JP2013192954A - 外科用器具使用のデータの管理 - Google Patents
外科用器具使用のデータの管理 Download PDFInfo
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- JP2013192954A JP2013192954A JP2013057932A JP2013057932A JP2013192954A JP 2013192954 A JP2013192954 A JP 2013192954A JP 2013057932 A JP2013057932 A JP 2013057932A JP 2013057932 A JP2013057932 A JP 2013057932A JP 2013192954 A JP2013192954 A JP 2013192954A
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Abstract
【解決手段】 この外科用器具は、本体アセンブリ、及び選択的に連結可能なエンドエフェクタアセンブリを備えている。エンドエフェクタアセンブリは、送信用アセンブリ、及びエンドエフェクタを備えることができる。本体アセンブリは、トリガー、及び送信用アセンブリと連結するように構成されているケーシングを備えている。情報送信システムは、センサーから受信された器具情報を、例えば、外科用器具に接続された安全なゲートウェイを経由して、安全なサーバーへ送信する。外科用器具は、較正キットで事前に試験を行い、使用前に外科用器具に外科医が特定する設定値を予め決定し、ロードすることができる。
【選択図】 図1
Description
図1は、例示的な医療用装置(10)の構成要素を概略的ブロックフォームで示す。図示されるように、医療用装置(10)は、制御モジュール(12)、電源(14)、エンドエフェクタ(16)を備える。単に例示的な電源(14)には、NiMH電池、Liイオン電池(例えば、プリズムセル式リチウムイオン電池、等)、Ni−カドミ電池、又は本明細書の教示を考慮すれば当業者には明らかであると思われる任意の他のタイプの電源を含んでもよい。制御モジュール(12)は、マイクロプロセッサー、特定用途向け集積回路(ASIC)、メモリー、プリント回路基板(PCB)、記憶装置(例えば、ソリッドステートドライブ若しくはハードディスク)、ファームウェア、ソフトウェア、又は本明細書の教示を考慮すれば当業者には明らかであると思われる他の適切な任意の他の好適な制御モジュール部品を含んでもよい。制御モジュール(12)及び電源(14)は、回路基板等において、ケーブル及び/又はプリントパターン等の電気的接続(22)によって連結されて、電力を電源(14)から制御モジュール(12)へ運搬する。代替的に、電源(14)は、制御モジュール(12)に選択的に連結されてもよい。このことによって、電源(14)を医療用装置(10)から切り離し、かつ取り外すことが可能となり、そのことによって、例えば、本明細書の様々な教示に従って、再滅菌及び再使用を行うため電源(14)を容易に再充電又は再利用することが更に可能となる。加えて又は代替的に、制御モジュール(12)は、アフターサービス、試験、交換、又は本明細書の教示を考慮すれば当業者には明らかであると思われる他のあらゆる目的のために取り外されることが可能である。
図2は、医療用装置(10)がとることのできる、単に例示的な形態を表す。図2は、超音波外科用器具(24)と、カートリッジ(26)と、ジェネレイタ(28)と、ジェネレイタ(28)を外科用器具(50)に連結することのできるケーブル(30)とを備える例示的な超音波外科用システム(50)を示す。好適なジェネレイタ(28)は、GEN300(Cincinnati,OhioのEthicon Endo−Surgery,Inc.により販売)である。ほんの一例として、ジェネレイタ(28)は、発明の名称「Surgical Generator for Ultrasonic and Electrosurgical Devices」、2011年4月14日公開の米国特許出願公開第2011/0087212号、及び発明の名称「Surgical Instrument with Modular Shaft and End Effector」、2011年10月10日出願の米国特許出願第13/269,870号(それら明細書の開示内容は、参照により本明細書に組み入れられる)の教示に従って構成され得る。外科用器具(50)は超音波外科器具を参照して記載されるが、以下に記載する技術は、本明細書の教示を考慮することで当業者には明かとなるであろうように、エンドカッター、把持具、カッター、ステープラー、クリップ適用器具、アクセス装置、薬物/遺伝子治療送達装置、及び超音波、無線周波数、レーザー等を使用するエネルギー送達装置、及び/又はこれらの任意の組み合わせを含むが、これらに限定されない多様な外科器具と共に使用できることに留意するべきである。また、本実施例は、ケーブル接続による外科器具(50)を参照して記載されるが、外科器具(50)は、その開示が参照により本明細書に組み込まれる、「Cordless Hand−held Ultrasonic Cautery Cutting Device」と題された2009年6月4日公開の米国特許出願公開第2009/0143797号に開示されているもの等のコードレス変換器を含んでもよいということが理解されるである。更に、手術装置(50)は、2004年8月31日に発行された「Robotic Surgical Tool with Ultrasound Cauterizing and Cutting Instrument」と題する米国特許第6,783,524号に開示されたようなロボット支援手術環境で使用されるか使用するように適応されてもよい。
超音波エネルギーを用いて組織を手術するように構成されている外科用器具もあれば、電気エネルギー及び/又は熱エネルギー、等の他の種類のエネルギーを患者の組織に供給するように構成し得る、図3〜4に示されるような外科用器具(159)等の外科用器具もある。
本実施例の電気的外科用器具(159)は、ハンドピース(160)と、ハンドピース(160)から遠位に延びる送信用アセンブリ又はシャフト(170)と、シャフト(170)の遠位端に配置されるエンドエフェクタ(180)とを具備する。本実施例のハンドピース(160)は、ピストル形握り(162)と、旋回運動するトリガー(164)と、起動ボタン(166)と、連結制御器機器(168)とを具備する。トリガー(164)は、ピストル形握り(162)に向かって、かつ、ピストル形握り(162)から離れて旋回心軸で回転し、以下により詳細に記述されるようなエンドエフェクタ(180)を選択的に駆動させることができる。起動ボタン(166)は、米国特許出願シリアル番号第13/235,660号、及び/又は本明細書で引用され、参照されることによって本明細書に組み入れられる他の様々な参考文献に記述される方法で、エンドエフェクタ(180)と連通する無線周波回路を選択的に作動させることができる。幾つかのバージョンにおいて、起動ボタン(166)もまた、ボタン(166)が同時に押圧されなければ、トリガー(164)は十分に作動し得ないような具合に、トリガー(164)に対する機械的ロックアウトとして機能する。そのようなロックアウトを提供し得る方法の例は、本明細書で引用される参考文献の1つ又は2つ以上に開示される。ピストル形握り(162)、トリガー(164)及びボタン(166)は、あらゆる適切な方法で一部変更、置き換え、補足、等を行うことができ、しかも、本明細書における、それら構成要素に関する記述は、単に例示的であるものと解釈されるべきである。本実施例の連結制御器168は、米国特許出願シリアル番号第13/235,660号(その明細書は、参照により本明細書に組み入れられる)に記述される方法でシャフト(170)の連結セクション(176)を選択的に制御することができる。
本実施例のエンドエフェクタ(180)は、第1のジョー(182)と、第2のジョー(184)とを具備する。本実施例において、第2のジョー(184)は、シャフト(170)に対してしっかり固定され、他方、第1のジョー(182)は、シャフト(170)に対して、第2のジョー(184)に向かって、かつ、第2のジョー(184)から離れて旋回心軸で回転する。幾つかのバージョンにおいて、ロッド又はケーブル等の駆動部は、シース(172)を通って延びることが可能であり、かつ、シャフト(170)による駆動部のロッド/ケーブル/等の長手方向の運動が、シャフト(170)に対して、かつ、第2のジョー(184)に対して第1のジョー(182)の旋回運動を提供するような具合に、旋回継手(pivotal coupling)(183)において第1のジョー(182)と接合されることが可能である。当然ながら、ジョー(182、184)は、その代わりに、他の適切ないかなる種類の運動をも行うことができ、かつ、他の適切なあらゆる方法で駆動されてもよい。ほんの一例として、また、以下により詳細に記述されるように、ジョー(182、184)は、駆動され、したがって、幾つかのバージョンにおいて、駆動部のロッド/ケーブル/等が単に排除され得るような具合に、発射レバー(195)の長手方向の並進運動によって閉じられることが可能である。
更に図4〜5に示されるように、本実施例の電気的外科用器具(159)は、エンドエフェクタ(180)の長さの一部分に沿って長さ方向に移動させることのできる発射ビーム(firing beam)(195)を具備する。発射ビーム(195)は、シャフト(170)内部において同軸上に位置決めされ、シャフト(170)の長さに沿って延び、また、(本実施例における連結セクション(176)を含む)シャフト(170)内部において長手方向に移動するが、発射ビーム(195)とシャフト(170)とは、任意の他の適切な関係を有することができるものと解釈されるべきである。発射ビーム(195)は、鋭利な遠位ブレード(197)と、上部フランジ(196)と、(図示されない)下部フランジとを具備する。発射ビーム(195)は、米国特許出願シリアル番号第13/235,660号の教示及び/又は本明細書で引用され、参照されることによって、本明細書に組み込まれる他の様々な参考文献の教示に従って、構成され、かつ操作されることが可能である。遠位ブレード(197)は、ジョー(182、184)のスロット(186、188)を通って延び、上部フランジ(196)は、(図示されていない)窪みの中に上部ジョー(184)が設置されており、また、(図示されていない)下部フランジは、図示されていない)窪みの中に下部ジョー(182)が設置されている。遠位ブレード(197)と、上部フランジ(196)と、(図示されていない)下部フランジとの相対的配置は、発射ビーム(195)の遠位端において、「I−レバー」タイプの横断面を提供し、また、米国特許出願シリアル番号第13/235,660号の教示及び/又は本明細書で引用され、参照されることによって、本明細書に組み込まれる他の様々な参考文献の教示に従って、構成され、かつ、操作されることが可能である。
例示的な使用方法において、エンドエフェクタ(180)は、套管針(トロカール)を通って患者の中に挿入される。エンドエフェクタ(180)と、シャフト(170)の一部とが套管針を通って挿入されるとき、連結セクション(176)は、実質的に一直線である。そのとき、エンドエフェクタ(180)を、患者内部の解剖学的構造に対して所望の位置及び方向に位置付けるために、連結制御装置168を操作して、シャフト(170)の連結セクション(176)を旋回心軸で回転させるか、又は収縮させることができる。そのとき、解剖学的構造の組織の2つの層は、トリガー(164)をピストル形グリップ(162)の方に強く握ることによって、ジョー(182、184)の間に捕捉される。そのような組織層は、患者の解剖学的構造の範囲を限定する同一の自然内腔(例えば、血管、胃腸管の一部分、生殖器官の一部分、等)の一部であることがある。例えば、一方の組織層は、(例えば、電気的外科用器具(159)を使用する前の、血管による流体経路が、エンドエフェクタ(180)等によって範囲が限定される長手方向軸に垂直であるような具合に、)血管の長さの同一部位に沿って、血管の頂部を含むことがあり、一方、他の組織層は、血管の底部を含むことがある。換言すれば、ジョー(182、184)の長さは、血管の長さに対して垂直に(又は少なくとも概して横に)方向を合わせることができる。上述のように、フランジ(162、166)は、カムの作用によって、トリガー(164)をピストル形グリップ(162)の方に強く圧力をかけることによって、発射ビーム(195)が遠位に作動するとき、ジョー(182)をジョー(184)に向かって旋回心軸で回転させるように作動する。
幾つかの事例において、同一のハンドルアセンブリ(60、120、160)を用いながら、様々なシャフト長さ及び/又は様々なタイプのエンドエフェクタ(16、80、150、180)の間で変化することは有用であり得る。例えば、幾つかの処置において、大量の組織を切断する必要があり、様々な長さのエンドエフェクタ(80、150、180)、及び/又は送信用アセンブリ(70、102、170)のためのシャフトを必要とすることがある。そのような交換可能なシャフト及び/又はエンドエフェクタ(80、150、180)は、様々な外科的処置(例えば、開腹手術のための短いシャフト、低侵襲的腹腔鏡手術のための長いシャフト等)のために通常のハンドルアセンブリ(60、120、160)が用いられるのを可能にすることができる。更に、シャフト及び/又はエンドエフェクタ(80、150、180)を交換し、同時に同一のハンドルアセンブリ(60、120、160)を再使用することは、様々な長さのシャフトを備えた新たな外科用器具(50、101、159)を使用することに比べて、時間効率及び/又はコスト効率がより高いかもしれない。ほんの一例として、そのようなシャフト及び/又はエンドエフェクタ(80、150、180)は、様々な長さ及び/又は種類を識別するためのカラーコードを備えることができる。もう1つの事例において、ハンドルアセンブリ(60、120、160)は、様々なタイプのエンドエフェクタを用いるように構成されることが可能である。例えば、ハンドルアセンブリ(60、120、160)は、超音波エンドエフェクタ(80、150)及び/又は無線周波エンドエフェクタ(180)を操作するための諸構成要素を具備することができる。このように、シャフト及び/又はエンドエフェクタ(80、150、180)を通常のハンドルアセンブリ(60、120、160)と交換することによって、時間及び/又はコストを節約することができる。したがって、モジュラーシャフトをハンドルアセンブリ(60、120、160)に連結するための様々な連結機構を以下に記述する。超音波エンドエフェクタ(80)が用いられるバージョンにおいて、変換器(100)の少なくとも一部分は、シャフト及びエンドエフェクタ(80)と一体になっていてもよいし、また、したがって、ハンドルアセンブリ(60)と選択的に連結されてもよい。代わりに、変換器(100)は、シャフト及びエンドエフェクタ(80)がハンドルアセンブリ(60)と選択的に連結されるとき、シャフト及びエンドエフェクタ(80)が変換器(100)と選択的に連結されるような具合に、ハンドルアセンブリ(60)と一体になっていてもよい。
図7は、情報を送信するための装置(10)を用いた、情報送信システム(300)の概略図を示す。様々な種類の装置又は器具(10、24、101、159)は、取り外し可能なエンドエフェクタ(16、80、150、180)、各々の送信用アセンブリ(70、102、170)、及び再使用可能なハンドルアセンブリ(60、120、160)であって、上述のように、様々なシャフトの長さ及び/又はタイプの間で変えることは有用であるかもしれないものと一緒にシステム(300)の中で使用されることが可能であるものと解釈されるべきである。装置(10)は、上述のように、ジェネレイタ(28)に接続されるように示される。とは言え、ジェネレイタ(28)は、装置(10)の中に組み込まれるか、又は幾つかのバージョンでは省略されることが可能である。装置(10)中のセンサー(20)は、器具(24、101、159)のいずれかに具備されることが可能であるが、患者に外科的処置が行われる間、装置(10)の使用に関する情報を収集することができる。そのような情報は、ジェネレイタ(28)に送信されることが可能であり、ジェネレイタ(28)は、次いで、その情報を安全なゲートウェイ(302)を経由して安全なサーバー(304)へ送信する。本実施例の安全なゲートウェイ(302)は、セキュアWebゲートウェイ(SWG)技術であって、ジェネレイタ(28)とサーバー(304)との間のトラフィックを安全にし、モニターし、かつ制御するため(そのようなトラフィックが暗号化されるかどうかとは関係なく)、非破壊工作ソフト、URLフィルタリング、Webコンテンツフィルタリング、帯域幅管理(bandwidth management)、アプリケーション・コントロール、及び/又はキャッシングケイパビリティ(caching capabilities)、等の機能を組み合わせたSWG技術を含む。サーバー(304)は、ホスピタルネットワーク外部の安全なサーバーであっても良く、その情報を、安全ウェブインターフェース(306)を経由して固有の患者ファイル(308)へ連通する。患者ファイル(308)は、外科的処置の間、装置(10)が用いられた第1の患者に特有の患者病歴を含み、その患者ファイル(308)から情報は収集され、送信される。第1の患者に用いられた特定の装置(10)及び構成要素は、例えば、追跡記録され、次いで、図7に示される装置を経て、患者ファイル(308)の中に入れられることが可能である。情報は、第1の患者に対して行われた関連する外科的処置において、装置(10)を使用した直後、患者ファイル(308)に共用されることが可能である。病院が、患者に関連する全体験の全体にわたって、患者のケアを追跡することを望む限りにおいて、システム(300)は、ツール、サービス、及び材料の種類であって、患者の病院体験の間、患者に対して、又は患者のために用いられたもののような情報を含むが、それらに限定されず、特定の外科的処置の間、患者に対して使用された装置(10)に関する所望の情報を提供することによって、システム(300)は、この目的を支援する。例えば、装置(10)等のデバイスと、それの取り付けられた取り外し可能な構成要素とが、患者に使用された時間の量、そのような使用に関連する電気特性、並びに使用されたデバイス及び/又はデバイスの構成要素のタイプのような情報を追跡することによって、コストは、その追跡された情報に基づいて計算されることが可能である。更に、そのような情報を追跡すること、及びデータのモニタリングを追跡することによって、今後の外科的改善のための分析及び推奨は、追跡された処置のデータから得られて、結果を改善し、今後の類似の外科的手術のための最優良事例を確立することができる。システム(300)を使用する病院は、装置(10)を用いる間に追跡されたデータのどのタイプが、外科的処置の間、装置(10)が使用された特定の患者に関連するかを制御することができ、このようにして、そのデータは、患者ファイル(308)の中で見る価値がある。システム(300)は、下述のように、セキュアプロセスを経て、情報を送信する。
図9〜12は、患者に対する外科的処置の間、装置(10)で、例えば、装置(10)のセンサー(20)を経て、追跡可能なサンプル器具の使用特性のグラフ図を示す。センサー(20)は、一例において、外科的処置の間、外科医が装置(10)で使用する技術を追跡することができる。センサー(20)からのフィードバックは、例えば、有線又は無線の接続を経て、サーバー(304)等の受信装置、又はコンピュータ若しくはスマートフォン等の他の適切な装置へ送信されることが可能である。そのとき、ソフトウェアプログラムを使用し、例えば、米国特許出願第13/276,725号(その明細書の開示内容は、参照により本明細書に組み入れられる)の教示に従って、記述されるような方法で、外科医、手術室(「OR」)のスタッフ、生物医学の研究者、又は他の人々によって使用されるように、送信データを分析することができる。
図13A及び13Bは、較正キットを用いて、例えば、処置の間、装置(10)のための少なくとも1つの選ばれたAppに適用されることが可能である結果のセッティングを設定し、かつ記憶するプロセスを表す。このプロセスを用いて、各々の外科医のために、異常な外科技術/傾向のようなユニークな使用の特異性を学び、かつ説明して、一貫性のある手術の成績を助長することができる。Appとして上述される、年代測定ができる所望のエンドエフェクタ、及び/又はシャフトアセンブリが、使用者によって選択される(600)。加えて、較正キットが設定される(602)。較正キットは、例えば、既知のパラメータと特性とを有する合成組織モデル、ブタの脇腹肉等の組織、又は他の適切な試験可能な有機組織及び/若しくは合成組織、適切な試験可能な源(例えば、ブタ)由来のサンプル導管、並びに試験可能な源由来の他の適切な試験可能なパーツだけでなく、有機体及び/又は合成品であってもよい他の適切な試験可能な材料を包含することができる。較正キットは、データを集めて、外科医の使用行為と装置(10)に関する好みとの試験、例えば、外科的処置の間、患者に関する使用法を試験する前の試験材料に関する試験を行うのを助ける様々な材料を含む。例えば、外科医が加えることを望む好ましい力、外科医が用いる傾向がある平均速度、及び/又は本明細書の教示を考慮すれば当業者には明らかであると思われる他のパラメータのような、幾つかの様々なパラメータは、追跡され、較正されることが可能である。本実施例において、ジェネレイタ(28)は、較正モードと、少なくとも1種類の外科的処置のモードとの間の選択を提供する。
(1) 外科用器具システムであって、
(a)外科用器具であって、
(i)様々な種類のエンドエフェクタアセンブリと連通することができる本体、
(ii)前記本体と取り外し可能なように連結されているモジュール式エンドエフェクタアセンブリ、
(iii)前記エンドエフェクタを作動させることのできる電源、及び
(iv)前記エンドエフェクタと関連する情報を送信するように構成されているセンサー、を備える外科用器具と、
(b)前記センサー又は前記電源の少なくとも一方からのデータを受信することのできる記憶装置と、
を具備する、外科用器具システム。
(2) 前記電源は、前記記憶装置へ情報を送信するように構成されているジェネレイタを備える、実施態様1に記載の外科用器具システム。
(3) 前記センサーは、前記ジェネレイタから電力を受け取るように構成されており、前記電力を受け取ると同時に、前記センサーは前記ジェネレイタへ情報を送信するように構成されている、実施態様2に記載の外科用器具システム。
(4) 前記記憶装置は、ゲートウェイ及びサーバーを備えて、前記ゲートウェイは、前記サーバーに対してセキュアキーを求めるコールを起動するように構成されている、実施態様2に記載の外科用器具システム。
(5) 前記サーバーは、前記セキュアキーを用いて前記ゲートウェイに応答するように構成されている、実施態様4に記載の外科用器具システム。
(7) 前記ゲートウェイは、前記サーバーへの情報のアップロードを起動するように構成されている、実施態様5に記載の外科用器具システム。
(8) 前記サーバーは、前記アップロードされた情報を患者カルテ情報へ送信するように構成されている、実施態様7に記載の外科用器具システム。
(9) 前記アップロードされた情報は、エンドエフェクタアセンブリの振動データ、又はエンドエフェクタアセンブリの使用時間データの少なくとも一方を含む、実施態様8に記載の外科用器具システム。
(10) 前記患者カルテ情報は、前記エンドエフェクタアセンブリの振動データ、又は前記エンドエフェクタアセンブリの使用時間データ(time usage data)の少なくとも一方に基づいてコストを計算するように構成されているソフトウェア・アプリケーションを含む、実施態様9に記載の外科用器具システム。
(12) 前記ソフトウェア・アプリケーションは、1つ又は2つ以上の患者カルテ情報からアップロードされた情報を解析して、前記本体或いは1つ又は2つ以上のエンドエフェクタアセンブリの少なくとも一方の、外科医専用の使用に関する報告書を作成するように構成されている、実施態様10に記載の外科用器具システム。
(13) 前記センサーは加速度計を備える、実施態様1に記載の外科用器具システム。
(14) 前記記憶装置は、病院のネットワークの外部に安全なサーバーを有する、実施態様1に記載の外科用器具システム。
(15) 前記電源は、前記センサー、前記本体、又は前記エンドエフェクタアセンブリの少なくとも1つの、1つ又は2つ以上のシリアル番号を受信するように構成されている、実施態様1に記載の外科用器具システム。
(a)前記器具が用いられる時、又は前記器具が第1の患者に対する処置に用いられた後、前記外科用器具の前記取り外し可能な送信用アセンブリ、前記エンドエフェクタ、又は前記本体の少なくとも1つに配置されるセンサーを経て、データを捕捉する工程と、
(b)前記データを前記センサーから、プロセッサーを経由して、安全なゲートウェイまでアップロードする工程と、
(c)セキュアキーの認証を起動する工程と、
(d)前記セキュアキーの認証に基づいて、前記アップロードされたデータを、前記プロセッサーを経て、安全なサーバーへ送信する工程と、
を含む、方法。
(17) (a)前記外科用器具の前記取り外し可能な送信用アセンブリ、前記エンドエフェクタ、又は前記本体の少なくとも1つに関連する1つ又は2つ以上の固有シリアル番号を前記ジェネレイタにアップロードする工程と、
(b)前記アップロードされたデータを、前記安全なサーバーから前記第1の患者の患者カルテ情報へ送信する工程と、
(c)前記情報を、前記プロセッサーを経由してディスプレイ画面に表示する工程と、
を更に含む、実施態様16に記載の方法。
(18) 前記アップロードされたデータを患者カルテ情報へ送信する工程は、エンドエフェクタの振動データ、又はエンドエフェクタの使用時間データの少なくとも一方を含むアップロードされたデータを送信する工程を含み、
(a)前記エンドエフェクタの振動データ、又は前記エンドエフェクタの使用時間データの少なくとも一方に基づくコストを計算する工程と、
(b)前記コストを、前記プロセッサーを経由して前記ディスプレイ画面に表示する工程と、
(c)前記本体、前記取り外し可能な送信用アセンブリ、又は前記エンドエフェクタの少なくとも1つの、1つ又は2つ以上の製造業者又は供給メーカーに前記コストを送信する工程と、
を更に含む、実施態様17に記載の方法。
(19) 1つ又は2つ以上の患者カルテ情報からのアップロードされたデータを解析して、前記本体、1つ又は2つ以上の取り外し可能な送信用アセンブリ、或いは1つ又は2つ以上のエンドエフェクタの少なくとも1つの、外科医専用の使用に関する報告書を作成する工程を更に含む、実施態様17に記載の方法。
(20) 較正された設定値を、ジェネレイタと連通する外科用器具に記憶するための方法であって、前記外科用器具が、本体から遠位に延びる選定された取り外し可能な送信用アセンブリを含み、選定されるエンドエフェクタが前記送信用アセンブリの遠位端に配置される、方法であって、
(a)エンドエフェクタアセンブリを前記器具本体と連結して、第1の組立てられた外科用器具を提供する工程と、
(b)前記ジェネレイタが較正モードである間に、較正キットの材料で前記第1の組立てられた外科用器具を使用する工程であって、前記ジェネレイタは、前記較正キットの前記第1の組立てられた外科用器具を使用する行為に基づいて、較正された使用設定値を選定又は確立することができる、工程と、
(c)前記エンドエフェクタアセンブリを前記器具本体から切り離す工程と、
(d)もう1つのエンドエフェクタアセンブリを前記器具本体に連結して、第2の組立てられた外科用器具を提供する工程と、
(e)外科的処置において、前記第2の組立てられた外科用器具を使用する工程であって、前記ジェネレイタは、前記確立された較正された使用設定値に従って、前記エンドエフェクタを駆動することができる、工程と、を含む、方法。
Claims (20)
- 外科用器具システムであって、
(a)外科用器具であって、
(i)様々な種類のエンドエフェクタアセンブリと連通することができる本体、
(ii)前記本体と取り外し可能なように連結されているモジュール式エンドエフェクタアセンブリ、
(iii)前記エンドエフェクタを作動させることのできる電源、及び
(iv)前記エンドエフェクタと関連する情報を送信するように構成されているセンサー、を備える外科用器具と、
(b)前記センサー又は前記電源の少なくとも一方からのデータを受信することのできる記憶装置と、
を具備する、外科用器具システム。 - 前記電源は、前記記憶装置へ情報を送信するように構成されているジェネレイタを備える、請求項1に記載の外科用器具システム。
- 前記センサーは、前記ジェネレイタから電力を受け取るように構成されており、前記電力を受け取ると同時に、前記センサーは前記ジェネレイタへ情報を送信するように構成されている、請求項2に記載の外科用器具システム。
- 前記記憶装置は、ゲートウェイ及びサーバーを備えて、前記ゲートウェイは、前記サーバーに対してセキュアキーを求めるコールを起動するように構成されている、請求項2に記載の外科用器具システム。
- 前記サーバーは、前記セキュアキーを用いて前記ゲートウェイに応答するように構成されている、請求項4に記載の外科用器具システム。
- 前記ゲートウェイは、前記セキュアキーを認証するように構成されている、請求項5に記載の外科用器具システム。
- 前記ゲートウェイは、前記サーバーへの情報のアップロードを起動するように構成されている、請求項5に記載の外科用器具システム。
- 前記サーバーは、前記アップロードされた情報を患者カルテ情報へ送信するように構成されている、請求項7に記載の外科用器具システム。
- 前記アップロードされた情報は、エンドエフェクタアセンブリの振動データ、又はエンドエフェクタアセンブリの使用時間データの少なくとも一方を含む、請求項8に記載の外科用器具システム。
- 前記患者カルテ情報は、前記エンドエフェクタアセンブリの振動データ、又は前記エンドエフェクタアセンブリの使用時間データの少なくとも一方に基づいてコストを計算するように構成されているソフトウェア・アプリケーションを含む、請求項9に記載の外科用器具システム。
- 前記サーバーは、前記本体若しくは前記エンドエフェクタアセンブリの少なくとも一方の1つ又は2つ以上の製造業者又は供給メーカーに前記コストを送信するように構成されている、請求項10に記載の外科用器具システム。
- 前記ソフトウェア・アプリケーションは、1つ又は2つ以上の患者カルテ情報からアップロードされた情報を解析して、前記本体或いは1つ又は2つ以上のエンドエフェクタアセンブリの少なくとも一方の、外科医専用の使用に関する報告書を作成するように構成されている、請求項10に記載の外科用器具システム。
- 前記センサーは加速度計を備える、請求項1に記載の外科用器具システム。
- 前記記憶装置は、病院のネットワークの外部に安全なサーバーを有する、請求項1に記載の外科用器具システム。
- 前記電源は、前記センサー、前記本体、又は前記エンドエフェクタアセンブリの少なくとも1つの、1つ又は2つ以上のシリアル番号を受信するように構成されている、請求項1に記載の外科用器具システム。
- 外科用器具と連通するジェネレイタからの情報をアップロードするための方法であって、前記外科用器具は、本体から遠位に延びる取り外し可能な送信用アセンブリを含み、前記送信用アセンブリの遠位端にエンドエフェクタが配置される、方法であって、
(a)前記器具が用いられる時、又は前記器具が第1の患者に対する処置に用いられた後、前記外科用器具の前記取り外し可能な送信用アセンブリ、前記エンドエフェクタ、又は前記本体の少なくとも1つに配置されるセンサーを経て、データを捕捉する工程と、
(b)前記データを前記センサーから、プロセッサーを経由して、安全なゲートウェイまでアップロードする工程と、
(c)セキュアキーの認証を起動する工程と、
(d)前記セキュアキーの認証に基づいて、前記アップロードされたデータを、前記プロセッサーを経て、安全なサーバーへ送信する工程と、
を含む、方法。 - (a)前記外科用器具の前記取り外し可能な送信用アセンブリ、前記エンドエフェクタ、又は前記本体の少なくとも1つに関連する1つ又は2つ以上の固有シリアル番号を前記ジェネレイタにアップロードする工程と、
(b)前記アップロードされたデータを、前記安全なサーバーから前記第1の患者の患者カルテ情報へ送信する工程と、
(c)前記情報を、前記プロセッサーを経由してディスプレイ画面に表示する工程と、
を更に含む、請求項16に記載の方法。 - 前記アップロードされたデータを患者カルテ情報へ送信する工程は、エンドエフェクタの振動データ、又はエンドエフェクタの使用時間データの少なくとも一方を含むアップロードされたデータを送信する工程を含み、
(a)前記エンドエフェクタの振動データ、又は前記エンドエフェクタの使用時間データの少なくとも一方に基づくコストを計算する工程と、
(b)前記コストを、前記プロセッサーを経由して前記ディスプレイ画面に表示する工程と、
(c)前記本体、前記取り外し可能な送信用アセンブリ、又は前記エンドエフェクタの少なくとも1つの、1つ又は2つ以上の製造業者又は供給メーカーに前記コストを送信する工程と、
を更に含む、請求項17に記載の方法。 - 1つ又は2つ以上の患者カルテ情報からのアップロードされたデータを解析して、前記本体、1つ又は2つ以上の取り外し可能な送信用アセンブリ、或いは1つ又は2つ以上のエンドエフェクタの少なくとも1つの、外科医専用の使用に関する報告書を作成する工程を更に含む、請求項17に記載の方法。
- 較正された設定値を、ジェネレイタと連通する外科用器具に記憶するための方法であって、前記外科用器具が、本体から遠位に延びる選定された取り外し可能な送信用アセンブリを含み、選定されるエンドエフェクタが前記送信用アセンブリの遠位端に配置される、方法であって、
(a)エンドエフェクタアセンブリを前記器具本体と連結して、第1の組立てられた外科用器具を提供する工程と、
(b)前記ジェネレイタが較正モードである間に、較正キットの材料で前記第1の組立てられた外科用器具を使用する工程であって、前記ジェネレイタは、前記較正キットの前記第1の組立てられた外科用器具を使用する行為に基づいて、較正された使用設定値を選定又は確立することができる、工程と、
(c)前記エンドエフェクタアセンブリを前記器具本体から切り離す工程と、
(d)もう1つのエンドエフェクタアセンブリを前記器具本体に連結して、第2の組立てられた外科用器具を提供する工程と、
(e)外科的処置において、前記第2の組立てられた外科用器具を使用する工程であって、前記ジェネレイタは、前記確立された較正された使用設定値に従って、前記エンドエフェクタを駆動することができる、工程と、を含む、方法。
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US11848093B2 (en) | 2023-12-19 |
US20240105306A1 (en) | 2024-03-28 |
EP2642418B1 (en) | 2021-10-06 |
US20220415474A1 (en) | 2022-12-29 |
JP6305685B2 (ja) | 2018-04-04 |
EP3955259A3 (en) | 2022-06-15 |
EP3955259A2 (en) | 2022-02-16 |
US20200045132A1 (en) | 2020-02-06 |
EP2642418A2 (en) | 2013-09-25 |
US20130253480A1 (en) | 2013-09-26 |
AU2013201085A1 (en) | 2013-10-10 |
CN103315780A (zh) | 2013-09-25 |
CA2809441A1 (en) | 2013-09-22 |
US11456068B2 (en) | 2022-09-27 |
CA2809441C (en) | 2022-02-15 |
EP2642418A3 (en) | 2016-10-26 |
US10455052B2 (en) | 2019-10-22 |
US20150358426A1 (en) | 2015-12-10 |
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