JP2004000540A - 多相の生浸食性移植片 - Google Patents
多相の生浸食性移植片 Download PDFInfo
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- JP2004000540A JP2004000540A JP2003098451A JP2003098451A JP2004000540A JP 2004000540 A JP2004000540 A JP 2004000540A JP 2003098451 A JP2003098451 A JP 2003098451A JP 2003098451 A JP2003098451 A JP 2003098451A JP 2004000540 A JP2004000540 A JP 2004000540A
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- Prior art keywords
- tissue
- carrier
- polymeric material
- implant
- bone
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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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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Rheumatology (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
【解決手段】本発明の担体は異なる機械的特性を有する組織の間の接触領域に埋め込むことができ、この領域内の異なるタイプの組織の増殖および再生を支援することができる。又、この担体は、異なる機械的特性、例えば多孔性、堅さおよび圧縮性を有する生浸食性ポリマー物質を含む。更に、本ポリマー物質は分解剤を含み、使用中のポリマー物質の分解を強化するようになっている。
【選択図】 なし
Description
【発明の属する技術分野】
本発明は、多相の生分解性(biodegradable)または生浸食性(bioerodible)の移植材料または担体(キャリア)並びに、該担体の製造方法、および皮下組織を受け、誘発し、さらに支持するための生理的な系における該担体の使用方法に関する。
【0002】
【従来の技術】
損傷または欠損組織の治療および修復に用いられる装置は、当該技術分野で周知である。組織に損傷が生じた場合は、それが再生している間、この組織は適度に安定な状態で支持されていなければならない。幾つかのタイプの構造組織、例えば骨は、治癒過程で外傷領域が顕著に害されない限り、自然に再生することができる。外部支持体、例えばギブス包帯またはつり包帯を外傷領域の保護のために用いることができる。内部支持体、例えば支持棒またはピンも重症例には用いることができる。
【0003】
損傷組織領域の細胞密度が低いか、または脈管構造を欠いている場合(関節軟骨の場合のように)は、治癒過程はしばしば数カ月もしくは数年に及び、また全く治癒過程が開始しないこともある。内部支持ピンを用いる場合は、外科的な埋め込みが必要であり、数カ月もしくは数年後にピンを外科的に除去することがしばしば要求される。支持ピンを外科的に埋め込みさらに除去することは、患者の器官系に望ましくないショックまたは外傷を与える。のみならず、一旦、内部支持体を除去すると、この領域に穴または空洞が残り、これはその後増殖組織で自然に充填される必要があり、それによって治癒過程が完了する。この穴または空洞によって、しばらくの間、組織は引き続いて損傷または破損を受け易くなる。
【0004】
特許文献1は、損傷組織を修復するために再建手術で使用する移植片を開示する。この移植片は、二種類の細孔をもつ多孔性構造を有する有機ポリマー物質の多孔性マトリックスを含む。この移植片はその全体に亙って実質的に均質な特性を有するが、2つの異なるタイプの細孔を備えている。
【0005】
したがって、好ましい実施例では、この構造は、10〜60ミクロンの大きさの細孔をもつ多孔性マトリックスに、分散された15〜250ミクロンの大きさをもつ細孔を含む。その結果、比較的大きな細孔が、小さな細孔をもつ均質なマトリックス内に実質的に均質に分散されている。
【0006】
先に提唱されたこの移植片は、特定の形態、例えばメニスカス型または血管型に製造できるとされ、したがって、1つのタイプの体組織に隣接した場所での使用を目的とする。
【0007】
特許文献2は、骨折、骨切り術および関節固定術用の再吸収性外科用装置に関する。この開示されている装置は、層状複合構造を有する成分を含み、さらにこの装置は、丈夫で柔軟性があり、少なくとも部分的に再吸収性のポリマー性表層と、この表層より実質的に堅くて頑丈な、部分的に再吸収性の内側層とを有する。この内側層はまた、ポリマー物質から製造することができる。使用に際して、体組織は、外側層とのみ接触し、(少なくとも外側層が生体分解されるか、または再吸収されるまでは)内側層と接触しない。
【0008】
【特許文献1】
欧州特許出願公開公報第0277678号
【特許文献2】
国際特許出願公開公報第8700059号
【特許文献3】
米国特許第3991776号
【特許文献4】
米国特許第4346709号
【非特許文献1】
D. F. Williams,「ポリマーのインビボ分解における細胞性酵素の役割に関する幾つかの発見」(”Some Observations on the Role of Cellular Enzymes in the In−Vivo Degradation of Polymers”),「移植物質の侵食および分解」(”Corrosion and Degradation of Implant Materials”),ASTM STB 684, American Society for Testing and Materials, 1979, 61−75ページ)
【非特許文献2】
R. Langer,「制御遊離:薬剤デリバリーの新規な方法」(”Controlled Release: A New Approach to Drug Delivery”), Technology Review,1981年4月、26−34ページ
【0009】
【発明が解決しようとする課題】
この先に提案されている装置は、したがって、第一タイプの組織と第二タイプの組織との間の接触面で、それらと接触する状態で生理的な系で使用することを特に目的としているわけではない。そのかわり、この装置は、単一タイプの組織と接触する使用を目的としており、本来は、骨治癒の間の損傷骨の支持を提供する。
【0010】
【課題を解決するための手段】
本発明にしたがえば、二相構造を含む移植可能組織支持系が提供されるが、この二相構造は、第一および第二の隣接相を含み、この第一の相は第一のポリマー物質を含み、第二の相は、第二の生浸食性ポリマー物質を含む。この場合、第一の物質および第二の物質は、第一タイプの組織と第二タイプの組織との間の接触領域で、それぞれのタイプの組織と接触する状態で生理的な系で使用するとき移植に適するようになっている。この第一および第二タイプの組織は異なる硬度特性を有し、第一および第二のポリマー物質は異なる硬度特性を有し、しかも、第一および第二のポリマー物質は、第一および第二タイプの組織の硬度特性にそれぞれ実質的に匹敵する硬度特性を有する。
【0011】
骨の硬度特性と実質的に匹敵する硬度特性を有するであろう第一の相は、第一の層を含み、軟骨の硬度特性と実質的に匹敵する硬度特性を有するであろう第二の相は、第一の層の上に位置する第二の層を含むことができる。
【0012】
好ましくは、組織の増殖を受け入れる侵入用部位は、少なくともこの物質の1つの内に存在し、この物質内に伸びる通路またはこの物質の中に細孔を含むことができる。この細孔は50〜200μmの大きさをもつ。
【0013】
第一および第二のポリマー物質は、第一および第二タイプの組織の圧縮性および多孔性特性に実質的に匹敵する圧縮性特性および多孔性特性を有することができる。
【0014】
この系は実質的に円筒形である。
【0015】
少なくともポリマー物質の1つは分解剤を含み、使用中のこのポリマー物質の分解を強化するようなっている。少なくともポリマー物質の1つは、細胞増殖因子または、組織の増殖および修復を誘発、促進もしくは支援する治療薬剤を含むことができる。
【0016】
本発明はまた、生浸食性組織移植片(移植物)の製造方法に関する。これは、ポリマーを選択された粘度を有する液状物に調製するという第一の工程を含み、この場合、この方法は、選択された時間、選択された圧力の下でこの液状物から相当量の液体を抽出し、この抽出液体によって形成される細孔を有する修飾ポリマーを製造し、この修飾ポリマーを型(モールド)に入れ、このポリマーに選択された時間、選択された圧縮を加え、さらに粘度、真空圧、圧縮量と時間を選択して、型成形されるポリマーの硬度特性を、選択されたタイプの組織の硬度特性に実質的に匹敵させるという工程をさらに含む。
【0017】
この方法はさらに、選択された第二の真空圧の下で選択された第二の時間の間、第二の液状物から相当量の液体を抽出して、第二のポリマーを第二の選択された粘度を有する液状物に調製し、この抽出液によって形成された細孔を有する第二の修飾ポリマーを製造し、第二の修飾ポリマーを、型内の第一の圧縮された修飾ポリマーの上に入れ、この第二のポリマーに第二の選択された圧縮を第二の選択された時間の間加え、さらに、第二の粘度、真空圧、圧縮量および時間を選択して、異なる第二タイプの組織の硬度特性に実質的に匹敵し、かつ第一の型成形ポリマーの硬度特性とは異なる第二の型成形ポリマーの硬度特性を完成させるという工程を含むことができる。
【0018】
この方法は、粘度、真空圧、圧縮量および時間を選択し、第一および第二タイプの組織の圧縮性特性にそれぞれ実質的に匹敵する、第一および第二の型成形ポリマーの圧縮性特性を達成する工程を含むことができる。
【0019】
上記方法は、粘度、真空圧、圧縮量および時間を選択し、第一および第二タイプの組織の多孔性特性にそれぞれ実質的に匹敵する、第一および第二の型成形ポリマーの多孔性特性を達成する工程を含むことができる。
【0020】
第二の型成形ポリマーは、軟骨と実質的に同じ硬度特性をもち、一方、第一の型成形ポリマーは骨と実質的に同じ硬度特性をもつことができる。
【0021】
本発明の好ましい担体は、担体本体内に向かう組織の内方成長のために好都合の侵入を提供する。これらの部位は、組織が成長チャンネル(細孔)を抜けて担体の外側表面を侵襲することを可能にする。これらの細孔は、再生組織または表層再修復組織の促進および受け入れのために存在する。本発明の担体は、生理的な系の2つの異なる組織(例えば軟骨と骨)が隣合う場所に埋め込むことができるように特に調節されている。本発明の担体はまた、支持組織または脈管組織(例えば靭帯および腱付着部位)、成長板、骨膜と骨の接触面並びに硝子質軟骨および隣接組織などに埋め込むことができる。
【0022】
本発明の組織担体は、生浸食性(bioerodible)ポリマー物質を含み、この物質は、水性液体に曝されると実質的にまたは完全に一定期間の間に分解される。この担体が分解される間、増殖組織は侵入用部位に入り込み、それによって、損傷または病的領域における迅速な組織の再生を促すための「足場」を提供する。この担体は、容易に治癒しない組織領域の治癒を促進するのに特に適している。分解可能な担体は、組織が再生している間、このような組織領域に暫定的な支持を与える。したがって、本発明による好ましい担体は、病的または損傷組織の再生を促進、支持、受容する生浸食性足場状のネットワークを提供する。このようにして、患者は、慣用的な体内棒もしくはピン、またはその他の非分解性物質に伴う不都合な外傷やリスクを被らない。さらに、他の方法を用いた場合、通常の組織では治癒しない傷を治癒させることができる。
【0023】
広くとらえれば、本発明の一実施例は、互いに近接して配置された、異なる機械的特性を有する少なくとも2つの生浸食性ポリマー物質を含む。この2つの生浸食性ポリマー物質は、2つの異なるタイプの組織に隣接する生理的な系に配置することができる。各々のポリマー物質はまた、物質分解を早める酵素またはその他の薬剤を含むことができる。この担体はまた、正常組織の分化および増殖を促進する、1つまたはそれ以上の細胞増殖因子または他の薬剤を含むことができる。1つの物質中の酵素、細胞増殖因子または他の薬剤は、他方の物質中の添加物と異なる比率で混合されて、所望の応用にしたがい、種々の程度の生浸食性または組織再生をもたらす。各ポリマー物質は、好ましくは、多孔構造を有し、この多孔構造の細孔に組織が侵入し、さらに一時的に接着し得る。
【0024】
また別の好ましい実施例では、担体は、組織支持系として皮下に移植することができる。好ましくは担体は、2つの異なるタイプの組織の間の接触領域に移植することができる。少なくとも担体の一部は、第一タイプの組織の成長を受け入れるための侵入用部位を有する第一の物質を含む。さらに、この担体は、第二タイプの組織の成長を受け入れる侵入用部位を有する第二の物質を含む。一旦この担体が埋め込まれると、第一の物質は第一タイプの組織の内に実質的にあり、第二の物質は第二タイプの組織の内に実質的にあることになる。第一の物質内の侵入用部位は、第一の物質の内部へと伸びる細孔を含み、第二の物質内の侵入用部位は、第二の物質の内部へと伸びる細孔を含むことができる。
【0025】
この担体は、生理的な系の2つのタイプの組織(例えば関節軟骨と骨)間の接触領域内に移植することを目的とする。そのような場合、皮膚、その下の軟骨を貫通し、さらに骨の中に入る細孔を開け、それによって、担体を移植することができる通路を提供する。一旦設置されると、担体の第一の物質は実質的に骨内にあって、第二の物質は実質的に軟骨内にあることになる。皮膚はこの担体の上で縫合され、感染が組織領域に侵入するのを防ぐ。
【0026】
本発明はまた、生浸食性担体の製造方法を意図するが、これは、ポリマーを可溶化して粘稠な形態にし、続いてこの粘稠ポリマーから相当量の溶媒を抽出して、得られた修飾ポリマーの内部に細孔を形成することを含む。この修飾ポリマー内部の細孔は、担体の外側表面から続く侵入用部位となる。また、この修飾ポリマーに複数のより大型の通路を機械的加工により配置し、侵入用部位の数を増す。第二の修飾ポリマーは、型(モールド)の中で第一のポリマーおよび第二のポリマーを一緒に接合し加圧硬化させることによって、第一のポリマーに付加することができる。さらに、別の修飾ポリマーもまた付加することができる。
【0027】
本発明には種々の修正および変更形が可能であるが、その特定の実施例を図面の範囲内で実施例として示しながら、ここで詳細に開示する。しかしながら、当該図面はその開示した特定の形に本発明を制限するものではなく、反対に、本発明の目的は、請求の範囲によって限定された発明の概念および範囲内に含まれる全ての修正物、同等物および変更物を含むことは理解されよう。
【0028】
【発明の実施の形態】
さて図面に戻って、第一の生浸食性ポリマー物質14および第二の生浸食性ポリマー物質12を含む担体10を、図1に示す。第一の物質14および第二の物質12は、好ましくは、ポリグリコール酸(polyglycolic acid: PLG)とポリ乳酸(polylactic acid: PLA)の共重合体(各々の濃度は50/50)を基剤とした物質から製造される。PLA/PLG共重合体物質中にさらに含むことができるものは、この共重合体内に均質に分散される酵素で、これは、該ポリマー物質の分解を強化することができる。本発明で用いることができる分解性ポリマー物質は、ポリエステル、ポリアミド、ポリペプチドまたは多糖類といった周知の一般的な分類でしばしば見出されるものである。ある種の典型的な酵素分解性ポリマー物質は、例えば縫合用の生分解性物質として長い間用いられてきた。これらの典型的な生分解性物質は、アルキルヒドロキシル酸類(例えば、乳酸、グリコール酸、ヒドロキシプロピオン酸、ヒドロキシ酪酸のようなモノマー単位およびそれらの組み合わせのポリエステル類を含む)を含む。乳酸およびグリコール酸はこの目的に最も普通に用いられ、好ましくは本発明に使用される。乳酸(PLA)およびグリコール酸(PGA)のポリマーは、特許文献3(引用することにより本明細書の一部とする)に開示されたように、当該技術分野で周知である。
【0029】
本発明を実施するために用いることができる酵素は広範囲であるが、最もしばしば用いられるものは、エステル加水解能を有するプロテアーゼ類またはヒドロラーゼ類である。そのような酵素は、プロテイナーゼK、ブロメライン、プロナーゼE、セルラーゼ、デキストラナーゼ、エラスターゼ、プラスミンストレプトキナーゼ、トリプシン、キモトリプシン、パパイン。キモパパイン、コラゲナーゼ、スブチリシン、クロストリドペプチダーゼA、フィシン、カルボキシペプチダーゼA、ペクチナーゼ、ペクチンエステラーゼ、オキシドリダクターゼまたはオキシダーゼを含む。
【0030】
天然に出現する酵素のポリマー物質またはポリマー材を分解する能力は、当該技術分野で既知である(例えば、非特許文献1参照)。
【0031】
また本発明の物質12および14として適切な比率の50%PLAおよび50%PLGを、担体が配置される組織領域の増殖速度を活発に増加させる、細胞増殖因子(例えば、形質転換細胞増殖因子β(transforming growth factor−β)またはその他の治療薬剤(例えばステロイドやホルモン)とともに埋め込むことができる。ポリマー物質内に治療薬剤を分散させることは当該分野で知られており、ランジャーの著書(非特許文献2)に一般的に記載されている。概略すれば、治療薬剤はポリマー物質内に均質に分散され、取り込まれており、この薬剤の遊離は液体がポリマー物質内を拡散する速度に左右される。周辺組織に制御された速度で侵食によって遊離される治療薬剤の例は、特許文献4(引用することにより本明細書の一部とする)に開示されている。
【0032】
図1に関して、第一の物質14は第二の物質12に結合している。ここで、物質14は、物質12と異なる機械的特性を有する本体を含む。物質14および12は両方とも、第一の物質14と第二の物質12にそれぞれ形成された多数の細孔16および18に加えて、酵素および治療薬剤を含むことができる。細孔の大きさは、物質12および14の処理方法にしたがって変動する。好ましくは、物質12または物質14内の各々の多孔度は、それぞれの物質の物質体積領域の50%より多い。さらに、細孔の大きさは50から200μmの間である。しかし、細孔の密度は以下に述べるように、選択した特定の製造方法にしたがい細孔の大きさ同様、これらの範囲を越えて変動し得ることは理解されよう。好ましくは、物質12は、担体が設置される組織周辺の多孔性と一般的に適合する多孔性を有するように製造される。同様に、物質14はその周辺組織と実質的に同じ多孔性となるよう製造することができる。したがって、所望する特定の用い方にしたがって、担体10の製造方法は、種々の大きさおよび密度の細孔を含むように迅速かつ容易に変更することができる。
【0033】
担体10はまた、部分的にまたは完全に担体10を貫通する複数の通路20を有する。通路20は、周辺組織に入り込みおよび/または一時的に付着し得る部位または場所を提供できるように適切に配置されている。通路20は、一般に細孔16または18より直径が大きく、以下に述べるように機械的方法により設けることができる。
【0034】
細孔16および通路20によって形成される、多数の侵入用部位または侵入場所を有する物質12の断面図が、図1Aに示される。図1Aおよび図1Bの比較で示されるように、物質14は物質12より多孔性は低いが、これは、物質12の周辺組織よりも物質14を取りまくより多孔性の低い組織に実質的に適合させるためである。さらに、物質12および14を配置する組織周辺の機械的特性に実質的に適合するように、多孔性の他に、例えば硬度や圧縮性のような機械的特性を有する物質12および14を製造することができる。
【0035】
多分に異なる機械的特性を有する組織担体10は、異なる機械的特性を有する組織領域が隣合う接合部領域への設置に特に適している。担体10の中の物質はそれぞれ、組織の接合部領域の特性と移植後に実質的に適合するように処理して、例えば多孔性、硬度などの機械的特性を持たせることができる。図2に図示したように、担体10を設置し得る生理的環境は、ヒトまたは動物の軟骨およびその下の骨であるが、これに限られるものではない。担体10は、皮膚24を貫通する穴22に挿入でき、その下の軟骨26および骨に挿入できることが示されている。また別に、担体10は、完全に骨28の中に配置され、皮質骨と網状骨との間の接合部領域に構造的支持を提供することができる。したがって、穴22と移植可能担体10は、異なるタイプの組織間の接合部を有するいずれの生理的な系にも設置することができる。本明細書で用いる「組織」とは、動物またはヒトの組織内の皮下のいずれの場所に見出すことができる細胞性物質をすべて含む。2つの異なるタイプの組織(すなわち、骨、軟骨、腱、皮膚、靱帯、セメント質など)を連結するいずれの領域にも、結合させた担体10の異なる物質12と14を埋め込むことができる。各々の物質を結合させ、この組み合わせを組織接合部に移植する(埋め込む)ことによって、担体10は、組織接合部が修復過程中に離れないように保持することができ、このことは迅速な治癒の促進に役立ち得る。
【0036】
図3は、異なる組織領域内、例えば軟骨26と骨28に完全に埋め込まれた担体10を示す。穴22に担体10を挿入後、外側の皮膚24は、穴の通路の上で縫合され、感染がその下の領域に侵入するのを防止する。本発明から理解し得るように、担体10は、標的領域の大きさおよび構造にしたがい、種々の機械的特性を有するいずれの所望形にも製作できる。この実施例では、担体16の形は円筒形で、問題の領域につくった穴22の内径に適合する外径を有する。しかし、他の形も製作でき、穴に挿入することができる。用いる形に拘わらず、担体は、生体侵食前または侵食中に内腔または骨の大きさに適合するように延長させることができる。さらにまた、物質12および14の釣合いのとれた大きさは、接触面領域に対する担体10の相対的な位置関係にしたがって変動させることができる。例えば、軟骨26は図3に示したものよりも厚いかもしれず、例えば、軟骨の厚さは、骨28内の穴22の深さに等しいかまたはそれより大きいかもしれない。結果として、物質14を物質12より大きくまたは厚く作製して、軟骨26と骨28との間の境界の相対的な移動に対応させることができる。
【0037】
骨28は、上の軟骨26より一般に多孔性が低く、より堅い物質である。したがって、図3に示すように細孔18は細孔16よりも相対的に小さく作製することができる。細孔18と16に与えられた侵入用部位または侵入場所は、一般にそれぞれ周辺の骨28と組織26に適合するように異なっている。骨28と軟骨26の組織が再生し、担体10並びに細孔18および16でそれぞれ部分的に置換された損傷領域内に増殖する間、担体10は幾分硬い支持構造を維持する。担体10の構造が徐々に侵食または分解されるにつれ、組織の再生が起こり、その場所は、侵食の間に失われる構造的支持体と置き換えられる。したがって、本発明は、損傷または不完全領域の再生組織の改良された固定手段を提供し、さらにまた、通常の棒やピンのように後で取り除く必要のない一時的な支持構造を提供する。生浸食性担体10は、脈管構造または細胞集団の欠落のために緩慢な治癒が生じる接合部領域で特に有用である。
【0038】
図4に示すように、担体10を作製する方法は、簡単で、高価な装置を必要としない。特に、ポリマーを基材とする原料30のPLA/PLG混合物は、原料として好ましくは固形のものが用いられる。ポリマーを基剤とする固形の出発材料は、例えばバーミンガムポリマー杜(Birmingham Polymers Inc., Birmingham,アラバマ)から購入できる。原料を混合容器に入れ、アセトンのような液体で可溶化または溶解32して、PLA/PLGポリマーの液状物を生成する。続いてこの液状物をエタノールのような適切な溶媒で沈澱させ34、液相の一部を除去して、適度に粘稠な混合物質を得る。この物質を傍らに取っておき、第一の物質と称する。続いて、可溶化および沈澱工程32、34を、第二の物質のために繰り返す。例えば、第一の物質は、図1〜3に示した、物質14を製造するために用いることができ、第二の物質は、物質12を製造するために用いることができる。
【0039】
最終生成物の多孔性、堅さまたは圧縮性の程度に応じて、多かれ少なかれアセトンおよび/またはエタノールを用いることができる。例えば、アセトンを多く使用する場合は、最終生成物はより高い多孔性、より小さい圧縮硬度およびその結果より低い粘稠度を有する。物質12を軟骨26の近くに配置する場合、物質12を作る.ために用いられる生成物の適切な粘度は、約0.43dl/gm(平均分子量12〜15kD)であろう。反対に、物質14を骨近傍に配置する場合、物質14を作るために用いられる生成物の目標粘度は、約0.53dl/gm(平均分子量は60〜70kD)であろう。埋め込まれる担体10の周辺の組織の機械的特性にしたがい、多かれ少なかれ溶解剤および/または沈澱剤を原料に加えることができ、それによって、得られた生成物は、周辺の組織と実質的に同じ機械的特性を有する。
【0040】
約20ミリトールの適切な真空中に30分放置して、所望の状態までこの物質を乾燥させることによって、得られた生成物は、その機械的特性および所望の多孔性をもつに至る。種々の真空圧をより長時間または短時間用いることによって、この物質の多孔性を増加または減少させることができる。温度調節付き加圧室は、その生成物を配置し得る標的組織領域に機械的に適合するものとするために殆どの溶解剤および沈殿剤を効果的に除去するのに適している。
【0041】
一旦生成物を加圧し、原体材料内に細孔を付与した後、この材料を型(モールド)に入れる。好ましくは、型は、修飾した材料を受け入れるための1つまたはそれ以上の窪みをもつテフロン材(「テフロン」は登録商標)で作製される。型の各窪みは、担体10に要求される特定の幾何学的構造にしたがって成形される。第一の物質14または第二の物質12のいずれかが初めに型に入れられ、さらにプラグもまた型に挿入される。このプラグを当該材料に向けて作用させることができ、それによって、当該プラグと型の周壁との間の物質を加圧(36)することができる。
【0042】
このプラグは複数の長く伸びた鋭利な歯を含むことができ、これは少なくとも部分的に当該物質中に入り込み、例えば円筒形の担体構造の長軸に沿って伸びる通路20を形成する。プラグによる圧縮の時間は、所望の機械的特性にしたがって変動させることができる。例えば、より強い圧縮によって低多孔性、低圧縮性の物質を生じ、これは、より重く、より密度の高い組織(例えば皮質骨)に適しており、一方、弱い圧縮によって、高多孔性、高圧縮性物質を生じ、これは軟骨や靱帯のようなより軽い組織の置換に適している。骨が第一の物質14が配置される標的領域である場合、プラグを介した加圧硬化は室温で約48時間継続させることができる。しかしながら、硬化の程度は、所望の機械的特性にしたがい大幅に変更することができる。
【0043】
また別のバッチの物質、例えば第二の物質12を、例えば第一の物質14に接してその上に加える(38)ことができる。続いて第一および第二の物質、14と12に、その中に縦方向に伸びる歯をもつプラグを介して加圧硬化を施す。加圧硬化は大幅に変動させることができるが、好ましい時間は約48時間で、先の物質の硬化時間と同じである。第一および第二の物質14と12の組み合わせが型内で完全に硬化した後、得られた担体10を型から取り出し、または抜き取り、前記の歯によって作られた通路に対して実質的に垂直な打抜き穴を担体に配置する。担体10に打抜き穴または横方向通路20を配置する好ましい方法は、直径が約1.5mmの通路を作る特別な平面上で担体10を回転させることを含む。
【0044】
得られた担体10は、適度に硬く、しかも多孔質の多相構造を有する、型または接着によって作られた第一および第二の物質14と12を含み、その後これは、最終的には20ミリトール、40℃で48時間凍結乾燥され、溶媒の残りが除かれる。第一の物質14は巨大孔と微小孔を有するが、より大きな分子量、より長時間の硬化、さらにより高い圧縮性を有するために、おそらく物質12よりより剛性が高いであろう。第一の物質14は、好ましくは密度の高い組織(例えば肋軟骨下の骨)と結びつき、増殖骨組織の固定を提供するが、一方、第二の物質12は、密度の低い組織(例えば軟骨)と結びつく。
【0045】
図2および3に示したように、担体10は、骨軟骨欠損領域にプレス挿入(圧入)できる。生浸食性物質14と12の膨張特性は、欠損領域内の担体10の保持を改善すると期待される。周辺組織の機械的特性に類似する物質14および12の特性は、接合部が連結される間、圧迫が集中するのを防ぐ。機械的特性(例えば多孔性)を適合させることによって、組織から担体10への栄養物の交換が、あたかも正常な増殖パターンのように提供される。担体10の共焦点レーザー走査電顕写真によって、種々の大きさの細孔16と18をもつ担体10を明らかにすることができるが、これは、一般に微小孔を有する多孔質で、当該物質の断面領域のすみからすみまで互いに連絡しあいうる。
【0046】
本発明の前述の記載は、特定の実施例についてであるが、この担体並びにその製造および使用方法に関する修飾と変更は、本発明の範囲を逸脱すること無く為され得ることは、当業者にとって明白であろう。例えば、硬化時間および圧力は、溶解剤と沈殿剤の相対的濃度と同様に変更し得る。さらに、担体10は、それが設置される特定の環境にしたがい、種々の大きさや形にすることができる。さらにまた、種々の量の酵素または他の薬剤をポリマー物質に取り込ませ、要求される治癒時間の程度に応じて、侵食性を変えることができる。最後に、種々の量の細胞増殖因子、ホルモンまたはその他の薬剤をポリマー物質に取り込ませ、この移植物の組織の増殖および修復の誘発、促進さらに支援能力を変えることができる。したがって、以下の請求の範囲の目的は、本発明の真髄および範囲内に含まれるすべての同等な修正および変更を包含することである。
【図面の簡単な説明】
【図1】図1は、本発明の二相性担体の斜視図である。
図1Aは、平面A−Aで切断した図1の断面図である。
図1Bは、平面B−Bで切断した図1の断面図である。
【図2】図2は、本発明の組織担体を埋め込むために調製した生理的な系の一例の断面図である。
【図3】図3は、本発明の組織担体を埋め込まれた生理的な系の一例の断面図である。
【図4】図4は、本発明の二相性担体を製造するために用いられる工程の流れ図である。
【符号の説明】
10 担体
12,14 生浸食性ポリマー物質
16,18 細孔
20 通路
22 穴
24 皮膚
26 軟骨
28 骨
Claims (9)
- 生浸食性ポリマー物質(12)を含み、該ポリマー物質が、使用時に軟骨内に移植できるように調整されており、該ポリマー物質が該軟骨の剛性特性を有する、生浸食性組織移植片。
- 生浸食性ポリマー物質(12)を含み、該ポリマー物質が、使用時に骨内に移植できるように調整されており、該ポリマー物質が該骨の剛性特性を有する、生浸食性組織移植片。
- 移植される軟骨または骨の圧縮率特性を有する、請求項1または2のいずれかに記載の移植片。
- 内部に組織の増殖を受け入れる侵入用部位を有し、上記ポリマー物質内に伸びる通路(20)を含む、請求項1〜3のいずれかに記載の移植片。
- 組織の内方成長および修復を誘発、促進または支援する細胞増殖因子または治療薬剤を上記ポリマー物質内に包含させた、請求項1〜3のいずれかに記載の移植片。
- 生浸食性ポリマー物質を含み、該ポリマー物質が、生理的な系で使用されるとき、皮下組織に移植することができるようにされており、該ポリマー物質は、該組織の剛性特性および圧縮率特性を有する生浸食性組織移植片。
- 使用中のポリマー物質の分解を早めるように調整されている分解剤を含む、請求項1〜6のいずれかに記載の移植片。
- 細孔を有し、該細孔の大きさが50〜200マイクロメートルである、請求項1〜7のいずれかに記載の移植片。
- 細孔を有し、実質的に骨に匹敵する多孔性特性を有する、請求項2に記載の移植片。
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AU (1) | AU667877B2 (ja) |
CA (1) | CA2117379C (ja) |
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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- 1993-02-12 EP EP93905051A patent/EP0625891B1/en not_active Expired - Lifetime
- 1993-02-12 JP JP5514318A patent/JPH07503869A/ja active Pending
- 1993-02-12 CA CA002117379A patent/CA2117379C/en not_active Expired - Fee Related
- 1993-02-12 AU AU36192/93A patent/AU667877B2/en not_active Expired
- 1993-09-20 US US08/123,812 patent/US5607474A/en not_active Expired - Lifetime
-
1997
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US7988716B2 (en) | 2004-04-26 | 2011-08-02 | Howmedica Osteonics Corp. | Stent for a vascular meniscal repair and regeneration |
US9289201B2 (en) | 2006-08-07 | 2016-03-22 | Howmedica Osteonics Corp. | Medical device for repair of tissue and method for implantation and fixation |
JP2010505480A (ja) * | 2006-10-06 | 2010-02-25 | セルゲン エージー | 3次元的な人工的仮骨延長 |
JP2012500059A (ja) * | 2008-08-13 | 2012-01-05 | スメド−ティーエイ/ティーディー・エルエルシー | 空間的に変動する孔隙率を備えた整形外科用移植片 |
JP2010240412A (ja) * | 2009-03-31 | 2010-10-28 | Tyco Healthcare Group Lp | 複数ゾーン移植物 |
JP2010240413A (ja) * | 2009-03-31 | 2010-10-28 | Tyco Healthcare Group Lp | 複数ゾーン移植物 |
JP2010240416A (ja) * | 2009-03-31 | 2010-10-28 | Tyco Healthcare Group Lp | 複数ゾーン移植物 |
Also Published As
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WO1993015694A1 (en) | 1993-08-19 |
CA2117379A1 (en) | 1993-08-19 |
JPH07503869A (ja) | 1995-04-27 |
EP0625891B1 (en) | 1997-01-08 |
DE69307299D1 (de) | 1997-02-20 |
CA2117379C (en) | 1999-11-16 |
US5607474A (en) | 1997-03-04 |
AU3619293A (en) | 1993-09-03 |
AU667877B2 (en) | 1996-04-18 |
EP0625891A1 (en) | 1994-11-30 |
HK71597A (en) | 1997-06-06 |
DE69307299T2 (de) | 1997-04-30 |
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