JP2013500085A - セラミックおよびポリマー性充填剤に基づく多孔性複合性移植物 - Google Patents
セラミックおよびポリマー性充填剤に基づく多孔性複合性移植物 Download PDFInfo
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- JP2013500085A JP2013500085A JP2012521876A JP2012521876A JP2013500085A JP 2013500085 A JP2013500085 A JP 2013500085A JP 2012521876 A JP2012521876 A JP 2012521876A JP 2012521876 A JP2012521876 A JP 2012521876A JP 2013500085 A JP2013500085 A JP 2013500085A
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Abstract
Description
(Ca)i{(P1−x−y−zBxCyDz)Oj}2:
式中、B、CおよびDは、およそ0.1〜0.4Åのイオン半径を有する元素より選択され;
xは、0より大きいかまたは0に等しいが1未満であり;
yは、0より大きいかまたは0に等しいが1未満であり;
zは、0より大きいかまたは0に等しいが1未満であり;
x+y+zは、0より大きいが1未満であり;
iは、2より大きいかまたは2に等しいが4未満であるかまたは4に等しく;そして
jは4−δに等しい、式中、δは、0より大きいかまたは0に等しいが1未満であるかまたは1に等しい
を有する。
マトリックス26の例示する形式に関して、マトリックス26は、相互連結された複数の空隙を有する有機的な網状の泡(foam)構造から形成されてもよい。より具体的には、1つの形式において、ポリウレタンの泡をフラッシュフレーム処理(flash−flame)して、泡のウェブ中の気体バブル間の薄壁を破裂させそして除去し、孔が閉鎖されているのではなく相互連結されているスポンジを提供する。この形状を有する多孔泡構造は、望ましい場合、商業的に入手可能であるか、または調製可能であり、そして支柱28の通路34の形成を促進する。支柱28が中空でない形式に関しては、マトリックス注入時に、セラミック材料と接触する、ポリマー性球体などの孔形成剤を用いて、マトリックス26を形成し、そして次いで、マトリックスの焼成中に除去してもよい。泡構造にセラミック材料の水性スラリーを含浸して、泡の間膜(ligament)または支柱をコーティングし、そして空隙を実質的に満たす。孔から過剰なスラリーを取り除き、そしてコーティングされた構造を乾燥させて、典型的には緑色体(すなわち非焼成コーティング泡構造)と呼ばれるものを形成する。乾燥は、当業者によって認識されるであろうように、数分から数時間に渡って起こってもよい。スラリーのコーティングが泡構造全体で所望の厚みを達成するまで、このプロセスを反復する。コーティングの典型的な厚みは、約10〜約100ミクロンであってもよい。次いで、コーティングされた構造を加熱して、柔軟な有機性の泡をまず焼き切り、そして次いで焼成し、それによって、マクロ孔30の形式の相互連結された複数の空隙を有する融合セラミック泡を提供する。加熱は、典型的には、約25℃から最大約500℃の温度で行われる。焼成は、典型的には、約900℃〜約1500℃の温度で行われる。温度が加熱温度から焼成温度まで傾斜するようにして、加熱および焼成を続けて行ってもよい。
実施例1
生体吸収性セラミック材料および生物学的に安定なポリマー性材料で形成される多孔性マトリックスを含む複合ブランクであって、そこから例えばデバイス10などの移植物を得られうる前記ブランクを、以下のように調製した。
Claims (33)
- 移植可能医学的デバイスであって:
前記デバイスの外部輪郭(outer profile)を規定する外表面(external surface)を含むボディであって:
各々、中空の内部を含む、相互連結された複数の支柱(strut)によって規定される相互連結された一連のマクロ孔(macropore)を含む多孔性マトリックス;
前記の相互連結された一連のマクロ孔の少なくとも一部を実質的に満たす充填剤(filler material);および
前記外表面の少なくとも一部まで伸長し、そして前記の相互連結された複数の支柱の少なくとも一部の前記の中空の内部と連絡する、複数の開口部
をさらに含む前記ボディ
を含む前記デバイス。 - 前記の相互連結された複数の支柱の、前記の中空の内部が、相互連結され、そして互いに連絡している、請求項1のデバイス。
- 前記の中空の内部が、前記の相互連結された一連のマクロ孔から分離されている、請求項2のデバイス。
- 前記の相互連結された複数の支柱の、前記の中空の内部が、前記の充填剤を実質的に含まない、請求項1のデバイス。
- 前記外表面の前記一部が、前記の複数の開口部、前記多孔性マトリックスの暴露された領域、および前記充填剤の暴露された領域によって規定される、請求項1のデバイス。
- 前記外表面の前記一部が、前記デバイスの前記外部輪郭の周囲に広がる、請求項5のデバイス。
- 前記多孔性マトリックスの1またはそれより多い前記の暴露された領域が、1またはそれより多い前記の複数の開口部を取り囲み、そして前記開口部を、前記充填剤の前記の暴露された領域の隣接するものから分離する、請求項5のデバイス。
- 前記多孔性マトリックスがセラミック材料を含み、そして前記充填剤がポリマー性材料を含む、請求項5のデバイス。
- 前記セラミック材料が生体吸収性であり、そして前記ポリマー性材料が生物学的に安定である、請求項8のデバイス。
- セラミック材料がカルシウムに基づくセラミックを含む、請求項9のデバイス。
- 前記のカルシウムに基づくセラミックが、カルシウム、酸素およびリンを含む化合物によって規定され;そして
前記元素の少なくとも1つの一部が、約0.1〜約0.6Åのイオン半径を有する元素で置換されている
請求項10のデバイス。 - 前記化合物が、式:
(Ca)i{(P1−x−y−zBxCyDz)Oj}2:
式中、B、CおよびDは、およそ0.1〜0.4Åのイオン半径を有する元素より選択され;
xは、0より大きいかまたは0に等しいが1未満であり;
yは、0より大きいかまたは0に等しいが1未満であり;
zは、0より大きいかまたは0に等しいが1未満であり;
x+y+zは、0より大きいが1未満であり;
iは、2より大きいかまたは2に等しいが4未満であるかまたは4に等しく;そして
jは4−δに等しい、式中、δは、0より大きいかまたは0に等しいが1未満であるかまたは1に等しい
を有する、請求項11のデバイス。 - 前記ポリマー性材料がポリエーテルエーテルケトンである、請求項10のデバイス。
- 前記多孔性マトリックスの前記の暴露された領域が、前記の外表面で、細胞付着および骨伝導を促進し、そして前記の複数の開口部が、前記ボディ内への骨および組織内殖を促進する、請求項9のデバイス。
- 前記充填剤が前記の相互連結された一連のマクロ孔全体に注入され、そしてその各々を実質的に満たす、請求項1のデバイス。
- 移植可能医学的デバイスであって:
前記デバイスの外部輪郭を規定する外表面を含むボディであって:
相互連結された複数の支柱によって規定される相互連結された一連のマクロ孔を含み、前記の相互連結された支柱が、前記の相互連結された一連のマクロ孔から分離された、相互連結された複数の通路(passage)をさらに規定する、生体吸収性セラミックマトリックス;
前記の相互連結された一連のマクロ孔全体に注入され、そしてこれを実質的に満たす、生物学的に安定なポリマー性材料
をさらに含み;
前記の相互連結された複数の通路が、前記ポリマー性材料を実質的に含まない
前記ボディ
を含む前記デバイス。 - 前記の相互連結された複数の通路の少なくとも一部が、前記外表面まで伸長し、そして開口する、請求項16のデバイス。
- 前記ボディが、隣接する骨または骨性組織の間に位置づけられるように構成され、そして前記外表面が反対の位置に位置づけられた骨結合部分を含み、該部分が各々、前記の隣接する骨または骨性組織と結合するように構築された複数の骨結合突起を含む、請求項17のデバイス。
- 前記外表面の少なくとも一部が、前記ポリマー性材料の暴露された領域、および前記の相互連結された複数の支柱の少なくとも一部の1またはそれより多い暴露された領域によって規定され、前記の相互連結された複数の支柱の前記一部の前記の1またはそれより多い暴露された領域の少なくとも1つが、前記外表面まで伸長し、そして開口する、前記の相互連結された複数の通路の前記一部の少なくとも1つを取り囲む、請求項18のデバイス。
- 前記ボディが隣接する骨または骨性組織の間に位置づけられた際に生じる生物学的活性が、前記の相互連結された複数の支柱の前記一部の、前記の1またはそれより多い暴露された領域を、漸次、取り除き、そして新規骨で置換し、そして前記外表面まで伸長し、そして開口する、前記の相互連結された複数の通路の前記一部内への骨および組織内殖を生成する、請求項19のデバイス。
- 前記セラミックマトリックスが、硫酸カルシウム、炭酸カルシウム、ヒドロキシアパタイト、炭酸アパタイト、フルオロアパタイト、α型リン酸三カルシウム、β型リン酸三カルシウム、リン酸四カルシウム、リン酸八カルシウムおよびSkelite(登録商標)からなる群より選択される、カルシウムに基づくセラミックを含む、請求項16のデバイス。
- 前記ポリマー性材料が、ポリエーテルエーテルケトン(PEEK)、カーボン強化PEEK、およびポリエーテルケトンケトン(PEKK)からなる群より選択される、請求項16のデバイス。
- 移植可能医学的デバイスであって、前記デバイスの外部輪郭を規定する外表面を含むボディを含み、前記外表面が、1またはそれより多い開口部を含むマトリックスの1またはそれより多い暴露された領域、および前記の1またはそれより多い開口部の少なくとも一部を実質的に満たす生物学的に安定な充填剤を含み、移植後、破骨細胞活性が、前記マトリックスの部分を、漸次、取り除き、そして骨芽細胞活性が、前記マトリックスの前記部分を新規骨で、漸次、置換する、リモデリングプロセスを、前記マトリックスが経て、そして前記リモデリングプロセスの開始が、前記マトリックスの前記の1またはそれより多い暴露された領域に限定される、前記デバイス。
- 前記リモデリングプロセスの前記開始が、移植に際して暴露される前記マトリックスの前記の1またはそれより多い領域に限定される、請求項23のデバイス。
- 前記の1またはそれより多い開口部が、相互連結された複数の支柱によって規定される、相互連結された一連のマクロ孔によって規定される、請求項23のデバイス。
- 前記の相互連結された複数の支柱が各々、中空の内部を含む、請求項25のデバイス。
- 前記の1またはそれより多い開口部が、前記マトリックスを少なくとも部分的に通じるチャネルによって規定される、請求項23のデバイス。
- 前記の生物学的に安定な材料が、前記の1またはそれより多い開口部全体に注入され、そしてその各々を実質的に満たす、請求項23のデバイス。
- 前記デバイスの前記外部輪郭を規定する前記外表面の実質的にすべてが、前記マトリックスの暴露された領域および前記の生物学的に安定な充填剤によって規定される、請求項23のデバイス。
- 前記の生物学的に安定な充填剤が、ポリエーテルエーテルケトン(PEEK)、カーボン強化PEEK、およびポリエーテルケトンケトン(PEKK)からなる群より選択される、請求項23のデバイス。
- 前記マトリックスが、カルシウム、酸素およびリンを含む化合物によって規定される、カルシウムに基づくセラミック材料によって形成され、前記元素の少なくとも1つの一部が、約0.1〜約0.6Åのイオン半径を有する元素で置換されている、請求項23のデバイス。
- 前記化合物が、式:
(Ca)i{(P1−x−y−zBxCyDz)Oj}2:
式中、B、CおよびDは、およそ0.1〜0.4Åのイオン半径を有する元素より選択され;
xは、0より大きいかまたは0に等しいが1未満であり;
yは、0より大きいかまたは0に等しいが1未満であり;
zは、0より大きいかまたは0に等しいが1未満であり;
x+y+zは、0より大きいが1未満であり;
iは、2より大きいかまたは2に等しいが4未満であるかまたは4に等しく;そして
jは4−δに等しい、式中、δは、0より大きいかまたは0に等しいが1未満であるかまたは1に等しい
を有する、請求項31のデバイス。 - 前記マトリックスがSkelite(登録商標)によって形成される、請求項23のデバイス。
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PCT/US2010/043249 WO2011011785A2 (en) | 2009-07-24 | 2010-07-26 | Implantable medical devices |
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WO2011011785A3 (en) | 2011-04-07 |
CA2768971A1 (en) | 2011-01-27 |
BR112012001637A2 (pt) | 2016-04-12 |
CN102648008A (zh) | 2012-08-22 |
US20160213821A1 (en) | 2016-07-28 |
US10933172B2 (en) | 2021-03-02 |
US20110022180A1 (en) | 2011-01-27 |
EP2456477B1 (en) | 2015-01-21 |
US20200376174A1 (en) | 2020-12-03 |
RU2545823C2 (ru) | 2015-04-10 |
RU2012102469A (ru) | 2013-08-27 |
JP5972788B2 (ja) | 2016-08-17 |
AU2010275377A1 (en) | 2012-02-23 |
WO2011011785A2 (en) | 2011-01-27 |
US9399086B2 (en) | 2016-07-26 |
US12005160B2 (en) | 2024-06-11 |
AU2010275377B2 (en) | 2014-06-19 |
EP2456477A2 (en) | 2012-05-30 |
BR112012001637B1 (pt) | 2018-05-22 |
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