A biological indicator device

Abstract

The utility model discloses a biological indicator device, including first culture container, sealing element and second culture container, sealing element detachable seal setting is in first culture container, sealing element includes the first passageway for intercommunication outside and the second passageway of intercommunication first culture container, second culture container includes outer tube and inner tube, outer tube is hollow, forms and has assembled cavity, outer tube can be inserted into first passageway, inner tube can be slidably inserted on outer tube, one end of inner tube penetrates assembled cavity, and is used for inserting into second passageway, first culture container is used for carrying culture medium, second culture container is used for carrying sterilization carrier, after sterilization is completed, operating personnel inserts outer tube in first passageway, and then pushes and inserts inner tube in second passageway, to transfer sterilization carrier in inner tube to first culture container, ensure the sealing property of transfer process, solve the problem that existing sterilization carrier is vulnerable to pollution in the transfer process.

Description

Technical Field

[0001] This utility model relates to the field of biological indicator technology, and in particular to a biological indicator device. Background Technology

[0002] Biological indicators are tools used to assess the effectiveness of sterilization processes. In the field of biovalidation technology for sterilization processes, biological indicators serve as core detection tools for evaluating sterilization efficacy, and their accuracy directly impacts the quality and safety of medical devices and sterile products.

[0003] Currently, the most commonly used bioindicators on the market are those with a separate structure. These bioindicators separate the sterilization carrier from the reconstitution medium. Specifically, the sterilization carrier is typically packaged in a primary packaging bag, while the reconstitution medium is stored separately in another container. After sterilization, the operator must remove the sterilization carrier from the packaging bag and transfer it to a vessel containing the reconstitution medium for incubation.

[0004] However, during the transfer process, the lack of stability in the connection between the packaging bag and the culture medium container makes it easy for the culture medium containing the carrier to spill or overflow, causing not only environmental pollution but also the introduction of exogenous microbial contamination, thus affecting the reliability of the test results. Furthermore, open transfer operations increase the risk of contamination of the sterilization carrier and culture medium, potentially leading to false positive results and misleading the assessment of sterilization effectiveness.

[0005] Therefore, existing technologies still need to address this issue. Utility Model Content

[0006] In view of the shortcomings of the prior art, the purpose of this utility model is to provide a biological indicator device, which aims to solve the problem of easy contamination during the transfer of existing sterilization carriers.

[0007] The biological indicator device provided in this application adopts the following technical solution:

[0008] A biological indicator device, comprising:

[0009] A first culture container, the first culture container being used to hold the culture medium;

[0010] A sealing element is detachably and sealingly disposed on the first culture container; the sealing element includes a first channel for communicating with the outside world and a second channel for communicating with the first culture container.

[0011] A second culture container; wherein the second culture container includes:

[0012] The outer tube is hollow and has an assembly cavity; the outer tube can be inserted into the first channel.

[0013] The inner tube is slidably inserted into the outer tube; one end of the inner tube passes through the assembly cavity and is used to be inserted into the second channel; the second culture container is used to hold the sterilization carrier.

[0014] Optionally, in the biological indicator device, the sealing element further includes an elastic locking element; one end of the elastic locking element is connected to the first channel, and the other end is connected to the second channel; the elastic locking element connects the first channel and the second channel.

[0015] Optionally, in the biological indicator device, the cross-sectional shape of the elastic locking member is frustoconical; the diameter of the elastic locking member is smaller than the diameter of the first channel and smaller than or equal to the diameter of the second channel.

[0016] Optionally, in the biological indicator device, the diameter of the first channel is larger than the diameter of the second channel.

[0017] Optionally, in the biological indicator device, the first channel has a frustum-shaped cross-section, and the second channel has a square cross-section.

[0018] Optionally, in the biological indicator device, the outer tube includes a sealing portion and a fixing portion; the sealing portion has a frustum-shaped cross-section; the fixing portion has a square cross-section; and the sealing portion is used to be inserted into the first channel.

[0019] Optionally, in the biological indicator device, the diameter of the sealing portion is larger than the diameter of the second channel.

[0020] Optionally, in the biological indicator device, the fixing part is provided with an internal thread; the outer surface of the inner tube is provided with an external thread; and the fixing part is screwed to the inner tube.

[0021] Optionally, in the biological indicator device, the length of the inner tube is greater than the length of the outer tube.

[0022] Optionally, in the biological indicator device, an auxiliary component is provided at the end of the inner tube opposite to the sealing portion; the auxiliary component is elastic and is used to squeeze the sterilization carrier into the first culture container.

[0023] Compared with the prior art, the embodiments of this utility model have the following advantages:

[0024] This invention discloses a biological indicator device, comprising a first culture container and a second culture container; the first culture container holds the culture medium; the second culture container holds the sterilized carrier. After sterilization, the operator inserts the outer tube into the first channel and then pushes the inner tube into the second channel to transfer the sterilized carrier in the inner tube into the first culture container, ensuring the airtightness of the transfer process and solving the problem of easy contamination during the transfer of sterilized carriers in existing methods. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is one of the schematic diagrams of the biological indicator culture device in the embodiments of this application;

[0027] Figure 2 This is the second schematic diagram of the biological indicator culture device in the embodiments of this application;

[0028] Figure 3 This is a cross-sectional view of the first culture container in an embodiment of this application;

[0029] Figure 4 yes Figure 3 Enlarged view of point A in the middle;

[0030] Figure 5 This is a cross-sectional view of the second culture container in an embodiment of this application.

[0031] Explanation of reference numerals in the attached drawings: 100, first culture container; 110, first sealing cap; 200, sealing element; 210, first channel; 220, second channel; 230, elastic locking element; 231, annular platform; 300, second culture container; 310, outer tube; 311, assembly cavity; 312, sealing part; 313, fixing part; 320, inner tube; 321, auxiliary component; 330, second sealing cap. Detailed Implementation

[0032] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0033] The present application will be further described in detail below with reference to the accompanying drawings.

[0034] like Figure 1 and Figure 2 As shown in the figure, this application discloses a biological indicator culture device, which includes a first culture container 100, a sealing element 200, and a second culture container 300. The first culture container 100 is used to hold a culture medium. The sealing element 200 is detachably and sealingly disposed on the first culture container 100. The sealing element 200 includes a first channel 210 for communicating with the outside and a second channel 220 for communicating with the first culture container 100. The second culture container 300 includes an outer tube 310 and an inner tube 320. The outer tube 310 is hollow and forms an assembly cavity 311. The outer tube 310 can be inserted into the first channel 210. The inner tube 320 is slidably inserted into the outer tube 310. One end of the inner tube 320 passes through the assembly cavity 311 and is used to be inserted into the second channel 220. The second culture container 300 is used to hold a sterilization carrier.

[0035] The sealing element 200 is used to seal the first culture container 100. In actual use, the sealing element 200 functions similarly to a stopper and can be a wooden stopper or a rubber stopper. The sealing element 200 includes a first channel 210 and a second channel 220 that are interconnected. The sealing element 200 is inserted into the top of the first culture container 100, and the second channel 220 is located inside and outside the first culture container 100. The second culture container 300 includes an outer tube 310 and an inner tube 320 inserted into the outer tube 310.

[0036] Specifically, the sterilization carrier is first carried in the inner tube 320 of the second culture container 300. When it is necessary to transfer the sterilization carrier to the first culture container 100, the outer tube 310 is first inserted into the first channel 210; then the inner tube 320 is pushed so that it passes through the assembly cavity 311 of the outer tube 310 and is inserted into the second channel 220, so that the sterilization carrier enters the first culture container 100.

[0037] like Figure 1 and Figure 2As shown, in this embodiment, before the first culture container 100 and the second culture container 300 are connected, both the first culture container 100 and the second culture container 300 are sealed. Specifically, a first sealing cap 110 is provided at the opening of the first channel 210, and a second sealing cap 330 is provided at one end of the outer tube 310. Before transferring the sterilization carrier, the first sealing cap 110 and the second sealing cap 330 are removed, the second culture container 300 is placed upright, and the first culture container 100 is inserted upside down into the outer tube 310. After the inner tube 320 is pushed into the second channel 220, the first culture container 100 and the second culture container 300 are flipped over, that is, the first culture container 100 is placed upright, and the second culture container 300 is inserted upside down into the first culture container 100. At this time, the sterilization carrier in the inner tube 320 is slowly transferred to the first culture container 100. After the sterilization carrier in the inner tube 320 has been completely transferred to the first culture container 100, the inner tube 320 is pulled out and the first sealing cap 110 is resealed to seal the opening of the first channel 210.

[0038] like Figure 1 and Figure 5 As shown, in this embodiment, one end of the inner tube 320 is inserted into the assembly cavity 311 of the outer tube 310, and the other end extends out of the assembly cavity 311. The opening of the inner tube 320 is located at the end of the inner tube 320 that is inserted into the assembly cavity 311. Before the sterilization carrier is transferred, the opening of the inner tube 320 is always in the assembly cavity 311, and the outer tube 310 is provided with a second sealing cap 330. Therefore, the sterilization carrier will not leak. During the transfer of the sterilization carrier, the outer tube 310 is in close contact with the inner wall of the first channel 210. At this time, the assembly cavity 311 of the outer tube 310 is connected to the second channel 220, and the inner tube 320 passes through the assembly cavity 311 and enters the second channel 220, completing the transfer of the sterilization carrier. It can be seen that the sterilization carrier is always transferred in a sealed environment and will not be contaminated by the outside.

[0039] like Figure 3 and Figure 4As shown, in this embodiment, the sealing member 200 further includes an elastic locking member 230; one end of the elastic locking member 230 is connected to the first channel 210, and the other end is connected to the second channel 220; the elastic locking member 230 connects the first channel 210 and the second channel 220. In use, the elastic locking member 230 is disposed between the first channel 210 and the second channel 220. The cross-sectional shape of the elastic locking member 230 is conical, and the diameter of the elastic locking member 230 is smaller than the diameter of the first channel 210 and smaller than or equal to the diameter of the second channel 220. Specifically, the diameter of the elastic locking member 230 is smaller than the diameter of the inner tube 320. During the transfer of the sterilization carrier, the outer tube 310 abuts against the inner wall of the first channel 210, and the inner tube 320 passes through the assembly cavity 311 and through the elastic locking member 230 to extend into the second channel 220.

[0040] like Figure 4 As shown, in this embodiment, the elastic locking member 230 is generally shaped like a frustum, and the diameter of the end of the elastic locking member 230 connected to the first channel 210 is larger than the diameter of the end of the elastic locking member 230 connected to the second channel 220. This design creates an annular platform 231 at the connection between the elastic locking member 230 and the first channel 210. When the outer tube 310 is inserted into the first channel 210, the annular platform 231 can abut against the port of the outer tube 310, preventing the outer tube 310 from being inserted too deeply. In one embodiment, the elastic locking member 230 is generally shaped like a cone, meaning the port of the elastic locking member 230 connected to the second channel 220 is in a closed state, ensuring the sterility of the environment.

[0041] Before the inner tube 320 is inserted, the port of the elastic locking member 230 near the second channel 220 is in a closed state. After the inner tube 320 passes through the assembly cavity 311, it passes through the elastic locking member 230 and enters the second channel 220. Since the diameter of the elastic locking member 230 is smaller than the diameter of the inner tube 320 and it is elastic, the elastic locking member 230 fits tightly against the inner tube 320, ensuring a seal during the transfer process. After the transfer is completed, the inner tube 320 is withdrawn from the second channel 220, and the elastic locking member 230 returns to a closed state. This further prevents contamination of the first culture container 100. In this embodiment, the transfer process is carried out in a sterile, sealed large container. Both the first culture container 100 and the second culture container 300 are clean and sterile. The elastic locking member 230 is provided to further prevent contamination of the sterilization carrier or culture medium during the transfer process.

[0042] like Figure 5As shown, in one embodiment, the diameter of the first channel 210 is larger than the diameter of the second channel 220, and the cross-sectional shape of the first channel 210 is frustoconical; the cross-sectional shape of the second channel 220 is square. Specifically, the first channel 210 is designed as a frustoconical to prevent the outer tube 310 from being inserted too deeply during the transfer of the sterilization carrier. Simultaneously, it ensures that the inner tube 320 is aligned with the second channel 220, guaranteeing accurate insertion of the inner tube 320 into the second channel 220. In this embodiment, the first channel 210 is designed as a frustoconical, resulting in a larger opening at the inlet end of the first channel 210, ensuring that the outer tube 310 can be inserted into the first channel 210 and abut against the inner wall of the first channel 210. Meanwhile, the second channel 220 is located in a cylindrical tube, adapting to the shape of the inner tube 320, ensuring smooth transfer of the sterilization carrier.

[0043] In this embodiment, the diameter of the second channel 220 is smaller than the diameter of the inner tube 320, and the second channel 220 is made of an elastic material, such as a rubber tube, a silicone tube, or another tube made of an elastic material. Thus, when the inner tube 320 is inserted into the second channel 220, the inner wall of the second channel 220 fits tightly against the outer wall of the inner tube 320, preventing air or other microorganisms from entering the first culture container 100 through the gap between the second channel 220 and the inner tube 320.

[0044] like Figure 5 As shown, in another embodiment of this utility model, the outer tube 310 includes a sealing part 312 and a fixing part 313; the sealing part 312 has a frustum-shaped cross-section; the fixing part 313 has a square cross-section; the sealing part 312 is used to be inserted into the first channel 210. Specifically, in actual use, the shape of the sealing part 312 is adapted to the shape of the first channel 210, that is, the cross-sectional shape of the first channel 210 is a truncated cone, and the cross-sectional shape of the sealing part 312 is an inverted frustum. This design allows the sealing part 312 to be perfectly aligned with the first channel 210 for insertion into the first channel 210, and to be in tight sealing contact with the annular platform 231, ensuring that the inner tube 320 can enter the second channel 220 in a sealed environment.

[0045] In this embodiment, the diameter of the sealing part 312 is larger than the diameter of the second channel 220. The fixing part 313 is provided with internal threads; the outer surface of the inner tube 320 is provided with external threads; the fixing part 313 is screwed to the inner tube 320. The length of the inner tube 320 is greater than the length of the outer tube 310. Specifically, the inner tube 320 is longer than the outer tube 310, and the inner tube 320 is screwed to the fixing part 313. During the transfer of the sterilization carrier, the operator inserts the sealing part 312 into the inner wall of the first channel 210, holds the fixing part 313, and then rotates the inner tube 320 so that the outer tube 310 passes through the assembly cavity 311 and extends into the second channel 220, completing the transfer of the sterilization carrier.

[0046] like Figure 1 and Figure 5 As shown, in one embodiment, an auxiliary member 321 is provided at the end of the inner tube opposite to the sealing part 312; the auxiliary member 321 is elastic and is used to squeeze the sterilization carrier into the first culture container 100. Specifically, the auxiliary member 321 is provided at the end of the inner tube opposite to the sealing part 312, and the auxiliary member 321 is made of an elastic material, which can be a rubber part or a silicone part. In actual use, after the operator inserts the sealing part 312 into the first channel 210, the inner tube is rotated so that the inner tube is inserted into the second channel 220. When the sterilization carrier is transferred from the inner tube to the first culture container 100, the auxiliary member 321 is squeezed to accelerate the transfer of the sterilization carrier.

[0047] In summary, this utility model discloses a biological indicator device, including a first culture container, a sealing element, and a second culture container. The first culture container is used to hold a culture medium. The sealing element is detachably and sealingly disposed on the first culture container. The sealing element includes a first channel for communicating with the outside and a second channel for communicating with the first culture container. The second culture container includes an outer tube and an inner tube. The outer tube is hollow and forms an assembly cavity. The outer tube can be inserted into the first channel. The inner tube is slidably inserted into the outer tube. One end of the inner tube passes through the assembly cavity and is used to be inserted into the second channel. The second culture container is used to hold a sterilization carrier. After sterilization, the operator inserts the outer tube into the first channel and then pushes the inner tube into the second channel to transfer the sterilization carrier in the inner tube to the first culture container, ensuring the sealing of the transfer process and solving the problem of easy contamination during the transfer of existing sterilization carriers.

[0048] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other.

[0049] It should be noted that this utility model uses a biological indicator device as an example to introduce the specific structure and working principle of the utility model, but the application of this utility model is not limited to biological indicator devices, and can also be applied to the production and use of other similar workpieces.

[0050] It should be understood that this invention is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this invention is limited only by the appended claims.

[0051] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A biological indicator device, characterized in that, include: A first culture container, the first culture container being used to hold the culture medium; A sealing element, which is detachably and sealingly disposed on the first culture container; The sealing element includes a first channel for communicating with the outside world and a second channel for communicating with the first culture container; A second culture container; wherein the second culture container includes: The outer tube is hollow and has an assembly cavity; the outer tube can be inserted into the first channel. The inner tube is slidably inserted into the outer tube; one end of the inner tube passes through the assembly cavity and is used to be inserted into the second channel; the second culture container is used to hold the sterilization carrier.

2. The biological indicator device according to claim 1, characterized in that, The sealing element further includes an elastic locking element; one end of the elastic locking element is connected to the first channel, and the other end is connected to the second channel; the elastic locking element connects the first channel and the second channel.

3. The biological indicator device according to claim 2, characterized in that, The cross-sectional shape of the elastic locking member is conical; the diameter of the elastic locking member is smaller than the diameter of the first channel and smaller than or equal to the diameter of the second channel.

4. The biological indicator device according to claim 1, characterized in that, The diameter of the first channel is larger than the diameter of the second channel.

5. The biological indicator device according to claim 4, characterized in that, The first channel has a frustum-shaped cross-section; the second channel has a square cross-section.

6. The biological indicator device according to claim 1, characterized in that, The outer tube includes a sealing part and a fixing part; the sealing part has a frustum-shaped cross-section; the fixing part has a square cross-section; the sealing part is used to be inserted into the first channel.

7. The biological indicator device according to claim 6, characterized in that, The diameter of the sealing part is larger than the diameter of the second channel.

8. The biological indicator device according to claim 7, characterized in that, The fixing part is provided with internal threads; the outer surface of the inner tube is provided with external threads; the fixing part is screwed to the inner tube.

9. The biological indicator device according to claim 8, characterized in that, The length of the inner tube is greater than the length of the outer tube.

10. The biological indicator device according to claim 6, characterized in that, An auxiliary component is provided at the end of the inner tube opposite to the sealing part; the auxiliary component is elastic and is used to squeeze the sterilization carrier into the first culture container.

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