JP5897560B2 - 縫合糸ディスペンサー及び縫合糸を送達するためのシステム - Google Patents
縫合糸ディスペンサー及び縫合糸を送達するためのシステム Download PDFInfo
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Description
本願は、参照することによってその全体が本明細書に組み込まれる、2010年6月11日に出願された米国特許仮出願第61/354,009号の利益を主張する。
本発明は、低侵襲外科的処置を含む、外科的処置中、患者内の手術部位に縫合糸を包装、選択、及び送達するためのシステムに関する。
幾つかの実施形態において、以後使用される特定用語の定義には、以下のものが挙げられる。
上で論じられるように、本発明は、組成物、構成、留置縫合糸の製造方法及び使用方法を提供する。本発明は、留置縫合糸を手術部位に送達することによって、先行技術の問題及び不利点を克服する。留置縫合糸は、組織を縫合、隣接、及び保持するために、手術部位において、内視鏡及び/又はロボット支援外科手術ツールによって、操作することができる多くのデバイスは、MIS処置に使用される外科的要素及び付属品を送達するために提案されている。デバイスは、例えば、Rudnickらの米国特許第6,986,780号の表題「Surgical Element Delivery System And Method」及びJulianらの米国特許第7,125,403号の表題「in Vivo Accessories For Minimally Invasive Robotic Surgery」に開示されており、これらの両方は、参照によってそれらの全体が本明細書に組み込まれる。
幾つかの実施形態において、留置縫合糸は、縫合スレッドの長さに沿って一方向に向けられた1つ以上のリテーナを有する単方向性であるか;あるいは典型的に該スレッドの一部に沿って一方向に向けられた1つ以上のリテーナを有し、次に該スレッドの異なる部分上の別(多くの場合、反対)方向に向けられた1つ以上のリテーナを有する双方向性である(米国特許第5,931,855号及び第6,241,747号において、バーブ付きリテーナとともに記載されているように)。いずれの数の連続的又は間欠的構成のリテーナも可能であるが、一般的形態の双方向性留置縫合糸は、縫合スレッドの一端に針を含み、縫合スレッドには、縫合糸の遷移点(多くの場合、中点)に達するまで、針から「離れて」突出する先端を有するバーブがあり;遷移点で、縫合スレッドの残存長に沿ってバーブの構成は、それ自体約180°逆転してから(今やバーブは反対方向に面するように)、反対端で第2の針に取り付けられる(その結果、縫合糸のこの部分上のバーブも、最も近い針から「離れて」突出する先端を有する)。針から「離れて」突出するとは、バーブの先端が更に針から離れており、バーブを含む縫合糸の部分が、幾つかの実施形態において、反対方向より針の方向に組織をより容易に貫入することを意味する。言い換えれば、典型的な双方向性留置縫合糸の両「ハーフ」上のバーブは、中央を向く先端を有し、それらの間に遷移セグメント(バーブを欠いている)が組み入れられ、いずれかの端に針が取り付けられている。
上記のように、低侵襲遠隔外科手術システムは、内部手術部位内で作業するときの外科医の器用さを助長させるため、並びに、外科医が離れた場所から患者に対して手術できるようにするために開発されている。遠隔外科手術システムでは、外科医は、コンソールで、手術部位の画像が提供される。好適な表示において手術部位の画像を見る一方、外科医は、コンソールの入力デバイスを操作することによって、患者における外科的処置を行う。入力デバイスは、外科手術ツールを位置付けし、操作するロボットアームを制御する。外科的処置中、遠隔外科手術システムは、マスター制御デバイスの操作に応答して、例えば、針を保持若しくは駆動する、血管を把持する、又は組織を切除する等の外科医のために様々な機能を行う、様々な外科手術ツール、又は組織把持器具、焼灼、持針器等のエンドエフェクタを有する器具の機械的作動及び制御を提供し得る。Intuitive Surgical,IncのDA VINCI(登録商標)Surgical Systemは、MIS遠隔外科手術システムの一例である。
図4A〜4Gは、本発明の実施形態によるMIS縫合糸送達ツールで用いるのに適している様々な縫合糸カートリッジを示す。概して、カートリッジは、アクセスポートの直径よりも小さい直径を有するべきである、即ち、一般的には、カートリッジは、10mm以下の直径であるべきである。カートリッジの長さは、収容される縫合糸の量によって決定される。実際に、カートリッジは、縫合糸送達ツールの長さのわずかであることが好ましい。したがって、カートリッジは、好ましくは、120mm以下の長さであり、より好ましくは、80mm以下の長さである。状況次第では、カートリッジは、10mm以下の長さである。カートリッジはまた、カートリッジを縫合糸送達ツールに取り付ける、又は縫合糸送達ツールの駆動機構を係合するために、連結器、開口溝等を有するべきである。本明細書で論じられるカートリッジ及びスプールのそれぞれは、縫合糸送達ツールを係合するために適切な噛合特性の付加により、本明細書で論じられる縫合糸送達ツールのそれぞれで用いるのに適合性がある。
場合によっては、幾つかの実施形態において、遠隔外科手術システムにおいて、縫合糸送達ツールへのカートリッジの送達、装填、交換、又は縫合糸の送達を自動化することが望ましい。一例では、遠隔外科手術が、遠隔位置で行われる場合、幾つかの実施形態において、縫合糸送達システムにカートリッジを装填するための患者側の助手がいない。別例では、幾つかの実施形態において、外科医と患者側の助手との間の情報交換に依存するというよりはむしろ、外科医に、インターフェースとして外科医のコンソールを使用した縫合糸の選択をさせることが、より好都合であるか、又は信頼性がある。縫合糸カートリッジマガジンは、複数の縫合糸カートリッジを保持する。セレクター機構は、マガジン中の利用可能なカートリッジから縫合糸送達ツールに装填されるべきカートリッジを、外科医が選択することを可能にする。カートリッジのロード/アンロード機構は、縫合糸送達ツール上/中にカートリッジをロードし、縫合糸の展開後、カートリッジをアンロードする。これは、外科医が縫合糸を選択し、助手を使わずに、外科医のコンソール制御を使用して、手術部位に縫合糸を展開することを可能にする。
第1の端部に近接して配置される第1の複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される第2の複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸と、
細長いシャフトと、
前記細長いシャフトの遠位端に連結されるスプールであって、前記留置縫合糸が、スプールに取り外し可能に固定される、スプールと、
前記細長いシャフトの近位端に取り付けられた駆動装置であって、前記駆動装置によって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して前記スプール及び前記細長いシャフトの遠位端を導入するように操作される、駆動装置と、を備える、縫合糸ディスペンサー。
前記スプールが、前記第1の針のための第1の針ドックと、前記第2の針のための第2の針ドックと、を備える、段落104に記載のディスペンサー。
前記カバーが、開口されて、前記留置縫合糸にアクセスすることができる、段落104に記載のディスペンサー。
前記駆動装置が、前記カバーに連結され、患者内の前記カバーを開口して、前記留置縫合糸へのアクセスを許可する、段落104に記載のディスペンサー。
留置縫合糸と、
外科手術ツールに取り外し可能に取り付けられるように適合される、スプールと、
前記留置縫合糸を選択的に受容することができる、前記スプール中のチャネルと、を備える、縫合糸ディスペンサー。
第1の端部に近接して配置される複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸と、
細長い管を備える、内視鏡器具と、
前記細長い管の遠位端内に位置付けられる、縫合糸カートリッジであって、前記留置縫合糸が、前記縫合糸カートリッジに取り外し可能に固定される、縫合糸カートリッジと、
前記細長いシャフトの近位端に取り付けられるインターフェースであって、前記インターフェースによって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して、前記細長いシャフトの遠位端を導入するように操作される、インターフェースと、を備える、縫合糸ディスペンサー。
前記縫合糸カートリッジが、前記第1の針用の第1の針ドックと、前記第2の針用の第2の針ドックと、を備える、段落148に記載のディスペンサー。
前記カバーは、患者内に開口されて、前記留置縫合糸へのアクセスを許可することができる、段落148に記載のディスペンサー。
それぞれ縫合糸を装填された複数のカートリッジと、
選択された縫合糸を有するカートリッジを選択することができる、カートリッジセレクターと、
選択されたカートリッジを内視鏡を通して移動させ、選択されたカートリッジを露出させて、患者内の手術部位内から、留置縫合糸へのアクセスを許可することができる、カートリッジ駆動装置と、を備える、システム。
前記複数のカートリッジを受容するために複数のベイを有する前記患者の外側のハウジングと、
患者内の手術部位に送達するために、前記複数のベイのうちの1つ及び前記複数のカートリッジのうちの1つを、前記内視鏡器具のルーメンを用いて整列させることができる、アライナと、を備える、段落158に記載のシステム。
カートリッジを手術部位に送達することであって、カートリッジが、セルフリテーナ及び針を有する縫合糸を含む、送達することと、
内視鏡器具を用いて前記カートリッジにアクセスすることと、
前記内視鏡器具を用いて、前記縫合糸を前記カートリッジから取り出すことと、
前記内視鏡器具を用いて、前記縫合糸を用いて組織を縫合することと、を含む、方法。
(1) 縫合糸ディスペンサーであって、
第1の端部に近接して配置される第1の複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される第2の複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸(self-retaining suture)と、
細長いシャフトと、
前記細長いシャフトの遠位端に連結されるスプールであって、前記留置縫合糸が、前記スプールに取り外し可能に固定される、スプールと、
前記細長いシャフトの近位端に取り付けられた駆動装置であって、前記駆動装置によって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して前記スプール及び前記細長いシャフトの遠位端を導入するように操作される、駆動装置と、
を備える、縫合糸ディスペンサー。
(2) 前記留置縫合糸が、前記第1の端部における第1の針と、前記第2の端部における第2の針と、を備え、
前記スプールが、前記第1の針のための第1の針ドックと、前記第2の針のための第2の針ドックと、を備える、実施態様1に記載のディスペンサー。
(3) 前記スプールが、前記第1のセグメントの前記リテーナを前記第2のセグメントの前記リテーナから分離させるために、複数の縫合糸収容領域を備える、実施態様1に記載のディスペンサー。
(4) 前記スプールが、前記スプールが第2のスプールによって置き換えられるように適合されるように、前記細長いシャフトの前記遠位端に取り外し可能に連結される、実施態様1に記載のディスペンサー。
(5) 前記ディスペンサーが、前記留置縫合糸の特性を特定するための機械可読コードを有して提供される、実施態様1に記載のディスペンサー。
(6) 前記駆動装置が、内視鏡外科手術ツール及び腹腔鏡外科手術ツールのうちの少なくとも1つに、前記縫合糸ディスペンサーを装着するように適合される装着具である、実施態様1に記載の縫合糸ディスペンサー。
(7) 前記スプールが、約12mm以下の直径を有する、実施態様1に記載の縫合糸ディスペンサー。
(8) 遠隔手術システムと組み合わせた、実施態様1に記載の縫合糸ディスペンサー。
(9) 複数のスプールを受け入れ、分配することができる、実施態様1に記載の縫合糸ディスペンサー。
(10) 縫合糸ディスペンサーであって、
留置縫合糸と、
外科手術ツールの遠位端に取り外し可能に取り付けられるように適合される、スプールと、
前記留置縫合糸を選択的に受容することができる、前記スプールの外面に形成された螺旋状のチャネルと、
を備える、縫合糸ディスペンサー。
(12) 縫合糸ディスペンサーであって、
第1の端部に近接して配置される複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸と、
細長い管を備える、内視鏡器具と、
前記細長い管の遠位端内に位置付けられる、縫合糸カートリッジであって、前記留置縫合糸が、前記縫合糸カートリッジに取り外し可能に固定される、縫合糸カートリッジと、
前記細長いシャフトの近位端に取り付けられるインターフェースであって、前記インターフェースによって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して、前記細長いシャフトの前記遠位端を導入するように操作される、インターフェースと、
を備える、縫合糸ディスペンサー。
(13) 内視鏡を用いて、患者内の手術部位に、縫合糸を送達するためのシステムであって、
それぞれ縫合糸を装填された複数のカートリッジと、
選択された縫合糸を有するカートリッジを選択することができる、カートリッジセレクターと、
前記選択されたカートリッジを前記内視鏡を通して移動させ、前記選択されたカートリッジを露出させて、患者内の手術部位内から、前記留置縫合糸へのアクセスを許可することができる、カートリッジ駆動装置と、
を備える、システム。
(14) 前記内視鏡を位置付け、それによって、前記選択されたカートリッジを、患者内に位置付けるための外科手術ロボットを更に備える、実施態様13に記載のシステム。
(15) 低侵襲手術法であって、
カートリッジを手術部位に送達することであって、カートリッジが、セルフリテーナ及び針を有する縫合糸を含む、送達することと、
内視鏡器具を用いて前記カートリッジにアクセスすることと、
前記内視鏡器具を用いて、前記縫合糸を前記カートリッジから取り除くことと、
前記内視鏡器具を用いて、前記縫合糸を用いて組織を縫合することと、を含む、方法。
Claims (14)
- 縫合糸ディスペンサーであって、
第1の端部に近接して配置される第1の複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される第2の複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸と、
細長いシャフトと、
前記細長いシャフトの遠位端に連結されるスプールであって、前記留置縫合糸が、前記スプールに取り外し可能に固定される、スプールと、
前記細長いシャフトの近位端に取り付けられた駆動装置であって、前記駆動装置によって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して前記スプール及び前記細長いシャフトの遠位端を導入するように操作される、駆動装置と、
を備える、縫合糸ディスペンサー。 - 前記留置縫合糸が、前記第1の端部における第1の針と、前記第2の端部における第2の針と、を備え、
前記スプールが、前記第1の針のための第1の針ドックと、前記第2の針のための第2の針ドックと、を備える、請求項1に記載のディスペンサー。 - 前記スプールが、前記第1のセグメントの前記リテーナを前記第2のセグメントの前記リテーナから分離させるために、複数の縫合糸収容領域を備える、請求項1に記載のディスペンサー。
- 前記スプールが、前記スプールが第2のスプールによって置き換えられるように適合されるように、前記細長いシャフトの前記遠位端に取り外し可能に連結される、請求項1に記載のディスペンサー。
- 前記ディスペンサーが、前記留置縫合糸の特性を特定するための機械可読コードを有して提供される、請求項1に記載のディスペンサー。
- 前記駆動装置が、内視鏡外科手術ツール及び腹腔鏡外科手術ツールのうちの少なくとも1つに、前記縫合糸ディスペンサーを装着するように適合される装着具である、請求項1に記載の縫合糸ディスペンサー。
- 前記スプールが、約12mm以下の直径を有する、請求項1に記載の縫合糸ディスペンサー。
- 遠隔手術システムと組み合わせた、請求項1に記載の縫合糸ディスペンサー。
- 複数のスプールを受け入れ、分配することができる、請求項1に記載の縫合糸ディスペンサー。
- 縫合糸ディスペンサーであって、
留置縫合糸と、
外科手術ツールの遠位端に取り外し可能に取り付けられるコネクタ部を有するスプールと、
前記留置縫合糸を選択的に受容することができる、前記スプールの外面に形成された螺旋状のチャネルと、
を備え、
前記外科手術ツールは、細長いシャフト、及び、前記細長いシャフトの近位端に取り付けられた駆動装置を有し、
前記スプールの前記コネクタ部は、前記細長いシャフトの遠位端に取り外し可能に取り付けられ、
前記駆動装置は、前記細長いシャフトの前記遠位端に対する前記スプールの前記コネクタ部の取り付けおよび取り外しを制御し、
前記駆動装置を患者の体の外側で操作することによって、前記スプール及び前記細長いシャフトの前記遠位端がアクセスポートを通して患者内の手術部位に導入され、前記スプール及び前記細長いシャフトの前記遠位端が、前記アクセスポート内を摺動可能であり、前記アクセスポート周辺を旋回可能である、縫合糸ディスペンサー。 - 前記縫合糸の特性を特定することができる機械可読コードを有する、請求項10に記載の縫合糸ディスペンサー。
- 縫合糸ディスペンサーであって、
第1の端部に近接して配置される複数のリテーナを有する第1のセグメントと、第2の端部に近接して配置される複数のリテーナを有する第2のセグメントと、を有する、細長い縫合糸本体を有する、留置縫合糸と、
細長い管を備える、内視鏡器具と、
前記細長い管の遠位端内に位置付けられる、縫合糸カートリッジであって、前記留置縫合糸が、前記縫合糸カートリッジに取り外し可能に固定される、縫合糸カートリッジと、
前記細長いシャフトの近位端に取り付けられるインターフェースであって、前記インターフェースによって、前記ディスペンサーが、患者内の手術部位に、アクセスポートを通して、前記細長いシャフトの前記遠位端を導入するように操作される、インターフェースと、
を備える、縫合糸ディスペンサー。 - 内視鏡を用いて、患者内の手術部位に、縫合糸を送達するためのシステムであって、
それぞれ縫合糸を装填された複数のカートリッジと、
選択された縫合糸を有するカートリッジを選択することができる、カートリッジセレクターと、
前記選択されたカートリッジを前記内視鏡を通して移動させ、前記選択されたカートリッジを露出させて、患者内の手術部位内から、前記留置縫合糸へのアクセスを許可することができる、カートリッジ駆動装置と、
を備える、システム。 - 前記内視鏡を位置付け、それによって、前記選択されたカートリッジを、患者内に位置付けるための外科手術ロボットを更に備える、請求項13に記載のシステム。
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BR112012031606B1 (pt) | 2020-11-10 |
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MX2012014456A (es) | 2013-02-07 |
EP2579787B1 (en) | 2016-11-30 |
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MX337815B (es) | 2016-03-18 |
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