JP4840886B2 - 足関節置換人工装具 - Google Patents
足関節置換人工装具 Download PDFInfo
- Publication number
- JP4840886B2 JP4840886B2 JP2009051377A JP2009051377A JP4840886B2 JP 4840886 B2 JP4840886 B2 JP 4840886B2 JP 2009051377 A JP2009051377 A JP 2009051377A JP 2009051377 A JP2009051377 A JP 2009051377A JP 4840886 B2 JP4840886 B2 JP 4840886B2
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- JP
- Japan
- Prior art keywords
- talus
- tibia
- alignment
- joint
- trunk
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
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- A61F2002/4625—Special 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 with relative movement between parts of the instrument during use
- A61F2002/4627—Special 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 with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Transplantation (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dentistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Description
本発明は、足関節置換人工装具およびシステム、ならびに関連する手術器具および手技に関する。
1970年代の初めから中頃まで、一般にリウマチ、あるいは変形性関節症または外傷性関節炎などが引き起こす足関節の負傷または疾患を持つ患者は、自分の足関節が機能不全になった場合ほとんど選択肢を持たなかった。これらの患者が自分の足関節のいくらかの機能を再構築するのを助ける最も一般的な手段は、固定による関節の閉塞であったが、これは今日も一般的に用いられる手法である。しかし、固定は足関節を硬化させ、また多くの場合は下肢に対する動きを制限して、これが限られた使用や膝関節や股関節へのさらなる圧迫をもたらしていた。
(項目1)
人工装具の固定用のマルチピース幹アセンブリであって、上記マルチピース幹アセンブリは、上記マルチピース幹アセンブリより小さな外科的開口部を介した挿入のためにそれぞれ大きさと構成が決められた二つ以上の幹部品のアセンブリを含み、上記幹部品のそれぞれは、取り付け部位を備え、上記取り付け部位は、前記マルチピース幹アセンブリを取り付けるために、上記幹部品のうちの別のものの嵌合する取り付け部位にインサイチュで連結され得る、マルチピース幹アセンブリ。
(項目2)
上記インプラントは、関節インプラント、固定(関節固定術)インプラント、骨切り術固定インプラント、または骨折固定インプラントのうちの一つを含む、項目1に記載のマルチピース幹アセンブリ。
(項目3)
項目1で定義されるマルチピース幹アセンブリを含む人工装具。
(項目4)
人工関節面をさらに含む、項目3に記載の人工装具。
(項目5)
項目1に定義されるマルチピース幹アセンブリを提供するステップと、
外科的切開を介して一つの幹部品を挿入するステップと、
上記外科的切開を介して別の幹部品を挿入するステップと、
上記マルチピース幹アセンブリを形成するために上記幹部品同士をインサイチュで連結するステップとを含む方法。
(項目6)
項目1に定義されるマルチピース幹アセンブリと、上記軸アセンブリに連結される第一の人工関節面と、上記第一の人工関節面と関節運動して人工関節を形成する第二の人工関節面とを含む、人工装具アセンブリ。
(項目7)
上記関節運動する人工関節面が、上記人工関節が軸の周囲を回転できるようにする相補的な玉継ぎ手面を含む、項目6に記載の人工装具アセンブリ。
(項目8)
上記相補的な玉継ぎ手面は、関節運動するだけでなく、自然骨に対する前方、後方、および側方への移動に適応する、項目7に記載の人工装具アセンブリ。
(項目9)
関節運動する人工関節面それぞれが、軸に沿って曲線を描く細長い溝を各面に形成するように、第一の弧に対して垂直な第二の弧に沿って掃過される上記第一の弧によって画定される面を含む、掃過された弧として幾何学的に特徴付けられる鞍状形部品を含む、項目6に記載の人工装具アセンブリ。
(項目10)
距骨に結合される第一の人工関節面と、脛骨に結合される第二の人工関節面と、人工足関節を形成するように関節運動する上記第一および第二人工関節とを含み、上記関節運動する人工足関節面のそれぞれは、軸に沿って曲線を描く細長い溝を各面に形成するように、第一の弧に対して垂直な第二の弧に沿って掃過される上記第一の弧によって画定される面を含む、掃過された弧として幾何学的に特徴付けられる鞍状形部品を含む、人工装具アセンブリ。
(項目11)
上記人工関節面のうち少なくとも一つが、ネジもその他の留め具も用いることのない確実な固定手段を提供するスナップ式および/または連結式での組み立て手段を含む、項目10に記載の人工装具アセンブリ。
(項目12)
上記人工関節面のうち少なくとも一つが、プラスチック関節面の取り付けに適応する、項目10に記載の人工装具アセンブリ。
(項目13)
上記プラスチック関節面が超高分子量ポリエチレンを含む、項目12に記載の人工装具アセンブリ。
(項目14)
第一の骨に結合される第一の人工関節面と、第二の骨に結合される第二の人工関節面とを含む人工装具アセンブリであって、上記第一および第二の人工関節は、人工関節を形成するように関節運動し、上記人工関節面のうち少なくとも一つが、ネジもその他の留め具も用いることのない確実な固定手段を提供するスナップ式および/または連結式での組み立て手段を含む、人工装具アセンブリ。
(項目15)
上記人工関節面のうち少なくとも一つがプラスチック関節面の取り付けに適応する、項目14に記載の人工装具アセンブリ。
(項目16)
上記プラスチック関節面が超高分子量ポリエチレンを含む、項目15に記載の人工装具アセンブリ。
(項目17)
足底部の切開部を介する踵骨を介するアクセスによって、脛骨の主軸に対して構築される骨髄内ガイダンスを用いて取り付けられる足関節置換システム。
(項目18)
脛骨の主軸に対して骨髄内ガイダンスをX線透視可視化を用いて構築するための手段を含む、項目17に記載の足関節置換システム。
(項目19)
骨の切り込みを作製するための手段を含む項目17に記載の足関節置換システム。
(項目20)
踵骨、距骨、および脛骨内を通るインライン骨髄内経路を構築するステップを含む方法。
(発明の概要)
本発明は整形外科用人工装具およびシステム、ならびに関連する手術器具および手技を提供する。
この説明は、開示の簡便性のために論理的セクションに分けられる。セクションIは、後述する足関節全置換システムと方法の解剖学的背景を示すために、読者を下肢および足関節の解剖学に案内する。セクションIIは、足関節全置換システムの脛骨および距骨−踵骨部品と望ましい形状、はめ合わせ、および機能を持つ器具の代表的な実施形態の構造説明を提供する。セクションIIIは、足関節全置換システムの埋め込みに有用なシステム、方法、および技法と、望ましい形状、はめ合わせ、および機能を達成するための器具の代表的な実施形態の説明を提供する。
図1に示すように、足部は中足骨13と結合する14本の指骨すなわち足の指の骨11を含む。距骨15が脛骨16と腓骨18を支える、7本の足根骨14、ならびにかかとの骨すなわち踵骨17も存在する。足根骨の中で、距骨15と踵骨17は最も大きく互いに隣接している。その他の足根骨は舟状骨19、3本の楔状骨21、および立方骨23を含む。
(A.概略)
図2は足関節全置換システム10を示す。一般的に言えば、システム10は脛骨16への取り付けのために大きさと構造が決定される脛骨の土台12を含む。また図2に示すように、脛骨の土台12は望ましくは脛骨の幹28を含む。このシステムはまた距骨15への取り付けのために大きさと構造が決定される距骨の土台20を含む。また図2に示すように、距骨の土台20は距骨の幹26を含む。
脛骨の土台12、距骨の土台20、および/またはそれらが持つ関節運動する人工関節面22と24は様々に構成されてもよく、様々な技術的特徴を有する。構造と特徴の代表的な例をここに説明する。
(a.距骨の幹)
距骨の幹26は様々に大きさと構造が決定されてもよい。図2に示すように、幹26は距骨を踵骨に橋渡しする。この幹26は、もしそれが患者にとって必要または有益なものならば、距骨下関節の固定とともに距骨の土台を支える二重機能を提供する。
距骨の幹26のように、脛骨の幹28は、関節置換材料または人工装具技術に一般的に用いられる材料であればどのようなものから作られても良く、これは金属、セラミック、チタン、チタン合金、タンタル、クロムコバルト、外科用スチール、ポリエチレン、吸収性ポリマー、またはその他の関節全置換金属および/またはセラミック、骨内部成長面、焼結ガラス、人工骨、セメントで結合されていない金属または陶材面、またはそれらの組み合わせを含むがこれに限定されるものではない。脛骨の幹28はさらに、一つ以上の抗菌剤、抗血栓剤、および骨誘導剤、またはそれらの組み合わせなどのコーティングで塗装されても良い。これらの薬剤はさらに、脛骨の幹28の孔を充満するかもしれない生分解性担体材料に含まれても良い。米国特許第5,947,893号を参照されたい。
図4Aは、それが関節インプラント、固定(関節固定術)インプラント、骨切り術固定インプラント、または骨折固定インプラントのどれであれ、インプラントの固定に幹を必要とする外科手技での使用に適するマルチピース脛骨の幹30を図解するものである。図で示した実施形態では、幹30は、先端(すなわち上部)部品32、一つ以上の中間部品34、および底部(すなわち下部)部品36を含む。幹30の骨内の先端部品32の方向への進展を容易にするために、先端部品30は望ましくは凸形またはドーム形である。
関節運動する人工関節面22と24は、プラスチック(例えばポリエチレン)、セラミック、または金属またはその組み合わせ(例えば金属で裏打ちしたプラスチック)で作られ得る。それらは様々な構造を有し、様々な方法で関節運動し得る。多種の代表的な実施形態を説明のためにここで記述する。
図5に示すように、関節運動する面22と24の基本的な配置は玉継手を形成できる。この配置では、関節運動する面22と24は嵌合する凹状と凸状面を含む。ある配置では、脛骨の人工関節面22は凹状半球体を含み、距骨の人工関節面24は、取り付けられた時凹状半球体と結合する凸状半球体を含む。これは、それらが置換する自家の関節面の構造を模倣する。
図6は、関節運動する面22と24が関節運動するだけでなく人工関節が脛骨の軸の周囲を回転できるようにする相補的な玉継ぎ手面を含む実施形態を図解する。これにより人工装具の機能と寿命を最大限にするために、より一様な面22と24の磨耗が可能になる。
図7A、7B、および7Cは関節運動する面22と24が関節運動し、脛骨の軸の周囲を回転するだけでなく、嵌合する関節面の脛骨に対する前方、後方、および側方への移動に適応する相補的な玉継ぎ手面を含む実施形態を図解する。
先の実施形態は基本的な関節運動配置として、玉継手を示す。図8Aでは、関節運動する脛骨と距骨の面22と24がそれぞれ鞍状形部品を含むように示される。鞍状形は幾何学的に(好適な実施形態で一定半径である)掃過された弧として特徴付けられ、第一の弧(好適な実施形態で一定半径である)に対して垂直な第二の弧(これもまた好適な実施形態で一定半径である)に沿って掃過される第一の弧によって画定される面を含む。外形は各面22と24に対して、軸に沿って曲線を描く細長い溝を形成する。
スナップ式アセンブリもまた脛骨の部品の中に組み込まれてもよい。図13に示すように、脛骨の土台12は、前述し、図4Aに示したようにマルチピース幹を含むように示される脛骨の幹30を含む。この実施形態では、脛骨の土台12と幹30は望ましくは金属部品を含む。
(A.骨髄内ガイダンス)
望ましくは、足関節置換システム10は低侵襲骨髄内ガイダンスを用いて取り付けられる。骨髄内ガイダンスは脛骨の主軸に対して踵骨を介した低侵襲アクセスによって、足底部の切開を介して構築される。脛骨の軸に沿った骨髄内ガイダンスは、足関節への前方アクセスを介した適切に方向付けられた距骨15と脛骨16の骨の切り込みを可能にする。足関節全システム10の適切な全体配置と長期的結果の向上が達成される。
足関節置換手順での固定を含む手順(例えば、距骨下関節の固定、全距骨固定、または三重関節固定術)とともに、足関節置換手順(すなわち、脛骨と距骨の足関節面のいずれかまたは両方のための人工装具置換の取り付け)での使用に申し分なく適した代表的な取り付け器具、システム、および手法を記述する。
図19は人工装具の取り付け手順の際に足関節と脛骨との位置合わせ作業に使用される代表的な位置合わせ工具100を示す。位置合わせ工具100は足支えアセンブリ102と脚支え104を含む。足支えアセンブリ102は、人工装具の取り付け手順の際に足留め106と踵留め108によって足が固定される足支え106を含む。脚部のふくらはぎは脚支え104に適切に固定される。足支えアセンブリ102と脚支え104はともに、取り付け手順の際に脚部に対して足と足関節を保定する。
図24は踵骨、距骨、および脛骨内を通るインライン骨髄内経路の構築作業に使用される代表的な器具132と手技を示す。器具132は脛骨の中につながる踵骨と距骨を通る骨髄内ガイド経路を構築する足底カニューレ134を含む。
図25A、25B、25Cおよび図26は脛骨と距骨の土台12と20を取り付けるために距骨と脛骨に骨の切り込みを作製する目的で足関節への前方アクセスを構築するために使用される代表的な器具138と手技を示す。
図で示した実施形態では、脛骨と距骨の土台12と20はともに、個別の幹部品を含む。先に述べたように、これらの幹部品は土台に高い固定性と支持性を提供する。これらの幹部品の脛骨と距骨への取り付けのための通路の作製をここで記述する。
図27Aと27Bは空になった関節腔158を介する前方アクセスを利用して脛骨の土台12の幹部品が取り付けられる脛骨内部の骨髄内経路の構築の目的に使用される代表的な器具160と手技を示す。
図28Aから28Dは距骨と踵骨を橋渡しする距骨−踵骨経路構築の目的に使用される代表的な器具166と手技を示す。距骨の土台20幹部品は距骨−踵骨経路に取り付けることができる。器具166と手技は先に空になった関節腔158を介する前方アクセスによって作動する。
図29Aから29Dおよび図30は脛骨の幹30と土台12を取り付ける目的に使用される代表的な器具184と手技を示す。
前述のように、図28Aから28Eは距骨の土台20の幹部品26が取り付けられる距骨と踵骨を橋渡しする経路Pを構築する目的に使用される代表的な器具166と手技を示す(図28E参照)。図31は踵骨の幹部品31の経路Pへの取り付けを示す。
医師は次に採寸ブロック(図示せず)を用いて最適な脛骨の人工関節面22を決定する。
図34と35は今しがた記述した形状、はめ合い、および機能の様々な治具、固定具、リーマー、補助土台が堅くならびに簡単に取り付けられてもよい代表的なメイン取り付け土台212を示す。これらの冶具、固定具、リーマー、および補助土台は記述したような一連の作業を達成するための形状、はめ合い、および機能をもち、一連の作業には(1)足関節と脛骨の位置合わせ、(2)踵骨、距骨、および脛骨内を通るインライン骨髄内経路の構築、(3)脛骨と距骨の土台12と20を取り付けるための、距骨と脛骨内に適切に方向付けられた骨の切り込みを作製する目的のための前方アクセスの構築、ならびに(4)脛骨と距骨の土台12と20の取り付けが含まれる。遮るもののない足関節への外科的アクセスを可能にするため、これらの冶具、固定具、リーマー、および補助土台は好ましくは要望に応じて取り外し可能である。メイン取り付け土台212は、一部の部品では使い捨てが許容されているものの、望ましくは再使用のための洗浄と滅菌を容易にするように設計される。
必要ならばまたは望ましければ、記述した器具および手法は人工装具の簡便な置換を提供する。
(1)それが関節インプラント、固定(関節固定術)インプラント、骨切り術固定インプラント、または骨折固定インプラントのいずれであろうと、インプラントの固定に幹が必要とされる全ての外科手技での使用に適しているマルチピース幹部品(例えば図4A参照)。このマルチピース幹部品構造は、大きい部品を取り付けるために小さな外科的開口部を使用する低侵襲手技において骨の成分同士を固定するのに申し分なく適している。二つ以上の小さな幹部品は、大きな幹部品を作るためにお互い連続してインサイチュで(図4B参照)取り付けることができる。マルチピース幹部品の取り付けのための代表的な器具や手順を図29Aから29Dに示す。
Claims (4)
- 足関節と脛骨とを位置合わせするための位置合わせ工具であって、
垂直状態から実質的に水平な状態へと旋回するように大きさと構造が決定された足支えアセンブリを備え、
該足支えアセンブリは、
足留めおよび踵留めを備える足支えであって、該足支えを通る1対の溝を規定する、足支えと、
該足支えに垂直方向に滑るように固定される中間板であって、該中間板は、該中間板の第一の面から延びる第一の対の位置合わせ棒を備え、該第一の対の位置合わせ棒は、中央−側方平面において脛骨の両側に配置されるように、該中間板において大きさと構造が決定され、該第一の対の位置合わせ棒は、該足支えの該1対の溝を通って伸びるように大きさと構造が決定され、該中間板の垂直移動は、該1対の溝の中で垂直に該第一の対の位置合わせ棒を移動させる、中間板と、
該中間板に水平方向に滑るように固定される裏板であって、該裏板は、前方−後方平面において脛骨の両側に配置されるように大きさと構造が決定されている第二の対の位置合わせ棒を備える、裏板と、
該第一の対の位置合わせ棒により規定される中央−側方平面と、該第二の対の位置合わせ棒により規定される前方−後方平面との間の交差点において、該裏板に配置されている軸受筒であって、該軸受筒は、該中間板および該足支えの開口を通って伸びるように大きさと構造が決定されている、軸受筒と
を備え、
該軸受筒は、該足支えに対する該裏板の水平移動によって該第二の対の位置合わせ棒を水平方向に移動させ、該第一の対の位置合わせ棒と該第二の対の位置合わせ棒とは、X線透視法を用いた場合に可視化され得る材料から形成されている、
位置合わせ工具。 - 前記足支えアセンブリ内に足が配置される場合に脚部のふくらはぎを支持するように大きさと構造が決定された脚支えをさらに備える、請求項1に記載の位置合わせ工具。
- 前記中間板と前記足支えとが、蟻形固定により滑るように固定されている、請求項1に記載の位置合わせ工具。
- 前記中間板と前記裏板とが、蟻形固定により滑るように固定されている、請求項1に記載の位置合わせ工具。
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2006
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JP2014131738A (ja) * | 2012-12-27 | 2014-07-17 | Wright Medical Technology Inc | 人工足首関節置換のシステム及び方法 |
USD1013876S1 (en) | 2020-01-08 | 2024-02-06 | Restor3D, Inc. | Osteotomy wedge |
USD1013875S1 (en) | 2020-01-08 | 2024-02-06 | Restor3D, Inc. | Spinal implant |
US11806028B1 (en) | 2022-10-04 | 2023-11-07 | Restor3D, Inc. | Surgical guides and processes for producing and using the same |
US12042159B1 (en) | 2022-10-04 | 2024-07-23 | Restor3D, Inc. | Surgical guides and processes for producing and using the same |
US11960266B1 (en) | 2023-08-23 | 2024-04-16 | Restor3D, Inc. | Patient-specific medical devices and additive manufacturing processes for producing the same |
Also Published As
Publication number | Publication date |
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WO2006099270A2 (en) | 2006-09-21 |
JP4852596B2 (ja) | 2012-01-11 |
CA2601090A1 (en) | 2006-09-21 |
US11446152B2 (en) | 2022-09-20 |
AU2006223238A1 (en) | 2006-09-21 |
EP1861047B1 (en) | 2017-05-31 |
US20170189198A1 (en) | 2017-07-06 |
US20060229730A1 (en) | 2006-10-12 |
CA2601090C (en) | 2013-08-20 |
US7534246B2 (en) | 2009-05-19 |
EP1861047A4 (en) | 2013-06-19 |
EP1861047A2 (en) | 2007-12-05 |
WO2006099270A3 (en) | 2008-05-02 |
US9629726B2 (en) | 2017-04-25 |
US20220387181A1 (en) | 2022-12-08 |
JP2009148597A (ja) | 2009-07-09 |
US20090182433A1 (en) | 2009-07-16 |
JP2008537689A (ja) | 2008-09-25 |
US20140296995A1 (en) | 2014-10-02 |
AU2006223238B2 (en) | 2011-09-29 |
US8715362B2 (en) | 2014-05-06 |
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