Blood chamber tightness detection device for plasma separator

Abstract

The utility model relates to the technical field of detection, and particularly discloses a plasma separator blood chamber tightness detection device which comprises an aerosol generator, a plasma separator and a particle size detection analyzer. Wherein the output end of the aerosol generator is connected with the blood chamber input end of the plasma separator; the plasma output end of the plasma separator is connected with the particle size detection analyzer; a hollow fiber membrane is arranged in the plasma separator; the aerosol generator is used for preparing liquid particle aerosol. According to the plasma separator blood chamber sealing performance detection device, the liquid particle aerosol is adopted as leakage detection particles and is not prone to deposition on a fiber membrane of the plasma separator, and the complexity degree of follow-up treatment of the plasma separator can be effectively reduced.

Description

Technical Field

[0001] The present application relates to the field of detection technology, and in particular to a device for detecting the tightness of a blood chamber in a plasma separator. Background Art

[0002] Plasma adsorption therapy is an advanced medical technology. In this therapy, plasma is separated from the formed elements of the blood, such as red blood cells, white blood cells, and platelets, through a specific procedure. After separation, the formed elements can be returned to the body, while the plasma is processed to remove pathogenic plasma pathological components, such as autoantibodies, immune complexes, paraproteins, abnormally elevated substances, and protein-bound toxins. This therapy can treat many conditions that are ineffective with conventional therapies, including autoimmune diseases such as systemic lupus erythematosus (SLE), autoantibody-mediated diseases, thrombotic thrombocytopenic purpura (TTP), and hemolytic uremic syndrome (HUS). The key to plasma adsorption therapy lies in the effective use of the plasma separator. As an important medical device, the performance of the plasma separator directly affects the effectiveness of plasma separation. If the fiber membrane in the plasma separator ruptures, resulting in an incomplete seal within the plasma separator chamber, the quality and efficiency of plasma separation will be severely affected, and thus the overall therapeutic efficacy. Therefore, ensuring the seal of the plasma separator chamber is crucial for the successful implementation of plasma adsorption therapy.

[0003] In existing technology, wet leak testing is commonly used to test the integrity of fiber membranes in blood purifiers (including plasma separators, dialyzers, and hemoperfusion devices). Specifically, the dialyzer is filled with water for injection, which seals the pores in the hollow fiber membrane wall. The water is then drained, and compressed air is injected into the dialyzer inlet and outlet to maintain pressure. The integrity of the hollow fiber membrane wall is determined by measuring the pressure drop per unit time. However, this technique is only suitable for dialyzer hollow fiber membranes, which typically have pores smaller than 10 nanometers. Water surface tension can effectively block these pores, thus enabling membrane integrity testing. However, the hollow fiber membranes used in plasma separators have larger pores, typically 0.2 to 0.5 microns, making this method difficult to effectively detect and significantly affecting test accuracy.

[0004] Existing technologies often use suspended particles to test the integrity of hollow fiber membranes, which offers some advantages. However, since suspended particles often contain solid particles, they can easily accumulate on the hollow fiber membranes during testing. This necessitates pre-treatment to remove the solid particles before subsequent use, complicating subsequent handling and use of the hollow fiber membranes. Therefore, it is necessary to develop a testing device that eliminates the need for complex post-test processing. Utility Model Content

[0005] In view of this, the purpose of the present application is to provide a plasma separator blood chamber tightness detection device to solve the problem that the existing detection method is prone to clogging the hollow fiber membrane, thereby complicating the subsequent processing process of the hollow fiber membrane.

[0006] In order to achieve the above technical objectives, the present application provides a plasma separator blood chamber tightness detection device, comprising an aerosol generator 1, a plasma separator 2, and a particle size detection analyzer 3;

[0007] The output end of the aerosol generator 1 is connected to the blood chamber input end 22 of the plasma separator 2; the plasma output end 25 of the plasma separator 2 is connected to the particle size detection analyzer 2;

[0008] The plasma separator 2 is provided with a hollow fiber membrane 21;

[0009] The aerosol generator 1 is used to prepare an initial aerosol in the form of liquid particles.

[0010] Furthermore, it also includes a rate detector 11, which is arranged between the aerosol generator 1 and the plasma separator 2 and is used to detect the migration rate of the aerosol.

[0011] Furthermore, the initial aerosol is liquid particles of a saline solution.

[0012] Furthermore, the initial aerosol is liquid particles of sodium chloride solution.

[0013] Furthermore, the particle size of the liquid particles in the initial aerosol is less than or equal to 10.00 μm.

[0014] Furthermore, the particle size of the liquid particles in the initial aerosol is 0.02-2.00 μm.

[0015] Furthermore, the plasma separator 2 is placed vertically, with the blood chamber input end 22 of the plasma separator 2 at the bottom and the blood chamber output end 23 at the top.

[0016] Furthermore, the blood chamber output end 23 of the plasma separator 2 is not provided with an end cap.

[0017] Furthermore, the plasma separator 2 is not provided with an end cap.

[0018] Furthermore, the particle size detection analyzer 3 is also connected to the blood chamber input end 22 of the plasma separator 2 for detecting the particle size of the liquid particles in the initial aerosol.

[0019] The present application provides an application of a plasma separator blood chamber tightness detection device, which is applied to defect detection of hollow fiber membranes in the medical field.

[0020] In summary, the present application provides a plasma separator blood chamber tightness detection device, comprising an aerosol generator 1, a plasma separator 2, and a particle size detection analyzer 3; the output end of the aerosol generator 1 is connected to the blood chamber input end 22 of the plasma separator 2; the plasma output end 25 of the plasma separator 2 is connected to the particle size detection analyzer 2; the aerosol generator 1 is used to prepare liquid particle aerosol. The test method adopted in the present application is simple and has high test accuracy. Compared with the prior art, the aerosol used in the present application is liquid particle, which is not easy to accumulate at the filter membrane and clog the filter membrane, simplifies the subsequent hollow fiber membrane processing procedure, reduces production energy consumption, and can effectively control the manufacturing cost in the production process of medical hollow fiber membranes. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0022] Figure 1 This is a schematic diagram of a plasma separator blood chamber tightness detection device provided in Example 1 of the present application;

[0023] Figure numerals: 1. aerosol generator; 11. rate detector; 2. plasma separator; 21. hollow fiber membrane; 22. blood chamber input end; 23. blood chamber output end; 24. plasma output end; 25. plasma output end; 3. particle size detection analyzer. DETAILED DESCRIPTION

[0024] The following will clearly and completely describe the technical solutions of the embodiments of this application in conjunction with the accompanying drawings. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments in this specification, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection requested by this application.

[0025] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate the description of this application and simplify the description. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0026] Unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be interpreted broadly. For example, they can refer to fixed, removable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this application.

[0027] Example 1, see Figure 1 The utility model provides a plasma separator blood chamber tightness detection device, comprising an aerosol generator 1, a plasma separator 2, and a particle size detection analyzer 3;

[0028] The output end of the aerosol generator 1 is connected to the blood chamber input end 22 of the plasma separator 2; the plasma output end 25 of the plasma separator 2 is connected to the particle size detection analyzer 3;

[0029] The plasma separator 2 is provided with a hollow fiber membrane 21;

[0030] The aerosol generator 1 is used to prepare an initial aerosol in the form of liquid particles.

[0031] It should be noted that the aerosol generator 1 is used to prepare a liquid aerosol having a specific particle size and emit the aerosol at a specific rate, so that the aerosol can migrate in a stable state. Aerosol particles with a particle size smaller than that of the hollow fiber membrane will pass through the pores of the hollow fiber membrane and migrate to the particle size detection analyzer. The particle size detection analyzer then detects the particle size of the liquid particles in the aerosol, and the integrity of the hollow fiber membrane is determined based on the detection results. If the particle size of the liquid particles detected in the aerosol is larger than the theoretical pore size of the hollow fiber membrane, the hollow fiber membrane is defective; otherwise, the hollow fiber membrane structure is intact.

[0032] In some embodiments, a rate detector 11 is further included. The rate detector 11 is disposed between the aerosol generator 1 and the plasma separator 2 and is used to detect the migration rate of the aerosol.

[0033] Specifically, the migration rate of the aerosol is less than 0.35 cm / s.

[0034] It should be noted that migration rate is crucial for maintaining the stability of liquid particle aerosols. When the aerosol migration rate is less than 0.35 cm / s, the liquid particle aerosol is less likely to be cut by the fiber membrane or fused due to collisions. It can maintain a stable state during the migration and detection process, thereby improving detection accuracy. Therefore, when the aerosol migration rate is detected to be greater than or equal to 0.35 cm / s, the aerosol emission rate of aerosol generator 1 needs to be adjusted promptly to ensure that the detected migration rate meets the standard.

[0035] In some embodiments, the initial aerosol is liquid particles of a saline solution.

[0036] Preferably, the initial aerosol is liquid particles of sodium chloride solution.

[0037] It should be noted that the detection device provided by the present invention can be applied to the detection of medical hollow fiber membranes. Usually, the plasma separator 2 provided with a medical hollow fiber membrane needs to be tested for defects before use. In order to avoid the substances used for the test from contaminating the plasma separator 2, it is necessary to wet it or pre-flushed it with physiological saline. Sodium chloride solution has good compatibility with blood and is not likely to have adverse effects in the process of plasma separation; at the same time, the liquid particles of sodium chloride solution have high surface tension and good stability, and are not likely to break and wet the fiber membrane during migration, so that the plasma separator 2 can remain dry after defect detection. Therefore, after the present application uses an aerosol of liquid particles of sodium chloride solution for detection, the plasma separator 2 does not need to be pre-flushed or subjected to other tedious pretreatments of the fiber membrane again in subsequent use.

[0038] Preferably, the initial aerosol concentration is less than 100 mg / m 3 Liquid particles of sodium chloride solution.

[0039] More preferably, the initial aerosol concentration is less than 30 mg / m 3 Liquid particles of sodium chloride solution.

[0040] It should be noted that the concentration of the salt solution is crucial to the stability of the liquid particulate aerosol it forms. When the salt solution concentration is low, due to the low solute content and low viscosity, the low-concentration salt solution is more easily dispersed into small droplets when the same external force (such as ultrasonic vibration or air pressure from the nebulizer) is applied, thus more conducive to the formation of liquid particulate aerosol.

[0041] In some embodiments, the particle size of the liquid particles in the initial aerosol is less than or equal to 10.00 μm.

[0042] Preferably, the particle size of the liquid particles in the initial aerosol is 0.02-2.00 μm.

[0043] It should be noted that for aerosols with a relatively concentrated particle size range, the migration rate will be more consistent and the shape will be more stable during the migration process. In this case, the phenomenon of aerosol fusion caused by violent collisions is less likely to occur, thereby improving the accuracy of detection.

[0044] In some embodiments, the plasma separator 2 is placed vertically, with the blood chamber input end 22 of the plasma separator 2 at the bottom and the blood chamber output end 23 at the top.

[0045] It should be noted that due to the diffusion characteristics of the aerosol itself, when it is generated by the aerosol generator, it tends to migrate from a high-concentration area to a low-concentration area; secondly, in the actual detection process, the aerosol generator 1 is located below the plasma separator 2, and the aerosol generator 1 transports the aerosol upward. Therefore, the vertical placement of the plasma separator 2 conforms to the running trajectory of the initial aerosol, which helps the aerosol to be quickly and evenly distributed in the fiber membrane, thereby improving the detection efficiency.

[0046] In some embodiments, the blood chamber output end 23 of the plasma separator 2 is not provided with an end cap.

[0047] Preferably, the plasma separator 2 is not provided with an end cap.

[0048] It should be noted that removing the end cap at the input end of the plasma separator 2 can increase the input end diameter of the aerosol, allowing the aerosol to migrate more rapidly into the fiber membrane and be quickly and evenly distributed within the fiber membrane, thereby improving the detection speed. Removing the end cap at the output end of the plasma separator 2 can allow the aerosol to escape naturally, which is beneficial for avoiding a large amount of aerosol from failing to be removed in time and clogging at the output end of the plasma separator, causing the aerosols to collide with each other and fuse, thereby increasing the particle size and ultimately affecting the accuracy of the test results. Therefore, during the detection process, the end caps at both ends of the plasma separator 2 can be opened to further improve the detection rate and the accuracy of the test results.

[0049] In some embodiments, the particle size detection analyzer 3 is further connected to the blood chamber input end 22 of the plasma separator 2 for detecting the particle size of the liquid particles in the initial aerosol.

[0050] It should be noted that by detecting the particle size of the liquid particles in the initial aerosol, it is ensured that the particle size of the liquid particles in the formed liquid particle aerosol is always stable within a specific range, thereby ensuring the smooth implementation of subsequent detection work.

[0051] Comparative Example 1. The comparative example of the present invention provides a plasma separator blood chamber tightness detection device. The difference from Example 1 is that the aerosol generator 1 is composed of an air compressor and a smoke collector; the output end of the air compressor is connected to the input end of the smoke collector; the output end of the smoke collector is used to connect to the input end of the plasma separator 2; the smoke collector contains aerosol, and the aerosol is tobacco particles.

[0052] It should be noted that when tobacco particles are used as a solid aerosol, their stability is superior to that of liquid particulate aerosols. However, in actual testing operations, many tobacco particles cannot penetrate the hollow fiber membrane and accumulate on one side of the fiber membrane or clog the membrane pores. This phenomenon requires backwashing the hollow fiber membrane after the test is completed, which increases the complexity of subsequent processing.

[0053] The above are only preferred embodiments of the present application and are not intended to limit the present invention. Although the present application has been described in detail with reference to examples, those skilled in the art can still modify the technical solutions described in the aforementioned examples or make equivalent replacements for some of the technical features therein. However, any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. A plasma separator blood chamber tightness detection device, characterized in that: It includes an aerosol generator (1), a plasma separator (2), and a particle size detection analyzer (3); The output end of the aerosol generator (1) is connected to the blood chamber input end (22) of the plasma separator (2); the plasma output end (25) of the plasma separator (2) is connected to the particle size detection analyzer (3); The plasma separator (2) is provided with a hollow fiber membrane (21); The aerosol generator (1) is used to prepare liquid particulate initial aerosol.

2. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: It also includes a rate detector (11), which is arranged between the aerosol generator (1) and the plasma separator (2) and is used to detect the migration rate of the aerosol.

3. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: The initial aerosol is liquid particles of a salt solution.

4. The plasma separator blood chamber tightness detection device according to claim 3, characterized in that: The initial aerosol is liquid particles of sodium chloride solution.

5. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: The particle size of the liquid particles in the initial aerosol is less than or equal to 10.00 μm.

6. The plasma separator blood chamber tightness detection device according to claim 5, characterized in that: The particle size of the liquid particles in the initial aerosol is 0.02-2.00 μm.

7. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: The plasma separator (2) is placed vertically, with the blood chamber input end (22) of the plasma separator (2) at the bottom and the blood chamber output end (23) at the top.

8. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: The blood chamber output end (23) of the plasma separator (2) is not provided with an end cap.

9. The plasma separator blood chamber tightness detection device according to claim 8, characterized in that: The plasma separator (2) is not provided with an end cap.

10. The plasma separator blood chamber tightness detection device according to claim 1, characterized in that: The particle size detection analyzer (3) is also connected to the blood chamber input end (22) of the plasma separator (2) and is used to detect the particle size of the liquid particles in the initial aerosol.

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