JP7080894B2 - スポット凝固制御及びアルゴリズムを有する外科用器具 - Google Patents
スポット凝固制御及びアルゴリズムを有する外科用器具 Download PDFInfo
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Description
本出願は、(1)その開示内容が参照により本明細書に組み込まれる、2016年11月16日出願の米国特許仮出願第62/422,698号、名称「Ultrasonic Surgical Shears with Contained Compound Lever Clamp Arm Actuator」、(2)その開示内容が参照により本明細書に組み込まれる、2017年5月19日出願の米国特許仮出願第62/508,720号、名称「Ultrasonic and Electrosurgical Instrument with Replaceable End Effector Features」、及び(3)その開示内容が参照により本明細書に組み込まれる、2017年6月14日出願の米国特許仮出願第62/519,482号、名称「Ultrasonic and Electrosurgical Instrument with Removable Features」の優先権を主張するものである。
図1A~図2及び図13A~図13Cは、第1の例示的な超音波外科用器具(10)を示す。器具(10)の少なくとも一部は、米国特許第5,322,055号、同第5,873,873号、同第5,980,510号、同第6,325,811号、同第6,773,444号、同第6,783,524号、米国特許出願公開第2006/0079874号、同第2007/0191713号、同第2007/0282333号、同第2008/0200940号、米国特許第8,623,027号、同第9,023,071号、同第8,461,744号、同第9,381,058号、米国特許出願公開第2012/0116265号、米国特許第9,393,037号、同第9,095,367号、米国特許出願第61/410,603号、及び/又は米国特許出願公開第2015/0080924号の教示の少なくとも一部に従って構成されかつ動作可能となり得る。前述の特許、特許公開、及び特許出願のそれぞれの開示は、参照により本明細書に組み込まれる。追加的にあるいは代替的に、器具(10)の少なくとも一部は、その開示内容が参照により本明細書に組み込まれる、2017年4月20日発行の米国特許出願公開第2017/0105755号、名称「Surgical Instrument with Dual Mode End Effector and Compound Lever with Detents」、及び/又は、その開示内容が参照により本明細書に組み込まれる、2016年7月18日出願の米国特許出願第62/363,411号、名称「Surgical Instrument with Dual Mode End Effector」の少なくとも一部の教示に従って構成されかつ動作可能となり得る。
図17~図18は、第2の例示的な超音波外科用器具(301)を示す。以下に特に記載しない限り、この例の器具(301)は、上述した器具(10)と同様に構成されかつ動作可能となり得る。器具(301)の特定の詳細はしたがって、以下の説明からは省略されることになり、そのような詳細は、器具(10)の説明において既に上述されていることが理解される。
場合によっては、超音波外科用器具が、操作者にカスタム動作モード、具体的にはスポット凝固モードを提供することが有益となり得る。エンドエフェクタ(12)に所定の間隙を形成するために、上述の外科用器具(10、301)などの超音波外科用器具の能力を改善することは、患者の組織に対してスポット凝固を実施するなど、超音波及び/又はRFエネルギーを患者の組織に提供する際に望ましくなり得る。エンドエフェクタ(12)に所定の間隙を形成することを目的とする例示的な器具及び特徴は、その開示内容が参照により本明細書に組み込まれる、本明細書と同日出願の米国特許出願第[代理人整理番号END8130USNP2.0652948]、名称「Surgical Instrument with Selectively Actuated Gap-Setting Features for End Effector」に記載されている。本明細書の教示が米国特許出願第[代理人整理番号END8130USNP2.0652948]の教示と容易に組み合わされ得る様々な方式が、本明細書の教示に鑑みれば当業者には明らかとなろう。
図30に示すように、先端双極(RF)エネルギーと超音波エネルギーとを同時に作用させることを利用して、スポット凝固のための連続的な作動を可能にするための方法(9400)が提供される。スポット凝固は、デバイスが空気中においても組織内においても、基礎となるエネルギーを絶えず作動させなければならず、またいくつかの環境においては、検出される高インピーダンスが原因で、空気中で作動されるとき、先端双極(RF)エネルギーが短絡し得るという難題を呈している。
以下の実施例は、本明細書の教示を組み合わせるか又は適用することができる、様々な非網羅的な方法に関する。以下の実施例は、本出願における又は本出願の後の出願におけるどの時点でも提示され得る、いずれの請求項の適用範囲をも限定することを目的としたものではないと理解されよう。一切の棄権を意図するものではない。以下の実施例は、単なる例示の目的で与えられるものにすぎない。本明細書の様々な教示は、他の多くの方法で構成及び適用が可能であると考えられる。また、いくつかの変形では、以下の実施例において言及される特定の特徴を省略してよいことも考えられる。したがって、本発明者又は本発明者の利益の継承者により、後日、そうである旨が明示的に示されない限り、以下に言及される態様又は特徴のいずれも重要なものとしてみなされるべきではない。以下に言及される特徴以外の更なる特徴を含む請求項が本出願において、又は本出願に関連する後の出願において示される場合、それらの更なる特徴は、特許性に関連するいかなる理由によっても追加されたものとして仮定されるべきではない。
外科用器具であって、(a)エンドエフェクタであって、(i)超音波ブレード、(ii)開放位置から閉鎖位置に向かって超音波ブレードに対して移動するように構成されたクランプアームであって、超音波ブレード及びクランプアームが、開放位置において組織を受容するように構成され、クランプアームは、閉鎖位置において超音波ブレードに対して組織をクランプするように構成されているクランプアーム、(iii)クランプアームと動作可能に接続された第1の電極、並びに(iv)超音波ブレードに関連付けられた第2の電極を含み、これらの電極が、エンドエフェクタ内に捕捉された組織に双極高周波(RF)エネルギーを印加するように動作可能である、エンドエフェクタと、(b)クランプアームに動作可能に接続され、クランプアームをそれぞれ開放位置から閉鎖位置に向かって選択的に方向付けるように構成されたクランプアームアクチュエータと、(c)超音波ブレードを作動させ、それによってエンドエフェクタにおいて切断及び封止モードを提供するように動作可能な第1のボタンと、(d)電極を作動させ、それによってエンドエフェクタにおいてスポット凝固モードを提供するように動作可能な第2のボタンと、を備える、外科用器具。
エンドエフェクタから近位方向に突出し、超音波ブレードに動作可能に接続された音響導波管を含むシャフトアセンブリを更に備え、音響導波管が、超音波トランスデューサに接続するように構成されている、実施例1に記載の外科用器具。
シャフトアセンブリから近位方向に突出する本体を更に備える、実施例2に記載の外科用器具。
第1及び第2のボタンが本体上に位置する、実施例3に記載の外科用器具。
第1のボタンが本体上に位置し、第1のボタンが本体からクランプアームアクチュエータに向かって横方向に延在する、実施例3に記載の外科用器具。
第1のボタンは、クランプアームアクチュエータが本体に向かって移動し、第1のボタンに係合したときに作動されるように構成されている、実施例3~5のいずれか一つに記載の外科用器具。
クランプアームアクチュエータが近位端を有し、本体が近位端を有し、アクチュエータの近位端は本体の近位端に向かって移動可能であり、それによってクランプアームを閉鎖位置に向かって付勢し、第1のボタンが本体の近位端に位置し、第1のボタンが、クランプアームアクチュエータの近位端によって作動されるように構成されている、実施例3~6のいずれか一つに記載の外科用器具。
第2のボタンが第1のボタンに対して遠位に位置している、実施例1~7のいずれか一つに記載の外科用器具。
クランプアームが頂部パッド及び底部パッドを備え、底部パッドが頂部パッドと超音波ブレードとの間に位置している、実施例1~8のいずれか一つに記載の外科用器具。
頂部パッド及び底部パッドがクランプアーム内で離間している、実施例9に記載の外科用器具。
第1の電極が頂部パッドに含められている、実施例9又は10に記載の外科用器具。
前記底部パッドに含まれた第3の電極を更に備え、第3の電極はが、第1の電極とは反対の極性を有する、実施例9~11のいずれか一つに記載の外科用器具。
第3の電極が高周波(RF)電極である、実施例12に記載の外科用器具。
超音波ブレードが第2の電極を画定する、実施例1~12のいずれか一つに記載の外科用器具。
クランプアームが超音波ブレードの第2の電極に近位方向に面するように位置付けられた第3の電極を更に備える、実施例1~11のいずれか一つに記載の外科用器具。
第2のボタンが、本体上にあり、クランプアームアクチュエータに向かって延在している、実施例1~15のいずれか一つに記載の外科用器具。
外科用器具であって、(a)エンドエフェクタであって、(i)第1の電極を提供する超音波ブレード、並びに(ii)開放位置から中間位置及び閉鎖位置に向かって超音波ブレードに対して移動するように構成されたクランプアームを含み、超音波ブレード及びクランプアームが、開放位置において組織を受容するように構成され、クランプアームが、閉鎖位置において超音波ブレードに対して組織をクランプするように構成され、クランプアームが、開放位置と閉鎖位置との間の中間位置において所定の間隙を画定するように超音波ブレードからオフセットされ、クランプアームが、クランプアーム及び超音波ブレードを中間位置に付勢するように別個に離間されるように構成された第2の電極及び第3の電極を含み、第1及び第2の電極が、第3の電極とは反対の極を有し、第2の電極が、クランプアクチュエータ内で第3の電極に対して超音波ブレードの近位に位置付けられている、エンドエフェクタと、(b)エンドエフェクタから近位に突出し、超音波ブレードに動作可能に接続された音響導波管を含むシャフトアセンブリであって、音響導波管が超音波トランスデューサに接続するように構成されている、シャフトアセンブリと、(c)シャフトアセンブリから近位に突出する本体と、(d)クランプアームに動作可能に接続され、開放構成から閉鎖構成へと本体に対して選択的に移動し、それによってクランプアームをそれぞれ開放位置から中間位置及び閉鎖位置に向かって方向付けるように構成されたクランプアームアクチュエータと、(e)第1、第2、及び第3の電極を作動させるように動作可能な第1のボタンと、(f)クランプアームアクチュエータが閉鎖構成にあるときに、第1、第2、及び第3の電極を停止させるように構成された第2のボタンと、を備える、外科用器具。
外科用器具を使用して凝固を実行する方法であって、(a)超音波エネルギーを第1の超音波強度でエンドエフェクタに送達することと、(b)高周波(RF)エネルギーを第1のRF強度でエンドエフェクタに送達することと、(c)エンドエフェクタと組織との接触を検出することと、(d)エンドエフェクタと組織との接触の検出に応じて、第1の超音波強度から第2の超音波強度又は第1のRF強度から第2のRF強度への一方又は両方の変化を行わせることと、を含む、方法。
(a)組織からのエンドエフェクタの解放を検出することと、(b)組織からのエンドエフェクタの解放を検出すると、第2の超音波強度から第1の超音波強度又は第2のRF強度から第1のRF強度への一方又は両方の変化を行わせることと、を更に含む、実施例18に記載の方法。
エンドエフェクタと組織との接触を検出する行為が、RFパルスの閾値インピーダンス値をRFパルスの観測インピーダンス値と比較することを含み、エンドエフェクタと組織との接触は、RFパルスの観測インピーダンス値がRFパルスの閾値インピーダンス値を下回るときに存在する、実施例18又は19に記載の方法。
閾値インピーダンス値が4000オームに設定される、実施例20に記載の方法。
本明細書の様々な例は、互いに解放可能に連結されている2つ以上のモジュール式構成要素を説明するものであるが、いくつかの変形例では、そのようなモジュール性及び解放可能な連結が排除され得ることを理解されたい。例えば、器具(10)のいくつかの変形形態は、第2のモジュール式アセンブリ(200)が第1のモジュール式アセンブリ(100)から取り外されることを可能にしない単一の組み合わせユニットとして、第1のモジュール式アセンブリ(100)及び第2のモジュール式組立品(200)を提供し得る。いくつかのそのような変形例では、連結部材(300)は、省略されるか(いくつかの他の特徴部が、第1のモジュール式アセンブリ(100)と第2のモジュール式アセンブリ(200)との間の恒久的連結を提供するために使用されている)、あるいは、連結部材(300)は、第1のモジュール式アセンブリ(100)から第2のモジュール式アセンブリ(200)を連結解除するように連結部材(300)が操作され得ないように修正されてもよい。同様に、器具(301)のいくつかの変形形態は、クランプアームアセンブリ(400)がシャフトアセンブリ(330)から取り外されることを防止し得る。例えば、ラッチ部材(412)は省略されてもよく、クランプアームアセンブリ(400)は、シャフトアセンブリ(330)と恒久的に連結されてもよい。
(1) 外科用器具であって、
(a)エンドエフェクタであって、
(i)超音波ブレード、
(ii)開放位置から閉鎖位置に向かって前記超音波ブレードに対して移動するように構成されたクランプアームであって、前記超音波ブレード及び前記クランプアームが、前記開放位置において組織を受容するように構成され、前記クランプアームが、前記閉鎖位置において前記超音波ブレードに対して組織をクランプするように構成されている、クランプアーム、
(iii)前記クランプアームと動作可能に接続された第1の電極、並びに
(iv)前記超音波ブレードに関連付けられた第2の電極を含み、前記電極が、前記エンドエフェクタ内に捕捉された組織に双極高周波(RF)エネルギーを印加するように動作可能である、エンドエフェクタと、
(b)前記クランプアームに動作可能に接続され、前記クランプアームをそれぞれ前記開放位置から前記閉鎖位置に向かって選択的に方向付けるように構成されたクランプアームアクチュエータと、
(c)前記超音波ブレードを作動させ、それによって前記エンドエフェクタにおいて切断及び封止モードを提供するように動作可能な第1のボタンと、
(d)前記電極を作動させ、それによって前記エンドエフェクタにおいてスポット凝固モードを提供するように動作可能な第2のボタンと、を備える、外科用器具。
(2) 前記エンドエフェクタから近位方向に突出し、前記超音波ブレードに動作可能に接続された音響導波管を含むシャフトアセンブリを更に備え、前記音響導波管が、超音波トランスデューサに接続するように構成されている、実施態様1に記載の外科用器具。
(3) 前記シャフトアセンブリから近位方向に突出する本体を更に備える、実施態様2に記載の外科用器具。
(4) 前記第1及び第2のボタンが前記本体上に位置する、実施態様3に記載の外科用器具。
(5) 前記第1のボタンが前記本体上に位置し、前記第1のボタンが前記本体から前記クランプアームアクチュエータに向かって横方向に延在する、実施態様3に記載の外科用器具。
(7) 前記クランプアームアクチュエータが近位端を有し、前記本体が近位端を有し、前記アクチュエータの前記近位端は前記本体の前記近位端に向かって移動可能であり、それによって前記クランプアームを前記閉鎖位置に向かって付勢し、前記第1のボタンが前記本体の前記近位端に位置し、前記第1のボタンが、前記クランプアームアクチュエータの前記近位端によって作動されるように構成されている、実施態様6に記載の外科用器具。
(8) 前記第2のボタンが前記第1のボタンに対して遠位に位置している、実施態様3に記載の外科用器具。
(9) 前記クランプアームが頂部パッド及び底部パッドを備え、前記底部パッドが前記頂部パッドと前記超音波ブレードとの間に位置している、実施態様1に記載の外科用器具。
(10) 前記頂部パッド及び前記底部パッドが前記クランプアーム内で離間している、実施態様9に記載の外科用器具。
(12) 前記底部パッドに含まれた第3の電極を更に備え、前記第3の電極が、前記第1の電極とは反対の極性を有する、実施態様11に記載の外科用器具。
(13) 前記第3の電極が高周波(RF)電極である、実施態様12に記載の外科用器具。
(14) 前記超音波ブレードが前記第2の電極を画定する、実施態様1に記載の外科用器具。
(15) 前記クランプアームが前記超音波ブレードの前記第2の電極に近位方向に面するように位置付けられた第3の電極を更に備える、実施態様1に記載の外科用器具。
(a)エンドエフェクタであって、
(i)第1の電極を提供する超音波ブレード、並びに
(ii)開放位置から中間位置及び閉鎖位置に向かって前記超音波ブレードに対して移動するように構成されたクランプアームを含み、前記超音波ブレード及び前記クランプアームが、前記開放位置において組織を受容するように構成され、前記クランプアームが、前記閉鎖位置において前記超音波ブレードに対して組織をクランプするように構成され、前記クランプアームが、前記開放位置と前記閉鎖位置との間の前記中間位置において所定の間隙を画定するように前記超音波ブレードからオフセットされ、前記クランプアームが、前記クランプアーム及び前記超音波ブレードを前記中間位置に付勢するように別個に離間されるように構成された第2の電極及び第3の電極を含み、前記第1及び第2の電極が、前記第3の電極とは反対の極を有し、前記第2の電極が、前記クランプアームアクチュエータ内で前記第3の電極に対して前記超音波ブレードの近位に位置付けられている、エンドエフェクタと、
(b)前記エンドエフェクタから近位に突出し、前記超音波ブレードに動作可能に接続された音響導波管を含むシャフトアセンブリであって、前記音響導波管が超音波トランスデューサに接続するように構成されている、シャフトアセンブリと、
(c)前記シャフトアセンブリから近位に突出する本体と、
(d)前記クランプアームに動作可能に接続され、開放構成から閉鎖構成へと前記本体に対して選択的に移動し、それによって前記クランプアームをそれぞれ前記開放位置から前記中間位置及び前記閉鎖位置に向かって方向付けるように構成されたクランプアームアクチュエータと、
(e)前記第1、第2、及び第3の電極を作動させるように動作可能な第1のボタンと、
(f)前記クランプアームアクチュエータが前記閉鎖構成にあるときに、前記第1、第2、及び第3の電極を停止させるように構成された第2のボタンと、を備える、外科用器具。
(17) 外科用器具を使用して凝固を実行する方法であって、
(a)超音波エネルギーを第1の超音波強度でエンドエフェクタに送達することと、
(b)高周波(RF)エネルギーを第1のRF強度で前記エンドエフェクタに送達することと、
(c)前記エンドエフェクタと組織との接触を検出することと、
(d)前記エンドエフェクタと前記組織との前記接触の検出に応じて、前記第1の超音波強度から第2の超音波強度又は前記第1のRF強度から第2のRF強度への一方又は両方の変化を行わせることと、を含む、方法。
(18) (a)前記組織からの前記エンドエフェクタの解放を検出することと、
(b)前記組織からの前記エンドエフェクタの解放を検出すると、前記第2の超音波強度から前記第1の超音波強度又は前記第2のRF強度から前記第1のRF強度への一方又は両方の変化を行わせることと、を更に含む、実施態様17に記載の方法。
(19) 前記エンドエフェクタと組織との接触を検出する行為が、RFパルスの閾値インピーダンス値を前記RFパルスの観測インピーダンス値と比較することを含み、前記エンドエフェクタと前記組織との前記接触は、前記RFパルスの前記観測インピーダンス値が前記RFパルスの前記閾値インピーダンス値を下回るときに存在する、実施態様18に記載の方法。
(20) 前記閾値インピーダンス値が4000オームに設定される、実施態様19に記載の方法。
Claims (9)
- 外科用器具であって、
(a)エンドエフェクタであって、
(i)超音波ブレード、
(ii)開放位置から閉鎖位置に向かって前記超音波ブレードに対して移動するように構成されたクランプアームであって、前記超音波ブレード及び前記クランプアームが、前記開放位置において組織を受容するように構成され、前記クランプアームが、前記閉鎖位置において前記超音波ブレードに対して組織をクランプするように構成されている、クランプアーム、
(iii)前記クランプアームと動作可能に接続された第1及び第3の電極、並びに
(iv)前記超音波ブレードに関連付けられた第2の電極を含み、前記第1及び前記第2の電極が、前記エンドエフェクタ内に捕捉された組織に双極高周波(RF)エネルギーを印加するように動作可能である、エンドエフェクタと、
(b)前記クランプアームに動作可能に接続され、前記クランプアームをそれぞれ前記開放位置から前記閉鎖位置に向かって選択的に方向付けるように構成されたクランプアームアクチュエータと、
(c)前記超音波ブレードを作動させ、それによって前記エンドエフェクタにおいて切断及び封止モードを提供するように動作可能な第1のボタンと、
(d)前記第1、前記第2及び前記第3の電極を作動させ、それによって前記エンドエフェクタにおいてスポット凝固モードを提供するように動作可能な第2のボタンと、を備え、
前記クランプアームは頂部パッドと底部パッドを備え、前記底部パッドは、前記頂部パッドと前記超音波ブレードの間に配置され、前記頂部パッドと前記底部パッドは、前記クランプアーム内で離間され、前記第1の電極は、前記頂部パッドに含まれ、前記第3の電極は前記底部パッドに含まれ、前記第3の電極が、前記第2の電極と同じ極性を有する、外科用器具。 - 前記エンドエフェクタから近位方向に突出し、前記超音波ブレードに動作可能に接続された音響導波管を含むシャフトアセンブリを更に備え、前記音響導波管が、超音波トランスデューサに接続するように構成されている、請求項1に記載の外科用器具。
- 前記シャフトアセンブリから近位方向に突出する本体を更に備える、請求項2に記載の外科用器具。
- 前記第1及び第2のボタンが前記本体上に位置する、請求項3に記載の外科用器具。
- 前記第1のボタンが前記本体上に位置し、前記第1のボタンが前記本体から前記クランプアームアクチュエータに向かって延在する、請求項3に記載の外科用器具。
- 前記第1のボタンは、前記クランプアームアクチュエータが前記本体に向かって移動し、前記第1のボタンに係合したときに作動されるように構成されている、請求項5に記載の外科用器具。
- 前記クランプアームアクチュエータは前記本体向かって移動可能であり、それによって前記クランプアームを前記閉鎖位置に向かって付勢し、前記第1のボタンが、前記クランプアームアクチュエータによって作動されるように構成されている、請求項6に記載の外科用器具。
- 前記第2のボタンが前記第1のボタンに対して遠位に位置している、請求項3に記載の外科用器具。
- 前記超音波ブレードが前記第2の電極を画定する、請求項1に記載の外科用器具。
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US15/798,835 US11039848B2 (en) | 2016-11-16 | 2017-10-31 | Surgical instrument with spot coagulation control and algorithm |
US15/798,835 | 2017-10-31 | ||
PCT/US2017/062023 WO2018094053A1 (en) | 2016-11-16 | 2017-11-16 | Surgical instrument with spot coagulation control and algorithm |
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JP2019547243A Active JP7094975B2 (ja) | 2016-11-16 | 2017-11-16 | エンドエフェクタ用の選択的に作動される間隙設定特徴を有する外科用器具 |
JP2019547241A Active JP7091355B2 (ja) | 2016-11-16 | 2017-11-16 | 取り外し可能なクランプアームアセンブリを有する外科用器具 |
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