U.S. patent application number 11/446812 was filed with the patent office on 2007-01-11 for sterilization confirmation tester and test pack.
This patent application is currently assigned to OLYMPUS CORPORATION. Invention is credited to Yosuke Kanamori, Yuki Nagai, Kaori Obi, Sawako Sato, Maiko Shiga.
Application Number | 20070008160 11/446812 |
Document ID | / |
Family ID | 34656240 |
Filed Date | 2007-01-11 |
United States Patent
Application |
20070008160 |
Kind Code |
A1 |
Nagai; Yuki ; et
al. |
January 11, 2007 |
Sterilization confirmation tester and test pack
Abstract
The present invention provides a sterilization confirmation
tester and a test pack which enables effective sterilization to be
confirmed in a simple and sure manner by providing a simulation of
the structure of an endoscope and so forth. The sterilization
confirmation tester according to the present invention has a
function of confirming effective sterilization treatment after
sterilization performed by a sterilization apparatus. The
sterilization confirmation tester includes a structure
corresponding to at lest one of the components which form the
endoscope.
Inventors: |
Nagai; Yuki; (Tokyo, JP)
; Shiga; Maiko; (Yokosuka-shi, JP) ; Kanamori;
Yosuke; (Tokyo, JP) ; Sato; Sawako; (Tokyo,
JP) ; Obi; Kaori; (Tokyo, JP) |
Correspondence
Address: |
SCULLY SCOTT MURPHY & PRESSER, PC
400 GARDEN CITY PLAZA
SUITE 300
GARDEN CITY
NY
11530
US
|
Assignee: |
OLYMPUS CORPORATION
TOKYO
JP
|
Family ID: |
34656240 |
Appl. No.: |
11/446812 |
Filed: |
June 5, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/JP04/18028 |
Dec 3, 2004 |
|
|
|
11446812 |
Jun 5, 2006 |
|
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Current U.S.
Class: |
340/610 |
Current CPC
Class: |
A61B 1/00057 20130101;
A61B 2090/702 20160201; A61B 1/121 20130101; A61L 2/28 20130101;
G01N 31/226 20130101; A61L 2202/24 20130101 |
Class at
Publication: |
340/610 |
International
Class: |
G08B 21/00 20060101
G08B021/00 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 5, 2003 |
JP |
2003-408333 |
Dec 16, 2003 |
JP |
2003-418723 |
Claims
1. A sterilization confirmation tester for confirming effective
sterilization performed by a sterilization apparatus, the
sterilization confirmation tester having a structure which
corresponds to at least one component of an endoscope.
2. The sterilization confirmation tester according to claim 1,
wherein the aforementioned structure includes a conduit simulation
portion which is a structure corresponding to a conduit of the
endoscope.
3. The sterilization confirmation tester according to claim 2,
wherein the aforementioned structure includes a casing for storing
a sterilization confirmation indicator and two tubes connected to
the casing so as to communicate with the interior space thereof,
and wherein the aforementioned conduit simulation portion includes
conduits of the two tubes.
4. The sterilization confirmation tester according to claim 3,
wherein the aforementioned casing has a separatable portion which
has a function of separating into parts so as to form an opening
upon the application of a predetermined amount of force to the
separatable portion.
5. The sterilization confirmation tester according to claim 4,
further including a culture medium bag which covers the portion
where the opening is to be formed, in a watertight manner, and
which includes a culture medium for a biological indicator.
6. The sterilization confirmation tester according to claim 4,
wherein a seal is adhered to the casing in order to seal the
separatable portion in a watertight manner.
7. The sterilization confirmation tester according to claim 5,
wherein a seal is adhered to the casing in order to seal the
separatable portion in a watertight manner.
8. The sterilization confirmation tester according to claim 1,
wherein the aforementioned structure is covered with a packaging
member.
9. The sterilization confirmation tester according to claim 1,
wherein the aforementioned structure is configured so as to have
contact faces where a lever member, which is a component of the
operating lever, and a main unit member of an main operating unit
portion are in contact with each other, in a state in which the
operating lever of the operating portion of the endoscope is
mounted to the main operating unit portion thereof.
10. The sterilization confirmation tester according to claim 2,
further comprising a conduit body having a conduit simulation
portion, wherein the aforementioned conduit simulation portion is
configured so as to enable the length thereof to be adjusted in the
longitudinal direction.
11. The sterilization confirmation tester according to claim 10,
wherein the aforementioned conduit body comprises: a first conduit
body having the aforementioned conduit simulation portion; and a
second conduit body which has another conduit simulation portion
connected so as to communicate with the conduit simulation portion
of the first conduit body, and which is slidably mounted within the
first conduit body.
12. The sterilization confirmation tester according to claim 11,
wherein at lest one of the first conduit body and the second
conduit body includes an elastic member for maintaining the
interiors of the conduit simulation portions thereof in a
watertight state.
13. The sterilization confirmation tester according to claim 11,
wherein at lest one of the conduit simulation portion of the first
conduit body and the conduit simulation portion of the second
conduit body stores a sterilization confirmation indicator
therewithin for confirming effective sterilization by the
sterilization treatment performed by the sterilization
apparatus.
14. The sterilization confirmation tester according to claim 12,
wherein at lest one of the conduit simulation portion of the first
conduit body and the conduit simulation portion of the second
conduit body stores a sterilization confirmation indicator
therewithin for confirming effective sterilization by the
sterilization treatment performed by the sterilization
apparatus.
15. The sterilization confirmation tester according to 14, wherein
the sterilization effected by the sterilization apparatus is
high-pressure and high-temperature steam sterilization or ethylene
oxide gas sterilization, and wherein the sterilization confirmation
indicator has a function of producing a reaction corresponding to
effective sterilization.
16. The sterilization confirmation tester according to claim 10,
having a function of allowing the tip of the conduit simulation
portion to be extracted from the side face side of the conduit
body, while a desired length of the remaining conduit simulation
portion is stored within the conduit body, thereby enabling the
length of the conduit simulation portion which remains within the
conduit body to be adjusted.
17. The sterilization confirmation tester according to claim 2,
wherein a thermal insulating member is provided so as to cover the
entire region of, or at least a part of, the outer face of the
conduit simulation portion.
18. The sterilization confirmation tester according to claim 2,
further including a connection portion for connecting with another
sterilization confirmation tester in a state in which respective
conduit simulation portions communicate with one another.
19. The sterilization confirmation tester according to claim 18,
further including a plurality of the conduit simulation portions,
wherein the aforementioned connection portion is provided
corresponding to the opening of each of the plurality of conduit
simulation portions.
20. The sterilization confirmation tester according to claim 19,
wherein a sterilization confirmation indicator is provided within
one of the plurality of conduit simulation portions in order to
confirm effective sterilization after the sterilization treatment
by the sterilization apparatus.
21. A test pack employed for confirming effective sterilization of
a sterilization apparatus, including a plurality of sterilization
confirmation testers each of which has a structure corresponding to
at least one of the components which form an endoscope, and wherein
the aforementioned sterilization confirmation testers are
configured so as to have structures each of which corresponds to at
least one of the components of the endoscope, and which differ from
one another.
22. A sterilization confirmation test pack comprising: a plurality
of sterilization confirmation testers, which is configured so as to
be stored within a sterilization apparatus, and which includes a
conduit simulation portion having a structure corresponding to a
conduit of a medical device, and a connection portion for
connecting with another sterilization confirmation tester; a
packaging member configured so as to store the plurality of
sterilization confirmation testers; and a thermal insulating member
provided to at least a part of the packaging member.
Description
[0001] This application is a continuation application of
PCT/JP2004/018028 filed on Dec. 3, 2004 and claims the benefit of
Japanese Applications No. 2003-408333 filed in Japan on Dec. 5,
2003 and No. 2003-418723 filed in Japan on Dec. 16, 2003, the
entire contents of each of which are incorporated herein by their
reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a sterilization
confirmation tester and test pack, and particularly to a
sterilization confirmation tester and test pack including an
indicator to confirm sterilization employed in sterilization
treatment for medical devices, particularly for a medical device
and so forth having a lengthy tubular structure.
[0004] 2. Description of the Related Art
[0005] Conventionally, medical devices used for the purpose of
examination or treatment have been subjected to cleansing and
sterilization in order to prevent infection and so forth. In
particular, in a case of using a medical endoscope, it is
indispensable to sterilize the endoscope in a sure manner after the
use thereof.
[0006] Examples of recently employed sterilization techniques
include high-pressure and high-temperature steam sterilization
(which will be referred to as "autoclave sterilization" hereafter),
and ethylene oxide gas sterilization (which will be referred to as
"EOG sterilization" hereafter), which provide the advantage of
enabling medical devices to be used immediately after sterilization
without involving troublesome operations, and which are also
advantageous in terms of running costs.
[0007] In sterilization such as autoclave sterilization, EOG
sterilization, or the like, in general, operation is performed to
confirm whether or not the sterilization treatment has effected
satisfactory sterilization.
[0008] Examples of conventional confirmation methods for confirming
effective sterilization in sterilization treatment using autoclave
sterilization or EOG sterilization include: a method in which a
tape-shaped chemical indicator (which will also be referred to as
"CI" hereafter) is attached to a medical device (sterilization
apparatus); and a method in which a sheet-shaped chemical indicator
or biological indicator (which will also be referred to as "BI"
hereafter) is introduced among the objects to be sterilized.
[0009] Examples of the types of the aforementioned BIs and CIs used
in conventional sterilization confirmation methods include: a type
formed in a tape shape for installation outside of a medical
device; and a sheet-shaped type which can be installed at a portion
within a medical device (at a portion having a certain space
relatively near the opening). Also, examples of the aforementioned
CIs include linear type CIs used for lengthy tubular medical
devices. Also, testers (test packs) are conventionally known having
a configuration in which such a liner type CI is provided within a
predetermined tube beforehand, thereby offering a function of
confirming effective sterilization.
[0010] As a conventional example of such a type of tester, Japanese
Unexamined Patent Application Publication No. 2002-355297 has
proposed a sterilization confirmation indicator having a
configuration in which a flocculent member which has adsorbed a
sterilization confirmation indicator component is inserted into a
slender tube, thereby providing a function of confirming effective
sterilization of the tube.
[0011] Also, various proposals have been conventionally presented
with respect to the structure of a sterilization confirmation
tester in which a biological indicator and a culture medium are
integrally formed, which are disclosed in Japanese Unexamined
Patent Application Publication No. 10-201466, and so forth, for
example.
SUMMARY OF THE INVENTION
[0012] The present invention relates to a sterilization
confirmation tester for confirming effective sterilization
performed by a sterilization apparatus. The sterilization
confirmation tester has a structure which corresponds to at least
one component of an endoscope.
[0013] Also, the test pack according to the present invention
includes multiple sterilization confirmation testers each of which
has a structure corresponding to at least one of the components
which form an endoscope. The aforementioned sterilization
confirmation testers are configured so as to have structures each
of which corresponds to at least one of the components of the
endoscope, and which differ from one another.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an overall diagram which shows a schematic
configuration of a sterilization confirmation tester according to a
first embodiment of the present invention.
[0015] FIG. 2 is an enlarged longitudinal cross-sectional view
along line II-II in FIG. 1, which shows the cross-section of a
conduit tube and an outer cover member thereof included in the
sterilization confirmation tester shown in FIG. 1.
[0016] FIG. 3 is an overall diagrams which shows a schematic
configuration of a sterilization confirmation tester according to a
second embodiment of the present invention.
[0017] FIG. 4 is an enlarged longitudinal cross-sectional diagram
along line IV-IV in FIG. 3, which shows the cross-section of a
conduit tube and an outer cover member thereof included in the
sterilization confirmation tester shown in FIG. 3.
[0018] FIG. 5 is a side cross-sectional view which shows the
schematic configuration of a sterilization confirmation tester
according to a third embodiment of the present invention.
[0019] FIG. 6 is a top view which shows the schematic configuration
of the sterilization confirmation tester shown in FIG. 5, when
viewed from the top side.
[0020] FIG. 7 is a side cross-sectional view which shows the
schematic configuration of a sterilization confirmation tester
according to a fourth embodiment of the present invention.
[0021] FIG. 8 is a top view which shows the schematic configuration
of the sterilization confirmation tester shown in FIG. 7, when
viewed from the top side.
[0022] FIG. 9 is a side view which shows the schematic
configuration of a sterilization confirmation tester according to a
fifth embodiment of the present invention.
[0023] FIG. 10 is a perspective view which shows only an indicator
casing which is one of the components of the sterilization
confirmation tester shown in FIG. 9.
[0024] FIG. 11 is a diagram which shows a sixth embodiment of the
present invention, and is an external view which shows a test pack
storing two sterilization confirmation testers having structures
corresponding to two different components of an endoscope.
[0025] FIG. 12 is an external view of an indicator casing of a
sterilization confirmation tester according to a seventh embodiment
of the present invention.
[0026] FIG. 13 is an external view which shows a state in which the
indicator casing shown in FIG. 12 has been opened.
[0027] FIG. 14 is an external view of an indicator casing of a
sterilization confirmation tester including a culture medium
according to an eighth embodiment of the present invention.
[0028] FIG. 15 is an external view which shows a state in which the
indicator casing shown in FIG. 14 has been opened.
[0029] FIG. 16 is a perspective view which shows a schematic
configuration of a sterilization confirmation tester according to a
ninth embodiment of the present invention, at a basic length.
[0030] FIG. 17 is a perspective view which shows a schematic
configuration of the sterilization confirmation tester according to
the ninth embodiment of the present invention, with a length
modified from the state shown in FIG. 16.
[0031] FIG. 18 is a cross-sectional view along line XVIII-XVIII in
FIG. 16 showing the sterilization confirmation tester.
[0032] FIG. 19 is a cross-sectional view along line XIX-XIX in FIG.
17 showing the sterilization confirmation tester.
[0033] FIG. 20 shows a sterilization confirmation tester according
a tenth embodiment of the present invention, and is a
cross-sectional view which shows a schematic configuration of the
sterilization confirmation tester including a conduit simulation
portion having a predetermined length.
[0034] FIG. 21 is a cross-sectional view which shows a schematic
configuration of the sterilization confirmation tester shown in
FIG. 20, with the length of the conduit simulation portion having
been adjusted by extracting the conduit simulation portion
outward.
[0035] FIG. 22 is a cross-sectional view which shows a schematic
configuration of a sterilization confirmation tester according to
an eleventh embodiment of the present invention.
[0036] FIG. 23 is a cross-sectional view which shows a schematic
configuration of a sterilization confirmation tester according to a
twelfth embodiment of the present invention.
[0037] FIG. 24 is a cross-sectional view which shows a
configuration of a sterilization confirmation tester formed of
multiple sterilization confirmation test units shown in FIG. 23,
which are connected so as to communicate with one another.
[0038] FIG. 25 is a cross-sectional view which shows a schematic
configuration of a sterilization confirmation test pack employing a
sterilization confirmation tester according to a thirteenth
embodiment of the present invention.
[0039] FIG. 26 is an external view which shows a sterilization
confirmation test pack including opening/closing means.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)
[0040] Description will be made below regarding embodiments
according to the present invention with reference to the
drawings.
First Embodiment
[0041] FIG. 1 is an overall diagram which shows a schematic
configuration of a sterilization confirmation tester (corresponding
to a conduit) according to a first embodiment of the present
invention. FIG. 2 is an enlarged longitudinal cross-sectional view
along line II-II in FIG. 1, which shows the cross-section of a
conduit tube and an outer cover member thereof included in the
sterilization confirmation tester shown in FIG. 1.
[0042] A sterilization confirmation tester 10 according to the
present embodiment is for confirming effective sterilization of a
sterilization apparatus. The sterilization confirmation tester 10
has a structure which corresponds to at least one of the components
of an endoscope, i.e., which corresponds to a conduit of the
endoscope.
[0043] Specifically, as shown in FIG. 1, the sterilization
confirmation tester 10 comprises: two conduit tubes 1 formed in a
slender and tubular shape; an outer cover member 4, which is a
coating member, provided so as to cover the outer face of the
conduit tubes 1; and an indicator casing 2 configured so as to
allow a biological indicator, a chemical indicator 3, or the like
(which will simply be referred to as "indicator" hereafter), for
example, to be inserted and extracted as desired. Note that the
outer cover member 4 does not necessarily have to be provided on
the outer face of the conduit tube 1. Furthermore, proximal ends 1a
of the two conduit tubes 1 are each provided to both ends of the
indicator casing 2. Note that, with such an arrangement, the two
conduit tubes 1 are preferably formed in approximately the same
shape and size. With such an arrangement, the indicator casing 2 is
preferably disposed near the center after the two conduit tubes 1
and the indicator casing 2 are assembled together to form the
sterilization confirmation tester 10.
[0044] The indicator casing 2 comprises: an indicator storage
cylinder 2b which is formed of a transparent or opaque resin or the
like and which has openings at both ends thereof; and two caps 2a
which enable both ends of the indicator casing 2 to be switched
between the opened state and the closed state.
[0045] The tip of each of the two caps 2a is configured so as to
have an opening 2c which allows the one end 1a of each of the two
conduit tubes 1 to be continuously provided. With such an
arrangement, the proximal ends 1a of the two conduit tubes 1 are
each detachably connected to the tip ends of the two caps 2a.
Furthermore, a watertight member (not shown) such as an O-ring or
the like is provided to each connection portion where the one end
1a of the conduit tube 1 is connected to the cap 2a. This provides
a watertight structure to each of these connection portions.
[0046] Furthermore, the caps 2a are detachably provided via the
base ends thereof to both ends of the indicator storage cylinder 2b
through a watertight member (not shown) such as an O-ring or the
like. This also provides a watertight structure to each connection
portion between the cap 2a and the indicator storage cylinder
2b.
[0047] The conduit tube 1 is formed of a tubular member having a
hollow structure in which openings 1c are formed at both ends
thereof. The various kinds of the conduit tubes 1 are formed in
various kinds of shapes which simulate the shapes (determined by
the length, inner diameter, and so forth) of various kinds of
endoscope conduits, treatment tools, and so forth. That is to say,
in the sterilization confirmation tester 10, the conduit of the
conduit tube 1 corresponds to the conduit which is one of the
components of a medical device such as an endoscope or the like.
Specifically, the conduit tubes 1, each of which is a component
corresponding to a conduit, are formed in a shape within a range of
the length L from around 300 to 4000 mm, and the inner diameter
.phi. of around 0.1 to 100 mm, for example. With such an
arrangement, a desired one of the conduit tubes 1 having a desired
shape is selected according to the user's need. On the other hand,
the cap 2a (the tip thereof) is configured so as to allow any one
of these conduit tubes 1 to be connected thereto in a watertight
manner. Thus, the conduits within the two conduit tubes 1 are each
connected to the indicator casing 2 so as to communicate with the
interior space within the indicator casing 2.
[0048] The outer cover member 4 is formed of the same material as
that of a flexible hose, operating unit, and so forth of an
endoscope, or a material exhibiting the same thermal insulating
performance as that of these components, e.g., resin such as
urethane, rubber, or the like, for example. The outer cover member
4 according to the present embodiment has a structure in which the
outer face of the conduit tube 1 is directly coated with a resin
material such as urethane, rubber, or the like, as shown in FIG. 2,
thereby providing a coating structure to the outer face of the
conduit tube 1.
[0049] Description will be made below regarding the operation of
the sterilization confirmation tester 10 having such a
configuration for confirming effective sterilization.
[0050] First, an indicator 3 is installed at a predetermined
position in the aforementioned sterilization confirmation tester
10. In this case, the indicator 3 suitable for the sterilization
method is selected. Specifically, the caps 2a are detached from the
indicator storage cylinder 2b, and the indicator 3 is installed
within the indicator storage cylinder 2b. Next, the caps 2a are
connected to the indicator 2b. After the connection, each of the
caps 2a and the indicator storage cylinder 2b are connected through
a watertight member, thereby ensuring that the interior space
formed of the caps 2a and the indicator storage cylinder 2b remains
watertight.
[0051] The sterilization confirmation tester 10 in this state is
mounted within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the conduit tube 1 from the opening 1c. Then, the sterilization
agent passes through the conduit tube 1, and acts upon the
indicator 3 stored in the indicator casing 2.
[0052] After this sterilization step, the sterilization
confirmation tester 10 is extracted from the sterilization
apparatus, and confirmation of effective sterilization is made.
This confirmation is made as follows.
[0053] First, let us consider a case of employing a biological
indicator as the indicator 3. In this case, after the extraction of
the indicator 3 from the indicator storage cylinder 2b of the
indicator casing 2 in a sterile environment, the indicator 3 is
introduced into a predetermined culture medium. After the culturing
step, effective sterilization is confirmed based upon whether or
not bacteria appear on the culture medium.
[0054] Next, let us consider a case of employing a chemical
indicator as the indicator 3. In this case, after the extraction of
the indicator 3 from the indicator storage cylinder 2b of the
indicator casing 2, effective sterilization is confirmed by
checking for the change in color of the indicator 3. Note that an
arrangement in which the indicator storage cylinder 2b of the
indicator casing 2 is formed of transparent resin has the advantage
of allowing the change in color of the indicator 3 to be checked
without a step for extracting the indicator 3, thereby effecting
confirmation of effective sterilization.
[0055] The sterilization confirmation tester 10 according to the
aforementioned first embodiment has a structure which is a
simulation of the tubular structure of an endoscope. This provides
confirmation of effective sterilization at a corresponding portion
of an endoscope with high reliability.
[0056] Description has been made in the above first embodiment
regarding an arrangement in which the outer cover member 4, which
is provided in the form of a coating to the outer face of the
conduit tube 1, is formed of the same material as that of a
flexible hose, operating unit, and so forth (conduit in the present
embodiment) of an endoscope, or a material exhibiting the same
thermal insulating performance as that of these components, e.g.,
resin such as urethane, rubber, or the like. However, the outer
cover member 4 is not restricted to such an arrangement. Also,
other arrangements may be made providing the same functions and
advantages, as described below, for example, instead of the first
embodiment described above.
[0057] The sterilization confirmation tester 10 according to the
present embodiment can also be applied to other cases in addition
to the case described in the present first embodiment. For example,
the sterilization confirmation tester 10 can also be applied to
confirmation of effective sterilization of a treatment tool (not
shown) used together with the endoscope simply by employing the
conduit tube 1 formed with the same length, inner diameter, and so
forth, as those of the treatment tool. In the same way, embodiments
described below can also be applied to confirmation of effective
sterilization of any treating tool or the like by employing the
structure of the sterilization confirmation tester 10 which is a
simulation of the structure of the treatment tool or the like used
together with the endoscope.
Second Embodiment
[0058] FIG. 3 and FIG. 4 are diagrams which show a second
embodiment of the present invention. Of these, FIG. 3 is an overall
diagrams which shows a schematic configuration of a sterilization
confirmation tester (for a conduit) according to the present
embodiment. FIG. 4 is an enlarged cross-sectional diagram which
shows the cross-section of a conduit tube and an outer cover member
thereof included in the sterilization confirmation tester shown in
FIG. 3, and is a longitudinal cross-sectional view along line IV-IV
in FIG. 3.
[0059] The second embodiment has generally the same configuration
as that of the first embodiment described above, except for the
outer cover member. Accordingly, the same components as those of
the aforementioned first embodiment are denoted by the same
reference numerals, description thereof will be omitted, and
description will be made below regarding only the different
components.
[0060] As shown in FIG. 3, a sterilization confirmation tester 10A
according to the present embodiment comprises the two conduit tubes
1, the indicator casing 2, the indicator 3, and an outer cover
member 4A. Of these, the conduit tubes 1, the indicator casing 2,
and the indicator 3 are the same as those of the aforementioned
first embodiment.
[0061] The outer cover member 4A according to the present
embodiment is configured so as to allow an assembly formed of the
indicator casing 2 storing the indicator 3 and the two conduit
tubes 1 to be detachably mounted therewithin, in a state in which
the indicator casing 2 and the two conduit tubes 1 are continuously
provided, as shown in FIG. 3. Accordingly, as shown in FIG. 3, the
components corresponding to the conduit of an endoscope, i.e., the
two conduit tubes 1 are enclosed within the outer cover member
4A.
[0062] The outer cover member 4A is formed in a tubular structure,
and is formed of the same material as that of a flexible hose,
operating unit, and so forth (a conduit in the present embodiment)
of an endoscope, or a material exhibiting the same thermal
insulating performance as that of these components, e.g., resin
such as urethane, rubber, or the like, in the same way as with the
outer cover member 4 of the aforementioned first embodiment.
[0063] The outer cover member 4A has openings formed at both ends
thereof. Furthermore, a cap member 4a is detachably mounted at each
of the openings through a predetermined watertight member. This
provides a watertight connection between each of cap members 4a and
the outer cover member 4A after mounting the cap members 4a to both
ends of the outer cover member 4A. On the other hand, the outer
cover member 4A allows the assembly formed of the conduit tubes 1
and the indicator casing 2 to be stored within the interior space
thereof after the cap members 4a are detached from the outer cover
member 4A.
[0064] On the other hand, each of the aforementioned cap members 4a
has a through hole formed at approximately the center thereof. Such
an arrangement allows the conduit tube 1 to be detachably inserted
into the through hole through a predetermined watertight member.
This ensures that the join between the conduit tube 1 and the cap
member 4a is watertight. The other components are the same as those
of the aforementioned first embodiment.
[0065] Description will be made below regarding the operation of
the sterilization confirmation tester 10A having such a
configuration according to the present embodiment for confirming
effective sterilization.
[0066] First, the indicator 3 is installed within the indicator
casing 2 of the sterilization confirmation tester 10A in the same
way as with the first embodiment.
[0067] The indicator casing 2, which stores the indicator 3
therewithin and which has the conduit tubes 1 connected to both
ends thereof, is introduced into the outer cover member 4A with the
cap members 4a having been detached, so as to be stored
therewithin.
[0068] The two cap members 4a, with proximal ends of the conduit
tubes 1 having been inserted into the through holes of the two cap
members 4a, are each attached so as to cover the openings formed at
both ends of the outer cover member 4A.
[0069] The sterilization confirmation tester 10A in such a state is
installed within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the conduit tube 1 from the opening 1c. Then, the sterilization
agent passes through the conduit tube 1, and acts upon the
indicator 3 stored in the indicator casing 2.
[0070] After this sterilization step, the sterilization
confirmation tester 10 is extracted from the sterilization
apparatus, and confirmation of effective sterilization is made.
Now, let us consider a case of employing a biological indicator as
the indicator 3. In this case, first, the cap members 4a are
detached, and the assembly formed of the conduit tubes 1 and the
indicator casing 2 is extracted from the outer cover member 4A in a
sterile environment.
[0071] Subsequently, the indicator 3 is extracted from the
indicator storage cylinder 2b of the indicator casing 2 in this
sterile environment, and is introduced into a predetermined culture
medium. After the culturing step, effective sterilization is
confirmed based upon whether or not bacteria appear on the culture
medium.
[0072] On the other hand, let us consider a case of employing a
chemical indicator as the indicator 3. In this case, after the
extraction of the assembly formed of the conduit tubes 1 and the
indicator casing 2 from the outer cover member 4A, the indicator 3
is extracted from the indicator storage cylinder 2b of the
indicator casing 2, in the same way. Then, effective sterilization
is confirmed by checking for the change in color of the indicator
3. Note that an arrangement in which the indicator storage cylinder
2b of the indicator casing 2 is formed of transparent resin has the
advantage of allowing the change in color of the indicator 3 to be
checked from the outside of the indicator storage cylinder 2b of
the indicator casing 2 without a step for extracting the indicator
3, thereby effecting confirmation of effective sterilization.
[0073] As described above, the aforementioned second embodiment
offers the same advantages as those of the first embodiment
described above.
[0074] Note that the configuration of the outer cover member 4A of
the sterilization confirmation tester 10A according to the
aforementioned second embodiment is not restricted to such an
arrangement described above. For example, an arrangement may be
made in which the outer cover member 4A has a connection portion at
a certain position thereof which allows the outer cover member 4A
to be divided into two parts and which allows these two parts to be
connected with each other in a watertight manner so as to form the
outer cover member 4A. Such an arrangement allows the interior
space within the outer cover member 4A to be opened and closed as
desired. With such an arrangement, the aforementioned connection
portion needs to be formed with a watertight structure.
[0075] Such an arrangement has the advantage of allowing the
indicator 3 stored within the indicator casing 2 to be extracted
more rapidly after the sterilization, by dividing the outer cover
member 4A at the connection portion.
Third Embodiment
[0076] FIG. 5 and FIG. 6 are diagrams which show a third embodiment
of the present invention of these, FIG. 5 is a side cross-sectional
view which shows the schematic configuration of a sterilization
confirmation tester (corresponding to a conduit) according to the
present embodiment. FIG. 6 is a top view which shows the schematic
configuration of the sterilization confirmation tester shown in
FIG. 5, when viewed from the top side.
[0077] The third embodiment has generally the same configuration as
those of the aforementioned first and second embodiments, except
for the outer cover member. Accordingly, the same components as
those of the aforementioned first and second embodiments are
denoted by the same reference numerals, detailed description
thereof will be omitted, and description will be made below
regarding only the different components.
[0078] As shown in FIG. 5 and FIG. 6, a sterilization confirmation
tester 10B according to the present embodiment comprises the two
conduit tubes 1, the indicator casing 2, the indicator 3, and an
outer cover member 4B. Of these, the conduit tubes 1, the indicator
casing 2, and the indicator 3 are the same as those of the
aforementioned first and second embodiments.
[0079] The outer cover member 4B according to the present
embodiment has a configuration which allows an assembly formed of
the indicator casing 2 storing the indicator 3 and the two conduit
tubes 1 to be detachably stored therewithin, as shown in FIG. 5, in
the same way as with the aforementioned second embodiment.
Accordingly, as shown in FIG. 5, the components corresponding to
the conduit of an endoscope, i.e., the two conduit tubes 1 are
enclosed within the outer cover member 4B.
[0080] The aforementioned outer cover member 4B comprises: two
hemispherical shells 8a and 8b each of which has a flange 8d formed
at the perimeter thereof; two fasteners 6 for fastening and fixing
the two shells 8a and 8b via the flanges 8d of the two shells 8a
and 8b; two O-rings 7 which are watertight members, one of which is
introduced between the one fastener 6 and shell 8a and the other
one of which is introduced between the other fastener 6 and the
shell 8b, thereby providing a watertight seal between the one
fastener 6 and the shell 8a and between the other fastener 6 and
the shell 8b; a sheet 5 for mounting an assembly formed of the
aforementioned conduit tubes 1 and the indicator casing 2 within
the outer cover member 4B; and so forth.
[0081] The two shells 8a and 8b are formed of the same material as
that of a flexible hose, operating unit, and so forth (which
correspond to the conduit as described in the present embodiment)
of an endoscope, or a material exhibiting the same thermal
insulating performance as that of these components, e.g., resin
such as urethane, rubber, or the like, in the same way as with the
outer cover members 4 and 4A according to the aforementioned first
and second embodiments.
[0082] Of these shells, the shell 8a has two through holes 8c
formed at predetermined position on the outer face thereof. The
through holes 8c allow the proximal ends of the two conduit tubes 1
connected to the indicator casing 2 stored within the outer cover
member 4B to be detachably inserted thereinto through predetermined
watertight members (not shown). Such a state provides a watertight
seal between the conduit tube 1 and the through hole 8c.
[0083] With such an arrangement, the aforementioned two shells 8a
and 8b are assembled into an approximately spherical structure with
the sheet 5 interposed between the opposing flanges 8d. In this
state, these flanges 8d are pressed to correspond to each other by
the fasteners 6 with the O-rings 7 introduced therebetween, thereby
ensuring that the interior space within the outer cover member 4B
is watertight.
[0084] Each of the fasteners 6 is formed in a channel-shaped
(C-shaped) cross-section and is formed of an elastic member. The
fasteners 6 are provided for fastening the flanges 8d of the two
shells 8a and 8b, thereby ensuring that the interior space within
the aforementioned outer cover member 4B is watertight, as
described above. With such an arrangement, the shells 8a and 8b are
fastened and fixed by the fasteners 6 at a minimum of two positions
on the perimeter of each flange 8d. Accordingly, at least two
fasteners 6 are provided. The other components are the same as
those of the aforementioned first and second embodiments.
[0085] Description will be made below regarding the operation of
the sterilization confirmation tester 10B having such a
configuration according to the present invention for confirming
effective sterilization.
[0086] First, the indicator 3 is installed within the indicator
casing 2 of the sterilization confirmation tester 10B in the same
way as with the first and second embodiments.
[0087] The proximal ends of the conduit tubes 1 connected to both
ends of the indicator casing 2 within which the indicator 3 has
been installed are each inserted into the through holes 8c formed
on the shell 8a.
[0088] Next, the two shells 8a and 8b are joined to each other with
the sheet 5 introduced therebetween. Furthermore, the shells 8a and
8b are fastened and fixed by the fasteners 6 at predetermined
position (two positions) on the flanges 8d of the shells 8a and 8b
with the O-rings 7 introduced therebetween. Thus, the assembly
formed of the conduit tubes 1 and the indicator casing 2 is stored
within the outer cover member 4B. This ensures that the interior of
the outer cover member 4B is watertight.
[0089] The sterilization confirmation tester 10B in such a state is
installed within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the indicator casing 2 from the through hole 8c formed on the shell
8a through the conduit tube 1. Then, the sterilization agent passes
through the conduit tube 1, and acts upon the indicator 3 stored in
the indicator casing 2.
[0090] After this sterilization step, the sterilization
confirmation tester 10B is extracted from the sterilization
apparatus, and confirmation of effective sterilization is made.
Now, let us consider a case of employing a biological indicator as
the indicator 3. In this case, first, the fasteners 6 are detached
so as to separate the shells 8a and 8b from one another, and the
assembly formed of the conduit tubes 1 and the indicator casing 2
is extracted from the interior of the outer cover member 4B in a
sterile environment.
[0091] Subsequently, the indicator 3 is extracted from the
indicator storage cylinder 2b of the indicator casing 2 in this
sterile environment, and is introduced into a predetermined culture
medium. After the culturing step, effective sterilization is
confirmed based upon whether or not bacteria appear on the culture
medium.
[0092] On the other hand, let us consider a case of employing a
chemical indicator as the indicator 3. In this case, after the
extraction of the assembly formed of the conduit tubes 1 and the
indicator casing 2 from the outer cover member 4B, the indicator 3
is extracted from the indicator storage cylinder 2b of the
indicator casing 2, in the same way. Then, effective sterilization
is confirmed by checking for the change in color of the indicator
3. Note that an arrangement in which the indicator storage cylinder
2b of the indicator casing 2 is formed of transparent resin has the
advantage of allowing the change in color of the indicator 3 to be
checked from the outside of the indicator storage cylinder 2b of
the indicator casing 2 without a step for extracting the indicator
3, thereby effecting confirmation of effective sterilization.
[0093] As described above, the aforementioned third embodiment
offers the same advantages as that of the first and second
embodiments described above.
[0094] Description has been made regarding an arrangement in which
the spherical shells 8a and 8b are assembled into the approximately
spherical outer cover member 4B. The present invention is not
restricted to such an arrangement. Also, an arrangement may be made
as described below.
Fourth Embodiment
[0095] FIG. 7 and FIG. 8 are diagrams which show a fourth
embodiment of the present invention. Of these, FIG. 7 is a side
cross-sectional view which shows the schematic configuration of a
sterilization confirmation tester (corresponding to a conduit)
according to the present embodiment. FIG. 8 is a top view which
shows the schematic configuration of the sterilization confirmation
tester shown in FIG. 7, when viewed from the top side.
[0096] The fourth embodiment has generally the same configuration
as that of the aforementioned third embodiment, except for the
structure of the outer cover member and the fasteners thereof.
Accordingly, the same components as those of the aforementioned
third embodiment are denoted by the same reference numerals,
detailed description thereof will be omitted, and description will
be made below regarding only the different components.
[0097] As shown in FIG. 7 and FIG. 8, a sterilization confirmation
tester 10C according to the present embodiment comprises the two
conduit tubes 1, the indicator casing 2, the indicator 3, and an
outer cover member 4C. Of these, the conduit tubes 1, the indicator
casing 2, and the indicator 3 are the same as those of the
aforementioned first through third embodiments.
[0098] The outer cover member 4C according to the present
embodiment has a configuration which allows an assembly formed of
the indicator casing 2, storing the indicator 3, and the two
conduit tubes 1 to be detachably stored therewithin, as shown in
FIG. 7, in the same way as with the aforementioned second and third
embodiment. Accordingly, as shown in FIG. 7, the components
corresponding to the conduit of an endoscope, i.e., the two conduit
tubes 1 are enclosed within the outer cover member 4C.
[0099] The aforementioned outer cover member 4C comprises: two
box-shaped shells 11a and 11b each of which has an opening on one
side thereof and a flange 11d formed around the perimeter of the
opening; two bolts 9 which are fasteners for fastening and fixing
the flanges 11d of the two shells 11a and 11b; the sheet 5, which
is interposed between the aforementioned two shells 11a and 11b,
for mounting an assembly formed of the aforementioned conduit tubes
1 and the indicator casing 2 within the outer cover member 4C; the
two O-rings 7 which are watertight members, one of which is
introduced between the aforementioned sheet 5 and the shell 11a and
the other one of which is introduced between the sheet 5 and the
shell 11b, thereby providing a watertight seal between the
aforementioned sheet 5 and the shell 11a and between the sheet 5
and the shell 11b; and so forth.
[0100] The two shells 11a and 11b are formed of the same material
as that of a flexible hose, operating unit, and so forth (which
correspond to the conduit as described in the present embodiment)
of an endoscope for example, or a material exhibiting the same
thermal insulating performance as that of these components, e.g.,
resin such as urethane, rubber, or the like, in the same way as
with the outer cover members 4, 4A, and 4B according to the
aforementioned first through third embodiments.
[0101] Of these shells, the shell 11a has two through holes 11c
formed at predetermined position on the outer face thereof. The
through holes 11c allow the proximal ends of the two conduit tubes
1 connected to the indicator casing 2 stored within the outer cover
member 4C to be detachably inserted thereinto via predetermined
watertight members (not shown). Such a state provides a watertight
seal between the conduit tube 1 and the through hole 11c.
[0102] With such an arrangement, the aforementioned two shells 11a
and 11b are assembled into an approximately box-shaped structure
with the sheet 5 interposed between the opposing flanges 11d. In
this state, these flanges 11d are pressed into contact with each
other by the bolts 9 with the O-rings 7 introduced therebetween,
thereby ensuring that the interior space within the outer cover
member 4C is watertight.
[0103] With the present embodiment, there are at least two
(preferably four) fastening/fixing portions at the perimeter of the
flange 11d as shown in FIG. 8. Accordingly, at least two (or four)
bolts 9 are provided. The other components are the same as those of
the aforementioned first and second embodiments.
[0104] Description will be made below regarding the operation of
the sterilization confirmation tester 10C having such a
configuration according to the present embodiment for confirming
effective sterilization.
[0105] First, the indicator 3 is installed within the indicator
casing 2 of the sterilization confirmation tester 10C in the same
way as with the first through third embodiments.
[0106] The proximal ends of the conduit tubes 1 connected to both
ends of the indicator casing 2, within which the indicator 3 has
been installed, are each inserted into the through holes 11c formed
on the shell 11a.
[0107] Next, the two shells 11a and 11b are joined to each other
with the sheet 5 introduced therebetween. Furthermore, the shells
11a and 11b are fastened by the bolts 9 at predetermined position
(four positions) on the flanges 11d of the shells 11a and 11b with
the O-rings 7 introduced therebetween. Thus, the assembly formed of
the conduit tubes 1 and the indicator casing 2 is stored within the
outer cover member 4C. This ensures that the interior of the outer
cover member 4C is watertight.
[0108] The sterilization confirmation tester 10C in such a state is
installed within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the indicator casing 2 from the through hole 11c formed on the
shell 11a through the conduit tube 1. Then, the sterilization agent
passes through the conduit tube 1, and acts upon the indicator 3
stored in the indicator casing 2.
[0109] After this sterilization step, the sterilization
confirmation tester 10C is extracted from the sterilization
apparatus, and confirmation of effective sterilization is made.
Now, let us consider a case of employing a biological indicator as
the indicator 3. In this case, first, the bolts 9 are detached so
as to separate the shells 11a and 11b from one another, and the
assembly formed of the conduit tubes 1 and the indicator casing 2
is extracted from the interior of the outer cover member 4C in a
sterile environment.
[0110] Subsequently, the indicator 3 is extracted from the
indicator storage cylinder 2b of the indicator casing 2 in this
sterile environment, and is introduced into a predetermined culture
medium. After the culturing step, effective sterilization is
confirmed based upon whether or not bacteria appear on the culture
medium.
[0111] On the other hand, let us consider a case of employing a
chemical indicator as the indicator 3. In this case, after the
extraction of the assembly formed of the conduit tubes 1 and the
indicator casing 2 from the outer cover member 4C, the indicator 3
is extracted from the indicator storage cylinder 2b of the
indicator casing 2, in the same way. Then, effective sterilization
is confirmed by checking for the change in color of the indicator
3. Note that an arrangement in which the indicator storage cylinder
2b of the indicator casing 2 is formed of transparent resin has the
advantage of allowing the change in color of the indicator 3 to be
checked from the outside of the indicator storage cylinder 2b of
the indicator casing 2 without a step for extracting the indicator
3, thereby effecting confirmation of effective sterilization.
[0112] As described above, the aforementioned fourth embodiment
offers the same advantages as those of the first through third
embodiments described above.
[0113] Note that the sheet 5 according to the aforementioned third
and fourth embodiments may be formed in an approximately circular
shape, for example. Also, the sheet 5 may be formed in the shape of
a square, rectangle, triangle, or the like. Also, the sheet 5 may
be formed in an easily usable shape as necessary.
[0114] The sterilization confirmation testers (10, 10A, 10B, 10C),
which are exemplary arrangements according to the aforementioned
first through fourth embodiments, are formed in a shape
corresponding to the conduit of an endoscope (see FIG. 1 through
FIG. 8).
[0115] A sterilization confirmation tester according to an
embodiment described below is an arrangement which corresponds to
at least one of the components forming a endoscope, e.g., an
arrangement which corresponds to a structure for mounting the
operating lever of an operating unit to an operating main unit of
the endoscope.
Fifth Embodiment
[0116] FIG. 9 and FIG. 10 are diagrams which show a fifth
embodiment of the present invention. Of these, FIG. 9 is a side
view which shows the schematic configuration of a sterilization
confirmation tester (corresponding to an operating unit) according
to the present embodiment. FIG. 10 is a perspective view which
shows only an indicator casing which is one of the components of
the sterilization confirmation tester according to the present
embodiment.
[0117] A sterilization confirmation tester 10D according to the
present embodiment comprises: an indicator casing 2D for installing
the indicator 3 having the same structure as that employed in the
aforementioned first through fourth embodiments; and a holder 12
for holding the indicator casing 2D.
[0118] A sterilization confirmation tester 10D according to the
present embodiment is for confirming effective sterilization of a
sterilization apparatus. The sterilization confirmation tester 10D
has a structure which corresponds to at least one of the components
of an endoscope, i.e., which corresponds to the contact faces of a
main unit member and a lever member of the operating unit of the
endoscope.
[0119] The indicator casing 2D is formed in a cylindrical shape
having an opening at one end thereof, and has a flange 2Da around
the perimeter of the opening. The indicator casing 2D is formed of
a material equivalent to that of the operating unit and so forth of
an endoscope, e.g., resin such as polysulfone resin or the like,
metal such as stainless steel or the like, or the like.
Furthermore, the indicator casing 2D is configured so as to allow
the indicator 3 to be installed at a predetermined position on the
inner wall of the indicator casing 2D.
[0120] The holder 12 has a channel-shaped (C-shaped) cross-section,
and is formed of the same material as that of the aforementioned
indicator casing 2D, i.e., the material equivalent to that of the
operating unit and so forth of an endoscope, e.g., resin such as
polysulfone resin or the like, metal such as stainless steel or the
like, or the like.
[0121] Furthermore, a protrusion 12a is provided on the wall face
12a, which is an inner face of the bottom wall of the holder 12, so
as to protrude toward the opposite wall face 12c. The protrusion
12a is formed of an elastic member having such a height that it
provides a gap between the top of the protrusion 12a and the wall
face 12c which is somewhat smaller than the height of the indicator
casing 2D. Such an arrangement allows the indicator casing 2D to be
held with the outer face of the bottom thereof being pressed by the
protrusion 12a in the direction X1 indicated by the arrow in FIG.
9. At this stage, the indicator casing 2D is situated in a space
between the opposing wall face 12c and the top of the protrusion
12a of the holder 12 as shown in FIG. 9. In this state, the
indicator casing 2D is held with the face 2Db of the flange 2Da
thereof being in contact with the opposing wall face 12c of the
holder 12.
[0122] The contact faces of the indicator casing 2D and the holder
12 are formed with a surface roughness equivalent to that of the
contact faces where a lever member, which is a component of the
operating lever of the operating unit of an endoscope, and a main
unit member, which is a component of the endoscope main unit, are
in contact with each other.
[0123] Description will be made below regarding the operation of
the sterilization confirmation tester 10D having such a
configuration according to the present embodiment for confirming
effective sterilization.
[0124] First, the indicator casing 2 storing the indicator 3 is
mounted at a predetermined position of the holder 12, i.e., in a
space between the opposing wall face 12c and the top of the
protrusion 12a of the holder 12 as shown in FIG. 9.
[0125] Next, the sterilization confirmation tester 10D is installed
within a given sterilization apparatus (not shown), and
sterilization treatment is executed. As a result, a sterilization
agent such as ethylene oxide gas, steam, or the like, is introduced
into the interior of the indicator casing 2D from a slight gap in
the contact portion where the opposing wall face 12c of the holder
12 and the face 2Db of the flange 2Da of the indicator casing 2D
are pressed into contact therewith. Then, the sterilization agent
acts upon the indicator 3 stored in the indicator casing 2.
[0126] After this sterilization step, the sterilization
confirmation tester 10D is extracted from the sterilization
apparatus, and confirmation of effective sterilization is made.
Now, let us consider a case of employing a biological indicator as
the indicator 3. In this case, first, the indicator casing 2D is
extracted from the holder 12 in a sterile environment.
[0127] Subsequently, the indicator 3 is extracted from the
indicator casing 2 in this sterile environment, and is introduced
into a predetermined culture medium. After the culturing step,
effective sterilization is confirmed based upon whether or not
bacteria appear on the culture medium.
[0128] On the other hand, let us consider a case of employing a
chemical indicator as the indicator 3. In this case, after the
extraction of the indicator casing 2D from the holder 12 in the
same way, the change in color of the indicator 3 is checked for
through the opening of the indicator casing 2D, thereby making
confirmation of sterilization results.
[0129] With the above fifth embodiment as described above, the
sterilization confirmation tester 10D is formed with a structure
which is a simulation of a gap which typically occurs between the
operating lever of the operating unit and the endoscope main unit
of the endoscope and so forth. This provides confirmation of
effective sterilization at a corresponding portion of an endoscope
with high reliability.
[0130] The sterilization confirmation tester 10D can also be
applied to other cases, as well as a case described in the
aforementioned fifth embodiment. Now, let us consider a case in
which the effective sterilization of a treatment tool (not shown)
or the like used together with the endoscope, for example, is
confirmed using the sterilization confirmation tester 10D according
to the present embodiment. In this case, this confirmation of
effective sterilization can be made simply by using the holder 12
and the indicator casing 2D having the contact faces with a surface
roughness equivalent to that of the contact faces of this treatment
tool.
[0131] By the way, description has been made in the above first
through fifth embodiments regarding exemplary arrangements of the
sterilization confirmation tester which is a simulation of a
predetermined portion of an endoscope. Such an arrangement requires
that confirmation operations (sterilization confirmation test),
including installation of each sterilization confirmation tester
and confirmation thereof, should be performed for each
sterilization confirmation tester.
[0132] Accordingly, an arrangement which has a function of allowing
sterilization and subsequent confirmation of effective
sterilization to be performed all at the same time and with respect
to various kinds of sterilization confirmation testers
corresponding to various portions of an endoscope, would be very
convenient. Next, description will be made regarding a test pack
having a function of storing multiple sterilization confirmation
testers having structures corresponding to two different components
of an endoscope according to an embodiment.
Sixth Embodiment
[0133] FIG. 11 is a diagram which shows a sixth embodiment of the
present invention, and is an external view which shows a test pack
storing two sterilization confirmation testers having structures
corresponding to two different components of an endoscope.
[0134] A test pack 20 according to the present embodiment is formed
in an approximately bag-like shape for storing multiple
sterilization confirmation testers. For example, the test pack 20
is formed of a sterilization peel pack or the like, for example.
Here, the peel pack as used here represents a packaging member
having a function of allowing air such as vapor or the like to pass
therethrough while preventing liquid and bacteria from passing
therethrough, which has been widely employed as a conventional
packaging member in the field of medical devices.
[0135] Furthermore, a tearable portion 20a, formed in the shape of
a perforated line for example, is provided at one of the four
corners of the test pack 20. The tearable portion 20a is provided
for facilitating opening of the test pack 20.
[0136] The test pack 20 is configured so as to allow at least two
sterilization confirmation testers to be stored as shown in FIG.
11. With such an arrangement, each sterilization confirmation
tester, which is to be stored in this test pack 20, has a structure
corresponding to at least one of the components of the
endoscope.
[0137] Specifically, FIG. 11 shows a state in which the
aforementioned test pack 20 simultaneously stores the sterilization
confirmation tester 10 according to the aforementioned first
embodiment, i.e., a tester corresponding to a conduit of the
endoscope, and the sterilization confirmation tester 10D according
to the aforementioned fifth embodiment, i.e., a tester which is a
simulation of the gap between the contact faces of the operating
lever of the operating unit of the endoscope and the endoscope main
unit.
[0138] Description will be made regarding the operations including
simultaneous sterilization treatment for multiple sterilization
confirmation testers and subsequent confirmation of effective
sterilization, using the test pack 20 having such a configuration.
First, the two sterilization confirmation testers 10 and 10D having
different structures as described above are stored within the test
pack 20, and the test pack 20 is sealed.
[0139] This test pack 20 is installed within a given sterilization
apparatus (not shown), and sterilization treatment is executed. As
a result, a sterilization agent such as ethylene oxide gas, steam,
or the like, is introduced into the interior of the test pack 20.
Then, the sterilization agent acts upon the indicators 3 stored in
the indicator casings 2 and 2D of the sterilization confirmation
testers 10 and 10D.
[0140] After this sterilization step, the sterilization
confirmation testers 10 and 10D are extracted from the
sterilization apparatus, and confirmation of effective
sterilization is made. Now, let us consider a case of employing
biological indicators as the indicators 3. In this case, first, the
test pack 20 is opened by being torn along the tearable portion 20a
of the test pack 20, the sterilization confirmation testers 10 and
10D are extracted from the test pack 20, and the indicators 3 are
extracted therefrom, in a sterile environment.
[0141] Subsequently, each indicator 3 thus extracted is introduced
into a predetermined culture medium. After the culturing step,
effective sterilization is confirmed based upon whether or not
bacteria appear on the culture medium.
[0142] On the other hand, let us consider a case of employing
chemical indicators as the indicators 3. In this case, each
indicator 3 is extracted from the indicator storage cylinder 2b of
the indicator casing 2, and effective sterilization is confirmed by
checking for the change in color of the indicator 3. Note that an
arrangement in which the indicator storage cylinder 2b of the
indicator casing 2 is formed of transparent resin has the advantage
of allowing the change in color of the indicator 3 of the
sterilization confirmation tester 10 to be checked from the outside
without a step for extracting the indicator 3, thereby effecting
confirmation of effective sterilization. In particular, for the
indicator 3 of the sterilization confirmation tester 10, such an
arrangement provides the advantage of allowing the confirmation of
effective sterilization to be made without opening the test pack
20. On the other hand, with regard to the indicator 3 of the
sterilization confirmation tester 10D, after the extraction of the
sterilization confirmation tester 10D from the opened test pack 20,
the indicator casing 2D is extracted from the holder 12. Then, the
change in color of the indicator 3 is checked for through the
opening of the indicator casing 2D, thereby confirming effective
sterilization.
[0143] With the above sixth embodiment as described above, the
sterilization treatment and the subsequent confirmation of
effective sterilization can be performed simultaneously for
multiple different testers. This means that there is no need to
perform a series of confirmation operations for each tester,
thereby improving the efficiency of the confirmation
operations.
[0144] And now, description has been made regarding the indicator
casing 2 according to the above first through fourth embodiments,
which comprises the indicator storage cylinder 2b and the two caps
2a detachably provided to both ends thereof, as described above.
Description will be made regarding the indicator casing 2 having
another structure according to an embodiment, which is employed
instead of the indicator casing 2 according to the above first
through fourth embodiments.
Seventh Embodiment
[0145] Specifically, FIG. 12 and FIG. 13 show a seventh embodiment
according to the present invention. Of these, FIG. 12 is an
external view of an indicator casing of a sterilization
confirmation tester. On the other hand, FIG. 13 is an external view
which shows a state in which the indicator casing shown in FIG. 12
has been opened.
[0146] An indicator casing 2E according to the present embodiment
has generally the same configuration as that of the indicator
casing 2 employed in the sterilization confirmation tester
according to the aforementioned first through fourth embodiments,
except that the structure of an indicator storage cylinder 2Eb is
somewhat different. Accordingly, the same components as those of
the aforementioned first through fourth embodiments are denoted by
the same reference numerals, detailed description thereof will be
omitted, and description will be made below regarding only the
different components.
[0147] As shown in FIG. 12, the indicator casing 2E comprises the
indicator storage cylinder 2Eb and the two caps 2a integrally
provided to both ends thereof.
[0148] With such an arrangement, the proximal ends 1a of the two
conduit tubes 1 are each detachably connected to the tip ends of
the two caps 2a in a watertight manner.
[0149] Furthermore, each of the two caps 2a and the indicator
storage cylinder 2Eb are integrally connected with each other in a
watertight manner.
[0150] Furthermore, a separatable portion 2Ec, which is separating
means, is formed at around the center of the indicator storage
cylinder 2Eb, which allows the indicator storage cylinder 2Eb to be
separated into two parts by simply applying a certain amount of
force. The separatable portion 2Ec is provided at a desired
position on the outer face of the indicator storage cylinder 2Eb in
the form of a perforated line or the like, for example.
[0151] Accordingly, upon applying a predetermined, or greater,
amount of force to the indicator storage cylinder 2Eb in the
direction where the indicator storage cylinder 2Eb is to be bent
with the separatable portion 2Ec as a fulcrum, i.e., in the
direction A indicated by the arrow in FIG. 12, the indicator
storage cylinder 2Eb comes to be separated along the separatable
portion 2Ec, thereby forming an openings 2Ed (see FIG. 13), which
allows the object stored within, such as the indicator 3 or the
like to be extracted. That is to say, the indicator casing 2E
includes the separatable portion 2Ec having a function of
separating the indicator casing 2E into two parts so as to form
openings upon receipt of a predetermined amount of force.
[0152] Furthermore, a watertight seal 13 is adhered to the
separatable portion 2Ec, thereby ensuring that the indicator casing
2E is watertight. The other components are generally the same as
those of the aforementioned first embodiment.
[0153] Description will be made below regarding the operations for
confirmation of effective sterilization using the sterilization
confirmation tester including the aforementioned indicator casing
2E having such a configuration.
[0154] First, the indicator 3 is installed within the indicator
casing 2E. Then, the watertight seal 13 is adhered to the
separatable portion 2Ec.
[0155] The sterilization confirmation tester including the
aforementioned indicator casing 2E having such a configuration is
installed within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the conduit tube 1 from the opening thereof (1c, see FIG. 1). Then,
the sterilization agent passes through the conduit tube 1, and acts
upon the indicator 3 stored in the indicator casing 2E.
[0156] After this sterilization step, the sterilization
confirmation tester is extracted from the sterilization apparatus,
and confirmation of effective sterilization is made. Now, let us
consider a case of employing a biological indicator as the
indicator 3. In this case, first, force is applied to the indicator
casing 2E with the separatable portion 2Ec as a fulcrum, in the
direction A indicated by the arrow in FIG. 12 such that the
indicator casing 2E is separated into two parts in a sterile
environment as shown in FIG. 13. Subsequently, the indicator 3 is
extracted from the indicator casing 2E through the opening 2Ed.
Then, the indicator 3 is introduced into a predetermined culture
medium. After the culturing step, effective sterilization is
confirmed based upon whether or not bacteria appear on the culture
medium.
[0157] In a case where the same confirmation test of the
sterilization treatment is repeatedly performed, after a new
indicator 3 is installed within the indicator casing 2E, a
structure is formed with the openings 2Ed of the indicator storage
cylinder 2Eb paired at the separatable portion 2Ec. Then, the
watertight seal 13 is adhered to the separatable portion 2Ec. The
subsequent procedure is the same as that described above.
[0158] Also, a chemical indicator may be employed as the indicator
3. In this case, an arrangement employing the transparent indicator
storage cylinder 2Eb has the advantage of allowing the change in
color of the indicator 3 to be checked without a step for
extracting the indicator 3 from the indicator storage cylinder 2Eb,
thereby effecting confirmation of effective sterilization. Note
that the same confirmation test of the sterilization treatment may
be repeatedly performed. In this case, first, the indicator storage
cylinder 2Eb is separated into two parts at the separatable portion
2Ec, and a new indicator 3 is installed in the indicator storage
cylinder 2Eb. Then, the watertight seal 13 is adhered to the
separatable portion 2Ec. The subsequent operations are the same as
described above.
[0159] With the aforementioned seventh embodiment as described
above, the separatable portion 2Ec allows the indicator storage
cylinder 2Eb to be separated into two parts simply by applying a
predetermined amount of force to a predetermined portion of the
indicator storage cylinder 2Eb of the indicator casing 2E in the
direction where the indicator storage cylinder 2Eb is to be bent.
This facilitates installation/extraction of the indicator 3
into/from the indicator casing 2E, thereby reducing the operating
time.
[0160] In a case where a biological indicator is employed as the
indicator 3, the indicator 3 needs to be extracted from the
interior of the indicator casing 2E in a sterile environment. The
present embodiment enables the operation for extracting the
indicator 3 to be executed in a simple and sure manner. This
suppresses error in confirmation of effective sterilization,
thereby improving the precision of the confirmation of effective
sterilization.
Eighth Embodiment
[0161] And now, in a case where a biological indicator is employed
as the indicator 3, the operations in a sterile environment for
confirming effective sterilization are required.
[0162] Accordingly, an arrangement, which has a function of
enabling the indicator 3 to be introduced into a predetermined
culture medium in a sterile environment in a simple manner while
allowing the user to remain in a space other than the sterilization
environment, would be every convenient.
[0163] FIG. 14 and FIG. 15 show an eighth embodiment according to
the present invention. Of these, FIG. 14 is an external view of an
indicator casing of a sterilization confirmation tester including a
culture medium. On the other hand, FIG. 15 is an external view
which shows a state in which the indicator casing shown in FIG. 14
has been opened.
[0164] An indicator casing 2F according to the present embodiment
has generally the same configuration as that of the indicator
casing 2E employed in the sterilization confirmation tester
according to the aforementioned seventh embodiment, except that the
indicator casing 2F aseptically and integrally includes a culture
medium used for a culturing step for a biological indicator
employed as the indicator 3. Accordingly, the same components as
those of the aforementioned seventh embodiment are denoted by the
same reference numerals, detailed description thereof will be
omitted, and description will be made below regarding only the
different components.
[0165] As shown in FIG. 14, the indicator casing 2F comprises the
indicator storage cylinder 2Fb, the two caps 2a integrally provided
to both ends thereof, and a culture medium bag 15 including a
culture medium 14.
[0166] Furthermore, a separatable portion 2Fc, which is separating
means, is formed at around the center of the indicator storage
cylinder 2Eb, which allows the indicator storage cylinder 2Eb to be
separated into two parts simply by applying a certain amount of
force, in the same way as with the aforementioned seventh
embodiment. Furthermore, the watertight seal 13 is adhered to the
separatable portion 2Fc, thereby ensuring that the interior thereof
is watertight, in the same way as with the aforementioned seventh
embodiment.
[0167] Furthermore, the indicator storage cylinder 2Fb integrally
includes the aforementioned culture medium bag 15 in a watertight
manner. The culture medium bag 15 is formed of a transparent resin
film or the like, for example. Furthermore, the culture medium bag
15 is formed having a size margin which ensures that the culture
medium bag 15 does not tear due to tension or the like even in the
state shown in FIG. 15, i.e., in the state in which the indicator
storage cylinder 2Fb has been separated into two parts at the
separatable portion 2Fc. With such an arrangement, upon separating
the indicator storage cylinder 2Fb into two parts, the culture
medium bag 15 covers the portions where the indicator storage
cylinder 2Fb has been opened, in a watertight manner, and provides
a culture medium for the biological indicator, as described later.
Note that the culture medium bag 15 may have a mechanism for
activating the culture medium 14.
[0168] Furthermore, the indicator casing 2F has a vent hole 2Fd
formed at a portion which is to be covered with the watertight seal
13, around the separatable portion 2Fc of the indicator storage
cylinder 2Fb, thereby forming a communicating passage between the
inside and the outside of the indicator storage cylinder 2Fb.
Furthermore, a filter 16 is provided to the vent hole 2Fd, which
allows only air to pass therethrough while preventing bacteria,
dust, and the like which are present in the surrounding area from
passing therethrough, for example. The other components are
generally the same as those of the first embodiment described
above.
[0169] Description will be made below regarding the operations for
confirmation of effective sterilization using the sterilization
confirmation tester including the aforementioned indicator casing
2F having such a configuration.
[0170] First, the indicator 3 is installed within the indicator
casing 2F in the same way as with the aforementioned seventh
embodiment. Then, the watertight seal 13 is adhered to the
separatable portion 2Fc, thereby ensuring that the separatable
portion 2Fc is watertight.
[0171] The sterilization confirmation tester including the
aforementioned indicator casing 2F having such a configuration is
installed within a given sterilization apparatus (not shown), and
sterilization treatment is executed according to a predetermined
procedure. As a result, a sterilization agent such as ethylene
oxide gas, steam, or the like, is introduced into the interior of
the conduit tube 1 from the opening thereof (1c, see FIG. 1). Then,
the sterilization agent passes through the conduit tube 1, and acts
upon the indicator 3 stored in the indicator casing 2F.
[0172] After this sterilization step, the sterilization
confirmation tester is extracted from the sterilization apparatus,
and confirmation of effective sterilization is made. With the
present embodiment, a biological indicator is employed as the
indicator 3. In this case in which a biological indicator is
employed as the indicator 3, first, a predetermined amount of force
is applied to a predetermined portion of the indicator storage
cylinder 2Fb of the indicator casing 2F in the same way as with the
aforementioned seventh embodiment. As a result, the indicator
storage cylinder 2Fb is separated into two parts as shown in FIG.
15, whereupon the indicator 3 is introduced into the culture medium
14 through the opening.
[0173] Then, the watertight seal 13 is peeled off, whereupon the
vent hole 2Fd is exposed. This allows air, which is necessary for
culturing bacteria, to be introduced into the interior of the
culture bag 15 through the conduit tube 1 and the vent hole 2Fd,
while the indicator storage cylinder 2Fb remains closed.
[0174] The sterilization confirmation tester in this state is
installed in an incubator or the like, and cultivation is performed
at a constant temperature for a predetermined period of time.
Subsequently, effective sterilization is confirmed based upon
whether or not bacteria appear on the culture medium.
[0175] Specifically, in the event that a bacterial culture does not
appear after the culturing, due to the absence of bacteria on the
indicator 3 introduced into the culture medium 14 in the culture
medium bag 15, determination is made that sterilization has been
properly performed.
[0176] As described above, the aforementioned eighth embodiment
allows the culturing treatment to be performed for a biological
indicator after sterilization treatment in a simple manner without
involving special operations in a sterile environment. This permits
easier sterilization treatment. At the same time, this ensures that
the indicator 3 is in a sterilization state at all times throughout
the step in which the indicator 3 is introduced into the culture
medium 14 without any particular need to be concerned about whether
or not a sterilization environment is maintained. This eliminates a
cause of error in confirmation of effective sterilization.
Accordingly, this reduces the operating time and improves the
precision of the confirmation.
[0177] The first through eighth embodiments described above provide
a sterilization confirmation tester and a test pack, which are
configured so as to correspond to a medical device having a
particular structure such as an endoscope or the like, thereby
allowing confirmation of effective sterilization to be made for the
endoscope or the like in a sure and simple manner.
Ninth Embodiment
[0178] FIG. 16 through FIG. 19 show a sterilization confirmation
tester according to a ninth embodiment of the present invention.
FIG. 16 and FIG. 17 are perspective views which show the schematic
configuration of the sterilization confirmation tester. FIG. 16
shows the sterilization confirmation tester at its a basic length.
FIG. 17 shows the sterilization confirmation tester at a modified
length. FIG. 18 and FIG. 19 are cross-sectional views along line
XVIII-XVIII in FIG. 16 and line XIX-XIX line in FIG. 17,
respectively, each of which shows the sterilization confirmation
tester. FIG. 18 shows the sterilization confirmation tester in a
state corresponding to the state shown in FIG. 16. FIG. 19 shows
the sterilization confirmation tester in a state corresponding to
the state shown in FIG. 17.
[0179] As shown in FIG. 16, a sterilization confirmation tester 101
according to the present embodiment is configured so that it can be
stored in a sterilization apparatus. The sterilization confirmation
tester 101 includes two conduit simulation portions (first and
second conduit simulation portions 101A1 and 101A2) having
structures corresponding to the conduits of a medical device. With
such an arrangement, the first and second conduit simulation
portions 101A1 and 101A2 are configured such that the lengths
thereof can be adjusted in the longitudinal direction.
[0180] Specifically, the aforementioned sterilization confirmation
tester 101 includes a first and second conduit body 101A and 103
including the aforementioned first and second conduit simulation
portions 101A1 and 101A2 therewithin. With such an arrangement, the
second conduit body 103 is slidably mounted within the first
conduit body 101A. Such an arrangement allows the lengths of the
aforementioned first and second conduit simulation portions 101A1
and 101A2 to be adjusted in the longitudinal direction by sliding
the second conduit body 103 relative to the first conduit body
101A.
[0181] As shown in FIG. 18, the aforementioned first conduit
simulation portion 101A1 includes a conduit portion 102a included
in the first conduit body 101A and a conduit portion 105a included
in the second conduit body 103 as described below. On the other
hand, the aforementioned second conduit simulation portion 101A2
includes a conduit portion 102b included in the first conduit body
101A and a conduit portion 105b included in the second conduit body
103 as described later.
[0182] Now, description will be made regarding the structures of
the aforementioned first and second conduit bodies 101A and
103.
[0183] The aforementioned first conduit body 101A includes a
conduit portion 102 which forms a part of the aforementioned first
conduit simulation portion 101A1 and a part of the aforementioned
second conduit simulation portion 101A2. The conduit portion 102
includes the two conduit portions 102a and 102b having different
diameters, for example. In this case, one of these conduit
portions, the conduit portion 102a corresponds to the
aforementioned first conduit portion 101A1. The other conduit
portion, i.e., the conduit portion 102b corresponds to the
aforementioned second conduit simulation portion 101A2.
[0184] While description has been made in the present embodiment
regarding an arrangement in which the aforementioned conduit
portion 102 includes the conduit portions 102a and 102b having
different diameters, the present invention is not restricted to
such an arrangement. Also, an arrangement may be made in which the
conduit portion 102 includes the conduit portions 102a and 102b
having the same diameter. Also, an arrangement may be made in which
the conduit portion bifurcates. Also, the conduit portion 102 may
include only a single conduit portion, or may include multiple (two
or more) conduit portions.
[0185] On the other hand, the aforementioned second conduit body
103 is slidably mounted within the aforementioned first conduit
body 101A so as to allow the lengths of the conduit simulation
portions to be adjusted as desired in the longitudinal direction.
Furthermore, a ring-shaped elastic member 104b is attached to the
inner face of the first conduit body 101A on the base end side
which is in contact with the outer face of the second conduit body
103. The elastic member 104b maintains a watertight seal between
the inner face of the first conduit body 101A and the outer face of
the second conduit body 103 while allowing the second conduit body
103 to be moved in a sliding manner.
[0186] Accordingly, such an arrangement allows the aforementioned
first conduit body 101A or the aforementioned second conduit body
103 to be moved in a sliding manner from the state shown in FIG. 16
to the state shown in FIG. 17. As a result, with regard to the
aforementioned first conduit body 101A and second conduit body 103,
the lengths of the conduit bodies can be modified to the state
shown in FIG. 17 while the interior portion thereof remains
watertight by actions of the aforementioned elastic member
104b.
[0187] With such an arrangement, an elastic member 104a is
connected to the outer face of the aforementioned second conduit
body 103 on the tip side thereof as shown in FIG. 18. The elastic
member 104a can be moved integrally with the second conduit body
103. The elastic member 104a also maintains a watertight seal
between the aforementioned second conduit body 103 and first
conduit body 101A.
[0188] While description has been made in the present embodiment
regarding an arrangement in which the aforementioned elastic member
104b is attached to the first conduit body 101A side, the present
invention is not restricted to such an arrangement. Also, the
elastic member may be attached to the second conduit body 103 side.
Specifically, an arrangement may be made in which another elastic
member 104a is provided so as to provide a watertight seal between
the first conduit body 101A and the second conduit body 103.
[0189] On the other hand, the aforementioned second conduit body
103 includes a conduit portion 105 which forms a part of the
aforementioned first conduit simulation portion 101A1 and a part of
the aforementioned second conduit simulation portion 101A2 in the
same way as with the aforementioned conduit portion 102 of the
first conduit body 101A. With the present embodiment, the conduit
portion 102 includes the two conduit portions 102a and 102b having
different diameters. Accordingly, the aforementioned conduit
portion 105 includes the two conduit portions 105a and 105b which
communicate with the aforementioned conduit portions 102a and 102b,
respectively. With such an arrangement, one of these conduit
portions, the conduit portion 105a corresponds to the
aforementioned first conduit simulation portion 110A1. The other
conduit portion, i.e., the conduit portion 105b corresponds to the
aforementioned second conduit simulation portion 101A2.
[0190] These two conduit portions 105a and 105b are inserted into
the aforementioned two conduit portions 102a and 102b,
respectively, as shown in FIG. 18. Furthermore, the base ends of
these two conduit portions 105a and 105b are connected to the
aforementioned second conduit body 103. Furthermore, elastic
members 107 and 108 are connected to the tips thereof. These
elastic members 107 and 108 maintain a watertight seal between the
inner face of the conduit portion 102a and the outer face of the
conduit portion 105a and between the inner face of the conduit
portion 102b and the outer face of the conduit portion 105b,
respectively.
[0191] With such an arrangement, the base end of the aforementioned
conduit portion 105 is connected to the aforementioned second
conduit body 103. Accordingly, upon the second conduit body 103
being moved from the position shown in FIG. 18 to the position
shown in FIG. 19, the conduit portion 105 is moved from the
position shown in FIG. 18 to the position shown in FIG. 19. This
enables the lengths of the first and second conduit simulation
portions 101A1 and 101A2 to be modified.
[0192] Such an arrangement including the aforementioned conduit
portion 102 and conduit portion 105 allows the aforementioned
lengths to be modified while the interior thereof remains
watertight by actions of the elastic members 107 and 108. The
elastic members 107 and 108 are connected to the conduit portion
105 as described above. Accordingly, the elastic members 107 and
108 are moved integrally with the conduit portion 105.
[0193] Note that, with regard to the sterilization confirmation
tester 101 according to the present embodiment, the region 106
other than the conduit portion 102 of the first conduit body 101A
may be configured in the form of a cavity, or may be filled with a
certain material.
[0194] Furthermore, the aforementioned sterilization confirmation
tester 101 is formed so as to be simulation of a medical device
having conduits such as an endoscope or the like. Furthermore, CIs
(or BIs) 109 and 109a are installed in the interior spaces of the
aforementioned first conduit simulation portion 101A1 or the second
conduit simulation portion 101A2 (the interior spaces of the
conduit portions 102a and 105a, or the interior spaces of the
conduit portions 102b and 105b). Alternatively, the CIs (or BIs)
109 and 109a are installed in the interior spaces of the
aforementioned first conduit body 101A or the second conduit body
103 (the interior spaces of the conduit portions 102a and 102b, or
the interior spaces of the conduit portions 105a and 105b).
[0195] Furthermore, all the members employed in the aforementioned
sterilization confirmation tester 101 are formed of materials which
enable these members to be subjected to treatment in the
sterilization apparatus.
[0196] Next, description will be made regarding the operation of
the sterilization confirmation tester according to the present
embodiment with reference to FIG. 16 through FIG. 19.
[0197] It is assumed that confirmation of effective sterilization
is made using the sterilization confirmation tester 101 according
to the present embodiment after the sterilization treatment for a
predetermined medical device such as an endoscope or the like. In
this case, the CIs (or BIs) 109 and 109a are provided within the
aforementioned conduit portion 102 and conduit portion 105 forming
the aforementioned first and second conduit simulation portions
101A1 and 101A2 of the sterilization confirmation tester 101. In a
case that a BI is employed as an indicator, the BI needs to be
extracted in a sterile environment after the sterilization step.
Accordingly, the conduit tester itself may be sealed with a seal
pack or the like.
[0198] The operator adjusts the lengths of the first and second
conduit simulation portions 101A1 and 10A2 as necessary so as to
match the conduit length of the medical device to be tested, by
sliding the first conduit body 101A or the second conduit body
103.
[0199] After the adjustment of the lengths of the first and second
conduit simulation portions 101A1 and 101A2, the operator installs
the aforementioned sterilization confirmation tester 101 which is a
simulation of the conduit length of the medical device to be
tested, in the sterilization apparatus, and sterilization step is
executed according to a desired procedure.
[0200] For example, let us consider a case in which a steam
pressure sterilization apparatus is employed as the aforementioned
sterilization apparatus. In this case, steam infiltrates into the
conduit portion 102 and the conduit portion 105 of the first
conduit body 101A and the second conduit body 103. On the other
hand, let us consider a case in which a gas sterilization apparatus
is employed as the aforementioned sterilization apparatus. In this
case, gas infiltrates into the conduit portion 102 and the conduit
portion 105 of the first conduit body 101A and the second conduit
body 103.
[0201] After the sterilization step, the operator extracts the
aforementioned sterilization confirmation tester 101 from the
sterilization apparatus, and extracts the CIs (or BIs) 109 and 109a
from the conduit portion 102 or the conduit portion 105.
[0202] Then, in a case that the extracted indicator is a CI, the
operator determines the effectiveness of sterilization of the
aforementioned sterilization confirmation tester 101 according to a
predetermined criterion (whether or not the color of the CI has
changed, and so forth). In a case that the extracted indicator is a
BI, the operator extracts the BI in a sterile environment, and the
BI is introduced into a culture medium suitable for culturing.
Then, effective sterilization is confirmed based upon whether or
not a bacterial culture has appeared from the BI.
[0203] With such an arrangement, in the event that determination
has been made that the aforementioned sterilization tester 101 has
been sterilized, determination is made that the medical device to
be tested can be sterilized by the aforementioned sterilization
step. Conversely, in the event that determination has been made
that the aforementioned conduit simulation portion has not been
sterilized, determination is made that the medical device to be
tested cannot be sterilized by the aforementioned sterilization
step.
[0204] Note that, with the present embodiment, the medical device
to be tested may be installed in the sterilization apparatus along
with the aforementioned sterilization confirmation tester 101 at
the same time.
[0205] Also, with the present embodiment, the aforementioned
sterilization method is not restricted to high-pressure and
high-temperature steam sterilization (autoclave sterilization) or
EOG gas sterilization. Also, other sterilization methods may be
employed. In this case, there is a need to employ an indicator such
as the aforementioned CI or BI having a function of producing a
reaction suitable for the sterilization method employed.
[0206] As can be understood from the above description, with the
present embodiment, the sterilization confirmation tester 101
according to the present invention allows the lengths of the first
and second conduit simulation portions 101A1 and 101A2 to be
adjusted. Such an arrangement has a function of providing a
simulation of the length of the conduit portion of medical devices
having various kinds and lengths of the conduits such as an
endoscope and so forth. This enables effective sterilization of the
interior of the conduit of the medical device to be tested, such as
an endoscope or the like, to be confirmed in a simple and sure
manner after sterilization treatment by a desired sterilization
apparatus.
Tenth Embodiment
[0207] FIG. 20 and FIG. 21 show a sterilization confirmation tester
according to a tenth embodiment of the present invention. FIG. 20
is a cross-sectional view which shows a schematic configuration of
the sterilization confirmation tester including a conduit
simulation portion having a predetermined length. FIG. 21 is a
cross-sectional view which shows a schematic configuration of the
sterilization confirmation tester with the length of the conduit
simulation portion having been adjusted by extracting the conduit
simulation portion outward. Note that, in FIG. 20 and FIG. 21, the
same components as those of the aforementioned ninth embodiment are
denoted by the same reference numerals, description thereof will be
omitted, and description will be made regarding only the different
components.
[0208] As shown in FIG. 20, a sterilization confirmation tester
101B according to the present embodiment includes a conduit
simulation portion 102A which includes a conduit portion having a
structure corresponding to the conduit of a medical device such as
an endoscope or the like in the same way as with the aforementioned
ninth embodiment. The difference is that the conduit simulation
portion 102A is stored within the aforementioned sterilization
confirmation tester 101B in a coil shape or an accordion-fold shape
such that it remains not to bend sharply. Note that the length of
the aforementioned conduit simulation portion 102A, which has been
installed within the sterilization confirmation tester 101B
beforehand, is inscribed on the outer face of the conduit
simulation portion 102A. That is to say, the operator can confirm
beforehand the initial length of the conduit simulation portion
102A stored within the sterilization confirmation tester 101B.
[0209] Furthermore, the aforementioned conduit simulation portion
102A is configured so as to allow it to be extracted from the base
end side of the aforementioned sterilization confirmation tester
101B (right side in the drawing). That is to say, the
aforementioned sterilization confirmation tester 101B is configured
so as to allow the length of the conduit simulation portion 102A
remaining in the sterilization confirmation tester 101B to be
adjusted as necessary by extracting a portion of the conduit
simulation portion 102A from the sterilization confirmation tester
101B, corresponding to the length of the conduit of an endoscope or
the like to be tested, as shown in FIG. 21.
[0210] Note that, with regard to the conduit simulation portion
102A which remains within the sterilization confirmation tester
101B after the extraction step, one end thereof may be cut off at
the insertion opening (insertion portion) of the aforementioned
sterilization confirmation tester 101B on the tip end side thereof
(left side in the drawing).
[0211] Elastic members or screws 110 are provided to the connection
portions (insertion portion) where the conduit simulation portion
102A is connected to the sterilization confirmation tester 101B.
The elastic members or screws 110 thus provided ensures that the
interior of the sterilization confirmation tester 101B remains
watertight. Note that elastic members or screws 110a are fit to the
insertion opening of the aforementioned sterilization tester 101 on
the tip end side. On the other hand, elastic members or screws 110b
are fit to the extraction opening of the aforementioned
sterilization tester 101 on the base end side.
[0212] With the sterilization confirmation tester 101B according to
the present embodiment having such a configuration described above,
the length of the conduit simulation portion 102A which remains
within the sterilization confirmation tester 101B can be adjusted
by extracting the conduit simulation portion 102A from the
sterilization confirmation tester 101B as necessary corresponding
to the length of the conduit of an endoscope or the like to be
tested, in the same way as with the aforementioned ninth
embodiment.
[0213] Note that, with regard to the sterilization confirmation
tester 101B according to the present embodiment, the region 106
other than the conduit simulation portion 102A may be configured in
the form of a cavity, or may be filled with a certain material.
[0214] Furthermore, the aforementioned sterilization confirmation
tester 101B is formed so as to be a simulation of a medical device
having conduits such as an endoscope or the like. Furthermore, CI
(or BI) 109 is installed in the interior space within the
aforementioned conduit simulation portion 102A.
[0215] Furthermore, all the members employed in the aforementioned
sterilization confirmation tester 101B are formed of materials
which enable these members to be subjected to treatment in the
sterilization apparatus.
[0216] Next, description will be made regarding the operation of
the sterilization confirmation tester according to the present
embodiment with reference to FIG. 20 and FIG. 21.
[0217] It is assumed that confirmation is made with respect to
effective sterilization of a predetermined medical device such as
an endoscope and so forth using the sterilization confirmation
tester according to the present embodiment. In this case, the CI
(or BI) 109 is provided within the aforementioned conduit
simulation portion 102A of the sterilization confirmation tester
101B. In a case that a BI is employed as an indicator, the BI needs
to be extracted in a sterile environment after the sterilization
step. Accordingly, the conduit tester itself may be sealed within a
seal pack or the like.
[0218] The operator adjusts the length of the conduit simulation
portion 102A which remains within the sterilization confirmation
tester 101B as necessary so as to match the conduit length of the
medical device to be tested, by extracting the tip of the conduit
simulation portion 102A from the extraction opening formed on the
base end side of the sterilization confirmation tester 101B.
[0219] After the adjustment of the length of the conduit simulation
portion, the operator installs the aforementioned sterilization
confirmation tester 101B, which is a simulation of the conduit
length of the medical device to be tested, in the sterilization
apparatus, and the sterilization step is executed according to a
desired procedure.
[0220] For example, let us consider a case in which a steam
pressure sterilization apparatus is employed as the aforementioned
sterilization apparatus. In this case, steam infiltrates into the
conduit simulation portion 102A of the sterilization confirmation
tester 101B. On the other hand, let us consider a case in which a
gas sterilization apparatus is employed as the aforementioned
sterilization apparatus. In this case, gas infiltrates into the
conduit simulation portion 102A of the sterilization confirmation
tester 101B. Then, the steam or gas acts upon the CI (or BI) 109
installed in the conduit simulation portion 102A.
[0221] After the sterilization step, the operator extracts the
aforementioned sterilization confirmation tester 101B from the
sterilization apparatus, and extracts the CI (or BI) 109 from the
conduit simulation portion 102A.
[0222] Then, in a case that the extracted indicator is a CI, the
operator determines the effectiveness of sterilization of the
aforementioned sterilization confirmation tester 101B according to
a predetermined sterilization criterion (whether or not the color
of the CI has changed, and so forth). In a case that the extracted
indicator is a BI, the operator extracts the BI in a sterile
environment, and the BI is introduced into a culture medium
suitable for culturing the BI. Then, effective sterilization is
confirmed based upon whether or not a bacterial culture has
appeared from the BI.
[0223] With such an arrangement, in the event that determination
has been made that the aforementioned sterilization tester 101B has
been sterilized, determination is made that the medical device to
be tested can be sterilized by the aforementioned sterilization
step. Conversely, in the event that determination has been made
that the aforementioned conduit body has not been sterilized,
determination is made that the medical device to be tested cannot
be sterilized by the aforementioned sterilization step.
[0224] Note that, with the present embodiment, the medical device
to be tested may be installed in the sterilization apparatus along
with the aforementioned sterilization confirmation tester 101B at
the same time.
[0225] Also, with the present embodiment, the aforementioned
sterilization method is not restricted to high-pressure and
high-temperature steam sterilization (autoclave sterilization) or
EOG gas sterilization. Also, other sterilization methods may be
employed. In this case, there is a need to employ an indicator such
as the aforementioned CI or BI having a function of producing a
reaction suitable for the sterilization method employed.
[0226] Thus, the present embodiment having such a configuration
described above is fully capable of corresponding to a medical
device which has a long conduit. This provides the advantage of
expanding the range of usage thereof, as well as the same
advantages as those of the aforementioned ninth embodiment.
Eleventh Embodiment
[0227] FIG. 22 shows a sterilization confirmation tester according
to an eleventh embodiment of the present invention, and is a
cross-sectional view which shows a schematic configuration of the
sterilization confirmation tester. Note that, in FIG. 22, the same
components as those of the aforementioned ninth embodiment are
denoted by the same reference numerals, description thereof will be
omitted, and description will be made regarding only the different
components.
[0228] As shown in FIG. 22, a sterilization confirmation tester
101C according to the present embodiment has generally the same
configuration as that of the sterilization confirmation tester 101
according to the aforementioned ninth embodiment, or that of the
sterilization confirmation tester 101B according to the
aforementioned tenth embodiment, except for the following
difference. That is to say, the difference is that at least one of
the sterilization confirmation tester 101C and a conduit simulation
portion 102B includes a thermal insulating member 111 for
suppressing the flow of heat to/from the aforementioned conduit
simulation portion 102B. Accordingly, the thermal insulating member
111 is provided so as to cover the entire region of or a part of
the outer face of the conduit simulation portion 102B.
[0229] Note that the aforementioned thermal insulating member 111
may be formed of a member forming a flexible hose of an
endoscope.
[0230] Also, the sterilization confirmation tester 101C according
to the present embodiment is a simulation of a medical device
having conduits such as an endoscope and so forth, and a CI (or BI)
109 is installed in the interior of the aforementioned conduit
simulation portion 102B, in the same way as with the aforementioned
two embodiments, i.e., the ninth and tenth embodiments.
[0231] The other components are the same as those of the ninth
embodiment and the tenth embodiment.
[0232] Also, the sterilization confirmation tester according to the
present embodiment operates in generally the same way as with the
ninth embodiment and the tenth embodiment described above.
[0233] As described above, the sterilization confirmation tester
according to the present embodiment has a function of enabling the
length of the conduit simulation portion 102B to be adjusted in the
same way as with the ninth embodiment and the tenth embodiment
described above. In addition, the sterilization confirmation tester
according to the present embodiment includes the thermal insulating
member 111 for reducing the thermal conductivity, thereby
suppressing the flow of heat to/from the conduit simulation portion
102B. Such an arrangement can simulate the thermal conductivity of
the conduit portion of medical devices such endoscopes and the
length of the conduit portion of medical devices, such as
endoscopes, having various kinds and lengths of conduits. This
enables effective sterilization for the interior of the conduit of
the medical device to be tested, such as an endoscope or the like,
to be confirmed in a simple and sure manner after sterilization
treatment by a desired sterilization apparatus.
Twelfth Embodiment
[0234] FIG. 23 and FIG. 24 show a sterilization confirmation tester
according to a twelfth embodiment of the present invention. FIG. 23
is a cross-sectional view which shows a schematic configuration of
the sterilization confirmation test unit. FIG. 24 is a
cross-sectional view which shows a configuration of a sterilization
confirmation tester formed of multiple sterilization confirmation
test units shown in FIG. 23, which are connected so as to
communicate with one another. Note that, in FIG. 23 and FIG. 24,
the same components as those of the aforementioned eleventh
embodiment are denoted by the same reference numerals, description
thereof will be omitted, and description will be made regarding
only the different components.
[0235] As shown in FIG. 23, a sterilization confirmation test unit
101D according to the present embodiment has generally the same
configuration as that of the sterilization confirmation tester 10C.
With the present embodiment, multiple sterilization test units
having different conduit simulation portions including the
aforementioned sterilization confirmation test unit 101D are
connected so as to communicate with one another. Such an
arrangement provides an improved sterilization confirmation tester
having a function of allowing the overall length of the conduit
simulation portion to be adjusted in the longitudinal
direction.
[0236] That is to say, the sterilization confirmation test unit
101D according to the present embodiment includes connection
portions 112 and 113 for connecting so as to communicate the
conduit simulation portion 102B with a different conduit simulation
portion (conduit portion). These connection portions 112 and 113
are fit to the opening portions on both sides of the aforementioned
conduit simulation portion 102B in a watertight manner. Note that
these connection portions 112 and 113 are configured in the form of
a screw structure, for example. In this case, an arrangement may be
made in which one of these connection portions is configured in the
form of a male screw, and the other connection portion is
configured in the form of a female screw.
[0237] With the present embodiment, let us consider a case in which
the aforementioned sterilization confirmation test unit 101D is
connected to another sterilization confirmation test unit 101E as
shown in FIG. 24, for example. In this case, upon connecting the
connection portion 113 of the sterilization confirmation test unit
101D to the connection portion 112 of the sterilization
confirmation test unit 110E, the conduit simulation portion 102B
communicates with a conduit simulation portion 102B1 while
maintaining a watertight connection between the sterilization
confirmation test unit 101D and the sterilization confirmation test
unit In a case of using a sterilization confirmation test unit 101F
shown in FIG. 24, having a structure in which a conduit simulation
portion 102C bifurcates, an arrangement may be made in which one
side face (opening portion) has a single connection portion 112,
and the other side face (opening portion) has two connection
portions, e.g., a connection portion 113a and a connection portion
113b.
[0238] With such an arrangement, the sterilization confirmation
test unit 101F can be connected to a sterilization confirmation
test unit 101G. The sterilization confirmation test unit 101G
includes two conduit simulation portions 102D1 and 102D2 which are
to be connected so as to communicate with two conduit simulation
portions 102C1 and 102C2, respectively, which are included in the
sterilization confirmation test unit 101F. The sterilization
confirmation test unit 101G is configured so as to have the
connection portions 112a, 112b, 113a, and 113b, formed on both side
faces corresponding to the opening portions of these conduit
simulation portions 102D1 and 102D2. As described above, with the
present embodiment, the sterilization confirmation test unit may
have a predetermined number of the connection portions, with the
number of the connection portions matching the number of the
opening portions of the conduit simulation portions.
[0239] The other components are the same as those of the
aforementioned eleventh embodiment.
[0240] Next, description will be made regarding the operation of
the sterilization confirmation tester according to the present
embodiment with reference to FIG. 23 and FIG. 24.
[0241] It is assumed that confirmation is made with respect to
effective sterilization of a predetermined medical device such as
an endoscope and so forth using the sterilization confirmation
tester according to the present embodiment. In this case, one of or
each of the aforementioned conduit simulation portions 102B, 102B1,
102C, 102C1, 102C2, 102D1, and 102D2 stores a CI (or BI) 109
therewithin. In a case that a BI is employed as an indicator, the
BI needs to be extracted in a sterile environment after the
sterilization step. Accordingly, the conduit testers 101D and 101H
themselves may be sealed with a seal pack or the like.
[0242] The operator selects the sterilization confirmation test
units from among the various different types (e.g., a type such as
the sterilization confirmation test unit 101D having a single
conduit simulation portion, a type such as the sterilization
confirmation test unit 101F having a structure in which a conduit
simulation portion is divided into two (102C1, 102C2) or more, and
a type such as the sterilization confirmation test unit 101G having
two conduit simulation portions (102D1, 102D2), corresponding to
the conduit structure of the medical device to be tested.
Furthermore, the operator determines the order of connection
therebetween such that the sterilization confirmation tester is a
simulation of the conduit structure of the medical device to be
tested.
[0243] For example, in a case where the operator disposes the
sterilization confirmation test units as shown in FIG. 24, the
operator connects the sterilization confirmation test unit 101D and
the sterilization confirmation test unit 101E with each other
through the connection portion 113 and the connection portion 112
such that the conduit simulation portion 102B and the conduit
simulation portion 102B1 communicate with each other. Subsequently,
the operator connects the sterilization confirmation test unit 101E
and the sterilization confirmation test unit 101F with each other
through the connection portion 113 and the connection portion 112
in the same way. Furthermore, the operator connects the
sterilization confirmation test unit 101F and the sterilization
confirmation test unit 101G with each other through the connection
portions 113a and 113b and the connection portions 112a and 112b in
the same way, thereby forming the sterilization confirmation tester
101H according to the present embodiment. With such an arrangement,
these sterilization confirmation units are connected so as to
communicate with one another while maintaining the interior thereof
in a watertight state.
[0244] Subsequently, after assembly of the sterilization
confirmation tester 101H so as to be a simulation of the conduit
structure of the medical device to be tested, the operator installs
the sterilization confirmation tester 101H in the sterilization
apparatus, and the desired sterilization treatment is executed.
[0245] For example, let us consider a case in which a steam
pressure sterilization apparatus is employed as the aforementioned
sterilization apparatus. In this case, steam infiltrates into the
conduit simulation portions 102B, 102B1, 102C, 102C1, 102C2, 102D1,
and 102D2 of the sterilization confirmation tester 101H. On the
other hand, let us consider a case in which a gas sterilization
apparatus is employed as the aforementioned sterilization
apparatus. In this case, gas infiltrates into the conduit
simulation portions 102B, 102B1, 102C, 102C1, 102C2, 102D1, and
102D2 of the sterilization confirmation tester 101H. Then, the
steam or gas acts upon the CIs (or BIs) 109 installed in the
conduit simulation portions.
[0246] After the sterilization step, the operator extracts the
aforementioned sterilization confirmation tester 101H from the
sterilization apparatus, and extracts the CI (or BI) 109 from the
aforementioned conduit simulation portion.
[0247] Then, in a case that the extracted indicator is a CI, the
operator determines the effectiveness of sterilization of the
aforementioned sterilization confirmation tester 101H according to
a predetermined criterion (whether or not the color of the CI has
changed, and so forth). In a case that the extracted indicator is a
BI, the operator extracts the BI in a sterile environment, and the
BI is introduced into a culture medium suitable for culturing the
BI. Then, effective sterilization is confirmed based upon whether
or not a bacterial culture has appeared from the BI.
[0248] With such an arrangement, in the event that determination
has been made that the aforementioned sterilization tester 101H has
been sterilized, determination is made that the medical device to
be tested can be sterilized by the aforementioned sterilization
step. Conversely, in the event that determination has been made
that the sterilization tester 101H has not been sterilized,
determination is made that the medical device to be tested cannot
be sterilized by the aforementioned sterilization step.
[0249] Note that, with the present embodiment, the medical device
to be tested may be installed in the sterilization apparatus along
with the aforementioned sterilization confirmation tester 101H at
the same time.
[0250] Also, with the present embodiment, the aforementioned
sterilization method is not restricted to high-pressure and
high-temperature steam sterilization (autoclave sterilization) or
EOG gas sterilization. Also, other sterilization methods may be
employed. In this case, there is a need to employ an indicator such
as the aforementioned CI or BI having a function of producing a
reaction suitable for the sterilization method employed.
[0251] As can be understood from the above description, with the
present embodiment, the sterilization confirmation test pack 101H
has a function of simulating the conduit portion of medical devices
such as endoscopes and so forth. This enables effective
sterilization of the interior of the conduit of the medical device
to be tested, such as an endoscope or the like, to be confirmed in
a simple and sure manner after sterilization treatment by a desired
sterilization apparatus.
Thirteenth Embodiment
[0252] FIG. 25 and FIG. 26 show a sterilization confirmation tester
according to a thirteen embodiment of the present invention. FIG.
25 is a cross-sectional view which shows a schematic configuration
of a sterilization confirmation test pack employing a sterilization
confirmation tester. FIG. 26 is an external view which shows a
sterilization confirmation test pack including opening/closing
means. Note that, in FIG. 26, the same components as those of the
aforementioned thirteenth embodiment are denoted by the same
reference numerals, description thereof will be omitted, and
description will be made regarding only the different
components.
[0253] As shown in FIG. 25 and FIG. 26, a sterilization
confirmation test pack 101I includes: the sterilization
confirmation tester 101H having the same configuration as that of
the aforementioned thirteenth embodiment; and a packaging member
120 for storing the sterilization confirmation tester 101H.
[0254] Note that, with the present embodiment, the aforementioned
sterilization confirmation tester 101H stored in the packaging
member 120 has a structure in which multiple sterilization
confirmation test units are connected so as to communicate with one
another. However, the present invention is not restricted to a
particular arrangement such as this. Also, the operator can select
a desired number of the sterilization confirmation test units
having desired structures from among the aforementioned
sterilization confirmation test units (see FIG. 24) and can connect
these sterilization confirmation test units thus selected so as to
communicate with one another such that the sterilization
confirmation tester 101H is a simulation of the conduit structure
of the medical device to be tested.
[0255] The aforementioned packaging member 120 is configured so as
to store part of or all of the aforementioned sterilization test
units 101D through 101G. Such an arrangement may or may not allow
the aforementioned sterilization confirmation tester 101H to be
inserted/extracted.
[0256] Also, the aforementioned packaging member 120 may be
configured so as to include a thermal insulating member 111A for
reducing the thermal conductivity thereof as shown in FIG. 25,
thereby suppressing the flow of heat to/from the sterilization
confirmation tester 101H or the conduit simulation portions 102B
(102B1, 102C, 102C1, 102C2, 102D1, 102D2).
[0257] Note that, with the present embodiment, the aforementioned
packaging member 120 may be configured so as to include a filter,
which has the nature of allowing steam, gas, and so forth, to pass
therethrough, or a film, which has the nature of preventing steam,
gas, and so forth, from passing therethrough, provided to at least
a part of thereof. Also, an arrangement may be made in which the
whole of the packaging member 120 is formed of a transparent
member. This allows visual confirmation of the sterilization
confirmation tester 101H stored therein to be made immediately.
[0258] Also, the aforementioned thermal insulating member 111A may
be formed of the same member as that forming a flexible hose of an
endoscope which is a medical device.
[0259] Also, the sterilization confirmation test pack 101I
according to the present embodiment may include the opening/closing
means 121 provided to the aforementioned packaging member 120 as
shown in FIG. 26, thereby allowing the sterilization confirmation
tester 101H, which is to be stored therewithin, to be
inserted/extracted. With such an arrangement, the aforementioned
opening/closing means 121 need to be configured so as to ensure
that the interior of the aforementioned packaging member 120
remains watertight.
[0260] The other components are the same as those of the
aforementioned thirteenth embodiment.
[0261] Next, description will be made regarding the operation of
the sterilization confirmation test pack according to the present
embodiment with reference to FIG. 25 and FIG. 26. Note that the
operation of the sterilization confirmation test pack according to
the present embodiment is generally the same as that according to
the aforementioned thirteenth embodiment. Accordingly, description
will be made regarding only the different components from the
aforementioned thirteenth embodiment.
[0262] After assembly of the sterilization confirmation tester 101H
having a structure in which the multiple sterilization confirmation
testers 101D through 101G are connected so as to communicate with
one another, and so as to be a simulation of the conduit structure
of the medical device to be tested, the operator wraps so as to
cover a part of or all of the aforementioned sterilization
confirmation tester 101H in the packaging member 120.
[0263] In this case, an arrangement may be made in which a part of
or all of the sterilization confirmation tester 101H is wrapped so
as to be covered by the packaging member 120 beforehand. Also, the
packaging member 120 may include the aforementioned opening/closing
means 121, thereby allowing the operator to store the
aforementioned sterilization confirmation tester 101H in the
packaging member 120 through the opening/closing means 121.
[0264] After the sterilization step, the operator extracts the
aforementioned sterilization confirmation test pack 101I including
the sterilization confirmation tester 101H from the sterilization
apparatus. Then, the operator extracts the sterilization
confirmation tester 101H from the packaging member 120. In this
stage, in a case that the aforementioned packaging member 120
includes the opening/closing means 121, the operator can extract
the sterilization confirmation tester 101H stored therewithin
through the opened opening/closing means 121.
[0265] Subsequently, the operator extracts the CI (or BI) 109 from
the aforementioned conduit simulation portion 102B of the
sterilization confirmation tester 101H thus extracted.
[0266] Then, in a case that the extracted indicator is a CI, the
operator determines the effectiveness of sterilization of the
aforementioned sterilization confirmation tester 101H according to
a predetermined criterion (whether or not the color of the CI has
changed, and so forth). In a case that the extracted indicator is a
BI, the operator extracts the BI in a sterile environment, and the
BI is introduced into a culture medium suitable for culturing the
BI. Then, effective sterilization is confirmed based upon whether
or not a bacterial culture has appeared from the BI.
[0267] With such an arrangement, in the event that determination
has been made that the aforementioned sterilization tester 101H has
been sterilized, determination is made that the medical device to
be tested can be sterilized by the aforementioned sterilization
step. Conversely, in the event that determination has been made
that the sterilization tester 101H has not been sterilized,
determination is made that the medical device to be tested cannot
be sterilized by the aforementioned sterilization step.
[0268] Note that, with the present embodiment, the medical device
to be tested may be installed in the sterilization apparatus along
with the aforementioned sterilization confirmation test pack 101I
at the same time.
[0269] Also, with the present embodiment, the aforementioned
sterilization method is not restricted to high-pressure and
high-temperature steam sterilization (autoclave sterilization) or
EOG gas sterilization. Also, other sterilization methods may be
employed. In this case, there is a need to employ an indicator such
as the aforementioned CI or BI having a function of producing a
reaction suitable for the sterilization method employed.
[0270] Thus, with the present embodiment having such a
configuration described above, the sterilization confirmation test
pack 101I has a function of simulating the conduit portion of
medical devices such as endoscopes and so forth, while providing a
function as a simply handled test pack. This enables effective
sterilization of the interior of the conduit of the medical device
to be tested, such as an endoscope or the like, to be confirmed in
a simple and sure manner after sterilization treatment by a desired
sterilization apparatus.
[0271] The sterilization confirmation tester and the sterilization
confirmation test pack employing such a sterilization confirmation
tester according to the ninth embodiment through the thirteenth
embodiment described above provides the advantage of allowing
confirmation of effective sterilization to be made in a simple and
sure manner with respect to the interior of the conduit of medical
devices having various kinds of conduit structures such as
endoscopes and so forth.
[0272] The sterilization confirmation tester and the sterilization
confirmation test pack employing such a sterilization confirmation
tester according to the present invention provide the advantage of
allowing confirmation of effective sterilization to be made in a
simple and sure manner with respect to the interior of the conduit
of medical devices having various kinds of conduit structures such
as endoscopes and so forth. Such an arrangement is particularly
effective in a case in which endoscopic examination followed by
reprocessing of the endoscope is repeatedly performed in the course
of a day using a single endoscope.
[0273] Note that the present invention is not restricted to the
first through thirteenth embodiments described above. Rather,
various modification may be made without departing from the spirit
and scope of the invention.
* * * * *