1. Field of the Invention
The present invention relates to a device for sterilization check and, in particular, to a device for sterilization check capable of checking a sterilization effect on an internal pipeline of an endoscope.
2. Description of the Related Art
Medical endoscopes perform an observation of organs and the like by having an insertion unit inserted into a body cavity, or various remedies and treatments by using a treatment instrument inserted into a treatment instrument insertion path (which is also referred to as a “treatment tool insertion channel or a “forceps channel”) of the endoscope. Therefore, when an endoscope having once been used is to be reused for another patient, the endoscope is required to be disinfected and sterilized after the end of examination and treatment to prevent infection between patients via the endoscope. Disinfection or sterilization is achieved by methods of using a disinfectant liquid, ethylene oxide gas, formalin gas, hydrogen peroxide gas plasma, ozone, a sterilized autoclave which uses water vapor high temperature and high pressure, and others.
A hydrogen peroxide plasma method is a typical advanced sterilizing methodology for endoscopes. In this method, hydrogen peroxide is decomposed with plasma to generate active hydroxy radicals, thereby achieving sterilization. Also, using an autoclave that sterilizes an endoscope with steam at high temperature and high pressure is a disinfecting and sterilizing methodology that has been widespread. Either methodology has many advantages, such as a highly reliable sterilization effect, free of residual toxicity, and low running cost.
In this sterilizing process, an operation of checking whether the sterilization effect by that sterilizing process has been sufficiently obtained is normally performed. In this checking operation, a sterilization indicator indicating that a subject to be sterilized has been subjected to the sterilizing process is used. The sterilization indicator indicates that the subject to be sterilized has been exposed to a sterilizing medium (heat or gas) for a predetermined period of time, and is a member having a non-reversible discoloration characteristic. In general, the sterilization indicator having this discoloration characteristic is a card-shaped, label-shaped, or tape-shaped material, and may be directly affixed to a medical instrument such as an endoscope or may be enclosed in a hermetically-sealed package. A doctor or a nurse checks the color of the sterilization indicator when opening the hermetically-sealed package and, if the color is changed to a predetermined color, believes that the sterilizing process is complete and uses the instrument for examinations, operations, and others.
In the case of a medical instrument configured not to have an elongated pipeline in the subject to be sterilized, a general sterilization indicator is affixed to the surface of the subject to be sterilized, thereby allowing the sterilization effect to be checked.
However, the inner pipeline of the endoscope has an elongated pipeline structure, which is difficult to check whether the sterilizing medium has reliably reached the inside of the inner pipeline. Therefore, even if the surface of the endoscope is exposed to the sterilizing medium, it is not known whether this sterilizing medium has passed through the inner pipeline, and the operation of checking whether the sterilizing process has been appropriately performed is not sufficient.
Japanese Patent Application Laid-Open No. 2002-355297 suggests an indicator for sterilization check, in which a linear subject having attached thereto a sterilization indicator composite is inserted in a narrow pipeline to allow sterilization in the pipeline to be checked.
Japanese Patent Application Laid-Open No. 2005-204826 suggests, as a device for sterilization check suitable for checking a sterilization effect on an elongated inner pipeline as an endoscope, a device including a pipeline tube having a variable pipeline diameter and an indicator case connected to the pipeline tube and capable of accommodating an indicator for sterilization check in a space communicating with an inner space of the pipeline tube.
Meanwhile, in the indicator for sterilization check described in Japanese Patent Application Laid-Open No. 2002-355297, in order to facilitate insertion into a simple pipeline such as a catheter, the linear subject having attached thereto the sterilization indicator composite is entirely covered with resin to ensure its stiffness.
However, the inner pipeline of the endoscope is elongated, for example, as a treatment instrument insertion path 56 shown in
In the device for sterilization check described in Japanese Patent Application Laid-Open No. 2005-204826, a pipeline corresponding to the inner pipeline of the endoscope is configured by simulation, and based on a change of the indicator for sterilization check accommodated in the space communicating with the inner space of the pipeline the sterilization effect on the inner pipeline of the endoscope is checked. That is, in this device for sterilization check, the sterilization effect is indirectly checked by using the pipeline obtained by simulating the inner pipeline of the endoscope, and the sterilization effect on the inner pipeline of the endoscope cannot be directly checked. Moreover, the number of places to be measured is one, and it is merely confirmed that the sterilizing medium has passed through the inside of the pipeline configured by simulation. This is not sufficient as a check of the sterilization effect.
The present invention was made in view of these circumstances, and has an object of providing a device for sterilization check capable of reliably checking a sterilization effect on an inner pipeline of an endoscope even in a place that is difficult to reach by a sterilizing medium.
To achieve the object described above, a device for sterilization check for an endoscope according to the present invention comprising an elongated insertion member insertable into an inner pipeline of the endoscope, wherein a plurality of indicator holding members each capable of holding a sterilization indicator for checking a sterilization effect by a sterilizing medium introduced to the inner pipeline are arranged on the insertion member along a longitudinal direction of the insertion member, and ones of the indicator holding members adjacent to each other along the longitudinal direction of the insertion member are coupled together via a flexible coupling member deformable along a shape of the inner pipeline of the endoscope.
According to the present invention, the plurality of sterilization indicators are arranged over the entire inner pipeline of the endoscope. Therefore, the sterilization effect on the inner pipeline of the endoscope can be reliably checked even in a place that is difficult to reach by a sterilizing medium.
A preferred embodiment of the present invention is described in detail below according to the attached drawings.
First, the structure of an endoscope to which a device for sterilization check of the present embodiment is applied is described.
A universal cable 16 is connected to the handy operating part 12, and a light guide (LG) connector 18 is provided at the tip of this universal cable 16. The LG connector 18 is removably coupled to a light source device not shown, thereby causing illumination light to be sent to an illumination window 46 (refer to
The handy operating part 12 is provided with an air-supply/water-supply button 24, a suction button 26, and a shutter button 28 side by side with each other, and is provided also with paired angle knobs 30. Furthermore, the handy operating part 12 is provided with a treatment instrument insertion opening 32 into which a treatment instrument such as forceps is inserted.
The insertion part 14 is configured of a soft part (a flexible pipe part) 36, a bending part 38, undo tip part 40, sequentially from a handy operating part 12 side.
The bending part 38 is remotely operated to be bent by rotating the angle knobs 30 of the handy operating part 12. With this, the tip part 40 can be oriented to a desired direction.
As shown in
Behind the observation window 44, a CCD (not shown) is disposed, and a signal cable (not shown) is connected to a substrate supporting this CCD. The signal cable is inserted into the insertion part 14, the handy operating part 12, the universal cable 16, the LG connector 18, and the cable 20 of
Behind the illumination windows 46 of
The air-supply/water-supply nozzle 48 communicates with an air-supply/water-supply valve (not shown) operated by the air-supply/water-supply button 24 of
The forceps opening 50 communicates with a treatment instrument insertion opening 32 via a treatment instrument insertion path (not shown in
Next, the device for sterilization check of the present embodiment is described.
As shown in
The indicator holder 62 is a holding member for holding a sterilization indicator 66. As shown in
In the body part 62A of the indicator holder 62, an indicator accommodating part (a recessed part) 68 capable of replaceably accommodating the sterilization indicator 66 is provided. On a side surface of the body part 62A, a plurality of openings (window parts) 70A, 70B, and 70C are formed for exposing the sterilization indicator 66 accommodated in the indicator accommodating part 68 to the front surface.
The first and second openings 70A and 70B are arranged on an outer circumferential surface of the body part 62A at the positions same in a circumferential direction but different in an axial direction (both of end positions in the axial direction). The third opening 70C is arranged on the outer circumferential surface of the indicator holder 62 at a position opposite to the first and second openings 70A and 70B in the circumferential direction and at an approximately center part in the axial direction. The outer circumferential surface (an outer wall part) of the body part 62A except these openings 70A, 70B, and 70C functions as a support part (a dropping-off preventive member) preventing the sterilization indicator 66 accommodated in the indicator accommodating part 68 from dropping off.
The coupling parts 62B of the indicator holder 62 are each a portion fitting in an end opening of the tube body 64 to be coupled to the tube body 64. Although not shown, preferably, as members for preventing the coupling the indicator holder 62 and the tube body 64 from being easily released (a coupling-release preventive member), a projection is formed on either one surface of the inner circumferential surface of the tube body 64 and the outer circumferential surface of the coupling part 62B, and a recessed part that can be engaged with the projection is provided on the other surface. In this case, the coupling therebetween is not released unless a force equal to a predetermined value or more is applied in a direction in which the indicator holder 62 and the tube body 64 are away from each other.
The coupling between the indicator holder 62 and the tube body 64 is not meant to be restricted to the embodiment described above. For example, the indicator holder 62 and the tube body 64 may be coupled together by forming a male thread on the outer circumferential surface of the coupling part 62B and forming a female thread on the inner circumferential surface of the tube body 64 and screwing the indicator holder 62 and the tube body 64 with these threads. Also, in another embodiment, the indicator holder 62 and the tube body 64 may be coupled together via an adhesive.
The sterilization indicator 66 is to check the sterilization effect of the sterilizing means introduced to the inner pipeline (for example, a treatment instrument insertion path) of the endoscope 10, and a commercially-available chemical indicator (CI) or biological indicator (BI) is used. These indicators are well known, and are not described in detail herein.
The tube body 64 is a coupling member coupling adjacent indicator holders 62 together along the longitudinal direction of the device for sterilization check 60, is made of a soft resin having a stiffness lower than that of the indicator holder 62, and is configured to have flexibility allowing deformation along the shape of the inner pipeline of the endoscope 10. Note in the present embodiment that the coupling member coupling the indicator holders 62 together is not restricted to the tube body 64 but can be configured of a solid stick body.
Next, a method of checking the sterilization effect in the treatment instrument insertion path as an inner pipeline of the endoscope 10 by using the device for sterilization check 60 of the present embodiment is described. It is assumed herein that a process of cleaning the endoscope 10 has already been performed.
First, the device for sterilization check 60 is prepared. Here, if the sterilization indicator 66 is not accommodated in the indicator accommodating part 68 of each indicator holder 62, the sterilization indicator 66 is inserted and arranged into the indicator accommodating part 68 as shown in
Next, as shown in
In this state, the endoscope 10 is set in a sterilizing device (for example, a hydrogen peroxide plasma sterilizing device). Then, the endoscope 10 is subjected to a sterilizing process in the sterilizing device for a predetermined period of time.
While the sterilizing process is being performed in the sterilizing device, the surface of the endoscope 10 is exposed to the sterilizing medium, the sterilizing medium (for example, hydrogen peroxide) enters from an open end of the treatment instrument insertion path 56, that is, the treatment instrument insertion opening 32 or the forceps opening 50, into the treatment instrument insertion path, and therefore the inside of the treatment instrument insertion path 56 is also exposed to the sterilizing medium. Here, since the device for sterilization check 60 is inserted and arranged in the treatment instrument insertion path 56, each sterilization indicator 66 of the device for sterilization check 60 reacts with the sterilizing medium with which the treatment instrument insertion path 56 is filled.
After the end of the sterilizing process, a sterilizing worker extracts the device for sterilization check 60 from the treatment instrument insertion path 56 of the endoscope 10 and checks the sterilization effect. Here, if the entire area of the treatment instrument insertion path 56 is filled with the sterilizing medium, each sterilization indicator of the device for sterilization check 60 appropriately react, and it can be confirmed that the sterilizing process in the treatment instrument insertion path 56 has been reliably performed. If all or part of the sterilizing indicators 66 does not appropriately reacts, the sterilizing medium may not have permeated the entire area of the treatment instrument insertion path 56 or the sterilizing device may have had some anomaly (trouble). In this case, some measures have to be taken, such as performing the sterilizing process again.
As has been described in the foregoing, according to the device for sterilization check 60 of the present embodiment, the plurality of indicator holders 62 are coupled to each other via the tube bodies 64. Therefore, the device for sterilization check 60 can be easily inserted in the inner pipeline (in this example, the treatment instrument insertion path 56 of
Note that while the case has been exemplarily described in which the sterilization effect in the treatment instrument insertion path 56 as the inner pipeline of the endoscope 10 is checked in the present embodiment, this is not meant to be restrictive and the sterilization effect in another inner pipeline such as an air-supply/water-supply pipeline (an air-supply/water-supply channel), for example, can also be checked similarly.
Also, the device for sterilization check 60 may be of a disposable type (a throwaway type) or a reuse type (a repeatedly usable type). In the case of a reuse type, an operation of replacing the sterilization indicators 66 by new ones is required every time the device for sterilization check 60 is used. However, the components other than the sterilization indicators 66 can be used, and the reuse type is advantageous compared with the case of a disposable type in view of cost. By contrast, in the case of a disposable type, the device can be provided with the sterilization indicators 66 being accommodated in the indicator accommodating part 68 of each indicator holder 62 at the stage of manufacture and shipping. Therefore, the operation of replacing the sterilization indicators 66 is not required, and the work load on the sterilization worker can be reduced compared with the case of the reuse type.
Furthermore, while the indicator accommodating part (the recessed part) 68 for replaceably accommodating the sterilization indicators 66 is provided on the body part 62A of the indicator holder 62 in the present embodiment, this is not meant to be restrictive. For example, as shown in
Still Further, the space between the indicator holders 62 for arrangement is not particularly restricted in the present embodiment, when the indicator holders 62 are equidistantly arranged, the sterilization effect on the inner pipeline of the endoscope 10 can be checked uniformly along the longitudinal direction of the inner pipeline.
On the other hand, the indicator holders 62 may be non-equidistantly arranged. For example, according to the shape of the inner pipeline of the endoscope or a distance from the end opening thereof, the space between the sterilization indicators for arrangement is made long in a place that is easy for the sterilizing medium to reach and, on the other hand, the space between the sterilization indicators for arrangement is made short in a place that is difficult for the sterilizing medium to reach. With this, the sterilization effect on the inner pipeline of the endoscope can be more efficiently checked.
Note that as a method of changing the space between the indicator holders 62 for arrangement, a plurality of tube bodies 64 having a plurality of lengths can be prepared, a tube body having a short length is used for connection when the space between the indicator holders 62 adjacent to each other is shortened, and a tube body having a long length is used for connection when the space is lengthened. With this, the space between the indicator holders 62 can be easily changed.
While the device for sterilization check of the present invention has been described in detail above, as a matter of course, the present invention is not meant to be restricted to the examples described above and may be variously improved or modified within a range not deviating from the gist of the present invention.
<Note>
As can be understood from the detailed description of the embodiment above, the specification includes disclosure of various technical ideas including the following aspects of the present invention.
(First Aspect):
A device for sterilization check for an endoscope, comprising: an elongated insertion member insertable into an inner pipeline of the endoscope, wherein a plurality of indicator holding members each capable of holding a sterilization indicator for checking a sterilization effect by a sterilizing medium introduced to the inner pipeline are arranged on the insertion member along a longitudinal direction of the insertion member, and ones of the indicator holding members adjacent to each other along the longitudinal direction of the insertion member are coupled together via a flexible coupling member deformable along a shape of the inner pipeline of the endoscope.
According to the first aspect of the present invention, the plurality of sterilization indicators are arranged over the entire inner pipeline of the endoscope, and therefore the sterilization effect on the inner pipeline of the endoscope can be reliably checked even in a place that is difficult to reach by a sterilizing medium.
(Second Aspect):
The device for sterilization check according to the first aspect of the present invention, wherein the coupling member is configured of a tube body.
According to the second aspect of the present invention, the device for sterilization check can be easily inserted even into an elongated bent inner pipeline.
(Third Aspect):
The device for sterilization check according to the first or second aspect of the present invention, wherein the indicator holding members are equidistantly arranged along the longitudinal direction of the insertion member.
According to the third aspect of the present invention, the sterilization indicators can be equidistantly arranged over the entire area of the inner pipeline of the endoscope, and therefore the sterilization effect on the inner pipeline of the endoscope can be uniformly checked along the longitudinal direction of the inner pipeline.
(Fourth Aspect):
The device for sterilization check according to the first or second aspect of the present invention, wherein the indicator holding members are non-equidistantly arranged along the longitudinal direction of the insertion member.
According to the fourth aspect of the present invention, according to the shape of the inner pipeline of the endoscope or a distance from the end opening thereof, a space between the sterilization indicators for arrangement can be made long in a place that is easy for the sterilizing medium to reach and, on the other hand, the space between the sterilization indicators for arrangement can be made short in a place that is difficult for the sterilizing medium to reach. With this, the sterilization effect on the inner pipeline of the endoscope can be more efficiently checked.
(Fifth Aspect):
The device for sterilization check according to the fourth aspect of the present invention, wherein ones of the indicator holding members adjacent to each other along the longitudinal direction of the insertion member have a space therebetween, the space being configured to be shorter as a distance from an end opening of the inner pipeline of the endoscope is longer.
According to the fifth aspect of the present invention, as the distance from the end opening of the inner pipeline of the endoscope is longer, the space between the sterilization indicators for arrangement is shorter, and therefore the sterilization effect can be more reliably checked even in a place that is difficult for the sterilizing medium to reach.
(Sixth Aspect):
The device for sterilization check according to any one of the first to fifth aspects of the present invention, wherein the indicator holding members are each provided with an indicator accommodation part capable of replaceably accommodating the sterilization indicator.
According to the sixth aspect of the present invention, the sterilization indictor is replaceably accommodated in the indicator holding members, and therefore the device for sterilization check can be reused.
(Seventh Aspect):
The device for sterilization check according to any one of the first to fifth aspects of the present invention, wherein the indicator holding members each have a surface to which the sterilization indicator is affixed.
According to the seventh aspect of the present invention, the structure of the indicator holding members can be simplified, and therefore can be easily manufactured.
(Eighth Aspect):
The device for sterilization check according to any one of the first to seventh aspects of the present invention, wherein the inner pipeline is a treatment instrument insertion path or an air-supply/water-supply path provided inside the endoscope.
According to the eighth aspect of the present invention, the sterilization effect on a treatment instrument insertion path or an air-supply/water-supply path of the endoscope can be reliably checked.
Number | Date | Country | Kind |
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2011-180566 | Aug 2011 | JP | national |
Number | Name | Date | Kind |
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6010662 | Lin et al. | Jan 2000 | A |
Number | Date | Country |
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2002-355297 | Dec 2002 | JP |
2005-204826 | Aug 2005 | JP |
Number | Date | Country | |
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20130053635 A1 | Feb 2013 | US |