JP5611980B2 - 組織のロール型足場 - Google Patents
組織のロール型足場 Download PDFInfo
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- JP5611980B2 JP5611980B2 JP2011543718A JP2011543718A JP5611980B2 JP 5611980 B2 JP5611980 B2 JP 5611980B2 JP 2011543718 A JP2011543718 A JP 2011543718A JP 2011543718 A JP2011543718 A JP 2011543718A JP 5611980 B2 JP5611980 B2 JP 5611980B2
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Description
本発明は、2008年12月31日に出願した、米国暫定特許出願第61/142,053号及び第61/142,065号の優先権を主張する。この出願はまた、2009年8月18日に出願した米国暫定特許出願第61/234,692号、及び2009年9月1日に出願した米国暫定特許出願第61/238,770号の優先権を主張する。これらの各出願は、ここに、全体を引用して組み込まれている。
臨床研究と診療は、組織部位近位に減圧を提供することが、その組織部位において新しい組織の成長を増進及び促進することを示している。この現象の適用は数多くあるが、減圧の適用は創傷治療に特に成功している。この治療(医学界では、頻繁に、「負圧創傷治療」、「減圧治療」、又は「真空治療」と呼ばれる)は、より早い治癒、及び肉芽組織の良好な形成を含む、多くの利点を提供する。典型的には、減圧は、多孔パッドあるいはその他のマニフォールドデバイスを介して組織に適用されている。多孔パッドは、減圧を組織に分配して、組織から取り出した流体を導くことができる孔を含んでいる。多孔パッドは、しばしば、治療を容易にするその他の部材を有するドレッシングに組み込まれている。足場も、欠陥部位に配置して、欠陥部位内への組織の成長をサポートすることができる。この足場は、通常、生体吸収性であり、新しい組織を適所に残す。
フローは、機械的、化学的、及び/又は電気的ポテンシャルを変更する方法あるいは装置によって、組織空間内へ、組織空間を通って、あるいは組織空間から誘導される。これらのフロー発生器は、組織部位、内因性あるいは外因性流体の部位又はリザーバから、フロー発生器の位置あるいはその延長エレメント(すなわち、マニフォールド又は足場)の配置位置へ、ポテンシャルに勾配あるいは変化を付ける。一の実施例では、フロー源が、減圧源を具えている。本発明のシステム及び装置は、また、アプリケーションとマニフォールドに適用する負圧量を制御するバルブあるいはバルブアレイを具える。所定の態様では、ここに述べた足場及び/又はマニフォールドが、圧力センサを具える。このように、いくつかの実施例では、源によって適用される負圧量が、マニフォールド又は足場で、あるいは組織ダメージ部位において検出される負圧量に基づいて調整される。
フロー発生器は、流体フローを刺激する駆動力である。マニフォールドは、フロー源あるいはフロー発生器と、組織空間との間のフローパターンを改善する装置である。マクロスケールレベルのフローは、単一ポイントへ、あるいは複数の選択的に配置されたポイントへ局在化するために使用される特別なマニフォールドによって改善され、マニフォールド/足場、及び、最終的には組織空間内のマイクロスケールフロー経路の開始部位を作る。マニフォールドは、また、組織空間からの流体を除去する導管及び、組織空間へ外因性流体を送達する装置としても作用する。
組織再生の分野では生物学的及び合成足場を用いて、組織修復と再生用に、タンパク質付着と細胞の内方成長をサポートしている。足場技術におけるこの分野の現状は、タンパク質吸収と、細胞の移動のための周辺組織空間の固有の特性に頼っている。本発明によって使用する足場は、マニフォールドに連結されており、組織部位における流体フローの経路を導く物理的ガイダンスを提供して、付着したタンパク質と細胞のそれぞれの動きと移動用の道を作っている。これは、組織空間内で所定の組織化パターンをつくる暫定マトリックスの設定に一体化されている。流体フロー導入型及び勾配導入型の組織生成について述べた方法と装置は、足場の設計に直接関係する。このコンテキストにおいて、足場は、流体源からマニフォールド内のフロー開始ポイントへの、組織空間内の流体フローの経路を細胞レベルパターンに改善するように働く。足場は、マニフォールドの特徴を具体化する、あるいはマニフォールドと組み合わせて、組織部位内のフロー経路の改善を行う。所定の態様では、足場は、空隙率が高い改良型生体吸収特性を有する網状構造である。
所定の態様では、本発明にかかる装置及び方法は、生物活性材に関する。生物活性材は、いくつかの場合は、マニフォールドあるいは足場材料に直接組み込まれていても良い(すなわち、生物活性マニフォールド及び/又は足場を作る)。例えば、コラーゲンあるいはフィブリンなど組織の成長を容易にする物質を、マニフォールド又は足場材料の上あるいは中に直接組み入れることができる。同様に、異常な免疫反応を防ぐ必要がある(例えば、組織移植)ようなアプリケーションでは、ラパミシンなどの免疫調整材をマニフォールド又は足場構造に組み込むことができる。
ここに開示された装置とシステムは、以下のものを含む様々なコンテキストにおいて、組織修復及び再生に使用することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、損傷部位又は機能障害部位において欠損組織の再生を促す。外傷、手術、やけどあるはその他の原因(例えば、炎症あるいは自己免疫障害)による組織欠損は、本発明の方法、足場、マニフォールド、フロー源及びシステムを用いて再生することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、例えば、自己免疫障害や、ブドウ球菌感染症などの消耗性感染症で生じるような、病気に冒された組織の病変進行を遅らせることができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、インビボでの研究、エックスビボでの足場又はインプラントの準備、あるいはインビボでの移植において、脂肪組織などの移植された組織の生存能力を維持することができる。マニフォールドと組み合わせたフロー発生器を用いて、組織に栄養素流体フローを提供し、組織からの廃棄物の除去を制御することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、既存の組織の拡張を促進することができる。本発明の方法、足場、マニフォールド、フロー源及びシステムを用いて、追加の組織量を必要とする、あるいは所望される場合に組織の成長を促すことができる。組織の拡張は、インビボでも、例えば、必要な栄養素を組織に提供する組織培養環境などのエックスビボでもできる。ここでは、栄養素が減圧の適用によって注入される。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、自然治癒反応において組織形成速度を速めることができる。本発明の方法、足場、マニフォールド、フロー源及びシステムを用いて、暫定マトリックスの形成を強化し、安定した位置決めを容易にし、組織空間への細胞の回復を助けることによって、組織の成長を早めることができる。同様に、ここに開示した装置と方法を用いて、選択した組織部位において新しい組織の形成を促進することができる。このような新しい細胞形成を用いて、組織部位をバルキング(すなわち、体積と質量を加える)することができる。このような方法を用いて、傷害によって失われた、又は成長する間の奇型による組織特徴を再生する、あるいは特徴の外観を改良することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、幹細胞又はその他の多能性細胞の特定の系統への分化を刺激することができる。本発明の方法、足場、マニフォールド、フロー源及びシステムを用いたフローアプリケーションは、組織空間において発育を助ける必要がある特定の細胞系統へ多能性細胞を方向づけることができる。例えば、脂肪(例えば、茶色又は白色含脂肪細胞)前駆細胞を、組織薄層の部分として提供し、インビトロで、あるいはインビボの組織部位で、マトリックス上で成長させることができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、外因性成長ファクタ、たんぱく質、細胞、あるいは薬剤を組織空間に導入して、組織修復、再生、及び/又は、維持を強化することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、インビボでの移植に順次使用できる、インビトロでのマトリクスの形成を容易にすることができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、移植した組織の宿主環境との一体化を促進することができる。これは自己移植、同種移植、あるいは異種移植に適用することができる。移植した組織は、周辺組織から、あるいは吸引脂肪などの順次分裂した組織から、切除した全組織部位であっても良い。このようなアプリケーションでは、マニフォールド材料は、免疫抑制剤を含んでおり、組織の拒絶のチャンスを低減することができる。
フロー発生器をマニフォールド及び/又は足場と組み合わせて、細胞と組織によって発現したECMの付着とオリエンテーションを案内することができる。ECMのオリエンテーションは、続く細胞層と組織の付着及びコロニー化を組織化し、方向づける際にインパクトを有する。
米国特許番号 4,787,906
米国特許番号 6,103,255
米国特許番号 6,135,116
米国特許番号 6,365,146
米国特許番号 6,695,823
米国特許番号 6,696,575
米国特許番号 6,767,334
米国特許番号 6,814,079
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米国特許番号 6,994,702
米国特許番号 7,004,915
米国特許番号 7,070,584
米国特許番号 7,077,832
米国特許番号 7,108,683
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米国特許番号 7,186,244
米国特許番号 7,214,202
米国特許番号 7,279,612
米国特許番号 7,316,672
米国特許番号 7,346,945
米国特許番号 7,351,250
米国特許番号 7,384,786
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Claims (28)
- キャビティを有する創傷を治療するシステムにおいて:
減圧を供給する圧力源と;
足場薄層と組織薄層を具える足場であって、当該足場薄層が多孔性構造及びエッジを有し、前記組織薄層と流体連通する積層を形成しており、当該積層が二つの端面を有するほぼ円筒形状に巻かれており、前記足場が前記創傷のキャビティ内で位置決めを行い、前記創傷に減圧を提供するためのものである、足場と;
前記圧力源と前記足場に流体連通して、前記足場薄層と前記創傷に減圧を提供するマニフォールドとを具え、
前記足場が組織形成用の構造的なマトリックスを提供することを特徴とするシステム。 - 請求項1に記載のシステムが更に、実質的に不浸透性材料で形成したドレープを具え、前記創傷内の前記足場と前記マニフォールドを覆い、前記マニフォールドによって提供される場合に、前記創傷内の減圧を実質的に維持する、ドレープを具えることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記マニフォールドが前記足場の一方の端面近傍に、前記足場薄層の一方の端面に流体連結して配置されていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記積層が更に、巻いた積層の端部部分を、やはり端部部分を具える足場薄層と共に具え、前記マニフォールドが前記足場薄層の端部部分と流体連通していることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記組織薄層が脂肪組織を具えることを特徴とするシステム。
- 請求項5に記載のシステムにおいて、前記脂肪組織が吸引脂肪由来であることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記組織薄層が同種移植片、自己移植片、あるいは異種移植片を具えることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記足場薄層が生体不活性材料あるいは生体吸収性材料でできていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記足場薄層が発泡体又はゲル材料でできていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記足場薄層が、抗生物質、抗体、及び成長ファクタからなる群から選択された生物活性剤を具えることを特徴とするシステム。
- 請求項10に記載のシステムにおいて、前記生物活性剤が、成長ホルモン(GH)、骨形態形成たんぱく質(BMP)、形質変換成長ファクタ−α(TGF−α)、TGF−β、繊維芽細胞成長ファクタ(FGF)、顆粒球−コロニー刺激ファクタ(G−CSF)、顆粒球/マクロファージ−コロニー刺激ファクタ(GM−CSF)、上皮成長ファクタ(EGF)、血小板由来成長ファクタ(PDGF)、インスリン様成長ファクタ(IGF)、脈管内皮成長ファクタ(VEGF)、肝細胞成長ファクタ/散乱ファクタ(HGF/SF)、インターロイキン、腫瘍壊死ファクタ−α(TNF−α)、あるいは神経成長ファクタ(NGF)であることを特徴とするシステム。
- 請求項8に記載のシステムにおいて、前記足場薄層がコラーゲンでできていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記マニフォールドが生物不活性材料でできていることを特徴とするシステム。
- 請求項1に記載のシステムにおいて、前記マニフォールドが生体吸収性材料でできていることを特徴とするシステム。
- キャビティを有する創傷を治療する装置において:
足場薄層と組織薄層を具える足場であって、当該足場薄層が多孔性構造及びエッジを有し、前記組織薄層と流体連通する積層を形成しており、当該積層が二つの端面を有するほぼ円筒形状に巻かれており、前記足場が前記創傷のキャビティ内で位置決めを行い、前記創傷に減圧を提供する、足場と;
減圧源に連結しており、前記足場に流体連通して、前記足場薄層と前記創傷に減圧を提供するポートを有するマニフォールドとを具え、
前記足場が組織形成用の構造的なマトリックスを提供することを特徴とする装置。 - 請求項15に記載の装置が更に、実質的に不浸透性材料で形成したドレープを具え、前記創傷内の前記足場と前記マニフォールドを覆い、前記マニフォールドによって提供される場合に、前記創傷内の減圧を実質的に維持する、ドレープを具えることを特徴とする装置。
- 請求項15に記載の装置において、前記マニフォールドが前記足場の一方の端面近傍に、前記足場薄層の一方の端面に流体連通して配置されていることを特徴とする装置。
- 請求項15に記載の装置において、前記積層が更に、前記巻いた積層の一方の端部に端部部分を、やはり端部部分を具える前記足場薄層と共に具え、前記マニフォールドが前記足場薄層の端部部分と流体連通していることを特徴とする装置。
- 請求項15に記載の装置において、前記組織薄層が、脂肪組織を具えることを特徴とする装置。
- 請求項19に記載の装置において、前記脂肪組織が吸引脂肪由来であることを特徴とする装置。
- 請求項15に記載の装置において、前記組織薄層が同種移植片、自己移植片、あるいは異種移植片を具えることを特徴とする装置。
- 請求項15に記載の装置において、前記足場薄層が生体不活性あるいは生体吸収性材料でできていることを特徴とする装置。
- 請求項15に記載の装置において、前記足場薄層が発泡体又はゲル材料でできていることを特徴とする装置。
- 請求項15に記載の装置において、前記足場薄層が、抗生物質、抗体、及び成長ファクタからなる群から選択された生物活性剤を具えることを特徴とする装置。
- 請求項24に記載の装置において、前記生物活性剤が、成長ホルモン(GH)、骨形態形成たんぱく質(BMP)、形質変換成長ファクタ−α(TGF−α)、TGF−β、繊維芽細胞成長ファクタ(FGF)、顆粒球−コロニー刺激ファクタ(G−CSF)、顆粒球/マクロファージ−コロニー刺激ファクタ(GM−CSF)、上皮成長ファクタ(EGF)、血小板由来成長ファクタ(PDGF)、インスリン様成長ファクタ(IGF)、脈管内皮成長ファクタ(VEGF)、肝細胞成長ファクタ/散乱ファクタ(HGF/SF)、インターロイキン、腫瘍壊死ファクタ−α(TNF−α)、あるいは神経成長ファクタ(NGF)であることを特徴とする装置。
- 請求項22に記載の装置において、前記足場薄層がコラーゲンでできていることを特徴とする装置。
- 請求項15に記載の装置において、前記マニフォールドが生物不活性材料でできていることを特徴とする装置。
- 請求項15に記載の装置において、前記マニフォールドが生体吸収性材料でできていることを特徴とする装置。
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JP2011543715A Expired - Fee Related JP5553417B2 (ja) | 2008-12-31 | 2009-12-29 | 流体の流れを神経組織に提供するシステム |
JP2011543718A Expired - Fee Related JP5611980B2 (ja) | 2008-12-31 | 2009-12-29 | 組織のロール型足場 |
JP2011543712A Expired - Fee Related JP5611979B2 (ja) | 2008-12-31 | 2009-12-29 | 流体の流れを神経組織に提供するシステム[関連出願の相互参照] |
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JP2011543715A Expired - Fee Related JP5553417B2 (ja) | 2008-12-31 | 2009-12-29 | 流体の流れを神経組織に提供するシステム |
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CN (4) | CN102264408B (ja) |
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