JP2010514518A - 生侵食性内部人工器官、及び該生侵食性内部人工器官を製造する方法 - Google Patents
生侵食性内部人工器官、及び該生侵食性内部人工器官を製造する方法 Download PDFInfo
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Abstract
Description
は、実質的に電気陰性の材料を含有する本体を有する。前記電気陽性材料は、前記本体上にコーティングとして提供される。前記内部人工器官は、電気陽性材料及び電気陰性材料を含有する本体を備え、前記電気陽性材料及び電気陰性材料の各々の濃度は本体の長さに沿って変化する。前記内部人工器官は、異なる電流または電流密度を提供する複数の区域を備え、それらの区域は前記内部人工器官の長さに沿って位置する。前記区域は、経時的にほぼ連続して体液に晒され得る。
前記内部人工器官は、ガルバニック腐食によって侵食され、治療効果のために制御された電流を生じる。前記内部人工器官は、埋め込み後に、管腔から除去される必要がなくてもよい。前記内部人工器官は、低い血栓形成性(thrombogenecity)と、高い初期強度とを
有し得る。前記内部人工器官は、拡張後に、低いスプリングバック(はね返り)を示し得る。前記内部人工器官が埋め込まれた管腔は、再狭窄の減少を示し得る。内部人工器官は侵食性であり得る。内部人工器官の異なる部分の侵食速度を制御することができ、内部人工器官が所定の方法で侵食されるのを可能にし、例えば制御されていない破砕及び塞栓の可能性を低減する。例えば、侵食の所定の方法とは、内部人工器官の第1端から内部人工器官の第2端に向かうことであり得る。制御された侵食速度及び所定の侵食の方法は、内部人工器官が特定の程度の侵食に侵食されるのに掛かる時間を延長することができ、内部人工器官が埋め込まれる通路の開存性を維持できる時間を延長することができ、侵食中に放出される粒子の大きさに対するより良好な制御を可能にすることができ、かつ/または、埋め込み通路の細胞が内部人工器官の周りにより良好に内皮化(endothelialize)するのを可能にすることができる。
工器官またはその一部を指す。質量低減は、例えば、内部人工器官を形成する材料の溶解、及び/または内部人工器官の崩壊、及び/またはガルバニック反応によって生じ得る。化学変化としては、内部人工器官またその一部が形成される材料の酸化/還元、加水分解、置換、及び/または付加反応、または他の化学反応が挙げられる。侵食は、生体環境、例えば内部人工器官が埋め込まれる身体自体または体液との内部人工器官の化学的かつ/または生物学的相互作用の結果であってもよく、かつ/または侵食は、内部人工器官に対して、例えば、反応速度を増大するために、化学的反応物またはエネルギーのような引き金となる作用を与えることによって、引き起こされてもよい。例えば、内部人工器官またはその一部は、体内管腔内に埋め込まれるとガルバニック侵食(galvanic erosion)を受け得る、相対的に電気陰性の金属(例えばマグネシウム、鉄)と、相対的に電気陽性の金属(例えば鉄、白金)とから形成され得る。例えば、内部人工器官またはその一部は、例えばマグネシウム、カルシウム、それらの合金などの活性金属から形成することができ、それらの活性金属は、対応する金属酸化物及び水素ガスを生成する水との反応(レドックス反応)によって侵食され得る。例えば、内部人工器官またはその一部は、水による加水分解によって侵食され得る侵食性もしくは生侵食性ポリマー、または侵食性もしくは生侵食性ポリマーのアロイ及び/またはブレンドから形成され得る。前記侵食は、治療効果を提供し得る期間にわたって、望ましい程度で生じる。例えば、内部人工器官のガルバニック侵食は、Mg2+のような治療に有用なイオンを放出することができる。前記治療に有用なイオンは、内部人工器官の良好な内皮化のために細胞増殖を調節することができる。いくつかの実施形態において、ガルバニック侵食は、腫瘍病変の治療、内皮化の促進、及び/または細胞増殖の調節に用いられ得る治療電流を提供する。例えば、内部人工器官は、管腔壁の支持または薬剤送達のような該内部人工器官の機能がもはや必要とされないか、または所望されない場合、一定期間後に、実質的な質量の低減を示し得る。特定の実施形態では、内部人工器官は、埋め込み後、1日以上、例えば約60日以上、約180日以上、約600日以上、または1000日以下において、約10パーセント以上、例えば約50パーセント以上の質量低減を示す。実施形態において、内部人工器官の一部のみが侵食性(erodibility)を示す。例えば、内部層または本体は侵食性であるが、外部層またはコ
ーティングは非侵食性(non-erodible)であってもよい。いくつかの実施形態において、内部人工器官は、内部人工器官の位置の長期にわたる識別を提供し得る放射線不透過性物質の非侵食性コーティングまたは層を備える。
とも約2mA、少なくとも約3mA、少なくとも約4mA、少なくとも5mA、少なくとも6mA、少なくとも7mA、少なくとも8mA、または少なくとも約9mA)、かつ/または多くとも約10mA(例えば多くとも約9mA、多くとも約8mA、多くとも約7mA、多くとも約6mA、多くとも約5mA、多くとも約4mA、多くとも約3mA、多くとも約2mA)の電流密度を有する。いくつかの実施形態において、治療電流は所望の継続時間の所望の範囲内に維持されている電流密度を有する。例えば、内部人工器官の約2パーセントから(例えば約5パーセントから、約10パーセントから、約15パーセントから、または約20パーセントから)、内部人工器官の約95パーセントまで(例えば、約90パーセントまで、約80パーセントまで、約75パーセントまで、約60パーセントまで、約50パーセントまで、約40パーセントまで、約30パーセントまで、約20パーセントまで、約15パーセントまで、約10パーセントまで、または約5パーセントまで)の侵食の間に、電流密度は、約±2パーセント(例えば約±5パーセント、約±10パーセント、または約±15パーセント)に維持され得る。内皮細胞に対するマグネシウムイオンの作用は、例えば、マイエル(Maier)ら、Biochemica et Biophysica Acta、第1689巻(2004年)、第6〜12頁にさらに記載されている。腫瘍病変の治療における電流の作用は、例えば、ニルソン(Nilsson)ら、Bioelectrochemistry and Bioenergetics、第47巻(1998年)、第11〜18頁、及びフォン オイラー(von Euler)
ら、Bioelectrochemistry、第62巻(2004)、第57〜65頁に記載されている。
細胞増殖の調節における電流の使用は、例えば、シ(Shi)ら、Biomaterials、第25巻(
2004年)、第2477〜2488頁に記載されている。
て内部人工器官本体を端54から接合部50へと徐々に体液に露出させる。生侵食性ポリマーコーティング56の厚さを調整することによって、侵食が接合部50に向かって進行するにつれて、露出の面積が減少することが可能であり、電流密度を所望の期間にわたって所望の範囲内に維持するのを助けることができる。
、第46巻(2004年)、第955〜977頁に記載されているように、アノードとカソードとの間の距離の増大の関数として指数関数的に減少し得る。電流制御層は、上記に図示したように侵食性であってもよいし、または非侵食性であってもよい。非侵食性コーティングは、例えば厚みの変化の代わりに、またはそれに加えて、ステントの長さに沿った空隙率を変化させることによって、ステント本体の体液への露出を制御することができる。電流制御層は、例えばポリマー、セラミック、または金属であり得る。電流制御層の組成は、ステントの長さに沿って変化することができる。電流制御層はまた、多孔性非侵食性層を覆う侵食性層のような複数の層を備えることができる。内面及び外面のようなステントの異なる領域において、異なる材料、厚さ及び空隙率を用いることができる。
は、生体液中に浸漬されると、ガルバニック腐食によって侵食され得るガルバニ電池または生体電気バッテリーを形成することができる。いくつかの実施形態において、内部人工器官本体は、ほぼ純粋な金属元素、合金または複合材の形態にある1つ以上の相対的に電気陰性の金属を含有する。適当な電気陰性金属としては、マグネシウム、鉄、亜鉛及びそれらの合金のような金属元素が挙げられる。合金の他の例としては、重量で、50〜98%のマグネシウム、0〜40%のリチウム、0〜5%鉄、及び5%未満の他の金属または希土類;または79〜97%のマグネシウム、2〜5%のアルミニウム、0〜12%のリチウム及び1〜4%の希土類(セリウム、ランタン、ネオジム及び/またはプラセオジムなど);または85〜91%のマグネシウム、6〜12%のリチウム、2%のアルミニウム及び1%の希土類;または86〜97%のマグネシウム、0〜8%のリチウム、2%〜4%アルミニウム及び1〜2%の希土類;または8.5〜9.5%のアルミニウム、0.15%〜0.4%のマンガン、0.45〜0.9%の亜鉛及び残量のマグネシウム;または4.5〜5.3%のアルミニウム、0.28%〜0.5%のマンガン及び残量のマグネシウム;または55〜65%のマグネシウム、30〜40%のリチウム及び0〜5%他の金属及び/または希土類のような、マグネシウム合金が挙げられる。マグネシウム合金はまた、AZ91D、AM50A及びAE42という名称で入手可能である。他の侵食性金属または金属合金は、ボルツ(Bolz)の米国特許第6,287,332号(例えば亜鉛−チタン合金及びナトリウム−マグネシウム合金);ヒューブライン(Heublein)の米国特許出願第20020004060号;及びパーク(Park)、Science and Technology of Advanced Materials、第2巻、第73〜78頁(2001年);及びヒューブラインら、Heart
、第89巻、第651〜656頁(2003年)に記載されている。上記文献のすべては、参照により余すところなく本願に援用される。具体的には、パーク(Park)は、Mg−X−Ca合金、例えばMg−Al−Si−Ca、Mg−Zn−Ca合金を記載している。
たは少なくとも約40mm2)かつ/または、多くとも約50mm2(例えば多くとも約40mm2、多くとも約30mm2、多くとも約20mm2、多くとも約10mm2、多くとも約5mm2、多くとも約2mm2または多くとも約1mm2)の面積を有し得る。
とも約100ナノメートル、多くとも約10ナノメートル)の厚さを有する。前記厚さは均一であってもよいし、または不均一であってもよい。例えば、前記厚さは、内部人工器官の一端から他端へと、全体的に直線的に、全体的に非直線的に(例えば全体的に放物線状に増大、全体的に指数関数的に増大)、または段階的に、増大し得る。内部人工器官上の所与の位置におけるポリマー層の厚さは、所望の電流密度と関連付けられ得る。例えば、より長期間にわたって侵食されるより厚いポリマー層は、電気陰性金属カソードの体液への露出の速度を低減することによって、相対的に高い電流密度を減ずることができる。より短期間にわたって侵食されるより薄いポリマー層は、電気陰性金属カソードの体液への露出の速度を増大させることによって、相対的に低い電流密度を補償することができる。いくつかの実施形態において、前記層は内部人工器官本体を部分的に被覆する。例えば、前記層は内部人工器官本体の表面積の少なくとも約10パーセント(例えば少なくとも約20パーセント少なくとも約30パーセント、少なくとも約40パーセント、少なくとも約50パーセント、少なくとも約60パーセント、少なくとも約70パーセント、少なくとも約80パーセント、少なくとも約90パーセント、または少なくとも約95パーセント)、かつ/または多くとも100パーセント(例えば多くとも約95パーセント、多くとも約90パーセント、多くとも約80パーセント、多くとも約70パーセント、多くとも約60パーセント、多くとも約50パーセント、多くとも約40パーセント、多くとも約30パーセント、または多くとも20パーセント)を被覆することができる。
。酸化物層のような電流制御層は、例えば、ユー(You)ら、Scripta mater、第42巻(2000年)、第1089〜1094頁に記載されているように、周囲温度または高温で前記チューブを空気に晒すことによって、生侵食性チューブの表面上に形成され得る。いくつかの実施形態では、例えば、ワン(Wan)ら、南交通大学(South Jiaotong University)、成都(Chengdu)、2005年及びグレイ(Gray)ら、Journal of Alloys and Compounds、第336巻(2002年)、第88〜113頁に記載されているように、酸化物層はプラズマ侵入イオン注入を用いて堆積される。酸化物、水素化物、及び/またはフッ化物層を形成する方法としては、例えばガスト(Gust)ら、Thin Solid Films、第383号(2001年)、第224〜226号に記載されているような真空アーク堆積、並びに、例えばバッカー(Bakker)ら、Corrosion Science、第47巻(2005年)、第1211〜1225
頁及び2006年10月20日出願の米国仮特許出願第60/862,318号に記載されているような電気化学的イオン還元及びプラズマ侵入イオン注入が挙げられる。前記マスクは、後の工程に進む前に、周囲雰囲気または不活性雰囲気下において除去することができる。
載されているように、アノード層はパルスレーザー堆積法によって内部人工器官の一部の上に堆積され得る。例えば、内部人工器官が電流制御層形成前にマスクされていた場合には、アノードは内部人工器官本体の陰極材料と特定の部分において直接接触し得る。いくつかの実施形態では、アノード層とカソードとの間の電気的接触を得るために、レーザーを用いて不活性雰囲気下で内部人工器官に凹部(例えば凹部48)を形成し、アノード材料の少なくとも一部がカソード材料と直接接触するように、前記凹部をパルスレーザー堆積法によって陽極材料で充填し得る。いくつかの実施形態では、アノードは、金属クラスターアレイの形態にある。該アレイは、例えば無電解めっき法及びリソグラフィー法によって形成することができる。
い。例えば、内部人工器官の中間部分は、より大きな厚みのゆっくりと侵食され得る第1ポリマーを有し、内部人工器官の端部分は、より小さな厚みの急速に侵食され得る第2ポリマーを含んでもよい。侵食の指向性は、体内管の特定位置(例えば弱化された位置)に対する開存性のより一層の維持を可能にすることができる。ポリマー層は、同一の方法または異なる方法で施され得る。例えば、第1の、最内側ポリマー層は内部人工器官前駆体上に噴霧被覆することができ、第2の、外側ポリマー層は、第1層上に浸漬被覆されたポリマーを備え得る。
れる(工程314)。プラズマ侵入イオン注入は、例えば、ワン(Wan)ら、南交通大学(South Jiaotong University)、成都(Chengdu)、2005年、及びグレイ(Gray)ら、Journal
of Alloys and Compounds、第336巻(2002年)、第88〜113頁に記載されている。第1生侵食性材料よび第2生侵食性材料はガルバニ対を形成する。次に、1つ以上の電流制御コーティング(例えば酸化物、水素化物、及び/またはフッ化物層)及び/または1つ以上の電流制御ポリマー層が、前記生侵食性チューブに施される(工程316及び工程318)。次に、例えば、最終内部人工器官にストラットを提供するために、生侵
食性チューブの選択部分を除去することができる(工程320)。いくつかの実施形態で、生侵食性チューブの選択部分の除去は、対向電極の勾配の形成の前または後に行われる。
第6,726,712号に記載されている。内部人工器官及び内部人工器官の搬送はまた、ミネソタ州メープルグローブ所在のボストン サイエンティフィック シメッドから入手可能なRadius(登録商標)またはSymbiot(登録商標)システムによって例示される。
いくつかの実施形態では、アノード及びカソードの位置によって、内部人工器官は、内部のカソード面から外部のアノード面へ、外部のカソード面から内部のアノード面へ、中央のカソード部分から外部及び内部のアノード部分へ、または外部及び内部のカソード部分から中央のアノード部分へと連続して侵食されるように構成されている。これらの構造は、内部人工器官が初期には複数の層の強度を用いて体内管を支持し、厚さを経時的に(例えば細胞が内部人工器官を内皮化した後に)減少させるのを可能にすることができる。厚さの減少は、内部人工器官の可撓性を増大させて、体内管の自然な状態により適合させることができる。
化剤、抗炎症剤、麻酔剤、抗凝血剤及び抗生物質が挙げられる。治療薬、薬剤または薬学的活性化合物は、内部人工器官によって保持されたポリマーコーティング内に分散させることができる。ポリマーコーティングは単層を越えるものを含むことができる。例えば、コーティングは、二層、三層または、それ以上の層、例えば五層を有し得る。前記治療薬は、遺伝子治療薬(genetic therapeutic agent)、非遺伝子治療薬(non-genetic therapeutic agent)または細胞であり得る。治療薬は、単独でまたは組み合わせて用いることができる。治療薬は、例えば非イオン性であってもよいし、または治療薬はアニオン性及び/またはカチオン性であってもよい。治療薬の一例は、パクリタキセルのような再狭窄を抑制するものである。治療薬はまた、例えば、疼痛、内部人工器官の付着物、または治療した管腔の硬化または壊死を治療及び/または抑制するために用いることができる。上記コーティング及び/またはポリマー部分のいずれも染色されるか、または放射線不透過性にされ得る。
他の実施形態は特許請求の範囲内に存する。
Claims (28)
- 間にガルバニ電池が形成される相対的に電気陰性の材料及び相対的に電気陽性の材料と、
内部人工器官が分解するときに、ガルバニ電池の電流または電流密度を調節するのに有効である、内部人工器官の少なくとも一部を覆う電流制御コーティングとを備える生侵食性内部人工器官。 - 前記電流制御コーティングは、前記電気陰性材料及び電気陽性材料の少なくとも一方の体液への露出を制御する請求項1に記載の内部人工器官。
- 前記電流制御コーティングは、可変の厚さ、侵食速度、及び/または空隙率を有する請求項2に記載に記載の内部人工器官。
- 前記電流制御コーティングの厚さはステントの軸線に沿って変化する請求項3に記載の内部人工器官。
- 前記電流制御コーティングの厚さは直線的に変化する請求項4に記載の内部人工器官。
- 前記電流制御コーティングの厚さは非直線的に変化する請求項4に記載の内部人工器官。
- 前記電流制御コーティングの厚さは放物線状に変化する請求項6に記載の内部人工器官。
- 前記電流密度は時間の関数として増大する請求項1に記載の内部人工器官。
- 前記電流制御コーティングは、ポリマー、セラミック、または金属である請求項1に記載の内部人工器官。
- 前記内部人工器官は、実質的に電気陰性材料を含有する本体を有する請求項1に記載の内部人工器官。
- 前記電気陽性材料は、前記本体上にコーティングとして提供されている請求項10に記載の内部人工器官。
- 前記内部人工器官は、前記電気陽性材料及び前記電気陰性材料を含有する本体を有し、前記電気陽性材料及び前記電気陰性材料の各々の濃度は、前記本体の長さに沿って変化する請求項1に記載の内部人工器官。
- 前記内部人工器官は異なる電流または電流密度を提供する複数の区域を備える請求項1に記載の内部人工器官。
- 前記区域は内部人工器官の長さに沿って存在する請求項13に記載の内部人工器官。
- 前記区域は経時的にほぼ連続して体液に露出される請求項14に記載の内部人工器官。
- 内部人工器官が体内に埋め込まれたときに、間にガルバニ電池が形成されるカソード領域及びアノード領域を備える内部人工器官であって、
前記アノード領域は、同アノード領域の約5重量パーセント〜約50重量パーセントが
分解する間に、ガルバニ電池によって生じる電流密度が±10パーセントの間に維持されるように、ガルバニック腐食によって分解される、内部人工器官。 - 前記内部人工器官はガルバニック腐食及び生侵食の双方を受ける請求項16に記載の内部人工器官。
- 前記カソード領域及びアノード領域の双方は生侵食性である請求項16に記載の内部人工器官。
- 前記電流密度は、腫瘍治療、再狭窄抑制、または細胞増殖の促進を行うのに十分である請求項16に記載の内部人工器官。
- 前記カソード領域はマグネシウムまたはマグネシウム合金を含有する請求項16に記載の内部人工器官。
- 前記マグネシウム合金は、亜鉛、アルミニウム、マグネシウム、リチウム、鉄、ニッケル、銅及びそれらの合金のうちから選択される材料を含有する請求項20に記載の内部人工器官。
- 前記カソード領域は、鉄、白金及び金のうちから選択される材料を含有する請求項16に記載の内部人工器官。
- ポリマーコーティングをさらに備える請求項16に記載の内部人工器官。
- 酸化マグネシウム、水素化マグネシウム及びフッ化マグネシウムのうちから選択されるコーティングをさらに備える請求項16に記載の内部人工器官。
- 内部人工器官は一端から他端に向かって侵食される請求項16に記載の内部人工器官。
- 間にガルバニ電池が形成される相対的に電気陰性の材料と相対的に電気陽性の材料とを含む本体を備え、前記電気陰性材料及び電気陽性材料の濃度は前記本体の長さに沿って変化する、侵食性内部人工器官。
- 前記本体は、電気陰性材料及び電気陽性材料を含有する合金から形成されている請求項26に記載の内部人工器官。
- 前記本体は電流制御層を備える請求項26に記載の内部人工器官。
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PCT/US2007/088888 WO2008083190A2 (en) | 2006-12-28 | 2007-12-27 | Bioerodible endoprostheses and methods of making same |
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US8715339B2 (en) | 2014-05-06 |
US8080055B2 (en) | 2011-12-20 |
US20120065726A1 (en) | 2012-03-15 |
CA2674195A1 (en) | 2008-07-10 |
US20080161906A1 (en) | 2008-07-03 |
EP2125065A2 (en) | 2009-12-02 |
WO2008083190A2 (en) | 2008-07-10 |
DE602007010669D1 (de) | 2010-12-30 |
EP2277563A3 (en) | 2011-02-23 |
WO2008083190A3 (en) | 2009-08-20 |
WO2008083190A9 (en) | 2008-09-04 |
EP2125065B1 (en) | 2010-11-17 |
EP2277563B1 (en) | 2014-06-25 |
ATE488259T1 (de) | 2010-12-15 |
ES2506144T3 (es) | 2014-10-13 |
EP2277563A2 (en) | 2011-01-26 |
ES2356274T3 (es) | 2011-04-06 |
JP5355418B2 (ja) | 2013-11-27 |
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