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JP2005040170A - Method of sterilizing endoscope with high-temperature, high-pressure steam - Google Patents

Method of sterilizing endoscope with high-temperature, high-pressure steam Download PDF

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Publication number
JP2005040170A
JP2005040170A JP2003200154A JP2003200154A JP2005040170A JP 2005040170 A JP2005040170 A JP 2005040170A JP 2003200154 A JP2003200154 A JP 2003200154A JP 2003200154 A JP2003200154 A JP 2003200154A JP 2005040170 A JP2005040170 A JP 2005040170A
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JP
Japan
Prior art keywords
endoscope
temperature
space
sterilization
pressure steam
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JP2003200154A
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Japanese (ja)
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JP4472280B2 (en
Inventor
Hiroki Moriyama
宏樹 森山
Seisuke Takase
精介 高瀬
Takehiro Nishiie
武弘 西家
Masaaki Miyagi
正明 宮城
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Olympus Corp
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Olympus Corp
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Priority to JP2003200154A priority Critical patent/JP4472280B2/en
Application filed by Olympus Corp filed Critical Olympus Corp
Priority to CNB2004800212391A priority patent/CN100534536C/en
Priority to DE602004032442T priority patent/DE602004032442D1/en
Priority to KR1020067001315A priority patent/KR100845079B1/en
Priority to CA002532652A priority patent/CA2532652C/en
Priority to US10/896,791 priority patent/US7399273B2/en
Priority to AU2004257531A priority patent/AU2004257531B2/en
Priority to EP04748037A priority patent/EP1645293B1/en
Priority to PCT/JP2004/010772 priority patent/WO2005007205A1/en
Publication of JP2005040170A publication Critical patent/JP2005040170A/en
Application granted granted Critical
Publication of JP4472280B2 publication Critical patent/JP4472280B2/en
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a method of sterilizing an endoscope with high-temperature, high-pressure steam to quickly and securely sterilize the inside of a conduit built in the endoscope. <P>SOLUTION: The endoscope 2 is stored in a chamber 52 of a high-temperature high-pressure steam sterilization device to be sterilized with high-temperature, high-pressure steam. In the sterilization, steam can penetrate into the conduit 6 as by a conventional method, and also into a space 47 on the outside of the conduit 56 by a ventilation part 37. Accordingly, the endoscope can be sterilized from both sides of the conduit 56, though sterilized only in the inside of the conduit 56 by the conventional method, and the sterilization can be carried out in a short period of time. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

【0001】
【発明の属する技術分野】
本発明は内視鏡を高温高圧蒸気で滅菌処理する内視鏡の高温高圧蒸気滅菌処理方法に関する。
【0002】
【従来の技術】
体腔内等に挿入することによって体腔内の深部等を観察したり、必要に応じて処置具を用いることにより治療処置等を行なうことができる内視鏡が医療分野において広く用いられるようになった。
医療用内視鏡の場合、使用した内視鏡を確実に消毒滅菌することが感染症等を防止するために必要不可欠になる。
【0003】
最近では、消毒滅菌を行う場合、煩雑な作業を伴わず、滅菌後にすぐに使用でき、しかもランニングコストの面でも有利となるオートクレーブ滅菌(高温高圧蒸気滅菌)が内視鏡機器の滅菌方法として主流になりつつある。
例えば、特開2000−51323号公報の従来例では、内視鏡を高温高圧蒸気滅菌する際に、内視鏡内外の圧力差による内視鏡の外皮の破損を防ぐための滅菌処理方法が開示されている。
【0004】
【特許文献1】
特開2000−51323号公報
【0005】
【発明が解決しようとする課題】
しかしながら、上記従来例では内視鏡に内蔵され、端部が内視鏡外部に開放している細長の管路内の滅菌を速やかに、かつ確実に行うことに関しては特に述べられていない。
【0006】
(発明の目的)
本発明は、上述した点に鑑みてなされたもので、内視鏡に内蔵された管路内の滅菌を従来より速やかに、かつ確実に行うことができる内視鏡の高温高圧蒸気滅菌処理方法を提供することを目的とする。
【0007】
【課題を解決するための手段】
一端が挿入部先端部で内視鏡外部に開口し、他端が挿入部以外の部位で内視鏡外部に開口し、その内側に流体等を通すための管路を少なくとも一つ有する内視鏡を高温高圧蒸気により滅菌する内視鏡の高温高圧蒸気滅菌処理方法において、
前記管路の外側に連通し内視鏡外皮部で覆われて密閉された空間部と内視鏡外部とを選択的に連通する連通手段を有する内視鏡に対して、
前記連通手段により前記空間部と内視鏡外部とを連通させ、前記空間部と内視鏡外部とを一旦陰圧状態にした後に前記空間部と内視鏡外部とに蒸気を入れて、前記内視鏡を高温高圧蒸気滅菌する工程、
を具備したことにより、内視鏡の管路内側の他に、空間部から流入され蒸気による管路の外側から高温高圧蒸気滅菌処理を行うようにして、細長の管路の場合でも滅菌を速やかに、かつ確実に行うことができるようにしている。
【0008】
【発明の実施の形態】
以下、図面を参照して本発明の実施の形態を説明する。
(第1の実施の形態)
図1ないし図8は本発明の第1の実施の形態に係り、図1は第1の実施の形態に係る内視鏡装置の全体構成を示し、図2は内視鏡をトレイに収納した状態で示し、図3は電気コネクタ部の構成を示し、図4は内視鏡の管路系を示し、図5は高温高圧蒸気滅菌装置を示し、図6は高温高圧蒸気滅菌装置による滅菌工程の概略を示し、図7は内視鏡検査後のリプロセスの処理工程を示し、図8は本実施の形態による滅菌作用を内視鏡の模式図により従来例との比較で示す説明図である。
【0009】
図1に示すように内視鏡検査を行う内視鏡装置1は撮像手段を備えた内視鏡2と、内視鏡2に着脱自在に接続されて内視鏡2に設けられたライトガイドに照明光を供給する光源装置3と、内視鏡2と信号ケーブル4を介して接続されて内視鏡2の撮像手段を制御すると共に撮像手段から得られた信号を処理するビデオプロセッサ5と、プロセッサ5から出力される被写体像に対応する映像を表示するモニタ6から構成されている。
【0010】
この内視鏡2は観察や処置等の内視鏡検査に使用された後には、洗浄された後に、高温高圧蒸気により滅菌処理を行うことが可能なように、高温高圧蒸気に対する耐性を備えた部材で構成されている。また、この内視鏡2は、後述するように内視鏡2の挿入部7や操作部8等の外装部材(外皮部)の内側の空間部47にも積極的(強制的)に高温高圧蒸気を流入させて滅菌処理を行う構造にしているので、内部の信号線等も高温高圧蒸気に対する耐性を備えた部材で構成されていることが特徴の1つとなっている。
【0011】
内視鏡2は可撓性を有する細長の挿入部7と、挿入部7の基端側に接続された操作部8と、操作部8の側部から延出された可撓性を有する連結コード(ユニバーサルコード)9と、この連結コード9の端部に設けられ、光源装置3に着脱自在に接続されるコネクタ部10と、このコネクタ部10の側部に設けられ、プロセッサ5に着脱自在に接続される信号ケーブル4におけるその端部のコネクタ4aが着脱自在に接続可能な電気コネクタ部11とを有している。
電気コネクタ部11には内視鏡2の内部と外部とを連通する図3に示す通気部37が設けられている。
【0012】
挿入部7と操作部8の接続部には接続部の急激な曲がりを防止する弾性部材を有する挿入部側折れ止め部材12が設けられており、操作部8と連結コード9の接続部には同様の操作部側折れ止め部材13、連結コード9とコネクタ部10の接続部には同様のコネクタ部側折れ止め部材14が設けられている。
【0013】
挿入部7は可撓性を有する柔軟な可撓管部15と、この可撓管部15の先端側に設けられ、操作部8の操作により湾曲可能な湾曲部16と、先端に設けられ図示しない観察光学系、照明光学系等が設けられた先端部17から構成されている。
【0014】
先端部17には送気操作、送水操作によって図示しない観察光学系の外表面の光学部材に向けて洗滌液体や気体を噴出するための送気送水ノズル18と、挿入部7に配設された処置具を挿通したり体腔内の液体を吸引するための図示しない処置具チャンネルの先端側の開口である吸引口が設けられている。
又、この先端部17には観察対象物に向けて開口した液体を噴出するための送液口とが設けられている。
【0015】
コネクタ部10には光源装置3に内蔵された図示しない気体供給源と着脱自在に接続される気体供給口金21と、液体供給源である送水タンク22と着脱自在に接続される送水タンク加圧口金23及び液体供給口金24とが設けられている。又、前記吸引口より吸引を行うための図示しない吸引源と接続される吸引口金25が設けられている。又、送液口より送水を行うための図示しない送水手段と接続される注入口金26が設けられている。
【0016】
又、高周波処置等を行った際に内視鏡に高周波漏れ電流が発生した場合に漏れ電流を高周波処置装置に帰還させるためのアース端子口金27が設けられている。
【0017】
操作部8には送気操作、送水操作を操作する送気送水操作ボタン28と吸引操作を操作するための吸引操作ボタン29と、前記湾曲部の湾曲操作を行うための湾曲操作ノブ30と、前記ビデオプロセッサ5を遠隔操作する複数のリモートスイッチ31、前記処置具チャンネル連通した開口である処置具挿入口32が設けられている。
【0018】
内視鏡2の電気コネクタ部11に防水キャップ33が着脱自在に接続可能である。
防水キャップ33には図示しない圧力調整弁が設けられている。
また、図1に示すようにこの内視鏡2は高圧蒸気滅菌の際には、滅菌用収納ケース34が用いられる。
【0019】
この収納ケース34は、滅菌処理する内視鏡2を収納するトレイ35と、このトレイ35の上部側を覆う蓋部材36から構成されている。
トレイ35と蓋部材36には複数の図示しない通気孔が設けられており、その孔を通じて水蒸気が透過できるようになっている。図2(A)はこのトレイ35に内視鏡2を収納した状態を示す。
【0020】
図2(A)に示すようにトレイ35には内視鏡2の形状に対応して、内視鏡2を凹部内に収納規制する凹部形状が形成された規制部49が形成されている。例えば図2(A)におけるA−A断面は図2(B)のようになっている。この規制部49は内視鏡2のそれぞれの部分が所定の位置に収まるようにそれぞれの部分より少し大きな凹部形状に形成されている。
【0021】
図3は、電気コネクタ部11の内側の構造を示す。
電気コネクタ部11のケーシング46の内側に水密的に取り付けられた絶縁製の支持板39には、撮像信号線及びリモートスイッチ31の信号線が接続される複数の接点ピン38が設けられている。
【0022】
また、本実施の形態における内視鏡2にの電気コネクタ部11には、支持板39には、内視鏡2の内部と外部を連通する孔或いは開口としての通気部37が設けられている。この通気部37により、内視鏡2の外部と、内視鏡2の外皮部により密閉された内部の空間部47とを連通するようにしている。
この通気部37の一部に、蒸気は通すが、蒸気よりも大きい物体は通さない小孔48aを多数設けたフィルタ48を図示のように設けるようにしても良い。
【0023】
本実施の形態では、高温高圧蒸気で滅菌処理する際にこの通気部37から空間部47内に高温高圧蒸気を流入させ、この空間部47に連通する送気送水用管路等の管路の外側を高温高圧蒸気で短時間に滅菌処理できるようにしている。
【0024】
防水キャップ33を電気コネクタ部11に装着した時は、水密状態で装着される為、外部の液体は接点ピン38に触れたり、通気部37から内視鏡2の内部に侵入することはない。
【0025】
そして、内視鏡検査が終了すると、内視鏡2の洗浄を行う。このとき、内視鏡2の電気コネクタ部11に、防水キャップ33を装着し、洗浄液が内視鏡2の内部に侵入したり、電気信号の接点ピン38に触れて将来的に接点ピン38の表面を劣化(通電不良など)させたりしないように防止する。
【0026】
洗浄工程が終わると、図2のトレイ35に内視鏡2を所定形状で収納する。このとき、コネクタ部10周辺の窪み49aは、コネクタ部10の形状に沿った窪みになっており、電気コネクタ部11から防水キャップ33を完全に取り外さないと、コネクタ部10(及び電気コネクタ部11)を窪み82a内に収納できないようにしている。
【0027】
図4は、内視鏡2の内部に内蔵されている様々な管路を模式的に示す。
管路40は主に挿入部7内にあり、その管路先端40aは、先端部17において外部に対して開口しており、管路後端40bは操作部8において外部に対して開口している。管路40は例えば処置具挿通用あるいは吸引用の管路である。
【0028】
管路41は主に連結コード9内にあり、その管路先端41aは、操作部8において外部に対して開口しており、管路後端41bは吸引口金25によってコネクタ部10において外部に対して開口している。管路41は例えば吸引用の管路である。
【0029】
管路42は主に操作部8内にあり、その管路先端は管路後端40bと共通で、操作部8において外部に対して開口しており、管路後端は管路先端41aと共通で操作部8において外部に対して開口している。管路42は例えば吸引用の管路である。
【0030】
そして、管路後端41b(吸引口金25)に図示しない吸引器からの管路を接続して吸引器で吸引操作し、管路先端41a、管路後端40bを塞いでおくと、管路41、管路42、管路40という経路で管路先端40aから吸引を行うことができる。
【0031】
管路43は主に挿入部7内にあり、その管路先端43aは、先端部17において外部に対して開口しており、管路後端43bは操作部8において外部に対して開口している。管路43は例えば先端部17のレンズ面の洗浄で送気や送水を行う送気送水用の管路である。
【0032】
管路44は主に連結コード9内にあり、その管路先端は管路後端43bと共通で、操作部8において外部に対して開口しており、管路後端44bは送水タンク加圧口金23,気体供給口金24によってコネクタ部10において外部に対して開口している。管路後端43bをふさいで、管路後端44b(送水タンク加圧口金23,気体供給口金24)から送気又は送水を行うと、管路先端43aから送気または送水ができる。
【0033】
管路45は主に挿入部7、連結コード9内にあり、その管路先端45aは、先端部17において外部に対して開口しており、管路後端45bは注入口金26によってコネクタ部10において外部に対して開口している。管路45は例えば観察対象物に送液する前方送水用の管路である。
【0034】
このように、内視鏡2内には両端が外部に対して開口し、内側に流体等を挿通可能とする様々な管路が内蔵されている。しかも、挿入部7と連結コード9とは共に柔軟な部材で形成され、中実ではなく、中空状である。また、挿入部7と連結コード9の中の管路の大部分は、柔軟な動きに対応できるように中空部分に非固定状態で配置されて、管路周囲は他の内蔵物はあるものの、殆ど空間になっている。
【0035】
これらの管路の中間部分(ここでは端部から離れた位置という意味で、ある程度広い範囲を指す)における管路の外側(で内視鏡2の外皮内側)は周囲の空間部47と連通し、この空間部47は通気部37により外部と連通している。つまり、管路外側は空間部47と連通する(連通手段となる)通気部37を介して外部と連通する状態となっている。そして、この通気部37による連通状態は防水キャップ33の装着/未装着(取り外し)により選択できる。
【0036】
本実施の形態では、例えばある管路の開口部と開口部とを結ぶ経路の真ん中の部分周辺には、充填剤や固形物により内視鏡2の外皮内側を充填してしまうことなく、上記空間部47が形成される空間が確保されている。また、その空間部47と通気部37との経路の途中にも様々な内蔵物や部品が存在するが、それらは蒸気の通りを遮断しないように配置されている。従って、この経路により蒸気は阻害されることなく通ることができる。
【0037】
本実施の形態に係る内視鏡2では、通気部37を設けることにより、滅菌処理を行う場合に、内視鏡2の内部に設けられた各管路におけるその周囲の空間部47と連通させることができ、プレバキュームの際に空間部47もプレバキューム状態に設定でき、その後の高温高圧蒸気滅菌する工程において、(管路の内側はもとより)管路の外側の空間部47にも高温高圧蒸気を速やかに供給して充満可能にして高温高圧蒸気滅菌処理を短時間で終了できるようにしていることが特徴となっている。
【0038】
この場合の作用は図8を参照して後述する。
また、本実施の形態に係る内視鏡2をトレイ35に収納して高温高圧蒸気滅菌を行う高温高圧蒸気滅菌装置50を図5に示す。
この高温高圧蒸気滅菌装置50は、その前面に設けた扉51を開くと、その内側が高温高圧蒸気滅菌を行う滅菌室となるチャンバ52になっており、そこにトレイ35に収納した内視鏡2を投入して扉51を閉じて滅菌処理を行うことができる。
【0039】
このチャンバ52の形状は、例えば、内視鏡2を収納した滅菌用収納ケース34を1個だけ、ぎりぎりで入るようにな収納サイズにしている。
また、この高温高圧蒸気滅菌装置50の一部に、コネクタ部10(電気コネクタ部11)と防水キャップ33の相対的な状態を検知する手段を設けるようにしても良い。
【0040】
例えば電気コネクタ部11近傍と防水キャップ33のそれぞれに何らかのチップを設け、高温高圧蒸気滅菌装置50によってそれらチップの距離を測定することで、電気コネクタ部11に防水キャップ33が装着されているか否かを検知できるようにしても良い。
これ以外の機構により、電気コネクタ部11に防水キャップ33が装着されているか否かを検知する手段を設けるようにしても良い。
【0041】
上記高温高圧蒸気滅菌装置50等による高温高圧の蒸気滅菌の代表的な条件としては米国規格協会承認、医療機器開発協会発行の米国規格ANSI/AAMIST37−1992では滅菌工程の前に減圧するプレバキュームタイプにおいては滅菌工程132℃で4分、滅菌工程の前に減圧しないグラビティタイプにおいては滅菌工程132℃で10分とされている。
【0042】
高圧蒸気滅菌の滅菌工程時の温度条件については高圧蒸気滅菌装置の形式や滅菌工程の時間によって異なるが、一般的には115℃から138℃程度の範囲で設定される。滅菌装置の中には142℃程度に設定可能なものもある。
【0043】
時間条件については滅菌工程の温度条件によって異なるが、一般的には3分〜60分程度に設定される。滅菌装置の種類によっては100分程度に設定可能なものもある。
この工程での滅菌室内の圧力は一般的には大気圧に対して+0.2MPa程度に設定される。
【0044】
一般的なプレバキュームタイプの高圧蒸気滅菌工程には滅菌対象機器を収容した滅菌室内を滅菌工程の前に減圧状態にするプレバキューム工程と、この後に滅菌室内に高圧高温蒸気を送り込んで滅菌を行う滅菌工程が含まれている。
【0045】
プレバキューム工程は、後の滅菌工程時に滅菌対象機器の細部にまで蒸気を浸透させるための工程であり、滅菌室内を減圧させることによって滅菌対象機器全休に高圧高温蒸気が行き渡るようになる。
プレバキューム工程における滅菌室内の圧力は一般的には大気圧に対して−0.07MPa〜−0.09MPa程度に設定される。
【0046】
滅菌後の滅菌対象機器を乾燥させるために滅菌工程後に滅菌室内を再度減圧状態にする乾燥工程が含まれているものがある。この工程では滅菌室内を減圧して滅菌室内から蒸気を排除して滅菌室内の滅菌対象機器の乾燥を促進する。この工程における滅菌室内の圧力は一般的には大気圧に対して−0.07〜−0.09MPa程度に設定される。
【0047】
本実施の形態では、後述するように内視鏡2を高温高圧蒸気滅菌する際には防水キャップ33を電気コネクタ部11から取り外した状態で行う。そして、上述したように内視鏡2に通気部37を設けておくことにより、短時間で高温高圧蒸気滅菌処理を完了できるようにしている。
【0048】
次に本実施の形態による内視鏡2の高温高圧蒸気滅菌する方法を説明する。
まず、高温高圧蒸気滅菌装置50により内視鏡2を高温高圧蒸気滅菌する場合の全工程の一例を図6に示す。
【0049】
図6に示すように、高温高圧蒸気滅菌する全工程は予熱工程、プレバキューム工程、滅菌工程、陰圧乾燥工程からなる。なお、図6において、実線は圧力状態を示し、点線は温度状態を示している。また、圧力は大気圧の状態を0として、加圧した場合には正の値で、陰圧にした場合を負の値で示している。
【0050】
図6では、プレバキュームは−0.09〜−0.07MPaの陰圧において3回行っている。この間、蒸気供給がなされ、温度も上昇する(図6では非常にラフな線で模式的に示している)。
【0051】
滅菌工程では、0.22MPaの圧力に設定して135℃(温度と圧力は対応している)の温度で実施している。
【0052】
また、図7は内視鏡2で内視鏡検査を行った後、洗浄作業と滅菌作業とを行って再び内視鏡検査が可能とするリプロセスの工程を示す。
【0053】
図7に示すようにステップS1において内視鏡検査を行い、内視鏡検査が終了したら、ステップS2に示すように防水キャップ33を電気コネクタ部11に装着してこの電気コネクタ部11を防水にして内視鏡2の水密を確保する。
【0054】
そして、ステップS3及びッステップS4の洗浄作業を行う。ステップS3においては水密状態の内視鏡2を洗浄槽等に挿入して内視鏡2の外表面及び管路内の洗浄を行う。
【0055】
その後、ステップS4に示すように洗浄液のリンス及び乾燥が行われて洗浄作業を終了する。
この洗浄作業が終了したらステップS5に示すように防水キャップ33を電気コネクタ部11から取り外し、内視鏡2をトレイ35に収納する。
【0056】
内視鏡2をトレイ35に収納する場合、防水キャップ33を外してないと、コネクタ10がトレイ35の規制部49a内に収納できないので、ユーザは、(防水キャップ33を外してない)内視鏡2が次のステップに移るのに不適切な状態であることを認識することができる。この様子を図2において、防水キャップ33を取り付けた状態を2点鎖線で示している。
【0057】
更には、仮にユーザがコネクタ10がトレイ35に収納されていなくても強引に高温高圧蒸気滅菌装置50に投入しようとした場合、チャンバ52の収納形状が、内視鏡2を収納した滅菌用収納ケース34がぎりぎり1つ入る形状であれば、コネクタ10が収納されずに浮いていれば、チャンバ52に入れられないので、それによっても、滅菌作業に移ることができないことを認識することができる。
【0058】
また、前述のように、高温高圧蒸気滅菌装置50によって防水キャップ33が電気コネクタ部11に装着されているか否かを検知手段で検知するようにしてもよい。
【0059】
このようにして内視鏡2を滅菌用収納ケース34のトレイ35に収納し、蓋部材36で蓋をする。この後、ステップS6に示すように内視鏡2を収納した滅菌用収納ケース34を滅菌用パック(ピールパックなど)に収納(梱包)する。滅菌用パックへの梱包は外気中の菌が侵入できない(空気、水蒸気は透過するが菌が侵入できない)ように確実に行う。
【0060】
そして、ステップS7からステップS10までの滅菌作業を行う。まず、ステップS7においては、トレイ35(或いは滅菌用収納ケース34)収納状態の内視鏡2を高温高圧蒸気滅菌装置50に投入する。
【0061】
以下の滅菌作業においては、チャンバ52の空間が、通気部37を介して、内視鏡2の内部(より正確には前述した管路の中間部分周辺の空間部47)と連通している。
【0062】
高温高圧蒸気滅菌装置50では、ステップS9の高温高圧蒸気滅菌工程に進む前に、ステップS8の予熱及びプレバキューム工程(陰圧工程)がある。
特にプレバキューム工程によって、チャンバ52内部及び内視鏡2内の空間部47を陰圧にし、蒸気供給を行うと共に元の圧力に戻す。このプロセスを最低1回行う。
【0063】
プレバキューム工程は複数回ある方が、チャンバ52及び内視鏡2内の空間部47の空気を蒸気に完全に置換しやすくなり、望ましい。
このプレバキューム工程の後にステップS9の高温高圧蒸気滅菌を行う。
この高温高圧蒸気滅菌により内視鏡2を高温高圧蒸気で滅菌することができる。
【0064】
この高温高圧蒸気滅菌の後にステップS10に示すように陰圧の乾燥工程(バキュームによる乾燥工程)を行う。
このように陰圧にして乾燥を行う工程を行うことにより、内視鏡2内の空間部47に入った蒸気を通気部37を介して外部に排出除去することができ、内視鏡2内が水で湿った状態になることがなく、かつ内視鏡2内の構成部品の耐久性を保つことができる(錆や湿気による劣化を極力回避できる)。このため、陰圧による乾燥を行うことが望ましい。
【0065】
この乾燥の工程を行った後に、高温高圧蒸気滅菌装置50から滅菌用パックに覆われた内視鏡2を取り出す。
そして、ステップS11に示すように内視鏡検査を行う前に滅菌用パックを開封して滅菌されて滅菌用収納ケース34に収納された内視鏡2を取り出す。
【0066】
次に、通気部37を設けたことによる作用効果を図8を参照して説明する。図8(A)は本実施の形態におけるチャンバ52内に通気部37を設けた内視鏡2Aを収納した場合を模式的に示し、比較のためにチャンバ52内に通気部37を形成していない内視鏡2′を収納した場合を図8(B)に示す。なお、図8(A),図8(B)において、実際には内視鏡2及び2′は滅菌用収納ケース34に収納され、さらに蒸気を通す滅菌用パックで覆われるが、簡単化のため省略している。
【0067】
図8(A)では内視鏡2は通気部37により、内視鏡2の内部の空間部47とチャンバ52内の空間部52aとが連通しているのに対して、図8(B)の内視鏡2′では通気部37が設けてないので、内視鏡2′の内部の空間部47はチャンバ52内の空間部52aと遮断されている。
【0068】
また図8(A),(B)において、内視鏡2は、端部53,54とそれらに固定された外皮管体55と、端部53,54で両端が開口し、外皮管体55内に収納された管路56(例えば管路45を模擬したもの)、空間部47からなる。図8(A)では端部54に通気部37が設けられている。
【0069】
図8(B)の場合、空間部47はチャンバ52の空間部52aとは遮断された密閉空間となるため、高温高圧滅菌工程においてチャンバ52内の空間部52aが高温高圧蒸気で充満されていても空間部47内は圧力が高くならず、温度もなかなか上がらない。
【0070】
そのため、プレバキュームの工程後に管路56内に蒸気が入っても、その蒸気は管路56の奥(端部54から離れた位置)にいくほど、蒸気の温度は上昇しにくくなる(管路56の途中で空間部47により温度が低下しやすい)。そのため、滅菌を確実に行うには、かなり長い時間がかかる恐れがある。
【0071】
一般に内視鏡検査は、同じ日に複数例実施されることが多く、最初の検査で使った内視鏡をリプロセスして、同じ日に再度、そして何度も使うことがよくある。そのとき、できるだけ早く確実にリプロセスできることが望まれている。
【0072】
本実施の形態に係る内視鏡2の場合には図8(A)の状態になり、通気部37が設けられているので、プレバキューム後の蒸気供給で蒸気が通気部37から空間部47に入る。
【0073】
従って、チャンバ52内の空間部52aと空間部47とは略同等の圧力、略同等の蒸気の存在になりやすく、そうなると、管路56の奥の方であっても管路56の内側はもとより外側からもチャンバ52の空間部52aに充満される高温高圧蒸気により同様のレベルの熱を加えられ、管路56内のどの位置も速やかに滅菌が可能となる。
【0074】
また、通気部37の重要な要素は、そのサイズにある。
仮に、通気部37が空間部47の容積に対して非常に小さい(細い)ものであったとする(例えば0.1mmなど)。
そうなると、チャンバ52内の圧力変化のスピードに対して、空間部47が同期することができず、タイムラグが生じる。
【0075】
プレバキューム工程では、チャンバ52内では、例えば−0.08MPaの状態が3回繰り返し行われても、空間部47内は−0.08MPaに至る前に(例えば,0.03MPa程度で)チャンバ52内では(高温高圧蒸気の)圧力上昇の工程に入ることもありうる。
【0076】
そうなると、空間部47内は十分なブレバキュームを行っていないので、もともと空間部47内にあった空気がかなり残り、蒸気への置換が不十分となりうる。この場合、チャンバ52内の最低圧力状態を長く保持するようにすれば、空間部47内の圧力もやがて同様の圧力になるうるが、時間が長びくのはユーザが望む状態とは反対の方向である。
【0077】
高温高圧蒸気による滅菌工程においても、チャンバ52内が0.22MPaに到達しても、空間部47内はなかなか到達せず遅れるので、結局、滅菌を達成する為には、滅菌時間(最高温度状態)を長く延ばさなければならず、これもユーザの望む状態とは反対の方向である。
以上より、通気部37のサイズは、空間部47の容積に対して適度の大きさが望ましい。
【0078】
例えば1mm以上、できれば5mm、10mmと、大きい方がより望ましい。
また、できれば、通気部37に連通した内視鏡2の内部の空間部47の中で、最もクリアランスの小さな部分のクリアランスの面積よりも、通気部37の面積が大きい方が、通気部37が蒸気侵入のボトルネックとなるのを防ぐことができる。
【0079】
このように、本実施の形態では、プレバキューム工程、高温高圧蒸気滅菌工程において、チャンバ52内と内視鏡2内の空間部47とが常時略同等の圧力で工程が推移するようにした(そうなるような内視鏡2内の内部空間の容積と通気部37のサイズを設定した)。そうすることで、短い時間内に確実に管路内の滅菌処理ができる。
【0080】
なお、図3で示したように通気部37の一部に、蒸気は通すが、ある程度の大きさの物体は通さないフィルタ48が設けてあると、内視鏡2内で使用されている潤滑剤などが、万が一、防水キャップ33を外した状態での滅菌作業中に通気部37から外部に出てしまうことを防止できる。なお、蒸気のみを通す程度の小さな孔を多数設けたフィルタを取り付けるようにしても良い。
【0081】
従って本実施の形態は以下の効果を有する。
内視鏡2に内蔵された管路内の滅菌をより速やかに確実に行うことができる。また、簡単な構成で管路内等の滅菌処理を短時間に行うことができる。
【0082】
(第2の実施の形態)
次に本発明の第2の実施の形態を図9を参照して説明する。第1の実施の形態では電気コネクタ部11に通気部37を設けた場合で説明した。本実施の形態は通気部37を電気コネクタ部11以外の部分に設けて改良したものである。
【0083】
通気部37を電気コネクタ部11に設けた場合の改善すべき点を以下に列挙する。
(a)電気コネクタ部11(あるいはコネクタ部10)は、光源装置3やプロセッサ5と接続する部分である為、挿入部7から最も離れた位置にある。従って、通気部37を介して挿入部7に内蔵された管路に蒸気が届きにくい(通気部37が十分大きけれぱよいが)。
【0084】
(b)第1の実施の形態の中でも述べたように、通気部37はできるだけ大きい方が望ましい。しかし、内視鏡2と、高温高圧蒸気滅菌ができない既存の内視鏡とを共通に光源装置3やプロセッサ5に接続可能にする場合(互換性確保)、内視鏡2の電気コネクタ部11を従来の内視鏡より大きくすることはできない。
そのような限られたスペースに通気部37を設けなければならず、通気部37は比較的小さなサイズにせざるを得ない。
【0085】
(c)図3で示した接点ピン38のすぐ内側の空間部47は数多くの配線で入り組んでいる。場合によっては、それが通気部37からの蒸気の侵入を阻害することもありうる。それらの配線は電気コネクタ部11から少し離れた位置では束ねられて1本あるいは数本のケーブルになる。
【0086】
これらの点を考慮して図9に示す内視鏡2Bでは、内視鏡2B内の空間部47に連通する通気部37を、操作部8の一部に設けるようにしている。この場合、通気部37には、水密キャップ60を着脱自在とし、またこの水密キャップ60は紐部材61によって操作部8に繋がれているようにしいてる。
これら通気部37、水密キャップ60は破線で示す操作部8の後端付近に設けるようにしても良い。
【0087】
なお、図9の内視鏡2Bを滅菌用収納ケース34に収納する場合、検査中や洗浄時に通気部37に装着していた水密キャップ60を外さないと、内視鏡2Bを滅菌用収納ケース34に収納できないようなトレイ35の形状にしている。
また、通気部37と外部との連通状態をユーザに告知する手段を設けるようにしても良い。
【0088】
本実施の形態によれば、通気部37を操作部8に設けることによって、挿入部7に近い部位に形成でき、通気部37から浸入した蒸気を内視鏡2内の空間部47全体に行き渡らせやすい。
【0089】
また、水密キャップ60を紐部材61で繋ぐようにすることにより、水密キャップ60を紛失することを防止できる。
図10に示す変形例の内視鏡2Cでは、通気部37は第1の実施の形態と同様、電気コネクタ部11内に設けられている。
【0090】
この場合、そのままでは上述した(a)及び(b)の改善すべき点が残るが、通気部37にチューブ62の一端62bを接続し、連結コード9内を挿通して他方の端部62aを操作部8の内部の空間部47に連通させるようにして、改善すべき点をほぼ解消している。
【0091】
つまり、このチューブ62で蒸気侵入路を形成し、チューブ62により内視鏡2Cの挿入部7から離れた操作部8や連結コード9側に蒸気を侵入し易くし、かつ既存の内視鏡の場合と同様に共通の光源装置3やプロセッサ5に接続可能にしている。
【0092】
本変形例によれば、通気部37を操作部8に設けた場合における操作部8の重量が増してしまうこともなく、既存の内視鏡の場合と同様の操作性を確保することができる。
【0093】
また、別の変形例として、通気部37を、電気コネクタ部11ではなく、コネクタ部10において電気コネクタ部11よりも操作部8側寄り、例えば吸引口金25や注入口金26近傍に設けても良い。
そうすれば通気部37を比較的大きくすることもでき、上記(b)、(c)の改善すべき点を解決できる。
【0094】
さらに別の変形例として、複数箇所に通気部を設けるようにしても良い。図11はこの場合の内視鏡2Dを示す。
【0095】
この内視鏡2Dでは図9に示したように操作部8に通気部37を防水キャップ60で覆うことができるように設けると共に、さらにコネクタ部10における電気コネクタ部11以外の部分、例えば吸引口金25や注入口金26近傍に通気部37bを設けるようにしている。また、この通気部37bも例えば紐部材61bに接続された防水キャップ61bで防水できるようにしている。
このように1つの内視鏡2Dにおける複数箇所、例えば離間した複数箇所に通気部37、37bを設けるようにしても良い。
【0096】
このようにすると細長の内視鏡2Dにおける細長の管路をその内側からはもとより、管路の外側の複数箇所の通気部37、37bから蒸気滅菌で短時間に高温状態に設定した短時間での滅菌を行うことができる。
【0097】
[付記]
1.一端が挿入部先端部で内視鏡外部に開口し、他端が挿入部以外の部位で内視鏡外部に対し開口し、その内側に流体等を通すための管路を少なくとも一つ有し、前記管路の外側に連通し内視鏡外皮部で覆われて密閉された空間部と内視鏡外部とを選択的に連通する連通手段を有する内視鏡に対して、
前記連通手段により前記空間部と内視鏡外部との連通を遮断して前記内視鏡を洗浄する洗浄工程と、
前記洗浄工程により洗浄された前記内視鏡に対して前記連通手段により前記空間部と内視鏡外部とを連通させ、前記空間部と内視鏡外部とを常時略等圧状態にしながら、前記空間部と内視鏡外部とを一時陰圧状態にした後に前記空間部と内視鏡外部とに蒸気を入れて、前記内視鏡を高温高圧蒸気滅菌する工程と、
を具備したことを特徴とする内視鏡の高温高圧蒸気滅菌処理方法。
【0098】
2.付記1において、高温高圧蒸気滅菌装置の運転前に、前記連通手段により前記空間部と内視鏡外部とを連通させない場合、その非連通状態をユーザに告知する。
3.付記2において、洗浄工程の後に、前記内視鏡を所定状態で専用トレイに収納する工程と、収納時に、前記連通手段により前記空間部と内視鏡外部とを連通させないと所定状態の収納ができないようにしたことを特徴とする。
【0099】
4.付記1において、前記連通手段は内視鏡の撮像信号線と外部装置を接続する信号接続コネクタ部以外に設けた。
5.付記4において、前記連通手段は内視鏡コネクタ部における信号接続コネクタ部以外にある。
6.付記4において、前記連通手段は内視鏡操作部の一部に設けたことを特徴とする。
【0100】
7.付記1において、前記連通手段を複数設けたことを特徴とする。
8.付記1において、前記連通手段は内視鏡外部に開放する端部と内視鏡内部の所定位置にある端部とを繋ぐ管路部材からなることを特徴とする。
9.付記1において、前記連通手段は、水蒸気は通すが、ある大きさ以上の物体は通さないフィルタを有することを特徴とする。
【0101】
10.一端が挿入部先端部で内視鏡外部に開口し、他端が挿入部以外の部位で内視鏡外部に対し開口し、その内側に流体等を通すための管路を少なくとも一つ有し、前記管路の外側が内視鏡外皮部で覆われて密閉された空間部に連通すると共に、高温高圧蒸気に対する耐性を有する内視鏡において、
前記管路の外側を高温高圧蒸気で滅菌するための高温高圧蒸気流入用開口を前記内視鏡外皮部に設けたことを特徴とする内視鏡。
【0102】
11.付記10において、前記高温高圧蒸気流入用開口は外部装置に着脱自在に接続可能とするコネクタ部に設けられる。
12.付記10において、前記高温高圧蒸気流入用開口は防水用キャップの装着により密閉され、前記空間部側を水密状態に保持して洗浄液による洗浄を可能にした。
13.付記10において、前記高温高圧蒸気流入用開口は、内視鏡外部と略等圧状態にする機能を持つ。
【0103】
(付記10〜13の背景)
先行例として特公平4ー5451号がある。この先行例の内視鏡において、開口が開示されているが、内視鏡自体が高温高圧蒸気による耐性を有していないので、高温高圧蒸気滅菌に対する開示も示唆もない。
(付記10〜13の目的)
簡単な構成で管路内等の滅菌を従来より速やかに、かつ確実に行うことができる内視鏡を提供することを目的として付記10〜13の構成にした。
【0104】
【発明の効果】
以上説明したように本発明によれば、内視鏡の高温高圧蒸気滅菌を行う際、内視鏡に内蔵された管路内の滅菌をより速やかにかつ確実に行うことができる。
【図面の簡単な説明】
【図1】本発明の第1の実施の形態に係る内視鏡装置の全体構成図。
【図2】内視鏡をトレイに収納した状態で示す平面図及びA−A断面図。
【図3】電気コネクタ部の構成を示す断面図。
【図4】内視鏡の管路系を示す図。
【図5】高温高圧蒸気滅菌装置を示す斜視図。
【図6】高温高圧蒸気滅菌装置による滅菌工程の概略を示す図。
【図7】内視鏡検査後のリプロセスの処理工程を示すフローチャート図。
【図8】本実施の形態による滅菌作用を内視鏡の模式図により従来例との比較で示す説明図。
【図9】本発明の第2の実施の形態に係る内視鏡を示す平面図。
【図10】図9の内視鏡の第1変形例の概略を示す平面図。
【図11】図9の内視鏡の第2変形例を示す平面図。
【符号の説明】
1…内視鏡装置
2…内視鏡
3…光源装置
4…信号ケーブル
5…プロセッサ
6…モニタ
7…挿入部
8…操作部
9…連結コード
10…コネクタ部
11…電気コネクタ部
17…先端部
18…送気送水ノズル
21…気体供給口金
23…送水タンク加圧口金
24…液体供給口金
25…吸引口金
26…注入口金
32…処置具挿入口
33…防水キャップ
34…滅菌用収納ケース
35…トレイ
37…通気部
40〜45、56…管路
47…空間部
50…高温高圧蒸気滅菌装置
52…チャンバ
53,54…端部
[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an endoscope high-temperature high-pressure steam sterilization method for sterilizing an endoscope with high-temperature high-pressure steam.
[0002]
[Prior art]
Endoscopes that can be used for observing deep parts in body cavities by inserting into body cavities, etc., and performing treatment treatments by using treatment tools as needed, have come to be widely used in the medical field. .
In the case of a medical endoscope, it is indispensable to surely disinfect and sterilize the used endoscope in order to prevent infections and the like.
[0003]
Recently, when disinfecting and sterilizing, autoclave sterilization (high-temperature and high-pressure steam sterilization), which does not involve complicated work, can be used immediately after sterilization, and is advantageous in terms of running cost, is the mainstream sterilization method for endoscope equipment. It is becoming.
For example, in the conventional example of Japanese Patent Laid-Open No. 2000-51323, a sterilization method for preventing damage to the outer skin of the endoscope due to a pressure difference between the inside and outside of the endoscope is disclosed when the endoscope is sterilized at high temperature and high pressure steam. Has been.
[0004]
[Patent Document 1]
JP 2000-51323 A
[0005]
[Problems to be solved by the invention]
However, in the above-described conventional example, there is no particular description regarding quick and reliable sterilization in an elongated pipe line that is built into an endoscope and whose end is open to the outside of the endoscope.
[0006]
(Object of invention)
The present invention has been made in view of the above-described points, and a high-temperature high-pressure steam sterilization method for an endoscope capable of performing sterilization in a duct built in an endoscope more quickly and reliably than before. The purpose is to provide.
[0007]
[Means for Solving the Problems]
An endoscope having one end opened to the outside of the endoscope at the distal end of the insertion portion, the other end opened to the outside of the endoscope at a portion other than the insertion portion, and at least one conduit for allowing fluid or the like to pass therethrough In the high-temperature high-pressure steam sterilization processing method of the endoscope that sterilizes the mirror with high-temperature high-pressure steam,
For an endoscope having communication means that selectively communicates between a space portion that is communicated with the outside of the duct and is covered and sealed with an endoscope skin portion and the exterior of the endoscope,
The space means is communicated with the exterior of the endoscope by the communicating means, and after the space and the exterior of the endoscope are once in a negative pressure state, steam is put into the space and the exterior of the endoscope, A process of sterilizing the endoscope at high temperature and high pressure steam,
In addition to the inner pipe line of the endoscope, the high-temperature and high-pressure steam sterilization treatment is performed from the outside of the pipe line that flows in from the space, so that sterilization can be performed quickly even in the case of an elongated pipe line. It is possible to carry out it reliably and reliably.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will be described below with reference to the drawings.
(First embodiment)
1 to 8 relate to a first embodiment of the present invention, FIG. 1 shows an overall configuration of an endoscope apparatus according to the first embodiment, and FIG. 2 shows that the endoscope is housed in a tray. 3 shows the configuration of the electrical connector section, FIG. 4 shows the endoscope conduit system, FIG. 5 shows the high-temperature high-pressure steam sterilizer, and FIG. 6 shows the sterilization process by the high-temperature high-pressure steam sterilizer. FIG. 7 shows processing steps of reprocessing after endoscopy, and FIG. 8 is an explanatory diagram showing the sterilization action according to this embodiment in comparison with a conventional example by a schematic diagram of an endoscope. is there.
[0009]
As shown in FIG. 1, an endoscope apparatus 1 that performs an endoscopic examination includes an endoscope 2 that includes an imaging unit, and a light guide that is detachably connected to the endoscope 2 and provided in the endoscope 2. A light source device 3 for supplying illumination light to the endoscope, a video processor 5 connected to the endoscope 2 via a signal cable 4 for controlling the imaging means of the endoscope 2 and processing signals obtained from the imaging means. The monitor 6 displays a video corresponding to the subject image output from the processor 5.
[0010]
This endoscope 2 has resistance to high-temperature and high-pressure steam so that it can be sterilized with high-temperature and high-pressure steam after being used for endoscopy such as observation and treatment after being cleaned. It is composed of members. In addition, the endoscope 2 is actively (forcedly) heated and pressurized at a space 47 inside the exterior member (outer skin portion) such as the insertion portion 7 and the operation portion 8 of the endoscope 2 as described later. Since the structure is such that the sterilization process is performed by injecting steam, one of the features is that the internal signal lines and the like are also composed of members having resistance to high-temperature and high-pressure steam.
[0011]
The endoscope 2 has an elongated insertion portion 7 having flexibility, an operation portion 8 connected to the proximal end side of the insertion portion 7, and a flexible connection extending from a side portion of the operation portion 8. A cord (universal cord) 9, a connector portion 10 provided at an end portion of the connecting cord 9 and detachably connected to the light source device 3, and provided on a side portion of the connector portion 10 and detachable from the processor 5 The connector 4a at the end of the signal cable 4 to be connected to the electric connector 11 is detachably connectable.
The electrical connector portion 11 is provided with a ventilation portion 37 shown in FIG. 3 that communicates the inside and the outside of the endoscope 2.
[0012]
The connecting portion between the insertion portion 7 and the operation portion 8 is provided with an insertion portion side anti-folding member 12 having an elastic member for preventing a sudden bending of the connection portion. A similar connector portion side bending prevention member 14 is provided at a connection portion between the operation portion side bending prevention member 13 and the connecting cord 9 and the connector portion 10.
[0013]
The insertion portion 7 is provided with a flexible flexible tube portion 15 having flexibility, a bending portion 16 which is provided on the distal end side of the flexible tube portion 15 and can be bent by the operation of the operation portion 8, and is provided at the distal end. It is composed of a tip portion 17 provided with an observation optical system, an illumination optical system, and the like.
[0014]
An air supply / water supply nozzle 18 for ejecting a cleaning liquid or gas toward the optical member on the outer surface of the observation optical system (not shown) by an air supply operation and a water supply operation and an insertion portion 7 are disposed at the distal end portion 17. A suction port which is an opening on the distal end side of a treatment tool channel (not shown) for inserting the treatment tool or sucking the liquid in the body cavity is provided.
Further, the tip portion 17 is provided with a liquid supply port for ejecting a liquid that is opened toward the observation object.
[0015]
The connector unit 10 includes a gas supply base 21 that is detachably connected to a gas supply source (not shown) built in the light source device 3, and a water supply tank pressure base that is detachably connected to a water supply tank 22 that is a liquid supply source. 23 and a liquid supply cap 24 are provided. A suction base 25 connected to a suction source (not shown) for performing suction from the suction port is provided. In addition, an injection base 26 connected to a water supply means (not shown) for supplying water from the liquid supply port is provided.
[0016]
In addition, when a high frequency leakage current is generated in the endoscope when a high frequency treatment or the like is performed, an earth terminal cap 27 is provided for returning the leakage current to the high frequency treatment device.
[0017]
The operation unit 8 includes an air supply / water supply operation button 28 for operating an air supply operation and a water supply operation, a suction operation button 29 for operating the suction operation, a bending operation knob 30 for performing the bending operation of the bending portion, A plurality of remote switches 31 for remotely operating the video processor 5 and a treatment instrument insertion port 32 which is an opening communicating with the treatment instrument channel are provided.
[0018]
A waterproof cap 33 can be detachably connected to the electrical connector portion 11 of the endoscope 2.
The waterproof cap 33 is provided with a pressure adjustment valve (not shown).
Further, as shown in FIG. 1, the endoscope 2 uses a sterilization storage case 34 in the case of high-pressure steam sterilization.
[0019]
The storage case 34 includes a tray 35 that stores the endoscope 2 to be sterilized and a lid member 36 that covers the upper side of the tray 35.
The tray 35 and the lid member 36 are provided with a plurality of air holes (not shown) through which water vapor can pass. FIG. 2A shows a state where the endoscope 2 is stored in the tray 35.
[0020]
As shown in FIG. 2 (A), the tray 35 is formed with a restricting portion 49 having a concave shape for restricting the storing of the endoscope 2 in the concave portion, corresponding to the shape of the endoscope 2. For example, the AA cross section in FIG. 2 (A) is as shown in FIG. 2 (B). The restricting portion 49 is formed in a concave shape that is slightly larger than each portion so that each portion of the endoscope 2 is in a predetermined position.
[0021]
FIG. 3 shows an internal structure of the electrical connector portion 11.
A plurality of contact pins 38 to which the imaging signal lines and the signal lines of the remote switch 31 are connected are provided on an insulating support plate 39 that is watertightly attached to the inside of the casing 46 of the electrical connector portion 11.
[0022]
Further, in the electrical connector portion 11 of the endoscope 2 according to the present embodiment, the support plate 39 is provided with a ventilation portion 37 as a hole or opening that communicates the inside and the outside of the endoscope 2. . The ventilation portion 37 allows the outside of the endoscope 2 to communicate with the internal space portion 47 sealed by the outer skin portion of the endoscope 2.
A filter 48 having a large number of small holes 48a through which steam passes but does not allow passage of an object larger than the steam may be provided as shown in the drawing.
[0023]
In the present embodiment, when sterilizing with high-temperature and high-pressure steam, high-temperature and high-pressure steam is caused to flow into the space 47 from the ventilation portion 37, and a pipe such as an air / water supply conduit communicating with the space 47 is provided. The outside can be sterilized with high-temperature and high-pressure steam in a short time.
[0024]
When the waterproof cap 33 is attached to the electrical connector portion 11, it is attached in a watertight state, so that external liquid does not touch the contact pins 38 or enter the endoscope 2 from the ventilation portion 37.
[0025]
Then, when the endoscopy is completed, the endoscope 2 is cleaned. At this time, a waterproof cap 33 is attached to the electrical connector portion 11 of the endoscope 2 so that the cleaning liquid enters the endoscope 2 or touches the contact pin 38 of the electrical signal in the future. Prevent the surface from deteriorating (such as poor energization).
[0026]
When the cleaning process is finished, the endoscope 2 is stored in a predetermined shape in the tray 35 of FIG. At this time, the recess 49a around the connector portion 10 is a recess along the shape of the connector portion 10, and the connector portion 10 (and the electrical connector portion 11) must be removed unless the waterproof cap 33 is completely removed from the electrical connector portion 11. ) Cannot be stored in the recess 82a.
[0027]
FIG. 4 schematically shows various conduits built in the endoscope 2.
The conduit 40 is mainly in the insertion portion 7, the conduit tip 40 a is open to the outside at the tip 17, and the conduit rear end 40 b is open to the outside at the operation portion 8. Yes. The conduit 40 is, for example, a treatment instrument insertion or suction conduit.
[0028]
The pipe 41 is mainly in the connecting cord 9, the pipe tip 41 a is open to the outside in the operation part 8, and the pipe rear end 41 b is connected to the outside in the connector part 10 by the suction cap 25. Open. The conduit 41 is, for example, a suction conduit.
[0029]
The pipe line 42 is mainly in the operation unit 8, and the pipe front end is common to the pipe rear end 40 b and is open to the outside in the operation unit 8. The pipe rear end is connected to the pipe front end 41 a. In common, the operation unit 8 is open to the outside. The conduit 42 is, for example, a suction conduit.
[0030]
Then, a pipe line from an aspirator (not shown) is connected to the pipe rear end 41b (suction cap 25), and suction operation is performed with the aspirator, and the pipe front end 41a and the pipe rear end 40b are closed. Suction can be performed from the pipe tip 40a through the path 41, pipe 42, and pipe 40.
[0031]
The conduit 43 is mainly in the insertion portion 7, the conduit tip 43 a is open to the outside at the tip 17, and the conduit rear end 43 b is open to the outside at the operation portion 8. Yes. The conduit 43 is an air / water supply conduit that supplies air or water by cleaning the lens surface of the distal end portion 17, for example.
[0032]
The pipe 44 is mainly in the connecting cord 9, the pipe tip is common with the pipe rear end 43 b, opens to the outside in the operation unit 8, and the pipe rear end 44 b is a water tank pressurization. The connector part 10 is opened to the outside by a base 23 and a gas supply base 24. When the pipe rear end 43b is blocked and air is supplied or supplied from the pipe rear end 44b (water supply tank pressurizing base 23, gas supply base 24), air or water can be supplied from the pipe front end 43a.
[0033]
The pipe 45 is mainly in the insertion portion 7 and the connecting cord 9, the pipe tip 45 a is open to the outside at the tip 17, and the pipe rear end 45 b is connected to the connector part 10 by the inlet 26. Is open to the outside. The pipe 45 is, for example, a forward water feed pipe that feeds liquid to the observation object.
[0034]
As described above, the endoscope 2 includes various ducts that are open at both ends to the outside and allow fluid and the like to be inserted inside. Moreover, both the insertion portion 7 and the connecting cord 9 are formed of flexible members and are not solid but hollow. In addition, most of the pipes in the insertion portion 7 and the connecting cord 9 are arranged in a non-fixed state in the hollow part so as to be able to cope with flexible movement, and there are other built-in parts around the pipes, Almost space.
[0035]
The outer side of the pipe (inside the outer skin of the endoscope 2) in the middle part of these pipes (in this case, a range that is somewhat wide in the sense of the position away from the end) is in communication with the surrounding space 47. The space portion 47 communicates with the outside through the ventilation portion 37. That is, the outside of the pipe line is in a state of communicating with the outside through the ventilation portion 37 that communicates with the space portion 47 (becomes communication means). And the communication state by this ventilation part 37 can be selected by mounting | wearing / non-mounting (removal) of the waterproof cap 33. FIG.
[0036]
In the present embodiment, for example, the inner periphery of the endoscope 2 is not filled with a filler or a solid material around the middle portion of the path connecting the opening and the opening of a certain pipe line, for example, A space in which the space 47 is formed is secured. Further, various built-in objects and parts exist in the middle of the path between the space portion 47 and the ventilation portion 37, but they are arranged so as not to block the passage of steam. Therefore, the vapor can pass through this route without being obstructed.
[0037]
In the endoscope 2 according to the present embodiment, when the sterilization process is performed, the ventilation portion 37 is provided so as to communicate with the surrounding space portion 47 in each pipe line provided in the endoscope 2. In the prevacuum, the space 47 can also be set in a prevacuum state, and in the subsequent high-temperature and high-pressure steam sterilization process, the space 47 outside the pipe (not only inside the pipe) is also high-temperature and high-pressure. It is characterized in that steam can be supplied promptly so that it can be filled so that the high-temperature and high-pressure steam sterilization process can be completed in a short time.
[0038]
The operation in this case will be described later with reference to FIG.
FIG. 5 shows a high-temperature and high-pressure steam sterilization apparatus 50 that houses the endoscope 2 according to the present embodiment in the tray 35 and performs high-temperature and high-pressure steam sterilization.
When the door 51 provided on the front surface of the high-temperature / high-pressure steam sterilizer 50 is opened, the inside becomes a chamber 52 serving as a sterilization chamber for performing high-temperature / high-pressure steam sterilization, and an endoscope housed in the tray 35 therein. 2 can be put in and the door 51 can be closed to perform sterilization.
[0039]
The shape of the chamber 52 is, for example, a storage size such that only one sterilization storage case 34 storing the endoscope 2 can be inserted.
Moreover, you may make it provide a part which detects the relative state of the connector part 10 (electric connector part 11) and the waterproof cap 33 in a part of this high temperature / high pressure steam sterilization apparatus 50. FIG.
[0040]
For example, whether or not the waterproof cap 33 is attached to the electrical connector unit 11 by providing some chips in the vicinity of the electrical connector unit 11 and the waterproof cap 33 and measuring the distance between the chips by the high-temperature and high-pressure steam sterilizer 50. May be detected.
A mechanism for detecting whether or not the waterproof cap 33 is attached to the electrical connector portion 11 may be provided by a mechanism other than this.
[0041]
Typical conditions for high-temperature and high-pressure steam sterilization using the above-described high-temperature and high-pressure steam sterilizer 50 and the like are pre-vacuum types that are approved by the American Standards Association and are decompressed before the sterilization process according to the American standard ANSI / AAMIST 37-1992 issued by the Medical Device Development Association. Is 4 minutes at the sterilization step 132 ° C., and in the gravity type in which the pressure is not reduced before the sterilization step, it is 10 minutes at the sterilization step 132 ° C.
[0042]
The temperature conditions during the sterilization process of high-pressure steam sterilization vary depending on the type of the high-pressure steam sterilization apparatus and the time of the sterilization process, but are generally set in the range of about 115 ° C to 138 ° C. Some sterilizers can be set to about 142 ° C.
[0043]
About time conditions, although it changes with temperature conditions of a sterilization process, it is generally set to about 3 to 60 minutes. Some types of sterilizers can be set to about 100 minutes.
The pressure in the sterilization chamber in this step is generally set to about +0.2 MPa with respect to atmospheric pressure.
[0044]
In a general pre-vacuum type high-pressure steam sterilization process, a pre-vacuum process in which the sterilization chamber containing the device to be sterilized is depressurized before the sterilization process, and then high-pressure high-temperature steam is sent into the sterilization chamber for sterilization. A sterilization step is included.
[0045]
The pre-vacuum process is a process for allowing the steam to penetrate into the details of the sterilization target device in the subsequent sterilization process. By reducing the pressure in the sterilization chamber, the high-pressure and high-temperature steam is distributed throughout the sterilization target device.
The pressure in the sterilization chamber in the pre-vacuum process is generally set to about -0.07 MPa to -0.09 MPa with respect to atmospheric pressure.
[0046]
Some include a drying step in which the inside of the sterilization chamber is decompressed again after the sterilization step in order to dry the sterilization target device after sterilization. In this step, the interior of the sterilization chamber is depressurized to remove steam from the sterilization chamber and promote drying of the sterilization target device in the sterilization chamber. The pressure in the sterilization chamber in this step is generally set to about -0.07 to -0.09 MPa with respect to atmospheric pressure.
[0047]
In the present embodiment, as will be described later, when the endoscope 2 is sterilized at high temperature and high pressure steam, the waterproof cap 33 is removed from the electrical connector portion 11. As described above, the ventilation portion 37 is provided in the endoscope 2 so that the high-temperature and high-pressure steam sterilization process can be completed in a short time.
[0048]
Next, a method for high-temperature high-pressure steam sterilization of the endoscope 2 according to the present embodiment will be described.
First, FIG. 6 shows an example of all the steps when the endoscope 2 is sterilized at high temperature and high pressure steam by the high temperature and high pressure steam sterilization apparatus 50.
[0049]
As shown in FIG. 6, all the processes for high-temperature and high-pressure steam sterilization consist of a preheating process, a pre-vacuum process, a sterilization process, and a negative pressure drying process. In FIG. 6, the solid line indicates the pressure state, and the dotted line indicates the temperature state. Further, the pressure is represented by a positive value when the atmospheric pressure is set to 0, and a negative value when the pressure is negative.
[0050]
In FIG. 6, pre-vacuum is performed three times at a negative pressure of -0.09 to -0.07 MPa. During this time, steam is supplied and the temperature rises (indicated schematically by a very rough line in FIG. 6).
[0051]
In the sterilization process, the pressure is set to 0.22 MPa and the temperature is 135 ° C. (temperature and pressure correspond).
[0052]
FIG. 7 shows a reprocessing process in which after the endoscopic inspection is performed with the endoscope 2, the cleaning operation and the sterilization operation are performed to enable the endoscopic inspection again.
[0053]
As shown in FIG. 7, an endoscopy is performed in step S1, and when the endoscopy is completed, a waterproof cap 33 is attached to the electrical connector unit 11 to make the electrical connector unit 11 waterproof as shown in step S2. To secure the water tightness of the endoscope 2.
[0054]
Then, the cleaning operation of step S3 and step S4 is performed. In step S3, the endoscope 2 in a watertight state is inserted into a cleaning tank or the like, and the outer surface of the endoscope 2 and the inside of the pipeline are cleaned.
[0055]
Thereafter, as shown in step S4, the cleaning liquid is rinsed and dried to finish the cleaning operation.
When this cleaning operation is completed, the waterproof cap 33 is removed from the electrical connector portion 11 as shown in step S5, and the endoscope 2 is stored in the tray 35.
[0056]
When the endoscope 2 is housed in the tray 35, the connector 10 cannot be housed in the restricting portion 49a of the tray 35 unless the waterproof cap 33 is removed. It can be recognized that the mirror 2 is in an inappropriate state for moving to the next step. In FIG. 2, this state is shown by a two-dot chain line with the waterproof cap 33 attached.
[0057]
Furthermore, if the user tries to forcefully insert the connector 10 into the high-temperature high-pressure steam sterilizer 50 even if the connector 10 is not stored in the tray 35, the storage shape of the chamber 52 is the storage for sterilization in which the endoscope 2 is stored. If the case 34 has a shape that fits in just one, if the connector 10 is floated without being accommodated, it cannot be put into the chamber 52, so that it can be recognized that the sterilization operation cannot be performed. .
[0058]
Further, as described above, the detection means may detect whether or not the waterproof cap 33 is attached to the electrical connector portion 11 by the high-temperature high-pressure steam sterilizer 50.
[0059]
In this way, the endoscope 2 is stored in the tray 35 of the sterilization storage case 34 and the lid member 36 covers the endoscope 2. Thereafter, as shown in step S6, the sterilization storage case 34 storing the endoscope 2 is stored (packed) in a sterilization pack (such as a peel pack). Packing in a sterilization pack should be done so that germs in the open air cannot enter (air and water vapor can penetrate but bacteria cannot enter).
[0060]
Then, the sterilization operation from step S7 to step S10 is performed. First, in step S <b> 7, the endoscope 2 stored in the tray 35 (or sterilization storage case 34) is put into the high-temperature high-pressure steam sterilizer 50.
[0061]
In the following sterilization operation, the space of the chamber 52 communicates with the inside of the endoscope 2 (more precisely, the space portion 47 around the intermediate portion of the conduit described above) via the ventilation portion 37.
[0062]
In the high-temperature high-pressure steam sterilization apparatus 50, there is a preheating and pre-vacuum process (negative pressure process) in step S8 before proceeding to the high-temperature high-pressure steam sterilization process in step S9.
In particular, in the pre-vacuum process, the space portion 47 in the chamber 52 and the endoscope 2 is set to a negative pressure, and steam is supplied and the pressure is returned to the original pressure. Perform this process at least once.
[0063]
It is desirable that the pre-vacuum process is performed a plurality of times because it becomes easy to completely replace the air in the space portion 47 in the chamber 52 and the endoscope 2 with steam.
After this pre-vacuum process, high-temperature high-pressure steam sterilization in step S9 is performed.
The endoscope 2 can be sterilized with high-temperature high-pressure steam by this high-temperature high-pressure steam sterilization.
[0064]
After this high-temperature and high-pressure steam sterilization, a negative pressure drying step (vacuum drying step) is performed as shown in step S10.
By performing the process of drying with a negative pressure in this way, the vapor that has entered the space 47 in the endoscope 2 can be discharged and removed to the outside through the ventilation portion 37, and the inside of the endoscope 2 can be removed. Does not become wet with water, and the durability of the components in the endoscope 2 can be maintained (deterioration due to rust and moisture can be avoided as much as possible). For this reason, it is desirable to perform drying by negative pressure.
[0065]
After performing this drying step, the endoscope 2 covered with the sterilization pack is taken out from the high-temperature high-pressure steam sterilizer 50.
Then, as shown in step S11, before performing the endoscopic examination, the sterilization pack is opened and sterilized, and the endoscope 2 stored in the sterilization storage case 34 is taken out.
[0066]
Next, the function and effect obtained by providing the ventilation portion 37 will be described with reference to FIG. FIG. 8A schematically shows the case where the endoscope 2A provided with the ventilation portion 37 in the chamber 52 in the present embodiment is housed, and the ventilation portion 37 is formed in the chamber 52 for comparison. FIG. 8B shows a case where an endoscope 2 'that does not exist is housed. In FIGS. 8A and 8B, the endoscopes 2 and 2 'are actually stored in a sterilization storage case 34 and further covered with a sterilization pack through which steam passes. Therefore, it is omitted.
[0067]
In FIG. 8A, the endoscope 2 communicates with the space portion 47 in the endoscope 2 and the space portion 52a in the chamber 52 by the ventilation portion 37, whereas in FIG. In the endoscope 2 ′, since the ventilation portion 37 is not provided, the space portion 47 inside the endoscope 2 ′ is blocked from the space portion 52 a in the chamber 52.
[0068]
8A and 8B, the endoscope 2 includes end portions 53 and 54, a skin tube body 55 fixed to the end portions 53 and 54, and both end portions 53 and 54 that are open at both ends. It consists of a pipe line 56 (for example, a model of the pipe line 45) and a space 47 accommodated therein. In FIG. 8A, a ventilation portion 37 is provided at the end portion 54.
[0069]
In the case of FIG. 8B, since the space 47 is a sealed space that is cut off from the space 52a of the chamber 52, the space 52a in the chamber 52 is filled with high-temperature and high-pressure steam in the high-temperature and high-pressure sterilization process. However, the pressure in the space 47 does not increase and the temperature does not rise easily.
[0070]
Therefore, even if steam enters the pipeline 56 after the pre-vacuum process, the steam temperature is less likely to rise as it goes deeper in the pipeline 56 (position away from the end portion 54) (pipeline). 56, the temperature tends to decrease due to the space 47). Therefore, it can take a considerably long time to perform sterilization reliably.
[0071]
In general, a plurality of endoscopic examinations are often performed on the same day, and the endoscope used in the first examination is often reprocessed and used again and again on the same day. At that time, it is desired to be able to reprocess as quickly and reliably as possible.
[0072]
In the case of the endoscope 2 according to the present embodiment, the state is as shown in FIG. 8A and the ventilation portion 37 is provided, so that steam is supplied from the ventilation portion 37 to the space portion 47 by the supply of steam after pre-vacuum. to go into.
[0073]
Therefore, the space portion 52a and the space portion 47 in the chamber 52 are likely to have substantially the same pressure and substantially the same vapor, and in that case, not only the inner side of the pipe line 56 but also the inner side of the pipe line 56. A similar level of heat is applied from the outside by the high-temperature and high-pressure steam that fills the space 52 a of the chamber 52, and any position in the pipe 56 can be sterilized quickly.
[0074]
An important element of the ventilation portion 37 is its size.
Assume that the ventilation portion 37 is very small (thin) with respect to the volume of the space portion 47 (for example, 0.1 mm).
If so, the space 47 cannot be synchronized with the speed of the pressure change in the chamber 52, and a time lag occurs.
[0075]
In the pre-vacuum process, in the chamber 52, for example, even if the state of −0.08 MPa is repeatedly performed three times, the space portion 47 has the chamber 52 before reaching −0.08 MPa (for example, about 0.03 MPa). It is possible to enter the process of increasing the pressure (of high-temperature high-pressure steam).
[0076]
When this happens, the space 47 is not sufficiently bleeded up, so that the air originally in the space 47 remains considerably, and the replacement with steam may be insufficient. In this case, if the minimum pressure state in the chamber 52 is kept long, the pressure in the space 47 may eventually become the same pressure, but the time is prolonged in the direction opposite to the state desired by the user. is there.
[0077]
Even in the sterilization process using high-temperature and high-pressure steam, even if the inside of the chamber 52 reaches 0.22 MPa, the inside of the space 47 does not easily reach and is delayed. Therefore, in order to achieve sterilization, the sterilization time (maximum temperature state) ) Must be extended for a long time, which is also the opposite of the user's desired state.
From the above, it is desirable that the size of the ventilation portion 37 is appropriate with respect to the volume of the space portion 47.
[0078]
For example, it is more desirable that the larger one is 1 mm or more, preferably 5 mm or 10 mm.
Further, if possible, in the space portion 47 in the endoscope 2 communicating with the ventilation portion 37, the ventilation portion 37 has a larger area than the clearance area of the portion with the smallest clearance. It can prevent becoming a bottleneck of vapor intrusion.
[0079]
As described above, in the present embodiment, in the pre-vacuum process and the high-temperature and high-pressure steam sterilization process, the process in the chamber 52 and the space portion 47 in the endoscope 2 are always performed at substantially the same pressure ( The volume of the internal space in the endoscope 2 and the size of the ventilation part 37 were set so as to be so). By doing so, the sterilization process in the pipe line can be surely performed within a short time.
[0080]
As shown in FIG. 3, if a filter 48 that allows vapor to pass through but does not pass an object of a certain size is provided in a part of the ventilation portion 37, lubrication used in the endoscope 2 is provided. It is possible to prevent the agent and the like from coming out of the ventilation portion 37 during the sterilization operation with the waterproof cap 33 removed. In addition, you may make it attach the filter which provided many small holes which only let vapor | steam pass.
[0081]
Therefore, this embodiment has the following effects.
Sterilization of the pipe line built in the endoscope 2 can be performed more quickly and reliably. In addition, the sterilization process in the pipe line and the like can be performed in a short time with a simple configuration.
[0082]
(Second Embodiment)
Next, a second embodiment of the present invention will be described with reference to FIG. In the first embodiment, the case where the ventilation portion 37 is provided in the electrical connector portion 11 has been described. In the present embodiment, the ventilation portion 37 is provided in a portion other than the electrical connector portion 11 and improved.
[0083]
The points to be improved when the ventilation portion 37 is provided in the electrical connector portion 11 are listed below.
(A) Since the electrical connector portion 11 (or the connector portion 10) is a portion connected to the light source device 3 and the processor 5, the electrical connector portion 11 (or the connector portion 10) is located farthest from the insertion portion 7. Therefore, it is difficult for the vapor to reach the pipe line built in the insertion portion 7 through the ventilation portion 37 (although the ventilation portion 37 may be sufficiently large).
[0084]
(B) As described in the first embodiment, the ventilation portion 37 is desirably as large as possible. However, when the endoscope 2 and the existing endoscope that cannot be sterilized at high temperature and high pressure can be commonly connected to the light source device 3 and the processor 5 (ensure compatibility), the electrical connector portion 11 of the endoscope 2 is used. Cannot be made larger than a conventional endoscope.
The ventilation part 37 must be provided in such a limited space, and the ventilation part 37 must be relatively small in size.
[0085]
(C) The space 47 just inside the contact pin 38 shown in FIG. 3 is complicated by many wires. In some cases, it may hinder the invasion of vapor from the ventilation portion 37. These wires are bundled at a position slightly away from the electrical connector portion 11 to form one or several cables.
[0086]
In consideration of these points, in the endoscope 2B shown in FIG. 9, a ventilation portion 37 communicating with the space portion 47 in the endoscope 2B is provided in a part of the operation portion 8. In this case, a watertight cap 60 is detachably attached to the ventilation portion 37, and the watertight cap 60 is connected to the operation portion 8 by a string member 61.
The ventilation portion 37 and the watertight cap 60 may be provided near the rear end of the operation portion 8 indicated by a broken line.
[0087]
In the case where the endoscope 2B of FIG. 9 is stored in the sterilization storage case 34, the endoscope 2B is stored in the sterilization storage case unless the watertight cap 60 attached to the ventilation portion 37 during inspection or cleaning is removed. The shape of the tray 35 is such that it cannot be stored in 34.
Further, a means for notifying the user of the communication state between the ventilation portion 37 and the outside may be provided.
[0088]
According to the present embodiment, by providing the ventilation portion 37 in the operation portion 8, the ventilation portion 37 can be formed near the insertion portion 7, and the vapor that has entered from the ventilation portion 37 is spread over the entire space portion 47 in the endoscope 2. Easy to do.
[0089]
Further, by connecting the watertight cap 60 with the string member 61, it is possible to prevent the watertight cap 60 from being lost.
In the endoscope 2C of the modification shown in FIG. 10, the ventilation portion 37 is provided in the electrical connector portion 11 as in the first embodiment.
[0090]
In this case, although the points (a) and (b) to be improved remain as they are, the one end 62b of the tube 62 is connected to the ventilation portion 37, and the other end portion 62a is inserted through the connecting cord 9. The points to be improved are substantially eliminated by communicating with the space 47 inside the operation unit 8.
[0091]
That is, the tube 62 forms a vapor intrusion path, makes it easy for the vapor to enter the operation unit 8 and the connecting cord 9 side away from the insertion unit 7 of the endoscope 2C by the tube 62, and for the existing endoscope. Similarly to the case, it can be connected to the common light source device 3 and the processor 5.
[0092]
According to this modification, the operability similar to that of an existing endoscope can be ensured without increasing the weight of the operation unit 8 when the ventilation unit 37 is provided in the operation unit 8. .
[0093]
As another modified example, the ventilation portion 37 may be provided in the connector portion 10 closer to the operation portion 8 side than the electrical connector portion 11, for example, in the vicinity of the suction base 25 or the injection base 26, instead of the electrical connector portion 11. .
If it does so, the ventilation part 37 can also be enlarged comparatively and the point which should improve the said (b) and (c) can be solved.
[0094]
As yet another modification, ventilation portions may be provided at a plurality of locations. FIG. 11 shows the endoscope 2D in this case.
[0095]
In this endoscope 2D, as shown in FIG. 9, the operation portion 8 is provided with the ventilation portion 37 so as to be covered with the waterproof cap 60, and further, a portion other than the electrical connector portion 11 in the connector portion 10, for example, a suction cap 25 and the injection cap 26 are provided with a ventilation portion 37b. Further, the ventilation portion 37b can be waterproofed by a waterproof cap 61b connected to the string member 61b, for example.
As described above, the ventilation portions 37 and 37b may be provided at a plurality of locations in one endoscope 2D, for example, at a plurality of spaced locations.
[0096]
In this way, the elongated pipe line in the elongated endoscope 2D is not only from the inside, but also from a plurality of vents 37, 37b outside the pipe line in a short time set to a high temperature state by steam sterilization. Can be sterilized.
[0097]
[Appendix]
1. One end opens to the outside of the endoscope at the distal end of the insertion portion, the other end opens to the outside of the endoscope at a portion other than the insertion portion, and has at least one conduit for allowing fluid etc. to pass inside An endoscope having communication means that selectively communicates with the outside of the endoscope and the space portion that is sealed with the outer skin portion of the endoscope and communicated with the outside of the duct,
A cleaning step of cleaning the endoscope by blocking communication between the space and the outside of the endoscope by the communication means;
While communicating the space portion and the endoscope exterior by the communicating means with respect to the endoscope cleaned in the cleaning step, while the space portion and the endoscope exterior are always in a substantially isobaric state, A step of temporarily putting the space and the outside of the endoscope in a negative pressure state, and then putting steam into the space and the outside of the endoscope to sterilize the endoscope at high temperature and high pressure steam; and
An endoscopic high-temperature high-pressure steam sterilization treatment method for an endoscope.
[0098]
2. In Supplementary Note 1, before the operation of the high-temperature and high-pressure steam sterilizer, when the communication means does not allow communication between the space and the outside of the endoscope, the non-communication state is notified to the user.
3. In Supplementary Note 2, after the cleaning process, the endoscope is stored in a dedicated tray in a predetermined state, and when the storage means is not connected to the outside of the endoscope by the communication means during storage, the endoscope is stored in a predetermined state. It is characterized by not being able to.
[0099]
4). In Supplementary Note 1, the communication means is provided in addition to the signal connection connector portion for connecting the imaging signal line of the endoscope and the external device.
5. In Supplementary Note 4, the communication means is other than the signal connection connector portion in the endoscope connector portion.
6). The supplementary note 4 is characterized in that the communication means is provided in a part of the endoscope operation section.
[0100]
7. The supplementary note 1 is characterized in that a plurality of the communication means are provided.
8). In Supplementary Note 1, the communication means includes a duct member that connects an end portion that opens to the outside of the endoscope and an end portion at a predetermined position inside the endoscope.
9. In Supplementary Note 1, the communication means includes a filter that allows water vapor to pass but does not pass an object of a certain size or larger.
[0101]
10. One end opens to the outside of the endoscope at the distal end of the insertion portion, the other end opens to the outside of the endoscope at a portion other than the insertion portion, and has at least one conduit for allowing fluid etc. to pass inside In addition to the outside of the conduit communicating with the sealed space covered with the outer skin of the endoscope, and the endoscope having resistance to high-temperature and high-pressure steam,
An endoscope characterized in that an opening for inflow of high-temperature and high-pressure steam for sterilizing the outside of the conduit with high-temperature and high-pressure steam is provided in the outer skin part of the endoscope.
[0102]
11. In Supplementary Note 10, the high-temperature and high-pressure steam inflow opening is provided in a connector portion that can be detachably connected to an external device.
12 In Supplementary Note 10, the high-temperature and high-pressure steam inflow opening is hermetically sealed by attaching a waterproof cap, and the space portion side is kept in a water-tight state to enable cleaning with a cleaning liquid.
13. In Supplementary Note 10, the high-temperature and high-pressure steam inflow opening has a function of being in a substantially equal pressure state to the outside of the endoscope.
[0103]
(Background of appendices 10-13)
There is Japanese Patent Publication No. 4-5451 as a preceding example. In this prior example endoscope, an opening is disclosed, but since the endoscope itself does not have resistance to high-temperature high-pressure steam, there is no disclosure or suggestion for high-temperature high-pressure steam sterilization.
(Purpose of Supplementary Notes 10-13)
For the purpose of providing an endoscope that can sterilize the inside of a pipe line and the like with a simple configuration more quickly and reliably than in the past, the configurations of Additional Notes 10 to 13 are used.
[0104]
【The invention's effect】
As described above, according to the present invention, when high-temperature high-pressure steam sterilization of an endoscope is performed, sterilization in a pipe line built in the endoscope can be performed more quickly and reliably.
[Brief description of the drawings]
FIG. 1 is an overall configuration diagram of an endoscope apparatus according to a first embodiment of the present invention.
FIGS. 2A and 2B are a plan view and a cross-sectional view taken along the line AA in a state where the endoscope is stored in a tray.
FIG. 3 is a cross-sectional view showing a configuration of an electrical connector portion.
FIG. 4 is a diagram showing a pipeline system of an endoscope.
FIG. 5 is a perspective view showing a high-temperature high-pressure steam sterilizer.
FIG. 6 is a diagram showing an outline of a sterilization process by a high-temperature high-pressure steam sterilizer.
FIG. 7 is a flowchart showing processing steps of reprocessing after endoscopy.
FIG. 8 is an explanatory view showing the sterilization effect according to the present embodiment in comparison with a conventional example by a schematic diagram of an endoscope.
FIG. 9 is a plan view showing an endoscope according to a second embodiment of the present invention.
FIG. 10 is a plan view showing an outline of a first modification of the endoscope of FIG. 9;
FIG. 11 is a plan view showing a second modification of the endoscope shown in FIG. 9;
[Explanation of symbols]
1. Endoscope device
2. Endoscope
3. Light source device
4 ... Signal cable
5 ... Processor
6 ... Monitor
7 ... Insertion part
8 ... Operation part
9 ... Connection code
10 ... Connector
11 ... Electric connector
17 ... Tip
18 ... Air / water nozzle
21 ... Gas supply cap
23 ... Water tank pressure cap
24 ... Liquid supply cap
25 ... Suction cap
26. Injection cap
32 ... Treatment instrument insertion port
33 ... Waterproof cap
34 ... Storage case for sterilization
35 ... Tray
37 ... Ventilation part
40-45, 56 ... pipeline
47. Space part
50 ... High temperature high pressure steam sterilizer
52 ... Chamber
53, 54 ... end

Claims (2)

一端が挿入部先端部で内視鏡外部に開口し、他端が挿入部以外の部位で内視鏡外部に開口し、その内側に流体等を通すための管路を少なくとも一つ有する内視鏡を高温高圧蒸気により滅菌する内視鏡の高温高圧蒸気滅菌処理方法において、
前記管路の外側に連通し内視鏡外皮部で覆われて密閉された空間部と内視鏡外部とを選択的に連通する連通手段を有する内視鏡に対して、
前記連通手段により前記空間部と内視鏡外部とを連通させ、前記空間部と内視鏡外部とを一旦陰圧状態にした後に前記空間部と内視鏡外部とに蒸気を入れて、前記内視鏡を高温高圧蒸気滅菌する工程、
を具備したことを特徴とする内視鏡の高温高圧蒸気滅菌処理方法。
An endoscope having one end opened to the outside of the endoscope at the distal end of the insertion portion, the other end opened to the outside of the endoscope at a portion other than the insertion portion, and at least one conduit for allowing fluid or the like to pass therethrough In the high-temperature high-pressure steam sterilization processing method of the endoscope that sterilizes the mirror with high-temperature high-pressure steam,
For an endoscope having communication means that selectively communicates between a space portion that is communicated with the outside of the duct and is covered and sealed with an endoscope skin portion and the exterior of the endoscope,
The space means is communicated with the exterior of the endoscope by the communicating means, and after the space and the exterior of the endoscope are once in a negative pressure state, steam is put into the space and the exterior of the endoscope, A process of sterilizing the endoscope at high temperature and high pressure steam,
An endoscopic high-temperature high-pressure steam sterilization treatment method for an endoscope.
一端が挿入部先端部で内視鏡外部に開口し、他端が挿入部以外の部位で内視鏡外部に対し開口し、その内側に流体等を通すための管路を少なくとも一つ有し、前記管路の外側に連通し内視鏡外皮部で覆われて密閉された空間部と内視鏡外部とを選択的に連通する連通手段を有する内視鏡に対して、
前記連通手段により前記空間部と内視鏡外部との連通を遮断して前記内視鏡を洗浄する洗浄工程と、
前記洗浄工程により洗浄された前記内視鏡に対して前記連通手段により前記空間部と内視鏡外部とを連通させ、前記空間部と内視鏡外部とを一旦陰圧状態にした後に前記空間部と内視鏡外部とに蒸気を入れて、前記内視鏡を高温高圧蒸気滅菌する工程と、
を具備したことを特徴とする内視鏡の高温高圧蒸気滅菌処理方法。
One end opens to the outside of the endoscope at the distal end of the insertion portion, the other end opens to the outside of the endoscope at a portion other than the insertion portion, and has at least one conduit for allowing fluid etc. to pass inside An endoscope having communication means that selectively communicates with the outside of the endoscope and the space portion that is sealed with the outer skin portion of the endoscope and communicated with the outside of the duct,
A cleaning step of cleaning the endoscope by blocking communication between the space and the outside of the endoscope by the communication means;
The space section and the exterior of the endoscope are communicated with the endoscope cleaned by the cleaning step by the communication means, and the space section and the exterior of the endoscope are once brought into a negative pressure state, and then the space. A step of putting steam into the part and outside of the endoscope, and sterilizing the endoscope at high temperature and high pressure steam;
An endoscopic high-temperature high-pressure steam sterilization treatment method for an endoscope.
JP2003200154A 2003-07-22 2003-07-22 Endoscope high-temperature high-pressure steam sterilization treatment method Expired - Fee Related JP4472280B2 (en)

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JP2003200154A JP4472280B2 (en) 2003-07-22 2003-07-22 Endoscope high-temperature high-pressure steam sterilization treatment method
DE602004032442T DE602004032442D1 (en) 2003-07-22 2004-07-22 HIGH-TEMPERATURE AND HIGH-PRESSURE STEAM STERILIZATION METHOD FOR AN ENDOSCOPE, AND ENDOSCOPE
KR1020067001315A KR100845079B1 (en) 2003-07-22 2004-07-22 High temperature and high pressure steam sterilization method for endoscope, and endoscope
CA002532652A CA2532652C (en) 2003-07-22 2004-07-22 Method for high-temperature high-pressure steam sterilization treatment of endoscope and endoscope
CNB2004800212391A CN100534536C (en) 2003-07-22 2004-07-22 High temperature and high pressure steam sterilization method for endoscope, and endoscope
US10/896,791 US7399273B2 (en) 2003-07-22 2004-07-22 Method for high-temperature high-pressure steam sterilization treatment of endoscope and endoscope
AU2004257531A AU2004257531B2 (en) 2003-07-22 2004-07-22 High temperature and high pressure steam sterilization method for endoscope, and endoscope
EP04748037A EP1645293B1 (en) 2003-07-22 2004-07-22 High temperature and high pressure steam sterilization method for endoscope, and endoscope
PCT/JP2004/010772 WO2005007205A1 (en) 2003-07-22 2004-07-22 High temperature and high pressure steam sterilization method for endoscope, and endoscope

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US10350318B2 (en) * 2015-05-15 2019-07-16 Virender K. Sharma Method and system for steam sterilization of endoscopes
IT201600105276A1 (en) * 2016-10-19 2018-04-19 Steelco Spa METHOD AND RECONDITIONING DEVICE OF A MEDICAL INSTRUMENT, IN PARTICULAR AN ENDOSCOPE
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