JP2012523897A - 靭帯修復のための患者固有の関節置換術の装置 - Google Patents
靭帯修復のための患者固有の関節置換術の装置 Download PDFInfo
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Abstract
Description
本出願は、2009年4月16日に「靭帯修復のための患者固有の関節置換術の装置」という名称で出願された米国特許仮出願第61/169,823号の利益および優先権を主張する。
本明細書に記載された実施形態は、関節靭帯に関する外科手術のための整形外科の方法、システムおよび装置に関する。一部の実施形態は、こうした靭帯の修復または置換を容易にするために患者特有データから設計された手術のテンプレートを含んでいる。
誘導モールドは、靭帯の修復および置換のために、手法を計画し外科的介入を準備し、外科的介入を実施する際に利用することが可能である。一部の実施形態では、ACLまたはPCLは、1つもしくは複数の処置の工程で1つもしくは複数の誘導モールドを使用して、修復、置換、再建、または治療されることが可能である。たとえば、回旋腱板、距腱および非常に多く頻繁にある靭帯を含む、他の腱ならびに靭帯の損傷はまた、本明細書に記載された実施形態を使用して対処されることが可能である。
ACLは、特別な束の形態学的特徴のない連続した線維である。微小解剖学は、より大きな束に分類した、複数のコラーゲン線維を含む。解剖学的描写の欠落に関わらず、線維配置は、前内側帯および後外側帯の、2つの下位分割または束に「機能的に」分割されてきた。前内側帯の線維は、大腿骨取付部の近位部から脛骨のフットプリントの前内側面に跨る。後外側帯線維は大腿骨の遠位および脛骨の後外側に付着している。後外側帯は、膝が延びると緊張し、前内側帯は、膝が屈曲すると緊張状態になる。大腿骨および脛骨上の内部構造ならびに付着位置のため、ACLは、脛骨の前方移転および内部回転、内反および外反角状、ならびに膝の過伸展に抑制を提供する。
1.膝の評価およびACL断裂の確認
2.移植片の採取
3.関節鏡視下確認および関節内の疾患治療
4.顆間切痕の準備
5.骨性トンネルの配置
6.移植片の埋込みおよび固定
7.創縫合および手術後の課題
これらの工程のそれぞれの通常の特徴の記載は、以下の小区分に含まれる。
膝の評価は、手術前に評価すること、ならびに患者に麻酔を施した上で、たとえば、身体診察およびKT−1000膝関節計によって、損傷した膝と反対側の膝を比較することを含むことが可能である。ACLの完全断裂が臨床的に明白である場合、自家移植片は外科手術の関節鏡部分より前に採取されてもよい。
移植片の選択は、個々の外科医および患者の好みに応じて行ってもよい。しばしば、自家移植片は、両端部に骨プラグを有する患者の膝蓋腱の中部3分の1から採取されるが、他の自家移植片採取源、同種移植片採取源、または異種移植片採取源を使用してもよい。患者の膝蓋腱の中部3分の1から採取する場合、膝蓋腱全幅の40%以下の移植片幅が、目標値にすることが可能であり、手術用メスは、それに応じて設定される。たとえば、腱幅が少なくとも25mmである場合、膝蓋は10mm離して設定される。さらに小柄な患者では、若干小さい移植片幅が目標値にされ得る。骨の取付部から開始すると、腱の中央3分の1は、その線維線で切断することが可能である。次いで、電気焼灼器を使用して骨腱接合部を描き、骨プラグのマージンの外形を描くことが可能である。しっかりと固定できるために、最低限の輪郭合わせの形成をした骨性トンネルに、ぴたりと嵌合するプラグを再生可能に獲得する手技を使用して骨プラグを採取することは有利である。さらに、採取位置の膝蓋骨骨折の危険性を最小化する、骨プラグ採取手技を実施することは有利である。円形振動鋸(Stryker)は、様々な直径(9、10、または11mm)の円筒状骨プラグを提供し、たとえば、直径10mmの鋸刃と共に使用可能である。この装置は、以下の利点を提供できる。(a)採取が容易で迅速であり、(b)円筒状骨プラグを対応する骨性トンネルより1mm小さい直径で再生可能であり、(c)膝蓋骨の採取位置で生じる応力を低減させ、(d)均一のサイズ化のため移植片の挿入が容易である。しかし、この装置および他の同様の装置が患者の骨上に手動で配置されるので、装置の配置および骨プラグの配置は、外科医の所期の配置または理想的な配置と異なる可能性がある。一旦採取されると、自家移植片が準備され、外科医により、または助手により、サイドテーブルに埋込み用に成形できる一方で、外科医は自家移植片を受け取るための骨性トンネルを準備する。
関節内部分の外科手術は、助手が移植片をサイドテーブルで準備している間に実行されることが可能である。通常、関節鏡は、膝蓋腱の外側縁を露出するために皮膚弁を退縮させることによって生成された前内側ポータルに挿入される。前内側ポータルは、同様に生成されることが可能であり、どちらのポータルも既存の皮膚切断のマージン内に配置されることが可能である。個別の標準的な関節鏡用ポータルは、代替の移植片を使用するときに含まれ得る。ACL再建は通常、高流量を含み、個別のカニューレを通して、または関節鏡を通したポンプによって、達成され得る。完璧な診断に用いる関節鏡の検査は、破断したACLを確認するため、ならびに半月板および関節軟骨の状況に接近するために実行可能である。各関節内の構造は、たとえば、留め金を使用して調査可能であり、連続写真画像は、情報管理目的に撮られ得る。好ましくは、あらゆる関連した関節内の負傷は、靭帯再建を進める前に治療される。たとえば、半月板断裂は、修復または切除されることが可能であり、関節軟骨損傷は、情報管理され、また適切だと判断される場合は、たとえば、軟骨形成術または微小破壊によって、治療されることが可能である。
一部の実施形態では、断裂したACLの残余物は、脛骨のフットプリントが、明白に確認できるように、完全半径リセクタを使用して創面切除を施すことが可能である。靭帯粘液は、視覚化を高めるために除去することが可能である。膝蓋下脂肪体はほとんど切除されず、後十字靭帯(PCL)は通常保護される。切痕形成は、直視下で軟組織を除去するために、たとえば振動リセクタを使用して、切痕の外側壁から軟組織および骨膜を創傷切除することから始めることが可能である。骨性トンネルの開口を含む外側壁の全表面は切除可能である。一旦切痕が軟組織を適切に切除すると、追加の骨の切痕形成に対する必要性に関して評価することが可能であり、外側壁の視覚化が困難である場合、または切痕骨棘が存在するためにACL移植片に衝突して裁断し得る場合は、追加の骨の切痕形成に対する必要性に関して評価が実施され得る。関節鏡の掘削器具または全半径レセクタを使用して、処置することが可能である。t切痕の拡張が所望される場合は、Y4インチの湾曲した骨刀がポータルを通して導入され得、大骨片は捕捉器具で除去され得る。関節軟骨除去は最小が望ましい。たとえば、骨性トンネルを生成するためにピンまたはドリルを配置するために、ピン、ドリルおよび他の道具を配置するための視覚的目印に依存する場合、目印を適切に確認するのに、さらに材料を取り除くことが必要になり得る。たとえば、切痕の後部マージンが明白に確認されて、オーバーザトップポジションとしていわゆる「残存の隆起線」を誤解することを回避するのは有利である。視覚的目印の選択におけるこの過失によって、大腿骨トンネルを、目印の視覚確認のみに依存する処置では所望より前方に配置させることになり得る。
理想の骨性トンネル位置の選択は、ACL再建において重要な工程である。正常なACLは、大量の線維からなる。各線維は、異なる長さであり、異なる起始および挿入を有し、膝の可動域内で異なる張力下にある。ACLを置換する移植片は、平行線維を含む。骨性トンネルの配置を最適に選択しても、移植片の線維は、可動域で長さおよび張力が変化する可能性がある。したがって、ACLの置換は、元の靭帯を複製しないことがある。しかし、骨性トンネルの中心を最も等尺の点に配置することは、移動中に獲得可能な安定性を最大化する。
関節鏡での視覚化のもとで、移植片は、近位の縫合上で頭部を牽引しながら大腿骨トンネルに入る。海綿面は、新しい靭帯のコラーゲン線維が大腿骨トンネルの後方にあるように、前方外側に配置される。移植片は、早期にペンで印をつけた骨プラグと靭帯の接合がトンネル口部で視覚化されると、完全に着座される。カニューレ挿入した干渉スクリューを使用して移植片を固定してもよいが、他の代替固定方法も利用可能である。
手術の最終工程において、自家移植片から(たとえば、膝蓋骨内で)生成された骨欠損は、脛骨トンネルから獲得された骨の中核を使用して移植される。支帯組織は、移植片を適切な位置に維持させるために欠損部を囲んで縫合することが可能である。膝蓋腱は、腱を短くすることなく、あらゆる触診可能な空隙を最小化するために緩く再接合される。側関節腱、皮下組織、および皮膚は、別個の層に閉鎖される。手術後、リハビリテーションが数週間続行される。ACL再建に関する術後合併症は、たとえば、1つまたは複数の動きの低下、再発不安定、ならびに膝蓋大腿機能障害および疼痛を含み得る。
本明細書に記載された一部の実施形態では、誘導テンプレートは、大腿骨および脛骨の移植トンネルを高精度で再生可能で、侵襲性を最小化することが可能になるように選択および/または設計することが可能である。
ACL修復のように、後十字靭帯(PCL)負傷を管理するための治療が、引き続き展開している。
断裂した靭帯を修復するか、または再建するかの決定は、多くの要因に依存する。MRIは、どの構造が修復可能であり、どれが再建可能であるかを決定する際に特に役立つ。一般に、修復は、再建ほど効果が強くなく、術後プロトコルの変形形態は、しばしばこの差を反映して設計される。残念ながら、ACL負傷のように、中間物質PCL破断の一次修復は、一貫して成功していない。例外はPCL骨または靭帯挿入剥離の場合であり、その場合これらの負傷の修復は通常、好ましい結果をもたらす。いくつかの外科的手法は、治療を要し、膝への後内側、後外側、および後部手法ならびにすべての関節鏡手技を含み得る、他の関連した靭帯および半月板損傷に依存して利用することが可能である。さらに、様々な固定方法が論じられており、骨片の大きさに依存する。大きい剥離片に対して、AOねじが使用可能であり、より小さい片がキルシュナー鋼線すなわち引き寄せ締結法で、または穿孔穴を通って縫合修復によって固定されることが可能である。
いくつかの異なる方法は、PCL修復または再建に対して開発されてきた。ほとんどの外科医は現在、正常な解剖学的再建がPCL再建後、最良の潜在的な着実な結果を生じることに同意している。移植片選択、固定のテンプレート、トンネルの配置、ならびに埋込み対大腿骨トンネル手技を含み、多数の変形形態が存在する。2つの最も一般的に用いられる再建術は、下腿トンネルおよび大腿骨埋込み手技である。さらに、一部の研究は、二重束構築がPCLの生物力学を体外で再製造する最良の機会を有すると示しているが、臨床研究では、この手技の改善された結果が体内で一重束再建を通じて確認されていない。
様々な組織が、膝の再建に使用されてきた。自家移植片組織は、膝蓋、膝腱、または大腿四頭筋腱を含む。アキレス腱、膝蓋腱、および前脛骨筋腱は、最も一般的に使用される同種移植組織である。いくつかの研究では、移植された同種移植腱は血管を移植し、細胞再生を受け、まさに自家移植片組織がするように十分に成熟すると、関節鏡および組織学方法によって立証したが、この工程がしばしば好まれるのは、同種移植組織と共により時間がかかる。アキレス腱同種移植は、その高抗張力、より短い手術時間、通過の容易性、およびすでに障害が起きた膝でドナー位置の羅患し難いため好まれることが多い。さらなる利点は、その非常に優れた大きさおよび長さ、ならびに他の移植選択肢と比較すると、非常に用途を広げる一端での骨取付けを含む。金属および生体干渉ねじ、ボタン、皮質ねじおよび軟組織座金、またはステープルを含み、固定の複数の方法も存在する。軟組織を骨に固定するほとんどの場合、最もしっかりと固定されると示されたように、ねじおよび軟組織座金の使用が好まれる。
生体力学の研究は、一重束術を実行するときに前外側束の再建を支持する。解剖学的フットプリントにおいて大腿骨トンネルを前方に配置することが、同寸法の移植片の配置より良い正常な膝の弛緩を再建するために示された。ACL手術と同様に、骨性トンネルの配置は、処置の成功にとり重要になり得る。脛骨トンネル配置の変形形態は、大腿骨トンネル配置の変形形態より低い程度で移植行動に影響を及ぼす可能性がある。さらに、同寸でない移植片が伸張され固定された位置は、膝力学に著しい効果がある可能性がある。
一重束術は、後内側束と比較される場合、そのより大きいサイズおよびより大きい生体力学特性のために、前外側束を再建するために開発された。移植片を生来の前外側束の生体構造位置に配置させるため、単一脛骨および大腿骨トンネルを利用できる。正常な解剖学的再生は、トンネルを大腿骨の解剖学的前外側束のフットプリントの前方に配置する理想的な配置であり得る。前方に引き出す力を有する90度の膝屈曲で移植片の伸張を伴うこの手法で、好結果が報告された。
二重束再建は、PCLの複雑な機能の生体構造をより正確に再生するよう導入された。二重束PCL再建が、運動の全域を通して正常な膝の生体力学をより近接に回復し得ると、死体研究で示された。従来の一重束再建は、膝の生体力学を膝の中間屈曲角から深屈曲角で回復させるが、膝が完全伸展に近い場合、残余部の弛緩があり得る。生体力学の研究は、さらに後内側束は膝屈曲内で後方脛骨の転移を低減し、ならびにこの束は膝の屈曲全域で重要な役割を果たすことが可能であることを示した。技術的に難易度が高いが、二重束再建は、正常な膝力学の回復が改善されたために、慢性PCL欠損に好ましい外科的手技になった。
脛骨の埋込み術は、長い脛骨トンネルを通過する骨プラグの課題、および後脛骨の出口点で摩滅する可能性の課題を回避するために最初に導入された。脛骨の埋込み術はまた、神経血管構造の保護を促進することが可能である。PCLの脛骨の挿入に後方進入路を利用すると、後方の露出が簡単になる。その手技は、膝蓋腱自家移植片で最も一般的に利用されてきたが、最近、二重束のアキレス同種移植との併用が述べられている。
複合したPCL−PLS(後外側支持構造)障害は、整形外科医が経験し得る最も複雑な膝の障害パターンの1つである。PCLとPLSの両方が破断すると、実質的な後方移動、外旋、および内反開口が、すべて膝屈曲の異なる角度で存在し得る。この複合は、通例、複数の手術計画を有する外科医を必要とする複雑な手術の難問を生み出す。弓状靭帯の向上、二頭筋腱固定術、および同種移植片または同種移植組織を有する膝窩腓骨靭帯再建を含み、再建の多くの手技が考案された。慢性の後外側不安定の症例は、組織の冗長およびLCLの後方に過度の傷跡が残ることを実証し、膝窩筋複合体の特定の構造の確認を困難にしている。したがって、負傷したPLSの外科治療のタイミングは重要であり、慢性傷害の再建より好ましい結果を一貫してもたらす鋭敏な治療を伴う。PLSを含む慢性のPCL障害は、さらに手術の難易度が高い。PLS障害が無視されるか、もしくは認識されない場合、他の靭帯の修復または再建が、再建を慢性的に反復して伸張するため、失敗の著しい危険性があり得る。慢性傷害設定におけるPLS障害の外科治療は、欠損した構造の修復よりむしろ再建を中心にする。膝窩腓骨靭帯の解剖学的再建、必要に応じてLCLの再建が好まれる。内反不正配列または側方動揺が存在する場合、脛骨近位骨切術が配列を矯正するために実行され得る。その骨切術はPLS再建を伴って実行され得るが、骨切術は単独で患者の症状を緩和し得るので、手術が実施され得、それによってさらなる手術介入が回避される。
靱帯損傷に関連する認識および適切な治療の失敗は、PCL手術で遭遇する最も頻発する問題である。手術前および手術室の両方で注意深く検査し、MRIおよび関節鏡所見の両方に注意を払うことで、すべての負傷した構造の確認を向上させることが可能である。多くの患者にとって、好結果は、すべての断裂した構造の修復および/または再建に依存する。代わりにまたはこれに加えて、手術中の患者の動脈、静脈または脛骨神経の損傷は、深刻な合併症の可能性がある。負傷は、ガイドピンの通過時、または拡掘中に起こり得る。本明細書に記載された一部の実施形態では、PCL脛骨ガイドは、手術中にそのような負傷の可能性を軽減させるために保護照準アームを備えて設計されている。脛骨トンネルの後部皮質を通って手動で穿孔することは、下腿トンネル手技のための重要な安全対策であり得る。後内側の安全な切断は、この危険性を減少させることができる別の戦略である。脛骨の埋込み手技は、下腿トンネルを除去することによって、神経血管の損傷の危険性を抑制する別の方法である。
ACL修復の状況において上記に記載したすべての実施形態はまた、PCL修復、ならびに他の靭帯または腱の修復に適用され得る。
一部の実施形態では、本明細書に記載された方法ならびに装置を使用して、半腱様筋および/または薄筋自家移植片片(膝腱)のために配置し、移植片を採取することが可能である。このような移植片の位置は、正確に配置することが困難であり得、その困難によって、一部の外科医が処置すべてを回避する事態をもたらす可能性がある。位置は一般に、関節脛骨プラトー隆起から約5cm遠位にある。患者固有の情報に基づく手術装置は、こうした移植片の正確な配置を提供することができ、外科医がこのような処置を実行する能力、ならびに処置自体とそれによる患者の転帰の信頼性を向上させる。
(3.1 撮像手技)
当業者には理解されるように、撮像手技を使用する実施形態の実施は、X線撮像および処理の従来の方法、X線トモシンセシス、A−スキャン、B−スキャンおよびC−スキャンを含む超音波、コンピュータ断層撮影(CTスキャン)、磁気共鳴画像(MRI)、光学コヒーレンス断層撮影、単一光子放出テンプレートコンピュータ断層画像(SPECT)および陽電子放出断層撮影(PET)を当業者が備えている技術の範囲内で使用することが好ましい。しかし、他の撮像手技も可能である。撮像手技は、文献に完全に説明されており、本明細書に記載する必要はない。たとえば、「X−Ray Structure Determination:A Practical Guide」第2版、StoutおよびJensen編、1989、John Wiley & Sons出版、「Body CT:A Practical Approach」Slone編、1999、McGraw−Hill出版、「X−ray Diagnosis:A Physician’s Approach」Lam編、1998、Springer−Verlag出版、「Dental Radiology:Understanding the X−Ray Image」Laetitia Brocklebank編、1997、Oxford University Press出版を参照のこと。「The Essential Physics of Medical Imaging」(第2版)、Jerrold T. Bushberg et alも参照のこと。
上記に記載された非侵襲撮影手技の代替として、または追加として、解剖学的領域(たとえば、羅患軟骨領域もしくは軟骨欠損の領域)のサイズの測定、軟骨厚さの測定および/または軟骨もしくは骨の湾曲は、手術中に関節鏡検査または関節切断中、獲得することが可能である。手術中の測定は、必要ないが、1つまたは複数の関節表面の領域に実際に接触することを含むことが可能である。
靭帯、半月板および他の関節構造は、2次元および3次元で表示が可能である。様々なパラメトリック曲面表示については、たとえば、「Computer Graphics:Principles and Practice in C」Foley, J.D. et al著、Addison−Wesley出版、第2版、1995を参照のこと。
患者固有のインプラントおよび処置、ならびに他の装置および処置の両方の使用のための手術支援は、軟骨下骨を含む、関節軟骨または骨の外表面に適用した装置を使用して、関節修復システムの配列および被移植位置または関節を整合するために、提供されることが可能である。装置は、球形、円形、長円形、楕円形、湾曲したまたは不規則な形状であり得る。形状は、羅患軟骨の領域または羅患軟骨の領域よりわずかに大きい、もしくは羅患軟骨の領域より実質的に大きい領域を整合または包囲するために、選択あるいは調節されることが可能である。領域は、全関節表面または重量荷担面を包含することが可能である。このような装置は通常、大部分または全関節表面の置換が検討される場合、好まれる。
Claims (20)
- 靭帯修復の方法であって、
靭帯に関連する少なくとも1つの表面の電子画像データを獲得することと、
前記表面の少なくとも一部に一致する少なくとも1つの接触表面を有し、前記靭帯修復に関与する手術器具の移動を方向付けする少なくとも1つのガイドを含む第1のテンプレートを、前記画像データの少なくとも一部に基づいて生成することと、を含む方法。 - 前記靭帯は、前十字靭帯である、請求項1に記載の方法。
- 前記靭帯は、後十字靭帯である、請求項1に記載の方法。
- 靭帯移植片のためのトンネルの位置を決定することをさらに含む、請求項1に記載の方法。
- 前記トンネルの位置を決定することは、第1の関節表面上の前記靭帯の起始、および前記第1の関節表面に対向する第2の関節表面上の挿入位置を確認することを含む、請求項4に記載の方法。
- 前記トンネルの位置を決定することは、前記画像データに基づいて、骨の目印および靭帯の残余部のうちの少なくとも1つを確認することを含む、請求項4に記載の方法。
- 前記表面は、前記トンネルの位置に隣接しているか、または、非重量負荷面である、請求項4に記載の方法。
- 前記第1のテンプレートは、ドリルガイド孔を含み、前記方法は、
少なくとも1つの接触表面が前記表面の少なくとも一部分に接触するように、前記テンプレートを位置づけすることと、
靭帯トンネルを穿孔することであって、前記穿孔が前記ドリルガイド孔によって誘導されることをさらに含む、請求項1に記載の方法。 - 前記第1のテンプレート上の前記ドリルガイド孔の形状、位置ならびに配向の少なくとも1つは、少なくとも一部、隣接した皮質骨までのトンネルの距離に基づく、請求項8に記載の方法。
- 前記ドリルガイド孔は、所望の穿孔深さが得られるように、止め具を含む、請求項9に記載の方法。
- 前記画像データは、手術前に入手される、請求項1に記載の方法。
- 前記画像データは、CTスキャンおよびMRIスキャンのうちの少なくとも1つによって入手される、請求項1に記載の方法。
- 前記画像データは、関節屈曲、関節伸展、関節外転、関節内転、および関節回転のうちの少なくとも1つで入手される、請求項1に記載の方法。
- 前記画像データに基づく移植片採取位置を確認することと、
前記移植片採取位置を形成する靭帯および骨の少なくとも1つを採取することを誘導する前記第1のテンプレートを使用することと、をさらに含む請求項1に記載の方法。 - 前記靭帯に関連する第2の表面上の、少なくとも1つのガイドを含む第2のテンプレートの位置を配列するために、前記第2のテンプレートを前記第1のテンプレートと相互参照することと、
前記第2のテンプレートの少なくとも1つのガイドを使用する前記手術器具の移動を前記ガイドに対して方向付けすることと、をさらに含む請求項1に記載の方法。 - 前記第1および第2の表面は、対向する関節表面である、請求項15に記載の方法。
- 前記第1の表面は、大腿骨表面であり、前記第2の表面は、脛骨表面である、請求項16に記載の方法。
- 前記第1のテンプレートは、組織開創器を含む、請求項1に記載の方法。
- 前記組織開創器は、フランジおよび拡張器のうち1つである、請求項18に記載の方法。
- 一重束および二重束靭帯再建のうち少なくとも1つにおける前記テンプレートを使用することをさらに含む、請求項1に記載の方法。
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WO2010121147A1 (en) | 2010-10-21 |
EP2419035B1 (en) | 2017-07-05 |
EP2419035A4 (en) | 2013-01-16 |
SG175229A1 (en) | 2011-11-28 |
BRPI1014917A2 (pt) | 2016-04-19 |
US20170065347A1 (en) | 2017-03-09 |
CN102448394A (zh) | 2012-05-09 |
CN102448394B (zh) | 2015-07-22 |
US8500740B2 (en) | 2013-08-06 |
AU2010236263A1 (en) | 2011-11-10 |
US20130317511A1 (en) | 2013-11-28 |
US9308053B2 (en) | 2016-04-12 |
AU2015205950A1 (en) | 2015-08-20 |
SG10201401326SA (en) | 2014-10-30 |
US20100298894A1 (en) | 2010-11-25 |
EP2419035A1 (en) | 2012-02-22 |
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