This application claims benefit of Japanese Application No. 2008-041676 filed in Japan on Feb. 22, 2008; the contents of which are incorporated by this reference.
1. Field of the Invention
The present invention relates to an endoscope washing and disinfecting evaluation apparatus for evaluating quality of endoscope washing and disinfecting by a washing and disinfecting apparatus.
2. Description of the Related Art
In recent years, endoscopes have been in wide use in a field of medicine and in industrial fields. Ordinary endoscopes are repeatedly used in endoscopic examinations. An endoscope after being used in an endoscopic examination is subjected to washing and disinfecting processing by a washing and disinfecting apparatus.
The endoscope which has been cleaned by the washing and disinfecting processing is to be used in a next endoscopic examination.
As described above, endoscopes are subjected to washing and disinfecting processing by a washing and disinfecting apparatus. An examination for evaluating, in particular, quality of washing and disinfecting (i.e., cleanliness) of a channel of an endoscope is desired to be performed on an endoscope which has been subjected to washing and disinfecting processing at appropriate intervals to check or evaluate quality of the washing and disinfecting processing.
In a conventional method, when cleanliness of a channel of an endoscope is to be evaluated, sterile water is infused from one opening into the channel by a syringe, a distal end portion of the endoscope where the channel opens is put into a collection container such as a beaker, and the sterile water having passed through the channel is collected as a collection liquid by the collection container.
After the collection, the collection liquid is filtered through a filter which traps only bacteria, and bacteria adherent to the filter are cultivated using a medium. The cleanliness is evaluated from a result of the cultivation using the medium.
Japanese Patent Application Laid-Open Publication No. 2006-326225 discloses an evaluation apparatus including a hollow body simulating an endoscope with a channel, a first housing portion in which a biological indicator for performing sterilization evaluation on the hollow body is housed, and a second housing portion in which a medium solution for cultivating bacteria adherent to the biological indicator is housed.
The evaluation apparatus is subjected to sterilization processing by a single sterilization apparatus together with an endoscope. With the process, sterilization of an endoscope by the sterilization apparatus is evaluated without using an actual endoscope.
Note that Japanese Patent Application Laid-Open Publication No. 11-133030 discloses a detection method including attaching an acid pigment solution to an article surface to which protein may be fixed, removing the acid pigment solution from the article surface by cleaning, bringing a predetermined amount of an alkali extraction liquid into contact with the article surface after being cleaned, collecting the extraction liquid, and detecting presence or absence of protein fixation to the article surface and the degree of fixation from acid pigments dissolved in the extraction liquid.
An endoscope washing and disinfecting evaluation apparatus according to the present invention includes a stripping solution storage section attached, in a state substantially sealed from outside, to one opening of a channel of an endoscope for storing a stripping solution to be infused from the one opening into the channel, a bacteria collection container attached, in a state substantially sealed from outside, to the other opening of the channel in which a filter for trapping a bacterium contained in the stripping solution when the stripping solution having passed through the channel and flowed out from the other opening is filtered through the filter is placed, and a medium supply section for placing the bacterium trapped by the filter in a state substantially sealed from outside and supplying a medium for cultivation.
Embodiments of the present invention will be described below with reference to the drawings.
As shown in
The endoscope 2 has an elongated insertion portion 5 which is inserted into a body cavity for an endoscopic examination, an operation portion 6 which is provided at a rear end of the insertion portion 5, and a universal cable 7 extending from the operation portion 6.
A channel 8 called a treatment instrument channel into which a treatment instrument (not shown) is to be inserted is provided in the insertion portion 5. A distal end of the channel 8 opens at a distal end surface of the insertion portion 5 while a rear end of the channel 8 opens at a treatment instrument insertion opening (hereinafter abbreviated as an insertion opening) 9 near a front end of the operation portion 6 (which is plugged when not in use).
The endoscope 2 after use in an endoscopic examination is washed and disinfected or sterilized (hereinafter the term washing and disinfecting includes sterilization) by a washing and disinfecting apparatus or sterilizing apparatus.
To evaluate or check whether the endoscope 2 after washing and disinfecting is properly washed and disinfected, the evaluation apparatus 1 is connected (attached) to the endoscope 2, as shown in
In the stripping solution unit 3, a clean stripping solution 3d is stored in a sealed container 3a. One end of a tube 3b is fixed to a cap at a distal end of the container 3a while a connection base portion 3c which is detachably connected to one end of the channel 8 serving as the target at the time of evaluating washing and disinfecting (i.e., cleanliness) of the endoscope 2 is provided at the other end of the tube 3b.
Specifically, the one end of the channel 8 in the example of
Note that a configuration in which the tube 3b is not extended, the connection base portion 3c is provided at the stripping solution unit 3, and the stripping solution unit 3 is connected to the insertion opening 9 may be adopted. The container 3a storing the stripping solution in the stripping solution unit 3 is formed of a flexible container which deforms under pressure or the like.
The bacteria collection unit 4 is detachably connected to a distal end portion 5a of the insertion portion 5 where the other end of the channel 8 opens.
The bacteria collection unit 4 includes a bacteria collection container 11 in, e.g., an annular shape in which a cavity is formed, a top cover 12 which covers an open upper end of the bacteria collection container 11, a syringe 13 detachably connected to an open base at a bottom of the bacteria collection container 11 and serving as a suction section or a collection section for collecting the stripping solution 3d through the channel 8 by suction operation, and a syringe 15 (see
In the bacteria collection container 11, a circumferential groove is formed at an appropriate height in an inner peripheral surface, and a filter 16 having a large number of minute openings which allows passage of the stripping solution 3d but does not allow passage of bacteria and traps the bacteria is attached. The filter 16 is detachable from the circumferential groove.
The medium solution 14 is supplied to the filter 16 having trapped bacteria through infusion by the syringe 15 serving as a medium supply section.
A base projecting upward is provided, e.g., near a center of the top cover 12, and a sealing film 17 which covers an opening in the top cover 12 is attached to the base.
The sealing film 17 has, for example, an annular portion which adheres tightly to the base and an openable portion on an upper end side of the annular portion which is projecting in, e.g., a conical shape, has a cross-shaped cut at a center, and can open and close freely by virtue of the cut.
Under normal conditions, elastic force of an elastic member forming the sealing film 17 brings segments of a cut portion into contact with each other and maintains a sealed state. Pushing the openable portion with the distal end portion 5a of the endoscope 2 opens the cut and lets the distal end portion 5a in. In this case, the cut portion adheres tightly to an outer peripheral surface of the distal end portion 5a and maintains a state sealed from outside.
Note that distal end portions of the segments of the cut portion typically expand, as shown in, e.g.,
Alternatively, in order to improve sealing function, magnet powder or the like may be mixed in the cut portion, and the openable portion may be configured (to improve the sealing function) such that adjacent ones of the segments of the cut portion stick to each other due to magnetic force when the cut portion is not pushed or when the distal end portion 5a is inserted.
The present invention is not limited to the openable portion with the above-described structure. An opening portion through which the distal end portion 5a passes in close contact by press fitting or the like may be formed at the center of the sealing film 17, and the opening portion may be freely opened and closed with a cover. Alternatively, an opening portion of the base of the top cover 12 may be formed with an elastic member having an inner diameter slightly smaller than an outer diameter of the distal end portion 5a such that the distal end portion 5a can be press-fitted into the opening portion of the top cover 12, and the opening portion may be closed with a cover or the like when the distal end portion 5a is not inserted.
Note that the evaluation apparatus 1 before use is stored in a sterilized transparent bag 18 made of plastic or the like, as shown in, e.g.,
Note that, as an example, the stripping solution unit 3 filled with the stripping solution 3d, the bacteria collection unit 4 with the syringe 13 attached to the bacteria collection container 11, and the syringe 15 infused with the medium solution 14 are stored in the bag 18.
In the stripping solution unit 3, the connection base portion 3c is hermetically sealed with sealing tape or the like. In the bacteria collection unit 4, a connection between the bacteria collection container 11 and the syringe 13 is hermetically sealed with sealing tap or the like and is fixed (so as not to move).
In the syringe 15, a distal end opening portion is hermetically sealed with sealing tape or the like, and a syringe cylindrical container which is infused with the medium solution 14 and a movable portion which can slide inside the syringe cylindrical container are fixed to each other with sealing tape or the like.
The work of setting up the evaluation apparatus 1 to be ready for evaluation can be easily performed by removing sealing tape or the like.
Note that the present invention is not limited to the example shown in
A method for evaluating cleanliness (related to washing and disinfecting processing) of a channel of the endoscope 2 will be described with reference to
A user takes out the endoscope 2 to be subjected to cleanliness evaluation from a repository or the like which has been washed and disinfected. The user also takes out the stripping solution unit 3 and bacteria collection unit 4 from the bag 18.
The user attaches the stripping solution unit 3 and bacteria collection unit 4 to the one and other ends, respectively, of the channel 8 (serving as an evaluation target), as shown in step S1 in
More specifically, the user attaches the stripping solution unit 3 to the insertion opening 9 and attaches the bacteria collection unit 4 to the distal end portion 5a (or attaches the distal end portion 5a to the bacteria collection unit 4).
A state after the attachment is as shown in
The user operates a movable portion of the syringe 13 attached to the bacteria collection unit 4, as shown in step S2. That is, the user performs suction operation such that a sucking negative pressure space is formed inside the syringe 13. With the suction operation, the stripping solution 3d in the stripping solution unit 3 is sucked toward the insertion opening 9 and passes from the insertion opening 9 through the channel 8.
Note that, in the suction operation, the container 3a of the stripping solution unit 3 may be deformed to facilitate infusion of the stripping solution 3d in the container 3a from the insertion opening 9 into the channel 8.
The stripping solution 3d having been taken from a distal end opening of the channel 8 at the distal end portion 5a into the bacteria collection unit 4, to which the distal end opening is attached in a state sealed from outside, is passed through (i.e., is filtered through) the filter 16 placed in the bacteria collection container 11 and is collected into the syringe 13.
After the user performs suction into the syringe 13 and collects the stripping solution 3d into the syringe 13 by an amount set in advance, the user removes the distal end portion 5a of the endoscope 2 from the bacteria collection unit 4. When the distal end portion 5a of the endoscope 2 is removed from the bacteria collection unit 4, the base portion at an upper end of the bacteria collection unit 4 is sealed by the openable portion at the sealing film 17.
The user also removes the syringe 13 after the use in the collection from the bacteria collection container 11.
The user takes out the syringe 15 infused with the medium solution 14 from the bag 18 and attaches an inlet of the syringe 15 to the bacteria collection container 11, as shown in step S3.
The user operates the movable portion of the syringe 15 and infuses the medium solution 14 stored in the syringe 15 into the bacteria collection container 11.
The amount of the medium solution 14 when the medium solution 14 reaches the filter 16 serves as a guide for determining a predetermined amount by which the medium solution 14 is to be infused. Note that a state in
A calibration marking corresponding to the predetermined amount of the syringe 15 may be marked to allow the user to achieve a state in which the medium solution 14 has reached the filter 16 by pushing forward the movable portion (piston) of the syringe 15 to the marked calibration marking. Alternatively, the bacteria collection unit 4 may be configured such that the medium solution 14 reaches the filter 16 when the user pushes forward the movable portion to an upper limit of movable scope.
The bacteria collection container 11 may be formed of an optically transparent member to allow the user to check how the medium solution 14 is infused.
Note that although the base at the bottom of the bacteria collection container 11 is open to outside from when the syringe 13 is removed from the bacteria collection container 11 to when the syringe 15 is attached, quick replacement of the syringe 13 with the syringe 15 allows a sufficient reduction in contamination by bacteria within the time for replacement. That is, it is possible for the bacteria collection container 11 to maintain a substantially-sealed-system state.
An openable portion like the openable portion of the above sealing film 17 may be attached to the base portion in order to reduce or eliminate contamination by bacteria.
Note that if the medium solution 14 spills out when the syringe 15 is removed from the bacteria collection container 11 after step S3, a sealing film may be attached as described above to also function to prevent an outflow.
After the user infuses the medium solution 14 into the bacteria collection container 11 by the predetermined amount, as in step S3, the user performs the operation of placing the bacteria collection container 11 at an appropriate location or the like to cultivate or propagate in the medium solution bacteria trapped by the filter 16, if any, as shown in step S4.
The user observes a surface of the filter 16 of the bacteria collection container 11 after a lapse of a predetermined time.
Note that the top cover 12 is made of, e.g., an optically transparent member, and the surface of the filter 16 can be observed without removing the top cover 12.
The user can evaluate quality of washing and disinfecting processing, i.e., cleanliness by the observation of the surface of the filter 16, as shown in step S5.
More specifically, if propagation of bacteria cannot be visually identified by the observation of the surface of the filter 16, an evaluation result indicating sufficient washing and disinfecting (including sterilization) processing, i.e., that a sufficient level of cleanliness is ensured can be obtained. On the other hand, if propagation of bacteria can be visually identified by the observation of the surface of the filter 16, an evaluation result indicating insufficient washing and disinfecting processing, i.e., insufficient cleanliness can be obtained.
Note that the predetermined time for cultivating or propagating bacteria in the medium solution 14 may be set in advance to an appropriate value such that an observation result itself as to whether propagation of bacteria can be visually identified which is obtained by the observation of the surface of the filter 16 corresponds to an evaluation result as to cleanliness. In the case, temperature conditions may be defined in addition to the time (for leaving the bacteria collection container 11 as it stands) for higher-accuracy evaluation.
As described above, according to the present embodiment, a user can obtain, with simple work, a more reliable evaluation result as to whether the channel 8 of the endoscope 2 after washing and disinfecting has been sufficiently disinfected, i.e., cleanliness in a substantially-sealed-system state. In the case, it is possible to easily obtain a reliable evaluation result without a clean room.
As a modification of the present embodiment, the filter 16 may be impregnated with a protein detection solution in advance such that a simple evaluation result based on a protein detection result can be obtained after step S2 in
The protein detection solution may detect ATP (Adenosine TriPhosphate) of an organism.
In the above embodiment, the case of the channel 8 called a treatment instrument channel, whose one end is the insertion opening 9 and whose other end opens at the distal end portion 5a of the insertion portion 5, has been described. However, cleanliness evaluation can also be performed on another channel.
The air supply channel 19a and water supply channel 19b are formed in the insertion portion 5, meet on the distal end side of the insertion portion 5, and reach one end of a nozzle (not shown). The other end of the nozzle opens at the distal end surface of the distal end portion 5a.
By operation similar to (but different in parts related to the insertion opening 9 from) the operation described with reference to
As shown in
The suction line 20b communicates with the channel 8 in the insertion opening 9 through the universal cable 7 and operation portion 6. In other words, the channel 8 forks near the rear end of the insertion portion 5 into branches, one extending toward the insertion opening 9 and the suction line 20b extending toward the operation portion 6.
Washing and disinfecting of the suction line 20b can be evaluated by operation similar to (but different in parts related to the insertion opening 9 from) the operation described with reference to
As described above, according to the present embodiment, a reliable evaluation result as to cleanliness can be obtained with simple work.
A second embodiment of the present invention will be described with reference to
As shown in
A user feeds the stripping solution 3d being pushed forward from the syringe 22a from an insertion opening 9 to which the syringe 22a is attached (through a connection base portion 3c) toward a channel 8 and feeds the stripping solution 3d from an opening in the channel 8 of a distal end portion 5a which is the other end of the channel 8 toward a bacteria collection unit 4B, by performing the operation of pushing forward a movable portion of the syringe 22a.
Note that the stripping solution infusion section is not limited to the syringe 22a. For example, the container 3a according to the first embodiment may be made of a flexible member, and a user may infuse the stripping solution 3d inside from the insertion opening 9 as the one opening into the channel 8 by performing the operation of denting the container 3a.
The bacteria collection unit 4B according to the present embodiment is obtained by attaching a syringe 15 storing a medium solution 14 to a bottom of a bacteria collection container 11 instead of the syringe 13, in the bacteria collection unit 4 according to the first embodiment.
The bacteria collection container 11 is connected to a collection container 23 for collecting a stripping solution having passed through a filter 16 through, e.g., a tube 24. The present embodiment is configured not to have the syringe 13 according to the first embodiment. The present embodiment is identical in other respects to the first embodiment.
In the first embodiment, the stripping solution 3d having passed through the channel 8 and then the filter 16 is collected into the syringe 13 connected to the bottom of the bacteria collection container 11. In the present embodiment, the stripping solution 3d is collected into the collection container 23 through the tube 24.
In the present embodiment, since the syringe 15 storing the medium solution 14 is initially attached to a bottom of the bacteria collection container 11, the work of replacing the syringe 13 with the syringe 15 in the first embodiment is unnecessary. It is possible to place the bacteria collection container 11 in a state in which bacteria trapped by the filter 16 are cultivated in the medium solution 14 by operating the syringe 15 and pushing forward the medium solution 14.
That is, according to the present embodiment, the syringe replacement work is unnecessary after bacteria collection. The bacteria collection container 11 can be placed in the state in which bacteria trapped by the filter 16 are cultivated in the medium solution 14 by operating the syringe 15 and pushing forward the medium solution 14 immediately after the bacteria collection. Note that a membrane filter may be adopted as the filter.
Procedures for evaluation by the evaluation apparatus 1B according to the present embodiment are as shown in
As shown in a first step, S11, the stripping solution unit 22 is attached to one end of the channel 8 of the endoscope 2, and the bacteria collection unit 4B is attached to the other end.
Step S11 is same as step S1 in
In a next step, S12, a movable portion of the syringe 22a is operated, and the stripping solution 3d in the syringe 22a is pushed forward. The stripping solution 3d pushed forward is infused into the channel 8, and the infused stripping solution 3d is passed through the channel 8. The stripping solution 3d having flowed out from the distal end portion 5a into the bacteria collection unit 4B is filtered through the filter 16 and is collected by the collection container 23 through the tube 24.
In a next step, S13, the syringe 15 storing the medium solution 14 is operated, and the medium solution 14 is infused into the bacteria collection container 11. In the present embodiment, the collection container 23 for collecting the stripping solution 3d and the syringe 15 storing the medium solution 14 are separately formed, and the stripping solution 3d is collected by the collection container 23 connected to the bacteria collection container 11 through the tube 24. It is thus possible to infuse the medium solution 14 immediately after collecting the stripping solution 3d by the collection container 23.
Steps S14 and S15 after the work are same as steps S4 and S5 in
According to the present embodiment, an evaluation result as to cleanliness can be obtained with simple work without the work of replacing the syringe 13 with the syringe 15 according to the first embodiment. Since replacement work is unnecessary, a sealed or closed system state can be more reliably maintained. It is thus possible to obtain a more reliable evaluation result.
As a first modification of the present embodiment, the configuration below may be adopted. In the present modification, a bacteria collection unit 4C is adopted, as shown in
Note that, in the bacteria collection unit 4C according to the present modification, the work of infusing a medium solution is unnecessary, as will be described below. Accordingly, the syringe 15 (for infusing a medium solution) in
Although
In the case of such a configuration, the tube 24 and the collection container 23 (shown in
After the stripping solution 3d having passed through the channel 8 is filtered through the filter 16, an endoscope 2 is removed from the bacteria collection unit 4C, and a top cover 12 to which the filter 16 is attached is removed from the bacteria collection container 11, as shown in
As shown in
In the present modification, an open system state is brought about when the top cover 12 with the filter 16 attached is removed from the bacteria collection container 11 and at the time of the work of pushing the filter 16 against the medium container 25. However, a substantially-sealed-system state can be maintained by performing the work in a short time. Since the substantially-sealed-system state can be maintained, a reliable evaluation result can be obtained.
A configuration like a second modification to be described below may be adopted.
In
The stripping solution, which has passed through the channel 8 and flowed out from a distal end of the insertion portion 5 serving as a distal end opening, is collected into a collection container 26. In this case, an open upper end of the collection container 26 is sealed with a sealing member 27 to prevent bacteria and the like from entering the collection container 26 from surroundings or the air.
Note that, in the example shown in
For example, a base 29 including a cock 28 which opens and closes is provided near a bottom of the collection container 26. Note that a sealing cap for sealing an end of the base 29 in a clean state is attached at an end of the base 29.
A sealed system state is maintained when a stripping solution having passed through the channel 8 is collected.
In the sealed system state as in
The cock 28 is opened, and the stripping solution is infused into the bacteria collection unit 4C′ and is filtered through the filter 16. After that, an evaluation result can be obtained by same procedures as the procedures in the first modification.
The present modification is also capable of maintaining a substantially-sealed-system state and obtaining a reliable evaluation result as to cleanliness.
Although the example in which the base 29 including the cock 28 is provided in the collection container 26 has been described with reference to
A third embodiment of the present invention will be described with reference to
In the channel brush 31 with cotton, for example, a cotton portion 31b made of, e.g., capsular cotton is provided, at a distal end of a wire 31a, as a harvesting portion which harvests waste material adherent to the inner surface (inner wall) of the channel 8 by rubbing against the inner surface. For example, a ring-shaped portion to be grasped and operated by a user is provided at a rear end of the wire 31a.
Note that the cotton portion 31b as the harvesting portion is not limited to a portion using cotton, and a spongy material such as a sponge may be adopted instead. The cotton portion 31b is made of a member which can be readily impregnated with liquid and is elasticized.
In the reagent-containing distal end cap 32, a reagent solution 32b which detects protein in waste material is stored in, e.g., a cylindrical transparent container 32a. The reagent solution 32b is used for a biuret reaction and is composed of sodium hydrate and a copper sulfate solutions Note that a reagent which detects ATP instead of a reagent which detects protein may be used.
For example, a sealing film 32c similar to the sealing film 17 according to the first embodiment and the sealing member 27 according to the second modification of the second embodiment is provided at an upper end of the cylindrical transparent container 32a.
Procedures for evaluating cleanliness will be described with reference to
In a first step, S21, a user attaches the reagent-containing distal end cap 32 to the distal end of the insertion portion 5 of the endoscope 2 in a sealed state from outside, as shown in
In a next step, S22, the user moistens the cotton portion 31b at a distal end of the channel brush 31 with cotton with sterile water (or a sterilized stripping solution) and inserts the cotton portion 31b from the insertion opening 9 of the endoscope 2 toward a distal end opening of the channel 8 (more specifically a treatment instrument channel) while rubbing the cotton portion 31b against the inner surface of the channel 8.
Protein in waste material adherent to the inner surface of the channel 8 can be harvested more reliably by inserting the cotton portion 31b while rubbing the cotton portion 31b against the inner surface of the channel 8, as described above, than by inserting the cotton portion 31b without rubbing.
In a next step, S23, the user leaves the reagent solution 32b stand or waits for a fixed time (e.g., a reaction time required for a biuret reaction) while the cotton portion 31b of the channel brush 31 with cotton pushed out from the distal end opening is totally immersed in the reagent solution 32b.
In a next step, S24, the user observes a change in color of the reagent solution 32b after a lapse of the fixed time. To check in detail, transmittance or absorbance of light of a color (with a wavelength) corresponding to a biuret reaction may be measured using a spectroscope.
As shown in step S25, an evaluation result which is a result of simply quantifying protein adherent to the cotton portion 31b, i.e., left in the channel 8 (more specifically the treatment instrument channel) can be obtained on the basis of a result of the observation, i.e., the degree of change in color.
In this case, an evaluation result as to washing and disinfecting processing, i.e., cleanliness can be obtained by detecting presence or absence of protein in deposit on the inner surface of the channel 8 to check whether washing and disinfecting processing has been sufficiently performed.
More specifically, for example, if the reagent solution 32b has turned into purple, an evaluation result indicating insufficient washing and disinfecting processing can be obtained. On the other hand, if the reagent solution 32b has not turned into purple, an evaluation result indicating sufficient cleaning processing can be obtained.
According to the present embodiment, it is possible to simply evaluate protein or the like in waste material adherent to or left in the elongated channel 8 such as a channel of the endoscope 2 with high accuracy.
According to the present embodiment, it is possible to harvest more protein in waste material as deposit firmly adherent to the inner surface of the channel 8 by brushing with the cotton portion 31b than by simply supplying a stripping solution into the channel.
Since a reagent necessary for, e.g., a biuret reaction which reacts with waste material and changes in coloration is prepared in advance and is stored in the reagent-containing distal end cap 32, the trouble of reagent preparation is saved compared to a conventional example.
Note that although an example in which protein in waste material is detected has been described in the above explanation, the present embodiment can be applied to detection of ATP. The present embodiment can also be used in bacteria detection.
Note that
The cotton portion 31b of the channel brush 31 with cotton projecting from the distal end opening of the endoscope 2 is immersed in the solution 35a. In the present modification, a bacteria collection unit 4 provided with a filter 16 is attached at a bottom of the container 35 through a cock 36 which opens and closes.
In the present modification, a vibrator 37 which produces a vibration is detachably attached to a side surface of the container 35.
The vibrator 37 produces a vibration in the container 35. The vibration is transmitted to the cotton portion 31b inside the container 35. The transmission facilitates separation of bacteria adherent to the cotton portion 31b toward the solution 35a.
After the vibration is produced in the above-described manner, the cock 36 is opened, and the solution 35a is infused into the bacteria collection unit 4. At the time, the solution 35a is filtered through the filter 16. After that, an evaluation result can be obtained by same procedures as the procedures in the first embodiment.
Note that although an example in which the cotton portion 31b is provided at the distal end of the channel brush 31 has been described in the above explanation, for example, a channel brush 39 in which a plurality of spatulas 38 made of silicon rubber are provided at the distal end of the wire 31 a may be adopted, as shown in
The reagent solution 32b may be filtered through the filter 16 of the bacteria collection unit according to the first or second embodiment, as the solution 35a. It is also possible to obtain an evaluation result as to washing and disinfecting processing by infusing a medium solution to reach the filter 16, through which the reagent solution 32b has been filtered, as described in the first or second embodiment and observing a surface of the medium solution after a lapse of a predetermined time.
A fourth embodiment of the present invention will be described with reference to
The evaluation apparatus 1E includes a filter main body (hereinafter simply abbreviated as a main body) 41 used to harvest or collect bacteria directly from a portion to be evaluated and a medium tube (hereinafter simply abbreviated as a tube) 42 for supplying a medium solution to a filter having trapped bacteria harvested by the main body 41 and cultivating the bacteria.
The main body 41 includes, e.g., a sheet-like bag or storage portion 43, and one surface (an upper surface in the description below) forming part of the storage portion 43 is formed of a filter 43a.
A large number of holes having diameters of, e.g., 0.45 μm or less are formed in the filter 43a not to pass but to trap bacteria. Alternatively, the filter 43a is formed to be a net with a mesh size of 0.45 μm or less.
An upper surface of the filter 43a is initially in a sterilized state and is covered with a cover film 44 (note that a grasping portion 46 to be described below is also covered). The upper surface and an inner surface (a surface on the storage portion 43 side) of the filter 43a and an interior of the storage portion 43 are in an aseptic state.
In the storage portion 43, a base portion which is open to outside is covered with, e.g., a screw cap 45. The grasping portion 46 is provided on a side opposite to the base portion to make it easy for a user grasping the main body 41 to perform the work below.
In the tube 42, a sterilized medium solution 42b is stored in a tube main body 42a which is sterilized in advance, and a base which is open to outside is covered with a sterilized cap 42c.
Procedures for evaluating disinfecting processing of, e.g., an exterior portion of the endoscope 2 as a medical device to be evaluated according to the present embodiment will be described with reference to
In a first step, S31, a user removes the cover film 44 from the main body 41.
In a next step, S32, the user pushes a clean surface of the filter 43a which is exposed after the cover film 44 is removed in the main body 41 against, e.g., an outer surface of an insertion portion 5 of the endoscope 2 to be evaluated such that the filter 43a is stuck to the outer surface. After that, the user removes the main body 41 from the endoscope 2 while grasping, e.g., the grasping portion 46.
The user removes the screw cap 45 of the main body 41 and also removes the cap 42c of the tube 42. In a next step, S33, the user connects the base of the tube 42 to the base portion of the main body 41 while inserting the base into the base portion and infuses the medium solution 42b in the tube 42 into the storage portion 43 of the main body 41 while manually squeezing the tube 42.
In the case, if the main body 41 is stored in a sterilized bag (not shown), and the infusion is performed in a sealed state, the surface of the filter 43a can be prevented from being contaminated. Rapid infusion of the medium solution 42b in the tube 42 into the storage portion 43 of the main body 41 reduces contamination by the air.
After infusing the medium solution 42b in the tube 42 into the storage portion 43 until the tube 42 becomes substantially empty, the user attaches the screw cap 45 to the main body 41.
In a next step, S34, the user puts the main body 41 in, e.g., a dedicated Petri dish 48 with the filter 43a on an upper surface of the main body 41 facing upward and performs cultivation at an appropriate temperature.
As shown in step S35, the user observes a state of the filter 43a after a lapse of a predetermined time. More specifically, the user can obtain an evaluation result as to washing and disinfecting processing by measuring the number of bacteria cultivated in the filter 43a.
According to the present embodiment, an evaluation result as to washing and disinfecting processing can be obtained without troublesome operation. Evaluation can be performed without a clean room. Skilled aseptic operation is also unnecessary.
A method of use is substantially the same as the method of use in the fourth embodiment. In the present case, the work of infusing the medium solution 42b is unnecessary. It is possible to prevent contamination by the air and obtain an evaluation result as to cleanliness.
As shown in
Note that if the distal end surface of the endoscope 2 is pressed, as shown in
An embodiment or the like obtained by, e.g., combining parts of the above embodiments and others also belongs to the present invention. The present invention can be applied to a medical device such as a treatment instrument including a channel, in addition to a channel of an endoscope.
According to the present invention, it is possible to obtain a reliable evaluation result as to cleanliness of a channel of an endoscope.
The present invention can be widely used to check whether a channel of an endoscope repeatedly used in endoscopic examinations has been sufficiently washed and disinfected.
Having described the embodiments of the invention referring to the accompanying drawings, it should be understood that the present invention is not limited to those precise embodiments and various changes and modifications thereof could be made by one skilled in the art without departing from the spirit or scope of the invention as defined in the appended claims.
Number | Date | Country | Kind |
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2008-041676 | Feb 2008 | JP | national |