JP2014519893A - 患者特有の寛骨臼調整ガイド - Google Patents

患者特有の寛骨臼調整ガイド Download PDF

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JP2014519893A
JP2014519893A JP2014511538A JP2014511538A JP2014519893A JP 2014519893 A JP2014519893 A JP 2014519893A JP 2014511538 A JP2014511538 A JP 2014511538A JP 2014511538 A JP2014511538 A JP 2014511538A JP 2014519893 A JP2014519893 A JP 2014519893A
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acetabular
adjustment
patient
guide
acetabulum
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JP5918356B2 (ja
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アール. ホワイト,ジョン
ディー. ペリー,ランス
ピー. スミス,アーロン
ディー. メリデュー,ジェイソン
モリソン,ブライアン
スローン,ダブリュー.ジェイソン
ディー. ウィット,タイラー
エー. ボリンガー,マーク
メッツガー,ロバート
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Biomet Manufacturing LLC
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4609Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of acetabular cups
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    • A61B17/1617Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material with mobile or detachable parts
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    • A61B17/1662Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1664Bone 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 hip
    • A61B17/1666Bone 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 hip for the acetabulum
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
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    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
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    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

寛骨臼装置は、骨連動面(408)を含む患者特有の寛骨臼調整ガイド(400)を含む。上記骨連動面は、寛骨臼端面(84)と相補的に適合するように構成され形成された第1部(402)と、患者の寛骨臼(82)の寛骨臼周辺領域と相補的に適合するように構成され形成された第2部(404)とを有する。上記寛骨臼調整ガイドは、上記第2部を通って伸長し、自身を通る複数の調整ピン(420)をガイドする複数のガイド構造(406)を含む。上記骨連動面および上記複数のガイド構造は、特定の患者のスキャンから手術前に復元された上記特定の患者の上記寛骨臼の3次元モデルから準備される。

Description

発明の詳細な説明
〔関連出願のクロスリファレンス〕
本願は、2011年2月25日に出願された米国特許仮出願第61/446,660号の利益を主張する、2011年5月19日に出願された米国通常出願第13/111,007号の優先権を主張する。
本願は、2011年3月7日に全て出願された、米国特許出願第13,041,469号、第13/041,495号、第13/041,665号および第13/041,883号の一部継続出願である。米国特許出願第13,041,469号、第13/041,495号、第13/041,665号および第13/041,883号は、それぞれ、2010年12月23日に出願された米国特許出願第12/978,069号の一部継続出願である。米国特許出願第12/978,069号は、2010年12月20日に出願された米国特許出願第12/973,214号の一部継続出願である。米国特許出願第12/973,214号は、2010年11月29日に出願された米国特許出願第12/955,361号の一部継続出願である。米国特許出願第12/955,361号は、2010年11月3日に共に出願された米国特許出願第12/938,913号および第12/938,905号の一部継続出願である。米国特許出願第12/938,913号および第12/938,905号は、2010年9月29日に出願された米国特許出願第12/893,306号の一部継続出願である。米国特許出願第12/893,306号は、2010年9月22日に出願された米国特許出願第12/888,005号の一部継続出願である。米国特許出願第12/888,005号は、2010年2月26日に出願された米国特許出願第12/714,023号の一部継続出願である。米国特許出願第12/714,023号は、2009年10月1日に出願された米国特許出願第12/571,969号の一部継続出願である。米国特許出願第12/571,969号は、2009年6月18日に出願された米国特許出願第12/486,992号の一部継続出願であり、2009年2月20日に出願された米国特許出願第12/389,901号の一部継続出願である。米国特許出願第12/389,901号は、2008年9月16日に出願された米国特許出願第12/211,407号の一部継続出願である。米国特許出願第12/211,407号は、2008年2月29日に出願された米国特許出願第12/039,849号の一部継続出願である。米国特許出願第12/039,849号は、(1)2007年8月2日に出願された米国特許仮出願第60/953,620号、2007年7月3日に出願された米国特許仮出願第60/947,813号、2007年4月12日に出願された米国特許仮出願第60/911,297号、および2007年3月1日に出願された米国特許仮出願第60/892,349号の利益を主張し、(2)2006年6月9日に出願された米国特許仮出願第60/812,694号の利益を主張する、2007年5月31日に出願された米国特許出願第11/756,057号の一部継続出願であり、(3)2006年2月27日に出願された米国特許出願第11/363,548号(2010年8月24日に発行された米国特許第7,780,672号)の一部継続出願である、2008年1月9日に出願された米国特許出願第11/971,390号の一部継続出願であり、(4)2007年8月2日に出願された米国特許仮出願第60/953,637号の利益を主張する、2008年2月4日に出願された米国特許出願第12/025,414号の一部継続出願である。
本願は、2010年3月5日に出願された米国特許仮出願第61/310,752号の利益を主張する、2010年8月31日に出願された米国特許出願第12/872,663号の一部継続出願である。
本願は、2009年6月12日に出願された米国特許出願第12/483,807号の一部継続出願である。米国特許出願第12/483,807号は、2009年2月13日に出願された米国特許出願第12/371,096号の一部継続出願である。米国特許出願第12/371,096号は、2007年4月17日に出願された米国特許仮出願第60/912,178号の利益を主張する、2008年4月16日に出願された米国特許出願第12/103,824号の一部継続出願である。
本願は、また、2007年4月17日に出願された米国特許仮出願第60/912,178号の利益を主張する、2008年4月16日に出願された米国特許出願第12/103,824号の一部継続出願である。
上記出願による開示は、本明細書中に参考として援用される。
〔はじめに〕
本教示は、患者特有の寛骨臼調整ガイド、および、それに関する道具であって、患者の寛骨臼に寛骨臼インプラントをガイドする道具を提供する。
〔概要〕
本教示は、寛骨臼装置を提供する。一態様では、寛骨臼システムは、骨連動面(a bone engagement surface)を含む患者特有の寛骨臼調整ガイドを含む。骨連動面は、寛骨臼の端面に相補的に適合するように構成され形成された第1部、および患者の寛骨臼の周辺領域に相補的に適合するように構成され形成された第2部を有する。寛骨臼調整ガイドは、第2部に向かって延伸する複数のガイド構造であって、当該ガイド構造を通して複数の調整ピンをガイドするガイド構造を含む。骨連動面および複数のガイド構造は、患者をスキャンして手術前に復元された患者特有の寛骨臼の3次元モデルから作成される。
寛骨臼装置は、さらに、ハンドル、シャフトおよび寛骨臼連結器(an acetabular coupler)を含む寛骨臼挿入具(an acetabular inserter)と、当該寛骨臼挿入具のシャフトと着脱可能に連結する第1調整アダプター(a first alignment adapter)を含んでいてよい。第1調整アダプターは、寛骨臼調整ガイドのガイド構造に対応するように形成された複数の孔を含む。そのため、患者から調整ピンを取り外すことなく、寛骨臼調整ガイドが取り外されると、調整ピンは調整アダプターの孔を通り抜けることができる。
本教示は、さらに、患者の寛骨臼に寛骨臼インプラントを挿入する方法を提供する。上記方法は、患者特有の寛骨臼調整ガイドの表面を、相補的な患者の寛骨臼の端面および周辺領域に連動するステップと、複数の調整ピンを、対応する寛骨臼調整ガイドの調整孔に通し、患者の寛骨臼周辺領域に挿入するステップと、を含む。上記方法は、さらに、調整ピンを患者から取り外すことなく、寛骨臼調整ガイドを取り外すステップと、寛骨臼挿入具と連結する第1調整アダプターを調整ピン全体に渡ってガイドするステップと、寛骨臼インプラントを寛骨臼挿入具と共に注入するステップと、を含む。
本教示は、第1表面および第1表面と反対側の第2表面を含む環状寛骨臼ガイドを含む寛骨臼装置を提供する。第1表面は、患者特有であり、患者の寛骨臼の3次元画像に従って、患者の寛骨臼周辺の寛骨臼端面に適合するように作られる。寛骨臼ガイドは、第1表面に対する患者特有の前傾および外転角度に向けられた円筒形の内側ガイド表面を含む。寛骨臼装置は、さらに、寛骨臼ガイドの内面と一致可能な外側表面と、特別仕様ではない寛骨臼器具と連結する急速接続要素(a quick-connection component)と、を有する患者特有のアダプターを含む。
さらに、本教示の適用可能な分野は、以下の説明から明らかにされる。以下の説明および特定の例は、単に例示を目的とし、本教示の範囲を限定するものではないことが理解されるであろう。
〔図面の簡単な説明〕
本教示は、詳細な説明および添付の図面に基づいてより完全に理解されるであろう。
図1は、寛骨臼注入処置の準備における患者を例示する図である。
図1Aは、患者の解剖に関して示されている、本教示に係る寛骨臼ガイドの透視図である。
図2は、本教示に係る寛骨臼インプラントを保持する寛骨臼挿入具と共に示された、図1Aの寛骨臼ガイドの周囲の透視図である。
図3は、寛骨臼挿入具および寛骨臼インプラントの透視図である。
図3Aは、本教示に係る挿入時に解剖学的構造上の軸Aについて回転する寛骨臼インプラントの周囲の透視図である。
図3Bは、本教示に係る挿入時に解剖学的構造上の軸Bについて回転する寛骨臼インプラントの周囲の透視図である。
図4は、図3の寛骨臼挿入具および寛骨臼インプラントの分解組立図である。
図4Aは、本教示に係る使用のためのモジュールの拡孔器の透視図である。
図4Bは、図4Aの拡孔器の頭部の底面図である。
図4Cは、図4Aの拡孔器の駆動部の透視図である。
図4Dは、図4Cの拡孔器の駆動部の末端の底面図である。
図4Eは、本教示に係る使用のためにアダプターと組み立てられた、図4Aのモジュールの拡孔器の透視図である。
図4Fは、図4Eのアダプターの天面図である。
図4Gは、図4Eのアダプターの底面図である。
図4Hは、本教示に係る患者特有のアダプターと組み立てられた拡孔器周囲の図である。
図5は、本教示に係る、例示の寛骨臼調整ガイドの周囲の透視図である。
図6は、複数のガイドピンを有している、図5の寛骨臼調整ガイドの周囲の透視図である。
図7は、図6のガイドピンによってガイドされた器具を有する寛骨臼カップの挿入を説明する透視図である。
図8は、例示の寛骨臼インプラントの周囲の透視図である。
図9は、本教示に係る、例示の衝撃装置の透視図である。
図10は、本教示に係る、例示のオフセット衝撃装置の透視図である。
図11Aは、本教示に係る、患者特有の寛骨臼ガイドの周囲の図である。
図11Bは、図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによって寛骨臼を拡孔するためにガイドされた拡孔器患者特有のアダプターの周囲の図である。
図11Cは、図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによってガイドされたものさしであって、インプラントの長さを測るための長さものさしの周囲の図である。
図12は、図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによって寛骨臼を拡孔するためにガイドされた患者特有のアダプターを有する拡孔器の透視図である。
図13は、本教示に係る、患者特有の表を付け替えた大腿部のインプラントの周囲の図である。
図14Aは、本教示に係る患者特有の大腿部のインプラントの周囲の腹側の図である。
図14Bは、図14Aの大腿部のインプラントの周囲の腹側の図である。
〔種々の態様の説明〕
以下の説明は、単なる例示に過ぎず、本教示、適用または使用を制限することを意図しているものでは全くない。
本教示は、概して、患者特有の寛骨臼ガイド、およびそれと結合する挿入具であって、例えば、接合置換または修正手術のような、整形外科手術において使用される挿入具を提供する。患者特有の寛骨臼ガイドは、通常のインプラント要素と共にでも、コンピュータアシスト画像方法で作成された患者特有のインプラント要素と共にでも使用されてもよい。患者の解剖学的構造の3次元画像を得るために、コンピュータモデリングは、患者の解剖学的構造のMRIまたはCTスキャンを使用し、種々のCADプログラム、および/または、利用可能なソフトウェア、例えば、Materialise USA、Ann Arbor、Michiganによって、患者特有の人工器官要素、並びに、患者特有のガイドおよびテンプレートを得てもよい。
患者特有の調整ガイドおよびインプラントは、概して、患者特有の解剖学的構造に適合するように形成される。患者特有の調整ガイドは、概して、患者の3D解剖学的構造画像に基づくコンピュータモデリングを使用して形成される。また、患者特有の調整ガイドは、上述のコンピュータ方法による3次元画像/モデルの患者の(軟骨もしくはその他の軟組織を有するまたは有さない)骨表面に適合して接触かつ一致するように作られた連動面を有する。患者特有の調整ガイドは、例えば、ガイド腔、またはカニューレが挿入されたガイド杭、またはカニューレが挿入されたガイド伸長部、または、ドリルガイド、拡孔器、切断器、および切断台のような他の器具を支持あるいはガイドするために、もしくは、外科医が承認した手術前の計画にしたがってピンあるいは他の留め金具を挿入するために使用される容器のような、オーダーメイドのガイド構造を含んでいてもよい。患者特有の調整ガイドは、侵入が極微の外科手術において、特に、複数の最小侵入切開を伴う外科手術において使用されてもよい。種々の調整ガイドおよび手術前に計画された手順は、譲受し、同時係属中の米国特許出願第11/756057号(出願日:2007年5月31日)、米国特許出願第12/211407号(出願日:2008年9月16日)、米国特許出願第11/971390号(出願日:2008年1月9日)、米国特許出願第11/363548号(出願日:2006年2月27日)、および米国特許出願第12/025414号(出願日:2008年2月4日)に一般に開示されている。上記出願による開示は、本明細書中にて参考として援用される。
例えば、上記で参照した米国特許出願第11/756057号(出願日:2007年5月31日)に開示されているように、接合置換または修正手順のための手術前の計画段階では、例えば、復元される脚全体の接合部のような、関連する患者の解剖学的構造のMRIスキャンまたは一連のCTスキャンは、医療施設または医者の診療所で実行されてもよい。得られたスキャンデータは、製造業者に送られてもよい。スキャンデータは、接合部の3次元画像/モデルの作成に使用されてもよいし、コンピュータファイル形式または他のコンピュータの表現において、インプラントの最初の寸法合わせおよび調整を与えるために使用されてもよい。インプラントの最初の寸法合わせおよび調整は、個々の外科医によって使用される調整プロトコルのような調整方法を使用して得てもよい。
最初の寸法合わせの結果は、印刷された、または、対応する閲覧ソフトウェアによって電子形式で与えられた最初の手術計画である。外科医特有の調整プロトコルを使用する場合、最初の手術計画は外科医特有であってもよい。インタラクティブソフトウェアと関連するコンピュータファイル形式において、最初の手術計画は、外科医または再検討する他の医療従業者に送られてもよい。外科医は、接合のインタラクティブな画像において、漸進主義的に、インプラント要素の画像の位置を操作してもよい。さらに、外科医は、切除面、インプラントの種類、およびインプラント挿入方向を選択または変更してもよい。例えば、外科医は、下記のように、寛骨臼インプラントに関する患者特有の前傾および外転角度を選択してもよい。外科医は、手術計画を変更および/または承認した後、最後に承認した計画を製造業者に送信してもよい。
手術計画が外科医によって承認された後、患者特有の調整ガイドは、例えば、手術計画にしたがって、CADプログラム、または、Materialiseによって提供されるソフトウェアのような他の画像ソフトウェアを使用して創り出してもよい。患者特有の調整ガイドを機械で作るためのコンピュータ指示のツールパス(tool paths)は、ツールパスデータファイルに生成され、格納されてもよい。ツールパスは、CNC製作機械または他のオートメーション化した機械システムへの入力として与えられてもよい。そして、調整ガイドは、ポリマー、セラミック、金属または他の適当な材料から機械加工され、滅菌されてもよい。滅菌された調整ガイドは、手術進行時に使用するために外科医または医療施設に運ばれてもよい。
本教示は、少なくとも第1および第2の解剖学的構造の非平行の軸に向かってガイドされる方向に関して、患者特有の寛骨臼ガイド、およびそれに関する挿入具であって、患者の骨盤の寛骨臼に寛骨臼インプラントを挿入する挿入具を提供する。図1、3Aおよび3Bを参照すると、「A」で示される第1解剖学的構造軸は、患者の骨盤80(骨盤の半分のみが示されている)の寛骨臼82を通過し、通常、患者に対して上方/下方の方向に向いている。第2解剖学的構造軸は、「B」で示され、実質的に、第1軸Aに対して垂直である。以下に記すように、本教示は、図3Aに示すように、寛骨臼インプラント200をガイドし、図3Aに示す軸Aに対する選択された前傾角度、および、図3Bに示す軸Bに対する選択された外転角度に向くように配置する器具および方法を提供する。前傾および外転角度は、インタラクティブなまたは他の外科医の入力で決定されてもよく、患者特有であってもよい。
図1Aを参照すると、本教示に係る例示の寛骨臼ガイド100は、寛骨臼82の周辺領域と連動する第1面108と、第1面108と反対側の第2面110とを含む。寛骨臼連動第1面108は、オーダーメイドであってもよいし、上述のように、患者の寛骨臼および骨盤の周辺領域の3次元画像もしくはモデルを使用して、特定の患者の寛骨臼82周辺の寛骨臼端面84に適合、反映させた、患者特有のものであってもよい。第1面108は、寛骨臼ガイドを患者の寛骨臼82に入れ子状に重ね入れたり、密接に結合させたりすることができる。
寛骨臼ガイド100は、例えば、寛骨臼ガイド100を通って、対応する孔104を突き通す、骨釘または鋲のような一時的な留め具120を用いて、骨盤80に一時的にかつ着脱可能に取り付けられてもよい。寛骨臼ガイド100は、内面102によって規定される開口を有する環状であってもよい。内面102は、例えば、円筒形の面であってもよい。内面102は、寛骨臼ガイド100の第1面108および第2面110に関して、図2、3Aおよび3Bに示すように、第1軸Aについて選択された前傾角度、および、第2軸Bに関して選択された外転角度が得られるように、向けられていてもよい。前傾および外転角度は、外科医に選択されたものでも患者特有のものであってもよいし、特定の患者に対する手術前の計画立案時の外科医の入力によって決定されてもよい。前傾角度は、例えば、第1軸Aに対して前方へ約10〜20度の範囲であってよい。外転角度は、第2軸Bに対して下方へ約40〜50度の範囲であってよい。
図2〜4を参照すると、寛骨臼ガイド100は、寛骨臼82が孔を広げられ、ワルシャワのBiomet社から市販され利用可能なMagnum(登録商標)寛骨臼カップのような寛骨臼インプラント200を受容する準備がされた後、寛骨臼72の周囲の骨盤80に取り付けられてもよい。寛骨臼インプラント200は、本教示に係る挿入具300を用いて、準備された寛骨臼82に挿入されてもよい。衝撃装置としても機能する挿入具300は、近位の埋め込み面318を有するハンドル304と、シャフト302と、平坦または平面部320を伴う面を有するガイド連動部310とを含んでいてよい。ガイド連動部310は、寛骨臼インプラントをガイドする寛骨臼ガイド100の内面102と適合し、一致可能である外面312を有していてよい。内面102および外面312は円筒形であってよい。
図4を参照すると、挿入具300は、ワルシャワのBiomet社から市販され利用可能なMagnum(登録商標)システムの中間部材のような中間部材250を介して、寛骨臼インプラント200と連動可能である。より詳しくは、挿入具300は、玉軸受の軸受筒のような、中間部材250の容器252に挿入され、当該容器と連動する末端部314を含んでいてよい。寛骨臼インプラント200は、寛骨臼インプラント200の周縁端上の対応する切り抜き202に、中間部材250の複数の指状突起254の位置を合わせることによって、挿入具300上に設置されてもよい。寛骨臼インプラント200は、手締めはめ込みが得られるまで、挿入具300に対して寛骨臼インプラント200を回転させることによって、挿入具300と固定されてもよい。
図2を参照すると、挿入具300上に設置された寛骨臼インプラント200を伴う挿入具300は、寛骨臼ガイド100に向けられる。寛骨臼インプラント200を選択された前傾および外転方向に寛骨臼ガイド100を通ってガイドして、挿入具300のガイド連動部310の外面312が寛骨臼ガイド100の内面102と接触するようにしてもよい。ガイド連動部310の外面312は、寛骨臼ガイドの内面102で調整することにより、埋め込み深さをフィードバックすることもできる。挿入具300のガイド連動部310の平面部320および/または外面312が、寛骨臼ガイド100の第2面110と面一であり、第2面110を越えて、または、第2面110より上に突き出していない場合に、寛骨臼82への寛骨臼インプラント200の完全な埋め込みが示されていてもよい。深さのしるし322は、挿入具シャフト302上にあってもよいし、図2に示すように挿入具300のガイド連動部310上にあってもよい。
寛骨臼インプラント200が選択された前傾および外転方向で寛骨臼82内に完全に設置された後、挿入具300および中間部材250は、取り外される。一時的な留め具120は取り外され、寛骨臼ガイドは離される。
寛骨臼ガイド100は、生物学的適合性のある、金属、セラミックまたはポリマーのような任意の材料から作られる。寛骨臼ガイド100は、選択された材料に応じた種々の製造方法(例えば、機械加工、鋳造、成形、ステレオリソグラフィー、または他の層堆積方法を含む)によって作成されてもよい。一態様では、寛骨臼ガイド100は、使い捨ての合成樹脂材料から作られていてもよい。
患者特有の寛骨臼ガイド100は、患者特有の拡孔器アダプター360と適合する、標準(患者特有ではない)モジュールの拡孔器331であって、特定の患者の寛骨臼を計画前の患者特有の方向に拡孔する拡孔器と共に使用されてもよい。これは、図4Hで示し、図4A〜4Hに関しての説明のように、寛骨臼インプラント200が選択された前傾および外転方向で収容されることを可能にする。
図4A〜4Cは、拡孔器駆動部330および拡孔器頭部350を含む、拡孔モジュールの拡孔器331の一例を示す。拡孔器駆動部330は、接続機構335によって拡孔器頭部350と着脱可能に結合されてもよい。接続機構335は、ばねを利用して力を加えられるものであってよいし、スナップフィット(snap-fit)であってよいし、取り外し可能な他の種の接続で合ってもよい。接続機構335は、ネジで固定された接続、または容易に着脱可能な他の留め具を含む。典型的な急速接続接続部が図4A〜4Dに示されており、当該接続部は、図4E〜4Hに示されているように、拡孔器331と拡孔器アダプター360との接続にも使用される。
拡孔器頭部350は、周縁部351によって縁取りされている、半球体の拡孔面353を有する中空のカップ形状であってもよい。拡孔面353は、複数の拡孔構造、すなわち拡孔歯357を規定する。幾つかのアーム、すなわち棒342は、周縁部351と接続し、急速接続機構335の第1要素を形成してもよい。図4Bに示すように、アーム342は、中央のハブ341で互いに接着し、フレーム343を形成してもよい。
拡孔器駆動部330は、ハンドル、すなわち、近位端(不図示)で駆動部ツールと接続し、末端接続部338を有する駆動部シャフト334を収容するスリーブを含んでいてもよい。末端接続部338は、駆動部シャフト334と結合する、ばね負荷のスライダ、すなわちトリガー336で操作される急速接続機構335の第2要素を形成してもよい。末端接続部338は、幾つかの開口、すなわちスロット344と、対応する幾つかの可動のまたは格納式のピン346とを含んでいてよい。スロット344の数は、アーム342の数に対応しており、スロット344はアーム342を収容する大きさおよび形で形成される。4つのアーム、スロットおよびピンが示されているが、それより少なくても、多い数でもよく、例えば、拡孔器頭部350に均等に放射状に配置される2または3のアーム、スロットおよびピンが使用されてもよい。拡孔器駆動部330を拡孔器頭部350に接続するために、スロット344は、ピン344が引っ込められた位置のときに、アーム342上に配置される。ピン344は、末端接続部338から離れる方向にスライダ336を動かすことによって、引っ込められる。スライダ336が解放されると、アーム342はピン344とスロット344の壁との間でつかまえられ、拡孔器駆動部330は拡孔器頭部350としっかりと接続される。
図4E〜4Hを参照すると、患者特有の拡孔器アダプター360は、第1部362および第2部368を含んでよい。第1部362は外面364を有してよい。外面364は、例えば円筒形であってよい。外面364は、患者特有のガイド100の内面102と一致して、図4Hに示すように、選択された患者特有の第1軸Aに対する前傾角度、および、選択された軸Bに対する外転角度を提供するように、その形、大きさ、向きが決められてもよい。この点に関して、アダプター360の外面364は患者特有である。
拡孔器アダプター360は、急速接続接続部により拡孔器と結合してもよい。例えば、拡孔器アダプター360は、拡孔器駆動部330と拡孔器頭部350との接続に使用される、対応する急速接続機構335の要素を用いて、拡孔器駆動部330と拡孔器頭部350との間で結合してもよい。図4E〜4Hを参照すると、第1部362は、第1部262の近位周縁部363と結合し、拡孔器駆動部330の末端接続部338と連動するように形成されている、つまり、対応するスロット344内で対応するピン346によって掴まれている、幾つかのアーム370を含んでいてよい。このことについて、第1部362のアーム370は、拡孔器駆動部330の急速接続要素と相補的である要素を提供して、拡孔器駆動部330と拡孔器頭部350との間で急速接続機構335を完成させる。
同様に、拡孔器アダプター360の第2部368は、急速接続機構335を完成させる拡孔器頭部350の急速接続要素と相補的な急速接続要素を含んでいてよい。より詳細には、第2部368は、拡孔器頭部350のアーム342を掴む、幾つかのスロット374およびピン372を含んでよい。よって、図4Aおよび4Eに示すように、拡孔器駆動部330を拡孔器頭部350に結合するために使用されている、同種の急速接続機構335が、拡孔器駆動部330と拡孔器頭部350との間で、拡孔器アダプター360を結合するために使用されてもよい。なお、急速接続機構335は、示された例示の実施形態に限るものではなく、患者特有ではないモジュールの拡孔器に使用される、任意の急速接続機構であってよい。急速接続機構335は、スナップフィット、先細の接続部、糸で繋がれた接続部、または、相補的な拡孔器駆動部330の要素「a」および拡孔器頭部350の要素「b」を有する任意の他の接続部を含む。急速接続機構335が逆の順序で使用されて、a−b−a−bの順になるように、拡孔器アダプター360をその間に結合する。図示された急速接続機構335では、要素「a」がスロットおよびピンを含み、要素「b」がアームを含む。
図4Hを参照すると、患者特有のアダプター360を有する組み立てられた拡孔器331は、患者特有の寛骨臼ガイド100と共に使用されて、手術前の計画に基づいて、選択された患者特有の方向にインプラントを収容するために、患者の寛骨臼82を拡孔してもよい。図1〜4に関して上述したように、寛骨臼ガイド100は、内面102が拡孔器頭部350をガイドする方向を提供する或る位置のみで寛骨臼82に取り付けられる。特に、拡孔器アダプター360の外面364は、寛骨臼ガイド100の内面102と、相補的に密接するように一致する。そのため、拡孔器頭部350は、手術前に計画された特定の方向に向けられ、対応する軸AおよびBに対して選択された前傾および外転方向に、寛骨臼を拡孔することができる。寛骨臼82が拡孔された後、寛骨臼インプラント200は、図2および3に関して説明した挿入具/衝撃装置300を用いて、同じ選択された方向に埋め込まれる。
図1A、2および4Hに示す例示の寛骨臼ガイド100は、寛骨臼82の周囲に配置するために環状である。他の実施形態では、寛骨臼82の周囲の一部のみに配置された寛骨臼ガイド400が使用されてもよい。図5〜10を参照すると、患者特有の寛骨臼調整ガイド400および寛骨臼インプラントをガイドする他の器具が示されている。患者特有の寛骨臼調整ガイド400は、患者の骨盤80、寛骨臼82、寛骨臼の縁領域84、寛骨臼周辺領域および通常股関節を含む、患者の関連した解剖学的構造の3次元画像に基づいて、外科手術のための手術前の計画において準備されてもよい。患者の解剖学的構造の3次元画像は、MRI、CT、X線または特定の患者をスキャンする他のものを用いて、上述した市販され利用可能なソフトウェアによって作り出されてもよい。
図5および6を参照すると、寛骨臼調整ガイド400は、寛骨臼82の端面84の周囲に配置されるように構成され適合された第1部402と、特定の患者の骨盤80の寛骨臼周辺領域の周囲に配置されるように構成され適合された第2部404とを含んでよい。寛骨臼調整ガイド400は、3次元的に湾曲した、患者特有の骨連動面408を含んでよい。骨連動面408は、或る位置および方向のみで密接して接触/入れ子状に重ね入れるために、寛骨臼の端面84の一部と、患者の骨盤80の近接した寛骨臼周辺領域の一部とに相補的に一致するように規定される。寛骨臼調整ガイド400の第2部404は、寛骨臼中心軸CCに平行な複数の調整ピン420をガイドするための、延伸された貫通溝、開口、または、寛骨臼周辺領域に向けられた他のガイド構造406を複数規定するために、手術前計画中に設計される。その位置および向きは、特定の患者向けの手術前の計画にしたがって決定される。第2部404は、追加の材料で補強されてもよいし、および/または、安定性のために厚さをより大きくしてもよい。
貫通穴の形である3つのガイド構造406、および対応する数の調整ピン420は、図5および6に示されている。患者および/または手順に応じて、異なる数のガイド構造406および調整ピン420が使用されてもよい。調整ピン420は、平行に規定されている患者特有の向きであり、寛骨臼中心軸CCを配置するために実施可能である。例えば、図7に示すように、寛骨臼調整ガイド400が取り外された後、調整ピン420は、上記同一の軸に沿って、寛骨臼インプラント200の挿入に関する他の器具を移動可能にガイドしてよい。以下に記すように、寛骨臼インプラント200を位置決めし、挿入し、埋め込むために使用される種々の器具のガイドおよび支持を容易にするために、ガイド構造の406の向きおよび位置は、患者特有でよく、手術前に決定されてよい。
図7を参照すると、調整ピン420が骨の中に挿入された後、寛骨臼調整ガイド400が取り外されてよい。寛骨臼の位置決め器具、または挿入具、または挿入具/衝撃装置450は、寛骨臼に寛骨臼インプラント200を挿入するために、調整ピン420によってガイドされてよい。挿入具450は、取っ手453を有するハンドル451と、患者特有の調整アダプター470と結合するシャフト452とを含んでよい。患者特有の調整アダプター470は、調整ピン420と相補的な複数の調整開口478を規定するアーム474を含んでよい。そのため、調整アダプター470は、着脱可能に調整ピン420全体に渡ってスライドしてもよい。この点で、アーム474の形および大きさ、並びに、調整開口478の配置、配列および外形は、寛骨臼調整ガイド400のガイド構造406に一致させるために、手術前の計画中に決定されてよい。調整アダプター470は、挿入具450のシャフト452を移動可能に収容する連結開口472を含んでよく、挿入具450のシャフト452と完全に連結してよい。連結開口472は、例えば、締りばめ、または、スナップ方式の側方溝であってよい。代わりに、シャフトがモジュールとして挿入具450と連結している場合、連結開口472は、挿入具450のシャフト452を収容する、囲まれた穴であってよい。挿入具450は、取っ手453を回転させることにより、シャフト452の末端において、連結器480を用いて、寛骨臼インプラント200と接続してもよいし、分離していてもよい。連結器480は、モジュールとしてシャフト452と接続していてもよい。寛骨臼インプラント200を挿入している間、調整ピン420は、挿入具/衝撃装置450および寛骨臼インプラント200の向きの安定、ガイドおよび固定に役立ち、かつ、患者の画像スキャンを用いて手術前の計画において決定した通りに、寛骨臼82に対する所望の位置および向きに寛骨臼インプラント200を配置することに役立つ。
同様の患者特有の調整アダプター470は、例えば、準備およびインプラント処理の間使用される拡孔器または衝撃装置のような、他の種類の挿入具、または衝撃装置、または拡孔器駆動ハンドルもしくは他の器具を有する拡孔器をガイドするために使用されてよい。図9および10を参照すると、第1および第2衝撃装置(または他の寛骨臼器具)500a、500bは、それぞれ、第1および第2患者特有の調整アダプター470a、470bを有することが示されている。第1衝撃装置500aは、通常、最小侵入処理に使用されるオフセット衝撃装置500aであり、第2衝撃装置500bは、真っ直ぐな非オフセットの衝撃装置である。第1および第2衝撃装置500a、500bの各々は、モジュールでよく、それぞれ、末端接続器512を用いて、第1シャフト504aまたは第2シャフト504bと連結器510の末端で連結するハンドルを含む。第1衝撃装置500aの第1シャフト504aは、ハンドル502および末端接続器512を通る(寛骨臼中心軸CCと一致するように設計された)長軸Cに対してオフセットである。第2衝撃装置500bのシャフト504bは、ハンドル502と同軸である。
図9に示したように、オフセット第1シャフト504aは、長軸Cに対してオフセットし、実質的に平行な中央部505cと、オフセットを規定する、中央部505cに対してある角度を有する第1および第2末端部505a、505bとを含んでよい。第1末端部505aは、末端接続器512と連結する駆動部490のシャフト492を収容するために、カニューレを挿入されてもよいし、中空であってもよい。そのため、末端接続器512は、駆動部490の取っ手494を回転させることにより、寛骨臼インプラント200に固定されてもよい。第1調整アダプター470aは、第1末端部505aが貫通する連結開口472(囲まれた穴または側方開口/溝)を含む。図7の調整アダプター470および挿入具450に関して上述したように、アーム474の形および大きさ、並びに、調整孔478の配置および配列/外形は、寛骨臼調整ガイド400のガイド構造406並びに調整ピン420の配置および向きに一致させるために、手術前の計画において決定されてよい。そのため、平行な調整ピン420は、平行な調整孔478を貫通して、寛骨臼インプラント200および寛骨臼82に対して第1衝撃装置500aをガイドすることができる。第1調整アダプター470aは、第1衝撃装置500aと着脱可能に連結してよく、軸CCおよび調整ピン420に対して調整孔406の向きを調整して維持している間、第1部505aに対する位置をスライドして調整されてもよい。
図10を参照すると、第2衝撃装置500bは同様に使用されてよい。シャフト504bが実質的に真っ直ぐ(非オフセット)であるため、図7に示す挿入具450と同様に、末端接続器512は、ハンドル502またはハンドル(不図示)に取り付けられた取っ手を単に回転させることにより、寛骨臼インプラント200に取り付けられてよい。各衝撃装置500a、500bは、モジュールでよく、そのため、ハンドル502、シャフト504a、504bおよび/または連結器510は、調整アダプター470a、470bを着脱可能に搭載するために、ばらばらになっていてよい。追加的に、または、代わりに、連結開口472は、衝撃装置500a、500bを分解することなく、調整アダプター470a、470bを着脱可能に収容するために、スナップ方式の側方開口または側方溝であってよい。
いくつかの実施形態では、1以上の従来の寛骨臼器具のために、同じ調整アダプターが使用されてよい。例えば、同じ調整アダプター470(または470b)は、挿入具/衝撃装置450もしくは衝撃装置500b、または、拡孔器331のような寛骨臼拡孔器のどちらと共にでも、任意に使用されてよい。
患者特有の寛骨臼調整ガイド400が患者の寛骨臼/寛骨臼周辺の領域と相補的な連動面を有しているが、調整アダプター470、470aおよび470bは、使用中、骨面から離れているため、患者特有の連動面を有していてもよいし、有していなくてもよいことが上述の説明から理解されるであろう。むしろ、アーム上474上の調整孔478の位置および配列は、患者特有である。そのため、対応する調整アダプター470、470a、470bは、寛骨臼調整ガイド400を用いて患者の寛骨臼周囲に既に固定されている複数の調整ピン420を覆うように搭載されてよい。
寛骨臼調整ガイド400および調整アダプター470、470a、470bは、使い捨ての高分子材料、または、任意の他の生物学的適合性材料から作られていてよい。調整アダプター470、470a、470bは、寛骨臼の挿入具、配置器具、拡孔器、衝撃装置、および寛骨臼の処置の間に使用される他の器具と共に、使用されてよい。寛骨臼調整ガイド400および1以上の調整アダプター470は、一組の調整ピン420を有する一式の形で与えられてもよい。他の再使用可能な、特別仕様ではない器具は、例えば、挿入具、拡孔器、衝撃装置等を含んでいてもよい。上記一式は、外科医によって承認され選択されるように、特別仕様で作られた、または、特別仕様ではない寛骨臼インプラント200を含んでいてよい。
図11Aから12を参照すると、拡孔器331’と共に使用する、別の患者特有の調整ガイド400’が示されている。寛骨臼ガイド100および400に関して上記で説明したように、寛骨臼ガイド400’は、寛骨臼82の端面84の周囲に配置されるように適合して形成された第1部402’と、特定の患者の骨盤80の寛骨臼周辺領域の周囲に配置されるように適合して形成された第2部404’とを含んでよい。寛骨臼調整ガイド400’は、3次元的に湾曲した患者特有の骨連動面408’を含んでよく、骨連動面408’は、特定の患者の解剖学的構造と入れ子状に重なるように一致する第1および第2部402’、404’の下側の面である。図11Aに示す例示の実施形態では、第1部402’は、寛骨臼および寛骨臼82の少なくとも一部の内側の端面84全体の周囲に伸長してよい。同様に、第2部404’は、追加の安定性および取付領域が特定の患者のために望まれる、もしくは、外科医によって好まれる場合、寛骨臼84の周囲の寛骨臼周辺領域全体の周囲に伸長してよい。骨連動面408’は、ただ1つの位置および向きでぴったりと接触する/入れ子状に重ねるために、寛骨臼の端面84の一部、寛骨臼82の一部、および、患者の骨盤80の近隣の寛骨臼周辺領域の一部と相補的に一致するように設計されてよい。図5−7に関して上記で説明したように、予め定められた寛骨臼の中心軸CCと平行に複数の調整ピン420をガイドするために、寛骨臼調整ガイド400の第2部404’は、手術前の計画中に、複数の延伸する貫通溝、孔、または他のガイド構造、または、寛骨臼周辺領域に向けられた穴406’を規定するように設計されてもよい。調整ピン420が骨に固定された後、寛骨臼ガイド400’は、下記に説明するように、拡孔器と共に使用するために、残っている調整ピン420を取り外されてもよい。
拡孔器331’または331''は、図11Bおよび12に示すように、それぞれ、調整ピン420によって、寛骨臼中心軸CCに沿ってガイドされてよい。既製の、または標準の(特別仕様ではない)拡孔器331’、331''は、調節可能な、または患者特有のアダプター470’、470''と共同して使用されてよい。アダプター470’は、1以上のアーム474’(図11Bには2つのアーム474’が示されている)を含んでよい。各アーム474’は、急速連結配列474’によって拡孔器431’のシャフト330’と連結してよい。急速連結配列474’は、例えば、シャフト330’または他の連結器を収容するために形成された、アームにおける開口であってよい。各アーム474’は、対応する調整ピン420を収容するために配置され形成された、少なくとも1つの開口478’を含んでよい。当該調整ピン420は、患者特有の調整ガイド400’を用いて、ガイド400''の対応する穴406を通って予め定められた位置および向きで骨に固定される。したがって、アーム474’上の開口478’の位置および向き、並びに、寛骨臼中心軸との関係は、患者特有である。いくつかの実施形態では、1つのアーム474’は、1以上の開口478’を含んでよい。アーム474’は、互いに完全に取り付けられてよいし、モジュール方式でまたは単独でシャフト330’と連結してもよい。調整ピンの1つ、例えばピン420’は、インプラント200’の長さおよび対応する内部髄放線管(intramedullary canal)の深さを決定するために、患者の脚の長さを測定するための固定された参照点を与えてよい。図11Cに示すように、インプラント200’は、頭部203’および軸状部201’を含んでよい。ものさし、または他の測定装置477は、長さを測定し、インプラント200’を所定の大きさに作るために、ピン420’と連結してよい。図11Bに示すように、ものさし477は、ピン477’全体に渡ってスライド可能に配置されてよい。インプラントの適切な埋め込みおよび配置を確立するために、長さは、インプラントおよび(図11Bに示すように)インプラント後の前に測定されてよい。
図12を参照すると、調整ピン420が、患者特有の外形、位置および向きで患者の骨盤80上に固定され、図5−7に関して上述したように、寛骨臼中心軸CCも決定した後、特別仕様ではない拡孔器331''は、調整ピン420全体に渡ってスライドするように設計された患者特有のアダプター470''と連結されてよい。異なる数のアーム474''が使用され、各アーム474''が1以上のピン420を収容するための開口478''を1以上含んでもよいが、図12に示す実施形態では、アダプター470''は、モノリシックであり、対応する開口478''を通ってそれぞれ2つの調整ピン420を収容するための2つのアーム474''を含んでよい。アダプター470''は、図4A−4Gに関して上述したように拡孔器331''のシャフトに対する急速接続によって、または、スナップフィットもしくはネジ入れ可能なソケットもしくは差込みカップリングのような別の種の接続部335''によって、拡孔器331''と連結してよい。拡孔器331''は、拡孔器ブレード333''を含む、ブレード型であってよい。或る実施形態では、ブレード333''は、取り外し可能であり、取り換え可能であり、かつ/または、使い捨てであってよい。各ブレード333''は、半円形もしくは四半分の円形でよく、一組のネジもしくは溝もしくはあご部によって、チャックもしくは拡孔器331''の他の支持部337''に取り付けられてよい。
図13、14Aおよび14Bに示すように、いくつかの処置では、上述の寛骨臼インプラント200は、患者特有に付け替える、または置き換えた近隣の大腿部の要素と組織化するために使用されてよい。例えば、患者特有に付け替えるインプラントは、手術前の計画中に、患者のスキャンから復元された画像モデルに基づいて設計されてよい。
図13を参照すると、大腿部の頭部92が救助可能であり、切除の必要なく、置き換えられる場合、大腿部の頭部92の病気のあるまたは欠陥のある面を、画像で明らかにしてよい。大腿部の要素600は、低骨品質および/または大腿部の頭部92の管領域のような欠陥部位を置き換えるために設計されてよい。大腿部の要素600は、寛骨臼インプラントもしくは患者本来の寛骨臼を組織化するために、ドーム形状の部位、または外側に凸の組織化された表面603を有するドーム602と、手術前の計画で決められた通りに、取り付けられた軟組織を用いてもしくは用いないで、大腿部の頭部92の表面と相補的に一致するように設計された、内向きの骨連動面604とを含んでよい。大腿部の要素600は、大腿部の頭部92を通って挿入され、大腿部の首部94内で固定される短軸状部606を有してよい。軸状部Dの軸は、患者の首部94に対して選択された位置および向き、かつ、近位の大腿骨に対して選択された前傾向きで配置されるために、軸状部606は、手術前の計画中に、患者のスキャンからの患者の解剖学的構造の3次元復元に基づいて設計されてよい。追加として、軸状部606の長さ、並びに軸状部606の長さ方向の横断面607の大きさおよび形は、手術前の計画、および患者の首部94の復元モデルに基づいて設計されてもよい。そのため、骨の保護および適切な取付支持は、特定の患者に対して、釣り合いのとれている、かつ/または、最適化される。
図14Aおよび14Bを参照すると、大腿部の頭部92が切除された近位の大腿骨のための患者特有の大腿部のインプラント618は、大腿部の頭部要素620、大腿部の首部要素624および大腿部の軸状部要素622を含んでよい。大腿部のインプラント618は、手術前の計画中に、患者のスキャンからの患者の解剖学的構造の3次元的な復元に基づいて設計されてよい。そのため、大腿部の頭部インプラント620および大腿部の首部要素624は、外科医の決定および好みに基づいて、患者の大腿骨または寛骨臼の軸Dおよび回転Rの中心を協同して保持する。大腿部の首部要素624は、大きさおよび向きに関して、患者の大腿部の首部94と一致するように設計されてよい。大腿部の軸状部インプラント622は、標準の(特別仕様ではない)軸状部の大きさから選択されてもよいし、または、長さ、横断面、および/もしくは、形を特定の患者に合わせて作られてもよい。
前述の説明は、単に、本教示の例示的な配列を開示および記述する。さらに、種々の実施形態の間の特徴、要素および/または機能の混合および調和は、ここに明白に意図されている。そのため、上記に別のものを記載することなく、本分野の通常の知識を有する者は、この開示から、或る実施形態の特徴、要素および/または機能を適切に別の実施形態に組み込んでもよいことが理解されるであろう。さらに、本発明の本質的な目的から逸脱することなく、特定の状態または材料を本発明の教示に適合させるために、多くの改良が加えられてもよい。この説明、添付の図面および特許請求の範囲から、本分野の通常の知識を有する者は、次の特許請求の範囲に規定される本教示の意図および目的から逸脱せずに、種々の変更、改良および変形が可能なことが容易に認識するであろう。
寛骨臼注入処置の準備における患者を例示する図である。 患者の解剖に関して示されている、本教示に係る寛骨臼ガイドの透視図である。 本教示に係る寛骨臼インプラントを保持する寛骨臼挿入具と共に示された、図1Aの寛骨臼ガイドの周囲の透視図である。 寛骨臼挿入具および寛骨臼インプラントの透視図である。 本教示に係る挿入時に解剖学的構造上の軸Aについて回転する寛骨臼インプラントの周囲の透視図である。 本教示に係る挿入時に解剖学的構造上の軸Bについて回転する寛骨臼インプラントの周囲の透視図である。 図3の寛骨臼挿入具および寛骨臼インプラントの分解組立図である。 本教示に係る使用のためのモジュールの拡孔器の透視図である。 図4Aの拡孔器の頭部の底面図である。 図4Aの拡孔器の駆動部の透視図である。 図4Cの拡孔器の駆動部の末端の底面図である。 本教示に係る使用のためにアダプターと組み立てられた、図4Aのモジュールの拡孔器の透視図である。 図4Eのアダプターの天面図である。 図4Eのアダプターの底面図である。 本教示に係る患者特有のアダプターと組み立てられた拡孔器周囲の図である。 本教示に係る、例示の寛骨臼調整ガイドの周囲の透視図である。 複数のガイドピンを有している、図5の寛骨臼調整ガイドの周囲の透視図である。 図6のガイドピンによってガイドされた器具を有する寛骨臼カップの挿入を説明する透視図である。 例示の寛骨臼インプラントの周囲の透視図である。 本教示に係る、例示の衝撃装置の透視図である。 本教示に係る、例示のオフセット衝撃装置の透視図である。 本教示に係る、患者特有の寛骨臼ガイドの周囲の図である。 図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによって寛骨臼を拡孔するためにガイドされた拡孔器患者特有のアダプターの周囲の図である。 図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによってガイドされたものさしであって、インプラントの長さを測るための長さものさしの周囲の図である。 図11Aの患者特有の寛骨臼ガイドを使用して配置された調整ピンによって寛骨臼を拡孔するためにガイドされた患者特有のアダプターを有する拡孔器の透視図である。 本教示に係る、患者特有の表を付け替えた大腿部のインプラントの周囲の図である。 本教示に係る患者特有の大腿部のインプラントの周囲の腹側の図である。 図14Aの大腿部のインプラントの周囲の腹側の図である。

Claims (26)

  1. 第1部および第2部を有する骨連動面を含む患者特有の寛骨臼調整ガイドを備え、
    上記第1部は、特定の患者の寛骨臼の端面と相補的に適合するように構成され形成され、上記第2部は、上記特定の患者の画像スキャンから手術前に復元された上記特定の患者の上記寛骨臼の3次元モデルに基づいて、上記特定の患者の寛骨臼の寛骨臼周辺領域と相補的に適合するように構成され形成され、
    上記寛骨臼調整ガイドは、上記患者向けの手術前の計画に基づいて配列され構成された複数のガイド構造であって、当該ガイド構造を通る複数の調整ピンをガイドするために、上記第2部を通って伸長する複数のガイド構造を含むことを特徴とする寛骨臼装置。
  2. 寛骨臼器具と連結可能な患者特有の調整アダプターをさらに備え、
    上記調整アダプターは、対応する上記調整ピン全体に渡ってスライドするために、上記寛骨臼調整ガイドの上記ガイド構造に一致するように構成された複数の孔を含むことを特徴とする請求項1に記載の寛骨臼装置。
  3. 上記複数のガイド構造は、3つのガイド穴を含み、
    上記患者特有の調整アダプターの上記複数の孔は、3つの対応する孔を含むことを特徴とする請求項2に記載の寛骨臼装置。
  4. 上記ガイド構造は平行なガイド穴であることを特徴とする請求項2に記載の寛骨臼装置。
  5. 寛骨臼挿入具をさらに備え、
    上記寛骨臼挿入具は、上記調整アダプターのスナップ方式の側方開口部を貫通するシャフトを含むことを特徴とする請求項4に記載の寛骨臼装置。
  6. 寛骨臼挿入具をさらに備え、
    上記寛骨臼挿入具は、上記調整アダプターと着脱可能に連結するシャフトであって、上記ガイド穴と平行なシャフトを含むことを特徴とする請求項4に記載の寛骨臼装置。
  7. 寛骨臼衝撃装置をさらに備え、
    上記寛骨臼衝撃装置は、上記調整アダプターと着脱可能に連結するシャフトを含むと共に、上記衝撃装置の上記シャフトの中央部から外れているハンドルを有することを特徴とする請求項4に記載の寛骨臼装置。
  8. 上記患者特有の調整アダプターは、患者特有の面を有し、上記寛骨臼挿入具に対してスライド可能であることを特徴とする請求項4に記載の寛骨臼装置。
  9. 特定の患者の寛骨臼の3次元モデルおよび手術前の計画に基づいて、上記特定の患者の上記寛骨臼の寛骨臼領域および寛骨臼周辺領域と相補的に適合するように構成され形成された骨連動面を含む患者特有の寛骨臼調整ガイドであって、患者の寛骨臼周辺領域において複数の調整ピンをガイドするための、当該寛骨臼調整ガイドを通って伸長する複数のガイド構造を含む寛骨臼調整ガイドと、
    ハンドル、シャフトおよび寛骨臼連結器を含む寛骨臼器具と、
    上記寛骨臼器具の上記シャフトと着脱可能に連結する第1調整アダプターとを備え、
    上記第1調整アダプターが、上記寛骨臼調整ガイドの上記ガイド構造と一致するように構成された複数の孔を含むことにより、上記患者から上記調整ピンを取り外すことなく上記寛骨臼調整ガイドが取り外された後、上記調整ピンが上記調整アダプターの上記孔を貫通することができることを特徴とする寛骨臼装置。
  10. 上記寛骨臼器具の上記シャフトは、上記第1調整アダプターの連結開口部に着脱可能に挿入されることを特徴とする請求項9に記載の寛骨臼装置。
  11. 上記連結開口部はスナップ方式の側方開口部であることを特徴とする請求項10に記載の寛骨臼装置。
  12. 上記第1調整アダプターと着脱可能に連結可能であるシャフトを有する第2調整器具をさらに備えることを特徴とする請求項9に記載の寛骨臼装置。
  13. ハンドルおよび当該ハンドルから軸を外して置かれたシャフトを有する寛骨臼衝撃装置と、
    上記寛骨臼衝撃装置の上記シャフトと着脱可能に連結する第2調整アダプターと、をさらに備え、
    上記第2調整アダプターが、上記寛骨臼調整ガイドの上記ガイド構造と相補的な複数の孔を含むことにより、上記患者から上記調整ピンを取り外すことなく上記寛骨臼調整ガイドが取り外された後、上記調整ピンが上記第2調整アダプターの上記孔を貫通することができることを特徴とする請求項9に記載の寛骨臼装置。
  14. 上記寛骨臼衝撃装置の上記シャフトは、上記第2調整アダプターの連結開口部に着脱可能に挿入されることを特徴とする請求項13に記載の寛骨臼装置。
  15. 上記連結開口部はスナップ方式の側方開口部であることを特徴とする請求項14に記載の寛骨臼装置。
  16. 上記衝撃装置はモジュール方式であることを特徴とする請求項14に記載の寛骨臼装置。
  17. 寛骨臼インプラントをさらに備えることを特徴とする請求項9に記載の寛骨臼装置。
  18. 患者の寛骨臼に寛骨臼インプラントを挿入する方法であって、
    寛骨臼調整ガイドの患者特有の面を、相補的な患者の端面および寛骨臼周辺領域に連動させるステップと、
    上記寛骨臼調整ガイドの対応する調整孔を通って、上記患者の上記寛骨臼周辺領域に、複数の調整ピンを挿入するステップと、
    上記患者から上記調整ピンを取り外すことなく、上記寛骨臼調整ガイドを取り外すステップと、
    寛骨臼挿入具と連結する第1調整アダプターを、上記調整ピンを通ってガイドするステップと、
    上記寛骨臼挿入具を用いて、寛骨臼インプラントを差し込むステップと、を含むことを特徴とする方法。
  19. 寛骨臼インプラント挿入具と連結する第1調整アダプターを、上記調整ピンを通ってガイドするステップは、上記第1調整アダプターの相補的な孔に上記調整ピンを挿入するステップを含むことを特徴とする請求項18に記載の方法。
  20. 上記寛骨臼挿入具および上記第1調整アダプターを取り外すステップと、
    衝撃装置と連結する第2調整アダプターを、上記調整ピンを通ってガイドするステップと、
    上記衝撃装置を用いて、上記寛骨臼インプラントを埋め込むステップと、をさらに含むことを特徴とする請求項18に記載の方法。
  21. 衝撃装置と連結する第2調整アダプターを、上記調整ピンを通ってガイドするステップは、上記調整ピンを、上記第2調整アダプターの相補的な孔に挿入するステップを含むことを特徴とする請求項20に記載の方法。
  22. 上記第1および第2調整アダプターは同一であることを特徴とする請求項21に記載の方法。
  23. 上記衝撃装置は、オフセット衝撃装置であり、上記第1および第2調整アダプターは異なることを特徴とする請求項21に記載の方法。
  24. 第1面および当該第1面と反対側の第2面を含む環状寛骨臼ガイドと、
    上記第1面は、患者特有であり、患者の寛骨臼の3次元画像に基づいて、上記患者の上記寛骨臼の周囲の寛骨臼端面に適合するように作られ、上記寛骨臼ガイドは、上記第1面に対して患者特有の前傾および外転角度に向けられた円筒形のガイド内面を含み、
    上記寛骨臼ガイドの上記内面と一致可能な外面を有し、かつ、特別仕様ではない寛骨臼器具と連結する急速接続要素を有する患者特有のアダプターと、を備えることを特徴とする寛骨臼装置。
  25. 上記寛骨臼器具と併用されることを特徴とする請求項24に記載の寛骨臼装置。
  26. 上記寛骨臼器具は寛骨臼拡孔器であることを特徴とする請求項25に記載の寛骨臼装置。
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