JP2004000635A - 固定装置に対する吸収性の組織支持骨格の取付方法 - Google Patents
固定装置に対する吸収性の組織支持骨格の取付方法 Download PDFInfo
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- JP2004000635A JP2004000635A JP2003153256A JP2003153256A JP2004000635A JP 2004000635 A JP2004000635 A JP 2004000635A JP 2003153256 A JP2003153256 A JP 2003153256A JP 2003153256 A JP2003153256 A JP 2003153256A JP 2004000635 A JP2004000635 A JP 2004000635A
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- tissue
- component
- support
- scaffold
- skeleton
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Abstract
【解決手段】上記装置は一定の組織支持骨格部品および一定の支持骨格固定部品を備えており、この支持骨格部品は各種の縫合線、織地、繊維、糸、弾性体、補強要素および当該支持骨格部品を上記固定部品に係合して固定的に取り付けた状態に維持するための連結用の突出部分の少なくとも1種類を介して上記固定部品に固定的に取り付けられている。
【選択図】 図1
Description
【0001】
本発明は病気のまたは損傷した筋骨格組織の修復および再生を容易にする生体吸収性の組織支持骨格の移植片装置に関する。
【背景技術】
【0002】
組織工学(TE)は既存組織構造の維持または新規組織成長の可能化に対する工学分野の適用である。このような工学的手法は一般に一定の傷または欠陥部分を治療または修復するために細胞が接着および増殖して新しい組織を合成することのできる一定の構築用の支持骨格として作用する一定の生体相容性の組織支持骨格の配給を含む。好ましくは、この組織支持骨格は各種の生体吸収性の材料により作成されている。このような生体吸収性の組織支持骨格は身体が傷または欠陥部分を治療または修復するために新しい組織を合成した後にその身体により吸収される。合成の生体吸収性で生体相容性の各種のポリマーが当該技術分野において知られており、グリコール酸、グリコリド、乳酸、ラクチド(d,l,メソ形およびこれらの混合物)、ε−カプロラクトン、トリメチレン・カーボネートおよびp−ジオキサノン等の各種モノマーの脂肪族ポリエステル、ホモポリマー、およびコポリマー(ランダム型、ブロック型、セグメント型およびグラフト型)を含む。
【0003】
多くの吸収性の組織支持骨格が組織の修復および再生における使用において認識されている。例えば、ポリラクチドのようなポリヒドロキシ酸の各種ポリマーにより構成されている多孔質メッシュ・プラグ材が骨の気孔部分を治癒するために用いられている。さらに最近になって、別の組織工学的な支持骨格が報告されている。これらの支持骨格はその支持骨格内に多孔質部分を形成するための滲出性の物質、真空発泡技法および沈殿したポリマー・ゲル塊体等の使用を含む多数の異なる処理により製造されている。室温よりも高い温度において昇華する各種の放散性の化合物を伴うポリマー溶融物が知られている。織物を基材とする布地の組織支持骨格および凍結乾燥により形成した生体相容性で生体吸収性の発泡体組織支持骨格が知られている。約10μm乃至約200μmの気孔寸法を有する一定のポリヒドロキシ酸の多孔質で連続気泡型の発泡体が各種の血管および細胞の内部成長のために用いられている。この発泡体はまた各種の繊維、糸、編組物、編地、スクリム等により補強できる。
【0004】
関節軟骨は各種の関節内における骨の間の接合面を被覆している一定の組織であり、2種類の主な相、すなわち、一定の固体基質部分および一定の間質液の相により構成されている。この軟骨にその硬さおよび強度を与えている基質は各種の軟骨細胞により製造および維持されている。一方、間質液相はその軟骨組織に対して粘弾性作用を及ぼす。このような関節軟骨を修復する場合に、上記の組織工学的な支持骨格を関節の移動により位置ずれしないように下層の骨に固定する必要がある。
【0005】
関節軟骨を修復するための多数の方法が知られている。一例の既知の関節軟骨修復片は無被覆状態または丈夫で柔軟な材料の一定の被膜により被覆されている不織フェルト状の繊維材料の支持層を含む。このような修復片を下層の骨に固定するための手段は細長い各種のファスナー、縫合処理、接着剤による結合、および骨のアンダーカット部分内における機械的な連結を含む。
【0006】
治癒が生じるまで一定の生体材料の位置を保持するための一例の取付方法は幾つかの工程を含む。先ず、縫合線を、少なくとも2本の縫合線が表面から出ている状態で、肋軟骨下板を通して骨組織内に固定する。その後、これら2本の縫合線を移植片の中を通して引っ張り、その軟骨修復材料の位置を固定するために用いる。
【0007】
多数工程の方法を必要とすることを避けるために、幾つかのこれまでの研究が支持骨格およびこれらの支持骨格を下層の骨に固定するための手段を結合する装置を記載している。例えば、一例の既知のプロテーゼ用の吸収可能な関節軟骨支持骨格において、一定の吸収性の基材部品が一定のパイロット穴を通して海綿質の中に挿入されて、その骨の中に一定の装置を固定することを可能にするために適合している。この支持骨格は生体相容性で生体吸収性の繊維により製造されている。このような装置を形成する場合に、その支持骨格を上記基材に取り付けるためにその基材部品の上部の中における複数の穴を通してその支持骨格内における複数の繊維の一部が圧縮により押し込まれる。しかしながら、このように基材に対して支持骨格を取り付けるために用いられる圧縮力はその支持骨格を損傷する可能性がある。
【0008】
また、別の既知の生体吸収性の軟骨修復システムにおいては、一定の多孔質で生体吸収性の挿入物が半径方向に外側に延出している複数のフランジ部分により一定の支持フレームの各側壁部内に保持され、これらのフランジ部分は上記側壁部内の各窓部の中を通過している。これにより、一定の支持骨格およびこの支持骨格を下層の骨に固定するための一定の手段を結合する単一の装置が得られるが、この支持骨格は上記のような半径方向に外側に延出している複数のフランジ部分を含むように製造する必要がある。
【0009】
上記生体相容性の組織支持骨格はまたヒアルロン酸(HA)、コラーゲン、アルギネート、キトサン、小腸粘膜下物質(SIS)およびこれらの混合物等のような生体を基礎とするポリマーにより調製されている。このようなHAおよびコラーゲン等における種々の生体ポリマーの3次元多孔質発泡体および不織構造が知られている。
【考案の開示】
【発明が解決しようとする課題】
【0010】
各種の新しい組織構造の成長において構造的な支持体として作用する多数の組織工学的に処理した支持骨格装置が存在している。これらの装置を下層の骨に固定するための手段がこれまでに記載されているが、これらの既に開示されている方法および装置における制限は多数工程の固定処理の必要性、支持骨格に対する損傷の可能性、および固定手段に取り付けるための極めて独特な形状に製造する必要のある支持骨格等を含む。従って、骨または軟骨等のような、硬質組織に強固に固定するための組織工学的な支持骨格装置に対する要望が存在しており、この場合に、これらの支持骨格は、組織の内部成長が生じている間に、一定の固定装置の中にその位置が保持されている。
【課題を解決するための手段】
【0011】
本発明は一定の支持骨格固定部品および当該支持骨格固定部品に対して固定して取り付けられる一定の組織支持骨格部品を備えている組織支持骨格移植片装置に関する。これらの組織支持骨格部品および支持骨格固定部品は各種の縫合線、繊維、結線、糸および弾性帯等のような取付手段により互いに固定的に取り付けられる。さらに、このような取付手段と機能において等価な任意の手段もまた本発明の範囲に含まれると考えられる。あるいは、上記組織支持骨格部品は一定の織物により包むことができ、この織物がさらに上述したような取付手段を介して上記固定部品に固定的に取り付けられる。また、別の実施形態において、一定の補強要素を上記支持骨格部品の中に埋め込んでその支持骨格部品の周囲に配置することによりこの支持骨格部品の上記固定部品に対する相対位置を維持して、この補強要素における埋め込まれていない部分が上記固定部品に固定的に取り付けられる。さらに別の実施形態においては、上記支持骨格固定部品は上記組織支持骨格部品に係合してこの組織支持骨格部品をその支持骨格固定部品に固定的に取り付けた状態に維持するための少なくとも1個の連結用の突出部分を有している。すなわち、これらの突出部分は上記組織支持骨格部品をその支持骨格固定部品に固定的に取り付けるために用いられている。
【発明の効果】
【0012】
従って、本発明によれば、骨または軟骨等のような、硬質組織に強固に固定するための組織工学的な支持骨格装置が提供でき、この場合に、これらの支持骨格は、組織の内部成長が生じている間に、一定の固定装置の中にその位置が保持されている。
【発明を実施するための最良の形態】
【0013】
関節軟骨の修復において、その移植片の構造は組織の内部成長を容易にするために有効である必要があり、この移植片は一定の手術室環境内における取り扱いを容易にするための十分な構造的完全性および物理的特性を有している必要がある。それゆえ、この移植片を構成している各種の部品は互いに固定的に取り付ける必要がある。
【0014】
図1および図2において、移植片10は支持骨格部品20、固定部品30、および縫合線15を備えている。この固定部品30は支持骨格支持体32および固定ポスト34を有している。さらに、この支持骨格支持体32は支持骨格部品20との間における流体の流れを可能にするために当該支持体32を貫通している複数の孔36を有している。好ましくは、固定ポスト34は当該固定ポスト34の移植部位に対する取付性を改善する複数のリブ、セレーション、またはその他の表面粗さまたは係合手段38を含むことができる。
【0015】
上記固定部品30の設計は本発明における重要な要素ではない。しかしながら、例えば、各種の縫合線、繊維、糸、弾性帯等による結び付けにより上記支持骨格の支持骨格支持体に対する固定が行なわれる場合の特定の実施形態においては、上記装置は内部を貫通している複数の孔36を伴う支持骨格を備えていることが好ましい。これにより、支持骨格部品20は、例えば、縫合線15により、このような支持骨格支持体32の上面部に固定される。
【0016】
上記移植片10は一定の手術室環境内における取り扱いを容易にするためだけではなく、上記組織支持骨格の固定装置に対する相対位置を維持するために十分な構造的完全性および物理的特性を有する必要がある。また、支持骨格部品20および固定部品30はその外科処置の前、その途中、またはその後において分離しないように固定的に取り付けられる必要がある。このような十分な強度および物理的特性は支持骨格20、固定部品30および縫合線15をそれぞれ形成するために使用する各種の材料の選択によりその移植片に現れる。
【0017】
図1および図2は固定部品30の骨格支持体32の上面部に配置されている組織工学的に処理した支持骨格部品20をそれぞれ示している図である。さらに、図1は支持骨格部品20を固定部品30に固定するために用いられている縫合線15を示している。この縫合線15は支持骨格20の中を通して縫い付けられていて、この縫合線15を固定ポスト34に結び付けることにより固定部品30に取り付けられている。この結び付けが終わると、余分の縫合線15が除去される。
【0018】
図2は支持骨格部品20を固定部品30に固定するための縫合線15の好ましい利用方法を示している図である。この縫合線15は支持骨格20の中を通して縫い付けられていて、支持骨格支持体32の中の各孔36を通過している。この結び付けが終わると、余分の縫合線15が除去される。
【0019】
さらに、図3において示されている、本発明の別の実施形態において、織物54が支持骨格部品20および支持骨格支持体32を包んでおり、この織物54が取付手段56により固定部品30の固定ポスト34に取り付けられている。この取付手段は各種の縫合線、繊維、糸、結線、弾性体、およびこれらの機能的な等価物を含む。好ましくは、縫合線がこの取付手段として用いられている。
【0020】
さらに、図4において示されている、別の実施形態において、補強要素63の一部分が支持骨格部品20の周囲に配置されていて当該部品20の中に部分的に埋め込まれている。さらに、この補強要素63の埋め込まれていない部分64は取付手段66により固定部品30の固定ポスト34に取り付けられている。この補強要素63は各種の繊維、糸、編組物、織地、編地およびスクリムにより構成できる。好ましくは、この補強要素63は織地により構成されている。また、取付手段66は各種の縫合線、繊維、糸、結線、弾性帯、およびこれらの機能的な等価物を含む。好ましくは、縫合線がこの取付手段として用いられている。
【0021】
上記の実施形態において、支持骨格部品20を形成することおよび当該支持骨格部品20の中に補強要素63を埋め込むことを同時に行なうための好ましい方法は一定の凍結乾燥処理法またはフリーズ−ドライ処理法である。つまり、この補強要素63はそのフリーズ−ドライ法の開始の前に一定のポリマー溶液中に浸漬される。その後、支持骨格部品20を形成する際に、この補強要素63が部分的に埋め込まれてこれら支持骨格部品20と補強要素63との間に一定の固定された取付状態が形成される。これにより、支持骨格部品20は一定の多孔質の高分子発泡支持体として形成される。
【0022】
本発明の別の実施形態において、上記固定装置からの複数の連結用の突出部分が上記組織支持骨格をこの固定装置に固定するために用いられている。図5は支持骨格支持体32および固定ポスト34を備えている支持骨格固定装置30を示している図である。さらに、支持骨格支持体32の上面部37の上の多数の位置において複数の突出部分35が配置されている。
【0023】
さらに、図6において分かるように、支持骨格20を固定装置30の支持部品32に接触して配置する場合に、複数の突出部分35が支持骨格部品20の中に直接的に侵入することによりこの組織支持骨格部品20に係合して、この支持骨格部品20の本体部分の中に一定の連結関係で固定的に埋め込まれる。従って、この支持骨格部品20は医者により配置される間に適当な位置に維持されている。このように、複数の突出部分が支持骨格の本体部分に対する侵入によりその支持骨格部品の支持骨格支持体に対する固定された取付状態を形成するので、この支持骨格部品はこれらの突出部分により侵入可能な材料により構成されている必要があり、この場合に、これらの突出部分はその配置中に一定の連結関係で埋め込まれた状態に維持される。このような支持骨格の例はフェルト状および高分子の発泡体支持骨格を含むがこれらに限らない。さらに、本発明の装置において好ましい材料は凍結乾燥処理した生体吸収性の各種の発泡体支持骨格である。
【0024】
上記の組織工学的に処理した支持骨格に侵入および係合してこれらを上記固定装置の支持骨格支持体上の適当な位置に維持する突出部分またはこれらの機能的に等価な特徴部分に対応する多数の別の形状を当該技術分野における熟練者が設計できるので、これらの突出部分の数および形状は図5において示されている数および形状に限定されない。
【0025】
上述した支持骨格部品20および固定部品30を取り付ける方法は当該技術分野において既に報告されている組織工学的に処理した種々の支持骨格において使用可能である。初めに述べたように、従来技術の組織工学的に処理した支持骨格は多孔質メッシュ・プラグ材、滲出、真空形成、または凍結乾燥により形成した多孔質支持骨格、織物を基材とする繊維質の支持骨格および各種の繊維、糸、編組物、編地およびスクリムにより補強した凍結乾燥処理した発泡体を含むがこれらに限らない。
【0026】
本発明の支持骨格部品20および固定部品30はステンレス・スチール、コバルト−クロム、チタンおよびチタン合金等を含むがこれらに限らない生体相容性の金属、アルミナ、ジルコニア、および硫酸カルシウム等を含むがこれらに限らない生体不活性なセラミック、またはリン酸カルシウムを等含む吸収性のガラス材またはセラミック、または自家移植片、同種移植片、または異種移植片の骨組織、またはポリエチレン、ポリビニル・アルコール(PVA)、ポリメチルメタクリレート(PMMA)、シリコーン、ポリエチレン・オキシド(PEO)、ポリエチレン・グリコール(PEG)、およびポリウレタン等を含むがこれらに限らない非生体吸収性のポリマー等のような非吸収性の材料、または生体相容性で吸収性の生体ポリマー等により構成できる。本明細書において用いられているように、用語の「生体ポリマー(biopolymer)」は自然に存在している各種のポリマー、ならびに、これらの合成的な修飾物または誘導体を含むと理解される。このような生体ポリマーはヒアルロン酸、コラーゲン、組換えコラーゲン、セルロース、エラスチン、アルギネート、コンドロイチン硫酸、キトサン、キチン、ケラチン、シルク、小腸粘膜下物質(SIS)およびこれらの混合物を含むがこれらに限らない。これらの生体ポリマーはさらに架橋剤を導入することまたは側鎖残基の疎水性を変化することによりそれぞれの機械的なまたは崩壊性の特性を高めるために修飾できる。
【0027】
好ましい実施形態において、上記の支持骨格部品20および固定部品30は好ましくは生体吸収性のポリマーによりそれぞれ構成されている。本発明の取付方法を利用しているこのような装置は身体により完全に吸収可能な一定の組織工学的に処理した支持骨格移植片装置を提供する。
【0028】
種々の生体吸収性のポリマーが本発明による組織工学的に処理した支持骨格移植片装置を作成するために使用できる。適当な生体相容性で生体吸収性のポリマーの例は各種の脂肪族ポリエステル、ポリアルキレン・オキサレート、ポリアミド、ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリ酸無水物、およびポリホスファゼンから成る群から選択される各種のポリマーを含む。
【0029】
現在において、各種の脂肪族ポリエステルが本発明による発泡体支持骨格部品の作成において使用するための好ましい吸収性のポリマーに含まれている。これらの脂肪族ポリエステルは一定の線形、分枝状または星形の構造を有する各種のホモポリマーまたはコポリマー(ランダム型、ブロック型、セグメント型、テーパー・ブロック型、グラフト型、トリブロック型等)とすることができる。さらに、これら脂肪族のホモポリマーおよびコポリマーを作成するために適しているモノマーは乳酸、ラクチド(L−,D−,メソ形およびD,L混合物)、グリコール酸、グリコリド、ε−カプロラクトン、p−ジオキサノン(1,4−ジオキサン−2−オン)、トリメチレン・カーボネート(1,3−ジオキサン−2−オン)、バレロラクトン、ブチロラクトン、デカラクトン、2,5−ジケトモルホリン、ピバロラクトン、ジエチルプロピオラクトン、エチレン・カーボネート、エチレン・オキサレート、3−メチル−1,4−ジオキサン−2,5−ジオン、3,3−ジエチル−1,4−ジオキサン−2,5−ジオン、ブチロラクトン、1,4−ジオキセパン−2−オン、1,5−ジオキセパン−2−オン、6,6−ジメチル−ジオキセパン−2−オンおよび6,8−ジオキサビシクロオクタン−7−オンから成る群から選択できるがこれらに限らない。
【0030】
上記脂肪族ポリエステルは一般的に一定の開環重合において合成される。また、これらのモノマーは一定の有機金属触媒および一定の開始剤の存在下に一定の昇温条件下において重合する。この有機金属触媒は好ましくは、例えば、オクタン酸第一錫等のような錫を基材としており、約10,000/1乃至約100,000/1の範囲のモノマー対触媒のモル比において上記モノマー混合物中に存在している。また、開始剤は一般的に一定のアルカノール(各種のジオールおよびポリオールを含む)、グリコール、ヒドロキシ酸、またはアミンであり、約100/1乃至約5,000/1の範囲のモノマー対開始剤のモル比において上記モノマー混合物中に存在している。さらに、この重合反応は、所望の分子量および粘度が達成されるまで、一般に約80℃乃至約240℃、好ましくは約100℃乃至約220℃の一定の温度範囲で行なわれる。
【0031】
上記組織支持骨格移植片の調製において使用できる適当な溶媒はギ酸、ギ酸エチル、酢酸、ヘキサフルオロイソプロパノール(HFIP)、環状エーテル(すなわち、THF,DMFおよびPDO)、アセトン、C2乃至C5のアルコールの酢酸エステル(酢酸エチルおよび酢酸t−ブチル等)、グライム(すなわち、モノグライム、エチル・グライム、ダイグライム、エチル・ダイグライム、トリグライム、ブチル・ダイグライムおよびテトラグライム等)、メチルエチルケトン、ジプロピレングリコール・メチル・エーテル、ラクトン(γ−バレロラクトン、δ−バレロラクトン、β−ブチロラクトン、γ−ブチロラクトン等)、1,4−ジオキサン、1,3−ジオキソラン、1,3−ジオキソラン−2−オン(エチレン・カーボネート)、ジメチルカーボネート、ベンゼン、トルエン、ベンジル・アルコール、p−キシレン、ナフタレン、テトラヒドロフラン、N−メチル・ピロリドン、ジメチルホルムアミド、クロロホルム、1,2−ジクロロメタン、モルホリン、ジメチルスルホキシド、ヘキサフルオロアセトン・セスキヒドレート(HFAS)、アニソールおよびこれらの混合物を含むがこれらに限らない。これらの溶媒の中で、好ましい溶媒は1,4−ジオキサンである。この溶媒中における上記ポリマーの均質な溶液は標準的な技法により調製される。
【0032】
本発明のさらに別の実施形態において、上記のポリマーおよび混合物は一定の治療剤放出基質として使用できる。このような基質を形成するために、上記ポリマーは上記装置を形成する前に一定の治療剤と混合される。本発明のポリマーと共に使用できる種々の異なる治療剤が多様にある。一般に、本発明の各種の薬剤組成物を介して投与できる治療剤は抗生物質および抗ウイルス剤等のような抗感染薬、化学療法薬(すなわち、抗ガン剤等)、抗拒絶薬、鎮痛薬および鎮痛薬配合物、抗炎症剤、ステロイド等のホルモン、骨形態発生タンパク質(すなわち、BMP2,4,6および12等)を含む増殖因子、音響ヘッジホッグ(sonichedgehog)、骨形態発生様タンパク質(すなわち、GFD−5,GFD−7およびGFD−8等)、表皮増殖因子(EGF)、線維芽細胞増殖因子(すなわち、FGF1乃至9等)、血小板誘導増殖因子(PDGF)、インスリン様増殖因子(IGF−IおよびIGF−II等)、形質転換増殖因子(すなわち、TGF−βI乃至III等)、脈菅内皮増殖因子(VEGF)、およびその他の自然に誘導された、あるいは、遺伝工学的に処理されたタンパク質、多糖類、糖タンパク質、リポタンパク質および各種細胞を含むがこれらに限らない。
【0033】
本発明の基質材料は上記ポリマーと共に1種類以上の治療薬を混合することにより配合できる。あるいは、上記ポリマー上に、好ましくは一定の薬剤的に許容可能なキャリヤーと共に、一定の治療薬を塗布することができる。上記ポリマーを溶解しない任意の薬剤用のキャリヤーが使用できる。また、上記治療薬は一定の液体、細かく分割された固体、または任意のその他の適当な物理的形態として存在できる。一般的であるが、随意的に、上記基質は各種の希釈剤、キャリヤー、賦形剤、安定化剤等のような1種類以上の添加物を含むことができる。
【0034】
上記治療薬の量は採用する特定の薬物および治療される医療状況に応じて決まる。一般的に、この薬物の量は上記基質の重量に基づいて約0.001%乃至約70%、さらに一般的に約0.001%乃至約50%、最も一般的に約0.001%乃至約20%が代表的である。上記薬物配給用の基質の中に含まれるポリマーの量および種類は所望の放出プロファイルおよび採用する薬物の量に応じて変化する。
【0035】
各種の体液に接触すると、上記ポリマーは一定の持続されたまたは延長された期間にわたり分散した薬物の付随的な放出を伴って漸進的に(主に加水分解により)崩壊する。このことにより、各種の有効量(例えば、0.0001mg/kg/時乃至10mg/kg/時)の薬物の延長された(例えば、1時間乃至5,000時間、好ましくは2時間乃至800時間にわたる)配給が可能になる。また、このような投薬形態は治療される対象、苦痛の深刻さの程度、処方医の判断等により必要に応じて投与できる。上記およびこれに類似の処置の後に、当該技術分野における熟練者であれば種々の配合物を調製できるようになる。
【0036】
別の実施形態において、上記固定装置はヒドロキシアパタイト、リン酸三カルシウム等のような生体相容性のセラミック、または生体相容性で吸収性の合成物との混合物、または各種の金属合金により製造できる。これらの装置はまた天然の各種材料(すなわち、同種移植片の骨、異種移植片の骨、サンゴ等)により作成することも可能である。
【0037】
以下の実施例は本発明の原理および実施の例示であるが、本発明の範囲を制限していない。すなわち、本発明の範囲および趣旨に含まれる多数の別の付加的な実施形態が当該技術分野における熟練者において明らかになる。
【0038】
以下の実施例において、各種のポリマーおよびモノマーはそれぞれの化学的組成および純度(NMR,FTIR)、熱分析(DSC)、および各種の従来的な分析技法による分子量について特徴付けられている。
【0039】
以下の各種のポリマーおよびコポリマーの固有粘度(I.V.,dL/g)は0.1g/dLの一定濃度において溶媒としてクロロホルムまたはヘキサフルオロイソプロパノール(HFIP)を用いて25℃において一定のサーモスタットにより制御された水の中に浸漬した一定の50ボア・キャノン−ウッベローデ(Cannon―Ubbelhode)希釈粘度計によりそれぞれ測定されている。
【実施例1】
【0040】
実施例1:上記固定部品に対する組織工学的な支持骨格部品の縫合線による取り付け
一定の射出成形処理により生体吸収性の各種の固定部品を製造した。この使用した固定部品の設計は図1において示されている設計と同じである。また、これらの固定部品を製造するために用いたポリマーはクロロホルム中で測定した場合に1.79dL/gの一定の固有粘度を有するプラック社(Purac)(オランダ国、ゴリンケム)により製造されている85%PLAおよび15%PGA(85/15PLA/PGA)の一定のコポリマーであった。射出成形装置(ニイガタ(Niigata)NN35MI)は18mmの一定のバレル直径を有していた。また、ホッパーは上記ポリマーを乾燥状態に維持するための一定の窒素パージを伴って取り付けられていた。さらに、供給、移動および圧縮の各領域の温度はそれぞれ185℃、185℃および191℃であった。また、ダイおよび金型の各温度はそれぞれ191℃および24℃であった。さらに、最大射出速度は80mm/秒および最大射出圧力は85Kgf/cm2(8.34×106Pa)であった。また、保持圧力は70Kgf/cm2(6.86×106Pa)であった。この射出成形および保持のための全体の時間は3秒であり、保持工程の終了段階における冷却時間は20秒であった。この結果として得た各固定部品は7mmの直径の支持骨格支持体をそれぞれ有していた。
【0041】
各支持骨格部品はそれぞれ以下のように作成した。糸を作成する従来的な方法によりPGA/PLA(90/10)のコポリマーを連続的なマルチフィラメント型の糸に溶融押出しした後に、強度、伸び率、および破断に要するエネルギーを高めるために延伸した。これらの糸は直径が約20ミクロンの複数のフィラメントを有していた。その後、これらの糸を切断およびけん縮処理して均一な2.0インチ(5.08cm)の長さにして2.0インチのステープル繊維を形成した。
【0042】
次に、乾燥した平札状の針でパンチ処理した不織基質を上記90/10PGA/PLAコポリマーのステープル繊維におより調製した。これらのステープル繊維を標準的な不織機械上に広げてカード状にした。この結果として得られたマットはウエブ状のステープル繊維の形態であった。その後、これらウエブ状の繊維を針によりパンチ処理して乾燥状態の平札状の針でパンチ処理した不織基質、すなわち、上記支持骨格部品を形成した。
【0043】
次に、上記支持骨格部品を水中ですすいだ後に、エタノール中でさらにインキュベーションすることにより上記製造処理中に用いたあらゆる残留の薬品または処理補助物質を除去した。
【0044】
上記支持骨格部品を以下のように上記固定部品に取り付けた。この支持骨格部品の7mmの直径のディスク材を一定のスチール製の罫線付きダイにより切り出した。次に、90/10PGA/PLAコポリマーの連続的な編組物(直径が約20ミクロンの多数のフィラメント)をこの支持骨格部品の中を通して縫い付けて、上記固定部品の支持骨格支持体の中の各孔に通した。これにより、この支持骨格部品を固定部品に結合した。
【0045】
上記の実施例において、重合化したε−カプロラクトンを示すためのPCL、重合化したグリコリドを示すためのPGA、重合化した(L)ラクチドを示すためのPLA等のような特定の略語が用いられている。加えて、各コポリマーの前に示されているそれぞれのパーセント値は各成分のモル・パーセント値を示している。
【産業上の利用可能性】
【0046】
本発明は一定の支持骨格固定部品および当該支持骨格固定部品に対して固定して取り付けられる一定の組織支持骨格部品を備えている組織支持骨格移植片装置に適用できる。これらの組織支持骨格部品および支持骨格固定部品は各種の縫合線、繊維、結線、糸および弾性帯等のような取付手段により互いに固定的に取り付けられる。さらに、このような取付手段と機能において等価な任意の手段もまた本発明の適用範囲に含まれる。
【0047】
本発明の具体的な実施態様は以下のとおりである。
(1)前記組織支持骨格部品が一定の生体吸収性のポリマーを含む請求項1に記載の装置。
(2)前記固定部品が一定の生体吸収性のポリマーを含む請求項1に記載の装置。
(3)前記取付手段が縫合線を含む請求項1に記載の装置。
(4)前記縫合線が一定の生体吸収性のポリマーを含む実施態様(3)に記載の装置。
(5)前記組織支持骨格部品および前記固定部品が一定の生体吸収性のポリマーを含む実施態様(4)に記載の装置。
【0048】
(6)前記生体吸収性のポリマーが脂肪族ポリエステル、ポリアルキレン・オキサレート、ポリアミド、ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリ酸無水物およびポリホスファゼンから成る群から選択される実施態様(5)に記載の装置。
(7)前記脂肪族ポリエステルが乳酸、ラクチド(L−,D−,メソ形およびD,L混合物を含む)、グリコール酸、グリコリド、ε−カプロラクトン、p−ジオキサノン(1,4−ジオキサン−2−オン)、トリメチレン・カーボネート(1,3−ジオキサン−2−オン)、バレロラクトン、ブチロラクトン、デカラクトン、2,5−ジケトモルホリン、ピバロラクトン、ジエチルプロピオラクトン、エチレン・カーボネート、エチレン・オキサレート、3−メチル−1,4−ジオキサン−2,5−ジオン、3,3−ジエチル−1,4−ジオキサン−2,5−ジオン、ブチロラクトン、1,4−ジオキセパン−2−オン、1,5−ジオキセパン−2−オン、6,6−ジメチル−ジオキセパン−2−オンおよび6,8−ジオキサビシクロオクタン−7−オンの各種のホモポリマーおよびコポリマーから成る群から選択される実施態様(6)に記載の装置。
(8)前記組織支持骨格部品が前記織地の中に包まれており、当該織地が縫合線、結線、糸、弾性帯または繊維を介して前記固定部品に固定的に取り付けられている請求項1に記載の装置。
(9)前記織地が前記縫合線を介して前記固定部品に固定的に取り付けられている実施態様(8)に記載の装置。
(10)前記縫合線、前記組織支持骨格部品、前記固定部品および前記織地が一定の生体吸収性のポリマーをそれぞれ含む実施態様(9)に記載の装置。
【0049】
(11)前記生体吸収性のポリマーが脂肪族ポリエステル、ポリアルキレン・オキサレート、ポリアミド、ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリ酸無水物およびポリホスファゼンから成る群から選択される実施態様(10)に記載の装置。
(12)前記組織支持骨格部品が前記補強要素の中に部分的に埋め込まれている一定の多孔質の凍結乾燥処理した高分子発泡体を含み、当該補強要素が前記縫合線、繊維、結線、糸または弾性帯により前記固定部品に固定的に取り付けられている請求項1に記載の装置。
(13)前記補強要素が前記縫合線により前記固定部品に固定的に取り付けられている実施態様(12)に記載の装置。
(14)前記縫合線、前記組織支持骨格部品、前記固定部品および前記補強要素が一定の生体吸収性のポリマーをそれぞれ含む実施態様(13)に記載の装置。
(15)前記生体吸収性のポリマーが脂肪族ポリエステル、ポリアルキレン・オキサレート、ポリアミド、ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリ酸無水物およびポリホスファゼンから成る群から選択される実施態様(14)に記載の装置。
【0050】
(16)前記組織支持骨格支持部品が前記組織支持骨格部品を当該組織支持骨格支持部品に係合して固定的に取り付けた状態に維持するための前記連結用の突出部分の少なくとも1個を有しており、前記組織支持骨格部品が前記突出部分により侵入可能な一定の材料を含み、当該突出部分が埋め込み可能である請求項1に記載の装置。
(17)前記組織支持骨格部品および前記固定部品が一定の生体吸収性のポリマーを含む実施態様(16)に記載の装置。
(18)前記生体吸収性のポリマーが脂肪族ポリエステル、ポリアルキレン・オキサレート、ポリアミド、ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリ酸無水物およびポリホスファゼンから成る群から選択される実施態様(17)に記載の装置。
(19)前記脂肪族ポリエステルが乳酸、ラクチド(L−,D−,メソ形およびD,L混合物を含む)、グリコール酸、グリコリド、ε−カプロラクトン、p−ジオキサノン(1,4−ジオキサン−2−オン)、トリメチレン・カーボネート(1,3−ジオキサン−2−オン)、バレロラクトン、ブチロラクトン、デカラクトン、2,5−ジケトモルホリン、ピバロラクトン、ジエチルプロピオラクトン、エチレン・カーボネート、エチレン・オキサレート、3−メチル−1,4−ジオキサン−2,5−ジオン、3,3−ジエチル−1,4−ジオキサン−2,5−ジオン、ブチロラクトン、1,4−ジオキセパン−2−オン、1,5−ジオキセパン−2−オン、6,6−ジメチル−ジオキセパン−2−オンおよび6,8−ジオキサビシクロオクタン−7−オンの各種のホモポリマーおよびコポリマーから成る群から選択される実施態様(18)に記載の装置。
【図面の簡単な説明】
【0051】
【図1】本発明の一定の装置の下部斜視図である。
【図2】本発明の一定の装置の下部斜視図である。
【図3】本発明の一定の装置の上部斜視図である。
【図4】本発明の一定の装置の下部斜視図である。
【図5】本発明の一定の装置における固定部品の上部斜視図である。
【図6】本発明の一定の装置の断面図図である。
【符号の説明】
【0052】
10 移植片
15 縫合線
20 支持骨格部品
30 固定部品
32 支持骨格支持体
34 固定ポスト
36 孔
38 係合手段
Claims (1)
- 組織支持骨格移植片装置において、
一定の組織支持骨格部品、および
一定の組織支持骨格支持部品を有する一定の固定部品を備えており、
前記組織支持骨格部品が、各種の繊維、縫合線、結線、糸、弾性帯、織地、当該組織支持骨格部品の中に部分的に埋め込まれている補強要素および当該組織支持骨格部品を前記固定部品に係合して固定的に取り付けた状態に維持するための前記組織支持骨格支持体上における複数の連結用の突出部から成る群から選択される一定の取付手段を介して前記固定部品に固定的に取り付けられている移植片装置。
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US10/159,178 US6989034B2 (en) | 2002-05-31 | 2002-05-31 | Attachment of absorbable tissue scaffolds to fixation devices |
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US (1) | US6989034B2 (ja) |
EP (1) | EP1366718A3 (ja) |
JP (1) | JP4326839B2 (ja) |
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-
2002
- 2002-05-31 US US10/159,178 patent/US6989034B2/en not_active Expired - Fee Related
-
2003
- 2003-05-15 AU AU2003204210A patent/AU2003204210B2/en not_active Ceased
- 2003-05-29 JP JP2003153256A patent/JP4326839B2/ja not_active Expired - Fee Related
- 2003-05-30 CA CA2430435A patent/CA2430435C/en not_active Expired - Fee Related
- 2003-06-02 EP EP03253440A patent/EP1366718A3/en not_active Withdrawn
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008521560A (ja) * | 2004-11-30 | 2008-06-26 | オステオバイオロジクス・インコーポレーテッド | 関節面の欠損を治療するためのインプラント及びそのデリバリーシステム |
Also Published As
Publication number | Publication date |
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US6989034B2 (en) | 2006-01-24 |
AU2003204210A1 (en) | 2003-12-18 |
US20030225459A1 (en) | 2003-12-04 |
CA2430435C (en) | 2011-12-13 |
EP1366718A2 (en) | 2003-12-03 |
JP4326839B2 (ja) | 2009-09-09 |
CA2430435A1 (en) | 2003-11-30 |
AU2003204210B2 (en) | 2007-06-07 |
EP1366718A3 (en) | 2006-04-19 |
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