DE69431457T3 - Stent - Google Patents

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DE69431457T3
DE69431457T3 DE69431457T DE69431457T DE69431457T3 DE 69431457 T3 DE69431457 T3 DE 69431457T3 DE 69431457 T DE69431457 T DE 69431457T DE 69431457 T DE69431457 T DE 69431457T DE 69431457 T3 DE69431457 T3 DE 69431457T3
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polymer
stent
solvent
poly
solution
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DE69431457T2 (de
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Eric P. Berg
Ronald J. Tuch
Michael Dror
Rodney G. Wolff
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Medtronic Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146Porous materials, e.g. foams or sponges
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/22Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
    • A61L2300/222Steroids, e.g. corticosteroids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42Anti-thrombotic agents, anticoagulants, anti-platelet agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • A61L2300/608Coatings having two or more layers

Description

  • Diese Erfindung betrifft intravaskuläre Stents zur Behandlung von Verletzungen von Blutgefäßen und insbesondere Stents mit einem Gerüst, auf das eine therapeutische Substanz oder ein Wirkstoff bzw. Arzneimittel aufgebracht ist.
  • Obwohl angioplastische Verfahren zur Behandlung von verschlossen Arterien stark an Beliebtheit zugenommen haben, bleibt das Problem der Restenose nach der angioplastischen Behandlung ein erhebliches Problem. Restenose ist der Verschluß einer peripheren oder koronaren Arterie nach einer Verwundung der Arterie, die durch Maßnahmen zur Öffnung eines verschlossenen Abschnitts der Arterie durch Angioplastie, wie z. B. durch Ballondehnung, Atherektomie oder Laser-Abtragungsbehandlung der Arterie verursacht ist. Bei diesen angioplastischen Verfahren tritt Restenose in einer Rate von etwa 30–60% in Abhängigkeit von dem Ort des Gefäßes, der Länge der Verwundung und einer Anzahl von anderen Variablen auf.
  • Ein Aspekt der Restenose kann einfach mechanisch sein, z. B. aufgrund des elastischen Zurückspringens der Arterienwand und/oder der durch das angioplastische Verfahren verursachten Sezierungen in der Gefäßwand. An diese mechanischen Probleme hat man sich erfolgreich durch die Verwendung von Stents gewandt, um Sezierungen zusammenzufügen und ein elastisches Zurückspringen des Gefäßes zu verhindern, wodurch das Ausmaß von Restenose für viele Patienten reduziert wird. Der Stent wird typischerweise mit einem Katheter in ein Vaskulärlumen eingeführt und bis zur Berührung des erkrankten Bereichs der Arterienwand expandiert, wodurch eine innere Stütze für das Lumen bereitgestellt wird. Beispiele für Stents, die erfolgreich auf einem PTCA-Ballon eingeführt und zur gleichen Zeit mit der Ballonexpansion einer betroffenen Arterie expandiert wurden, schließen die in der US-A-4733665 (Palmaz), US-A-4800882 (Gianturco) und US-A-4886062 (Wiktor) offenbarten Stents ein, die hier im gesamten Umfang als Referenz eingefügt werden.
  • Es wird angenommen, dass ein anderer Aspekt von Restenose eine natürliche Heilungsreaktion auf die Verletzung der Arterienwand ist, die durch angioplastische Verfahren verursacht ist. Das Endergebnis der komplexen Schritte des Heilungsprozesses ist eine Intimahyperplasie, die Migration und Proliferation von medialen glatten Muskelzellen, bis die Arterie wieder verschlossen ist.
  • Um sich an beide Aspekte des Restenoseproblems zu wenden, wurde vorgeschlagen, Stents zur Verfügung zu stellen, die Endothelzellen tragen (siehe Dichek, D. A. et al. ”Seeding of Intravascular Stents With Genetically Engineered Endothelial Cells”, Circulation 80: 1347–1353 (1989)). Bei diesem Experiment wurden Endothelzellen von Schafen, die einem durch Retroviren vermittelten Gentransfer entweder von bakterieller Beta-Galactosidase oder von humanem Gewebeplasminogen-Aktivator unterzogen waren, auf Stents aus rostfreiem Stahl verteilt und solange wachsen gelassen, bis die Stents bedeckt waren. Die Zellen konnten daher an die Gefäßwand abgegeben werden, wo sie therapeutische Proteine bereitstellen konnten. Andere Verfahren zur Bereitstellung therapeutischer Substanzen für die Gefäßwand umfassen einfache heparinbeschichtete metallische Stents, wobei eine Heparinbeschichtung ionisch oder kovalent an den Stent gebunden ist. Es wurden auch noch weitere Verfahren zur Bereitstellung therapeutischer Substanzen für die Gefäßwand mittels Stents vorgeschlagen, wie in der US-A-5102417 (Palmaz), WO-91/12779 ”Intraluminal Drug Eluting Prosthesis” und WO-90/133 32 ”Stent With Sustained Drug Delivery”. In den letzten beiden wurde vorgeschlagen, dass Antiplättchenmittel, Antigerinnungsmittel, antimikrobielle Mittel, Antimetabolitenmittel und andere Wirkstoffe bzw. Arzneimittel durch Stents zugeführt werden können, um das Auftreten von Restenose zu vermindern.
  • Metallstents, wie die in der US-A-4733665 (Palmaz), der US-A-4800882 (Gianturco) und der US-A-4886062 (Wiktor) offenbarten Stents, können insofern zur Wirkstoffabgabe geeignet sein, dass sie einen engen Kontakt zwischen einer auf der äußeren Oberfläche des Stents aufgebrachten Substanz und den Geweben des zu behandelnden Gefäßes aufrecht erhalten können. Jedoch gibt es erhebliche Probleme, die überwunden werden müssen, um eine therapeutisch signifikante Menge einer Substanz auf dem Metall des Stents sicher zu befestigen, diese während der Expansion des Stents bis zur Berührung der Blutgefäßwand auf dem Stent zu halten, und auch die Wirkstoffabgaberate des auf dem Stent befindlichen Wirkstoffs an die Gefäßwand zu regeln.
  • Es bleibt daher ein Bedarf für Mittel zur Bereitstellung eines Stents mit einer therapeutisch signifikanten Menge eines darauf aufgebrachten Wirkstoffs.
  • Wir haben ein Verfahren zur Herstellung eines intravaskulären Stents entdeckt, das diesen Bedarf erfüllt.
  • Im Hinblick auf einen Aspekt stellt die Erfindung daher ein Verfahren zur Herstellung eines intravaskulären Stents gemäß Anspruch 1 zur Verfügung.
  • Bei dem erfindungsgemäßen Verfahren wird auf den Stentkörper und insbesondere auf seine das Gewebe berührende Oberfläche eine Lösung aufgetragen, die ein Lösungsmittel, ein in dem Lösungsmittel gelöstes Polymer und eine in dem Lösungsmittel dispergierte therapeutische Substanz, (d. h. einen Wirkstoff bzw. ein Arzneimittel) enthält, und das Lösungsmittel wird danach verdampft, so dass auf dem Stent eine Wirkstoff eluierende Polymeroberfläche zurückbleibt. Der Einschluss eines Polymers in engem Kontakt mit einem Wirkstoff auf dem Stent ermöglicht, dass der Wirkstoff auf dem Stent in einer elastischen bzw. nachgebenden Matrix während der Expansion des Stents zurückgehalten wird und verlangsamt auch die Verabreichung von Wirkstoff nach einer Implantation. In dem erfindungsgemäßen Verfahren weist der Stent eine Metalloberfläche auf. Das Verfahren ist auch ein äußerst einfaches Verfahren, da es ausgeführt werden kann, indem die Lösung einfach auf den Stent gesprüht wird. Die auf dem Stent einzuschließende Wirkstoffmenge wird einfach durch Auftragen mehrerer dünner Schichten der Lösung kontrolliert, wobei zwischen den Beschichtungen trocknen gelassen wird. Die Gesamtbeschichtung sollte allgemein dünn genug sein, so dass sie das Profil des Stents für eine intravaskuläre Abgabe durch einen Katheter nicht erheblich erhöht. Sie ist daher vorzugsweise weniger als 0,002 Zoll (0,05 mm) dick und besonders vorzugsweise weniger als 0,001 Zoll (0,025 mm) dick. Die Haftung der Beschichtung und die Rate, mit der der Wirkstoff abgegeben wird, kann durch die Auswahl eines geeigneten bioabsorbierbaren oder biostabilen Polymers und durch das Verhältnis von Wirkstoff zu Polymer in der Lösung kontrolliert werden. Durch dieses Verfahren können Wirkstoffe, wie Glucocorticoide (z. B. Dexamethason, Betametason), Heparin, Hirudin, Tocopherol, Angiopeptin, Aspirin, ACE-Hemmstoffe, Wachstumsfaktoren, Oligonukleotide, und allgemeiner Antiplättchen-Mittel, Antigerinnungsmittel, antimitotische Mittel, Antioxidantien, Antimetabolitenmittel und antientzündliche Mittel auf einen Stent aufgebracht werden, während der Expansion des Stents auf dem Stent zurückgehalten werden und der Wirkstoff kann mit einer kontrollierten Geschwindigkeit eluieren. Die Freisetzungsgeschwindigkeit kann darüber hinaus durch Variieren des Verhältnisses von Wirkstoff zu Polymer in den mehreren Schichten geregelt werden. Zum Beispiel würde ein höheres Verhältnis von Wirkstoff zu Polymer in den äußeren Schichten als in den inneren Schichten zu einer höheren Anfangsdosis führen, die mit der Zeit abnehmen würde.
  • Bei der Anwendung kann der gemäß der vorliegenden Erfindung hergestellte Stent Wirkstoffe an ein Körperlumen abgeben, indem der Stent transluminal in einen ausgewählten Abschnitt des Körperlumens eingeführt wird, und der Stent bis zur Berührung des Körperlumens radial expandiert wird. Die transluminale Abgabe kann durch einen Katheter ausgeführt werden, der für die Einführung bzw. Abgabe von Stents ausgelegt ist, und die radiale Expansion kann durch eine Ballonexpansion des Stents oder eine Kombination von Selbstexpansion und Ballonexpansion erreicht werden.
  • Somit stellt die vorliegende Erfindung ein Verfahren zur Herstellung eines Stents zur Verfügung, der in ein ausgewähltes Blutgefäß eingeführt und darin expandiert werden kann, ohne eine therapeutisch erhebliche Menge eines darauf aufgebrachten Wirkstoffs zu verlieren. Sie stellt auch ein Verfahren zur Herstellung eines wirkstoffhaltigen Stents zur Verfügung, der eine verzögerte Freisetzung des Wirkstoffes an Gefäßgewebe erlaubt.
  • Die darunterliegende Struktur des erfindungsgemäß verwendeten Stents ist der durch einen Ballon expandierbare Typ und aus Metallmaterial. Somit können metallische Stent-Ausführungen, wie die in der US-A-473 3 665 (Palmaz), US-A-4800882 (Gianturco) und US-A-4886062 (Wiktor) offenbarten Stents, in der vorliegenden Erfindung verwendet werden. Der Stent kann eigentlich aus jedem beliebigen bioverträglichen Metallmaterial mit für die Ausführung geeigneten physikalischen Eigenschaften hergestellt werden. Zum Beispiel haben sich Tantal und rostfreier Stahl für viele derartige Ausführungen als geeignet erwiesen und können bei der vorliegenden Erfindung verwendet werden. Wenngleich die Stentoberfläche sauber und frei von Kontaminanten sein soll, die während der Herstellung aufgebracht werden könnten, benötigt die Stentoberfläche keine besondere Oberflächenbehandlung, um die bei der vorliegenden Erfindung aufgebrachte Beschichtung zu halten. Sowohl die inneren als auch die äußeren Oberflächen des Stents können mit der Beschichtung gemäß der vorliegenden Erfindung versehen sein.
  • Um den beschichteten Stent gemäß dem Verfahren der vorliegenden Erfindung bereitzustellen, wird zuerst eine Lösung hergestellt, die ein Lösungsmittel, ein in dem Lösungsmittel gelöstes Polymer und eine in dem Lösungsmittel dispergierte therapeutische Substanz enthält. Das Lösungsmittel, das Polymer und die therapeutische Substanz sollten natürlich wechselseitig kompatibel bzw. verträglich sein. Das Lösungsmittel sollte dazu in der Lage sein, das Polymer in der gewünschten Konzentration in Lösung zu halten. Darüber hinaus sollten das Lösungsmittel und das Polymer die therapeutischen Eigenschaften der therapeutischen Substanz nicht chemisch verändern. Jedoch muss die therapeutische Substanz in dem Lösungsmittel lediglich dispergiert vorliegen, so dass sie entweder als eine echte Lösung mit dem Lösungsmittel oder in feinen Partikeln in dem Lösungsmittel dispergiert vorliegen kann. Beispiele für einige geeignete Kombinationen von Polymer, Lösungsmittel und therapeutischer Substanz sind in Tabelle 1 nachstehend aufgeführt. Tabelle 1
    POLYMER LÖSUNGSMITTEL THERAPEUTISCHE SUBSTANZ
    Poly(L-milchsäure) Chloroform Dexamethason
    Poly(milchsäure-coglycolsäure) Aceton Dexamethason
    Polyetherurethan N-Methylpyrrolidon Tocopherol (Vitamin E)
    Silikonhaftmittel Xylol Dexamethason-phosphat
    Poly(hydroxybutyrat-cohydroxyvalerat) Dichlormethan Aspirin
    Fibrin Wasser (gepufferte Salzlösung) Heparin
  • Die Lösung wird auf den Stent aufgebracht und die Lösung wird verdampfen gelassen, wodurch auf der Stentoberfläche eine Beschichtung aus dem Polymer und der therapeutischen Substanz zurückgelassen wird. Die Lösung wird durch Sprühen der Lösung auf den Stent aufgebracht. Es wurde herausgefunden, dass Sprühen mit einem feinen Spray, wie dem durch ein Airbrush-Gerät erhältlichen Spray, eine Beschichtung mit der größten Gleichmäßigkeit bereitstellt und die beste Kontrolle der Menge des auf den Stent aufzubringenden Beschichtungsmaterials bereitstellt. Mehrere Aufbringungsschritte stellen eine verbesserte Gleichmäßigkeit der Beschichtung und eine verbesserte Kontrolle der Menge der auf den Stent aufzutragenden therapeutischen Substanz bereit.
  • Das gewählte Polymer sollte ein Polymer sein, das bioverträglich ist und eine Reizung der Gefäßwand minimiert, wenn der Stent implantiert ist. Das Polymer kann entweder ein biostabiles oder ein bioabsorbierbares Polymer sein, in Abhängigkeit von der gewünschten Freisetzungsrate oder dem gewünschten Stabilitätsgrad des Polymers, aber ein bioabsorbierbares Polymer kann wünschenswerter sein, da es, anders als ein biostabiles Polymer, nicht so lange nach der Implantation vorliegt, um irgendwelche ungünstigen chronischen örtlichen Reaktionen auszulösen. Bioabsorbierbare Polymere, die verwendet werden können, umfassen Poly(L-milchsäure), Polycaprolacton, Poly(lactid-coglycolid), Poly(hydroxybutyrat), Poly(hydroxybutyrat-covalerat), Polydioxanon, Polyorthoester, Polyanhydrid, Poly(glycolsäure), Poly(D,L-milchsäure), Poly(glycolsäure-cotrimethylencarbonat), Polyphosphoester, Polyphosphoesterurethan, Poly(aminosäuren), Cyanoacrylate, Poly(trimethylencarbonat), Poly(iminocarbonat), Copoly(ether-ester), (z. B. PEO/PLA), Polyalkylenoxalate, Polyphosphazene und Biomoleküle, wie Fibrin, Fibrinogen, Cellulose, Stärke, Collagen, und Hyaluronsäure. Ebenfalls können biostabile Polymere mit einer relativ geringen chronischen Gewebereaktion, wie Polyurethane, Silikone und Polyester, verwendet werden, und andere Polymere können auch verwendet werden, wenn sie gelöst und auf dem Stent gehärtet oder polymerisiert werden können, wie Polyolefine, Polyisobutylen und Ethylen-Alphaolefin-Copolymere; Acrylpolymere und Copolymere; Vinylhalogenidpolymere und Copolymere, wie Polyvinylchlorid; Polyvinylether, wie Polyvinylmethylether; Polyvinylidenhalogenide, wie Polyvinylidenfluorid und Polyivinylidenchlorid; Polyacrylonitril, Polyvinylketone; Polyvinylaromaten, wie Polystyrol; Polyvinylester, wie Polyvinylacetat; Copolymere von Vinylmonomeren miteinander und mit Ole-finen, wie Ethylen-Methylmethacrylat-Copolymere, Acrylonitril-Styrol-Copolymere, ABS-Harze und Ethylen-Vinylacetat-Copolymere; Polyamide, wie Nylon 66 und Polycaprolactam; Alkydharze; Polycarbonate; Polyoxymethylene; Polyamide; Polyether; Epoxyharze, Polyurethane; Rayon; Rayontriacetat; Cellulose, Celluloseacetat, Cellulosebutyrat; Celluloseacetatbutyrat; Cellophan; Cellulosenitrat; Cellulosepropionat; Celluloseether und Carboxymethylcellulose.
  • Das Verhältnis von therapeutischer Substanz zu Polymer in der Lösung hängt von der Wirksamkeit des Polymers ab, die therapeutische Substanz auf dem Stent sicher festzuhalten, und von der Geschwindigkeit, mit der die Beschichtung die therapeutische Substanz an das Gewebe des Blutgefäßes freisetzen soll. Mehr Polymer kann nötig sein, wenn es eine relativ schlechte Wirksamkeit hinsichtlich der Zurückhaltung der therapeutischen Substanz auf dem Stent aufweist, und mehr Polymer kann notwendig sein, um eine Elutionsmatrix bereitzustellen, die die Elution einer sehr löslichen therapeutischen Substanz begrenzt. Daher kann ein sehr breites Verhältnis von therapeutischer Substanz zu Polymer geeignet sein und das Gewichtsverhältnis kann von etwa 10:1 bis etwa 1:100 reichen.
  • Die bei der vorliegenden Erfindung verwendete therapeutische Substanz kann eigentlich jede beliebige therapeutische Substanz sein, die gewünschte therapeutische Eigenschaften zum Aufbringen auf ein Blutgefäß besitzt. Dies kann sowohl feste als auch flüssige Substanzen einschließen. Zum Beispiel können Glucocorticoide (z. B. Dexamethason, Betamethason), Heparin, Hirudin, Tocopherol, Angiopeptin, Aspirin, ACE-Hemmstoffe, Wachstumsfaktoren, Oligonukleotide und allgemein Antiplättchen-Mittel, Antigerinnungsmittel, Antimitotische Mittel, Antioxidanzien, Antimetabolitenmittel und antientzündliche Mittel verwendet werden. Antiplättchen-Mittel können Wirkstoffe bzw. Arzneimittel, wie Aspirin und Dipyridamol, einschließen. Aspirin wird als ein analgetischer, antipyretischer, antientzündlicher und Antiplättchen-Wirkstoff klassifiziert. Dipyridimol ist ein Wirkstoff, der dahingehend ähnlich mit Aspirin ist, daß er Antiplättchen-Eigenschaften aufweist. Dipyridimol wird auch als Koronargefäßerweiterungsmittel klassifiziert. Antigerinnungsmittel können Wirkstoffe, wie Heparin, Coumadin, Protamin, Hirudin und Zecken-Antigerinnungsprotein einschließen. Antimitotische Mittel und Antimetabolitenmittel können Arzneimittel, wie Methotrexat, Azathioprin, Vincristin, Vinblastin, Fluoruracil, Adriamycin und Mutamycin einschließen.
  • Ausführungsformen der Erfindung werden nun weiter unter Bezugnahme auf die folgenden, nicht einschränkenden Beispiele und die angefügten Zeichnungen beschrieben, wobei:
  • 1 eine Kurve zeigt, die Elutionsprofile für Stents gemäß der vorliegenden Erfindung mit einer Beschichtung aus Dexamethason und Poly(L-milchsäure) darstellt die gemäß Beispiel 6 hergestellt sind, und
  • 2 eine Kurve zeigt, die Elutionsprofile für sterilisierte Stents gemäß der vorliegenden Erfindung mit einer Beschichtung aus Dexamethason und Poly(L-milchsäure) darstellt, die gemäß Beispiel 7 hergestellt sind.
  • In den Beispielen beziehen sich Prozentangaben und Verhältnisse auf das Gewicht, soweit nichts anderes angegeben ist.
  • BEISPIEL 1 (VERGLEICHSBEISPIEL)
  • Eine 1%ige Lösung von Dexamethason in Aceton wurde hergestellt und bildete eine klare Lösung. Die Lösung wurde in ein Airbrush-Reservoir (Badger #200) gegeben.
  • Tantaldrahtstents nach Wiktor wurden mit der Lösung in kurzen Stößen besprüht, während die Stents gedreht wurden. Das Aceton verdampfte schnell von den Stents und ließ einen weißen Rückstand auf dem Stentdraht zurück. Das Verfahren wurde weitergeführt, bis sämtliche Stentdrähte beschichtet waren. Die Wirkstoffelutionsgeschwindigkeit des Stents wurde durch Eintauchen des Stents in phosphatgepufferte Salzlösung (pH 7,4) bestimmt. Es wurde beobachtet, dass bei weniger als 31 Stunden Spuren von Dexamethason auf den eingetauchten Stents verblieben.
  • BEISPIEL 2 (VERGLEICHSBEISPIEL)
  • Eine 2%ige Lösung von Dexamethason in Aceton wurde hergestellt und bildete eine Lösung mit suspendierten Dexamethason-Partikeln. Die Lösung wurde in ein Rohr gegeben. Tantaldrahtstents nach Wiktor wurden schnell eingetaucht und trocknen gelassen. Jeder Stent wurde 12 bis 15 mal in die Lösung getaucht, um eine weiße Oberflächenbeschichtung bereitzustellen. Zwei Stents wurden auf einen Angioplastie-Ballon gesetzt und auf dem Ballon aufgeblasen. Etwa 80% der Dexamethasonbeschichtung schuppten sich von den Stents ab.
  • BEISPIEL 3 (VERGLEICHSBEISPIEL)
  • Es wurde eine Lösung von 1% Dexamethason und 0,5% Polycaprolacton (Aldrich 18,160-9) in Aceton hergestellt. Die Lösung wurde in ein Rohr gegeben. Tantaldrahtstents nach Wiktor wurden schnell eingetaucht und trocknen gelassen. Jeder Stent wurde 12 bis 15 mal in die Lösung getaucht, um eine weiße Oberflächenbeschichtung bereitzustellen. Ein derart beschichteter Stent wurde auf einem Angioplastie-Ballon mit 3,5 mm expandiert, wodurch eine erhebliche Menge der Beschichtung abgelöst wurde.
  • BEISPIEL 4 (VERGLEICHSBEISPIEL)
  • Es wurde eine Lösung von 1% Dexamethason und 0,5% Poly(L-milchsäure) (Medisorb) in Aceton hergestellt. Die Lösung wurde in ein Rohr gegeben. Tantaldrahtstents nach Wiktor wurden schnell eingetaucht und trocknen gelassen. Jeder Stent wurde 12 bis 15 mal in die Lösung eingetaucht, um eine weiße Oberflächenbeschichtung bereitzustellen. Ein derart beschichteter Stent wurde auf einem Angioplastie-Ballon mit 3,5 mm expandiert, wodurch verursacht wurde, dass nur ein geringer Teil der Beschichtung (weniger als 25%) abgelöst wurde.
  • BEISPIEL 5
  • Es wurde eine Lösung hergestellt, die eine 2%ige Dispersion von Dexamethason und eine 1%ige Lösung von Poly(L-milchsäure) (CCA Biochem MW = 550.000] in Chloroform enthielt. Die Lösung wurde in ein Airbrushgerät (Badger) gegeben. Tantaldrahtstents nach Wiktor wurden mit kurzen Stößen besprüht und trocknen gelassen. Jeder Stent wurde etwa 20 mal mit der Lösung besprüht, um eine weiße Oberflächenbeschichtung bereitzustellen. Ein so beschichteter Stent wurde auf einem Angioplastie-Ballon mit 3,5 mm expandiert. Während des gesamten Verlaufs blieb die Beschichtung auf dem Stent haften.
  • BEISPIEL 6
  • Es wurde eine Lösung hergestellt, die eine 2%ige Dispersion von Dexamethason und eine 1%ige Lösung von Poly(L-milchsäure) (CCA Biochem MW = 550.000) in Chloroform enthielt. Die Lösung wurde in ein Airbrushgerät (Badger #250-2) gegeben. Tantaldrahtstents nach Wiktor wurden an einer Befestigung aufgehängt und mit 24 kurzen Stößen besprüht (6 Stöße aus jeder der vier Richtungen senkrecht zu der Stentachse) und wurden trocknen gelassen. Die resultierenden Stents hatten ein Beschichtungsgewicht von etwa 0,0006 bis 0,0015 Gramm. Drei der Stents wurden auf Langzeitelution geprüft, indem ein Stent in 3,0 ml phosphatgepufferte Salzlösung (pH 7,4) bei Umgebungstemperatur ohne Rühren gegeben wurde. Die Menge von eluiertem Dexamethason wurde durch Messung der Absorption bei 244 nm in einem UV-VIS-Spektrophotometer ermittelt. Die Ergebnisse dieser Prüfung sind in 1 dargestellt.
  • BEISPIEL 7
  • Eine Lösung, die eine 2%ige Dispersion von Dexamethason und eine 1%ige Lösung von Poly(L-milchsäure) (Medisorb 100-L) in Chloroform enthielt, wurde zusammen mit einer Kontrollösung mit 1% Poly(L-milchsäure) (Medisorb 100-L) in Chloroform hergestellt. Die Lösungen wurden in ein Airbrushgerät {Badger #250-2) gegeben. Tantaldrahtstents nach Wiktor wurden auf einem Ballon mit 3,0 mm expandiert, an einer Befestigung aufgehängt und mit 16 kurzen Stößen (2–3 Stößen von etwa 1 Sekunde gefolgt von mehreren Minuten Trocknungszeit zwischen den Anwendungen) besprüht. Die resultierenden Dexamethason-beschichteten Stents hatten ein mittleres Beschichtungsgewicht von 0,0012 Gramm, während die polymerbeschichteten Stents ein mittleres Polymergewicht von etwa 0,0004 Gramm aufwiesen. Die Stents wurden in Ethylenoxid sterilisiert. Drei der sterilisierten Dexamethason-beschichteten Stents wurden auf Langzeitelution geprüft, indem ein Stent in 3,0 ml phosphatgepufferte Salzlösung (pH 7,4) bei Umgebungstemperatur ohne Rühren gegeben wurde. Die Menge von eluiertem Dexamethason wurde durch Messen der Absorption bei 244 nm in einem UV-VIS-Spektrophotometer ermittelt. Die Ergebnisse dieser Prüfung sind in 2 dargestellt. Dexamethason-beschichtete Stents und Polymer-beschichtete Kontrollstents wurden in die Koronararterien von 8 Schweinen (N = 12 für jeden Typ) gemäß dem in ”Restenosis After Balloon Angioplasty – A Practical Proliferative Model in Porcine Coronary Arteries,” von Robert S. Schwartz et al., Circulation 82 (6): 2190–2200 (1990) und ”Restenosis and the Proportional Neointimal Response to Coronary Artery Injury: Results in a Porcine Model” von Robert S. Schwartz et al., J Am Coll Cardiol 19: 267–274 (1992) dargestellten Verfahren mit dem Ergebnis implantiert, dass im Vergleich zu den Kontrollen die Dexamethason-beschichteten Stents das mit der Arterienverletzung verbundene Proliferationsausmaß reduzierten.

Claims (11)

  1. Verfahren zur Herstellung eines intravaskulären Stents, das die folgenden Schritte umfaßt: (a) Bereitstellen eines im wesentlichen zylinderförmigen, Ballon-expandierbaren Stentkörpers mit einer Metalloberfläche; (b) Aufsprühen einer Lösung, die ein Lösungsmittel, ein in dem Lösungsmittel gelöstes Polymer und eine in dem Lösungsmittel dispergierte therapeutische Substanz aufweist, in einer Mehrzahl von Aufbringungs- und Trocknungsschritten auf den Stentkörper; und (c) Verdampfen des Lösungsmittels.
  2. Verfahren nach Anspruch 1, wobei das Konzentrationsverhältnis der therapeutischen Substanz zu dem Polymer in der Lösung zwischen einigen der Mehrzahl von Aufbringungsschritten geändert wird.
  3. Verfahren nach Anspruch 1 oder 2, wobei das Polymer ein bioabsorbierbares Polymer ist.
  4. Verfahren nach Anspruch 3, wobei das Polymer aus Poly(L-milchsäure), Poly(lactid-coglycolid) und Poly(hydroxbutyrat-covalerat) ausgewählt ist.
  5. Verfahren nach Anspruch 1 oder 2, wobei das Polymer ein biostabiles Polymer ist.
  6. Verfahren nach Anspruch 5, wobei das Polymer aus Silikonen, Polyurethanen, Polyestern, Vinyl-Homopolymeren und -Copolymeren, Acrylat-Homopolymeren und -Copolymeren, Polyethern und Cellulosederivaten ausgewählt ist.
  7. Verfahren nach Anspruch 1 oder 2, wobei das Polymer aus Poly(L-milchsäure), Poly(lactid-coglycolid), Fibrin, Silikon, Polyurethan und Poly(phosphoesterurethan) ausgewählt ist.
  8. Verfahren nach einem der Ansprüche 1 bis 7, wobei das Gewichtsverhältnis der therapeutischen Substanz zu dem Polymer in der Lösung in dem Bereich von 10:1 bis 1:100 liegt.
  9. Verfahren nach einem der Ansprüche 1 bis 8, wobei die therapeutische Substanz aus Glucocorticoiden, Dexamethason, Dexamethasonnatriumphosphat, Antigerinnungsmitttel, Heparin, Hirudin, Zecken-Antigerinnungspeptid, Angiopeptin, antimitotischen Mitteln und Oligonukleotiden ausgewählt ist.
  10. Verfahren nach Anspruch 9, wobei die therapeutische Substanz Dexamethason ist.
  11. Verfahren nach einem der Ansprüche 1 bis 4 und 7 bis 10, das die folgenden Schritte umfaßt: (a) Bereitstellen eines im wesentlichen zylinderförmigen, Ballon-expandierbaren Metallstentkörpers, (b) Aufsprühen einer Lösung, die ein Lösungsmittel, ein in dem Lösungsmittel gelöstes bioabsorbierbares Polymer und ein in dem Lösungsmittel dispergiertes Glucocorticoid auf weist, in einer Mehrzahl von Aufbringungs- und Trocknungsschritten auf den Stentkörper, und (c) Verdampfen des Lösungsmittels.
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DE69431457T2 (de) 2003-06-26
EP0623354A1 (de) 1994-11-09
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EP1181943A1 (de) 2002-02-27
US5776184A (en) 1998-07-07
US5464650A (en) 1995-11-07
EP0623354B2 (de) 2010-12-01
US5679400A (en) 1997-10-21
DE69431457D1 (de) 2002-11-07
US5624411A (en) 1997-04-29
JPH0833718A (ja) 1996-02-06
US5837008A (en) 1998-11-17

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