JP2003503153A - ステントの被覆 - Google Patents

ステントの被覆

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Publication number
JP2003503153A
JP2003503153A JP2001507394A JP2001507394A JP2003503153A JP 2003503153 A JP2003503153 A JP 2003503153A JP 2001507394 A JP2001507394 A JP 2001507394A JP 2001507394 A JP2001507394 A JP 2001507394A JP 2003503153 A JP2003503153 A JP 2003503153A
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Japan
Prior art keywords
stent
copolymer
drug
rate
pla
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JP2003503153A5 (ja
Inventor
ヤン、ダーチュアン
エル． スタンスラスキー、ジョエル
ワン、リシャオ
アール． スミス、スコット
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Boston Scientific Limited
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Boston Scientific Limited
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Publication of JP2003503153A publication Critical patent/JP2003503153A/ja
Publication of JP2003503153A5 publication Critical patent/JP2003503153A5/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L31/10—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A61L2300/608—Coatings having two or more layers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Prostheses (AREA)

Abstract

(57)【要約】 ステントは含まれる活性薬剤を制御可能に放出するためのポリマー被覆を有する。ポリマー被覆は、単体である場合は薬剤を高速な第１の速度にて放出する第１のポリマー材料と、単体である場合は薬剤を長期間にわたって低速な第２の速度にて放出する第２のポリマー材料との混合物を含む。ステント被覆の一つは、高速放出親水性ポリマー材料と、低速放出疎水性材料とを使用する。ステント被覆の一つは、高速放出ＰＬＡ−ＰＥＯ共重合体と低速放出ＰＬＡ−ＰＣＬ共重合体との混合物を含む。活性薬剤の一つはタキソールである。タキソール送配ステントの一つの用途は、血管形成術後の再狭窄抑制を行うことである。

Description

【発明の詳細な説明】
【０００１】 （発明の分野） 本願は概して医療用器具に関する。より具体的には、本発明は時間の経過に伴
って薬剤を放出し得るステント被覆に関する。特に、本発明は、継続した期間に
わたって、再狭窄抑制薬剤を放出するのに適した２つの共重合体の混合物を含む
。
【０００２】 （発明の背景） 先進諸国において、血管疾患は死亡及び疾病の原因である。アメリカ合衆国に
おいては、すべての死因のうち半分以上が心臓血管疾患である。アテローム性動
脈硬化症は最も一般的な形態の血管疾患であり、体器官への血液の不十分な供給
を招き、それにより心臓発作、脳卒中、及び腎不全が引き起こされる。アテロー
ム性動脈硬化症は、動脈壁の血管平滑筋細胞が過増殖を経て、内側脈管内層に侵
入して拡がる脈管損傷の形態である。この脈管損傷の形態は、局所的な血液凝固
が起きた場合に、血管を完全に閉塞させることがある。これは、その動脈によっ
て養われる組織の壊死を招き得る。冠動脈の場合においては、この閉塞は心筋梗
塞を招き、死亡につながることがある。
【０００３】 冠動脈の閉塞は、冠状動脈バイパス手術及び／又は血管形成術により治療され
得る。双方の処置とも、初めは成功したように見えるかもしれないが、このよう
な治療後の再狭窄、すなわち狭窄の再発の影響により、実質的に元に戻ってしま
うことがある。再狭窄は、管の平滑筋細胞の過増殖を含むと考えられている。特
に、血管形成術を用いて治療される患者の約３分の１は、術後６ヶ月以内に再狭
窄及び閉塞を起こす。
【０００４】 再狭窄から脈管が閉塞するのを防止するために、ステントが使用される。ステ
ントは、ほぼ管状構造をなし、中実の壁または格子状の壁のいずれかを有し、さ
らにバルーンにて拡張可能であるか、または自己拡張型であってもよい。血管形
成術バルーン拡張の後、以前に収縮していた脈管は少なくとも一時的に拡張され
る。ステントはカテーテル上を送配されて、血管壁に対して、適所で拡張されて
もよいし、あるいは適所で拡張を許容されてもよい。ステントを適所において用
いる場合、再狭窄が抑制されても、抑制されなくても、任意の再狭窄の内方への
力に対抗するステントの構造的強度により閉塞の確率及び／又は度合いは減少す
る。再狭窄はステントの長さにわたって起こり得、少なくともステントによって
部分的に対向され得る。また、再狭窄は、狭窄の内方への力に対抗するものが存
在しないステントの両端を通り越した部分でも起こり得る。
【０００５】 再狭窄を抑制するために治療薬が使用され、様々な成功を収めてきた。西太平
洋のイチイ属の木の樹皮から単離される抗−微小管剤（ａｎｔｉｍｉｃｒｏｔｕ
ｂｕｌｅ ａｇｅｎｔ）であるタキソール（商標）は、ある癌の抑制において特
に有効であり、再狭窄との戦いにおいて有効であると考えられている。タキソー
ルの全身投薬は望ましくない副作用を生じることがあり、治療方法として局所的
な投与が好ましい。
【０００６】 タキソールの局所的な投与は、少なくとも血管形成術に対する身体の通常の反
応時間に合致した期間のようなより長期間にわたって行われると、より有効とな
り得る。同時に、初期期間中においてはタキソールの高い初期投薬量を供給する
ことが望ましいこともある。数日または数カ月までもの期間にわたるタキソール
の局所的な投与は、再狭窄の抑制において最も効果的であり得る。
【０００７】 治療薬の投与を制御するためには様々な技術が利用され得る。ポリマー材料中
に活性薬剤の異種溶液及び／又は分散物を取込んだモノリシックな層、すなわち
被膜を有する要素が公知である。前記要素において、薬剤がポリマーを介してポ
リマーと体液との界面へ拡散し、周囲の体液に放出されるので、薬剤の拡散は速
度制限されている。また、いくつかの要素においては、可溶性材料はポリマー材
料の中に溶解または分散されて、前記材料が溶解した後に付加的な細孔またはチ
ャネルが残される。同様に、母材要素は概して拡散を制限されるが、要素のチャ
ネルまたは他の内部の幾何学的構造が薬剤を体液に放出する役割を果たしている
。前記チャネルは、予め存在するチャネルか、あるいは薬剤または他の可溶性材
料が放出された後に残ったチャネルであってもよい。
【０００８】 通常、溶損可能または分解可能な要素が、ポリマー中に物理的に固定された活
性薬剤を有する。活性薬剤は、ポリマー材料中に溶解及び／又は分散され得る。
ポリマー材料は、大抵、時間が経つにつれ不安定な結合の加水分解により加水分
解的に劣化し、ポリマーは体液中に徐々に溶損し、活性薬剤を体液中に放出する
。概して、親水性ポリマーは疎水性ポリマーと比較して、速い溶損速度を有する
。疎水性ポリマーは、活性薬剤のほぼ純粋な表面拡散を有し、表面から内部へ溶
損すると考えられている。親水性ポリマーは、水をポリマー表面に浸透させ、表
面下において不安定な結合の加水分解を許容する。この加水分解はポリマーの均
一な溶損または大量の溶損を生じ得る。
【０００９】 継続した期間にわたって、治療薬を放出することが可能なステントの被覆が望
まれる。治療薬が必要な期間とほぼ同じ期間にわたって薬剤を放出することが可
能なステント被覆が好都合である。また、ステント被覆の組成を制御することに
よって活性薬剤の投薬速度及び期間を制御するための方法も利点を有する。
【００１０】 （発明の概要） 本発明は、ステント本体、該本体の少なくとも一部を覆って配置されるステン
ト被覆、及び該被覆の少なくとも一部に放出可能に分散された活性薬剤を有する
ステントを備える。好ましい活性薬剤は、パクリタキセル（ｐａｃｌｉｔａｘｅ
ｌ）、類似体、誘導体、及びそれらの組み合わせである。被覆は、高速な第１の
放出速度を有する第１の共重合体と、第１の放出速度に比べ低速な第２の放出速
度を有する第２の共重合体との混合物を含み得る。第１共重合体及び第２共重合
体は、好ましくは溶損可能であるか、または生物分解性である。実施の形態の一
つにおいては、第１共重合体は第２共重合体よりも親水性である。実施の形態の
一つにおいては、第１共重合体はポリ乳酸／ポリエチレンオキサイド（ＰＬＡ−
ＰＥＯ）共重合体を含み、第２共重合体はポリ乳酸／ポリカプロラクトン（ＰＬ
Ａ−ＰＣＬ）共重合体を含む。
【００１１】 時間の経過により送配される活性薬剤の相対量及び投薬速度は、低速放出ポリ
マーに対して、高速放出ポリマーの相対量を制御することによって制御され得る
。初期放出速度を速めるためには、高速放出ポリマーの割合が、低速放出ポリマ
ーに対して増加され得る。投薬量の大部分が長期間にわたって放出されることが
所望される場合には、ポリマーの大部分は低速放出ポリマーであり得る。ステン
トは、ポリマー、活性薬剤、及び溶媒の溶液または分散物をステントに噴霧する
ことによって被覆され得る。溶媒はポリマー及び活性薬剤の被覆を残して、蒸発
させられ得る。活性薬剤はポリマー中に溶解及び／又は分散され得る。いくつか
の実施の形態においては、共重合体はステント本体上に押出し成形され得る。
【００１２】 ステントは、血管形成術などの処置の後に冠血管などの身体の脈管内に配置さ
れて用いられ得る。ステントは適所に留置され、溶損可能または生物分解性の被
覆は分解するのを許容される。ポリマー被覆が分解するにつれて、活性薬剤が血
管壁に吸収され得る。
【００１３】 （発明の詳細な説明） 本発明は、目標の期間にわたって生物活性薬剤または他の治療物質を送配する
ためのポリマー被覆を有するステントからなる。ポリマー被覆は、第１ポリマー
及び第２ポリマーを含み、第１ポリマーは単独で、第２ポリマーのみよりも速く
活性薬剤を放出する。従って、第１ポリマーにより固定される活性薬剤は、第２
ポリマーに比べて短期間内に消耗される。好ましい実施の形態において、第１ポ
リマーは親水性であり、第２ポリマーは疎水性である。
【００１４】 図面を参照すると、いくつかの図を通じて同一の参照符号は同一の要素を示し
ている。図１は非拡張状態にある本発明に従ったステント１０の斜視図を示して
いる。ステント１０の骨格フレームは、好ましくは、独特な反復蛇行パターンを
形成するワイヤ状部材１２を備える。この反復蛇行パターンは、多数のＵ字形湾
曲部１４から成る。Ｕ字形湾曲部１４内の領域は、開口部１６である。ワイヤ１
２は、この蛇行パターンの認識可能な始点または終点を有することなく、拡張可
能な蛇行要素１８を形成する。蛇行要素１８はステント１０の長手方向の軸線に
沿って配置され、よって隣接する蛇行要素１６のＵ字形湾曲部１４同士は相互連
結要素２０を介して連結され得る。相互連結要素２０により、連続したワイヤ１
２の骨組みが、ステント１０を形成する多数の蛇行要素１８の間に形成されてい
る。
【００１５】 図２は本発明に従ったさらに好ましいステント１１０の斜視図を示す。本ステ
ント１１０も連続したワイヤ１１２の骨組みを有する。しかしながら、この骨組
みは反復する方形パターン要素１１４によって継続される。方形ワイヤ要素１１
４内の領域は、開口部１１６である。方形ワイヤ要素１１４は、ステント１１０
の長手方向の軸線に沿って縦に整列される。隣接する方形ワイヤ要素１１４同士
は、同様な方形ワイヤ要素１１４の半分の長さ分偏倚している。ステントの終端
は、ある方形ワイヤ要素１１４の完結部、及び隣接する方形ワイヤ要素の次の開
口端１２２により形成される。従って、ステントの終端は、交互に開閉するワイ
ヤ構造を有する。
【００１６】 これらのステントは、本発明を具体化し得るステントの一例である。これら及
びその他の適当なステントは、１９９７年６月１３日に出願された「ポリマー積
層ステント（Ｐｏｌｙｍｅｒｉｃ Ｌａｙｅｒｅｄ Ｓｔｅｎｔ）」と題せられ
る米国特許出願第０８／８７４，１９０号にて開示され、本開示は参考としてこ
こに援用される。
【００１７】 骨格材料を示す際に用いられるワイヤなる用語は、金属材料に限定されるもの
と誤解されるべきではない。実際、ステントを形成する「ワイヤ」１０，１１０
は脈管患部を支持するのに必要な構造的及び機械的特性を有する任意の生体適合
性物質からなってもよい。従って、金属及びポリマー材料の双方とも適当である
。好ましい生体適合性金属材料の例は、ステンレス鋼、タンタル、ニチノール、
及び金を含む。好ましいポリマー材料は、以下のリスト、すなわち、 ポリ（Ｌ−ラクチド）（ＰＬＬＡ）、ポリ（Ｄ，Ｌ−ラクチド）（ＰＬＡ）、
ポリグリコリド（ＰＧＡ）、ポリ（Ｌ−ラクチド−ｃｏ−Ｄ，Ｌ−ラクチド）（
ＰＬＬＡ／ＰＬＡ）、ポリ（Ｌ−ラクチド−ｃｏ−グリコリド）（ＰＬＬＡ／Ｐ
ＧＡ）、ポリ（Ｄ，Ｌ−ラクチド−ｃｏ−グリコリド）（ＰＬＡ／ＰＧＡ）、ポ
リ（グリコリド−ｃｏ−トリメチレンカーボネート）（ＰＧＡ／ＰＴＭＣ）、ポ
リエチレンオキサイド（ＰＥＯ）、ポリジオキサノン（ＰＤＳ）、ポリカプロラ
クトン（ＰＣＬ）、ポリヒドロキシブチラート（ＰＨＢＴ）、ポリ（ホスファゼ
ン）、ポリ（Ｄ，Ｌ−ラクチド−ｃｏ−カプロラクトン）（ＰＬＡ／ＰＣＬ）、
ポリ（グリコリド−ｃｏ−カプロラクトン）（ＰＧＡ／ＰＣＬ）、ポリ酸無水物
（ＰＡＮ）、ポリ（オルトエステル）、ポリ（リン酸塩エステル）、ポリ（アミ
ノ酸）、ポリ（ヒドロキシブチラート）、ポリアクリレート、ポリアクリルアミ
ド、ポリ（ヒドロキシエチルメタクリラート）、エラスチンポリペプチド共重合
体、ポリウレタン、ポリシロキサン、及びそれらの共重合体から選択され得るが
、該リストは全てを網羅しているわけではない。
【００１８】 ステントの骨格の骨組みも同様に、様々な方法により形成され得る。骨組みは
、連続した構造を形成するよう、溶接もしくは成型されるか、または共に屈曲さ
れるか、または編まれたフィラメントもしくは繊維から成ってもよい。
【００１９】 大抵、脈管患部の局所領域を拡張及び治療することは共に有益である。従って
、治療薬がポリマーに取り込まれて、ポリマー表面処理剤としてステント１０に
塗布され得る。表面処理剤へ治療薬を取り込むことは、ステントを薬物送達シス
テムに変えることにより、本医療器具の範囲を大いに広げる。抗トロボゲン薬剤
（ａｎｔｉ−ｔｈｒｏｍｂｏｇｅｎｉｃ ａｇｅｎｔｓ）、抗新血管形成薬剤（
ａｎｔｉ−ａｎｇｉｏｇｅｎｅｓｉｓ ａｇｅｎｔｓ）、抗増殖薬剤（ａｎｔｉ
−ｐｒｏｌｉｆｅｒａｔｉｖｅ ａｇｅｎｔｓ）、増殖因子（ｇｒｏｗｔｈ ｆ
ａｃｔｏｒｓ）、及び放射化学物質を使用する薬剤及び処理剤が、ポリマー表面
処理剤の母材内から容易に分散され得る。好ましい治療薬の特定の例は、アンギ
オペプチン（ａｎｇｉｏｐｅｐｔｉｎ）、コルヒチン、ロバスタチン、トラピジ
ル、チクロピジン、ヒルジン、タキソール、ヘパリン、血管内皮細胞増殖因子（
ＶＥＧＦ）、トランスフォーミング増殖因子−β（ＴＧＦ−β）、インスリン様
成長因子（ＩＧＦ）、血小板由来増殖因子（ＰＤＧＦ）、及び繊維芽細胞増殖因
子（ＦＧＦ）を含む。
【００２０】 このような表面処理剤の塗布は、浸漬または噴霧工程のいずれかを介して行わ
れる。どちらの工程にも、ポリマー母材内に治療薬を取り込むためには溶媒キャ
リヤが好ましい。塗布された混合物は、好ましくは、溶媒、ポリマー、および治
療薬からなり、後に溶媒が蒸発して図３に示されるようにポリマー被覆３０が残
る。
【００２１】 上述されたように、本発明は放出可能な治療薬を取り込んだポリマー被覆に関
し、薬剤の割合及び持続時間は、嵌植の際に治療を最適化する選択されたパラメ
ータに制御される。親水性ポリマーと疎水性ポリマーとの混合物の選択された比
率が薬剤放出の所望の制御を提供することが見出された。
【００２２】 好ましい実施の形態においては、親水性ポリマーはポリ乳酸（ＰＬＡ）及びポ
リエチレンオキサイド（ＰＥＯ）の共重合体を含む。好ましい実施の形態におい
ては、第２ポリマーはポリ乳酸（ＰＬＡ）及びポリ（カプロラクトン）（ＰＣＬ
）の共重合体を含む。ＰＬＡ−ＰＥＯ共重合体は親水性であり、被覆されたステ
ントが配置される体内環境において、同様の疎水性ポリマーに比して速く溶損す
る。ＰＬＡ−ＰＣＬ共重合体は疎水性であり、比較される親水性ポリマーより遅
く分解する。好ましい実施の形態においては、ポリマー被覆はＰＬＡ−ＰＣＬ及
びＰＬＡ−ＰＥＯの混合物から形成される。好ましい実施の形態では、親水性ポ
リマーは約１０，０００（Ｍｎ）以上の分子量を有し、第２ポリマーは約２０，
０００（Ｍｎ）以上の分子量を有する。
【００２３】 ＰＬＡ−ＰＥＯ共重合体の構造は当業者には周知である。例えば、ここに援用
される米国特許第５，４７６，９０９号及び５，５４８，０３５号を参照された
い。また、ＰＬＡ−ＰＣＬ共重合体の構造も当業者には周知である。例えば、こ
こに援用される米国特許第５，４７０，８２９号を参照されたい。
【００２４】 好ましい実施の形態の一つは、ＰＬＡ−ＰＥＯ共重合体を約２０重量％、及び
ＰＬＡ−ＰＣＬ共重合体を約８０重量％含む。別の実施の形態は、ＰＬＡ−ＰＥ
Ｏ共重合体約５０重量％、及びＰＬＡ−ＰＣＬ共重合体を約５０重量％含む。Ｐ
ＬＡ−ＰＥＯ約２０％及びＰＬＡ−ＰＣＬ約８０％を有する実施の形態は、ＰＬ
Ａ−ＰＥＯ対ＰＬＡ−ＰＣＬが５０％対５０％である組み合わせを有する実施の
形態に比して、長期間にわたるが、低速な初期放出にて活性薬剤を放出する。Ｐ
ＬＡ−ＰＥＯ及びＰＬＡ−ＰＣＬの相対的な量は、高い初期投薬速度と、それに
続く遅いけれども長期にわたる投薬速度との所望の組み合わせを達成するように
調整され得る。
【００２５】 好ましい実施の形態の一つにおいては、活性薬剤または治療物質は再狭窄抑制
薬剤である。好ましい再狭窄抑制薬剤は、タキソール、パクリタキセル、類似化
合物、誘導体、およびそれらの混合物などの微小管安定化剤を含む。例えば、本
発明における使用に適していると考えられる誘導体は、２’−サクシニルタキソ
ール、２’−サクシニルタキソールトリエタノールアミン、２’−グルタリルタ
キソール、２’−グルタリルタキソールトリエタノールアミン塩、Ｎ（ジメチル
アミノエチル）グルタミンを有する２’−Ｏ−エステル、及びＮ（ジメチルアミ
ノエチル）グルタミド塩酸塩を有する２’−Ｏ−エステルである。
【００２６】 タキソールはポリマー材中に溶解または分散され、該ポリマー材はステント本
体に付着させられ得る。ＰＬＡ−ＰＥＯ及びＰＬＡ−ＰＣＬの混合化合物を有す
る実施の形態において、ポリマー化合物はステント上に噴霧、浸漬、または押出
し成形され得る。
【００２７】 本発明のポリマー被覆は様々なステントと共に用いることが可能である。本被
覆の好ましい用途は、冠状動脈のステントである。前記ステントは、再狭窄を抑
制するために血管形成術に続いて使用され得る。ステント本体は、いかなる再狭
窄に対しても脈管を拡げて保持し、再狭窄抑制薬剤を送配するのに有用である。
実施の形態の一つにおいては、被覆はステントをほぼ連続して覆っている。別の
実施の形態においては、被覆は主としてステント構造物を覆っているが、開口部
を覆ってはいない。例えば、ステントはワイヤメッシュで形成されており、被覆
はワイヤに密に付着するが、その間の開口部を被覆することはない。
【００２８】 本発明によるステントは、所望の放出投薬プロフィールに従って選択され、治
療医師に提供されて使用され得る。血管形成術の処置の後に、再狭窄抑制の活性
薬剤を有する被覆されたステントは、狭窄して先刻拡張された冠動脈部位に送配
され得る。前記送配は、カテーテルの末端に配置される膨張可能なバルーン上に
ステントを取り付けるといった当業者に周知の方法を用いて行われ得る。ステン
トが拡張された部位の近くの位置に進められた状態において、ステントは内側の
血管壁に接する位置まで外側に押し付けられ得る。ステントが自己拡張型である
場合は、ステントを送配装置内から展開することによりステントは送配され、ス
テントは内側の血管壁に対して拡張するのを許容される。活性薬剤が溶損するポ
リマー被覆から放出されるとき、活性薬剤は内側の血管壁によって吸収され得る
。時間の経過により、ポリマー被覆は体液によって溶損される。
【００２９】 本明細書に包含される本発明の多数の利点は上記に述べられた。しかしながら
、本開示は、あらゆる点において、実例にすぎないことが理解されるであろう。
本発明の範囲を越えることなく、細部にわたって、特に部品の形状、寸法、及び
配置について変更されてもよい。もちろん、本発明の範囲は、添付された請求項
が表される言語において規定される。
【図面の簡単な説明】
【図１】 本発明の一実施の形態に従ったステントを示す斜視図。
【図２】 本発明に従ったさらに好ましいステントを示す斜視図。
【図３】 ステント上に配置された本発明のポリマーの被覆を表す図１のス
テントの拡大部分平面図。
───────────────────────────────────────────────────── フロントページの続き (81)指定国 ＥＰ(ＡＴ，ＢＥ，ＣＨ，ＣＹ， ＤＥ，ＤＫ，ＥＳ，ＦＩ，ＦＲ，ＧＢ，ＧＲ，ＩＥ，Ｉ Ｔ，ＬＵ，ＭＣ，ＮＬ，ＰＴ，ＳＥ)，ＯＡ(ＢＦ，ＢＪ ，ＣＦ，ＣＧ，ＣＩ，ＣＭ，ＧＡ，ＧＮ，ＧＷ，ＭＬ， ＭＲ，ＮＥ，ＳＮ，ＴＤ，ＴＧ)，ＡＰ(ＧＨ，ＧＭ，Ｋ Ｅ，ＬＳ，ＭＷ，ＭＺ，ＳＤ，ＳＬ，ＳＺ，ＴＺ，ＵＧ ，ＺＷ)，ＥＡ(ＡＭ，ＡＺ，ＢＹ，ＫＧ，ＫＺ，ＭＤ， ＲＵ，ＴＪ，ＴＭ)，ＡＥ，ＡＬ，ＡＭ，ＡＴ，ＡＵ， ＡＺ，ＢＡ，ＢＢ，ＢＧ，ＢＲ，ＢＹ，ＣＡ，ＣＨ，Ｃ Ｎ，ＣＲ，ＣＵ，ＣＺ，ＤＥ，ＤＫ，ＤＭ，ＥＥ，ＥＳ ，ＦＩ，ＧＢ，ＧＤ，ＧＥ，ＧＨ，ＧＭ，ＨＲ，ＨＵ， ＩＤ，ＩＬ，ＩＮ，ＩＳ，ＪＰ，ＫＥ，ＫＧ，ＫＰ，Ｋ Ｒ，ＫＺ，ＬＣ，ＬＫ，ＬＲ，ＬＳ，ＬＴ，ＬＵ，ＬＶ ，ＭＡ，ＭＤ，ＭＧ，ＭＫ，ＭＮ，ＭＷ，ＭＸ，ＮＯ， ＮＺ，ＰＬ，ＰＴ，ＲＯ，ＲＵ，ＳＤ，ＳＥ，ＳＧ，Ｓ Ｉ，ＳＫ，ＳＬ，ＴＪ，ＴＭ，ＴＲ，ＴＴ，ＴＺ，ＵＡ ，ＵＧ，ＵＺ，ＶＮ，ＹＵ，ＺＡ，ＺＷ (72)発明者 スタンスラスキー、ジョエル エル． アメリカ合衆国 55427 ミネソタ州 ニ ュー ホープ エンサイン アベニュー ノース 4016 (72)発明者 ワン、リシャオ アメリカ合衆国 55369 ミネソタ州 メ ープル グローブ エイティーシックスス プレイン ノース 12822 (72)発明者 スミス、スコット アール． アメリカ合衆国 55318 ミネソタ州 チ ャスカ カウンティ ロード テン 6950 Ｆターム(参考） 4C081 AB13 BB06 CA192 CC01 CG05 CG06 DA03 DC04 4C167 AA44 AA50 AA52 AA55 BB02 BB05 BB06 BB07 BB26 CC09 DD01 GG01 GG16 GG43

Claims (13)

    【特許請求の範囲】
  1. 【請求項１】 ステント本体と、 前記本体の少なくとも一部を覆って配置されるステント被覆と、 前記被覆中に分散された生物活性薬剤とを備え、前記被覆は第１の共重合体及
    び第２の共重合体を含み、第１の共重合体は前記薬剤を第１の速度にて放出し、
    第２の共重合体は前記薬剤を第２の速度にて放出し、第２の速度は第１の速度よ
    りも低速であり、よって前記薬剤は前記被覆から第１の速度よりも遅く、かつ第
    ２の速度よりも速い速度にて放出されるステント。
  2. 【請求項２】 前記第１の共重合体が親水性である請求項１に記載のステン
    ト。
  3. 【請求項３】 前記第２の共重合体が疎水性である請求項１に記載のステン
    ト。
  4. 【請求項４】 前記第１の共重合体が親水性であり、かつ前記第２の共重合
    体が疎水性である請求項１に記載のステント。
  5. 【請求項５】 前記第１の共重合体がＰＬＡ―ＰＥＯを含む請求項１に記載
    のステント。
  6. 【請求項６】 前記第２の共重合体がＰＬＡ―ＰＣＬを含む請求項１に記載
    のステント。
  7. 【請求項７】 前記第１の共重合体がＰＬＡ―ＰＥＯを含み、かつ前記第２
    の共重合体がＰＬＡ―ＰＣＬを含む請求項１に記載のステント。
  8. 【請求項８】 前記薬剤が、パクリタキセル（ｐａｃｌｉｔａｘｅｌ）、パ
    クリタキセル類似体、パクリタキセル誘導体、及びそれらの組み合わせからなる
    群から選択される薬剤を含む請求項７に記載のステント。
  9. 【請求項９】 長期間にわたって生物活性薬剤を制御可能に放出するための
    ステントであって、 ステント本体と、 生物活性薬剤と、 前記薬剤を前記ステント本体に付着させ、かつ時間の経過により前記薬剤を前
    記ステント本体から放出させる手段とを備え、前記薬剤を制御可能に放出するた
    めの前記手段は、前記薬剤を第１の期間にわたって第１の速度にて放出する第１
    の手段と、前記薬剤を第２の期間にわたって第２の速度にて放出する第２の手段
    との組み合わせを含み、前記第１の速度は前記第２の速度より速く、かつ前記第
    １の期間は前記第２の期間よりも短いステント。
  10. 【請求項１０】 放出するための前記第１の手段が生体吸収性ポリマー材料
    を含み、かつ放出するための前記第２の手段が生体吸収性ポリマー材料を含み、
    第１の手段は第２の手段よりも速く吸収される請求項９に記載のステント。
  11. 【請求項１１】 生物活性薬剤をヒトの体内に放出するステントであって、 ステント本体と、 前記ステント本体の少なくとも一部を覆って配置されるポリマー被覆と、 前記ポリマー被覆に混合された生物活性物質とを備え、前記ポリマー被覆はＰ
    ＬＡ−ＰＥＯ共重合体とＰＬＡ−ＰＣＬ共重合体との混合物を含むステント。
  12. 【請求項１２】 前記生物活性薬剤が、パクリタキセル、パクリタキセル類
    似体、パクリタキセル誘導体、及びそれらの組み合わせからなる群から選択され
    る薬剤を含む請求項１１に記載のステント。
  13. 【請求項１３】 ＰＬＡ−ＰＥＯ共重合体とＰＬＡ−ＰＣＬ共重合体との混
    合物を有する被覆を備えるステントを供給する工程を備え、前記被覆はパクリタ
    キセル、パクリタキセル類似体、パクリタキセル誘導体、及び混合されたそれら
    の組み合わせからなる群から選択される再狭窄抑制薬剤を含み、よって前記ＰＬ
    Ａ−ＰＥＯ共重合体のみにより放出されるよりも長い期間であり、かつＰＬＡ―
    ＰＣＬ共重合体のみにより放出されるよりも短い期間にわたって前記薬剤が放出
    される再狭窄を抑制するための方法。
JP2001507394A 1999-07-02 2000-06-06 ステントの被覆 Pending JP2003503153A (ja)

Applications Claiming Priority (3)

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US09/346,975 1999-07-02
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