Sterilization process verification device

Abstract

The sterilization process verification device comprises an outer cylinder and an inner cylinder which are nested with each other, the first end of the outer cylinder is open, the outer cylinder is provided with a first inner cavity, the inner cylinder is at least partially inserted into the first inner cavity from the first end of the outer cylinder, and the depth of the inner cylinder inserted into the outer cylinder is adjustable; the hollow pipe is connected to the second end of the outer cylinder, and the hollow pipe is communicated with the interior of the outer cylinder; the first end of the inner cylinder is open, the inner cylinder is provided with a second inner cavity, and after the outer cylinder and the inner cylinder are connected in a nested mode, the second inner cavity and at least part of the first inner cavity jointly form a cavity for containing an indicator. According to the utility model, the PCD is designed into a split nested structure, and the part, inserted into the outer cylinder, of the inner cylinder can be adjusted, so that the size of the cavity for placing the indicator can be adjusted, the PCD can adapt to indicators of different specifications and sizes, the universality of the PCD is improved, and the PCD does not occupy too much space.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a sterilization process verification device for verifying the effect of a sterilization process. Background Art

[0002] The Process Challenge Device (PCD) is a device that has a specific sterilization difficulty for a sterilization process and is used to evaluate the effect of the sterilization process. A complete PCD consists of at least three components: ① a part with a certain resistance to the penetration of the sterilization medium; ② a cavity for loading biological / chemical indicators; ③ biological / chemical indicators in the cavity. Among them, component ① has a certain resistance to the penetration of the sterilization medium, so that the sterilization medium cannot easily penetrate into the cavity where the indicator is placed. When using it, you can choose a PCD with corresponding resistance according to the purpose of use and the scope of sterilized items. When the sterilization medium penetrates component ① and reaches the cavity where the indicator is loaded, under specific sterilization conditions, the chemical indicator in the cavity will change color (the spores on the biological indicator are killed), and finally the effect of the sterilization process is evaluated based on the change of the indicator. To ensure the accuracy of the PCD evaluation results, the resistance of the PCD should be similar to or even stronger than that of the sterilized items.

[0003] Existing PCDs usually use hollow tubes to adjust the resistance of PCDs. One end of the hollow tube is connected to the inside of the cavity, and the other end is an open end. The hollow tube connects the inside and outside of the cavity. When the cavity is sealed, the hollow tube becomes the only channel for the sterilization medium to enter the cavity. By changing the length of the hollow tube, the difficulty of the sterilization medium entering the cavity can be controlled, thereby simulating the resistance of the sterilized items. Existing PCDs have the following shortcomings during use: the cavity structure size is single and cannot be adjusted according to the size of the indicator. For example, by using a large-sized cavity to achieve the purpose of compatibility with indicators of different sizes, the cavity will be larger, occupy a large space, and be inconvenient to use. In addition, since the hollow tube is located outside the cavity, it is inevitable that the hollow tube will be bent during use. After the tube is bent, it is easy to get blocked and may also break, resulting in failure to achieve the intended purpose. Utility Model Content

[0004] The utility model aims to provide a sterilization process verification device which can be placed with indicators of different specifications and sizes and has good versatility.

[0005] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0006] A sterilization process verification device comprises: an outer cylinder and an inner cylinder nested with each other, the first end of the outer cylinder is open, the outer cylinder has a first inner cavity, the inner cylinder is at least partially inserted into the first inner cavity from the first end of the outer cylinder, and the depth of the inner cylinder inserted into the outer cylinder is adjustable; a hollow tube connected to the second end of the outer cylinder, the hollow tube and the outer cylinder are internally connected; the first end of the inner cylinder is open, the inner cylinder has a second inner cavity, after the outer cylinder and the inner cylinder are nested and connected, the second inner cavity and at least part of the first inner cavity together form a cavity for loading an indicator.

[0007] It can be seen from the above technical scheme that the utility model designs the PCD into a split nested structure consisting of an inner tube and an outer tube. The inner tube can be inserted into the outer tube, and the part of the inner tube inserted into the outer tube can be adjusted, so that the size of the cavity for placing the indicator can be adjusted to accommodate indicators of different specifications and sizes, thereby improving the versatility of the PCD and not taking up too much space.

[0008] Optionally, the hollow tube includes a straight section connected to the outer tube and a spiral section connected to the straight section.

[0009] Furthermore, the outer tube is provided with an annular protective groove which is concave from the end surface of the second end of the outer tube to the first end of the outer tube along the axis of the outer tube, and the spiral section of the hollow tube can be accommodated in the protective groove.

[0010] Furthermore, the outer groove wall of the protection groove is provided with a through hole.

[0011] A protection groove is provided on the side wall of the outer tube, and the hollow tube is accommodated in the protection groove, so that the hollow tube can be protected from being squeezed by external force, and at the same time, the hollow tube can be accommodated to reduce the overall volume of the PCD device.

[0012] Optionally, the second end of the outer cylinder is provided with a protrusion protruding outward along the axis of the outer cylinder, the outer wall of the protrusion is provided with an external thread, and the sleeve nut and the protrusion are threadedly matched; the hollow tube passes through the sleeve nut and the protrusion in sequence and extends into the outer cylinder.

[0013] Optionally, the inner cylinder and the outer cylinder are connected by threads.

[0014] Furthermore, a thread groove is provided on the inner wall of the first inner cavity close to the second end of the outer tube, and an external thread matching with the thread groove on the inner wall of the first inner cavity is provided on the outer peripheral wall of the first end of the inner tube.

[0015] Optionally, a seal is provided between the inner tube and the outer tube, and the seal includes a sealing ring and / or a sealing gasket; the sealing ring is provided between the inner wall of the outer tube and the outer wall of the inner tube; the sealing gasket is provided in the gap between the first end of the inner tube and the first inner cavity.

[0016] Optionally, it also includes a wireless recorder for presetting sterilization parameters that need to be recorded according to different sterilization methods.

[0017] Furthermore, a sealable mounting hole is provided on the outer wall of the end portion of the second end of the inner tube, and the wireless recorder is arranged in the mounting hole.

[0018] After setting up the wireless recorder, the experimenter can record the sterilization parameters according to different sterilization methods. Then, based on the indicator culture results and the data recorded by the wireless recorder, they can analyze the suitability of the product sterilization parameters and the matching degree of the process verification device, and then correct the length of the hollow tube and the space size of the cavity, shortening the development process. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the embodiments of the utility model, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0020] Figure 1 It is a schematic diagram of the structure of an embodiment of the utility model;

[0021] Figure 2 A top view of an embodiment of the utility model;

[0022] Figure 3 For along Figure 2 Sectional view along line AA;

[0023] Figure 4 It is a schematic diagram of the exploded structure of an embodiment of the utility model.

[0024] The specific implementation of the utility model is further described in detail below with reference to the accompanying drawings. DETAILED DESCRIPTION

[0025] The utility model is described in detail below in conjunction with the accompanying drawings. When describing the embodiments of the utility model in detail, for the convenience of explanation, the drawings representing the device structure will not be partially enlarged according to the general proportion, and the schematic diagram is only an example, which should not limit the scope of protection of the utility model. It should be noted that the drawings are simplified in form and use non-precise proportions, which are only used to facilitate and clearly assist in explaining the purpose of the embodiments of the utility model. At the same time, in the description of this application, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated; the terms "positive", "negative", "bottom", "upper", "lower", etc. indicate the orientation or position relationship based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the utility model and simplifying the description, rather than indicating or implying 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 utility model.

[0026] In the description of the present utility model, it should be noted that, unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, it can also be the internal connection of two elements, it can be a wireless connection, or it can be a wired connection. For ordinary technicians in this field, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0027] like Figure 1 , Figure 2 , Figure 3 and Figure 4 As shown, the sterilization process verification device of this embodiment includes a device body 1 and a hollow tube 2, and the device body 1 has a cavity that can accommodate biological indicators or chemical indicators. The device body 1 of this embodiment is composed of an outer cylinder 1-1 and an inner cylinder 1-2 that are nested with each other. One end of the outer cylinder 1-1 is open, and the outer cylinder 1-1 has a first inner cavity 1-1a. The inner cylinder 1-2 can be inserted into the first inner cavity 1-1a from the open end of the outer cylinder 1-1. The inner cylinder 1-2 is at least partially inserted into the outer cylinder 1-1 (the first inner cavity 1-1a). Both the outer cylinder 1-1 and the inner cylinder 1-2 have a certain resistance to the penetration of the sterilization medium. For the convenience of description, the open end of the outer cylinder 1-1 is defined as the first end of the outer cylinder, and the other end of the outer cylinder 1-1 is the second end of the outer cylinder 1-1. The end of the inner cylinder 1-2 inserted into the outer cylinder 1-1 is the first end of the inner cylinder 1-2, and the other end of the inner cylinder 1-2 (i.e., the end exposed outside the outer cylinder) is the second end of the inner cylinder 1-2. The second end of the outer cylinder 1 - 1 is provided with a through hole for the hollow tube 2 to pass through.

[0028] The inner cylinder 1-2 is also a structure with one end (first end) open and one end (second end) closed, and the inner cylinder 1-2 has a second inner cavity 1-2a. The open end of the inner cylinder 1-2 extends into the first inner cavity 1-1a of the outer cylinder 1-1. After the inner cylinder 1-2 and the outer cylinder 1-1 are assembled together, the second inner cavity 1-2a of the inner cylinder 1-2 and at least part of the first inner cavity 1-1a together form a cavity for accommodating the indicator. The depth of the inner cylinder 1-2 inserted into the outer cylinder 1-1 is adjustable, so that the size of the cavity for accommodating the indicator can be adjusted. For example, when the size of the indicator used is large, the inner cylinder 1-2 can be pulled out more, and when the size of the indicator used is small, the inner cylinder 1-2 can be inserted more inward to achieve the effect of being compatible with indicators of different sizes. Moreover, the inner cylinder 1-2 can be inserted into the outer cylinder 1-1, and the structure is compact and does not take up too much space.

[0029] In this embodiment, the outer cylinder 1-1 and the inner cylinder 1-2 are connected by threads, and a thread groove is processed on the inner wall of the first inner cavity 1-1a near the second end of the outer cylinder 1-1, and an external thread matching the thread groove on the inner wall of the first inner cavity 1-1a is processed on the outer peripheral wall of the first end of the inner cylinder 1-2. After the inner cylinder 1-2 is inserted into the outer cylinder 1-1, the inner cylinder 1-2 and the outer cylinder 1-1 can be connected together by threads, and the size of the cavity of the device body 1 can be adjusted by rotation. The inner cylinder 1-2 and the outer cylinder 1-1 are matched and connected by the stud screws that match each other, which is convenient for adjusting the size of the cavity and improves the assembly efficiency between the outer cylinder and the inner cylinder. In addition to realizing a detachable connection between the inner cylinder and the outer cylinder by thread matching, in other embodiments, the inner cylinder and the outer cylinder can also be connected by other methods, such as a snap-on connection. The threads that cooperate between the inner tube and the outer tube can also be processed at other positions of the inner and outer tubes, such as the thread groove is processed on the inner wall of the first inner cavity near the first end, and the external thread is processed on the outer peripheral wall of other positions of the inner tube, as long as the threaded connection of the inner and outer tubes can be achieved.

[0030] The hollow tube 2 is inserted from the through hole at the second end of the outer tube 1-1, thereby communicating with the interior of the cavity of the device body 1. In this embodiment, a cylindrical protrusion 1-1b protruding outward along the axis of the outer tube 1-1 is provided at the second end of the outer tube 1-1, and the hollow tube 2 passes through the protrusion 1-1b and extends into the cavity of the device body 1. In this embodiment, an external thread is processed on the outer wall of the protrusion 1-1b, and the sleeve nut 3 can be matched with the thread on the outer wall of the protrusion 1-1b. The sleeve nut 3 can be used to conveniently fix the hollow tube 2 to prevent the hollow tube 2 from falling off during the test.

[0031] Optionally, the hollow tube 2 of this embodiment includes a straight section 2a connected to the outer tube 1-1 and a spiral section 2b coiled into a spiral shape. Setting a part of the hollow tube 2 as the spiral section can not only extend the length of the hollow tube 2 as needed to meet the test requirements, but also shorten the length of the hollow tube 2 on its own axis by the spiral section, thereby reducing space occupancy and making it more convenient for operators to operate.

[0032] More preferably, an annular protective groove 1-1c is provided on the outer tube 1-1 along the axis of the outer tube 1-1, which is concave from the end surface of the second end of the outer tube 1-1 to the first end of the outer tube 1-1. The spiral section 2b of the hollow tube 2 can be accommodated in the protective groove 1-1c. The outer groove wall of the protective groove 1-1c can protect the hollow tube 2 to prevent the hollow tube 2 from being bent, flattened, or folded by external forces during operation, thereby solving the problem of the hollow tube being not durable in the prior art and effectively extending the service life of the product. Optionally, evenly distributed through holes 1-1d are provided on the outer groove wall of the protective groove 1-1c.

[0033] In order to ensure the sealing effect after the inner tube and the outer tube are matched, that is, to ensure the sealing of the cavity, a sealing member is provided between the outer tube 1-1 and the inner tube 1-2, and the sealing member includes a sealing ring and / or a sealing gasket. In this embodiment, a sealing ring 4 is provided between the inner wall of the outer tube 1-1 and the outer wall of the inner tube 1-2, and the sealing ring 4 of this embodiment is provided on the inner wall of the first end of the outer tube 1-1. In this embodiment, a sealing gasket 5 is provided at the gap between the first end of the inner tube 1-2 and the end of the first inner cavity 1-1a of the outer tube 1-1 close to the first end of the outer tube 1-1.

[0034] The inner tube and the outer tube can be made of stainless steel, and the hollow tube can be a stainless steel tube or a polytetrafluoroethylene tube. The length of the hollow tube can be 200mm to 10000mm, and the inner diameter can be 0.1mm to 3mm, and can be quickly replaced according to the use requirements.

[0035] In order to solve the problem of long development cycle of new product sterilization process parameters and process verification devices, optionally, the sterilization process verification device of this embodiment also includes a wireless recorder, which is arranged on the inner cylinder 1-2, specifically, at the end of the second end of the inner cylinder 1-2. In this embodiment, a sealable mounting hole 1-2b is arranged on the outer wall of the end of the second end of the inner cylinder 1-2, and a wireless recorder (not shown) is arranged in the mounting hole 1-2b. The wireless recorder can preset the sterilization parameters that need to be recorded according to different sterilization methods, and the sterilization parameters include but are not limited to temperature, humidity, gas concentration, etc. Therefore, the experimenter can analyze the suitability of the product sterilization parameters and the matching degree of the process verification device according to the indicator culture results and the data recorded by the wireless recorder, and then correct the length of the capillary and the space size of the cavity, shorten the development process, and solve the problem that the existing verification device can only obtain the indicator culture results after the test is completed, and cannot provide data support for the result analysis, which easily leads to the problem of too long development cycle for determining the sterilization process parameters of new products and designing process verification devices.

[0036] The following is a description of the use of the sterilization process verification device of this embodiment.

[0037] When in use, first select a hollow tube 2 with a suitable length and inner diameter according to the test verification requirements, and then insert one end of the hollow tube 2 through the sleeve nut 3 and the protrusion 1-1b in sequence, and then extend it into the outer tube 1-1, and connect the air flow inside and outside the cavity through the hollow tube 2; place the indicator in the outer tube 1-1, and then insert the inner tube 1-2 into the outer tube 1-1, adjust the depth of the inner tube 1-2 inserted into the outer tube 1-1, that is, adjust the size of the cavity, and then ensure a good seal between the inner tube 1-2 and the outer tube 1-1. Then pack the assembled PCD in a packaging bag and sterilize it together with the sterilized items. After sterilization, take out the indicator to verify the sterilization effect.

[0038] When selecting a hollow tube, the inner diameter of the spiral section of the hollow tube is slightly larger than the diameter of the annular protective groove, so that the spiral section of the hollow tube can be placed in the protective groove. The protective groove can protect the hollow tube from external force and accommodate the hollow tube, thereby reducing the volume of the PCD device and facilitating use.

[0039] The utility model solves the problem that the existing PCD has a single structure and size and cannot adjust the volume of the cavity according to the size of the indicator, improves the versatility of the PCD, and is conducive to reducing the user's use cost. In the above embodiment, a thread groove is provided on the inner wall of the outer tube, and an outer thread is provided on the outer wall part of the inner tube and the outer tube. The inner tube and the outer tube are detachably connected through the threaded cooperation. By changing the screwing process of the inner tube inserted into the outer tube, the volume of the cavity can be adjusted so as to put indicators of different specifications and sizes.

[0040] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A sterilization process verification device, characterized in that: include: An outer cylinder and an inner cylinder nested with each other, wherein the first end of the outer cylinder is open, the outer cylinder has a first inner cavity, the inner cylinder is at least partially inserted into the first inner cavity from the first end of the outer cylinder, and the depth of the inner cylinder inserted into the outer cylinder is adjustable; A hollow tube connected to the second end of the outer tube, wherein the hollow tube is in communication with the inner portion of the outer tube; The first end of the inner cylinder is open, and the inner cylinder has a second inner cavity. After the outer cylinder and the inner cylinder are nested and connected, the second inner cavity and at least a part of the first inner cavity together form a cavity for loading the indicator.

2. The sterilization process verification device according to claim 1, characterized in that: The hollow tube includes a straight section connected to the outer tube and a spiral section connected to the straight section.

3. The sterilization process verification device according to claim 2, characterized in that: The outer tube is provided with an annular protective groove which is concave from the end surface of the second end of the outer tube toward the first end of the outer tube along the axis of the outer tube, and the spiral section of the hollow tube can be accommodated in the protective groove.

4. The sterilization process verification device according to claim 3, characterized in that: The outer groove wall of the protection groove is provided with a through hole.

5. The sterilization process verification device according to claim 1, characterized in that: The second end of the outer cylinder is provided with a protrusion protruding outward along the axis of the outer cylinder, the outer wall of the protrusion is provided with an external thread, and the sleeve nut is threadedly matched with the protrusion; The hollow tube passes through the sleeve nut and the protrusion in sequence and extends into the outer tube.

6. The sterilization process verification device according to claim 1, characterized in that: The inner cylinder and the outer cylinder are connected by threads.

7. The sterilization process verification device according to claim 6, characterized in that: The inner wall of the first inner cavity close to the second end of the outer tube is provided with a thread groove, and the outer peripheral wall of the first end of the inner tube is provided with an external thread matching with the thread groove on the inner wall of the first inner cavity.

8. The sterilization process verification device according to claim 1, characterized in that: A sealing member is provided between the inner tube and the outer tube, and the sealing member comprises a sealing ring and / or a sealing gasket; The sealing ring is arranged between the inner wall of the outer tube and the outer wall of the inner tube; The sealing gasket is arranged at a gap between the first end of the inner tube and the first inner cavity.

9. The sterilization process verification device according to claim 1, characterized in that: It also includes a wireless recorder for presetting sterilization parameters that need to be recorded according to different sterilization methods.

10. The sterilization process verification device according to claim 9, characterized in that: A sealable mounting hole is arranged on the outer wall of the end portion of the second end of the inner cylinder, and the wireless recorder is arranged in the mounting hole.

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