Medical bag interface assembly leak detection device and detection tooling

Abstract

The utility model provides a kind of medical bag interface assembly leakproofness detection device and its detection tool, it is related to medical instrument technical field.The specific includes sealing tester and detection tool;Sealing tester has aeration unit, gas flow detection unit, aeration interface and gas inlet interface;Detection tool includes bottom disc, tool outlet pipe and outer cover;Bottom disc upper surface is equipped with detection acupoint, and elastic sealing ring is fixed in detection acupoint inside;Bottom disc is equipped with gas passage with the communication of detection acupoint;Tool outlet pipe one end is communicated with gas passage, and other end forms gas outlet to be used to connect with the gas inlet interface of sealing tester;Outer cover is covered in the outside of bottom disc and is sealedly connected with bottom disc, and detection acupoint is located in outer cover inside, and outer cover is equipped with gas inlet and is connected with tool gas inlet pipe, and tool gas inlet pipe is used to connect with the aeration interface of sealing tester.The utility model can be used for the sealing integrity of medical bag interface assembly is quickly, simply, effectively detected.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, and in particular to a sealing test device for a medical bag interface component and its testing fixture. Background Technology

[0002] Medical bags include products such as urine bags, infusion bags, and oxygen bags. They mainly consist of bags made of soft materials and interface components connected to the bag opening. The bags are typically made of multi-layer co-extruded film, and the interface components include combination caps and interface fittings.

[0003] Taking large-volume infusion bags as an example, the composite cap is typically composed of an outer cap, a rubber gasket, and an inner cap. An interface fitting is fixed to the bag opening and connects to the opening of the composite cap. The manufacturing process involves bag making, interface welding, medication filling, sealing the composite cap and interface by welding, and checking the weld seal to ultimately form a sealed infusion bag. However, if a through-weld defect occurs during the welding process between the composite cap and the interface fitting, leakage may occur. Although a high-voltage discharge microporous inspection machine can remove leaking defective products, in cases of welding defects (such as a well-welded inner cap but a weld gap in the outer cap), these defects may go undetected because there is no obvious leakage problem. However, in clinical use, if the syringe penetrates the inner cap, the medication may leak from the poorly welded area, seriously affecting infusion safety.

[0004] Therefore, how to quickly, easily, and effectively test the sealing integrity of the interface components of medical bags has become a technical problem that urgently needs to be solved in the production process of medical bags. Utility Model Content

[0005] The purpose of this invention is to provide a device for testing the sealing integrity of medical bag interface components and its testing fixture, so as to quickly, easily and effectively test the sealing integrity of medical bag interface components.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, this utility model provides a sealing performance testing device for medical bag interface components, including a sealing tester and a testing fixture;

[0008] The sealing tester has an inflation unit, a gas flow detection unit, an inflation interface connected to the inflation unit, and an air inlet interface connected to the gas flow detection unit.

[0009] The testing fixture includes:

[0010] The chassis has detection acupoints on its upper surface, and an elastic sealing ring for docking with the medical bag interface assembly is fixed inside the detection acupoints; a gas channel communicating with the detection acupoints is provided inside the chassis.

[0011] The tooling outlet pipe has one end connected to the gas channel and the other end forming an outlet, which is used to connect to the air inlet of the sealing tester.

[0012] An outer cover is provided outside the chassis and is sealed to the chassis. The detection acupoint is located inside the outer cover. The outer cover is provided with an air inlet and connected to a tooling air inlet pipe. The tooling air inlet pipe is used to connect to the inflation interface of the sealing tester.

[0013] In an optional embodiment, multiple acupoints are provided, and all of the multiple acupoints are connected to the gas channel.

[0014] In an optional embodiment, multiple gas channels and multiple tooling outlet pipes are provided, and the multiple gas channels are connected to multiple detection acupoints in a one-to-one correspondence, and the multiple tooling outlet pipes are connected to the multiple gas channels in a one-to-one correspondence.

[0015] In an optional embodiment, the upper surface edge of the chassis is provided with an assembly groove extending circumferentially along the chassis, and the lower end of the outer cover peripheral wall abuts against the interior of the assembly groove.

[0016] In an optional embodiment, a sealing element is provided between the lower end of the peripheral wall of the outer cover and the inner wall of the assembly groove, and the sealing element is fixed to the peripheral wall of the outer cover or to the groove wall of the assembly groove.

[0017] In an optional embodiment, the seal is a rubber gasket.

[0018] In an optional embodiment, the chassis has multiple support legs at its lower end.

[0019] Secondly, this utility model also provides a sealing test fixture for a medical bag interface assembly, applied to the medical bag interface assembly sealing test device described in any of the foregoing embodiments, wherein the medical bag interface assembly sealing test fixture includes:

[0020] The chassis has detection acupoints on its upper surface, and an elastic sealing ring for docking with the medical bag interface assembly is fixed inside the detection acupoints; a gas channel is provided inside the chassis, and the detection acupoints are connected to the gas channel.

[0021] The tooling exhaust pipe has one end connected to the gas channel and the other end forming an exhaust port;

[0022] The outer cover is placed outside the chassis and is sealed to the chassis. The detection acupoint is located inside the outer cover. The outer cover is provided with an air inlet, and a tooling air inlet pipe is connected to the air inlet.

[0023] Beneficial effects:

[0024] The testing method is as follows: The interface component to be tested is placed upside down on the testing acupoint, forming a seal between the elastic sealing ring and the acupoint. The outer cover is placed over the chassis and sealed to it. The tooling inlet pipe is connected to the inflation port of the sealing tester, and the tooling outlet pipe outlet is connected to the inlet port of the sealing tester. The sealing tester is started, and its inflation unit introduces gas (applying a 3.0 kg gas source pressure) into the outer cover through the inflation port. This is maintained for a period of time, and the gas flow rate is monitored using its gas flow rate detection unit. If the gas flow rate is ≤1 ml / min, the interface component is considered to have good sealing performance; if the gas flow rate is ≥1 ml / min, leakage is indicated.

[0025] This embodiment enables rapid, simple, and effective testing of the sealing integrity of medical bag interface components. Furthermore, the structure of this embodiment, through the mating of the elastic sealing ring with the medical bag interface component, can effectively adapt to interface components of different sizes or shapes, reducing the risk of leakage and improving the reliability of sealing tests. Attached Figure Description

[0026] To more clearly illustrate the specific embodiments of this utility model or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the overall structure of the sealing performance testing fixture for the medical bag interface assembly in this embodiment of the present invention. Figure 1 ;

[0028] Figure 2 This is a schematic diagram of the overall structure of the sealing performance testing fixture for the medical bag interface assembly in this embodiment of the present invention. Figure 2 ;

[0029] Figure 3 This is a top view of the overall structure of the sealing test fixture for the medical bag interface component in this embodiment of the present invention.

[0030] Figure 4 for Figure 3 Sectional view along axis AA;

[0031] Figure 5 This is a schematic diagram of the overall structure of the medical bag interface assembly sealing test fixture, excluding the cover, in an embodiment of this utility model. Figure 1 ;

[0032] Figure 6This is a schematic diagram of the overall structure of the medical bag interface assembly sealing test fixture, excluding the cover, in an embodiment of this utility model. Figure 2 ;

[0033] Figure 7 This is a top view of the overall structure of the medical bag interface assembly sealing test fixture, excluding the cover, in this embodiment of the utility model.

[0034] Figure 8 for Figure 7 BB-direction sectional view;

[0035] Figure 9 This is an isometric view of the assembly structure of the medical bag interface component and the other structures in the sealing test fixture, excluding the cover, in this embodiment of the utility model.

[0036] Figure 10 This is a top view of the assembly structure of the medical bag interface component sealing test fixture, excluding the cover, with the medical bag interface component in this embodiment of the utility model.

[0037] Icons: 100-Interface component; 1-Chassis; 11-Detection acupoint; 12-Gas channel; 13-Assembly slot; 2-Tooling air outlet pipe; 3-Outer cover; 4-Tooling air inlet pipe; 5-Support leg. Detailed Implementation

[0038] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0039] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0040] It should be noted that similar labels and letters in the accompanying drawings indicate similar items. Therefore, once an item is defined in one accompanying drawing, it does not need to be further defined and explained in subsequent accompanying drawings.

[0041] In the description of this utility model, it should be noted that the terms "upper," "lower," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the utility model product is in use. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0042] Furthermore, the terms "horizontal" and "vertical" do not imply that the component must be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0043] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," and "connect" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0044] The following detailed description, in conjunction with the accompanying drawings, outlines some embodiments of the present invention. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0045] Example 1

[0046] This embodiment provides a sealing performance testing device for medical bag interface components, including a sealing tester and testing fixtures. Specifically, the sealing tester is a prior art technology mainly used to monitor and evaluate the sealing quality of products, ensuring that the product can effectively prevent the entry of external substances (such as air, moisture, etc.) or the leakage of internal substances. This instrument typically determines whether a sample is leaking by monitoring changes in gas flow rate. The sealing tester has an inflation unit, a gas flow rate detection unit, an inflation interface connected to the inflation unit, and an inlet interface connected to the gas flow rate detection unit.

[0047] This embodiment features a specially designed testing fixture that works in conjunction with the aforementioned sealing tester to form a sealing performance testing device for medical bag interface components. (Refer to...) Figures 1 to 10The testing fixture includes a chassis 1, a fixture air outlet pipe 2, and an outer cover 3. An air inlet pipe 4 is connected to the outer cover 3. Specifically: the upper surface of the chassis 1 has a detection acupoint 11, and an elastic sealing ring (not shown) for mating with the medical bag interface assembly 100 is fixed inside the detection acupoint 11; a gas channel 12 communicating with the detection acupoint 11 is provided inside the chassis 1. One end of the fixture air outlet pipe 2 is connected to the gas channel 12, and the other end forms an air outlet, which is used to connect to the air inlet interface of the sealing tester. The outer cover 3 covers the outside of the chassis 1 and is sealed to the chassis 1. The detection acupoint 11 is located inside the outer cover 3. An air inlet is provided on the outer cover 3 and connected to the fixture air inlet pipe 4, which is used to connect to the inflation interface of the sealing tester.

[0048] The testing method is as follows: The interface component 100 to be tested is placed upside down on the detection acupoint 11, forming a seal between the elastic sealing ring and the detection acupoint 11. The outer cover 3 is placed over the chassis 1 and sealed to it. The tooling inlet pipe 4 is connected to the inflation port of the sealing tester, and the outlet of the tooling outlet pipe 2 is connected to the inlet port of the sealing tester. The sealing tester is started, and its inflation unit introduces gas (applying a gas source pressure of 3.0 kg) into the outer cover through the inflation port. This is maintained for a period of time, and the gas flow rate is monitored using its gas flow rate detection unit. If the gas flow rate is ≤1 ml / min, the interface component 100 is considered to have good sealing performance; if the gas flow rate is ≥1 ml / min, leakage is indicated.

[0049] This embodiment enables rapid, simple, and effective testing of the sealing integrity of the medical bag interface assembly. Furthermore, the structure of this embodiment, through the mating of the elastic sealing ring with the medical bag interface assembly 100, effectively adapts to interface assemblies 100 of different sizes or shapes, reducing the risk of leakage and improving the reliability of the sealing test.

[0050] Furthermore:

[0051] In an optional embodiment of this example, multiple detection acupoints 11 are provided, and all of the multiple detection acupoints 11 are connected to the gas channel 12. The design of multiple detection acupoints 11 allows for the simultaneous detection of multiple medical bag interface components 100, which can significantly improve production efficiency and is especially suitable for large-scale production scenarios.

[0052] Furthermore, multiple gas channels 12 and tooling outlet pipes 2 are preferably provided, with each gas channel 12 corresponding to a specific detection point 11, and each tooling outlet pipe 2 corresponding to a specific gas channel 12. Each detection point 11 corresponds to an independent gas channel 12 and tooling outlet pipe 2, which can avoid gas interference between adjacent detection points and ensure that the detection results of each interface component 100 are independent and accurate.

[0053] In an optional embodiment of this invention, the upper surface edge of the chassis 1 is provided with an assembly groove 13 extending circumferentially along the chassis 1, and the lower end of the peripheral wall of the outer cover 3 abuts against the interior of the assembly groove 13. The design of the assembly groove 13 makes the connection between the outer cover 3 and the chassis 1 more stable, ensuring that no gaps are generated between the outer cover 3 and the chassis 1 during operation, ensuring that the outer cover 3 always covers the detection acupoint 11 to form a closed space, reducing the influence of external airflow on gas detection, and further improving the sensitivity of the sealing test.

[0054] In an optional embodiment of this invention, a sealing element is provided between the lower end of the peripheral wall of the outer cover 3 and the inner wall of the assembly groove 13. The sealing element is fixed to the peripheral wall of the outer cover 3 or to the groove wall of the assembly groove 13. Adding a sealing element (including but not limited to a rubber gasket) between the assembly groove and the outer cover can effectively seal the tiny gaps at the connection, prevent the test gas from escaping, and ensure the accuracy of the test results.

[0055] In an optional embodiment of this invention, the chassis 1 is provided with multiple support legs 5 at its lower end. The support legs 5 are designed to provide additional support for the chassis 1, preventing tilting or shaking caused by uneven ground or external forces during the testing process, and ensuring the stability of the testing data.

[0056] Secondly, this utility model also provides a sealing performance testing fixture for a medical bag interface assembly, applicable to any of the optional embodiments of the first aspect of the aforementioned medical bag interface assembly sealing performance testing device. The fixture includes a base 1, a fixture vent pipe 2, and an outer cover 3. The upper surface of the base 1 is provided with a detection acupoint 11, and an elastic sealing ring for docking with the medical bag interface assembly 100 is fixed inside the detection acupoint 11. A gas channel 12 is provided inside the base 1, and the detection acupoint 11 communicates with the gas channel 12. One end of the fixture vent pipe 2 communicates with the gas channel 12, and the other end forms an air outlet. The outer cover 3 covers the outside of the base 1 and is sealed to the base 1. The detection acupoint 11 is located inside the outer cover 3, and an air inlet is provided on the outer cover 3, to which a fixture air inlet pipe 4 is connected. Its usage and beneficial effects are described in the relevant section of the first aspect.

[0057] Finally, it should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to mutually. The above embodiments in this specification are only used to illustrate the technical solutions of this utility model, and not to limit it. Although this utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the various embodiments of this utility model.

Claims

1. A device for detecting the sealing performance of a medical bag interface assembly, characterized in that, Includes sealing testers and testing fixtures; The sealing tester has an inflation unit, a gas flow detection unit, an inflation interface connected to the inflation unit, and an air inlet interface connected to the gas flow detection unit. The testing fixture includes: The chassis has detection acupoints on its upper surface, and an elastic sealing ring for docking with the medical bag interface assembly is fixed inside the detection acupoints; a gas channel communicating with the detection acupoints is provided inside the chassis. The tooling outlet pipe has one end connected to the gas channel and the other end forming an outlet, which is used to connect to the air inlet of the sealing tester. An outer cover is provided outside the chassis and is sealed to the chassis. The detection acupoint is located inside the outer cover. The outer cover is provided with an air inlet and connected to a tooling air inlet pipe. The tooling air inlet pipe is used to connect to the inflation interface of the sealing tester.

2. The medical bag interface assembly sealing test device according to claim 1, characterized in that: The detection acupoints are provided in multiple locations, and all of the detection acupoints are connected to the gas channel.

3. The medical bag interface assembly sealing test device according to claim 2, characterized in that: The gas channel and the tooling outlet pipe are provided with multiple gas channels, and the multiple gas channels are connected to multiple detection acupoints in a one-to-one correspondence. The multiple tooling outlet pipes are connected to the multiple gas channels in a one-to-one correspondence.

4. The medical bag interface assembly sealing test device according to claim 1, characterized in that: The upper surface edge of the chassis is provided with an assembly groove extending circumferentially along the chassis, and the lower end of the outer cover peripheral wall abuts against the interior of the assembly groove.

5. The medical bag interface assembly sealing test device according to claim 4, characterized in that: A sealing element is provided between the lower end of the peripheral wall of the outer cover and the inner wall of the assembly groove. The sealing element is fixed to the peripheral wall of the outer cover or to the groove wall of the assembly groove.

6. The medical bag interface assembly sealing test device according to claim 5, characterized in that: The sealing element is a rubber gasket.

7. The medical bag interface assembly sealing test device according to claim 1, characterized in that: The chassis is equipped with multiple support legs at its lower end.

8. A tooling for testing the sealing performance of a medical bag interface assembly, characterized in that: The medical bag interface assembly sealing performance testing device according to any one of claims 1-7, wherein the medical bag interface assembly sealing performance testing fixture comprises: The chassis has detection acupoints on its upper surface, and an elastic sealing ring for docking with the medical bag interface assembly is fixed inside the detection acupoints; a gas channel is provided inside the chassis, and the detection acupoints are connected to the gas channel. The tooling exhaust pipe has one end connected to the gas channel and the other end forming an exhaust port; The outer cover is placed outside the chassis and is sealed to the chassis. The detection acupoint is located inside the outer cover. The outer cover is provided with an air inlet, and a tooling air inlet pipe is connected to the air inlet.

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