JP2011518618A - 詰まった血管通路を突き抜けて進むためのカテーテルシステム及び方法 - Google Patents
詰まった血管通路を突き抜けて進むためのカテーテルシステム及び方法 Download PDFInfo
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Abstract
を貫通するための、回転する切削ヘッドのカテーテルが開示されている。カテーテルの回転する切削ヘッドは、使用しないときには外側の保護シース内に安全に留まるように設計されている。外側の保護シースは1つ若しくはそれ以上の螺旋状のグロウブ又はスロットを有し、切削ヘッドは、これら螺旋状のグロウブ又はスロットに嵌合する突き出たブレード又は突出部を有している。内側のカテーテル又は切削ヘッドに取り付けられたワイヤへのトルクの適用が切削ヘッドに回転を加え、切削ヘッドの突き出たブレード又は突出部に対するシースの螺旋状のグロウブ又はスロットの力が、保護シースから外方へ切削ヘッドを前進させる。切削ヘッドは、伸長した時点で、自由に回転することができる。装置は、切削ヘッドを病気の部分に指向させるのにガイドワイヤを用いてもよい。
Description
或る実施形態では、カテーテル及び切削ヘッド自体さえも、その中心部が中空であってもよく、装置は、カテーテル及び切削ヘッドを所望の位置へ向かわせるのにガイドワイヤを用いてもよい。その代わりに、ガイドワイヤが、カテーテル管(チューブ:tube)の外側に取り付けられたガイド部に取り付けられてもよい。少なくとも幾つかの実施形態では、シースヘッドは、動作停止装置(motion stop)として働き、切削ヘッドの前方への伸長を制限するように設計された、1つ若しくはそれ以上の(例えば機械的な障害物のような)動作停止要素を含んでいてもよい。
本技術のその他の適用には、装置が尿管を行き来するように意図されることになる腎結石の除去;装置が胆管を行き来するように意図されることになる胆石の除去;装置が尿道を行き来するように意図されることになる尿道の前立腺肥大閉塞の除去;装置が卵管を行き来するように意図されることになる閉塞した卵管の除去;血栓の治療,肺の中に閉じ込められた物質の除去、などがある。
一般に、人体の管腔内で場所を占めるあらゆる好ましからざる物質は、これらの技法によって外科的に除去することができる。同様に、殆どの例では人間の患者における適用が引き合いに出されているけれども、同じ技法が動物においても有用であることは明白である。
螺旋状のセルフタッピングねじビットは、若干異なるように設計されている。様々の物質を貫通して切削するのには正しく効果的ではあるけれども、ドリルビットは、物質を切削しその後その物質を除去するように構成されており、一方、セルフタッピングねじビットは、第一義的には、物質を貫通して通路を切削するために設計されている。何れのタイプの装置についても、問題は、切削あるいは閉塞物除去の効能ではない;問題は、周囲の動脈に不用意に損傷を及ぼすことを防止することである。
切削ヘッドの回転方向は、随意的に変化させられることができ、例えば、ヘッドを反時計回り方向に回転させることによって障害物または閉塞物を貫通して鈍的切開を実行し、その後、組立体(アッセンブリ:assembly)全体を後退させる間は時計回り方向へ回転させられる。所望の切削が達成されると、切削ヘッドは迅速に保護シースに戻されなければならない。装置全体は、ミリメータ単位の直径の典型的な動脈内で操作され、カテーテル上でかなりの距離にわたって身体内へねじ込まれなければならない。
また、この議論に関して、「スロット(slot)」とは、中空のカテーテルヘッド(106)の内側から外側に開口する開口部であると見なされ、一方、「グロウブ(grove)」はライフル・グロウブ(rifle grove)に似ており、当該「グロウブ」は、中空のシースヘッドの内側から外側の全部にわたって広がるのではなく、シースヘッド材料の途中まで侵入しているに過ぎない。
ブレードの角度およびその設計は、当該ヘッドが、単に閉塞している材料を貫通して切削することだけを企図したものであるのか、閉塞部分を貫通して切削し且つ閉塞部分を実際に除去(減量)することを企図したものであるのか、に依って異なる。例えば、材料を除去することを企図したブレードは、塞いでいる材料と身体の管腔との間でリンク(link)としての役割を果たす傾向があるように、或る角度で曲がっているかも知れない。一方、切削だけを企図したブレードは、このようなリンクの役割を果たす傾向がない、代替的な角度を有することになろう。
(「トルク伝達コネクタ」の一つの可能なタイプである)内側トルク伝達チューブは、外側カテーテルチューブに対し相対的に捩ることができ、その結果、ハンドル端部(104)で内側チューブにトルクが加えられると、切削ヘッド(108)は回転するが、外側カテーテルチューブに結合されたカテーテル・シースヘッド自体は概略的には静止状態に留まる。この代わりに、内側チューブ(408)に代えてケーブルが用いられてもよい。
幾つかの実施形態では、切削ヘッド(108)が、カテーテルヘッド(106)のシースヘッド部分に対して、どれだけ回転したか、若しくはどれだけ伸長したか、を測定するためにセンサが用いられてもよく、おそらく機械的もしくは電子的な計算および表示機構に支援されたこれらセンサは、切削ヘッドがどれだけ回転し、及び/又は伸長したかを操作者に示すことができる。
他の実施形態では、カテーテルハンドルは、ユーザが精密な制御されたやり方で切削ヘッドを回転させ前進させることができるようにする、例えば電子モータなどの機構、及び、例えばボタンや引き金などの制御手段を備えている。
この機構は、例えば、マイクロプロセッサ若しくはフィードバック制御のモータ,マイクロプロセッサ及びソフトウェアで構成され、当該ソフトウェアは、切削ヘッドの回転または伸長センサから情報を受け取り、この回転フィードバックデータを、ボタン又は引き金によってもたらされるオペレータの指示と関連付けて用い、オペレータの各命令に対して精密な量だけ切削ヘッドを前進または引き込ませる、ように作用する。
この方法は、オペレータに、内側トルク伝達チューブ又はケーブル(408)のバネ作用によって引き起こされるエラーについて、何等の心配もする必要を無くする。マイクロプロセッサ(又は他の回路)制御のモータは、自動的に、これらエラーを補償し、ボタン又はレバーを移動させ、正しいトルク量に矯正し、オペレータの更なる努力を要することなく、命令を実行することができる。
この代わりに、オペレータが、トルク伝達コネクタの回転と切削ヘッドの回転の差、或いは、切削ヘッドが前記中空のシースヘッドを出て行く程度の差を補償できるようにするために、例えば、バーニヤ(vernier)又は一連のガイドされたマーキング等の、マイクロプロセッサを用いない方法が、使用されてもよい。
医師は、蛍光透視法あるいはその他の技術により閉塞部を視認することができ、当面の問題に最も適した設計の切削ヘッド(及び組み合わされるシースヘッド)を装着するように選択することができる。この代わりに、工程中、使用に伴って、切削ヘッド(108)のブレード(202),(204)が、切れ味が鈍くなったり或いは欠けたりした場合には、医師は、残りのカテーテルを使用することを継続しながら、鈍くなった或いは欠損した切削ヘッド(108)を新しい切削ヘッドと取り替えるように選択することができる。
Claims (49)
- カテーテルチューブと回転可能な切削ヘッドとを備えたカテーテルであって;
前記回転可能な切削ヘッドは、前記カテーテルチューブ内に配置され;
前記回転可能な切削ヘッドに加えられるトルクは、前記切削ヘッドに前記カテーテルチューブとの相互作用を生じせしめ、前記切削ヘッドに回転と前記カテーテルチューブの少なくとも部分的に外側で前方への伸長を生じせしめる、
ことを特徴とするカテーテル。 - 前記切削ヘッドは少なくとも一つの突出部を有し、前記カテーテルチューブは1つ若しくはそれ以上のスロット又はグロウブを有しており;
前記切削ヘッドの少なくとも一つの突出部と前記1つ若しくはそれ以上のスロット又はグロウブとの間での機械的な相互作用が、前記切削ヘッドに回転と前記カテーテルチューブの少なくとも部分的に外側での前方への伸長の両方を生じせしめる、
ことを特徴とする請求項1に記載のカテーテル。 - 1つ若しくはそれ以上のスロット又はグロウブの少なくとも幾つかは螺旋状である、ことを特徴とする請求項1に記載のカテーテル。
- 前記切削ヘッドの前方への伸長は、前記カテーテルチューブに取り付けられた1つ若しくはそれ以上の動作停止要素によって制限される、ことを特徴とする請求項1に記載のカテーテル。
- 前記切削ヘッドの前方への伸長は、前記カテーテルチューブによって制限されない、ことを特徴とする請求項1に記載のカテーテル。
- 前記カテーテルチューブは中空でトルク伝達コネクタを包含しており、該トルク伝達コネクタへのトルクの適用は前記回転可能な切削ヘッドを回転せしめる、ことを特徴とする請求項1に記載のカテーテル。
- 手動の機構またはフィードバック制御される電子モータによって、トルクが前記トルク伝達コネクタに加えられる、ことを特徴とする請求項6に記載のカテーテル。
- 前記中空のカテーテルチューブを通じて治療薬または可視化染料剤が投与される、ことを特徴とする請求項6に記載のカテーテル。
- 前記中空のカテーテルチューブの内側にガイドワイヤがねじ込まれ、該ガイドワイヤは、前記回転可能な切削ヘッドの中心の開口部を通って前記中空のチューブから出て行く、ことを特徴とする請求項6に記載のカテーテル。
- 前記カテーテルチューブの一部分のみが前記回転可能な切削ヘッドを包含し、前記カテーテルチューブの外側に取り付けられたガイド部を通ってガイドワイヤがねじ込まれ、該ガイドワイヤは、前記カテーテルチューブの前記回転可能な切削ヘッドを包含している部分より前で前記ガイド部を出て行く、ことを特徴とする請求項1に記載のカテーテル。
- 前記回転可能な切削ヘッドは、1つ若しくはそれ以上のブレードエッジを有している、ことを特徴とする請求項1に記載のカテーテル。
- 前記切削ヘッドの前記カテーテル外部への伸長の進展は、センサによってモニタされている、ことを特徴とする請求項1に記載のカテーテル。
- 前記切削ヘッドの切削の有効性は、超音波振動,無線周波数(RF)エネルギー或いは光エネルギーによって向上させられる、ことを特徴とする請求項1に記載のカテーテル。
- 前記切削ヘッドは、カテーテルのX線不透過性の特徴とは異なるX線不透過性の特徴を有している、ことを特徴とする請求項1に記載のカテーテル。
- 前記カテーテルは、冠動脈或いは末梢肢動脈から頑強なアテローム性動脈硬化プラーク或いは慢性完全閉塞を除去するのに用いられる、ことを特徴とする請求項1に記載のカテーテル。
- 前記カテーテルは、閉塞した冠動脈或いは末梢肢動脈に対する前治療として用いられ、その後、前記閉塞した動脈は、前記カテーテルの使用に続く、アテローム切除,ステント或いはバルーン血管形成を受ける、ことを特徴とする請求項14に記載のカテーテル。
- カテーテルチューブと;
前記カテーテルチューブの遠位部分に取り付けられた中空のシースヘッドと;
少なくとも部分的に前記中空のシースヘッド内部に配置されている回転可能な切削ヘッドと;を備え、
前記切削ヘッドの回転は、前記切削ヘッドに前記シースヘッドとの機械的な相互作用を生じせしめ、前記切削ヘッドに回転と前記中空のシースヘッドの更に外側での前進の両方を生じせしめる、
ことを特徴とするカテーテル。 - 前記中空のシースヘッドは、開口部と1つ若しくはそれ以上の螺旋状のスロット又グロウブを有し;
前記回転可能な切削ヘッドは、前記螺旋状のスロット又グロウブと係合可能な少なくとも一つの突出部を有しており;
前記回転可能な切削ヘッドの少なくとも一つの突出部と前記1つ若しくはそれ以上の螺旋状のスロット又はグロウブとの間での機械的な相互作用が、前記切削ヘッドに回転と前記中空のシースヘッド内の開口部を通じての前進の両方を生じせしめる、
ことを特徴とする請求項16に記載のカテーテル。 - 前記カテーテルチューブは中空でトルク伝達コネクタを包含しており、該トルク伝達コネクタへのトルクの適用は前記回転可能な切削ヘッドを回転せしめる、ことを特徴とする請求項16に記載のカテーテル。
- 手動の機構またはフィードバック制御される電子モータによって、トルクが前記トルク伝達コネクタに加えられる、ことを特徴とする請求項18に記載のカテーテル。
- 前記中空のカテーテルチューブを通じて治療薬または可視化染料剤が投与される、ことを特徴とする請求項18に記載のカテーテル。
- 前記中空のカテーテルチューブの内側にガイドワイヤがねじ込まれ、該ガイドワイヤは、前記回転可能な切削ヘッドの中心の開口部を通って前記中空のチューブから出て行く、ことを特徴とする請求項18に記載のカテーテル。
- 前記カテーテルチューブの外側に取り付けられたガイド部を通ってガイドワイヤがねじ込まれ、該ガイドワイヤは、前記中空のシースヘッドよりも前かで、若しくは前記中空のシースヘッドの側部の開口を通って、前記ガイド部を出て行く、ことを特徴とする請求項18に記載のカテーテル。
- 前記回転可能な切削ヘッドは、1つ若しくはそれ以上のブレードエッジを有している、ことを特徴とする請求項16に記載のカテーテル。
- 前記切削ヘッドの前記中空シースヘッド開口部の外部への前進の進展は、センサによってモニタされている、ことを特徴とする請求項16に記載のカテーテル。
- 前記切削ヘッドの切削の有効性は、超音波振動,無線周波数(RF)エネルギー或いは光エネルギーによって向上させられる、ことを特徴とする請求項16に記載のカテーテル。
- 前記切削ヘッドは、カテーテルのX線不透過性の特徴とは異なるX線不透過性の特徴を有している、ことを特徴とする請求項16に記載のカテーテル。
- 前記カテーテルは、冠動脈或いは末梢肢動脈から頑強なアテローム性動脈硬化プラーク或いは慢性完全閉塞を除去するのに用いられる、ことを特徴とする請求項16に記載のカテーテル。
- 前記カテーテルは、閉塞した冠動脈或いは末梢肢動脈に対する前治療として用いられ、その後、前記閉塞した動脈は、前記カテーテルの使用に続く、アテローム切除,ステント或いはバルーン血管形成を受ける、ことを特徴とする請求項26に記載のカテーテル。
- 中空のカテーテルチューブと;
前記カテーテルチューブの遠位部分に取り付けられた中空のシースヘッドと;を備え、
前記中空のシースヘッドは、開口部と1つ若しくはそれ以上の螺旋状のスロット又グロウブを有し;
前記回転可能な切削ヘッドは、前記螺旋状のスロット又グロウブと係合可能な少なくとも一つの突出部を有しており;
トルク伝達コネクタであって、当該トルク伝達コネクタへの適用が前記回転可能な切削ヘッドに回転を生じさせる、トルク伝達コネクタを備え;
前記回転可能な切削ヘッドの少なくとも一つの突出部と前記1つ若しくはそれ以上の螺旋状のスロット又はグロウブとの間での機械的な相互作用が、前記切削ヘッドに回転と前記中空のシースヘッド内の開口部を通じての前進の両方を生じせしめる、
ことを特徴とするカテーテル。 - 手動で、若しくはマイクロプロセッサ制御の電子モータによって、前記トルク伝達コネクタにトルクが加えられ、前記マイクロプロセッサ制御の電子モータは、前記電気モータの回転と前記切削ヘッドの回転との間の回転の差を補償する、ことを特徴とする請求項28に記載のカテーテル。
- 前記中空のカテーテルチューブを通じて治療薬または可視化染料剤が投与される、ことを特徴とする請求項28に記載のカテーテル。
- 前記中空のカテーテルチューブの内側にガイドワイヤがねじ込まれ、該ガイドワイヤは、前記回転可能な切削ヘッドの中心の開口部を通って前記中空のチューブから出て行く、ことを特徴とする請求項28に記載のカテーテル。
- 前記カテーテルチューブの外側に取り付けられたガイド部を通ってガイドワイヤがねじ込まれ、該ガイドワイヤは、前記中空のシースヘッドよりも前かで、若しくは前記中空のシースヘッドの側部の開口を通って、前記ガイド部を出て行く、ことを特徴とする請求項28に記載のカテーテル。
- 前記回転可能な切削ヘッドは、1つ若しくはそれ以上のブレードエッジを有している、ことを特徴とする請求項28に記載のカテーテル。
- 前記切削ヘッドの前記中空シースヘッド開口部の外部への前進の進展は、センサによってモニタされている、ことを特徴とする請求項28に記載のカテーテル。
- 前記切削ヘッドの切削の有効性は、超音波振動,無線周波数(RF)エネルギー或いは光エネルギーによって向上させられる、ことを特徴とする請求項28に記載のカテーテル。
- 前記切削ヘッドは、カテーテルのX線不透過性の特徴とは異なるX線不透過性の特徴を有している、ことを特徴とする請求項28に記載のカテーテル。
- 前記カテーテルは、冠動脈或いは末梢肢動脈から頑強なアテローム性動脈硬化プラーク或いは慢性完全閉塞を除去するのに用いられる、ことを特徴とする請求項28に記載のカテーテル。
- 前記カテーテルは、閉塞した冠動脈或いは末梢肢動脈に対する前治療として用いられ、その後、前記閉塞した動脈は、前記カテーテルの使用に続く、アテローム切除,ステント或いはバルーン血管形成を受ける、ことを特徴とする請求項37に記載のカテーテル。
- 血管腔内のアテローム性動脈硬化閉塞部または病変部を治療する方法であって、
前記血管腔を通ってカテーテルチューブを前記閉塞部または病変部へねじ込むステップと;
前記カテーテルチューブの内側に装備されたトルク伝達コネクタを回転させるステップと;を備え、
前記トルク伝達コネクタは、前記カテーテルチューブの遠位端部の中空シースヘッドの内部に装備された回転可能な切削ヘッドに結合され、前記シースヘッドは、前述の回転が無い場合には、前記回転可能な切削ヘッドを、前記血管腔および閉塞部または病変部に接触することから保護し;
前記回転可能な切削ヘッドと前記中空のシースヘッドとの間での機械的な相互作用が、前記切削ヘッドに回転と前記中空のシースヘッドからの少なくとも部分的に出て行くことの両方を生じせしめ、回転する回転可能な切削ヘッドが、前記閉塞部または病変部に接触し、当該閉塞部または病変部を切削できるようにする、
ことを特徴とする方法。 - 前記中空のシースヘッドは、開口部と1つ若しくはそれ以上の螺旋状のスロット又グロウブを有し;
前記回転可能な切削ヘッドは、前記螺旋状のスロット又グロウブと係合可能な少なくとも一つの突出部を有しており;
前記回転可能な切削ヘッドの少なくとも一つの突出部と前記1つ若しくはそれ以上の螺旋状のスロット又はグロウブとの間での機械的な相互作用が、前記切削ヘッドに回転と前記中空のシースヘッド内の開口部を通じての前進の両方を生じせしめる、
ことを特徴とする請求項39に記載の方法。 - 前記トルク伝達コネクタの回転は、前記トルク伝達コネクタの回転と前記切削ヘッドの回転の差を補償するように、或いは、前記切削ヘッドが前記中空のシースヘッドをから出ている程度を補償するように、調節される、ことを特徴とする請求項39に記載の方法。
- 前記カテーテルチューブは中空である、ことを特徴とする請求項39に記載の方法。
- 前記中空のカテーテルチューブを通じて治療薬または可視化染料剤を投与するステップを更に備える、ことを特徴とする請求項42に記載の方法。
- 前記カテーテルチューブは、ガイドワイヤを用いて、前記血管病変部を貫通してねじ込まれる、ことを特徴とする請求項39に記載の方法。
- 前記閉塞部または病変部は、前記回転可能な切削ヘッドに装着された1つ若しくはそれ以上のブレードエッジによって切削される、ことを特徴とする請求項39に記載の方法。
- 前記切削ヘッド,閉塞部または病変部に対して、超音波振動,無線周波数(RF)エネルギー或いは光エネルギーを適用するステップを更に備える、ことを特徴とする請求項39に記載の方法。
- 前記方法は、閉塞した冠動脈或いは末梢肢動脈を前治療するのに用いられ、その後、同じ工程中に、前記閉塞した動脈は、更に、アテローム切除,ステント或いはバルーン血管形成によって治療される、ことを特徴とする請求項39に記載の方法。
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CN (1) | CN102014773B (ja) |
AU (1) | AU2009240503B2 (ja) |
CA (1) | CA2722401C (ja) |
WO (1) | WO2009132218A1 (ja) |
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JP5419965B2 (ja) | 2014-02-19 |
CN102014773A (zh) | 2011-04-13 |
CA2722401C (en) | 2016-10-04 |
CA2722401A1 (en) | 2009-10-29 |
US20180256187A1 (en) | 2018-09-13 |
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