JP2014240020A - 患者毎に特有の補綴装置、それを含むシステム、その製造方法及び関節修復システム - Google Patents
患者毎に特有の補綴装置、それを含むシステム、その製造方法及び関節修復システム Download PDFInfo
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- A61F2/00—Filters 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
Description
1999年10月14日に公開されたフォフォノフ(Fofonoff)に対する特許文献1、
2001年6月12日に公開された、サイモン(Simon)他に対する特許文献2、及び、
2001年3月15日に公開された、マンズマン(Mannsmann)に対する特許文献3。
2001年9月4日にビベー・ハンセン(Vibe−Hansen)他に対して発行された特許文献4、
1998年12月1日にノートン(Naughton)に対して発行された特許文献5、
1998年6月23日にシュワルツ(Schwartz)他に対して発行された特許文献6、
1986年9月2日にキャプラン(Caplan)他に対して発行された特許文献7、
1991年8月29日にバカンティ(Vacanti)他に対して発行された特許文献8、
1993年3月30日にキャプラン(Caplan)他に対して発行された特許文献9、
1993年7月13日にキャプラン(Caplan)他に対して発行された特許文献10、
2001年12月11日にハードウイック(Hardwick)他に対して発行された特許文献11、
2001年8月28日にルーガー(Rueger)他に対して発行された特許文献12、及び、
1989年7月11日にグランデ(Grande)に対して発行された特許文献13。
しかしながら、同種移植及び自家移植システム、及び、組織担体等の生物学的置換材料による臨床結果は、これらの材料の大部分が、交換が意図されている正常及び健全な人体組織の配置又は構造と、同様又は同一の形態学的な配置又は構造を達成することができないので、不確実なものとなっている。さらに、これらの生物学的置換材料の、機械的な耐久性も不確実なままである。
2002年5月7日にシュモツァー(Schmotzer)に対して発行された特許文献14、
2001年3月20日にアフリアト(Afriat)他に対して発行された特許文献15、及び、
2000年10月3日にアテシアン(Ateshian)他に対して発行された特許文献16。
通常、これらの補綴装置の移植では、下部組織及び骨の欠損に伴い、元の軟骨で可能だった機能は完全には回復されることはなく、さらに、若干の装置では、かなりの量の組織と骨の欠損に伴う、重度の長期にわたる合併症により、感染、骨溶解、及び移植片の弛みが含まれる場合がある。
2002年9月3日にラニング(Running)に対して発行された特許文献19、
2002年5月14日にミールク(Miehlke)他に対して発行された特許文献20、
2002年5月7日にシュモツァー(Schmotzer)に対して発行された特許文献14、
2002年2月5日にクラコビッツ(Krakovits)他に対して発行された特許文献21、
2001年3月20日にアフリアト(Afriat)他に対して発行された特許文献15、
2000年10月3日にアテシアン(Ateshian)他に対して発行された特許文献16、及び、
2000年1月11日にカウフマン(Kaufman)他に対して発行された特許文献22。
通常、これらの補綴装置の移植では、下部組織及び骨の欠損に伴い、元の軟骨で可能だった機能は完全には回復されることはなく、さらに、若干の装置では、かなりの量の組織と骨の欠損に伴う、重度の長期にわたる合併症により、移植片の弛みが引き起こされる場合がある。こうした合併症の1つに骨溶解がある。原因の如何にかかわらず、いったん補綴(装置)が関節から弛んでしまうと、その補綴は、交換する必要が生じることになる。患者の骨ストックが限られているので、関節形成のための交換外科手術の可能な回数も制限される。
マッキーバー(McKeever)の設計は、装置の骨合わせ面から伸びる、上面斜視図から「t」字状に見える横部材であり、「t」字が伸長する周囲表面は骨表面に隣接しているが、この「t」字部分は骨表面に貫入する形となっている。非特許文献2を参照のこと。
代替的な付着設計は、マッキントッシュ(MacIntosh)の設計であり、その設計は、「t」字型に形成されたフィンに代わって、一連の複数の平坦な鋸歯又は歯が存在するものである。非特許文献3を参照のこと。
また、本発明の他の目的とするところは、患者毎に特有の補綴装置の製造方法を提供することにある。
さらに、本発明の他の目的とするところは、関節修復システムを提供することにある。
本発明の患者毎に特有の補綴システムは、請求項1に記載の患者毎に特有の補綴装置(300、400、500)と、脛大腿関節面の脛骨表面の代わりとなる脛骨コンポーネントから成ることを特徴とする。
本発明の患者毎に特有の補綴装置の製造方法は、患部膝関節の解剖学上の画像を撮る段階、前記解剖学上の画像から患部関節の関節面の設計形状を誘導する段階、及び、骨対向面と患部関節の関節面設計形状を摸した関節対向面が設計または選択される段階、を含むことを特徴とする。
本発明の関節修復システムは、患者毎に特有の補綴装置と一つまたは二つの外科ツールを備えたことを特徴とする。
当業者には理解されるように、本明細書中に記載の方法は、論理上可能な限り記載事例の任意の順で、及び記載事例の記載順で行われ得る。さらに、或る範囲の値が与えられる場合、その範囲の上限及び下限間全ての間にある値、及び、その範囲内の任意の他に示された又はそれらの間にある値が本発明の範囲内に含まれることが理解される。また、(本明細書に)記載された発明的な変更に見られる選択的な特徴はいずれも、個別に請求項として設定されてもよく、又は、本明細書中に記載の特徴のいずれか1つ又は複数と組み合わされてもよいことが意図される。
スタウト(Stout)及びジェンセン(Jensen)編「X線構造測定:実用的案内」(X−Ray Structure Determination:A Practical Guide)第2版、1989、ジョン・ウィリー・アンド・サンズ(John Wiley & Sons)出版。
スローン(Slone)編「ボディーCT:実践的手法」(Body CT:A Practical Approach)、1999、マックグロー・ヒル(McGraw−Hill)出版。
ラム(Lam)編「X線診断:外科医の手法」(X−ray Diagnosis:A Physician's Approach)、1998、シュプリンガー・フェアラーク(Springer−Verlag)出版。及び、
ラエティティア・ブロックルバンク(Laetitia Brocklebank)編「歯の放射線学:X線画像の理解」(Dental Radiology:Understanding the X−Ray Image)、1997、オクスフォード・ユニバーシティ・プレス(Oxford University Press)出版。さらに、以下を参照のこと。
ジェロルド・ティー・ブッシュバーグ(Jerrold T. Bushberg)他「医療撮影の基礎物理学」(The Essential Physics of Medical Imaging)第2版。
本明細書に説明されている方法及び構成は、軟骨の疾病(例えば、骨関節炎(変形性関節炎))、骨損傷、軟骨損傷、外傷、及び/又は、過用又は老化に起因する劣化から生じる欠損を治療するために使用可能である。本発明により、とりわけ、保健医療従事者は、こうした欠損を評価し、且つ治療することが可能となる。対象となる領域のサイズ、体積及び形状は、欠損を有する軟骨領域のみを含むことも可能であるが、好適には、欠損軟骨を囲んでいる軟骨の隣接部分も含んでいる方がよい。
本発明の実施では、プラスチック、金属、結晶フリーの金属、セラミック、又は生体物質(例えば、コラーゲン又は他の細胞外マトリックス材)、ヒドロキシ・アパタイト、細胞(例えば、幹細胞、軟骨細胞等)、又はその組み合わせを含む、多種多様な使用材料が見出されるが、これらに限定されない。欠損及び関節面及び/又は軟骨下骨に関して取得された情報(例えば、測定値)に基づいて、修復材料が形成され、又は選択される。さらに、本明細書に説明されている1つ又は複数の技術を用いることにより、特定の軟骨欠損へ適合する曲率を有する軟骨置換又は再生物質は、関節面の輪郭及び形状に従い、さらに、周囲の軟骨の厚みに適合することになる。修復材料は、材料の任意の組み合わせを含み、さらに、通常、例えば、容易に曲がったり変化したりしない、少なくとも1つの柔軟性のない材料を含むことが可能である。
今日では、関節修復システムは、多くの場合、例えば、下部の骨(例えば、膝補綴の場合の大腿骨)へアンカー固定される補綴を含む、金属材料及び/又はポリマー材料を使用している。例えば、2001年3月20日にアフリアト(Afriat)他に対して発行された米国特許第6,203,576号、及び、2001年11月27日にオグル(Ogle)他に対して発行された米国特許第6,322,588号、及び、そこに引用された参照文献を参照されたい。多種多様な金属は、本発明の実施にとり有効であり、いかなる評価基準に基づいても選択可能である。例えば、材料選択は、所望される程度の剛性を付与する弾性に基づくものであってもよい。適当な金属の例には、銀、金、プラチナ、パラジウム、イリジウム、銅、スズ、鉛、アンチモン、ビスマス、亜鉛、チタニウム、コバルト、ステンレス鋼、ニッケル、鉄合金、Elgiloy(登録商標)等のコバルト合金、コバルト・クロム・ニッケル合金、及びMP35N、ニッケル・コバルト・クロム・モリブデン合金、及びニチノール(TM、商標)、ニッケルチタン合金、アルミニウム、マンガン、鉄、タンタル、Liquidmetal(登録商標)合金(リキッド・メタル・テクノロジーズ(Liquid Metal Technologies)、www.liquidmetal.comから市販)のような非晶質金属、例えば患者の体液又は組織、及びその組み合わせと接触して移植された基材の石灰化を阻止するために多価金属イオンをゆっくり形成可能な他の金属が含まれるが、これらに限定されない。
2002年1月10日付けの「バイオ・コンパチブル・ポリマー材料」(Bio−Compatible Polymeric Materials)と題されたPCT公開第WO 02/02158 A1号公報、
2002年1月3日付けの「バイオ・コンパチブル・ポリマー材料」(Bio−Compatible Polymeric Materials)と題された国際公開公報第WO 02/00275 A1号、及び、
2002年1月3日付けの「バイオ・コンパチブル・ポリマー材料」(Bio−Compatible Polymeric Materials)と題された国際公開公報第WO 02/00270 A1号。
1971年9月20日にハーン(Hahn)に対して発行された米国特許第3,605,123号、
1974年5月7日にトロンゾ(Tronzo)に対して発行された米国特許第3,808,606号、及び、
1974年10月29日にトロンゾ(Tronzo)に対して発行された米国特許第3,843,975号、
1967年4月18日にスミス(Smith)に対して発行された米国特許第3,314,420号、
1976年10月26日にシャーバック(Scharbach)に対して発行された米国特許第3,987,499号、及び、
ドイツ特許公開公報第2,306,552号。
1つ又は複数の被覆層があってもよく、その層は、同一の、又は異なる空隙率を有することができる。例えば、
1976年2月17日にカーン(Kahn)他に対して発行された米国特許第3,938,198号、を参照のこと。
1980年7月22日にモリス(Morris)に対して発行された米国特許第4,213,816号、を参照のこと。
多孔性被覆は、粉末の形で、さらに、その全体を、その粉末を基材へ接着する高温にさらすことで適用可能となる。適当なポリマー、及び/又は、粉体の被覆の選択は、例えば、それぞれのメルトインデックスに基づく等、本明細書での教示及び参照文献を考慮して決定可能である。
修復材料は、単独の、又は非生体材料と組み合わされた、1つ又は複数の生体材料を含んでいてもよい。例えば、いかなる基材も設計又は形成可能であり、さらに、基材となるように、胎児軟骨細胞等の適当な軟骨置換材料、又は再生材料(複数可)を適用することも可能である。その後、細胞は、軟骨欠損を囲む軟骨の厚み(及び/又は、曲率)に達するまで、基材と共に成長する。培養液中の種々の基材で細胞(例えば、軟骨細胞)を成長させる条件は、例えば、以下のものに、生体外及び生体内についての説明がある。
1995年12月26日にシルブカ(Slivka)他に対して発行された米国特許第5,478,739号、
1998年12月1日にナウトン(Naughton)他に対して発行された米国特許第5,842,477号、
2001年9月4日にビベーハンセン(Vibe−Hansen)他に対して発行された米国特許第6,283,980号、及び、
2002年4月2日にサルツマン(Salzmann)他に対して発行された米国特許第6,365,405号。
適当な基材の例には、プラスチック、組織担体、骨置換材料(例えば、ヒドロキシアパタイト、生体再吸収可能材料)、又は、軟骨置換又は再生材料をその上で成長させるのに適当な、いかなる他の材料も含まれるが、これらに限定されない。
2002年3月21日に公開された、アレキサンダー(Alexander)他に対する国際公開公報第WO 02/22014号、及び、
1997年8月7日に公開されたリー(Lee)に対する国際公開公報第WO 97/27885号。
ある実施形態では、自己材料は、材料の再吸収、移植部位を囲む組織の炎症及び/又は瘢痕化を含む、ホストに対する免疫学的合併症の危険を減少させるので、好適である。
アレキサンダー(Alexander)に対する国際公開公報第WO 02/22014号は、軟骨内部のグリコサミノグリカン含有量をモニターするために、関節軟骨撮像用のガドリニウムを使用することを説明している。
その後、移植部位を囲む軟骨の生化学組成と同様の生化学組成を達成するために、軟骨置換又は再生材料を作成可能、又は、いわば培養可能となる。所望される生化学組成を得るために用いられる培養条件には、例えば、濃度の変更が含まれていてもよい。軟骨置換又は再生材料の生化学組成は、例えば、ある栄養物及び生長因子の濃度及び暴露時間の制御により影響を受ける場合がある。
[A. 軟骨モデル]
軟骨の厚み及び曲率に関する情報を用いて、関節軟骨及び下部の骨の表面の物理モデルが作成可能である。この物理モデルは、関節内の限定領域を表す場合もあり、又は関節全体を取り囲む場合もある。例えば、膝関節では、物理モデルは、前部又は後部の大腿骨顆のみ、大腿骨顆及びノッチ領域の双方、内側脛骨プラトー、外側脛骨プラトー、脛骨プラトー全体、内側膝蓋骨、外側膝蓋骨、膝蓋骨全体、又は関節全体を取り囲んでいてもよい。また、このモデルでは、半月板の有無、並びにいくつかの又は全ての軟骨の有無を考慮に入れてもよい。軟骨の罹患領域の位置は、例えば、国際公開公報第WO 02/22014号で説明されるように、三次元座標系、又は三次元ユークリッド距離を用いて決定できる。
本明細書に説明されているように、様々なサイズ、曲率、及び厚みの修復システムが得られる。これらの修復システムは、個々の患者に適切なシステムを選択可能なライブラリシステムを創設するために、目録化して記憶させておくことができる。換言するならば、欠損又は関節面は、特定の被験者ごとに評価され、そして適当な形状及びサイズを有する、前から存在する修復システムが、ライブラリから選択され、さらなる操作(例えば、形成)及び移植のために利用される。
上述のように、本明細書に説明されている方法及び構成は、例えば、関節面の罹患軟骨又は欠損軟骨等の関節面の一部分だけを交換するのに使用可能である。これらのシステムでは、関節面修復システムは、罹患又は欠損軟骨の領域のみを交換するように設計可能であり、又は、罹患又は欠損軟骨の領域を越えて隣接する正常な軟骨へ例えば3mm又は5mmほど広げることも可能である。ある実施形態では、補綴が交換するのは、関節面(例えば、単一大腿骨顆のような、与えられた任意の関節面等)のほぼ70%から80%未満(又はこの範囲内の任意の値)、好ましくは、ほぼ50%から70%未満(又はこの範囲内の任意の値)、さらに好ましくは、ほぼ30%から50%未満(又はこの範囲内の任意の値)、さらに好ましくはほぼ20%から30%未満(又はこの範囲内の任意の値)、さらに好ましくは、関節面のほぼ20%未満である。
[A. 形成]
ある例では、修復材料の形成は、例えば、必要な軟骨材料の厚みが一定でない場合(例えば、異なる複数のセクションの軟骨置換、又は異なる厚みを必要とする再生材料の場合)等、形成(例えば、所望される厚みへの成長)の前又は後に必要とされる場合もある。
関節修復システムは、周囲の、又は隣接する軟骨又は軟骨下骨又は半月板又は他の組織と、概ねの解剖学的適合又は組み合わせをなすよう、形成又は選択できる。修復システムの形状は、電子画像(例えば、MRI、CT、デジタル断層合成、光コヒーレンス断層撮影等)の分析に基づくことができる。関節修復システムが罹患軟骨又は欠損軟骨の領域の置換を意図している場合は、電子画像による健康な軟骨の形状の仮想再構成を提供する方法を用いて、概ねの解剖学的適合が達成可能である。
ラピッド・プロトタイピングは、対象物のコンピュータモデルから三次元対象物を作る技術である。複数の二次元層からプロトタイプを作るために、特別なプリンタが使用される。コンピュータソフトウェアは、対象物の表現を複数の明確な二次元層に分け、その後、三次元プリンタは、ソフトウェアにより区分された、各層に対する材料の層を作る。様々な作成された層を1つにして、所望されるプロトタイプを形成する。ラピッド・プロトライピング技術に関する追加の情報は、2002年6月27日に公開された、ラッセル(Russell)他に対する米国特許公開公報第2002/0079601A1号で利用可能である。ラピッド・プロトタイピングを用いる利点は、この方法が、有毒な、又は、強力な化合物を安全に使用する、自由形式製作技術の使用を可能にしているからである。これらの化合物は、賦形剤包装材料へ安全に取り入れられ、作業者がそのような化合物に曝露されるのを抑えることになる。
患者に手術を行う前に、外科医は、例えば直立方向(erect)AP X線を用いて、手術前に膝の位置合わせを確定することができる。手術前評価を行う際に、存在するいずれの側棘及び膝蓋骨棘も確定することができる。
図4〜38の装置200を内側区画に挿入するために、内側から膝蓋腱にかけて小さな関節切開を行う。切開が行われると、内側顆を晒し、適したメス及び湾曲骨切カッター(curved osteotome)を用いて関節線よりも約1cm下に内側スリーブを作成する。内側スリーブの作成後、内側脛骨プラトーの周りにZ−リトラクタを配置し、脛骨及び大腿骨に沿って半月板及び骨棘の前部部分を切除する。この時点で、膝は約60°以上曲がるものとする。Z−リトラクタを移動させ、大腿骨の最も遠位の側面に対して、脛骨プラトーの縁を覆うように移植片を配置する。移植片は真直ぐに押す。いくつかの例では、外反ストレスを加えると移植片の挿入が容易になり得る。
図39〜49に示す装置300を挿入するために、修復すべき顆に応じて、前部から内側にかけての又は前部から外側にかけての皮膚の切開を行い、この切開は、膝蓋骨の上縁の約1cm近くから始まる。この切開は通常、例えば膝蓋骨の縁に沿って6〜10cmの範囲とすることができる。当業者には理解されるように、状況下によっては、範囲のより長い切開が必要とされ得る。
図85〜87に示す装置を挿入するために、膝蓋腱に対して外側又は内側になされる、図4〜38に関して上述した切開を用いることが適し得る。まず、膝蓋骨を外側にめくり返し、脂肪体及び滑膜を膝蓋骨の周縁から裏返す。所望であれば、骨棘を切除することができる。生来の膝蓋骨620を再表面化する前に、亜脱臼があるかどうかを判定するために膝にいくつかの動きの範囲の手作を行うものとする。亜脱臼がある場合、移植片600を中間に置く(medialized)必要があるであろう。次に、生来の膝蓋骨を平面すなわち平坦になるようにカットして、平坦面が移植片に呈示されるようにすることができる。次に、通常、膝蓋骨620の幾何学的中心が移植片600の幾何学的中心に位置合わせされる。移植片600を膝蓋骨620にアンカー固定するために、1つ又は複数の穴又は孔612を膝蓋面に形成して、移植片600のペグ610を受け入れるようにすることができる。
上述した移植片のうちの1つ又は複数をキットになるように組み合わせて、外科医が手術の際に用いるべき1つ又は複数の移植片を選択することができるようにする。
202 上面
204 下面
206 周縁
208 移植片の外形(上縁)
210 下縁
212 関節アンカー
214 横部材
220 クロスバー部材
221 溝
222 溝
224 関節上面
230、231、234 フィレット
250 脛骨プラトー
251 関節面
252 (関節面の)表面全体
260 平坦な、後部及び前部間の面
262 傾斜した、後部及び前部間の面
264 キール
300 移植片
302 脛骨プラトー嵌合面(湾曲状嵌合面)、下面
304 凸状関節当接面、骨嵌合面、近位面、上面
306 アンカー(ペグ)
310 ステム
312 ヘッド
314 首部
360 平坦面又は面取りカット部
400 移植片
402 移植片の上面
404 移植片の下面
410 外側顆コンポーネント
420 内側顆コンポーネント
430 ブリッジ(ペグ)
495 面取りカット部
496 遠位カット部
497 前部カット部
498 後部カット部
499 人工膝関節置換術(「TKA」)の根本的な膝
500 移植片
502 上面(内面)
503 角をなして曲がった(angled)面
504 下面
510 大腿骨外側顆又は大腿骨内側顆(の内の一方)
512 大腿骨(移植片のブリッジ部)
513 上部
514 ノッチ
515 底部
517 内側
519 外側
521 レール
523 キール
530 ペグ
560 輪郭面
561 前部カット部
562 後部カット部
563 遠位カット部
564 面取りカット部
600、601 表面形状
610、620 断面
700 移植片
710 第1のコンポーネント
720 第2のコンポーネント
722 遠位面
724 近位面
726 平坦化部
728 大腿骨への取り付けを容易にする機構
730 テーパ面
800 膝蓋骨
810 移植片
802 平滑面
812 プレート(構造)
814 ドーム
850 (ブランクとしての初期段階の)移植片
852 下面
854 ペグ
856 円形ドーム
858 円形プレート部(縁)
860 上面(関節面)
862、862' カットライン
900 移植片
1000 大腿骨
1002 外側顆
1004 内側顆
1006 顆間窩
1008 外側上顆
1010 内側上顆
1012 膝蓋面
1020 膝(関節)
1022 脛骨プラトー
1023 脛骨プラトーの縁
1024 大腿骨
1050 膝関節
Claims (24)
- 上面(304、402、502)及び下面(302、404、504)を有する、患者膝関節の大腿骨顆補綴用の補綴装置(300、400、500)であって、
前記上面(304,402、502)は、大腿骨顆の表面の少なくとも一部と対面し、前記大腿骨顆のカットされた骨の少なくとも一つの平面を有し、
前記下面(302、404、504)は、脛骨面の重量負担部分の少なくとも一部と対面し、患者の膝関節の前記大腿骨顆の突出した形状に一致する三次元形状を有することを特徴とする患者毎に特有の補綴装置。 - 前記補綴装置は、患者の膝関節の膝蓋骨面の少なくとも一部を覆うよう構成されたことを特徴とする請求項1に記載の患者毎に特有の補綴装置。
- 前記補綴装置は、患者の第2の大腿骨顆の少なくとも一部を覆うよう構成されたことを特徴とする請求項1に記載の患者毎に特有の補綴装置。
- 前記大腿骨顆面は、骨を切除することで準備がなされることを特徴とする請求項1に記載の患者毎に特有の補綴装置。
- 前記大腿骨顆面は、軟骨を切除することで準備がなされたことを特徴とする請求項1に記載の患者毎に特有の補綴装置。
- 前記大腿骨顆面は、前記患者毎に特有の補綴装置の前記上面(304,402、502)の少なくとも一つの平面を有する片方に、少なくとも一つの平面が形成されることにより準備されることを特徴とする請求項1に記載の患者毎に特有の補綴装置。
- 前記膝関節の動きの範囲は、正常な膝関節の動きの80%〜99.9%まで回復することを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記膝関節の動き範囲は、正常な膝関節の動きの90%〜99.9%まで回復することを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記膝関節の動きの範囲は、正常の膝関節の動きの95%〜99.9%まで回復することを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記補綴装置(300、400、500)は、前記大腿骨の第2の顆の少なくとも一部と対面するよう形成されたことを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記補綴装置(300、400、500)は、前記上面(402、502)の内側または外側の一方のから延びるレールをさらに含むことを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記下面(302、404、504)は、健康な関節の解剖学的構造(anatomy)を模したことを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記下面(302、404、504)は、手術前の関節の解剖学的構造(anatomy)を模したことを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 前記上面及び前記下面を有する、膝関節の大腿骨遠位部(distal femur)に適した補綴装置(300、400、500)であって、前記上面は、脛大腿関節面の大腿骨面と連通するように構成され、前記下面は、該脛大腿関節面の脛骨面と連通するように構成されたことを特徴とする請求項1に記載の患者の膝関節用の患者毎に特有の補綴装置。
- 請求項1に記載の患者毎に特有の補綴装置(300、400、500)と、脛大腿関節面の脛骨面の代わりとなる脛骨コンポーネントから成ることを特徴とする患者毎に特有の補綴システム。
- 前記膝蓋大腿関節面の前記膝蓋面の代わりとなるように設計された膝蓋骨コンポーネントをさらに含むことを特徴とする請求項15に記載の患者毎に特有の補綴システム。
- 前記脛骨コンポーネントが、前記脛大腿関節面の脛骨面の代わりとなることを特徴とする請求項15に記載の患者毎に特有の補綴システム。
- 前記脛骨コンポーネント及前記患者毎に特有の補綴装置の少なくとも一つは非対称であることを特徴とする請求項15に記載の患者毎に特有の補綴システム。
- 前記脛骨コンポーネント、大腿骨コンポーネント、及び膝蓋骨コンポーネント少なくとも一つは非対称であることを特徴とする請求項16に記載の患者毎に特有の補綴システム。
- 請求項1に記載の患者毎に特有の補綴装置(300、400、500)を製造することを特徴とする患者毎に特有の補綴装置の製造方法。
- 患者の患部関節の関節面を修復するための患者毎に特有の補綴装置(300、400、500)の製造方法であって、
患部膝関節の解剖学上の画像を撮る段階、
前記解剖学上の画像から患部関節の関節面の設計形状を誘導する段階、及び、
骨対向面と患部関節の関節面設計形状を摸した関節対向面が設計または選択される段階、を含むことを特徴とする患者毎に特有の補綴装置の製造方法。 - 前記選択された補綴装置は、患部関節の関節面の設計形状を摸した形状にさらに導かれることを特徴とする請求項21に記載の患者毎に特有の補綴装置の製造方法。
- 前記設計または選択するための外科ツールをさらに備えることを特徴とする請求項21に記載の患者毎に特有の補綴装置の製造方法。
- 請求項1に記載の患者毎に特有の補綴装置と一つまたは二つの外科ツールを備えたことを特徴とする関節修復システム。
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