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DE69622231T2 - Längsflexibler und expandierbarer stent - Google Patents

Längsflexibler und expandierbarer stent

Info

Publication number
DE69622231T2
DE69622231T2 DE69622231T DE69622231T DE69622231T2 DE 69622231 T2 DE69622231 T2 DE 69622231T2 DE 69622231 T DE69622231 T DE 69622231T DE 69622231 T DE69622231 T DE 69622231T DE 69622231 T2 DE69622231 T2 DE 69622231T2
Authority
DE
Germany
Prior art keywords
stent
segments
segment
connecting elements
adjacent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE69622231T
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English (en)
Other versions
DE69622231D1 (de
Inventor
J. Brown
L. Davis
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Boston Scientific Scimed Inc
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Scimed Life Systems Inc
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27015561&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69622231(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US08/511,076 external-priority patent/US6818014B2/en
Application filed by Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Publication of DE69622231D1 publication Critical patent/DE69622231D1/de
Application granted granted Critical
Publication of DE69622231T2 publication Critical patent/DE69622231T2/de
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Expired - Lifetime legal-status Critical Current

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Classifications

    • 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 sheets 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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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 sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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 sheets 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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525—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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • 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 sheets 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 sheets 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 sheets 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
    • 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 sheets 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 sheets 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 sheets 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
    • 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 sheets 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 sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Description

    Gebiet der Erfindung
  • Diese Erfindung betrifft eine Endoprothesenvorrichtung zur Implantierung in ein Köpergefäß, typischerweise ein Blutgefäß. Insbesondere betrifft sie einen rohrförmigen ausdehnbaren Stent mit verbesserter Flexibilität in Längsrichtung.
    • Hintergrund der Erfindung
  • Stents werden zur Behandlung von Stenosen, Strikturen oder Aneurismen in Blutgefäßen in diese eingebracht oder implantiert. Sie werden implantiert, um kollabierende, teilweise verstopfte, geschwächte oder erweiterte Abschnitte eines Blutgefäßes zu verstärken. Sie wurden auch in den Harntrakt oder in Gallengängen implantiert. Typischerweise weist ein Stent einen unausgedehnten (geschlossenen) Durchmesser für die Platzierung und einen ausgedehnten (geöffneten) Durchmesser nach der Platzierung im Gefäß oder Gang auf. Einige Stents sind selbstausdehnbar und einige werden mechanisch mit einer radial nach außen gerichteten Kraft vom Inneren des Stents aus ausgedehnt, z. B. durch Aufblasen eines Ballons.
  • Ein Beispiel ihr den letzteren Typ wird in US Patent Nr. 4,733,665 von Palmaz dargestellt, welches am 29. März 1988 erteilt wurde und eine Reihe von Stentkonfigurationen zur Implantierung mit Hilfe eines Katheters offenbart. Der Katheter umfasst eine Anordnung, in der ein Ballon innerhalb des Stents aufgeblasen wird, wodurch der Stent durch plastische Deformierung ausgedehnt wird, nachdem er in das Blutgefäß eingeführt wurde.
  • Ein Typ eines selbstexpandierenden Stents wird in US Patent Nr. 4,503,569 von Dotter beschrieben, welches am 12. März 1985 erteilt wurde und einen Formgedächtnisstent offenbart, welcher sich mittels einer Temperaturänderung zu einer implantierten Konfiguration ausdehnt. Andere Typen von selbstexpandierenden Stents, die nicht aus Formgedächtnismaterial hergestellt sind, sind ebenfalls bekannt.
  • Diese Erfindung betrifft Stents all dieser Typen, sofern sie so konfiguriert sind, dass sie in Längsrichtung flexibel sind, wie unten im Detail beschrieben. Flexibilität ist ein wünschenswertes Merkmal in einem Stent, damit er sich Krümmungen in einem Gefäß anpasst. Solche Stents sind im Stand der Technik bekannt. Beispiele sind in US Patent Nr. 4,856,516 von Hillstead; U.S. Patent Nr. 5,104,404 von Wolff; U.S. Patent Nr. 4,994,071 von MacGregor; U.S. Patent Nr. 5,102,417 von Palmaz; U.S. Patent Nr. 5,195,984 von Schatz; U.S. Patent Nr. 5,135,536 von Hillstead; U.S. Patent 5,354,309 von Shepp-Pesch et al.; EPA Patentanmeldung 0 540 290 A2 von Lau; EPA Patentanmeldung 0 364 787 B1 von Schatz und PCT-Anmeldung WO 94/17754 (entsprechend der deutschen Patentanmeldung 43 03 181) dargestellt.
  • WO 95/31945, ein Dokument unter Artikel 54(3) EPÜ, offenbart Stents, die aus einem ersten elastischen Element und einem zweiten deformierbaren Element gebildet werden. Es werden hierin eine Vielzahl von unterschiedlichen Stentgestaltungen offenbart. Es gibt insbesondere einen Stent mit einer Gestaltung, die der in dieser vorliegenden Anmeldung offenbarten Fig. 2 entspricht. Das Dokument enthält keine Details hinsichtlich der Struktur eines solchen Stents.
  • Allgemein gesprochen sind diese Arten von Stents gegliedert und für gewöhnlich aus einer Reihe von in einer Linie ausgerichteten, ausdehnbaren, relativ unflexiblen, kreisförmigen Abschnitten gebildet, welche über flexible Elemente verbunden sind, so dass sie einen im wesentlichen rohrförmigen Körper bilden, welcher bis zu einem bestimmten Grad zur Gelenkigkeit oder Biegung in der Lage ist. Leider besteht ein Problem mit solchen Stents darin, dass Haften, Überlappen oder gegenseitiges Stören zwischen benachbarten Segmenten innerhalb einer Biegung auftreten kann, indem sich die Segmente aufeinander zu bewegen und miteinander in Kontakt kommen oder, indem die Segmente auf der Außenseite einer Biegung sich voneinander wegbewegen und dabei große Lücken hinterlassen können. Dies kann zu einer unzureichenden Gefäßunterstützung, einem Gefäßtrauma, Fließstörungen, Zerrungen, Platzen des Ballons während der Ausdehnung und schwieriger Rückführung von Vorrichtungen, die durch bereits implantierte Vorrichtungen und an ununterstützten Bereichen des Gefäßes installiert werden sollen.
  • Insbesondere EP 540 290 offenbart einen ausdehnbaren Stent bestehend aus einer Vielzahl von radial ausdehnbaren zylindrischen wellenförmigen Elementen, die über Verbindungselemente parallel zu der Längsachse des Stents miteinander verbunden sind.
  • Eine rhombische Konfiguration mit diagonalen Verbindungen zwischen jedem Rhombus jedes Segments ist ebenso bekannt, aber solche geschlossenen Konfigurationen weisen keine Flexibilität auf.
  • Es ist eine Aufgabe dieser Erfindung, einen in Längsrichtung flexiblen Stent offener Konfiguration bereitzustellen, der diese Probleme vermeidet und verbesserte Flexibilität (radial und longitudinal), mehr in den Stentkörpersegmenten als in flexiblen Verbindungen zwischen diesen Segmenten, zeigt.
  • Zu diesem Zweck stellt die Erfindung einen rohrförmigen ausdehnbaren Stent, wie in dem unabhängigen Anspruch 1 definiert, bereit.
    • Kurze Beschreibung der Figuren
  • Fig. 1 zeigt eine flächige Ansicht einer erfindungsgemäßen unausgedehnten Stentkonfiguration.
  • Fig. 2 zeigt das Muster der Fig. 1 in einem rohrförmigen unausgedehnten Stent.
  • Fig. 3 zeigt einen ausgedehnten Stent der Konfiguration der Fig. 1.
  • Fig. 4 zeigt eine flächige Ansicht einer alternativen erfindungsgemäßen unausgedehnten Stentkonfiguration.
    • Beschreibung der besten Ausführung der Erfindung
  • Mit Blick auf die Figuren zeigen Fig. 1 und Fig. 2 eine fragmentarische flächige Ansicht einer unausgedehnten Stentkonfiguration bzw. des tatsächlichen (unausgedehnten) rohrförmigen Stents. Das heißt, der Stent wird aus Anschaulichkeitsgründen in Fig. 1 flächig dargestellt und kann aus einem flächigen Muster 10 (Fig. 1), welches durch Rollen des Musters, indem die Kanten 12 und 14 (Fig. 1) zusammengebracht werden, zu einer rohrförmigen Gestalt geformt wird, hergestellt werden. Die Kanten können dann miteinander durch Schweißen oder ähnliches verbunden werden, so dass eine Konfiguration wie die in Fig. 2 dargestellte bereitgestellt wird.
  • Wie aus diesen Figuren ersichtlich, setzt sich die Konfiguration aus einer Vielzahl von benachbarten Segmenten, die im allgemeinen als 16 bezeichnet werden, zusammen, von denen jedes in einem wellenförmigen flexiblen Muster von im wesentlichen parallelen Streben 18 geformt ist. Strebenpaare werden an abwechselnden Endbereichen 19a und 19b miteinander verbunden. Wie aus Fig. 1 ersichtlich, sind die verbindenden Endbereiche 19b eines Segments gegenüber den verbindenden Endbereichen 19a von benachbarten Segmenten angeordnet. Die dargestellten Endbereiche sind im allgemeinen elliptisch, können aber auch abgerundet oder rechtwinklig oder spitz oder ähnliches sein. Es ist jede Konfiguration der Endbereiche akzeptabel, solange sie, wie dargestellt, ein wellenförmiges Muster aufweisen. Wenn die flächige Form 10 zu einem unausgedehnten Rohr wie in Fig. 2 geformt wird, sind die Segmente zylindrisch, aber die Endbereiche 19 der benachbarten Segmente bleiben im Verhältnis zueinander in einer gegenüberliegenden Position.
  • Ein mehr bevorzugtes Herstellungsverfahren beginnt mit einem dünnwandigen Rohr, welches anschließend mit Laser zugeschnitten wird, um die gewünschte Konfiguration bereitzustellen. Es kann ebenso chemisch geätzt oder elektroerosiv bearbeitet werden (EDM; electrical discharge machine), um eine geeignete Konfiguration zu bilden.
  • Verbindungselemente 20 erstrecken sich von einem Endbereich 19 eines Segments 16 zu einem anderen Endbereich 19 eines anderen benachbarten Segments 16, aber nicht zu einem gegenüber angeordneten Endbereich 19 eines benachbarten Segments 16. Es sind mindestens 3 Streben zwischen den Punkten jeder Seite eines Segments 16, an denen ein Verbindungselement 20 einen Endbereich 19 kontaktiert, eingeschlossen. Dies führt dazu, dass die Verbindungselemente 20 sich in einer abgewinkelten Ausrichtung zwischen den Segmenten über den Rand des rohrförmigen Stents erstrecken. Die Verbindungselemente 20 weisen bevorzugt dieselbe Länge auf, können aber von einem Segment zum anderen variieren. Auch die diagonale Richtung kann sich von einem Segment zum anderen umkehren, indem sie sich in dem einem Fall nach oben und in dem anderen Fall nach unten erstreckt, obwohl alle Verbindungselemente zwischen jedem Segmentpaar im wesentlichen parallel sind. Fig. 1 zeigt z. B. wie sie sich nach unten von rechts nach links erstrecken. Nach oben wäre eine Erstreckung von oben links nach rechts in dieser Konfiguration.
  • Aufgrund dieser winkeligen Erstreckung der Verbindungselemente 20 zwischen benachbarten Segmenten und Schleifen werden die nächsten benachbarten Endbereiche 19 zwischen den Segmenten 16 bei Ausdehnung des Stents wie in Fig. 3 dargestellt, gegeneinander versetzt und sind nicht mehr gegenüberliegend angeordnet, so dass die Möglichkeit des Aneinanderhaftens oder Überlappens zwischen den Segmenten, das heißt, des Verklemmens, minimiert wird.
  • Die Anzahl an Verbindungselementen 20 kann abhängig von den Umständen bei jedem einzelnen Fall variieren. Drei pro Segment sind ausreichend für die gezeigte Konfiguration und wenigstens drei werden typischerweise verwendet.
  • Die in Fig. 4 dargestellte alternative Gestaltung beinhaltet längere Streben 18a in den beiden Endsegmenten 16a als in den Zwischensegmenten 16. Dies ermöglicht es für die Endsegmente (16a) weniger Kompressionswiderstand aufweisen zu müssen als die Zwischensegmente (16), so dass ein graduellerer Übergang von dem natürlichen Gefäß zu der Stützstruktur des Stents ermöglicht wird. Ansonsten ist die Konfiguration dieselbe wie in Fig. 1 dargestellt.
  • Wie bereits erwähnt, ist diese Erfindung anwendbar auf selbstausdehnende Konfigurationen, mechanisch ausdehnbare Konfigurationen und auf eine große Vielzahl an Materialien, einschließlich sowohl Metall als auch Kunststoff und jedes andere Material, welches als ausdehnbarer Stent einsetzbar ist. Der Stent kann beispielsweise aus Metalldraht oder -band, z. B. aus Tantal, rostfreiem Stahl oder Ähnlichem bestehen. Er kann dünnwandig sein. Er kann aus einer Formgedächtnislegierung wie Nitinol oder Ähnlichem, etc., bestehen.
  • Die obigen Beispiele und Offenbarungen sind zur Veranschaulichung gedacht und nicht erschöpfend.

Claims (13)

1. Rohrförmiger, flexibler, dehnbarer Stent (10) mit einer Längsachse, umfassend:
a) eine Vielzahl von zylindrisch geformten Segmenten (16), die auf einer gemeinsamen Längsachse ausgerichtet sind, so dass sie einen im allgemeinen rohrförmigen Stentkörper definieren,
b) wobei jedes Segment (16) durch ein Glied definiert ist, das in einem wellenförmigen Muster von miteinander verbundenen im wesentlichen parallelen Streben (18) geformt ist, so dass der Rand des dehnbaren Stentkörpers definiert wird,
c) und in welchem benachbarte Streben in einem gegebenen Segment abwechselnd an gegenüberliegenden Enden (19a, 19b) miteinander verbunden sind,
d) wobei die miteinander verbundenen Strebenenden (19) eines Segmentes (16) im wesentlichen gegenüber den miteinander verbundenen Enden (19) eines benachbarten Segments angeordnet sind, und
e) eine Vielzahl von miteinander verbundenen Elementen (20), von denen sich jedes winkelig von einem Ende an einem Segment zu einem anderen Ende, nicht zu einem gegenüberliegenden Ende, an einem benachbarten Segment erstreckt,
f) wobei die Verbindungselemente (20) so verteilt sind, dass sich mindestens drei Streben zwischen jedem Verbindungspunkt auf gegenüberliegenden Seiten der Segmente (16) befinden und
g) bei der die Verbindungselemente (20) sich bei normalem Gebrauch nicht biegen oder krümmen,
h) wobei bei Ausdehnung des Stents (10) die gepaarten Streben (18) der benachbarten Segmente (16) relativ zueinander um den Rand des Stentkörpers herum versetzt sind, um das Biegen des Stents in Längsrichtung innerhalb der Segmente (16) und ohne Störung zwischen benachbarten Segmenten zu akkomodieren.
2. Stent nach Anspruch 1, wobei die Orientierung der Verbindungselemente (20) entlang der Längsrichtung des Stents sich von einem Segment zum anderen umkehrt.
3. Stent nach Anspruch 1 oder 2, wobei die Verbindungselemente (20) zwischen den benachbarten Segmenten (16) dieselbe Länge aufweisen.
4. Stent nach Anspruch 1, 2 oder 3, wobei der Stent Endsegmente (16a) und Zwischensegmente (16) umfasst und die Endsegmente (16ä) des Stents längere Streben als die Zwischensegmente (16) des Stents umfassen.
5. Stent nach Anspruch 4, wobei die Orientierung der Verbindungselemente (20) entlang der Längsrichtung des Stents sich von einem Segment zum anderen umkehrt.
6. Stent gemäß einem der vorangegangenen Ansprüche bestehend aus Metall.
7. Stent nach Anspruch 6, wobei das Metall eine Formgedächtnislegierung (shape memory alloy) ist.
8. Stent nach Anspruch 6, wobei der Stent dünnwandig ist.
9. Stent nach einem der vorangegangenen Ansprüche, wobei die Länge der Verbindungselemente (20) von einem Segment (16) zum anderen variiert.
10. Stent nach einem der vorangegangenen Ansprüche in einer selbstausdehnbaren Gestaltung.
11. Stent nach einem der Ansprüche 1 bis 9 in einer mechanisch ausdehnbaren Gestaltung.
12. Stent nach einem der Ansprüche 1 bis 9 aus Nitinol.
13. Stent nach einem der vorangegangenen Ansprüche, wobei die benachbarten Verbindungselemente (20), die sich von einem zylindrisch geformten Segment (16) aus erstrecken, von sechs Streben voneinander getrennt werden.
DE69622231T 1995-03-01 1996-02-28 Längsflexibler und expandierbarer stent Expired - Lifetime DE69622231T2 (de)

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PCT/US1996/002615 WO1996026689A1 (en) 1995-03-01 1996-02-28 Improved longitudinally flexible expandable stent

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EP1163889A2 (de) 2001-12-19
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EP0758216A1 (de) 1997-02-19
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WO1996026689A1 (en) 1996-09-06
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