JP5603598B2 - 生物分解層を有するステント - Google Patents
生物分解層を有するステント Download PDFInfo
- Publication number
- JP5603598B2 JP5603598B2 JP2009545647A JP2009545647A JP5603598B2 JP 5603598 B2 JP5603598 B2 JP 5603598B2 JP 2009545647 A JP2009545647 A JP 2009545647A JP 2009545647 A JP2009545647 A JP 2009545647A JP 5603598 B2 JP5603598 B2 JP 5603598B2
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- Prior art keywords
- stent
- rapamycin
- coronary
- laminated
- polymer
- Prior art date
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Images
Classifications
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- 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
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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
- 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
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- A—HUMAN NECESSITIES
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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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
Description
本願は、2007年1月8日付けで出願された米国仮出願第60/884,005号および2007年4月17日付けで出願された米国仮出願第60/912,408号の優先権を主張し、それらの出願をここに出典明示して本願明細書の一部とみなす。
a.ステントフレームワークを供し;
b.該ステントフレームワーク上で複数の層を沈着させて、積層冠状動脈用ステントを形成することを含み、ここに、少なくとも1つの該層は生体吸収性ポリマーを含む積層冠状動脈用ステントを調製する方法を提供する。好ましくは、ステントフレームワークは生体吸収性である。1つの具体例において、ステントフレームワークはマグネシウムを含む吸収性物質で作製される。
a.ステントフレームワーク;
b.該積層冠状動脈用ステントを形成するための該ステントフレームワーク上で沈着した複数の層を含み;ここに、少なくとも1つの該層は、生体吸収性ポリマーを含む積層冠状動脈用ステントを提供する。
a.ステントフレームワークを供し;
b.該ステントフレームワーク上に複数の層を沈着させて、積層冠状動脈用ステントを形成することを含み;ここに、少なくとも1つの該層は、生体吸収性ポリマー、治療上望ましい形態の少なくとも1つの医薬薬剤および/または少なくとも1つの活性な生物学的薬剤を含み;該ステントフレームワーク上での該複数の層の各層の沈着は、以下の工程:
i.1以上の医薬薬剤および/または少なくとも1つの活性な生物学的薬剤の固体粒子を形成するのに十分な条件下で、少なくとも1つの超臨界流体溶媒および1以上の医薬薬剤および/または少なくとも1つの活性な生物学的薬剤を含む超臨界または近超臨界流体の溶液を形成し;
ii.少なくとも1つの超臨界流体溶媒および少なくとも1つのポリマーを含む超臨界または近超臨界流体の溶液を形成し、ポリマーの固体粒子を形成するのに十分な条件下で該第1の開口部または第2の開口部を介して超臨界または近超臨界流体の溶液を放出させ;
iii.ポリマーおよび医薬薬剤および/または活性な生物学的薬剤粒子を該フレームワークに沈着させ、ここに、電位は、フレームワークおよびポリマーおよび医薬薬剤および/または活性な生物学的薬剤の間に維持され、それにより該層を形成し;次いで
iv.該医薬薬剤の形態学および/または該生物学的薬剤の活性を実質的に改変しない条件下で、該層を焼結させることを含むことを特徴とする積層冠状動脈用ステントを調製する方法を提供する。好ましくは、フレームワークは静電的に帯電される。1つの具体例において、フレームワークは生物分解性である。
a.生体吸収性ポリマーを含むシートを形成し;
b.該冠状動脈用ステントのパターンを該シートに刻み込み;次いで
c.該シートを捲いて、該冠状動脈用ステントを形成することを含む冠状動脈用ステントを調製する方法を提供する。1つの具体例において、該シートの形成は、複数の層を沈着させて該シートを形成し、該冠状動脈用ステントは積層冠状動脈用ステントである。
本願明細書に言及された全ての刊行物および特許出願をここに出典明示して、個々の刊行物および特許出願の各々が参照により取り込まれるように具体的および個々に示されるような同一の範囲まで、本願明細書の一部とみなす。
・ステント製造プロセス(例えば、チューブストックのレーザー切断、シートストックへのリトグラフィック転写等)を介してステント形態を直接的に創製する。本発明のステント形態は従来のステントより2〜100×薄い(それはそれ自体または自然にポリマーラミネート(群)の追加強度および物理的特性なくして用いることを困難にする)。
・既存の永久金属ステント(ステンレス鋼、コバルト−クロム、ニチノール、白金合金、金、銀等)をエッチングすることによりステント形態を創製して、オリジナルのステントのテンプレートにおいてワイヤーフレームを創製する。生体吸収性伝導物質からステント形態を創製して、引き続いて適用される生分解性ポリマー(群)+薬物(群)についてのテンプレートとして用いる(例えば、J lnterv Cardiol. 17(6):391-5(2004年12月)に記載された伝導性ポリマー物質またはマグネシウム。
・ミセルプロセス(e−RESS、e-DPC、圧縮気体(compressed-gas)焼結)でなされるようなステント形態の薬物およびポリマーでのスプレーコーティング。
・異なる物質が各工程で沈着され得る複数でかつ連続的なコーティング焼結工程を行い、かくして、最終ステントを構築する薬物(群)、ポリマー(群)または薬物+ポリマーの多数の薄層を持つ積層構造を創製する
・ステントの内部(管腔)表面上でマスクの包含を含むポリマー(群)+薬物ラミネート(群)の沈着を行う。かかるマスクは、ステント形態の内径を通って挿入された非伝導性マンドレルと同じくらい単純であり得る。このマスキングは、加えられるいずれかの層に先立って生じることができたか、またはいくつかの層が全ステント形態のまわりで連続的に沈着された後、意図的に挿入することができる。
・フィルム成形プロセス(スピンコーティング、溶媒成形、押出成形、吹込成形)
・eRESS、eDPCおよび焼結のミセル圧縮気体方法。シート基材の連続コーティングによって、ポリマーシートを一連のコート−焼結−コート−焼結−コート−焼結工程により形成できる。
本願明細書に用いた、以下の用語および語句は、それらが用いられる文脈が特記される範囲を除いて、後記する意味を有すると一般的に意図される。
エコナゾール、ACE阻害薬、エナラプリル、エフェドリン、エピネフリン、エポエチンおよびエポエチン誘導体、モルフィナン系、カルシウム拮抗薬、イリノテカン、モダフィニル、オルリスタット、ペプチド系抗生物質、フェニトイン、リルゾール、リセドロネート、シルデナフィル、トピラマート、マクロライド系抗生物質、エストロゲンおよびエストロゲン誘導体、プロゲストゲンおよびプロゲストゲン誘導体、テストステロンおよびテストステロン誘導体、アンドロゲンおよびアンドロゲン誘導体、エテンザミド、エトフェナメート、エトフィブラート、フェノフィブラート、エトフィリン、エトポシド、ファムシクロビル、ファモチジン、フェロジピン、フェノフィブラート、フェンタニル、フェンチコナゾール、ジャイレース阻害薬、フルコナゾール、フルダラビン、フルアリジン(fluarizine)、フルオロウラシル、フルオキセチン、フルルビプロフェン、イブプロフェン、フルタミド、フルバスタチン、フォリトロピン、ホルモテロール、ホスホマイシン、フロセミド、フシジン酸、ガロパミル、ガンシクロビル、ゲムフィブロジル、ゲンタマイシン、イチョウ、オトギリソウ(Saint John's wort)、グリベンクラミド、経口抗糖尿病薬のごとき尿素誘導体、グルカゴン、グルコサミンおよびグルコサミン誘導体、グルタチオン、グリセロールおよびグリセロール誘導体、視床下部ホルモン、ゴセレリン、ジャイレース阻害薬、グアネチジン、ハロファントリン、ハロペリドール、ヘパリンおよびヘパリン誘導体、ヒアルロン酸、ヒドララジン、ヒドロクロロチアジドおよびヒドロクロロチアジド誘導体、サリチラート、ヒドロキシジン、イダルビシン、イホスファミド、イミプラミン、インドメタシン、インドラミン、インスリン、インターフェロン、ヨウ素およびヨウ素誘導体、イソコナゾール、イソプレナリン、グルシトールおよびグルシトール誘導体、イトラコナゾール、ケトコナゾール、ケトプロフェン、ケトチフェン、ラシジピン、ランソプラゾール、レボドパ、レボメタドン、甲状腺ホルモン、リポ酸およびリポ酸誘導体、リシノプリル、リスリド、ロフェプラミン、ロムスチン、ロペラミド、ロラタジン、マプロチリン、メベンダゾール、メベベリン、メクロジン、メフェナム酸、メフロキン、メロキシカム、メピンドロール、メプロバメート、メロペネム、メサラジン、メスクシミド、メタミゾール、メトホルミン、メトトレキセート、メチルフェニデート、メチルプレドニソロン、メチキセン、メトクロプラミド、メトプロロール、メトロニダゾール、ミアンセリン、ミコナゾール、ミノサイクリン、ミノキシジル、ミソプロストール、マイトマイシン、ミゾラスチン、モエキシプリル、モルヒネおよびモルヒネ誘導体、月見草(evening primrose)、ナルブフィン、ナロキソン、チリジン、ナプロキセン、ナルコチン、ナタマイシン、ネオスチグミン、ニセルゴリン、ニセタミド、ニフェジピン、ニフルミン酸、ニモジピン、ニモラゾール、ニムスチン、ニソルジピン、アドレナリンおよびアドレナリン誘導体、ノルフロキサシン、ノバミンスルホン、ノスカピン、ナイスタチン、オフロキサシン、オランザピン、オルサラジン、オメプラゾール、オモコナゾール、オンダンセトロン、オキサセプロール、オキサシリン、オキシコナゾール、オキシメタゾリン、パントプラゾール、パラセタモール、パロキセチン、ペンシクロビル、経口ペニシリン系、ペンタゾシン、ペンチフィリン、ペントキシフィリン、パーフェナジン、ペチジン、植物エキス剤、ファナゾン、フェニラミン、バルビツール酸誘導体、フェニルブタゾン、フェニトイン、ピモジド、ピンドロール、ピペラジン、ピラセタム、ピレンゼピン、ピリベジル、ピロキシカム、プラミペキソール、プラバスタチン、プラゾシン、プロカイン、プロマジン、プロピベリン、プロプラノロール、プロピフェナゾン、プロスタグランジン類、プロチオンアミド、プロキシフィリン、クエチアピン、キナプリル、キナプリラート、ラミプリル、ラニチジン、レプロテロール、レセルピン、リバビリン、リファンピシン、リスペリドン、リトナビル、ロピニロール、ロキサチジン、ロキシスロマイシン、ルスコゲニン、ルトシドおよびルトシド誘導体、サバジラ、サルブタモール、サルメテロール、スコポラミン、セレギリン、セルタコナゾール、セルチンドール、セルトラリオン(sertralion)、ケイ酸塩、シルデナフィル、シンバスタチン、シトステロール、ソタロール、スパグルム酸、スパルフロキサシン、スペクチノマイシン、スピラマイシン、スピラプリル、スピロノラクトン、スタブジン、ストレプトマイシン、スクラルファート、スフェンタニル、スルバクタム、スルホンアミド系、スルファサラジン、スルピリド、スルタミシリン、スルチアム、スマトリプタン、塩化スキサメトニウム、タクリン、タクロリムス、タリオロール(taliolol)、タモキシフェン、タウロリジン、タザロテン、テマゼパム、テニポシド、テノキシカム、テラゾシン、テルビナフィン、テルブタリン、テルフェナジン、テルリプレシン、テルタトロール、テトラサイクリン系、テトリゾリン(teryzoline)、テオブロミン、テオフィリン、ブチジン、チアマゾール、フェノチアジン、チオテパ、チアガビン、チアプリド、プロピオン酸誘導体、チクロピジン、チモロール、チニダゾール、チオコナゾール、チオグアニン、チオキソロン、チロプラミド、チザニジン、トラゾリン、トルブタミド、トルカポン、トルナフテート、トルペリゾン、トポテカン、トラセミド、抗エストロゲン系、トラマドール、トラマゾリン、トランドラプリル、トラニルシプロミン、トラピジル、トラドゾン、トリアムシノロンおよびトリアムシノロン誘導体、トリアムテレン、トリフルペリドール、トリフルリジン、トリメトプリム、トリミプラミン、トリペレナミン、トリプロリジン、トリフォスファミド(trifosfamide)、トロマンタジン、トロメタモール、トロパルピン、トロキセルチン、ツロブテロール、チラミン、チロスリシン、ウラピジル、ウルソデオキシコール酸、ケノデオキシコール酸、バラシクロビル、バルプロ酸、バンコマイシン、ベクロニウム塩化物、バイアグラ、ベンラファキシン、ベラパミル、ビダラビン、ビガバトリン、ビロアジン、ビンブラスチン、ビンカミン、ビンクリスチン、ビンデシン、ビノレルビン、ビンポセチン、ビクイジル、ワルファリン、ニコチン酸キサンチノール、キシパミド、ザフィルルカスト、ザルシタビン、ジドブジン、ゾルミトリプタン、ゾルピデム、ゾプリコン、ゾチピン等である。例えば、米国特許第6,897,205号参照;また、米国特許第6,838,528号;米国特許第6,497,729号参照。
次の実施例は当業者が本発明をより明確に理解し、実施するのを可能とするために挙げられる。それらは、本発明の範囲を制限すると考えられるべきではなく、その例示的および代表的なものであると考えられるべきである。
この実施例において、1枚のポリマーフィルムは、シートの表面を横切るシリンダーを回転させることにより刻印される。ポリマーシートは、伝導性基材上に異なるポリマーの交互の層をスプレーすることにより調製された生体吸収性ポリマーから作製される。層が適用される順序は所望のフィルムの機械的特性によって決定される。薬物は、各層、あるいは選択的に所望の層間で適用し得る。薬物は乾燥粉末コーティング技術を用いて適用される。円筒状のパターン化されたロッドはポリマーフィルムを横切って捲かれ、グラビア印刷様プロセスにおいてステントを創製する。いくらかの方法は、フォトレジスト・エッチング工程を用いるごときパターン付のロッドの創製のために存在する。別法として、パターンは、固体ロッドにレーザー切断できた。平らなポリマーシートを完成したステントの周囲よりわずかに大きな幅で、条片に切断する。次いで、ポリマー条片は、ある形態として作用する滑らかな無パターンのシリンダー(すなわち、テフロン)の周囲に捲く。次いで、この目的物を圧力管に入れ密閉する。ジクロロフルオロメタンのごとき気体を、管の内部の圧力が管の温度の気体の蒸気圧に等しくなるまで、圧力管に加える。適当な気体は、37℃の温度のジクロロフルオロメタンである。気体はポリマー条片を焼結させ、継ぎ目を一緒に結合し、テフロンシリンダー上で支持されたポリマーステントを創製する。ステントを焼結した後、支持体を外す。
この実施例において、マグネシウムのごとき生体吸収性金属を生体吸収性ポリマー(群)が層様式でスプレーできる形態として用いる。PLAのごとき1つのタイプのポリマー層をステント上にスプレーし焼結させる。次いで、PGAのごときもう一つのタイプの第2のポリマー層を第1のポリマー層を保持する金属形態上にスプレーする。ステントを再び焼結して、金属−ポリマータイプI−金属−ポリマータイプIIよりなる3層構造を創製する。このプロセスを同一またはさらなるタイプのポリマーで繰り返して、所望の厚みのコーティングおよび所望の機械的特性を構築できる。いずれかの2層間で、ラパマイシンまたはタキソールあるいは他の抗再狭窄薬のごとき薬物をいずれかの所与のポリマー層または金属ベースステント自体に乾燥粉末コーティングできる。
ステンレス鋼のごとき金属ベースのステントをテフロンまたは同様に滑らかなロッド上で支持しつつ、ほとんどないくらいの小さなサイズにエッチングする。ロッドの外径は、ステントの内径よりわずかに小さく、エッチングされた金属ステントを支持し、内部(管腔)表面をマスクするように機能する。マスクは、この表面上に沈着した物質の量を制限するであろう。ステントは、実施例2のごとくコーティングして、所望の機械的およびコーティングの特性を達成できる。さらに、第2の薬物はいずれかの所望の層中で沈着させて、所望の溶出プロフィールを達成できる。
実施例3に対する別法は、ステントの管腔表面についてのマスクの除去である。双方のステント表面を薬物(群)およびポリマーでコーティングする。ステントはステント固定物上でそれ自身の機械強度により支持される。単一または複数の薬物(例えば、パクリタキセルあるいはピクロリムス)は、ポリマーコーティングのいずれかの層中でまたはポリマーコートの厚みを介して沈着できる。
平らな表面上で個々のポリマー層をスプレーすることにより創製したポリマーシートを、圧縮気体、気体または超臨界気体を用いて一緒に結合した。1枚のポリマーを完成したステントの周囲をわずかに超える幅まで切断する。次いで、シートを完成したステントの内径と等しい外径を持つ滑らかなロッド(黒鉛、テフロンまたは同様の物質)の周囲で折り畳む。特定の直径は特定のステント適用によって決定する。次いで、この目的物をポリマーの連続的なシリンダーを一緒に形成する層を焼結できる気体、圧縮気体または超臨界気体に曝露する。
Claims (19)
- a.ステントフレームワーク;および
b.積層冠状動脈用ステントを形成するための該ステントフレームワーク上で沈着した複数の層を含む積層冠状動脈用ステントであって、
ここに、少なくとも1つの該層は生体吸収性ポリマーを含み;
ステントフレームワーク上の層は、300mmHgより大きいステントに対するフープ強度を提供し、かつ、ステントフレームワークは、積層冠状動脈用ステントの厚みの約50%以下の厚みを有することを特徴とする該ステント。 - ステントフレームワークが、管をレーザー切断し;シートへのリトグラフィック転写および/または先に調製された金属ステントをエッチングすることにより調製されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが生体吸収性であることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが、マグネシウムを含む吸収性物質で調製されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが、生体吸収性ポリマーまたは導電性ポリマーで調製されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが、生物学的適合性の非生体吸収性物質で調製されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが、ステンレス鋼で調製されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- ステントフレームワークが、積層冠状動脈用ステントの厚みの約1%以下の厚みを有することを特徴とする請求項1記載の積層冠状動脈用ステント。
- 該生体吸収性ポリマーが、PGAポリ(グリコリド)、LPLAポリ(1−ラクチド)、DLPLAポリ(dl−ラクチド)、PCLポリ(e−カプロラクトン) PDO、ポリ(ジオキソラン)PGA−TMC、85/15 DLPLG p(dl−ラクチド−co−グリコリド)、75/25 DLPL、65/35 DLPLG、50/50 DLPLG、TMCポリ(トリメチルカーボネート)、p(CPP:SA)ポリ(1,3−ビス−p(カルボキシフェノキシ)プロパン−co−セバシン酸)から選択されることを特徴とする請求項1記載の積層冠状動脈用ステント。
- 該複数の層が4、10、20、50、100層またはそれを超えることを特徴とする請求項1記載の積層冠状動脈用ステント。
- 少なくとも1つの該層が、1以上の活性な薬剤を含むことを特徴とする請求項1記載の積層冠状動脈用ステント。
- 1以上の該活性な薬剤が、マクロライド免疫抑制(リムス)薬を含むことを特徴とする請求項11記載の積層冠状動脈用ステント。
- マクロライド免疫抑制薬が、1以上のラパマイシン、40−O−(2−ヒドロキシエチル)ラパマイシン(エベロリムス)、40−O−ベンジル−ラパマイシン、40−O−(4'−ヒドロキシメチル)ベンジル−ラパマイシン、40−O−[4'−(1,2−ジヒドロキシエチル)]ベンジル−ラパマイシン、40−O−アリル−ラパマイシン、40−O−[3'−(2,2−ジメチル−1,3−ジオキソラン−4(S)−イル)−プロプ−2'−エン−1'−イル]−ラパマイシン、(2':E,4'S)−40−O−(4',5'−ジヒドロキシペント−2'−エン−1'−イル)−ラパマイシン、40−O−(2−ヒドロキシ)エトキシカルボニルメチル−ラパマイシン、40−O−(3−ヒドロキシ)プロピル−ラパマイシン、40−O−(6−ヒドロキシ)ヘキシル−ラパマイシン、40−O−[2−(2−ヒドロキシ)エトキシ]エチル−ラパマイシン、40−O−[(3S)−2,2−ジメチルジオキソラン−3−イル]メチル−ラパマイシン、40−O−[(2S)−2,3−ジヒドロキシプロプ−1−イル]−ラパマイシン、40−O−(2−アセトキシ)エチル−ラパマイシン、40−O−(2−ニコチノイルオキシ)エチル−ラパマイシン、40−O−[2−(N−モルホリノ)アセトキシ]エチル−ラパマイシン、40−O−(2−N−イミダゾリルアセトキシ)エチル−ラパマイシン、40−O−[2−(N−メチル−N'−ピペラジニル)アセトキシ]エチル−ラパマイシン、39−O−デスメチル−39,40−O,O−エチレン−ラパマイシン、(26R)−26−ジヒドロ−40−O−(2−ヒドロキシ)エチル−ラパマイシン、28−O−メチル−ラパマイシン、40−O−(2−アミノエチル)−ラパマイシン、40−O−(2−アセトアミノエチル)−ラパマイシン、40−O−(2−ニコチンアミドエチル)−ラパマイシン、40−O−(2−(N−メチル−イミダゾ−2'−イルカルボエトキシアミド)エチル)−ラパマイシン、40−O−(2−エトキシカルボニルアミノエチル)−ラパマイシン、40−O−(2−トリルスルホンアミドエチル)−ラパマイシン、40−O−[2−(4',5'−ジカルボエトキシ−l',2',3'−トリアゾール−1'−イル)−エチル]−ラパマイシン、42−エピ−(テトラゾリル)ラパマイシン(タクロリムス)、および42−[3−ヒドロキシ−2−(ヒドロキシメチル)−2−メチルプロパノエート]ラパマイシン(テムシロリムス)を含むことを特徴とする請求項12記載の積層冠状動脈用ステント。
- a.ステントフレームワーク;および
b.該積層冠状動脈用ステントを形成するための該ステントフレームワーク上で沈着した複数の層を含む積層冠状動脈用ステントであって、
ここに、少なくとも1つの該層は、生体吸収性ポリマーを含み、
ステントフレームワーク上の層は、冠状動脈管腔を開いたままとするのに十分なフープ強度を提供し、かつ、ステントフレームワークは、積層冠状動脈用ステントの厚みの約50%以下の厚みを有する該ステント。 - a.ステントフレームワークを供し;
b.該ステントフレームワーク上に複数の層を沈着させて、該積層冠状動脈用ステントを形成することを含み;ここに、少なくとも1つの該層は、生体吸収性ポリマー、結晶または半結晶である治療上望ましい形態学の少なくとも1つの医薬薬剤を含み;該ステントフレームワーク上での該複数の層の各層の沈着は、以下の工程:
i.第1の開口部を介して乾燥粉末形態で少なくとも1つの医薬薬剤を放出させ;
ii.少なくとも1つの超臨界流体溶媒および少なくとも1つのポリマーを含む超臨界または近超臨界流体の溶液を形成し、ポリマーの固体粒子を形成するのに十分な条件下で該第2の開口部を介して該超臨界または近超臨界流体の溶液を放出させ;
iii.ポリマーおよび医薬薬剤粒子を該フレームワークに沈着させ、ここに、電位は、フレームワークおよびポリマーおよび医薬薬剤および/または活性な生物学的薬剤の間に維持され、それにより該層を形成し;次いで
iv.該医薬薬剤の形態学を実質的に改変しない条件下で、該層を焼結させることを含み、
ステントフレームワーク上の層は、冠状動脈管腔を開いたままとするのに十分なフープ強度を提供し、かつ、ステントフレームワークは、積層冠状動脈用ステントの厚みの約50%以下の厚みを有することを特徴とする積層冠状動脈用ステントを調製する方法。 - a.複数の層を沈着させて、生体吸収性ポリマーを含むラミネートシートを形成し;
b.該シートに該冠状動脈用ステントのパターンを刻み込み;次いで
c.該シートを捲いて、該冠状動脈用ステントを形成することを含み;ここに、該複数の層の各層の沈着は、以下の工程:
i.第1の開口部を介して乾燥粉末形態で少なくとも1つの医薬薬剤を放出させ;
ii.少なくとも1つの超臨界流体溶媒および少なくとも1つのポリマーを含む超臨界または近超臨界流体の溶液を形成し、ポリマーの固体粒子を形成するのに十分な条件下で第1の開口部または第2の開口部を介して該超臨界または近超臨界流体の溶液を放出させ;
iii.ポリマーおよび医薬薬剤粒子を沈着させ、ここに、電位は、ラミネートシートが形成される支持体およびポリマーおよび医薬薬剤粒子の間に維持され、それにより該層を形成し;次いで
iv.該医薬薬剤の形態学を実質的に改変しない条件下で、該層を焼結させることを含み、
ここに、該形態学は結晶または半結晶であり、
ステントフレームワーク上の層は、冠状動脈管腔を開いたままとするのに十分なフープ強度を提供し、かつ、ステントフレームワークは、積層冠状動脈用ステントの厚みの約50%以下の厚みを有する
ことを特徴とする積層冠状動脈用ステントを調製する方法。 - 該活性な薬剤が医薬薬剤を含み、該医薬薬剤の少なくとも50%が結晶または半結晶であることを特徴とする請求項11記載の積層冠状動脈用ステント。
- 該ステントフレームワークが、余りにも弱いので、その上の沈着がなくてはステントとして機能しないことを特徴とする請求項1記載の積層冠状動脈用ステント。
- 該ステントフレームワークが、生体吸収性ポリマーの弾性記憶を克服することを特徴とする請求項18記載の積層冠状動脈用ステント。
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US9737642B2 (en) | 2017-08-22 |
EP2111184A1 (en) | 2009-10-28 |
CN101711137A (zh) | 2010-05-19 |
US20180000996A1 (en) | 2018-01-04 |
WO2008086369A1 (en) | 2008-07-17 |
EP2111184B1 (en) | 2018-07-25 |
EP2111184A4 (en) | 2013-03-20 |
US20100063580A1 (en) | 2010-03-11 |
US10617795B2 (en) | 2020-04-14 |
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