JP5259196B2 - バッテリ性能を向上させた外科器具 - Google Patents

バッテリ性能を向上させた外科器具 Download PDF

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JP5259196B2
JP5259196B2 JP2008002069A JP2008002069A JP5259196B2 JP 5259196 B2 JP5259196 B2 JP 5259196B2 JP 2008002069 A JP2008002069 A JP 2008002069A JP 2008002069 A JP2008002069 A JP 2008002069A JP 5259196 B2 JP5259196 B2 JP 5259196B2
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power source
end effector
instrument
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cartridge
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フレデリック・イー・シェルトン・ザ・フォース
ジェイムズ・アール・ジョルダノ
ジェフリー・エス・スウェイズ
ダグラス・ジェイ・シーベナラー
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/30Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00017Electrical control of surgical instruments
    • A61B2017/00022Sensing or detecting at the treatment site
    • A61B2017/00026Conductivity or impedance, e.g. of tissue
    • A61B2017/0003Conductivity or impedance, e.g. of tissue of parts of the instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/00234Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00362Packages or dispensers for MIS instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/0046Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
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    • A61B17/00Surgical instruments, devices or methods
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
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    • A61B2017/07271Stapler heads characterised by its cartridge
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    • AHUMAN NECESSITIES
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    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08Accessories or related features not otherwise provided for
    • A61B2090/0807Indication means
    • A61B2090/0811Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361Image-producing devices, e.g. surgical cameras

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Description

開示の内容
〔関連出願〕
本願は、参照して開示内容を本明細書に組み入れる以下に示す同時出願の米国特許出願に関連する。
1.ジェイ・ジョーダーノ(J. Giordano)らによる米国特許出願第__/_____号(名称:「制御ユニットとセンサトランスポンダとの間で無線通信を行う外科器具(SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND SENSOR TRANSPONDERS)」)(代理人整理番号:060338/END5923USNP)
2.ジェイ・ジョーダーノ(J. Giordano)らによる米国特許出願第__/_____号(名称:「制御ユニットと遠隔センサとの間で無線通信を行う外科器具(SURGICAL INSTRUMENT WITH WIRELESS COMMUNICATION BETWEEN CONTROL UNIT AND REMOTE SENSOR)」)(代理人整理番号:060339/END5924USNP)
3.ジェイ・ジョーダーノ(J. Giordano)らによる米国特許出願第__/_____号(名称:「制御ユニットとセンサトランスポンダとの間で無線通信するために要素を備えた外科器具(SURGICAL INSTRUMENT WITH ELEMENTS TO COMMUNICATE BETWEEN CONTROL UNIT AND END EFFECTOR)」)(代理人整理番号:060340/END5925USNP)
4.エフ・シェルトン(F. Shelton)らによる米国特許出願第__/_____号(名称:「外科器具におけるカートリッジの再使用の防止(PREVENTION OF CARTRIDGE REUSE IN A SURGICAL INSTRUMENT)」)(代理人整理番号:060341/END5926USNP)
5.ジェイ・スウェイズ(J. Swayze)らによる米国特許出願第__/_____号(名称:「滅菌後の外科器具のプログラミング(POST-STERILIZATION PROGRAMMING OF SURGICAL INSTRUMENTS)」)(代理人整理番号:060342/END5927USNP)
6.エフ・シェルトン(F. Shelton)らによる米国特許出願第__/_____号(名称:「インターロックとこのインターロックを含む外科器具(INTERLOCK AND SURGICAL INSTRUMENT INCLUDING SAME)」)(代理人整理番号:060343/END5928USNP)
〔発明の背景〕
内視鏡外科器具は、小さな切開部が術後の回復時間を短縮し合併症を低減するため、従来の開放外科装置よりも好まれる場合が多い。したがって、トロカールのカニューレを介して所望の外科部位に遠位エンドエフェクタを正確に配置するのに適した様々な内視鏡外科器具の開発が著しく進展した。このような遠位エンドエフェクタは、診断効果または治療効果を果たすべく様々な方式で組織に係合する(例えば、エンドカッター、把持器、カッター、ステープラ、クリップアプライヤ、アクセス装置、薬物/遺伝子治療送達装置、および超音波、RF、レーザーなどを用いたエネルギー装置)。
既知の外科ステープラは、組織を長手方向に切断すると同時にその切開部の両側にステープルを列状に止めるエンドエフェクタを含む。エンドエフェクタは、器具が内視鏡や関節鏡に用いられる場合、カニューレの通路内を通過できる一対の協働するジョー部材を含む。一方のジョー部材は、横方向に離隔した少なくとも2列のステープルを有するステープルカートリッジを受容する。他方のジョー部材は、カートリッジ内のステープルの列に整合したステープル成形ポケットを有するアンビルを画定している。この器具は、複数の往復ウェッジを含む。これらのウェッジは、遠位側に駆動されると、ステープルカートリッジの開口を通過して、ステープルを支持しているドライバに係合し、ステープルをアンビルに向かって発射させる
内視鏡用途に適した外科ステープラの例が、閉じる動作と発射する動作を別個に行うエンドカッターを開示する米国特許第5,465,895号に記載されている。この装置を使用する医師は、発射の前に組織の位置を合わせるために組織に対してジョー部材を閉じることができる。医師は、ジョー部材が組織を適切に把持していると判断したら、1回の発射ストロークで外科ステープラを作動させて、組織の切断およびステープル止めを行うことができる。切断とステープル止めを同時に行うことにより、別個の外科器具を用いて切断とステープル止めを別々に行う場合に生じうる合併症を防止することができる。
発射する前に組織に対して閉じることができる1つの具体的な利点は、医師が、十分な量の組織が対向するジョーの間に把持されているかを含め、切断のために所望の位置に配置されたか否かを、内視鏡を介して確認することができる。このように確認しない場合は、対向したジョーが、互いに近付きすぎて、特に遠位端部で圧迫され、切断された組織を有効にステープル止めすることができない。これとは反対に、クランプされた組織の量が過剰であると、詰まって不完全な発射となる。
内視鏡ステープラ/カッターは、世代毎に複雑さと機能が増してきている。この理由の1つは、全てまたは大多数の外科医が操作できるレベルの低い発射力(FTF)が求められていることによる。より低いFTFのための既知の1つの解決策は、COまたは電気モータの使用である。このような装置は、別の点から、従来の手動装置よりも格段に優れているとは言えない。外科医は通常、大抵の外科医が可能な上限の力(通常は約15〜30ポンド(約6.9〜約13.6kg))で切断/ステープルサイクルが完了したことを確認するために、ステープルの成形でエンドエフェクタが受ける力に比例した力分布を感じることを好む。また、外科医は通常、ステープル取付けの制御を維持すること、装置のハンドルで感じる力が大きすぎる場合または他の臨床上の理由で、いつでも停止できることを望む。
この要求を満たすべく、補助電源が器具の発射を補助する、いわゆる「動力補助」内視鏡外科器具が開発された。例えば、ある種の動力補助装置では、使用者が発射トリガーを引くと、モータが補助電力を入力に供給する。このような装置は、切断操作を完了するために、操作者が加える必要がある発射の力を低減するべく、荷重のフィードバックおよび制御を操作者に伝達することができる。このような1つの動力補助装置が、参照して開示内容を本明細書に組み入れる、2006年1月31日出願のシェルトン(Shelton)らによる米国特許出願第11/343,573号(名称:「荷重のフィードバックを与えるモータ駆動外科切断/締結器具(Motor-driven surgical cutting and fastening instrument with loading force feedback)」)に開示されている。
内視鏡外科器具の複雑さおよび機能を増大させる別の理由は、器具の構成要素を監視して、器具の構成要素をより厳密に制御する要求である。例えば、センサおよび制御システムが、電子ロックアウトなどを含む外科器具の新しい機能を実現するために用いられている。例えば、このような1つのロックアウト装置が、参照して本明細書に組み入れる、2006年1月31日出願のスウェイズ(Swayze)らによる米国特許出願第11/343,439号(名称:「電子ロックアウトおよび電子ロックアウトを含む外科器具(Electronic Lockouts And Surgical Instrument Including Same)」)に開示されている。
あらゆる種類の外科器具で電子部品を使用する課題は、適当な電源を用意することである。殆どの外科器具は、密閉された滅菌パッケージ内で保管される。このため、一般に、外科器具がパッケージングされた後、外科器具の電源の状態を調べるため、または所望に応じて充電するために外科器具にアクセスするのが現実的でない。したがって、外科器具の有効期間は、電源が電荷を確実に保持できる期間によって制限される。しかしながら、多くの種類の外科器具では、高ピーク出力の電源を選択するのが望ましい。高ピーク出力の電源は、外科器具に用いられるモータ、センサ、および制御システムを駆動するのに適している。しかしながら、リチウムイオンバッテリなどの高ピーク出力の電源は、通常は、所望の長期に亘って十分な電荷を維持しない。したがって、電源の選択は、長い有効期間の要求と高ピーク出力の要求をトレードオフしなければならない。
〔発明の概要〕
一態様では、本発明は、内視鏡器具または関節鏡器具などの外科器具の構成要素を含む組立体に関する。この組立体は、パッケージ、このパッケージ内の外科器具の構成要素、およびパッケージ内の電源を含むことができる。電源は、外科器具の構成要素と電気的に通信するように配置することができる。この組立体はまた、パッケージ内の補助電源および回路要素を含むことができる。この回路要素は、電源および補助電源と電気的に通信する。
別の態様では、本発明は、外科器具に用いるためのエンドエフェクタカートリッジに関する。このエンドエフェクタカートリッジは、電気要素、電源、および回路要素を含むことができる。回路要素は、エンドエフェクタカートリッジが外科器具内に装着されると電源と電気要素を電気的に接続するように構成することができる。
さらに別の態様では、本発明は、パッケージ、およびこのパッケージ内のエンドエフェクタカートリッジを含む組立体に関する。エンドエフェクタカートリッジは、電気要素を含むことができる。組立体は、パッケージ内の電源およびパッケージ内の回路要素も含むことができる。回路要素は、エンドエフェクタカートリッジが外科器具内に装着されると電源と電気要素を電気的に接続するように構成することができる。外科器具およびその構成要素を再生する方法も開示する。
〔詳細な説明〕
本発明の様々な実施形態を、添付の図面を参照しながら一例として説明する。
本発明の様々な実施形態は、外科器具および/またはその構成要素が滅菌パッケージされたまま電荷を加えるまたは維持できる電源を有する外科器具および/またはその構成要素に関する。本発明は、内視鏡または関節鏡外科器具などの、少なくとも1つの電源を含むあらゆるタイプの外科器具に用いることができる。システムの特徴を説明する前に、本発明の実施形態を用いることができるあるタイプの外科器具、すなわち内視鏡ステープル止め/切断器具(エンドカッター)を、まず一例として説明する。
図1および図2は、ハンドル6、シャフト8、関節動作ピボット14でシャフト8に旋回可能に接続された関節動作エンドエフェクタ12を含む内視鏡外科器具10を示している。エンドエフェクタ12の正確な配置および向きは、(1)シャフト8の自由回転接合部29で閉鎖チューブ(詳細は図4および図5を参照)を回転させてエンドエフェクタ12を回転させるための回転ノブ28、および(2)関節動作ピボット14を中心にエンドエフェクタ12を関節動作させるための関節動作制御部16を含め、ハンドル6に設けられた制御部によって容易に行うことができる。例示されている実施形態では、エンドエフェクタ12は、組織をクランプ、切断、およびステープル止めするためのエンドカッターとして機能するように構成されているが、他の実施形態では、把持器、カッター、ステープラ、クリップアプライヤ、アクセス装置、薬物/遺伝子治療装置、および超音波、RF、またはレーザー装置などの他のタイプの外科器具のエンドエフェクタなどの様々なタイプのエンドエフェクタを用いることができる。
器具10のハンドル6は、エンドエフェクタ12を作動させるための閉鎖トリガー18および発射トリガー20を含むことができる。様々な外科処置に用いられるエンドエフェクタを有する外科器具は、エンドエフェクタ12を作動させるために、異なる数または種類のトリガーまたは他の適当な制御部を有することができることを理解されたい。エンドエフェクタ12は、図示されているように、好ましくは細長いシャフト8によってハンドル6から離隔している。一実施形態では、外科器具10の医師すなわち操作者が、関節動作制御部16を用いてシャフト8に対してエンドエフェクタ12を関節動作させることができる。この詳細が、参照して開示内容を本明細書に組み入れる、2006年1月10日出願に出願された、ジョフレイ・シー・ヒューイ(Geoffrey C. Hueil)らによる係属中の米国特許出願第11/329,020号(名称:「関節動作エンドエフェクタを備えた外科器具(Surgical Instrument Having An Articulating End Effector)」)に開示されている。
この例では、エンドエフェクタ12は、特に、ステープル溝型部材22、およびアンビル24などの旋回可能なクランプ部材を含む。ステープル溝型部材22とアンビル24は、エンドエフェクタ12内にクランプされた組織のステープル止めおよび切断を確実に行うことができるように一定の間隔に維持される。ハンドル6は、ピストルグリップ26を含む。医師が、閉鎖トリガー18をピストルグリップ26に向かって引いて、エンドエフェクタ12のステープル溝型部材22に向かってアンビル24をクランプすなわち閉じて、アンビル24と溝型部材22との間に配置された組織をクランプすることができる。発射トリガー20は、閉鎖トリガー18よりも外側に位置する。閉鎖トリガー18が閉鎖位置にロックされると、発射トリガー20がピストルグリップ26に向かって僅かに回転し、操作者が片手で操作することができる。次に、操作者が、発射トリガー20をピストルグリップ26に向かって引いて、エンドエフェクタ12内にクランプされた組織のステープル止めおよび切断を行うことができる。米国特許出願第11/343,573号に、閉鎖トリガー18のロックおよびロック解除のための様々な構造が示されている。他の実施形態では、例えば、対向したジョーなどのアンビル24以外の異なるタイプのクランプ部材を用いることができる。
本明細書で用いる「近位」および「遠位」は、器具10のハンドル6を把持している医師を基準に用いていることを理解されたい。したがって、エンドエフェクタ12は、近位側のハンドル6に対して遠位側である。さらに、分かりやすくするために、「垂直」および「水平」などの空間用語を図面に対して用いることを理解されたい。しかしながら、外科器具は、様々な向きおよび位置で用いることができ、このような語は、限定や絶対を意図するものではない。
まず、閉鎖トリガー18を作動させることができる。医師が、エンドエフェクタ12の配置に満足したら、医師は、閉鎖トリガー18を、ピストルグリップ26に近接した完全に閉じたロック位置まで引くことができる。次に、発射トリガー20を作動させることができる。医師が圧力を解除すると、発射トリガー20は、開位置(図1および図2を参照)に戻る。この例では、ハンドル6のピストルグリップ26に設けられたハンドル6の解除ボタン30を押圧すると、ロックされた閉鎖トリガー18を解放することができる。
図3は、様々な実施形態に従ったエンドエフェクタ12の組立分解図である。例示されている実施形態に示されているように、エンドエフェクタ12は、上記した溝型部材22およびアンビル24に加えて、切断器具32、スレッド33、溝型部材22内に取外し可能に配置されたステープルカートリッジ34、および螺旋ねじシャフト36を含むことができる。切断器具32は、例えば、ナイフとすることができる。アンビル24は、溝型部材22の近位端部に接続されたピボット点25で開閉することができる。アンビル24は、このアンビル24を開閉するために機械閉鎖システム(詳細を後述)の構成要素内に挿入されるタブ27をその近位端部に備えることもできる。閉鎖トリガー18が作動する、すなわち器具10の使用者によって引かれると、アンビル24が、クランプすなわち閉位置にピボット点25を中心に旋回することができる。エンドエフェクタ12のクランプに満足したら、操作者は、詳細を後述するように、発射トリガー20を作動させて、ナイフ32およびスレッド33を溝型部材22に沿って長手方向に移動させ、エンドエフェクタ12内にクランプされた組織を切断することができる。スレッド33の溝型部材22に沿った運動により、ステープルカートリッジ34のステープルが、閉じたアンビル24に向かって切断された組織内を進み、アンビル24に曲げられて切断された組織を閉じる。参照して開示内容を本明細書に組み入れる米国特許第6,978,921号(名称:「Eビーム発射機構を含む外科ステープラ器具(Surgical stapling instrument incorporating an E-beam firing mechanism)」)に、このような2ストロークの切断/締結器具が詳細に開示されている。スレッド33をカートリッジ34の一部とし、切断動作の後にナイフ32が引き戻されても、スレッド33が引き戻されないようにすることができる。溝型部材22およびアンビル24は、導電材料(金属など)から形成することができ、様々な実施形態では、エンドエフェクタ内のセンサと通信するアンテナの一部として機能することができる。カートリッジ34は、非導電材料(プラスチックなど)から形成することができ、センサは、詳細を後述するように、カートリッジ34に接続するかまたはその内部に配置することができる。
ここに開示する外科器具10の実施形態は、切断された組織をステープル止めするエンドエフェクタ12を用いているが、他の実施形態では、切断された組織を締結またはシールするための異なる技術を用いることができることに留意されたい。例えば、切断された組織を閉じるためにRFエネルギーまたは接着剤を用いるエンドエフェクタを用いることができる。イエーツ(Yates)らによる米国特許第5,709,680号(名称:「電気外科止血装置(Electrosurgical Hemostatic Device)」)、およびイエーツ(Yates)らによる米国特許第5,688,270号(名称:「埋込みおよび/またはオフセット電極を備えた電気外科止血装置(Electrosurgical Hemostatic Device With Recessed And/Or Offset Electrodes)」)に、RFエネルギーを用いて切断された組織を閉じる切断器具が開示されている。参照して本明細書に組み入れるモーガン(Morgan)らによる米国特許出願第11/267,811号およびシェルトン(Shelton)らによる米国特許出願第11/267,363号に、接着剤を用いて切断された組織を閉じる切断器具が開示されている。したがって、本明細書では、切断/ステープル止め動作などについて述べているが、これは例示的な実施形態であり、限定することを意図するものではないことを理解されたい。他の組織締結技術を用いることもできる。
図4および図5は、様々な実施形態に従ったエンドエフェクタ12およびシャフト8の組立分解図であり、図6は側面図である。例示されている実施形態に示されているように、シャフト8は、近位閉鎖チューブ40、およびピボットリンク44によって旋回可能に連結された遠位閉鎖チューブ42を含むことができる。遠位閉鎖チューブ42は、アンビル24を開閉するためにアンビル24のタブ27が挿入される開口45を含む。閉鎖チューブ40、42内に、近位スパインチューブ46を配置することができる。近位スパインチューブ46内に、かさ歯車組立体52を介して第2(または遠位)駆動シャフト50に接続された第1の回転(または近位)駆動シャフト48を配置することができる。第2の駆動シャフト50は、螺旋ねじシャフト36の近位駆動歯車56に係合する駆動歯車54に接続されている。垂直かさ歯車52bが、近位スパインチューブ46の遠位端部の開口57内に回転可能に配置することができる。遠位スパインチューブ58を用いて、第2の駆動シャフト50および駆動歯車54、56を覆うことができる。第1の駆動シャフト48、第2の駆動シャフト50、および関節動作組立体(例えば、かさ歯車組立体52a‐52c)は、本明細書では、総称して「主駆動シャフト組立体」と呼ぶこともある。
ステープル溝型部材22の遠位端部に配置された軸受38は、螺旋駆動ねじ36が溝型部材22に対して自由に回転できるように螺旋駆動ねじ36を受容する。螺旋ねじシャフト36は、この回転により、ナイフ32がステープル溝型部材22内を遠位側または近位側(回転方向によって決まる)に移動するように、ナイフ32のねじ開口(不図示)に結合させることができる。したがって、詳細を後述するように、発射トリガー20の作動によって第1の駆動シャフト48が回転すると、かさ歯車組立体52a‐52cにより、第2の駆動シャフト50が回転し、駆動歯車54、56の噛合によって螺旋ねじシャフト36が回転して、ナイフ32が溝型部材22に沿って長手方向に移動し、エンドエフェクタ内にクランプされた全ての組織が切断される。スレッド33は、例えばプラスチックから形成することができ、傾斜した遠位面を有することができる。スレッド33が溝型部材22を横断する際、その傾斜した前面が、ステープルカートリッジ34内のステープルを、クランプされた組織を介してアンビル24に向かって押し上げることができる。アンビル24がステープルを曲げて、切断された組織がステープル止めされる。ナイフ32が引き戻されると、このナイフ32とスレッド33が係合解除され、スレッド33が溝型部材22の遠位端部にスレッド33が残置される。
様々な実施形態によると、図7‐図10に示されているように、外科器具は、ハンドル6内にバッテリ64を含むことができる。例示されている実施形態は、エンドエフェクタ12内の切断器具の配置および荷重の力について使用者にフィードバックする。加えて、この実施形態は、使用者が発射トリガー18を引く際の力を利用して器具10に動力を供給することができる(いわゆる「動力補助」モード)。例示されている実施形態に示されているように、ハンドル6は、互いに結合してハンドル6の外面を形成する下部外面部品59、60および上部外面部品61、62を含む。ハンドル部品59‐62は、プラスチックなどの非導電材料から形成することができる。リチウムイオンバッテリなどのバッテリ64を、ハンドル6のピストルグリップ部分26内に配置することができる。バッテリ64は、ハンドル6のピストルグリップ部分26の上部内に配置されたモータ65に電力を供給する。バッテリ64は、例えば、LiCoOやLiNiOなどのリチウムイオン化学またはニッケル水素化学などを含む任意の適当な構造または化学に従って製造することができる。様々な実施形態によると、モータ65は、約5000RPM〜100,000RPMの最大回転速度を有するDCブラシ駆動モータとすることができる。モータ64は、第1のかさ歯車68および第2のかさ歯車70を含む90度かさ歯車組立体66を駆動することができる。かさ歯車組立体66は、遊星歯車組立体72を駆動することができる。遊星歯車組立体72は、駆動シャフト76に接続されたピニオン歯車74を含むことができる。ピニオン歯車74は、駆動シャフト82を介して螺旋歯車ドラム80を駆動する、噛合するリング歯車78を駆動することができる。リング84を、螺旋歯車ドラム80に螺合させることができる。したがって、モータ65が回転すると、リング84が、間に配置されたかさ歯車組立体66、遊星歯車組立体72、およびリング歯車78によって螺旋歯車ドラム80に沿って移動する。
ハンドル6は、操作者が発射トリガー20をハンドル6のピストルグリップ部分26に向かって引いて(または閉じて)エンドエフェクタ12で切断/ステープル止め動作を行ったことを検出するために発射トリガー20と通信するモータ運転センサ110も含むことができる。このセンサ110は、例えば、レオスタットすなわち可変抵抗器などの比例センサとすることができる。発射トリガー20が引かれると、センサ110がこの動きを検出し、モータ65に供給される電圧(電力)を示す電気信号を送信する。センサ110が可変抵抗器などである場合、モータ65の回転は、発射トリガー20の運動量に通常は比例させることができる。すなわち、操作者が、発射トリガー20を僅かに引くすなわち閉じた場合、モータ65の回転速度が比較的低い。発射トリガー20が、完全に引くすなわち完全に閉じた場合、モータ65の回転速度が最大となる。言い換えれば、使用者が発射トリガー20を強く引けば引く程、モータ65に供給される電圧が大きくなり、回転速度が大きくなる。別の実施形態では、例えば、制御ユニット(詳細を後述)は、モータ65を制御するために、センサ110からの入力に基づいてモータ65にPWM制御信号を出力することができる。
ハンドル6は、発射トリガー20の上部に近接した中間ハンドル部品104を含むことができる。ハンドル6は、中間ハンドル部品104のポストと発射トリガー20との間に配置された付勢ばね112を含むことができる。この付勢ばね112は、発射トリガー20を完全な開位置に付勢することができる。この方式では、操作者が発射トリガー20を解放すると、付勢ばね112により、発射トリガー20が開位置に戻されて、センサ110の作動が停止し、モータ65の回転が停止される。さらに、使用者が発射トリガー20を閉じる際に、付勢ばね112によって、使用者が閉鎖動作に対して抵抗を感じる。これにより、使用者が、モータ65による回転の程度についてのフィードバックを受ける。さらに、操作者が、発射トリガー20を引くのを停止すると、センサ110に力がかからなくなって、モータ65が停止する。したがって、使用者は、エンドエフェクタ12の配置を停止することができるため、切断/締結動作の制御の手段が得られる。
螺旋歯車ドラム80の遠位端部は、ピニオン歯車124に噛合するリング歯車122を駆動する遠位駆動シャフト120を含む。ピニオン歯車124は、主駆動シャフト組立体の第1の駆動シャフト48に接続されている。この方式では、モータ65の回転により、主駆動シャフト組立体が回転し、上記したように、エンドエフェクタ12が作動する。
螺旋歯車ドラム80に螺合したリング84は、スロットアーム90のスロット88内に受容されるポスト86を含むことができる。スロットアーム90は、ハンドル外面部品59と60との間に結合されたピボットピン96を受容する開口92をその反対側の端部94に有する。ピボットピン96は、発射トリガー20の開口100および中間ハンドル部品104の開口102内に配置される。
加えて、ハンドル6は、モータ逆回転(またはストローク終了)センサ130およびモータ停止(またはストローク開始)センサ142を含むことができる。様々な実施形態では、モータ逆回転センサ130は、リング84が螺旋歯車ドラム80の遠位端部に達すると、螺旋歯車ドラム80に螺合したリング84がモータ逆回転センサ130に接触して作動させるように、螺旋歯車ドラム80の遠位端部に配置されたリミットスイッチとすることができる。モータ逆回転センサ130は、作動すると、制御ユニットに信号を送信し、この制御ユニットが、モータ65の回転を逆転する信号をモータ65に送信し、切断動作後にエンドエフェクタ12のナイフ32が引き戻される。
モータ停止センサ142は、例えば、通常は閉じたリミットスイッチとすることができる。様々な実施形態では、このセンサ142は、リング84が螺旋歯車ドラム80の近位端部に達するとリング84がスイッチ142を作動させるように、螺旋歯車ドラム80の近位端部に配置することができる。
動作の際、器具10の操作者が発射トリガー20を引くと、センサ110が、発射トリガー20の移動を検出して、制御ユニットに信号を送信し、この制御ユニットがモータ65に信号を送信し、モータ65が、操作者が発射トリガー20を引いた力に比例した速度で順方向に回転する。モータ65の順方向回転により、遊星歯車組立体72の遠位端部のリング歯車78が回転し、これにより螺旋歯車ドラム80が回転し、螺旋歯車ドラム80に螺合したリング84がこの螺旋歯車ドラム80上を遠位側に移動する。螺旋歯車ドラム80の回転はまた、上記した主駆動シャフト組立体を駆動し、これによりエンドエフェクタ12内でナイフ32が作動する。すなわち、ナイフ32およびスレッド33が溝型部材22を長手方向に移動して、エンドエフェクタ12内にクランプされた組織を切断する。また、ステープル止め型エンドエフェクタが用いられている実施形態では、エンドエフェクタ12のステープル止め動作も行われる。
エンドエフェクタ12の切断/ステープル動作が完了すると、螺旋歯車ドラム80のリング84が、螺旋歯車ドラム80の遠位端部に到達し、モータ逆回転センサ130が作動して、制御ユニットに信号を送信し、この制御ユニットがモータ65に信号を送信して、モータ65が逆回転する。これにより、ナイフ32が引き戻され、螺旋歯車ドラム80のリング84が、螺旋歯車ドラム80の近位端部に戻る。
中間ハンドル部品104は、図8および図9に最もよく示されているように、スロットアーム90に係合する後部肩106を含む。中間ハンドル部品104はまた、発射トリガー20に係合する前進運動ストッパー107も有する。スロットアーム90の運動は、上記したように、モータ65の回転によって制御されている。リング84が螺旋歯車ドラム80の近位端部から遠位端部に移動する際にスロットアーム90が反時計回りの方向に回転すると、中間ハンドル部品104は、半時計回りの方向に自由に回転する。したがって、使用者が発射トリガー20を引くと、発射トリガー20が中間ハンドル部品104の前進運動ストッパー107に係合して、中間ハンドル部品104が反時計回りの方向に回転する。しかしながら、スロットアーム90に係合している後部肩106により、中間ハンドル部品104は、スロットアーム90が許容する範囲で半時計回りの方向に回転することができる。この方式では、何らかの理由でモータ65が回転を停止しなければならない場合、スロットアーム90の回転が停止し、中間ハンドル部品104がスロットアーム90によって半時計回りの方向に自由に回転できないため、発射トリガー20をさらに引くことができない。
閉鎖トリガー18を引いてエンドエフェクタ12のアンビル24を閉じるすなわちクランプするための例示的な閉鎖システムの構成要素が、図7‐図10に示されている。例示されている実施形態では、閉鎖システムは、閉鎖トリガー18およびヨーク250の両方の整合した開口に挿入されたピン251によって閉鎖トリガー18に接続されたヨーク250を含む。閉鎖トリガー18の回転中心となるピボットピン252を、ピン251が閉鎖トリガー18内に挿入される位置からずれた閉鎖トリガー18の別の開口内に挿入する。したがって、閉鎖トリガー18が引かれると、ヨーク250がピン251で取り付けられている閉鎖トリガー18の上部が半時計回りの方向に回転する。ヨーク250の遠位端部が、ピン254によって第1の閉鎖ブラケット256に接続されている。第1の閉鎖ブラケット256は、第2の閉鎖ブラケット258に結合されている。閉鎖ブラケット256と258は、集合的に、これらの長手方向の運動によって近位閉鎖チューブ40が長手方向に移動するように、近位閉鎖チューブ40(図4を参照)の近位端部が受容される開口を画定している。器具10は、近位閉鎖チューブ40内に配置された閉鎖ロッド260も含む。閉鎖ロッド260は、この閉鎖ロッド260をハンドル6に固定するために、例示されている実施形態では下部外面部品59などのハンドル外面部品の1つのポスト263が配置される窓261を含むことができる。この方式では、近位閉鎖チューブ40は、閉鎖ロッド260に対して長手方向に移動することができる。閉鎖ロッド260は、近位スパインチューブ46のキャビティ269内に適合し、キャップ271(図4を参照)によってその内部に保持される遠位カラー267も含むことができる。
動作の際、閉鎖トリガー18が引かれてヨーク250が回転すると、閉鎖ブラケット256、258により、近位閉鎖チューブ40が遠位側(すなわち、器具10のハンドル端部から離れる方向)に移動し、これにより遠位閉鎖チューブ42が遠位側に移動し、アンビル24が、ピボット点25を中心にクランプすなわち閉位置まで回転する。閉鎖トリガー18がロック位置から解除されると、近位閉鎖チューブ40が近位側にスライドし、これにより遠位閉鎖チューブ42が近位側にスライドし、遠位閉鎖チューブ42の窓45内に挿入されているタブ27によって、アンビル24が、ピボット点25を中心にクランプされていない開位置まで回転する。この方式では、閉鎖トリガー18を引いてロックすることにより、操作者は、組織をアンビル24と溝型部材22との間にクランプすることができ、切断/ステープル止め動作の後に、閉鎖トリガー18をロック位置から解除して、組織のクランプを解除することができる。
詳細を後述する制御ユニットは、ストローク終了センサ130、ストローク開始センサ142、およびモータ運転センサ110からの出力を受信し、これらの入力に基づいてモータ65を制御することができる。例えば、閉鎖トリガー18をロックした後に操作者が初めに発射トリガー20を引くと、モータ運転センサ110が作動する。ステープルカートリッジ34がエンドエフェクタ12内に存在すると、カートリッジロックアウトセンサ(不図示)が閉じ、制御ユニットがモータ65に制御信号を出力し、モータ65が順方向に回転する。エンドエフェクタ12がストロークの最後に達すると、モータ逆回転センサ130が作動する。制御ユニットが、この出力をモータ逆回転センサ130から受信し、モータ65を逆回転させることができる。ナイフ32が完全に引き戻されると、モータ停止センサスイッチ142が作動して、制御ユニットがモータ65を停止させる。
他の実施形態では、比例型センサ110の代わりに、オン・オフ型センサを用いることができる。このような実施形態では、モータ65の回転速度は、操作者が加える力に比例しない。むしろ、モータ65は、一定の速度で回転する。しかしながら、発射トリガー20が歯車駆動列に係合しているため、操作者は、力のフィードバックを受けることができる。
器具10は、ステープルカートリッジ34(または外科器具のタイプによっては別のタイプのカートリッジ)の状態、使用者の入力負荷、閉鎖および発射の際のステープラの進行、カートリッジ34に適合した外科器具または器具などを決定するためのセンサなどのエンドエフェクタ12に関連した様々な状態を検出するための多数のセンサをエンドエフェクタ12内に含むことができる。センサは、誘導信号によって受動的に電力供給を受けても良いし、例えば、エンドエフェクタ12内のバッテリなどの遠隔電源によって電力供給を受けても良い。センサは、例えば、磁気抵抗センサ、光学センサ、電気機械センサ、無線IC(RFID)センサ、微小電気機械システム(MEMS)センサ、運動センサ、または圧力センサを含むことができる。これらのセンサは、例えば、図11に示されているように、器具10のハンドル6内に配置できる制御ユニット300と通信することができる。センサは、任意の適当な有線または無線方式で制御ユニット300に接続することができる。
図12に示されているように、様々な実施形態によると、制御ユニット300は、プロセッサ306および1または複数のメモリユニット308を含むことができる。メモリ308に保存された命令行動を実行することにより、プロセッサ306は、様々なエンドエフェクタのセンサおよび他のセンサ(モータ運転センサ110、ストローク終了センサ130、およびストローク開始センサ142など)に基づいて、モータ65またはユーザーディスプレイ(不図示)などの器具10の様々な構成要素を制御することができる。制御ユニット300は、器具10の外科的な使用の際にバッテリ64によって電力供給を受けることができる。制御ユニット300が、各センサおよび/またはモータに対して直接的な有線接続を有していない実施形態では、制御ユニット300は、様々なセンサ/モータなどに対して無線信号を送受信するために誘導要素302(例えば、コイルやアンテナ)を含むことができる。受信アンテナとして機能する誘導要素302が受け取る入力信号は、復調器310によって復調し、デコーダ312によって復号することができる。出力信号は、エンコーダ316、変調器318、および誘導要素302を介して送信することができる。様々な実施形態は、受信用誘導要素と送信用誘導要素を別々に含むことができる(不図示)。
様々な実施形態によると、制御ユニット300は、マイクロコントローラ、システム・オン・チップ(SC)またはシステム・イン・パッケージ(SIP)などとして具現することもできる。別法では、制御ユニット300は、2つ以上の別個の構成要素として具現することができる。図11に示されているように、制御ユニット300を、器具10のハンドル6内に含めることができ、器具10の1または複数のセンサ368を、エンドエフェクタ12内に配置することができる。制御ユニット300とセンサ358が無線通信する実施形態では、制御ユニット300の誘導要素302を、1または複数のワイヤ(例えば、ワイヤ322)および/または第2の誘導要素(例えば、コイル320や324)を介してトランスポンダに誘導結合することができる。回転接合部29やピボット14などの関節動作接合部を通るワイヤを設けなくても良いように、第2の誘導要素320、324を配置することができる。
図13は、溝型部材22の遠位端部のカートリッジ34内に保持または埋め込まれたトランスポンダ368を含むエンドエフェクタ12の線図である。センサ368は、エポキシなどの適当な接着材料でカートリッジ34に結合することができる。この実施形態では、センサ368は、磁気抵抗センサを含む。アンビル24も、トランスポンダ368に面した永久磁石369をその遠位端部に含む。カートリッジ34も、この例の実施形態ではスレッド33に結合された永久磁石370を含む。これにより、センサ368が、エンドエフェクタ12の開と閉の両方と(アンビル24が開閉する際に、永久磁石369がトランスポンダに対して離れるまたは近づくため)、ステープル止め/切断動作の完了(切断動作の一部としてスレッド33が溝型部材22を移動する際に、永久磁石370がセンサ368に向かって移動するため)を検出することができる。例えば、図示されている無線IC(RFID)センサ371を含め、様々な他のセンサおよび/またはセンサタイプを、エンドエフェクタ12および/またはカートリッジ34内に含めることができる。
図13は、ステープルカートリッジ34のステープル380およびステープルドライバ382も示している。既に説明したように、様々な実施形態によると、スレッド33が溝型部材22を横断すると、スレッド33がステープルドライバ382を駆動させ、これによりステープル380がエンドエフェクタ12内に保持された切断された組織内に進入し、ステープル380がアンビル24によって成形される。上記したように、このような外科切断/締結器具は、本発明を有利に利用できる外科器具の1タイプである。本発明の様々な実施形態は、1または複数のセンサを有するあらゆるタイプの外科器具に用いることができる。
上記した実施形態では、バッテリ64または他の適当な電源は、器具10の発射動作のために少なくとも部分的に電力を供給する。したがって、この器具は、いわゆる「動力補助」装置と呼ぶことができる。このような動力補助装置のさらなる詳細および別の実施形態は、参照して本明細書に組み入れる米国特許出願第11/343,573号に開示されている。しかしながら、器具10は必ずしも、動力補助装置とする必要はなく、本発明の特徴を利用できる1タイプの装置の一例にすぎないことを理解されたい。例えば、器具10は、バッテリ64によって電力が供給され、かつ制御ユニット300によって制御されるユーザーディスプレイ(LCDまたはLEDディスプレイなど)を含むことができる。エンドエフェクタ12内のセンサセンサ368からのデータを、このようなディスプレイに表示することができる。
一般に、器具10などの外科器具は、使用前に洗浄および滅菌される。ある滅菌技術では、図14および図15に示されているように、器具10を、プラスチックおよび/またはTYVEK容器またはバッグなどの密閉されたパッケージ280内に配置する。次に、パッケージ280と器具を、γ線、x線、または高エネルギー電子などのパッケージを透過できる放射線の場に配置する。この放射線が、器具10上およびパッケージ280内の細菌を死滅させる。次に、滅菌された器具10を滅菌パッケージ280内に保管することができる。密閉された滅菌パッケージ280は、医療施設または他の使用環境で開封されるまで器具10の滅菌を維持する。放射線の代わりに、エチレンオキシドやスチームなどの器具10の他の滅菌手段を用いることができる。器具10は、滅菌された状態または滅菌されていない状態で消費者に供給することができる。器具10が、滅菌されていない状態で供給される場合、消費者は、病院内で器具10を滅菌するか、または外部の請負業者に送ることができる。
図16は、器具10、および補助電源402を備えたパッケージ280の様々な実施形態による側面図を示している。補助電源402は、接続部404および回路要素(不図示)を介して器具10(例えば、バッテリ64)と電気通信することができる。補助電源402は、器具の電源を充電および/または再充電するために電力を供給することができる。補助電源402は、あらゆる種類のバッテリまたは他の適当な電源とすることができる。例えば、リチウムイオンバッテリまたはニッケル水素バッテリなどの充電式バッテリ、または亜鉛/炭素、Zn/アルカリ/MnO、Li/MnO、Zn/AgO、Li/FeSなどの非充電式バッテリを含むことができる。
回路要素は、器具10を使用する際に器具10のバッテリ64または他の電源が適当な電荷を有するように、器具10に補助電源402から供給される電力を調節することができる。物理的に、回路要素は、例えば、パッケージ280内、補助電源402内、または器具内などを含む任意の適当な位置に単独要素として配置することができる。接続部404は、例えば、直接的な有線接続や誘導結合などを含む任意の適当な種類の接続とすることができる。誘導結合では、接続部404は、互いに近接して誘導要素を含むことができる。第1の誘導要素の電流が、第2の誘導要素に対応する電流を誘導し、接続部404を介して電力を伝送することができる。
図17は、回路要素410を介して器具の電源406(例えば、バッテリ64)に接続された補助電源402の例示的な模式線図を示している。補助電源402は、任意の適当な方法または充電プロフィールに従って器具の電源406を充電することができる。例えば、回路要素410は、電源402と406との間に直接的な接続部(例えば、誘導または配線)を含むことができる。補助電源402は、例えば、器具10が保管されている時に器具の電源406の電荷が低下したら、この電源406を充電するために充電電流を供給することができる。また、例えば、補助電源402は、器具の電源の電流状態に基づいて充電電流を供給することができる。図18に示されているように、回路要素410は、器具の電源406の電荷を監視して、電源406の電荷が所定の閾値に達すると、補助電源402から電流を供給するために、1または複数のスイッチ402または抵抗器(不図示)を含むことができる。補助電源402によって供給される電流は、例えば、図19に示されているように、マイクロプロセッサ414およびスイッチネットワーク416を含む様々な他の手段によって調節することができる。プロセッサ444の機能は、上記したプロセッサ306によって、または器具10の任意の他の制御システムによって果たすことができる。
様々な実施形態によると、補助電源402は、器具10を使用する際に、器具の電源406を比較的迅速に充電することができる。例えば、図18を参照すると、スイッチ412は、器具10およびパッケージ280が保管された状態で開位置にしたままにすることができる。したがって、器具の電源406の電荷が低下しうる。器具10を使用する際は、スイッチ412を閉じて、補助電源402が電源406に充電電流を供給し、電源406が使用前に充電される。例えば、スイッチ412は、パッケージ280を開封したときに自動的に閉じるように構成することができる。様々な実施形態では、スイッチは、図16に示されているように、タブ405を含むことができる。タブ405は、パッケージ280の一部に結合して、このパッケージ280が開封された時にスイッチ412が閉じられるように構成することができる。また、例えば、医師が、器具10を使用する時またはその前に、タブ450を引いてスイッチ412を閉じ、電源406を充電することができる。
上記したように、ある種のエンドエフェクタカートリッジ34は、電源を必要とするセンサまたは他の電気要素を有することができる。例えば、図3は、電源456を備えたカートリッジ34を示している。電源456は、カートリッジおよび/またはエンドエフェクタ12内の電子部品を動作するのに適したあらゆる電源を用いることができる。例えば、電源456は、コンデンサやバッテリなどを含むことができる。電源456は、図20に示されているように、例えば、遠位端部を含むカートリッジ34内の任意の適当な位置に配置することができ、図21に示されているようにスレッド33の一部とすることができる。
エンドエフェクタカートリッジ34は、上記した方法に従って保管および滅菌することができる。例えば、図20は、滅菌のためにパッケージ450内に密封されたカートリッジ34を示している。図示されているように、パッケージ450は、補助電源452も含む。この補助電源は、カートリッジの電源456に電力を供給することができる。電源402と同様に、電源452は、カートリッジ34の電源456を充電または再充電してカートリッジ34の保管寿命を長くすることができる。補助電源452は、接続部454、および上記した回路要素に類似の回路要素(不図示)を介してカートリッジ34に接続することができる。補助電源452、回路要素、およびカートリッジの電源は、例えば、図17‐図19を用いて説明した方法を含むあらゆる適当な有線または無線(例えば、誘導)の方法に従って電源456に接続してこの電源456を充電することができる。
様々な実施形態によると、カートリッジ電源456は、小さな静電容量を有することができる。したがって、この電荷を不必要に使用しないことが望ましいであろう。例えば、カートリッジ電源456は、カートリッジ34を使用できるようになるまで、負荷から電気的に絶縁することができる。カートリッジ34は、このカートリッジ34がエンドエフェクタ12内に装着されると閉じるカットオフスイッチまたは他の回路要素を含むことができる。カットオフスイッチが閉じると、電源456は、その負荷(例えば、カートリッジ34に設けられたあらゆるセンサまたは他の動力式電子部品)に接続することができる。
カットオフスイッチは、任意の適当な方法で具現することができる。例えば、図3に示されているように、カートリッジ34は、溝型部材22内に固定されると、この溝型部材の突出部(不図示)を受容する対応する凹部401を含むことができる。スイッチ要素は、このような凹部401内に配置することができる。カートリッジ34が溝型部材22内に装着されると、突出部が凹部401内に受容されて、カットオフスイッチが閉じ、電源456がその負荷に接続される。図21は、カットオフスイッチの別の実施形態を示している。図示されているように、カットオフスイッチは、カートリッジ34の側壁に配置された一対の電気接点462を含むことができる。カートリッジ34が溝型部材22内に装着されると(図3を参照)、接点462は、溝型部材22の導電性の側壁によって短絡し、スイッチが閉じ、電源456が負荷に接続される。
切断型外科器具を用いて本発明の様々な実施形態を説明してきたが、他の実施形態では、ここに開示する本発明の外科器具は、切断型外科器具でなくても良く、むしろ遠隔センサトランスポンダを含むあらゆるタイプの外科器具に用いることができることを理解されたい。例えば、本発明の外科器具は、非切断内視鏡器具、把持器、ステープラ、クリップアプライヤ、アクセス装置、薬物/遺伝子治療送達装置、および超音波、RF、レーザーなどを用いたエネルギー装置とすることができる。加えて、本発明は、例えば、関節鏡器具に用いることができる。
ここに開示する装置は、1回の使用で廃棄するように設計するか、または複数回使用するように設計することができる。しかしながら、いずれの場合も、この装置は、少なくとも1回使用した後に再使用するために再生することができる。この再生には、装置の分解ステップ、続く特定の部品の洗浄または交換ステップ、そして再組立ステップの任意の組合せを含むことができる。具体的には、この装置は、分解してから、装置の任意の数の特定の部品を、任意の組合せで選択的に交換または除去することができる。特定の部品の洗浄および/または交換の際に、本装置は、次の使用のために、外科手術の直前に再生設備で、または手術チームによって再組立てすることができる。当業者であれば、装置の再生は、分解、洗浄/交換、および再組立のために様々な技術を用いることができることを理解できよう。このような技術の使用および得られる再生された装置は、本明細書の範囲内である。
特定の実施形態を用いて本発明を説明してきたが、これらの実施形態に対して様々な改良および変更を加えることができる。例えば、様々なタイプのエンドエフェクタを用いることができる。また、特定の構成要素の材料を開示したが、他の材料を用いることもできる。上記した説明および添付の特許請求の範囲は、このような全ての改良および変更を含むものとする。
参照して本明細書に組み入れると述べた全ての特許文献、刊行物、または他の開示資料の全てまたは一部は、組み入れる資料が、本明細書に開示した定義、記載、または他の開示資料に反しない程度に組み入れるものとする。したがって、必要な範囲で、ここに明確に記載した開示は、参照して本明細書に組み入れる全ての反する資料に対して優先されるものである。参照して本明細書に組み入れると述べたが、ここに開示する定義、記載、または他の開示資料に反する全ての資料またはその一部は、組み入れる資料と本開示資料との間に対立が起こらない範囲で組み入れるものとする。
〔実施の態様〕
(1)組立体において、
パッケージと、
前記パッケージ内の外科器具構成要素と、
前記パッケージ内の電源であって、前記外科器具構成要素と電気的に通信するように配置されるように構成された、電源と、
前記パッケージ内の補助電源と、
前記電源および前記補助電源と電気的に通信する回路要素と、
を含む、組立体。
(2)実施態様(1)に記載の組立体において、
前記パッケージは滅菌されている、組立体。
(3)実施態様(1)に記載の組立体において、
前記電源はバッテリである、組立体。
(4)実施態様(1)に記載の組立体において、
前記バッテリは、リチウムイオン電池およびニッケル水素電池からなる群から選択される少なくとも1つの電池を含む、組立体。
(5)実施態様(1)に記載の組立体において、
前記電源はコンデンサである、組立体。
(6)実施態様(1)に記載の組立体において、
前記回路要素は、前記電源と前記補助電源との間の直接的な電気接続を含む、組立体。
(7)実施態様(6)に記載の組立体において、
前記直接的な電気接続は誘導結合を含む、組立体。
(8)実施態様(1)に記載の組立体において、
前記回路要素は、前記電源と前記補助電源との間の電気通信を制御するように構成された制御回路を含む、組立体。
(9)実施態様(8)に記載の組立体において、
前記制御回路は、前記補助電源と前記電源との間にスイッチを含む、組立体。
(10)実施態様(9)に記載の組立体において、
前記スイッチは、前記パッケージが開封されると閉じるように構成されている、組立体。
(11)実施態様(9)に記載の組立体において、
前記スイッチは、取外し可能なタブを含む、組立体。
(12)実施態様(8)に記載の組立体において、
前記制御回路はマイクロプロセッサを含む、組立体。
(13)実施態様(12)に記載の組立体において、
前記マイクロプロセッサは、前記外科器具の使用中に前記外科器具の少なくとも1つの構成要素を制御するように構成されている、組立体。
(14)実施態様(1)に記載の組立体において、
前記外科器具構成要素はエンドカッターを含む、組立体。
(15)実施態様(1)に記載の組立体において、
前記外科器具構成要素は、外科器具のためのエンドカッターカートリッジを含む、組立体。
(16)実施態様(1)に記載の組立体において、
前記電源は、前記外科器具構成要素と電気的に通信しない、組立体。
(17)実施態様(1)に記載の組立体において、
前記補助電源は、亜鉛電池、Zn/アルカリ/MnO電池、Li/MnO電池、Zn/AgO電池、Li/FeS電池からなる群から選択される少なくとも1つの電池を含む、組立体。
(18)外科器具に使用するためのエンドエフェクタカートリッジにおいて、
電気要素と、
電源と、
前記エンドエフェクタカートリッジが外科器具内に装着されると、前記電源と前記電気要素を電気的に接続するように構成された回路要素と、
を含む、エンドエフェクタカートリッジ。
(19)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記電気要素は、受動センサおよび能動センサからなる群から選択される少なくとも1つのセンサを含む、エンドエフェクタカートリッジ。
(20)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記電気要素は、無線IC(RFID)要素を含む、エンドエフェクタカートリッジ。
(21)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記電気要素は、前記エンドエフェクタカートリッジの状態、前記エンドエフェクタカートリッジの種類、および前記エンドエフェクタカートリッジに適合した外科器具からなる群の少なくとも1つを示すように構成されている、エンドエフェクタカートリッジ。
(22)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記回路要素は、前記エンドエフェクタカートリッジが前記外科器具内に装着されると前記電気要素と前記電源との間の電気接続を閉じるように構成されているスイッチを含む、エンドエフェクタカートリッジ。
(23)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記回路要素は、少なくとも2つの電極を含み、前記カートリッジが外科器具内に装着されると前記電極間が電気的に接続される、エンドエフェクタカートリッジ。
(24)実施態様(18)に記載のエンドエフェクタカートリッジにおいて、
前記回路要素は、前記エンドエフェクタカートリッジが前記外科器具内に装着されると作動するように構成された接触スイッチを含む、エンドエフェクタカートリッジ。
(25)組立体において、
パッケージと、
前記パッケージ内のエンドエフェクタカートリッジであって、電気要素を含む、エンドエフェクタカートリッと、
前記パッケージ内の電源と、
前記パッケージ内の回路要素であって、前記エンドエフェクタカートリッジが外科器具内に装着されると前記電源と前記電気要素を電気的に接続するように構成されている、回路要素と、
を含む、組立体。
(26)実施態様(25)に記載の組立体において、
前記パッケージは滅菌されている、組立体。
(27)実施態様(25)に記載の組立体において、
前記回路要素は、前記エンドエフェクタカートリッジが前記外科器具内に装着されると前記電気要素と前記電源との間の電気接続を閉じるように構成されたスイッチを含む、組立体。
(28)エンドエフェクタカートリッジを処理する方法において、
実施態様(18)に記載のエンドエフェクタカートリッジを用意するステップと、
前記エンドエフェクタカートリッジを滅菌するステップと、
前記エンドエフェクタカートリッジを滅菌パッケージ内に保管するステップと、
を含む、方法。
本発明の様々な実施形態に従った外科器具の斜視図である。 本発明の様々な実施形態に従った外科器具の斜視図である。 本発明の様々な実施形態に従った外科器具のエンドエフェクタの組立分解図である。 本発明の様々な実施形態に従った外科器具のシャフトの組立分解図である。 本発明の様々な実施形態に従った外科器具のエンドエフェクタおよびシャフトの組立分解図である。 本発明の様々な実施形態に従ったエンドエフェクタの側面図である。 本発明の様々な実施形態に従った外科器具のハンドルの組立分解図である。 本発明の様々な実施形態に従ったハンドルの一部の斜視図である。 本発明の様々な実施形態に従ったハンドルの一部の斜視図である。 本発明の様々な実施形態に従ったハンドルの側面図である。 本発明の様々な実施形態に従った外科器具の斜視図である。 本発明の様々な実施形態に従った外科器具に用いる制御ユニットのブロック図である。 本発明の様々な実施形態に従った外科器具に用いられるエンドエフェクタの側面図である。 本発明の様々な実施形態に従った滅菌容器内の外科器具を示す図である。 図14の線15‐15に沿って見た断面図である。 本発明の様々な実施形態に従った滅菌容器内の外科器具を示す図である。 本発明の様々な実施形態に従った外科器具に用いる回路の模式的な線図である。 本発明の様々な実施形態に従った外科器具に用いる別の回路の模式的な線図である。 本発明の様々な実施形態に従った外科器具に用いる別の回路の模式的な線図である。 本発明の様々な実施形態に従った滅菌パッケージ内の外科器具の構成要素を示す図である。 本発明の様々な実施形態に従った外科器具の構成要素を示す図である。

Claims (5)

  1. 組立体において、
    パッケージと、
    前記パッケージ内の外科器具構成要素と、
    前記パッケージ内の電源であって、前記外科器具構成要素と電気的に通信するように配置されるように構成された、電源と、
    前記パッケージ内の補助電源と、
    前記電源および前記補助電源と電気的に通信するスイッチであって、前記スイッチは前記パッケージが密封された状態では開位置に保持され、前記スイッチはタブを含み、前記タブは前記パッケージが開封されたときに前記スイッチが自動的に閉じるように前記パッケージの一部に結合して構成されている、スイッチと、
    を含む、組立体。
  2. 請求項1に記載の組立体において、
    前記パッケージは滅菌されている、組立体。
  3. 請求項1に記載の組立体において、
    前記電源はバッテリである、組立体。
  4. 請求項1に記載の組立体において、
    前記バッテリは、リチウムイオン電池およびニッケル水素電池からなる群から選択される少なくとも1つの電池を含む、組立体。
  5. 請求項1に記載の組立体において、
    前記電源はコンデンサである、組立体。
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EP2353538A3 (en) 2013-03-27
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