Testing device for detecting endotoxin transfer of semipermeable membrane
By designing a semipermeable membrane endotoxin transfer test device and using a clamp and peristaltic pump system to detect whether the semipermeable membrane allows endotoxins to pass through, the problem of the existing technology that is unable to effectively detect endotoxin transfer is solved, ensuring that the micropore size of the semipermeable membrane is appropriate, avoiding the use of unqualified products, and ensuring patient safety.
Patent Information
- Application Number
- CN202422359586.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-26
- Publication Date
- 2025-09-16
- Estimated Expiration
- 2034-09-26
AI Technical Summary
Existing technologies cannot effectively detect whether the dialysis membrane of a hemodialyzer can prevent endotoxins from entering the blood from the dialysate, leading to potential medical risks.
A semipermeable membrane endotoxin transfer test device was designed. Using a clamp, a peristaltic pump, and a piping system, the pressure difference allowed the endotoxin in the dialysate to pass through the semipermeable membrane into the blood chamber. The device was used to detect whether endotoxin had passed through the membrane and to determine whether the pore size of the semipermeable membrane was too large.
It can effectively detect whether the semipermeable membrane allows endotoxins to pass through, ensure that the micropore size of the semipermeable membrane is appropriate, prevent unqualified products from entering clinical use, and ensure patient safety.
Smart Images
Figure CN223346687U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of hemodialyzer detection equipment, in particular to a testing device for detecting endotoxin transfer through a semipermeable membrane. Background Art
[0002] The dialysis membrane of a hemodialyzer is a semipermeable membrane and the core component of the hemodialyzer, shaped like a hollow fiber. Blood flows through the hollow fibers, and the inner layer of each dialysis membrane is evenly distributed with micropores of approximately 2 to 5 nm, providing excellent particle size separation for blood components. The outer cortex and the middle spongy support layer effectively prevent endotoxins in the dialysate from entering the bloodstream, ensuring the safety of the dialysis process. The dense middle support layer also fully guarantees the strength of the hollow fiber membrane, ensuring that the product will not break or rupture during use.
[0003] During dialysis, the dialysate flows in the opposite direction outside the hollow fiber membrane. Using the principle of semi-permeable membrane, some small molecules and medium-molecular solutes in the blood are removed into the dialysate through the micropores on the dialysis membrane through diffusion, convection and filtration, and the electrolyte regulation between the blood / dialysate is achieved, thereby achieving the purpose of removing toxins, excess water, maintaining acid-base balance and stabilizing the internal environment.
[0004] However, the bacterial and endotoxin limits for standard dialysate and ultrapure dialysate are not zero. Endotoxins in the hemodialysis process are pyrogenic substances, such as lipopolysaccharide (LPS), peptidoglycan (PGS) or bacterial DNA, which can enter the dialyzer blood chamber from the dialyzer dialysate chamber through the membrane by diffusion and convection and enter the patient's blood. These compounds have the ability to stimulate innate and adaptive immune responses and are known to activate Toll-like receptors (TLRs) in peripheral blood monocytes, leading to the release of interleukin-1β, tumor necrosis factor and other proinflammatory cytokines. These cytokines can lead to micro-inflammation that often occurs in patients receiving dialysis treatment. The ability of the hemodialysis membrane to limit the passage of these compounds cannot be inferred from the performance characteristics commonly studied and requires additional testing.
[0005] Transfer testing devices on the market are generally used to detect internal membrane rupture. Some products produced also have some defective products. If such defective products flow into use due to problems with the dialysis membrane, they may cause certain medical accidents and bring harm to the user. For this reason, we propose a semipermeable membrane endotoxin transfer testing device. Utility Model Content
[0006] The purpose of the present invention is to provide a testing device for detecting endotoxin transfer through a semipermeable membrane, so as to solve the problems raised in the above-mentioned background technology.
[0007] To achieve the above-mentioned purpose, the present invention provides the following technical solutions: a test device for detecting endotoxin transfer through a semipermeable membrane, comprising a base, a conical test tube, a first peristaltic pump and a hemodialyzer, wherein brackets are welded on both sides of the upper end of the base, and a number of clamping blocks are slidably connected to the brackets on both sides, a pair of conical test tubes are placed on both sides of the upper end of the base, a hose is inserted into one side of the conical test tube, and the outer wall of the hose is connected to the first peristaltic pump, and the end of the hose is connected to the hemodialyzer.
[0008] Preferably, the clamping blocks on both sides are fixed by a cross bar, and the clamping block on one side is threadedly connected to a threaded adjustment rod.
[0009] Preferably, a sliding groove is provided on the inner wall of the clamping block, and the inner wall of the sliding groove matches the outer wall of the bracket, and a pair of screw holes is provided on the surface of the clamping block.
[0010] Preferably, the conical test tube on one side is filled with water for bacterial endotoxin testing, and the conical test tube on the other side is an empty bottle.
[0011] Preferably, both sides of the outer wall of the hemodialyzer are threadedly connected with docking nuts, and the side of the docking nut away from the hemodialyzer is threadedly connected with a branch pipe docking joint.
[0012] Preferably, the lateral part of the branch pipe joint is connected to a lateral pipe, and the vertical part of the branch pipe joint is connected to a vertical pipe. The vertical pipes on both sides are connected to a pair of the conical test tubes through hoses, and the lateral pipes on both sides are connected through hoses, and the outer wall of the hose is connected to a second peristaltic pump.
[0013] Preferably, the hemodialyzer, the branch pipe joint, the transverse pipe, the hose and the second peristaltic pump form a blood chamber.
[0014] Preferably, the hemodialyzer, the branch pipe joint, the vertical pipe, the hose and the first peristaltic pump constitute a dialysate dialysis chamber.
[0015] Preferably, the outer wall side of the first peristaltic pump and the second peristaltic pump are glued to a mounting plate, and the surface of the mounting plate is threadedly connected to a docking screw, and the first peristaltic pump and the second peristaltic pump are respectively detachably connected to the clamping block through the mounting plate and the docking screw.
[0016] Compared with the prior art, the beneficial effects of the present invention are: when the semipermeable membrane endotoxin transfer test device is used, the clamp serves as a fixed component of the detection equipment and is connected to the bracket by a sliding connection. The placement height of the clamp is controlled by a threaded adjustment rod to ensure that the clamp is firmly fixed on the surface of the bracket. The adjustment structure makes it convenient for users to arrange and distribute the various devices above according to their needs, making it convenient for users to use.
[0017] The hemodialyzer, branch butt joint, transverse pipes, flexible hoses, and second peristaltic pump form the blood chamber, while the hemodialyzer, branch butt joint, vertical pipes, flexible hoses, and first peristaltic pump form the dialysate chamber. By leveraging pressure differentials, endotoxins in the dialysate have an inward driving force, allowing them to pass through the dialysis membrane (semipermeable membrane) and enter the blood chamber for circulation. If endotoxins are detected in the blood chamber, it indicates that the endotoxins have passed through the semipermeable membrane, and the pore size of the semipermeable membrane is too large to restrict the passage of endotoxins, resulting in a substandard product.
[0018] The first peristaltic pump and the second peristaltic pump are used as power sources and are connected to the mounting plate by adhesive connection, and are fixedly connected to the clamping block by docking screws. This connection method is easy to operate and use by users. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 This is a schematic diagram of the three-dimensional structure of the utility model;
[0020] Figure 2 This is a schematic diagram of the connection structure between the base and the bracket of the utility model;
[0021] Figure 3 This is a schematic diagram of the enlarged structure of the hemodialyzer of the present utility model;
[0022] Figure 4 This is an enlarged structural diagram of the first peristaltic pump and the second peristaltic pump of the utility model;
[0023] Figure 5 This is the principle diagram of the process flow of this utility model.
[0024] In the figure: 1. Base; 2. Bracket; 3. Clamp; 31. Threaded adjustment rod; 32. Screw hole; 33. Slide; 4. Conical test tube; 5. Hose; 6. First peristaltic pump; 61. Mounting plate; 62. Docking screw; 7. Hemodialyzer; 71. Docking nut; 72. Branch pipe joint; 73. Horizontal pipe; 74. Vertical pipe; 8. Second peristaltic pump. DETAILED DESCRIPTION
[0025] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.
[0026] Example 1
[0027] See also Figure 1-5The utility model provides a technical solution: a test device for detecting endotoxin transfer through a semipermeable membrane, comprising a base 1, a conical test tube 4, a first peristaltic pump 6 and a hemodialyzer 7. Brackets 2 are welded on both sides of the upper end of the base 1, and a number of clamping blocks 3 are slidably connected to the brackets 2 on both sides. A pair of conical test tubes 4 are placed on both sides of the upper end of the base 1, a hose 5 is inserted into the conical test tube 4 on one side, and the outer wall of the hose 5 is connected to the first peristaltic pump 6, and the end of the hose 5 is connected to the hemodialyzer 7. The clamping blocks 3 on both sides are fixed by a cross bar, and the clamping block 3 on one side is threadedly connected to a threaded adjusting rod 31. The inner wall of the clamping block 3 is provided with a slide groove 33, and the inner wall of the slide groove 33 is aligned with the inner wall of the slide groove 33. The outer walls of the bracket 2 match each other, and a pair of screw holes 32 are provided on the surface of the clamping block 3. The clamping block 3 serves as a fixed component of the detection equipment and is connected to the bracket 2 by a sliding connection. The placement height of the clamping block 3 is controlled by a threaded adjustment rod 31. When adjusting the height of the clamping block 3, it is only necessary to slide the clamping block 3 along the outer wall of the bracket 2 to a suitable position, and then rotate the threaded adjustment rod 31. The end of the threaded adjustment rod 31 contacts the clamping block 3, thereby increasing the friction coefficient between the clamping block 3 and the bracket 2, ensuring that the clamping block 3 is firmly fixed to the surface of the bracket 2. This adjustment structure makes it convenient for users to arrange and distribute the above devices according to their needs, making it convenient for users to use.
[0028] Example 2
[0029] See also Figure 1-5The utility model provides a technical solution: a test device for detecting endotoxin transfer through a semipermeable membrane, wherein bacterial endotoxin test water is filled into a conical test tube 4 on one side, and the conical test tube 4 on the other side is an empty bottle, and the outer wall of the hemodialyzer 7 is threadedly connected with a docking nut 71 on both sides, and the docking nut 71 is threadedly connected with a branch pipe joint 72 on the side away from the hemodialyzer 7, and the branch pipe joint 72 is connected with a horizontal pipe 73 at the horizontal part, and a vertical pipe 74 at the vertical part of the branch pipe joint 72, and the vertical pipes 74 on both sides are respectively connected with a pair of conical test tubes 4 through a hose 5, and the horizontal pipes 73 on both sides are connected by the hose 5, and the outer wall of the hose 5 is connected with a second creeping pipe. The hemodialyzer 7, the branch butt joint 72, the transverse pipe 73, the hose 5 and the second peristaltic pump 8 constitute a blood chamber, and the hemodialyzer 7, the branch butt joint 72, the vertical pipe 74, the hose 5 and the first peristaltic pump 6 constitute a dialysate dialysis chamber. When the user needs to test the hemodialyzer 7, the user can start the first peristaltic pump 6 and the second peristaltic pump 8 respectively to make the bacterial endotoxin test water in the conical test tube 4 flow from the hose 5 into the blood chamber, and the dialysate dialysis chamber is circulated by the second peristaltic pump 8. The two flow in opposite directions. By utilizing the pressure difference, the endotoxin in the dialysate has an inward driving force and can enter the blood chamber through the semipermeable membrane of the dialysis membrane for circulation. If endotoxin is detected in the blood chamber, it means that the endotoxin has passed through the semipermeable membrane. The micropore size of the semipermeable membrane is too large. At this time, the semipermeable membrane cannot limit the passage of endotoxin, and the product is unqualified. Otherwise, it is a qualified product.
[0030] Example 3
[0031] See also Figure 1-5 The utility model provides a technical solution: a test device for detecting endotoxin transfer through a semipermeable membrane, wherein the outer wall side of the first peristaltic pump 6 and the second peristaltic pump 8 is connected to a mounting plate 61 by glue, and the surface of the mounting plate 61 is threadedly connected to a docking screw 62, and the first peristaltic pump 6 and the second peristaltic pump 8 are respectively connected to the clamping block 3 by threads in a detachable manner through the mounting plate 61 and the docking screw 62. The first peristaltic pump 6 and the second peristaltic pump 8 serve as power sources and are connected to the mounting plate 61 by an adhesive connection, and are fixedly connected to the clamping block 3 by the docking screw 62. This connection method is easy for users to operate.
[0032] Working principle: For this type of semipermeable membrane endotoxin transfer test device, first install the devices one by one on the clamping block 3 according to the test device installation requirements. At this time, adjust the placement height of the clamping block 3 appropriately according to the user's needs. When adjusting the height of the clamping block 3, just slide the clamping block 3 along the outer wall of the bracket 2 to a suitable position, rotate the threaded adjustment rod 31, and the end of the threaded adjustment rod 31 contacts the clamping block 3 to increase the friction coefficient between the clamping block 3 and the bracket 2, ensuring that the clamping block 3 is firmly fixed on the surface of the bracket 2. Then, when the user needs to test the hemodialyzer 7, The user can start the first peristaltic pump 6 and the second peristaltic pump 8 respectively to make the bacterial endotoxin test water in the conical test tube 4 flow into the blood chamber from the hose 5, and the dialysate in the dialysate chamber is circulated through the second peristaltic pump 8. The two flow in opposite directions. By utilizing the pressure difference, the endotoxin in the dialysate has an inward driving force and can enter the blood chamber circulation through the semipermeable membrane of the dialysate membrane. Finally, if endotoxin is detected in the blood chamber, it means that the endotoxin has passed through the semipermeable membrane. The micropore size of the semipermeable membrane is too large. At this time, the semipermeable membrane cannot limit the passage of endotoxin, and the product is unqualified. Otherwise, it is a qualified product.
[0033] Although the embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and variations may be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A semipermeable membrane endotoxin transfer test device, comprising a base (1), a conical test tube (4), a first peristaltic pump (6) and a hemodialyzer (7), characterized in that: Brackets (2) are welded to both sides of the upper end of the base (1), and a plurality of clamping blocks (3) are slidably connected to the brackets (2) on both sides. A pair of conical test tubes (4) are placed on both sides of the upper end of the base (1), and a hose (5) is inserted into one of the conical test tubes (4). The outer wall of the hose (5) is connected to a first peristaltic pump (6), and the end of the hose (5) is connected to a hemodialyzer (7).
2. A semipermeable membrane endotoxin transfer detection test device according to claim 1, characterized in that: The clamping blocks (3) on both sides are fixed by cross bars, and the clamping block (3) on one side is threadedly connected to a threaded adjustment rod (31).
3. A semipermeable membrane endotoxin transfer detection test device according to claim 2, characterized in that: The inner wall of the clamping block (3) is provided with a sliding groove (33), and the inner wall of the sliding groove (33) matches the outer wall of the bracket (2). A pair of screw holes (32) are provided on the surface of the clamping block (3).
4. The semipermeable membrane endotoxin transfer detection test device according to claim 1, characterized in that: The conical test tube (4) on one side is filled with water for bacterial endotoxin testing, and the conical test tube (4) on the other side is an empty bottle.
5. The semipermeable membrane endotoxin transfer detection test device according to claim 1, characterized in that: Both sides of the outer wall of the hemodialyzer (7) are threadedly connected with docking nuts (71), and the side of the docking nut (71) away from the hemodialyzer (7) is threadedly connected with a branch pipe docking joint (72).
6. The semipermeable membrane endotoxin transfer detection test device according to claim 5, characterized in that: The horizontal portion of the branch pipe joint (72) is connected to a horizontal pipe (73), and the vertical portion of the branch pipe joint (72) is connected to a vertical pipe (74). The vertical pipes (74) on both sides are connected to a pair of the conical test tubes (4) through hoses (5). The horizontal pipes (73) on both sides are connected to each other through the hose (5), and the outer wall of the hose (5) is connected to a second peristaltic pump (8).
7. The semipermeable membrane endotoxin transfer detection test device according to claim 6, characterized in that: The hemodialyzer (7), the branch pipe joint (72), the transverse pipe (73), the hose (5) and the second peristaltic pump (8) form a blood chamber.
8. The semipermeable membrane endotoxin transfer detection test device according to claim 7, characterized in that: The hemodialyzer (7), the branch pipe joint (72), the vertical pipe (74), the hose (5) and the first peristaltic pump (6) constitute a dialysate dialysis chamber.
9. The semipermeable membrane endotoxin transfer detection test device according to claim 1, characterized in that: A mounting plate (61) is glued to one side of the outer wall of the first peristaltic pump (6) and the second peristaltic pump (8), and a butt screw (62) is threadedly connected to the surface of the mounting plate (61). The first peristaltic pump (6) and the second peristaltic pump (8) are detachably connected to the clamping block (3) through the mounting plate (61) and the butt screw (62).