JP2005515810A - 間置関節形成システム及び方法 - Google Patents
間置関節形成システム及び方法 Download PDFInfo
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- JP2005515810A JP2005515810A JP2003561468A JP2003561468A JP2005515810A JP 2005515810 A JP2005515810 A JP 2005515810A JP 2003561468 A JP2003561468 A JP 2003561468A JP 2003561468 A JP2003561468 A JP 2003561468A JP 2005515810 A JP2005515810 A JP 2005515810A
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Abstract
Description
本出願は、2001年1月22日に提出され米国特許出願番号第60/349,367号を与えられた米国特許仮出願の一部継続であり、かつ2002年3月15日に提出され米国特許出願第10/098,601号を与えられた米国特許出願の一部継続である2002年4月12日に提出され米国特許出願第10/121,455号を与えられた米国特許出願の一部継続である2002年6月12日に提出され米国特許出願第10/167,372号を与えられた米国特許出願の一部継続であり、その各々の開示全体が参照により本明細書に組み込まれる。
1)構成要素を挿入し任意に該当部位において最終的に形成できるように、少なくとも部分的にまた任意に完全に体外で成形される1つまたはそれ以上の構成要素
2)例えば重ねてまたは連結して該当部位において組み立てるのに適する複数の予備形成構成要素
3)挿入して関節部位内に配置するのに適する挿入可能な開放型(例えば受け皿形)モールドであり、流動性の生体適合物質がモールドと接触してまた(または)結合して硬化して最終プロテーゼを形成できるようにする条件の下で、該当部位の開放型モールドまで送り込まれるのに適する流動性の生体適合物質と組み合わせて使用されるもの
4)該当部位に配置され該当部位において該当の硬化性生体適合物質を充填されるのに適する1つまたはそれ以上の一般に伸張性のエンベロープ型(例えば、バルーン・タイプ)のモールドであり、モールドのうち1つまたはそれ以上が一般に非伸張性の予備形成材料の1つまたはそれ以上の領域を与える。例えば、1つの実施態様においては、この種の複数のエンベロープ部(例えば2区画の単一エンベロープ)をそれぞれ脛骨内側面及び脛骨外側面の両方に使用するのに適するものにすることができる。
a)スペーサとして、
b)緩衝材として、
c)(病変表面に比べて)改良された摩擦係数を持つ表面として、及び(または)
d)(病変状態に比べて)体重負荷面積を増大し、関節表面の相合性を向上させるため、に機能する。
1.部分A及びBを含む二部システムから成る組成であり、混合すると重合して、ポリジメチルシロキサン(PDMS)などポリシロキサンを含むソフト・セグメント及びMDI、PPDI、水素化MDI(Bayer社のDesmadur W)、ヘキサメチレン・ジイソシアネート(HDI)またはそれらの組み合わせから選択される異性体を含めてジイソシアネートまたはポリイソシアネートと低分子量ジオール、低分子量トリオール、トリアミン及び多官能価アミンまたはそれらの組み合わせから成るグループから選択される連鎖延長剤との反応生成物として形成されるハード・セグメントになる。
2.二部システムから成る組成であり、1つの部分(部分A)はカルビノール停止反応PDMSオリゴマー(例えば製品“KF6001からKF6003“までとしてShin-etsu Chemical Co.が市販するもの、または製品”DMS-C15“としてGellest,Inc.が市販するもの)とジイソシアネートまたは異なる性質のジイソシアネート及び(または)ポリイソシアネートの混合物との反応生成物として調製されるNCO停止反応プリポリマーを含む。
3.二部システムから成る組成であり、1つの部分(部分A)が、1つまたはそれ以上のカルビノール停止反応PDMSオリゴマーと共に1つまたはそれ以上のジイソシアネート及び(または)ポリイソシアネートと、OHまたはアミノ官能性を有する1つまたはそれ以上のオリゴマー(例えばPTMO)との反応生成物として形成されるプリポリマーであり、該当のカルビノール停止反応PDMSオリゴマーより溶解パラメータが大きい(すなわち、極性が大きい)が、部分Bに使用されるイソシアネートと連鎖延長剤の反応生成物の溶解パラメータより小さい(すなわち極性が小さい)。
4.上記の3の組成の例として、組成は、1つの部分(部分A)が1つまたはそれ以上のカルビノール停止反応PDMDオリゴマーと共に1つまたはそれ以上のジイソシアネート及び(またはポリイソシアネート)と1つまたはそれ以上のOH停止反応水素化ポリブタジエン・オリゴマーとの反応生成物として形成されるプリポリマーである二部システムから成る。
5.3の組成の別の例として、組成は、1つの部分(部分A)が、1つまたはそれ以上ジイソシアネート及び(または)ポリイソシアネート、1つまたはそれ以上のカルビノール停止反応PDMSオリゴマー、1つまたはそれ以上のOH停止反応水素化ポリブタジエン・オリゴマー及びポリテトラメチレン・オキシド・ジオール(PTMO)など1つまたはそれ以上のOH停止反応ポリエーテル・オリゴマーの反応生成物として形成されるプリポリマーである、二部システムから成る。特定の実施態様においては、部分Aを形成するために使用される成分の量及び比率は、光学的に透明なプリポリマーに安定性を与えるように調整される。
6.本明細書において説明される組成に関して、部分Aは、プリポリマーの全てまたはその一部がタイプXYXZXであるように調製することができる。ここで、Xはジイソシアネート及び(または)ポリイソシアネート成分であり、Yは比較的非極性のマクロジオール成分(PDMSバックボーンを持つものなど)であり、Zはより極性の大きいポリオール成分(PTMOまたはポリヘキサメチレン・カーボネートのバックボーンを持つマクロジオールなど)である。
Claims (45)
- 哺乳類の体内において整形関節を生成または修正するためのシステムであり、該システムが、支持骨に並置される少なくとも1つの主要な面及び相対する骨に並置される少なくとも1つの第二の主要な面を有するインプラントを提供するために関節部位に挿入し関節部位に配置するように構成された1つまたはそれ以上の部分的または全面的に予備形成された高分子構成要素を含み、
該システムにおいて、前記インプラントが、膝インプラントであり、膝の脛骨表面に配置されるように構成され、これに相合する第一の主要な面、及び膝の大腿顆に接して配置されるように構成された第二の主要な面を用意し、
かつ、該システムにおいて、前記第二の主要な面が該当部位におけるその性能を助長するために大腿骨滑り路を備え、前記滑り路がほぼ中央の窪み形状を有し、
前記インプラントが、該当部位における固定を改良するために脛骨プラトーの縁を越えて遠位方向に延びるように構成された1つまたはそれ以上の脛骨用突起をさらに備える、
システム。 - 前記高分子構成要素が、体外モールドにおいて部分的または完全に硬化される生体適合物質からなる単一の予備形成構成要素の形で提供される、請求項1に記載のシステム。
- 前記脛骨用突起が脛骨プラトーの縁を越えて遠位方向に延びることによって前記脛骨プラトーの後部を捕捉するように構成され、前記予備成形構成要素の寸法が、前後寸法で約30mmから約60mmまでの間であり、内側−外側寸法が約20mmから約40mmまでの間であり、後部唇の最大厚みが約8mmから約20mmまでの間またはインプラント中央の厚みより約3mmから約10mm大きい、請求項1に記載のシステム。
- 前記インプラントが、前部固定のためにインプラントに組み込まれ部分的にインプラントから延びる少なくとも1つの補助的構成要素をさらに含む、請求項1に記載のシステム。
- 前記補助的構成要素が、固定を改良するために関節部位の軟組織及び(または)骨に取り付けられるように構成された1つまたはそれ以上の突起を備える、請求項4に記載のシステム。
- 前記突起が、体外成形工程中に前記予備形成構成要素に組み込まれるように構成される、請求項5に記載のシステム。
- 前記突起が、前記予備形成構成要素と一体に形成される縫合及び線維生体適合物質の少なくとも一方から成る、請求項6に記載のシステム。
- 接着剤、縫合、ピン、ステープル、ねじ及びそれらの組み合わせから成るグループから選択される、前記インプラントを前記関節部位に固定するための1つまたはそれ以上の別個の構成要素をさらに含む、請求項1に記載のシステム。
- 複数の予備形成構成要素が、手術現場で選択し使用するために対応する複数のまたはある範囲のスタイル及びサイズで用意される、請求項2に記載のシステム。
- 前記高分子構成要素のうち1つまたはそれ以上がポリウレタンから成る、請求項1に記載のシステム。
- 前記ポリウレタンが、ポリイソシアネート、短連鎖及び長連鎖ポリオールから調製され、かつ任意に疎水性添加剤、錫及び(または)アミン触媒及び酸化防止剤から成るグループから選択される1つまたはそれ以上の成分を含む、請求項10に記載のシステム。
- 前記ポリウレタンが、芳香性ポリイソシアネート、PTMO及び短連鎖ジオールから成る、請求項10に記載のシステム。
- 前記疎水性添加剤がヒドロキシル停止反応ポリブタジエンから成り、前記錫及び(または)アミン触媒がイソシアネート-ヒドロキシル反応を優先的に促進するように構成され、UL22、Cotin222、1,4−ジアザアビシクロ[2.2.2]オクタン(dabco)及びジブチル錫ジラウレート(DBTDL)及びそれらの組み合わせから成るグループから選択される、請求項11に記載のシステム。
- 前記ポリウレタンが、芳香性、脂肪族及びアリルアキル・ジイソシアネート及びそれらの組み合わせから成るグループから選択されるイソシアネートから成る、請求項10に記載のシステム。
- 前記イソシアネートが、トルエン・ジイソシアネート、ナフタリン・ジイソシアネート、フェニレン・ジイソシアネート、キシリレン・ジイソシアネート、ジフェニルメタン・ジイソシアネート、シクロヘキサン・ジイソシアネート、シクロヘキシル-ビス・メチレン・ジイソシアネート、イソフォロン・ジイソシアネート及びヘキサメチレン・ジイソシアネートから成るグループから選択される、請求項14に記載のシステム。
- 前記高分子構成要素が、サイトカイン、成長因子、自己成長因子、ヒドロキシアパタイト、コラーゲン及びそれらの組み合わせから成るグループから選択される生物学的に活性の物質が取り付けられている1つまたはそれ以上の表面を有する、請求項1に記載のシステム。
- 前記高分子構成要素の前記表面が、組織接着を促進するために反応性基を与えられまたはそれにより修正される、請求項1に記載のシステム。
- 前記反応性基が、前記高分子構成要素を製造するために使用される重合体によって与えられ、アミン、ヒドロキシ基またはその他の反応性または水素結合官能性から選択される、請求項17に記載のシステム。
- 前記滑り路が、その最も低い点で約0.5mmmから約5mmのまで深さ、約20mmから約50mmまでの長さ、10mmから30mmまでの幅のほぼ中央の卵形の窪み形状を有する、請求項1に記載のシステム。
- 前記構成要素がカップ自体の平面に対して実質的に直交する前部カップ縁及び脛骨棘の対応する形状に合わせてテーパー形である後部近心縁を有するモールドにおいて予備形成される、請求項2に記載のシステム。
- 前記モールドが、サイズ決定、前記関節部位との整合、インプラント厚み及び角度補正を制御できるように構成される、請求項20に記載のシステム。
- 型枠と骨の間に硬化性バイオポリマーを送り込めるようにするために、大腿骨表面に合わせて形成されこれに接して保持されるのに適する膝蓋骨−大腿骨関節型枠をさらに含む、請求項1に記載のシステム。
- 前記高分子構成要素が、体外モールドにおいて部分的または完全に硬化されるポリウレタンから成る単一の予備形成構成要素の形状を有し、かつ、前記予備形成構成要素を含む前記インプラントが、前部固定のために前記インプラントに組み込まれこれから部分的に延びる少なくとも1つの補助的構成要素をさらに含む、請求項1に記載のシステム。
- 前記ポリウレタンが、芳香性、脂肪族及びアリルアキル・ジイソシアネート及びそれらの組み合わせから成るグループから選択されるイソシアネートから成る、請求項23に記載のシステム。
- 前記イソシアネートが、トルエン・ジイソシアネート、ナフタリン・ジイソシアネート、フェニレン・ジイソシアネート、キシリレン・ジイソシアネート、ジフェニルメタン・ジイソシアネート、シクロヘキサン・ジイソシアネート、シクロヘキシル-ビス・メチレン・ジイソシアネート、イソフォロン・ジイソシアネート及びヘキサメチレン・ジイソシアネートから成るグループから選択される、請求項24に記載のシステム。
- 前記高分子構成要素が、サイトカイン、成長因子、自己成長因子、ヒドロキシアパタイト、コラーゲン及びそれらの組み合わせから成るグループから選択される生物学的に活性の物質が取り付けられている1つまたはそれ以上の表面を有する、請求項23に記載のシステム。
- 前記高分子構成要素の前記表面が、組織接着を促進するために反応性基を与えられまたはそれにより修正される、請求項3に記載のシステム。
- 前記滑り路が、その一番低い点で約0.5mmから約5mmまでの深さ、約20mmから約50mmまでの長さ、10mmから約30mmまでの幅のほぼ中央の卵形の窪み形状を有する、請求項3に記載のシステム。
- 前記滑り路が、その一番低い点で約0.5mmから約5mmまでの深さ、約20mmから約50mmまでの長さ、10mmから約30mmまでの幅のほぼ中央の卵形の窪み形状を有する、請求項15に記載のシステム。
- 前記生体適合物質がポリウレタンから成り、前記滑り路が、その一番低い点で約0.5mmから約5mmまでの深さ、約20mmから約50mmまでの長さ、10mmから約30mmまでの幅のほぼ中央の卵形の窪み形状を有する、請求項23に記載のシステム。
- 哺乳類の体内の整形関節の磨耗面を生成または修正するためのシステムであり、該システムが、支持骨に並置される少なくとも1つの主要な面及び相対する骨に並置される少なくとも1つの第二の主要な面を有するインプラントを提供するために、関節部位に挿入し関節部位に配置するのに適する1つまたはそれ以上の部分的または全面的に予備形成された高分子構成要素を含む、システム。
- 前記高分子構成要素のうち1つまたはそれ以上が、自然の関節窩を再確立したら整形関節部位の相対する骨表面と整合するように埋植された構成要素が最終的に形成されるように構成された条件の下で、体内に挿入され配置されるように構成された埋植可能な構成要素を提供するために、体外成形によって少なくとも部分的に硬化され部分的に形成されるように構成された硬化性重合体系を使用することによって、使用時に形成される、請求項31に記載のシステム。
- 前記高分子構成要素が、前記整形関節部位の前記相対する骨表面と整合する表面を有する最終プロテーゼを提供するために最小限に侵襲的に前記整形関節部位で組み立てられるように構成された複数の包装された予備形成構成要素を含む、請求項31に記載のシステム。
- 前記関節部位における前記構成要素の保持及びはめ合いを改良するために充分な方法で前記部分的に予備形成された構成要素に粗面加工、パターン加工及び(または)凸凹加工の表面を与えるように構成された成形表面を有する体外モールドをさらに含む、請求項31に記載のシステム。
- 前記モールドが、前記関節部位に形成された前記構成要素を固定するために前記予備形成構成要素に組み込まれるように構成された補助的手段をさらに与える、請求項34に記載のシステム。
- 前記補助的手段が、固定を改良するために前記関節部位の軟組織及び(または)骨に取り付けられるように構成された1つまたはそれ以上の突起を含む、請求項35に記載のシステム。
- 前記凸凹加工の表面が、前記予備形成構成要素と一体で前記体外成形工程中に形成される1つまたはそれ以上の突起を有する輪郭を有する、請求項34に記載のシステム。
- 前記突起が、前記体外成形工程中に前記予備形成構成要素に組み込まれるように構成される、請求項36に記載のシステム。
- 前記突起が、前記構成要素自体と一体的に形成される縫合及び(または)線維生体適合物質から成る、請求項37に記載のシステム。
- モールド自体とは関連せずに、接着剤、縫合、ピン、ステープル、ねじ及びそれらの組み合わせから成るグループから選択される、前記関節部位に前記構成要素を固定するための別個の手段をさらに備える、請求項34に記載のシステム。
- 前記1つまたはそれ以上の予備形成高分子構成要素が、最小限に侵襲的に関節に挿入されるように構成される、請求項31に記載のシステム。
- 前記予備形成構成要素及び(または)対応するモールドが、手術現場で選択し使用するために複数のあるいはある範囲のスタイル及びサイズで用意される、請求項32に記載のシステム。
- 前記インプラントが、膝の脛骨表面に使用するのに適し、大腿顆及び対応する内側脛骨プラトー、外側脛骨プラトーまたはその両方の形状に整合させるように構成された部分を備える、請求項31に記載のシステム。
- 前記高分子構成要素が、ポリウレタン、ポリウレア、ハイドロジェル、ポリシロキサン、ポリアクリレート及びエポキシ及びそれらの組み合わせから成るグループから選択される材料から製造される、請求項31に記載のシステム。
- 前記高分子構成要素がポリウレタンから成る、請求項44に記載のシステム。
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US10/121,455 US20020183850A1 (en) | 2000-08-28 | 2002-04-12 | Method and system for mammalian joint resurfacing |
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2003
- 2003-01-22 JP JP2003561468A patent/JP4324478B2/ja not_active Expired - Fee Related
- 2003-01-22 WO PCT/US2003/002142 patent/WO2003061522A2/en active Application Filing
- 2003-01-22 CA CA002473858A patent/CA2473858A1/en not_active Abandoned
- 2003-01-22 EP EP03703997A patent/EP1474071B1/en not_active Expired - Lifetime
- 2003-01-22 US US10/500,929 patent/US20040247641A1/en not_active Abandoned
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Cited By (3)
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JP2016193218A (ja) * | 2010-03-11 | 2016-11-17 | ジョン オコナー | 部分的又は単顆ベアリング膝関節置換のための人工脛骨コンポーネント、このような人工脛骨コンポーネントの選択方法、このような人工脛骨コンポーネントの埋入方法、および外科医のためのキット |
US10350077B2 (en) | 2010-03-11 | 2019-07-16 | Biomet Limited | Tibial prosthetic component for a partial or unicondylar bearing knee replacement, method of selecting such a tibial prosthetic component, method of implanting such a tibial prosthetic component and a kit for a surgeon |
JP2015512307A (ja) * | 2012-03-30 | 2015-04-27 | ジンマー,インコーポレイティド | 脛骨補綴システム、キット、及び方法 |
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JP4324478B2 (ja) | 2009-09-02 |
WO2003061522A3 (en) | 2003-10-16 |
AU2010200382A1 (en) | 2010-02-25 |
CA2473858A1 (en) | 2003-07-31 |
WO2003061522A9 (en) | 2005-04-28 |
US20040247641A1 (en) | 2004-12-09 |
EP1474071A4 (en) | 2007-08-22 |
EP1474071A2 (en) | 2004-11-10 |
WO2003061522A2 (en) | 2003-07-31 |
EP1474071B1 (en) | 2010-05-19 |
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