DE19916086B4 - Implantable prosthesis, especially vascular prosthesis (stent) - Google Patents
Implantable prosthesis, especially vascular prosthesis (stent) Download PDFInfo
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- DE19916086B4 DE19916086B4 DE1999116086 DE19916086A DE19916086B4 DE 19916086 B4 DE19916086 B4 DE 19916086B4 DE 1999116086 DE1999116086 DE 1999116086 DE 19916086 A DE19916086 A DE 19916086A DE 19916086 B4 DE19916086 B4 DE 19916086B4
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Classifications
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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
- 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
- A61F2/915—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 with bands having a meander structure, adjacent bands being connected to each other
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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
- 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
- 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
- A61F2/915—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 with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—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 with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- 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
- 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
-
- 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
- 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
- A61F2210/0095—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof radioactive
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00598—Coating or prosthesis-covering structure made of compounds based on metal oxides or hydroxides
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00856—Coating or prosthesis-covering structure made of compounds based on metal nitrides
- A61F2310/0088—Coating made of titanium nitride
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
Abstract
Prothese zum Implantieren in ein Lumen des menschlichen Körpers, um das Lumen offenzuhalten, vorzugsweise Gefäßprothese zum Offenhalten eines Blutgefäßes (Stent), wobei der Stent eine längliche, im wesentlichen hohlzylindrische Form mit einer Seitenwand aufweist, die mit einer Vielzahl von Durchbrüchen bzw. Öffnungen versehen ist und der Stent in dem Lumen von einem ersten geringeren Durchmesser auf einen zweiten größeren Durchmesser aufweitbar ist, indem er sich an die Wand des Lumens anlegt und diese abstützt und das Lumen offenhält, wobei die Seitenwand des Stents (15) eine rauhe Oberfläche (P) aufweist, dadurch gekennzeichnet, dass die Oberfläche des Stents (10) mit einem harten, spröden, keramikartigen Material (40) aus Iridiumoxid oder Titannitrid mit einer Schichtdicke zwischen 0,05 und 5 Mikrometern beschichtet ist.prosthesis to implant into a lumen of the human body to keep the lumen open, preferably vascular prosthesis to keep a blood vessel (stent) open, the stent being an elongated, has an essentially hollow cylindrical shape with a side wall, which is provided with a plurality of openings or openings and the Stent in the lumen from a first smaller diameter to one second larger diameter is expandable by lying on the wall of the lumen and supports them and keep the lumen open, the side wall of the stent (15) having a rough surface (P) has, characterized in that the surface of the Stents (10) with a hard, brittle, ceramic-like material (40) made of iridium oxide or titanium nitride with a layer thickness between 0.05 and 5 microns is coated.
Description
Die Erfindung bezieht sich auf eine Prothese zum Implantieren in ein Lumen des menschlichen Körpers, um dieses Lumen offenzuhalten, vorzugsweise eine Gefäßprothese zum Offenhalten eines Blutgefäßes, gemäß dem Oberbegriff des Patentanspruchs 1.The Invention relates to a prosthesis for implantation in a Lumens of the human body, to keep this lumen open, preferably a vascular prosthesis for keeping a blood vessel open, according to the preamble of claim 1.
Derartige Stents weisen eine längliche, im wesentliche hohlzylindrische Form mit einer Seitenwand auf, die mit einer Vielzahl von Durchbrüchen bzw. Öffnungen versehen ist, sodass der Stent in dem Lumen von einem ersten geringen Durchmesser auf einen zweiten größeren Durchmesser aufweitbar ist, bis er sich an die Wand des Lumens anlegt und diese abstützt, wodurch das Lumen offengehalten wird. Der Stent wird mit Hilfe eines Katheters mit dem ersten geringen Durchmesser in das Lumen transportiert und dann dort auf den zweiten Durchmesser aufgeweitet.such Stents have an elongated, essentially hollow cylindrical shape with a side wall on the with a large number of openings or openings is provided so that the stent in the lumen from a first minor Diameter to a second larger diameter is expandable until it lies against the wall of the lumen and this supported, which keeps the lumen open. The stent is removed using a Catheter with the first small diameter transported into the lumen and then expanded to the second diameter there.
Insbesondere bei Stents für Blutgefäße kann durch die Beschädigung der Gefäßwand bei der Entfernung von Ablagerungen das Risiko einer Restenose, d. h. einer Wiederverengung, nicht ausgeschlossen werden, da sich durch die Beschädigung Muskelzellen in der entsprechenden Region der Gefäßwand rasch ausbreiten, sodass häufig innerhalb einer Periode zwischen drei und sechs Monaten nach der Behandlung das Gefäß wiederum verengt wird.In particular for stents for Blood vessels can go through the damage the vessel wall at removal of deposits the risk of restenosis, d. H. a narrowing, cannot be ruled out because of the damage Muscle cells in the corresponding region of the vascular wall rapidly spread out so often within a period between three and six months after the Treat the vessel in turn is narrowed.
Um eine solche Restenose zu vermeiden, ist es in der Zwischenzeit üblich, einen Stent in dem Blutgefäß nach der primären Erweiterung der Ablagerung mit Hilfe eines Ballons zu plazieren. Hierbei sind mehrere Arten von Stents gebräuchlich.Around In the meantime, to avoid such restenosis, it is common to have one Stent in the blood vessel after the primary Placing extension of the deposit using a balloon. Several types of stents are used here.
Bei einer Art von Stents wird dieser auf den Dilatationsballon eines Ballonkatheters aufgekrimpt und anschließend in das gefährdete Blutgefäß geführt, wo er durch Aufblasen des Ballons aufgeweitet wird, bis er an der Innenwand des Gefäßes anliegt. Anschließend wird der Ballon wiederum entfernt. Der Stent muß eine ausreichende Steifigkeit bei gleichzeitig ausreichender Elastizität aufweisen, sodass er einerseits den Bewegungen der Gefäßwand folgen kann, andererseits diese ausreichend abstützt.at a kind of stent is placed on the dilatation balloon Balloon catheters crimped on and then passed into the endangered blood vessel where it is inflated by inflating the balloon until it hits the inside wall of the vessel. Then will the balloon again removed. The stent must have sufficient rigidity with sufficient elasticity at the same time, so that it on the one hand can follow the movements of the vessel wall, on the other hand, it supports them sufficiently.
Andere Stents sind aus Federstahl gefertigt und werden auf einen kleinen Durchmesser zusammengedrückt und in einem Katheter aufgenommen. Dieser Stent wird im Blutgefäß freigegeben, sodass er durch seine Federeigenschaft expandiert und die Gefäßwand abstützt.Other Stents are made of spring steel and are made on a small Diameter compressed and taken up in a catheter. This stent is released in the blood vessel, so that it expands due to its spring properties and supports the vessel wall.
Schließlich sind noch Stents aus sogenannten Gedächtnismaterialien bekannt, die im wesentlichen beliebig verformbar sind und erst in dem Blutgefäß aufgrund der dort herrschenden Bedingungen, insbesondere der Temperatur in ihre vorgegebene Struktur expandieren, in der sie die Gefäßwand abstützen.Finally are still stents made of so-called memory materials known, which are essentially deformable and only in due to the blood vessel the conditions prevailing there, in particular the temperature in expand their given structure in which they support the vessel wall.
Die Gegenwart des Stents in dem Blutstrom kann jedoch wiederum die Thrombusbildung und andere Ablagerungen begünstigen; auch dieses kann zu einer erneuten langsamen Verengung des Blutgefäßes führen. Die Thrombusbildung, eine Fibrose und auch eine Restenose des behandelten Blutgefäßes kann signifikant reduziert werden, wenn entsprechend wirkende Arzneimittel in der Nähe des Stents angewendet werden, z. B. indem der Stent mit einer biodegradierbaren Schicht versehen ist, in der die Arzneimittel eingearbeitet sind, sodass sie bei der Biodegradation der Beschichtung langsam freigegeben werden.The However, the presence of the stent in the bloodstream can in turn prevent thrombus formation and favor other deposits; this can also lead to a slow slow narrowing of the blood vessel. The Thrombus formation, fibrosis and also restenosis of the treated Blood vessel can be significantly reduced if correspondingly acting drugs nearby of the stent are applied, e.g. B. by the stent with a biodegradable Layer is provided, in which the drugs are incorporated, so that they are slowly released when the coating degrades.
Eine Restenose kann jedoch auch durch den direkten Kontakt zwischen der Außenwand des Stents an der Innenwand des Gefäßes ausgelöst werden, sodass diese Irritation des Gewebes zu einer Fibrose der Gefäßwand und schließlich zu einer Restenose des Gefäßes führt. Dieses Risiko kann durch die oben erwähnte Beschichtung des Stents reduziert werden, in die Arzneimittel eingearbeitet sind.A Restenosis can also be caused by direct contact between the outer wall of the stent can be triggered on the inner wall of the vessel, causing this irritation of the tissue to fibrosis of the vascular wall and finally to leads to restenosis of the vessel. This Risk can be caused by the above Coating of the stent can be reduced, in which drugs are incorporated.
Zur Verhinderung, bzw. zumindest zur Reduzierung der Bildung einer Restenose ist auch versucht worden, das behandelte Blutgefäß radioaktiv zu bestrahlen, indem z. B. der Stent selbst radioaktive Eigenschaften aufweist.to Prevention, or at least to reduce the formation of restenosis attempts have been made to radioactively treat the treated blood vessel, by z. B. the stent itself has radioactive properties.
Es ist Aufgabe der Erfindung, den Stent und insbesondere dessen Oberfläche so zu modifizieren, dass eine Irritation des Gefäßes und damit eine traumatische Reaktion mit entsprechender Proliferation von Gewebezellen und Erzeugen von Thromben verhindert wird; außerdem soll die Oberfläche des Stents so gestaltet sein, dass eine zusätzliche biodegradierbare Beschichtung wirkungsvoll aufgebracht wird, die z. B. antifibrotische und antithrombotische Arzneimittel abgibt; auf diese Weise soll verhindert werden, dass sich bei der Implantation des Stents Gewebeirritationen bzw. Restenosen einstellen.It is the object of the invention, the stent and in particular its surface modify that an irritation of the vessel and thus a traumatic Reaction with appropriate proliferation of tissue cells and generation is prevented by thrombi; the surface of the stent should also be designed so that an additional biodegradable coating is applied effectively z. B. delivers antifibrotic and antithrombotic drugs; this is to prevent the implantation Stop tissue irritation or restenosis of the stent.
Diese Aufgabe ist gemäß der Erfindung durch die Merkmale des Patentanspruchs 1 gelöst.This Object is according to the invention solved the features of claim 1.
Während bisher alle im klinischen Einsatz befindlichen Stents eine polierte und glatte Oberfläche aufweisen und eine glatte Oberfläche auch als günstigste Eigenschaft eines Bioimplantates weltweit angesehen wurde, besteht die überraschend einfache Lösung gemäß der Erfindung darin, dass die Seitenwand des Stents bzw. die Elemente der Seitenwand eine rauhe Oberfläche aufweisen. Hierzu ist dir Oberfläche des Stents mit einem harten, spröden und keramikartigen Material aus Iridiumoxid oder Titannitrid mit einer Schichtdichte zwischen 0,05 und 5 Mikrometern beschichtet.So far, all stents in clinical use have a polished and smooth surface and a smooth surface has also been regarded as the cheapest property of a bioimplant worldwide, the surprisingly simple solution according to the invention is that the side wall of the stent or the elements of the side wall are one have a rough surface. For this purpose, the surface of the stent is made with a hard, brittle and ceramic-like material made of iridium oxide or titanium trid coated with a layer density between 0.05 and 5 micrometers.
Es wurde von den Erfindern gefunden, dass durch eine solche rauhe Oberfläche eine Katalysatorwirkung erreicht wird, die die oxidative Gegenreaktion, die von den Leukozyten bei der Entzündungsreaktion vermittelt wird, abbaut und somit die Entzündungsreaktion verhindert. Die rauhe Oberfläche hat ferner den Vorteil, dass die Gewebezellen hier besser anhaften. Ebenso kann auf die rauhe Oberfläche wirkungsvoll eine dünne Beschichtung aufgebracht werden, in die Arzneimittel eingearbeitet sind, die dann bei dem biologischen Abbau der dünnen Beschichtung sukzessive freigegeben werden.It was found by the inventors that such a rough surface Catalytic effect is achieved, which is the oxidative counter reaction, which is mediated by the leukocytes in the inflammatory reaction, breaks down and thus the inflammatory reaction prevented. The rough surface also has the advantage that the tissue cells adhere better here. Likewise, the rough surface effectively a thin one Coating applied, incorporated into the drug are, which then successively in the biodegradation of the thin coating be released.
Zusätzlich erlaubt die rauhe Oberfläche des Stents ein sehr gutes Anhaften des Stents auf dem Ballon eines Ballonkatheters, mit dem er in das Lumen eingebracht wird. Gegenüber herkömmlichen Stents wird die Haftung des Stents auf dem Ballon erheblich verbessert.Additionally allowed the rough surface the stent adheres very well to the balloon of a Balloon catheter with which it is inserted into the lumen. Compared to conventional stents the stent's adhesion to the balloon is significantly improved.
Der Gedanke, die Oberfläche des Stents rauh zu gestalten, läuft der bisherigeri Entwicklung bei derartigen Stents entgegen. Bisher wurde stets darauf geachtet, die Oberfläche möglichst glatt zu gestalten, insbesondere, um bei dem Vorschub des Stents etwa durch eine Körperarterie an der Wand der Arterie nur einen geringen Reibungs- und Gleitwiderstand zu haben. Entgegen aller Befürchtungen hat es sich gezeigt, dass eine rauhe Oberfläche eines Stents gemäß der Erfindung die Reibung an der Gefäßwand praktisch nicht verschlechtert; es wurde gefunden, dass sich selbst schon beim Vorschieben des Stents durch die Arterien Blutbestandteile in der rauhen Oberfläche anlagern, wodurch die Oberfläche quasi geglättet wird.The Thought the surface designing the stent roughly runs contrary to the previous development in such stents. So far care was always taken to make the surface as smooth as possible, in particular in order to advance the stent through a body artery only slight friction and sliding resistance on the wall of the artery to have. Contrary to all fears it has been shown that a rough surface of a stent according to the invention the friction on the vessel wall is practical not deteriorated; it was found to be itself blood components when the stent is advanced through the arteries in the rough surface attach, which makes the surface quasi smoothed becomes.
In Tierversuchen wurde mit Stents gemäß der Erfindung Restenose nur in etwa 4 % der Fälle entdeckt, während für herkömmliche Stahlstents sich etwa der doppelte Wert und für Stents mit einer Goldbeschichtung ein noch höherer Wert ergibt. Offensichtlich ermöglicht die rauhe Oberfläche des Stents eine raschere Besiedlung mit Endothelzellen und glatten Muskelzellen. Dies wurde in einem Schüttelmodell mit Zellkulturen nachgewiesen. Des weiteren ist der geringe Wert für Restenosen die der rauhen Stentoberfläche innehaftenden Katalysatorwirkung zuzuschreiben, insbesondere wenn die rauhe Oberfläche des Stents durch eine äußere Beschichtung mit dem erwähnten Iridiumoxid oder Titannitrat gebildet wird. Diese Katalysatorwirkung kann dadurch zustande kommen, dass H2O2, das von Leukozyten bei der Auslösung der Gegenreaktion freigesetzt wird, in Wasser und Sauerstoff zerlegt wird. Da H2O2 der stärkste Stimulator von NFKB ist, einem wichtigen Signalübermittler für die Proliferation und Restenoseentwicklung, wird die Signalkaskade zur Einleitung einer Restenose bereits am Anfang durch die katalytische Wirkurig unterbrochen.In animal experiments, restenosis according to the invention was only discovered in about 4% of the cases, while about twice the value for conventional steel stents and an even higher value for stents with a gold coating. Obviously, the rough surface of the stent enables faster colonization with endothelial cells and smooth muscle cells. This was demonstrated in a shake model with cell cultures. Furthermore, the low value for restenoses is attributable to the catalyst action inherent in the rough stent surface, in particular if the rough surface of the stent is formed by an outer coating with the aforementioned iridium oxide or titanium nitrate. This catalyst effect can come about by decomposing H 2 O 2 , which is released by leukocytes when the counter-reaction is triggered, into water and oxygen. Since H 2 O 2 is the most powerful stimulator of NFKB, an important signal transmitter for proliferation and restenosis development, the signaling cascade for the initiation of restenosis is interrupted at the beginning by the catalytic agent.
Gemäß einer bevorzugten Ausführungsform der Erfindung weist die Seitenwand des Stents im Querschnitt drei im wesentlichen konzentrische schichtenartige Bereiche auf, nämlich
- – einen zentralen Bereich mit einer ersten Schichtdicke, der im wesentlichen die Grundform des Stents und dessen mechanische Eigenschaften festlegt und z. B. aus medizinischem 316L-Edelstahl gefertigt ist;
- – einen Zwischenbereich mit einer zweiten geringeren Schichtdicke, der die Grundstruktur bzw. die Elemente des Stents des zentralen Bereiches vollständig umgibt und aus einem Material besteht, das auch bei dem Aufweiten des Stents den zentralen Bereich weiterhin lückenlos umhüllt; dieser Zwischenbereich kann z. B. aus einem Edelmetall, wie z. B. Gold oder Platin bestehen oder aus einer Legierung aus Platin und Iridium; und
- – einen Außenbereich mit einer noch geringeren Schichtdicke, der auf den Zwischenbereich aufgebracht ist und der die raube Oberfläche des Stents bildet; das bevorzugte Material ist, wie erwähnt, Iridiumoxid oder Titannitrid.
- - A central area with a first layer thickness, which essentially defines the basic shape of the stent and its mechanical properties and z. B. is made of medical grade 316L stainless steel;
- - An intermediate area with a second, smaller layer thickness, which completely surrounds the basic structure or the elements of the stent of the central area and consists of a material that continues to completely cover the central area even when the stent is expanded; this intermediate area can e.g. B. from a precious metal, such as. B. gold or platinum or an alloy of platinum and iridium; and
- An outer region with an even smaller layer thickness, which is applied to the intermediate region and which forms the rough surface of the stent; the preferred material, as mentioned, is iridium oxide or titanium nitride.
Die Dicke der Seitenwand des Stents im zentralen Bereich, also üblicherweise einem Grundkörper aus 316L-Edelstahl, liegt üblicherweise zwischen 50 und 130 Mikrometern, die Dicke des Zwischenbereiches zwischen 4 und 15 Mikrometern und die Dicke des Außenbereiches zwischen 0,05 Mikrometern und einem Mikrometer und ist vorzugsweise im Bereich von 0,5 Mikrometern.The Thickness of the side wall of the stent in the central area, i.e. usually a basic body made of 316L stainless steel, is usually between 50 and 130 microns, the thickness of the intermediate area between 4 and 15 microns and the thickness of the outside area between 0.05 micrometers and one micrometer and is preferred in the range of 0.5 microns.
Der Zwischenbereich kann eine homogene Beschichtung mit z. B. einer im wesentlichen glatten Oberfläche sein , kann aber auch mit im wesentlichen regelmäßig aneinander anschließenden Erhebungen und Vertiefungen versehen sein; die Erhebungen und Vertiefungen haben dann vorzugsweise eine Größe im Bereich zwischen 20 und 500 Nanometern. Der Zwischenbereich wird hierzu bevorzugt aus einem Teilchenmaterial mit Teilchengrößen zwischen 50 und 500 Nanometern gebildet; dieses Teilchenmaterial kann in herkömmlicher Weise, z. B nach pulvermetallurgischen Verfahren, auf die leicht angerauhte Oberfläche des zentralen Grundkörpers aufgebracht werden. Dieser aus im wesentlichen sphärischen Teilchen aufgebaute Zwischenbereich ist ausreichend duktil, um beim Expandieren des Stents den Grundkörper bzw. dessen Elemente vollständig zu umgeben.The A homogeneous coating with e.g. B. one essentially smooth surface , but can also be carried out with surveys and which follow one another at regular intervals Indentations; who have elevations and recesses then preferably a size in the range between 20 and 500 nanometers. The intermediate area becomes this preferably from a particle material with particle sizes between 50 and 500 nanometers formed; this particle material can be in conventional Way, e.g. B by powder metallurgy, on the light roughened surface of the central body be applied. This consists of essentially spherical particles built-up intermediate area is ductile enough to expand the basic body of the stent or its elements completely to surround.
Das Material des Außenbereiches eines Stents gemäß der Erfindung kann entweder nur tatsächlich auf die äußere Oberfläche des Stents aufgebracht werden, d. h. auf die Seite, mit der der Stent an der Innenwand des Gefäßes bzw.The material of the outer region of a stent according to the invention can either only actually be applied to the outer surface of the stent, ie to the side with which the stent on the inner wall of the vessel or
Lumens anliegt. Bevorzugt wird jedoch hier eine Gesamtbeschichtung aller Elemente des Stents vorgenommen.lumen is applied. However, an overall coating of all is preferred here Elements of the stent are made.
Gemäß einer bevorzugten Ausführungsform der Erfindung wird der zentrale Bereich des Stents, wie erwähnt, aus 316L-Stahl hergestellt, der Zwischenbereich aus Gold und der Außenbereich aus Iridiumoxid. Ein Vorteil eines solchen Aufbaues ist, dass die Iridiumoxidschicht in der elektrochemischen Spannungsreihe das gleiche Potential wie Gold, nämlich + 180 Millivolt aufweist, wohingegen Stahl bei 160 Millivolt liegt. Würde der zentrale Bereich unmittelbar hermetisch mit Iridiumoxid beschichtet, könnten, da das Iridiumoxid relativ spröde ist und wenig plastische Konfigurationsänderungen erlaubt, bei der Aufdehnung des Stents haarfeine Risse im Bereich von 10 Nanometern entstehen, die zwar klinisch, hämodynamisch und mechanisch keinerlei Relevanz haben, eine sichere elektrische Trennung des zentralen Edelstahlbereiches von der Umgebung nicht gewährleisten würden, da durch die unterschiedlichen elektostatischen Spannungswerte von Stahl und Iridium quasi eine Batteriequelle entstehen würde. Erst durch die duktile BeschichtunG des zentralen Bereiches mit Gold bzw. einem anderen Edelmetall oder einer Legierung kann dieser hermetische Verschluß erreicht werden.According to one preferred embodiment of the Invention, the central area of the stent is, as mentioned, from Made of 316L steel, the intermediate area made of gold and the outer area made of iridium oxide. An advantage of such a structure is that the iridium oxide layer the same potential as in the electrochemical series Gold, namely + 180 millivolts, whereas steel is 160 millivolts. Would the central area immediately hermetically coated with iridium oxide, because the iridium oxide is relatively brittle is and allows little plastic configuration changes in which Expansion of the stent shows hairline cracks in the range of 10 nanometers arise, although clinically, hemodynamically and mechanically have no relevance, a safe electrical No separation of the central stainless steel area from the environment guarantee would because of the different electostatic voltage values of steel and Iridium would become a battery source. First due to the ductile coating of the central area with gold or another noble metal or an alloy, this hermetic seal can be achieved become.
Ein weiterer Grund ist, dass der Zwischenbereich aus einem Edelmetall bzw. einer Edelmetalllegierung im Röntgenbild bei der Implantation des Stents im Gegensatz zu Stahl sehr gut sichtbar ist, da Gold eine etwa sechsfach höhere Röntgendichte als Stahl hat und somit eine Dicke des Zwischenbereiches von z. B. 10 Mikrometern gleich gut sichtbar ist wie Stahl mit einer Dicke von etwa 60 Mikrometern. Durch die Kombination beider Materialien ist somit die Röntgendichte entsprechend 120 Mikrometer Stahl ausreichend, um bei der Operation die Plazierung des Stents sehr gut verfolgen zu können.On Another reason is that the intermediate area is made of a precious metal or a precious metal alloy in the x-ray image during implantation of the stent, in contrast to steel, is very visible because of gold an approximately six times higher radiopacity as steel and thus has a thickness of the intermediate area of z. B. 10 micrometers is equally visible as steel with a thickness of about 60 microns. By combining both materials is thus the x-ray density corresponding to 120 microns of steel sufficient to perform the operation to be able to follow the placement of the stent very well.
Die Beschichtung mit Iridiumoxid hat zudem noch den Vorteil, dass Iridium etwa durch Neutronenbeschuß z. B. in einem Reaktor in ein radioaktives Isotop umgewandelt werden kann, nämlich 192Ir. Das Isotop hat eine Halbwertzeit von 74 Tagen und emittiert sowohl β- als auch γ-Strahlung, die, wie oben bereits erwähnt, die Ausbildung von Restenose verhindern können.The coating with iridium oxide also has the advantage that iridium, for example, by neutron bombardment. B. can be converted into a radioactive isotope in a reactor, namely 192 Ir. The isotope has a half-life of 74 days and emits both β and γ radiation, which, as already mentioned above, can prevent the formation of restenosis.
Des weiteren ist Iridium ein Edelmetall mit dem Atomgewicht von 77 und trägt somit bei der Beobachtung der Implantation auf einem Röntgenschirm auch zur besseren Sichtbarkeit des Stents bei.Of Furthermore, iridium is a precious metal with an atomic weight of 77 and thus bears when observing the implantation on an x-ray screen also for better Visibility of the stent at.
Schließlich sei noch darauf hingewiesen, dass die vorgestellten Merkmale der Erfindung unabhängig von der Konstruktion des Stents sind: sie können sowohl bei Stents angewendet werden, die durch einen Ballonkatheter expandierbar sind, ebenso bei Stents, die aus Federstahl konstruiert sind und nach Freigabe selbsttätig expandieren, und schließlich auch für Stents aus Gedächtnismaterialien wie Nitinol etc.After all still noted that the presented features of the invention independently of the construction of the stent are: they can be applied to both stents that are expandable by a balloon catheter, as well for stents constructed from spring steel and after approval automatic expand, and finally, too for stents from memory materials like Nitinol etc.
Die Erfindung ist in Ausführungsbeispielen anhand der Zeichnung näher erläutert. In dieser stellen dar:The Invention is based on exemplary embodiments closer to the drawing explained. In this represent:
In
Der
Stent
Die
Beschichtung
Auf
diese Beschichtung
In
Der
Zwischenbereich
Der
Aufbau des Zwischenbereiches (
Die Mikrokugeln des Zwischenbereiches können auch aus Platin, einer Platin-Iridium-Legierung mit einem Anteil zwischen etwa 2 Gew.-% bis etwa 10 Gew.-% Iridium oder einer anderen Edelmetall-Legierung bestehen.The Microspheres of the intermediate area can also be made of platinum, one Platinum-iridium alloy with a proportion between about 2% by weight up to about 10% by weight iridium or another noble metal alloy consist.
Die
Mikrokugeln werden auf den zentralen Bereich
Auf
diese gewellte Oberfläche
des Zwischenbereiches
Durch
das Herstellungsverfahren des Zwischenbereiches
Vorzugsweise
nimmt der Durchmesser der Mikrokugeln
Es
ist auch möglich,
in diese Zwischenräume
Die
Oberfläche
des fertiggestellten Stents hat eine ausreichende Rauhigkeit, sodass
auch hier noch die oben erwähnte
biodegradierbare Beschichtung
Claims (15)
Applications Claiming Priority (4)
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US5905398A | 1998-04-11 | 1998-04-11 | |
US09/059054 | 1998-04-11 | ||
US09/059,054 US5980566A (en) | 1998-04-11 | 1998-04-11 | Vascular and endoluminal stents with iridium oxide coating |
US09/059053 | 1998-04-11 |
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DE19916086A1 DE19916086A1 (en) | 1999-10-14 |
DE19916086B4 true DE19916086B4 (en) | 2004-11-11 |
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DE1999116086 Expired - Fee Related DE19916086B4 (en) | 1998-04-11 | 1999-04-09 | Implantable prosthesis, especially vascular prosthesis (stent) |
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