JP2020518312A - 脊椎手術を支援するための術中追跡を提供するシステム - Google Patents
脊椎手術を支援するための術中追跡を提供するシステム Download PDFInfo
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Abstract
Description
2つ以上の能動センサであって、2つ以上の能動センサの各々は、1つ以上の加速計及び/又は1つ以上のジャイロスコープを含む、能動センサ;
2つ以上の取り付けデバイスであって、2つ以上の取り付けデバイスの各々は、上記能動センサ、電源、及び無線送信機のうちの1つ以上を備え、2つ以上の取り付けデバイスは、上記2つ以上の能動センサによって収集される位置データの3つの軸のうちの2つが、脊椎手術患者の矢状面に対して平行又は一定の角度で実質的に平行であると推定される平面上にあるような配置で、2つ以上の椎骨に取り付けられるように構成され、
上記2つ以上の取り付けデバイスが脊椎手術中に2つ以上の椎骨に取り付けられているとき、2つ以上の能動センサの各々は、2つ以上の取り付けデバイスの各々が取り付けられている2つ以上の椎骨の各々の位置及び/又は方向データを提供するように構成されている、取り付けデバイス;
複数のコンピュータ実行可能命令を記憶するように構成された1つ以上のコンピュータ可読記憶デバイス;及び
1つ以上のコンピュータ可読記憶デバイスと通信し、システムに以下のことを行わせるために複数のコンピュータ実行可能命令を実行するように構成された、1つ以上のハードウェアコンピュータプロセッサ:
2つ以上の取り付けデバイスの各々の無線送信機から、位置及び/又は方向データを、実質的にリアルタイムで受信すること;
1つ以上の慣性測定ユニットの位置及び/又は方向データに少なくとも部分的に基づき、及び2つ以上の取り付けデバイスの各々の無線送信機から受信した位置及び/又は方向データの間の共通基準として重力を使用して、上記2つ以上の取り付けデバイスが取り付けられている2つ以上の椎骨の位置及び/又は方向を動的に決定すること;
2つ以上の取り付けデバイスが取り付けられている2つ以上の椎骨の決定された位置及び方向を、所定の外科手術計画と比較することに少なくとも部分的に基づいて、脊椎手術のための1つ以上の性能測定基準を動的に作成すること;及び、
作成された1つ以上の性能測定基準に少なくとも部分的に基づいて、脊椎手術を実施するためのガイダンス命令を動的に作成すること。
図1は、患者特異的な脊椎治療、手術、及び処置を策定するための、反復良循環の例示的実施形態の概要を示すフローチャートである。図1に示すように、システム、方法、及びデバイスのいくつかの実施形態は、反復良循環を形成できる1つ以上のプロセスを含む。例えば、反復良循環は、以下のうちの1つ以上を含むことができる:(1)画像解析;(2)ケースシミュレーション;(3)インプラント製造(4)ケースサポート;(5)データ収集;(6)機械学習;及び/又は(7)予測モデリング。特定の実施形態は、上記プロセスの任意のサブセットを含み得る。さらに、反復良循環の1つ以上のプロセス又はテクニックを繰り返すことができる。
本明細書で説明されるように、特定の実施形態では、システムは、脊椎手術の有効性増大をもたらすため及び/又はコストを制御するために、1つ以上の患者固有のスクリュー及び/又はケージを設計し、製造し、修正し、及び/又は選択のためのガイダンスを提供するように構成することができる。例えば、1つ以上の患者固有のスクリュー及び/又はケージは、スクリュー及び/又はケージの既存の範囲又は在庫から選択することができる。特に、いくつかの実施形態では、システムは、1つ以上の医用画像の解析に少なくとも部分的に基づいて、特定の椎骨及び/又は椎間腔などの特定の解剖学的部位において特定の患者に使用される1つ以上のスクリュー及び/又はケージを、設計し、製造し、修正し、及び/又は選択のためのガイダンスを提供するように構成することができる。例えば、システムは、特定の椎骨に挿入するための特定のスクリュー及び/又は特定の椎間腔に挿入するための特定のケージを設計するように構成することができる。
特定の実施形態では、システムは、例えばケースサポートの一部として、ケージ計画及び/又はケージ設計を提供するように構成することができる。システムは、ある患者に適合しそうな特定のケージを決定し、そのような1つ以上のケージを推奨するように構成することができる。より具体的には、いくつかの実施形態では、システムは、特定の患者の脊椎を過度に伸延すること及び/又は脊椎をその生理学的能力を超えて過剰矯正しようと試みることがないことを確実とするためのガイドラインとして使用できる1つ以上の靭帯の長さを決定又は重視するように構成することができる。より具体的には、ケージ選択に関して、特定の患者の縦靭帯の長さを越える脊椎の過伸展を生じ得るケージを選択しないことが重要となり得る。したがって、いくつかの実施形態では、システムは、単に脊椎に沿った直線を測定するのではなく、1つ以上の縦靭帯の1つ以上の寸法を測定するように構成される。
いくつかの実施形態では、システムは、1つ以上の靱帯長さを測定する際に前方又は後方アプローチを利用し、患者特異的ケージの1つ以上の寸法の設計又は決定にそれを使用し、手術の結果として患者の脊椎が過伸展されないことを確実とするように構成することができる。図10Aは、ケージの設計、製造、修正、及び/又は選択の例示的実施形態を示すフローチャートである。特に、図10Aに示すように、いくつかの実施形態では、システムは、前方アプローチを利用するように構成することができる。
いくつかの実施形態では、システムは、例えば、手術の結果として患者の脊椎が過伸展又は過伸延されないことを確実とするため、患者特異的なケージの1つ以上の寸法を設計又は決定に関して、各椎骨終板の中央によって画定される曲線を解析するか及び/又は重視するように構成することができる。図11Aは、ケージの設計、製造、修正、及び/又は選択の例示的実施形態を示すフローチャートである。図11Bは、ケージの設計、製造、修正、及び/又は選択の例示的実施形態を示す概略図である。特に、図11A及び図11Bに示すように、いくつかの実施形態では、システムは、ミッドプレートアプローチを利用するように構成することができる。
本明細書で論じるように、特定の実施形態では、システムは、1つ以上の患者特異的スクリューを設計し、製造し、修正し、及び/又は選択のためのガイダンスを提供するように構成することができる。これは、製造及び/又は保管を必要とするスクリューの在庫を減少させることでコストを実質的に削減することにより、有利となり得る。また、滅菌コストの削減により、関連コストをさらに削減することができる。より少ないスクリュー、ケージ、及び/又はそれらのセットが、各手術のためのカスタマイズされたキャディーとして提供されることから、手術時間の短縮及び外科処置の単純化が外科医及びスタッフにとってさらなる利点となり得る。
一般的に言えば、蛍光透視及び/又はCTスキャンのような特定の術中撮像を、脊椎の弯曲及び/又はその矯正の術中評価のために使用することができる。しかしながら、このようなプロセスは、一般に、脊椎弯曲の瞬間的な視覚評価を提供するにすぎない。したがって、脊椎弯曲/アンギュレーションのライブ追跡を可能にし、外科医に実質的な補助を提供し、それによって外科医がライブ制御下で必要となり得る脊椎のさらなる矯正を行えるようにすることは有利となり得る。同時に、光電子受動センサに基づくものなどの、特定のライブ追跡デバイスは、通常の手術と比較して多くの追加の工程が必要とされ得ることから、外科医のワークフローを妨げ得る。
いくつかの実施形態では、システムは、外科手術のための1つ以上の予測モデル又はアルゴリズムを作成するように構成される。特定の実施形態では、1つ以上の予測モデル及び/又はアルゴリズムは、外科的処置、例えば脊椎の外科的処置から生じ得る1つ以上の外科的パラメータ及び/又は変数を予測するように構成される。いくつかの実施形態では、予測モデル及び/又はアルゴリズムは、所望の外科的結果を達成するための外科手術計画を作成するように構成される。例えば、本明細書に開示されたシステムは、術前の患者入力データにアクセスし、脊椎ロッドを患者に移植するための外科手術計画を作成するように構成することができ、作成された外科手術計画は患者に合わせてカスタマイズされており、特定の患者のための最適な術後脊椎弯曲を生成するように構成される。
いくつかの実施形態では、システムは、胸椎後弯又は骨盤傾斜角などの術後パラメータを決定するための予測モデルを作成するように構成された、コンピュータにより実行される方法(computer−implemented method)を実施するように構成され、当該コンピュータにより実行される方法は、電子データベースからのデータセットにアクセスすることを含み、当該データセットは患者に関するデータ(例えば、X線画像又は臨床情報)及び手術戦略に関するデータ(例えば、上端固定椎、下端固定椎など)を含む。いくつかの実施形態では、コンピュータにより実行される方法は、データセットにおいて、どのパラメータがモデルの入力であるべきで、どのパラメータがモデルの出力であるべきかを確定するように構成される。例えば、モデルの出力は、システムが予測するように構成されたパラメータであり得る。
いくつかの実施形態では、予測モデリングに関連する1つ以上のプロセス又はテクニックを実施するために、システムは、1名以上の患者から収集できる以下のデータ要素又はパラメータのうちの1つ以上を受信、アクセス、及び/又は取得するように構成することができる。
図16は、患者特異的な脊椎治療、手術、及び処置を策定するためのシステムの実施形態を示す概略図である。いくつかの実施形態では、メインサーバシステム1602は、画像解析モジュール1604、ケースシミュレーションモジュール1606、術中追跡モジュール1608、データ利用モジュール1610、予測モデリングモジュール1628、計画データベース1612、手術データベース1614、外科医データベース1616、及び/又は文献データベース1618を含む。メインサーバシステムは、ネットワーク1620に接続することができる。ネットワークは、メインサーバを1つ以上のインプラント製造施設システム1626、1つ以上の医療施設クライアントシステム1622、及び/又は1つ以上のユーザアクセスポイントシステム1624に接続するように構成することができる。
いくつかの実施形態では、本明細書に記載されたシステム、プロセス、及び方法は、図17に示されるようなコンピューティングシステムを使用して実施される。例示的なコンピュータシステム1702は、1つ以上のネットワーク1718を介して1つ以上のコンピューティングシステム1720及び/又は1つ以上のデータソース1722と通信する。図17は、コンピューティングシステム1702の実施形態を示すが、コンピュータシステム1702のコンポーネント及びモジュールにおいて、提供される機能を組み合わせてより少ないコンポーネント及びモジュールとしてもよく、又はさらに分離されて追加のコンポーネント及びモジュールとしてもよいことは理解される。
Claims (10)
- 脊椎手術を支援するための術中追跡を提供するためのシステムであって、
2つ以上の能動センサ(1302)であって、2つ以上の前記能動センサ(1302)の各々は、1つ以上の加速計及び/又は1つ以上のジャイロスコープを含む、能動センサ;
2つ以上の取り付けデバイスであって、2つ以上の前記取り付けデバイスの各々は、前記能動センサ(1302)、電源、及び無線送信機のうちの1つ以上を備え、2つ以上の前記取り付けデバイスは、2つ以上の前記能動センサによって収集された位置データの3つの軸のうちの2つが、脊椎手術患者の矢状面に対して平行又は一定の角度で実質的に平行であると推定される平面上にあるような配置で、2つ以上の椎骨に取り付けられるように構成され、
2つ以上の前記取り付けデバイスは、脊椎手術中に2つ以上の椎骨に取り付けられており、2つ以上の前記能動センサ(1302)の各々は、2つ以上の前記取り付けデバイスの各々が取り付けられている2つ以上の前記椎骨の各々の位置及び/又は方向データを提供するように構成されている、取り付けデバイス;
複数のコンピュータ実行可能命令を記憶するように構成された1つ以上のコンピュータ可読記憶デバイス;及び
1つ以上のハードウェアコンピュータプロセッサであって、1つ以上の前記コンピュータ可読記憶デバイスと通信し、かつ、前記システムに、
2つ以上の前記取り付けデバイスの各々の前記無線送信機から、前記位置及び/又は方向データを、実質的にリアルタイムで受信すること、
前記位置及び/又は方向データに少なくとも部分的に基づき、かつ2つ以上の前記取り付けデバイスの各々の前記無線送信機から受信した前記位置及び/又は方向データの間の共通基準として重力を使用して、2つ以上の前記取り付けデバイスが取り付けられている2つ以上の前記椎骨の位置及び/又は方向を動的に決定すること、
前記2つ以上の取り付けデバイスが取り付けられている2つ以上の前記椎骨の前記決定された位置及び方向を、所定の手術計画と比較することに少なくとも部分的に基づいて、脊椎手術のための1つ以上の性能測定基準を動的に作成すること、及び、
作成された1つ以上の性能測定基準に少なくとも部分的に基づいて、脊椎手術を実施するためのガイダンス命令を動的に作成すること、を行わせるために、複数のコンピュータ実行可能命令を実行するように構成された、ハードウェアコンピュータプロセッサ;
を含む、システム。 - 1つ以上の前記能動センサ(1302)の各々は、6自由度の慣性測定ユニットであるように構成される、請求項1に記載のシステム。
- 1つ以上の前記能動センサ(1302)の各々は、9自由度の慣性測定ユニットであるように構成される、請求項1に記載のシステム。
- 2つ以上の前記取り付けデバイスは、椎骨アンカーを備える、請求項1に記載のシステム。
- 2つ以上の前記取り付けデバイスは、椎骨スクリューを備える、請求項1に記載のシステム。
- 前記椎骨スクリューは、少なくとも1つのセンサ(1302)を備える単軸スクリューである、請求項5に記載のシステム。
- 前記椎骨スクリューは、少なくとも1つのセンサ(1302)を備える多軸スクリューである、請求項5に記載のシステム。
- 2つ以上の前記取り付けデバイスは、外科用器具(1400)を備える、請求項1に記載のシステム。
- 2つ以上の前記取り付けデバイスは、スクリュー(1306)、ナット、アンカー、及び/又はその他のインプラント、並びに前記スクリュー(1306)、ナット、アンカー、及び/又はその他のインプラントと連結されるように構成された追加のハウジング構造(1410)を備え、前記追加のハウジング構造(1410)は、1つ以上の前記能動センサ及び/又は受動センサ(1302)を備える、請求項1に記載のシステム。
- 前記追加のハウジング構造(1410)は、前記スクリュー(1306)、ナット、アンカー、及び/又はその他のインプラントを椎骨に固定するために使用可能な取外し可能なハンドル(1412)と共に使用されるように、及び/又は当該ハンドルと連結されるように、構成される、請求項9に記載のシステム。
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