JP2005524431A - 案内管を有する内視鏡 - Google Patents
案内管を有する内視鏡 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00147—Holding or positioning arrangements
- A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
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- A—HUMAN NECESSITIES
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- A61B1/00064—Constructional details of the endoscope body
- A61B1/00071—Insertion part of the endoscope body
- A61B1/00078—Insertion part of the endoscope body with stiffening means
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- A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
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- A61B1/00142—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with means for preventing contamination, e.g. by using a sanitary sheath
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- A61B1/0052—Constructional details of control elements, e.g. handles
- A61B1/0053—Constructional details of control elements, e.g. handles using distributed actuators, e.g. artificial muscles
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Abstract
案内管を有する内視鏡が本明細書に記載されている。この組立体は、案内管の管腔内に滑動挿入できる。案内管は、弛緩形態からその全長に沿って硬化可能であるように形成されている。内視鏡は、本装置を操縦して蛇行路に通すのを容易にするために操縦可能遠位部分を有する。弛緩形態では、案内管の一部分は、内視鏡の制御可能遠位部分により画成された形状あるいはカーブをとることができる。内視鏡のこの形状あるいはカーブをとると、案内管は内科医あるいは外科医により硬化されてその形状あるいはカーブを維持し、その一方、いかなる不当な圧力も組織壁に加えずに内視鏡が遠位方向に蛇行路を通過して進められる。
Description
[000]本出願は、２０００年４月３日出願の米国特許仮出願第６０／１９４１４０号の優先権を主張する２００１年２月２０日出願の米国特許出願第０９／７９０２０４号の一部継続出願である２００１年１０月２日出願の米国特許出願第０９／９６９９２７号の一部継続出願であり、これらの各々の全体を、引用により本明細書に援用する。
[0002]本発明は一般に、内視鏡および内視鏡に関する医学的手順に関する。より詳細には本発明は、例えば結腸鏡検査および治療などのために案内管装置を使用して蛇行路に沿って可撓性内視鏡を挿入するのを容易にするための方法および装置に関する。
[0003]内視鏡は患者の体の内部を目に見えるようにするための医療機器である。内視鏡は、結腸鏡検査法、気管支鏡検査法、胸腔鏡検査法、腹腔鏡検査法、およびビデオ内視鏡検査法などを含む様々な異なる診断および介入手順に使用できる。
[0004]結腸鏡検査法は、可撓性内視鏡あるいは結腸鏡が、結腸の診断的検査および／または外科的治療のために患者の結腸に挿入される医学的手順である。標準結腸鏡は通常長さ１３５〜１８５ｃｍ、直径１２〜１９ｍｍであり、この機器の先端に位置するイメージング（画像式）光ファイバ束あるいは小型カメラ、照明ファイバ、ガス注入あるいは洗浄、空気および水チャネル、および真空チャネルにも使用できる１つまたは２つの機器チャネルを含む。
[0005]結腸鏡は患者の肛門を介して挿入され、結腸を通され、これによって結腸、回盲弁、末端の回腸の一部分を直接目視検査できる。結腸鏡の挿入は、結腸が蛇行し入り組んだ経路であるので難しい。結腸鏡を相当操作せずには、結腸に結腸鏡を通せないことがしばしばあり、これによってこの手順はより困難となり、かつ時間がかかり、腸穿孔などの合併症が生じる可能性が高まる。
[0006]操縦可能結腸鏡が、結腸のカーブを通過する正しい経路を容易に選択できるように発明されている。しかしながら、結腸鏡の結腸への挿入が進むつれ、選択した経路に沿って結腸鏡を前進させるのがより難しくなる。各々の曲がり角で結腸壁は結腸鏡のカーブに適合してこのカーブ形状を維持しなければならない。結腸鏡は、各曲がり角の外面に沿って結腸の粘膜表面を擦する。各曲がり角での結腸鏡の摩擦および弛みが積み重なるので、結腸鏡の前進あるいは後退は挿入が進むにつれて困難になる。加えて、結腸壁に加わる力は摩擦が積み重なるにつれ増加する。蛇行状態が極端な場合、結腸に結腸鏡を完全に通すことは不可能になることもある。
[0007]体の内部構造の医学的検査あるいは治療のための操縦可能内視鏡、カテーテルおよび挿入装置は、米国特許第４５４３０９０号、第４７５３２２３号、第５３３７７３２号、第５３３７７３３号、第５３８３８５２号、第５４８７７５７号および第５６６２５８７号に記載され、これらの全開示を、引用により本明細書に取り込む。
[0008]内視鏡組立体と、例えば結腸などの蛇行路において結腸壁と過度には接触せずに蛇行路を通過できるこの組立体を前進させる方法とが、本明細書で説明される。この組立体は一般に、案内管の管腔内に滑動挿入可能な内視鏡が組み合わさっている。内視鏡は、ハンドルから延びるシャフトを有する任意の従来の内視鏡でもよい。シャフトの遠位端は好ましくは、蛇行路に組立体を操縦して通すのを容易にするために操作される制御可能遠位部分を含む。案内管は、弛緩形態からその全長に沿って硬化可能なように形成されている従来の可撓性導管でもよい。弛緩形態では案内管の一部は、内視鏡の制御可能遠位部分により画成される形状あるいはカーブ形状をとることができる。内視鏡の形状あるいはカーブ形状をとると、案内管は、この形状あるいはカーブ形状を維持するために内科医あるいは外科医により硬化される。
[0009]あるいは案内管は、自動制御される近位部分と選択的に操縦可能な遠位部分とを有する内視鏡でも使用できる。このような制御可能内視鏡は、任意のカーブ路を通過できる形状をとるように内科医あるいは外科医により手動で操縦可能な遠位部分と、内視鏡を前進あるいは後退させる際、近位部分に沿ってこの形状を伝えるために例えばコンピュータなどにより自動制御される近位部分とを有することもある。より詳細な例は同時係属米国特許出願第０９／９６９９２７号に記載され、これは、上記のとおり、全体が引用より本明細書に取り込まれている。
[0010]案内管は、１つ以上の引張りワイヤまたは引張り部材を介して互いに隣接して結合されている複数の個々のセグメントから成ることもある。これらの引張り部材は、セグメントの各々の周りに周方向に配置されることもあり、好ましくは、個々のセグメントの各々を通過して案内管の全長を走行している。案内管を硬化するには、引張り部材を引っ張るか引き締め、これによってセグメントを引き寄せて一緒にし、これによって案内管全体を硬くする。次いで引張り部材を弛緩し、これによって個々のセグメントは互いに対して動けるようになる。
[0011]例えば結腸内で使用中、内科医あるいは外科医は通常まず初めに、患者体内の内視鏡の遠位部分を前進させる。結腸の第１のカーブに近づくと、ユーザは内視鏡の遠位部分を適切に操縦して、当該経路を通過するためにカーブ形状をとるようにする。この時点で内視鏡は好ましくは、患者に対して静止状態に保持され、その一方、案内管は、案内管の遠位端が内視鏡の遠位先端に位置するか、またはこの遠位先端を僅かに越えるまで、弛緩かつ可撓状態で内視鏡のシャフト上に沿って進められる。いったん案内管あるいは少なくともその遠位部分が、内視鏡の制御可能遠位部分により形成されたカーブ形状をとると、案内管は、好ましくはその長さに沿って硬化されてそのカーブ形状を維持する。いったんこれが行われると、内視鏡は硬化案内管内でさらに進められて、結腸壁にいかなる圧力をも加えずにカーブ状経路を通過する。内視鏡を前進させるためのステップは、体内の所望の領域に到達するまで必要に応じて繰り返すことが可能である。
[0012]この診査的手順の間の任意の時点で、案内管は、内視鏡はそのまま残して結腸から取り除くことができる。結腸からこの組立体を取り除くには案内管がまず初めに引き出され、次いで内視鏡が引き出される。あるいは前述のステップは、当該領域から案内管および内視鏡の両方を後退させるために、逆の順序で繰り返されることも可能である。
[0013]案内管の外面は好ましくは管状カバーを有し、この管状カバーは管の少なくとも大部分を被覆して、細片および液体が個々のセグメントとセグメントとの間から案内管の管腔内に入らないようにする。カバーは、組織がセグメントとセグメントとの間に挟まれないようにし、これによって案内管の前進あるいは後退を容易にする。組立体が動く間、組織が案内管と内視鏡との間に挟まれないように、選択的に伸張可能ベローズまたは付加的カバーを、案内管の遠位開口上に広がるように配置できる。この付加的カバーは単に、案内管の表面上に広がるカバーの一体的延長部であることもあり、または案内管の遠位端に取り付けられた別個のカバーであることもある。このカバーは、内視鏡シャフトと案内管との間のシールを維持するために内視鏡の遠位端に取り付けられるか、またはこの遠位端の近くに取り付けられることも可能である。これらのカバーおよびそれらの変形は実行可能な任意の従来の方法により取り付けられる。案内管の遠位端の面上に広がるカバーを利用する場合、内視鏡シャフトの遠位部分が案内管を通って遠位方向に進められるので、カバーは好ましくは、内視鏡に沿って遠位方向に延びるか、または単に内視鏡と一緒に遠位方向に滑動する。シャフトが案内管管腔内に引っ込められると、カバーは好ましくは再び、内視鏡の遠位端の近位方向の運動と一緒に近位方向に後退するか、または単に内視鏡と一緒に後退することもある。付加的カバーの使用も、案内管の内部管腔の無菌性を維持するのを支援する。
[0028]図１に示す案内管組立体１０の変形の代表的な図は、分かりやすくするために部分的に分解されている。組立体１０は一般に、案内管管腔１６を経て案内管１４に挿入可能な内視鏡１２を備えている。内視鏡１２は、ハンドル１８を有しハンドル１８からシャフト２０が延びている任意の従来のタイプの内視鏡でよい。シャフト２０の遠位端は好ましくは制御可能遠位部分２２を含み、遠位部分２２は、本装置を操縦して体内に通すのを容易にするように操作できる。内視鏡シャフト２０は案内管管腔１６内に滑動可能に配置され、これによって制御可能遠位部分２２が案内管１４を完全に通過し、案内管１４の遠位端に画成された遠位開口から出るようにできる。
[0029]あるいは案内管１４は、詳細に後述するように、自動制御される近位部分と選択的に操縦可能な遠位部分とを有する内視鏡で使用することも可能である。このような制御可能内視鏡は、任意のカーブ路を通過できる形状をとるように内科医あるいは外科医により手動で操縦可能な遠位部分と、内視鏡を前進あるいは後退させる際、近位部分に沿ってその形状を伝播させるために例えばコンピュータなどにより自動制御される近位部分とを有することもある。より詳細な例が同時係属米国特許出願第０９／９６９９２７号に記載され、この全体を引用により本明細書に援用する。
[0030]このような内視鏡の一例が図４に示されており、図４は操縦可能内視鏡８０の一変形を示す。内視鏡８０は、手動で、すなわち選択的に操縦可能な遠位部分８４と、自動制御される近位部分８６とを有する細長い本体８２とを有する。選択的に操縦可能な遠位部分８４は選択的に操縦できる、すなわち任意の方向に完全に１８０゜まで曲げられる。イメージング光ファイバ束９２および１つ以上の照明用ファイバ９４が、近位端９０から遠位端８８まで本体８２を通って延びていてよい。あるいは内視鏡は、内視鏡本体８２の遠位端８８に位置する、例えばＣＣＤカメラなどの小型ビデオカメラを有するビデオ内視鏡として形成してもよい。ビデオカメラからの画像は、伝送ケーブルまたは無線伝送によりビデオモニタへ伝送され、そこで画像は実時間で目視されるか、または記録装置により例えば磁気テープなどのアナログ記録媒体、あるいは例えばコンパクトディスクおよびデジタルテープなどのデジタル記録媒体に記録されてもよい。随意的に、内視鏡８０の本体８２は、ガス注入あるいは洗浄、空気および水チャネル、真空チャネル等にも使用できる１つまたは２つの機器チャネル９６、９８を含んでよい。内視鏡８０の本体８２は、好ましくは可撓性が高く、従って座屈やキンクが生じずに短い直径のカーブに沿って曲げることができ、しかもその際様々なチャネルは損傷されない。内視鏡として使用されように形成された場合、内視鏡８０の本体８２は通常、長さは１３５〜１８５ｃｍであり、直径は約１２〜１３ｍｍである。内視鏡８０は様々な別のサイズおよび形態にして、その他の医療および産業上の用途に使用できる。
[0031]近位ハンドル１００は細長い本体８２の近位端９０に取り付けられている。ハンドル１００は、り、接眼レンズ１０４は、直接に目視するためにおよび／またはビデオカメラ１０６または記録装置１０８に接続するために、イメージング光ファイバ束９２に接続されている接眼レンズ１０４を含むこともある。ハンドル１００は、照明用ファイバ９４に接続されているかまたはこれと連続している照明用ケーブル１１６により、照明源１１０に接続されていることもある。ハンドル１００上の第１のルアーロック取付け具１１２および第２のルアーロック取付け具１１４が、機器チャネル９６、９８に接続されていることもある。
[0032]ハンドル１００は、制御器ケーブル１１８を経由して電子式運動制御器１２２に接続されていることもある。操縦制御装置１０２は、第２のケーブル１２０を経由して電子式運動制御器１２２に接続されていることもある。操縦制御装置１０２により、ユーザは、所望の方向に本体８２の操縦可能遠位部分８４を選択的に操縦する、すなわち選択的に曲げることができる。操縦制御装置１０２は、図示のようにジョイスティック制御器であることもあり、あるいはその他の既知の操縦制御機構であることもある。電子式運動制御器１２２は、本体８２の自動制御される近位部分８６の運動を制御することもある。電子式運動制御器１２２は、マイクロコンピュータ上で実行する運動制御プログラムを使用するか、または特定用途向け運動制御器を使用して実施できる。あるいは電子式運動制御器１２２はニューラルネットワーク制御器を使用して実施することも可能である。
[0033]軸方向運動トランスデューサ１２４が、内視鏡本体８２を前進あるいは後退させる際、内視鏡本体８２の軸方向運動を測定するために設けられることもある。軸方向運動トランスデューサ１２４は、多くの可能な形態で作ることができる。例として、図４の軸方向運動トランスデューサは、内視鏡８０の本体８２を完全にまたは部分的に取り囲むこともあるリング１２６として形成されている。軸方向運動トランスデューサ１２４は好ましくは、例えば手術台あるいは患者の体上の内視鏡８０のための挿入点などの基準固定点に取り付けられている。内視鏡８０の本体８２が滑動して軸方向運動トランスデューサ１２４を通過すると、軸方向運動トランスデューサ１２４は、基準固定点に対する内視鏡本体８２の軸方向位置を示す信号を発生し、遠隔測定法またはケーブル（不図示）により電子式運動制御器１２２に信号を送る。軸方向運動トランスデューサ１２４は光学的、電子的あるいは機械的方法を使用して、内視鏡本体８２の軸方向位置を測定することも可能である。軸方向運動トランスデューサ１２４のためのその他の可能な形態は、同時係属米国特許出願第０９／９６９９２７号にさらに記載されている。
[0034]図５は、ニュートラルすなわち直線状位置での内視鏡８０の本体８２の1つのセクションのワイヤフレームモデルを示す。内視鏡本体８２の内部構造の大部分は、分かりやすくするためにこの図面では取り除かれている。内視鏡本体８２はセグメントすなわちセクション１、２、３、．．．に分割されている。各セグメントの幾何学的形状はａ、ｂ、ｃおよびｄ軸に沿った４つの長さ寸法により定められており、隣接セグメントの各々は好ましくは、各セグメントが互いに対して独立的に角変位できるようにする接続部により互いに接続されている。例えばセグメント１の幾何学的形状は４つの長さ寸法ｌ１ａ，ｌ１ｂ，ｌ１ｃ，ｌ１ｄにより定められ、セグメント２の幾何学的形状は４つの長さ寸法ｌ２ａ，ｌ２ｂ，ｌ２ｃ，ｌ２ｄにより定められる、等々。各隣接セグメント１、２、３、．．．等は好ましくは、例えば電気式、空圧式、液圧式モータなどの線形アクチュエータ（不図示）により個別に制御される。線形アクチュエータはいくつかの互いに異なる動作原理のうちの1つを利用することも可能である。例えばａ軸の方向に内視鏡本体８２を曲げるには、小さくする量と大きくする量とが等しいとの条件下で寸法ｌ１ａ，ｌ２ａ，ｌ３ａ，．．．ｌ１０ａを小さくし、寸法ｌ１ｂ，ｌ２ｂ，ｌ３ｂ，．．．ｌ１０ｂを大きくする。これらの寸法の変化量は、結果として生じるカーブの半径を決める。あるいは個々のモータを作動して、互いに隣接するセグメントを互いに対して動かし、これによって、結果として生じる曲率を達成することも可能であり、これは米国特許出願第０９／９６９９２７号にさらに詳細に記載されている。
[0035]自動制御される近位部分８６において、各セグメントは、電子式運動制御器１２２により自動制御され、電子式運動制御器１２２はカーブ伝播法を使用して、内視鏡本体８２の形状を制御する。内視鏡本体８２が操縦されて、選択的に操縦可能な遠位部分８４のおかげで結腸Ｃ内のカーブを通過し、この時点で自動制御近位部分８６はカーブ内にある。内視鏡本体８２が１ユニット分遠位方向に進められると、セグメント１は１’により示されている位置へ移動し、セグメント２は、セグメント１が前に占めていた位置２へ移動し、セグメント３は、セグメント２が前に占めていた位置へ移動する、等々。軸方向運動トランスデューサ１２４は、基準固定点に対する内視鏡本体８２の軸方向位置を示す信号を発生し、その信号を電子式運動制御器１２２へ送り、電子式運動制御器１２２の制御下、内視鏡本体８２が１ユニット分前進するたび、自動制御される近位部分８６内の各セグメントは通知されて、各セグメントが現在入っているスペースを前に占めていたセグメントの形状をとる。このようにしてカーブ形状は、内視鏡本体８２の自動制御近位部分８６の長さに沿って近位方向に伝播する。カーブ形状は、内視鏡本体８２が遠位方向に前進する際、スペース内で固定されているように見える。
[0036]同様に、内視鏡本体８２が近位方向に引き出されるとき、内視鏡本体８２が１ユニット分近位方向に動かされるたび、自動制御近位部分８６内の各セグメントは信号を受けて、前記セグメントが現在入っているスペースを前に占めていたセグメントの形状をとる。カーブは、内視鏡本体８２の自動制御近位部分８６の長さに沿って遠位方向に伝播し、カーブは、内視鏡本体８２が近位方向に後退する際、スペース内に固定されているように見える。内視鏡本体８２が前進あるいは後退するときはいつでも、軸方向運動トランスデューサ１２４は好ましくは位置変化を検出し、電子式運動制御器１２２は、内視鏡本体８２の自動制御近位部分８６に沿って近位方向または遠位方向に選択カーブ形状を伝播して、空間的に固定された位置にカーブ形状を維持する。これによって内視鏡本体８２は、結腸Ｃの壁に不必要な力を加えずに蛇行カーブを通過できる。
[0037]例えば結腸内などで組立体１０を使用する一例では、内科医あるいは外科医は、通常まず初めに、患者体内で内視鏡１２の遠位部分２２を前進させる。内視鏡１２が、カーブ路をうまく通過するために操縦することを必要とする第１の時点に到達すると、ユーザは、この通路を通過するためにカーブ形状をとるように遠位部分２２を適切に操縦できる。内視鏡１２が患者に対して静止して保持されているこの時点で、案内管１４は、案内管１４が制御可能遠位部分２２の遠位先端に位置するか、またはこれより短い距離前に位置するか、またはこれより短い距離先に位置するまでシャフト２０上に沿って進められる。この短い距離は、２、３センチメートルから数インチまでをとる。案内管１４がシャフト２０上に沿って進められる間、案内管１４は好ましくは硬くない状態にあり、制御可能遠位部分２２により形成されたカーブ形状をとるのに十分な可撓性を有する。
[0038]いったん案内管１４、あるいは少なくともその遠位部分が、制御可能遠位部分２２により形成されたカーブ形状をとると、案内管１４は好ましくはその長さ部分にわたり硬化されて、そのカーブ形状を維持する。いったんこれが達成されると、内視鏡１２のシャフト２０は、結腸壁にいかなる圧力も加えることなしにカーブ路を通過するように、硬化案内管１４内でさらに進められる。
[0039]あるいは自動制御可能内視鏡８０が利用される場合、自動制御可能内視鏡８０は一般に、従来の内視鏡１２と同様に使用される。しかしながら内視鏡本体８２は、その全長に沿ってか、または操縦可能遠位部分８４の近位に位置するいくつかのセグメントに沿って自動制御可能なので、操縦可能遠位部分８４は、従来の内視鏡１２で可能であろうよりも案内管１４の遠位端のさらに先まで前進可能である。制御可能内視鏡８０は、本明細書に記載のように、その他の全ての面で従来の内視鏡１２と同様に使用できる。
[0040]再び図１において、ベローズすなわちカバー２６は、細片および液体が案内管管腔１６内に入るのを阻止するために案内管１４の遠位開口２４を被覆することもある。シャフト２０の遠位部分２２が案内管１４を通って遠位方向に進められて案内管管腔１６から出る際、カバー２６は好ましくは、シャフト２０上に沿ってあるいはこれと一緒に遠位方向に延び、しかもその際案内管管腔１６とのシールを維持するように形成されている。シャフト２０が案内管管腔１５内に引き戻されるときか、あるいは案内管１４がシャフト２０に対して遠位方向に進められるとき、カバー２６は好ましくは、遠位部分２２の近位方向運動と一緒に、遠位開口２４上に沿って近位方向に引き戻されるように形成されている。カバー２６の使用は随意的であり、案内管管腔２６の無菌性を維持するのに使用されることもある。カバー２６は、シャフト２０が案内管管腔１６内に引き戻されるとき、組織が挟まれたり引き裂かれたりするのを阻止するために使用されることもある。
[0041]案内管１４は、その全長に沿って硬化できる、任意の従来の適切に可撓性の導管でよい。図１に示す変形は複数の個々のセグメント２８から成り、セグメント２８は、いくつかの、すなわち１つ以上の引張り（tensioning）ワイヤあるいは部材３０を介して互いに隣接して連結されている。セグメント２８は、一連の互いに接続されているボール−ソケット形セグメントであることもあり、ボール−ソケット形セグメントにより、互いに隣接するセグメント２８は互いに対して角変位して、カーブを通過するために角度を成すことができる。これらのセグメント２８は、図１の組立体１０の横断面図である図２に示すように、セグメント２８の周りに周方向に配置されてもよい。この変形では、それぞれ互いに９０度を成して配置されている４つの引張りワイヤ３０Ａ、３０Ｂ、３０Ｃ、３０Ｄがある。４本のワイヤがこの例では示されているが、例えば３本などの、より少ない数のワイヤを使用することも可能である。これらのワイヤ３０Ａ、３０Ｂ、３０Ｃ、３０Ｄの各々は、各セグメント２８の壁内に画成された一体的チャネル、すなわち管腔を通っていてもよい。さらに、それらは個別に操作されるか、またはそれらはすべて同時に操作されて、案内管１４をその長さに沿って硬化あるいは弛緩させるために引張り力をもたらす。
[0042]図２は、セグメント２８に対するシャフト２８の相対位置も示す。図から分かるように、照明用ファイバ、光ファイバなどおよび作業チャネルのための任意の数のチャネル３４を含むこともあるシャフト２０は、案内管管腔１６内に滑動可能に配置されている。この変形は、シャフト２０の外面とセグメント２８の内面との間の分離間隙を示す。この間隙は、使用されている内視鏡の直径と案内管１４の所望の横断面領域とに依存して変化可能だが、案内管管腔１６内でシャフト２０が抑制されずに通過できるようにする僅かな分離が好ましい。本発明の一部分として利用できる硬化可能導管構造体の一例が、Zehelらに対する米国特許第５２５１６１１号にさらに詳細に示され記載されており、引用により本命最初に取り込む。
[0043]案内管１４の外面は好ましくは、案内管１４の少なくとも大部分を被覆する管状カバー３２を有する。管状カバー３２は、カバー２６と一緒に使用される場合、体環境の細片および液体と内部管腔１６との間の隔壁を提供することも可能である。さらに、カバー２６は管状カバー３２の一体的延長部であることもあり、したがって連続的材料層から成ることもある。管状カバー３２は、本体管腔の壁に沿っての案内管１４の挿入および運動を容易するために、かつ、組織が挟まれるあるいは捕捉されるのを阻止するために、また個々のセグメント２８の間に滑らかな表面を提供するために、滑らかなカバーを提供することもある。管状カバー３２は例えばＰＴＦＥ、ＦＥＰ、Tecoflexなどの様々な重合体材料から形成できる。
[0044]図３は、分かりやすくするために壁の一部分が部分的に取り除かれている案内管変形１４の側面図を示す。図示のように、個々のセグメント２８は互いに隣接して位置決めされ、相互接続用スリーブ４０がセグメント２８間に配置されている。この変形では、スリーブ４０は、案内管１４が曲がって互いに異なる姿勢をとれるようにする枢転構造体を提供するのに使用することもできる。あるいはセグメント２８は、互いに嵌合するように形成されている曲線状ボール−ソケット形継手であることもある。管状カバー３２も、案内管１４の少なくとも大部分を被覆していることが分かる。随意的に、案内管１４の遠位端部分は、内視鏡１２の制御可能遠位部分２２のように、案内管１４が通過のために最適な通路を画成するように制御可能であるように形成されていることも可能である。
[0045]随意的に、ベローズすなわちカバー２６は、従来の内視鏡シャフト２０あるいは制御可能シャフト８２の遠位端に付加することもできる。本明細書において、自動制御可能内視鏡８２は、案内管１４内で使用されるとき、かつベローズすなわちカバー２６を使用することにより、従来の内視鏡と置換できる。使用法に関する記載は、従来の内視鏡１２での使用に関して記載するが、これは簡潔にするために行われるのであり、制限する意図ではない。この記載は、制御可能内視鏡８０での使用にも同様に適用されるものとする。何故ならば両者は、所望の使用法および結果に依存して容易に置換できるからである。図６Ａは、内視鏡１２が案内管管腔１６に自由に挿入できかつこれから自由に引き出せるように、シャフト２０または８０がカバー２６に取り付けられていない変形を示す。カバー２６は組立体から完全に除くこともできるが、好ましくは、邪魔のない案内管管腔１６を維持するのを支援するだけでなく、組立体を前進させる間、本体管腔の壁が内視鏡シャフト２０または８０と案内管１４との間に挟まれるのを阻止するためにも使用される。図６Ａに示すように、カバー２６は、取り付け領域５０で案内管１４の外面または遠位端に別個に取り付けられてよい。カバー２６はガセット状領域５２をさらに含むこともあり、ガセット状領域５２により、カバー２６は、シャフト２０あるいは８０が前進する間、ベローズのように小型でコンパクトな断面材形状に圧縮したり、また伸ばしたりできる。シャフト２０あるいは８０が引き戻されると、ガセット状領域５２により、カバー２６は自身を再圧縮あるいは再形成してそのコンパクトな形状に戻れる。この変形では、カバー２６はシャフト２０あるいは８０に取り付けられていない。したがって、いったん組立体が結腸内の所定個所に到達すると、カバー２６は内視鏡１２内の作業チャネルを経て取り除かれるか、またはあまり好ましくはないが、手順が始まる前にカバー２６に作業ツールを単に突き通すことも可能である。
[0046]図６Ｂは、カバー２６が、取り付け領域５４に沿って、制御可能遠位部分２２の遠位端の近傍でまたはこの遠位端で、内視鏡シャフト２０あるいは８０に取り付けられることも可能である別の変形を示す。シャフト２０あるいは８０が案内管管腔１６内に進められるかあるいはこれから引き戻される際、カバー２６は内視鏡１２に取り付けられたままである。図7に示すシャフト２０あるいは８０は、案内管管腔１６を通って遠位位置へ進められている。シャフト２０あるいは８０が進められると、ガセット状領域５２が、遠位運動に対応するために伸びるのが見られるであろう。ガセット状領域５２は、シャフト２０あるいは８０が、用途に依存して、例えば２、３あるいは数インチなど任意の実際的な距離の位置へ案内管１４を越えて進められるように構成される。この変形では。シャフト２０あるいは８０は、患者の結腸内でシャフト２０あるいは８０をまず初めに前進させる前に、この遠位位置まで案内管管腔１６を通って延ばされている。またこのように延ばすことにより十分な空間を得、これによって制御可能遠位部分２２が、前進時に案内管１４が沿って進む所望の形状あるいはカーブをとるように操作されるのに十分なスペースを有するようにする。
[0047]カバー６０が弾性管状部材として形成されている別の変形が、図８Ａに示されている。図から分かるように、内視鏡シャフト２０あるいは８０が引っ込み位置にあるとき、カバー６０は、弛緩すると管状構造体を形成するように形成されている。内視鏡シャフト２０あるいは８０が、図9に示すように遠位方向に進められると、カバー６０は、案内管管腔１６の無菌性を維持するためにシャフト２０あるいは８０と一緒に伸びる。
[0048]カバー６２が弾性起伏ダイヤフラムとして形成されているさらに別の変形が、図８Ｂに示されている。内視鏡シャフト２０あるいは８０が引っ込められると、カバー６２は、裏返され、カバー６２の一部分が案内管管腔１６内に近位方向に引っ張られるように形成されている。このようなカバー６２の材料は、任意の数のエラストマー、エラストマー材料、あるいは例えばネオプレンあるいはラテックスなどのゴムタイプ材料を含むことも可能である。内視鏡シャフト２０あるいは８０が遠位方向に進められると、カバー６２も同様に、図9に同様に示されているように、シャフト２０あるいは８０と一緒に遠位方向に戻りかつ伸びる。
[0049]あるいは、カバーは単に、図１０に示すように、非弾性であるプラスチックカバーあるいは包装材料６４で良い。このようなカバー６４は、従来入手可能であり、内視鏡シャフト２０あるいは８０と一緒に進められ、内視鏡シャフト２０あるいは８０が引っ込められると同様に引っ込められる。
[0050]図１１Ａ〜１１Ｅは、案内管１４を使用して従来の内視鏡１２を前進させる変形を示す。図１１Ａは患者の結腸Ｃを例示的に示す。内視鏡１２は患者の肛門Ａを経て結腸Ｃに挿入できる。遠位部分２２が直腸Ｒを通って進められると、遠位部分２２は直腸Ｒの第１の湾曲点に遭遇する。ここで、制御可能遠位部分２２は、Ｓ字結腸Ｓへの最適路を選択するために従来の内視鏡と同程度に操作される。最適路は、結腸Ｃの壁との接触が最小の状態で内視鏡１２を前進させるために最も効率的な通路を示す通路である。
[0051]いったん遠位部分２２が操作されて適正な形状を選択すると、肛門Ａおよび直腸Ｒを通して、内視鏡１２上に沿って案内管１４を前進させることができ、その一方、内視鏡１２は結腸Ｃに対して静止したままに維持される。案内管１４は好ましくは弛緩状態にあり、制御可能遠位部分２２により画成された形状に容易に適合できる。案内管１４は、図１１Ｂに示すように、遠位部分２２の遠位端へ前進させることも、あるいは部分２２より僅かな距離手前に前進させることも、あるいは僅かな距離先に前進させることも可能である。いったん案内管１４が遠位方向に進められると、案内管１４を、内視鏡１２により画成された形状を維持するようにその長さに沿って硬化させ得る。
[0052]次いで、硬化された状態で案内管１４は、好ましくは、結腸Ｃに対して静止状態に保持され、その一方、内視鏡１２は、遠位部分２２が次の湾曲点に到達するまで案内管１４を通ってさらに進められる。次いで制御可能遠位部分２２が操作されて、図１１Ｃに示すように、下行結腸Ｄ内への最適路を選択する。いったん最適路が選択されると、内視鏡１２は好ましくは、結腸Ｃに対して静止状態に維持され、その一方、案内管１４は弛緩状態にされて内視鏡１２上に沿って進められる。案内管１４は、図１１Ｄに示すように、内視鏡１２の遠位端に到達するまで遠位方向に進められる。この時点で、制御可能遠位部分２２により画成された形状をとった案内管１４は、この形状を維持するためにその長さに沿って硬化される。次いで、図１１Ｅに示すように、結腸Ｃと不必要に接触せずに内視鏡１２を前進させるカラムとしての強度を得るために硬化された案内管１４を使用しながら、内視鏡１２を再び遠位方向に前進させる。内視鏡１２は、遠位部分１２が下行結腸Ｄと横行結腸Ｔとの間の湾曲部に到達するまで進めることができる。いったんこの点に到達すると、前述のステップは、内視鏡１２が横行結腸Ｔおよび上行結腸Ｇをうまく通過して盲腸に到達するまで、あるいは結腸Ｃ内の所望の個所に到達するまで繰り返すことができる。
[0053]診査手順の間の任意の時点で、案内管の後退７０により、図１２に示すように、内視鏡１２をそのまま残して、案内管１４を結腸Ｃから取り除くこともできる。もし内視鏡１２が結腸Ｃ内に残される場合には、内視鏡１２は、任意の従来の内視鏡あるいは結腸鏡が従来の結腸鏡検査の間に使用及び操作されるように使用および操作されることも可能である。案内管２２は部分的に引っ込めることもでき、これによって、内視鏡１２の近位部分を引き続き支持および案内しながら、遠位部分２２を操縦あるいは操作して結腸Ｃを検査あるいは治療することが可能となる。結腸Ｃから組立体を取り除くには、まず初めに案内管１４を図示のように引き戻し、次いで内視鏡１２を引き戻すことができる。あるいは前述のステップは、結腸Ｃから案内管１４および内視鏡１２の両方を後退させるために、逆の順序で繰り返すこともできる。
[0054]前述の用途への案内管システムおよび方法の適用は、体内の前述の領域に制限されず、任意の数のさらなる治療用途を含む。その他の治療部位は、体内の器官本体の周りの領域を含む。さらに本発明は、例えばパイプシステム、ダクトなど上での探査手順などの、蛇行路が存在するその他の環境内で使用することも可能である。さらに様々なその他の硬化可能案内管装置および用途が、本明細書に記載の範囲を越えて利用されることも可能である。当業者には明らかである、本発明を実施するための前述の組立体および方法の変更と本発明の態様の変形とは、本特許請求の範囲にあるものとする。
Claims (21)
- 蛇行路を通して内視鏡を進めるためのシステムであって、
近位端と制御可能遠位端とこれら両者間にわたる長さ部分とを有する内視鏡シャフトと、
貫通する内部管腔が画成された長さ部分を有する細長い案内管であり、前記内視鏡シャフトを前記管腔内に滑らせながら受け入れるようになっており、かつ、前記案内管の前記長さ部分を選択的に硬化するために前記案内管の前記長さ部分に沿って配置されている少なくとも１つの引張り部材をさらに備えている前記細長い案内管と、
を備え、
前記案内管の少なくとも一部は、引張り力が前記引張り部材に加わっているとき、前記制御可能遠位端が画成した形状に適合しこの形状を維持するようにさらになっている、
システム。 - 前記内視鏡シャフトが従来の内視鏡シャフトを含む、請求項１に記載のシステム。
- 前記内視鏡シャフトが、近位端および選択的に操縦可能な遠位端を有すると共にこれら両者間に少なくとも１つの管腔が画成された細長い本体を含み、前記細長い本体は、接合部を介して相互接続されている複数のセグメントと、隣接するセグメントを作動するために少なくとも大多数のセグメントの各々に取り付けられた少なくとも１つのモータとを含み、前記各モータは独立に制御可能であり、前記遠位端が選択されたカーブ形状をとると、前記複数のセグメントは、各モータが前記隣接セグメントを選択的に作動することにより、前記細長い本体に沿って前記選択されたカーブ形状を伝播させるように形成されている、請求項１に記載のシステム。
- 前記案内管が、互いに隣接して接続された複数のセグメントを含み、少なくとも大多数の前記セグメントは互いに対して角変位可能である、請求項１に記載のシステム。
- 前記案内管が、前記案内管の前記長さ部分に沿って配置されている少なくとも３つの引張り部材を備えている、請求項１に記載のシステム。
- 前記引張り部材の各々が、前記案内管の周りに互いに対して周方向に配置されている、請求項５に記載のシステム。
- 前記案内管の外面の少なくとも大部分を覆って配置された管状カバーをさらに含む、請求項１に記載のシステム。
- 前記案内管管腔の遠位端を覆って配置されたカバーをさらに含む、請求項１に記載のシステム。
- 前記カバーがガセット状領域を備え、前記ガセット状領域は、前記内視鏡シャフトが前記案内管管腔の前記遠位端に対して遠位方向に進められると、第１の圧縮形態から第２の長手方向に広がった形態へ広がるようになっている、請求項８に記載のシステム。
- 前記カバーが、前記内視鏡シャフトが前記案内管管腔内に位置決めされると、外側に裏返されるようになっている、請求項８に記載のシステム。
- 前記カバーが、前記内視鏡が前記案内管の前記遠位端に対して遠位方向に進められると、遠位方向に伸びるようになっている、請求項８に記載のシステム。
- 前記カバーが、前記案内管の前記遠位端と前記内視鏡シャフト上の遠位個所に沿う間に取り付けられている、請求項８に記載のシステム。
- 前記カバーが、前記案内管の前記遠位端と前記内視鏡シャフトの前記遠位端を覆う間に取り付けられている、請求項８に記載のシステム。
- 前記カバーが、前記案内管管腔の前記遠位端と前記内視鏡シャフトの前記遠位端との全体を覆って配置されている、請求項８に記載のシステム。
- 蛇行路を通して内視鏡を前進させる方法であって、
前記蛇行路に沿って前記蛇行路内のカーブに遭遇するまで内視鏡シャフトを前進させるステップと、
前記カーブを通過できる任意の形状をとるように前記内視鏡シャフトの制御可能遠位端を操作するステップと、
案内管の一部が前記内視鏡シャフトの前記遠位端により画成された前記任意の形状をとるように、前記内視鏡シャフト上に沿って可撓状態で前記案内管を前進させるステップと、
前記任意の形状が前記案内管により維持されるように前記案内管の長さ部分を硬化するステップと、および
前記硬化された案内管を通して前記内視鏡シャフトをさらに前進させるステップと、
を含む方法。 - 前記案内管を弛緩するステップをさらに含む、請求項１５に記載の方法。
- 前記可撓状態で前記案内管を前進させる前記ステップが、前記内視鏡シャフトを覆って前記案内管を前進させるステップを含む、請求項１５に記載の方法。
- 前記案内管を、前記案内管の遠位端が前記内視鏡シャフトの前記遠位端に隣接して位置するか、またはその極近位に位置するか、またはその極遠位に位置するまで、前記内視鏡シャフトを覆って前進させる、請求項１７に記載の方法。
- 前記内視鏡の前記制御可能遠位端を操作するステップが、前記任意の形状をとるように前記遠位端を手動で制御するステップを含む、請求項１５に記載の方法。
- 前記案内管を前進させる前記ステップが、前記内視鏡シャフトが前記案内管に対して遠位方向に進められ-----ると、前記案内管の前記遠位端を覆って配置されるカバーを広げるステップを含む、請求項１５に記載の方法。
- 前記案内管の前記長さ部分を硬化する前記ステップが、前記案内管の前記長さ部分に沿って配置されている少なくとも３つの引張り部材を引っ張るステップを含む、請求項１５に記載の方法。
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/139,289 US6837846B2 (en) | 2000-04-03 | 2002-05-02 | Endoscope having a guide tube |
| PCT/US2003/013600 WO2003092476A2 (en) | 2002-05-02 | 2003-05-02 | Endoscope having a guide tube |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2005524431A true JP2005524431A (ja) | 2005-08-18 |
| JP2005524431A5 JP2005524431A5 (ja) | 2006-06-15 |
| JP4459047B2 JP4459047B2 (ja) | 2010-04-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2004500668A Expired - Lifetime JP4459047B2 (ja) | 2002-05-02 | 2003-05-02 | 蛇行路を通して内視鏡を進めるためのシステム |
Country Status (8)
| Country | Link |
|---|---|
| US (10) | US6837846B2 (ja) |
| EP (1) | EP1499227B1 (ja) |
| JP (1) | JP4459047B2 (ja) |
| CN (1) | CN1649537A (ja) |
| AT (1) | ATE483396T1 (ja) |
| AU (1) | AU2003234324A1 (ja) |
| DE (1) | DE60334449D1 (ja) |
| WO (1) | WO2003092476A2 (ja) |
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-
2002
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2003
- 2003-05-02 DE DE60334449T patent/DE60334449D1/de not_active Expired - Lifetime
- 2003-05-02 AU AU2003234324A patent/AU2003234324A1/en not_active Abandoned
- 2003-05-02 WO PCT/US2003/013600 patent/WO2003092476A2/en active Application Filing
- 2003-05-02 EP EP03728638A patent/EP1499227B1/en not_active Expired - Lifetime
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- 2003-05-02 JP JP2004500668A patent/JP4459047B2/ja not_active Expired - Lifetime
- 2003-05-02 CN CNA038099861A patent/CN1649537A/zh active Pending
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Also Published As
| Publication number | Publication date |
|---|---|
| EP1499227A2 (en) | 2005-01-26 |
| US20020161281A1 (en) | 2002-10-31 |
| US20040193008A1 (en) | 2004-09-30 |
| ATE483396T1 (de) | 2010-10-15 |
| JP4459047B2 (ja) | 2010-04-28 |
| US20060009678A1 (en) | 2006-01-12 |
| WO2003092476A3 (en) | 2004-04-15 |
| EP1499227B1 (en) | 2010-10-06 |
| US20060015009A1 (en) | 2006-01-19 |
| US20040210109A1 (en) | 2004-10-21 |
| US20070043259A1 (en) | 2007-02-22 |
| DE60334449D1 (de) | 2010-11-18 |
| AU2003234324A8 (en) | 2003-11-17 |
| CN1649537A (zh) | 2005-08-03 |
| US20040193009A1 (en) | 2004-09-30 |
| US6837846B2 (en) | 2005-01-04 |
| WO2003092476A2 (en) | 2003-11-13 |
| US20050124855A1 (en) | 2005-06-09 |
| US20040220450A1 (en) | 2004-11-04 |
| US20060015010A1 (en) | 2006-01-19 |
| AU2003234324A1 (en) | 2003-11-17 |
| EP1499227A4 (en) | 2005-12-14 |
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