JP7130751B2 - 装置及びデータ機能の状態ハンドリングを伴うインタラクティブ外科システム - Google Patents
装置及びデータ機能の状態ハンドリングを伴うインタラクティブ外科システム Download PDFInfo
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Description
本出願は、米国特許法第119条(e)の下で、その開示は参照によりその全体が本明細書に組み込まれる、「INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES」と題する2018年3月28日出願の米国特許仮出願第62/649,302号に対する優先権の利益を主張する。
・「INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES」と題する米国特許仮出願第62/649,302号、
・「DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD」と題する米国特許仮出願第62/649,294号、
・「SURGICAL HUB SITUATIONAL AWARENESS」と題する米国特許仮出願第62/649,300号、
・「SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER」と題する米国特許仮出願第62/649,309号、
・「COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS」と題する米国特許仮出願第62/649,310号、
・「USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT」と題する米国特許仮出願第62/649,291号、
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES」と題する米国特許仮出願第62/649,296号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER」と題する米国特許仮出願第62/649,333号、
・「CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES」と題する米国特許仮出願第62/649,327号、
・「DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK」と題する米国特許仮出願第62/649,315号、
・「CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES」と題する米国特許仮出願第62/649,313号、
・「DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,320号、
・「AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,307号、及び
・「SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許仮出願第62/649,323号。
・「INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES」と題する米国特許出願第____________号、代理人整理番号END8499USNP/170766、
・「SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES」と題する米国特許出願第____________号、代理人整理番号END8499USNP2/170766-2、
・「SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS」と題する米国特許出願第____________号、代理人整理番号END8499USNP3/170766-3、
・「COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS」と題する米国特許出願第____________号、代理人整理番号END8499USNP4/170766-4、
・「SURGICAL HUB CONTROL ARRANGEMENTS」と題する米国特許出願第____________号、代理人整理番号END8499USNP5/170766-5、
・「DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD」と題する米国特許出願第____________号、代理人整理番号END8500USNP/170767、
・「COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS」と題する米国特許出願第____________号、代理人整理番号END8500USNP1/170767-1、
・「SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT」と題する米国特許出願第____________号、代理人整理番号END8500USNP2/170767-2、
・「DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME」と題する米国特許出願第____________号、代理人整理番号END8500USNP3/170767-3、
・「SURGICAL HUB SITUATIONAL AWARENESS」と題する米国特許出願第____________号、代理人整理番号END8501USNP/170768、
・「SURGICAL SYSTEM DISTRIBUTED PROCESSING」と題する米国特許出願第____________号、代理人整理番号END8501USNP1/170768-1、
・「AGGREGATION AND REPORTING OF SURGICAL HUB DATA」と題する米国特許出願第____________号、代理人整理番号END8501USNP2/170768-2、
・「SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER」と題する米国特許出願第____________号、代理人整理番号END8502USNP/170769、
・「DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE」と題する米国特許出願第____________号、代理人整理番号END8502USNP1/170769-1、
・「STERILE FIELD INTERACTIVE CONTROL DISPLAYS」と題する米国特許出願第____________号、代理人整理番号END8502USNP2/170769-2、
・「COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS」と題する米国特許出願第____________号、代理人整理番号END8503USNP/170770、
・「USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT」と題する米国特許出願第____________号、代理人整理番号END8504USNP/170771、
・「CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY」と題する米国特許出願第____________号、及び代理人整理番号END8504USNP1/170771-1、及び
・「DUAL CMOS ARRAY IMAGING」と題する米国特許出願第____________号、代理人整理番号END8504USNP2/170771-2。
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES」と題する米国特許出願第____________号、代理人整理番号END8506USNP/170773、
・「ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES」と題する米国特許出願第____________号、代理人整理番号END8506USNP1/170773-1、
・「CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER」と題する米国特許出願第____________号、代理人整理番号END8507USNP/170774、
・「CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET」と題する米国特許出願第____________号、代理人整理番号END8507USNP1/170774-1、
・「CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION」と題する米国特許出願第____________号、代理人整理番号END8507USNP2/170774-2、
・「CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES」と題する米国特許出願第____________号、代理人整理番号END8508USNP/170775、
・「DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK」と題する米国特許出願第____________号、代理人整理番号END8509USNP/170776、及び
・「CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES」と題する米国特許出願第____________号、代理人整理番号END8510USNP/170777。
・「DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8511USNP/170778、
・「COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8511USNP1/170778-1、
・「CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8511USNP2/170778-2、
・「AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8512USNP/170779、
・「CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8512USNP1/170779-1、
・「COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8512USNP2/170779-2、
・「DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8512USNP3/170779-3、及び
・「SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS」と題する米国特許出願第____________号、代理人整理番号END8513USNP/170780。
図12は、本開示の1つ又は2つ以上の態様による、外科用器具又はツールの制御システム470の論理図を示す。システム470は、制御回路を備える。制御回路は、プロセッサ462及びメモリ468を備えるマイクロコントローラ461を含む。例えば、センサ472、474、476のうちの1つ又は2つ以上が、プロセッサ462にリアルタイムなフィードバックを提供する。モータドライバ492によって駆動されるモータ482は、長手方向に移動可能な変位部材を動作可能に連結して、Iビームナイフ要素を駆動する。追跡システム480は、長手方向に移動可能な変位部材の位置を判定するように構成されている。位置情報は、長手方向に移動可能な駆動部材の位置、並びに発射部材、発射バー、及びIビームナイフ要素の位置を判定するようにプログラム又は構成され得るプロセッサ462に提供される。追加のモータが、Iビームの発射、閉鎖管の移動、シャフトの回転、及び関節運動を制御するために、ツールドライバインターフェースに提供されてもよい。ディスプレイ473は、器具の様々な動作条件を表示し、データ入力のためのタッチスクリーン機能を含んでもよい。ディスプレイ473上に表示された情報は、内視鏡撮像モジュールを介して取得された画像とオーバーレイさせることができる。
図20は、他の利点の中でも、インダクタレス同調を提供するように構成された発生器800の簡略ブロック図である。発生器800の追加の詳細は、2015年6月23日出願の米国特許第9,060,775号、表題「SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES」に説明されており、その全体が参照により本明細書に組み込まれる。発生器800は、電力変圧器806を介して非絶縁段階804と通信する患者絶縁段階802を含んでもよい。電力変圧器806の二次巻線808は、絶縁段階802内に収容され、例えば、超音波外科用器具、RF電気外科用器具、並びに単独又は同時に送達可能な超音波及びRFエネルギーモードを含む多機能型外科用器具などの様々な外科用器具に駆動信号を送達するために駆動信号出力部810a、810b、810cを画定するためのタップ構成(例えば、センタタップ又は非センタタップ構成)を備え得る。具体的には、駆動信号出力部810a、810cは、超音波駆動信号(例えば、420Vの二乗平均根(root-meanaquare、RMS)駆動信号)を超音波外科用器具に出力してもよく、駆動信号出力部810b、810cは、電力変圧器806のセンタタップに対応する駆動出力部810bにより、電気外科用駆動信号(例えば、100VのRMS駆動信号)をRF電気外科用器具に出力してもよい。
外科処置は、異なる場所で異なる外科医によって実施され、他者よりもはるかに少ない経験を有する外科医もいる。所与の外科処置について、所望される結果を実現しようとするために変更され得る多くのパラメータが存在する。例えば、発生器によって供給されるエネルギーを利用する所与の外科処置について、外科医は、多くの場合、所望される結果を実現しようとするために、どのエネルギーのモードを利用するか、どのレベルの出力電力を利用するか、エネルギーの印加の持続時間などを判定するために、経験のみに頼る。複数の異なる外科処置に対する所望される結果を実現する可能性を増加させるために、各外科医は、経時的に複数の場所で複数の外科処置と関連付けられた情報の大規模で正確なデータセット内で識別される重要な関係に基づいて、最善の推薦を提供されるべきである。しかしながら、そのようなデータセットが、損傷、不正確、及び/又は安全でないように与えられ得、それによって、そこから導出される最善の推奨の適用性を問う。例えば、ソースからクラウドベースのシステムに送信されるデータについて、データは、クラウドベースのシステムに遷移している間に失われ得、データの機密性は、クラウドベースのシステムに遷移している間に含められ得、及び/又はデータの内容は、クラウドベースのシステムに遷移している間に変更され得る。
外科用ハブ106の機能のうちの1つは、外科システム102の構成要素間の相互作用を制御する、それらから情報を収集する、又はそれらを調整するために、外科システム102の他の構成要素とペアリングすることである(本明細書では「接続」又は「連結」とも称される)。病院の手術室が互いに物理的に近接している可能性が高いため、外科システム102の外科用ハブ106は、隣接する手術室内の外科システム102の構成要素と知らずにペアリングされる場合があり、これは、外科用ハブ106の機能との顕著に干渉することになる。例えば、外科用ハブ106は、異なる手術室で外科用器具を非意図的に作動させるか、又は隣接する手術室で異なる進行中の外科処置から情報を記録する場合がある。
外科処置中、超音波又はRF外科用器具などの外科用器具は、外科用ハブ106の発生器モジュール140に連結され得る。加えて、足又は手のスイッチ又は起動装置などの別個の外科用器具コントローラが、発生器から外科用器具へのエネルギーの流れを起動するために、外科用器具の操作者によって使用され得る。複数の外科用器具コントローラ及び複数の外科用器具は、手術室で同時に使用され得る。誤った外科用器具コントローラを押す又は起動することは、望ましくない結果をもたらし得る。本開示の態様は、外科用ハブ106が外科用器具コントローラと外科用器具とのペアリングを調整して、患者及び操作者の安全を確保する解決策を提示する。
外科処置では、術者の注意は、手の作業に集中しなければならない。例えば、複数のディスプレイなどの複数のソースから情報を受信することは、有用であるが、気を散らし得る。外科用ハブ106の撮像モジュール138は、気が散ることを最小限に抑える様式で、術者に関連情報をインテリジェントに収集、分析、編成/パッケージ、及び伝播するように構成される。
外科処置では、第2の外科用ハブが、第1の外科用ハブの制御下に既にある状態で手術室内に持ち込まれ得る。第2の外科用ハブは、例えば、ロボットシステムの一部として手術室内に持ち込まれる外科用ロボットハブであり得る。第1及び第2の外科用ハブ間の調整なしでは、ロボット外科用ハブは、手術室内にある外科システム102の全ての他の構成要素とペアリングすることを試みることになる。単一の手術室内の2つのハブ間の競合から生じる混乱は、望ましくない結果をもたらし得る。また、外科処置中にハブ間の器具分配を整理することは、時間がかかる場合がある。
状況認識は、データベース及び/又は器具から受信されたデータから外科処置に関する情報を判定又は推定するための、外科システムのいくつかの態様の能力である。情報は、実行される処置の種類、手術される組織の種類、又は処置の対象である体腔を含み得る。外科処置に関するコンテキスト情報によると、外科システムは、例えば、外科システムが、それに接続されるモジュール式装置(例えば、ロボットアーム及び/又はロボット外科用ツール)を制御し、外科処置の過程で外科医にコンテキスト化された情報又は提案を提供する様式で改善し得る。
「近位」及び「遠位」という用語は、本明細書では、外科用器具のハンドル部分を操作する臨床医を基準として使用される。「近位」という用語は、臨床医に最も近い部分を指し、「遠位」という用語は、臨床医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」などの空間的用語が、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よう。しかしながら、外科用器具は、多くの向き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したものではない。
当業者は、一般に、本明細書で使用され、かつ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)で使用される用語は、概して「オープンな」用語として意図されるものである(例えば、「含む(including)」という用語は、「~を含むが、それらに限定されない(including but not limited to)」と解釈されるべきであり、「有する(having)」という用語は、「~を少なくとも有する(having at least)」と解釈されるべきであり、「含む(includes)」という用語は、「~を含むが、それらに限定されない(includes but is not limited to)」と解釈されるべきであるなど)ことを理解するであろう。更に、導入された請求項記載(introduced claim recitation)において特定の数が意図される場合、かかる意図は当該請求項中に明確に記載され、またかかる記載がない場合は、かかる意図は存在しないことが、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)」という導入句を、請求項記載を導入するために含むことがある。しかしながら、かかる句の使用は、「a」又は「an」という不定冠詞によって請求項記載を導入した場合に、たとえ同一の請求項内に「1つ又は2つ以上の」又は「少なくとも1つの」といった導入句及び「a」又は「an」という不定冠詞が含まれる場合であっても、かかる導入された請求項記載を含むいかなる特定の請求項も、かかる記載事項を1つのみ含む特許請求の範囲に限定されると示唆されるものと解釈されるべきではない(例えば、「a」及び/又は「an」は通常、「少なくとも1つの」又は「1つ又は2つ以上の」を意味するものと解釈されるべきである)。定冠詞を使用して請求項記載を導入する場合にも、同様のことが当てはまる。
「一態様」、「態様」、「例示」、「一例示」などへの任意の参照は、その態様に関連して記載される特定の機能、構造、又は特性が少なくとも1つの態様に含まれると意味することは特記に値する。したがって、本明細書の全体を通じて様々な場所に見られる「一態様では」、「態様では」、「例示では」、及び「一例示では」という句は、必ずしも全てが同じ態様を指すものではない。更に、特定の特徴、構造、又は特性は、1つ又は2つ以上の態様において任意の好適な様態で組み合わせることができる。
本明細書で参照され、かつ/又は任意の出願データシートに列挙される任意の特許出願、特許、非特許刊行物、又は他の開示資料は、組み込まれる資料が本明細書と矛盾しない範囲で、参照により本明細書に組み込まれる。それ自体、また必要な範囲で、本明細書に明瞭に記載される開示内容は、参考として本明細書に組み込まれているあらゆる矛盾する記載に優先するものとする。現行の定義、見解、若しくは本明細書に記載される他の開示内容と矛盾する任意の内容、又はそれらの部分は本明細書に参考として組み込まれるものとするが、参照内容と現行の開示内容との間に矛盾が生じない範囲においてのみ、参照されるものとする。
(1) 外科用装置とのデータ通信を認証するように構成された外科用ハブであって、
プロセッサと、
前記プロセッサに連結されたメモリと、を備え、前記メモリが、命令を記憶し、前記命令は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用ハブと関連付けられた公開鍵を前記外科用装置に送信することと、
前記外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記外科用装置に割り当てられた識別子を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記外科用装置からデータ通信を受信することであって、各データ通信が、前記外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように、前記プロセッサによって実行可能である、外科用ハブ。
(2) 前記外科用装置に割り当てられた前記識別子が、前記外科用装置の固有のシリアル番号を含む、実施態様1に記載の外科用ハブ。
(3) 前記命令は、
複数の外科用ハブに通信可能に連結されたクラウドベースのシステムにメッセージを送信することであって、前記メッセージが、前記クラウドベースのシステムと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた前記共有秘密を含み、前記共有秘密が、前記外科用装置に割り当てられた前記識別子を含む、送信することと、
前記外科用装置から受信された各データ通信を前記クラウドベースのシステムに送信することであって、各データ通信は、前記外科用装置から受信された前記共有秘密を使用して暗号化されて、前記クラウドベースのシステムが、前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して、各データ通信を復号化することを可能にする、送信することと、を行うように、前記プロセッサによって更に実行可能である、実施態様1に記載の外科用ハブ。
(4) 前記命令は、
複数の副構成要素を含む複数構成要素外科用装置が前記外科用ハブに通信可能に連結されていることを検出することであって、各副構成要素が、識別子と関連付けられている、検出することと、
前記外科用ハブと関連付けられた公開鍵を前記複数構成要素外科用装置に送信することと、
前記複数構成要素外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記複数構成要素外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記複数構成要素外科用装置を形成するように組み合わされる前記複数の副構成要素と関連付けられた前記識別子の固有の文字列を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記複数構成要素外科用装置からデータ通信を受信することであって、各データ通信が、前記複数構成要素外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記複数構成要素外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の前記完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように、前記プロセッサによって更に実行可能である、実施態様1に記載の外科用ハブ。
(5) 前記複数構成要素外科用装置を形成するように組み合わされる前記複数の副構成要素と関連付けられた前記識別子の前記固有の文字列が、前記複数の副構成要素と関連付けられた前記識別子のランダムな順序付けを含む、実施態様4に記載の外科用ハブ。
(7) 外科用装置とのデータ通信を認証するように構成された外科用ハブであって、前記外科用ハブが、制御回路を備え、前記制御回路は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用ハブと関連付けられた公開鍵を前記外科用装置に送信することと、
前記外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記外科用装置に割り当てられた識別子を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記外科用装置からデータ通信を受信することであって、各データ通信が、前記外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の前記完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように構成されている、外科用ハブ。
(8) 外科用ハブであって、前記外科用ハブに連結された外科用装置を認証するように構成されており、
プロセッサと、
前記プロセッサに連結されたメモリと、を備え、前記メモリが、命令を記憶し、前記命令は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用装置から暗号化された識別子及びソースIDを受信することと、
前記外科用ハブから、前記ソースIDと関連付けられた外科用装置製造元のサーバに、第1のメッセージを送信することであって、前記第1のメッセージが、前記暗号化された識別子を含み、前記第1のメッセージが、前記外科用装置製造元と関連付けられた公開鍵を使用して暗号化される、送信することと、
前記外科用装置製造元の前記サーバから第2のメッセージを受信することであって、前記第2のメッセージが、前記外科用ハブと関連付けられた公開鍵を使用して暗号化され、暗号化された前記第2のメッセージが、前記外科用装置の前記暗号化された識別子と関連付けられた共有秘密を含む、受信することと、
前記第2のメッセージを暗号化するために使用された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化された第2のメッセージを復号化して、前記外科用装置の前記暗号化された識別子と関連付けられた前記共有秘密を明らかにすることと、
前記共有秘密を使用して前記外科用装置の前記暗号化された識別子を復号化して、前記識別子を明らかにして、前記外科用装置及びその製造元を認証することと、行うように、前記プロセッサによって実行可能である、外科用ハブ。
(9) 前記識別子が、前記外科用装置の固有のシリアル番号を含む、実施態様8に記載の外科用ハブ。
(10) 前記命令は、
復号化された前記識別子を、認可された識別子のリストと比較することと、
前記リスト内の認可された識別子に対する前記復号化された識別子の一致に基づいて、前記外科用装置の使用を許可することと、を行うように、前記プロセッサによって更に実行可能である、実施態様8に記載の外科用ハブ。
複数の外科用ハブに通信可能に連結されたクラウドベースのシステムから、認可された識別子の前記リストをダウンロードすることを行うように、前記プロセッサによって更に実行可能である、実施態様10に記載の外科用ハブ。
(12) 前記外科用装置から前記暗号化された識別子及び前記ソースIDを受信することが、
前記外科用装置のメモリ装置から前記暗号化された識別子及び前記ソースIDを読み取ることを含む、実施態様8に記載の外科用ハブ。
(13) 前記命令は、
連結された前記外科用装置のメモリ装置から使用データを読み取ることと、
前記外科用装置が前記外科用ハブに連結されるたびに、読み取られた前記使用データのうちの少なくとも一部分を記憶することと、
前記読み取られた使用データを、以前に記憶された使用データと比較して、前記使用データの不一致を識別することと、
識別された不一致に基づいて、前記外科用装置の前記外科用ハブとの使用を防止することと、を行うように、前記プロセッサによって更に実行可能である、実施態様8に記載の外科用ハブ。
(14) 前記命令は、
前記外科用装置と前記外科用ハブとの前記連結のレコードを、クラウドベースのシステム又は外科システム内の前記クラウドベースのシステムに通信可能に連結された複数の他の外科用ハブのうちの少なくとも一方に送信することであって、前記レコードが、前記外科用装置に割り当てられた前記固有の識別子を、前記外科用ハブに割り当てられた固有の識別子にリンクさせる、送信することを行うように、前記プロセッサによって更に実行可能である、実施態様8に記載の外科用ハブ。
(15) 前記外科用装置に割り当てられた前記固有の識別子が、シリアル番号を含む、実施態様14に記載の外科用ハブ。
前記外科用装置と前記外科用ハブとの前記連結の前記レコードを発生レコード(genesis record)として記憶することであって、前記発生レコードが、タイムスタンプを含む、記憶することを行うように、前記プロセッサによって更に実行可能である、実施態様14に記載の外科用ハブ。
(17) 前記命令は、
前記外科用ハブに対する前記外科用装置の後続の連結毎に新しいレコードを記憶することであって、前記外科用装置と関連付けられた一連のレコード内の各新しいレコードが、最新のレコードの暗号ハッシュ、前記外科用ハブに割り当てられた前記固有の識別子に対する前記外科用装置に割り当てられた前記固有の識別子のリンク、及びタイムスタンプを含む、記憶することを行うように、前記プロセッサによって更に実行可能である、実施態様16に記載の外科用ハブ。
(18) 前記命令は、
前記クラウドベースのシステムに通信可能に連結された前記複数の他の外科用ハブのうちの1つに対する前記外科用装置の連結のレコードを受信することと、
前記複数の他の外科用ハブのうちの前記1つに対する前記外科用装置の前記連結の新しいレコードを記憶することであって、前記外科用装置と関連付けられた一連のレコード内の前記新しいレコードが、最新のレコードの暗号ハッシュ、前記複数の他の外科用ハブのうちの前記1つに割り当てられた固有の識別子に対する前記外科用装置に割り当てられた前記固有の識別子のリンク、及びタイムスタンプを含む、記憶することと、を行うように、前記プロセッサによって更に実行可能である、実施態様17に記載の外科用ハブ。
(19) 前記命令は、
前記外科用ハブ及び前記外科システム内の前記複数の他の外科用ハブに対する前記外科用装置の連結を、前記発生レコードに遡って追跡することを行うように、前記プロセッサによって更に実行可能である、実施態様18に記載の外科用ハブ。
(20) 前記命令は、
追跡された前記連結を分析して、前記外科用装置の過去の使用が障害事象の一因となったか、又は障害事象を引き起こしたか否かを判定することを行うように、前記プロセッサによって更に実行可能である、実施態様19に記載の外科用ハブ。
Claims (20)
- 外科用装置とのデータ通信を認証するように構成された外科用ハブであって、
プロセッサと、
前記プロセッサに連結されたメモリと、を備え、前記メモリが、命令を記憶し、前記命令は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用ハブと関連付けられた公開鍵を前記外科用装置に送信することと、
前記外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記外科用装置に割り当てられた識別子を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記外科用装置からデータ通信を受信することであって、各データ通信が、前記外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように、前記プロセッサによって実行可能である、外科用ハブ。 - 前記外科用装置に割り当てられた前記識別子が、前記外科用装置の固有のシリアル番号を含む、請求項1に記載の外科用ハブ。
- 前記命令は、
複数の外科用ハブに通信可能に連結されたクラウドベースのシステムにメッセージを送信することであって、前記メッセージが、前記クラウドベースのシステムと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた前記共有秘密を含み、前記共有秘密が、前記外科用装置に割り当てられた前記識別子を含む、送信することと、
前記外科用装置から受信された各データ通信を前記クラウドベースのシステムに送信することであって、各データ通信は、前記外科用装置から受信された前記共有秘密を使用して暗号化されて、前記クラウドベースのシステムが、前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して、各データ通信を復号化することを可能にする、送信することと、を行うように、前記プロセッサによって更に実行可能である、請求項1に記載の外科用ハブ。 - 前記命令は、
複数の副構成要素を含む複数構成要素外科用装置が前記外科用ハブに通信可能に連結されていることを検出することであって、各副構成要素が、識別子と関連付けられている、検出することと、
前記外科用ハブと関連付けられた公開鍵を前記複数構成要素外科用装置に送信することと、
前記複数構成要素外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記複数構成要素外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記複数構成要素外科用装置を形成するように組み合わされる前記複数の副構成要素と関連付けられた前記識別子の固有の文字列を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記複数構成要素外科用装置からデータ通信を受信することであって、各データ通信が、前記複数構成要素外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記複数構成要素外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の前記完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように、前記プロセッサによって更に実行可能である、請求項1に記載の外科用ハブ。 - 前記複数構成要素外科用装置を形成するように組み合わされる前記複数の副構成要素と関連付けられた前記識別子の前記固有の文字列が、前記複数の副構成要素と関連付けられた前記識別子のランダムな順序付けを含む、請求項4に記載の外科用ハブ。
- 前記識別子の固有の文字列の各識別子が、前記複数構成要素外科用装置の各それぞれの副構成要素と関連付けられた固有のシリアル番号を含む、請求項5に記載の外科用ハブ。
- 外科用装置とのデータ通信を認証するように構成された外科用ハブであって、前記外科用ハブが、制御回路を備え、前記制御回路は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用ハブと関連付けられた公開鍵を前記外科用装置に送信することと、
前記外科用装置からメッセージを受信することであって、前記メッセージが、前記外科用ハブと関連付けられた前記公開鍵を使用して暗号化され、暗号化された前記メッセージが、前記外科用装置と関連付けられた共有秘密、及び前記共有秘密と関連付けられたチェックサム関数を含み、前記共有秘密が、前記外科用装置に割り当てられた識別子を含む、受信することと、
送信された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化されたメッセージを復号化して、前記共有秘密及び前記チェックサム関数を明らかにすることと、
前記外科用装置からデータ通信を受信することであって、各データ通信が、前記外科用装置から受信された前記共有秘密を使用して暗号化され、各データ通信が、各受信された通信の前記データに基づいて、前記チェックサム関数を介して導出されたチェックサム値を含む、受信することと、
前記外科用装置が前記外科用ハブから連結解除されるまで、前記共有秘密を使用して各データ通信を復号化することであって、各データ通信の前記完全性が、その関連付けられたチェックサム値に基づいて検証可能である、復号化することと、を行うように構成されている、外科用ハブ。 - 外科用ハブであって、前記外科用ハブに連結された外科用装置を認証するように構成されており、
プロセッサと、
前記プロセッサに連結されたメモリと、を備え、前記メモリが、命令を記憶し、前記命令は、
外科用装置が前記外科用ハブに通信可能に連結されていることを検出することと、
前記外科用装置から暗号化された識別子及びソースIDを受信することと、
前記外科用ハブから、前記ソースIDと関連付けられた外科用装置製造元のサーバに、第1のメッセージを送信することであって、前記第1のメッセージが、前記暗号化された識別子を含み、前記第1のメッセージが、前記外科用装置製造元と関連付けられた公開鍵を使用して暗号化される、送信することと、
前記外科用装置製造元の前記サーバから第2のメッセージを受信することであって、前記第2のメッセージが、前記外科用ハブと関連付けられた公開鍵を使用して暗号化され、暗号化された前記第2のメッセージが、前記外科用装置の前記暗号化された識別子と関連付けられた共有秘密を含む、受信することと、
前記第2のメッセージを暗号化するために使用された前記公開鍵と関連付けられた秘密鍵を使用して、前記暗号化された第2のメッセージを復号化して、前記外科用装置の前記暗号化された識別子と関連付けられた前記共有秘密を明らかにすることと、
前記共有秘密を使用して前記外科用装置の前記暗号化された識別子を復号化して、前記識別子を明らかにして、前記外科用装置及びその製造元を認証することと、行うように、前記プロセッサによって実行可能である、外科用ハブ。 - 前記識別子が、前記外科用装置の固有のシリアル番号を含む、請求項8に記載の外科用ハブ。
- 前記命令は、
復号化された前記識別子を、認可された識別子のリストと比較することと、
前記リスト内の認可された識別子に対する前記復号化された識別子の一致に基づいて、前記外科用装置の使用を許可することと、を行うように、前記プロセッサによって更に実行可能である、請求項8に記載の外科用ハブ。 - 前記命令は、
複数の外科用ハブに通信可能に連結されたクラウドベースのシステムから、認可された識別子の前記リストをダウンロードすることを行うように、前記プロセッサによって更に実行可能である、請求項10に記載の外科用ハブ。 - 前記外科用装置から前記暗号化された識別子及び前記ソースIDを受信することが、
前記外科用装置のメモリ装置から前記暗号化された識別子及び前記ソースIDを読み取ることを含む、請求項8に記載の外科用ハブ。 - 前記命令は、
連結された前記外科用装置のメモリ装置から使用データを読み取ることと、
前記外科用装置が前記外科用ハブに連結されるたびに、読み取られた前記使用データのうちの少なくとも一部分を記憶することと、
前記読み取られた使用データを、以前に記憶された使用データと比較して、前記使用データの不一致を識別することと、
識別された不一致に基づいて、前記外科用装置の前記外科用ハブとの使用を防止することと、を行うように、前記プロセッサによって更に実行可能である、請求項8に記載の外科用ハブ。 - 前記命令は、
前記外科用装置と前記外科用ハブとの前記連結のレコードを、クラウドベースのシステム又は外科システム内の前記クラウドベースのシステムに通信可能に連結された複数の他の外科用ハブのうちの少なくとも一方に送信することであって、前記レコードが、前記外科用装置に割り当てられた前記固有の識別子を、前記外科用ハブに割り当てられた固有の識別子にリンクさせる、送信することを行うように、前記プロセッサによって更に実行可能である、請求項8に記載の外科用ハブ。 - 前記外科用装置に割り当てられた前記固有の識別子が、シリアル番号を含む、請求項14に記載の外科用ハブ。
- 前記命令は、
前記外科用装置と前記外科用ハブとの前記連結の前記レコードを発生レコードとして記憶することであって、前記発生レコードが、タイムスタンプを含む、記憶することを行うように、前記プロセッサによって更に実行可能である、請求項14に記載の外科用ハブ。 - 前記命令は、
前記外科用ハブに対する前記外科用装置の後続の連結毎に新しいレコードを記憶することであって、前記外科用装置と関連付けられた一連のレコード内の各新しいレコードが、最新のレコードの暗号ハッシュ、前記外科用ハブに割り当てられた前記固有の識別子に対する前記外科用装置に割り当てられた前記固有の識別子のリンク、及びタイムスタンプを含む、記憶することを行うように、前記プロセッサによって更に実行可能である、請求項16に記載の外科用ハブ。 - 前記命令は、
前記クラウドベースのシステムに通信可能に連結された前記複数の他の外科用ハブのうちの1つに対する前記外科用装置の連結のレコードを受信することと、
前記複数の他の外科用ハブのうちの前記1つに対する前記外科用装置の前記連結の新しいレコードを記憶することであって、前記外科用装置と関連付けられた一連のレコード内の前記新しいレコードが、最新のレコードの暗号ハッシュ、前記複数の他の外科用ハブのうちの前記1つに割り当てられた固有の識別子に対する前記外科用装置に割り当てられた前記固有の識別子のリンク、及びタイムスタンプを含む、記憶することと、を行うように、前記プロセッサによって更に実行可能である、請求項17に記載の外科用ハブ。 - 前記命令は、
前記外科用ハブ及び前記外科システム内の前記複数の他の外科用ハブに対する前記外科用装置の連結を、前記発生レコードに遡って追跡することを行うように、前記プロセッサによって更に実行可能である、請求項18に記載の外科用ハブ。 - 前記命令は、
追跡された前記連結を分析して、前記外科用装置の過去の使用が障害事象の一因となったか、又は障害事象を引き起こしたか否かを判定することを行うように、前記プロセッサによって更に実行可能である、請求項19に記載の外科用ハブ。
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US15/940,648 US11069012B2 (en) | 2017-12-28 | 2018-03-29 | Interactive surgical systems with condition handling of devices and data capabilities |
US15/940,648 | 2018-03-29 | ||
PCT/US2018/044148 WO2019133057A1 (en) | 2017-12-28 | 2018-07-27 | Interactive surgical systems with condition handling of devices and data capabilities |
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