DE69916157T3 - Stent mit lokaler Rapamycin-Zufuhr - Google Patents

Stent mit lokaler Rapamycin-Zufuhr Download PDF

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DE69916157T3
DE69916157T3 DE69916157T DE69916157T DE69916157T3 DE 69916157 T3 DE69916157 T3 DE 69916157T3 DE 69916157 T DE69916157 T DE 69916157T DE 69916157 T DE69916157 T DE 69916157T DE 69916157 T3 DE69916157 T3 DE 69916157T3
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stent
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rapamycin
struts
restenosis
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Carol Wright
Gerard H. Llanos
Ronald Rakos
Kirsten King
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Cordis Corp
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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
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
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    • A61F2/915Stents 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 with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
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    • 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
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    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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
    • A61F2/915Stents 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 with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • 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
    • 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
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    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
    • 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
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    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
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    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
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    • A61L2300/606Coatings

Description

  • Die lokale Abgabe von Rapamycin, insbesondere von einem intravaskulären Stent, direkt aus Poren in den Stentkörper oder gemischt oder gebunden an eine Polymerbeschichtung, die auf den Stent aufgetragen ist, um die Proliferation von neointimalem Gewebe zu inhibieren und dadurch Restenose zu verhindern. Die vorliegende Erfindung gemäß Anspruch 1 fördert auch die Leistung des Stents beim Inhibieren von Restenose.
  • Das erneute Verengen (Restenose) einer artheriosklerotischen Koronararterie nach perkutaner Transluminalkoronarangioplastie (PTCA) erfolgt bei 15 bis 50% der Patienten, die sich diesem Eingriff unterziehen, und erfordert nachfolgend entweder eine weitere Angioplastie oder ein Koronararterienbypasstransplantat. Während die genauen hormonellen und zellulären Prozesse, die die Restenose fördern, noch bestimmt werden müssen, ist unser derzeitiges Verständnis das, dass das Verfahren der PTCA neben dem Öffnen der artheriosklerotisch obstruierten Arterie auch die residenten glatten Muskelzellen der Koronararterie (SMC) verletzt. In Reaktion auf diese Verletzung setzen adhärierte Plättchen, infiltrierende Makrophagen, Leukozyten oder die glatten Muskel-Zellen (SMC) selbst von Zellen stammende Wachstumsfaktoren frei mit nachfolgender Proliferation und Migration von medialen SMC durch die innere elastische Lamina zu dem Gebiet der Gefäßintima. Eine weitere Proliferation und Hyperplasie der SMC der Intima und, am wichtigsten, die Produktion großer Mengen extrazellulärer Matrix über eine Periode von drei bis sechs Monaten führt zum Auffüllen und Verengen des Vaskularraums, was ausreichend ist, um den koronaren Blutfluss wesentlich zu blockieren.
  • Mehrere kürzlich verfolgte experimentelle Ansätze, um die Proliferation von SMC zu verhindern, verliefen erfolgversprechend, obwohl die Mechanismen für die meisten der verwendeten Agenzien noch unklar ist. Heparin ist das am besten bekannte und charakterisierte Agens, das die Inhibierung der Proliferation von SMC sowohl in vitro als auch in Tiermodellen für Ballonangioplastie-vermittelter Verletzung verursacht. Der Mechanismus der SMC-Inhibierung mit Heparin ist noch nicht bekannt, kann aber auf einer oder allen der folgenden Ursachen beruhen: 1) verringerte Expression der wachstumsregulierenden Protoonkogene C-fos und C-myc, 2) verringerte zelluläre Produktion von Gewebeplasminogenaktivator; und 3) Binden und Dequestration von Wachstumsregulationsfaktoren, wie beispielsweise fi brovalenter Wachstumsfaktor (FGF).
  • Andere Agenzien, von denen gezeigt wurde, dass sie die Fähigkeit besitzen, die Verdickung der Myointima bei Tiermodellen für vaskuläre Ballonverletzung verringern, sind Angiopeptin (ein Somastotatin-Analog), Calciumkanalblocker, Inhibitoren des Angiotensinumwandelnden Enzyms (Captopril, Cilazapril), Cyclosporin A, Trapidil (ein Mittel gegen Angina pectoris, Antithrombozytenmittel), Terbinafin (Antimykotikum), Colchicin und Taxol (Antitubulin antiproliferative Mittel), und C-myc- und C-myb-Antisense-Oligonukleotide.
  • Zusätzlich hat man gezeigt, dass ein Ziegenantikörper gegen das SMC-Mitogen aus Blutplättchen gewonnener Wachstumsfaktor (PDGF) bei der Verringerung der Verdickung der Myointima in einem Rattenmodell für Ballonangioplastie-Verletzung wirksam ist, was impliziert, dass PDGF direkt bei der Ätiologie der Restenose beteiligt ist. Während man noch von keiner Therapie zeigen konnte, dass sie bei der Verhinderung der Restenose nach Angioplastie klinisch erfolgreich ist, legt somit der experimentelle Erfolg in viv0 von mehreren Verbindungen, von denen bekannt ist, dass sie das SMC-Wachstum inhibieren, nahe, dass diese Agenzien als eine Klasse die Fähigkeit aufweisen, klinische Restenose zu verhindern und verdienen es, sorgfältig beim Menschen evaluiert zu werden.
  • Die koronare Herzerkrankung ist in der westlichen Welt die Haupttodesursache bei Männern über 40 Jahren und bei Frau über 50 Jahren. Die meisten mit Koronararterien in Beziehung stehenden Todesfälle beruhen auf Arteriosklerose. Arteriosklerotische Läsionen, die den Blutstrom beschränken oder blockieren, sind die Hauptursache von mit ischämischer Herzerkrankung verbundener Mortalität und führt zu 500.000 bis 600.000 Todesfällen jährlich in den USA. Um dem Krankheitsprozess Einhalt zu gebieten und die fortgeschritteneren Erkrankungszustände zu verhindern, bei denen der Herzmuskel selbst beeinträchtigt ist, ist eine direkte Intervention vermittels perkutaner Transluminallcoronarangioplastie (PTCA) oder eines Koronararterienbypasstransplantates (CABG) verwendet worden.
  • PTCA ist ein Verfahren, bei dem ein mit einem kleinen Ballon an der Spitze versehener Katheter in eine verengte Koronararterie hinuntergeführt und dann expandiert wird, um die Arterie erneut zu öffnen. Sie wird derzeit bei etwa 250.000 bis 300.000 Patienten jedes Jahr durchgeführt. Der Hauptvorteil dieser Therapie besteht darin, dass die Patienten, bei denen der Eingriff erfolgreich ist, sich nicht des invasiveren chirurgischen Eingriffes des Koronararterienbypasstransplantates unterziehen müssen. Eine Hauptschwierigkeit bei der PTCA ist das Problem des Post-Angioplastieverschlusses des Gefäßes sowohl unmittelbar nach der PTCA (akute Reokklusion) als auch langfristig (Restenose).
  • Der Mechanismus der akuten Reokklusion scheint verschiedene Faktoren zu involvieren und kann aus einem Rückspringen des Gefäßes mit ein hergehendem Verschluss der Arterie und/oder Ablagerung von Blutplättchen entlang der beschädigten Strecke des neu eröffneten Blutgefäßes gefolgt von Bildung eines Fibrin/Erythrozytenthrombus resultieren. Vor kurzem sind Intravaskularstents als ein Mittel zur Verhinderung des akuten erneuten Verschlusses nach PTCA untersucht worden.
  • Die Restenose (chronischer Wiederverschluss) nach Angioplastie ist ein graduellerer Prozess als die akute Reokklusion. 30% der Patienten mit unvollständigen Läsionen und 50% mit chronischen vollständigen Läsionen werden eine Restenose nach Angioplastie entwickeln. Während der genaue Mechanismus der Restenose noch aktiv untersucht wird, sind die allgemeinen Aspekte des Restenoseprozesses identifiziert worden:
    In der normalen Arterienwand proliferieren glatte Muskelzellen (SMC) mit einer geringen Geschwindigkeit (< 0,1%/Tag; Lit). SMC in der Gefäßwand existieren in einem „kontraktilen” Phänotyp, der dadurch gekennzeichnet ist, dass 80 bis 90% des Zytoplasmavolumens der Zelle durch den kontraktilen Apparat ausgefüllt sind. Endoplasmatisches Reticulum, Golgikörperchen und freie Ribosomen sind nur wenig vorhanden und in dem perinukleären Bereich angeordnet. Die extrazelluläre Matrix umgibt SMC und ist reich an Heparinähnlichen Glykosylaminoglykanen, von denen man annimmt, dass sie für die Aufrechterhaltung der SMC im Zustand des kontraktilen Phänotyps verantwortlich sind.
  • Nach Druckexpansion eines Intrakoronarballonkatheters während Angioplastie werden glatte Muskelzellen im Inneren der Arterienwand verletzt. Von Zellen abgegebene Wachstumsfaktoren wie beispielsweise der von Blutplättchen gewonnene Wachstumsfaktor (PDGF), der basische Fibroblastenwachstumsfaktor (bFGF), der epidermale Wachstumsfaktor (EGF) etc., die von Plättchen (d. h. PDGF), die an der beschädigten Oberfläche des Arterienhohlraumes adhärieren, von eindringenden Makrophagen und/oder Leukozyten oder direkt von SMC (d. h. BFGF) freigesetzt werden, provozieren eine Proliferation und eine Migrationsantwort in medialen SMC. Diese Zellen erfahren eine phänotypische Änderung von dem kontraktilen Phänotyp zu einem „synthetischen” Phänotyp, der dadurch gekennzeichnet ist, dass er nur wenige kontraktile Filamentenbündel, aber ein extensives raues endoplasmatisches Reticulum, Golgi und freie Ribosomen aufweist. Die Proliferation/Migration beginnt üblicherweise innerhalb von 1 bis 2 Tagen nach der Verletzung und erreicht ein Maximum nach zwei Tagen in der Media, wobei sie danach schnell abnimmt (Campbell et al., In: Vascular Smooth Muscle Cells in Culture, Campbell, J. H. and Campbell, G. R., Hrsg., CRC Press, Boca Ration, 1987, Seiten 39–55); Clowes, A. W. und Schwartz, S. M., Circ. Res. 56: 139–145, 1985).
  • Schließlich wandern synthetische Tochterzellen zur Intimaschicht aus arteriellen glatten Muskeln und proliferieren weiter. Die Proliferation und Migration setzt sich fort, bis sich die beschädigte Hohlraumendothelschicht regeneriert, wobei zu dieser Zeit die Proliferation innerhalb der Intima aufhört, üblicherweise innerhalb von 7 bis 14 Tagen nach der Verletzung. Die verbleibende Erhöhung der Verdickung der Intima, die über die nächsten 3 bis 6 Monate erfolgt, beruht mehr auf einer Erhöhung der extrazellulären Matrix als der Zellzahl. Die Migration und Proliferation von SMC ist somit eine akute Antwort auf Gefäßverletzung, während die intimale Hyperplasie eine mehr chronische Antwort ist (Liu et al., Circulation, 79: 1374–1387, 1989).
  • Patienten mit symptomatischer Reokklusion benötigen entweder wiederholte PTCA oder CABG. Da 30 bis 50% der Patienten, die sich einer PTCA unterziehen, eine Restenose ausbilden werden, hat die Restenose den Erfolg von PTCA als ein therapeutischer Ansatz für Koronararterienerkrankung beschränkt. Da die Proliferation und Migration von SMC innig mit der pathophysiologischen Antwort auf Arterienverletzung verbunden sind, stellt die Verhinderung der Proliferation und Migration von SMC ein Ziel für die pharmakologische Intervention bei der Prävention von Restenose dar.
  • Zusammenfassung der Erfindung
  • Neue Merkmal und Anwendungen der Stenttechnologie
  • Die derzeitigen Bemühungen, die klinische Leistung von Stents zu verbessern, haben einige Änderungen entweder des Auftragens einer Beschichtung auf das Metall, das Befestigen einer Abdeckung oder Membran oder das Einbetten von Material auf der Oberfläche über Ionenbombardierung umfasst. Ein Stent gemäß Anspruch 1, der so konstruiert ist, dass er Reservoires umfasst, ist ein neuer Ansatz, der mehrere wichtige Vorteile gegenüber existierenden Technologien aufweist.
  • Lokale Wirkstoffabgabe von einem Stent, um Restenose zu inhibieren
  • Bei dieser Anwendung ist es wünschenswert, ein therapeutisches Agens an die Stelle der arteriellen Verletzung abzugeben. Der herkömmliche Ansatz bestand darin, das therapeutische Agens in ein Polymermaterial einzubauen, das dann auf den Stent aufgebracht wird. Das ideal Beschichtungsmaterial muss in der Lage sein, sowohl vor als auch nach der Expansion fest an den Metallstent zu binden, in der Lage sein, den Wirkstoff bei einem ausreichenden Beladungsumfang zurückzuhalten, um die erforderliche Dosis zu erhalten, in der Lage sein, den Wirkstoff kontrolliert über eine Spanne von mehreren Wochen freizusetzen und so dünn wie möglich zu sein, um die Vergrößerung des Profils zu minimieren.
  • Zusätzlich sollte das Beschichtungsmaterial nicht zu irgendwelchen nachteiligen Reaktionen durch den Körper beitragen (d. h. sollte nicht-thrombogen, nicht-entzündlich etc. sein). Bis heute ist das ideale Beschichtungsmaterial für diese Anwendung noch nicht entwickelt worden.
  • Eine Alternative besteht darin, den Stent so zu konstruieren, dass er Reservoires enthält, die mit dem Wirkstoff beladen werden. Obgleich nicht erfindungsgemäß, könnte eine Beschichtung oder Membran aus biokompatiblen Materialien über die Reservoires aufgebracht werden, die die Diffusion des Wirkstoffes aus den Reservoires in die Arterienwand kontrollieren würde.
  • Ein Vorteil dieses Systems besteht darin, dass die Eigenschaften der Beschichtung optimiert werden können, um eine überragende Biokompatibilität und überragende Adhäsionseigenschaften zu erreichen, ohne dass es zusätzlich erforderlich wird, dass sie in der Lage ist, den Wirkstoff zu beladen und freizusetzen. Die Größe, Form, Position und Anzahl von Reservoires kann verwendet werden, um die Menge an Wirkstoff und somit die abgegebene Dosis zu kontrollieren.
  • Beschreibung der Zeichnungen
  • Die Erfindung wird besser im Zusammenhang mit den folgenden Figuren verstanden werden, wobei 1 und 1A Ansichten von oben und Querschnittsansichten eines Stents sind, der Reservoires enthält, wie in der vorliegenden Erfindung beschrieben;
  • 2a und 2b ähnliche Ansichten einer alternativen Ausführungsform des Stents mit offenen Enden sind;
  • 3a und 3b weitere alternative Figuren einer Vorrichtung sind, die ein Rillenreservoir enthält; und
  • 4 eine Layout-Ansicht einer Vorrichtung ist, die ein Reservoir wie in 3 enthält.
  • Detaillierte Beschreibung der Erfindung
  • Pharmakologische Bemühungen, um Restenose durch pharmakologische Mittel zu verhindern, waren bisher nicht erfolgreich und alle umfassten die systemische Verabreichung der Versuchsagenzien. Weder Aspirindipyridamol, Ticlopidin, akute Heparinverabreichung, chronisches Warfarin (6 Monate) noch Methylprednisolon waren bei der Verhinderung der Restenose wirksam, obwohl Plättchen-Inhibitoren bei der Verhinderung von akuter Reokklusion nach Angioplastie wirksam waren. Die Calciumantagoisten waren ebenfalls nicht bei der Verhinderung von Restenose erfolgreich, obwohl sie noch untersucht werden. Andere Agenzien, die derzeit untersucht werden, umfassen Thromboxan-Inhibitoren, Prostacyclin-Mimetika, Plättchenmembranrezeptor-Blocker, Thrombin-Inhibitoren und Inhibitoren des Angiotensin-umwandelnden Enzyms. Diese Agenzien müssen systemisch verabreicht werden und es kann sein, dass ein Erreichen einer therapeutische wirksamen Dose nicht möglich ist; antiproliferative (oder Anti-Restenose-)Konzentrationen können die bekannten toxischen Konzentrationen dieser Agenzien überschreiten, so dass die Spiegel, die ausreichend sind, um eine Inhibierung der glatten Muskeln zu produzieren, nicht erreicht werden können (Lang et al., 42 Ann. Rev. Med., 127–132 (1991); Popma et al., 84 Circulation, 1426–1436 (1991)).
  • Zusätzlich haben klinische Versuche, bei denen die Wirksamkeit von dietätischen Fischölergän-Zungen, Thromboxan-Rezeptorantagonisten, Cholesterin-senkenden Mitteln und Serotonin-Antagonisten untersucht worden sind, entweder widersprüchliche oder negative Ergebnisse erbracht, so dass bis jetzt noch keine pharmakologischen Agenzien klinisch verfügbar sind, um Post-Angioplastierestenose zu verhindern (Franklin, S. M. und Faxon, D. P., 4 Coronary Artery Disease, 232–242 (1993); Serruys, P. W. et al., 88 Circulation, (part 1) 1588–1601, (1993)).
  • Umgekehrt haben sich Stents bei der Verhinderung der Verringerung der Proliferation von Restenose als nützlich erwiesen. Stents, wie beispielsweise der im Layout in 4 dargestellte Stent 10, ballonexpandierbare, mit Schlitzen versehene Metallröhren (üblicherweise aber nicht beschränkt auf rostfreien Stahl), die, wenn sie innerhalb des Hohlraumes einer angioplastierten Koronararterie expandiert werden, eine strukturelle Stütze der arteriellen Wand bereitstellen. Diese Stütze ist dabei nützlich, einen für den Blutstrom offenen Weg zu erhalten. In zwei randomisierten klinischen Studien wurde gezeigt, dass Stents den Angiographieerfolg nach PTCA erhöhen, das Lumen des stenosierten Blutgefäßes erhöhen und das Wiederauftreten von Läsionen nach 6 Monaten verringern (Serruys et al., 331 New Eng Jour. Med. 495 (1994); Fischman et al., 331 New Eng Jour. Med, 496–501 (1994)). Zusätzlich scheinen, in einer vorläufigen Studie, Heparin-beschichtete Stents den gleichen Vorteil der Verringerung des Stenosedurchmessers bei der Nachsorge zu besitzen, wie er bei Nicht-Heparin beschichteten Stents beobachtet wurde. Zusätzlich scheint eine Heparin-Beschichtung den weiteren Vorteil aufzuweisen, dass eine Verringerung der sub-akuten Thrombose nach Stentimplantation erfolgt (Serruys et al., 93 Circulation, 412–422, (1996)). Somit ist gezeigt worden, dass 1) eine anhaltende mechanische Expansion einer stenosierten Koronararterie ein Mittel zur Verhinderung von Restenose bereitstellt, und 2) die Beschichtung von Stents mit Heparin sowohl die Machbarkeit als auch die klinische Nützlichkeit der Abgabe von Wirkstoffen von der Oberfläche des Stents an lokales, verletztes Gewebe gezeigt hat.
  • Viele Mittel werden aktiv als antiproliferative Agenzien zur Anwendung bei der Restenose untersucht und haben eine Aktivität in experimentellen Tiermodellen gezeigt. Diese umfassen: Heparin und Heparin-Fragmente (Clowes and Karnovsky, 265 Nature, 25–626, (1977); Guyton, J. R. et al. 46 Circ. Res., 625–634, (1980); Clowes, A. W. und Clowes, M. M., 52 Lab. Invest., 611–616, (1985); Clowes, A. W. und Clowes, M. M., 58 Circ. Res., 839–845 (1986); Majesky et al., 61 Circ Res., 296–300, (1987); Snow et al., 137 Am. J. Pathol., 313–330 (1990); Okada, T. et al., 25 Neurosurgery, 92–898, (1989) Colchicin (Currier, J. W. et al., 80 Circulation, 11–66, (1989), Taxol (Lit.), Inhibitoren des Angiotensin-umwandelnden Enzyms (ACE) (Powell, J. S. et al., 245 Science, 186–188 (1989)), Angiopeptin (Lundergan, C. F. et al., 17 Am. J. Cardiol. (Suppl. B); 132B–136B (1991)), Cyclosporin A (Jonasson, L. et al., 85 Proc. Nati, Acad. Sci., 2303 (1988)), Ziegen-Anti-Kaninchen-PDGF-Antikörper (Ferns, G. A. A., et al., 253 Science, 1129–1132 (1991)), Terbinafin (Nemecek, G. M. et al., 248 J. Pharmacol. Exp. Thera., 1167–11747 (1989)), Trapidil (Liu, M. W. et al., 81 Circulation, 1089–1093 (1990)), Interferon-gamma (Hansson, G. K. und Holm, 84 J. Circulation, 1266–1272 (1991)), Steroide (Coburn, M. D. et al., 15 J. Vase. Surg., 510–518 (1992), siehe auch Berk, B. C. et al., 17 J. Am. Coll. Cardiol., 111B–117B (1991)), ionisierende Bestrahlung (Lit.), Fusionstoxine (Lit.), Antisense-Oligonukleotide (Lit.), Genvektoren (Lit.) und Rapamycin (siehe unten).
  • Von besonderem Interesse ist Rapamycin. Rapamycin ist ein Macrolid-Antiobiotikum, das die IL-2 vermittelte T-Zellproliferation blockiert und antientzündliche Aktivität besitzt. Während der genaue Mechanismus von Rapamycin noch aktiv untersucht wird, hat man gezeigt, dass Rapamycin das Fortschreiten der G,- in die S-Phase von T-Zellen durch den Zellzyklus verhindert, indem spezifische Zell-Cycline und Cyclin-abhängige Proteinkinasen inhibiert werden (Siekierka, Immunol. Res. 13: 110–116, 1994). Die antiproliferative Wirkung von Rapamycin ist nicht auf T-Zellen beschränkt; Marx et al. (Circ Res 76: 412–417, 1995) haben gezeigt, dass Rapamycin die Proliferation von sowohl Ratten- als auch menschlichen SMC in vitro verhindert, während Poon et al. gezeigt haben, dass die Migration von Ratten-, Schweine- und menschlichen SMC auch durch Rapamycin inhibiert werden kann (J Clin Invest 98: 2277–2283, 1996). Rapamycin ist somit in der Lage, sowohl die entzündliche Antwort zu inhibieren, von der bekannt ist, dass sie nach Arterienverletzung und Stent-Implantation erfolgt, ebenso wie die hyperproliferative SMC-Antwort. Tatsächlich wurde gezeigt, dass die kombinierten Wirkungen von Rapamycin zu einer verringerten hyperproliferativen SMC-Antwort in einem Femoralarterientransplantatrattenmodell und sowohl in Ratten- als auch Schweinarterienballonverletzungsmodellen (Gregory et al., Transplantation 55: 1409–1418, 1993; Gallo et al., im Druck, (1997)) führen. Diese Beobachtungen stützen eindeutig die potentielle Verwendung von Rapamycin bei dem klinischen Hintergrund von Restenose nach Angioplastie.
  • Obwohl das ideale Agens für die Restenose noch nicht identifiziert worden ist, sind einige erwünschte Eigenschaften klar: Inhibierung von lokaler Thrombose ohne das Risiko systemischer Blutungskomplikationen und fortgesetzte Verhinderung der Dequale der arteriellen Verletzung, einschließlich örtlicher Entzündung und fortgesetzter Verhinderung der Proliferation der glatten Muskeln an der Stelle der Angioplastie ohne ernsthafte systemische Komplikationen. So sehr die Stents wenigstens einen Teil des Restenoseprozesses verhindern, so kann doch ein Agens, das die Entzündung und die Proliferation von SMC verhindert, in Kombination mit einem Stent die wirksamste Behandlung für Post-Angioplastierestenose darstellen.
  • Experimente
  • Agenzien: Rapamycin (Sirolismus), Strukturanaloga (makrocyclische Lactone) und Inhibitoren der Zellzyklusprogression.
  • Abgabeverfahren
  • Diese können variieren:
    • – Lokale Abgabe derartiger Agenzien (Rapamycin) aus den Streben eines Stents, aus einem Stenttransplantat, Transplantaten, Stentabdeckung oder -hülse.
    • – umfassend Co-Mischung mit Polymeren (sowohl abbaubar als auch nicht-abbaubar), um den Wirkstoff an dem Stent oder dem Transplantat zu halten.
    • – oder Einschließen des Wirkstoffes in das Metall des Stents oder des Transplantatkörpers, der modifiziert worden ist, um Mikroporen oder Kanäle zu enthalten, wie im Folgenden erklärt werden wird.
    • – oder umfassend kovalente Bindung des Wirkstoffes an den Stent vermittels lösungschemischer Techniken (wie beispielsweise das Carmeda-Verfahren) oder trockenchemische Techniken (z. B. Dampfablagerungsverfahren wie beispielsweise rf-Plasmapolymerisation) und Kombinationen davon.
    • – intravaskuläre Katheterabgabe aus einem Tandemballon oder einem porösen Ballon für intramurale Aufnahme.
    • – Extravaskularabgabe durch die pericardiale Route.
    • – Extravaskulare Abgabe durch die adventiale Anwendung von langsam wirkenden Formulierungen.
  • Anwendungen: für die Inhibierung von Zellproliferation, um die neointimale Proliferation und Restenose zu verhindern.
  • Prävention von Tumorexpansion ausgehend von Stents
  • Prävention des Einwachsens von Gewebe in Katheter und Shunts, was deren Versagen induziert.
  • 1. Experimentelles Stentabgabeverfahren-Abgabe aus der Polymermatrix
  • Eine Lösung von Rapamycin, hergestellt in einem mit der Polymerträgerlösung mischbaren Lösungsmittel, wird mit der Polymerlösung mit einem Endkonzentrationsbereich von 0,001 Gew.-% bis 30 Gew.-% des Wirkstoffes gemischt. Polymere sind biokompatibel (d. h. erregen keine negative Gewebereaktion oder fördern keine murale Thrombenbildung) und abbaubar, wie beispielsweise Lacton-basierte Polyester oder Copolyester, z. B. Polylactid, Polycaprolactan-glycolid, Polyorthoester, Polyanhydride; Poly-Aminosäuren; Polysaccharide; Polyphosphazene; Poly(Ether-Ester)-Copolymere, z. B. PEO-PLLA, oder Mischungen davon. Nichtresorbierbare biokompatible Polymere können auch geeignete Kandidaten sein. Polymere wie beispielsweise Polydimethylsiloxan; Poly(Ethylen-Vingylacetat); Acrylat-basierte Polymere oder Copolymere, z. B. Poly(Hydroxyethylmethylmethacrylat, Polyvinylpyrrolidinon; fluorierte Polymere wie beispielsweise Polytetrafluorethylen; Zelluloseester.
  • Die Polymer/Wirkstoff-Mischung wird auf die Oberflächen des Stents entweder durch Tauchbeschichtungsverfahren oder Sprühbeschichtungsverfahren oder Bürstenstreichverfahren oder Tauch/Schleuderbeschichtungsverfahren oder Kombinationen davon aufgetragen und man erlaubt, dass das Lösungsmittel verdampft, um einen Film mit eingeschlossenem Rapamycin zurückzulassen.
  • 2. Experimentelle Stentabgabeverfahren-Abgabe aus mikroporösen Depots im Stent durch eine Polymermembranabdeckung
  • Ein Stent, dessen Körper so modifiziert worden ist, dass er Mikroporen oder Kanäle enthält, wird in eine Lösung aus Rapamycin im Bereich von 0,001 Gew.-% bis gesättigt, in organischem Lösungsmittel, wie beispielsweise Aceton oder Methylenchlorid, für eine ausreichende Zeit eingetaucht, um zu erlauben, dass die Lösung in die Poren eindringt. (Die Eintauchlösung kann auch verdichtet werden, um die Beladungseffizienz zu verbessern.) Nachdem man erlaubt hat, dass das Lösungsmittel verdampft, wird der Stent kurz in ein frisches Lösungsmittel eingetaucht, um überschüssigen, oberflächengebundenen Wirkstoff zu entfernen. Eine Lösung aus Polymer, ausgewählt aus einem in dem ersten experimentellen Verfahren identifizierten, wird auf den Stent aufgetragen, wie oben detailliert angegeben. Diese äußere Polymerschicht wird als Diffusionskontrolle für die Freisetzung von Wirkstoff dienen.
  • 3. Experimentelle Stentabgabeverfahren-Abgabe vermittels Lyse eines kovalenten Wirkstofflinkers
  • Rapamycin wird so modifiziert, dass es eine hydrolytisch oder enzymatisch labile kovalente Bindung zum Befestigen an der Oberfläche des Stents enthält, der selbst chemisch derivatisiert ist, um eine kovalente Immobilisierung zu erlauben. Kovalente Bindungen wie beispielsweise Ester, Amide oder Anhydride können dazu geeignet sein.
  • 4. Experimentelles Verfahren-Pericardiale Abgabe
    • A: Polymerblatt Rapamycin wird mit einer Konzentration, wie sie zuvor hervorgehoben wurde, mit einem abbaubaren Polymer, wie beispielsweise Poly(caprolacton-glycolid) oder nicht-abbaubaren Polymeren, z. B. Polydimethylsiloxan, kombiniert und als eine dünne Schicht gemischt gegossen, wobei die Stärke von 10 l bis 1.000 l reicht. Das sich ergebende Blatt kann perivaskulär auf das Zielgefäß gewickelt werden. Das absorbierbare Polymer wäre bevorzugt.
    • B: Konformationsbeschichten: Rapamycin wird mit einem Polymer kombiniert, das eine Schmelztemperatur gerade oberhalb 37°C, Bereich 40° bis 45°C, aufweist. Die Mischung wird in einem geschmolzenen Zustand auf die Außenseite des Zielgefäßes aufgetragen. Nach dem Abkühlen auf Körpertemperatur verfestigt sich die Mischung an der Blutgefäßwand anpassend. Sowohl nicht-abbaubare als auch abbaubare biokompatible Polymere sind geeignet.
  • Wie in den Figuren zu erkennen ist, ist es auch möglich, die derzeit hergestellten Stents zu modifizieren, um die Wirkstoffdosierungen wie beispielsweise Rapamycin adäquat bereitzustellen. Wie in den 1a, 2a und 3a ersichtlich ist, kann eine jede Stentstrebe 10, 20, 30 modifiziert werden, so dass sie ein bestimmtes Reservoir oder einen Kanal 11, 21, 31 aufweist. Ein jedes dieser Reservoirs ist offen. Diese Reservoirs können den abzugebenden Wirkstoff halten. 4 zeigt einen Stent 40 mit einem Reservoir 45, das am Scheitelpunkt einer flexiblen Strebe erzeugt ist. Natürlich soll dieses Reservoir 45 nützlich sein bei der Abgabe von Rapamycin oder einem anderen Wirkstoff an einem spezifischen Flexibilitätspunkt des Stents. Entsprechend kann dieses Konzept für Stents der „zweiten Generation” nützlich sein.
  • In einer jeden der vorher erwähnten Vorrichtungen ist es jedoch nützlich, dass die angewandte Wirkstoffdosis mit genügender Spezifität und in genügender Konzentration aufgetragen wird, um eine wirksame Dosierung in dem Bereich der Läsion bereitzustellen. In dieser Hinsicht muss die Reservoirgröße in den Stentstreben bei einer Größe von etwa 1,27 × 10–5 m (0,0005'') bis etwa 7,62 × 10–5 m (0,003'') gehalten werden. Dann sollte es möglich sein, in geeigneter Weise die Wirkstoffdosierung an der erwünschten Stelle und in der erwünschten Menge anzuwenden.
  • Diese und andere Konzepte werden hierin offenbart. Es wäre für den Leser offenkundig, dass Modifikationen am Stent oder der angewandten Wirkstoffdosierung möglich sind. In einem jeden Fall sollte jedoch verstanden werden, dass eine jegliche der offensichtlichen Modifikationen in den Schutzumfang der vorliegenden Erfindung fallen soll, die sich aus den beigefügten Ansprüchen ergeben soll.

Claims (7)

  1. Stent umfassend: einen im Allgemeinen dünnwandigen Zylinder, wobei der Zylinder eine Vielzahl von Verstrebungen (10, 20, 30) enthält, wobei die Verstrebungen expandierbar von der Kraftstärke abhängen, die auf die Verstrebung ausgeübt wird, und die Verstrebungen eine im Allgemeinen gleichförmige Dicke aufweisen; und einen Kanal (11, 21, 31), der in wenigstens einer der Verstrebungen gebildet ist, wobei der Kanal auf drei Seiten einen geschlossenen Umfang und eine offene Oberseite aufweist und der Kanal in allen Abmessungen kleiner ist als die Verstrebung und der Kanal ein darin aufgetragenes therapeutisches Agens enthält.
  2. Stent nach Anspruch 1, wobei der Kanal einen im Allgemeinen rechteckige Umfang aufweist.
  3. Stent nach Anspruch 2, wobei das therapeutische Agens auf den Kanal beschichtetes Rapamycin ist.
  4. Stent nach Anspruch 3, wobei der Kanal eine rechtwinklige Form aufweist.
  5. Stent nach Anspruch 3, der Verstrebungen mit den Kanälen enthält.
  6. Stent nach Anspruch 1, wobei das therapeutische Agens Rapamycin ist.
  7. Stent umfassend eine im Allgemeinen dünnwandige Struktur mit einer Vielzahl von Verstrebungen (10, 20, 30), wobei die Verstrebungen expandierbar sind, um die Form eines Lumens anzunehmen, in die der Stent eingesetzt wird, wobei die Verstrebungen eine Dicke aufweisen und ein Kanal (11, 21, 31) in wenigstens einer der Verstrebungen gebildet ist, wobei der Kanal einen geschlossene Umfang auf drei Seiten und eine offene Oberseite aufweist, und der Kanal in drei Abmessungen kleiner ist als die Verstrebung und der Kanal ein darin aufgetragenes therapeutisches Agens enthält.
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EP0950386B2 (de) 2011-07-13
US6808536B2 (en) 2004-10-26
US20080317827A1 (en) 2008-12-25
EP0950386A2 (de) 1999-10-20
US7229473B2 (en) 2007-06-12
US20050085902A1 (en) 2005-04-21
US20100239636A1 (en) 2010-09-23
US20010027340A1 (en) 2001-10-04
US6585764B2 (en) 2003-07-01
DE69916157D1 (de) 2004-05-13
ES2218953T3 (es) 2004-11-16
ES2218953T5 (es) 2011-11-08
US20030176915A1 (en) 2003-09-18
US20070100436A1 (en) 2007-05-03
CA2269310A1 (en) 1999-10-16
US7666222B2 (en) 2010-02-23
EP0950386A3 (de) 2000-04-05
EP1407726A1 (de) 2004-04-14
PT950386E (pt) 2004-08-31
CA2639396A1 (en) 1999-10-16
CA2639393A1 (en) 1999-10-16
US7217286B2 (en) 2007-05-15
US20060282160A1 (en) 2006-12-14
DE69916157T2 (de) 2005-03-17
EP0950386B1 (de) 2004-04-07
US7223286B2 (en) 2007-05-29
US20070021825A1 (en) 2007-01-25
ATE263520T1 (de) 2004-04-15
US6273913B1 (en) 2001-08-14

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