JP6549667B2 - 骨再建及び整形外科インプラント - Google Patents
骨再建及び整形外科インプラント Download PDFInfo
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- JP6549667B2 JP6549667B2 JP2017183217A JP2017183217A JP6549667B2 JP 6549667 B2 JP6549667 B2 JP 6549667B2 JP 2017183217 A JP2017183217 A JP 2017183217A JP 2017183217 A JP2017183217 A JP 2017183217A JP 6549667 B2 JP6549667 B2 JP 6549667B2
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Description
本出願は、2013年10月15日に出願された「CRANIUM AND POSTCRANIAL BONE AND SOFT TISSUE RECONSTRUCTION(頭蓋及び後部頭蓋骨並びに軟組織の再建)」と題される米国仮特許出願第61/891,047号の利益を主張し、この米国仮特許出願の開示内容は、参照することにより本願に組み入れられる。
(関連技術)
(発明の分野)
(発明の序文)
完全生体構造再建
患者固有再建インプラント
大量にカスタマイズできる構成要素を使用するカスタマイズされたインプラントの形成
マスカスタマイズされたインプラントの形成
性別/民族固有の股関節インプラントの形成
最初に、プロセスは、1つ以上の骨が解析される幾つかの実施形態連を含む統計アトラスを含む。股関節インプラントの典型的な状況において、統計アトラスは、骨盤骨及び大腿骨のための骨モデルの幾つかの事例を含む。少なくとも寛骨臼構成要素(すなわち、臼蓋窩)及び大腿骨近位部構成要素(すなわち、大腿骨頭)に関して関節面幾何学的解析が行われる。特に、関節面幾何学的解析は、統計アトラスの所定の個体群からのそれぞれの骨に関するランドマーク、測定値、及び、形状特徴の計算を伴う。また、関節面幾何学的解析は、計算を表す統計値などの定量値を生成することを含む。これらの計算から、計算の分布がプロットされるとともに、計算の分布がその分布に基づいて解析される。例えばボール形状分布においては、個体群の約90パーセント(90%)がグループ化されることを観察でき、それにより、非患者固有インプラント(例えば、マスカスタマイズされたインプラント)を設計できるとともに、この非患者固有インプラントがこのグループ化に適切に適合することができ、したがって、患者固有インプラントと比べて患者のためのコストを低減できる。個体群の残りの10パーセント(10%)においては、患者固有インプラントがより良い手法かもしれない。
動物固有のインプラントの形成
患者固有の切断ガイドの形成
その結果、仮想テンプレーティングモジュールは、患者固有3D臼蓋窩モデルを使用して、患者の残存する骨に対する寛骨臼カップインプラントのサイズ及び位置を計算し、したがって、患者の残存する骨盤がどの程度保持されるようになっているのかに関する情報及び所望のインプラント方向に関する情報を冶具生成モジュールに与える。この骨保持データに従い、冶具生成モジュールは、骨保持データを利用して、1つ以上の骨切断/リーミングを割り当て、計画されたように寛骨臼インプラントを受け入れるために必要な残存骨まで患者の現在の骨盤を減少させる。意図される骨切断を使用して、冶具生成モジュールは、1つの方向のみによって患者の骨盤の2つの部分と結合するように構成される形状を有する切断ガイド/冶具の仮想3Dモデルを生成する。言い換えると、切断冶具の3Dモデルは、有形のリーミングガイドが患者の生体構造と正確に適合するように患者の骨盤の解剖学的表面の「ネガ」として形成される。この方法では、リーミング冶具の位置決めと関連付けられる任意の当て推量が排除される。冶具生成モジュールがリーミング冶具の仮想3Dモデルを生成した後、モジュールは、急速プロトタイピングマシン、CNCマシン、又は、有形のリーミング冶具を製造するための同様の装置のために必要なマシンコードを出力する。一例として、臼蓋窩をリーマー加工するための典型的な寛骨臼構成要素冶具は4ピース構造を備え、この場合、第1のピースは、天然の臼蓋窩内に受けられるとともに、第1のピースを留置ガイドとして使用して第2のピースが骨盤に固定されるまで第2のピースに一時的に取り付くように構成される。第2のピースが骨盤に締結された後、第1のピースが除去されてもよい。また、第3のピースは、リーマーが第3のピースに対して長手方向に横切っていくことができるようにするために第2のピースと一意的に接続する円筒状の或いは部分的に円筒状の構成要素を含むが、その方向は、第1のピースと第3のピースとの組み合わせを使用して固定される。リーミングの後、リーマーが除去されるとともに、第3のピースが第1のピースから取り外される。寛骨臼カップインプラントは、第4のピースを使用して、リーマー加工された臼蓋窩に装着される。特に、第4のピースは、単一の方向でのみ第1のピースと係合するように一意的に形成されるが、同時に、寛骨臼カップインプラントの内部の中に受けられるように形成される。インプラントカップが位置された後、第1及び第4のピースの両方が除去される。また、寛骨臼インプラントを着座させるための1つ以上の穴を骨盤にドリルで開けるために更なる冶具が形成されてもよいことも留意すべきであり、この場合、ドリル加工冶具のそれぞれは、ドリル用ビットの方向を検証するために第1のピースに対して連続して装着される。
外傷プレートの形成
外傷プレート留置ガイドの形成
カスタマイズされた切断ガイド及び留置ガイド、プレート
共通している或いは同様の領域が存在しなければ、他の想定し得るドナー骨を解析することによってプロセスを再び開始することができる。一方、共通している或いは同様の曲率を有する1つ以上の領域がドナー骨に存在する場合には、これらの領域が3Dドナー骨モデルで強調される。特に、強調された領域は、仮想3D骨移植片モデルの形状を模倣する。共通している領域が骨移植片を切除するのに適していると判断されれば、ソフトウェアは、骨移植片を仮想3Dモデルとして仮想的に切除して、その骨移植片(ドナー骨に関して固有/特有の輪郭を有する)を患者の異常な生体構造の仮想3Dモデルに適用し、それにより、再建の一環として切除される必要があるかもしれない患者の異常な生体構造の任意の領域及び想定し得る適合を検証する。患者の異常な生体構造の仮想3Dモデルに対する切除された骨の仮想3Dモデルの適用が満足できるとはいえない再建をもたらす状況では、プロセスが骨選択点で再び開始されてもよく或いは骨の異なる領域を切除するように再び開始されてもよい。しかし、患者の異常な生体構造の仮想3Dモデルに対する切除された骨の仮想3Dモデルの適用が適切な適合をもたらせば、システムは、骨移植片の切除と患者の残存する骨に対する骨移植片の装着とを容易にするために冶具設計を進める。
Claims (19)
- 外傷骨プレートを形成するために使用する仮想三次元外傷プレートを生成するシステムの作動方法であって、前記システムが
骨個体群の統計アトラスを使用して、三次元骨モデルにアクセスする又は三次元骨モデルを形成するステップと、
前記三次元骨モデルの表面上の点を指定するステップと、
前記骨個体群の全体にわたって前記点を伝搬するステップと、
伝搬された前記点間の隙間を埋めて、前記骨個体群の全体にわたって外傷プレートの三次元表示を形成するステップと、
前記骨個体群の全体にわたって外傷プレートのそれぞれの三次元表示ごとに三次元長手方向中線を決定するステップと、
前記骨個体群の少なくとも一部に固有の仮想三次元外傷プレートを生成するステップと、
を備える方法。 - 前記三次元骨モデルがテンプレート骨モデルを備える請求項1に記載の方法。
- 前記骨個体群は、性別、年齢、民族性、骨変形、及び、部分骨構成のうちの少なくとも1つを使用して分類される請求項1に記載の方法。
- 前記統計アトラスが二次元画像及び三次元画像のうちの少なくとも一方を含む請求項1に記載の方法。
- 前記統計アトラスは、X線画像、コンピュータ断層撮影画像、磁気共鳴画像、レーザ走査画像、超音波画像のうちの少なくとも1つを備える二次元画像を含む請求項4に記載の方法。
- 前記統計アトラスが骨パラメータに関する情報を含む請求項1に記載の方法。
- 前記統計アトラスは、骨の物理的な測定データを含む請求項1に記載の方法。
- 指定する前記ステップがソフトウェアによって自動的に行われる請求項1に記載の方法。
- 指定する前記ステップは、前記三次元骨モデルの前記表面上の最終的な外傷プレートのための境界形状を定めるステップを含む請求項1に記載の方法。
- 指定する前記ステップは、前記境界形状が定められた後にソフトウェアによって自動的に行われる請求項9に記載の方法。
- 前記ソフトウェアは、前記境界形状内の骨表面点の何%が指定されるのかを人が指定するのに応じてパーセントフィル作業を行う請求項10に記載の方法。
- 前記境界形状を定める前記ステップは、指定された点のそれらの最も外側の点を使用してソフトウェアによって自動的に行われる請求項9に記載の方法。
- 前記骨個体群の全体にわたって前記点を伝搬する前記ステップは、前記骨個体群内の各骨モデルにソフトウェアを自動的に適用させるステップを含む請求項1に記載の方法。
- 前記三次元長手方向中線がその長さに沿って複数の曲率を備える請求項1に記載の方法。
- 前記三次元長手方向中線の支配的な曲率を近似する所定の数の曲率半径が決定される請求項14に記載の方法。
- 前記所定の数の曲率半径のそれぞれが記録され、前記曲率半径をクラスタリングして前記骨個体群に最も良く適合するクラスタを形成するために少なくとも四次元特徴ベクトルが前記曲率半径に適用される請求項15に記載の方法。
- 前記曲率半径をクラスタリングすることによる出力が1つ以上のクラスタであり、前記各クラスタは、少なくとも前記骨個体群のサブセットに適合するべくマスカスタマイズされた外傷プレートに対応する請求項15に記載の方法。
- 前記各仮想三次元外傷プレートは、筋肉及び軟組織の付着位置を避けるように定められるパラメータ化された固定位置を含む請求項1に記載の方法。
- 前記各仮想三次元外傷プレートは、前記クラスタ骨個体群の全体にわたる前記各固定位置における骨の断面解析を使用して決定される寸法を有する締結具を含む請求項18に記載の方法。
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