JP2005176939A - Test body and test pack for sterilization check - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a test body and a test pack for sterilization check by which the effect of a sterilization process can be surely and easily checked by matching with the structure of an endoscope or others. <P>SOLUTION: In the test body for the sterilization check sterilization action can be checked using a sterilization device, and the test body for the sterilization check is formed by providing a construction corresponding to at least an element constituting the endoscope. The test pack has a plurality of test bodies for sterilization check and is used for checking the sterilization action of the sterilization device. Further, in the test pack one test body and another test body for sterilization check are respectively constituted by having a construction corresponding to at least an element of different constructions of the endoscope. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a test body and test pack for sterilization confirmation, and more particularly, to a test body and test pack for sterilization confirmation provided with an indicator for sterilization confirmation used for sterilization treatment of medical equipment, particularly medical equipment having a long tube shape. Is.

  In recent years, in the medical field, an endoscope that can be used for observational examination or the like by performing observation and inspection of a deep part in a body cavity by inserting a thin insertion part into the body cavity or the like, or using a treatment instrument as necessary. Mirrors are widely used. In such a medical endoscope, it is an indispensable condition for safely using the medical device that it is surely sterilized and sterilized when it is used for inspection or the like.

  Therefore, conventionally, for example, autoclave sterilization (high temperature high pressure steam sterilization), which is a sterilization means using steam or the like in a high temperature and high pressure environment, has been put into practical use. Moreover, when performing the sterilization process performed by such means, a sterilization confirmation indicator for confirming whether or not the sterilization process is surely performed is generally used.

  Conventionally, for example, when sterilizing a medical device having a long tube shape, the tubular portion tends to be difficult to be sterilized. Accordingly, various proposals have been made for sterilization confirmation indicators corresponding to medical devices having a long tube shape such as a catheter, an inhalation tube, and a cannula, for example, in Japanese Patent Application Laid-Open No. 2002-355297.

  Examples of the indicator for sterilization include a biological indicator that makes a determination by using the sterilizing effect on a specific microorganism as an index, a chemical indicator that makes a determination by using the degree of progress of a chemical reaction caused by a predetermined gas, and the like. .

  Sterilization is performed in a state where these indicators are stored in a predetermined test body for confirmation of sterilization, and after completion of this sterilization process, for example, the biological indicator is transferred to a predetermined medium and cultured to determine the sterilization effect. It will be. In this case, the structure of the test body for sterilization confirmation can be operated reliably and easily in an aseptic environment in order to prevent contamination of bacteria when transferring the sterilized biological indicator to the medium. It is desirable that

Thus, various proposals have been made regarding the shape of a test body for sterilization confirmation in which a biological indicator and a culture medium are integrated, for example, in Japanese Patent Application Laid-Open No. 10-201466.
JP 2002-355297 A JP-A-10-2014466

  For example, in a medical device having a characteristic structure such as a tube shape such as an endoscope, in order to confirm whether or not the sterilization process has been performed reliably, a device corresponding to the shape of the medical device is sterilized. It is preferable to use it as a test body for confirmation. In the case of an endoscope, specifically, for example, a tube tube having an elongated tube shape, which is a typical structure of an endoscope, a contact surface between an operation lever and an endoscope body in an operation unit, etc. Gaps, and pipe tubes covered with an outer skin. However, in the conventional means such as the above-mentioned Japanese Patent Application Laid-Open No. 2002-355297, a sterilization confirmation indicator for a sterilization confirmation test body configured by paying attention to such a shape is not disclosed.

  Further, the means disclosed in the above Japanese Patent Laid-Open No. 10-201466 etc. has a shape different from a shape that allows a sterilant such as ethylene oxide gas or steam to pass through (a shape in which the open end is opened). Therefore, even if this is used, it is possible to constitute a test body for sterilization confirmation that can easily and completely judge the result of sterilization processing of a medical device having a conduit such as an endoscope. It has the problem of being difficult.

  The present invention has been made in view of the above-described points, and an object of the present invention is to correspond to a medical device having a characteristic structure of each part such as an endoscope. It is intended to provide a test body for sterilization confirmation and a test pack configured so that the effect of the sterilization treatment can be reliably and easily confirmed.

  In order to achieve the above object, a test body for sterilization confirmation according to the present invention is a test body for sterilization confirmation for confirming sterilization action using a sterilization apparatus, and corresponds to at least one element constituting an endoscope. It is characterized in that it is formed.

  In addition, the test pack according to the present invention includes a plurality of test bodies for sterilization confirmation having a configuration corresponding to at least one element constituting the endoscope, and is used for confirming the sterilization action of the endoscope sterilization apparatus. It is a pack, and one sterilization confirmation test body and the other sterilization confirmation test body are each formed to have a configuration corresponding to at least one element of a different configuration of the endoscope. Features.

  According to the present invention, for example, a sterilization check configured to support a medical device having a characteristic structure of each part, such as an endoscope, and to reliably and easily check the effect of sterilization processing in the endoscope or the like. Test bodies and test packs can be provided.

The present invention will be described below with reference to the illustrated embodiments.
FIG. 1 is an overall view showing a schematic configuration of a test body for sterilization confirmation (corresponding to a pipe line) according to a first embodiment of the present invention. 2 is an enlarged cross-sectional view taken along the line AA of FIG. 1, showing an enlarged cross section of the tube tube and its exterior member in the test body for sterilization confirmation of FIG. 1.

  The test body 10 for sterilization confirmation according to the present embodiment confirms sterilization using a sterilization apparatus, and is a component corresponding to at least one element constituting the endoscope, that is, a tube in the endoscope. It has a configuration corresponding to a road.

  That is, the test body 10 for sterilization confirmation includes two pipe tubes 1 each having a hollow elongated shape as shown in FIG. 1 and an outer skin disposed so as to cover the outer peripheral portion of the pipe tube 1. And an indicator case 2 in which, for example, a biological indicator or a chemical indicator (hereinafter simply referred to as an indicator) 3 is detachably formed. And each end part of indicator case 2 is constituted in the form where each one end part 1a of two pipe tubes 1 was arranged in a row. In this case, the two pipe tubes 1 having substantially the same shape and the same size are used, and when the two pipe tubes 1 and the indicator case 2 are connected to each other, the indicator case 2 has a substantially central portion. It is desirable to arrange so that the

  The indicator case 2 includes a cylindrical indicator storage cylinder 2b made of a transparent resin or the like having openings at both ends, and two caps 2a that can be opened and closed at both ends.

  A hole 2c is formed at the tip of each of the two caps 2a so that one end 1a of each of the two pipe tubes 1 can be connected. Thereby, it connects with the front-end | tip part of each of the two caps 2a so that attachment of the one end part 1a of the two conduit tubes 1 is possible so that attachment or detachment is possible. And the watertight member (not shown), such as an O-ring (O-ring), is provided in the connection site | part in which the cap 2a and the one end part 1a of the conduit tube 1 are connected. Thereby, the said connection part has a watertight structure.

  In addition, the base end side of each cap 2a is detachably disposed via a watertight member (not shown) such as an O-ring with respect to both ends of the indicator storage cylinder 2b. Thus, a structure that ensures watertightness is also provided between each cap 2a and the indicator storage cylinder 2b.

  The pipe tube 1 is made of a hollow tube-shaped member, and openings 1c are formed at both ends thereof. The conduit tube 1 is formed by imitating various shapes having different shapes (length, inner diameter, etc.) such as an endoscope conduit and a treatment instrument. Specifically, for example, the length dimension L = 300 to 4000 mm, the inner diameter dimension φ is formed in a shape within the range of about 1 to 100 mm, the pipe tube 1 having a desired shape is selected as necessary, This can be arbitrarily attached to the cap 2a (the front end portion) in a watertight manner.

  The exterior member 4 is formed of, for example, the same material as the snake tube and the operation unit of the endoscope, or a material having a heat insulating effect corresponding thereto, that is, a resin such as urethane or rubber. As shown in FIG. 2, the exterior member 4 in the present embodiment directly coats a resin material such as urethane or rubber on the outer surface of the conduit tube 1, so that the exterior of the conduit tube 1 It covers the surface.

  The operation of confirming the effect of the sterilization process using the sterilization confirmation test body 10 configured as described above will be described below.

  First, the indicator 3 is installed at a predetermined position of the sterilization confirmation test body 10. For this purpose, the cap 2a is removed from the indicator storage cylinder 2b, and the indicator 3 is inserted into the indicator storage cylinder 2b. Next, the cap 2a is connected to the indicator storage cylinder 2b. At this time, a watertight member is interposed between the two, so that the internal space formed by the cap 2a and the indicator storage cylinder 2b is in a state in which watertightness is ensured.

  The sterilization confirmation test body 10 in this state is placed in a predetermined sterilization apparatus (not shown) and a predetermined sterilization process is executed. Thereby, a sterilizing agent such as ethylene oxide gas or steam enters from the opening 1c of the pipe tube 1 into the inside, and the sterilizing agent is stored in the indicator case 2 through the pipe tube 1. Acts on 3

  After the sterilization process is completed, the test body 10 for sterilization confirmation is taken out of the sterilization apparatus and the effect of the sterilization process is confirmed. This confirmation is as follows.

  First, when a biological indicator is used as the indicator 3, after removing the indicator 3 from the indicator storage cylinder 2b of the indicator case 2 in an aseptic environment, the indicator 3 is transferred to a predetermined medium and cultured. Confirm the effect of sterilization from the growth of the fungus.

  Further, when a chemical indicator is used as the indicator 3, the indicator storage cylinder 2b of the indicator case 2 is formed of a transparent resin, so that the color change of the indicator 3 is observed from the outside without taking out the indicator 3. Confirm the effect of sterilization treatment.

  As described above, according to the first embodiment, since the test body for sterilization confirmation 10 has a shape imitating the pipe shape of the endoscope, the effect of the sterilization treatment at the relevant part of the endoscope can be improved. Reliable results can be obtained for verification.

  In the first embodiment described above, the exterior member 4 is made of the same material as that of, for example, an endoscope snake tube or an operation unit (in this embodiment, a pipeline) on the outer peripheral surface of the pipeline tube 1. Or the example which provided the material which has the heat insulation effect corresponded to them, ie, resin, such as urethane and rubber | gum, etc. by coating is given. However, the form of the exterior member 4 is not limited to this, and apart from the example of the first embodiment described above, for example, the following functions and effects can be easily obtained in the following forms.

  3 and 4 are views showing a second embodiment of the present invention, and among these, FIG. 3 is an overall view showing a schematic configuration of a test body for sterilization confirmation (corresponding to a pipe line) of this embodiment. . 4 is an enlarged cross-sectional view taken along the line BB in FIG. 3, showing an enlarged cross section of the tube tube and its exterior member in the test body for sterilization confirmation of FIG.

  The second embodiment has substantially the same configuration as that of the first embodiment described above, and only the applied exterior member is different. Accordingly, the same components as those in the first embodiment described above are denoted by the same reference numerals, detailed description thereof is omitted, and only different members will be described below.

  As shown in FIG. 3, the test body 10A for sterilization confirmation according to the present embodiment includes two conduit tubes 1, an indicator case 2, an indicator 3, and an exterior member 4A, and of these, the conduit tube 1 and the indicator case. 2 and the indicator 3 are exactly the same as those in the first embodiment described above.

  As shown in FIG. 3, the exterior member 4A in the present embodiment is configured such that the indicator case 2 housing the indicator 3 and the two pipe tubes 1 are connected to each other so as to be freely inserted and removed. Has been.

  The exterior member 4A is, for example, the same material as the snake tube, the operation unit, etc. of the endoscope (a pipe line in the present embodiment), or the heat insulation corresponding thereto, like the exterior member 4 in the first embodiment. It is formed in a cylindrical shape by a material having an effect, for example, a resin such as urethane or rubber.

  Openings are formed at both ends of the exterior member 4A, and a base member 4a is detachably disposed in each opening via a predetermined watertight member. Thereby, when it is set as the state which attached the nozzle | cap | die member 4a to the both ends of the exterior member 4A, the watertight state between both is ensured. Further, in a state where the cap member 4a is removed from the exterior member 4A, the conduit tube 1 and the indicator case 2 can be accommodated in the internal space of the exterior member 4A.

  On the other hand, a through hole is formed in a substantially central portion of the base member 4a, and the tube tube 1 can be inserted into the through hole through a predetermined watertight member in a detachable manner. Thereby, the watertight state between the pipe tube 1 and the nozzle | cap | die member 4a is ensured. Other configurations are the same as those in the first embodiment.

  The operation when the effect of the sterilization process is confirmed using the test body 10A for sterilization confirmation of the present embodiment configured as described above will be described below.

  First, the indicator 3 is installed in the indicator case 2 of the sterilization confirmation test body 10A in the same manner as in the first embodiment.

  An indicator case 2 having a configuration in which an indicator 3 is disposed inside and a pipe tube 1 is continuously provided at both ends is housed inside from an opening on one end side of the exterior member 4A in a state where the cap member 4a is removed.

  In a state where each one end portion of the tube tube 1 is inserted into each through hole of each of the two cap members 4 a, each of the two cap members 4 a is attached so as to cover the openings at both ends of the exterior member 4.

  The test body 10A for sterilization confirmation in such a state is put into a predetermined sterilization apparatus (not shown) and a predetermined sterilization process is executed. Thereby, a sterilizing agent such as ethylene oxide gas or steam enters from the opening 1c of the pipe tube 1 into the inside, and the sterilizing agent is stored in the indicator case 2 through the pipe tube 1. Acts on 3

  After the sterilization process is completed, the test body 10A for sterilization confirmation is taken out of the sterilization apparatus and the effect of the sterilization process is confirmed. Therefore, when a biological indicator is used as the indicator 3, first, the cap member 4a is removed in an aseptic environment, and an assembly including the conduit tube 1 and the indicator case 2 is taken out from the exterior member 4A.

  Next, the indicator 3 is taken out from the indicator storage cylinder 2b of the indicator case 2 in the same environment, and after the indicator 3 is transferred to a predetermined medium and cultured, the effect of the sterilization treatment is confirmed from the growth state of the bacteria.

  Further, when a chemical indicator is used as the indicator 3, the indicator 3 is similarly taken from the outside of the indicator storage cylinder 2 b of the indicator case 2 after taking out an assembly composed of the pipe tube 1 and the indicator case 2 from the exterior member 4 </ b> A. Observe the color change. This confirms the effect of sterilization.

  As described above, according to the second embodiment, the same effects as those of the first embodiment can be obtained.

  The configuration of the exterior member 4A in the test body 10A for sterilization confirmation in the first embodiment described above is not limited to the above-described example, and for example, it is watertight while allowing a predetermined portion in the middle of the exterior member 4A to be separated. It is also conceivable to provide a connection part that can be connected to the exterior member 4A, so that the exterior member 4A can be arbitrarily divided into two parts, so that the internal space can be arbitrarily opened and closed. In this case, the connecting portion needs to be configured to have a watertight structure.

  With such a configuration, after the sterilization process is finished, the exterior member 4A is divided at the connection portion, whereby the indicator 3 housed in the indicator case 2 can be taken out more quickly. Can be obtained.

  5 and 6 are views showing a third embodiment of the present invention. Of these, FIG. 5 is a side sectional view showing a schematic configuration of a test body for sterilization confirmation (corresponding to a pipe line) of the present embodiment. is there. FIG. 6 is a top view showing a schematic configuration when viewed from the upper surface side of the test body for sterilization confirmation of FIG.

  The third embodiment has substantially the same configuration as the first and second embodiments described above, and the applied exterior member is different. Accordingly, the same components as those in the first and second embodiments described above are denoted by the same reference numerals, detailed description thereof is omitted, and only different members will be described below.

  As shown in FIGS. 5 and 6, the test body 10B for sterilization confirmation of the present embodiment includes two conduit tubes 1, an indicator case 2, an indicator 3, and an exterior member 4B. Of these, the conduit tube 1 The indicator case 2 and the indicator 3 are the same as those in the first and second embodiments described above.

  As shown in FIG. 5, the exterior member 4 </ b> B in the present embodiment is configured to be insertable / removable inside in a state where the indicator case 2 in which the indicator 3 is accommodated and the two conduit tubes 1 are connected. This is the same as in the second embodiment described above.

  The exterior member 4B includes two hemispherical shells 8a and 8b each having a flange portion 8d at the outer peripheral edge, and a fastening member 6 that clamps and fixes both flange portions 8d of the two shells 8a and 8b. And between the fastening member 6 and the shell 8a and between the fastening member 6 and the shell 8b, respectively. An O-ring 7 that is a watertight member to be held, and a seat 5 on which an assembly body including the pipe tube 1 and the indicator case 2 is placed inside the exterior member 4B, and the like.

  The two shells 8a and 8b are made of the same material as that of, for example, an endoscope snake tube, an operation portion, etc. (in this embodiment, a pipe line), like the exterior members 4 and 4A in the first and second embodiments described above. Or a material having a heat insulating effect corresponding to them, that is, a resin such as urethane or rubber.

  Of these, one shell 8a has two through holes 8c formed at predetermined positions on the outer peripheral surface thereof. One end of two pipe tubes 1 connected to the indicator case 2 housed in the exterior member 4B is detachably inserted into the through hole 8c via a predetermined watertight member. It has come to be. In this state, the pipe tube 1 and the through hole 8c are configured to be in a watertight state.

  The two shells 8a and 8b are formed so as to form a substantially spherical shape by sandwiching the sheet 5 and combining the two shells 8a and 8b so that the flange portions 8d are matched. In this state, the fastening member 6 sandwiches the O-ring 5 and presses both flange portions 8d, thereby ensuring a watertight state inside the exterior member 4B.

  The fastening member 6 is formed of a member having a channel shape in cross section and having elasticity. As described above, the fastening member 6 is provided to sandwich the flange portion 8d of the two shells 8a and 8b to ensure a watertight state inside the exterior member 4B. In this case, the fastening fixing portions of the shells 8a and 8b by the fastening member 6 are at least two places on the outer periphery of the flange portion 8d. Accordingly, at least two fastening members 6 are provided. Other configurations are the same as those in the first and second embodiments described above.

  The operation when the effect of the sterilization process is confirmed using the test body 10B for sterilization confirmation of the present embodiment configured as described above will be described below.

  First, the indicator 3 is installed in the indicator case 2 in the test body 10B for sterilization confirmation as in the first and second embodiments described above.

  One end of each of the tube tubes 1 connected to both ends of the indicator case 2 in which the indicator 3 is disposed is inserted into the through hole 8c of the shell 8a.

  Next, the two shells 8a and 8b are combined in a form in which the seat 5 is sandwiched, and further, the fastening member 6 holds the O-ring 7 at predetermined positions (two locations) of the flange portions 8d of the shells 8a and 8b. Tighten and fix. Thereby, the assembly which consists of the pipe tube 1 and the indicator case 2 is accommodated in the inside of the exterior member 4B. At this time, a watertight state is secured inside the exterior member 4B.

  The test body 10B for sterilization confirmation in such a state is put into a predetermined sterilization apparatus (not shown) and a predetermined sterilization process is executed. As a result, a sterilizing agent such as ethylene oxide gas or steam enters from the through-hole 8c of the shell 8a into the indicator case 2 through the conduit tube 1, and the sterilizing agent passes through the conduit tube 1 to indicate the indicator case. 2 acts on the indicator 3 housed in 2.

  After the sterilization process is completed, the test body 10B for sterilization confirmation is taken out of the sterilization apparatus and the effect of the sterilization process is confirmed. Therefore, when a biological indicator is used as the indicator 3, first, the fastening member 6 is removed in an aseptic environment, the shells 8a and 8b are divided, and the assembly composed of the pipe tube 1 and the indicator case 2 is externally provided. It is taken out from the inside of the member 4B.

  Next, the indicator 3 is taken out from the indicator storage cylinder 2b of the indicator case 2 in the same environment, and after the indicator 3 is transferred to a predetermined medium and cultured, the effect of the sterilization treatment is confirmed from the growth state of the bacteria.

  Further, when a chemical indicator is used as the indicator 3, the indicator 3 is similarly taken out from the outside of the indicator storage cylinder 2 b of the indicator case 2 after taking out an assembly composed of the pipe tube 1 and the indicator case 2 from the exterior member 4B. Observe the color change. This confirms the effect of sterilization.

  As described above, according to the third embodiment, the same effects as those of the first and second embodiments can be obtained.

  The shells 8a and 8b are substantially hemispherical, and when they are combined, the substantially spherical exterior member 4B is formed. However, the present invention is not limited to such a form. The following forms may be adopted.

  7 and 8 are views showing a fourth embodiment of the present invention. Of these, FIG. 7 is a side sectional view showing a schematic configuration of a test body for sterilization confirmation (corresponding to a pipe line) of the present embodiment. is there. 8 is a top view showing a schematic configuration when viewed from the upper surface side of the test body for sterilization confirmation of FIG.

  The fourth embodiment has substantially the same configuration as that of the third embodiment described above, and only the shape of the exterior member to be applied and the fastening member thereof are different. Accordingly, the same components as those in the third embodiment described above are denoted by the same reference numerals, detailed description thereof is omitted, and only different members will be described below.

  As shown in FIGS. 7 and 8, the test body 10C for sterilization confirmation according to the present embodiment includes two conduit tubes 1, an indicator case 2, an indicator 3, and an exterior member 4C. Of these, the conduit tube 1 The indicator case 2 and the indicator 3 are the same as those in the first to third embodiments described above.

  As shown in FIG. 7, the exterior member 4 </ b> C in the present embodiment is configured to be insertable / removable inside in a state in which the indicator case 2 that houses the indicator 3 and the two pipe tubes 1 are connected. This is the same as in the second and third embodiments described above.

  The exterior member 4C includes two box-shaped shells 11a and 11b each having an opening and a flange portion 11d at the outer peripheral edge, and sandwiching the flange portions 11d of the two shells 11a and 11b. And a seat 5 on which an assembly composed of the pipe tube 1 and the indicator case 2 is placed inside the exterior member 4C. The bolt 5 is a fastening member that fastens and fixes the bolt and the two shells 11a and 11b. And the watertight state between the sheet 5 and the shell 11a and between the sheet 5 and the shell 8b by being sandwiched between the sheet 5 and each of the shells 11a and 11b. It is comprised by O-ring 7 etc. which are watertight members.

  The two shells 11a and 11b are, for example, the same as the exterior member 4 and 4A or 4B in the first to third embodiments described above, for example, the serpentine tube of the endoscope, the operation unit, etc. (the pipeline in this embodiment). Or a material having a heat insulating effect corresponding thereto, that is, a resin such as urethane or rubber.

  Of these, one shell 11a has two through holes 11c formed at predetermined positions on the outer peripheral surface thereof. One end of two pipe tubes 1 connected to the indicator case 2 housed in the exterior member 4C is detachably inserted into the through hole 11c via a predetermined watertight member. It has come to be. In this state, the pipe tube 1 and the through hole 11c are configured to be in a watertight state.

  The two shells 11a and 11b are formed in a substantially box shape by sandwiching the sheet 5 and combining the two shells 11a and 11b so that the flange portions 11d match each other. In this state, the bolt 9 can sandwich the O-ring 7 and press both flange portions 11d, so that the watertight state inside the exterior member 4C is sufficiently secured.

  There are at least two tightening fixing portions on the outer periphery of the flange portion 11d, preferably four as shown in FIG. Accordingly, at least two or four bolts 9 are provided. Other configurations are the same as those in the first and second embodiments described above.

  The operation when confirming the effect of the sterilization process using the sterilization confirmation test body 10C of the present embodiment configured as described above will be described below.

  First, the indicator 3 is installed in the indicator case 2 of the sterilization confirmation test body 10C as in the first to third embodiments.

  One end of each of the tube tubes 1 connected to both ends of the indicator case 2 in which the indicator 3 is disposed is inserted into the through hole 11c of the shell 11a.

  Next, the two shells 11a and 11b are combined in a form in which the seat 5 is sandwiched, and the bolt 9 is tightened by sandwiching the O-ring 7 at predetermined positions (four locations) of the flange portions 11d of the shells 11a and 11b. Thereby, the assembly body which consists of the pipe tube 1 and the indicator case 2 is accommodated in the inside of the exterior member 4C. At this time, a watertight state is secured inside the exterior member 4C.

  The sterilization confirmation test body 10C in such a state is placed in a predetermined sterilization apparatus (not shown), and a predetermined sterilization process is executed. As a result, a sterilizing agent such as ethylene oxide gas or steam enters from the through-hole 11c of the shell 11a into the indicator case 2 through the conduit tube 1, and the sterilizing agent passes through the conduit tube 1 to indicate the indicator case. 2 acts on the indicator 3 housed in 2.

  After the sterilization process is completed, the test body 10C for sterilization confirmation is taken out of the sterilization apparatus and the effect of the sterilization process is confirmed. Therefore, when a biological indicator is used as the indicator 3, first, the bolt 9 is removed in an aseptic environment, the shells 11a and 11b are divided, and the assembly composed of the pipe tube 1 and the indicator case 2 is used as the exterior member. Remove from inside 4C.

  Next, the indicator 3 is taken out from the indicator storage cylinder 2b of the indicator case 2 in the same environment, and after the indicator 3 is transferred to a predetermined medium and cultured, the effect of the sterilization treatment is confirmed from the growth state of the bacteria.

  Further, when a chemical indicator is used as the indicator 3, the indicator 3 is similarly taken from the outside of the indicator storage cylinder 2 b of the indicator case 2 after taking out an assembly composed of the pipe tube 1 and the indicator case 2 from the exterior member 4 </ b> C. Observe the color change. This confirms the effect of sterilization.

  As described above, according to the fourth embodiment, the same effects as those of the first to third embodiments can be obtained.

  In addition, as a shape of the sheet | seat 5 in the above-mentioned 3rd and 4th embodiment, a substantially circular shape may be sufficient, for example. Also, the shape may be a square, a rectangle, a triangle, or the like, and an easy-to-use one may be used as necessary.

  The sterilization confirmation test bodies (10, 10A, 10B, 10C) exemplified in the first to fourth embodiments described above are formed so as to have a shape corresponding to the endoscope channel (FIG. 1 to FIG. 8).

  A test body for sterilization confirmation according to an embodiment described below is a component corresponding to at least one element constituting an endoscope, and for example, an operation lever in an operation unit of the endoscope is attached to the operation unit main body. It is the example formed having the structure equivalent to a structure.

  That is, FIG. 9 and FIG. 10 are views showing a fifth embodiment of the present invention, and among these, FIG. 9 is a view when viewed from the side of the test body for sterilization confirmation (corresponding to the operation unit) of this embodiment. It is a perspective view which shows schematic structure. FIG. 10 is a perspective view showing only the indicator case extracted from the constituent members of the test body for sterilization confirmation of the present embodiment.

  The test body 10D for sterilization confirmation of the present embodiment holds an indicator case 2D in which an indicator 3 having the same form as that used in the first to fourth embodiments is disposed, and the indicator case 2D. The holder 12 is constituted.

  The indicator case 2D has a cylindrical shape having an opening at one end, and is formed with a flange portion 2Da on the outer peripheral edge of the opening. The indicator case 2D is formed of the same material as the operation portion of the endoscope, for example, a resin such as polysulfone or a metal such as stainless steel. And the indicator 3 is affixed on the predetermined | prescribed site | part of the inner wall face of this indicator case 2D.

  The holder 12 has a channel shape (C shape) in cross section, and is made of the same material as the above-described indicator case 2D, that is, the same material as the operation portion of the endoscope, for example, resin such as polysulfone or metal such as stainless steel Etc. are formed.

  In addition, a projecting member 12a that protrudes toward the other wall surface 12c opposite to the wall surface 12b on the floor side of the inner wall surface of the holder 12 is disposed. The projecting member 12a is formed of an elastic member, and the dimension of the gap between the apex of the projecting member 12a and the wall surface 12c is set to be slightly smaller than the dimension in the height direction of the indicator case 2D. Thus, the indicator case 2D is configured such that the outer surface on the bottom side is pressed and supported in the arrow X1 direction shown in FIG. 9 by the protruding member 12a. At this time, the indicator case 2D is disposed in a space between the other wall surface 12c of the holder 12 and the apex of the projecting member 12a as shown in FIG. 9, and in this state, the flange portion 2Da of the indicator case 2D The one plane 2Db is held in contact with the other wall surface 12c of the holder 12.

  The contact surface roughness between the indicator case 2D and the holder 12 is formed to be equal to the contact surface when the operation lever of the operation unit of the endoscope and the endoscope main body come into contact with each other. Yes.

  The effect | action at the time of confirming the effect of a microbe process using the test body 10D for sterilization confirmation of this embodiment comprised in this way is demonstrated below.

  First, the indicator case 2 provided with the indicator 3 is arranged in a predetermined position of the holder 12, that is, in a space between the other wall surface 12c of the holder 12 and the apex portion of the protruding member 12a as shown in FIG.

  Next, the sterilization confirmation test body 10D is placed in a predetermined sterilization apparatus (not shown), and sterilization processing is executed. As a result, sterilizing agents such as ethylene oxide gas and steam are introduced into the indicator case 2D from a slight gap at the contact portion between the other wall surface 12b of the holder 12 and the flat surface 2Db of the flange portion 2Da of the indicator case 2D. The sterilant enters and acts on the indicator 3 stored in the indicator case 2.

  After this sterilization process is completed, the test body 10D for sterilization confirmation is taken out from the sterilization apparatus and the effect of the sterilization process is confirmed. Therefore, when a biological indicator is used as the indicator 3, the indicator case 2D is first removed from the holder 12 in an aseptic environment.

  Next, the indicator 3 is taken out from the indicator case 2 under the same environment, and after the indicator 3 is transferred to a predetermined medium and cultured, the effect of the sterilization treatment is confirmed from the growth status of the bacteria.

  Further, when a chemical indicator is used as the indicator 3, the indicator case 2D is similarly removed from the holder 12, and then the color change of the indicator 3 is observed from the opening of the indicator case 2D. This confirms the effect of sterilization.

  As described above, according to the fifth embodiment, the test body 10D for sterilization confirmation is shaped like a gap typified by the contact surface between the operation lever of the operation section of the endoscope and the endoscope main body. Therefore, a highly reliable result can be obtained for confirming the effect of the sterilization treatment at the site of the endoscope.

  In addition to the above-described example of the fifth embodiment, the sterilization confirmation test body 10D of the present embodiment is used for the results of sterilizing a treatment tool (not shown) used with an endoscope, for example. In order to use and confirm, if the contact surface of the holder 12 and the indicator case 2D is generated to be equivalent to the rubbing roughness of the contact surface in the treatment instrument, it can be easily handled.

  By the way, in the above-mentioned 1st-5th embodiment, it illustrated about the test body for sterilization confirmation of the shape imitating the predetermined part of an endoscope, and about each test body for sterilization confirmation individually An operation (sterilization confirmation test) for confirmation by putting in a sterilizer is necessary.

  Therefore, it is convenient if various sterilization confirmation test bodies corresponding to each part of the endoscope can be simultaneously sterilized and the sterilization effect can be confirmed. One embodiment to be described next relates to a test pack that can store a plurality of sterilization confirmation test bodies each having a configuration corresponding to two different elements constituting an endoscope.

  FIG. 11 is a view showing a sixth embodiment of the present invention, and is a test pack in a state in which two sterilization confirmation test bodies each having a configuration corresponding to two different elements constituting an endoscope are housed. FIG.

  The test pack 20 of the present embodiment is formed in a substantially bag shape so as to accommodate a plurality of test bodies for sterilization confirmation, and is formed of, for example, a sterilization peel pack. Here, the peel pack is a packaging member that allows gas such as vapor to pass but does not allow liquid or bacteria to pass through, and has been widely used in the medical device field.

  Further, for example, a perforated cutout 20a is provided at one of the four corners of the test pack 20. The cutout portion 20a is provided to facilitate the opening of the test pack 20.

  The test pack 20 contains at least two sterilization confirmation test bodies as shown in FIG. In this case, the sterilization confirmation test bodies that can be accommodated in the test pack 20 are each provided with a configuration corresponding to at least one of the components in the endoscope.

  Specifically, for example, in the present embodiment shown in FIG. 11, the test pack 20 corresponds to the sterilization confirmation test body 10 of the first embodiment described above, that is, the conduit of the endoscope. The test body and the test body 10D for sterilization confirmation of the fifth embodiment described above, that is, the test body that imitates the clearance between the operation lever and the endoscope main body in the operation section of the endoscope were simultaneously stored. Indicates the state of the case.

  In order to simultaneously sterilize a plurality of test bodies for sterilization using the test pack 20 having such a configuration and confirm the effect of the sterilization action, first, for sterilization confirmation of two different forms as described above The test bodies 10 and 10D are stored inside the test pack 20 and sealed.

  The test pack 20 is placed in a predetermined sterilization apparatus (not shown) and sterilization processing is executed. As a result, a sterilizing agent such as ethylene oxide gas or steam enters the inside of the test pack 20, and this sterilizing agent is stored in the indicator cases 2 and 2D of the test bodies 10 and 10D for sterilization confirmation. Acts on the indicator 3.

  After the sterilization process is completed, the sterilization confirmation test bodies 10 and 10D are taken out of the sterilization apparatus and the effect of the sterilization process is confirmed. That is, when a biological indicator is used as the indicator 3, first, the test pack 20 is opened along the cutout portion 20a of the test pack 20 in a sterile environment, and the test bodies 10 and 10D for sterilization confirmation are tested. After taking out from the pack 20, each indicator 3 is taken out.

  Then, after the indicator 3 taken out is transferred to a predetermined medium and cultured, the effect of the sterilization treatment is confirmed from the growth status of the bacteria.

  When a chemical indicator is used as the indicator 3, the indicator 3 of the test body 10 for sterilization confirmation can observe a color change from the outside without opening the test pack 20. This confirms the effect of sterilization. On the other hand, the indicator 3 of the test body 10D for sterilization confirmation is opened by removing the indicator case 2D from the holder 12 after opening the test pack 20 and taking out the test body 10D for sterilization confirmation. Observe the 3 color change. This confirms the effect of sterilization.

  As described above, according to the sixth embodiment, a plurality of different test bodies can be simultaneously sterilized, and the confirmation of the effect of the sterilization process for each test body can be collectively performed. For each type of test body, it is not necessary to perform a series of confirmation operations for each test body, which can contribute to the efficiency of the confirmation operation.

  By the way, the indicator case 2 used in the first to fourth embodiments described above is constituted by the indicator storage cylinder 2b and the two caps 2a that are detachably provided at both ends as described above. One embodiment to be described next is another embodiment that replaces the indicator case 2 in the first to fourth embodiments.

  12 and 13 show a seventh embodiment of the present invention. Among these, FIG. 12 is an external view of an indicator case in a test body for sterilization confirmation. FIG. 13 is an external view showing an opened state of the indicator case of FIG.

  The indicator case 2E of the present embodiment has substantially the same configuration as the indicator case 2 in the sterilization confirmation test body of the first to fourth embodiments described above, and only the structure of the indicator storage cylinder 2Eb is slightly different. Therefore, the same components as those in the first to fourth embodiments described above are denoted by the same reference numerals, detailed description thereof is omitted, and only different portions will be described below.

  As shown in FIG. 12, the indicator case 2E includes an indicator storage cylinder 2Eb and two caps 2a that are integrally disposed at both ends thereof.

  The two caps 2a are detachably and watertightly connected to the respective distal ends of the two caps 2a in such a manner that the respective one ends 1a of the two pipe tubes 1 are inserted therethrough.

  Further, each of the two caps 2a and the indicator storage cylinder 2Eb are integrally and watertightly connected.

  A split portion 2Ec, which is a splitting unit, is formed at a substantially central portion of the indicator storage cylinder 2Eb so as to be easily split into two by applying a predetermined amount of force. As this division part 2Ec, it is a means etc. which provide the perforation etc. in the predetermined position which desires division on the outer peripheral surface of indicator storage cylinder 2Eb beforehand, for example.

  Therefore, when the indicator storage cylinder 2Eb is applied with a force in a direction in which the indicator storage cylinder 2Eb is bent with the dividing portion 2Ec as a fulcrum, that is, in the direction of arrow A shown in FIG. The opening 2Ed (see FIG. 13) is formed so that the contents such as the indicator 3 can be taken out.

  And the watertight seal | sticker 13 is affixed on this division | segmentation part 2Ec. As a result, the watertight state of the indicator case 2E is secured. Other configurations are substantially the same as those in the first embodiment.

  The effect | action at the time of confirming the effect of a microbe process using the test body for sterilization confirmation provided with the said indicator case 2E comprised in this way is demonstrated below.

  First, the indicator 3 is installed inside the indicator case 2E. And the watertight seal | sticker 13 is affixed on the division | segmentation part 2Ec.

  Subsequently, the test body for sterilization confirmation provided with the indicator case 2E is put in a predetermined sterilization apparatus (not shown) and a predetermined sterilization process is executed. As a result, a sterilizing agent such as ethylene oxide gas or steam enters from the opening (1c; see FIG. 1) of the conduit tube 1 into the inside, and the sterilizing agent passes through the conduit tube 1 and enters the indicator case 2E. It acts on the indicator 3.

  After this sterilization process is completed, the test body for sterilization confirmation is taken out from the sterilization apparatus and the effect of the sterilization process is confirmed. When a biological indicator is used as the indicator 3, first, a force is applied to the indicator case 2E in the direction of arrow A in FIG. 12 with the dividing portion 2Ec as a fulcrum in an aseptic environment, and the indicator case 2E is shown in FIG. Divide it into two forms. Thereby, the indicator 3 is taken out from the opening 2Ed of the indicator case 2E, the indicator 3 is transferred to a predetermined medium and cultured, and then the effect of the sterilization treatment is confirmed from the growth state of the bacteria.

  In the case where the same sterilization confirmation test is repeated again, after the new indicator 3 is installed inside the indicator case 2E, the opening 2Ed of the indicator storage cylinder 2Eb matches at the dividing portion 2Ec. The watertight seal 13 is affixed to the divided portion 2Ec. The subsequent work is the same as the work described above.

  A chemical indicator may be used as the indicator 3. In this case, the color change of the indicator 3 may be observed from the outside without taking out the indicator 3 from the indicator storage cylinder 2Eb. When the same confirmation test for sterilization is repeated, the indicator storage cylinder 2Eb is divided by the dividing unit 2Ec and the new indicator 3 is installed in the dividing unit 2Ec in the above-described procedure, and then the water-tightness is supplied to the dividing unit 2Ec. The sticker 13 is pasted and the same operation is performed thereafter.

  As described above, according to the seventh embodiment, the indicator storage cylinder 2Eb is easily divided into two parts by applying a predetermined amount of force in a bending direction to a predetermined part of the indicator storage cylinder 2Eb of the indicator case 2E. Since the dividing portion 2Ec to be obtained is provided, the indicator 3 can be easily attached to and detached from the indicator case 2E. Therefore, the operation time can be shortened.

  In addition, when a biological indicator is used as the indicator 3, it is necessary to take out the indicator 3 from the inside of the indicator case 2E in an aseptic environment. Can do. Thereby, also when confirming the effect of a sterilization process, it can contribute to the reduction | decrease of the misjudgment, Therefore It can also contribute to the improvement of the precision of the effect confirmation of a sterilization process.

  By the way, when a biological indicator is used as the indicator 3, an operation in an aseptic environment is necessarily required to perform an operation for confirming the effect of the sterilization treatment.

  Therefore, it is extremely convenient if the user can easily move the indicator 3 to a predetermined medium at a place other than the sterile environment while the indicator 3 is placed in the sterile environment.

  14 and 15 show an eighth embodiment of the present invention, among which FIG. 14 is an external view of an indicator case provided with a culture medium in a test body for sterilization confirmation. FIG. 15 is an external view showing a state where the indicator case of FIG. 14 is opened.

  The indicator case 2F of the present embodiment has substantially the same configuration as the indicator case 2E in the sterilization confirmation test body of the seventh embodiment described above, but aseptically cultures the biological indicator as the indicator 3 The difference is that the culture medium is integrally provided. Therefore, the same components as those in the seventh embodiment are denoted by the same reference numerals, detailed description thereof is omitted, and only different portions will be described below.

  As shown in FIG. 12, the indicator case 2F is configured by an indicator storage cylinder 2Fb, two caps 2a that are integrally disposed at both ends thereof, and a medium bag 15 having a medium 14. .

  In the substantially central portion of the indicator storage cylinder 2Fb, there is formed a dividing portion 2Fc which is a dividing means for making it possible to easily divide into two parts by applying a predetermined amount of force in the same manner as in the seventh embodiment. Yes. And the watertight seal | sticker 13 is affixed on this division | segmentation part 2Fc, and it is the same as that of the said 7th Embodiment that the watertightness is ensured by this.

  Further, as described above, the culture medium bag 15 is integrally provided in the indicator storage cylinder 2Fb while ensuring water tightness. The medium bag 15 is formed of, for example, a transparent resin film or the like. Further, the medium bag 15 has a margin enough not to be broken by being pulled or the like even when the indicator storage cylinder 2Fb is in a state as shown in FIG. It is formed in size. The medium bag 15 may have a mechanism for activating the medium 14.

  In addition, in the indicator case 2F, a vent hole 2Fd is formed in the vicinity of the split portion 2Fc of the indicator storage cylinder 2Fb, and communicates the inside and outside of the indicator storage cylinder 2Fb at a site covered by the watertight seal 13. . The vent hole 2Fd is provided with a filter 16 which is formed so that, for example, germs and dust existing in the natural environment are not allowed to pass therethrough, but only air can pass therethrough. Other configurations are substantially the same as those in the first embodiment.

  The effect | action at the time of confirming the effect of a microbe process using the test body for sterilization confirmation provided with the said indicator case 2F comprised in this way is demonstrated below.

  First, the indicator 3 is installed in the indicator case 2F in the same manner as in the seventh embodiment described above. And the watertight seal | sticker 13 is affixed on the division | segmentation part 2Fc.

  Subsequently, the test body for sterilization confirmation provided with the indicator case 2F is put into a predetermined sterilization apparatus (not shown) and a predetermined sterilization process is executed. As a result, a sterilizing agent such as ethylene oxide gas or steam enters from the opening (1c; see FIG. 1) of the conduit tube 1 into the inside, and the sterilizing agent passes through the conduit tube 1 and enters the indicator case 2F. It acts on the indicator 3.

  After this sterilization process is completed, the test body for sterilization confirmation is taken out from the sterilization apparatus and the effect of the sterilization process is confirmed. Here, since a biological indicator is used as the indicator 3, first, a predetermined amount of force is applied to a predetermined position of the indicator storage cylinder 2Fb in the indicator case 2F as in the seventh embodiment. Then, the indicator storage cylinder 2Fb is divided into two as shown in FIG. 15, and the indicator 3 is dropped into the culture medium 14 from the opening 2Fd. Thereby, the indicator 3 is moved to the culture medium 14.

  Then, the watertight seal 13 is peeled off to expose the vent hole 2Fd. Thereby, the air required for the growth of the bacteria flows into the medium bag 15 through the vent hole 2Fd.

  The test body for sterilization confirmation in this state is placed in, for example, an incubator and cultured at a constant temperature for a predetermined period, and the effect of the sterilization treatment is confirmed from the growth status of the bacteria.

  In this case, it can be determined that sterilization has been reliably achieved if the bacteria are not attached to the indicator 3 dropped on the medium 14 inside the medium bag 15 and the bacteria do not grow. is there.

  As described above, according to the eighth embodiment, after the sterilization process is completed, the biological indicator can be easily cultured without particularly requiring an operation in an aseptic environment. Operability can be performed more simply. At the same time, when transferring the indicator 3 to the culture medium 14, the environment in which the indicator 3 exists is always maintained in a sterile state without being aware of the sterile environment. In this case, it is possible to eliminate an element that is erroneously determined, thereby contributing to shortening of the operation time and contributing to improvement of determination accuracy.

[Appendix]
According to the embodiment of the above invention, an invention having the following configuration can be obtained.

(1) In a test body for confirmation of sterilization having a configuration corresponding to a pipeline,
A test body for sterilization confirmation in which a conduit tube and an indicator case are integrally formed and the indicator case is divided and opened by applying force.

(2) In a test body for confirmation of sterilization after sterilization,
The test body for sterilization confirmation according to appendix (1), comprising a medium for easily culturing a biological indicator.

The whole figure which shows schematic structure of the test body for sterilization confirmation of the 1st Embodiment of this invention. FIG. 2 is a longitudinal sectional view taken along line AA in FIG. 1, showing an enlarged cross section of a duct tube and its exterior member in the test body for sterilization confirmation in FIG. 1. The whole figure which shows schematic structure of the test body for sterilization confirmation of the 2nd Embodiment of this invention. FIG. 4 is a longitudinal sectional view taken along line BB of FIG. 3, showing an enlarged cross section of the tube tube and its exterior member in the test body for sterilization confirmation of FIG. 3. The sectional side view which shows schematic structure of the test body for sterilization confirmation of the 3rd Embodiment of this invention. The top view which shows schematic structure at the time of seeing from the upper surface side of the test body for sterilization confirmation of FIG. The sectional side view which shows schematic structure of the test body for sterilization confirmation of the 4th Embodiment of this invention. The top view which shows schematic structure at the time of seeing from the upper surface side of the test body for sterilization confirmation of FIG. The perspective view which shows schematic structure at the time of seeing from the side surface of the test body for sterilization confirmation of the 5th Embodiment of this invention. The perspective view which takes out and shows only an indicator case among the structural members of the test body for sterilization confirmation of FIG. The external view of the test pack in the state which showed the 6th Embodiment of this invention and accommodated the test body for two sterilization confirmation provided with the structure corresponded to two different elements which comprise an endoscope. The external view of the indicator case in the test body for sterilization confirmation of the 7th Embodiment of this invention. FIG. 13 is an external view showing an opened state of the indicator case of FIG. 12. The external view of the indicator case provided with the culture medium in the test body for sterilization confirmation of the 8th Embodiment of this invention. The external view which shows the state which opened the indicator case of FIG.

Explanation of symbols

1 …… Pipe tube 2, 2D, 2E, 2F …… Indicator case 2a …… Cap (indicator case)
2b, 2Eb, 2Fb …… Indicator storage tube (indicator case)
2Ec, 2Fc ... division part 2Fd ... vent hole 3 ... indicators 4, 4A, 4B, 4C ... exterior member 6 ... fastening member 9 ... bolt (fastening member)
10, 10A, 10B, 10C, 10D …… Test body 12 for sterilization confirmation …… Holder 13 …… Watertight seal 14 …… Medium 15 …… Medium bag 16 …… Filter 20 …… Test pack agent Patent attorney Susumu Ito

Claims (5)

A test body for confirming sterilization using a sterilizer and having a configuration corresponding to at least one element constituting an endoscope, for confirming sterilization Test body. 2. The sterilization confirmation device according to claim 1, wherein the structure corresponding to at least one element constituting the endoscope has a structure corresponding to a conduit in the endoscope. Test body. 2. The structure corresponding to at least one element constituting an endoscope is formed so as to have a configuration in which an outer skin member is covered with respect to a conduit in the endoscope. Test body for sterilization confirmation as described in 1. The above structure corresponding to at least one element constituting the endoscope is formed to have a structure corresponding to a structure in which an operation lever in the operation part of the endoscope is attached to the operation part main body. The test body for sterilization confirmation according to claim 1. A test pack for use in confirming the sterilization action of a sterilization apparatus comprising a plurality of test bodies for sterilization confirmation having a configuration corresponding to at least one element constituting an endoscope, comprising: The test pack for sterilization confirmation is formed with a structure corresponding to at least one element of a different structure of the endoscope.

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