A biological sterilization indicator

Abstract

The present invention discloses a biological sterilization indicator, comprising a container with a top opening, a bacterial liquid carrier for loading bacterial liquid, a bearing member for supporting a culture liquid bottle, and a crushing gland; the bacterial liquid carrier is used to be placed on the inner bottom of the container; the bearing member is used to be placed on the inner side of the container and located above the bacterial liquid carrier, and a circumferentially arranged extrusion portion is provided on the side of the bearing member facing the top opening, and the inner extrusion surface formed by the extrusion portion is a gradually reduced closing structure from one side of the top opening to the other side of the container; the crushing gland is provided with a circumferentially arranged and axially extended elastic crushing portion, the inner side surface of the elastic crushing portion is used to apply a crushing force to the outer side of the bottle body of the culture liquid bottle, and the outer side surface of the elastic crushing portion is used to resist the inner extrusion surface. The biological sterilization indicator greatly reduces the pressing force required for crushing the culture liquid bottle by applying force to the weaker part of the side of the bottle body of the culture liquid bottle, and effectively improves the crushing rate of the culture liquid bottle.

Description

Technical Field

[0001] The invention relates to the technical field of biological sterilization, and in particular to a biological sterilization indicator. Background Art

[0002] In many industries, such as the medical industry and other similar industries, according to the national regulations on medical device sterilization, standard operations must include monitoring the effectiveness of sterilization equipment such as medical devices, instruments and other disposable and non-disposable products during sterilization. Currently, the industry mainly uses sterilization indicators to monitor the effectiveness of sterilization. Sterilization indicators mainly include chemical indicators and biological indicators.

[0003] Among them, chemical indicators are generally sterilized at the same time as the instruments, and the sterilization result is judged by observing the color change of the indicator card, and the judgment result can be read immediately; however, the monitoring results given by the chemical indicators can only show the monitoring results under specific sterilization conditions during the sterilization process, such as the monitoring results under specific temperature, pressure and other environments. Therefore, the reliability of its monitoring results is not guaranteed.

[0004] Biological indicators generally contain a known amount of test microorganisms, such as Bacillus stearothermophilus or Bacillus subtilis spores, which have the ability to resist specific sterilization treatments many times greater than other contaminating organisms. The monitoring principle is to sterilize the indicator and then reproduce and grow it with the help of nutrients to determine whether it survives the sterilization treatment (sterilization treatment results), thereby determining the sterilization effectiveness of medical devices and instruments.

[0005] Therefore, compared with chemical indicators, biological indicators are an actual response of microbial activity to the sterilization effect. The sterilization results obtained using biological indicators are more direct and more reliable.

[0006] Existing biological sterilization indicators generally include a container and a crushing mechanism disposed in the container. When in use, a bacterial liquid carrier is placed at the bottom of the container, and a culture liquid bottle is placed above the bacterial liquid carrier. The crushing mechanism squeezes and applies force to the culture liquid bottle to crush the culture liquid bottle, and then the culture liquid flows out and contacts with the bacterial liquid carrier for culture. The sterilization treatment result can then be judged based on the culture result.

[0007] However, in actual use, the existing biological sterilization indicator may have a low success rate in breaking the culture solution bottle when the breaking mechanism squeezes the culture solution bottle, resulting in the biological sterilization indicator being unable to feedback the monitoring results.

[0008] In summary, how to solve the problem that the culture medium bottle cannot be broken or the breaking success rate is low during the use of the biological sterilization indicator, resulting in the biological sterilization indicator being unable to feedback the monitoring results has become a technical problem that technical personnel in this field urgently need to solve. Summary of the invention

[0009] The object of the present invention is to provide a biological sterilization indicator to solve the problem that the culture fluid bottle is easily broken during the use of the biological sterilization indicator, and the success rate is low, so that the biological sterilization indicator cannot feedback the monitoring result.

[0010] In order to achieve the above-mentioned object, the present invention provides a biological sterilization indicator, comprising a container with an opening at the top, a bacterial liquid carrier for loading bacterial liquid, a carrier for supporting a fragile culture liquid bottle, and a crushing gland;

[0011] The bacterial liquid carrier is used to be placed on the inner bottom of the container;

[0012] The carrier is used to be placed inside the container and above the bacterial liquid carrier, and a circumferentially arranged extrusion portion is provided on one side of the carrier facing the top opening, and an inner extrusion surface formed by the extrusion portion is a gradually shrinking closing structure from one side of the top opening to the other side of the container;

[0013] The crushing cover is provided with an elastic crushing part which is arranged circumferentially and extends axially. The inner side surface of the elastic crushing part is used to apply a crushing force to the side surface of the bottle body of the culture liquid bottle, and the outer side surface of the elastic crushing part is used to resist the inner extrusion surface.

[0014] Preferably, the bearing member is fixed in axial position when installed in the container.

[0015] Preferably, the axial position of the carrier is not fixed when installed in the container, the inner diameter of the container gradually shrinks from the top opening to the bottom diameter of the container, and the extrusion portion is an elastic extrusion portion, and the outer side surface of the elastic extrusion portion is against the inner wall of the container.

[0016] Preferably, a convex structure is provided on the inner side of the crushing cover.

[0017] Preferably, the crushing gland is sealedly connected to the top opening of the container.

[0018] Preferably, there is an interference fit between the crushing cover and the top opening.

[0019] Preferably, the inner side surface of the crushing pressure cover cooperates with the outer side surface of the top opening, or the outer side surface of the crushing pressure cover cooperates with the inner side surface of the top opening.

[0020] Preferably, the bacterial liquid carrier comprises a gel shell and a glass fiber filter paper arranged in the gel shell.

[0021] Preferably, the bacterial liquid carrier is a bacterial sheet structure, and the bacterial sheet structure is placed vertically or horizontally in the container.

[0022] Preferably, the bottom cross-section of the container is a semicircular, square or special-shaped structure.

[0023] Preferably, the plastic shell and the glass fiber filter paper are connected by ultrasonic welding.

[0024] Preferably, it also includes a filter membrane arranged below the supporting member.

[0025] Compared with the background technology introduction, the above-mentioned biological sterilization indicator includes a container with a top opening, a bacterial liquid carrier for loading bacterial liquid, a supporting member for supporting a fragile culture liquid bottle and a crushing pressure cover; the bacterial liquid carrier is used to be placed on the inner bottom of the container; the supporting member is used to be placed on the inner side of the container and is located above the bacterial liquid carrier, and a circumferentially arranged extrusion portion is provided on the side of the supporting member facing the top opening, and the inner extrusion surface formed by the extrusion portion is a closing structure that gradually decreases from one side of the top opening to the other side of the container; the crushing pressure cover is provided with a circumferentially arranged and axially extended elastic crushing portion, the inner side surface of the elastic crushing portion is used to apply a crushing force to the side surface of the bottle body of the culture liquid bottle, and the outer side surface of the elastic crushing portion is used to resist the inner extrusion surface. In actual application of the biological sterilization indicator, the bacterial liquid carrier loaded with bacterial liquid is first placed at the bottom of the inner side of the container, and then the carrier and the culture liquid bottle are placed in sequence, and then the elastic crushing part of the crushing gland is extended into the container from the top opening of the container and abuts against the inner extrusion surface of the extrusion part, and the structure of the inner extrusion surface is a closing structure that gradually shrinks from one side of the top opening to the other side of the container. Therefore, as the crushing gland is pressed down, the elastic crushing part will produce a radial gathering movement under the extrusion of the inner extrusion surface, thereby generating an extrusion force on the side of the bottle body of the culture liquid bottle to break it, and then the culture liquid flows out and mixes with the bacterial liquid The carrier is contact cultured, and the sterilization treatment result is judged by the culture result, so as to realize the monitoring of biological sterilization; and in the above operation process, in the process of pressing and crushing the cap, the axial pressure is converted into radial force to act on the side of the bottle body of the culture fluid bottle, and the side of the bottle body of the culture fluid bottle is easier to break relative to the upper and lower ends of the culture fluid bottle, and in the process of converting the pressing force into radial force, the lever principle is fully utilized to greatly reduce the pressing force required for breaking the culture fluid bottle, thereby avoiding the situation that the culture fluid bottle cannot be broken or the breakage rate is low, and effectively ensuring that the biological sterilization indicator can normally feedback the monitoring results. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1A schematic diagram of the explosion structure of a biological sterilization detection device provided by an embodiment of the present invention;

[0027] Figure 2 A schematic structural diagram of a container provided in an embodiment of the present invention having a bottom cross-section that is a semicircle;

[0028] Figure 3 A schematic diagram of the structure of a bacterial liquid carrier provided in an embodiment of the present invention;

[0029] Figure 4 A schematic diagram of the structure of a filter membrane provided by an embodiment of the present invention;

[0030] Figure 5 A schematic diagram of the structure of a carrier provided by an embodiment of the present invention;

[0031] Figure 6 A schematic diagram of the structure of a culture solution bottle provided in an embodiment of the present invention;

[0032] Figure 7 A schematic diagram of the structure of a crushing gland provided in an embodiment of the present invention;

[0033] Figure 8 A schematic diagram of the explosion structure of a bacterial sheet when placed vertically in a biological sterilization detection device provided by an embodiment of the present invention;

[0034] Fig. 9 A schematic diagram of the explosion structure of a bacterial sheet when it is placed flat in a biological sterilization detection device provided by an embodiment of the present invention;

[0035] Fig.10 A schematic structural diagram of a container provided in an embodiment of the present invention having a square bottom cross-section;

[0036] Fig.11 A schematic diagram of a biological sterilization detection device provided in an embodiment of the present invention in which the bottom cross-section of the container is a special-shaped structure.

[0037] superior Figure 1-Figure 11 middle,

[0038] Container 1, bacterial liquid carrier 2, culture liquid bottle 3, carrier 4, extrusion part 41, inner extrusion surface 410, crushing cover 5, elastic crushing part 51, filter membrane 6. DETAILED DESCRIPTION

[0039] The core of the present invention is to provide a biological sterilization indicator to solve the problem that the culture fluid bottle is easily broken during the use of the biological sterilization indicator, and the success rate is low, so that the biological sterilization indicator cannot feedback the monitoring results.

[0040] In order to enable those skilled in the art to better understand the technical solution provided by the present invention, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0041] like Figure 1-Figure 11 As shown, a biological sterilization indicator provided by an embodiment of the present invention comprises a container 1 with a top opening, a bacterial liquid carrier 2 for loading bacterial liquid, a carrier 4 for supporting a fragile culture liquid bottle 3, and a crushing cover 5; the bacterial liquid carrier 2 is used to be placed on the inner bottom of the container 1; the carrier 4 is used to be placed on the inner side of the container 1 and above the bacterial liquid carrier 2, and a circumferentially arranged extrusion portion 41 is provided on the side of the carrier 4 facing the top opening, and an inner extrusion surface 410 formed by the extrusion portion 41 is a closing structure that gradually decreases from one side of the top opening to the other side of the container 1; the crushing cover 5 is provided with a circumferentially arranged and axially extending elastic crushing portion 51, the inner side surface of the elastic crushing portion 51 is used to apply a crushing force to the side surface of the bottle body of the culture liquid bottle 3, and the outer side surface of the elastic crushing portion 51 is used to abut against the inner extrusion surface 410.

[0042] In actual application of the biological sterilization indicator, the bacterial liquid carrier loaded with bacterial liquid is first placed at the bottom of the inner side of the container, and then the carrier and the culture liquid bottle are placed in sequence, and then the elastic crushing part of the crushing gland is extended into the container from the top opening of the container and abuts against the inner extrusion surface of the extrusion part, and the structure of the inner extrusion surface is a closing structure that gradually shrinks from one side of the top opening to the other side of the container. Therefore, as the crushing gland is pressed down, the elastic crushing part will produce a radial gathering movement under the extrusion of the inner extrusion surface, thereby generating an extrusion force on the side of the bottle body of the culture liquid bottle to break it, and then the culture liquid flows out and mixes with the bacterial liquid The carrier is contact cultured, and the sterilization treatment result is judged by the culture result, so as to realize the monitoring of biological sterilization; and in the above operation process, in the process of pressing and crushing the cap, the axial pressure is converted into radial force to act on the side of the bottle body of the culture fluid bottle, and the side of the bottle body of the culture fluid bottle is easier to break relative to the upper and lower ends of the culture fluid bottle, and in the process of converting the pressing force into radial force, the lever principle is fully utilized to greatly reduce the pressing force required for breaking the culture fluid bottle, thereby avoiding the situation that the culture fluid bottle cannot be broken or the breakage rate is low, and effectively ensuring that the biological sterilization indicator can normally feedback the monitoring results.

[0043] It should be noted that those skilled in the art should be able to understand that the culture liquid bottle should be a fragile structure, such as a bottle body made of a thin glass material, so that under the action of external force, the fragile structure breaks, the internal culture liquid flows out, and under the action of gravity, it fully contacts and mixes with the bacterial liquid carrier containing the bacterial liquid at the bottom.

[0044] It should also be noted that the descriptions of the top, bottom, upper, lower, etc. in the above-mentioned solutions are all based on the orientations defined when the container in the biological sterilization detection device is placed vertically. Such terms are only used to describe the elements because they are related to each other, and are by no means intended to involve a specific orientation of the device, indicate or imply a necessary or essential orientation of the device, or specify how to use, install, display or position the present invention described herein in use.

[0045] In some specific embodiments, the axial position of the carrier 4 may be fixed or not fixed when it is installed in the container 1. It should be noted that the carrier is mainly used to load and fix the culture medium bottle. Generally speaking, after the culture medium bottle is installed on the carrier, it will not move relative to the carrier.

[0046] For example, when the supporting member 4 is installed in the container 1, the axial position is fixed. At this time, a corresponding limiting boss structure may be provided on the inner side of the container. When the elastic crushing part on the crushing cover contacts the supporting member located at the bottom of the container, the bottom of the supporting member contacts the limiting boss in the container and is positioned immovably in the axial direction. When the crushing cover is pressed, the elastic crushing part is forced to gather under the joint action of the inner extrusion surface of the supporting member and the axial force, thereby achieving a crushing effect.

[0047] For another example, when the carrier 4 is installed in the container 1, the axial position is not fixed, and the inner diameter of the container 1 gradually shrinks from the top opening to the bottom diameter of the container 1, and the squeezing portion 41 is an elastic squeezing portion, and the outer side of the elastic squeezing portion abuts against the inner wall of the container 1. In this way, as the carrier 4 moves downward along the inner side of the container, the elastic squeezing portion will deform radially, and then the inner squeezing surface 410 of the elastic squeezing portion will squeeze the elastic crushing portion 51, and the elastic crushing portion 51 squeezes the culture liquid bottle to force it to break, and the culture liquid flows down to the bacterial liquid carrier under the action of gravity.

[0048] In a further embodiment, in order to ensure that the culture fluid bottle is broken, a breaking mechanism can be provided on the inner side of the top of the breaking gland to assist in breaking, thereby achieving the function of assisting the top breaking. This breaking structure can provide a double guarantee for breaking the culture fluid bottle. For example, when the gathering breaking (i.e., the elastic breaking part clamping breaking) does not work, i.e., the gathering breaking fails (e.g., caused by the breakage of the elastic breaking part), the breaking gland will continue to move downward. At this time, a protruding structure can be provided on the inner side of the breaking gland 5, and the protruding structure will contact the culture fluid bottle to form a break under the action of pressure.

[0049] In some more specific embodiments, the crushing cover 5 is generally sealed to the top opening of the container 1. The sealed connection can prevent leakage of the culture solution after crushing, and also prevent the culture solution from drying up in the high-temperature medical equipment, which would affect the interpretation structure.

[0050] Among them, the specific method of sealing connection can be that there is an interference fit between the crushing cover 5 and the top opening. Compared with the traditional sealing ring structure, the interference fit has a simpler and more stable sealing method.

[0051] It should be noted that the specific structural form of the interference fit can be that the inner side of the crushing cover 5 is matched with the outer side of the top opening, or the outer side of the crushing cover 5 is matched with the inner side of the top opening. Moreover, when the inner side of the crushing cover 5 is matched with the outer side of the top opening, the corresponding elastic crushing part can also be matched with the inner side of the top opening of the container.

[0052] In some more specific embodiments, the bacterial liquid carrier 2 generally includes a plastic shell and a glass fiber filter paper disposed in the plastic shell, and in order to prevent the glass fiber filter paper from falling, a more stable ultrasonic welding process is generally used between the two. Compared with traditional hot stamping, the welding is more stable.

[0053] In a further embodiment, the structure of the above-mentioned bacterial liquid carrier 2 is generally a bacterial sheet structure. By designing it as a bacterial sheet structure, the placement of the bacterial liquid carrier in the container is simpler and more convenient. In a specific embodiment, the bacterial sheet structure can be placed vertically or horizontally in the container. In actual application, it can be selected according to specific layout requirements and convenience of placement, and no further specific limitation is made here.

[0054] It should also be noted that, in order to facilitate processing, the bottom cross-section of the above-mentioned container 1 can be a semicircular, square or special-shaped structure, or other shapes selected by technical personnel in this field according to actual needs, and no further specific limitations are given here.

[0055] In a further embodiment, the biological sterilization detection device further includes a filter membrane 6 disposed below the carrier 4, which is mainly used to filter the broken residues of the culture medium bottle, etc. The filter membrane can be a nylon membrane, or other filter membrane materials commonly used by those skilled in the art, and no further specific limitation is made here.

[0056] The above is a detailed introduction to the biological sterilization detection device provided by the present invention. It should be noted that the various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments, and the same and similar parts between the various embodiments can be referred to each other.

[0057] It should also be noted that, in this article, terms such as "comprises", "includes" or any other variations thereof are intended to cover non-exclusive inclusion, so that an article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such articles or devices. In the absence of more restrictions, the elements defined by the sentence "comprises a ..." do not exclude the existence of other identical elements in the article or device including the above elements.

[0058] The principles and implementation methods of the present invention are described in this article using specific examples. The description of the above embodiments is only used to help understand the core idea of ​​the present invention. It should be pointed out that for ordinary technicians in this technical field, without departing from the principles of the present invention, the present invention can also be improved and modified, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

Claims

1. A biological sterilization indicator, characterized in that: It comprises a container (1) with an opening at the top, a bacterial liquid carrier (2) for loading bacterial liquid, a carrier (4) for supporting a fragile culture liquid bottle (3), and a crushing press cap (5); The bacterial liquid carrier (2) is used to be placed on the inner bottom of the container (1); The carrier (4) is used to be arranged on the inner side of the container (1) and located above the bacterial liquid carrier (2); a circumferentially arranged extrusion portion (41) is provided on the side of the carrier (4) facing the top opening, and an inner extrusion surface (410) formed by the extrusion portion (41) presents a gradually narrowing closing structure from one side of the top opening to the other side of the container (1); The crushing cover (5) is provided with a circumferentially arranged and axially extending elastic crushing portion (51), the inner side surface of the elastic crushing portion (51) is used to apply a crushing force to the side surface of the bottle body of the culture fluid bottle (3), and the outer side surface of the elastic crushing portion (51) is used to abut against the inner extrusion surface (410).

2. The biological sterilization indicator according to claim 1, wherein: When the bearing member (4) is installed in the container (1), the axial position is fixed.

3. The biological sterilization indicator of claim 1, wherein: When the bearing member (4) is installed in the container (1), the axial position is not fixed, the inner diameter of the container (1) gradually shrinks from the top opening to the bottom diameter of the container (1), and the extrusion portion (41) is an elastic extrusion portion, the outer side surface of the elastic extrusion portion abuts against the inner wall of the container (1).

4. The biological sterilization indicator of claim 1, wherein: A protruding structure is provided on the inner side of the crushing cover (5).

5. The biological sterilization indicator of claim 1, wherein: The crushing cover (5) is sealedly connected to the top opening of the container (1).

6. The biological sterilization indicator of claim 5, wherein: There is an interference fit between the crushing cover (5) and the top opening.

7. The biological sterilization indicator of claim 6, wherein: The inner side surface of the crushing pressure cover (5) cooperates with the outer side surface of the top opening, or the outer side surface of the crushing pressure cover (5) cooperates with the inner side surface of the top opening.

8. The biological sterilization indicator of claim 1, wherein: The bacterial liquid carrier (2) comprises a gel shell and glass fiber filter paper arranged in the gel shell.

9. The biological sterilization indicator of claim 8, wherein: The bacterial liquid carrier (2) is a bacterial sheet structure, and the bacterial sheet structure is placed vertically or horizontally in the container.

10. The biological sterilization indicator according to claim 8 or 9, characterized in that The bottom cross-section of the container (1) is semicircular or square.

11. The biological sterilization indicator of claim 8, wherein: The plastic shell and the glass fiber filter paper are connected by ultrasonic welding.

12. The biological sterilization indicator of any one of claims 1-9 and 11, wherein: It also includes a filter membrane (6) arranged below the carrier (4).

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