JP6894441B2 - 脊椎手術を容易にするためのシステム及び方法 - Google Patents
脊椎手術を容易にするためのシステム及び方法 Download PDFInfo
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Description
本特許出願は、2016年1月22日に出願された米国仮出願第62/286,166号に対する優先権を主張するものであり、この文献の完全な開示は、本明細書に完全に記載されているかのように、参照により本願に組み込まれる。
図2〜図13に示される例示的な実施形態によれば、脊椎パラメータの術前測定は、以下に記載の測定機能を含むソフトウェアアプリケーションを備えた例えば携帯電話又はタブレット等の、カメラ及びタッチスクリーンを備えた携帯型モバイル装置を使用して行うことができる。1つのそのような適切なアプリケーションはNuvaline(登録商標)である。しかしながら、本明細書に記載の画像操作及び測定を実行可能な任意のアプリケーションを使用してもよい。
様々な実施形態において、本明細書のシステム及び方法は、頸椎パラメータを測定し、手術中に矢状及び冠状の両方のバランスを評価し、それにより、評価を患者に対するユーザ動作に変換及び変形可能にする。いくつかの実施形態では、本明細書のシステム及び方法は、手術中に矢状アラインメントを評価する。以下、一実施形態について説明する。
Correction During Surgery”という表題の米国特許出願第15/045,084号に記載されており、この文献の全体の内容が、本明細書に完全に記載されているかのように、参照により本明細書に組み込まれる。
図1に示されている手術計画、評価、及び矯正システム10の実施形態を再び参照すると、システム10は、1つ又は複数の外科用インプラント14の位置を取得する空間追跡システム12、インプラント位置を一連の曲げ命令に変換するためのソフトウェアを含む制御ユニット16、及び曲げ命令を実行する曲げ装置18を含む。
図71のフローチャートは、よりグ全体的にアライメントされた脊椎のためのロッド曲げ命令を測定、計画、及び生成するための例示的な方法の概要を提供する。簡潔には、一実施形態によれば、脊柱の1つ又は複数の術前画像が取得される(ステップ1200)。ユーザは、画像を入力し、計画ソフトウェア及びインターフェイスを使用して、胸腰椎領域のPI、LL、上LL、下LL、C7PL、TK、及び頸椎領域のCL、ΔCL、TS、CSVA、CBVAを含み得る術前脊椎パラメータを測定する(ステップ1202)。ユーザは、欠陥を修正するために、全体的にアライメントされた脊柱の最適な脊椎パラメータを決定することを含む外科的介入を計画する(ステップ1204)。ユーザが手術計画に納得すれば、計画された脊椎パラメータ値が保存される。患者が手術のために準備されると、術前及び計画された脊椎の値がシステム10に入力される(ステップ1206)。外科医は、適切なインプラント及びねじ及び/又はプレートの配置に関して、手術計画をガイドとして使用して、欠陥を矯正するために脊椎手術を行う。手術中、ユーザは、神経監視システムを使用してもよい。手術中の任意の時点であるが、一般的に、インプラントの配置及び/又はロッド安定化のためのねじ又はフックの挿入後に、ユーザは、脊椎の術中画像を取得し、術前計画中に取得された脊椎パラメータを測定する(ステップ1208)。脊椎パラメータの測定は、患者のアライメントの現在の状態について外科医に通知され、術前変形及び/又は計画された矯正の比較を提供する(ステップ1210)。手術中の外科的パラメータが非病理的な範囲と異なる場合に、又はそれらパラメータが計画値と異なる場合に、外科医は、例えばインプラントの交換等を含む修正手段を講じてもよい。外科医は、脊柱が外科医の満足する箇所まで整列されるまで、脊椎パラメータの追加の術中評価を行うことができる(ステップ1208)。次に、ユーザは、ロッドの配置のための各ねじの位置を測定する(ステップ1212)。ユーザは、ねじの位置を手動で調整して配置を修正し、追加の脊椎前弯又は脊椎後弯を導入するか、又は他の脊柱のミスアライメントを修正することができる。インプラント及びねじに対するアライメント及び矯正調整の術中測定値は、所望の整列度が達成されるまで繰り返され得ることが理解されよう。
Claims (17)
- 脊椎手術中の脊柱の全体的なアライメントのためのシステムであって、
該システムは、撮像装置と、空間追跡システムと、曲げ装置と、制御ユニットとを有しており、
該制御ユニットは、
1つ又は複数の脊椎パラメータの計画された標的値を受信し、
該1つ又は複数の脊椎パラメータの前記計画された標的値に基づいて、前記脊柱の(i)矢状アライメント及び(ii)冠状アライメントのうちの少なくとも1つの所望の矯正に対応する1つ又は複数の範囲を決定し、
前記撮像装置及び前記空間追跡システムを介して、1つ又は複数の術中蛍光透視画像を取り込み、
前記取り込んだ1つ又は複数の術中蛍光透視画像に従って、前記1つ又は複数の脊椎パラメータの術中値を測定し、
前記1つ又は複数の脊椎パラメータの前記術中値を前記脊椎パラメータの前記計画された標的値と比較し、
該比較に基づいて、前記1つ又は複数の前記術中値が前記1つ又は複数の範囲内にあると判定し、1つ又は複数のねじの位置を測定し、
前記曲げ装置を介して、ロッドを前記1つ又は複数のねじの前記位置まで曲げるべく命令を計算するように構成される、
システム。 - 外科処置中に使用するためのシステムであって、当該システムは、
撮像装置と、
ロッド曲げ装置と、
制御ユニットと、を有しており、
該制御ユニットは、
患者の解剖学的パラメータの1つ又は複数の術前測定値を取得し、
前記解剖学的パラメータの1つ又は複数の計画された標的測定値を取得し、
前記解剖学的パラメータの前記計画された標的測定値に基づいて、脊柱の(i)矢状アライメント及び(ii)冠状アライメントのうちの少なくとも1つの所望の矯正に対応する1つ又は複数の範囲を決定し、
前記撮像装置から術中画像を取得し、
前記解剖学的パラメータの術中測定値を測定し、
前記解剖学的パラメータの前記術中測定値が前記1つ又は複数の範囲内にあると判定し、整形外科用ロッドを曲げるための命令を計算するように構成される、
システム。 - 前記解剖学的パラメータは、顎眉鉛直角である、請求項2に記載のシステム。
- 前記顎眉の軸線が、水平位置に対する患者の視線の角度である、請求項3に記載のシステム。
- 前記制御ユニットは、前記視線の角度のカラー指標をユーザに表示する、請求項4に記載のシステム。
- 前記解剖学的パラメータは、健康関連QOL(Quality of Life)スコアに相関するパラメータである、請求項2に記載のシステム。
- 前記解剖学的パラメータは、前記患者の骨盤に対する前記患者の頭部のアライメントに相関するパラメータである、請求項2に記載のシステム。
- 外科処置中に脊柱の全体的なアライメントを評価するためのプログラムであって、当該プログラムが、制御ユニットによって実行されると、該制御ユニットに、以下の段階を実行させ、該段階には、
1つ又は複数の脊椎パラメータの計画された標的値を受信することと、
前記1つ又は複数の脊椎パラメータの前記計画された標的値に基づいて、前記脊柱の(i)矢状アライメント及び(ii)冠状アライメントのうちの少なくとも1つの所望の矯正に対応する1つ又は複数の範囲を決定することと、
1つ又は複数の術中透視画像を取り込むことと、
前記取り込んだ1つ又は複数の術中透視画像に従って前記1つ又は複数の脊椎パラメータの術中値を測定することと、
前記1つ又は複数の脊椎パラメータの前記術中値を、前記脊椎パラメータの前記計画された標的値と比較することと、
該比較に基づいて、前記1つ又は複数の脊椎パラメータの前記術中値が前記1つ又は複数の範囲内にあると判定し、1つ又は複数のねじの位置を測定することと、
ロッドを前記1つ又は複数のねじの位置に曲げるための命令を計算することと、を含む、
プログラム。 - 前記脊椎パラメータのうちの少なくとも1つは、顎眉鉛直角である、請求項8に記載のプログラム。
- 当該段階は、前記眉の上に配置されたポイントと、前記顎の上に配置されたポイントとの間の線を計算することと、及び前記線と縦軸との間の角度を計算することとをさらに含む、請求項9に記載のプログラム。
- 前記段階は、前記1つ又は複数の脊椎パラメータの術前値を計算することをさらに含む、請求項8に記載のプログラム。
- 前記段階は、前記術中値と前記計画された標的値との比較に基づいて、前記1つ又は複数の脊椎パラメータの第2の標的値を計算することをさらに含む、請求項8に記載のプログラム。
- 前記脊椎パラメータのうちの少なくとも1つは、健康関連QOLスコアに相関するパラメータである、請求項8に記載のプログラム。
- 前記脊椎パラメータは、患者の骨盤に対する前記患者の頭部のアライメントに相関するパラメータである、請求項8に記載のプログラム。
- 前記脊椎パラメータのうちの少なくとも1つは、頚椎矢状縦軸である、請求項8に記載のプログラム。
- 前記脊椎パラメータのうちの少なくとも1つは、T1傾斜角である、請求項8に記載のプログラム。
- 前記脊椎パラメータのうちの少なくとも1つは、頚椎前弯である、請求項8に記載のプログラム。
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