Insoluble particle testing device for conveying system

Abstract

The embodiment of the utility model provides an insoluble particle testing device for a conveying system, and belongs to the technical field of medical instruments. The conveying system insoluble particle testing device comprises a tube body, a water supply unit and a rubber plug, the tube body is used for containing an intervention sheath tube of a conveying system, the tube body is provided with a first channel extending in the axial direction of the tube body, the two ends of the first channel are the first end and the second end respectively, the first end is used for allowing the intervention sheath tube of the conveying system to enter the tube body, and the second end is provided with a valve; the water supply unit is used for providing test water for the conveying system; the rubber plug is provided with a second channel extending in the axial direction of the rubber plug, the second channel is used for allowing an intervention sheath tube of the conveying system to penetrate through, and the rubber plug is used for enabling the intervention sheath tube of the conveying system to be connected with the first end of the tube body in a sealed mode. The insoluble particle testing device of the conveying system is simple in structure, convenient to disassemble and suitable for repeated use.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a testing device for insoluble particles in a delivery system. Background Art

[0002] Insoluble particles refer to those foreign, water-insoluble, 1-50um in diameter, invisible to the naked eye, mobile, non-metabolic harmful particles. After entering the blood system, insoluble particles may cause granulomas, vascular embolism, induce phlebitis, cause tumors or tumor-like reactions, cause pyrogenic reactions, and bring long-term and serious harm to patients.

[0003] With the rapid development of medical science and life science, coronary stent products, especially coronary drug-eluting stents, have become an important means of treating coronary heart disease. However, since coronary stent products are in direct contact with blood during use, if the products carry insoluble particles, they will enter the blood circulation, and will directly cause damage to the patient's body like the insoluble particles in the injection. In addition to coronary stent products, other interventional medical devices such as coronary balloons, intracranial stents, guidewires, catheters, embolization equipment, etc. may also carry insoluble particles. There are also devices for testing insoluble particles in the prior art, such as the patent with publication number CN203587474U, which discloses an insoluble particle testing system. However, the structure of the testing device of this scheme is relatively complex, and it is necessary to use peristaltic pumps, water bath equipment and other devices, and the multiple multi-section catheters in the test pipeline are bonded, which is inconvenient to clean and disassemble, and particles are easily left at the catheter connection, causing distortion of the test results. Utility Model Content

[0004] The embodiment of the present application provides a testing device for insoluble particles in a conveying system, which has a simple structure, is easy to disassemble, and is suitable for repeated use.

[0005] An embodiment of the present application provides a testing device for insoluble particles in a conveying system, which includes a tube body, a water supply unit and a rubber plug. The tube body is used to accommodate an interventional sheath of the conveying system. The tube body has a first channel extending along its axial direction, and the two ends of the first channel are respectively a first end and a second end. The first end is used for the interventional sheath of the conveying system to enter the tube body, and the second end is provided with a valve; the water supply unit is used to provide test water to the conveying system; the rubber plug has a second channel extending along its axial direction, and the second channel is used for the interventional sheath of the conveying system to pass through, and the rubber plug is used to seal the interventional sheath of the conveying system with the first end of the tube body.

[0006] In this scheme, the tube body simulates the blood vessel channel in the human body, the intervention sheath of the delivery system enters the first channel from the first end of the tube body, the water supply unit provides test water to the delivery system, and the test water enters the tube body through the intervention sheath of the delivery system, so as to realize the sampling of the insoluble particles brought by the intervention sheath of the delivery system. By arranging a rubber plug at the first end of the tube body, the rubber plug can make the intervention sheath of the delivery system and the first end of the tube body sealed and connected, ensure the sealing between the intervention sheath of the delivery system and the tube body, exclude the source of external insoluble particles as much as possible, and facilitate the accurate evaluation of the shedding of insoluble particles of the intervention sheath of the delivery system itself. In addition, the rubber plug makes the intervention sheath of the delivery system and the tube body tightly connected through its own deformation. When the particle test is completed, the rubber plug can be removed with a little force, so that the intervention sheath of the delivery system is separated from the tube body, which is convenient to disassemble and suitable for repeated use. After the rubber plug is disassembled, it is also conducive to cleaning the test particles remaining at the connection between the rubber plug and the first end of the tube body.

[0007] In some embodiments, along the axial direction of the rubber plug, the rubber plug includes at least a first tube segment and a second tube segment, the outer diameter of the first tube segment is smaller than the inner diameter of the first channel, and the outer diameter of the second tube segment is larger than the inner diameter of the first channel, so that the rubber plug is partially embedded in the tube body.

[0008] In the above technical solution, the outer diameter of the second tube segment in the rubber plug is larger than the inner diameter of the first channel, and the first tube segment is smaller than the inner diameter of the first channel, that is, the rubber plug is inserted into the first channel of the tube body after being squeezed and deformed by the first tube segment. After the first tube segment is squeezed and deformed, not only can the rubber plug be in close contact with the inner wall of the first channel of the tube body, but also the inner wall of the second channel of the rubber plug can be in close contact with the outer wall of the interventional sheath of the delivery system, thereby realizing a sealed connection between the interventional sheath and the first end of the tube body.

[0009] In some embodiments, a first locking member is disposed at the first end, the first locking member is detachably connected to the first end of the tube body, and the first locking member is used to fasten the rubber plug to the tube body.

[0010] In the above technical solution, by providing a first locking member at the first end, the first locking member can fasten the rubber plug to the first end of the tube body, avoiding the phenomenon of the rubber plug falling off the tube body, and further improving the installation stability of the rubber plug on the tube body.

[0011] In some embodiments, the first locking member has an internal thread, and the outer peripheral surface of the tube body close to the first end is provided with an external thread, and the internal thread is meshed with the external thread.

[0012] In the above technical solution, the first locking member is threadedly connected to the first end of the tube body, and the first locking member can be assembled and disassembled from the tube body by rotating the first locking member, which is convenient and quick to operate.

[0013] In some embodiments, the valve is a three-way valve having a first outlet port and a second outlet port, wherein the first outlet port is used to communicate with the particle tester, and the second outlet port is used to enable the first channel to communicate with the outside.

[0014] In the above technical solution, the valve is a three-way valve. When the first outlet end of the three-way valve is connected to the particle tester, it is convenient to test the particles contained in the test water; when the second outlet end of the three-way valve is connected to the outside, the air pressure in the pipe body is equal to that outside, so that the water supply unit can inject test water into the pipeline for particle testing.

[0015] In some embodiments, the second outlet port is provided with a first syringe filter.

[0016] In the above technical solution, since the second outlet end can communicate with the external environment, by arranging a first syringe filter at the second outlet end, the first syringe filter can prevent particles in the external environment from entering the tube body from the second outlet end, thereby ensuring the accuracy of the particle test results.

[0017] In some embodiments, a second locking member is disposed at the second end, the second locking member is threadedly engaged with the second end, and the second locking member is used to fasten the valve to the second end.

[0018] In some embodiments, a sealing ring is provided between the end of the second end and the valve.

[0019] In the above technical solution, the sealing ring is provided to improve the sealing performance between the valve and the second end of the tube body, thereby preventing external particles from affecting the test results.

[0020] In some embodiments, the tube body includes at least one of a straight tube, an S-shaped tube, or a hook-shaped tube.

[0021] In the above technical solution, by using a straight tube, an S-shaped tube or a hook-shaped tube as the tube body, blood vessels in different locations in the human body can be simulated, and the clinical use of the delivery system can be simulated more realistically and effectively.

[0022] In some embodiments, the water supply unit includes a syringe, the output end of the syringe is connected to a second syringe filter, and the second syringe filter is used to communicate with a water injection end on the interventional sheath of the delivery system.

[0023] In the above technical solution, a syringe is used to store test water and cooperate with a second syringe filter to inject the test water into the water injection end of the interventional sheath of the delivery system. The second syringe filter can filter the test water before entering the delivery system to eliminate the influence of insoluble particles in the test water as much as possible. The syringe has a simple structure and strong practicality, and has the advantage of being able to be tested and taken at any time.

[0024] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0026] Figure 1 A schematic diagram of the structure of an insoluble particle testing device for a delivery system provided in some embodiments of the present application;

[0027] Figure 2 An exploded schematic diagram of an insoluble particle testing device for a delivery system provided in some embodiments of the present application;

[0028] Figure 3 for Figure 2 A is an enlarged schematic diagram;

[0029] Figure 4 for Figure 2 A magnified schematic diagram of B;

[0030] Figure 5 for Figure 1 A schematic diagram of the structure of the middle tube body including an S-shaped tube;

[0031] Figure 6 for Figure 1 A schematic diagram of the structure in which the middle tube body includes a hook-shaped tube.

[0032] Icons: 10-tube body; 11-first end; 12-second end; 20-rubber plug; 21-first tube section; 22-second tube section; 30-first locking piece; 40-valve; 41-first outlet end; 42-second outlet end; 43-first syringe filter; 50-second locking piece; 51-sealing ring; 60-water supply unit; 61-syringe; 62-second syringe filter; 100-delivery system insoluble particle testing device; 200-delivery system; 201-interventional sheath. DETAILED DESCRIPTION

[0033] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0034] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for which protection is sought, but merely represents selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.

[0035] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0036] In the description of the embodiments of the present application, it should be noted that the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0037] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be fixedly connected, detachably connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0038] Example

[0039] The present application embodiment provides a testing device for insoluble particles in a conveying system. Figures 1 to 4 The delivery system insoluble particle testing device 100 includes a tube body 10, a water supply unit 60 and a rubber plug 20. The tube body 10 is used to accommodate the interventional sheath 201 of the delivery system 200. The tube body 10 has a first channel extending along its axial direction. The two ends of the first channel are respectively a first end 11 and a second end 12. The first end 11 is used for the interventional sheath 201 of the delivery system 200 to enter the tube body 10, and the second end 12 is provided with a valve 40; the water supply unit 60 is used to provide test water to the delivery system 200; the rubber plug 20 has a second channel extending along its axial direction. The second channel is used for the interventional sheath 201 of the delivery system 200 to pass through. The rubber plug 20 is used to make the interventional sheath 201 of the delivery system 200 sealed and connected to the first end 11 of the tube body 10.

[0040] In this solution, the tube body 10 simulates the blood vessel channel in the human body, and the interventional sheath 201 of the delivery system enters the first channel from the first end 11 of the tube body 10. The water supply unit 60 provides test water to the delivery system 200, and the test water enters the tube body 10 through the interventional sheath 201 of the delivery system 200, so as to achieve sampling of insoluble particles brought by the interventional sheath 201 of the delivery system 200. By providing a rubber plug 20 at the first end 11 of the tube body 10, the rubber plug 20 can make the interventional sheath 201 of the delivery system 200 and the first end 11 of the tube body 10 sealed and connected, ensuring the sealing between the interventional sheath 201 of the delivery system 200 and the tube body 10, eliminating the source of external insoluble particles as much as possible, and facilitating accurate evaluation of the shedding of insoluble particles of the interventional sheath 201 of the delivery system 200. In addition, the plug 20 deforms itself to tightly connect the interventional sheath 201 of the delivery system 200 and the tube body 10. When the particle test is completed, the plug 20 can be removed with a little force to separate the interventional sheath 201 of the delivery system 200 from the tube body 10. The plug 20 is easy to disassemble and suitable for repeated use. After the plug 20 is disassembled, it is also convenient to clean the test particles remaining at the connection between the plug 20 and the first end 11 of the tube body 10.

[0041] In some embodiments, please combine Figure 2 and Figure 3 , along the axial direction of the rubber plug 20, the rubber plug 20 at least includes a first tube section 21 and a second tube section 22, the outer diameter of the first tube section 21 is smaller than the inner diameter of the first channel, and the outer diameter of the second tube section 22 is larger than the inner diameter of the first channel, so that the rubber plug 20 is partially embedded in the tube body 10. The outer diameter of the second tube section 22 in the rubber plug 20 is larger than the inner diameter of the first channel, and the first tube section 21 is smaller than the inner diameter of the first channel, that is, the rubber plug 20 is inserted into the first channel of the tube body 10 after being squeezed and deformed by the first tube section 21. After the first tube section 21 is squeezed and deformed, not only can the rubber plug 20 be in close contact with the inner wall of the first channel of the tube body 10, but also the inner wall of the second channel of the rubber plug 20 can be in close contact with the outer wall of the intervention sheath 201 of the delivery system 200, thereby achieving a sealed connection between the intervention sheath 201 and the first end 11 of the tube body 10.

[0042] In some embodiments, the first end 11 is provided with a first locking member 30, the first locking member 30 is detachably connected to the first end 11 of the tube body 10, and the first locking member 30 is used to fasten the rubber plug 20 to the tube body 10. By providing the first locking member 30 at the first end 11, the first locking member 30 can fasten the rubber plug 20 to the first end 11 of the tube body 10, thereby preventing the rubber plug 20 from falling off from the tube body 10, and further improving the installation stability of the rubber plug 20 on the tube body 10.

[0043] The connection between the first locking member 30 and the tube body 10 may be interference fit, threaded connection, or clamping.

[0044] Optionally, see Figure 3 The first locking member 30 has an internal thread, and the outer peripheral surface of the tube body 10 close to the first end 11 is provided with an external thread, and the internal thread meshes with the external thread. The first locking member 30 is threadedly connected to the first end 11 of the tube body 10, and the first locking member 30 can be rotated to realize the assembly and disassembly with the tube body 10, which is convenient and quick to operate.

[0045] In some embodiments, see Figure 4 The valve 40 is a three-way valve, and the valve 40 has a first outlet end 41 and a second outlet end 42. The first outlet end 41 is used to communicate with the particle tester, and the second outlet end 42 is used to enable the first channel to communicate with the outside. The valve 40 is a three-way valve. When the first outlet end 41 of the three-way valve is connected to the particle tester, it is convenient to test the particles contained in the test water; when the second outlet end 42 of the three-way valve is connected to the outside, the air pressure of the pipe body 10 is equal to that of the outside, so that the water supply unit 60 can inject test water into the pipeline for particle testing.

[0046] In some embodiments, the second outlet port 42 is provided with a first syringe filter 43. Since the second outlet port 42 can communicate with the external environment, by providing the first syringe filter 43 at the second outlet port 42, the first syringe filter 43 can prevent particles in the external environment from entering the tube body 10 from the second outlet port 42, thereby ensuring the accuracy of the particle test results.

[0047] In some embodiments, please refer to Figure 4 The second end 12 is provided with a second locking member 50 , and the second locking member 50 is threadedly matched with the second end 12 , and the second locking member 50 is used to fasten the valve 40 to the second end 12 .

[0048] The second locking member 50 is a locking cap, which is detachably connected to the second end 12 of the tube body 10. In this embodiment, the locking cap is threadedly matched with the second end 12 of the tube body 10, the second end 12 is provided with an external thread, and the locking cap has an internal thread correspondingly. The second locking member 50 is threadedly connected to the tube body 10, and after the test is completed, the valve 40 and the second locking member 50 are disassembled and removed, which is conducive to cleaning the test particles remaining at the connection between the tube body 10 and the valve 40, thereby improving the accuracy of the particle test data.

[0049] In some embodiments, a sealing ring 51 is disposed between the end of the second end 12 and the valve 40. The sealing ring 51 provides better sealing between the valve 40 and the second end 12 of the tube body 10, thereby preventing external particles from affecting the test results.

[0050] In some embodiments, see Figure 5 and Figure 6 The tube body 10 includes at least one of a straight tube, an S-shaped tube or a hook-shaped tube. By using the tube body 10 as a straight tube, an S-shaped tube or a hook-shaped tube, blood vessels in different locations in the human body can be simulated, and the clinical use of the delivery system can be simulated more realistically and effectively.

[0051] In some embodiments, see Figure 2 The water supply unit 60 includes a syringe 61, and the output end of the syringe 61 is connected to a second syringe filter 62, and the second syringe filter 62 is used to communicate with the water injection end of the intervention sheath 201 of the delivery system. The syringe 61 is used to store test water and cooperate with the second syringe filter 62 to inject the test water into the water injection end of the intervention sheath 201 of the delivery system. The second syringe filter 62 can filter the test water before entering the delivery system to eliminate the influence of insoluble particles in the test water as much as possible. The syringe 61 has a simple structure and strong practicality, and has the advantage of being available for testing and taking at any time.

[0052] Of course, the test water drawn by the syringe 61 can be directly extracted from the water bath using the syringe 61 equipped with a second syringe filter 62. This is simple and easy to use. The temperature of the test water is about 37°C, making the test environment as close to the clinical environment as possible to improve the accuracy of the particle test.

[0053] The application fields of the insoluble particle testing device 100 for the delivery system are: particle testing of the surgical instrument intervention part of the delivery system, such as the aortic valve, the mitral valve, and the tricuspid valve. The specific usage method is as follows:

[0054] 1. Blank test

[0055] 1.1 Particle test water and beaker for testing Particle test requirements: Every 10ml contains less than 10 insoluble particles of 10um and above, and less than 2 insoluble particles of 25um and above.

[0056] 1.2 Inject 170 ml of particle test water into the tube body 10 through the syringe 61 and the second needle filter 62, plug the two ends of the tube body 10 with stoppers, and shake it up and down 20 times. Collect the eluate three times in total, and the volume of the collected eluate is at least 500 ml. The pre-sampling volume is 10 ml, the sampling volume for each test is 100 ml, and the test volume is 300 ml for three times. The contamination index Nb of the blank flushing liquid in the tube body 10 is ≤9.

[0057] 2. Preparation of eluent

[0058] 2.1 Heat 250 ml of particle test water at 37 ± 1 °C.

[0059] 2.2 Take a conveyor, insert the first locking piece 30 and the plug 20 into the interventional sheath 201 of the conveyor to be tested, insert it into the tube body 10, tighten the first locking piece 30 to make the plug 20 fit tightly against the tube body 10, use a syringe 61 to extract heated particle test water, install a second syringe filter 62 on the syringe 61 to flush the inner cavity of the interventional sheath 201, inject 60 ml of particle detection water into each inner cavity, and collect about 170 ml of eluent in the tube body.

[0060] 2.3 Simulate the release and recovery operations three times. After the operations are completed, shake the test device up and down 20 times.

[0061] 2.4 Collect the eluate into a beaker, with a total of at least 500 ml of eluate.

[0062] 3. Detection

[0063] After the eluate was left to stand for 3 minutes, stirring was started for particle testing. The pre-sampling volume was 10 ml, the sampling volume for each test was 100 ml, and the test was repeated three times with a test volume of 300 ml.

[0064] Table 1 Particle size classification and evaluation coefficient

[0065]

[0066] 4. Calculation formula (n is the total eluent volume / each sampling volume)

[0067] Number of particles in the eluent: Na = (na1*0.1+na2*0.2+na3*5)*n

[0068] The number of particles in the blank liquid of the tube in the test device is Nb = (nb1*0.1+nb2*0.2+nb3*5)*n

[0069] 5. Product contamination index: N = Na-Nb.

[0070] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0071] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A testing device for insoluble particles in a conveying system, characterized in that: include: A tube body, which is used to accommodate the interventional sheath of the delivery system, the tube body having a first channel extending along its axial direction, the two ends of the first channel are respectively a first end and a second end, the first end is used for the interventional sheath of the delivery system to enter the tube body, and the second end is provided with a valve; a water supply unit for supplying test water to the delivery system; The rubber plug has a second channel extending along its axial direction, the second channel is used for the insertion of the intervention sheath of the delivery system, and the rubber plug is used to seal the insertion sheath of the delivery system with the first end of the tube body.

2. The insoluble particle testing device for a conveying system according to claim 1, characterized in that: Along the axial direction of the rubber plug, the rubber plug at least includes a first tube segment and a second tube segment, the outer diameter of the first tube segment is smaller than the inner diameter of the first channel, and the outer diameter of the second tube segment is larger than the inner diameter of the first channel, so that the rubber plug is partially embedded in the tube body.

3. The insoluble particle testing device for a conveying system according to claim 2, characterized in that: The first end is provided with a first locking member, the first locking member is detachably connected to the first end of the tube body, and the first locking member is used to fasten the rubber plug to the tube body.

4. The insoluble particle testing device for a conveying system according to claim 3, characterized in that: The first locking member has an internal thread, and the outer peripheral surface of the tube body close to the first end is provided with an external thread, and the internal thread is meshed with the external thread.

5. The insoluble particle testing device for a conveying system according to any one of claims 1 to 4, characterized in that: The valve is a three-way valve having a first outlet end and a second outlet end. The first outlet end is used to communicate with the particle tester, and the second outlet end is used to enable the first channel to communicate with the outside.

6. The insoluble particle testing device for a conveying system according to claim 5, characterized in that: The second outlet end is provided with a first syringe filter.

7. The insoluble particle testing device for a conveying system according to any one of claims 1 to 4, characterized in that: The second end is provided with a second locking member, the second locking member is threadedly matched with the second end, and the second locking member is used to fasten the valve to the second end.

8. The insoluble particle testing device for a conveying system according to claim 7, characterized in that: A sealing ring is arranged between the end of the second end and the valve.

9. The insoluble particle testing device for a conveying system according to any one of claims 1 to 4, characterized in that: The tube body includes at least one of a straight tube, an S-shaped tube or a hook-shaped tube.

10. The insoluble particle testing device for a conveying system according to any one of claims 1 to 4, characterized in that: The water supply unit comprises a syringe, the output end of the syringe is connected with a second syringe filter, and the second syringe filter is used to be connected with a water injection end on the interventional sheath tube of the delivery system.

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