WO2004062533A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2004062533A1
WO2004062533A1 PCT/DE2003/003813 DE0303813W WO2004062533A1 WO 2004062533 A1 WO2004062533 A1 WO 2004062533A1 DE 0303813 W DE0303813 W DE 0303813W WO 2004062533 A1 WO2004062533 A1 WO 2004062533A1
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WO
WIPO (PCT)
Prior art keywords
stent
struts
strut
shaped
circumferential direction
Prior art date
Application number
PCT/DE2003/003813
Other languages
German (de)
French (fr)
Inventor
Thomas Nissl
Original Assignee
Qualimed Innovative Medizinprodukte Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Qualimed Innovative Medizinprodukte Gmbh filed Critical Qualimed Innovative Medizinprodukte Gmbh
Priority to AU2003287868A priority Critical patent/AU2003287868A1/en
Publication of WO2004062533A1 publication Critical patent/WO2004062533A1/en

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Classifications

    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61F2002/91533Stents 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
    • 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
    • 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
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough

Definitions

  • the invention relates to a stent with a tubular expandable scaffold according to the features in the preamble of claim 1.
  • Stents are used in the treatment of strictures, ie congenital or acquired vascular occlusions or constrictions.
  • the stents function in the area of the stenosis as vascular prostheses for supporting the inner walls of the vessel. They are implanted by means of catheter techniques in the place of stenosis.
  • stents are known in the art. They are available in metal, plastic and hybrid constructions. They can be self-expanding. Other embodiments can be modified by means of suitable tools, for example balloons, in diameter.
  • Stents in the embodiments according to DE 295 21 206 U1 as well as DE 296 08 037 U1 have a tubular support structure made of metal, which consists of several ring segments. These are formed from zig-zag or meandering form over bow sections endlessly adjoining oblique struts. Ring segments adjacent to the longitudinal axis of the stents are coupled via connectors.
  • a similar solution is disclosed in WO 96/26689.
  • the stents of known type fulfill their function depending on the embodiment more or less satisfactory.
  • the scaffolds often either fail to provide the necessary radial forces to adequately withstand a stenosis or are configured to interfere with the function of the vessel.
  • the stents also appear to be in need of improvement in terms of load behavior in the body, in particular with regard to bending, torsion and length stability.
  • the invention is therefore based on the prior art based on the object to provide a stent that conforms to the shape of a vessel body with uniform pressure distribution in the stenosis area and behaves length-stable even under axial bending or torsional stress in the body.
  • the scaffold consists of axially successive ring segments which are formed from undulating oblique struts. Adjacent ring segments are coupled by connectors.
  • a connector has a longitudinal portion extending in the longitudinal direction of the stent and a circumferentially directional U-shaped strut portion. The connectors each extend from the top of two V-shaped adjoining OHder oblique struts of a ring segment in the deepest of two V-shaped successive oblique struts of an adjacent ring segment.
  • the main point of the invention is the measure that in each case two oblique struts of a ring segment are connected via a pointing in the circumferential direction radial bar and each U-shaped strut portion of a connector has two circumferentially extending transverse struts, which are connected by an aligned parallel to the Stentlangsachse Axialsteg.
  • the opening angle between two transverse struts is smaller than the opening angle between two oblique struts.
  • the special design of the scaffold ensures high flexibility both in axial bending and in axial rotation.
  • the stent is characterized by a geometric fit to the environment. The conformations occur both in axial and in radial expansion without length change. Even when expanding there is no change in length of the scaffold. This ensures the design of the connectors.
  • the design of the scaffold is very well adaptable to different anatomical shapes, such as a trachea stent, where a horseshoe shape is favorable. Also, as a bronchial or esophageal stent, the inventively proposed stent is well suited.
  • the scaffold is made of a nitinol (nickel-titanium alloy) tube.
  • nitinol nickel-titanium alloy
  • the production of other metals such as cobalt alloys or stainless steel is possible.
  • the length of a cross strut corresponds approximately to the length of a diagonal strut. Also, the lengths of the radial webs and the lengths of the axial webs correspond approximately each other, in both cases a tolerance of ⁇ 3 mm is considered permissible.
  • the longitudinal sections of the connectors are dimensioned longer than the oblique struts.
  • the angle between a longitudinal section and the transverse strut connected to it is between 90 ° and 100 °.
  • the stent according to the invention is characterized in that shape adjustments take place in axial and radial extent, without length changes or constrictions on the support frame.
  • the pressure distribution in the stenosis area is even with geometrical form closure to the environment. This means that as a result of the stent geometry, the scaffold wraps around the invading form without building up stress peaks. Outside the loading range, the geometry remains neutral.
  • FIG. 1 shows the stent pattern of a stent according to the invention in one
  • FIG. 2 shows a detail of the stent pattern according to the figure 1 in an enlarged representation.
  • the supporting framework 1 shows the design of a stent according to the invention in a development of its supporting framework 1.
  • the supporting framework 1 is self-contained and has a tubular configuration.
  • the scaffold 1 is made of metal, in particular of a Nitinol tube and has in Stentlangsachse LA more ring segments 2, 3.
  • Each of the ring segments 2, 3 is formed from wavy adjoining oblique struts 4, 5, wherein in each case two oblique struts 4, 5 of a ring segment 2 and 3 are connected via a radial web 6 pointing in calculatorsnchtung U. This contour is referred to herein as V-shaped.
  • a connector 7 has a substantially parallel to the longitudinal axis Stentlangsachse LA longitudinal section 8 and a transverse thereto aligned U-shaped strut section 9.
  • a strut section 9 in each case comprises two transverse struts 10, 11 extending in the circumferential direction U. These struts are connected by an axial web 12 aligned parallel to the longitudinal axis of the stent LA.
  • the U-shaped strut sections 9 are each arranged in the space between two axially spaced adjacent ring segments 2, 3. It can be seen that the connectors 7 are arranged between the ring segments 2, 3 in series one behind the other. In this case, the connectors 7 each extend from the tip 13 of two adjoining each other via the radial web 6 oblique struts 4, 5 of a ring segment 2 in the lowest 14 of two again via a radial web 6 adjacent oblique struts 4, 5 of the adjacent ring segment 2.
  • the Longitudinalabimposing 8 is in each case connected to a radial web 6 in the lowest 14 between two oblique struts 4, 5, whereas the U-shaped strut section 9 is affiliated with a short projection 15 to the radial web 6 of a tip 13, wherein the projection 15 in extension to the longitudinal section 8 approximately is aligned at right angles to the radial web 6.
  • cross-shaped nodes 16 are formed in the connection areas between the ring segments 2, 3 and the connectors 7.
  • the opening angle ⁇ between two transverse struts 10, 11 is smaller than the opening angle ⁇ between two oblique struts 4, 5. Furthermore, it is clear that the length L 1 of a transverse strut 10, 11 is approximately the same length L 2 corresponds to a diagonal strut 4, 5. The lengths L 3 of the radial webs 6 and the lengths L 4 of the axial webs 12 are approximately the same length.
  • the longitudinal sections 8, however, are dimensioned longer than the oblique struts 4, 5.
  • the angle ⁇ between a longitudinal section 8 and a connected to it cross member 10 and 11 is dimensioned between 90 ° and 100 °.
  • the scaffold 1 is able to perform axial expansions (arrow A) and radial expansions (arrow R) without length changes. Unfavorable constrictions are avoided. There is a uniform pressure distribution in the stenosis area with a positive connection to the vessel inner wall. Due to the design of the scaffold 1, the stent is flexible, both in axial bending and in axial rotation. The great flexibility due to the degrees of freedom of the scaffold 1 is again exemplified in FIG. 1 by the arrows P.

Abstract

A stent comprises a tubular extending support structure (1), made from an axial series of annular segments (2, 3). The above are formed by corrugated interconnected inclined arms (4, 5). Adjacent annular segments (2, 3) are connected by means of connectors (7), whereby the connectors (7) run from the tip (13) of two V-shaped interconnected inclined arms (4, 5) of an annular segment (2) into the base (14) of two V-shaped interconnected inclined arms (4, 5) of an adjacent annular segment (3). The inclined arms (4, 5) of an annular segment (2, 3) are connected by means of a radial web (6) with a U pointing in the circumferential direction. The connector (7) has a longitudinal section (8) running in the stent longitudinal axis (LA) and a U-shaped arm section (9) with the U pointing in the circumferential direction. Each U-shaped arm section (9) has two transverse arms (10, 11), running in the U pointing in the circumferential direction, connected by an axial web (12), running parallel to the stent longitudinal axis (LA), whereby the included angle (A) between two transverse arms (10, 11) is smaller than the included angle (B) between two inclined arms (4,5).

Description

Stent stent
Die Erfindung betrifft einen Stent mit einem tubulären aufweitbaren Stützgerüst gemäß den Merkmalen im Oberbegriff von Patentanspruch 1.The invention relates to a stent with a tubular expandable scaffold according to the features in the preamble of claim 1.
Stents kommen bei der Behandlung von Stenosen, also angeborenen oder erworbenen Gefäßverschlüssen oder -Verengungen zur Anwendung. Die Stents fungieren im Bereich der Stenose als Gefäßprothesen zur Abstützung der Gefäßinnenwände. Sie werden mittels Kathedertechniken in den Ort der Stenose implantiert.Stents are used in the treatment of strictures, ie congenital or acquired vascular occlusions or constrictions. The stents function in the area of the stenosis as vascular prostheses for supporting the inner walls of the vessel. They are implanted by means of catheter techniques in the place of stenosis.
Vielfältige Stents sind im Stand der Technik bekannt. Es gibt sie in Metall-, Kunststoff- und Hybridkonstruktionen. Sie können selbstexpandierend sein. Andere Ausführungsformen lassen sich mittels geeigneter Werkzeuge beispielsweise Ballons, im Durchmesser verändern. Stents in den Ausführungsformen gemäß der DE 295 21 206 U1 ebenso wie der DE 296 08 037 U1 weisen ein tubuläres Stützgerüst aus Metall auf, welches aus mehreren Ringsegmenten besteht. Diese sind aus zick-zack bzw. mäanderförmig sich über Bogenabschnitte endlos aneinander schließende Schrägstreben gebildet. In der Längsachse der Stents benachbarte Ringsegmente sind über Verbinder gekoppelt. Eine ähnliche Lösung offenbart die WO 96/26689.Diverse stents are known in the art. They are available in metal, plastic and hybrid constructions. They can be self-expanding. Other embodiments can be modified by means of suitable tools, for example balloons, in diameter. Stents in the embodiments according to DE 295 21 206 U1 as well as DE 296 08 037 U1 have a tubular support structure made of metal, which consists of several ring segments. These are formed from zig-zag or meandering form over bow sections endlessly adjoining oblique struts. Ring segments adjacent to the longitudinal axis of the stents are coupled via connectors. A similar solution is disclosed in WO 96/26689.
Die Stents bekannter Bauart erfüllen ihre Funktion je nach Ausführungsform mehr oder weniger zufriedenstellend. In der Praxis hat sich herausgestellt, dass die Stützgerüste häufig entweder nicht die erforderlichen Radialkräfte bereitstellen können, um einer Stenose ausreichend standzuhalten, oder aber so konfiguriert sind, dass sie die Funktion des Gefäßes behindern. Auch erscheinen die Stents, was das Belastungsverhalten im Körper anbelangt, insbesondere hinsichtlich Biegung, Verdrehung und Längenstabilität verbesserungswürdig.The stents of known type fulfill their function depending on the embodiment more or less satisfactory. In practice, it has been found that the scaffolds often either fail to provide the necessary radial forces to adequately withstand a stenosis or are configured to interfere with the function of the vessel. The stents also appear to be in need of improvement in terms of load behavior in the body, in particular with regard to bending, torsion and length stability.
Der Erfindung liegt daher ausgehend vom Stand der Technik die Aufgabe zugrunde, einen Stent zu schaffen, der sich der Form eines Gefäßes körpergerecht bei gleichmäßiger Druckverteilung im Stenosebereich anpasst und sich auch unter axialer Biege- oder Verdrehbelastung im Körper längenstabil verhält.The invention is therefore based on the prior art based on the object to provide a stent that conforms to the shape of a vessel body with uniform pressure distribution in the stenosis area and behaves length-stable even under axial bending or torsional stress in the body.
Die Lösung dieser Aufgabe besteht nach der Erfindung in einem Stent gemäß den Merkmalen von Patentanspruch 1.The solution to this problem consists according to the invention in a stent according to the features of claim 1.
Das Stützgerüst besteht aus axial aufeinander folgenden Ringsegmenten, die aus sich wellenförmig aneinander schließenden Schrägstreben gebildet sind. Benachbarte Ringsegmente sind durch Verbinder gekoppelt. Ein Verbinder weist einen in Stentlangsachse verlaufenden Longitudinalabschnitt auf und einen in Umfangsnchtung weisenden U-förmigen Strebenabschnitt. Die Verbinder erstrecken sich jeweils von der Spitze zweier V-förmig aneinander schlie- ßender Schrägstreben eines Ringsegments in das Tiefste zweier V-förmig aneinander schließender Schrägstreben eines benachbarten Ringsegments.The scaffold consists of axially successive ring segments which are formed from undulating oblique struts. Adjacent ring segments are coupled by connectors. A connector has a longitudinal portion extending in the longitudinal direction of the stent and a circumferentially directional U-shaped strut portion. The connectors each extend from the top of two V-shaped adjoining ßender oblique struts of a ring segment in the deepest of two V-shaped successive oblique struts of an adjacent ring segment.
Kernpunkt der Erfindung bildet die Maßnahme, dass jeweils zwei Schrägstreben eines Ringsegments über einen in Umfangsrichung weisenden Radialsteg verbunden sind und jeder U-förmige Strebenabschnitt eines Verbinders zwei in Umfangsnchtung verlaufende Querstreben aufweist, die durch einen parallel zur Stentlangsachse ausgerichteten Axialsteg verbunden sind. Hierbei ist der Öffnungswinkel zwischen zwei Querstreben kleiner als der Öffnungswinkel zwischen zwei Schrägstreben.The main point of the invention is the measure that in each case two oblique struts of a ring segment are connected via a pointing in the circumferential direction radial bar and each U-shaped strut portion of a connector has two circumferentially extending transverse struts, which are connected by an aligned parallel to the Stentlangsachse Axialsteg. Here, the opening angle between two transverse struts is smaller than the opening angle between two oblique struts.
Das spezielle Design des Stützgerüstes sichert eine hohe Flexibilität sowohl bei axialer Biegung als auch bei axialer Verdrehung. Der Stent charakterisiert sich durch einen geometrischen Formschluss zum Umfeld. Die Formanpassungen geschehen sowohl in axialer als auch in radialer Ausdehnung ohne Längenveränderung. Auch beim Expandieren kommt es zu keiner Längenveränderung des Stützgerüstes. Dies gewährleistet die Gestaltung der Verbinder.The special design of the scaffold ensures high flexibility both in axial bending and in axial rotation. The stent is characterized by a geometric fit to the environment. The conformations occur both in axial and in radial expansion without length change. Even when expanding there is no change in length of the scaffold. This ensures the design of the connectors.
Das Design des Stützgerüsts ist sehr gut auf unterschiedliche anatomische Formen anpassbar, so beispielsweise als Trachea-Stent, wo eine Hufeisenform günstig ist. Auch als Bronchial- oder Ösophagus-Stent ist der erfindungsgemäß vorgeschlagene Stent gut geeignet.The design of the scaffold is very well adaptable to different anatomical shapes, such as a trachea stent, where a horseshoe shape is favorable. Also, as a bronchial or esophageal stent, the inventively proposed stent is well suited.
Vorzugsweise wird das Stützgerüst aus einem Nitinol (Nickel-Titan-Legierung)- Rohr gefertigt. Selbstverständlich ist auch die Herstellung aus anderen Metallen wie Kobaltlegierungen oder Edelstahl möglich.Preferably, the scaffold is made of a nitinol (nickel-titanium alloy) tube. Of course, the production of other metals such as cobalt alloys or stainless steel is possible.
Vorteilhafte Ausgestaltungen des grundsätzlichen Erfindungsgedankens sind in den abhängigen Ansprüchen 2 bis 5 charakterisiert.Advantageous embodiments of the basic concept of the invention are characterized in the dependent claims 2 to 5.
Die Länge einer Querstrebe entspricht etwa der Länge einer Schrägstrebe. Auch die Längen der Radialstege und die Längen der Axialstege entsprechen etwa einander, wobei in beiden Fällen eine Toleranz von ± 3 mm als zulässig erachtet wird.The length of a cross strut corresponds approximately to the length of a diagonal strut. Also, the lengths of the radial webs and the lengths of the axial webs correspond approximately each other, in both cases a tolerance of ± 3 mm is considered permissible.
Die Longitudinalabschnitte der Verbinder sind länger bemessen als die Schrägstreben. Der Winkel zwischen einem Longitudinalabschnitt und der mit ihm verbundenen Querstrebe ist zwischen 90° und 100° bemessen.The longitudinal sections of the connectors are dimensioned longer than the oblique struts. The angle between a longitudinal section and the transverse strut connected to it is between 90 ° and 100 °.
Wie bereits erwähnt, zeichnet sich der erfindungsgemäße Stent dadurch aus, dass Formanpassungen in axialer und radialer Ausdehnung erfolgen, ohne Längenänderungen oder Einschnürungen am Stützgerüst. Die Druckverteilung im Stenosebereich ist gleichmäßig bei geometrischem Formschluss zum Umfeld. Dies bedeutet, dass das Stützgerüst infolge der Stentgeometrie die eindringende Form umschmiegt, ohne Spannungsspitzen aufzubauen. Außerhalb des Belastungsbereichs bleibt die Geometrie neutral.As already mentioned, the stent according to the invention is characterized in that shape adjustments take place in axial and radial extent, without length changes or constrictions on the support frame. The pressure distribution in the stenosis area is even with geometrical form closure to the environment. This means that as a result of the stent geometry, the scaffold wraps around the invading form without building up stress peaks. Outside the loading range, the geometry remains neutral.
Die Erfindung ist nachfolgend anhand eines Ausführungsbeispiels näher beschrieben. Es zeigen:The invention is described below with reference to an embodiment. Show it:
Figur 1 das Stentmuster eines erfindungsgemäßen Stents in einer1 shows the stent pattern of a stent according to the invention in one
Abwicklung undSettlement and
Figur 2 einen Ausschnitt des Stentmusters gemäß der Figur 1 in vergrößerter Darstellungsweise.2 shows a detail of the stent pattern according to the figure 1 in an enlarged representation.
In der Figur 1 erkennt man das Design eines erfindungsgemäßen Stents in einer Abwicklung seines Stützgerüsts 1. In der Praxis ist das Stützgerüst 1 in sich geschlossen und besitzt eine tubuläre Konfiguration.1 shows the design of a stent according to the invention in a development of its supporting framework 1. In practice, the supporting framework 1 is self-contained and has a tubular configuration.
Das Stützgerüst 1 ist aus Metall gefertigt, insbesondere aus einem Nitinol-Rohr und weist in Stentlangsachse LA mehrere Ringsegmente 2, 3 auf. Jedes der Ringsegmente 2, 3 ist aus wellenförmig aneinander schließenden Schrägstreben 4, 5 gebildet, wobei jeweils zwei Schrägstreben 4, 5 eines Ringsegments 2 bzw. 3 über einen in Umfangsnchtung U weisenden Radialsteg 6 verbunden sind. Diese Kontur wird vorliegend als V-förmig bezeichnet. Untereinander sind die Ringsegmente 2, 3 durch Verbinder 7 gekoppelt. Ein Verbinder 7 weist einen im wesentlichen parallel zur Stentlangsachse LA verlaufenden Longitudinalabschnitt 8 und einen quer hierzu ausgerichteten U-förmig konfigurierten Strebenabschnitt 9 auf. Ein Strebenabschnitt 9 umfasst jeweils zwei in Umfangsnchtung U verlaufende Querstreben 10, 11. Diese sind durch einen parallel zur Stentlangsachse LA ausgerichteten Axialsteg 12 verbunden.The scaffold 1 is made of metal, in particular of a Nitinol tube and has in Stentlangsachse LA more ring segments 2, 3. Each of the ring segments 2, 3 is formed from wavy adjoining oblique struts 4, 5, wherein in each case two oblique struts 4, 5 of a ring segment 2 and 3 are connected via a radial web 6 pointing in Umfangsnchtung U. This contour is referred to herein as V-shaped. Are among each other the ring segments 2, 3 coupled by connectors 7. A connector 7 has a substantially parallel to the longitudinal axis Stentlangsachse LA longitudinal section 8 and a transverse thereto aligned U-shaped strut section 9. A strut section 9 in each case comprises two transverse struts 10, 11 extending in the circumferential direction U. These struts are connected by an axial web 12 aligned parallel to the longitudinal axis of the stent LA.
Die U-förmigen Strebenabschnitte 9 sind jeweils in dem Raum zwischen zwei mit axialem Abstand benachbarten Ringsegmenten 2, 3 angeordnet. Man erkennt, dass die Verbinder 7 zwischen den Ringsegmenten 2, 3 in Reihe hintereinander angeordnet sind. Hierbei erstrecken sich die Verbinder 7 jeweils von der Spitze 13 zweier sich über den Radialsteg 6 aneinander schließender Schrägstreben 4, 5 eines Ringsegments 2 in das Tiefste 14 zweier sich wiederum über einem Radialsteg 6 aneinander schließende Schrägstreben 4, 5 des benachbarten Ringsegments 2. Der Longitudinalabschnitt 8 ist jeweils an einen Radialsteg 6 im Tiefsten 14 zwischen zwei Schrägstreben 4, 5 angeschlossen, wohingegen der U-förmige Strebenabschnitt 9 mit einem kurzen Ansatz 15 an den Radialsteg 6 einer Spitze 13 angegliedert ist, wobei der Ansatz 15 in Verlängerung zum Longitudinalabschnitt 8 etwa rechtwinklig zum Radialsteg 6 ausgerichtet ist. Auf diese Weise entstehen kreuzförmige Knotenpunkte 16 in den Anschlussbereichen zwischen den Ringsegmenten 2, 3 und den Verbindern 7.The U-shaped strut sections 9 are each arranged in the space between two axially spaced adjacent ring segments 2, 3. It can be seen that the connectors 7 are arranged between the ring segments 2, 3 in series one behind the other. In this case, the connectors 7 each extend from the tip 13 of two adjoining each other via the radial web 6 oblique struts 4, 5 of a ring segment 2 in the lowest 14 of two again via a radial web 6 adjacent oblique struts 4, 5 of the adjacent ring segment 2. The Longitudinalabschnitt 8 is in each case connected to a radial web 6 in the lowest 14 between two oblique struts 4, 5, whereas the U-shaped strut section 9 is affiliated with a short projection 15 to the radial web 6 of a tip 13, wherein the projection 15 in extension to the longitudinal section 8 approximately is aligned at right angles to the radial web 6. In this way, cross-shaped nodes 16 are formed in the connection areas between the ring segments 2, 3 and the connectors 7.
Insbesondere anhand der Figur 2 erkennt man, dass der Öffnungswinkel α zwischen zwei Querstreben 10, 11 kleiner bemessen ist als der Öffnungswinkel ß zwischen zwei Schrägstreben 4, 5. Des Weiteren wird deutlich, dass die Länge L1 einer Querstrebe 10, 11 etwa der Länge L2 einer Schrägstrebe 4, 5 entspricht. Auch die Längen L3 der Radialstege 6 und die Längen L4 der Axialstege 12 sind etwa gleich lang.2, it can be seen that the opening angle α between two transverse struts 10, 11 is smaller than the opening angle β between two oblique struts 4, 5. Furthermore, it is clear that the length L 1 of a transverse strut 10, 11 is approximately the same length L 2 corresponds to a diagonal strut 4, 5. The lengths L 3 of the radial webs 6 and the lengths L 4 of the axial webs 12 are approximately the same length.
Die Longitudinalabschnitte 8 hingegen sind länger bemessen als die Schrägstreben 4, 5. Der Winkel γ zwischen einem Longitudinalabschnitt 8 und einer mit ihm verbundenen Querstrebe 10 bzw. 11 ist zwischen 90° und 100° bemessen.The longitudinal sections 8, however, are dimensioned longer than the oblique struts 4, 5. The angle γ between a longitudinal section 8 and a connected to it cross member 10 and 11 is dimensioned between 90 ° and 100 °.
Das Stützgerüst 1 ist in der Lage axiale Ausdehnungen (Pfeil A) und radiale Ausdehnungen (Pfeil R) ohne Längenänderungen zu vollziehen. Nachteilige Einschnürungen werden vermieden. Es erfolgt eine gleichmäßige Druckverteilung im Stenosebereich mit einem Formschluss zur Gefässinnenwand. Aufgrund der Gestaltung des Stützgerüst 1 ist der Stent flexibel, sowohl bei axialer Biegung als auch bei axialer Verdrehung. Die große Flexibilität infolge der Freiheitsgrade des Stützgerüstes 1 ist in der Figur 1 nochmals zusätzlich durch die Pfeile P exemplarisch verdeutlicht. The scaffold 1 is able to perform axial expansions (arrow A) and radial expansions (arrow R) without length changes. Unfavorable constrictions are avoided. There is a uniform pressure distribution in the stenosis area with a positive connection to the vessel inner wall. Due to the design of the scaffold 1, the stent is flexible, both in axial bending and in axial rotation. The great flexibility due to the degrees of freedom of the scaffold 1 is again exemplified in FIG. 1 by the arrows P.
BezuαszeichenaufstellunqBezuαszeichenaufstellunq
1 - Stützgerüst1 - Scaffold
2- Ringsegment2-ring segment
3- Ringsegment3 ring segment
4- Schrägstrebe4- diagonal strut
5- Schrägstrebe5-inclined strut
6- Radialsteg6- radial walkway
7- Verbinder7- connector
8- Longitudinalabschnitt8- longitudinal section
9- Strebenabschnitt9 strut section
10- Querstrebe10- cross strut
11 - Querstrebe11 - Cross strut
12- Axialsteg12- axial web
13- Spitze13- tip
14- Tiefste14- Deepest
15- Ansatz15- approach
16- Knotenpunkt16- node
LA- StentlangsachseLA stent longitudinal axis
Li- Länge v.10, 11Li length v.10, 11
L2" Länge v.4, 5L 2 "length v.4, 5
L3" Länge v.6L 3 "length v.6
L4- Länge v.12L 4 - length v.12
A- axiale AusdehnungA-axial expansion
P- PfeilP- arrow
R- radiale AusdehnungR- radial expansion
U- UmfangsnchtungU- circumference
α- Winkel ß" Winkel ŗinkel α- angle ß "angle rinkel

Claims

Patentansprüche Claims
1. Stent mit einem tubulären, aufweitbaren Stützgerüst (1) aus axial aufeinander folgenden Ringsegmenten (2, 3), die aus sich wellenförmig aneinander schließenden Schrägstreben (4, 5) gebildet und benachbarte Ringsegmente (2, 3) durch Verbinder (7) gekoppelt sind, wobei die Verbinder (7) sich jeweils von der Spitze (13) zweier V-förmig aneinander schließender Schrägstreben (4, 5) eines Ringsegments (2) in das Tiefste (14) zweier V-förmig aneinander schließender Schrägstreben (4, 5) eines benachbarten Ringsegments (3) erstrecken und jeder Verbinder (7) einen in Stentlängsrichtung (LA) verlaufenden Longitudinalabschnitt (8) und einen in Umfangsnchtung (U) weisenden U-förmigen Strebenabschnitt (9) aufweist, dadurch gekennzeichnet, dass jeweils zwei Schrägstreben (4, 5) eines Ringsegments (2 bzw.3) über einen in Umfangsnchtung (U) weisenden Radialsteg (6) verbunden sind und jeder U-förmige Strebenabschnitt (9) eines Verbinders (7) zwei in Umfangsnchtung (U) verlaufende Querstreben (10, 11) aufweist, die durch einen parallel zur Stentlangsachse (LA) ausgerichteten Axialsteg (12) verbunden sind, wobei der Öffnungswinkel (α) zwischen zwei Querstreben (10, 11) kleiner bemessen ist als der Öffnungswinkel (ß) zwischen zwei Schrägstreben (4, 5).1. Stent with a tubular, expandable support structure (1) consisting of axially successive ring segments (2, 3), which are formed from obliquely adjoining oblique struts (4, 5) and adjacent ring segments (2, 3) are coupled by connectors (7) The connectors (7) each extend from the tip (13) of two V-shaped diagonal struts (4, 5) of a ring segment (2) into the deepest part (14) of two V-shaped diagonal struts (4, 5 ) of an adjacent ring segment (3) and each connector (7) has a longitudinal section (8) running in the longitudinal direction of the stent (LA) and a U-shaped strut section (9) pointing in the circumferential direction (U), characterized in that in each case two oblique struts ( 4, 5) of a ring segment (2 or 3) are connected via a radial web (6) pointing in the circumferential direction (U) and each U-shaped strut section (9) of a connector (7) has two queues running in the circumferential direction (U) struts (10, 11), which are connected by an axial web (12) aligned parallel to the longitudinal axis of the stent (LA), the opening angle (α) between two cross struts (10, 11) being smaller than the opening angle (β) between two Oblique struts (4, 5).
2. Stent nach Anspruch 1 , dadurch gekennzeichnet, dass die Länge (L,) einer Querstrebe (10, 11) etwa der Länge (L2) einer Schrägstrebe (4, 5) entspricht, mit einer Toleranz von +/- 3 mm.2. Stent according to claim 1, characterized in that the length (L,) of a cross strut (10, 11) corresponds approximately to the length (L 2 ) of an oblique strut (4, 5), with a tolerance of +/- 3 mm.
3. Stent nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Längen (L3) der Radialstege (6) und die Längen (L4) der Axialstege (12) etwa einander entsprechen, mit einer Toleranz von +/- 3mm.3. Stent according to claim 1 or 2, characterized in that the lengths (L 3 ) of the radial webs (6) and the lengths (L 4 ) of the axial webs (12) correspond approximately to one another, with a tolerance of +/- 3mm.
4. Stent nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass die Longitudinalabschnitte (8) länger bemessen sind als die Schrägstreben (4, 5). Stent nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, der Winkel (γ) zwischen einem Logitudinalabschnitt (8) und der mit ihm verbundenen Querstrebe (10, bzw.11 ) zwischen 90° und 100° bemessen ist. 4. Stent according to one of claims 1 to 3, characterized in that the longitudinal sections (8) are longer than the oblique struts (4, 5). Stent according to one of claims 1 to 4, characterized in that the angle (γ) between a logitudinal section (8) and the transverse strut (10 or 11) connected to it is dimensioned between 90 ° and 100 °.
PCT/DE2003/003813 2003-01-09 2003-11-18 Stent WO2004062533A1 (en)

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DE10300475.0 2003-01-09

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US10610387B2 (en) 2015-06-12 2020-04-07 Abbott Cardiovascular Systems Inc. Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold
US11478370B2 (en) 2015-06-12 2022-10-25 Abbott Cardiovascular Systems Inc. Scaffolds having a radiopaque marker and methods for attaching a marker to a scaffold

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