A hemodiafiltration device and its leak detection method

Abstract

The present invention relates to the technical field of hemodialysis, and particularly relates to a hemodiafiltration device and a leakage detection method thereof. The hemodiafiltration device includes a dialyzer, an arterial side pipeline, a venous side pipeline, an additional pipeline, and a liquid supply unit. The hemodiafiltration device can be used to implement any one of hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF). The leakage detection method is used to detect whether there is a leakage point in the above-mentioned hemodiafiltration device to ensure the safety of the treatment process.

Description

Technical Field

[0001] The present invention relates to the technical field of hemodialysis, and particularly to a hemodiafiltration device and a leakage detection method thereof. Background Art

[0002] Hemodialysis (HD) is one of the renal replacement therapies for patients with acute and chronic renal failure. It involves draining the blood in the body to the outside, passing it through a dialyzer composed of countless hollow fibers, where the blood and an electrolyte solution (dialysate) with a concentration similar to that of the body are separated by the hollow fibers. Substance exchange occurs through diffusion, ultrafiltration, adsorption, and convection principles to remove metabolic wastes in the body, maintain electrolyte and acid-base balance; at the same time, excess water in the body is removed, and the entire process of returning the purified blood is called hemodialysis. Hemofiltration (HF) refers to a process in blood purification where no dialysate is used, but a certain amount of replacement fluid is continuously supplemented in the vascular access, mixed thoroughly with the blood, and then ultrafiltered at the same speed to remove excess water and toxins in the body. Compared with hemodialysis, hemofiltration has the advantages of having less impact on hemodynamics and a higher clearance rate of middle-molecular substances. Hemodiafiltration (HDF) combines the advantages of hemodialysis (HD) and hemofiltration (HF), that is, it efficiently removes small molecules through diffusion and efficiently removes middle molecules through convection. Ordinary HD has insufficient clearance of middle-molecular toxins and can induce the generation of new toxins, resulting in a relatively high incidence of complications, reducing the quality of life of patients and increasing the mortality rate.

[0003] Existing hemodiafiltration devices generally include a dialyzer and an extracorporeal blood purification circuit. Among them, the extracorporeal blood purification circuit is a connecting circuit for extracorporeal blood purification of the human body. The extracorporeal blood purification circuit consists of two groups of pipelines, an arterial pipeline and a venous pipeline, which are respectively connected to the dialyzer and respectively connected to the human artery and vein, so as to transport the blood in the human body to the dialyzer for purification and finally return it to the human body to form a cycle. The role of this extracorporeal circuit is to replace blood vessels and act as a pipeline for blood flow. Therefore, during the treatment process, it is necessary to ensure that there is no leakage in the extracorporeal circuit itself or at the joints. Currently, the leak detection process is all identified and detected manually, resulting in low detection efficiency and the inability to accurately detect and identify small leaks in the entire extracorporeal circuit.

[0004] The Chinese invention patent with the publication number CN216559571U discloses a hermeticity detection device for a hemodialyzer, which is used for leak detection in the production and processing link of an extracorporeal circulation pipeline, can effectively judge whether the product is qualified, and ensure the safety of the product. The Chinese invention patent with the publication number CN215134412U discloses a hemodialysis catheter bleeding alarm. When the blood outlet tube is separated from the hemodialysis indwelling needle or there is leakage at the indwelling needle interface due to poor sealing, the hemodialysis catheter bleeding alarm can detect the liquid flowing out of the blood outlet tube and issue an alarm in time to remind patients, their family members and medical staff to take countermeasures. The Chinese invention patent with the publication number CN204745126U provides an extracorporeal blood treatment machine (preferably a dialysis machine) including leak detection and a method for detecting leaks in the dialysis fluid loop of the dialysis machine. The Chinese invention patent with the publication number CN211234849U discloses a hemodialyzer leak detector, which solves the problem of detecting leak points of the hollow fiber membrane bundle in the hemodialyzer during the production process. The Chinese invention patent with the publication number CN 108697990 B discloses a method and device for checking whether a hemodialyzer has leaks, which is used to accurately identify micro-leaks in the membrane of the hemodialyzer. The above patents all involve independently detecting some pipelines or membrane systems in the hemodiafiltration equipment. However, during the actual dialysis treatment process, since there are many pipelines that need to be manually assembled and connected on the extracorporeal circulation pipeline, leakage is very likely to occur at each connection joint, resulting in the inability to guarantee the safety of treatment, and the above devices cannot effectively solve the above problems. Summary of the Invention

[0005] To solve the above technical problems, the purpose of the present invention is to provide a hemodiafiltration device and its leak detection method. The hemodiafiltration device can be used to carry out multiple treatment modes simultaneously, and the leak detection method can effectively solve the defects existing in the prior art to quickly and efficiently detect whether there are leaks in the above device and improve the safety of dialysis treatment.

[0006] To achieve the above technical effects, the present invention adopts the following technical solutions:

[0007] In the first aspect, the present invention provides a hemodiafiltration device, which can be used to implement any one of hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF). The hemodiafiltration device specifically includes:

[0008] A dialyzer, which is separated into a dialysate chamber and a blood chamber by a semipermeable membrane;

[0009] An arterial side pipeline, the end of which is connected to the blood chamber inlet, and an arterial kettle is also connected in series on the arterial side pipeline;

[0010] A venous side pipeline, the starting end of the venous side pipeline is connected to the outlet of the blood chamber, and a venous chamber is connected in series on this venous side pipeline;

[0011] An additional pipeline, the additional pipeline includes a liquid supply pipeline and a first liquid supply branch and a second liquid supply branch communicated with the liquid supply pipeline. The end of the liquid supply pipeline is provided with a second multi-way valve, and at least two pipeline outlets are provided on the second multi-way valve. The first liquid supply branch and the second liquid supply branch are respectively connected to the above two pipeline outlets, and the ends of the first liquid supply branch and the second liquid supply branch are respectively connected to the arterial chamber and the venous chamber, so as to directly convey liquid to the arterial chamber and the venous chamber.

[0012] A liquid supply unit, the liquid outlet end of the liquid supply unit is provided with a first multi-way valve, and the first outlet and the second outlet of the first multi-way valve are respectively connected to the starting end of the liquid supply pipeline and the starting end of the arterial side pipeline.

[0013] Further, a first peristaltic pump is provided on the arterial side pipeline.

[0014] Further, the hemodiafiltration device further includes a liquid collection unit. The end of the venous side pipeline is connected to the liquid collection unit to convey waste liquid to the liquid collection unit for recovery. And a first blocking device is provided on the venous side pipeline between the venous chamber and the liquid collection unit. The first blocking device can clamp the venous side pipeline to block the liquid flow.

[0015] Further, a monitoring unit is provided on the venous chamber.

[0016] Furthermore, the monitoring unit includes at least one pressure monitoring sensor. The pressure monitoring sensor is communicated with the venous chamber through a pressure monitoring pipeline to facilitate real-time monitoring of the pressure in the venous chamber.

[0017] Further, the monitoring unit further includes a liquid level sensor. The liquid level sensor is arranged in the venous chamber and is used for real-time monitoring of the liquid level in the venous chamber.

[0018] Further, the monitoring unit further includes a pressurizing pipeline. A gas passage is formed between the pressurizing pipeline and the pressure monitoring pipeline. The air inlet end of the pressurizing pipeline is further connected with an air inlet accessory, so that during the pressurizing process, the pressure monitoring sensor can detect the pressure in the venous chamber in real time. Specifically, the air inlet accessory is any one of an air compressor and an air pump, so that the venous chamber can be pressurized through the air inlet accessory to increase the pressure in the venous chamber.

[0019] Second aspect, the present invention also provides a leakage detection method for a hemodiafiltration device, which is mainly used to detect whether the arterial side pipeline, venous side pipeline and dialyzer can form a closed loop and whether the joints of the dialyzer are connected properly. Specifically, the joints of the dialyzer include a blood chamber inlet, a blood chamber outlet, a dialysate chamber inlet and a dialysate chamber outlet. The blood chamber inlet and the blood chamber outlet are respectively arranged at the top and bottom of the dialyzer, and the dialysate chamber inlet and the dialysate chamber outlet are arranged on the side wall of the dialyzer and communicate with the dialysate chamber at the same time. In addition, at least one degassing device is provided in the hemodiafiltration device to remove the air in the first preflush liquid and the second preflush liquid, so as to further improve the test accuracy. The degassing device can be rotated according to actual needs.

[0020] Further, for the leakage detection method of the hemodiafiltration device, this method is implemented before the treatment mode, and the treatment mode is any one of hemodialysis (HD), hemofiltration (HF) and hemodiafiltration (HDF). The leakage detection method of the hemodiafiltration device specifically includes the following steps:

[0021] S1: Construct a closed loop, and the closed loop includes a first test loop and a second test loop. Among them,

[0022] The first test loop includes a blood chamber and an arterial side pipeline and a venous side pipeline respectively arranged upstream and downstream of the blood chamber;

[0023] The second test loop includes a dialysate chamber and a dialysate input pipe and a dialysate output pipe respectively arranged upstream and downstream of the dialysate chamber. Solvent exchange can be carried out between the first test loop and the second test loop through a semipermeable membrane. Among them, the dialysate input pipe is used to transport replacement fluid or dialysate into the dialysate chamber, and the dialysate output pipe is used to output the replacement fluid or dialysate in the dialysate chamber outward;

[0024] S2: Fill the first test loop with the first preflush liquid to perform preflushing of the first test loop, and fill the second test loop with the second preflush liquid to perform preflushing of the second test loop, and make the first preflush liquid and the second preflush liquid respectively fill the first test loop and the second test loop;

[0025] S3: Build a test pressure in the closed loop by injecting a certain amount of gas into the first test loop;

[0026] S4: Judge whether the test pressure reaches the preset pressure value. If the test pressure is less than the preset pressure value, it is judged that there is a leakage point in the hemodiafiltration device.

[0027] Further, the first test circuit further includes a liquid supply unit disposed upstream of the arterial side pipeline, and the liquid supply unit is configured to deliver a first priming liquid into the arterial side pipeline.

[0028] Further, in step S2, the first test circuit or the second test circuit may be primed first. Preferably, in S2, the first test circuit is primed first, and after the first priming liquid fills the first test circuit, the second test circuit is primed.

[0029] Further, the first priming liquid and the second priming liquid may be the same or different liquids, specifically any one of normal saline, sterile normal saline, replacement fluid or sterile dialysate, and the first priming liquid is preferably sterile dialysate or sterile normal saline.

[0030] Further, before S3, there is also S2a, and S2a is: detecting whether the liquid level height in the venous chamber is at a preset height. When the liquid level height in the venous chamber is at the preset height, step S3 is implemented. When the liquid level height in the venous chamber is higher or lower than the preset height, a liquid level adjustment step is performed.

[0031] Specifically, the liquid level adjustment step can be performed by any one of the following adjustment methods:

[0032] Adjustment method one:

[0033] The air intake accessory selects an air pump with inflation and air extraction functions. During the adjustment process, the first flow blocking device is always kept open. When the liquid level height in the venous chamber is lower than the preset height, the air intake accessory sucks the gas in the venous chamber outwards to raise the liquid level in the venous chamber. When the liquid level height in the venous chamber is higher than the preset height, the air intake accessory delivers the gas in the external environment into the venous chamber to lower the liquid level height of the venous chamber, so as to achieve the purpose of adjusting the liquid level of the venous chamber. After the adjustment is completed, the first flow blocking device is closed to keep the liquid level in the venous chamber constant.

[0034] Adjustment method two:

[0035] When the liquid level height in the drip chamber is lower than the preset height, a certain amount of liquid is replenished into the drip chamber through the liquid replenishing assembly so that the liquid level height in the drip chamber is at the preset height. When replenishing the liquid, the first flow blocking device is closed, so that the first test circuit is closed. At the same time, to ensure that the liquid replenishing assembly can smoothly transport the liquid into the drip chamber for liquid replenishment, a gas solenoid valve should be provided on the drip chamber, and the gas solenoid valve is arranged at the top of the drip chamber and allows gas to pass through. During the liquid replenishment process, the gas solenoid valve is opened to maintain the air pressure balance inside and outside the drip chamber. At this time, liquid replenishment is carried out through the liquid replenishing assembly until the liquid level height in the drip chamber is constant and at the preset height. After the liquid replenishment is completed, the gas solenoid valve is closed. More specifically, the liquid replenishing assembly includes a liquid supply pipeline and a second liquid supply branch communicated with the liquid supply pipeline, and a second peristaltic pump is arranged on the liquid supply pipeline.

[0036] When the liquid level height in the drip chamber is higher than the preset height, the first flow blocking device is opened, and then the excess first pre-flushing liquid in the drip chamber is output outward through the venous side pipeline so that the liquid level in the drip chamber reaches the preset height.

[0037] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0038] First, a hemodiafiltration device provided by the present invention, by setting a dialyzer, an arterial side pipeline, a venous side pipeline, a liquid supply unit, and an additional pipeline including a first liquid supply branch and a second liquid supply branch, by connecting the end of the arterial side pipeline to the blood chamber inlet of the dialyzer and the starting end of the venous side pipeline to the blood chamber outlet, and then connecting the arterial drip chamber and the venous drip chamber in series to the arterial side pipeline and the venous side pipeline respectively, and then connecting the first liquid supply branch and the second liquid supply branch to communicate the arterial drip chamber and the venous drip chamber with the liquid supply unit respectively, enables the hemodiafiltration device to be simultaneously used for implementing various treatment schemes, including any one of hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF).

[0039] Second, a leakage detection method for a hemodiafiltration device provided by the present invention, by simultaneously constructing a first test circuit and a second test circuit, and by pressurizing the first test circuit under the full state of the first test circuit and the second test circuit to construct a test pressure, thereby enabling detection of whether there is liquid leakage at various locations including the arterial side pipeline, the venous side pipeline, the blood chamber inlet joint, the blood chamber outlet joint, the dialysate chamber inlet joint, and the dialysate chamber outlet joint, to ensure the tightness of the first test circuit and the second test circuit and improve the safety of treatment. Description of the Drawings

[0040] Figure 1The overall structural schematic diagram of a hemodiafiltration device provided by an embodiment of the present invention;

[0041] The reference numerals are: 10, the mainframe; 21, the blood chamber; 22, the dialysate chamber; 221, the dialysate inlet pipe; 221a, the second flow blocking device; 222, the dialysate outlet pipe; 222a, the third flow blocking device; 23, the degassing device; 30, the liquid supply unit; 31, the first liquid unit; 32, the second liquid unit; 33, the first multi-way valve; 34, the arterial side pipeline; 341, the arterial kettle; 342, the first peristaltic pump; 35, the liquid supply pipeline; 351, the second peristaltic pump; 36, the second multi-way valve; 361, the first liquid supply branch; 362, the second liquid supply branch; 40, the venous side pipeline; 41, the venous kettle; 411, the first flow blocking device; 42, the liquid collection unit; 50, the pressure monitoring sensor; 51, the pressure monitoring pipeline; 52, the liquid level sensor; 53, the pressurizing pipeline; 54, the air inlet accessory; 55, the gas solenoid valve. Detailed implementation manners

[0042] The embodiments of the technical solution of the present invention will be described in detail below with reference to the accompanying drawings. The following embodiments are only used to illustrate the technical solution of the present invention more clearly, so they are only examples and cannot be used to limit the protection scope of the present invention.

[0043] Unless otherwise specified, in the present invention, if there are terms such as "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the orientation or positional relationship indicated is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, the terms describing the orientation or positional relationship in the present invention are only used for illustrative purposes and cannot be understood as a limitation of this patent. For those of ordinary skill in the art, the specific meanings of the above terms can be understood in combination with the drawings and specific circumstances.

[0044] It should be specially noted that, in the present invention, the terms "upstream" and "downstream" are based on the fluid flow direction. "Upstream" and "starting end" refer to the direction from which the fluid flows, and "downstream" and "end" both refer to the direction to which the fluid flows. Here, the "fluid flow direction" refers to the direction from the arterial side pipeline to the venous side pipeline. At the same time, the first flow blocking device 411, the second flow blocking device 221a, and the third flow blocking device 222a referred to in the present invention can all be selected from any one of the flow blocking clips and solenoid valves.

[0045] Embodiment 1

[0046] As shown in Figure 1 the present embodiment provides a hemodiafiltration device which can be used to perform any one of hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF). The hemodiafiltration device specifically includes a main unit 10, a dialyzer, an arterial side pipeline 34, a venous side pipeline 40, an additional pipeline, and a liquid supply unit 30 installed on the main unit 10. Among them, the dialyzer is separated into a dialysate chamber 22 and a blood chamber 21 by a semipermeable membrane. The semipermeable membrane allows the solvents in the dialysate chamber 22 and the blood chamber 21 to exchange. The end of the arterial side pipeline 34 is connected to the inlet of the blood chamber 21, and an arterial chamber 341 is connected in series on the arterial side pipeline 34; the starting end of the venous side pipeline 40 is connected to the outlet of the blood chamber 21, and a venous chamber 41 is connected in series on the venous side pipeline 40. The additional pipeline includes a liquid supply pipeline 35 and a first liquid supply branch 361 and a second liquid supply branch 362 communicated with the liquid supply pipeline 35. The end of the liquid supply pipeline 35 is provided with a second multi-way valve 36, and two pipeline outlets are provided on the second multi-way valve 36. The starting ends of the first liquid supply branch 361 and the second liquid supply branch 362 are respectively connected to the above two pipeline outlets, and the ends of the first liquid supply branch 361 and the second liquid supply branch 362 are respectively connected to the arterial chamber 341 and the venous chamber 41 to facilitate directly delivering liquids to the arterial chamber 341 and the venous chamber 41.

[0047] In this embodiment, the liquid supply unit 30 is used to input the first priming liquid into the arterial side pipeline 34, and the liquid supply unit 30 can be any one of the first liquid unit 31 or the second liquid unit 32. The first liquid unit 31 is arranged inside the main machine 10, while the second liquid unit 32 is arranged independently of the main machine 10. Specifically, the first liquid unit 31 is a liquid preparation unit installed inside the main machine 10, and the liquid preparation unit can perform on-line preparation and output of dialysate or replacement fluid or normal saline, while the second liquid unit 32 is a liquid supply unit arranged independently of the main machine 10. The liquid supply unit is processed by a prefabrication method and can be installed on the main machine 10 in a detachable manner, so as to supply liquid to the hemodiafiltration device. The liquid supply unit 30 has a liquid outlet end, and the liquid outlet end is connected to the inlet of the first multi-way valve 33. The first outlet and the second outlet of the first multi-way valve 33 are respectively connected to the starting end of the liquid supply pipeline 35 and the starting end of the arterial side pipeline 34, so as to selectively supply liquid to the liquid supply pipeline 35 and the arterial side pipeline 34. In addition, a first peristaltic pump 342 is provided on the arterial side pipeline 34, a second peristaltic pump 351 is provided on the liquid supply pipeline 35, and a second multi-way valve 36 is provided at the connection of the liquid supply pipeline 35 with the first liquid supply branch 361 and the second liquid supply branch 362. The second multi-way valve 36 includes two pipeline outlets, the first liquid supply branch 361 and the second liquid supply branch 362 are respectively connected to the above two pipeline outlets, and the ends of the first liquid supply branch 361 and the second liquid supply branch 362 are respectively connected to the arterial chamber 341 and the venous chamber 41, so as to selectively transport liquid to the arterial chamber 341 and the venous chamber 41.

[0048] In this embodiment, in order to recover the first priming liquid input into the arterial side pipeline 34 by the liquid supply unit 30 and finally flowing into the venous chamber 41, the hemodiafiltration device further includes a liquid collection unit 42. The liquid collection unit 42 is arranged inside the main machine 10, and the end of the venous side pipeline 40 is connected to the liquid collection unit 42 to transport the waste liquid to the liquid collection unit 42 for recovery. And a first blocking device 411 is provided on the venous side pipeline 40 between the venous chamber 41 and the liquid collection unit 42, and the first blocking device 411 can clamp the venous side pipeline 40 to block the liquid flow.

[0049] In this embodiment, a monitoring unit is provided on the venous chamber 41. The monitoring unit is used to monitor the pressure and liquid level in the venous chamber 41. Specifically, the monitoring unit includes a pressure monitoring sensor 50. The pressure monitoring sensor 50 is communicated with the venous chamber 41 through a pressure monitoring pipeline 51, so as to monitor the pressure in the venous chamber 41 in real time. At the same time, the monitoring unit further includes a liquid level sensor 52. The liquid level sensor 52 is arranged in the venous chamber 41 and is used to monitor the liquid level height in the venous chamber 41 in real time. In addition, the monitoring unit further includes a pressurizing pipeline 53. A gas passage is formed between the pressurizing pipeline 53 and the pressure monitoring pipeline 51. Specifically, the end of the pressurizing pipeline 53 can be directly communicated with either the pressure monitoring pipeline 51 or the venous chamber 41. The air inlet end of the pressurizing pipeline 53 is further connected with an air inlet accessory 54. The air inlet accessory 54 is any one of an air compressor and an air pump, so as to pressurize the venous chamber 41 through the air inlet accessory 54 and increase the pressure in the venous chamber 41. During this process, the pressure monitoring sensor 50 can monitor the pressure in the venous chamber 41 in real time.

[0050] In this embodiment, the hemodiafiltration device should further include a control unit. The first flow blocking device 411, the air inlet accessory 54, the first peristaltic pump 342, the second peristaltic pump 351, the liquid level sensor 52, the pressure monitoring sensor 50, and the first multi-way valve 33 and the second multi-way valve 36 are all electrically connected or signal-connected to the control unit, so as to facilitate the control of the liquid and gas flow directions in the hemodiafiltration device.

[0051] Embodiment 2

[0052] Please refer to Figure 1 , this embodiment provides a leakage detection method for a hemodiafiltration device. The leakage detection step is implemented before the treatment mode. The treatment mode includes any one of hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF). And the hemodiafiltration device is a hemodiafiltration device provided in Embodiment 1. Specifically, the leakage detection method of the hemodiafiltration device is mainly used to detect whether the dialyzer can form a closed loop, whether the liquid outlet joint of the liquid supply unit 30 and each joint of the dialyzer are connected properly (the connection is considered proper when there is no liquid leakage). The joints of the dialyzer include the blood chamber 21 inlet joint, the blood chamber 21 outlet joint, the dialysate chamber 22 inlet joint, and the dialysate chamber 22 outlet joint. The blood chamber 21 inlet and the blood chamber 21 outlet are respectively arranged at the top and bottom of the dialyzer. The dialysate chamber 22 inlet and the dialysate chamber 22 outlet are arranged on the side wall of the dialyzer and are simultaneously communicated with the dialysate chamber 22.

[0053] In this embodiment, the leakage detection method of the hemodiafiltration device specifically includes the following steps:

[0054] S1: Connect the venous side pipeline 40, arterial side pipeline 34, dialyzer, dialysate input pipe 221, and dialysate output pipe 222 to construct a closed loop. The closed loop includes a first test loop and a second test loop. Specifically, the first test loop includes a blood chamber 21 and the arterial side pipeline 34 and venous side pipeline 40 respectively located upstream and downstream of the blood chamber 21; the second test loop includes a dialysate chamber 22 and the dialysate input pipe 221 and dialysate output pipe 222 respectively located upstream and downstream of the dialysate chamber 22. Solvent exchange can be carried out between the first test loop and the second test loop through the semipermeable membrane of the dialyzer. Among them, the dialysate input pipe 221 is used to transport the second preflushing liquid into the dialysate chamber 22, and the dialysate output pipe 222 is used to output the replacement liquid or dialysate in the dialysate chamber 22 outward. In addition, in order to seal both ends of the second test loop, second blocking devices 221a and third blocking devices 222a are respectively provided on the dialysate input pipe 221 and dialysate output pipe 222. When the second blocking device 221a and the third blocking device 222a respectively clamp the dialysate input pipe 221 and dialysate output pipe 222, a closed loop is formed between the dialysate input pipe 221, dialysate chamber 22, and dialysate output pipe 222.

[0055] S2: First, preflush the first test loop. The preflushing of the first test loop is provided with the first preflushing liquid by the liquid supply unit 30 and makes the first preflushing liquid fill the first test loop to avoid generating air bubbles in the first test loop. At this time, the liquid level sensor 52 provided in the venous chamber 41 detects the liquid level height in the venous chamber 41. When there is no liquid entering the venous chamber 41, it is an abnormal situation, which can prompt that the liquid outlet end joint of the liquid supply unit 30 is connected incorrectly and needs to be adjusted manually. If there is no such abnormal situation, then preflush the second test loop. When preflushing the second test loop, the second preflushing liquid is input into the dialysate chamber 22 by the dialysate input pipe 221 and makes the second preflushing liquid fill the dialysate chamber 22 and then output outward through the dialysate output pipe 222. At this time, both the first test loop and the second test loop are in a filled state. At this time, it is detected whether the liquid level height in the venous chamber 41 detected by the liquid level sensor 52 provided in the venous chamber 41 is at a preset height. When the liquid level height in the venous chamber 41 is at the preset height, step S3 is started. When the liquid level height in the venous chamber 41 is higher or lower than the preset height, a liquid level adjustment step is carried out. Specifically, the liquid level adjustment step adopts the following adjustment method:

[0056] When the liquid level height in the drip chamber 41 is lower than the preset height, a certain amount of liquid is replenished into the drip chamber 41 through the liquid replenishing component so that the liquid level height in the drip chamber 41 is at the preset height. Specifically, in this process, the control unit controls the gas solenoid valve 55 on the drip chamber 41 to open so that the gas inside and outside the drip chamber 41 can circulate, and then the first flow blocking device 411 is closed so that the first test circuit is closed. Then, the control unit controls the second peristaltic pump 351 and the second multi-way valve 36 to cooperate to deliver the first priming solution to the drip chamber 41 to raise the liquid level in the drip chamber 41 until the liquid level in the drip chamber 41 is at the preset height. When the liquid level height in the drip chamber 41 is higher than the preset height, the control unit opens the first flow blocking device 411, and then the excess first priming solution in the drip chamber 41 is output outward through the venous side pipeline 40 so that the liquid level in the drip chamber 41 reaches the preset height.

[0057] S3: When the liquid level height in the drip chamber 41 is at the preset height, the first flow blocking device 411, the second flow blocking device 221a, and the third flow blocking device 222a are closed. At this time, the initial venous pressure P0 in the drip chamber 41 is recorded by the pressure monitoring sensor 50. Then, the control unit controls the air inlet accessory 54 to work to inject a certain amount of gas into the first test circuit to build a test pressure in the closed circuit. After the injection process is completed, the pressure in the drip chamber 41 is detected again by the pressure monitoring sensor 50 and the test pressure Pv is recorded.

[0058] S4: Determine whether the test pressure Pv reaches the preset pressure value. If the test pressure is less than the preset pressure value, it is determined that there is a leakage point in the hemodiafiltration device. The preset pressure value is the standard value that the venous pressure can reach after injecting a certain amount of gas when there is no leakage at the first test circuit, the second test circuit, the blood chamber 21 inlet joint, the blood chamber 21 outlet joint, the dialysate chamber 22 inlet joint, the dialysate chamber 22 outlet joint, and the liquid outlet joint of the liquid supply unit 30 under the initial venous pressure P0. When there is a leakage point in the hemodiafiltration device, a prompt can be sent to the user in any one of the ways of display, voice, or buzzer to ensure the safety of the treatment process.

[0059] In this embodiment, the first pre-flushing liquid and the second pre-flushing liquid can be the same or different liquids. The second pre-flushing liquid can be any one of normal saline, sterile normal saline, replacement fluid or sterile dialysis fluid, and the first pre-flushing liquid is sterile dialysis fluid or sterile normal saline. In addition, to improve the accuracy of the leak detection, at least one degassing device 23 is provided in the hemodiafiltration device to remove the air in the first pre-flushing liquid and the second pre-flushing liquid, thereby improving the detection accuracy. Specifically, two sets of degassing devices 23 are provided, and the two sets of degassing devices 23 are respectively arranged upstream of the first multi-way valve 33 and upstream of the dialysis fluid input pipe 221 to prevent air bubbles from entering the first test circuit and the second test circuit, resulting in a decrease in the detection accuracy.

[0060] The above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the purpose and scope of the technical solutions of the present invention, and they should all be covered by the scope of the claims of the present invention. The technologies, shapes, and structures not described in detail in the present invention are all well-known technologies.

Claims

1. A hemodiafiltration device, characterized in that, it comprises: a dialyzer, which is divided into a dialysate chamber (22) and a blood chamber (21) by a semipermeable membrane; an arterial side pipeline (34), the end of the arterial side pipeline (34) is connected to the inlet of the blood chamber (21), and an arterial kettle (341) is also connected in series on the arterial side pipeline (34); a venous side pipeline (40), the starting end of the venous side pipeline (40) is connected to the outlet of the blood chamber (21), and a venous kettle (41) is connected in series on the venous side pipeline (40); an additional pipeline, the additional pipeline comprises a liquid supply pipeline (35) and a first liquid supply branch (361) and a second liquid supply branch (362) communicated with the liquid supply pipeline (35), the end of the liquid supply pipeline (35) is respectively connected to the arterial kettle (341) and the venous kettle (41) through the first liquid supply branch (361) and the second liquid supply branch (362); a liquid supply unit (30), a first multi-way valve (33) is arranged at the liquid outlet end of the liquid supply unit (30), and the first outlet and the second outlet of the first multi-way valve (33) are respectively connected to the starting end of the liquid supply pipeline (35) and the starting end of the arterial side pipeline (34); It further comprises a liquid collection unit (42), the end of the venous side pipeline (40) is connected to the liquid collection unit (42), and a first flow blocking device (411) is arranged on the venous side pipeline (40) between the venous kettle (41) and the liquid collection unit (42).

2. A hemodiafiltration device according to claim 1, characterized in that: a monitoring unit is arranged on the venous kettle (41).

3. A hemodiafiltration device according to claim 2, characterized in that: the monitoring unit comprises at least one pressure monitoring sensor (50), and the pressure monitoring sensor (50) is communicated with the venous kettle (41) through a pressure monitoring pipeline (51).

4. A hemodiafiltration device according to claim 3, characterized in that: the monitoring unit further comprises a liquid level sensor (52), and the liquid level sensor (52) is arranged in the venous kettle (41) and is used for monitoring the liquid level in the venous kettle (41).

5. A hemodiafiltration device according to claim 3, characterized in that: the monitoring unit further comprises a pressurizing pipeline (53), a gas passage is formed between the pressurizing pipeline (53) and the pressure monitoring pipeline (51), and an air inlet accessory (54) is further connected to the air inlet end of the pressurizing pipeline (53).

6. A hemodiafiltration device according to claim 5, characterized in that: the air inlet accessory (54) is any one of an air compressor and an air pump.

7. A leakage detection method for a hemodiafiltration device according to any one of claims 1-6, characterized in that, it comprises the following steps: S1: Construct a closed loop, the closed loop includes a first test loop and a second test loop, wherein, the first test loop includes a blood chamber (21) and an arterial side pipeline (34) and a venous side pipeline (40) respectively arranged upstream and downstream of the blood chamber (21); The second test loop includes a dialysate chamber (22) and a dialysate input pipe (221) and a dialysate output pipe (222) respectively arranged upstream and downstream of the dialysate chamber (22), and solvent exchange can be carried out between the first test loop and the second test loop through a semi-permeable membrane; S2: Fill the first test loop with a first pre-flushing liquid to perform pre-flushing of the first test loop, fill the second test loop with a second pre-flushing liquid to perform pre-flushing of the second test loop, and make the first pre-flushing liquid and the second pre-flushing liquid respectively fill the first test loop and the second test loop; S3: Build a test pressure in the closed loop by injecting a certain amount of gas into the first test loop; S4: Judge whether the test pressure reaches a preset pressure value. If the test pressure is less than the preset pressure value, it is judged that there is a leakage point in the hemodiafiltration device.

8. A leakage detection method for a hemodiafiltration device according to claim 7, characterized in that, Before S3, there is also S2a, and S2a is: detect whether the liquid level height in the venous chamber (41) is at a preset height. When the liquid level height in the venous chamber (41) is at the preset height, step S3 is implemented.

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