JP6259757B2 - コンピュータ支援手術の搭載器具追跡システム - Google Patents
コンピュータ支援手術の搭載器具追跡システム Download PDFInfo
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- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1675—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the knee
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- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1764—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the knee
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Description
コンピュータ支援手術の手術室は、術前使用のための第1のコンピュータを含む。例えば、患者の術前解析及び様々な要素の選択を第1のコンピュータで実行し得る。手術室は、ORコンピュータと呼ばれる第2のコンピュータを含むこともでき、ORコンピュータは、処置中に、外科医を支援し、且つ/又は1つ若しくは複数の外科器具を制御するために使用される。加えて、手術室は、器具上追跡システムの一実施形態を介して外科器具に搭載されたコンピュータ(独立式又は別のコンピュータと協働)を含み得る。本例では、第1のコンピュータが提供されるが、そのコンピュータの機能は、独立式であることができるORコンピュータでも実施されるため、幾つかの構成では省き得る。さらに、「術前計画」の全体は最終的に、OTTと併せて主にORコンピュータを使用してOR内部で瞬時に行うことができる。それにも関わらず、特定の用途で望ましい場合、第1のコンピュータを使用し得る。術前計画及び処置は、オンラインウェブリンクからのデータ又は能動的ガイダンスにより支援することもできる。本明細書において使用される場合、CASシステム又はCASコンピュータという用語は、CAS機能を実行するために、任意のコンピュータ及び電子構成要素の組み合わせで提供されるコンピュータ又は電子構成要素を指す。さらに、システムのマイクロ処理ユニットは、器具上追跡機器内に存在することができる。そのような構成では、計算及びユーザインタフェースは、使用されている外科器具上のコンピュータ内で、又は有線若しくは無線通信によりメインシステムコンピュータと協働して実行することができる。無線通信によりメインOTT CASコンピュータと協働して、そのようなシステムは、実行すべき理想的な切断に相対する切断機器の位置の誤差解析を実行し、単独で、又はそのためにOTTに設けられる1つ又は複数のプロジェクタにより提供される出力との任意の組み合わせで、器具上トラッカーの部分として提供される画面に是正措置及び他の情報を表示する。
・カメラ/dsp/処理NaturalPoint Optitrak SL−V120レンジ、
・コンピュータ:PC−Windows2000/XP Vista/7;1.5GHzプロセッサ;RAM256MB;ハードディスク空き容量5MB;USB2.0高速ポート(最小、速いほどよい)、
・COM:無線USBサポートを有するDYNADOCK W20ポートリプリケータ、
・プロジェクタ:MicrovisionのSHOWWXレーザピコプロジェクタ
が提供される。この実施形態は、「スマートカメラ」−局所的画像処理を実行する機能を有するカメラ−として知られるものを利用する。この処理は通常、フィールドプログラマブルゲートアレイ(FPGA:Field Programmable Gate Arrays)を通してプログラム可能であり得る。この特定の実施形態での構成要素の構成を利用して、OTT装置及びOTT CASコンピュータの両方で行われる画像処理を提供する。例えば、OTT装置のDSP(digital signal processing)は、マーカデータを検出して処理し、それからOTT CASコンピュータにマーカデータを転送する。構成は、送信する必要があるデータを最小化しながら、ホストコンピュータで必要とされる処理電力を大幅に低減もする。概略図は主に、特定のOTT装置又はOTT装置とOTT CASコンピュータとの間での撮像、データ処理、及び汎用コンピュータ処理機能を示すために有用であるが、この図が、実際の向き、特定の構成要素の間隔、及び/又は位置合わせを反映していないことがあることを理解されたい。電子通信機能(COM)は、有線接続又は任意の適する無線データ転送モードを介してコンピュータから、且つコンピュータに提供され、コンピュータは、本明細書に記載のOTT CASプロセス、アルゴリズム、及びモードと併用されるように適合され構成される。(使用される場合)OTT装置とOTT CASコンピュータとの間での処理データ交換のタイプ、種類、量、及び品質は、利用される特定のOTT CAS処置、モード、又はシステムの特定のパラメータ及び考慮事項に応じて様々である。
・カメラ:アナログカメラ有線又は無線;例えば、FPV無線カメラ、
・DSP:uCFGマイクロコントローラフレームグラッバ、これはPC PCIバスに接続され、PCの部分になる、
・コンピュータ:PC−Windows2000/XP Vista/7;1.5GHzプロセッサ;RAM256MB;ハードディスク空き容量5MB;USB2.0高速ポート(最小、速いほどよい)、
・COM:ハードワイヤード又はアナログ無線送信器、
・プロジェクタ:MicrovisionのSHOWWXレーザピコプロジェクタ
が提供される。この特定の実施形態での構成要素の構成は、追跡の画像処理がOTT上で実行され、画像信号が、PCの部分である専用フレームグラッバ(dedicated frame grabber)により捕捉される低コスト商品カメラの使用を提供するために利用される。フレームグラッバは、捕捉画像を受け入れ、PCによるいかなるオーバーヘッドプロセスもなくPCメモリに配置する。この実施形態は、より小型軽量で低コストのOTT装置になる。
・カメラ:Microsoft LifeCam、
・コンピュータ:Dell Precision R5500 Rack Workstation、
・COM:Carambola 8devices Core又はDTW−200D(CDMA2000 1X)及びDTW−500D(EVDO Rev A)、
・プロジェクタ:MicrovisionのSHOWWXレーザピコプロジェクタ
が提供される。この特定の実施形態での構成要素の構成は、電子OTT構成要素を提供するモジュール式解決策を提供するために利用される。この実施形態は、商品低コストカメラを使用し、モジュール式でカメラを使用できるようにし、そこから、OTT又は地上に基づくシステムを邪魔せずに技術の進歩を反映するようにカメラを変更又は更新することができる。
・カメラ:図15A等のスマートカメラ又はUSBカメラ、
・慣性センサ:Bosch SMB380、Freescale PMMA7660、Kionix KXSD9、
・搭載プロセッサ:ARMプロセッサ、
・コンピュータ:PC−Windows2000/XP Vista/7;1.5GHzプロセッサ;RAM256MB;ハードディスク空き容量5MB;USB2.0又はUSB3.0高速ポート(最小、速いほどよい)、
・COM:標準IEEE802.11通信プロトコル又はOTT搭載プロセッサと地上ステーションPCとの通信用の同様のプロトコル、
・プロジェクタ:MicrovisionのSHOWWXレーザピコプロジェクタ
が提供される。この特定の実施形態での構成要素の構成は、OTT装置搭載で複雑な処理を実行して、OTT CAS処置のために必要な身体追跡の大半を達成する実施形態を提供するために利用される。装置は、複雑な独立式追跡装置である。OTT装置は1つ又は複数の慣性センサをさらに含む。DSPは、慣性センサの使用を含み、「次のフレーム」での基準の位置を予測する。その結果、OTT装置上のDSPへの計算負荷が最小化される。
・視覚データ及びIRスペクトル画像データの受信及び処理、
・画像フレーム内の各マーカの質量中心の座標の特定、
・画像フレーム内の全てのマーカのサイズの特定、
・1つ又は複数の基準のサイズ及び座標の報告、
・画像フレーム内の質量中心の位置、マーカの配置、又は選択されたマーカの配置を特定するサブピクセル解析、
・中央コンピュータからの入力若しくは内部命令に基づいて、又はOTT CAS処理モード適合に応答して毎秒20〜60フレームの可変の制御可能なフレームレート。
限定ではなく考察のために、器具上追跡システムからのデータは、上述した広いカテゴリを把握するために、撮像データ及びセンサデータとして分類される。器具上追跡システム自体に提供されるか、又はコンピュータ支援手術コンピュータにより提供されるシステムリソースを使用して、データを処理し、コンピュータ支援手術システムが使用する出力を提供する。データ処理の所望の出力は、評価中の特定のプロセスに応じて、さらに詳細に後述するように、幾つかの異なる形態で来る。この概説のために、器具上追跡システムから得られるデータ出力が、手術野内の器具上トラッカーの向き、手術野に相対する器具又は器具上トラッカーの位置、手術を受けている生体構造への物理的変更、手術野内のOTT被追跡器具の移動、手術野内の器具の変位等の手術野に関する情報、追跡中の手術ステップの明確な進行、及び手術ステップ又はコンピュータ支援手術処置の開始、進行、又は完了に関連する他の情報等のことを含み得ることを考慮し得る。
多くのファクタ(例えば、基準フレーム、位置、相対移動等)によりOTT CASモードを検出し、決定し得ることを理解されたい。さらに、手術処置の状況では、器具/標的近接性又は使用に基づくOTT CASモードの定義属性の関連付けにも利点がある。以下の例を考える:A)ホバリング:手術野内の両器具及び標的だが接触なし、B)接近:両器具及び標的は手術野内であり、且つ器具及び標的は接触し、C)能動的ステップモード:両器具及び標的は手術野内であり、器具及び標的は接触し、且つ器具と組織との能動的係合がある。一態様では、OTT装置電子回路は、このモード選択機能を「スマートビュー」モジュールに組み込む。このモジュールは、メインCASシステムコンピュータ内又はソフトウェア及びファームウェアを含む電子回路がモード検出アルゴリズムの全て若しくはかなりの部分を実施するOTT装置内に提供され、OTT CASモード選択機能の異なるイベントをトリガーする。
1.OTT CASシステム及びCASシステム全般の時間/特別な分解能により、器具及び標的が所与のユーザ事前選択(設定可能)の距離エンベロープ内にある場合、接近モードの幾つか実施形態が適切であると見なされ得る。距離エンベロープは、測定範囲内で指定し得る。例示的な一範囲は、OTT CASシステムにより決定される10mm〜0mmであり得る。他の態様では、接近モードは、OTT CAS手術野内で外科器具の能動的要素と生体構造とが接触している可能性が高いと判断するOTT CASシステムにより描かれてもよい。
2.幾つかの態様では、OTT CASモードに「ヒステリシス」ファクタが提供される。このOTT CASヒステリシスファクタは、所定の時間期間にわたり連続する等を満たす場合にCASモードが維持されることになる状況のタイプ又はCAS条件を含むように選択される。換言すれば、OTT CASモードヒステリシスのパラメータは、「モードに固定する」ため、すなわち、そのOTT CASモードを維持するためには、ある時間期間にわたり連続して満たされなければならない。本明細書において使用する場合、連続しては、OTT処理時間及びサンプリングレートの時間領域の文脈内にあるものとして意味され、監視される考慮事項の絶対的な中断なしを示すことを意図されない。同様の例として、OTT CASモードの「アンロック」又は調整を許可するには、ヒステリシス条件又はヒステリシス条件の幾つかが、ある時間期間にわたり連続して満たされるべきではない。OTT CASモードヒステリシスファクタの使用は、遷移へのシステム応答を向上させ、システムがあるOTT CASモードから別のOTT CASモードに不適切にジャンプする可能性を回避又は低減し、システムが単一のOTT CASモードからの出力を提供していることから、ユーザがより安定したOTT CAS出力を見る可能性が高いため、システムの使用性を向上させる。
3.幾つかのOTT CASステップ中、プロジェクタの使用を必要としない、異なる入出力(IO)装置を必要とし(例えば、インプラント位置評価中、情報を骨に投影することは不可能であり得る)、且つ/又は定義された標的−器具関係を有さない(例えば、膝の移動範囲評価は、頸骨及び大腿骨の基準フレームのみを見る必要がある)、ユーザにより実行される活動がある。OTT CASシステムが他のソースから入力を受信してもよく、プロジェクタ出力が提供又は利用されないOTT CAS出力があることを理解されたい。
4.一般に、処理アルゴリズム及びOTT CASモードファクタは、骨、機器、インプラント等の相対移動等のことに関して、OTT CASモードがホバリングから能動的に進むにつれて低減する確率又は尤度に基づいて選択される。この一般的なプロセス仮定に対する一例外は、OTT CAS装置又はシステムが、手術野内の関与する関節又はOTT CAS処置若しくはステップの目的であるその関節のある範囲の移動を評価するプロセスに使用される場合である。
OTT CASモード例
骨の見当合わせ:
目的:基準フレームの原点と骨モデルの原点との幾何学的関係を見つけ出すこと。
手順:器具(例えば、ナビゲーションされるポインタ)を用いての骨の表面上のポイントのデジタル化及び骨モデルの所定の幾何学的形状データと突き合わせたこれらのポイントの処理。
OTT CASシステムがいかにこのタスクを識別するか:
− ポインタ及び骨(頸骨又は大腿骨)の基準フレーム(reference frame:RF)がOTTから見える。
タスクの開始:
− OTT CASシステムは、(少なくとも、この見当合わせに適する最小時間期間にわたり)シーンに共存する両基準フレーム(both reference frames coexisting in the scene)を認識する。
− 例えば、骨が見当合わせされるまで切断を行うことができないため、追加の「推測」ファクタは処置の段階である。この場合、このイベントのトリガーは、骨見当合わせプロセスが完了するまで、OTT装置が所定位置に維持されて、2つの基準フレームを手術野内に保つことであってもよい。このトリガーは任意選択的に、システムコンピュータがユーザに確認を促してユーザが応答することにより確認することができる。
− OTT装置の骨見当合わせ中に得られた情報に、必要であれば、ユーザの入力(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)を注釈付け、又は上書きし得る。
OTT CASモード:
ホバリング:
− 範囲条件:OTT装置がRFから遠く離れすぎているか、又は2つのRFが離れすぎている。この状況をトリガーする範囲は、システムの較正/調整中に、又はユーザの好みにより設定可能であり、最適なFOVを超えるカメラと標的生体構造の基準フレームとの距離閾値(ここで具現される事例では、200mmよりも大きい)として指定される。
トラッカー:低リフレッシュレート。
プロジェクタ:いかなる画像も骨に投影しないが(骨の位置がまだ定義されないため)、このモード/状態等の確認等の基本的な有用情報を、たまたま間にあった任意の反射面に投影することができる。トラッカーにより制限される低リフレッシュレート。
システム:ポインタの先端及び骨のRF位置を「世界」座標(world coordinate)において監視する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
接近:
− 範囲条件:中間OTT/RF及びRF/RF距離。この状況をトリガーする範囲は、システムの較正/調整中に、又はユーザの好みにより設定可能であり、100〜200mm等の標的生体構造基準フレームからの距離範囲として指定される。
トラッカー:高リフレッシュレート、ポインタ及び骨のRF読み取りの最適化(例えば、他のRFを無視するか、又は関心を払わない)。
プロジェクタ:上と同様に、いかなる定義画像も投影しないが(骨の位置がまだ定義されないため)、見当合わせポイントの収集を開始する「容易さ」に基づいて色を変える(例えば、赤、黄色、及び緑)立体画面を投影することができる。
システム:ポインタの先端及び骨のRF位置を「世界」座標において監視する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
能動的:
− より小さなOTT/RF及びRF/RF距離。例えば、ここでも上と同様に、ユーザの好みにより設定可能な、標的基準フレームからの70〜100mm未満の距離。
トラッカー:高リフレッシュレート、ポインタ及び骨のRF読み取りを最適化。
プロジェクタ:上と同じ。
システム:ポインタの先端及び骨のRF位置を「世界」座標において監視する。デジタル化された骨毎に、ポインタの先端位置を記録する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。見当合わせプロセスの進行を監視し、終了した場合、最終的な見当合わせ行列を計算する。
追加のIO装置(例えば、タッチスクリーン)を必要とすることもあり、必要としないこともある。
モード間遷移についてのOTT CAS考慮事項
− モードシフトは距離閾値に基づく。骨見当合わせ情報がない場合、骨−ポインタ「接触」又は「近さ」を特定することは不可能である。システムは代替として、ポインタ(IS見当合わせされる)と骨の基準フレーム(骨自体の代わりに)との公称距離を見る。次に、結果として生成される公称距離を使用して、その(骨)基準フレームが通常配置されることが推奨される(絵シート18〜23参照)公称位置に基づいて近似検討合わせを推定又は仮定し得る。別の代替は、単に、(別のデフォルトの骨又は前の患者若しくは手術からの骨の)システムによる任意の古い見当合わせ情報を使用して、システムがあるべき「モード」を決定するために、近似見当合わせを行うことである(任意選択的)。この選択肢の利用可能性もユーザにより設定可能/選択可能である。
− 又はユーザの入力による。
タスクの終了:
− 全ての見当合わせ目印がアクセスされ、指摘される(見当合わせプロセスは完全に完了する)。
− 又はシステムが、(少なくとも最小時間期間にわたり)ポインタのRFを見るのを止める。
− あるいは、プロセスは、ユーザの入力(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)により補足又は上書きすることができる。
骨切断/穿孔:
− 目的:割り振り及び移植のために、器具(通常、鋸、ドリル、バー、研削器等の電動式スマート機器)を用いて骨を再形成する。
手順:システムの方向を辿り、ユーザは一度に一表面を切断/穿孔(通常)する。この特定の活動は、実行すべき切断/孔毎に1つずつ、各骨の異なる個々の「標的表面」に適用され、したがって、骨に相対する器具の位置又は向きの誤差を使用又は処理する場合、システムは、そのような参照を維持する。異なる器具は異なる能動的要素(例えば、切断先端部)を有し、したがって、各器具の形状の異なる能動的要素は、器具又は器具の能動的要素が手術野内の生体構造と相互作用する場合、生体構造の異なる2D及び3D変更を生じさせる。したがって、各器具のガイダンスは、OTT CASプロセスステップ中、使用される器具及び能動的要素のタイプに伴って変わる。
システムOTT CASシステムがこのタスクをいかに識別するか:
− OTTが少なくとも1つの骨の基準フレーム(RF:reference frame)を検出する。
− 指名された骨が見当合わせされる。
− 切断中の骨の基準フレームは、ユーザ選択可能な最大距離内にある(例えば、200mm未満のみ)。
タスクの開始:
− システムは、(少なくとも最小時間期間にわたり)シーンに共存する両RF(both RFs coexisting in the scene)を認識する。
− システムは、(タッチスクリーン、音声コマンド、骨の基準フレーム又は骨自体上の特定の窪み又は印にポインタ又は切断機器で触れる等)ユーザの入力により補足又は上書きすることができる。
モード
ホバリング:
− OTTは骨から遠く離れすぎている。例えば、200mm(ユーザにより設定可能な値)を超える。
トラッカー:低リフレッシュレート
プロジェクタ:いかなる画像も投影せず(骨はプロジェクタの視野外にあり得る)、又は大まかな形状(例えば、骨と位置合わせするために、機器−例えば、鋸、ドリル等−をどの方向に移動すべきかを示す矢印)のみを表示し得る。任意選択的に、プロジェクタ出力は、前例と同じように単に異なる色を示すように変更される。トラッカーのリフレッシュ設定により制限される低リフレッシュレート。
システム:骨に相対する器具の位置及び向きを監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。双方向通信し、スマート機器を駆動する。
接近:
− OTTは骨に対して中間距離にある。例えば、100mm〜200mm。
トラッカー:高リフレッシュレート、ポインタ及び骨RF読み取りの最適化。プロジェクタ:中間リフレッシュレートで骨の幾何学的形状に対して正された位置合わせ支援(カラーテキスト、ライン、円、矢印等)を示す。
システム:骨に相対する器具の位置及び向きを監視し(すなわち、骨の座標において)、ロール、ピッチ、ヨー、及び距離のずれを計算する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。双方向通信し、スマート機器を駆動する。
能動的:
− OTTは骨に近い。例えば、70mm〜100mm。
トラッカー:高リフレッシュレート、ポインタ及び骨RF読み取りの最適化。プロジェクタ:高リフレッシュレートで骨の幾何学的形状に対して正された位置合わせ支援(カラーテキスト、ライン、円、矢印等)を示す。
システム:骨に相対する器具の位置を監視し(すなわち、骨の座標において)、ロール、ピッチ、ヨー、及び距離のずれを計算する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。双方向通信し、スマート機器を高速駆動する。
モード間遷移:
− 遷移は距離閾値に基づき得る。
− ユーザ入力に基づく遷移。
タスクの終了:
− ユーザは別のタスクに進む。
− 全ての切断及び微調整が完全に完了する。
− 一代替では、OTT CASシステムは、(少なくとも最小時間期間にわたり)骨のRFを見るのを止める。
− このステップは、(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)ユーザの入力により修正、補足、又は上書きすることができる。
骨切断の評価:
目的:新しい表面(例えば、平面、円筒形穴等)、向き、表面の凹凸、深さ等を評価する。
手順:表面の完全又は部分的なデジタル化(例えば、ナビゲーションされるポインタで表面に触れる/横切る)、「表面モニタ」(平坦な切断に置かれる平面を有するナビゲーションされる器具)を用いて切断位置及び向きを評価し、ナビゲーションされるポインタを用いての穴の深さを計測するなど。
OTT CASシステムがいかにこのタスクを識別する:
− OTTは、少なくとも1つの骨の基準フレーム(RF)並びに評価機器(表面モニタ又はポインタ)RFを見る。
− 指名された骨及び機器が見当合わせされた。
−少なくとも1つの切断が実行された。
− 切断中の骨は最大距離「D」内にある。
タスクの開始:
− システムは、上記条件が満たされる間、(少なくとも最小時間期間にわたり)シーンに共存する両RF(骨及び機器)を認識する。
− これは、(タッチスクリーン、音声コマンド、骨の基準フレーム又は骨自体上の特定の窪み又は印にポインタ又は切断機器で触れる等)ユーザの入力により補足又は上書きすることができる。
モード
ホバリング:
− OTTはRFから遠く離れすぎているか、又は2RFが離れすぎている。
トラッカー:低リフレッシュレート。
プロジェクタ:いかなる定義画像も投影せず(骨がプロジェクタの視野外にあり得るため)、又はプロセスを開始する「容易さ」に基づいて色を変える(例えば、赤、黄色、及び緑)立体画面を投影することができる。低リフレッシュレート、トラッカーのリフレッシュレートにより制限される。
システム:骨に相対する器具の位置を監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
接近:
− OTTは両RFに対して中間距離にあり、且つ中間骨−器具距離にある。
トラッカー:高リフレッシュレート、機器及び骨RF読み取りに向けて最適化。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセスを開始する「容易さ」に基づいて変わる立体画面を投影することができる。中間リフレッシュレート
システム:骨に相対する器具の位置を監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
能動的:
− OTTは両RFに対して中間/近接距離にあり、且つ小さな骨−器具距離。
トラッカー:高リフレッシュレート、機器及び骨RF読み取りに向けて最適化。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセス状態(開始からデータ収集の終了)に基づいて変わる立体画面を投影することができる。高リフレッシュレート。
システム:骨に相対する器具の位置を監視する(すなわち、骨の座標において)。デジタル化されたポイント毎にポインタの先端位置を記録するか、又は表面モニタの位置及び向きを記録する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。評価プロセスの進行を監視し、評価プロセスが終わった場合、パラメータを計算し、計算されたパラメータを記録し表示する。
追加のIO装置(例えば、タッチスクリーン)を必要とすることもあり、必要としないこともある。
モード間遷移:
− 単に距離閾値に基づく。
− 又はユーザの入力による。
タスクの終了:
− 評価プロセスが完全に完了する。
− 任意選択的に、OTT CASシステムは、(少なくとも最小時間期間にわたり)機器のRFを見るのを止める。
− OTT CASシステムは、(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)ユーザの入力により補足又は上書きすることができる。
インプラントの適合及び位置合わせの評価
目的:計画に従って予期された位置と、骨上のインプラントの実際の位置(又はトライアル)とを比較する。これは、トライアル中、インプラントセメント接着又はロックの前/最中/後に行うことができる。
手順:インプラント(例えば、大腿骨コンポーネント、頸骨トレー等)にRFが取り付けられ、「骨」座標系において追跡される。任意の所与の時間において、システムは、位置(骨に相対する)及びあるべき位置と比較された現在の誤差(もしあれば)を表示/記録することができる。
システムがこのタスクをいかに識別するか:
− OTTは、少なくとも1つの骨の基準フレーム(RF)並びに対応するインプラントのRFを見る。
− 指名された骨及びインプラントが見当合わせされた。
− 全ての切断が実行された。
− 骨及びインプラントは最大距離「D」内にある。
タスクの開始:
− システムは、上記条件が満たされる間、(少なくとも最小時間期間にわたり)シーンに共存する両RF(骨及びインプラント)を認識する。
− システムは、(タッチスクリーン、音声コマンド、骨の基準フレーム又は骨自体上の特定の窪み又は印にポインタ又は切断機器で触れる等)ユーザの入力により補足又は上書きすることができる。
モード
ホバリング:
− OTTはRFから遠く離れすぎているか、又は2RFが離れすぎている。
トラッカー:低リフレッシュレート。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセスを開始する「容易さ」に基づいて色を変える(例えば、赤、黄色、及び緑)立体画面を投影することができる。低リフレッシュレート、トラッカーのリフレッシュレートにより制限される。
システム:骨に相対するインプラント/トライアルの位置を監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
接近:
− 中間OTT/RF距離且つ骨に比較的近いインプラント/トライアル。
トラッカー:高リフレッシュレート、インプラント/トライアル及び骨RF読み取りに向けて最適化。
プロジェクタ:いかなる定義画像も投影せず(骨がプロジェクタの視野外にあり得るため)、又はプロセスを開始する「容易さ」に基づいて変わる立体画面を投影することができる。
システム:骨に相対するインプラントの位置を監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
能動的:
− より小さなOTT/RF距離且つインプラント/トライアルは骨に近い/接触している。
− トラッカー:高リフレッシュレート、インプラント及び骨RF読み取りに向けて最適化。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセス状態(開始からデータ収集の終了)に基づいて変わる立体画面を投影することができる。高リフレッシュレート。
システム:骨に相対するインプラント/トライアルの位置を監視する(すなわち、骨の座標において)。計画に従ってあるべき位置に相対する、ナビゲーションされるインプラントの実際の位置/向きにより定義される誤差を計算し表示する(且つ必要な場合には記録する)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。評価プロセスの進行を監視し、評価プロセスが終わった場合、パラメータを計算し、計算されたパラメータを記録し表示する。
追加のIO装置(例えば、タッチスクリーン)を必要とすることもあり、必要としないこともある。
モード間遷移:
− 単に距離閾値に基づく。
− 又はユーザの入力による。
タスクの終了:
− 評価プロセスが完全に完了する。
− (又は)システムは、(少なくとも最小時間期間にわたり)機器のRFを見るのを止める。
− システムは、ユーザの入力(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)により補足又は上書きすることができる。
移動範囲
目的:移植後の関節の移動範囲及び生体力学の評価。トライアル又は最終的な移植で行うことができる。
手順:トライアル(又は実際のインプラント)を配置した後、骨のRFを取り外し、傷を閉じる前、外科医は膝を屈曲させ、関節に触れ、最大屈曲及び過伸展のような限界位置に到達させる。この操作は、OTTを頸骨及び大腿骨のRFを向けている間に実行される。動的測定(大腿骨に相対する頸骨)が解剖学的用語で表現される。
システムがこのタスクをいかに識別するか:
− OTTは頸骨及び大腿骨の両方の基準フレーム(RF)を見る。
− 両方の骨は切断された。(骨の切断及びインプラントの配置は行われていてもよく、又は行われていなくてもよい。)
タスクの開始:
− システムは、上記条件が満たされる間、(少なくとも最小時間期間にわたり)シーンに共存する両RFを認識する。
− これは、(タッチスクリーン、音声コマンド、骨の基準フレーム又は骨自体上の特定の窪み又は印にポインタ又は切断機器で触れる等)ユーザの入力により補足又は上書きすることができる。
モード
ホバリング:
− OTTはRFから遠く離れすぎている。
トラッカー:低リフレッシュレート。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセスを開始する「容易さ」に基づいて色を変える(例えば、赤、黄色、及び緑)立体画面を投影することができる。低リフレッシュレート、トラッカーのリフレッシュレートにより制限される。
システム:大腿骨に相対する頸骨の位置を監視する。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
接近:
− 中間OTT/RF距離。
トラッカー:高リフレッシュレート、骨RF読み取りに向けて最適化。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセスを開始する「容易さ」に基づいて変わる立体画面を投影することができる。
システム:骨に相対するインプラントの位置を監視する(すなわち、骨の座標において)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。
能動的:
− より小さなOTT/RF距離且つインプラント/トライアルは骨に近い/接触している。
− トラッカー:高リフレッシュレート、インプラント及び骨RF読み取りに向けて最適化。
プロジェクタ:(骨がプロジェクタの視野外にあり得るため)いかなる定義画像も投影せず、又はプロセス状態(開始からデータ収集の終了)に基づいて変わる立体画面を投影することができる。高リフレッシュレート。
システム:大腿骨に相対する頸骨の位置を監視する。動的運動(屈曲/伸展、内反/外反、内部/外部回転、AP運動等)を計算して表示する(且つ必要な場合には記録する)。トラッカー、プロジェクタ、及び他のIO装置を駆動する。評価プロセスの進行を監視し、評価プロセスが終わった場合、記録された全てのパラメータを保存し、ユーザに通知する。
追加のIO装置(例えば、タッチスクリーン)を必要とすることもあり、必要としないこともある。
モード間遷移:
− 単に距離閾値に基づく。
− 又はユーザの入力による。
タスクの終了:
− 評価プロセスが完全に完了する。
− (又は)システムは、(少なくとも最小時間期間にわたり)骨のRFを見るのを止める。
− システムは、ユーザの入力(タッチスクリーン、音声コマンド、骨の基準フレーム上の特定の窪みにポインタで触れる等)により補足又は上書きすることができる。
任意の上記例での一態様では、低リフレッシュレートは、約30〜100Hzから1〜10Hz程までのリフレッシュレート変化を指す。
図37Aは、引き金力に応答して偏向し、アクチュエータを移動させる湾曲形態を示す。図37Bは、引き金力に応答して変形して形状回復する摺動台形形態を示す。図37Cは、引き金力に回転応答を提供するために使用される回転リーダ又はエンコーダを示す。図37Dは、引き金力に応答して移動して、シャフトをベース内に押下するフレームを示し、シャフトの移動は引き金力の指示として示される。図37Eは、偏向して、引き金力の量を示し得るピン留め要素(pinned element)を示す。
図39A、図39B、図39Cはそれぞれ、位置回復要素がなく、アクチュエータ82が駆動されない鋏型機構(scissor mechanism)80(39A)、位置回復要素84として張力ばねを有する鋏型機構80(39B)、及び位置回復要素84として圧縮ばねを有する鋏型構造80(39C)を示す。示されるアクチュエータの移動が、鋏のアームの上端部の高さ、ひいては鋏型機構の高さを決める。この高さは、器具の引き金への指を押し、器具の引き金に指を配置しているユーザにより感じられる。
図50は、外科器具の引き金と協働するために搭載され、OTT内の構成得要素に関連するトリガー信号を送受信するように構成された図49A及び図49Bの機構の一実施形態を有する外科器具と併用するために結合されたOTTの一実施形態を示す。
Claims (23)
- コンピュータ支援外科手術において外科器具とともに使用される器具上追跡・ガイド装置であって、
エンクロージャを規定し、前記外科器具の一部分と着脱可能に係合する表面を有する筐体と、
各々、前記外科器具が前記筐体と係合した場合に前記外科器具を用いたコンピュータ支援手術処置に選択された略全ての手術野を閲覧するために選択された画像出力を提供する構成を有する前記エンクロージャ内の第1のカメラ及び第2のカメラと、
少なくとも部分的に手術視野内に出力を提供する構成を有する前記エンクロージャ内のプロジェクタと、
2台のカメラのそれぞれから出力を受信し、前記2台のカメラのそれぞれからの出力の少なくとも一部分を使用して、画像処理動作を実行して、前記コンピュータ支援手術処置に使用するように構成される、前記エンクロージャ内の電子画像プロセッサと、を備える、装置。 - 外科器具の一部分と解放可能に係合する前記表面は、前記表面が前記外科器具に結合される場合、前記外科器具の能動的セグメントの少なくとも一部分が水平視野及び垂直視野内にあるように適合され構成される、請求項1に記載の装置。
- 前記外科器具の能動的セグメントの前記少なくとも一部分は、前記コンピュータ支援手術処置中に使用される略全ての外科器具能動要素である、請求項2に記載の装置。
- 前記プロジェクタからの出力は、前記筐体に取り付けられた外科器具に関連付けられた器具の前に出現するように投影される、請求項1に記載の装置。
- 前記プロジェクタからの出力は、患者の生体構造の一部分上又は外科シーン内の前記手術野の表面上若しくは前記表面内に投影されるように適合される、請求項1に記載の装置。
- 前記生体構造の一部分は骨である、請求項5に記載の装置。
- 前記適合される出力は、前記生体構造の湾曲、凸凹、又は状況に関して調整される、請求項5に記載の装置。
- 前記カメラの軸を通る水平視野は、外科器具が前記筐体に結合される場合、前記外科器具の能動的要素の前記軸を通る水平面により定義される平面に略平行するか、又は鋭角をなす、請求項1に記載の装置。
- 前記筐体上にディスプレイをさらに備える、請求項1に記載の装置。
- 前記ディスプレイは、器具上追跡・ガイド装置のユーザの入力装置として構成される、請求項9に記載の装置。
- 前記画像処理動作に関連する情報を前記筐体とは別個の構成要素に提供するように構成される、前記筐体内の通信要素をさらに備える、請求項1に記載の装置。
- 前記通信要素は、前記筐体とは別個の前記構成要素と無線で情報をやりとりする、請求項11に記載の装置。
- 前記通信要素は、前記筐体とは別個の前記構成要素への有線接続を介して情報を提供する、請求項11に記載の装置。
- 前記筐体とは別個の前記構成要素は、外科器具能動的セグメントを使用してコンピュータ支援手術についての情報の使用に関連する命令をコンピュータ可読媒体内に含むコンピュータである、請求項11に記載の装置。
- 前記筐体内の前記通信要素は、前記画像処理動作に関連する情報を、前記筐体とは別個の構成要素に提供するように構成される、請求項11に記載の装置。
- 少なくとも部分的に前記第1のカメラ及び前記第2のカメラの視野内に出力を生成する命令を受信し、前記プロジェクタに提供するように構成される前記筐体内の通信要素をさらに備え、
前記出力は、前記電子画像プロセッサの動作からの出力を使用して実行されるコンピュータ支援手術処理ステップに関連する少なくとも1つの視覚的に知覚可能な指示を含む、請求項1に記載の装置。 - 引き金及び前記引き金の動作により制御される能動的要素を有する外科器具をさらに備え、
前記筐体は前記外科器具と解放可能に係合して取り付けられる、請求項1に記載の装置。 - 前記装置内に構成され、前記器具の動作を制御する電子構成要素、通信構成要素、及びソフトウェア構成要素をさらに備える、請求項17に記載の装置。
- コンピュータ支援手術を実行するシステムであって、
器具の手術機能に対応する能動的要素を有する外科器具と、
前記外科器具の少なくとも一部分と係合するように構成された筐体を使用して、前記器具に結合された器具上追跡装置と、
前記外科器具及び手術野に関連する撮像情報を取得するように構成された、前記筐体内の少なくとも1台のカメラと、
前記外科器具の能動的要素又はその近傍に投影出力を提供するように構成された、前記筐体内のプロジェクタと、
前記器具上追跡装置から少なくとも部分的に得られたデータを使用してコンピュータ支援手術処置を実行し、且つ手術のステップ中に使用される出力を提供する、電子メモリ内に記憶されたコンピュータ可読命令を有するコンピュータと、を備える、システム。 - 前記プロジェクタは、出力を患者の生体構造、手術シーン内の表面、電子装置、又は前記プロジェクタの出力範囲内の他の物体の一部分に投影する投影機能のうちの1つ又は複数をさらに備える、請求項19に記載のシステム。
- 前記コンピュータは前記筐体内にある、請求項19に記載のシステム。
- 前記コンピュータは、前記器具上追跡装置とは別個であり、有線又は無線接続を介して接続される、請求項19に記載のシステム。
- 器具上追跡装置は、請求項1〜18のいずれか一項に記載の要素のうちの1つ又は複数を有する、請求項19又は21に記載のシステム。
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2012
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- 2012-06-27 CA CA2840397A patent/CA2840397A1/en not_active Abandoned
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EP2723270A4 (en) | 2015-04-08 |
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EP2723270B1 (en) | 2019-01-23 |
WO2013052187A3 (en) | 2013-08-22 |
AU2017201866A1 (en) | 2017-05-11 |
CN106913366B (zh) | 2021-02-26 |
CN103764061B (zh) | 2017-03-08 |
JP2014533964A (ja) | 2014-12-18 |
CN106913366A (zh) | 2017-07-04 |
AU2012319093A1 (en) | 2014-01-16 |
US10219811B2 (en) | 2019-03-05 |
WO2013052187A2 (en) | 2013-04-11 |
EP2723270A2 (en) | 2014-04-30 |
CA2840397A1 (en) | 2013-04-11 |
AU2017201866B2 (en) | 2018-10-18 |
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