JP5753075B2 - 半月板の人工器官及びこれに関連する方法 - Google Patents
半月板の人工器官及びこれに関連する方法 Download PDFInfo
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- JP5753075B2 JP5753075B2 JP2011504147A JP2011504147A JP5753075B2 JP 5753075 B2 JP5753075 B2 JP 5753075B2 JP 2011504147 A JP2011504147 A JP 2011504147A JP 2011504147 A JP2011504147 A JP 2011504147A JP 5753075 B2 JP5753075 B2 JP 5753075B2
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- prosthesis
- meniscus
- tibia
- body portion
- knee joint
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
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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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Landscapes
- Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
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- Vascular Medicine (AREA)
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- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Description
本開示の一つの態様に従った人口器官100が本明細書に示した図1、2、3、4、5、6、7、8、9及び10において参照される。特に図1は、人口器官100の斜視図である。図2は、当該人口器官100の上面図である。図3、4、5、6、7及び8は、当該人口器官100の断面図である。図3は、図2の切断線3−3に沿った当該人口器官100の断面図である。図4は、図3の切断線4−4に沿った当該人口器官100の断面図である。図5は、別の人口器官102と比較した本願人口器官100の断面図である。より具体的に、図5は、図2の断面線4−4に沿った人口器官100の断面面を、対応する切断線に沿った別の人口器官102の断面図と比較して示した図である。図6は図2の切断線6−6に沿った当該人口器官100の断面図である。図7は、図2の切断線7−7に沿った人口器官100の断面図である。図8は、図5と同様に、別の人口器官102と比較した人口器官100の比較断面図であるが、異なる切断線に沿った断面図である。より具体的に、図8は、図2の切断線8−8に沿った人口器官100の断面図であり、対応する切断線に沿った別の人口器官102の断面図と比較して示した図である。図9aは、大腿骨と脛骨との間に配置した図1及び図2の人口器官の挿入構造の断面図である。図9bは、大腿骨104と脛骨106の間に配置した張力をかける前の無荷重状態の人口器官100のダイアグラム断面図である。図10は、図9bと同様に大腿骨104と脛骨106の間に配置し、人口器官100に重力負荷をかけた状態の人口器官100の断面図である。
予め張力をかけた器官において、人工器官100と大腿骨との接触は、外側本体部108で最初に生じる。これは、重量が大腿骨を通じて人工器官に移動し、且つ外側本体部108を外側におし進めるにつれて、人工器官の中央本体部110を伸ばすことになる。外側本体部108の係合角度は、前記器官100に印加される圧縮力が少なくとも部分的に前記強化用繊維に移されるようになる。いくつかの場合には、前記外側本体部108は外側に強いられ、前記中央本体部110は、単に前記外側本体部を圧縮する大腿骨よりも、大腿骨を介して適用される重量に伸びる。前記中央本体部110および上下の関節面116、118のこの伸張は、前記人工器官100に作用する平均およびピークの荷重圧力を下げるのに加えて、前記人工器官と大腿骨と脛骨との間に接触領域を増加させる(例えば、図9bおよび10の間の移行を参照)。
一部の実施形態において、人工器官は、利用可能な人工器官の有限のライブラリ又はカタログから患者用に選択される。この点において、前記利用可能な人工器官は、多様なサイズ、多様な材質、及び/若しくは多様な形状のものである。一部の場合において、選定方法論が、患者の外科的特徴を基にした患者用の1若しくはそれ以上の適した人工器官及び/若しくは最適な人工器官を特定するために適用される。他の場合において、カスタムの人工器官が、患者の外科的特徴を基にして患者用に、特別に設計され、且つ制作される。患者用の適した人工器官を特定する特別な方法を開示する。本明細書に開示される方法は、患者用の適した人工器官を特定する目的で、個別に、互いに組み合わせて、及び/若しくは他の方法と組み合わせて使用され得ることが認識される。
構成される。この点について、一部の実施形態において、この有限要素モデルは自然の半月板を含まない。さらに、一部の場合において、患者の健全な膝関節の有限要素モデルは、損傷した膝関節における人工器官の効果の評価において使用するために作られる。
ここで図24を参照する。図24には、本開示の一態様に応じる外科的プロトコル320のブロック図が示されている。一般的に、外科的プロトコル320は、患者の膝関節への人工器官に関するものである。具体的な説明の実施形態では、外科的プロトコル320は、内側半月を置換するための外科的デバイスの移植に関するものである。他の実施形態では、同様の外科的プロトコルは、外科的デバイスと外側半月を置換するために利用されている。一部の場合において、外科手術で補綴具と外側及び内側半月両方を置換する。
移植された人工器官の固定的咬合をさせるのに手術的準備をされることがある。上記の方法のその他の変更は、本開示の範囲から逸脱することなく、当業者にとって明らかであろう。
芳香族ポリウレタンは、影響を受けやすい化学群を減らしている点において、従来のポリウレタンを改善している。Elast−Eon(商標)2、シロキサン系マクロジオール、芳香族ポリウレタンは、ソフトセグメントにシロキサンを組み込んでいる。Elast−Eon(商標)3、シロキサン系マクロジオール、変性ハードセグメント、芳香族ポリウレタンは、ハードセグメントにシロキサンを組み込むためにさらに柔軟性を高めるElast−Eon2の変形である。Elast−Eon(商標)4は、変性芳香族ハードセグメントポリウレタンである。
本発明の人工器官は、典型的な適用が「在庫」単位で満たされるように、様々なサイズで製造されていることがある。したがって、外科医は、注入処理中に在庫単位の中から適切なサイズのデバイスを選択することができる。また、別の実施形態では、交換する半月板は、コンピュータ支援製造(CAM)技術と相まったMRIのような医療用画像処理技術によって決定された患者の特性を生かすため、カスタム製造されている。
Claims (20)
- 損傷した半月板に置き換わる人工器官であって、
大腿骨の一部とかみ合う凹型の上側表面と、これに対向し、脛骨の一部とかみ合う部分的に凹型の下側表面とを有する中央部分であって、前記中央部分は約1MPa〜約10MPaの弾性係数を有する柔軟性の弾性ポリマー材質を有し、前記中央部分は前記上側表面と前記下側表面との間に約3mm未満の最小の厚みを有するものである、前記中央部分と、
前記中央部分を覆い、該中央部分と関連して厚さが増加する外側部分であって、弾性ポリマー材質から成り、該弾性ポリマー材質に組み込まれる少なくとも1の強化繊維によって張力がかかるものである、外側部分と
を有し、
前記外側部分は大腿骨と脛骨によって人工器官に加わる圧縮力によって前記中央部分から外側に放射状に移動するような大きさ及び形状を有するものであり、
前記外側部分は、さらに、前記人工器官が前記大腿骨と前記脛骨とのいずれかに強固に固定されることなく前記大腿骨と前記脛骨との間の膝関節内に移植できるように構成され、且つ前記人工器官が前記大腿骨と前記脛骨とのいずれかに強固に固定されることなく前記膝関節内に移植された場合に、前記外側部分が前記膝関節からの前記人工器官の望まれない排除を防ぐような大きさ及び形状を有するものである、人工器官。 - 前記少なくとも1の強化繊維が、約5N〜約78Nの力の張力を受けるものである、請求項1に記載の人工器官。
- 前記少なくとも1の強化繊維が、前記少なくとも1の強化繊維における最大張力の約8%〜約12%の力で張力を受けるものである、請求項1に記載の人工器官。
- 前記少なくとも1の強化繊維が前記外側部分内で前記中央部分の周囲に完全に伸びているものである、請求項1に記載の人工器官。
- 前記中央部分が、前記圧縮力によって前記外側部分が外側に放射状に移動するにつれて伸びるものである、請求項1に記載の人工器官。
- 前記大腿骨の一部と前記中央部分の上側表面との間の接触領域が、前記中央部分の伸縮により増加しているものであり、
前記脛骨の一部と前記中央部分の下側表面との間の接触領域が、前記中央部分の伸縮により増加しているものである、請求項5に記載の人工器官。 - 前記弾性ポリマー材質が、医療グレードのポリウレタンベースの材質である、請求項1に記載の人工器官。
- 前記弾性ポリマー材質が、ポリカーボネートポリウレタンである、請求項7に記載の人工器官。
- 少なくとも1の組み込まれた繊維が、超高分子量のポリエチレンを含むものである、請求項8に記載の人工器官。
- 前記外側部分が、天然の半月板と同様に半楕円形状の輪郭を有する第一のセクションを含むものである、請求項1に記載の人工器官。
- 前記外側部分が、該外側部分の前記第一のセクションの第一及び第二の末端を接続するブリッジ部分を含み、前記ブリッジ部分が、大腿骨の切れ込みとかみ合う大きさとされるものである、請求項10に記載の人工器官。
- 前記ブリッジ部分が、前記第一のセクションの第一の末端に隣接する第一の領域と、前記第一のセクションの第二の末端に隣接する第二の領域と、前記第一及び第二の領域の間に位置する第三の領域とを有し、当該第三の領域は前記第一のセクションの第一及び第二の末端から分離されているものであり、凹形断面を規定する前記ブリッジ部分の内側表面の容積は前記第一、第二、及び第三の領域でそれぞれ異なるものである、請求項11に記載の人工器官。
- 前記ブリッジ部分の前記内側表面の凹形断面が、略前方の前記第一の領域において約5mm〜約70mmの冠状面に平行な断面における第一の曲率半径と、略後方の前記第二の領域において約5mm〜約50mmの冠状面に平行な断面における第二の曲率半径と、及び略中央の前記第三の領域において約8mm〜約30mmの冠状面に平行な断面における第三の曲率半径とを有するものである、請求項12に記載の人工器官。
- 前記ブリッジ部分の前記内側表面の凹形断面が、略前方の前記第一の領域において約10mm〜約100mmの矢状面に平行な断面における第一の曲率半径と、略後方の前記第二の領域において約5mm〜約70mmの矢状面に平行な断面における第二の曲率半径とを有するものである、請求項13に記載の人工器官。
- 前記外側部分の増加した厚さが約4mm〜約15mmである、請求項1に記載の人工器官。
- 半月板の人工器官を製造する方法であって、
凹型の上側表面、当該上側表面に対向する部分的に凹型の下側表面、及び前記上側表面と下側表面との間に配置され、複数の凹部を有する外側表面、を有するコアを射出成形する工程と、
強化繊維を、前記外側表面の前記複数の凹部の少なくとも1つに巻き付ける工程と、
前記強化繊維を固定するために、前記外側表面及び前記強化繊維の周囲に外側部分を射出成形する工程と
を含み、前記人工器官は前記上側表面と前記下側表面とを有する中央部分を有し、前記中央部分は約1MPa〜約10MPaの弾性係数を有する柔軟性の弾性ポリマー材質を有し、前記中央部分は前記上側表面と前記下側表面との間に約3mm未満の最小の厚みを有するものであり、
前記外側部分は前記中央部分を覆い、前記中央部分と関連して厚さが増加し、弾性ポリマー材質から成り、前記弾性ポリマー材質に組み込まれる少なくとも1の強化繊維によって張力がかかるものであり、
前記外側部分は大腿骨と脛骨によって人工器官に加わる圧縮力によって前記中央部分から外側に放射状に移動するような大きさ及び形状を有するものであり、
前記外側部分は、さらに、前記人工器官が前記大腿骨と前記脛骨とのいずれかに強固に固定されることなく前記大腿骨と前記脛骨との間の膝関節内に移植できるように構成され、且つ前記人工器官が前記大腿骨と前記脛骨とのいずれかに強固に固定されることなく前記膝関節内に移植された場合に、前記外側部分が前記膝関節からの前記人工器官の望まれない排除を防ぐような大きさ及び形状を有するものである、方法。 - 前記コアを射出成形する工程が、ポリカーボネートポリウレタンを射出成形することを含み、及び、
前記強化繊維を巻き付ける工程が、超高分子量のポリエチレン繊維を巻き付けることを含む、請求項16に記載の方法。 - 請求項16に記載の方法であって、この方法は、さらに、
前記外側部分が射出成形される直前に、前記コアの温度を約100℃に加熱する工程を含むものである、方法。 - 請求項16に記載の方法であって、この方法は、さらに、
前記外側部分が射出される鋳型を、前記外側部分が射出成形された直後に冷却する工程を含むものである、方法。 - 請求項16に記載の方法であって、この方法は、さらに、
前記コアを射出成形した後に、前記複数の凹部を形成しているインサートを除去する工程を含むものである、方法。
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US12/100,090 US7611653B1 (en) | 2008-04-09 | 2008-04-09 | Manufacturing and material processing for prosthetic devices |
US12/100,115 | 2008-04-09 | ||
US12/100,059 US8016884B2 (en) | 2008-04-09 | 2008-04-09 | Tensioned meniscus prosthetic devices and associated methods |
US12/100,115 US7991599B2 (en) | 2008-04-09 | 2008-04-09 | Meniscus prosthetic device selection and implantation methods |
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