Self-checking method for hemodialysis apparatus, hemodialysis apparatus, and storage medium

Abstract

The application discloses a self-checking method of a hemodialysis device, the hemodialysis device and a storage medium. The method comprises the following steps: in a self-checking stage, inserting an arterial puncture needle into a first liquid storage bag containing sterilizing liquid, inserting a venous puncture needle into a second liquid storage bag, enabling the sterilizing liquid to pass through the arterial puncture needle, an arterial pipeline, a dialyzer, a venous pipeline, the venous puncture needle and the second liquid storage bag in sequence, and storing the sterilizing liquid in the second liquid storage bag; acquiring a first detection temperature and a second detection temperature of the sterilizing liquid in the first liquid storage bag and the second liquid storage bag respectively; activating a first heater when an absolute value of a temperature difference between the first detection temperature and the second detection temperature is greater than a preset temperature value, and activating a second heater when the absolute value of the temperature difference is less than or equal to the preset temperature value. In this way, the application can determine a heating mode problem of the hemodialysis device in the self-checking stage.

Description

Technical Field

[0001] This application relates to the field of hemodialysis technology, and in particular to a self-testing method for hemodialysis equipment, a hemodialysis equipment, and a storage medium. Background Technology

[0002] When hemodialysis equipment is in the self-test phase, operators spend a significant amount of time performing this test. This self-test phase often fails to identify solutions to persistent safety issues affecting blood purification treatment, such as the heating method setting: should the heater be placed on the intravenous line or the dialysate inlet line during hemodialysis? The inability of relevant technologies to resolve the heating method setting issue during the self-test phase reduces the safety of patients undergoing hemodialysis treatment. Summary of the Invention

[0003] Based on this, embodiments of this application provide a self-testing method for a hemodialysis device, a hemodialysis device, and a storage medium, which can determine the heating method of the hemodialysis device during the self-testing stage.

[0004] In a first aspect, this application provides a self-testing method for a hemodialysis device, the hemodialysis device comprising: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater; an intermediate membrane is disposed in the middle of the balance chamber, the intermediate membrane dividing the balance chamber into a dialysis side and a waste liquid side; the first end of the arterial tubing is fitted with the arterial puncture needle, the second end of the arterial tubing is connected to the blood inlet of the dialyzer, and the first end of the venous tubing is fitted with the venous puncture needle. The second end of the venous tubing is connected to the blood output end of the dialyzer; the first end of the dialysate inlet tubing is connected to the dialysis side outlet of the balance chamber; the second end of the dialysate inlet tubing is connected to the dialysate inlet end of the dialyzer; the first end of the waste liquid outlet tubing is connected to the waste liquid side inlet of the balance chamber; the second end of the waste liquid outlet tubing is connected to the waste liquid output end of the dialyzer; the first inlet pipe is connected to the dialysis side inlet of the balance chamber; the first outlet pipe is connected to the waste liquid side outlet of the balance chamber; the first heater is disposed in the venous tubing; and the second heater is disposed in the dialysate inlet tubing. The method includes:

[0005] When the hemodialysis device enters the self-test stage, the arterial puncture needle is inserted into the first liquid storage bag containing disinfectant, and the venous puncture needle is inserted into the second liquid storage bag, so that the disinfectant can pass through the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, the venous puncture needle and the second liquid storage bag in sequence, and the disinfectant is stored in the second liquid storage bag;

[0006] The first and second detection temperatures of the disinfectant in the first liquid storage bag and the second liquid storage bag are obtained respectively.

[0007] The first heater is activated when the absolute value of the temperature difference between the first and second detection temperatures is greater than a preset temperature value, and the second heater is activated when the absolute value of the temperature difference is less than or equal to the preset temperature value.

[0008] Secondly, this application provides a hemodialysis device, comprising: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater; an intermediate membrane is disposed in the middle of the balance chamber, the intermediate membrane dividing the balance chamber into a dialysis side and a waste liquid side; the first end of the arterial tubing is fitted with the arterial puncture needle, the second end of the arterial tubing is connected to the blood inlet end of the dialyzer, the first end of the venous tubing is fitted with the venous puncture needle, the second end of the venous tubing is connected to the blood outlet end of the dialyzer, and the first end of the dialysate inlet tube is connected to the balance chamber; The hemodialysis device includes an outlet on the dialysis side of the balance chamber, a second end of the dialysate inlet pipe connected to the dialysate inlet of the dialyzer, a first end of the waste liquid outlet pipe connected to the waste liquid inlet on the waste liquid side of the balance chamber, a second end of the waste liquid outlet pipe connected to the waste liquid outlet of the dialyzer, a first inlet pipe connected to the dialysis side inlet of the balance chamber, a first outlet pipe connected to the waste liquid side outlet of the balance chamber, a first heater disposed in the venous line, and a second heater disposed in the dialysate inlet pipe. The hemodialysis device further includes a memory and a processor. The memory stores a computer program, and the processor executes the computer program and, during execution, implements the self-testing method for the hemodialysis device as described above.

[0009] Thirdly, this application provides a computer-readable storage medium storing a computer program that, when executed by a processor, causes the processor to implement the self-testing method for a hemodialysis device as described above.

[0010] This application provides a self-testing method for a hemodialysis device, the hemodialysis device itself, and a storage medium. During the self-testing phase, after disinfecting all components of the hemodialysis device with a disinfectant, the disinfectant is stored in a second liquid storage bag. The absolute value of the temperature difference between the first and second detection temperatures of the first and second liquid storage bags determines whether to activate the heater installed on the venous line or the heater installed on the dialysate inlet line. This embodiment allows setting the heating mode for the patient's hemodialysis treatment during the self-testing phase. The heated blood meets the patient's safe blood temperature requirements, greatly improving the safety of hemodialysis treatment. Therefore, the self-testing method in this embodiment solves the problem of users not knowing how to set the heating mode of the hemodialysis device. It completes both disinfection of the hemodialysis device and selection of the heating mode during the self-testing phase, demonstrating higher compatibility and wider applicability. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the hemodialysis device of this application;

[0012] Figure 2 This is a schematic diagram of the hemodialysis tubing in one embodiment of the hemodialysis device of this application;

[0013] Figure 3 This is a schematic diagram of the dialyzer structure of one embodiment of the hemodialysis device of this application;

[0014] Figure 4 This is a flowchart illustrating an embodiment of the self-testing method for a hemodialysis device according to this application;

[0015] Figure 5 This is a schematic diagram of the balance chamber of an embodiment of the hemodialysis device of this application;

[0016] Figure 6 This is a schematic diagram of the first and second change curves shown in an embodiment of the self-testing method for the hemodialysis device of this application;

[0017] Figure 7 This is a schematic diagram of the third change curve when there is no liquid flow failure in the dialyzer, as shown in one embodiment of the self-testing method for the hemodialysis device of this application.

[0018] Figure 8 This is a schematic diagram of the third change curve when a liquid flow failure occurs in the dialyzer, as shown in one embodiment of the self-testing method for the hemodialysis device of this application. Detailed Implementation

[0019] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0020] The flowchart shown in the attached diagram is for illustrative purposes only and does not necessarily include all content and operations / steps, nor does it necessarily have to be performed in the order described. For example, some operations / steps can be broken down, combined, or partially merged, so the actual execution order may change depending on the actual situation.

[0021] In the following description, the use of suffixes such as "module," "part," or "unit" to denote elements is solely for the purpose of illustration and has no inherent meaning. Therefore, "module," "part," or "unit" may be used interchangeably.

[0022] The principle of hemodialysis is as follows: Blood is drawn from the body and passed through a dialyzer composed of numerous hollow fibers. The blood and a dialysate (electrolyte solution) containing similar concentrations to the body's own electrolytes exchange substances through diffusion, ultrafiltration, adsorption, and convection within and outside the hollow fibers. This process removes metabolic waste products, maintains electrolyte and acid-base balance, and simultaneously removes excess water. The purified blood is then returned to the patient. Hemodialysis is one of the renal replacement therapies for patients with acute and chronic renal failure. Hemodialysis equipment is an essential medical device for patients undergoing hemodialysis treatment, and the operational safety of the equipment itself is of significant practical importance to the safety of the patient's hemodialysis treatment.

[0023] Figure 1 The diagram shows the overall structure of the hemodialysis equipment. Figure 2This diagram illustrates the tubing principle of hemodialysis. The hemodialysis equipment includes a display unit, detection unit, alarm unit, pump drive unit, and fluid balance unit. In practical applications, the hemodialysis equipment undergoes several stages: power-on startup, tubing installation, self-test, hemodialysis, blood return, and power-off shutdown. During power-on startup, all components of the hemodialysis equipment are powered on, awaiting user commands. During tubing installation, the components are connected and arranged according to the tubing principle. During the self-test, the equipment checks for proper functioning of all components to identify potential safety risks. During hemodialysis, the patient's blood is used for hemodialysis treatment. During blood return, the user prepares to terminate the treatment, and all remaining blood in the tubing is returned to the patient. During power-off shutdown, all components of the hemodialysis equipment are de-energized.

[0024] When a hemodialysis device is in different stages, corresponding procedures need to be performed on it. Hemodialysis equipment can encounter various problems at different stages, with the self-test phase being particularly problematic. As a step before hemodialysis, the effectiveness of the self-test significantly impacts the safety of hemodialysis treatment. During the self-test phase, operators spend considerable time performing the checks, increasing their workload. More importantly, the self-test technology can only detect obvious faults (such as physical damage to the equipment's casing or power outages), but it cannot identify solutions to persistent safety issues in hemodialysis treatment. For example, the heating method of the hemodialysis equipment is crucial: during hemodialysis, the patient's blood flows through the extracorporeal circulation tubing, causing a drop in temperature. Heating is necessary, but the question remains: should the heater be placed on the venous line to directly heat the blood, or on the dialysate inlet line to directly heat the dialysate? This is the key issue in the hemodialysis heating method. The relevant technology does not involve the setting of heating mode during the self-testing stage of hemodialysis equipment. This leads to operators not knowing how to set the appropriate heating mode during hemodialysis, which reduces the safety and efficiency of hemodialysis treatment for patients.

[0025] This application provides a self-testing method for a hemodialysis device, the hemodialysis device itself, and a storage medium. During the self-testing phase, after disinfecting all components of the hemodialysis device with a disinfectant, the disinfectant is stored in a second liquid storage bag. The absolute value of the temperature difference between the first and second detection temperatures of the first and second liquid storage bags determines whether to activate the heater installed on the venous line or the heater installed on the dialysate inlet line. This embodiment allows setting the heating mode for the patient's hemodialysis treatment during the self-testing phase. The heated blood meets the patient's safe blood temperature requirements, greatly improving the safety of hemodialysis treatment. Therefore, the self-testing method in this embodiment solves the problem of users not knowing how to set the heating mode of the hemodialysis device. It completes both disinfection of the hemodialysis device and selection of the heating mode during the self-testing phase, demonstrating higher compatibility and wider applicability.

[0026] The embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0027] This application discloses a self-testing method for a hemodialysis device. The following will first describe the structural schematic of the dialyzer, as shown below. Figure 3 As shown, a dialyzer is a conduit and container for solute exchange between blood and dialysate. The dialyzer mainly consists of a supporting structure and hollow fibers. The hollow fibers are semi-permeable membranes, allowing only molecules smaller than the membrane pore size to pass through. The dialyzer comprises hollow fibers, an outer shell, a sealing layer, and end caps. The slender hollow fibers, made from the semi-permeable membrane, are bundled together and placed within a transparent cylindrical shell. Both sides are sealed and fixed to the shell with non-toxic medical polyurethane adhesive, with the hollow fibers opening outside the sealing layer. During hemodialysis, the patient's blood and dialysate are simultaneously introduced into the dialyzer. The blood and dialysate are distributed on the inner and outer sides of the hollow fibers, flowing in opposite directions. Through diffusion, a concentration equilibrium is achieved on both sides of the hollow fibers by utilizing the solute concentration gradient, dialysis gradient, and water pressure gradient between the inner and outer sides.

[0028] It should be noted that the main technical problem solved by the technical solution of this application embodiment is the setting of the heating method in hemodialysis equipment. There are two heating methods: a first heating method and a second heating method. The first heating method refers to placing the heater on the venous line; the second heating method refers to placing the heater on the dialysate inlet line. Clinical practice has proven that these two heating methods have different heating effects on patients during hemodialysis treatment. Related technologies do not know whether to use the first or second heating method during hemodialysis. If the operator selects the wrong method, it will not only result in poor heating of the patient's blood during hemodialysis but may also jeopardize the safety of the patient's hemodialysis treatment.

[0029] This application discloses a self-testing method for a hemodialysis device. The hemodialysis device includes: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater. An intermediate membrane is disposed in the middle of the balance chamber, dividing the chamber into a dialysis side and a waste liquid side. The first end of the arterial tubing is fitted with the arterial puncture needle, the second end of the arterial tubing is connected to the blood inlet of the dialyzer, and the first end of the venous tubing is fitted with the venous puncture needle. The venous catheter has a second end connected to the blood output end of the dialyzer, a first end connected to the dialysis side outlet of the balance chamber, a second end connected to the dialyzer's dialysis input end, a first end connected to the waste liquid output inlet of the balance chamber, a second end connected to the dialyzer's waste liquid output end, a first inlet pipe connected to the dialysis side inlet of the balance chamber, a first outlet pipe connected to the waste liquid side outlet of the balance chamber, a first heater disposed in the venous catheter, and a second heater disposed in the dialysis input catheter.

[0030] Arterial puncture needles are used to insert into the patient's artery during hemodialysis, while venous puncture needles are used to insert into the patient's vein during hemodialysis.

[0031] See Figure 4 The self-testing method for the hemodialysis device in this application embodiment includes the following steps:

[0032] Step S101: When the hemodialysis device enters the self-test stage, the arterial puncture needle is inserted into the first liquid storage bag containing disinfectant, and the venous puncture needle is inserted into the second liquid storage bag, so that the disinfectant can pass through the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, the venous puncture needle and the second liquid storage bag in sequence, and the disinfectant is stored in the second liquid storage bag.

[0033] If the hemodialysis equipment is already connected to tubing, it can directly enter the self-test stage. If the hemodialysis equipment is not connected to tubing, it needs to be connected first. When it is detected that the hemodialysis equipment is connected to tubing, the equipment is switched from the tubing connection stage to the self-test stage. When it is detected that the hemodialysis equipment is connected to tubing, the flow of fluid within the tubing of the hemodialysis equipment can be controlled.

[0034] Before the self-test phase, a first liquid storage bag stores a certain volume of disinfectant. An arterial puncture needle is inserted into the first liquid storage bag, and a blood pump installed on the arterial tubing operates. When the blood pump operates, it provides driving force to the arterial tubing, allowing the arterial puncture needle to receive the disinfectant. The disinfectant sequentially passes through the blood circuit (which includes the arterial puncture needle, arterial tubing, dialyzer, venous tubing, and venous puncture needle). The disinfectant effectively disinfects each component of the blood circuit. A second liquid storage bag stores the disinfectant that has already disinfected the blood circuit. During the self-test phase, the rate of disinfectant output from the venous tubing can be determined by the rate of increase in the weight of the disinfectant stored in the second liquid storage bag; the rate of disinfectant input into the arterial tubing can be determined by the rate of decrease in the weight of the disinfectant stored in the first liquid storage bag.

[0035] Step S102: Obtain the first detection temperature and the second detection temperature of the disinfectant in the first liquid storage bag and the second liquid storage bag, respectively.

[0036] The temperature of the disinfectant in the first liquid storage bag can be sampled periodically to obtain a first detection temperature, and the temperature of the disinfectant in the second liquid storage bag can be sampled periodically to obtain a second detection temperature.

[0037] During the self-inspection phase, the first liquid storage bag continuously outputs disinfectant through an arterial puncture needle, and the second liquid storage bag continuously receives disinfectant through a venous puncture needle; the first detection temperature represents the temperature of the disinfectant before disinfection; the second detection temperature represents the temperature of the disinfectant after disinfection.

[0038] It should be noted that the first temperature measurement is a periodically sampled value, and the second temperature measurement is a periodically sampled value.

[0039] Optionally, the blood purification device further includes: a first temperature sensor and a second temperature sensor; the first temperature sensor is disposed on a first liquid storage bag, and the second temperature sensor is disposed on a second liquid storage bag; the first temperature sensor is used to periodically sample the temperature of the disinfectant in the first liquid storage bag, for example, the temperature sampling period of the first temperature sensor is 2 seconds; the second temperature sensor is used to periodically sample the temperature of the disinfectant in the second liquid storage bag, for example, the temperature sampling period of the second temperature sensor is 2 seconds.

[0040] Step S103: When the absolute value of the temperature difference between the first detection temperature and the second detection temperature is greater than a preset temperature value, activate the first heater; when the absolute value of the temperature difference is less than or equal to the preset temperature value, activate the second heater.

[0041] It should be noted that if the first heater is activated, the second heater is not activated; if the second heater is activated, the first heater is not activated; the activated heater can heat, and the inactive heater does not heat; when the first heater is activated, the first heater can heat; when the second heater is activated, the second heater can heat.

[0042] If the first heater is activated, the liquid in the venous tubing (blood during hemodialysis and disinfectant during self-test) is heated by the first heater; if the second heater is activated, the liquid in the dialysate inlet tubing (dialysate during hemodialysis and disinfectant during self-test) is heated by the second heater.

[0043] Specifically, the absolute value of the temperature difference = |first detection temperature - second detection temperature|. This absolute value represents the degree of temperature change of the disinfectant after passing through the blood circuit. Generally, without considering the disinfectant flow rate in the blood circuit, the longer the liquid flow path in the blood circuit, the greater the degree of temperature change of the disinfectant. Conversely, the shorter the liquid flow path in the blood circuit, the smaller the degree of temperature change of the disinfectant.

[0044] The preset temperature value is used to measure whether the temperature change of the disinfectant is too large. This embodiment divides it into two cases: the first case is that the absolute value of the temperature difference is greater than the preset temperature value, which means that the temperature change of the disinfectant after passing through the blood circuit is too large; the second case is that the absolute value of the temperature difference is less than or equal to the preset temperature value, which means that the temperature change of the disinfectant after passing through the blood circuit is very small.

[0045] In the first scenario, the first heater needs to be activated. During the hemodialysis stage, the blood in the venous tubing is heated by the first heater. This is because the fluid flow path in the blood circuit is too long. Before the blood is returned to the patient's vein through the venous tubing, it needs to be heated by the first heater to prevent the temperature of the blood returned to the patient from being too low. This heating method directly heats the blood in the venous tubing, which is efficient. However, since the heated blood is directly returned to the patient's vein, the heating temperature needs to be set to an appropriate level. If the heating temperature of the first heater is too high or too low, it will compromise the safety of the patient's blood purification treatment.

[0046] In the second scenario, a second heater needs to be activated. During the hemodialysis stage, the dialysate in the dialysate inlet tubing is heated by the second heater. This is because the fluid flow path in the blood circuit is very short, eliminating the need to directly heat the blood in the venous tubing. Instead, the heated dialysate is output to the dialyzer, where the blood and heated dialysate exchange substances. During this exchange, the heated dialysate transfers some heat to the blood, thus raising the temperature of the blood in the blood circuit and ensuring safe blood flow. This heating method, which directly heats the dialysate in the dialysate inlet tubing, is equivalent to indirectly heating the blood in the blood circuit. This heat transfer method ensures the safety of heating the blood in the blood circuit, preventing the blood temperature from rising too high or too quickly. However, this heating method is too slow in heating the blood in the blood circuit.

[0047] Based on the relative magnitude between the absolute value of the temperature difference and the preset temperature value, the system determines whether to use the first or second heating method for the hemodialysis equipment. This allows the heating method to be set during the hemodialysis stage during the self-test phase, ensuring the patient's blood temperature remains safe during treatment and preventing heating malfunctions in the blood circuit. Therefore, this embodiment scientifically selects the heating method for the hemodialysis equipment during its self-test phase, improving the applicability and compatibility of the self-test method.

[0048] In some embodiments, the method may further include:

[0049] Step S104: Clip the waste liquid output pipe and the first inlet pipe, and open the dialysate input pipe and the first outlet pipe.

[0050] Specifically, the hemodialysis device further includes: a first stop clamp, a second stop clamp, a third stop clamp, and a fourth stop clamp; wherein the first stop clamp is installed in the waste liquid output pipeline, the second stop clamp is installed in the dialysate input pipeline, the third stop clamp is installed in the first inlet pipe, and the fourth stop clamp is installed in the first outlet pipe; by clamping the waste liquid output pipeline with the first stop clamp and the first inlet pipe with the third stop clamp, liquid cannot be transmitted between the waste liquid output pipeline and the first inlet pipe; by opening the dialysate input pipeline with the second stop clamp and the first outlet pipe with the fourth stop clamp, liquid can be transmitted between the dialysate input pipeline and the first outlet pipe.

[0051] Step S105: Detect the first flow rate of the disinfectant in the dialysis fluid inlet pipeline.

[0052] Step S106: When the first detected flow rate is within the preset safe flow rate range, detect the liquid storage volume on the dialysis side of the balance chamber.

[0053] Step S107: When the liquid storage volume on the dialysis side of the balance chamber is greater than the preset volume, detect whether there is liquid in the first outlet tube.

[0054] Specifically, according to the above description of the hemodialysis principle, during the self-test phase, the arterial tubing delivers disinfectant to the dialyzer. Due to the water pressure gradient between the inner and outer sides of the hollow fibers, the molecules of the disinfectant permeate through the semipermeable membrane into the dialysate inlet tubing. The flow rate of the disinfectant in the dialysate inlet tubing is the rate at which the dialyzer's semipermeable membrane permeates and delivers the disinfectant. The higher the rate at which the dialyzer's semipermeable membrane permeates and delivers the disinfectant, the higher the first detection flow rate. The rate at which the semipermeable membrane permeates and delivers the disinfectant refers to the flow rate of the disinfectant molecules passing through the semipermeable membrane under the action of the water pressure gradient.

[0055] To better illustrate this embodiment, Figure 5The diagram illustrates the structure of the balancing chamber. An intermediate membrane is positioned in the middle of the chamber, dividing it into a dialysis side and a waste fluid side. The intermediate membrane is elastic. The function of the balancing chamber is to ensure that the fluid inflow and outflow on both the dialysis and waste fluid sides remain balanced. "Maintaining balance" means that during hemodialysis, the fluid inflow and outflow on both sides of the balancing chamber are completely equal or approximately equal. During hemodialysis, the dialysis side of the balance chamber receives dialysate through the first inlet tube, and the dialysate is output to the dialysate inlet of the dialyzer through the dialysate inlet line. The waste liquid side of the balance chamber receives waste liquid generated by the dialyzer through the waste liquid outlet line, and the waste liquid is output through the first outlet tube. Utilizing the elastic compression of the intermediate membrane in the balance chamber, the dialysis side and the waste liquid side of the balance chamber are sequentially connected to liquids, and the liquid storage volumes of the dialysis side and the waste liquid side of the balance chamber are equal. This ensures that the volume of dialysate entering the dialyzer per unit time and the volume of waste liquid exiting the dialyzer per unit time remain balanced, thereby ensuring that the patient can maintain fluid balance during hemodialysis.

[0056] Specifically, when the first detected flow rate is within the preset safe flow rate range, it indicates that the rate at which the dialyzer's semipermeable membrane permeates and outputs disinfectant is normal, and the dialyzer's semipermeable membrane is in a normal liquid permeation state. When the first detected flow rate is not within the preset safe flow rate range, it indicates that the rate at which the dialyzer's semipermeable membrane permeates and outputs disinfectant is too high or too low, and the dialyzer's semipermeable membrane has suffered physical damage. At this time, a fault warning signal will be issued, and the user will immediately address the physical damage fault of the dialyzer once they notice the fault warning signal.

[0057] Optionally, the preset safe flow rate range is 1ml / min-3ml / min. When the first detection flow rate is between 1ml / min and 3ml / min, the liquid storage volume on the dialysis side of the balance chamber will be detected.

[0058] The blood circuit contains circulating disinfectant, and the dialyzer continuously generates waste fluid. The dialysate inlet line outputs the disinfectant permeated through the semipermeable membrane to the dialysis side of the balance chamber, where it is stored. The volume of liquid stored on the dialysis side of the balance chamber represents the total volume of disinfectant stored there. When the volume of liquid stored on the dialysis side of the balance chamber exceeds a preset volume, it indicates that the volume of liquid stored on the dialysis side is sufficient, and the liquid pressure on the dialysis side will be significantly greater than the pressure on the waste fluid side. The intermediate membrane of the balance chamber will deform towards the waste fluid side. If liquid is detected in the first outlet tube, it is determined that the intermediate membrane of the balance chamber is damaged, causing leakage. If no liquid is detected in the first outlet tube, it is determined that the intermediate membrane of the balance chamber is not damaged.

[0059] Therefore, when disinfecting the dialysate inlet tubing and the dialysis side of the balance chamber with disinfectant, it is also possible to determine whether the semipermeable membrane of the balance chamber is damaged, thus completing a comprehensive self-inspection process for the balance chamber.

[0060] In some embodiments, the method may further include:

[0061] Step S108: Detect the second flow rate of the disinfectant in the arterial tubing.

[0062] Step S109: Determine the preset safe flow range based on the second detected flow rate.

[0063] Specifically, there is a correlation between the preset safe flow range of the dialysate inlet tubing and the flow rate of the disinfectant in the arterial tubing. The second detection flow rate represents the flow rate of the disinfectant output from the arterial tubing to the blood inlet of the dialyzer. The disinfectant is output from the arterial tubing into the dialyzer and permeates through the semipermeable membrane under the action of the water pressure gradient.

[0064] Optionally, the preset safe flow range refers to: [minimum flow rate, maximum flow rate]; minimum flow rate = first proportional coefficient * second detection flow rate, maximum flow rate = second proportional coefficient * second detection flow rate; the first proportional coefficient and the second proportional coefficient are related to the chemical properties of the hollow fiber of the dialyzer itself. For example, when the semipermeable membrane is made of polyethersulfone, the first proportional coefficient can be 1 / 10, and the second proportional coefficient can be 1 / 4; for example, when the second detection flow rate is 10 ml / min, then the minimum flow rate = first proportional coefficient * second detection flow rate = 1 / 10 * 10 ml / min = 1 ml / min, and the maximum flow rate = 1 / 4 * 10 ml / min = 2.5 ml / min; where the preset safe flow range is [1 ml / min, 2.5 ml / min].

[0065] In some embodiments, the method may further include:

[0066] Step S110: When it is detected that there is no liquid in the first outlet tube, the arterial puncture needle is connected to the venous puncture needle, so that the disinfectant is circulated and flushed in the first circuit formed by the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, and the venous puncture needle.

[0067] Specifically, when it is determined that the liquid storage volume on the dialysis side of the balance chamber is greater than the preset volume, and no liquid is detected in the first outlet tube, it is determined that the intermediate membrane of the balance chamber is not damaged. In this case, the first circuit is circulated and flushed. During the circulated flushing of the first circuit, disinfectant can be used to disinfect each component of the first circuit. This circulated disinfection method not only saves the amount of disinfectant used, but also achieves a better disinfection effect on each component of the first circuit. In the later stages of hemodialysis, blood can be safely transferred in the first circuit. The self-testing method in this embodiment can perform a more comprehensive disinfection operation on each component of the first circuit, ensuring the safety of the patient's hemodialysis treatment.

[0068] Step S111: Connect the waste liquid output pipeline and the dialysate input pipeline. When the absolute value of the difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysate input pipeline is greater than or equal to a preset flow rate value, it is determined that the dialyzer has a blood leakage fault.

[0069] Preferably, when the waste liquid output line and the dialysate input line are connected, the first inlet line and the first outlet line are connected. The waste liquid output line is opened by the first stop clamp, the dialysate input line is opened by the second stop clamp, the first inlet line is opened by the third stop clamp, and the first outlet line is opened by the fourth stop clamp. When the disinfectant passes through the inside of the dialyzer, under the action of the water pressure gradient, the molecules of the disinfectant will permeate through the semipermeable membrane into the dialysate input line and the waste liquid output line. The disinfectant flow rate of the waste liquid output line represents the rate at which the molecules of the disinfectant permeate through the semipermeable membrane into the waste liquid output line; the disinfectant flow rate of the dialysate input line represents the rate at which the molecules of the disinfectant permeate through the semipermeable membrane into the dialysate input line.

[0070] In the circulating disinfection mode, when the disinfectant passes through the dialyzer, if the hollow fiber is in a normal state, the disinfectant will be evenly distributed on the hollow fiber, and the disinfectant flow rate in the waste liquid output line and the disinfectant flow rate in the dialysate input line will be equal or approximately equal. If |disinfectant flow rate in the waste liquid output line - disinfectant flow rate in the dialysate input line| < preset flow rate value, then it means that the disinfectant flow rate in the waste liquid output line and the disinfectant flow rate in the dialysate input line are equal or approximately equal. If the disinfectant flow rate in the pipeline is greater than or equal to the preset flow rate, it indicates that there is a significant difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysate input pipeline. This significant difference indicates a blood leakage fault in the dialyzer. Furthermore, when a blood leakage fault is detected, an audible and visual fault warning signal can be issued. Once the user notices the audible and visual fault warning signal, they can immediately address the blood leakage fault in the dialyzer. This embodiment can accurately identify the blood leakage fault in the dialyzer during the self-test phase, which is beneficial for troubleshooting the dialyzer.

[0071] Optionally, the preset flow rate value can be set based on previously accumulated clinical technical experience. The preset flow rate value is related to the dialyzer model. For different models of dialyzers on the market, there will be corresponding preset flow rates. For example, if the preset flow rate value is 2ml / min, and |disinfectant flow rate of waste liquid output line - disinfectant flow rate of dialysate input line| ≥ 2ml / min, then it is determined that the dialyzer has a blood leakage fault.

[0072] It should be noted that "dialysis machine leakage" refers to a situation where the hollow fibers of the dialyzer are damaged or have gaps, allowing the disinfectant solution inside the dialyzer to leak into the waste fluid output line and the dialysate input line. If this leakage occurs during hemodialysis, it can seriously compromise the safety of the patient's blood purification treatment.

[0073] It should be noted that during the cyclic flushing of the first circuit, to determine whether the dialyzer is leaking, the molecules of the disinfectant in the first circuit will permeate through the semi-permeable membrane into the dialysate inlet and waste liquid outlet lines. Therefore, the remaining amount of disinfectant in the first circuit will decrease. Thus, this embodiment of the application implicitly stipulates that the remaining amount of disinfectant in the first circuit is sufficient during cyclic flushing. If the remaining amount of disinfectant in the first circuit is less than the preset safe amount, it indicates that the remaining amount of disinfectant in the first circuit is insufficient, and the implementation of this embodiment will be stopped.

[0074] In some embodiments, the method may further include:

[0075] Step S112: When the disinfectant is circulating and rinsing in the first circuit, the flow rate of the disinfectant in the first circuit is detected. When the flow rate of the disinfectant in the first circuit is less than the safe flow rate value, a first fault warning signal is issued.

[0076] When the disinfectant is circulating and flushing within the first circuit consisting of the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, and the venous puncture needle, the flow rate of the disinfectant in the first circuit is detected. If the flow rate of the disinfectant in the first circuit is less than the safe flow rate value, a first fault warning signal is issued.

[0077] Specifically, as mentioned above, when the first circuit is circulated and flushed with disinfectant, the molecules of the disinfectant will permeate through the semi-permeable membrane into the dialysate inlet and waste outlet lines as the disinfectant flows through the dialyzer. This results in a decreasing total amount of disinfectant remaining in the first circuit. The safe flow rate represents a warning value for the remaining amount of disinfectant in the first circuit. When the flow rate of the disinfectant in the first circuit is less than the safe flow rate, it indicates that the remaining amount of disinfectant in the first circuit is too low. Upon noticing this first fault warning signal, the user will immediately address the flow rate issue in the first circuit, thus ensuring that the disinfectant in the first circuit can effectively disinfect during the circulation and flushing process.

[0078] It should be noted that the safe flow rate value can be a value obtained after conducting multiple technical experiments. For example, if the safe flow rate value is 3 ml / min, when the flow rate of the disinfectant in the first loop is ≥3 ml / min, the remaining total amount of disinfectant in the first loop is sufficient. Using the disinfectant to circulate and rinse the first loop will achieve the best disinfection effect.

[0079] In some embodiments, the method may further include:

[0080] Step S113: When the absolute value of the difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysis fluid input pipeline is less than the preset flow rate value, the first diameter of the arterial pipeline and the second diameter of the venous pipeline are detected respectively.

[0081] Step S114: When the first tube diameter is larger than the second tube diameter, the fluid pressure of the arterial tubing is sampled and recorded periodically, and the safe pressure range of the dialyzer is set according to the recorded fluid pressure of the arterial tubing.

[0082] Step S115: When the first tube diameter is less than or equal to the second tube diameter, the fluid pressure of the venous tubing is sampled and recorded periodically, and the safe pressure range of the dialyzer is set according to the recorded fluid pressure of the venous tubing.

[0083] If the absolute value of the difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysate input pipeline is less than the preset flow rate value, it can be determined that the dialyzer has not experienced a blood leakage fault.

[0084] Specifically, during the self-test phase, the arterial tubing delivers disinfectant to the dialyzer, which then delivers the disinfectant to the venous tubing. The disinfectant inside the dialyzer experiences fluid pressure, which affects the permeation efficiency of the disinfectant through the semipermeable membrane. Lower fluid pressure results in lower permeation efficiency, while higher pressure leads to greater permeation. However, excessive fluid pressure (e.g., exceeding the maximum pressure limit of the semipermeable membrane) can cause membrane rupture, leading to blood leakage – one of the reasons for "dialysis machine blood leakage."

[0085] It should be noted that the liquid pressure of the dialyzer can be divided into: intra-membrane pressure and extra-membrane pressure; in this embodiment, the liquid pressure of the dialyzer is: intra-membrane pressure, which refers to the pressure of the disinfectant after the semi-permeable membrane of the dialyzer is connected to the disinfectant.

[0086] If it is determined that there is no blood leakage fault in the dialyzer, when the first tubing diameter is larger than the second tubing diameter, the maximum pressure limit that the arterial tubing can withstand is greater than the maximum pressure limit that the venous tubing can withstand. The fluid pressure of the arterial tubing is representative, and the fluid pressure of the arterial tubing is taken as the fluid pressure of the dialyzer.

[0087] When the first tube diameter is less than or equal to the second tube diameter, the maximum pressure limit that the arterial tube can withstand is less than or equal to the maximum pressure limit that the venous tube can withstand. The fluid pressure of the venous tube is representative, and the fluid pressure of the venous tube is used as the fluid pressure of the dialyzer.

[0088] In this embodiment, during the self-test phase, the fluid pressure of the arterial line or the venous line is continuously recorded. The recorded fluid pressure can be used to construct the safe pressure range of the dialyzer, where the values ​​in the safe pressure range represent the safe changes in the fluid pressure of the dialyzer.

[0089] For example, when the first tubing diameter is less than or equal to the second tubing diameter, after 10 consecutive samplings of the intravenous fluid pressure, the intravenous fluid pressures are as follows: 800 mmHg, 850 mmHg, 930 mmHg, 1100 mmHg, 940 mmHg, 910 mmHg, 880 mmHg, 820 mmHg, 800 mmHg, and 790 mmHg. 790 mmHg is the minimum value among the 10 values, and 1100 mmHg is the maximum value among the 10 values. Therefore, the safe pressure range for the dialyzer is 790 mmHg - 1100 mmHg.

[0090] Only when the dialyzer's liquid pressure is within the dialyzer's safe pressure range will the dialysate pressure not be too high, and the dialysate pressure will not cause the dialyzer's semipermeable membrane to rupture.

[0091] If the liquid pressure in the dialyzer is not within the safe pressure range, the excessive pressure of the dialysate may cause the semipermeable membrane of the dialyzer to rupture.

[0092] This embodiment essentially pre-sets the safe pressure range of the dialyzer during the self-test phase, providing a data-driven theoretical basis for the safe operation of the dialyzer during subsequent hemodialysis stages. For example, during hemodialysis, simply controlling the blood pressure in the dialyzer within its safe pressure range can prevent membrane rupture, thus improving the safety of the patient's hemodialysis treatment.

[0093] It should be noted that the steps of this embodiment are performed under the condition that "the dialyzer does not experience any leakage," because the safe pressure range of the dialyzer represents the safe value of the dialyzer's fluid pressure when there is no leakage. Periodic sampling of the fluid pressure in the arterial or venous tubing is performed under the condition that "the dialyzer does not experience any leakage." Otherwise, if the dialyzer experiences leakage, the detected fluid pressure in the arterial or venous tubing will not fall within the safe value of the dialyzer's fluid pressure, making it impossible to set the safe pressure range for the dialyzer.

[0094] In some embodiments, the method may further include:

[0095] Step S116: Detect the second flow rate of the disinfectant in the arterial tubing.

[0096] Step S117: Determine the ratio between the first detection flow rate and the second detection flow rate, and display the ratio on the display screen of the hemodialysis device.

[0097] The second flow rate represents the flow rate of disinfectant output from the arterial tubing to the dialyzer; the flow rate of disinfectant in the arterial tubing can be sampled periodically. The first flow rate represents the flow rate of disinfectant in the dialyzer permeating through the semi-permeable membrane into the dialysate inlet tubing; the ratio between the first and second flow rates is determined and displayed, allowing the user to see the ratio and determine whether the disinfectant is permeating normally through the dialyzer's semi-permeable membrane; for example, when the dialyzer's semi-permeable membrane is functioning correctly, the ratio between the first and second flow rates will be equal to or close to a preset value, and the ratio will fluctuate within a very small range.

[0098] If the ratio between the first detection flow rate and the second detection flow rate fluctuates significantly, or if the ratio is not within the normal range, it indicates that the semipermeable membrane of the dialyzer is malfunctioning, such as being damaged or blocked.

[0099] This embodiment displays the ratio between the first detection flow rate and the second detection flow rate, which can be used as one of the important indicators to determine whether the semipermeable membrane of the dialyzer is malfunctioning.

[0100] In some embodiments, the method may further include:

[0101] Step S118: When it is detected that there is no liquid in the first outlet tube, the first pressure detection value of the liquid on the dialysis side of the balance chamber is detected.

[0102] Specifically, when there is no liquid in the first outlet tube, it is determined that the intermediate diaphragm of the balance chamber is not damaged. The first pressure detection value is obtained by detecting the pressure of the liquid on the dialysis side of the balance chamber. The first pressure detection value represents the liquid pressure on the dialysis side of the balance chamber when the volume of liquid stored on the dialysis side of the balance chamber is already very sufficient.

[0103] Step S119: Clip the dialysate inlet pipe and the first outlet pipe, and open the waste liquid outlet pipe and the first inlet pipe.

[0104] Step S120: Detect the third flow rate of the disinfectant in the waste liquid output pipeline.

[0105] Step S121: When the third detection flow rate is within the preset safe flow rate range, detect the liquid storage volume on the waste liquid side of the balance chamber.

[0106] Step S122: When the liquid storage volume on the waste liquid side of the balance chamber is greater than the preset volume, detect whether there is liquid in the first inlet pipe.

[0107] Step S123: When it is detected that there is no liquid in the first inlet pipe, detect the second pressure value of the liquid on the waste side of the balance chamber.

[0108] It should be noted that the specific implementation of this application embodiment is similar to the specific implementation of steps S104-S107 and S118 above. Therefore, the specific implementation of steps S119-S123 can be referred to the specific implementation of steps S104-S107 and S118. The specific implementation of steps S119-S123 will not be described in detail here.

[0109] The above method can also be used to double verify whether the intermediate diaphragm of the balance chamber is damaged, thus eliminating the judgment error of whether the intermediate diaphragm of the balance chamber is damaged.

[0110] Step S124: Determine whether the balancing chamber has liquid equalization performance based on the pressure difference between the first pressure detection value and the second pressure detection value.

[0111] Specifically, the first pressure detection value represents the liquid pressure on the dialysis side of the balance chamber; the second pressure detection value represents the liquid pressure on the waste liquid side of the balance chamber. If the balance chamber has liquid equalization performance, when liquid is alternately output from the dialysis side and the waste liquid side of the balance chamber, the pressure of the liquid output from the dialysis side (i.e., the first pressure detection value) is equal to or approximately equal to the pressure of the liquid output from the waste liquid side (i.e., the second pressure detection value). Therefore, when the pressure difference between the first and second pressure detection values ​​is within the user-allowed pressure error range, the balance chamber is judged to have liquid equalization performance. When the pressure difference between the first and second pressure detection values ​​is not within the user-allowed pressure error range, the balance chamber is judged to lack liquid equalization performance. The reason for "the balance chamber lacking liquid equalization performance" is usually that the intermediate diaphragm of the balance chamber has an elastic failure, resulting in a large difference between the elastic deformation force of the intermediate diaphragm near the dialysis side and the elastic deformation force near the waste liquid side.

[0112] In this embodiment, during the self-test phase, steps S104 and S119 are executed sequentially, causing the dialysis side of the balance chamber to be connected to the disinfectant solution output from the dialyzer's semi-permeable membrane, and the waste liquid side of the balance chamber to be connected to the disinfectant solution output from the dialyzer's semi-permeable membrane. Steps S104 and S119 simulate the alternating blood transfer process between the dialysis side and the waste liquid side of the balance chamber during hemodialysis. The pressure difference between the first and second pressure detection values ​​realistically simulates the difference in deformation of the intermediate membrane of the balance chamber when the dialysis side and the waste liquid side are subjected to force. This pressure difference determines whether the balance chamber possesses fluid equalization performance, thus completing a comprehensive self-test of the balance chamber.

[0113] Optionally, the balance chamber is judged to have fluid equalization performance based on the pressure difference between the first pressure detection value and the second pressure detection value; specifically: if |first pressure detection value - second pressure detection value| ≤ first preset pressure value, then the balance chamber is judged to have fluid equalization performance; if |first pressure detection value - second pressure detection value| > first preset pressure value, then the balance chamber is judged not to have fluid equalization performance; wherein the first preset pressure value can be a value set based on previously accumulated clinical technical experience, such as the first preset pressure value = 50 mmHg.

[0114] It should be noted that "whether the balancing chamber in S124 has liquid equalization performance" and "whether the intermediate diaphragm of the balancing chamber is damaged in S107" are two completely different technical issues. The technical issue of "whether the balancing chamber has liquid equalization performance" is used to evaluate whether the elastic deformation forces generated on both sides of the intermediate diaphragm of the balancing chamber are balanced. The technical issue of "whether the intermediate diaphragm of the balancing chamber is damaged" is used to evaluate whether the intermediate diaphragm of the balancing chamber has suffered physical damage (such as breakage or cracks on the intermediate diaphragm).

[0115] Therefore, this embodiment can perform self-inspection of the balance chamber of the hemodialysis device from multiple dimensions, and promptly detect any faults in the balance chamber; thus, the balance chamber can normally transmit dialysate and waste fluid during the hemodialysis stage, ensuring the safety of fluid flow within the blood circuit.

[0116] In some embodiments, the method may further include:

[0117] Step S125: Detect the liquid weight reduction rate of the first liquid storage bag and the liquid weight increase rate of the second liquid storage bag.

[0118] Step S126: When the absolute value of the difference between the liquid weight reduction rate and the liquid weight increase rate is greater than the preset weight change rate, it is determined that the hemodialysis equipment has a leakage fault.

[0119] During the self-test phase, when the arterial puncture needle is inserted into the first liquid storage bag containing disinfectant, and the venous puncture needle is inserted into the second liquid storage bag, the rate of decrease in liquid weight of the first liquid storage bag and the rate of increase in liquid weight of the second liquid storage bag are detected. If |liquid weight decrease rate - liquid weight increase rate| > a preset weight change rate, it is determined that the hemodialysis equipment has a leakage fault.

[0120] The liquid weight reduction rate of the first liquid storage bag represents the total amount of disinfectant output from the first liquid storage bag to the blood circuit per unit time. The liquid weight increase rate of the second liquid storage bag represents the total amount of disinfectant received from the blood circuit per unit time. When the disinfectant flows within the blood circuit, inside the dialyzer, the molecules of the disinfectant permeate through the semi-permeable membrane into the waste liquid output line and the dialysate input line. Due to the permeation effect of the semi-permeable membrane on the molecules of the disinfectant, the liquid weight increase rate of the second liquid storage bag is less than the liquid weight reduction rate of the first liquid storage bag. If the hemodialysis equipment does not have a leakage fault, and the problem is only due to the "permeation effect of the semi-permeable membrane on the molecules of the disinfectant," then |liquid weight reduction rate - liquid weight increase rate| ≤ preset weight change rate, meaning that the amount of disinfectant reduction caused by the blood circuit will be within the user's expected range.

[0121] If the hemodialysis equipment malfunctions due to leakage, the components of the blood circuit will cause the disinfectant to leak. In this case, |liquid weight reduction rate - liquid weight increase rate| > preset weight change rate, which means that the amount of disinfectant lost through the blood circuit exceeds the user's expected range.

[0122] Furthermore, when a leak is detected in the hemodialysis equipment, an audible and visual alarm signal can be issued. Once the user notices the audible and visual alarm signal, they will immediately address the leak in the hemodialysis equipment, thus ensuring the safe operation of the hemodialysis equipment.

[0123] It should be noted that a leakage malfunction in hemodialysis equipment refers to a damage to a component of the blood circuit, causing the disinfectant solution in the blood circuit to leak to the outside. This leakage malfunction includes blood leakage from the dialyzer. For example, when a leakage malfunction is identified, the causes could include: blood leakage from the dialyzer, damage to the arterial tubing, or damage to the venous tubing, etc.

[0124] In some embodiments, the method may further include:

[0125] Step S127: When the first detected temperature is greater than the safe temperature value, a second fault warning signal is issued.

[0126] Specifically, the first detection temperature represents the temperature at which the disinfectant is introduced into the blood circuit; the safe temperature value represents the maximum safe temperature of the disinfectant. Only when the first detection temperature is less than or equal to the safe temperature value can the disinfectant achieve the disinfection effect in the blood circuit. If the first detection temperature is greater than the safe temperature value, the high temperature will damage the disinfection activity of the disinfectant, and the high temperature of the disinfectant will also cause physical damage to the walls of the blood circuit.

[0127] When users notice the second fault alarm signal, they will immediately take action to address the high temperature fault of the disinfectant, in order to ensure the safe flow of the disinfectant in the blood circuit.

[0128] Optionally, the safe temperature value can be 60℃; the safe temperature value can be obtained based on the chemical properties of the disinfectant and after multiple tests.

[0129] In some embodiments, the method may further include:

[0130] Step S128: Plot the first curve of the first detected temperature over time and the second curve of the second detected temperature over time, and display the first curve and the second curve on the display screen of the hemodialysis device.

[0131] Specifically, such as Figure 6 As shown, users can directly see the first and second change curves. During the self-test phase, users can monitor the temperature changes of the disinfectant in the first and second liquid storage bags at any time. Users can comprehensively monitor the temperature changes of the disinfectant as it flows through the blood circuit.

[0132] In some embodiments, step S101, before the hemodialysis device enters the self-test phase, may further include:

[0133] Step S129: When it is detected that the hemodialysis device has been fully loaded with tubing, the dialyzer is weighed to obtain the first detection weight.

[0134] Specifically, the first test weight refers to the weight of the dialyzer before entering the self-test phase. Before entering the self-test phase, the dialyzer has not yet been connected to the disinfectant solution. The first test weight refers to the weight of the dialyzer in a dry state.

[0135] The method may further include:

[0136] Step S130: During the self-test phase, the dialyzer is weighed to obtain a second test weight.

[0137] The second test weight refers to the weight of the dialyzer during the self-test phase. During the self-test phase, the blood circuit is connected to the disinfectant solution, and the dialyzer is connected to the disinfectant solution. The second test weight refers to the weight of the dialyzer when the disinfectant solution is connected.

[0138] Step S131: Record the absolute value of the weight difference between the first detected weight and the second detected weight, and display a third curve of the absolute value of the weight difference over time on the display screen of the hemodialysis device.

[0139] Step S132: Determine whether the dialyzer has a liquid flow failure based on the third change curve.

[0140] Specifically, when there is no liquid flow malfunction in the dialyzer during the self-test phase, the disinfectant undergoes normal material permeation within the dialyzer. Therefore, the second test weight will remain constant or fluctuate within a small range. The absolute value of the weight difference = |first test weight -second test weight|, where the absolute value of the weight difference represents the weight of the disinfectant inside the dialyzer during the self-test phase. During the self-test phase, if there is no liquid flow malfunction in the dialyzer, the third variation curve will be a straight line, or it will fluctuate within a preset fluctuation range. Figure 7 As shown.

[0141] During the self-test phase, if a fluid flow malfunction occurs in the dialyzer, the absolute value of the weight difference will fluctuate drastically, and the third variation curve will also show drastic fluctuations; for example... Figure 8 As shown; for example, when the dialyzer shell cracks or breaks, the disinfectant inside the dialyzer will leak, the total amount of disinfectant stored in the dialyzer will decrease, and the weight of the disinfectant inside the dialyzer will suddenly drop, and the third change curve will fluctuate violently in a short period of time; based on the violent fluctuation of the third change curve, it can be determined that the dialyzer is in a liquid flow state, and the user will immediately deal with the liquid flow failure of the dialyzer.

[0142] It should be noted that dialyzer fluid flow failures include: cracks or damage to the dialyzer casing, blockages inside the dialyzer, etc.

[0143] The third change curve can be used to determine whether there is a fluid flow failure in the dialyzer, thus completing the self-testing process for the dialyzer.

[0144] It should be noted that the sequence numbers of the above steps (such as S101, S102, etc.) are only used to refer to each step and do not mean that the steps in this embodiment will be executed in the order of the sequence numbers. The steps in this embodiment will be executed in the logical order of the technical solution.

[0145] This application also provides a hemodialysis device, comprising: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater; an intermediate membrane is disposed in the middle of the balance chamber, dividing the chamber into a dialysis side and a waste liquid side; the first end of the arterial tubing is fitted with the arterial puncture needle, the second end of the arterial tubing is connected to the blood inlet of the dialyzer, and the first end of the venous tubing is fitted with the venous puncture needle. The second end of the venous tubing is connected to the blood output end of the dialyzer; the first end of the dialysate input tubing is connected to the dialysis side outlet of the balance chamber; the second end of the dialysate input tubing is connected to the dialysate input end of the dialyzer; the first end of the waste liquid output tubing is connected to the waste liquid side inlet of the balance chamber; the second end of the waste liquid output tubing is connected to the waste liquid output end of the dialyzer; the first inlet pipe is connected to the dialysis side inlet of the balance chamber; the first outlet pipe is connected to the waste liquid side outlet of the balance chamber; the first heater is disposed in the venous tubing; and the second heater is disposed in the dialysate input tubing.

[0146] The hemodialysis device further includes a memory and a processor. The memory stores a computer program, and the processor executes the computer program to implement the self-test method for the hemodialysis device as described above. For detailed explanations of the relevant content, please refer to the related content of the above methods; further details will not be repeated here.

[0147] This application also provides a computer-readable storage medium storing a computer program that, when executed by a processor, causes the processor to implement the self-testing method for a hemodialysis device as described above. For detailed descriptions of the related content, please refer to the relevant content of the above methods, which will not be repeated here.

[0148] The computer-readable storage medium can be an internal storage unit of the aforementioned hemodialysis device, such as a hard disk or memory. Alternatively, it can be an external storage device, such as an external hard disk, smart memory card, secure digital card, flash memory card, etc.

[0149] It should be understood that the terminology used in this application specification is for the purpose of describing particular embodiments only and is not intended to limit the application.

[0150] It should also be understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0151] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and such modifications or substitutions should all be covered within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A self-testing method for a hemodialysis device, characterized in that, The hemodialysis device includes: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater. An intermediate membrane is disposed in the middle of the balance chamber, dividing the chamber into a dialysis side and a waste liquid side. The first end of the arterial tubing is fitted with the arterial puncture needle, and the second end of the arterial tubing is connected to the blood inlet of the dialyzer. The first end of the venous tubing is fitted with the venous puncture needle, and the second end of the venous tubing is connected to the dialyzer. The dialyzer has a blood output terminal, a first end of a dialysate input line connected to the outlet of the dialysis side of the balance chamber, a second end of a dialysate input line connected to the dialysate input terminal of the dialyzer, a first end of a waste liquid output line connected to the inlet of the waste liquid side of the balance chamber, a second end of a waste liquid output line connected to the waste liquid output terminal of the dialyzer, a first inlet pipe connected to the inlet of the dialysis side of the balance chamber, a first outlet pipe connected to the outlet of the waste liquid side of the balance chamber, a first heater disposed in the venous line, and a second heater disposed in the dialysate input line; the method includes: When the hemodialysis device enters the self-test stage, the arterial puncture needle is inserted into the first liquid storage bag containing disinfectant, and the venous puncture needle is inserted into the second liquid storage bag, so that the disinfectant can pass through the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, the venous puncture needle and the second liquid storage bag in sequence, and the disinfectant is stored in the second liquid storage bag; The first and second detection temperatures of the disinfectant in the first and second liquid storage bags are obtained respectively; the first detection temperature is a periodically sampled value, and the second detection temperature is a periodically sampled value. When the absolute value of the temperature difference between the first detection temperature and the second detection temperature is greater than a preset temperature value, the first heater is activated to heat the fluid in the intravenous tubing; when the absolute value of the temperature difference is less than or equal to the preset temperature value, the second heater is activated to heat the fluid in the dialysate inlet tubing.

2. The method according to claim 1, characterized in that, The method further includes: Cut off the waste liquid output pipeline and the first inlet pipe, and open the dialysate input pipeline and the first outlet pipe; The first detection flow rate of the disinfectant in the dialysate inlet pipeline is detected; When the first detected flow rate is within the preset safe flow rate range, the liquid storage volume on the dialysis side of the balance chamber is detected; When the liquid storage volume on the dialysis side of the balance chamber is greater than a preset volume, the presence of liquid in the first outlet tube is detected.

3. The method according to claim 2, characterized in that, The method further includes: When it is detected that there is no liquid in the first outlet tube, the arterial puncture needle is connected to the venous puncture needle, so that the disinfectant is circulated and flushed in the first circuit formed by the arterial puncture needle, the arterial tubing, the dialyzer, the venous tubing, and the venous puncture needle; Connect the waste liquid output pipeline and the dialysis fluid input pipeline; When the absolute value of the difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysate input pipeline is greater than or equal to a preset flow rate value, it is determined that the dialyzer has a blood leakage fault.

4. The method according to claim 3, characterized in that, The method further includes: When the absolute value of the difference between the disinfectant flow rate in the waste liquid output pipeline and the disinfectant flow rate in the dialysis fluid input pipeline is less than the preset flow rate value, the first diameter of the arterial pipeline and the second diameter of the venous pipeline are detected respectively. When the first tube diameter is larger than the second tube diameter, the fluid pressure of the arterial tubing is sampled and recorded periodically, and the safe pressure range of the dialyzer is set according to the recorded fluid pressure of the arterial tubing. When the first tube diameter is less than or equal to the second tube diameter, the fluid pressure of the venous tubing is sampled and recorded periodically, and the safe pressure range of the dialyzer is set based on the recorded fluid pressure of the venous tubing.

5. The method according to claim 2, characterized in that, The method further includes: The second flow rate of the disinfectant solution in the arterial tubing is detected; Determine the ratio between the first detection flow rate and the second detection flow rate, and display the ratio on the display screen of the hemodialysis device; The preset safe flow range is determined based on the second detected flow rate.

6. The method according to claim 2, characterized in that, The method further includes: When it is detected that there is no liquid in the first outlet tube, the first pressure value of the liquid on the dialysis side of the balance chamber is detected. Cut off the dialysate inlet pipe and the first outlet pipe, and open the waste liquid outlet pipe and the first inlet pipe; The third flow rate of the disinfectant in the waste liquid output pipeline is detected; When the third detection flow rate is within the preset safe flow rate range, the liquid storage volume on the waste liquid side of the balance chamber is detected; When the liquid storage volume on the waste liquid side of the balance chamber is greater than the preset volume, the presence of liquid in the first inlet pipe is detected. When it is detected that there is no liquid in the first inlet pipe, the second pressure detection value of the liquid on the waste liquid side of the balance chamber is detected; The balance chamber is determined to have liquid equalization performance based on the pressure difference between the first pressure detection value and the second pressure detection value.

7. The method according to claim 1, characterized in that, The method further includes: The rate of decrease in liquid weight of the first liquid storage bag and the rate of increase in liquid weight of the second liquid storage bag were detected. When the absolute value of the difference between the liquid weight reduction rate and the liquid weight increase rate is greater than the preset weight change rate, it is determined that the hemodialysis equipment has a leakage fault.

8. The method according to claim 1, characterized in that, Before the hemodialysis equipment enters the self-test phase, the process also includes: When it is detected that the hemodialysis device has been fully loaded with tubing, the dialyzer is weighed to obtain the first detection weight; The method further includes: During the self-test phase, the dialyzer is weighed to obtain a second test weight; Record the absolute value of the weight difference between the first detected weight and the second detected weight, and display a third curve of the absolute value of the weight difference over time on the display screen of the hemodialysis device; The third variation curve is used to determine whether the dialyzer has a fluid flow failure.

9. A hemodialysis device, characterized in that, The hemodialysis device includes: a venous puncture needle, an arterial puncture needle, an arterial tubing, a venous tubing, a dialysate inlet tubing, a waste liquid outlet tubing, a dialyzer, a balance chamber, a first inlet tube, a first outlet tube, a first heater, and a second heater. An intermediate membrane is disposed in the middle of the balance chamber, dividing the chamber into a dialysis side and a waste liquid side. The first end of the arterial tubing is fitted with the arterial puncture needle, and the second end of the arterial tubing is connected to the blood inlet of the dialyzer. The first end of the venous tubing is fitted with the venous puncture needle, and the second end of the venous tubing is connected to the blood outlet of the dialyzer. The first end of the dialysate inlet tubing is connected to the outlet on the dialysis side of the balance chamber. The second end of the fluid input line is connected to the dialysate input end of the dialyzer; the first end of the waste fluid output line is connected to the inlet on the waste fluid side of the balance chamber; the second end of the waste fluid output line is connected to the waste fluid output end of the dialyzer; the first inlet pipe is connected to the inlet on the dialysis side of the balance chamber; the first outlet pipe is connected to the outlet on the waste fluid side of the balance chamber; the first heater is disposed in the venous line; and the second heater is disposed in the dialysate input line. The hemodialysis device further includes a memory and a processor. The memory stores a computer program, and the processor executes the computer program and, when executing the computer program, implements the self-testing method of the hemodialysis device as described in any one of claims 1-8.

10. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores a computer program that, when executed by a processor, causes the processor to implement the self-testing method for a hemodialysis device as described in any one of claims 1-8.

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