A detection method for determining the degree of clogging in clinical dialyzers

Abstract

This invention discloses a detection method for determining the degree of blockage in clinical dialyzers, comprising the following steps: S1, constructing a simulated pipeline system; This invention utilizes the above method to quickly reproduce pressure rise scenarios by simulating clinical pressure data, directly locating the blockage position, avoiding long-term on-site tracking by engineers, thus achieving the advantages of accurate positioning and high efficiency. It establishes a correspondence between the blockage standard sample and the flow valve scale, achieving quantification of the severity of blockage for the first time, providing accurate data for equipment maintenance, and achieving strong quantification. It can simulate various blockage scenarios such as arterial end face, venous end face, and side wall holes, and is applicable to different types of dialyzers and plasma separators. Furthermore, the operation process is repeatable, achieving good versatility and repeatability. It requires no complex detection equipment, only existing pipelines, valves, and pressure gauges, significantly reducing the cost of problem analysis.

Description

Technical Field

[0001] This invention relates to the field of blood purification technology, and more specifically to a detection method for determining the degree of blockage in a clinical dialyzer. Background Technology

[0002] During clinical use, products such as plasma separators and dialyzers frequently experience issues such as increased transmembrane pressure and increased pre-filter pressure, leading to equipment alarms and, in severe cases, requiring emergency shutdown. However, when clinical nurses report these pressure increases to engineers, the following issues arise:

[0003] It is difficult to determine the cause of the pressure increase and the corresponding location of the blockage, making it even more difficult to optimize product performance;

[0004] Engineers need to track product usage at clinical sites for a long time before they may encounter situations where pressure increases, wasting a lot of time.

[0005] There are no quantifiable indicators to measure the severity of hole blockage. Summary of the Invention

[0006] The purpose of this invention is to provide a detection method for determining the degree of blockage in a clinical dialyzer, which can identify the location of blockages causing increased clinical pressure and reduce the analysis cost of problems with increased clinical pressure. It can also quantify the severity of blockages, thereby solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution: a method for determining the degree of blockage in a clinical dialyzer, comprising the following steps:

[0008] S1. Construct a simulated pipeline system: Connect flow valve 1, flow valve 2, flow valve 3, flow valve 4 and flow valve 5 with pressure gauge 1, pressure gauge 2, pressure gauge 3, pressure gauge 4, as well as peristaltic pump 1 and peristaltic pump 2, and the pipeline connecting the dialyzer to be tested and the plasma separator, and the water tank according to the preset path to form a simulated system consistent with the clinical dialyzer workflow.

[0009] S2, Pipe clamping simulation of blockage scenario: The pipe clamping tool is used to selectively clamp different target pipes in the simulation system to simulate the blockage scenario at the corresponding location, and the pressure changes of each pressure gauge are recorded in real time.

[0010] S3, Pressure Comparison and Location Determination: Compare the pressure change data under various clamping scenarios with the dialyzer pressure increase data reported by the clinic.

[0011] If the pressure change in a certain clamping scenario is completely consistent with clinical data, then the clamping location is determined to be the actual clinical plugging location.

[0012] S4, Prepare plugging standard samples: Prepare end face membrane wire plugging standard samples: Prepare end face membrane wire samples with plugging ratios of 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8;

[0013] Preparation of standard samples for sidewall hole plugging: Prepare membrane fiber samples with the following proportions of no sidewall holes: 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8.

[0014] S5, Calibrate the flow valve scale: Connect the standard samples of each specification end face diaphragm plug hole to the simulated pipeline system in S1 respectively, use cow blood or human blood as experimental liquid, start the system and run stably for 2-3 minutes, and record the pressure value of each pressure gauge.

[0015] Adjust the corresponding flow valve to the pressure value, and mark the plugging ratio corresponding to the pressure value on the flow valve;

[0016] Similarly, standard samples of sidewall hole blockage of various specifications were connected to the simulation system, pressure values ​​were recorded, and flow valves were adjusted to mark the severity of the blockage.

[0017] S6, Determination of actual blockage: Connect the dialyzer and plasma separator that show increased pressure in clinical settings to the simulated pipeline system, and adjust the flow valve to make the system pressure value consistent with the clinical pressure data.

[0018] Based on the current scale of the flow valve and the corresponding relationship of S5 calibration, the actual number of blocked holes can be directly determined, which can be targeted at the end face or the side wall holes depending on the severity.

[0019] For example, the simulated system in the constructed simulated pipeline system includes blood inflow, filtration, and return paths that match clinical practice.

[0020] For example, the pressure comparison and the comparison with the data in the position determination include the pump pre-pressure, filter pre-pressure and transmembrane pressure before the machine is removed.

[0021] For example, the simulated pipe clamping and hole blocking scenario in the described simulated pipe clamping and hole blocking scenario includes:

[0022] Clamping the arterial end cap before tubing: Simulating the blockage of the arterial end face of the dialyzer or the blockage of the arterial chamber;

[0023] Clamping the rear tubing of the venous air chamber: Simulating the plugging of the venous end face of a dialyzer;

[0024] Clamping the dialyzer filter outlet pre-plasma pump tubing: Simulating the sidewall pore plugging of a hollow fiber membrane;

[0025] Clamping the tubing connected to the human body before the blood pump: Simulating the plugging of a central venous catheter;

[0026] Clamping the tubing connecting the venous reservoir to the human body: simulating central venous catheter blockage or venous reservoir occlusion.

[0027] For example, the pressure value recorded in the calibration flow valve scale and the flow valve mark corresponding to the severity of blockage are specifically: 3 / 4 blockage corresponding to the scale, forming a correspondence between the number of blockage holes on the end face diaphragm wire and the flow valve scale.

[0028] For example, the clamping simulation blockage scenario includes clamping the tubing before the arterial end cap, simulating blockage of the dialyzer arterial end face or blockage of the arterial chamber.

[0029] When clamping the tubing at the rear end of the venous air reservoir, simulate blocking the venous end face of the dialyzer;

[0030] When clamping the tubing before the plasma pump at the dialyzer filter outlet, simulate the blockage of the sidewall pores of the hollow fiber membrane.

[0031] For example, the pressure comparison and position determination process includes first adjusting the simulation system to the pressure parameters when the clinical dialyzer is first connected, running it stably for 2-3 minutes, then adjusting the flow valve to make the system pressure parameters consistent with the pressure rise parameters before the clinical dialyzer is disconnected, running it stably for another 2-3 minutes, and then recording the pressure change data.

[0032] For example, the calibration of the flow valve scale includes a stable operating time of 2-3 minutes after connecting to the simulated pipeline system, ensuring that the pressure value is stable before marking the flow valve scale.

[0033] For example, the experimental solution used in the determination of the actual degree of blockage is bovine blood, which is matched with the characteristics of clinical blood to improve the accuracy of the determination of the severity of blockage.

[0034] Compared with the prior art, the beneficial effects of the present invention are:

[0035] This invention utilizes the aforementioned method to rapidly reproduce pressure elevation scenarios by simulating clinical pressure data, directly locating the blockage site. This avoids long-term on-site tracking by engineers, achieving the advantages of precise location and high efficiency. It establishes a correspondence between the blockage standard sample and the flow valve scale, achieving, for the first time, the quantification of blockage severity. This provides accurate data for equipment maintenance and achieves strong quantification. It can simulate various blockage scenarios such as arterial end face, venous end face, and side wall holes, and is applicable to different types of dialyzers and plasma separators. The operation process is repeatable, achieving good versatility and repeatability. It requires no complex testing equipment, only existing pipelines, valves, and pressure gauges, significantly reducing problem analysis costs. It effectively determines the location of blockages causing clinical pressure elevation, reduces the cost of analyzing clinical pressure elevation problems, and quantifies the severity of blockages.

[0036] Other features and advantages of the invention will be set forth in the following description, and will be apparent in part from the description, or may be learned by practicing the invention. The objects and other advantages of the invention can be realized and obtained by means of the structures pointed out in the description and the drawings. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the structure of the present invention;

[0038] Figure 2 This is a flowchart of the method of the present invention.

[0039] In the diagram: 1. Flow valve one; 2. Pressure gauge one; 3. Peristaltic pump one; 4. Pressure gauge two; 5. Flow valve two; 6. Connecting pipeline; 7. Pressure gauge three; 8. Flow valve three; 9. Peristaltic pump two; 10. Flow valve four; 11. Pressure gauge four; 12. Flow valve five; 13. Water tank. Detailed Implementation

[0040] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] This invention provides a method for determining the degree of blockage in a clinical dialyzer, comprising the following steps:

[0042] S1. Construct a simulated pipeline system: Connect flow valve 1, flow valve 2, flow valve 3, flow valve 4, and flow valve 5 to pressure gauge 2, pressure gauge 2, pressure gauge 3, pressure gauge 4, as well as peristaltic pump 3, peristaltic pump 2, and the pipeline connecting pipeline 6 between the dialyzer to be tested and the plasma separator, and water tank 13 according to the preset path to form a simulated system consistent with the workflow of a clinical dialyzer.

[0043] S2, Pipe clamping simulation of blockage scenario: The pipe clamping tool is used to selectively clamp different target pipes in the simulation system to simulate the blockage scenario at the corresponding location, and the pressure changes of each pressure gauge are recorded in real time.

[0044] S3, Pressure Comparison and Location Determination: Compare the pressure change data under various clamping scenarios with the dialyzer pressure increase data reported by the clinic.

[0045] If the pressure change in a certain clamping scenario is completely consistent with clinical data, then the clamping location is determined to be the actual clinical plugging location.

[0046] S4, Prepare plugging standard samples: Prepare end face membrane wire plugging standard samples: Prepare end face membrane wire samples with plugging ratios of 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8;

[0047] Preparation of standard samples for sidewall hole plugging: Prepare membrane fiber samples with the following proportions of no sidewall holes: 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8.

[0048] S5, Calibrate the flow valve scale: Connect the standard samples of each specification end face diaphragm plug hole to the simulated pipeline system in S1 respectively, use cow blood or human blood as experimental liquid, start the system and run stably for 2-3 minutes, and record the pressure value of each pressure gauge.

[0049] Adjust the corresponding flow valve to the pressure value, and mark the plugging ratio corresponding to the pressure value on the flow valve;

[0050] Similarly, standard samples of sidewall hole blockage of various specifications were connected to the simulation system, pressure values ​​were recorded, and flow valves were adjusted to mark the severity of the blockage.

[0051] S6, Determination of actual blockage: Connect the dialyzer and plasma separator that show increased pressure in clinical settings to the simulated pipeline system, and adjust the flow valve to make the system pressure value consistent with the clinical pressure data.

[0052] Based on the current scale of the flow valve and the corresponding relationship of S5 calibration, the actual number of blocked holes can be directly determined, which can be targeted at the end face or the side wall holes depending on the severity.

[0053] Preferably, the simulated system in the simulated pipeline system includes blood inflow, filtration, and return paths that match clinical practice.

[0054] The comparison of data in the pressure comparison and position determination includes the pre-pump pressure, pre-filter pressure, and transmembrane pressure before the machine is removed from the equipment.

[0055] Furthermore, the simulated pipe clamping and hole plugging scenarios in the pipe clamping simulation include:

[0056] Clamping the arterial end cap before tubing: Simulating the blockage of the arterial end face of the dialyzer or the blockage of the arterial chamber;

[0057] Clamping the rear tubing of the venous air chamber: Simulating the plugging of the venous end face of a dialyzer;

[0058] Clamping the dialyzer filter outlet pre-plasma pump tubing: Simulating the sidewall pore plugging of a hollow fiber membrane;

[0059] Clamping the tubing connected to the human body before the blood pump: Simulating the plugging of a central venous catheter;

[0060] Clamping the tubing connecting the venous reservoir to the human body: simulating central venous catheter blockage or venous reservoir occlusion.

[0061] Furthermore, the pressure value is recorded in the calibration of the flow valve scale, and the flow valve marking is adjusted to correspond to the severity of the blockage. Specifically, the scale corresponding to 3 / 4 blockage is used to form the relationship between the number of blockage holes on the end face diaphragm wire and the flow valve scale.

[0062] Specifically, the clamping simulation of the blockage scenario includes clamping the tubing before the arterial end cap, simulating blockage of the dialyzer arterial end or arterial pot blockage.

[0063] When clamping the tubing at the rear end of the venous air reservoir, simulate blocking the venous end face of the dialyzer;

[0064] When clamping the tubing before the plasma pump at the dialyzer filter outlet, simulate the blockage of the sidewall pores of the hollow fiber membrane.

[0065] The pressure comparison and location determination process includes adjusting the simulation system to the pressure parameters when the clinical dialyzer is first connected before comparison, running it stably for 2-3 minutes, then adjusting the flow valve to make the system pressure parameters consistent with the pressure rise parameters before the clinical dialyzer is disconnected, running it stably for another 2-3 minutes, and then recording the pressure change data.

[0066] In addition, the calibration of the flow valve scale includes a stable operating time of 2-3 minutes after connecting to the simulated pipeline system. Ensure that the pressure value is stable before marking the flow valve scale.

[0067] Finally, bovine blood was used as the experimental solution in the actual determination of the degree of blockage, which was matched with the characteristics of clinical blood to improve the accuracy of the determination of the severity of blockage.

[0068] A plasma separator is experiencing an abnormally high transmembrane pressure of 79 mmHg, requiring location of the plugging point. Current pressure parameters are as follows:

[0069] Before discharging, the pump pressure was -40 mmHg, the filter pressure was 152 mmHg, the filtration pressure was 46 mmHg, the venous pressure was 98 mmHg, the transmembrane pressure was 79 mmHg, and the pressure drop was 54 mmHg.

[0070] Within half an hour of starting the machine, the pre-pump pressure was -36 mmHg, the pre-filter pressure was 67 mmHg, the filtration pressure was 50 mmHg, the venous pressure was 41 mmHg, the transmembrane pressure was 4 mmHg, and the pressure drop was 26 mmHg.

[0071] The specific implementation steps are as follows: build a simulated pipeline system and connect it to the same plasma separator pipeline used in hospitals;

[0072] Adjust the system parameters to simulate the pressure parameters within the first half hour after installation. Start peristaltic pump 3 and peristaltic pump 9 and run them for 2-3 minutes to ensure the system pressure is stable.

[0073] Gradually adjust flow valve 1, flow valve 5, flow valve 3, flow valve 4, and flow valve 5 to make the readings of pressure gauge 12, pressure gauge 24, pressure gauge 37, and pressure gauge 41 basically consistent with the "pressure parameters before shutdown". Then run it stably for 2-3 minutes again.

[0074] Record the adjustment results of the flow valves: only flow valve 2 (5) was reduced by 2 marks and flow valve 5 (12) was reduced by 3 marks, while the other flow valves remained unchanged;

[0075] Based on the corresponding clamp relationships: flow valve 2 (5) corresponds to the arterial end blood cap pipeline, and flow valve 5 (12) corresponds to the venous end air reservoir pipeline. Therefore, it is determined that the plasma separator has a blockage at the arterial blood cap (2 units) and a blockage at the venous air reservoir (3 units).

[0076] Based on the above steps, this method is used to quantify the degree of hole blockage;

[0077] Specific implementation steps:

[0078] Prepare standard samples as described above: end face membrane wire plug hole standard samples (3 / 4, 1 / 2, etc.), side wall hole plug hole standard samples (3 / 4, 1 / 2, etc.).

[0079] Calibrate the flow valve scale as described above: Connect the standard sample from the end face diaphragm wire plug to the system, use cow blood as the experimental solution, record the pressure value and mark the flow valve scale. For example, "1 / 4 plug" corresponds to adjusting the flow valve scale down by 2 scales, "3 / 8 plug" corresponds to adjusting it down by 3 scales, and so on.

[0080] Connect the plasma separator with abnormal pressure in the example to the system, use bovine blood as the experimental solution, and adjust the flow valves to match the pressure before disconnection (decrease flow valve 2.5 by 2 scales and decrease flow valve 5.12 by 3 scales).

[0081] Based on the established correspondence between the scale and the plugging ratio, the plugging ratio at the arterial blood cap is determined to be 1 / 4 (corresponding to 2 scales), and the plugging ratio at the venous air chamber or the central venous catheter is determined to be 1 / 4.

[0082] Based on the above embodiments, flow valve 1, flow valve 5, flow valve 8, flow valve 4, and flow valve 5 are marked with the above-mentioned scales, and ox blood is used instead of experimental liquid to determine the degree of blockage in the actual clinical situation.

[0083] When problems such as increased pressure occur during clinical use, the pressure value can be quickly reproduced based on the pressure data during clinical use, which plays a directional role in finding the cause of the increased pressure. It can also determine the degree of membrane pore blockage and sidewall pore contamination. Furthermore, it is simple to operate, reusable, and can simulate various complex clinical situations, while reducing the cost of problem analysis and improving the speed of problem analysis.

[0084] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method of determining the degree of clogging of a clinical dialyzer, characterized in that, It comprises the following steps: S1, build a simulated pipeline system: connect flow valve one (1), flow valve two (5), flow valve three (8), flow valve four (10) and flow valve five (12) with pressure gauge one (2), pressure gauge two (4), pressure gauge three (7), pressure gauge four (11), and peristaltic pump one (3) and peristaltic pump two (9) with the pipeline (6) of the dialyzer and plasma separator to be detected and the sink (13) according to the preset path to form a simulated system consistent with the clinical dialyzer working process; S2, simulate the scene of plugging the hole by clamping the pipe: use a pipe clamping tool to selectively clamp different target pipelines in the simulated system to simulate the plugging scene at the corresponding position, and record the pressure changes of each pressure gauge in real time; S3, pressure comparison and position determination: compare the pressure change data under each clamping scene with the clinical feedback dialyzer pressure rise data; If the pressure change of a certain clamping scene is completely consistent with the clinical data, it is determined that the clamping position is the actual plugging position in the clinic; S4, make a plugging standard sample: make an end face membrane plug plugging standard sample: prepare end face membrane samples with plugging ratios of 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8; Make a side wall hole plugging standard sample: prepare membrane samples with no side wall hole ratios of 3 / 4, 5 / 8, 1 / 2, 3 / 8, 1 / 4, and 1 / 8; S5, calibrate the flow valve scale: connect each specification end face membrane plugging standard sample to the simulated pipeline system in S1, use bovine blood or human blood as the experimental liquid, start the system and run it stably for 2-3 minutes, then record the pressure values of each pressure gauge; Adjust the corresponding flow valve to the pressure value, and mark the plugging ratio corresponding to the pressure value on the flow valve; Similarly, connect each specification side wall hole plugging standard sample to the simulated system, record the pressure values and adjust the flow valve to mark the corresponding plugging severity; S6, determine the actual plugging degree: connect the dialyzer and plasma separator with clinically elevated pressure to the simulated pipeline system, adjust the flow valve to make the system pressure value consistent with the clinical pressure data; According to the current scale of the flow valve and the corresponding relationship calibrated in S5, the number of actual plugging can be directly determined.

2. The method of claim 1, wherein: The simulated system in the simulated pipeline system comprises a path matching the clinical actual blood inflow, filtration, and backflow.

3. The method of claim 1, wherein the method comprises: a) determining the number of holes in the dialyzer; b) determining the number of holes in the dialyzer that are blocked; and c) determining the percentage of blocked holes in the dialyzer. The data comparison in the pressure comparison and position determination comprises the pre-pump pressure, pre-filter pressure, and transmembrane pressure before the machine.

4. The method of claim 1, wherein: The clamping simulation plugging scene in the clamping simulation plugging scene comprises: Clamp the arterial end blood cover front pipeline: simulate the plugging of the arterial end face of the dialyzer or the plugging of the arterial pot; Clamp the venous end blood cover rear pipeline: simulate the plugging of the venous end face of the dialyzer; Clamp the dialyzer filter outlet blood plasma pump front pipeline: simulate the plugging of the hollow fiber membrane side wall hole; Clamp the pipeline connected to the human body before the blood pump: simulate the plugging of the central venous catheter; Clamp the pipeline connected to the human body after the venous pot: simulate the plugging of the central venous catheter or the plugging of the venous pot.

5. The method of claim 1, wherein: the step of determining the degree of clogging of the dialyzer is performed by measuring the pressure drop across the dialyzer. In the calibration of the flow valve scale, the pressure values are recorded and the flow valve is adjusted to mark the corresponding plugging severity: 3 / 4 plugging corresponds to the scale, forming the relationship between the number of end face membrane plugging and the flow valve scale.

6. The method of claim 1, wherein: The pinch simulation analogs the scene of blocking the hole, including clamping the tube on the arterial end of the blood cover, simulating the arterial end of the dialyzer or the blockage of the arterial pot; Clamping the tube on the venous end of the blood cover, simulating the venous end of the dialyzer; Clamping the tube on the dialyzer filter outlet blood plasma pump, simulating the hole blocking of the hollow fiber membrane side wall.

7. The method of claim 1, wherein: the step of determining the degree of clogging of the dialyzer is performed by measuring the pressure drop across the dialyzer. The pressure comparison and position determination includes adjusting the simulation system to the pressure parameters of the clinical dialyzer just on the machine, and then adjusting the flow valve to make the system pressure parameters consistent with the pressure rise parameters before the clinical machine, and then recording the pressure change data after stable operation for 2-3 minutes.

8. The method of claim 1, wherein: the step of determining the degree of clogging of the dialyzer is performed by measuring the pressure drop across the dialyzer. The calibration of the flow valve scale includes stable operation time of 2-3 minutes after connecting the simulation pipeline system, and ensuring that the pressure value is stable before marking the flow valve scale.

9. The method of claim 1, wherein: the step of determining the degree of clogging of the dialyzer is performed by measuring the pressure drop across the dialyzer. The experimental liquid in the actual blocking degree determination adopts cow blood, which matches the characteristics of clinical blood to improve the accuracy of the blocking severity determination.

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