECG signal into a digital signal and sends it to the controller. The controller analyzes the ECG signal in real time and identifies ECG waveform characteristics, such as heart rate and heart rhythm.

[0032] S3: Hemodialysis Start-up: The controller starts the motor and drives the blood pump to operate according to the preset target blood flow. Blood enters the tubing system through the arterial tubing interface. At the same time, the controller adjusts the injection rate of the heparin pump according to the target blood flow to inject heparin into the tubing to prevent blood clotting.

[0033] S4: Real-time monitoring and feedback: The flow sensor monitors the blood flow rate in the tubing in real time and feeds the data back to the controller. The controller adjusts the motor speed according to the flow data to ensure that the blood flow is stable within the target range; the pressure sensor detects the pressure change in the blood pressure cuff in real time, and combined with the electrocardiogram signal, the controller calculates the patient's systolic and diastolic blood pressure.

[0034] S5: Linkage Control Adjustment: The controller performs comprehensive analysis based on real-time collected electrocardiogram signals, blood pressure data, and blood flow information. When it detects that the patient has arrhythmia, abnormal blood pressure, or other conditions, it automatically adjusts the dialysis parameters.

[0035] S6: Dialysis process recording: The controller records various parameters during the dialysis process in real time, including electrocardiogram data, blood pressure value, blood flow, heparin injection volume, etc., and stores the data in the device storage module. It can also be displayed on the screen in real time for medical staff to observe.

[0036] S7: Dialysis End Processing: When the preset dialysis time is reached or the end conditions are met, the controller stops the motor, shuts off the heparin pump, and simultaneously controls the air pump to release air and loosens the blood pressure cuff; medical staff provide follow-up care to the patient, and the equipment automatically processes the dialysis data and generates a dialysis report.

[0037] Beneficial Effects: By integrating ECG monitoring and hemodialysis functions, the redundant structure of two separate devices is avoided, effectively reducing the equipment's footprint. This is particularly suitable for space-constrained environments such as ICUs and operating rooms, while also lowering overall manufacturing costs. During treatment, the controller can uniformly process ECG data and dialysis parameters. When arrhythmias or abnormal blood pressure are detected, it can quickly and automatically adjust dialysis parameters, such as reducing blood flow and adjusting the heparin pump infusion rate, responding promptly to changes in the patient's vital signs and greatly improving treatment safety. Moreover, medical staff can simultaneously monitor multiple dimensions of data, including ECG, blood pressure, and blood flow, on a single display screen, eliminating the need to switch between multiple devices, significantly improving work efficiency and enabling a more timely and comprehensive understanding of the patient's condition. In addition, the device can record various parameters during dialysis in real time and generate dialysis reports, providing detailed and accurate data support for subsequent diagnosis and treatment, further optimizing the treatment process.

[0038] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0039] Figure 1 This is an overall isometric view of an embodiment of the integrated hemodialysis and electrocardiogram monitoring device of the present invention;

[0040] Figure 2This is a front sectional view of the integrated hemodialysis and electrocardiogram monitoring device of the present invention.

[0041] Figure 3 This is a side sectional view of the integrated hemodialysis and electrocardiogram monitoring device of the present invention.

[0042] Figure 4 This is an appendix to an embodiment of the integrated hemodialysis and electrocardiogram monitoring machine of the present invention. Figure 3 Detailed drawing at point A;

[0043] Figure 5 This is a schematic diagram illustrating the usage method of an embodiment of the integrated hemodialysis and electrocardiogram monitoring machine of the present invention.

[0044] The reference numerals in the accompanying drawings of the instruction manual include: 1. Main body; 2. Display screen; 3. Monitoring chamber; 4. Dialysis chamber; 5. Auxiliary chamber; 6. ECG monitoring module; 7. Lead wire; 8. Electrode pad; 9. Air pump; 10. Connecting tube; 11. Blood pressure cuff; 12. Connecting branch tube; 13. One-way valve; 14. Blood pump; 15. Inlet tube; 16. Outlet tube; 17. T-shaped three-way tube; 18. Outlet tube; 19. Connecting tube; 20. Diaphragm; 21. Push rod; 22. Motor; 23. Output shaft. Detailed Implementation

[0045] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0046] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0047] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0048] The following detailed description illustrates the specific implementation method:

[0049] Example 1:

[0050] As attached Figure 1 As shown: An integrated hemodialysis and electrocardiogram monitoring machine includes a main body 1, on which a display screen 2 and a controller are embedded. The preferred models of the display screen and controller are Advantech and Siemens SIMATIC S7-1200, respectively. During hemodialysis, the rapid changes in body fluids and electrolytes can significantly increase the burden on the heart, which can easily induce acute cardiac events such as arrhythmia and myocardial ischemia in critically ill patients. It is usually necessary to monitor the patient's electrocardiogram at the same time as hemodialysis. However, the existing hemodialysis machine and electrocardiogram monitor are two independent devices, which occupy a large area in the operating room and reduce the operating space for medical staff. Moreover, medical staff need to observe the data of two devices at the same time during dialysis to judge the patient's condition. If there is an observation error, it may lead to untimely observation of the patient's condition.

[0051] Therefore, in order to reduce the space occupied by the equipment and facilitate observation by medical staff, as shown in the attached document... Figure 1 and attached Figure 2As shown, the machine body 1 includes a monitoring chamber 3, a dialysis chamber 4, and an auxiliary chamber 5. The monitoring chamber 3 houses an electrocardiogram (ECG) monitoring module 6, which is electrically connected to a controller. The monitoring chamber 3 also includes an ECG signal acquisition unit for collecting ECG waveform signals from the patient. This unit includes lead wires 7, which are electrically connected to the ECG monitoring module 6. The other end of each lead wire 7 is electrically connected to several electrode pads 8, which are attached to the patient's skin to acquire ECG waveform signals. These signals are processed by the controller and transmitted in real-time to the display screen 2. The dialysis chamber 4 houses a motor 22 and a tubing system for extracorporeal blood circulation. This tubing system includes tubing sections, an arterial tubing interface, a venous tubing interface, and a heparin pump. The heparin pump is signal-connected to the controller, and the motor 22 is electrically connected to the controller. The preferred model of the motor 22 is Maxon. Motor 22 is a brushless DC servo motor. Motor 22 is equipped with a control component for controlling blood flow during dialysis. The control component includes a blood pump 14, preferably a Cole-Parmer peristaltic pump. The rotor of the blood pump 14 is coaxially welded to the output shaft 23 of motor 22. The blood pump 14 is connected to an inlet pipe 15 and an outlet pipe 16, which are respectively connected to an arterial tubing interface and a venous tubing interface. An auxiliary chamber 5 contains a power supply module, and a flow sensor is installed in the tubing section. The flow sensor is preferably a Sensirion SLF3x model and is connected to the controller signal. A dialysis chamber 4 contains a heater and a dehumidifier, both connected to the controller signal. The heater and dehumidifier are preferably a Watlow heater and a Seibu Giken dehumidifier module, respectively, to maintain a stable dialysis environment, prevent hypothermia caused by cold blood reinfusion (especially in critically ill patients), and reduce the risk of complications such as arrhythmias.

[0052] The specific implementation process is as follows: During hemodialysis treatment, the drastic changes in body fluids and electrolytes in a short period of time can significantly increase the burden on the patient's heart, which can easily induce acute cardiac events such as arrhythmia and myocardial ischemia in critically ill patients. Therefore, it is necessary to monitor the patient's electrocardiogram at the same time. However, the existing hemodialysis machine and electrocardiogram monitor are two independent devices, which occupy a large area and reduce the operating space for medical staff. Moreover, medical staff have to observe the data of two devices at the same time. If there is an observation error, it may lead to an untimely judgment of the patient's condition.

[0053] To address these issues, the device incorporates a display screen 2 and a controller within its main body 1. The main body 1 houses a monitoring chamber 3, a dialysis chamber 4, and an auxiliary chamber 5. The electrocardiogram (ECG) monitoring module 6 within the monitoring chamber 3 is electrically connected to the controller. Electrode pads 8 on the ECG monitoring module 6 are attached to the patient's skin to collect the patient's electrocardiogram (ECG) bioelectrical signals. These signals are then transmitted to the ECG monitoring module 6 via lead wires 7, which act as signal conduction lines. The ECG monitoring module 6 converts the received analog signals into digital signals, which are then transmitted to the controller for processing. The processed results are ultimately displayed on the display screen 2, allowing medical staff to monitor the patient's ECG status in real time without the need for a separate ECG monitor. This integration of ECG monitoring and hemodialysis functions reduces the number of devices required, saving space. Furthermore, medical staff can view ECG data on a single display screen 2, improving work efficiency.

[0054] The motor 22 inside the dialysis chamber 4 is electrically connected to the controller. The output shaft 23 of the motor 22 is coaxially welded to the rotor of the blood pump 14. When the motor 22 rotates, the output shaft 23 of the motor 22 rotates, driving the rotor of the blood pump 14 to rotate. Through the design of the blood pump 14 (peristaltic pump): a section of elastic pump tubing with a specific inner diameter and wall thickness is tightly clamped in a fixed pump slot. When the rotor with two or three rollers rotates, the rollers sequentially squeeze the pump tubing, forming a forward-moving "closed chamber." Since the size of the pump tubing and the geometric position of the rollers are fixed, the volume of this "closed chamber," that is, the volume of blood pushed by the pump per revolution, is a constant value. Based on this... Based on the principle of "constant blood volume per revolution", a direct and linear control relationship is established between the speed of motor 22 and blood flow (blood flow = blood volume per revolution × speed). When motor 22 rotates, it drives blood pump 14 to rotate through output shaft 23, thereby controlling the flow rate of blood in the tubing section and realizing extracorporeal blood circulation. The controller precisely controls the blood flow by adjusting the speed of motor 22 to meet the dialysis needs of different patients. For example, the blood flow can be controlled within the range of 100-500 mL / min according to the patient's condition. Because the speed of motor 22 and the flow of blood pump 14 are linearly related, adjusting the speed of motor 22 can accurately change the flow of blood pump 14.

[0055] The arterial and venous tubing interfaces in the tubing system are used to connect to the patient's blood vessels. The heparin pump is connected to the controller via a signal connection. The controller adjusts the injection rate of the heparin pump according to the blood flow to inject the anticoagulant heparin into the tubing, preventing blood from clotting during extracorporeal circulation and ensuring the smooth progress of the dialysis process. The flow sensor in the tubing section detects the blood flow rate in real time and transmits the signal to the controller. The controller further adjusts the speed of motor 22 based on the flow signal to keep the blood flow stable. For example, when the blood flow fluctuates due to changes in vascular access resistance during dialysis, the flow sensor detects the change and transmits it to the controller. The controller then adjusts the speed of motor 22 to restore the blood pump 14 flow to the set value, avoiding insufficient dialysis or excessive blood dilution caused by flow fluctuations.

[0056] The heater and dehumidifier in dialysis chamber 4 are both connected to the controller signal. The heater is used to heat the dialysate or blood to prevent low-temperature blood from being reinfused and causing the patient's body temperature to drop too low. This is especially important for critically ill patients and can reduce the risk of complications such as arrhythmia. The dehumidifier regulates the air humidity in dialysis chamber 4 to maintain a stable dialysis environment and provide a suitable treatment environment for the patient.

[0057] The power supply module in the auxiliary chamber 5 provides a stable power supply to all electrical components in the main body 1, such as the controller, motor 22, and electrocardiogram monitoring module 6, ensuring that the functions of each chamber can work together and guaranteeing the normal operation of the equipment. These structures work together to not only integrate hemodialysis and electrocardiogram monitoring, but also facilitate operation by medical staff.

[0058] A comparative experiment was conducted based on the integrated hemodialysis and electrocardiogram monitoring system of Example 1 and a conventional combination of separate hemodialysis equipment and electrocardiogram monitor. The specific experiment is as follows:

[0059] Experimental Objective: To compare the performance differences between the integrated hemodialysis and ECG monitoring system described in Example 1 and a conventional separate hemodialysis device combined with an ECG monitor. The focus is on evaluating the advantages of the integrated system in terms of space utilization, manufacturing cost, ease of operation, accuracy of blood pressure measurement, ECG monitoring response time, and blood flow control precision, in order to verify its clinical applicability and economic benefits.

[0060] Experimental steps:

[0061] 1. Experimental setup:

[0062] Experimental group: The integrated hemodialysis and electrocardiogram monitoring machine of Example 1 was used.

[0063] Control group: A combination of a mainstream stand-alone hemodialysis machine (with basic heart rate and blood pressure monitoring functions) and a standard multi-parameter electrocardiogram monitor was used to simulate real clinical use scenarios.

[0064] Experimental environment: Simulate an ICU or operating room setting, using the same mannequin patient (human model) for hemodialysis and electrocardiogram monitoring to ensure consistent environmental conditions.

[0065] 2. Parameter Measurement:

[0066] Space occupied: The total floor area of ​​the measuring equipment (including operating space).

[0067] Manufacturing costs: Costs are estimated based on market research and equipment components.

[0068] Blood pressure measurement accuracy: Measurement error value compared with a standard non-invasive blood pressure monitor (after calibration).

[0069] Blood flow control accuracy: The deviation between the actual measured value and the target value when the target blood flow rate is set (e.g., 200 mL / min).

[0070] Each parameter was measured 10 times and the average value was taken to reduce random error.

[0071] 3. Data Recording:

[0072] All data is recorded by independent observers to ensure objectivity.

[0073] Experimental data:

[0074]

[0075] Experimental conclusion:

[0076] Experimental results show that the integrated hemodialysis and ECG monitoring system is superior to traditional equipment combinations in several aspects. The integrated system significantly reduces space requirements and manufacturing costs, avoids the use of two separate dedicated medical devices, and reduces operational complexity and space occupation caused by device dispersion. In terms of performance, the integrated system achieves a more accurate blood pressure measurement with a smaller error range and higher blood flow control precision through an integrated control mechanism. These advantages stem from the modular design of the integrated system and the controller's ability to collaboratively process ECG, blood pressure, and dialysis parameters, reducing interference between devices and improving the work efficiency of medical staff and the safety of patient treatment. Therefore, the integrated system is more suitable for clinical environments with limited space and high efficiency requirements, such as ICUs and operating rooms.

[0077] Example 2:

[0078] As attached Figure 2 and attached Figure 3As shown, the difference from Embodiment 1 is that, because hemodialysis patients experience significant blood pressure changes during dialysis due to blood being expelled from the body, they are prone to hypertension or hypotension. Therefore, real-time monitoring is necessary to ensure the stability of the patient's blood pressure. An air pump 9 is welded into the monitoring chamber 3, and the air pump 9 is connected to a connecting pipe 10. The other end of the connecting pipe 10 is connected to a blood pressure cuff 11. A connecting branch pipe 12 is connected to the connecting pipe 10, and a one-way valve 13 is installed in the connecting branch pipe 12. A pressure sensor is embedded in the blood pressure cuff 11, preferably a TE Connectivity model. The MEMS pressure sensor is connected to the controller signal and monitors the patient's blood pressure through the blood pressure cuff 11. Based on pressure fluctuations, the systolic and diastolic blood pressures are calculated. The other end of the output tube 16 is connected to a T-shaped tee tube 17. One end of the T-shaped tee tube 17 is connected to an outlet tube 18, which is connected to the piping system. The top end of the T-shaped tee tube 17 is connected to a vertically positioned connecting tube 19. A diaphragm 20, made of silicone, is sealed and fixedly connected to the bottom of the connecting tube 19. The top of the diaphragm 20 is secured with adhesive. A push rod 21, coaxially arranged with the connecting tube 19, is fixedly connected by adhesive. The top end of the push rod 21 extends outside the connecting tube 19 and passes through the top wall of the dialysis chamber 4 and the bottom wall of the connecting branch tube 12. The top end of the push rod 21 extends below the one-way valve 13 and below the valve core of the one-way valve 13. The push rod 21 pushes the one-way valve 13 upward, keeping the blood pressure cuff in an inflated state to block arterial blood flow, thereby improving the accuracy of blood pressure measurement. The surface of the push rod 21 and the inner wall of the connecting tube 19 are both coated with polytetrafluoroethylene to reduce the movement resistance of the push rod 21.

[0079] The specific implementation process is as follows: During hemodialysis, the blood is circulated outside the body, causing significant changes in blood pressure, which can easily lead to hypertension or hypotension. To monitor and stabilize the patient's blood pressure in real time, when hemodialysis begins, motor 22 drives blood pump 14 to rotate. Blood enters blood pump 14 from inlet pipe 15, and is then transported by blood pump 14 to T-shaped three-way tube 17 through outlet pipe 16. At this time, the blood enters the tubing system through outlet pipe 18 to participate in the dialysis cycle. As the flow rate of blood pump 14 changes, the blood pressure in T-shaped three-way tube 17 changes. When blood flow increases, the blood exerts greater pressure on the diaphragm 20 at the bottom of the connecting tube 19. The diaphragm 20 arches upward, causing the push rod 21 to move upward. Since the top of the push rod 21 is located within the movement trajectory of the one-way valve 13, the upward-moving push rod 21 will push the one-way valve 13 upward, causing the one-way valve 13 to close. The air pump 9 inflates the blood pressure cuff 11 through the connecting tube 10. The blood pressure cuff 11 expands and compresses the patient's artery. At the same time, the pressure sensor on the blood pressure cuff detects the change in cuff pressure in real time and transmits the signal to the controller. The controller calculates the systolic and diastolic blood pressure based on the pressure fluctuations.

[0080] When blood flow stabilizes or decreases, the pressure on diaphragm 20 decreases, and push rod 21 resets under its own weight and the elasticity of diaphragm 20. One-way valve 13 opens to reduce the pressure inside blood pressure cuff 11, preventing excessive pressure from continuously squeezing the patient's arm. This design automatically controls the inflation process of blood pressure cuff 11 through changes in blood pump 14 flow, achieving coordination between blood pressure measurement and hemodialysis. Pressure sensor feeds blood pressure data back to controller. Controller combines ECG data collected by ECG monitoring module 6 with blood flow data detected by flow sensor in pipeline system to comprehensively assess the patient's condition. If abnormal blood pressure occurs, the speed of motor 22 can be adjusted to change the flow of blood pump 14, thereby adjusting the dialysis intensity and ensuring the patient's safety during dialysis. At the same time, it facilitates real-time monitoring of various data by medical staff, improving work efficiency.

[0081] Example 3:

[0082] As attached Figure 5 As shown, a method for using an integrated hemodialysis and electrocardiogram monitoring machine includes the following steps:

[0083] S1: Parameter initialization: Turn on the device, the controller reads the preset dialysis parameters, including target blood flow, heparin pump infusion rate, dialysate temperature, etc., and initializes monitoring components such as ECG monitoring module 6, flow sensor, and pressure sensor to complete the device self-test;

[0084] S2: ECG signal acquisition: The electrode pads 8 are attached to the patient's body surface, and the patient's ECG signal is transmitted to the ECG monitoring module 6 through the lead wire 7. The ECG monitoring module 6 converts the analog ECG signal into a digital signal and sends it to the controller. The controller analyzes the ECG signal in real time and identifies ECG waveform characteristics, such as heart rate and heart rhythm.

[0085] S3: Hemodialysis Start-up: The controller controls the motor 22 to start, driving the blood pump 14 to operate according to the preset target blood flow. Blood enters the tubing system through the arterial tubing interface. At the same time, the controller adjusts the injection rate of the heparin pump according to the target blood flow to inject heparin into the tubing to prevent blood clotting.

[0086] S4: Real-time monitoring and feedback: The flow sensor monitors the blood flow rate in the tubing in real time and feeds the data back to the controller. The controller adjusts the speed of motor 22 according to the flow data to ensure that the blood flow is stable within the target range; the pressure sensor detects the pressure change in the blood pressure cuff 11 in real time, and combined with the electrocardiogram signal, the controller calculates the patient's systolic and diastolic blood pressure.

[0087] When blood flow increases, the blood pressure in the output tube 16 increases, pushing the diaphragm 20 to move the push rod 21 upward, lifting the one-way valve 13, so that the blood pressure cuff 11 is kept in an inflated state, improving the accuracy of blood pressure measurement; when blood flow is stable or decreases, the push rod 21 returns to its original position, the one-way valve 13 opens, and the pressure of the blood pressure cuff 11 decreases.

[0088] S5: Linkage Control Adjustment: The controller performs comprehensive analysis based on real-time collected electrocardiogram signals, blood pressure data, and blood flow information. When it detects that the patient has arrhythmia, abnormal blood pressure, or other conditions, it automatically adjusts the dialysis parameters.

[0089] For example, when a patient experiences low blood pressure, the controller reduces the motor speed by 22, decreases blood flow, and adjusts the heparin pump infusion rate; when a patient has an abnormal heart rate, the controller issues an alarm and, according to a preset adjustment strategy, appropriately adjusts parameters such as dialysate temperature and blood flow to reduce the burden on the patient's heart.

[0090] S6: Dialysis process recording: The controller records various parameters during the dialysis process in real time, including electrocardiogram data, blood pressure value, blood flow, heparin injection volume, etc., and stores the data in the device storage module. It can also be displayed in real time on the display screen 2 for the convenience of medical staff to observe.

[0091] S7: Dialysis End Processing: When the preset dialysis time is reached or the end conditions are met, the controller controls motor 22 to stop running, shuts off the heparin pump, and simultaneously controls air pump 9 to release air and loosens blood pressure cuff 11; medical staff provide follow-up care to the patient, and the equipment automatically organizes the dialysis data and generates a dialysis report.

[0092] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An integrated hemodialysis and electrocardiogram monitoring machine, comprising a body (1), wherein a display screen (2) and a controller are embedded in the body (1), characterized in that: The body (1) includes a monitoring chamber (3), a dialysis chamber (4) and an auxiliary chamber (5). The monitoring chamber (3) is equipped with an electrocardiogram monitoring module (6), which is electrically connected to the controller. The monitoring chamber (3) is equipped with an electrocardiogram signal acquisition unit for acquiring the patient's electrocardiogram waveform signal. The dialysis chamber (4) is equipped with a motor (22) and a tubing system for supplying blood for extracorporeal circulation. The motor (22) is electrically connected to the controller. The motor (22) is equipped with a control component for controlling the blood flow rate during dialysis. The auxiliary chamber (5) is equipped with a power supply module.

2. The integrated hemodialysis and electrocardiogram monitoring device according to claim 1, characterized in that: The electrocardiogram signal acquisition unit includes a lead wire (7), which is electrically connected to the electrocardiogram monitoring module (6). The other end of the lead wire (7) is electrically connected to several electrode pads (8), which are used to attach to the patient's body surface to obtain electrocardiogram waveform signals.

3. The integrated hemodialysis and electrocardiogram monitoring device according to claim 1, characterized in that: An air pump (9) is fixedly installed inside the monitoring chamber (3). The air pump (9) is connected to a connecting pipe (10). The other end of the connecting pipe (10) is connected to a blood pressure cuff (11). A connecting branch pipe (12) is connected to the connecting pipe (10). A one-way valve (13) is installed inside the connecting branch pipe (12).

4. The integrated hemodialysis and electrocardiogram monitoring device according to claim 3, characterized in that: A pressure sensor is embedded in the blood pressure cuff (11), and the pressure sensor is connected to the controller signal.

5. The integrated hemodialysis and electrocardiogram monitoring device according to claim 4, characterized in that: The control components include a blood pump (14), the rotor of the blood pump (14) is coaxially fixedly connected to the output shaft (23) of the motor (22), and the blood pump (14) is connected to an inlet pipe (15) and an output pipe (16).

6. The integrated hemodialysis and electrocardiogram monitoring device according to claim 5, characterized in that: The other end of the output pipe (16) is connected to a T-shaped tee pipe (17). The outlet pipe (18) is connected to one side of the T-shaped tee pipe (17). The outlet pipe (18) is connected to the pipeline system. The top end of the T-shaped tee pipe (17) is connected to a vertically arranged connecting pipe (19). The bottom end of the connecting pipe (19) is fixedly connected to a diaphragm (20). The top of the diaphragm (20) is fixedly connected to a push rod (21). The top end of the push rod (21) extends to the bottom of the valve core of the one-way valve (13).

7. The integrated hemodialysis and electrocardiogram monitoring device according to claim 1, characterized in that: The piping system includes a pipe section, an arterial pipe interface, a venous pipe interface, and a heparin pump. The heparin pump is connected to the controller via a signal. The arterial pipe interface and the venous pipe interface are connected to the inlet pipe (15) and the outlet pipe (16), respectively.

8. The integrated hemodialysis and electrocardiogram monitoring device according to claim 7, characterized in that: A flow sensor is installed in the pipeline section, and the flow sensor is connected to the controller signal.

9. The integrated hemodialysis and electrocardiogram monitoring device according to claim 1, characterized in that: The dialysis chamber (4) is equipped with a heater and a dehumidifier, both of which are connected to the controller signal.

10. A method of using an integrated hemodialysis and electrocardiogram monitoring machine, operating based on the structure of the integrated hemodialysis and electrocardiogram monitoring machine according to any one of claims 1-9, characterized in that, Includes the following steps: S1: Parameter initialization: Turn on the device, the controller reads the preset dialysis parameters, including target blood flow, heparin pump injection rate, dialysate temperature, etc., and initializes the ECG monitoring module (6), flow sensor, pressure sensor and other monitoring components to complete the device self-test; S2: ECG signal acquisition: The electrode pads (8) are attached to the patient's body surface and the patient's ECG signal is transmitted to the ECG monitoring module (6) through the lead wire (7). The ECG monitoring module (6) converts the analog ECG signal into a digital signal and sends it to the controller. The controller performs real-time analysis of the ECG signal and identifies ECG waveform characteristics, such as heart rate and heart rhythm. S3: Hemodialysis start: The controller controls the motor (22) to start, driving the blood pump (14) to operate according to the preset target blood flow. Blood enters the pipeline system through the arterial pipeline interface. At the same time, the controller adjusts the injection rate of the heparin pump according to the target blood flow to inject heparin into the pipeline to prevent blood coagulation. S4: Real-time monitoring and feedback: The flow sensor monitors the blood flow rate in the pipeline in real time and feeds the data back to the controller. The controller adjusts the speed of the motor (22) according to the flow data to ensure that the blood flow is stable within the target range; The pressure sensor detects the pressure change in the blood pressure cuff (11) in real time. Combined with the electrocardiogram signal, the controller calculates the patient's systolic and diastolic blood pressure. S5: Linkage Control Adjustment: The controller performs comprehensive analysis based on real-time collected electrocardiogram signals, blood pressure data, and blood flow information. When it detects that the patient has arrhythmia, abnormal blood pressure, or other conditions, it automatically adjusts the dialysis parameters. S6: Dialysis process recording: The controller records various parameters during the dialysis process in real time, including electrocardiogram data, blood pressure value, blood flow, heparin injection volume, etc., and stores the data in the device storage module. At the same time, it can be displayed in real time on the display screen (2) for the convenience of medical staff to observe. S7: Dialysis End Processing: When the preset dialysis time is reached or the end conditions are met, the controller controls the motor (22) to stop running, shuts off the heparin pump, and simultaneously controls the air pump (9) to release air and loosens the blood pressure cuff (11); medical staff provide follow-up care to the patient, and the equipment automatically organizes the dialysis data and generates a dialysis report.

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