JP2017513566A - センサ適合を利用する外科用器具 - Google Patents

センサ適合を利用する外科用器具 Download PDF

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JP2017513566A
JP2017513566A JP2016558613A JP2016558613A JP2017513566A JP 2017513566 A JP2017513566 A JP 2017513566A JP 2016558613 A JP2016558613 A JP 2016558613A JP 2016558613 A JP2016558613 A JP 2016558613A JP 2017513566 A JP2017513566 A JP 2017513566A
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surgical instrument
processor
microcontroller
sensor
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JP2016558613A
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JP6710640B2 (ja
Inventor
ラインバック・リチャード・エル
アダムス・シェーン・アール
オーバーマイヤー・マーク・ディー
スウェンスガード・ブレット・イー
ライトル・トーマス・ダブリュ・ザ・フォース
シェルトン・フレデリック・イー・ザ・フォース
ハウザー・ケビン・エル
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Ethicon Endo Surgery LLC
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Ethicon Endo Surgery LLC
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    • H01M50/20Mountings; Secondary casings or frames; Racks, modules or packs; Suspension devices; Shock absorbers; Transport or carrying devices; Holders
    • H01M50/204Racks, modules or packs for multiple batteries or multiple cells
    • H01M50/207Racks, modules or packs for multiple batteries or multiple cells characterised by their shape
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    • H02J2310/10The network having a local or delimited stationary reach
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    • H02GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
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    • H02J7/007192Regulation of charging or discharging current or voltage the charge cycle being controlled or terminated in response to non-electric parameters in response to temperature
    • HELECTRICITY
    • H02GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
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    • H02J7/00Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
    • H02J7/02Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries for charging batteries from ac mains by converters

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  • Charge And Discharge Circuits For Batteries Or The Like (AREA)

Abstract

外科用器具は、ハンドルと、移動可能な入力部と、移動可能な入力部の位置を検出するように構成されたアナログセンサとを備えることができ、アナログセンサは、アナログデータを含むアナログ信号を生成するように構成されている。外科用器具は、入力チャネルを備えるマイクロコントローラを更に備えることができ、アナログセンサが、入力チャネルと信号通信し、マイクロコントローラが、アナログデータを基準値と比較するように構成され、マイクロコントローラが、この比較に応答してデジタル信号を生成するように構成されている。

Description

本発明は、外科用器具に関し、また様々な状況において、組織のステープル留め及び切断を行うように設計された、外科用ステープル留め及び切断器具並びにそのステープルカートリッジに関する。
本発明の特徴及び利点、並びにこれらを達成する方法は、添付の図面と併せて、本発明の実施形態の以下の記載を参照することによってより明らかになり、発明自体がより良好に理解される。
動作可能にそれに結合された交換式シャフト組立体を有する外科用器具の斜視図である。 図1の交換式シャフト組立体及び外科用器具の分解組立図である。 図1及び2の交換式シャフト組立体及び外科用器具の一部を示す別の分解組立図である。 図1〜3の外科用器具の一部の部分組立図である。 発射トリガーが完全作動位置にある、図4の外科用器具の一部の断面側面図である。 発射トリガーが非作動位置にある、図5の外科用器具の一部の別の断面図である。 交換式シャフト組立体の1つの形態の分解組立図である。 図7の交換式シャフト組立体の一部の別の分解組立図である。 図7及び8の交換式シャフト組立体の一部の別の分解組立図である。 図7〜9の交換式シャフト組立体の一部の断面図である。 明確にするためにスイッチドラムを省略した、図7〜10のシャフト組立体の一部の斜視図である。 スイッチドラムがその上に取り付けられた、図11の交換式シャフト組立体の一部の別の斜視図である。 図1の外科用器具の一部に動作可能に結合された図11の交換式シャフト組立体の一部の斜視図であり、その閉鎖トリガーは、非作動位置で示されている。 図13の交換式シャフト組立体及び外科用器具の右側面立面図である。 図13及び14の交換式シャフト組立体及び外科用器具の左側面立面図である。 図1の外科用器具の一部に動作可能に結合された図11の交換式シャフト組立体の一部の斜視図であり、その閉鎖トリガーが作動位置に、そしてその発射トリガーが非作動位置に示されている。 図16の交換式シャフト組立体及び外科用器具の右側面立面図である。 図16及び17の交換式シャフト組立体及び外科用器具の左側面立面図である。 図1の外科用器具の一部に動作可能に結合された図11の交換式シャフト組立体の右側面立面図であり、その閉鎖トリガーが作動位置に、そしてその発射トリガーが作動位置に示されている。 外科用器具を制御するための概略図の第1の部分である。 図19Aの概略図の第2の部分である。 外科用器具で使用するためのスイッチ回路の概略図である。 外科用器具で使用するためのスイッチ回路の別の概略図である。 図21のスイッチ回路を利用して外科用器具を制御するための概略図の第1の部分である。 図22Aの概略図の第2の部分である。
本願の出願人は、2013年3月1日に出願された以下の特許出願を所有し、これらはそれぞれの全体が参照することによって本明細書に組み込まれる:
米国特許出願第13/782,295号、名称「ARTICULATable Surgical Instruments With Conductive Pathways For Signal Communication」、
米国特許出願第13/782,323号、名称「ROTARY POWERED ARTICULATION JOINTS FOR SURGICAL INSTRUMENTS」、
米国特許出願第13/782,338号、名称「THUMBWHEEL SWITCH ARRANGEMENTS FOR SURGICAL INSTRUMENTS」、
米国特許出願第13/782,499号、名称「ELECTROMECHANICAL SURGICAL DEVICE WITH SIGNAL RELAY ARRANGEMENT」、
米国特許出願第13/782,460号、名称「MULTIPLE PROCESSOR MOTOR CONTROL FOR MODULAR SURGICAL INSTRUMENTS」、
米国特許出願第13/782,358号、名称「Joystick Switch Assemblies For Surgical Instruments」、
米国特許出願第13/782,481号、名称「SENSOR STRAIGHTENED END EFFECTOR DURING REMOVAL THROUGH TROCAR」、
米国特許出願第13/782,518号、名称「CONTROL METHODS FOR SURGICAL INSTRUMENTS WITH REMOVABLE IMPLEMENT PORTIONS」、
米国特許出願第13/782,375号、名称「ROTARY POWERED SURGICAL INSTRUMENTS WITH MULTIPLE DEGREES OF FREEDOM」、及び
米国特許出願第13/782,536号、名称「SURGICAL INSTRUMENT SOFT STOP」が、参照によってそれら全ての内容が本明細書に組み込まれる。
本願の出願人はまた、2013年3月14日に出願され、各々の全ての内容が参照によって本明細書に組み込まれる以下の特許出願を所有している:
米国特許出願第13/803097号、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE」、
米国特許出願第13/803,193号、名称「CONTROL ARRANGEMENTS FOR A DRIVE MEMBER OF A SURGICAL INSTRUMENT」、
米国特許出願第13/803,053号、名称「INTERCHANGEABLE SHAFT ASSEMBLIES FOR USE WITH A SURGICAL INSTRUMENT」、
米国特許出願第13/803,086号、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK」、
米国特許出願第13/803,210号、名称「SENSOR ARRANGEMENTS FOR ABSOLUTE POSITIONING SYSTEM FOR SURGICAL INSTRUMENTS」、
米国特許出願第13/803,148号、名称「MULTI−FUNCTION MOTOR FOR A SURGICAL INSTRUMENT」、
米国特許出願第13/803,066号、名称「DRIVE SYSTEM LOCKOUT ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS」、
米国特許出願第13/803,117号、名称「ARTICULATION CONTROL SYSTEM FOR ARTICULATABLE SURGICAL INSTRUMENTS」、
米国特許出願第13/803,130号、名称「DRIVE TRAIN CONTROL ARRANGEMENTS FOR MODULAR SURGICAL INSTRUMENTS」、及び
米国特許出願第13/803159号、名称「METHOD AND SYSTEM FOR OPERATING A SURGICAL INSTRUMENT」。
本願の出願人はまた、これらと同日に出願され、各々の全ての内容が参照によって本明細書に組み込まれる以下の特許出願を所有している:
米国特許出願第_______________号、名称「SURGICAL INSTRUMENT COMPRISING A SENSOR SYSTEM」(代理人整理番号END7386USNP/130458)、
米国特許出願第________________号、名称「POWER MANAGEMENT CONTROL SYSTEMS FOR SURGICAL INSTRUMENTS」(代理人整理番号END7387USNP/130459)、
米国特許出願第_______________号、名称「STERILIZATION VERIFICATION CIRCUIT」(代理人整理番号END7388USNP/130460)、
米国特許出願第________________号、名称「VERIFICATION OF NUMBER OF BATTERY EXCHANGES/PROCEDURE COUNT」(代理人整理番号END7389USNP/130461)、
米国特許出願第________________号、名称「POWER MANAGEMENT THROUGH SLEEP OPTIONS OF SEGMENTED CIRCUIT AND WAKE UP CONTROL」(代理人整理番号END7390USNP/130462)、
米国特許出願第________________号、名称「MODULAR POWERED SURGICAL INSTRUMENT WITH DETACHABLE SHAFT ASSEMBLIES」(代理人整理番号END7391USNP/130463)、
米国特許出願第________________号、名称「FEEDBACK ALGORITHMS FOR MANUAL BAILOUT SYSTEMS FOR SURGICAL INSTRUMENTS」(代理人整理番号END7392USNP/130464)、
米国特許出願第________________号、名称「SURGICAL INSTRUMENT CONTROL CIRCUIT HAVING A SAFETY PROCESSOR」(代理人整理番号END7394USNP/130466)、
米国特許出願第________________号、名称「SURGICAL INSTRUMENT COMPRISING INTERACTIVE SYSTEMS」(代理人整理番号END7395USNP/130467)、
米国特許出願第_________________号、名称「INTERFACE SYSTEMS FOR USE WITH SURGICAL INSTRUMENTS」(代理人整理番号END7396USNP/130468)、
米国特許出願第________________号、名称「MODULAR SURGICAL INSTRUMENT SYSTEM」(代理人整理番号END7397USNP/130469)、
米国特許出願第_________________号、名称「SYSTEMS AND METHODS FOR CONTROLLING A SEGMENTED CIRCUIT」(代理人整理番号END7399USNP/130471)、
米国特許出願第_________________号、名称「POWER MANAGEMENT THROUGH SEGMENTED CIRCUIT AND VARIABLE VOLTAGE PROTECTION」(代理人整理番号END7400USNP/130472)、
米国特許出願第_________________号、名称「SURGICAL STAPLING INSTRUMENT SYSTEM」(代理人整理番号END7401USNP/130473)及び
米国特許出願第_________________号、名称「SURGICAL INSTRUMENT COMPRISING A ROTATABLE SHAFT」(代理人整理番号END7402USNP/130474)。
本明細書に開示されるデバイス及び方法の構造、機能、製造、及び使用の原理を総合的に理解するために、ある特定の例示的実施形態がこれから記載される。これらの実施形態の1つ又は2つ以上の実施例が、添付の図面に例示されている。当業者であれば、本明細書に詳細に述べられ、添付の図面に示されるデバイス及び方法が、非限定的かつ例示的な実施形態であることが理解されるであろう。1つの例示的な実施形態との関連において例示又は記載される特徴は、他の実施形態の特徴と組み合わせられる場合がある。かかる修正及び変形は、本発明の範囲内に含まれることが意図される。
本明細書の全体を通じて、「様々な実施形態」、「いくつかの実施形態」、「一実施形態」、又は「ある実施形態」などへの参照は、その実施形態との関連において述べられる特定の特徴、構造、又は特性が、少なくとも1つの実施形態に含まれることを意味する。したがって、本明細書の全体を通じて適所において、「様々な実施形態において」、「いくつかの実施形態において」、「一実施形態において」、又は「ある実施形態において」などの語句が出現するが、これらは必ずしも全てが同じ実施形態を指すわけではない。更に、特定の特徴、構造、又は特性は、1つ又は2つ以上の実施形態において任意の好適な方法で組み合わされてもよい。故に、一実施形態に関して例示又は説明される特定の特徴、構造、又は特性は、1つ若しくは2つ以上の他の実施形態の特徴、構造、又は特性と、全体として又は部分的に、制限なしに組み合わせられてもよい。かかる修正及び変形は、本発明の範囲内に含まれることが意図される。
「近位」及び「遠位」という用語は、本明細書において、外科用器具のハンドル部分を操作する医師を基準にして用いられる。「近位」なる用語は、医師に最も近い部分を指し、「遠位」という用語は、医師から離れた位置にある部分を指す。便宜上及び明確性のために、「垂直」、「水平」、「上」、及び「下」などの空間的用語は、本明細書において図面に対して使用され得ることが更に理解されるであろう。しかしながら、外科用器具は、多くの方向及び位置で使用されるものであり、これらの用語は、限定的及び/又は絶対的であることを意図するものではない。
腹腔鏡下及び低侵襲性の外科手技を行うための、様々な代表的なデバイス及び方法が提供される。しかしながら、当業者は、本明細書に開示される様々な方法及びデバイスが、例えば、開腹外科手技を含めて、多数の外科手技及び用途で用いられ得ることを容易に理解するであろう。本明細書の「発明を実施するための形態」を読むにつれ、本明細書に開示される様々な器具を、例えば、天然のオリフィスから、又は組織に形成された切開口若しくは穿刺穴から、といった任意の方法で体内に挿入することが可能である点は当業者には更に認識されるところであろう。これらの器具の作動部分すなわちエンドエフェクタ部分は、患者の体内に直接挿入されてもよく、又は、外科用器具のエンドエフェクタ及び細長いシャフトを進めることが可能な作業通路を有するアクセスデバイスを介して挿入されてもよい。
図1〜6は、再利用されても、又は再利用されなくてもよい電動外科用切断及び締結器具10を描写する。図示の実施形態において、器具10は、ハンドル14を備えるハウジング12を有し、ハンドル14は、臨床医によって握持、操作、及び作動されるように構成されている。ハウジング12は、交換式シャフト組立体200への動作可能な装着のために構成され、交換式シャフト組立体200は、1つ若しくは2つ以上の外科的作業また手技を行うように構成される、それに動作可能に結合された外科用エンドエフェクタ300を有する。この「発明を実施するための形態」を読むにつれ、本明細書で開示する様々な形態の交換式シャフト組立体の、様々な独自で新規な配列もまた、ロボット制御される手術システムと関連させて効果的に用いることができることが理解されるであろう。したがって、「ハウジング」という用語はまた、本明細書で開示する交換式シャフト組立体及びそれらに対応する等価物を作動させるために利用できる少なくとも1つの制御運動を生成し加えるように構成された少なくとも1つの駆動システムを収容するか、ないしは別様に支持するロボットシステムのハウジング又は類似の部分を包含することができる。「フレーム」という用語は、手持型外科用器具の一部分を指すことができる。「フレーム」という用語はまた、ロボット制御式の外科用器具の一部分及び/又は外科用器具を動作可能に制御するために利用できるロボットシステムの一部分を表すことができる。例えば、本明細書で開示する交換式シャフト組立体は、米国特許出願第13/118241号、名称「SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS」、現在の米国特許出願公開第2012/0298719号で開示されている様々なロボットシステム、器具、構成要素及び方法と共に用いられ得る。米国特許出願第13/118,241号、名称「SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS」、現在の米国特許出願公開第2012/0298719号は、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。
図1〜3に描写されるハウジング12は、外科用ステープルカートリッジ304をその中で動作可能に支持するよう構成される外科用切断及び締結デバイスを備えるエンドエフェクタ300を含む交換式シャフト組立体200と関連付けて示されている。ハウジング12は、異なるサイズ及びタイプのステープルカートリッジを支持するよう適合されたエンドエフェクタを含む交換式シャフト組立体と関連付けて使用するように構成され得、異なるシャフト長さ、サイズ、及びタイプ等を有してもよい。これに加えて、ハウジング12はまた、エネルギーの他の運動及び形態、例えば、高周波(RF)エネルギー、超音波エネルギー及び/又は運動などを、様々な外科的用途及び手技と関連付けて使用するように適合されたエンドエフェクタ構成に印加するように構成されるこれらの組立体を含む種々の他の交換式シャフト組立体と共に効果的に使用することができる。更に、エンドエフェクタ、シャフト組立体、ハンドル、外科用器具、及び/又は外科用器具システムは、任意の好適な締結具を利用して組織を締結することができる。例えば、中に取り外し可能に格納された複数の締結具を備える締結具カートリッジが、シャフト組立体のエンドエフェクタに取り外し可能に挿入及び/又は装着され得る。
図1は、交換式シャフト組立体200を動作可能に結合させた外科用器具10を示している。図2及び3は、交換式シャフト組立体200のハウジング12又はハンドル14への装着を図示する。図4で分かるように、ハンドル14は、螺子、スナップ機構、接着剤などで相互接続され得る1対の相互接続可能なハンドルハウジング分割部16及び18を備え得る。図示の構成において、ハンドルハウジング分割部16、18は、臨床医に握持及び操作され得るピストルグリップ部分19を形成するように協働する。以下で更に詳細に論じるように、ハンドル14は、その中に複数の駆動システムを動作可能に支持し、それら駆動システムは、ハンドル14に動作可能に装着された交換式シャフト組立体の対応部分に、様々な制御運動を生成して加えるように構成されている。
ここで図4を参照すると、ハンドル14は、複数の駆動システムを動作可能に支持するフレーム20を更に有してもよい。例えば、フレーム20は、全体として30と示される「第1の」、つまり閉鎖駆動システムを動作可能に支持することができ、この閉鎖駆動システムは、ハンドルに動作可能に装着又は結合される交換式シャフト組立体200に閉鎖及び開放運動を加えるために用いられることができる。少なくとも1つの形態において、閉鎖駆動システム30は、フレーム20によって旋回式で支持される閉鎖トリガー32の形態をなすアクチュエータを含んでもよい。更に詳しくは、図4に示すように、閉鎖トリガー32は、ピン33を介してハウジング14と旋回式で結合される。このような構成は、閉鎖トリガー32が臨床医によって操作されることを可能にし、そのため、臨床医がハンドル14のピストルグリップ部分19を握持するとき、閉鎖トリガー32は開始又は「非作動」位置から「作動」位置へ、より具体的には完全圧縮又は完全作動位置へと容易に旋回できるようになっている。閉鎖トリガー32は、ばね又は他の偏向装置(図示せず)によって、非作動位置へと偏向させられてもよい。様々な形態において、閉鎖駆動システム30は、閉鎖トリガー32に旋回式で結合された閉鎖リンク機構組立体34を更に含む。図4で分かるように、閉鎖リンク機構組立体34は、第1の閉鎖リンク36と第2の閉鎖リンク38とを含んでもよく、これらは、ピン35によって、閉鎖トリガー32に旋回式で結合される。第2の閉鎖リンク38はまた、本明細書において「装着部材」とも呼ばれることがあり、横装着ピン37を含んでもよい。
依然として図4を参照すると、第1の閉鎖リンク36は、フレーム20に旋回式で結合される閉鎖解放組立体60と協働するように構成されたロック壁又は端部39を有してもよいことが観察できる。少なくとも1つの形態において、閉鎖解放組立体60は解放ボタン組立体62を備えてもよく、解放ボタン組立体62は、その上に形成された遠位突出ロック爪64を有する。解放ボタン組立体62は、解放ばね(図示せず)によって反時計回りの方向に旋回されてもよい。臨床医が閉鎖トリガー32をその非作動位置からハンドル14のピストルグリップ部分19に向かって押下すると、ロック爪64が第1の閉鎖リンク36上のロック壁39との保持係合に移る点に向かって、第1の閉鎖リンク36が上向きに旋回し、それによって、閉鎖トリガー32が非作動位置に復帰することが防止される。これについては、図18を参照されたい。したがって、閉鎖解放組立体60は、閉鎖トリガー32を完全作動位置にロックするように働く。臨床医が閉鎖トリガー32をロック解除して非作動位置に偏向させるように望むとき、臨床医は単純に、ロック爪64が移動して第1の閉鎖リンク36上のロック壁39との係合から外れるように、閉鎖解放ボタン組立体62を旋回させる。ロック爪64が移動させられて第1の閉鎖リンク36との係合から外れると、閉鎖トリガー32は再び非作動位置に旋回することができる。他の閉鎖トリガーロック及び解放装置もまた、用いられてもよい。
上記に更に付け加えて、図13〜15は、組織がシャフト組立体200の顎部の間に位置付けられ得るシャフト組立体200の開放、又は非クランプ構成と関連付けられる、その非作動位置にある閉鎖トリガー32を図示する。図16〜18は、組織がシャフト組立体200の顎部の間にクランプされるシャフト組立体200の閉鎖、又はクランプ形状と関連付けられる、その作動位置にある閉鎖トリガー32を図示する。図14と図17を比較すると、読者は、閉鎖トリガー32がその非作動位置(図14)からその作動位置(図17)まで移動させられたときに、閉鎖解放ボタン62が、第1の位置(図14)と第2の位置(図17)との間で旋回されることを理解するであろう。閉鎖解放ボタン62の回転は、上向き回転であると言及されてもよい。しかしながら、閉鎖解放ボタン62の少なくとも一部は、回路基板100に向かって回転されている。図4を参照すると、閉鎖解放ボタン62は、それから延在するアーム61と、例えばアーム61に取り付けられた永久磁石などの磁気素子63を含むことができる。閉鎖解放ボタン62が、その第1の位置からその第2の位置まで回転されると、磁気素子63は、回路基板100に向かって移動することができる。回路基板100は、磁気素子63の移動を検出するように構成された少なくとも1つのセンサを含むことができる。少なくとも1つの実施形態において、例えば、ホール効果センサ65が、回路基板100の底面に取り付けられ得る。ホール効果センサ65は、磁気素子63の移動によって生じたホール効果センサ65を取り囲む磁界における変化を検出するように構成され得る。ホール効果センサ65は、例えば、マイクロコントローラ7004(図59)と信号通信することができ、ホール効果センサは、閉鎖解放ボタン62が、閉鎖トリガー32の非作動位置及びエンドエフェクタの開放構成に関連付けられるその第1の位置にあるか、閉鎖トリガー32の作動位置及びエンドエフェクタの閉鎖構成に関連付けられるその第2の位置にあるか、及び/又は第1の位置と第2の位置との間のいずれかの位置にあるかどうかを判定することができる。
少なくとも1つの形態において、ハンドル14及びフレーム20は、本明細書で発射駆動システム80と呼ばれる別の駆動システムを動作可能に支持してもよく、この発射駆動システム80は、それに装着された交換式シャフト組立体のうちの対応する部分に発射運動を加えるように構成されている。発射駆動システム80はまた、本明細書において「第2の駆動システム」と呼ばれることもある。発射駆動システム80は、ハンドル14のピストルグリップ部分19に設置された電気モーター82を用いてもよい。様々な形態において、モーター82は、例えば約25,000RPMの最大回転数を有するブラシ付きDC駆動モーターであってもよい。他の構成において、モーターには、ブラシレスモーター、コードレスモーター、同期モーター、ステッパモーター、又は任意の他の好適な電気モーターを挙げることができる。モーター82は電源90によって電力供給されてもよく、電源90は一形態において、取り外し可能なパワーパック92を備えてもよい。図4で分かるように、例えば、パワーパック92は、遠位ハウジング部分96への装着用に構成されている近位ハウジング部分94を備えてもよい。近位ハウジング部分94及び遠位ハウジング部分96は、その中で複数の電池98を動作可能に支持するように構成されている。電池98はそれぞれ、例えば、リチウムイオン(「LI」)又は他の好適な電池を含んでよい。遠位ハウジング部分96は、制御回路基板組立体100に取り外し可能かつ動作可能な装着のために構成され、制御回路基板組立体100もまたモーター82に動作可能に結合される。直列に接続され得る多数の電池98が、外科用器具10の電源として使用されてもよい。加えて、電源90は交換可能及び/又は再充電可能であってもよい。
他の様々な形態に関連して上に概説したように、電気モーター82は、回転式シャフト(図示せず)を有することができ、その回転式シャフトは、長手方向に移動可能な駆動部材120上の駆動歯122の組又はラックとの噛合い係合をなして取り付けられる歯車減速機組立体84と動作可能に接合する。使用の際、電源90によって与えられる電圧極性により、電気モーター82を時計回りに動作させることができるが、電池によって電気モーターに加えられる電圧極性は、電気モーター82を反時計回りに動作させるために、逆転され得る。電気モーター82がある方向に回転されるとき、駆動部材120は遠位方向「DD」に軸方向に駆動される。モーター82が反対の回転方向に駆動されるとき、駆動部材120は近位方向「PD」に軸方向に駆動される。ハンドル14は、電源90によって電気モーター82に加えられる極性を逆転させるように構成され得るスイッチを備えることができる。本明細書で説明する他の形態と同様に、ハンドル14はまた、駆動部材120の位置及び/又は駆動部材120が移動させられている方向を検出するように構成されたセンサを有することもできる。
モーター82の作動は、ハンドル14上に旋回式で支持される発射トリガー130によって制御されることができる。発射トリガー130は、非作動位置と作動位置との間で旋回され得る。発射トリガー130は、ばね132又は他の偏向装置によって非作動位置へと偏向させられてもよく、そのため、臨床医が発射トリガー130を解放すると、発射トリガー130は、ばね132又は偏向装置によって非作動位置に旋回されるか、又は別様に復帰され得る。少なくとも1つの形態において、発射トリガー130は、上で論じたように、閉鎖トリガー32の「外側」に位置付けることができる。少なくとも1つの形態において、発射トリガー安全ボタン134が閉鎖トリガー32にピン35によって旋回式で取り付けられてもよい。安全ボタン134は、発射トリガー130と閉鎖トリガー32との間に位置付けられ、安全ボタン134から突出する旋回アーム136を有してもよい。これについては、図4を参照されたい。閉鎖トリガー32が非作動位置にあるとき、安全ボタン134はハンドル14内で拘束され、臨床医は容易には安全ボタン134に触れることができず、発射トリガー130の作動を防止する安全位置と、発射トリガー130が発射され得る発射位置との間で移動することもできない。臨床医が閉鎖トリガー32を押下すると、安全ボタン134及び発射トリガー130が下に旋回し、それらは次いで臨床医によって操作されることが可能となる。
上で論じたように、ハンドル14は、閉鎖トリガー32と発射トリガー130とを含むことができる。図14〜18Aを参照すると、発射トリガー130は、閉鎖トリガー32に旋回式で取り付けられ得る。閉鎖トリガー32は、それから延在するアーム31を含むことができ、発射トリガー130は、旋回ピン33の周りでアーム31に旋回式で取り付けられ得る。閉鎖トリガー32が、その非作動位置(図14)からその作動位置(図17)まで移動されると、発射トリガー130は、上で概説されたように、下向きに傾斜することができる。安全ボタン134が、その発射位置まで移動された後に、主に図18Aを参照すると、発射トリガー130は、外科用器具発射システムのモーターを作動させるために押下され得る。様々な例において、ハンドル14は、閉鎖トリガー32の位置及び/又は発射トリガー130の位置を判定するように構成された、例えばシステム800などの追跡システムを含むことができる。図14、17、及び18Aを主に参照すると、追跡システム800は、例えば、永久磁石802などの磁気素子を含むことができ、永久磁石は、発射トリガー130から延在するアーム801に取り付けられている。追跡システム800は、1つ又は2つ以上のセンサ、例えば、第1のホール効果センサ803及び第2のホール効果センサ804などを備えることができ、これらセンサは、磁石802の位置を追跡するように構成され得る。図14及び図17を比較する際に、読者は、閉鎖トリガー32がその非作動位置からその作動位置に移動されると、磁石802が、第1のホールセンサ803に近接する第1の位置と第2のホールセンサ804に近接する第2の位置との間を移動することができることを理解するであろう。図17と図18Aを比較する際に、読者は、発射トリガー130が、非発射位置(図17)から発射位置(図18A)に移動されると、磁石802が、第2のホール効果センサ804に対して移動することができることを更に理解するであろう。センサ803及び804は、磁石802の移動を追跡することができ、回路基板100上のマイクロコントローラと信号通信することができる。第1のセンサ803及び/又は第2のセンサ804からのデータを用いて、マイクロコントローラは、所定の経路に沿った磁石802の位置を判定することができ、この位置に基づいて、マイクロコントローラは、閉鎖トリガー32がその非作動位置にあるか、その作動位置にあるか、又はこれらの間の位置にあるかを判定することができる。同様に、第1のセンサ803及び/又は第2のセンサ804からのデータを用いて、マイクロコントローラは、所定の経路に沿った磁石802の位置を判定することができ、この位置に基づいて、マイクロコントローラは、発射トリガー130がその非発射位置にあるか、完全発射位置にあるか、又はこれらの間の位置にあるかを判定することができる。
上に示したように、少なくとも1つの形態において、長手方向に移動可能な駆動部材120はその上に、歯車減速機組立体84の対応する駆動歯車86と噛合い係合するために形成された歯122のラックを有している。また、モーター82が故障した場合に、臨床医が手動で長手方向に移動可能な駆動部材120を後退させられるように構成された手動作動式「脱出」組立体140が、少なくとも1つの形態に含まれる。この脱出組立体140は、手動で旋回されて駆動部材120内の歯124とのラチェット係合をなすように構成されたレバー又は脱出ハンドル組立体142を有してもよい。したがって、臨床医は、脱出ハンドル組立体142を使用して駆動部材120を近位方向「PD」にラチェットで駆動させることによって、駆動部材120を手動で後退させることができる。米国特許出願公開第2010/0089970号には、本明細書で開示する様々な器具と共に同様に用いられることができる脱出装置、並びに他の構成要素、装置、及びシステムが開示されている。米国特許出願第12/249,117号、名称「POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM」、現在の米国特許出願公開第2010/0089970号は、参照によってその全ての内容が本明細書に組み込まれる。
ここで図1及び7を参照すると、交換式シャフト組立体200は、ステープルカートリッジ304をその上に動作可能に支持するように構成されている細長いチャネル302を備える外科用エンドエフェクタ300を含む。エンドエフェクタ300は、細長いチャネル302に対して旋回式で支持されるアンビル306を更に含んでもよい。交換式シャフト組立体200は、関節継手270と、エンドエフェクタ300をシャフト軸SA−SAに対し所望の位置で解放可能に保持するように構成され得る関節ロック350(図8)とを更に含んでもよい。エンドエフェクタ300、関節継手270、及び関節ロック350の構成及び動作に関する詳細は、2013年3月14日に出願された、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK」の米国特許出願第13/803,086号に記載されている。2013年3月14日に出願された、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK」の米国特許出願第13/803,086号の開示全体が、参照によって本明細書に組み込まれる。図7及び図8から分かるように、交換式シャフト組立体200は、ノズル部分202及び203からなる近位ハウジング又はノズル201を更に有することができる。交換式シャフト組立体200は、閉鎖チューブ260を更に有することができ、閉鎖チューブ260はエンドエフェクタ300のアンビル306を閉鎖及び/又は開放するために利用され得る。主としてここで図8及び9を参照すると、シャフト組立体200はスパイン210を有することができ、スパイン210は、関節ロック350のシャフトフレーム部分212を固定可能に支持するように構成され得る。これについては、図8を参照されたい。スパイン210は、(1)その中に発射部材220を摺動可能に支持し、(2)スパイン210の周りに延びる閉鎖チューブ260を摺動可能に支持するように構成され得る。スパイン210はまた、近位関節駆動器230を摺動可能に支持するように構成され得る。関節駆動器230は、関節ロック350に動作可能に係合するように構成されている遠位端231を有する。関節ロック350は、エンドエフェクタフレーム(図示せず)上の駆動ピン(図示せず)に動作可能に係合するよう適合されている関節フレーム352と接合する。上に示したように、関節ロック350及び関節フレームの動作に関する更なる詳細は、米国特許出願第13/803,086号に見出すことができる。様々な状況において、スパイン210は、シャーシ240内で回転可能に支持されている近位端211を備えることができる。例えば、1つの配置において、スパイン210の近位端211は、シャーシ240内に支持されるように構成されたスパイン軸受216への螺合装着のためにスパイン上に形成された螺子部214を有する。これについては、図7を参照されたい。このような配置は、スパイン210のシャーシ240への回転可能な装着を容易にし、これにより、スパイン210は、シャーシ240に対してシャフト軸SA−SAの周りで選択的に回転され得る。
主として図7を参照すると、交換式シャフト組立体200は、閉鎖シャトル250を含み、閉鎖シャトル250は、これがシャーシ240に対して軸方向に移動され得るように、シャーシ240内に摺動可能に支持されている。図3及び7で分かるように、閉鎖シャトル250は、以下で更に詳細に論じられるように、第2の閉鎖リンク38に装着される装着ピン37への装着のために構成されている1対の近位側に突出するフック252を含む。閉鎖チューブ260の近位端261は、閉鎖シャトル250に対する相対的回転のために、閉鎖シャトル250に結合されている。例えば、U字型コネクタ263が、閉鎖チューブ260の近位端261において環状スロット262に挿入され、閉鎖シャトル250の垂直スロット253内に保持される。これについては、図7を参照されたい。このような配置は、閉鎖チューブ260がシャフト軸SA−SAの周りで閉鎖シャトル250に対して回転することを可能にしながら、閉鎖チューブ260を閉鎖シャトル250と共に軸方向移動させるために、閉鎖シャトル250に装着させるよう機能する。閉鎖ばね268は、閉鎖チューブ260上で軸支され、閉鎖チューブ260を近位方向「PD」で偏向させるよう機能し、これが、シャフト組立体がハンドル14に動作可能に結合されたときに、閉鎖トリガーを非作動位置に旋回させるよう機能することができる。
少なくとも1つの形態において、交換式シャフト組立体200は、関節継手270を更に有してもよい。しかしながら、他の交換式シャフト組立体は、関節屈曲可能でなくてもよい。図7で分かるように、例えば、関節継手270は二重旋回閉鎖スリーブ組立体271を有する。様々な形態によれば、二重旋回閉鎖スリーブ組立体271は、上部及び下部遠位突出タング273、274を有するエンドエフェクタ閉鎖スリーブ組立体272を含む。エンドエフェクタ閉鎖スリーブ組立体272は、参照により、本明細書に組み込まれる、2013年3月14日出願された、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING、AN ARTICULATION LOCK」の米国特許出願第13/803,086号に記載される様々な方法で、アンビル306上で開口タブと係合するための馬蹄形アパーチャ275とタブ276とを含む。それに更に詳細に記載されるように、馬蹄形アパーチャ275及びタブ276は、アンビル306が開放されているとき、アンビル上のタブと係合する。上部二重旋回リンク277は、上向きに突出する遠位及び近位旋回ピンを備え、これら遠位及び近位旋回ピンはそれぞれ、閉鎖チューブ260上で、上部近位突出タング273内の上部遠位ピンホール、及び上部遠位突出タング264内の上部近位ピンホールと係合する。下部二重旋回リンク278は、上向きに突出する遠位及び近位旋回ピンを備え、これら遠位及び近位旋回ピンはそれぞれ、下部近位突出タング274の下部遠位ピンホール、及び下部遠位突出タング265の下部近位ピンホールと係合する。図8も参照されたい。
使用の際、閉鎖チューブ260は、例えば閉鎖トリガー32の作動に応答してアンビル306を閉鎖するために遠位側(方向「DD」)に並進される。アンビル306は、閉鎖チューブ260を、したがってシャフト閉鎖スリーブ組立体272を遠位側に並進させて、前述した参照文献の米国特許出願第13/803,086号に記載された方式でアンビル360の近位表面に衝突させることによって閉鎖される。この参照文献に更に記載されるように、アンビル306は、閉鎖チューブ260及びシャフト閉鎖スリーブ組立体272を近位側に並進させて、タブ276及び馬蹄形アパーチャ275をアンビルタブに対して接触及び押圧させてアンビル306を持ち上げることによって開放される。アンビル開放位置において、シャフト閉鎖チューブ260は、その近位位置に移動させられる。
上に示したように、外科用器具10は、米国特許出願第13/803,086号に更に詳細に記載されたタイプ及び構造の関節ロック350を含んでもよく、この関節ロック350は、エンドエフェクタ300を定置に選択的にロックするよう構成かつ動作され得る。このような配置は、エンドエフェクタ300が、関節ロック350がそのロック解除状態にあるときに、シャフト閉鎖チューブ260に対して回転又は関節屈曲されることを可能にする。そのようなロック解除状態において、エンドエフェクタ300を閉鎖タブ260に対して関節屈曲させるために、エンドエフェクタ300を、例えば、患者の体内の手術部位の周囲にある軟組織及び/又は骨に対して位置付けて、押し当てることができる。エンドエフェクタ300はまた、関節駆動器230によって、閉鎖チューブ260に対して関節屈曲されてもよい。
更に上に示したように、交換式シャフト組立体200は、シャフトスパイン210内での軸方向移動に関して支持される発射部材220を更に含む。発射部材220は、遠位切断部分又はナイフバー280に装着されるように構成される中間発射シャフト部分222を含む。発射部材220はまた、本明細書において「第2のシャフト」及び/又は「第2のシャフト組立体」と呼ばれることもある。図8及び9で分かるように、中間発射シャフト部分222は、その遠位端部に長手スロット223を有してもよく、長手スロット223は、遠位ナイフバー280の近位端部282上のタブ284を受容するように構成され得る。長手スロット223及び近位端部282は、それら同士の相対運動が可能となるように寸法を定められ、構成されることができ、またスリップ継手286を備えることができる。スリップ継手286は、ナイフバー280を移動させることなく、又は少なくとも実質的に移動させることなく、発射駆動部220の中間発射シャフト部分222を移動させてエンドエフェクタ300を関節屈曲させることができる。エンドエフェクタ300が適切に配向されると、ナイフバー280を進め、チャネル302内に位置付けられたステープルカートリッジを発射させるために、中間発射シャフト部分222は、長手スロット223の近位側壁がタブ284と接するまで、遠位側に進められ得る。図8及び9で更に分かるように、シャフトスパイン210は中間発射シャフト部分222のシャフトフレーム210への組み立て及び挿入を容易にするために、その上に細長い開口又は窓213を有する。中間発射シャフト部分222がシャフトフレーム212に挿入されると、頂部フレーム分割部215がシャフトフレーム212と係合されて、それらの中に中間発射シャフト部分222及びナイフバー280を封入することができる。発射部材220の動作の更なる詳細は、米国特許出願第13/803,086号に見出すことができる。
上記に更に加えて、シャフト組立体200はクラッチ組立体400を有することができ、クラッチ組立体400は、関節駆動器230を発射部材220に選択的にかつ解放可能に結合するように構成され得る。1つの形態において、クラッチ組立体400は、発射部材220の周りに位置付けられたロックカラー又はスリーブ402を備えることができ、ロックスリーブ402は、ロックスリーブ402が関節駆動器360を発射部材220に結合する係合位置と、関節駆動器360が発射部材200に動作可能に結合されない係合解除位置との間で回転され得る。ロックスリーブ402が係合位置にあるとき、発射部材220が遠位側に移動することにより、関節駆動器360を遠位側に移動させることができ、またそれに対応して、発射部材220が近位側に移動することにより、関節駆動器230を近位側に移動させることができる。ロックスリーブ402が係合解除位置にあるとき、発射部材220の移動は関節駆動器230に伝達されず、その結果、発射部材220は関節駆動器230とは独立に移動することができる。様々な状況において、関節駆動器230が、発射部材220によって近位又は遠位方向に移動させられていないとき、関節駆動器230は関節ロック350によって所定位置に保持され得る。
主として図9を参照すると、ロックスリーブ402は、円筒状の、又は少なくとも実質的に円筒状の本体を備えることができ、この本体は、その中に画定された長手アパーチャ403を有し、その長手アパーチャは発射部材220を受容するように構成されている。ロックスリーブ402は、正反対向きで内向きのロック突出部404と、外向きのロック部材406とを備えることができる。ロック突出部404は、発射部材220と選択的に係合されるように構成され得る。より具体的には、ロックスリーブ402がその係合位置にあるとき、ロック突出部404は、発射部材220の中に画定された駆動ノッチ224内に位置付けることができ、遠位押力及び/又は近位引張力が発射部材220からロックスリーブ402に伝達され得るようになっている。ロックスリーブ402がその係合位置にあるとき、第2のロック部材406は、関節駆動器230の中に画定された駆動ノッチ232内に配置されることができ、ロックスリーブ402に加えられた遠位押力及び/又は近位引張力が関節駆動器230に伝達され得るようになっている。実質的に、発射部材220、ロックスリーブ402、及び関節駆動器230は、ロックスリーブ402がその係合位置にあるとき、互いに移動することになる。他方で、ロックスリーブ402がその係合解除位置にあるとき、ロック突出部404は、発射部材220の駆動ノッチ224内に位置付けられることができず、その結果、遠位押力及び/又は近位引張力が発射部材220からロックスリーブ402に伝達されることができない。それに応じて、遠位押力及び/又は近位引張力は関節駆動器230に伝達されなくてもよい。そのような状況において、発射部材220は、ロックスリーブ402及び近位関節駆動器230に対して近位側及び/又は遠位側に摺動され得る。
図8〜12で分かるように、シャフト組立体200は更に、スイッチドラム500を有し、このスイッチドラム500は閉鎖タブ260に回転可能に受容される。スイッチドラム500は、中空シャフト分割部502を備え、中空シャフト分割部502は、外向きに突出する作動ピン410をその中に受容するための、中空シャフト分割部上に形成されたシャフトボス504を有する。様々な状況において、作動ピン410は、スロット267を通って、ロックスリーブ402内に設けられた長手スロット408まで延在し、ロックスリーブ402が関節駆動器230と係合されたときに、ロックスリーブ402の軸方向移動を容易にする。ロータリートーションばね420は、図10に示されるように、スイッチドラム500上のボス504及びノズルハウジング203の一部に係合するように構成され、スイッチドラム500に偏向力を加える。スイッチドラム500は、その中に画定された、少なくとも部分的に環状の開口部506を更に備えることができ、その開口部506は、図5及び6を参照すると、ノズル半部202、203から延在する環状マウント204、205を受容し、スイッチドラム500と近位ノズル201との間の相対的な回転は許容するが、並進は許容しないように構成され得る。これらの図面で分かるように、マウント204及び205はまた、閉鎖チューブ260内の開口部266を通って延在し、シャフトスパイン210の凹部211内に定置される。しかしながら、マウント204、205がスイッチドラム500内のそれらの対応のスロット506に達する点へのノズル201の回転は、スイッチドラム500のシャフト軸SA−SAの周りの回転をもたらすであろう。スイッチドラム500の回転は、最終的に、作動ピン410及びロックスリーブ402のその係合位置と係合解除位置との間の回転をもたらすであろう。したがって、本質的には、ノズル201は、米国特許出願第13/803,086号に更に詳細に記載される様々な方法で、関節駆動システムを発射駆動システムと動作可能に係合かつ係合解除させるために使用され得る。
同様に図8〜12に示すように、シャフト組立体200は、スリップリング組立体600を備えることができ、スリップリング組立体600は、例えば、エンドエフェクタ300にかつ/若しくはエンドエフェクタ300から電力を導き、及び/又はエンドエフェクタ300にかつ/若しくはエンドエフェクタ300から信号を伝えるように構成され得る。スリップリング組立体600は、シャーシ240から延在するシャーシフランジ242上に取り付けられた近位コネクタフランジ604と、シャフトハウジング202、203において画定されるスロット内に位置付けられた遠位コネクタフランジ601とを備えることができる。近位コネクタフランジ604は、第1の面を備えることができ、遠位コネクタフランジ601は、第1の面に隣接して位置付けられ、かつ第1の面に対して移動可能である第2の面を備えることができる。遠位コネクタフランジ601は、シャフト軸SA−SAの周りで近位コネクタフランジ604に対して回転することができる。近位コネクタフランジ604は、その第1の面で画定された、複数の同心性の、又は少なくとも実質的に同心性の導電体602を備えることができる。コネクタ607は、コネクタフランジ601の近位側に取り付けられることができ、複数の接点(図示せず)を有してもよく、これらの接点のそれぞれは、導電体602のうちの1つとの電気接点に相当し、導電体602のうちの1つと電気接触している。このような配置は、近位コネクタフランジ604と遠位コネクタフランジ601との間の電気的接触を維持しながら、それらの間の相対的回転を可能にする。近位コネクタフランジ604は、電気コネクタ606を含むことができ、電気コネクタ606は、例えば、導電体602を、シャフトシャーシ240に取り付けられたシャフト回路基板610との信号通信状態に置く。少なくとも1つの例において、複数の導電体を備えるワイヤリングハーネスが、電気コネクタ606とシャフト回路基板610との間に延在することができる。電気コネクタ606は、シャーシ取り付けフランジ242の中に画定されるコネクタ開口部243を通って近位側に延在してもよい。これについては、図7を参照されたい。2013年3月13日出願の米国特許出願第13/800,067号、名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」は、参照によって全ての内容が本明細書に組み込まれる。2013年3月13日出願の米国特許出願第13/800,025号、名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」は、参照によって全ての内容が本明細書に組み込まれる。スリップリング組立体600に関する更なる詳細は、米国特許出願第13/803,086号に見出すことができる。
上で論じたように、シャフト組立体200は、ハンドル14に固定可能に取り付けられる近位部分と、長手方向軸の周りで回転可能である遠位部分とを含むことができる。回転可能な遠位シャフト部分は、上で論じたように、スリップリング組立体600の周りで近位部分に対して回転され得る。スリップリング組立体600の遠位コネクタフランジ601は、回転可能な遠位シャフト部分内に位置付けられ得る。更に、上記に加えて、スイッチドラム500もまた、回転可能な遠位シャフト部分内に位置付けられ得る。回転可能な遠位シャフト部分が回転されると、遠位コネクタフランジ601及びスイッチドラム500は、互いに同期して回転され得る。加えて、スイッチドラム500は、遠位コネクタフランジ601に対して第1の位置と第2の位置との間で回転され得る。スイッチドラム500が、その第1の位置にあるとき、関節駆動システムは、発射駆動システムから動作可能に係合解除されることができ、したがって、発射駆動システムの動作は、シャフト組立体200のエンドエフェクタ300を関節屈曲させることができない。スイッチドラム500が、その第2の位置にあるとき、関節駆動システムは、発射駆動システムと動作可能に係合されることができ、したがって、発射駆動システムの動作は、シャフト組立体200のエンドエフェクタ300を関節屈曲させることができる。スイッチドラム500が、その第1の位置とその第2の位置との間で移動されると、スイッチドラム500は、遠位コネクタフランジ601に対して移動される。様々な例において、シャフト組立体200は、スイッチドラム500の位置を検出するように構成された少なくとも1つのセンサを備えることができる。ここで図11及び12を参照すると、遠位コネクタフランジ601は、例えばホール効果センサ605を備えることができ、スイッチドラム500は、例えば、永久磁石505などの磁気素子を備えることができる。ホール効果センサ605は、永久磁石505の位置を検出するように構成され得る。スイッチドラム500が、その第1の位置とその第2の位置との間で回転されると、永久磁石505は、ホール効果センサ605に対して移動され得る。様々な例において、ホール効果センサ605は、永久磁石505が移動されたときに形成される磁界における変化を検出することができる。ホール効果センサ605は、例えば、シャフト回路基板610及び/又はハンドル回路基板100と信号通信し得る。ホール効果センサ605からの信号に基づいて、シャフト回路基板610及び/又はハンドル回路基板100上のマイクロコントローラは、関節駆動システムが発射駆動システムと係合しているか、又は発射駆動システムから係合解除されているかどうかを判定することができる。
図3及び7を再び参照すると、シャーシ240は、少なくとも1つの、好ましくは2つの、シャーシ240上に形成されたテーパ状装着部分244を含み、テーパ状装着部分244は、フレーム20の遠位装着フランジ部分700内に形成された対応するダブテールスロット702内に受容するよう適合されている。各ダブテールスロット702は、装着部分244をその中に収容的に受容するために、テーパ状であってもよく、又は換言すれば、多少V形であってもよい。図3及び7から更に分かるように、シャフト装着ラグ226が、中間発射シャフト222の近位端部に形成されている。以下で更に詳細に論じるように、交換式シャフト組立体200がハンドル14に結合されると、シャフト装着ラグ226は、長手駆動部材120の遠位端部125に形成された発射シャフト装着クレードル126に受容される。これについては、図3及び6を参照されたい。
様々なシャフト組立体の実施形態は、シャフト組立体200をハウジング12に、より具体的にはフレーム20に取り外し可能に結合させるために、ラッチシステム710を使用する。例えば、図7で分かるように、少なくとも1つの形態において、ラッチシステム710は、シャーシ240に移動可能に結合されるロック部材又はロックヨーク712を含む。例えば、図示した実施形態において、ロックヨーク712は、2つの間隔を空けて下向きに延在する脚部714を備えたU字型を有する。これら脚部714は、それぞれ、シャーシ240に形成された対応する穴245内に受容されるよう適合された、その上に形成された旋回ラグ716を有する。このような配置は、ロックヨーク712のシャーシ240への旋回装着を容易にする。ロックヨーク712は、2つの近位突出ロックラグ714を有してもよく、これら近位突出ロックラグ714は、フレーム20の遠位装着フランジ700内の、対応するロック移動止め又は溝704と解放可能に係合するように構成されている。これについては、図3を参照されたい。様々な形態において、ロックヨーク712はばね又は偏向部材(図示せず)によって近位方向に偏向させられる。ロックヨーク712の作動は、シャーシ240に取り付けられているラッチアクチュエータ組立体720上に摺動可能に取り付けられるラッチボタン722によって達成され得る。ラッチボタン722は、ロックヨーク712に対して近位方向に偏向されてもよい。以下に更に詳しく論じるように、ロックヨーク712は、ラッチボタンを遠位方向に偏向させることによって、非作動位置に移動されることができ、遠位方向のラッチボタンの偏向は、ロックヨーク712を、フレーム20の遠位装着フランジ700との保持係合から離れて旋回させる。ロックヨーク712が、フレーム20の遠位装着フランジ700との「保持係合」の状態にあるとき、ロックラグ716は、遠位装着フランジ700の対応するロック移動止め又は溝704の内部に、保持的に定置される。
組織を切断及び締結するように適合されている本明細書に記載されるタイプのエンドエフェクタ、並びに他のタイプのエンドエフェクタを含む交換式シャフト組立体を使用する場合、エンドエフェクタの作動中に、交換式シャフト組立体がハウジングから不注意に脱離することを防止することが望ましい場合がある。例えば、使用の際に、臨床医は、閉鎖トリガー32を作動させて、標的組織を所望の位置まで握持かつ操作することができる。標的組織が、所望の配向でエンドエフェクタ300内に位置付けられると、臨床医は、次いで、閉鎖トリガー32を完全に作動させ、アンビル306を閉鎖させ、切断及びステープル留めのために、標的組織を定位置でクランプする。この例において、第1の駆動システム30は、完全に作動されている。標的組織がエンドエフェクタ300内でクランプされた後に、シャフト組立体200のハウジング12からの不注意な脱離を防止することが望ましい場合がある。ラッチシステム710の1つの形態は、このような不注意な脱離を防止するように構成されている。
図7で最も具体的に分かるように、ロックヨーク712は、閉鎖シャトル250上に形成されている対応するロックラグ部分256に接触するよう適合された、少なくとも1つの、好ましくは2つの、ロックフック718を含む。図13〜15を参照すると、閉鎖シャトル250が非作動位置にあるとき(すなわち、第1の駆動システム30が、作動されておらず、アンビル306が開放されているとき)、ロックヨーク712は、遠位方向に旋回され、交換式シャフト組立体200をハウジング12からロック解除することができる。この位置にあるとき、ロックフック718は、閉鎖シャトル250上のロックラグ部分256に接触しない。しかしながら、閉鎖シャトル250が、作動位置まで移動されたとき(すなわち、第1の駆動システム30が、作動されており、アンビル306が閉鎖位置にあるとき)、ロックヨーク712は、非作動位置まで旋回されることが防止される。図16〜18を参照されたい。別の言い方をすれば、臨床医が、ロックヨーク712をロック解除位置まで旋回させようとし、例えば、ロックヨーク712が不注意にぶつけられるか、さもなければロックヨーク712を遠位側に旋回させ得る方法で接触されるならば、ロックヨーク712上のロックフック718は、閉鎖シャトル250上のロックラグ256と接触し、ロックヨーク712がロック解除位置に移動することを防止するであろう。
ハンドル14への交換式シャフト組立体200の装着について、これから、図3を参照して説明する。結合プロセスを開始するために、臨床医は、シャーシ240上に形成されたテーパ状装着部分244がフレーム20のダブテールスロット702と整列させられるように、交換式シャフト組立体200のシャーシ240をフレーム20の遠位装着フランジ700の上に又はそれに隣接させて定置することができる。臨床医は、次いで、シャフト組立体200を、シャフト軸SA−SAに対して垂直である設置軸IAに沿って移動させ、装着部分244を、対応するダブテール受容スロット702と「動作可能な係合」で定置させることができる。そうすることで、中間発射シャフト222上のシャフト装着ラグ226もまた、長手方向に移動可能な駆動部材120のクレードル126内に定置され、第2の閉鎖リンク38上のピン37の一部は、閉鎖ヨーク250の対応するフック252内に定置されるであろう。本明細書で用いられるとき、2つの構成要素の状況における「動作可能な係合」という用語は、作動運動をそれらに加えると、それらの構成要素が目的の行為、機能及び/又は手順を実行できるように、それらの2つの構成要素が互いに十分に係合していることを意味する。
上で論じたように、交換式シャフト組立体200の少なくとも5つのシステムが、ハンドル14の少なくとも5つの対応するシステムと動作可能に結合され得る。第1のシステムは、シャフト組立体200のフレーム又はスパインをハンドル14のフレーム20と結合及び/又は整列させるフレームシステムを含むことができる。別のシステムは、ハンドル14の閉鎖トリガー32と、閉鎖チューブ260と、シャフト組立体200のアンビル306とを動作可能に接続することができる閉鎖駆動システム30を含むことができる。上で概説したように、シャフト組立体200の閉鎖チューブ装着ヨーク250は、第2の閉鎖リンク38上のピン37と係合され得る。別のシステムは、ハンドル14の発射トリガー130をシャフト組立体200の中間発射シャフト222と動作可能に接続することができる発射駆動システム80を含むことができる。上で概説したように、シャフト装着ラグ226は、長手駆動部材120のクレードル126に動作可能に接続され得る。別のシステムは、(1)例えばシャフト組立体200などのシャフト組立体がハンドル14と動作可能に係合されていることを、例えばマイクロコントローラなどのハンドル14内のコントローラに伝えることができ、及び/又は(2)電力及び/若しくは通信信号をシャフト組立体200とハンドル14との間で伝達することができる電気システムを含むことができる。例えば、シャフト組立体200は、シャフト回路基板610に動作可能に取り付けられる電気コネクタ4010を含むことができる。電気コネクタ4010は、ハンドル制御盤100上の対応する電気コネクタ4000との係合に噛み合うよう構成される。回路及び制御システムに関する更なる詳細は、その開示全体が、先に参照により本明細書に組み込まれた、米国特許出願第13/803,086号に見出すことができる。第5のシステムは、シャフト組立体200をハンドル14に解放可能にロックするためのラッチングシステムからなってもよい。
本明細書に記載されるように、例えば、外科用ステープル留め器具などの外科用器具は、例えば、プロセッサ、コンピュータ、並びに/又はコントローラ(本明細書では、総じて「プロセッサ」と呼ばれる)、及びプロセッサ、コンピュータ、並びに/又はコントローラと信号通信する1つ若しくは2つ以上のセンサを含むことができる。様々な例において、プロセッサは、マイクロコントローラと、マイクロコントラーラに動作上結合される1つ又は2つ以上のメモリユニットとを備えることができる。メモリに記憶された命令コードを実行することにより、プロセッサは、例えば、モーター、様々な駆動システム、及び/又はユーザディスプレイなどの、外科用器具の様々な構成要素を制御することができる。プロセッサは、集積型及び/若しくは個々のハードウェア要素、ソフトウェア要素、並びに/又はそれら両者の組み合わせを用いて実現され得る。集積型のハードウェア要素の例には、プロセッサ、マイクロプロセッサ、マイクロコントローラ、集積回路、専用集積回路(ASIC)、プログラマブル論理デバイス(PLD)、デジタル信号プロセッサ(DSP)、フィールドプログラマブルゲートアレイ(FPGA)、論理ゲート、レジスタ、半導体デバイス、チップ、マイクロチップ、チップセット、マイクロコントローラ、システムオンチップ(SoC)、及び/又はシステムインパッケージ(SIP)を挙げることができる。個々のハードウェア要素の例には、回路及び/又は回路素子(例えば、論理ゲート、電界効果トランジスタ、バイポーラトランジスタ、レジスタ、コンデンサ、インダクタ、及び/又はリレー)を挙げることができる。ある特定の例において、プロセッサは、例えば1枚又は2枚以上の基板上に個々の回路素子又は構成要素と集積型の回路素子又は構成要素とを備えるハイブリッド回路を有してもよい。
プロセッサは、例えばTexas Instrumentsから入手可能なLM 4F230H5QRであってよい。一実施形態において、Texas InstrumentsのLM4F230H5QRは、容易に確認可能な他の特徴の中でも、最大40MHz、256KBの単一サイクルフラッシュメモリ若しくは他の不揮発性メモリのオンチップメモリと、40MHz超の性能を改善するためのプリフェッチバッファと、32KBの単一サイクルシリアルランダムアクセスメモリ(SRAM)と、StellarisWare(登録商標)ソフトウェアを搭載した内部リードオンリメモリ(ROM)と、2KBの電気的消去可能プログラム可能読み出し専用メモリ(EEPROM)と、1つ又は2つ以上のパルス幅変調(PWM)モジュールと、1つ又は2つ以上のアナログ直交エンコーダ入力部(QEI)と、12のアナログ入力チャネルを備えた、1つ又は2つ以上の12ビットアナログデジタル変換器(ADC)とを備えたARM Cortex−M4Fプロセッサコアである。他のマイクロコントローラが、本開示での使用に容易に代用されてよい。したがって、本開示はこの文脈条件に限定されるべきではない。
信号通信は、情報が、センサとプロセッサとの間で伝達される通信の任意の好適な形態を含むことができる。このような通信は、例えば、1つ又は2つ以上の導電体を利用する有線通信及び/又は無線送信機と受信機とを利用する無線通信を含むことができる。様々な例では、外科用器具は、外科用器具の第1の状態を検出するよう構成された第1のセンサと、外科用器具の第2の状態を検出するように構成された第2のセンサとを含むことができる。例として、外科用器具は、例えば、外科用器具の閉鎖トリガーが作動されているかどうかを検出するように構成された第1のセンサと、外科用器具の発射トリガーが作動されているかどうかを検出するよう構成された第2のセンサとを含むことができる。
外科用器具が、同一の状態を検出するように構成された2つ又はそれ以上のセンサを含むことができる様々な実施形態が想定される。少なくとも1つのこのような実施形態において、外科用器具は、プロセッサ、プロセッサと信号通信する第1のセンサ、及びプロセッサと信号通信する第2のセンサを備えることができる。第1のセンサは、第1の信号をプロセッサに通信するよう構成されることができ、第2のセンサは、第2の信号をプロセッサに通信するように構成されることができる。様々な例において、プロセッサは、第1の信号を第1のセンサから受信するための第1の入力チャネルと、第2の信号を第2のセンサから受信するための第2の入力チャネルとを含むことができる。他の例においては、マルチプレクサーデバイスは、第1の信号及び第2の信号を受信し、第1及び第2の信号のデータを、例えば、単一の、合成信号の一部として、プロセッサに通信することができる。いくつかの例において、例えば第1の絶縁線などの第1の導電体は、第1のセンサを第1の入力チャネルに接続することができ、第2の絶縁線などの第2の導電体は、第2のセンサを第2の入力チャネルに接続することができる。上で概説したように、第1のセンサ及び/又は第2のセンサは、プロセッサと無線で通信することができる。少なくとも1つのこのような例において、第1のセンサは、第1の無線送信機を含むことができ、第2のセンサは第2の無線送信機を含むことができ、プロセッサは、第1の信号及び/又は第2の信号を受信し、これらの信号をプロセッサに送信するように構成された少なくとも1つの無線信号受信機を含むことができるか及び/又は少なくとも1つの無線信号受信機と通信することができる。
以下により詳細に記述されるように、センサと協働して、外科用器具のプロセッサは、外科用器具が正確に動作していることを確認することができる。第1の信号は、外科用器具の状態に関するデータを含むことができ、第2のセンサは、同じ状態に関するデータを含むことができる。プロセッサは、第1の信号からのデータを第2の信号からのデータと比較し、2つの信号によって通信されたデータが同一であるか又は異なるかを判定するように構成されたアルゴリズムを含むことができる。2つの信号からのデータが同じである場合、プロセッサは、このデータを用いて外科用器具を動作させる。このような状況においては、プロセッサは、故障状態が存在しないことを推測することができる。様々な状況において、プロセッサは、第1の信号からのデータ及び第2の信号からのデータが、データの許容可能な、又は認識された範囲内にあるかどうかを判定することができる。2つの信号からのデータが、データの認識された範囲内にある場合、プロセッサは、信号の一方又は両方からのデータを用いて外科用器具を動作させてもよい。このような状況においては、プロセッサは、故障状態が存在しないことを推測することができる。第1の信号からのデータが、データの認識された範囲外にある場合、プロセッサは、故障状態が、第1のセンサに関して存在することを推測し、第1の信号を無視し、外科用器具を第2の信号からのデータに応答して作動させることができる。同様に、第2の信号からのデータが、データの認識された範囲外にある場合、プロセッサは、故障状態が、第2のセンサに関して存在することを推測し、第2の信号を無視し、外科用器具を第1の信号からのデータに応答して作動させることができる。プロセッサは、1つ又は2つ以上のセンサからの入力を選択的に無視するように構成され得る。
様々な例において、上記に加えて、プロセッサは、第1の信号からのデータが、第1の値と第2の値との間にあるかどうかを評価するように構成されたアルゴリズムを実現するように構成されたモジュールを含むことができる。同様に、アルゴリズムは、第2の信号からのデータが、第1の値と第2の値との間にあるかどうかを評価するように構成され得る。ある特定の例において、外科用器具は、少なくとも1つのメモリデバイスを備えてよい。メモリデバイスは、プロセッサと一体化されてもよく、プロセッサと信号通信してもよく、及び/又はプロセッサによりアクセス可能であってもよい。ある特定の例において、メモリデバイスは、それに記憶されたデータを含むメモリチップを有することができる。メモリチップ上に記憶されたデータは、例えばルックアップテーブルの形態であり得、プロセッサは、ルックアップテーブルにアクセスし、データの許容可能な、又は認識される範囲を確立することができる。ある特定の例において、メモリデバイスは、例えば、ビットマスクされた読み出し専用メモリ(ROM)又はフラッシュメモリなどの不揮発性メモリを備えることができる。不揮発性メモリ(NVM)は、例えば、プログラム可能ROM(PROM)、消去可能プログラム可能ROM(EPROM)、電気的消去可能プログラム可能ROM(EEPROM)、又は、ダイナミックRAM(DRAM)、ダブルデータレートDRAM(DDRAM)、及び/若しくはシンクロナスDRAM(SDRAM)などのバッテリバックアップ型のランダムアクセスメモリ(RAM)を含む、他の種類のメモリを含み得る。
上記に加えて、第1のセンサ及び第2のセンサは、冗長であってもよい。プロセッサは、第1のセンサからの第1の信号を、第2のセンサからの第2の信号と比較し、もしあれば、どんな措置を取るべきかを判定することができる。上記に加えて又は上記の代わりに、プロセッサは、第1の信号及び/又は第2の信号からのデータを、メモリデバイス内に記憶されたアルゴリズム及び/又はデータによって確立された限界値と比較するように構成され得る。様々な状況において、プロセッサは、それが受信する信号、例えば第1の信号及び/又は第2の信号などにゲインを適用するように構成され得る。例えば、プロセッサは、第1のゲインを第1の信号に、第2のゲインを第2の信号に適用することができる。ある特定の例において、第1のゲインは第2のゲインと同じであってよい。他の例において、第1のゲインは第2のゲインと異なってもよい。いくつかの例において、プロセッサは、第1のゲイン及び/又は第2のゲインを較正するように構成され得る。少なくとも1つのこのような状況において、プロセッサは、増幅された信号が、所望の、又は許容可能な範囲内にあるように、ゲインを変更することができる。様々な例において、非変更ゲイン及び/又は変更ゲインは、プロセッサに一体化した及び/又はプロセッサによってアクセス可能なメモリデバイス内に記録され得る。ある特定の実施形態において、メモリデバイスは、信号に適用されたゲインの履歴を追跡することができる。いずれにしても、プロセッサは、外科的手技前、外科的手技中、及び/又は外科的手技後に、この較正を提供するように構成され得る。
様々な実施形態において、第1のセンサは、第1のゲインを第1の信号に適用することができ、第2のセンサは、第2のゲインを第2の信号に適用することができる。ある特定の実施形態において、プロセッサは、1つ又は2つ以上の出力チャネルを含むことができ、第1及び第2のセンサと通信することができる。例えば、プロセッサは、第1のセンサと信号通信する第1の出力チャネルと、第2のセンサと信号通信する第2の出力チャネルを含むことができる。上記に加えて、プロセッサは。第1のセンサ及び/又は第2のセンサを較正するように構成され得る。プロセッサは、第1のセンサが第1の信号に適用している第1のゲインを変更するために、第1の較正信号を該第1の出力チャネルを通して送信することができる。同様に、プロセッサは、第2のセンサが第2の信号に適用している第2のゲインを変更するために、第2の較正信号を該第2の出力チャネルを通して送信することができる。
上で論じたように、プロセッサは、第1の信号及び/又は第2の信号から受信したデータを考慮して、外科用器具の動作を変更することができる。いくつかの状況において、プロセッサは、プロセッサが故障状態であると見なす冗長なセンサからの信号を無視することができる。いくつかの状況において、プロセッサは、外科用器具を安全な状態に復帰させることができ、及び/又は外科用器具のユーザに、センサの一方又は両方が、故障状態にあり得ることを警告することができる。ある特定の状況において、プロセッサは、外科用器具を使用不可にすることができる。様々な状況において、センサの1つ又は2つ以上が故障状態であり得ることをプロセッサが検出すると、プロセッサは外科用器具の特定の機能を停止及び/又は変更することができる。少なくとも1つのこのような状況において、センサの1つ又は2つ以上に欠陥がある状態であり得ることをプロセッサが検出すると、プロセッサは、例えば、外科用器具が手術部位から安全に取り外されることを可能にし得るこれらの制御に対する動作可能な制御を制限することができる。少なくとも1つの状況においては、プロセッサは、センサのうちの1つ又は2つ以上が故障状態であり得ることを検出する場合がある。ある特定の状況においては、センサのうちの1つ又は2つ以上が故障状態であり得ることをプロセッサが検出すると、プロセッサは、例えば、外科用器具のモーターによって供給され得る最大速度、電力、及び/又はトルクを制限することができる。様々な状況において、センサの1つ又は2つ以上が故障状態であり得ることをプロセッサが検出すると、プロセッサは、例えば、外科用器具のユーザに、異常稼働又は不良稼働するセンサを再較正させ得る再較正制御を可能にすることができる。同一の状態を検出するために2つのセンサを利用する様々な例示の実施形態が、本明細書に記載されているが、2つを超えるセンサを利用する様々な他の実施形態が想定される。本明細書に記載される2つのセンサシステムに適用される原理は、3つ又はそれ以上のセンサを含むシステムにも適合され得る。
上で論じたように、第1のセンサ及び第2のセンサは、外科用器具の同じ状態を検出するように構成され得る。例えば、第1のセンサ及び第2のセンサは、例えば、外科用器具のアンビルが、開放状態にあるかどうかを検出するよう構成され得る。少なくとも1つのこのような例において、例えば、第1のセンサは、閉鎖トリガーの作動位置への移動を検出することができ、第2のセンサは、アンビルのクランプ位置への移動を検出することができる。いくつかの例では、第1のセンサ及び第2のセンサは、外科用器具のエンドエフェクタからステープルを展開するように構成された発射部材の位置を検出するように構成され得る。少なくとも1つのこのような例において、例えば、第1のセンサは、外科用器具のハンドルにおけるモーター駆動ラックの位置を検出するように構成されてもよく、第2のセンサは、モーター駆動ラックと動作可能に結合される外科用器具のシャフトにおける発射部材又はエンドエフェクタの位置を検出するよう構成されてもよい。様々な例において、第1及び第2のセンサは、同一事象が発生していることを確認することができる。第1及び第2のセンサは、外科用器具の同一部分に及び/又は外科用器具の異なる部分に位置することができる。第1のセンサは、例えばハンドルに位置することができ、第2のセンサは、例えば、シャフト若しくはエンドエフェクタに位置することができる。
上記に加えて、第1及び第2のセンサは、2つの事象が同時に発生しているかどうかを判定するよう利用されてもよい。例えば、閉鎖トリガーとアンビルとが、同時に移動しているかどうか、又は同時に移動したかどうかである。ある特定の例において、第1及び第2のセンサは、2つの事象が同時に発生していないかどうかを判定するよう利用されてもよい。例えば、エンドエフェクタのアンビルが開放され、これと同時に外科用器具の発射部材が進められ、エンドエフェクタからステープルを展開することは、望ましくない場合がある。第1のセンサは、アンビルがクランプ位置にあるかどうかを判定するように構成されてもよく、第2のセンサは、発射部材が進められているかどうかを判定するように構成されてもよい。第1のセンサが、アンビルが非クランプ位置にあることを検出し、一方第2のセンサが、発射部材が進められていることを検出する場合には、プロセッサは、例えば、外科用器具のモーターへの電力の供給を遮ることができる。同様に、第1のセンサは、エンドエフェクタをクランプしないように構成された非クランプアクチュエータが押下されたかどうかを検出するように構成されてもよく、第2のセンサは、外科用器具のモーターを動作させるように構成された発射アクチュエータが押下されたかどうかを検出するように構成されてもよい。外科用器具のプロセッサは、例えば、モーターを停止させ、発射部材を後退させるようにモーターを逆転させ、及び/又は非クランプアクチュエータからの命令を無視することによって、これらの矛盾する命令を解決するように構成され得る。
いくつかの例において、上記に加えて、検出される状態は、外科用器具によって消費される電力を含み得る。少なくとも1つのこのような例において、第1のセンサは、外科用器具の電池から引き出される電流を監視するように構成されてもよく、第2のセンサは、電池の電圧を監視するように構成されてもよい。上で論じたように、このような情報は、第1のセンサ及び第2のセンサからプロセッサまで通信され得る。この情報を用いて、プロセッサは、外科用器具の電力引出を算出することができる。このようなシステムは、「供給側」電力モニタリングと呼ばれ得る。ある特定の例において、例えば、第1のセンサは、外科用器具のモーターによって引き出される電流を検出するように構成されてもよく、第2のセンサは、外科用器具のプロセッサによって引き出される電流を検出するように構成されてもよい。上で論じたように、このような情報は、第1のセンサ及び第2のセンサからプロセッサまで通信され得る。この情報を用いて、プロセッサは、外科用器具の電力引出を算出することができる。外科用器具の他の構成要素が電力を引き出す限り、センサは、各構成要素についての電力引出を検出し、この情報をプロセッサに通信するために利用され得る。このようなシステムは、「使用側」電力モニタリングと呼ばれ得る。供給側電力モニタリング及び使用側電力モニタリングを利用する様々な実施形態が想定される。様々な例では、プロセッサ及び/又はプロセッサによって実現されるアルゴリズムは、1つのセンサのみによって直接検知され得ないデバイスの状態を、1超のセンサを用いて算出するように構成され得る。この算出に基づいて、プロセッサは、外科用器具の機能をブロック及び/又は変更することを可能にし得る。
様々な状況において、プロセッサ及びセンサシステムによって検出され得る外科用器具の状態は、外科用器具の配向を含むことができる。少なくとも1つの実施形態において、外科用器具は、ハンドルと、ハンドルから延在するシャフトと、シャフトから延在するエンドエフェクタとを含むことができる。例えば、第1のセンサは、ハンドル内に位置付けられてもよく、第2のセンサは、シャフト内に位置付けられてもよい。例えば、第1のセンサは第1の傾きセンサを含んでよく、第2のセンサは第2の傾きセンサを含んでよい。第1の傾きセンサは、第1の平面に対する器具の配向を検出するように構成されてもよく、第2の傾きセンサは、第2の平面に対する器具の配向を検出するように構成されてもよい。第1の平面と第2の平面とは、直交していても、又は直交していなくてもよい。第1のセンサは、例えば、加速度計及び/又はジャイロスコープを備えることができる。第2のセンサは、例えば、加速度計及び/又はジャイロスコープを備えることができる。2超のセンサを備え、それぞれのこのようなセンサが、例えば、加速度計及び/又はジャイロスコープを備えることができる様々な実施形態が想定される。少なくとも1つの実現形態において、第1のセンサは、第1の軸に沿って配置された第1の加速度計を備えることができ、第2のセンサは、第1の軸とは異なる第2の軸に沿って配置された第2の加速度計を備えることができる。少なくとも1つのこのような例において、第1の軸は、第2の軸を横断してもよい。
上記に加えて、プロセッサは、第1及び第2の加速度計からのデータを利用して、重力が器具に対して作用している方向、すなわち、外科用器具に対する接地の方向を判定することができる。ある特定の例において、外科用器具を包囲する環境において発生する磁界は、加速度計のうちの1つに影響を及ぼす場合がある。上記に加えて、プロセッサは、加速度計からのデータが不一致の場合、加速度計からのデータを無視するように構成され得る。更に、プロセッサは、例えば、加速度計が、2つ又はそれ以上の強い極性配向の間でディザリングしている場合、加速度計からのデータを無視するように構成されてもよい。外部磁界が、外科用器具の加速度計の2つ又はそれ以上、及び/又は全てに影響を及ぼしている限り、プロセッサは、加速度計からのデータに依存する外科用器具の特定の機能を停止させることができる。様々な例において、外科用器具は、スクリーンを含むことができ、このスクリーンは、プロセッサによってスクリーンに通信された画像を表示するように構成され、プロセッサは、外科用器具のハンドルが再配向されたときに、又は少なくとも、ハンドルの再配向が、加速度計によって検出されたときに、スクリーン上に表示された画像の配向を変更するように構成され得る。少なくとも1つの例において、ハンドルが逆さまに配向されたときに、スクリーン上の表示は、逆さまにひっくり返ることができる。プロセッサが、加速度計のうちの1つ又は2つ以上からの配向データが不良であり得ると判定する場合には、プロセッサは、例えば、ディスプレイが、そのデフォルト位置から離れる方向に再配向されることを防止してもよい。
上記に加えて、外科用器具の配向は、単一のセンサから検出可能であっても又は検出可能でなくともよい。少なくとも1つの例において、例えば、外科用器具のハンドルは、第1のセンサを含むことができ、シャフトは、第2のセンサを含むことができる。第1のセンサ及び第2のセンサからのデータ、並びに/又は任意の他のセンサからのデータを利用して、プロセッサは、外科用器具の配向を判定することができる。いくつかの例において、プロセッサは、外科用器具の配向を判定するために、第1のセンサ信号、第2のセンサ信号、及び/又は任意の好適な数のセンサ信号からのデータを組み合せるように構成されたアルゴリズムを利用することができる。少なくとも1つの例において、ハンドル内に位置付けられたハンドルセンサは、重力に対してハンドルの配向を判定することができる。シャフト内に位置付けられたシャフトセンサは、重力に対してシャフトの配向を判定することができる。シャフト、又はシャフトの少なくとも一部が、ハンドルに対して関節屈曲しない実施形態では、プロセッサは、シャフト、又は非関節屈曲シャフト部分が指示している方向を判定することができる。いくつかの例において、外科用器具は、シャフトに対して関節屈曲し得るエンドエフェクタを含むことができる。外科用器具は、例えば、エンドエフェクタがシャフトに対して関節屈曲された方向及び程度を判定することができる関節センサを含むことができる。ハンドルセンサ、シャフトセンサ、及び関節センサからのデータを用いて、プロセッサは、エンドエフェクタが指示している方向を判定することができる。ハンドル、シャフト、及び/又はエンドエフェクタの長さを含む追加のデータを用いて、プロセッサは、例えば、エンドエフェクタの遠位先端の位置を判定することができる。このような情報を用いて、プロセッサは、外科用器具の機能をブロック及び/又は変更することを可能にすることができる。
様々な例において、外科用器具は第1のプロセッサに加えて冗長なプロセッサを含んでもよい。冗長なプロセッサは、第1のプロセッサが信号通信するセンサのうちのいくつか又は全てと信号通信し得る。冗長なプロセッサは、第1のプロセッサが実行するものと同様な計算のいくつか又は全てを実行することができる。冗長なプロセッサは、第1のプロセッサと信号通信し得る。第1のプロセッサは、第1のプロセッサが実行した計算を、冗長なプロセッサが実行した計算と比較するように構成され得る。同様に、冗長なプロセッサは、冗長なプロセッサが実行した計算を、第1のプロセッサが実行した計算と比較するように構成され得る。様々な例において、第1のプロセッサ及び冗長なプロセッサは、互いに独立して、外科用器具を動作させるように構成され得る。いくつかの例において、第1のプロセッサ及び/又は冗長なプロセッサは、他のプロセッサが故障状態であるかどうか及び/又は故障が他のプロセッサ内で並びに/若しくは外科用器具内で検出される場合、他のプロセッサを停止させているかどうかを判定するように構成されてもよい。第1のプロセッサ及び冗長なプロセッサは、双方とも、外科用器具の操作者と通信するように構成されることができ、これにより、例えば、プロセッサのうちの1つが、他のプロセッサが故障状態であると判定する場合、故障していないプロセッサが、故障状態が存在することを操作者と通信することができる。
様々な実施形態において、外科用器具は、プロセッサと、プロセッサと信号通信する1つ又は2つ以上のセンサとを含むことができる。センサは、デジタルセンサ及び/又はアナログセンサを含むことができる。デジタルセンサは、測定信号を生成することができ、電子チップを含むことができる。電子チップは、測定信号をデジタル出力信号に変換することができる。デジタル出力信号は、次いで、例えば、導電ケーブル、光ファイバケーブル、及び/又は無線エミッタなどの好適な伝送手段を利用して、プロセッサに送信され得る。アナログセンサは、測定信号を生成し、アナログ出力信号を用いて、この測定信号をプロセッサに通信することができる。アナログセンサは、例えば、ホール効果センサ、磁気抵抗センサ、光学センサ、及び/又は任意の他の好適なセンサを含むことができる。外科用器具は、アナログ出力信号がプロセッサに達する前に、アナログ出力信号を受信及び/又は調節するように構成され得る信号フィルタを含むことができる。信号フィルタは、例えば、ローパスフィルタを備えることができ、ローパスフィルタは、遮断周波数にある及び/又は遮断周波数よりも低い低周波数を有する信号をプロセッサまで通し、遮断周波数よりも高い高周波数を有する信号を減衰させ、又はその信号の振幅を低減する。いくつかの例では、ローパスフィルタは、それが受信するある特定の高周波数信号又はそれが受信する高周波数信号の全てを排除してもよい。ローパスフィルタはまた、ある特定の低周波数信号又は低周波数信号の全てを減衰し、それらの振幅を低減してもよいが、このような減衰は、ローパスフィルタが高周波数信号に適用する減衰とは異なる場合がある。任意の好適な信号フィルタが利用されてもよい。例えば、ハイパスフィルタが利用されてもよい。ロングパスフィルタが、光学センサからの信号を受信かつ調節するために利用されてもよい。様々な例において、プロセッサは、積分信号フィルタを含むことができる。いくつかの例において、プロセッサは、信号フィルタと信号通信し得る。いずれにしても、信号フィルタは、アナログ出力信号内の、又は信号フィルタが受信する信号内のノイズを低減するように構成され得る。
上記に加えて、センサからのアナログ出力信号は、プロセッサの入力チャネルに印加される一連の電圧電位を備えることができる。様々な例において、アナログセンサ出力信号の電圧電位は、定義された範囲内にあり得る。例えば、電圧電位は、例えば、約0V〜約12V、約0V〜約6V、約0V〜約3V、及び/又は約0V〜約1Vであり得る。いくつかの例において、電圧電位は、例えば、12V以下、6V以下、3V以下、及び/又は1V以下であり得る。いくつかの例において、電圧電位は、例えば、約0V〜約−12V、約0V〜約−6V、約0V〜約−3V、及び/又は約0V〜約−1Vであり得る。いくつかの例において、電圧電位は、例えば、−12V以上、−6V以上、−3V以上、及び/又は−1V以上であり得る。いくつかの例において、電圧電位は、例えば、約12V〜約−12V、約6V〜約−6V、約3V〜約−3V、及び/又は約1V〜約−1Vであり得る。様々な例において、センサは、電圧電位をプロセッサの入力チャネルに連続流で供給することができる。プロセッサは、このデータ流を、データがプロセッサに送達される速度を下回る速度でサンプリングし得る。様々な例において、センサは、電圧電位をプロセッサの入力チャネルに断続的に又は定期的間隔で供給することができる。いずれにしても、以下に更により詳細に記載されるように、プロセッサは、その入力チャネル又はチャネルに印加される電圧電位を評価し、この電圧電位に応答して、外科用器具を動作させるように構成され得る。
上記に加えて、プロセッサは、センサからのアナログ出力信号を評価するように構成され得る。様々な例において、プロセッサは、アナログ出力信号の全ての電圧電位を評価するように及び/又はアナログ出力信号をサンプリングするように構成され得る。アナログ出力信号をサンプリングする場合、プロセッサは、アナログ出力信号から電圧電位を定期的に得るために、定期的な評価を行うことができる。各評価について、プロセッサは、評価から得られた電圧電位を、基準値に対して比較することができる。様々な状況において、プロセッサは、この比較から、例えば0若しくは1、又はオン若しくはオフなどのデジタル値を算出することができる。例えば、評価された電圧電位が、基準値と等しい場合には、プロセッサは1のデジタル値を算出することができる。あるいは、プロセッサは、評価された電圧電位が基準値と等しい場合、0のデジタル値を算出してもよい。第1の実施形態に関して、プロセッサは、評価された電圧電位が基準値未満である場合、1のデジタル値を、評価された電圧電位が基準値を超える場合に、0のデジタル値を算出することができる。第2の実施形態に関して、プロセッサは、評価された電圧電位が基準値未満である場合、0のデジタル値を、評価された電圧電位が基準値を超える場合に、1のデジタル値を算出することができる。いずれの場合にも、プロセッサは、アナログ信号をデジタル信号に変換することができる。プロセッサが、センサ出力信号の電圧電位を連続的に評価しているとき、プロセッサは、電圧電位を基準値と連続的に比較し、デジタル値を連続的に算出することができる。プロセッサが、センサ出力信号の電圧電位を定期的な間隔で評価しているとき、プロセッサは、電圧電位を基準値と定期的な間隔で比較し、デジタル値を定期的な間隔で算出することができる。
上記に加えて、基準値は、プロセッサによって利用されるアルゴリズムの一部であり得る。基準値は、アルゴリズム内に予めプログラムされ得る。いくつかの例において、プロセッサは、アルゴリズム内の基準値を取得し、算出し、及び/又は変更することができる。いくつかの例において、基準値は、プロセッサによってアクセス可能であるか、及び/又はプロセッサと一体化されたメモリデバイスに記憶され得る。基準値は、メモリデバイス内に予めプログラムされ得る。いくつかの例において、プロセッサは、メモリデバイス内の基準値を取得し、算出し、及び/又は変更することができる。少なくとも1つの例において、基準値は、不揮発性メモリ内に記憶されてもよい。いくつかの例において、基準値は、揮発性メモリ内に記憶されてもよい。基準値は、定数値を含んでもよい。基準値は、変更可能若しくは上書きされてもよいか、又はそうでなくてもよい。ある特定の例において、基準値は、較正手順の結果として、記憶され、変更され、及び/又は別の方法で決定され得る。較正手順は、例えば、外科用器具の製造時に、外科用器具の初期化、又は初期起動時に、休止モードからの器具の起動時に、器具の使用時に、器具を休止モードに置く際に、及び/又は器具を完全に停止させる際に行われ得る。
更に上記に加えて、プロセッサは、デジタル値を記憶するように構成されてもよい。デジタル値は、電子論理ゲートにおいて記憶され得る。様々な例において、電子論理ゲートは、以下に更により詳細に記載されるように、センサによって検出された状態を評価するためにプロセッサによって参照され得る2進出力を供給することができる。プロセッサは、電子論理ゲートを含むことができる。電子論理ゲートの2進出力は更新され得る。様々な例において、プロセッサは、1つ又は2つ以上の出力チャネルを含むことができる。プロセッサは、2進出力を、出力チャネルのうちの少なくとも1つに供給することができる。プロセッサは、例えば、オフビットを表示するために、このような出力チャネルに低電圧を印加し、オンビットを表示するために出力チャネルに高電圧を印加することができる。低電圧及び高電圧は、閾値に対して測定され得る。少なくとも1つの例において、低電圧は、例えば電圧がない場合を含み得る。少なくとも1つの他の例において、例えば、低電圧は、第1の極性を有する電圧を含んでもよく、高電圧は、反対の極性を有する電圧を含んでもよい。
少なくとも1つの例において、プロセッサによって評価された電圧電位が、基準値と一致するか又は基準値よりも低い場合、電子論理ゲートは、「オン」の出力を維持することができる。評価された電圧電位が、基準値を超えると、論理ゲートの出力は、「オフ」に切り替えられ得る。プロセッサによって評価される電圧電位が、基準値と一致するか又は基準値よりも高い場合、電子論理ゲートは、「オフ」の出力を維持することができる。評価される電圧電位が、その後、基準値で又はそれより低い値で測定されると、論理ゲートの出力は、元の「オン」に替えられ得るなどである。様々な例において、電子論理ゲートは、その出力の履歴を維持しなくともよい。いくつかの例において、プロセッサは、電子論理ゲートの出力履歴を記録するように、すなわち、算出されたデジタル値の履歴を記録するように構成されたメモリデバイスを含むことができる。様々な例において、プロセッサは、例えば、現在のデジタル値及び/又は少なくとも1つの以前に存在したデジタル値を確認するために、メモリデバイスにアクセスするように構成され得る。
様々な例において、プロセッサは、算出されたデジタル値における変化に対する即時応答を提供することができる。プロセッサが、まず、例えば、算出されたデジタル値が「オン」から「オフ」に、又は「オフ」から「オン」に変更されたことを検出すると、プロセッサは、外科用器具の動作を即時に変更することができる。ある特定の例において、プロセッサは、例えば、算出されたデジタル値が、「オン」から「オフ」に又は「オフ」から「オン」に変更されたことを検出する際に、外科用器具の動作を即時に変更しなくてもよい。プロセッサは、ヒステリシスアルゴリズムを使用してよい。例えば、プロセッサは、デジタル値が、同様な方法で一定の連続回数で算出された後に、外科用器具の動作を変更してもよい。少なくとも1つのこのような例において、プロセッサは、1つ又は2つ以上の外科用器具センサからプロセッサが受信したデータに基づいて、「オン」値を算出し、「オン」2進値を出力論理ゲート及び/又は出力チャネルで表示してもよく、その後、いくつかの時点で、プロセッサは、1つ又は2つ以上の外科用器具センサからプロセッサが受信したデータに基づいて、「オフ」値を算出してもよい。しかしながら、プロセッサは、「オフ」2進値を出力論理ゲート及び/又は出力チャネルにおいて即時に表示しなくてもよい。むしろ、プロセッサが、「オフ」値を一定の連続回数で、例えば、10回などで算出した後に、プロセッサは出力論理ゲート及び/又は出力チャネルにおいて2進値を変更することを遅延してもよい。プロセッサが、出力論理ゲート及び/又は出力チャネルにおいて2進値を変更すると、プロセッサが、「オン」値を一定の連続回数で、例えば、10回等などで算出した後に、プロセッサは、同様に出力論理ゲート及び/又は出力チャネルにおいて2進値を変更することを遅延してもよい。
ヒステリシスアルゴリズムは、スイッチデバウンスを取り扱うために好適であり得る。外科用器具は、信号応答のいかなる急激な変化も取り除くためにコンデンサを利用するスイッチデバウンス回路を含むことができる。
上に挙げた例において、「オン」から「オフ」へ進むためのサンプリング遅延は、「オフ」から「オン」に進むためのサンプリング遅延と同様であった。サンプリング遅延が等しくない実施形態も想定される。例えば、出力チャネルにおける「オン」値が、外科用器具のモーターを作動させ、出力チャネルにおける「オフ」値がモーターを停止させる場合、例えば、「オン」遅延は、「オフ」遅延よりも長くてもよい。このような例において、プロセッサは、発射トリガーの偶然的又は予期しない移動に応答してモーターを急に作動させなくてもよく、他方では、プロセッサは、モーターを停止させるために、発射トリガーの解放に向けて迅速に反応してもよい。少なくとも1つのこのような例において、プロセッサは、例えば、発射トリガーが解放された後に、モーターが直ぐに停止され得るように、「オン」遅延を有するが「オフ」遅延を有さなくてもよい。上で論じたように、プロセッサは、2進出力値を変更する前に、一定の回数の連続する一貫した出力算出を待ち受けてもよい。他のアルゴリズムも考えられる。例えば、プロセッサは、一定の回数の連続する整合した2進出力算出を要求しなくてもよい。むしろ、プロセッサは、連続する算定の一定回数、又は百分率が2進出力を変更するために整合していることだけ要求してもよい。
上で論じたように、プロセッサは、基準値を利用して、アナログ信号をデジタル信号に変換することができる。上で論じたように、プロセッサは、基準値を利用して、アナログ入力データを、又はアナログ入力データのサンプルを、そのデジタル出力信号の一部として「オン」値又は「オフ」値に変換することができる。様々な例において、プロセッサは、「オン」値又は「オフ」値を出力しているかどうかを判定するために、1つを超える基準値を利用することができる。1つの基準値は、2つの範囲を定義することができる。基準値よりも低い範囲と基準値よりも高い範囲である。基準値それ自体は、状況に応じて、第1の範囲又は第2の範囲の一部であり得る。追加の基準値の使用は、追加の範囲を定義することができる。例えば、第1の基準値及び第2の基準値は、3つの範囲を定義することができ、第1の基準値よりも低い第1の範囲、第1の基準値と第2の基準値との間の第2の範囲、及び第2の基準値よりも高い第3の範囲である。重ねて、状況に応じて、第1の基準値は、第1の範囲又は第2の範囲の一部であってもよく、同様に、第2の基準値は、第2の範囲又は第3の範囲の一部であってもよい。アナログ信号からのデータの所与のサンプルについて、プロセッサは、サンプルが第1の範囲内、第2の範囲内、又は第3の範囲内にあるかどうかを判定することができる。少なくとも1つの例示の実施形態において、プロセッサは、サンプルが第1の範囲内にある場合、「オン」値を2進出力に割り当て、サンプルが第3の範囲内にある場合、「オフ」値を2進出力に割り当てることができる。あるいは、プロセッサは、サンプルが第1の範囲内にある場合、「オフ」値を2進出力に割り当て、サンプルが第3の範囲内にある場合、「オン」値を2進出力に割り当てることができる。
上記に加えて、プロセッサは、データサンプルが第2の範囲内にある場合、「オン」値又は「オフ」値を2進出力に割り当てることができる。様々な例において、第2の範囲内のアナログデータサンプルは、2進出力値を変更しなくてもよい。例えば、プロセッサが、第2の基準値よりも高いアナログデータを受信していて、ある特定の2進出力を生成した後に、プロセッサが第1の基準値と第2の基準値との間のアナログデータを受信する場合には、プロセッサは、2進出力を変更しなくてもよい。この例において、プロセッサが、第1の基準値よりも低いアナログデータを受信するならば、プロセッサは、その後、2進出力を変更してもよい。対応して、この例では、プロセッサが、第1の基準値よりも低いアナログデータを受信していて、ある特定の2進出力を生成した後に、プロセッサが第1の基準値と第2の基準値との間のアナログデータを受信する場合には、プロセッサは、2進出力を変更しなくてもよい。この例において、プロセッサが、第2の基準値よりも高いアナログデータを受信するならば、プロセッサは、その後、2進出力を変更してもよい。様々な例では、第1の基準値と第2の基準値との間の第2の範囲は、その範囲内ではプロセッサが2進出力信号を変更しなくてもよい観測窓を含んでもよい。ある特定の例では、プロセッサは、アナログ入力データが第1の範囲と第3の範囲との間を直接ジャンプしているかどうか、又はアナログ入力データが、第3の範囲に移行する前に第2の範囲に移行しているかどうかに応じて、異なるサンプリング遅延を利用してもよい。例えば、アナログ入力データが、第1の範囲と第3の範囲との間を直接ジャンプする場合と比べて、アナログ入力データが、第1の範囲又は第3の範囲へ移行する前に、第2の範囲に移行するならば、サンプリング遅延はより短くてもよい。
上で論じたように、例えば、ホール効果センサなどのアナログセンサは、外科用器具の状態を検出するために利用され得る。様々な例において、ホール効果センサは、正極性及び負極性を含むことができる線形アナログ出力を生成することができ、ある特定の例では、広範囲のアナログ出力値を生成することができる。このような広範囲の値は、いつも有用であるとは限らず、又は外科用器具に対して実際に可能である事象に対応しない場合もある。例えば、ホール効果センサは、エンドエフェクタのアンビルの配向を追跡するために利用され得るが、アンビルは、アンビルの運動に対するある特定の物理的拘束のために、例えば、約30度などの小さい可動域を移動するに過ぎない場合がある。ホール効果センサは、この可動域を外れるアンビルの運動を検出することができるが、実際には、ホール効果センサは、これを検出し得ず、その結果、ホール効果センサの出力範囲の一部は利用され得ない。プロセッサは、アンビルの考えられる可動域に相当するホール効果センサからの出力の範囲を認識するようにだけプログラムされる場合があり、出力のこの範囲から外れているデータを、この範囲よりも高くても又はこの範囲よりも低くても、ホール効果センサから受信する限り、プロセッサは、例えば、このようなデータを無視し、故障状態を生じさせ、外科用器具の動作を変更し、及び/又は外科用器具のユーザに通知し得る。このような例において、プロセッサは、センサからのデータの有効範囲を認識してもよく、この範囲の外側にあるセンサから受信した任意のデータは、プロセッサによって無効であると見なされてもよい。データの有効範囲は、第1の基準値、若しくは閾値、及び第2の基準値、若しくは閾値によって定義されてもよい。データの有効範囲は、正極性と負極性とを有するデータを含んでもよい。あるいは、データの有効範囲は、正極性からのデータ又は負極性からのデータのみを含んでもよい。
第1の基準値及び第2の基準値は、上記に加えて、固定値を含むことができる。ある特定の状況において、第1の基準値及び/又は第2の基準値は、較正され得る。第1の基準値及び/又は第2の基準値は、外科用器具が最初に製造されたとき及び/又はその後再製造されたときに較正され得る。例として、例えば閉鎖トリガーなどのトリガーは、較正手順中にその可動域全体を通して移動させることができ、例えば、外科用器具のハンドル内に位置付けられたホール効果センサは、閉鎖トリガーの運動、又は、例えば閉鎖トリガー上に位置付けられた永久磁石などの磁気素子の運動を検出することができる。閉鎖トリガーが、非クランプ位置にあるとき、ホール効果センサによって得られる読み取り値は、閉鎖トリガーの非クランプ位置と一致する第1の設定点として記憶され得る。同様に、閉鎖トリガーが、その完全クランプ位置にあるとき、ホール効果センサによって得られる読み取り値は、閉鎖トリガーの完全クランプ位置と一致する第2の設定点として記憶され得る。その後は、第1の設定点は、第1の基準値を定義することができ、第2の設定点は、第2の基準値を定義することができる。閉鎖トリガーの非クランプ位置と完全クランプ位置との間の位置は、第1の基準値と第2の基準値との間のデータの範囲に相当し得る。上で概説したように、プロセッサは、アナログセンサから受信したデータに応答して、デジタル出力値を生成することができる。少なくとも1つの例において、プロセッサは、アナログセンサから受信したデータが、第1の基準値にあるか又は第1の基準値よりも高いとき、「オフ」値をそのデジタル出力に割り当てることができる。あるいは、プロセッサは、例えば、アナログセンサから受信したデータが、第1の基準値よりも高いか、第1の基準値にあるか、又は第1の基準値の前約20%の範囲内にあるとき、「オフ」値をそのデジタル出力に割り当てることができる。第1の基準値と、第1の基準値の約20%低い範囲との間にあるアナログセンサからのデータは、非クランプ位置に適切に近い閉鎖トリガーの位置と一致することができる。少なくとも1つの例において、プロセッサは、アナログセンサから受信したデータが第1の基準値よりも低いとき、「オン」値をそのデジタル出力に割り当てることができる。あるいは、プロセッサは、アナログセンサから受信したデータが第2の基準値にあるか、第2の基準値よりも低いか、又は第2の基準値よりも約40%高い範囲内にあるとき、「オン」値をそのデジタル出力に割り当てることができ、これは、閉鎖トリガーが、例えば、その可動域を通して約3/4引かれたときの閉鎖トリガーの位置と一致する。同じ又は類似の属性が、例えば、外科用器具の発射トリガーに適用され得る。
上記に加えて、センサは、基準値を考慮して較正され得る。例として、例えば、+2Vの基準値が閉鎖トリガーの非クランプ位置に関連付けられ、閉鎖トリガーが非クランプ位置にあるときに、プロセッサが+2Vとは異なるセンサ出力値を検出する場合、プロセッサは、センサ、又はセンサのゲインを再較正することができ、これにより、センサ出力は、基準値と一致するか、又は少なくとも実質的に一致する。プロセッサは、閉鎖トリガーが非クランプ位置にあることを確認する独立した方法を利用してもよい。少なくとも1つのこのような例において、外科用器具は、閉鎖トリガーが非クランプ位置にあることを独立して確認することができる、プロセッサと信号通信する第2のセンサを含むことができる。第2のセンサもまた、例えば、ホール効果センサなどのアナログセンサを含むことができる。第2のセンサは、例えば、近接センサ、抵抗ベースのセンサ、及び/又は任意の他の好適なセンサを含むことができる。同じ又は類似の属性が、例えば、外科用器具の発射トリガーに適用され得る。
上で論じたように、図14〜18Aを参照すると、追跡システム800は、1つ又は2つ以上のセンサ、例えば、第1のホール効果センサ803及び第2のホール効果センサ804などを備えることができ、センサは、磁石802の位置を追跡するように構成され得る。図14及び図17を比較する際に、読者は、閉鎖トリガー32がその非作動位置からその作動位置に移動されると、磁石802が、第1のホール効果センサ803に近接する第1の位置と第2のホール効果センサ804に近接する第2の位置との間を移動することができることを理解するであろう。磁石802が、第1の位置にあるとき、磁石802の位置は、第1のホール効果センサ803及び/又は第2のホール効果センサ804によって検出され得る。外科用器具のプロセッサは、第1のセンサ803からのデータを用いて、磁石802の位置を判定し、第2のセンサ804からのデータを用いて、磁石802の位置を独立して判定することができる。このような例において、プロセッサは、第2のセンサ804からのデータを利用して、第1のセンサ803からのデータの完全性を確認することができる。あるいは、プロセッサは、第1のセンサ803からのデータを利用して、第2のセンサ804からのデータの完全性を確認することができる。プロセッサは、センサからのデータが磁石802の位置の一次判定又は二次判定をもたらすように用いられるべきであるかどうかを決定するために、任意の好適な階層構造を利用することができる。例えば、磁石802が第1の位置にあるとき、磁石802は、第2のセンサ804を包囲する磁界に対してよりも第1のセンサ803を包囲する磁界に対してより大きな妨害を提供し得、その結果として、プロセッサは、第1のセンサ803からのデータを、磁石802の位置の一次判定として利用してもよい。磁石802が第1のセンサ803よりも第2のセンサ804の近くにあるとき、磁石802は、第1のセンサ803を包囲する磁界に対してよりも第2のセンサ804を包囲する磁界に対してより大きな妨害を提供し得、その結果として、プロセッサは、第2のセンサ804からのデータを、磁石802の位置の一次判定として利用してもよい。
上記に加えて、第1のセンサ803に対する磁石802の経路は、閉鎖トリガー32が非クランプ位置とクランプ位置との間で移動されているときには第1の経路分割部に沿って、そして発射トリガー130が非発射位置と発射位置との間で移動されるときには第2の経路分割部に沿って、磁石802が移動するときに判定され得る。第1の経路分割部に沿って移動する際の磁石802を追跡する間に第1のセンサ803が生成する出力の範囲は、データの第1の有効値を定義することができ、一方第2の経路分割部に沿って移動する際の磁石802を追跡する間に第1のセンサ803が生成する出力の範囲は、データの第2の有効範囲を定義することができる。データの第1の有効範囲は、データの第2の有効範囲と連続してもよく又は連続しなくてもよい。いずれにしても、磁石802の第2のセンサ804に対する経路はまた、磁石802が、その第1の経路分割部とその第2の経路分割部とに沿って移動するときに判定され得る。磁石802が第1の経路分割部に沿って移動すると磁石802を追跡しつつ、第2のセンサ804が生成する出力の範囲は、データの第1の有効値を定義することができ、一方磁石802が第2の経路分割部に沿って移動すると磁石802を追跡しつつ、第2のセンサ804が生成する出力の範囲は、データの第2の有効範囲を定義することができる。第1のセンサ803及び/又は第2のセンサ804が、その対応のデータの第1の有効範囲とデータの第2の有効範囲から外れるデータを受信すると、プロセッサは、エラーが発生したことを推測し、外科用器具の動作を変更し、及び/又は外科用器具の操作者に通知してもよい。ある特定の例において、プロセッサは、第1のセンサ803及び第2のセンサ804からのデータを利用して、外科用器具が、外科用器具の動作に影響を及ぼし得る強い外部磁界内に位置付けられたかどうかを判定することができる。例えば、磁石802は、第1のセンサ803及び第2のセンサ804が同じ出力を生成しないような経路に沿って移動してもよく、第1のセンサ803及び第2のセンサ804が同じ出力を生成する場合には、プロセッサは、例えば、故障状態が存在することを判定することができる。
以下の全ての開示内容が参照によって本明細書に組み込まれる。
1995年4月4日に発行された米国特許第5,403,312号、名称「ELECTROSURGICAL HEMOSTATIC DEVICE」、
2006年2月21日に発行された米国特許第7,000,818号、名称「SURGICAL STAPLING INSTRUMENT HAVING SEPARATE DISTINCT CLOSING AND FIRING SYSTEMS」、
2008年9月9日に発行された米国特許第7,422,139号、名称「MOTOR−DRIVEN SURGICAL CUTTING AND FASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK」、
2008年12月16日に発行された米国特許第7,464,849号、名称「ELECTRO−MECHANICAL SURGICAL INSTRUMENT WITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS」、
2010年3月2日に発行された米国特許第7,670,334号、名称「SURGICAL INSTRUMENT HAVING AN ARTICULATING END EFFECTOR」、
2010年7月13日に発行された米国特許第7,753,245号、名称「SURGICAL STAPLING INSTRUMENTS」、
2013年3月12日に発行された米国特許第8,393,514号、名称「SELECTIVELY ORIENTABLE IMPLANTABLE FASTENER CARTRIDGE」、
米国特許出願第11/343,803号、名称「SURGICAL INSTRUMENT HAVING RECORDING CAPABILITIES」、
2008年2月14日に出願された米国特許出願第12/031,573号、名称「SURGICAL CUTTING AND FASTENING INSTRUMENT HAVING RF ELECTRODES」、
2008年2月15日に出願され、現在は米国特許第7,980,443号である米国特許出願第12/031,873号、名称「END EFFECTORS FOR A SURGICAL CUTTING AND STAPLING INSTRUMENT」、
現在米国特許第8,210,411号である米国特許出願第12/235,782号、名称「MOTOR−DRIVEN SURGICAL CUTTING INSTRUMENT」、
現在は米国特許出願公開第2010/0089970号である米国特許出願第12/249,117号、名称「POWERED SURGICAL CUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM」、
2009年12月24日に出願された米国特許出願第12/647,100号、名称「MOTOR−DRIVEN SURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROL ASSEMBLY」、
2012年9月29日に出願され、現在は米国特許出願公開第2012/0074198号である米国特許出願第12/893,461号、名称「STAPLE CARTRIDGE」、
2011年2月28日に出願され、現在は米国特許出願公開第2011/0226837号である米国特許出願第13/036,647号、名称「SURGICAL STAPLING INSTRUMENT」、
現在は米国特許出願公開第2012/0298719号である米国特許出願第13/118,241号、名称「SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS」、
2012年6月15日に出願された米国特許出願第13/524,049号、名称「ARTICULATABLE SURGICAL INSTRUMENT COMPRISING A FIRING DRIVE」、
2013年3月13日に出願された米国特許出願第13/800,025号、名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」、
2013年3月13日に出願された米国特許出願第13/800,067号、名称「STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM」、
2006年1月31日に出願された米国特許出願公開第2007/0175955号、名称「SURGICAL CUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM」、
2010年4月22日に出願された米国特許出願公開第2010/0264194号、名称「SURGICAL STAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR」は、参照により本明細書に組み込まれる。
様々な実施形態によると、本明細書に記載される外科用器具は、様々なセンサに結合された、1つ又は2つ以上のプロセッサ(例えば、マイクロプロセッサ、マイクロコントローラ)を備えてもよい。プロセッサ(複数可)に加えて、記憶装置(動作論理を有する)と通信インタフェースとが互いに結合されている。
プロセッサは、この動作論理を実行するように構成され得る。プロセッサは、当該技術分野で知られている多数のシングル又はマルチコアプロセッサのうちの任意の1つであってよい。記憶装置は、動作論理の永久及び一時(ワーキング)コピーを記憶するように構成された揮発性及び不揮発性記憶媒体を備え得る。
様々な実施形態において、上述のように、動作論理は、ユーザの運動データに関連付けられた収集された生体計測を処理するように構成され得る。様々な実施形態において、動作論理は、初期の処理を実施し、アプリケーションをホストするコンピュータにデータを伝送して命令を判断及び生成するように構成され得る。これらの実施形態の場合、動作論理は、ホストコンピュータから情報を受信し、ホストコンピュータにフィードバックを提供するように更に構成され得る。別の実施形態において、動作論理は、情報を受信しフィードバックを判定する上でより大きな役割を負うように構成され得る。いずれの場合も、それ自体で判定するか、ホストコンピュータからの命令に応答するかにかかわらず、動作論理は、ユーザへのフィードバックを制御及び提供するように更に構成され得る。
様々な実施形態において、動作論理は、プロセッサの命令セットアーキテクチャ(ISA)によってサポートされる命令によって、あるいは、高水準言語によって、そしてサポートされるISAにコンパイルして実現され得る。動作論理は、1つ又は2つ以上の論理ユニット又はモジュールを含み得る。動作論理は、オブジェクト指向の方式で実現され得る。動作論理は、マルチタスキング及び/又はマルチスレッド方式で実行されるように構成されてもよい。他の実施形態において、動作論理は、ゲートアレイなどのハードウェアに実現されてもよい。
様々な実施形態において、通信インタフェースは、周辺デバイスとコンピューティングシステムとの間の通信を促進するように構成され得る。この通信は、ユーザの身体部位の位置、姿勢、及び/又は運動データに関連する収集済みの生体データをホストコンピュータに伝送すること、並びに、触覚フィードバックに関連するデータをホストコンピュータから周辺デバイスへ伝送することを含み得る。様々な実施形態において、通信インタフェースは、有線通信インタフェースであっても、無線通信インタフェースであってもよい。有線通信インタフェースの例には、限定するものではないが、ユニバーサルシリアルバス(USB)インタフェースを挙げることができる。無線通信インタフェースの例には、限定するものではないが、Bluetoothインタフェースを挙げることができる。
様々な実施形態に対し、プロセッサは動作論理と共にパッケージ化されてもよい。様々な実施形態において、プロセッサは、動作論理と共にパッケージ化されてシステムインパッケージ(SiP)を形成してもよい。様々な実施形態において、プロセッサは、同じダイで動作論理と統合されてもよい。様々な実施形態において、プロセッサは、動作論理と共にパッケージ化されてシステムオンチップ(SoC)を形成してもよい。
様々な実施形態が、本明細書では、プロセッサによって実行されているソフトウェア、プログラムモジュール、及び/又はエンジンなど、コンピュータ実行可能な命令の一般的状況において説明され得る。一般的に、ソフトウェア、プログラムモジュール、及び/又はエンジンは、特定の動作を行う又は特定の抽象データタイプを実現するように構成された任意のソフトウェア要素を含む。ソフトウェア、プログラムモジュール、及び/又はエンジンは、特定のタスクを行う又は特定の抽象データタイプを実現するルーティン、プログラム、オブジェクト、構成要素、データ構造などを含み得る。ソフトウェア、プログラムモジュール、及び/又はエンジン構成要素並びに方法の実現形態は、コンピュータ読取可能媒体のいくつかの形態にわたって記憶及び/又は送信され得る。この点において、コンピュータ読取可能媒体は、計算デバイスが情報を記憶してアクセスできるように使用可能な任意の入手可能な媒体であることができる。いくつかの実施形態は更に、動作が通信ネットワークを通して接続される1つ又は2つ以上の遠隔処理デバイスによって行われる分散コンピューティング環境にて実行されてもよい。分散コンピューティング環境では、ソフトウェア、プログラムモジュール、及び/又はエンジンは、メモリ記憶デバイスを含むローカル及び遠隔コンピュータ記憶媒体の両方に配されていてもよい。情報及びプロセッサで実行される命令を記憶するために、ランダムアクセスメモリ(RAM)又は他の動的記憶デバイスなどのメモリが用いられ得る。メモリはまた、プロセッサによって命令を実行する間、一時変数又は他の中間情報を記憶するために使用されてもよい。
いくつかの実施形態は様々な動作を行う機能構成要素、ソフトウェア、エンジン、及び/又はモジュールを備えるように示されて記載されるが、このような構成要素又はモジュールは1つ又は2つ以上のハードウェア構成要素、ソフトウェア構成要素、及び/又はその組み合わせから実現されてもよいことが認識されるであろう。機能構成要素、ソフトウェア、エンジン、及び/又はモジュールは、例えば、論理デバイス(例えば、プロセッサ)によって実行されるように、論理(例えば、指示、データ、及び/又はコード)によって実現されてもよい。このような論理は、1つ又は2つ以上の種類のコンピュータ読取可能記憶媒体上に、論理デバイスの中又は外に記憶されてもよい。他の実施形態では、ソフトウェア、エンジン、及び/又はモジュールなどの機能構成要素は、プロセッサ、マイクロプロセッサ、回路、回路素子(例えば、トランジスタ、抵抗器、コンデンサ、インダクタなど)、集積回路、特定用途向け集積回路(ASIC)、プログラマブル論理デバイス(PLD)、デジタル信号プロセッサ(DSP)、フィールドプログラマブルゲートアレイ(FPGA)、論理ゲート、レジスタ、半導体デバイス、チップ、マイクロチップ、チップセットなどを含み得るハードウェア要素によって実現されてもよい。
ソフトウェア、エンジン、及び/又はモジュールの例としては、ソフトウェア構成要素、プログラム、アプリケーション、コンピュータプログラム、アプリケーションプログラム、システムプログラム、機械プログラム、オペレーティングシステムソフトウェア、ミドルウェア、ファームウェア、ソフトウェアモジュール、ルーティン、サブルーティン、機能、方法、手順、ソフトウェアインタフェース、アプリケーションプログラムインタフェース(API)、指示セット、計算コード、コンピュータコード、コードセグメント、コンピュータコードセグメント、文字、値、記号、又はその任意の組み合わせが挙げられる。実施形態がハードウェア要素及び/又はソフトウェア要素によって実現されているかの判定は、所望の計算率、動力レベル、耐熱性、処理サイクル予算、入力データレート、出力データレート、メモリリソース、データバス速度及びその他の設計又は性能上の制限などの、任意の数の要因によって変動し得る。
本明細書で説明したモジュールのうちの1つ又は2つ以上が、ファームウェア、ソフトウェア、ハードウェア、又はそれらの任意の組合わせとして実現された1つ又は2つ以上の組込みアプリケーションを備え得る。本明細書で記述したモジュールのうちの1つ又は2つ以上が、ソフトウェア、プログラム、データ、ドライバ、アプリケーションプログラムインタフェース(API)など、様々な実行可能モジュールを含み得る。ファームウェアは、ビットマスクされた読出し専用メモリ(ROM)又はフラッシュメモリ内など、不揮発性メモリ(NVM)を含み得るコントローラ2016及び/又はコントローラ2022のメモリ内に記憶されてもよい。様々な実現形態において、ファームウェアをROM内に記憶することで、フラッシュメモリを保護することができる。不揮発性メモリ(NVM)は、例えば、プログラム可能ROM(PROM)、消去可能プログラム可能ROM(EPROM)、電気的消去可能プログラム可能ROM(EEPROM)、又は、ダイナミックRAM(DRAM)、ダブルデータレートDRAM(DDRAM)、及び/若しくはシンクロナスDRAM(SDRAM)などのバッテリバックアップ型のランダムアクセスメモリ(RAM)を含め、他の種類のメモリを含み得る。
いくつかの場合では、様々な実施形態は製品として実現されてもよい。製品は、1つ又は2つ以上の実施形態の様々な動作を行うための論理、指示及び/又はデータを記憶するように構成されるコンピュータ読取可能記憶媒体を含んでいてもよい。様々な実施形態では、例えば、製品は、汎用プロセッサ又は特定用途向けプロセッサによって実行されるのに好適な、コンピュータプログラム指示を含む磁気ディスク、光学ディスク、フラッシュメモリ又はファームウェアを備えていてもよい。それらの実施形態はしかしながら、この状況に限定される。
本明細書で開示する実施形態に関連して説明した各種の機能的要素、論理ブロック、モジュール及び回路素子の各機能は、処理装置で実行されるソフトウェア、制御モジュール、論理、及び/又は論理モジュールなど、コンピュータ実行可能な命令の一般的な状況で実現され得る。一般に、ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、特定の動作を実施するように構成された任意のソフトウェア要素を含む。ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、特定のタスクを実施するかあるいは特定の抽象データ型を実現するルーティン、プログラム、オブジェクト、構成要素、データ構造などを含み得る。ソフトウェア、制御モジュール、論理、並びに/又は論理モジュール及び技術の実現形態が、何らかの形態のコンピュータ読取可能媒体に記憶され、かつ/又はそのコンピュータ読取可能媒体を介して渡され得る。この点において、コンピュータ読取可能媒体は、計算デバイスが情報を記憶してアクセスできるように使用可能な任意の入手可能な媒体であることができる。いくつかの実施形態は更に、動作が通信ネットワークを通して接続される1つ又は2つ以上の遠隔処理デバイスによって行われる分散コンピューティング環境にて実行されてもよい。分散コンピューティング環境において、ソフトウェア、制御モジュール、論理、及び/又は論理モジュールは、メモリ記憶デバイスを含めてローカル及びリモートコンピュータの記憶媒体の双方に配置され得る。
それに加えて、本明細書で説明した実施形態は例示的な実現形態を示すものであり、また、機能要素、論理ブロック、モジュール、及び回路素子は、説明した実施形態と調和する様々な他の方式で実現され得ることが明らかとなろう。更に、そのような機能要素、論理ブロック、モジュール、及び回路素子によって実施される動作は、所与の実現形態のために、結合及び/又は分離されてもよく、また、より多数の又はより少数の構成要素又はモジュールによって実施されてもよい。当業者には本開示を読むと明らかとなるように、本明細書で説明及び図示した個々の実施形態はそれぞれ、本開示の範囲から逸脱することなく、容易に他のいくつかの態様のいずれかの特徴から分離され、またそれらの特徴と結合され得る、別個の構成要素及び特徴を有する。説明したいずれの方法も、説明した事象の順序で、あるいは論理的に可能な任意の他の順序で実行され得る。
特筆すべきこととして、「一実施形態」又は「ある実施形態」に言及することは、その実施形態に関連して記述された特定の特徴、構造、又は特性が少なくとも1つの実施形態に含まれることを意味する。「一実施形態において」又は「一態様において」という語句が本明細書に出現するが、これは必ずしも同じ実施形態を指すものではない。
別段の定めがない限り、「処理する(processing)」、「計算する(computing)」、「算出する(calculating)」、「判定する(determining)」などの用語は、レジスタ内に物理量(例えば電子)として表現されるデータを、メモリ、レジスタ又は他のそのような情報記憶装置、伝送又は表示デバイス内に物理量として同様に表現される他のデータへと、操作及び/又は変換する、汎用プロセッサ、DSP、ASIC、FPGA又は他のプログラマブル論理デバイス、個別のゲート若しくはトランジスタ論理、個別のハードウェア構成要素、又は本明細書で説明した各機能を実施するように設計されたそれらの任意の組合わせなどの、コンピュータ若しくはコンピューティングシステム、又は同様の電子コンピューティングデバイスの動作及び/又はプロセスを指すものであることが明らかとなろう。
特筆すべきこととして、いくつかの実施形態は、「結合された」及び「接続された」という表現を、それらの派生語と共に用いて説明され得る。これらの用語は、互いに同義語となるように意図されたものではない。例えば、いくつかの実施形態は、2つ又はそれ以上の要素が互いに直接、物理的又は電気的接触をなすことを示すために、「接続された」及び/又は「結合された」という用語を用いて説明され得る。「結合された」という用語はまた、しかしながら、2つ又はそれ以上の要素が互いに直接、接触をなさないが、依然として互いに協働又は相互作用することをも意味し得る。例えばソフトウェア要素に関して言えば、「結合された」という用語は、インタフェース、メッセージインタフェース、アプリケーションプログラムインタフェース(API)、交換メッセージなどを指し得る。
参照により本明細書に組みこまれると述べられた任意の特許、公報、又は他の開示資料は、部分的にあるいは全体的に、その組み込まれた資料が既存の定義、記載内容、又は本開示に示した他の開示資料と矛盾しない範囲で本明細書に組みこまれることを理解されたい。このように、そして必要な範囲で、本明細書に明示的に記載されている開示は、参照により本明細書に組み込まれるいずれの矛盾する文献にも優先するものとする。参照により本明細書に組み込まれるものとされるが、既存の定義、記載、又は本明細書に記載される他の開示文献と矛盾するあらゆる文献、又はそれらの部分は、援用文献と既存の開示内容との間に矛盾が生じない範囲においてのみ組み込まれるものとする。
開示される実施形態は、通常の内視鏡及び開放手術器具における応用性、並びにロボット支援手術における応用性を有し得る。
本明細書で開示されるデバイスの実施形態は、1回の使用後に処分されるように設計されてもよく、あるいは、それらの実施形態は、複数回使用されるように設計されてもよい。実施形態は、いずれの場合も、少なくとも1回の使用後に再利用のために再調整され得る。かかる再調整には、デバイスの分解工程、それに続く特定の部品の洗浄又は交換工程、並びにその後の再組み立て工程の任意の組み合わせが含まれ得る。特に、デバイスの各実施形態は分解されてもよく、また、デバイスの任意の個数の特定の部片又は部品が、任意の組み合わせで選択的に交換されるか、あるいは取り外されてもよい。特定の部品の洗浄及び/又は交換の際、デバイスの各実施形態は、再調整用の施設で、又は外科手技の直前に外科チームによって、後の使用のために再組立てされてよい。当業者であれば、デバイスの再調整において、分解、洗浄/交換、及び再組み立てのための様々な技術を使用できる点は認識するであろう。かかる技術の使用、及びその結果として得られる再調整されたデバイスは、全て本出願の範囲内にある。
例に過ぎないが、本明細書で説明した実施形態は、手術前に処理されてもよい。まず、新品又は使用済みの器具が入手され、必要に応じて洗浄されてもよい。次いで器具を滅菌することができる。1つの滅菌技術では、器具は、プラスチックバッグ又はTYVEKバッグなど、閉鎖され封止される容器に入れられる。次いで、容器と器具は、ガンマ放射線、X線、又は高エネルギー電子など、容器を透過し得る放射線の場に置かれ得る。放射線により、器具上及び容器内の細菌が死滅され得る。次いで、滅菌された器具は、滅菌容器内に格納され得る。密封容器は、医療施設で開けられるまで、器具を滅菌状態に保ち得る。デバイスはまた、これらに限定されるものではないが、β線若しくはγ線、エチレンオキシド、又は水蒸気を含む、当該技術分野では既知の他の任意の技術を使用して滅菌することもできる。
当業者に理解されたいこととして、本明細書に記載した構成要素(例えば動作)、デバイス、目的、及びそれらに関連する論議は、構想を明らかにするための例として用いられており、様々な構成の変更が企図される。結果として、本明細書で用いるとき、記載した特定の例及びそれらに伴う論議は、より一般的な種類を代表することを意図したものである。一般に、特定の代表例を用いることは、その種類を代表することを意図したものであり、また、特定の構成要素(例えば動作)、デバイス、及び目的を含めないことは、限定するものと見なされるべきではない。
実質的に任意の複数及び/又は単数の用語を本明細書で用いることに関して言えば、当業者は、状況及び/又は用途に適切となるように、複数から単数へ、及び/又は単数から複数へ置き換えることができる。様々な単数/複数の置換えは、簡潔にするため、本明細書では明示的には記述されない。
本明細書に記載する主題はときに、種々の他の構成要素の中に含められた、又はそれらと接続された種々の構成要素を示している。理解されたいこととして、そのように表現したアーキテクチャは単なる例であり、実際に、同じ機能性を達成する多数の他のアーキテクチャが実現され得る。構想の意味で、同じ機能性を達成する構成要素の任意の配列が、所望の機能性を達成するように効果的に「関連付け」られる。したがって、特定の機能性を達成するように結合された任意の2つの構成要素は、アーキテクチャ又は中間の構成要素に関わらず、所望の機能性を達成するように互いに「関連付け」られたと見なされ得る。同様に、そのように関連付けられた任意の2つの構成要素もまた、所望の機能性を達成するように互いに「動作可能に接続」又は「動作可能に結合」されていると見なされることができ、また、そのように関連付けられることが可能な任意の2つの構成要素もまた、所望の機能性を達成するように互いに「動作可能に結合可能」であると見なされ得る。動作可能に結合可能である特定の例には、限定するものではないが、物理的に嵌合可能及び/若しくは物理的に相互作用する構成要素、並びに/又は、無線式で相互作用可能及び/若しくは無線式で相互作用可能な構成要素、並びに/又は、論理的に相互作用する、及び/若しくは論理的に相互作用可能な構成、要素が挙げられる。
いくつかの態様が、「結合された」及び「接続された」という表現を、それらの派生語と共に用いて説明され得る。これらの用語は互いに同義語とすることを意図したものではないことを理解されたい。例えば、いくつかの態様は、2つ又はそれ以上の要素が互いに直接、物理的又は電気的接触をなすことを示すために、「接続された」という用語を用いて説明され得る。別の例において、いくつかの態様は、2つ又はそれ以上の要素が直接、物理的又は電気的接触をなすことを示すために、「結合された」という用語を用いて説明され得る。「結合された」という用語はまた、しかしながら、2つ又はそれ以上の要素が互いに直接、接触をなさないが、依然として互いに協働又は相互作用することをも意味し得る。
場合によっては、1つ又は2つ以上の構成要素が、本明細書において、「ように構成される」、「ように構成可能である」、「ように動作可能である/動作する」、「適合される/適合可能である」、「ことが可能である」、「ように適合可能である/適合される」などと呼ばれることがある。当業者に理解されたいこととして、「ように構成される」は一般に、文脈上他の意味に解釈すべき場合を除き、アクティブ状態の構成要素及び/又は非アクティブ状態の構成要素及び/又はスタンドバイ状態の構成要素を包含することができる。
本明細書に記述した主題の特定の態様が図示され説明されているが、当業者には明らかとなるように、本明細書における教示に基づいて、変更及び修正が、本明細書に記述した主題及びその広範な態様から逸脱することなくなされ得、したがって、添付の特許請求の範囲は、全てのそのような変更及び修正を、本明細書に記述した主題の真の範囲内に含まれるものとして包含することになる。当業者には理解されることとして、一般に、本明細書で、そして特に添付の特許請求の範囲(例えば添付の特許請求の範囲の本文)で用いられる用語は概して「開放的」用語とすることを意図したものである(例えば、「含んで(including)」という用語は、「限定はしないが含んで(including but not limited to)」と解釈されるべきであり、「有して(having)」という用語は「少なくとも有して(having at least)」として解釈されるべきであり、「含む(includes)」という用語は「限定はしないが含む(includes but is not limited to)」と解釈されるべきである、など)。更に、導入されたクレーム記載(introduced claim recitation)において特定の数が意図される場合、そのような意図は当該クレーム中に明確に記載され、そのような記載がない場合は、そのような意図も存在しないことが当業者には理解されるであろう。例えば、理解を助けるものとして、後続の添付の特許請求の範囲では、「少なくとも1つの(at least one)」及び「1つ又は2つ以上の(one or more)」という導入句の使用が、クレーム記載を導入するために含まれることがある。しかし、そのような語句を使用するからといって、「a」又は「an」という不定冠詞によってクレーム記載を導入した場合に、たとえ同一のクレーム内に、「1つ又は2つ以上の」又は「少なくとも1つの」といった導入句と「a」又は「an」という不定冠詞との両方が含まれていても、そのような導入されたクレーム記載を含む特定のクレームが、そのような記載事項を1つのみ含むクレームに限定されるということが示唆されると解釈されるべきではない(例えば、「a」及び/又は「an」は、通常は、「少なくとも1つの」又は「1つ又は2つ以上の」を意味すると解釈されるべきである)。クレーム記載に導入するために用いられる定冠詞の使用についての同じことが言える。
更に、導入されたクレーム記載において特定の数が明示されている場合であっても、そのような記載は、通常、少なくとも記載された数を意味するように解釈されるべきであることは、当業者には理解されよう(例えば、他に修飾語のない、単なる「2つの記載事項」という記載がある場合、この記載は、少なくとも2つの記載事項、又は2つ又はそれ以上の記載事項を意味する)。更に、「A、B、及びCなどのうちの少なくとも1つ」に類する表記が用いられる場合、一般的に、そのような構文は、当業者がその表記を理解するであろう意味で意図されている(例えば、「A、B、及びCのうちの少なくとも1つを有するシステム」は、限定するものではないが、Aのみ、Bのみ、Cのみ、AとBの両方、AとCの両方、BとCの両方、及び/又はAとBとCの全て、などを有するシステムを含む)。「A、B、又はCなどのうちの少なくとも1つ」に類する表記が用いられる場合、一般的に、そのような構文は、当業者がその表記を理解するであろう意味で意図されている(例えば、「A、B、又はCのうちの少なくとも1つを有するシステム」は、限定するものではないが、Aのみ、Bのみ、Cのみ、AとBの両方、AとCの両方、BとCの両方、及び/又はAとBとCの全て、などを有するシステムを含む)。通常、2つ又はそれ以上の選択的な用語を表すあらゆる選言的な語及び/又は句は、説明文内であろうと、特許請求の範囲内であろうと、あるいは図面内であろうと、それら用語のうちの1つ、それらの用語のうちのいずれか、又はそれらの用語の両方を含む可能性を意図すると理解されるべきであることが、当業者には理解されよう。例えば、「A又はB」という句は通常、「A」又は「B」又は「A及びB」の可能性を含むと理解されよう。
添付の「特許請求の範囲」に関して言えば、当業者に明らかとなることとして、本明細書における引用した動作は一般に、任意の順序で実施されてよい。また、様々な動作上の流れがシーケンスで示されているが、理解されたいこととして、様々な動作は、図示した以外の順序で実施されてもよく、あるいは同時に実施されてもよい。そのような別の順序付けの例には、文脈上他の意味に解釈すべき場合を除き、重複、交互配置、割込み、再順序付け、増加的、予備的、追加的、同時、逆、又は他の異なる順序付けを挙げることができる。更に、「に応答する」、「に関連する」、又は他の過去時制の形容詞は一般に、文脈上他の意味に解釈すべき場合を除き、そのような変化形を除外するように意図するものではない。
手短に言えば、本明細書に記述した構想を用いる結果として得られる多数の利点について説明した。1つ又は複数の実施形態の上述の説明は、例示及び説明を目的として提示されたものである。網羅的なものにすること、又は、開示した厳密な形に限定することは意図されていない。上記の教示を鑑みれば、修正又は変形が可能である。1つ又は複数の実施形態は、原理及び実際の応用を説明し、それによって、様々な実施形態を様々な修正例と共に、企図される特定の用途に適するものとして当業者が利用できるようにするものである。本明細書と共に提出される「特許請求の範囲」が全体的な範囲を規定することが意図されている。
〔実施の態様〕
(1) 外科用器具であって、
ハンドルと、
移動可能な入力部と、
前記移動可能な入力部の位置を検出するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
入力チャネルを備えるマイクロコントローラであって、前記アナログセンサが、前記入力チャネルと信号通信し、前記マイクロコントローラが、前記アナログデータを基準値と比較するように構成され、前記マイクロコントローラが、前記比較に応答してデジタル信号を生成するように構成される、マイクロコントローラと、を備える、外科用器具。
(2) 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、前記アナログデータの各サンプルについてデジタルビットを生成するように構成される、実施態様1に記載の外科用器具。
(3) 前記マイクロコントローラが、サンプルが前記基準値より高い場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記基準値よりも低い場合、オフビットを生成するように構成される、実施態様2に記載の外科用器具。
(4) 前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成される、実施態様2に記載の外科用器具。
(5) 前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値より低い場合、オフビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値よりも高い場合、故障状態を生成するように構成され得る、実施態様4に記載の外科用器具。
(6) 前記マイクロコントローラが、サンプルが、前記第1の基準値と前記第2の基準値との間にある場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値より高い場合、オフビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値よりも低い場合、故障状態を生成するように構成され得る、実施態様4に記載の外科用器具。
(7) 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、出力チャネルを備え、前記マイクロコントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、実施態様1に記載の外科用器具。
(8) 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、出力チャネルを備え、前記マイクロコントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値未満である場合、オフビットを前記出力チャネルに供給するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値を超える場合、オンビットを前記出力チャネルに供給するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、実施態様1に記載の外科用器具。
(9) 前記アナログセンサが、ホール効果センサを含み、前記移動可能な入力部が、磁気素子を備え、前記磁気素子の移動が、前記ホール効果センサによって検出可能である、実施態様1に記載の外科用器具。
(10) 前記アナログセンサが、ホール効果センサ、磁気抵抗センサ、及び光学センサからなる群から選択される、実施態様1に記載の外科用器具。
(11) 前記ハンドルに装着可能なシャフト組立体を更に備え、前記シャフト組立体が、移動可能な顎部を備え、前記移動可能な入力部が、前記移動可能な顎部を移動させるように構成された閉鎖トリガーを備える、実施態様1に記載の外科用器具。
(12) 前記マイクロコントローラが、前記基準値を調整するように構成される、実施態様1に記載の外科用器具。
(13) 前記外科用器具が、メモリデバイスを更に備え、前記基準値が、前記メモリデバイスに記憶される、実施態様1に記載の外科用器具。
(14) 前記マイクロコントローラが、アルゴリズムによって動作され、前記基準値が、前記アルゴリズムに記憶される、実施態様1に記載の外科用器具。
(15) ステープルカートリッジを更に備える、実施態様1に記載の外科用器具。
(16) 外科用器具組立体であって、
移動可能な部分と、
前記移動可能な部分の位置を検出するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
入力チャネルを備えるプロセッサであって、前記アナログセンサが、前記入力チャネルと信号通信し、前記プロセッサが、前記アナログデータを基準値と比較するように構成され、前記プロセッサが、前記比較に応答してデジタル信号を生成するように構成される、プロセッサと、を備える、外科用器具組立体。
(17) 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記プロセッサが、出力チャネルを備え、前記プロセッサが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記プロセッサが、前記アナログデータを第2の基準値と比較するように構成され、前記プロセッサが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記プロセッサが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、実施態様16に記載の外科用器具組立体。
(18) 外科用器具であって、
トリガーを備えるハンドルであって、前記トリガーの作動が、外科用器具機能を生じるように構成され、前記トリガーが、磁気素子を備える、ハンドルと、
前記磁気素子の位置を追跡するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
コントローラであって、前記アナログセンサが、前記コントローラと信号通信し、前記コントローラが、前記アナログデータを基準値と比較するように構成され、前記コントローラが、前記比較に応答してデジタル信号を生成するように構成される、コントローラと、を備える、外科用器具。
(19) 前記コントローラが、前記アナログデータをサンプリングするように構成され、前記コントローラが、出力チャネルを備え、前記コントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記コントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記コントローラが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記コントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、実施態様18に記載の外科用器具。

Claims (19)

  1. 外科用器具であって、
    ハンドルと、
    移動可能な入力部と、
    前記移動可能な入力部の位置を検出するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
    入力チャネルを備えるマイクロコントローラであって、前記アナログセンサが、前記入力チャネルと信号通信し、前記マイクロコントローラが、前記アナログデータを基準値と比較するように構成され、前記マイクロコントローラが、前記比較に応答してデジタル信号を生成するように構成される、マイクロコントローラと、を備える、外科用器具。
  2. 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、前記アナログデータの各サンプルについてデジタルビットを生成するように構成される、請求項1に記載の外科用器具。
  3. 前記マイクロコントローラが、サンプルが前記基準値より高い場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記基準値よりも低い場合、オフビットを生成するように構成される、請求項2に記載の外科用器具。
  4. 前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成される、請求項2に記載の外科用器具。
  5. 前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値より低い場合、オフビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値よりも高い場合、故障状態を生成するように構成され得る、請求項4に記載の外科用器具。
  6. 前記マイクロコントローラが、サンプルが、前記第1の基準値と前記第2の基準値との間にある場合、オンビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値より高い場合、オフビットを生成するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値よりも低い場合、故障状態を生成するように構成され得る、請求項4に記載の外科用器具。
  7. 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、出力チャネルを備え、前記マイクロコントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、請求項1に記載の外科用器具。
  8. 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記マイクロコントローラが、出力チャネルを備え、前記マイクロコントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記マイクロコントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値未満である場合、オフビットを前記出力チャネルに供給するように構成され、前記マイクロコントローラが、サンプルが前記第2の基準値を超える場合、オンビットを前記出力チャネルに供給するように構成され、前記マイクロコントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、請求項1に記載の外科用器具。
  9. 前記アナログセンサが、ホール効果センサを含み、前記移動可能な入力部が、磁気素子を備え、前記磁気素子の移動が、前記ホール効果センサによって検出可能である、請求項1に記載の外科用器具。
  10. 前記アナログセンサが、ホール効果センサ、磁気抵抗センサ、及び光学センサからなる群から選択される、請求項1に記載の外科用器具。
  11. 前記ハンドルに装着可能なシャフト組立体を更に備え、前記シャフト組立体が、移動可能な顎部を備え、前記移動可能な入力部が、前記移動可能な顎部を移動させるように構成された閉鎖トリガーを備える、請求項1に記載の外科用器具。
  12. 前記マイクロコントローラが、前記基準値を調整するように構成される、請求項1に記載の外科用器具。
  13. 前記外科用器具が、メモリデバイスを更に備え、前記基準値が、前記メモリデバイスに記憶される、請求項1に記載の外科用器具。
  14. 前記マイクロコントローラが、アルゴリズムによって動作され、前記基準値が、前記アルゴリズムに記憶される、請求項1に記載の外科用器具。
  15. ステープルカートリッジを更に備える、請求項1に記載の外科用器具。
  16. 外科用器具組立体であって、
    移動可能な部分と、
    前記移動可能な部分の位置を検出するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
    入力チャネルを備えるプロセッサであって、前記アナログセンサが、前記入力チャネルと信号通信し、前記プロセッサが、前記アナログデータを基準値と比較するように構成され、前記プロセッサが、前記比較に応答してデジタル信号を生成するように構成される、プロセッサと、を備える、外科用器具組立体。
  17. 前記マイクロコントローラが、前記アナログデータをサンプリングするように構成され、前記プロセッサが、出力チャネルを備え、前記プロセッサが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記プロセッサが、前記アナログデータを第2の基準値と比較するように構成され、前記プロセッサが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記プロセッサが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、請求項16に記載の外科用器具組立体。
  18. 外科用器具であって、
    トリガーを備えるハンドルであって、前記トリガーの作動が、外科用器具機能を生じるように構成され、前記トリガーが、磁気素子を備える、ハンドルと、
    前記磁気素子の位置を追跡するように構成されたアナログセンサであって、アナログデータを含むアナログ信号を生成するように構成される、アナログセンサと、
    コントローラであって、前記アナログセンサが、前記コントローラと信号通信し、前記コントローラが、前記アナログデータを基準値と比較するように構成され、前記コントローラが、前記比較に応答してデジタル信号を生成するように構成される、コントローラと、を備える、外科用器具。
  19. 前記コントローラが、前記アナログデータをサンプリングするように構成され、前記コントローラが、出力チャネルを備え、前記コントローラが、前記デジタル信号を前記出力チャネルに通信するように構成され、前記基準値が、第1の基準値を含み、前記コントローラが、前記アナログデータを第2の基準値と比較するように構成され、前記コントローラが、サンプルが前記第1の基準値よりも低いか又は前記第2の基準値よりも高い場合、前記デジタル信号を変更するように構成され、前記コントローラが、サンプルが前記第1の基準値と前記第2の基準値との間にある場合、前記デジタル信号を変更しないように構成される、請求項18に記載の外科用器具。
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US14/226,093 US10028761B2 (en) 2014-03-26 2014-03-26 Feedback algorithms for manual bailout systems for surgical instruments
US14/226,075 US9743929B2 (en) 2014-03-26 2014-03-26 Modular powered surgical instrument with detachable shaft assemblies
US14/226,116 US20150272571A1 (en) 2014-03-26 2014-03-26 Surgical instrument utilizing sensor adaptation
US14/226,111 US9750499B2 (en) 2014-03-26 2014-03-26 Surgical stapling instrument system
US14/226,116 2014-03-26
US14/226,106 US20150272582A1 (en) 2014-03-26 2014-03-26 Power management control systems for surgical instruments
US14/226,125 US10201364B2 (en) 2014-03-26 2014-03-26 Surgical instrument comprising a rotatable shaft
US14/226,094 US20150272580A1 (en) 2014-03-26 2014-03-26 Verification of number of battery exchanges/procedure count
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