JP2010533563A - 吸着抑制表面を有する内部人工器官 - Google Patents
吸着抑制表面を有する内部人工器官 Download PDFInfo
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- JP2010533563A JP2010533563A JP2010517153A JP2010517153A JP2010533563A JP 2010533563 A JP2010533563 A JP 2010533563A JP 2010517153 A JP2010517153 A JP 2010517153A JP 2010517153 A JP2010517153 A JP 2010517153A JP 2010533563 A JP2010533563 A JP 2010533563A
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- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G65/02—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from cyclic ethers by opening of the heterocyclic ring
- C08G65/32—Polymers modified by chemical after-treatment
- C08G65/329—Polymers modified by chemical after-treatment with organic compounds
- C08G65/331—Polymers modified by chemical after-treatment with organic compounds containing oxygen
- C08G65/332—Polymers modified by chemical after-treatment with organic compounds containing oxygen containing carboxyl groups, or halides, or esters thereof
- C08G65/3322—Polymers modified by chemical after-treatment with organic compounds containing oxygen containing carboxyl groups, or halides, or esters thereof acyclic
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/082—Inorganic materials
- A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08G65/00—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule
- C08G65/02—Macromolecular compounds obtained by reactions forming an ether link in the main chain of the macromolecule from cyclic ethers by opening of the heterocyclic ring
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- C08G65/333—Polymers modified by chemical after-treatment with organic compounds containing nitrogen
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
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- C—CHEMISTRY; METALLURGY
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- Chemical & Material Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
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- Organic Chemistry (AREA)
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- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
回復促進表面およびこの表面に結合した一時的吸着抑制材料を含む内部人工器官（例えばステント）と、該内部人工器官の製造方法とを開示する。
Description
本発明は、例えば、吸着抑制表面（ｎｏｎ−ｆｏｕｌｉｎｇ ｓｕｒｆａｃｅ）を有する内部人工器官などの医療器具に関する。
身体には、動脈などの血管や他の体管腔を含めたさまざまな通路がある。これらの通路は、閉塞または弱化することがある。例えば、通路は、腫瘍で閉塞したり、プラークにより狭窄したり、動脈瘤のために弱化したりし得る。そうした際には、医療用内部人工器官を用いて通路を再開もしくは補強するか、さらには通路を内部人工器官と交換したりすることができる。内部人工器官とは、一般的に体内の通路または管腔内に留置される人工移植物をいう。多くの内部人工器官は、例えば、ステントや、ステントグラフト、被覆ステントなどの管状部材である。
内部人工器官は、体内の目的部位、例えば体管腔内の弱化または閉塞した部位に運ぶ際には、縮小または圧縮形態の内部人工器官を支持するカテーテルによって体内に送達することができる。目的部位に到達したら、管腔壁に接触することができるように内部人工器官を拡張する。
内部人工器官の設置に用いる拡張機構は、内部人工器官を径方向に拡張させる機構を含むことができる。拡張は、例えば、バルーンを担持するカテーテルと、体内での最終形態よりも寸法が縮小されたバルーン拡張型内部人工器官とを併用して行うことができる。内部人工器官を管腔壁に接触した状態で所定位置に固定するために、バルーンを膨張させて、内部人工器官を変形かつ／または拡張させる。次いで、バルーンを収縮させて、カテーテルを抜去する。
本発明は、吸着抑制表面を有する内部人工器官などの医療器具を提供することを目的とする。
一態様において、本発明は、触媒材料を含む表面と、該表面に付着させた吸着抑制材料とを有し、吸着抑制材料が表面へのタンパク質の吸着を減少させる、内部人工器官、例えばステントを特徴とする。
別の態様において、本発明は、内部人工器官の製造方法であって、表面を一時的吸着抑制層でコーティングするステップを含んでなり、表面が触媒材料を含んでなり、一時的吸着抑制層が表面へのタンパク質の吸着を減少させて、Ｈ２Ｏ２が表面に到達することを許容する、方法を特徴とする。
態様は以下の特徴を１つ以上含み得る。触媒材料はＨ２Ｏ２の分解を触媒する。触媒材料はセラミックである。触媒材料には酸化イリジウムが含まれる。触媒材料は、窒化チタンおよび白金活性炭から選択される。
さらに、態様は、以下の特徴を１つ以上含み得る。吸着抑制材料には、親水性化合物、例えば、親水性ポリマーが含まれる。親水性化合物としては、ポリエチレングリコール（「ＰＥＧ」）が挙げられる。ＰＥＧは、約１，０００〜約５０，０００の分子量を有する。吸着抑制材料は表面から放出可能である。吸着抑制材料は、この材料を表面に結合する選択的に切断可能な結合（ｐｒｅｆｅｒｅｎｔｉａｌｌｙ ｃｌｅａｖａｂｌｅ ｌｉｎｋ）を有する。この結合は、加水分解性結合、例えばエステル結合である。吸着抑制材料は層を形成する。吸着抑制材料は、第１ブロックと、第１ブロックと表面の間の第２ブロックとを有する。第１ブロックは、タンパク質をはじくという主要機能を有し、第２ブロックは、第１ブロックと表面をつなぐ結合（ｌｉｎｋａｇｅ）という主要機能を有する。第１ブロックと第２ブロックは、選択的に切断可能な結合を介してつながっている。第１ブロックはＰＥＧを含み、第２ブロックは、末端官能化シラン、例えばアミノシラン、例えばアミノプロピルトリエトキシシラン（「ＡＰＴＥＳ」）、および／または内皮細胞結合剤、例えばＲＧＤペプチドフラグメントを含む。第２ブロックと表面は、選択的に切断可能な結合、例えば加水分解性結合を介して結合させることができる。また、第２ブロックは、表面に永久結合させることもできる。
さらに、態様は以下の特徴を１つ以上含み得る。触媒材料を有する表面は、表面を吸着抑制層でコーティングする前に、アミノシラン、例えばＡＰＴＥＳで修飾するか、かつ／または表面を吸着抑制層でコーティングする前に、表面を内皮細胞結合剤、例えばＲＧＤペプチドフラグメントで修飾する。
態様および／または実施形態は、以下のさらなる利点を１つ以上有し得る。内部人工器官、例えばステントは、植え込みにより誘発される過酸化水素を効率的に除去する回復促進（ｐｒｏ−ｈｅａｌｉｎｇ）または触媒表面（例えば、ＩＲＯＸ）を有する。しかし、そのような表面にタンパク質が吸着すると、その効果が減少し得る。回復促進表面上に一時的または短期吸着抑制層を形成することにより、特に、Ｈ２Ｏ２が高濃度で生成されている初期炎症反応ステージにおけるタンパク質の吸着および／または細胞の付着に一時的に抗することができる。吸着抑制層は、Ｈ２Ｏ２を表面に拡散させ、それによって、Ｈ２Ｏ２を水と酸素に変換させる回復促進表面の持続時間を延長することができる。過酸化水素の放出が終わるか、弱まると、吸着抑制層は生分解されるため、回復促進表面は、自然に内皮細胞で被覆されるか、その下層の内皮細胞結合剤を露出させて、内部人工器官の内皮細胞による被覆を助けることができる。吸着抑制層が表面に残留する時間は、各吸着抑制部分と表面との結合化学（ｌｉｎｋａｇｅ ｃｈｅｍｉｓｔｒｙ）を選択することにより予め決定される。結合化学は、例えば物理的引力による、共有結合または非共有結合であり得る。
他の態様、特徴、および利点は、以下の説明や図面、および特許請求の範囲から明らかになるであろう。
図１Ａ〜１Ｃを見ると、ステント１０の植え込み時に、ステントは、カテーテル１４の先端部近くに坦持されるバルーン１２上に配置され、管腔１５を通って、バルーンとステントを坦持する部分が閉塞１８の領域に到達するまで進められる（図１Ａ）。次いで、ステントは、バルーン１２が膨張させられることにより径方向に拡張させられ、管壁に押し付けられる。これにより、閉塞１８が押し込まれて、閉塞１８を取り囲む管壁が径方向に拡がる（図１Ｂ）。次いで、バルーンから圧力を放出し、カテーテルを管から抜去し（図１Ｃ）、ステント１０を管腔１５内に留置する。
ステントの表面近くの領域の略断面図である図２Ａを見ると、吸着抑制部分を有する層２２の形態の吸着抑制材料が、例えばステンレススチールまたはポリマーで形成されるステント本体２０の上の、例えば、酸化イリジウム（「ＩＲＯＸ」）などのセラミックの回復促進表面２１を覆っている。図２Ｂを見ると、ステントの体内管腔での植え込み直後に、吸着抑制層２２は、タンパク質をはじいて、タンパク質の吸着を阻止し、Ｈ２Ｏ２を回復促進表面２１上に拡散させて、触媒的に水分子と酸素分子に分解させることができる。図２Ｃおよび２Ｄを見ると、ステントが植え込まれてから一定期間、例えば、実質的に身体がステントの植え込みを起因とする高レベルのＨ２Ｏ２放出を終えるまでの期間（例えば、約１〜２週間）が経過した後に、吸着抑制層２２は、生分解されるか、回復促進表面２１から分離し、タンパク質は、回復促進層に移動して、この層に特異的に吸着し、次いで、これらのタンパク質上に細胞が接着し、結果として、表面が自然に内皮細胞で被覆される。
例えばステントなどの異物が生物学的環境（例えば、生体内）に導入されると、異物の表面は、通常、生体の生来の防御機構により、数秒で非特異的吸着タンパク質により被覆される。より具体的に言えば、血管内へのステント植え込みに対する人体の初期反応の１つは、血液循環系の構成要素の１つである白血球の活性化である。この活性化により活性酸素化合物が増産される。このプロセスにおける鍵分子の１つは、多種の白血球のうちの１つを構成する好中性顆粒球により放出される過酸化水素、例えばＨ２Ｏ２である。Ｈ２Ｏ２が存在すると、平滑筋細胞の増殖が高まり、内皮細胞機能を弱め得るため、表面結合タンパク質の発現を刺激する。これらの表面タンパク質は、さらに多くの炎症細胞の接着を高める。回復促進表面上の一時的または短期吸着抑制層は、特にＨ２Ｏ２が高濃度で生成されている初期炎症反応ステージにおいて、タンパク質の吸着および／または細胞接着に一時的に抗する。吸着抑制層は、Ｈ２Ｏ２を表面に拡散させることを可能にし、それによって、回復促進表面がＨ２Ｏ２を水と酸素に変換する期間を延長する。過酸化水素の放出が終了または減少すると、吸着抑制層は生分解され、その結果、回復促進表面が自然に内皮細胞で被覆されることを可能にする。吸着抑制層が表面に残留する期間は、各吸着抑制部分と表面との結合力（または耐加水分解性）を制御することにより予め決定される。吸着抑制層は、非触媒層と共に用いてもよいし、直接ステント本体に適用してもよい。
吸着抑制層は吸着抑制部分を有する。実施形態において、強力にタンパク質を吸着する表面は細胞にも結合でき、タンパク質吸着を抑制する表面は細胞接着も抑制するであろう。親水性表面は不可逆的にタンパク質を吸着する傾向が強い。表面へのタンパク質および細胞の結合を減少させる望ましい方法は、表面に吸着抑制層を付けて表面の親水性を高める方法である。吸着抑制部分は、水性生体媒質に溶けている小分子に対する透過性により、過酸化水素を通過させて回復促進表面に到達させることできるだけでなく、付着した分子鎖による立体障害効果に起因するタンパク質吸着に抗し得る。吸着抑制層に移動性タンパク質分子が侵入してテザー鎖（例えば、ポリマー鎖）が可逆的に変形すると、セグメント濃度（例えば、ポリマーセグメントの濃度）が上昇するために鎖のエントロピー弾性と浸透圧との釣り合いによって制御される反発力が生じると考えられる。重なり反発力は、タンパク質分子が下層表面と直接接触することを阻止することができる。さらなる実施形態において、吸着抑制部分は、親水性ポリマーまたは有機分子、例えば、ポリエチレングリコール（「ＰＥＧ」）分子、オリゴエチレングリコール（「オリゴＥＧ」）分子、脂質−オリゴＥＧ分子、Ｐｌｕｒａｃｏｌ（登録商標）ポリオールまたはＰｌｕｒｏｎｉｃ（登録商標）ポリオール（ＢＡＳＦ社から入手可能）、例えば、プロピレングリコールとエチレングリコールのコポリマー、ポリ（２−ヒドロキシエチルメタクリレート）（「ＰＨＥＭＡ」）、ポリビニルピロリドン（「ＰＶＰ」）、ポリアクリル酸（「ＰＡＡ」）およびその誘導体、例えば、ポリアクリルアミド（「ＰＡＡｍ」）、エチレン酢酸ビニルビニルアルコールコポリマー（「ＥＶＡ」）、中性親水性表面基、例えばヒドロキシルを有するポリマー、負の電荷を持つ表面基、例えばカルボン酸もしくはスルホン酸またはそれらの塩を有するポリマー、グライム、ホスホリルコリンポリマー（例えば、ポリ（２−メタクリロイルオキシエチルホスホリルコリン、すなわち「ＰＭＰＣ」）、多糖類、リポ多糖類（例えば、ガングリオシド）、糖タンパク質（例えば、ムチン）、およびリン脂質を含む。特定の実施形態においては、吸着抑制部分はＰＥＧである。さらなる実施形態では、約１，０００〜約５０，０００ダルトンの分子量（ＭＷ）を有するＰＥＧが用いられる。好適な吸着抑制部分および表面修飾技術は、パチェッティ（Ｐａｃｅｔｔｉ）の米国特許第７，０５６，５９１号明細書；アルベルテ（Ａｌｂｅｒｔｅ）の米国特許第７，０８７，６６１号明細書；ウヤマ（Ｕｙａｍａ）、Ａｄｖａｎｃｅｓ ｉｎ Ｐｏｌｙｍｅｒ Ｓｃｉｅｎｃｅ、第１３７巻、ｐ．２４−２８（１９９８年）；スー（Ｓｕ），Ｐｏｌｙｍ．Ｐｒｅｐ．、第２８巻、ｐ．２９２−２９４（１９８７年）；ホフマン、ジェイ（Ｈｏｆｆｍａｎ，Ｊ．）、Ｂｉｏｍａｔｅｒ．Ｓｃｉ．Ｐｏｌｙｍｅｒ Ｅｄｎ．、第１０巻、ｐ．１０１１−１０１４（１９９９年）；およびワン（Ｗａｎｇ）、Ｓｕｒｆａｃｅ ａｎｄ Ｃｏａｔｉｎｇｓ Ｔｅｃｈｎｏｌｏｇｙ、第１９６巻、ｐ．３０７−３１１（２００５年）に記載されている。
実施形態において、吸着抑制化合物または部分は、所望期間後に回復促進表面から放出可能である。例えば、一時的吸着抑制部分は、特定期間、特にＨ２Ｏ２が最高濃度で生成されている初期炎症反応ステージの間、タンパク質の吸着および／または細胞の接着に抗する。実施形態において、この期間は、約１日〜約１カ月となるように予め決定される。過酸化水素の生成が終了または減少すると、吸着抑制化合物または部分が放出されて、回復促進表面が自然に内皮細胞で被覆され得る。いくつかの実施形態では、吸着抑制部分は生分解により放出される。例えば、吸着抑制部分は、加水分解性結合、例えば、エステルまたはアミド結合によって表面に結合する。放出時間は、結合の耐加水分解性の選択および／または加水分解性結合への水の接近の調節により制御することができる。例えば、通常、アミド結合はエステル結合よりも加水分解安定性が高い。結果として、エステル結合は、より容易に加水分解されるため、より急速に放出されるであろう。また、放出速度は、以下に詳細に説明するように加水分解性結合周囲の親水性／疎水性および立体障害を変更して加水分解時間を増減させることによって制御することもできる。別の実施形態においては、吸着抑制部分は、生物学的環境で溶解または酵素的に分解され得る。
図３Ａ〜３Ｃを見ると、回復促進表面２１から分離する一時的吸着抑制部分２２の機構を説明する略図が示されている。特に図３Ａを見ると、吸着抑制部分２２の簡素化された概略構造は、結合３２を介してつながっている２つのブロック３１および３３を有する。ブロック３３は、タンパク質を反発させるという主要機能を有するのに対し、ブロック３１は、反発ブロックを回復促進表面２１につなぐ結合という主要機能を有する。結合３２は、所定時間後、例えば、医療器具が植え込まれたときに身体がかなりの量のＨ２Ｏ２を生成するのを停止するまでに要する時間の後で加水分解し得るような特定の耐加水分解性を有するように予め決定される。吸着抑制部分は、結合３０を介して表面２１に結合している。結合３０は、共有結合性（例えば共有結合）であっても、非共有結合性（例えば、水素結合、イオン結合、ファンデルワールス力、または他の分子間力）であってもよい。
実施形態において、反発ブロック３３は、上述したような、吸着抑制化合物または部分、例えば、ＰＥＧ分子であり、結合ブロック３１は、シランまたはシラン誘導体、例えば、アミノシランを含み、結合３２は、加水分解性結合（例えば、エステルまたはアミド結合）であり、結合力は、耐加水分解性を選択するか、かつ／または加水分解性結合への水の接近を調節すること、例えば、加水分解性結合の親水性／疎水性ならびに加水分解性結合周囲の立体障害および／もしくは親水性／疎水性を変えて、加水分解時間を増減させることにより制御される。例えば、親水性は、加水分解性結合の片側もしくは両側のメチレン（−ＣＨ２−）基の数を増やすこと、例えば、シラン分子の分子量（「ＭＷ」）を増大させることにより制御し得る。実施形態において、ＰＥＧのＭＷは、約１，０００〜５０，０００の間で選択される。別の例としては、水分子が加水分解性結合に容易に近づけないように、加水分解性結合の片側または両側に、かさ高い側基または側鎖、例えば、メチル基、エチル基、ｎ−プロピル基、ｉ−プロピル基、ｎ−ブチル基、ｉ−ブチル基、ｓ−ブチル基またはｔ−ブチル基を組み込んで加水分解性結合周囲の立体障害を増大させることができる。いくつかの実施形態において、側基は、分枝脂肪族化合物または部分から選択される。他の実施形態では、側基は、分枝芳香族化合物または部分から選択される。さらに別の例としては、例えば、ＰＥＧと加水分解性結合の間および／またはシランと加水分解性結合の間に疎水性部分を加えて加水分解性結合周囲の疎水性を高めることができる。実施形態において、結合３０は、表面とシラン部分との間のＳｉ−Ｏ結合または接着相互作用である。シラン層は、デュウェズ（Ｄｕｗｅｚ）、Ｎａｔｕｒｅ Ｎａｎｏｔｅｃｈｎｏｌｏｇｙ、第１巻、ｐ．１２２−１２５（２００６年）に詳細に開示されている。
特に図３Ｂを見ると、結合３２は、生物学的環境において、例えば加水分解により切断され、反発ブロック３３が表面から離れる。特に図３Ｃを参照すると、反発ブロック３３が離れてしまうと、結合ブロック３１が露出され、次いで、結合３０が、例えば化学結合の破断または身体の巨大分子からの衝突により弱化または無効状態になり、結合ブロック３１を解放する。いくつかの実施形態において、結合ブロック３１は場合に応じて有するものであり、吸着抑制部分２２は反発ブロック３３のみを有する。別の実施形態では、結合ブロック３１は表面２１に結合したまま残り、内皮細胞（「ＥＤＣ」）結合剤、または、望ましい特定タンパク質の吸着を促進するＥＤＣ結合剤と結合したポリマーなど、生体に有益な部分を含む。さらなる実施形態において、ＥＤＣ結合剤は、ＲＧＤペプチド、ＲＧＤペプチドフラグメントを有する化合物である。例えば、図３Ｂの部分３１は、表面に永久結合したＲＧＤフラグメントを有するペプチドであり得る。ＥＤＣ結合剤および技術のさらなる例は、マニカ（Ｍａｎｉｃｋａ）の国際公開第２００６／１２４３６５号に開示されている。
実施形態において、回復促進表面は、表面に回復促進化合物を適用することにより得られる。実施形態において、回復促進化合物は、セラミック、例えば、酸化イリジウム（「ＩＲＯＸ」）、窒化チタン、もしくは白金活性炭、または、過酸化物と反応するか、他の手段により回復促進性となることが知られている任意の化合物から選択される。回復促進または触媒表面は、例えばＨ２Ｏ２を除去することにより回復を促進するが、回復促進表面に非特異的にすぐ吸着する表面結合タンパク質は、Ｈ２Ｏ２の表面への拡散を阻止し、それゆえ、表面の触媒機能を妨害する。特定の実施形態において、内皮細胞による被覆などの治療効果を有するＩＲＯＸ〔ＩＲＯＸおよび他のセラミックは、アルトら（Ａｌｔ ｅｔ ａｌ）の米国特許第５，９８０，５６６号明細書において詳細に論じられている〕は、さまざまな被覆法によりステント表面に適用される。例えば、ＩＲＯＸは、ステントをイリジウム化合物溶液に浸し、次いで乾燥させ、表面を酸化させてＩＲＯＸを得るか、またはイリジウム金属もしくは酸化イリジウムの物理的蒸着、例えばパルスレーザー蒸着またはスパッタリングにより、ステント表面にコーティングすることができる。溶液コーティング法およびステントコーティングとしてＩＲＯＸを使用することの利点についての詳細な説明は、米国特許第６，２４５，１０４号明細書に開示されており、この特許の全開示内容は、参照により本明細書の一部を構成する。
特定の実施形態において、回復促進表面は、２００７年５月２３日に出願された米国特許出願第１１／７５２，７７２号（代理人整理番号１０５２７−８０５００１）明細書と、２００７年５月２３日に出願された米国特許出願第１１／７５２，７３６号（代理人整理番号１０５２７−８０１００１）明細書およびその付属書類に記載されているような、選択された粗さおよび形態を有する。実施形態において、回復促進表面の形態は、比較的粗い表面から比較的平滑な表面までさまざまであり、それぞれ、特定の機械的効果および治療的効果を提供し得る。ある事例では、回復促進表面は、輪郭がはっきりとした粒子（ｄｅｆｉｎｅｄ ｇｒａｉｎｓ）と高粗さとを特徴とする形態を有し得る。別の事例において、回復促進表面は、被覆率が高く、概して低粗さの球面（ｇｌｏｂｕｌａｒ ｓｕｒｆａｃｅ）を特徴とする形態を有する。粒子の輪郭がはっきりした高粗さ形態では、間隔をおいて配置された粒子間および粒子周囲の隙間を特徴とする高表面積が得られ、例えば吸着抑制化合物が該隙間に蒸着されて、表面に結合されることにより、付着力を大いに高め得る。また、輪郭のはっきりした粒子形態は、動作の自由度を高めることができるとともに、ステントが使用時に撓んだときに破壊されにくく、それゆえ、回復促進表面は下層の基材からの回復促進セラミックの層間剥離を起こしにくく、上層の吸着抑制コーティングの層間剥離を減少させる。より平滑な球状表面形態では、化学組成および／または形態学的特徴を選択することにより内皮細胞の増殖を促進するように調整される表面が得られる。
セラミック製回復促進表面の形態は、その外観、例えば、極大値および／または粗さなどの特定の形態学的特徴の大きさおよび配置を特徴とする。例えば、ある事例において、表面は、定義可能なサブミクロン（１／１００００ｍｍ）サイズの粒子を特徴とする。実施形態において、粒子は、約５０〜５００ｎｍ、例えば約１００〜３００ｎｍの長さＬと、約５〜５０ｎｍ、例えば約１０〜１５ｎｍの幅Ｗを有する。粒子は、約５：１以上、例えば、１０：１〜２０：１のアスペクト比（縦横比）を有する。粒子は１つ以上の層にまたがっている。粒子間の間隔は約１〜５０ｎｍであり得る。特定の実施形態において、粒子は米粒に似ている。別の事例では、表面は、一連の浅い球状体（ｓｈａｌｌｏｗ ｇｌｏｂｕｌａｒ ｆｅａｔｕｒｅ）を有する、より連続的な表面を特徴とする。球状体は、極狭間隔で隣接している。実施形態において、表面はオレンジピールに似ている。球状体の直径は約１００ｎｍ以下、最小深さ、すなわち球状体の最大高さは、例えば約５０ｎｍ以下、例えば約２０ｎｍ以下である。別の実施形態において、表面は、高アスペクト比を有する輪郭のはっきりした粒子とより連続的な球状表面との間の特徴を有する。例えば、表面は、低アスペクト比を有する薄い平面状のフレークを含み得る。この形態タイプは、５０ＫＸのＦＥＳＥＭ画像で見える。
また、形態は、例えば、極大形態（ｌｏｃａｌ ｍｏｒｐｈｏｌｏｇｉｃａｌ ｍａｘｉｍａ）の間隔、高さおよび幅などの形態学的特徴の大きさおよび配置を特徴とする。例えば、セラミックの表面は、極大の中心間距離および／もしくは高さ、ならびに／または直径および／もしくは密度を特徴とする。特定の実施形態において、平均高さ、間隔および直径は、約４００ｎｍ以下の範囲、例えば約２０〜２００ｎｍである。特に、平均中心間距離は直径の約０．５〜２倍である。特定の実施形態において、形態タイプは球状形態であり、極大の幅は約１００ｎｍ以下の範囲、ピーク高さは約２０ｎｍ以下である。特定の実施形態において、セラミックは、約５ｎｍ未満、例えば約１〜５ｎｍのピーク高さ、および／または約１５ｎｍ未満、例えば約１０〜１５ｎｍのピーク間距離を有する。さらに別の特定の実施形態においては、形態は粒子タイプ形態として定義される。極大幅は、約４００ｎｍ以下、例えば約１００〜４００ｎｍ、極大高さは、約４００ｎｍ以下、例えば約１００〜４００ｎｍである。セラミックの選択された両形態（球状タイプおよび粒子タイプ）は、実質的に均一な略非晶質のＩＲＯＸからなる薄層上に形成可能であり、この薄層はイリジウム金属層上に形成され、イリジウム金属層は、チタンまたはステンレススチールなどの金属基材上に蒸着される。間隔、高さおよび幅のパラメータはＡＦＭデータから計算することができる。適切な計算法は、上掲した、ともに２００７年５月２３日に出願された米国特許出願第１１／７５２，７７２号（代理人整理番号１０５２７−８０５００１）および米国特許出願第１１／７５２，７３６（代理人整理番号１０５２７−８０１００１）の付属書類に記載されている。
（実施例）
ＩＲＯＸのプラズマ蒸着による、医療器具、例えば内部人工器官の表面への回復促進コーティングの適用；ＩＲＯＸの酸素含量を増大させるための酸素プラズマによる表面処理；表面にアミン基をグラフトするアミノプロピルトリエトキシシラン（「ＡＰＴＥＳ」）による表面のシラン化；弱結合（「ＷＬ」）、例えば第２エステル結合による、Ｎ−ヒドロキシスクシンイミド（「ＮＨＳ」）に結合したＰＥＧ分子であるＮＨＳ−ＷＬ−ＰＥＧとグラフト化表面との反応。より具体的には、ＷＬは以下の式を有する：
ＩＲＯＸのプラズマ蒸着による、医療器具、例えば内部人工器官の表面への回復促進コーティングの適用；ＩＲＯＸの酸素含量を増大させるための酸素プラズマによる表面処理；表面にアミン基をグラフトするアミノプロピルトリエトキシシラン（「ＡＰＴＥＳ」）による表面のシラン化；弱結合（「ＷＬ」）、例えば第２エステル結合による、Ｎ−ヒドロキシスクシンイミド（「ＮＨＳ」）に結合したＰＥＧ分子であるＮＨＳ−ＷＬ−ＰＥＧとグラフト化表面との反応。より具体的には、ＷＬは以下の式を有する：
基材のシラン化は、エタノールと酢酸からなる溶液中で実施する。まず、１００ｍｌの無水エタノールに５０μｌの酢酸を加える。次いで、エタノール溶液に、エタノールと１：１００容積比になるまでＡＰＴＥＳを加える。混合物を３０分間放置した後、混合物中に基材を入れる。次いで、混合物を３時間緩やかに攪拌する。次いで、基材を溶液から取り出し、大量のエタノールですすいで未反応シランをすべて除去する。シラン化またはグラフト化基材は次の反応ステップまでエタノール中で保存する。図４Ａを見ると、回復促進表面はＡＰＴＥＳで修飾されている。
グラフト化基材と、ＮＨＳ−ＷＬ−ＰＥＧ分子〔ＰＥＧは２０００〜２０，０００の分子量を有し、日油社（Ｎｉｐｐｏｎ Ｏｉｌ ａｎｄ Ｆａｔ）（ＮＯＦ）から入手可能、例えば、ｈｔｔｐ：／／ｗｗｗ．ｎｏｆ．ｃｏ．ｊｐ／ｅｎｇｌｉｓｈ／ｂｕｓｉｎｅｓｓ／ｄｄｓ／ｐｅｇｙｌａｔｉｏｎ／ａｃｔｉｖａｔｅｄ＿ｐｅｇ．ｈｔｍｌ＃ｂ１〕との反応は、まず、０．５Ｍの四ホウ酸ナトリウム（１０水塩）のｐＨ９．５溶液中に基材を入れて実施する。次いで、同容積のＮＨＳ−ＷＬ−ＰＥＧ（１０％ｗ／ｗ）のｐＨ４、０．０１Ｍリン酸ナトリウム緩衝液をホウ酸ナトリウム溶液に加える。混合物を１時間緩やかに攪拌して反応させる。反応完了時点で、基材には、弱結合を介してＰＥＧ分子が結合している。次いで、基材を大量の脱イオン（「ＤＩ」）水、次いで無水エタノールですすぎ、完全乾燥させ、使える状態になるまで乾燥保存する。図４Ｂを見ると、ＰＥＧ−ＷＬ部分は、室温反応により、アミノシランで修飾された回復促進表面に結合している。
本明細書に記載の内部人工器官、例えばステントは、血管、例えば冠血管系および末梢血管の内腔、または非血管の内腔用に構成することができる。例えば、内部人工器官は、食道または前立腺に用いるように構成し得る。他の内腔としては、胆管内腔、肝臓内腔、脾臓内腔、および尿道内腔が挙げられる。
本明細書に記載のステントはいずれも、染色したり、または、例えば、硫酸バリウム、白金もしくは金などの放射線不透過性物質を加えたり、放射線不透過性物質でコーティングしたりして放射線不透過性にすることができる。ステントは、金属材料、例えば、ステンレススチール〔例えば、３１６Ｌ、ＢｉｏＤｕｒ（登録商標）１０８（ＵＮＳ Ｓ２９１０８）、および３０４Ｌステンレススチール〕や、米国特許出願公開第２００３−００１８３８０号明細書、米国特許出願公開第２００２−０１４４７５７号明細書、および米国特許出願公開第２００３−００７７２００号明細書に記載されるようなステンレススチールと５〜６０重量％の１種以上の放射線不透過性元素（例えば、Ｐｔ、Ｉｒ、Ａｕ、Ｗ）とを含む合金（ＰＥＲＳＳ（登録商標））、ニチノール（ニッケル−チタン合金）、Ｅｌｇｉｌｏｙなどのコバルト合金、Ｌ６０５合金、ＭＰ３５Ｎ、チタン、チタン合金（例えば、Ｔｉ−６Ａｌ−４Ｖ，Ｔｉ−５０Ｔａ，Ｔｉ−１０Ｉｒ）、白金、白金合金、ニオブ、ニオブ合金（例えば、Ｎｂ−１Ｚｒ），Ｃｏ−２８Ｃｒ−６Ｍｏ、タンタル、およびタンタル合金を含み得る。他の材料例は、本発明の譲受人に譲渡された２００３年９月２６日に出願された米国特許出願第１０／６７２，８９１号明細書；および２００５年１月３日に出願された米国特許出願第１１／０３５，３１６号明細書に記載されている。他の材料としては、例えば、シェツキー、エル．マクドナルド（Ｓｃｈｅｔｓｋｙ，Ｌ．ＭｃＤｏｎａｌｄ）、“Ｓｈａｐｅ Ｍｅｍｏｒｙ Ａｌｌｏｙｓ”、Ｅｎｃｙｃｌｏｐｅｄｉａ ｏｆ Ｃｈｅｍｉｃａｌ Ｔｅｃｈｎｏｌｏｇｙ（第３版）、Ｊｏｈｎ Ｗｉｌｅｙ ＆ Ｓｏｎｓ、１９８２年、第２０巻、ｐ．７２６−７３６；および本発明の譲受人に譲渡された２００３年１月１７日に出願された米国特許出願第１０／３４６，４８７号明細書に記載されているような生体適合性の弾性金属、例えば、超弾性または疑弾性金属合金が挙げられる。
ステントは、所望の形状または寸法のもの〔例えば、冠動脈ステント、大動脈ステント、末梢血管ステント、消化管ステント、尿管ステント、気管／気管支ステント、および神経ステント〕であり得る。用途に応じて、ステントは、例えば、約１〜約４６ｍｍの直径を有し得る。特定の実施形態において、冠動脈ステントは、約２〜約６ｍｍの拡張径を有し得る。いくつかの実施形態において、末梢血管ステントは、約４〜約２４ｍｍの拡張径を有し得る。特定の実施形態において、消化管および／または尿管ステントは、約６〜約３０ｍｍの拡張径を有し得る。いくつかの実施形態において、神経ステントは、約１〜約１２ｍｍの拡張径を有し得る。腹部大動脈瘤（ＡＡＡ）ステントおよび胸部大動脈瘤（ＴＡＡ）ステントは、約２０〜約４６ｍｍの直径を有し得る。ステントは、バルーン拡張型、自己拡張型、または両型を組み合わせたものであり得る。ステントおよびステント送達についてのさらなる説明は、ヒース（Ｈｅａｔｈ）の米国特許第６，２９０，７２１号明細書に示されている。吸着抑制コーティングは、ステントの全表面、管腔側の面、反管腔側の面および断面（ｃｕｔｆａｃｅ）に施してもよく、あるいは選択された表面、例えば反管腔側の面および／または断面にのみに施してもよい。
本明細書に記載のすべての刊行物、特許出願、特許および他の参考文献は、参照によりその全内容が本明細書の一部を構成する。
さらなる実施形態は以下の特許請求の範囲に記載されている。
さらなる実施形態は以下の特許請求の範囲に記載されている。
Claims (36)
- 触媒材料を含んでなる表面と、
表面に結合する吸着抑制材料と
を含み、吸着抑制材料が表面へのタンパク質の吸着を減少させる、内部人工器官。 - 触媒材料がＨ２Ｏ２の分解を触媒する、請求項１に記載の内部人工器官。
- 触媒材料がセラミックである、請求項１に記載の内部人工器官。
- 触媒材料が酸化イリジウムを含んでなる、請求項１に記載の内部人工器官。
- 触媒材料が、窒化チタンおよび白金活性炭から選択される、請求項１に記載の内部人工器官。
- 吸着抑制材料が親水性化合物を含んでなる、請求項１に記載の内部人工器官。
- 化合物がＰＥＧを含んでなる、請求項６に記載の内部人工器官。
- ＰＥＧが、約１，０００〜約５０，０００の分子量を有する、請求項７に記載の内部人工器官。
- 吸着抑制材料が表面から放出可能である、請求項１に記載の内部人工器官。
- 吸着抑制材料が、この材料を表面に結合する選択的に切断可能な結合を有する、請求項１に記載の内部人工器官。
- 結合が加水分解性である、請求項１０に記載の内部人工器官。
- 結合がエステル結合である、請求項１０に記載の内部人工器官。
- 吸着抑制材料が層を形成する、請求項１に記載の内部人工器官。
- 吸着抑制材料が、第１ブロックと、表面と第１ブロックの間の第２ブロックとを含んでなる、請求項１に記載の内部人工器官。
- 第１ブロックがタンパク質をはじくという主要機能を有する、請求項１４に記載の内部人工器官。
- 第２ブロックが、表面に第１ブロックをつなぐ結合という主要機能を有する、請求項１４に記載の内部人工器官。
- 第１ブロックと第２ブロックが、選択的に切断可能な結合を介してつながっている、請求項１４に記載の内部人工器官。
- 第２ブロックと表面が、選択的に切断可能な結合を介してつながっている、請求項１７に記載の内部人工器官。
- 結合が加水分解性である、請求項１７に記載の内部人工器官。
- 第１ブロックがＰＥＧを含んでなり、第２ブロックがアミノシランを含んでなる、請求項１４に記載の内部人工器官。
- 第１ブロックがＰＥＧを含んでなり、第２ブロックがアミノシランを含んでなる、請求項１９に記載の内部人工器官。
- 第１ブロックがＰＥＧを含んでなり、第２ブロックが内皮細胞結合剤を含んでなる、請求項１９に記載の内部人工器官。
- 第２ブロックがさらに内皮細胞結合剤を含んでなる、請求項２１に記載の内部人工器官。
- 内皮細胞結合剤がＲＧＤペプチドフラグメントを含んでなる、請求項２２に記載の内部人工器官。
- 内部人工器官の製造方法であって、
表面を一時的吸着抑制層で被覆するステップを含んでなり、表面が触媒材料を含んでなり、一時的吸着抑制層が、表面へのタンパク質の吸着を減少させて、Ｈ２Ｏ２が表面に到達することを許容する、方法。 - 表面がＩＲＯＸを含んでなる、請求項２５に記載の方法。
- 吸着抑制層が親水性ポリマーを含んでなる、請求項２５に記載の方法。
- 表面を層で被覆する前に、表面をアミノシランで修飾するステップをさらに含んでなる、請求項２５に記載の方法。
- アミノシランがＡＰＴＥＳである、請求項２８に記載の方法。
- 層が親水性ポリマーを含んでなる、請求項２８に記載の方法。
- ポリマーが、ポリマーを表面に結合する加水分解性結合を有する、請求項２７に記載の方法。
- ポリマーが、ポリマーをアミノシランに結合する加水分解性結合を有する、請求項３０に記載の方法。
- 表面を層で被覆する前に、表面を内皮細胞結合剤で修飾するステップをさらに含んでなる、請求項２５に記載の方法。
- 内皮細胞結合剤がＲＧＤペプチドセグメントを含んでなる、請求項３３に記載の方法。
- 層が親水性ポリマーを含んでなる、請求項３３に記載の方法。
- ポリマーが、ポリマーを内皮細胞結合剤に結合する加水分解性結合を有する、請求項３５に記載の方法。
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| US95069507P | 2007-07-19 | 2007-07-19 | |
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| EP (1) | EP2187988B1 (ja) |
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-
2008
- 2008-07-17 JP JP2010517153A patent/JP2010533563A/ja not_active Withdrawn
- 2008-07-17 US US12/174,752 patent/US9284409B2/en not_active Expired - Fee Related
- 2008-07-17 WO PCT/US2008/070261 patent/WO2009012353A2/en active Application Filing
- 2008-07-17 EP EP08781933.0A patent/EP2187988B1/en not_active Not-in-force
Also Published As
| Publication number | Publication date |
|---|---|
| WO2009012353A3 (en) | 2010-03-18 |
| US20090149942A1 (en) | 2009-06-11 |
| EP2187988A2 (en) | 2010-05-26 |
| EP2187988B1 (en) | 2013-08-21 |
| WO2009012353A2 (en) | 2009-01-22 |
| US9284409B2 (en) | 2016-03-15 |
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