JP7423538B2 - 電動ハンドルを有する外科用ステープラ - Google Patents
電動ハンドルを有する外科用ステープラ Download PDFInfo
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Description
本出願は、2018年2月27日に出願された「電動ハンドルを有する外科用ステープラ(Surgical Stapler Having a Powered Handle)」という名称の米国仮特許出願第62/636,070号、及び2018年9月20日に出願された「電動ハンドルを有する外科用ステープラ」という名称の米国仮特許出願第62/734,154号の利益を主張するものである。これらの各文献は、その全体が引用により本明細書に組み入れられる。
図3に、電動ハンドルの一部分を切り欠いた図が示されている。図示の切欠図では、電動ハンドルの駆動システムを明確に示すため、電動ハンドルの幾つかの構成部品を除去している。図示の実施形態では、駆動システムが、固定ハンドル42内に位置するモータ112と、モータ112の出力シャフト上に位置するモータギア114と、モータギア114と駆動係合する補助ギア116とを含む。いくつかの実施形態では、モータ112がブラシ付きDCギアモータである。補助ギア116を通じた伝達力は、モータ112が固定ハンドル内で横方向中心に位置してハンドルのバランス及びユーザの人間工学の強化を可能にすることができるという利点を有する。さらに、いくつかの実施形態では、モータギア114及び補助ギア116を、ラック122に所望の作動トルクをもたらすように構成することができる。いくつかの実施形態では、モータ112が、モータ112と補助ギア116に結合されたモータギア114との間に動作結合されて所望の作動トルクをもたらすマルチギアトランスミッションを含むことができる。モータ112は、制御システムを介して電源130に電気的に結合することができる。ハンドル内の制御システムは、駆動システムと連動して、作動シャフト120の位置、従ってジョーアセンブリの作動を測定する。
図示の実施形態は、ポテンショメータに基づく位置センサ機構を含むが、他の実施形態では、例えばホール効果センサを含む磁気エンコーダの使用、作動シャフトが所定の距離だけ移動した時に作動するリミットスイッチの使用、作動シャフトに沿ったパターンの移動を測定するフォトダイオード、モータのシャフト上に位置する光学エンコーダ、又はその他の位置検知システムなどの光学系の使用を含む他の位置検知機構を使用することもできると想定される。
図11~図17に、電動ハンドル40の関節運動機構の実施形態を示す。図示の実施形態では、ハンドルが、シャフトの遠位端におけるジョーアセンブリを、完全な関節運動位置において長手方向中心位置に対するいずれかの方向に最大45°関節運動させることができる。いくつかの実施形態では、電動ハンドルが、ハンドルの近位端において手動で作動される関節運動ノブ190に結合された一連のコンポーネントを含む手動関節運動機構を使用する。他の実施形態では、手動で作動される関節運動ノブ及び関節運動機構のいくつかの関連する要素を、ハンドルの遠位端に隣接する位置などのハンドル上の他の位置に配置することもできる。
図20~図27に、電動ハンドルの手動復帰機構の実施形態を示す。手動復帰機構は、電源の故障、他の動力部品の故障、或いは機械的故障又は拘束の場合に冗長復帰機構を有利に提供することができる。
図32に、独立した空のジョーアセンブリと発射済みのリロードロックアウト機構とを有する外科用ステープラ装置の細長いシャフトと共に使用されるリロードカートリッジ250を示す。以下でさらに説明するように、ジョーアセンブリ内にリロードカートリッジ250が存在せずに、ユーザが開閉ストローク(open-close stroke)でジョーアセンブリを把持しようと試みた場合、二位置ロックアウトレバーが第1のロック位置に移動する。図示のように、リロードカートリッジは、リロードがジョーアセンブリのリロード支持体(reload support)内に位置する時に空のジョーアセンブリロックアウト機構を無効化(defeat)する第2の位置に二位置ロックアウトレバーを配置するようなサイズ及び位置決めの第1のロックアウトアクチュエータを含む。第1のロックアウトアクチュエータは、カートリッジの本体の側壁から横方向内向きに延びる傾斜ボス(ramped boss)252を含むことができる。
いくつかの実施形態では、ハンドルアセンブリが、発射の困難性に関する情報、試験時間に関する情報及び装置の状態を含む動作データを処理して場合によってはメモリモジュールに記憶又は保存する制御装置を含むことができる。従って、ステープラは、外科医がまさに実行しようとしている発射に関する知的判断を行うことができるように、外科医に特定の動作情報を伝えるユーザディスプレイを含むことが望ましいと考えられる。例えば、場合によっては、クランプ時間、及びクランプされた組織の厚みがステープラのエンドエフェクタにおいてステープルリロードカートリッジの動作パラメータ内でステープリングするのに適したものであるかどうかに関するいくつかの情報をユーザに提供することが望ましいと考えられる。
図示のハンドルアセンブリのいくつかの特徴に関して上述したように、ハンドルアセンブリは制御装置をさらに含むことができる。図示のように、制御装置は、様々な追加のセンサ、電源及びユーザディスプレイコンポーネントが電気的に結合された回路基板に電気的に結合されたマイクロコントローラを含むことができる。制御装置は、モータを駆動して、開放-クランプ機能を提供した後にステープラジョーアセンブリにおいてステープル発射機能を提供するように構成することができる。制御装置は、モータ負荷センサ、作動ラック位置センサ、シャフト認識センサ及び関節運動位置センサのうちの1つ又は2つ以上からのセンサデータに基づいてモータの動作パラメータを修正するようにさらに構成することができる。
図42~図44を参照して説明した光リングユーザディスプレイに加え、ハンドルアセンブリの特定の動作状態を示すようにハンドルをいくつかのパターンでうならせ又は振動させることなどの触覚フィードバックの使用を通じてさらなるユーザフィードバックを提供することもできる。いくつかの実施形態では、振動フィードバックモータなどの専用の触覚フィードバック生成器をハンドルアセンブリ内に配置して、いくつかの状態でユーザフィードバックを提供するように構成することができる。しかしながら、いくつかの実施形態では、さらなるコンポーネントを使用することなく触覚フィードバックを提供できることが望ましい。ハンドルアセンブリは、組織を切断して近づけるための線形作動力(linear actuation force)を提供するDCモータ及び減速機(reduction drive)を含むことができるので、このモータ及び駆動システムは、コンポーネント間の機械的間隙に起因するバックラッシュを含むことがある。このバックラッシュに起因して、ステープリングシステムのアクチュエータ及びジョーアセンブリの動きを生じないDCモータ出力シャフトの初期作動期間が存在する。従って、いくつかの実施形態では、DCモータを立て続けに時計回り及び反時計回りに駆動することによって、アクチュエータの大幅な並進を伴わずにユーザにハンドルアセンブリの著しい振動をもたらすことができる。このDCモータの触覚フィードバックモードを達成するために、制御システムは、それぞれがモータ及び駆動システムのバックラッシュに起因して作動シャフトの動きを生じない所定の持続時間を有する時計回りのピーク592と反時計回りのピーク594とが交互に入れ替わる実質的に方形波のモータ駆動波形プロファイル590でモータを駆動するように作動できる触覚フィードバックモジュールを含むことができる。図56に、ハンドルアセンブリ内のハンドルがうなる又は振動する感覚で触覚フィードバックをもたらす例示的なモータ駆動プロファイル590を示す。また、この方形波及び結果として生じるモータの振動は、例えば波形の隣接するピーク間に停止された中断(depowered pause)又は遅延を導入することによって変化させることができる。図57に、交互に入れ替わる時計回りのピーク592と反時計回りのピーク594との間に停止遅延時間(depowered time delay)596を取り入れて触覚フィードバックによる脈動感覚(pulsing sensation)を生成する例示的なモータ駆動波形プロファイル590’を示す。従って、触覚フィードモジュールは、ハンドルアセンブリの異なる動作状態に対応できる異なるパターンの又は脈動するうなり(pulsating buzzing)又は振動パターンを生じるように構成することができる。例示的なモータ駆動波形プロファイル590、590’は、理想的な方形波として示しているが、他の実施形態では、触覚モジュールが、作動シャフトの大幅な動きを伴わずにモータの動きを生じるように構成された他の波形プロファイルを含むこともできると想定される。
図47~図49を参照して上述したように、いくつかの実施形態では、制御システムを、アクチュエータ位置の規定の「ロックアウトゾーン」内の電流をモニタするように構成することができる。これらの実施形態では、制御システムが、電流閾値のみに依拠してロックアウト機構の係合の存在を判定することができる。いくつかの実施形態では、電流閾値が、ロックアウトゾーンの開始時のサンプルに、リロードロックアウトが無効化されておらずアクチュエータの移動が停止したことを示す一定の300mAを加えたものに基づいて決定されたものである。しかしながら、この制御システムの一要素ロックアウト検知モジュール(one factor lockout sensing module)は、アクチュエータがジョーアセンブリの発射ストロークに差し掛かっている時に把持領域の外側で最も効果的である。制御システムは、把持領域の外側ではモータの一定のPWM動作を指示する。さらに、アクチュエータが把持領域を越えて遠位方向に前進した時には既に組織のクランピングが行われており、従って組織の厚み及び一貫性の変動に起因するあらゆる潜在的な電流変動が最小化される。しかしながら、図32~図41を参照して上述した二位置ロックアウト機構は、把持器具ゾーン内で係合可能な場合にいくつかの動作的利点をもたらすので、制御システムのロックアウト検出モジュールのさらなる改善を必要とし得る。
・pmw=最大pmwの場合
・yn=モータ電流
・Δyn=傾斜=電流の変化=(yn-yn-1)
・xn=以前の5つのΔyの平均=[(Δyn+Δyn-1+Δyn-2+Δyn-3+Δyn-4)/5]
・12~40=許容範囲=12≦xn<40
・3つの連続値が必要=12≦xn,xn-1,xn-2<40
・最後の連続値は最初よりも大きくなければならない=xn>xn-2
・上記が真(TRUE)の場合=ロックアウトが係合(LOCKOUT ENGAGED)
・ロックアウトモジュール=真(TRUE)の場合
・pwm≠最大pwm(ランプアップ)の場合
・yn=モータ電流
・yb=電流ベースライン=最大pwmの最初のインスタンスにおけるy
・yths=電流閾値=電流ベースライン+[(5*位置)-200]
・電流は電流閾値を上回らなければならない=yn>yths
・上記が真(TRUE)の場合=ロックアウト係合(LOCKOUT ENGAGED)
・ロックアウトモジュール=偽(FALSE)の場合
・pwm=最大pwm(ランプアップ当たりの最初のインスタンス)の場合
・yn=モータ電流
・Δyn=傾斜=電流の変化=(yn-yn-1)
・xn=以前の5つのΔyの平均=[(Δyn+Δyn-1+Δyn-2+Δyn-3+Δyn-4)/5]
・zn=以前の3つのXの平均=(xn+xn-1+xn-2)/3
・15~40=許容範囲=15<zn<40
・yb=電流ベースライン=最大pwmの最初のインスタンスにおけるy
・yths=電流閾値=電流ベースライン+[(5*位置)-225]
・電流は電流閾値を上回らなければならない=yn>yths
・上記が真(TRUE)の場合=ロックアウト係合(LOCKOUT ENGAGED)
・ロックアウトモジュール=偽(FALSE)の場合
・遷移サブモジュール=偽(FALSE)の場合
・最大pwm遷移後10カウント以内の場合
・yn=モータ電流
・Δyn=傾斜=電流の変化=(yn-yn-1)
・電流変化の増加=Δyn>Δyn-1
・3つの連続値が必要=Δyn>Δyn-1>Δyn-2>Δyn-3
・上記が真(TRUE)の場合=ロックアウト係合(LOCKOUT ENGAGED)
・ロックアウトモジュール=偽(FALSE)の場合
・遷移サブモジュール=偽(FALSE)の場合
・遷移後サブモジュール=偽(FALSE)の場合
・pwm≠最大pwm(ランプダウン)の場合
・yn=モータ電流
・Δyn=傾斜=電流の変化=(yn-yn-1)
・電流変化の増加=Δyn>0
・3つの連続値が必要=Δyn、Δyn-1、Δyn-2>0
・上記が真(TRUE)の場合=ロックアウト係合(LOCKOUT ENGAGED)
いくつかの実施形態では、制御システムが、DCモータの移動方向を評価して補正する極性検証モジュールを含むことができる。ステープラハンドルアセンブリの製造中には、DCモータが逆極性配向で取り付けられる可能性がある。逆のモータ極性の発生を大幅に低減するために、いくつかのハンドルアセンブリ及び試験手順を実行することができる。しかしながら、これらの手順には時間が掛かり、間接費が加わる恐れがある。モータが意図せず逆極性配向で取り付けられた場合、ステープラは、ユーザ入力に応答して思い通りに機能しなくなる。逆極性のモータ取り付けの影響を抑えるために、いくつかの実施形態では、制御システムが、DCモータへの電力付与時にアクチュエータ位置をモニタするように構成されたモータ極性検証モジュールを含むことができる。従って、モータ極性検証モジュールは、ハンドルアセンブリの生産から極性検証手順を削除することができるので、ハンドルアセンブリの生産効率を高めてコストを削減することができるという利点を有する。極性検証モジュールは、特定のモータ極性が特定の作動方向をもたらすデフォルト極性仮定(default polarity assumption)を含むことができる。極性検証モジュールは、モータに既知の極性で電力を付与し、アクチュエータの位置の変化をモニタすることができる。
理解できるように、外科用ステープラの1又は2以上の把持、発射及び後退動作における制御システムの動作では、モータの電流引き込み、モータの速度、電力、トルク、ロックアウト作動、発射済みのリロードカートリッジの数、及びバッテリ寿命などに関する様々なデータを、ハンドルアセンブリ内に位置する固体メモリモジュールなどのメモリデバイスに記憶することができる。このデータは、検索して分析することが望ましい場合がある。いくつかの実施形態では、このデータを、有線又は無線通信プロトコルを介してハンドルアセンブリに電子的に結合することによって検索することができる。しかしながら、ハンドルアセンブリは外科装置であるため、以前に使用されたハンドルアセンブリにアクセスしてデータを検索することに関連する記号論理学的課題(logistical challenges)が存在し得る。従って、いくつかの実施形態では、外科用ステープラハンドルアセンブリが、外科手術の完了時にハンドルアセンブリから取り外すことができる取り外し可能メモリモジュールを含むことができる。
20 細長いシャフト
22 近位端
24 遠位端
30 ジョーアセンブリ
32 第1のジョー
34 第2のジョー
36 ステープル
40 ハンドルアセンブリ
42 固定ハンドル
44 トリガー
46 カプラ
50 リロード
L 中心長手方向軸線
Claims (21)
- 外科用ステープラのためのハンドルアセンブリであって、該ハンドルアセンブリは、
ハンドル本体であって、固定ハンドルと、前記ハンドル本体に移動可能に結合されたトリガーとを含むハンドル本体と、
前記ハンドル本体内に位置することができるモータ及び電源を含む、前記ハンドル本体内の電力システムと、
前記ハンドル本体内に収容され前記電力システムに動作可能に結合され、前記ハンドル本体内で長手方向に摺動可能な作動シャフトと、
前記ハンドル本体内に収容され前記作動シャフトの長手方向位置を特定するように構成された位置センサと、
前記電力システム、前記トリガー及び前記位置センサに電気的に結合された制御システムであって、当該制御システムは、前記作動シャフト上の前記長手方向位置におけるモータの少なくとも1つの動作パラメータを定め、前記長手方向位置は、把持器具ゾーン、ロックアウトゾーン及び発射ゾーンである前記作動シャフトに沿った3つの位置のうちの1つに対応し、
前記制御システムは、モータ極性検証モジュールをさらに含む、
ことを特徴とするハンドルアセンブリ。 - 前記ハンドルアセンブリは、ユーザディスプレイをさらに備える、
請求項1に記載のハンドルアセンブリ。 - 前記ユーザディスプレイは、多色LEDを含む、
請求項2に記載のハンドルアセンブリ。 - 前記少なくとも1つの動作パラメータは、パルス幅変調負荷サイクルを含む、
請求項1乃至3のいずれか1項に記載のハンドルアセンブリ。 - 前記制御システムは、前記モータの電流負荷をモニタするように構成される、
請求項1乃至4のいずれか1項に記載のハンドルアセンブリ。 - 前記制御システムは、触覚フィードバックモジュールをさらに含む、
請求項1乃至5のいずれか1項に記載のハンドルアセンブリ。 - 前記触覚フィードバックモジュールは、方向を素早く交互に入れ替える実質的に方形波のプロファイルで前記モータを駆動して、前記作動シャフトの動きを伴わずに前記ハンドルアセンブリの振動を発生させる、
請求項6に記載のハンドルアセンブリ。 - 前記実質的に方形波のプロファイルは、遅延セグメントをさらに含む、
請求項7に記載のハンドルアセンブリ。 - 外科用ステープラのためのハンドルアセンブリであって、該ハンドルアセンブリは、
ハンドル本体であって、固定ハンドルと、前記ハンドル本体に移動可能に結合されたトリガーとを含むハンドル本体と、
前記ハンドル本体内に位置することができるモータ及び電源を含む、前記ハンドル本体内の電力システムと、
前記ハンドル本体内に収容され前記電力システムに動作可能に結合され、前記ハンドル本体内で長手方向に摺動可能な作動シャフトと、
前記ハンドル本体内に収容され前記作動シャフトの長手方向位置を特定するように構成された位置センサと、
前記電力システム、前記トリガー及び前記位置センサに電気的に結合された制御システムであって、当該制御システムは、前記作動シャフト上の前記長手方向位置におけるモータの少なくとも1つの動作パラメータを定め、前記長手方向位置は、把持器具ゾーン、ロックアウトゾーン及び発射ゾーンである前記作動シャフトに沿った3つの位置のうちの1つに対応し、
前記制御システムに電気的に結合された取り外し可能メモリモジュールをさらに備える、
ハンドルアセンブリ。 - 前記メモリモジュールは、前記電源に電気的に結合される、
請求項9に記載のハンドルアセンブリ。 - 前記電源は、バッテリパックを含む、
請求項10に記載のハンドルアセンブリ。 - 前記バッテリパックは、該バッテリパック及び前記メモリモジュールに電気的に結合された放電抵抗器をさらに含み、前記メモリモジュールを除去すると、前記バッテリパックが前記放電抵抗器に電気的に結合されて前記バッテリパックが枯渇するようになる、
請求項11に記載のハンドルアセンブリ。 - 外科用ステープラのためのハンドルアセンブリであって、該ハンドルアセンブリは、
ハンドル本体であって、固定ハンドルと、前記ハンドル本体に移動可能に結合されたトリガーとを含むハンドル本体と、
前記ハンドル本体内に位置することができるモータ及び電源を含む、前記ハンドル本体内の電力システムと、
前記ハンドル本体内に収容され前記電力システムに動作可能に結合され、前記ハンドル本体内で長手方向に摺動可能な作動シャフトと、
前記ハンドル本体内に収容され前記作動シャフトの長手方向位置を特定するように構成された位置センサと、
前記電力システム、前記トリガー及び前記位置センサに電気的に結合された制御システムであって、当該制御システムは、前記作動シャフト上の前記長手方向位置におけるモータの少なくとも1つの動作パラメータを定め、前記長手方向位置は、把持器具ゾーン、ロックアウトゾーン及び発射ゾーンである前記作動シャフトに沿った3つの位置のうちの1つに対応し、
ロックアウト機構を有する取外し可能に結合された器具シャフトをさらに有し、
前記制御システムが、
前記モータの電流引き込み及び前記作動シャフトの前記長手方向位置をモニタし、前記モータの電流引き込みプロファイルの傾斜を計算し、前記計算された傾斜を使用して前記ロックアウト機構の係合を検出するように構成されたロックアウトモジュールを含み、
前記ロックアウトモジュールは、前記ロックアウト機構の係合の検出時に前記モータの動作を停止するように構成される、
ハンドルアセンブリ。 - 前記ロックアウトモジュールは、前記電流引き込みプロファイルの前記傾斜の連続する複数の平均値が所定のロックアウト許容範囲内に収まる時に前記ロックアウト機構の係合を検出するように構成される、
請求項13に記載のハンドルアセンブリ。 - 前記ロックアウトモジュールは、前記制御システムが負荷サイクルランプアップにおいて前記モータを駆動している時に前記ロックアウト機構の係合を検出するように構成されたロックアウトランプアップサブモジュールを含む、
請求項14に記載のハンドルアセンブリ。 - 前記ロックアウトランプアップサブモジュールは、前記モータの前記電流引き込みが電流閾値を超える負荷サイクルランプアップに前記モータがある状態で前記ロックアウト機構の係合を検出する、
請求項15に記載のハンドルアセンブリ。 - 前記ロックアウトモジュールは、前記制御システムが負荷サイクルランプアップ後の遷移期間において前記モータを駆動している時に前記ロックアウト機構の係合を検出するように構成されたロックアウト遷移サブモジュールを含む、
請求項13乃至16のいずれか1項に記載のハンドルアセンブリ。 - 前記ロックアウトモジュールは、前記制御システムが負荷サイクルランプアップ後の前記遷移期間後に所定の作動シャフト位置の範囲にわたって前記モータを駆動している時に前記ロックアウト機構の係合を検出するように構成されたロックアウト遷移後サブモジュールを備えている、
請求項17に記載のハンドルアセンブリ。 - 前記ロックアウトモジュールは、前記制御システムが負荷サイクルランプダウンにおいて前記モータを駆動している時に前記ロックアウト機構の係合を検出するように構成されたロックアウトランプダウンサブモジュールを含む、
請求項13乃至18のいずれか1項に記載のハンドルアセンブリ。 - 前記ロックアウトランプダウンサブモジュールは、前記モータが、前記モータの前記電流引き込みが複数の連続するモニタされた事象にわたって減少しない負荷サイクルランプダウンにある状態で前記ロックアウト機構の係合を検出する、
請求項19に記載のハンドルアセンブリ。 - 更なる使用ができないように構成されている、
請求項13ないし20のいずれか1項に記載のハンドルアセンブリ。
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US11064999B2 (en) | 2021-07-20 |
AU2019228507A1 (en) | 2020-08-13 |
CA3092330A1 (en) | 2019-09-06 |
KR20240108551A (ko) | 2024-07-09 |
JP2024028734A (ja) | 2024-03-05 |
US20190261984A1 (en) | 2019-08-29 |
WO2019169010A1 (en) | 2019-09-06 |
KR20200126409A (ko) | 2020-11-06 |
JP2021513906A (ja) | 2021-06-03 |
US11937815B2 (en) | 2024-03-26 |
EP3758620A1 (en) | 2021-01-06 |
US20210290234A1 (en) | 2021-09-23 |
KR102680497B1 (ko) | 2024-07-04 |
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