WO2006047977A1 - Stent to be implanted in or around a hollow organ, comprising marker elements made of an x-ray opaque material - Google Patents

Stent to be implanted in or around a hollow organ, comprising marker elements made of an x-ray opaque material Download PDF

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Publication number
WO2006047977A1
WO2006047977A1 PCT/DE2005/001661 DE2005001661W WO2006047977A1 WO 2006047977 A1 WO2006047977 A1 WO 2006047977A1 DE 2005001661 W DE2005001661 W DE 2005001661W WO 2006047977 A1 WO2006047977 A1 WO 2006047977A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
elements
stent according
marker
receiving elements
Prior art date
Application number
PCT/DE2005/001661
Other languages
German (de)
French (fr)
Inventor
Johannes Jung
Original Assignee
Campus Gmbh & Co. Kg
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 Campus Gmbh & Co. Kg filed Critical Campus Gmbh & Co. Kg
Priority to DE112005002918T priority Critical patent/DE112005002918A5/en
Publication of WO2006047977A1 publication Critical patent/WO2006047977A1/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
    • 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
    • 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
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the invention relates to a stent for implantation in or around a hollow organ with marker elements from a radiopaque material of the kind mentioned in the preamble of claim 1, and to a method for its production.
  • Stents are usually used in tubular hollow organs in order to expand or keep them open. They form a tube-like structure, which in their tube interior, the flow of body fluids or other physiological substances such. As food allows, wherein the Röh ⁇ renäußere rests against the surrounding hollow organ and this supports. They usually have a latticed or spiral
  • Structure consisting of wall segments. Grid openings are formed between and within the wall segments which make it possible for this structure to grow into the tissue at its implantation site.
  • Such stents are known per se and described for example in DE-A 197 46 88 or in WO 03/063 733.
  • stents are mounted on a balloon catheter, which is then introduced into the hollow organ to be treated.
  • This may be, for example, a coronary artery affected by a stenosis.
  • the balloon catheter is then dilated in order, on the one hand, to open the plaques causing the stenosis to or through the vessel wall press and thereby eliminate the stenosis and on the other hand to place the unfolded by the dilatation of the balloon catheter stent, which then ensures that the hollow organ retains its clearance.
  • self-expanding stents are used, which are introduced into the hollow organ in a first state of small diameter and then expand on their own in place into a second state with a larger diameter by an intrinsic spring force or are actively expanded.
  • stents in question which are made of a shape memory material.
  • rivet-shaped marker elements made of X-ray opaque material, which are in eye-shaped receiving elements of the lattice-shaped wall structure of the stent be fit form fit.
  • This type of design entails the risk that the rivet loses its positive fit due to mechanical stress or corrosion, z. B. in the.
  • the rivet head breaks, and then dissolves, escapes into the lumen of the stent and enters the hollow organ where it can cause serious complications, such as the occlusion of a blood vessel.
  • the object of the present invention is to provide a stent with marker elements made of an X-ray opaque material, which ensures permanent localizability within the hollow organ, and whose elasticity is not impaired by the marker elements. In addition, it should be ensured that the marker elements under no circumstances escape into the lumen of the stent and can enter the hollow organ.
  • a stent of the generic type which has a tubular grid wall running around a longitudinal axis made of elastic, in particular radially elastic wall segments which are arranged circumferentially one behind the other along the longitudinal axis and interconnected via connecting elements.
  • the stent has tube ends located at opposite axis ends.
  • the wall segments have spring elements with an elastic structure and receiving elements that are connected to the spring elements.
  • the receiving elements have cavities or recesses in the form of cavities, gaps, holes and / or recesses in which marker elements are arranged from a radiopaque material.
  • the receiving elements may be formed widened area compared to the spring elements.
  • the recesses may be configured, for example, in the form of recesses.
  • the stent according to the invention is characterized in that the recesses in the direction of the longitudinal axis have tapered, in particular conically tapered, Quer4.000s ⁇ surfaces and the radiopaque marker elements are conical and are arranged radially to the longitudinal axis in the recesses of the receiving elements.
  • the marker elements are thus arranged in the receiving elements similar to the capstone of a Roman vault.
  • the marker elements can not move in the tapering direction of the cross-sectional areas of the recesses, even if they break or corrode, and therefore can under no circumstances escape into the lumen of the stent.
  • the marker elements can in any case come off against the direction of tapering of the cross-sectional areas of the recesses, ie in the direction of the wall of the hollow organ where they cause no damage.
  • the recesses and the marker elements have round cross sections, and the marker elements are formed radially conically in the form of truncated cones.
  • round cross sections is to be understood as meaning circular, oval and elliptoid cross sections.
  • the recesses and the marker elements have substantially rectangular cross-sections, and the marker elements are conical in the form of truncated pyramids.
  • substantially rectangular cross-section "cuts" should also fall such cross sections, which go back to rectangles whose corners were rounded.
  • the marker elements are welded on their side remote from the longitudinal axis with the receiving elements and locked in this way permanently in the recesses.
  • welding points are set in the transition region between the receiving elements and the marker elements, for which purpose a laser can be used, for example.
  • the receiving elements are arranged at the tube ends of the stent. In this way, it is ensured that the ends of the stent can be reliably addressed in the X-ray image during the catheter operation or during a follow-up examination and thus the correct position of the stent can be checked.
  • receiving elements are arranged in the region between the tube ends.
  • these can be arranged on a line running around the grid wall in a helical line. In this way it can be determined in the X-ray image, whether the stent has been unfolded in place evenly and correctly.
  • the receiving elements are arranged circumferentially at the tube ends of the stent, thus forming a terminal, lying on the inside or outside of the hollow organ garland radiopaque markers.
  • the receiving elements are curved in a circular arc around the longitudinal axis of the stent transversely to their longitudinal direction.
  • the support effect at the tube ends may be impaired, since less supporting material is available here than in the region between the tube ends.
  • the length of the effective supportive area of the stent is therefore usually less than the absolute length of the stent itself.
  • terminal spring elements are arranged circumferentially at the tube ends in addition to the receiving elements. These terminal spring elements may be wider than the previously described spring elements in the region between the tube ends.
  • the receiving elements and the terminal spring elements are arranged cir ⁇ cumferentially alternately with each other.
  • the advantage of these embodiments is that the tube ends of the stent in the deployed state exert a better support on the vessel wall, with the result that the length of the effect of the stent, ie the region in which e.g. a restenosis can be effectively prevented is significantly greater.
  • the terminal spring element and the receiving elements are designed and / or arranged such that the ends of the elements pointing in the direction of the tube or stent ends have a circular, transversely to the longitudinal axis Describe arranged circumferential line, so it is arranged flush as it were.
  • This arrangement has the particular advantage that when placing the stent, i. when pushing forward with the help of a catheter, the pressure is distributed more evenly over the entire end peripheral surface of the stent.
  • the risk that a sealed marker peels off or even breaks greatly reduced.
  • the risk is reduced that individual terminal elements bend and possibly cut into the vessel wall.
  • the terminal spring elements are preferably wider, in particular at least twice as wide, configured as the wall segments.
  • the connecting elements and the spring elements form at least one continuous longitudinal web which extends in the longitudinal direction of the stent and the at least one component in the axial direction for receiving a compressive or tensile stress in the longitudinal direction.
  • the wall segments are particularly effectively positioned to each other, at the same time a change in length of the stent is reliably prevented.
  • the longitudinal web or the longitudinal webs has a helical wall surrounding the lattice wall or have.
  • This type of configuration can be produced particularly easily from a hollow cylinder by means of cutting, in particular laser and / or water jet cutting.
  • length changes due to compressive or tensile stresses or by compression of the stent are avoided as part of the forces occurring in the intended use reliably.
  • Ver ⁇ connecting elements are formed widened area compared to the spring elements.
  • This type of configuration can be easily produced by means of laser cutting.
  • Zu ⁇ before the deployment of the stenthuisele ⁇ elements are then formed, for example, slightly S-shaped.
  • the connecting elements In the unfolded state with a larger diameter, the connecting elements then have at least one component arranged parallel to the longitudinal web and support this in the effect described above.
  • the connecting elements have twice the width of the spring elements. This results in a particularly simple cutting pattern.
  • the connecting elements are shorter than the spring elements and expediently have a maximum length of 3/4, preferably a maximum 2/3 of the length of a spring element. Particularly preferred are lengths of 1/2 or less of the length of a spring element.
  • the radiopaque marker elements of the stent according to the invention preferably consist of a material which is selected from the group consisting of gold, platinum, silver, tantalum, plastic doped with barium sulfate and plastic doped with bismuth trioxide.
  • a material which is selected from the group consisting of gold, platinum, silver, tantalum, plastic doped with barium sulfate and plastic doped with bismuth trioxide may as well be used.
  • the spring, connecting and / or receiving elements of the stent according to the invention particularly preferably consist of a shape memory material.
  • the shape memory materials to be used are selected from the group consisting of nickel-titanium alloys and copper-zinc-aluminum alloys.
  • the nickel-titanium alloy nitinol has proven to be particularly suitable.
  • a hollow cylinder made of such material can, for example by means of a cutting technique, such. B. by means of laser or water jet, a substantially consisting of spring elements, connecting elements and receiving elements existing stent are cut out, the subsequently unfolded, the Harmon ⁇ diameter of the hollow organ to be treated corresponding shape can be impressed on known for Formge ⁇ memory materials. If the stent thus produced is subsequently compressed to the state of small diameter and, for example, introduced into a stenosed blood vessel with the aid of a catheter, the stent can be brought back into the previously impressed shape by heating to above the so-called conversion temperature. Optionally, this unfolding process can be assisted by use of a balloon catheter or completely replaced by it.
  • the spring, connecting and / or receiving elements can also consist of materials which are selected from the group consisting of stainless steel, plastic, or self-dissolving materials. Since these materials have no shape memory properties, the stents made from them have to be unfolded in situ with the aid of a balloon catheter. In particular, the self-dissolving materials are advantageous if a stent is not to be permanently applied.
  • the surface of the stent according to the invention is processed, in particular finished, smoothed, and / or polished. In this way, a smooth surface results, which in particular satisfies the requirements of the biocompatibility of the stent.
  • a method for producing a stent according to the invention in which the conical radiopaque marker elements are inserted from the side of the stent facing away from the longitudinal axis into the receiving elements and on this side by setting welding points on the receiving elements be attached.
  • a hollow cylinder consisting of a material which is selected from the group made of stainless steel, plastic, a self-dissolving Mate ⁇ material or a shape memory material, a tubular stent blank is cut out.
  • the spring, connecting and / or receiving elements of the wall segments by means of laser or Wasser ⁇ jet cutting are made from the stent blank.
  • FIG. 1 is a schematic representation of a stent 10 according to the invention in an unwound representation
  • FIG. 2 is an enlarged fragmentary view of the end portion of the stent shown in FIG. 1;
  • FIG. 3 is a plan view of a section along the line A - A in Fig. 2nd
  • FIG. 1 shows a schematic plan view of a stent 10 which is not yet expanded.
  • the stent 10 is cut out of a tube made of a suitable material, for example a shape memory material, by means of laser radiation.
  • the stent 10 has a longitudinal axis 11 and a grid wall 12, which is constructed from the individual wall segments 13.
  • the wall segments 13 consist of Fe ⁇ elements 16 arranged parallel to one another, which are connected via connecting elements 14 with spring elements 16 from the adjacent wall segment 13.
  • the stent 10 has receiving elements 17 arranged at the tube end 15, which are designed in the shape of an eye and have recesses 18 in which marker elements 19 of a radiopaque material, such as tantalum, are arranged.
  • the Recesses 18 and the marker elements 19 have an oval cross-section.
  • the stent also has terminal, preferably finger-like spring elements 20, wherein these and the receiving elements 17 are designed and arranged in such a way that the ends of the elements 20, 19 pointing in the direction of the tube ends 15 are flush and form a circular, Describe transverse to the longitudinal axis 11 of the stent 10 arranged circumferential line.
  • the advantage of this embodiment is that the tube ends 15 of the stent 10 in the deployed state exert a better support on the vessel wall, with the result that the effective length of the stent, ie the region in which e.g. a restenosis can be effectively prevented, is significantly greater.
  • this design has the advantage that when placing the stent 10, i. when pushing forward with the aid of a catheter, the pressure is distributed more uniformly over the entire end circumferential surface of the stent 10 and thus prevents individual terminal elements 17, 20 from cutting into the vessel wall.
  • Fig. 1 also reveals the approximately S-shaped configuration of the connecting elements 14. It is also clear in the figure that wall segments 13 arranged adjacent to one another are each arranged offset from one another, preferably by the width of two spring elements 16.
  • the connecting elements 14 and spring elements 16 thus form a continuous longitudinal web which has a component in the axial direction of the stent for absorbing compressive or tensile stresses in the longitudinal direction. Due to the described offset, the longitudinal web on a grid wall 12 of the stent 10 helically encircling shape.
  • the stent 10 produced in this way is expanded into a second state, which has a larger diameter than the first state. This second state is then impressed on the stent 10 in a known manner.
  • the stent 10 thus prepared is then compressed into a state having a small diameter. After the desired positioning, the stent 10 can then be expanded again by heating above the so-called conversion temperature into the imprinted form of the second state.
  • FIG. 2 shows an enlarged partial view of the end region of the stent 10 shown in FIG. 1 with the connecting elements 14, the spring elements 16, the recesses 18 of the receiving elements 17 and the marker elements 19 arranged therein, as well as the terminal spring elements 20.
  • the marker elements 19 are fastened in the receiving elements 17 by means of welding points 21 on the side of the stent facing away from the longitudinal axis.
  • FIG. 3 shows a plan view of a section through a stent 10 according to the invention along the line A-A in FIG. 2. Shown is a receiving element 17, a recess 18, a marker element 19 arranged in the recess 18, two terminal spring elements 20 as well as two welding points 21.
  • the receiving element 17 is curved arcuately around the longitudinal axis 11 of the stent 10 transversely to its longitudinal direction.
  • the recess 18 has tapered cross-sectional areas in the direction of the longitu ⁇ dinalen axis 11.
  • the radiopaque marker element 19 has a conical design and is arranged radially to the longitudinal axis 11 in the recess 18 of the receiving element 17. The marker element 19 is thus similar to the capstone of a Roman vault in the receiving element 17 Auf ⁇ arranged.
  • the marker element 19 can not move in the direction of tapering of the cross-sectional areas of the recess 18, even if it breaks or corrodes. At most, it can come off against the direction of the rejuvenation of the cross-sectional surfaces of the recess 18, that is to say in the direction of the wall of the hollow organ, where it causes no damage.
  • the recess 18 and the marker elements 19 can have round or substantially rectangular cross sections, and that the marker elements can be formed radially conically in the form of truncated cones or conically in the form of pyramidal stumps.
  • round cross-sections should be understood to mean circular, oval and elliptoid cross-sections.
  • substantially rectangular cross-sections should also include those cross-sections which can be traced back to corners with rounded corners.

Abstract

Disclosed is a stent (10) that is to be implanted in or around a hollow organ and is provided with marker elements (19) made of an x-ray opaque material. Said stent comprises receiving elements (17) that are joined to spring elements (15) and are equipped with recesses (18) in which marker elements (19) made of an x-ray opaque material are disposed. The inventive stent is characterized in that the receiving elements (17) are curved about the longitudinal axis (11) of the stent (10) like an arc of a circle while the diameter of the recesses (18) tapers in the direction of the longitudinal axis (11). Moreover, the x-ray opaque marker elements (19) are embodied conically in a radial direction and are arranged in the recesses (18) of the receiving elements (17) in a radial direction relative to the longitudinal axis (11).

Description

STENT ZUR IMPLANTATION IN ODER UM EIN HOHLORGAN MIT MARKERELEMENTEN AUS EINEM RÖNTGENOPAKEN MATERIAL STENT FOR IMPLANTATION IN OR A HOLLOW ORGAN WITH MARKER ELEMENTS FROM AN X-RAY OPTICAL MATERIAL
Beschreibungdescription
Die Erfindung betrifft einen Stent zur Implantation in oder um ein Hohlorgan mit Markerelementen aus einem röntgenopaken Ma¬ terial der im Oberbegriff des Anspruch 1 genannten Art, sowie ein Verfahren zu seiner Herstellung.The invention relates to a stent for implantation in or around a hollow organ with marker elements from a radiopaque material of the kind mentioned in the preamble of claim 1, and to a method for its production.
Stents werden üblicherweise in röhrenförmige Hohlorgane einge- setzt, um diese zu erweitern oder offen zu halten. Sie bilden eine röhrenartige Struktur aus, die in ihrem Röhreninneren den Durchfluss von Körperflüssigkeiten oder anderen physiologi¬ schen Substanzen, wie z. B. Nahrung ermöglicht, wobei das Röh¬ renäußere an das umgebende Hohlorgan anliegt und dieses stützt. Sie weisen meist eine gitter- oder spiralförmigeStents are usually used in tubular hollow organs in order to expand or keep them open. They form a tube-like structure, which in their tube interior, the flow of body fluids or other physiological substances such. As food allows, wherein the Röh¬ renäußere rests against the surrounding hollow organ and this supports. They usually have a latticed or spiral
Struktur auf, die aus Wandsegmenten besteht. Zwischen und in¬ nerhalb der Wandsegmente sind Gitteröffnungen ausgebildet, die es ermöglichen, dass diese Struktur an ihren Implantationsort in das Gewebe einwachsen kann.Structure consisting of wall segments. Grid openings are formed between and within the wall segments which make it possible for this structure to grow into the tissue at its implantation site.
Solches Stents sind an sich bekannt und beispielsweise in der DE-A 197 46 88 oder in der WO 03/063 733 beschrieben.Such stents are known per se and described for example in DE-A 197 46 88 or in WO 03/063 733.
In den meisten Fällen werden Stents auf einem Ballonkatheter montiert, der dann in das zu therapierende Hohlorgan einge¬ führt wird. Hierbei kann es sich z.B. um eine durch eine Ste¬ nose beeinträchtigte Koronararterie handeln. An Ort und Stelle wird der Ballonkatheter dann dilatiert, um einerseits die Pla¬ ques, die die Stenose bedingen, an bzw. durch die Gefäßwand zu drücken und dadurch die Stenose zu beseitigen und andererseits den durch die Dilatation des Ballonkatheters entfalteten Stent zu platzieren, der dann dafür sorgt, dass das Hohlorgan seine lichte Weite beibehält.In most cases, stents are mounted on a balloon catheter, which is then introduced into the hollow organ to be treated. This may be, for example, a coronary artery affected by a stenosis. In situ, the balloon catheter is then dilated in order, on the one hand, to open the plaques causing the stenosis to or through the vessel wall press and thereby eliminate the stenosis and on the other hand to place the unfolded by the dilatation of the balloon catheter stent, which then ensures that the hollow organ retains its clearance.
In anderen Fällen werden selbstexpandierende Stents verwendet, die einem ersten Zustand mit geringem Durchmesser in das Hohl¬ organ eingeführt und an Ort und Stelle dann in einen zweiten Zustand mit grosseren Durchmesser durch eine intrinsische Fe- derkraft von selbst expandieren oder aktiv expandiert werden. Hierfür kommen insbesondere Stents in Frage, die aus einem Formgedächtnis-Material hergestellt sind.In other cases, self-expanding stents are used, which are introduced into the hollow organ in a first state of small diameter and then expand on their own in place into a second state with a larger diameter by an intrinsic spring force or are actively expanded. For this purpose, in particular stents in question, which are made of a shape memory material.
In beiden Fällen findet die Platzierung des Stents unter rönt- genoskopischer Kontrolle statt. Da die üblicherweise für den Stents verwendeten Metalllegierungen nur eine geringe Röntgen- opazität aufweisen, ist es zu diesem Zweck hilfreich, den Stent ergänzend mit Materialien zu versehen, die eine höhere Röntgenopazität aufweisen.In both cases, placement of the stent takes place under X-ray scans. Since the metal alloys commonly used for the stents have only a low X-ray opacity, for this purpose it is helpful to supplement the material with materials which have a higher X-ray opacity.
Aus der EP 95302708 ist bekannt, die Enden des Stents mit ei¬ ner wenige Mikrometer dicken Schicht aus röntgenopakem Materi¬ al (Gold, Platin) zu beschichten. Diese Art der Markierung ist aufwändig und kostenintensiv. Überdies besteht die Gefahr, dass sich Teile der Beschichtung im Laufe der Zeit ablösen, so dass die Position des Stents innerhalb des Hohlorgans nicht mehr genau festgestellt werden kann. Außerdem kann die Be¬ schichtung zu einer Erhöhung der Steifigkeit des Stents füh¬ ren, so dass z.B. die Dilatation des Stents in dem zu thera- pierenden Hohlorgan beeinträchtigt werden kann.From EP 95302708 it is known to coat the ends of the stent with a layer of X-ray opaque material (gold, platinum) which is a few micrometers thick. This type of marking is complex and expensive. Moreover, there is a risk that parts of the coating will come off over time, so that the position of the stent within the hollow organ can no longer be determined accurately. In addition, the coating can lead to an increase in the stiffness of the stent, so that e.g. the dilatation of the stent in the hollow organ to be treated can be impaired.
Aus der WO 9733534 ist bekannt, nietenförmige Markerelemente aus röntgenopakem Material zu verwenden, die in ösenförmige Aufnahmeelemente der gitterförmigen Wandstruktur des Stents formschlüssig eingepaßt werden. Diese Art der Ausgestaltung birgt die Gefahr, dass die Niete durch mechanische Belastung oder Korrosion ihre Formschlüssigkeit verliert, z. B. in dem. der Nietenkopf bricht, und sich daraufhin löst, ins Lumen des Stents entweicht und in das Hohlorgan gelangt, wo sie folgen¬ schwere Komplikationen, wie z.B. die Okklusion eines Blutgefä¬ ßes, verursachen kann.From WO 9733534 it is known to use rivet-shaped marker elements made of X-ray opaque material, which are in eye-shaped receiving elements of the lattice-shaped wall structure of the stent be fit form fit. This type of design entails the risk that the rivet loses its positive fit due to mechanical stress or corrosion, z. B. in the. The rivet head breaks, and then dissolves, escapes into the lumen of the stent and enters the hollow organ where it can cause serious complications, such as the occlusion of a blood vessel.
Die Aufgabe der vorliegenden Erfindung besteht darin, einen Stent mit Markerelementen aus einem röntgenopaken Material be¬ reitzustellen, der eine dauerhafte Lokalisierbarkeit innerhalb des Hohlorgans gewährleistet, und dessen Elastizität durch die Markerelemente nicht beeinträchtigt wird. Darüber hinaus soll gewährleistet sein, dass die Markerelemente unter keinen Um- ständen ins Lumen des Stents entweichen und in das Hohlorgan gelangen können.The object of the present invention is to provide a stent with marker elements made of an X-ray opaque material, which ensures permanent localizability within the hollow organ, and whose elasticity is not impaired by the marker elements. In addition, it should be ensured that the marker elements under no circumstances escape into the lumen of the stent and can enter the hollow organ.
Diese Aufgabe wird mit den Merkmalen des Anspruches 1 gelöst.This object is achieved with the features of claim 1.
Erfindungsgemäß ist dabei ein Stent der gattungsgemäßen Art vorgesehen, der eine um eine longitudinale Achse verlaufende röhrenförmige Gitterwand aus elastischen, insbesonders radial elastischen Wandsegmenten aufweist, die circumferential ent¬ lang der longitudinalen Achse hintereinander angeordnet und über Verbindungselemente miteinander verbunden sind. Der Stent weist an entgegengesetzten Achsenenden liegende Röhrenenden auf. Die Wandsegmente weisen Federelemente mit einer elasti¬ schen Struktur auf sowie Aufnahmeelemente, die mit den Fe¬ derelementen verbunden sind. Die Aufnahmeelemente weisen Kavi- täten bzw. Ausnehmungen in Form von Aushöhlungen, Lücken, Lö¬ chern und/oder Aussparungen auf, in denen Markerelemente aus einem röntgenopaken Material angeordnet sind. Die Aufnahmeelemente können im Vergleich zu den Federelementen flächig verbreitert ausgebildet sein. Die Ausnehmungen können z.B. in Form von Aussparungen ausgestaltet sein.According to the invention, a stent of the generic type is provided which has a tubular grid wall running around a longitudinal axis made of elastic, in particular radially elastic wall segments which are arranged circumferentially one behind the other along the longitudinal axis and interconnected via connecting elements. The stent has tube ends located at opposite axis ends. The wall segments have spring elements with an elastic structure and receiving elements that are connected to the spring elements. The receiving elements have cavities or recesses in the form of cavities, gaps, holes and / or recesses in which marker elements are arranged from a radiopaque material. The receiving elements may be formed widened area compared to the spring elements. The recesses may be configured, for example, in the form of recesses.
Der erfindungsgemäße Stent ist dadurch gekennzeichnet, dass die Ausnehmungen in Richtung der longitudinalen Achse sich verjüngende, insbesonders konisch verjüngende, Querschnitts¬ flächen aufweisen und die röntgenopaken Markerelemente konisch ausgebildet sind und radial zur longitudinalen Achse in den Ausnehmungen der Aufnahmeelemente angeordnet sind. Die Marker¬ elemente sind also ähnlich dem Schlussstein eines römischen Gewölbes in den Aufnahmeelementen angeordnet.The stent according to the invention is characterized in that the recesses in the direction of the longitudinal axis have tapered, in particular conically tapered, Querschnitts¬ surfaces and the radiopaque marker elements are conical and are arranged radially to the longitudinal axis in the recesses of the receiving elements. The marker elements are thus arranged in the receiving elements similar to the capstone of a Roman vault.
Auf diese Weise ist gewährleistet, dass die Markerelemente sich nicht in Verjüngungsrichtung der Querschnittsflächen der Ausnehmungen bewegen können, selbst wenn sie brechen oder kor¬ rodieren, und daher unter keinen Umständen in das Lumen des Stents entweichen können. Die Markerelemente können sich al¬ lenfalls entgegen der Verjüngungsrichtung der Querschnitts- flächen der Ausnehmungen ablösen, also in Richtung zur Wand des Hohlorgans, wo sie keinen Schaden anrichten.In this way, it is ensured that the marker elements can not move in the tapering direction of the cross-sectional areas of the recesses, even if they break or corrode, and therefore can under no circumstances escape into the lumen of the stent. The marker elements can in any case come off against the direction of tapering of the cross-sectional areas of the recesses, ie in the direction of the wall of the hollow organ where they cause no damage.
In einer bevorzugten Ausgestaltung der Erfindung ist vorgese¬ hen, dass die Ausnehmungen und die Markerelemente runde Quer- schnitte aufweisen, und die Markerelemente radialkonisch in Form von Kegelstümpfen ausgebildet sind. Unter dem Begriff „runde Querschnitte" sollen dabei kreisförmige, ovale und el- liptoide Querschnitte verstanden werden.In a preferred embodiment of the invention, it is provided that the recesses and the marker elements have round cross sections, and the marker elements are formed radially conically in the form of truncated cones. The term "round cross sections" is to be understood as meaning circular, oval and elliptoid cross sections.
In einer weiteren bevorzugten Ausgestaltung der Erfindung ist vorgesehen, dass die Ausnehmungen und die Markerelemente im Wesentlichen rechteckige Querschnitte aufweisen, und die Mar¬ kerelemente konisch in Form von Pyramidenstümpfen ausgebildet sind. Unter den Begriff „im Wesentlichen rechteckige Quer- schnitte" sollen dabei auch solche Querschnitte fallen, die auf Rechtecke zurückgehen, deren Ecken abgerundet wurden.In a further preferred embodiment of the invention it is provided that the recesses and the marker elements have substantially rectangular cross-sections, and the marker elements are conical in the form of truncated pyramids. The term "substantially rectangular cross-section" "cuts" should also fall such cross sections, which go back to rectangles whose corners were rounded.
In einer Weiterbildung der Erfindung sind die Markerelemente auf ihrer der longitudinalen Achse abgewandten Seite mit den Aufnahmeelementen verschweißt und auf diese Weise dauerhaft in den Ausnehmungen arretiert. Vorzugsweise werden dabei im Über¬ gangsbereich zwischen den Aufnahmeelementen und den Markerele¬ menten Schweißpunkte gesetzt, wofür zum Beispiel ein Laser verwendet werden kann.In one development of the invention, the marker elements are welded on their side remote from the longitudinal axis with the receiving elements and locked in this way permanently in the recesses. Preferably, welding points are set in the transition region between the receiving elements and the marker elements, for which purpose a laser can be used, for example.
In einer weiteren bevorzugten Ausgestaltung der Erfindung ist vorgesehen, dass die Aufnahmeelemente an den Röhrenenden des Stents angeordnet sind. Auf diese Weise ist gewährleistet, dass die Enden des Stents im Röntgenbild während der Katheter¬ operation oder anlässlich einer Kontrolluntersuchung sicher angesprochen werden können und so die korrekte Lage des Stents kontrolliert werden kann.In a further preferred embodiment of the invention it is provided that the receiving elements are arranged at the tube ends of the stent. In this way, it is ensured that the ends of the stent can be reliably addressed in the X-ray image during the catheter operation or during a follow-up examination and thus the correct position of the stent can be checked.
Zusätzlich kann vorgesehen sein, dass auch im Bereich zwischen den Röhrenenden Aufnahmeelemente angeordnet sind. Insbesondere können diese auf einer die Gitterwand schraubenlinienartig um¬ laufenden Linie angeordnet sein. Auf diese Weise läßt sich im Röntgenbild feststellen, ob der Stent an Ort und Stelle gleichmäßig und korrekt entfaltet worden ist.In addition, it can be provided that receiving elements are arranged in the region between the tube ends. In particular, these can be arranged on a line running around the grid wall in a helical line. In this way it can be determined in the X-ray image, whether the stent has been unfolded in place evenly and correctly.
In einer besonders bevorzugten Ausgestaltung der Erfindung ist vorgesehen, dass die Aufnahmeelemente an den Röhrenenden des Stents circumferential angeordnet sind, also einen endständi- gen, an der Innen- oder Außenseite des Hohlorgans anliegenden Kranz röntgenopaker Markierungen ausbilden. In einer weiteren erfindungsgemäßen bevorzugten Ausgestaltung sind die Aufnahme¬ elemente quer zu ihrer Längsrichtung kreisbogenförruig um die longitudinale Achse des Stents gekrümmt. In erfindungsgemäßen Ausgestaltungen, bei denen die Aufnahme¬ elemente an den Röhrenenden angeordnet sind, kann die Stütz¬ wirkung an den Röhrenenden beeinträchtigt sein, da hier weni- ger stützendes Material zur Verfügung steht als im Bereich zwischen den Röhrenenden. Die Länge des effektiv stützenden Bereichs des Stents fällt daher in der Regel geringer aus, als die absolute Länge des Stents selbst beträgt.In a particularly preferred embodiment of the invention, it is provided that the receiving elements are arranged circumferentially at the tube ends of the stent, thus forming a terminal, lying on the inside or outside of the hollow organ garland radiopaque markers. In a further preferred embodiment according to the invention, the receiving elements are curved in a circular arc around the longitudinal axis of the stent transversely to their longitudinal direction. In configurations according to the invention in which the receiving elements are arranged at the tube ends, the support effect at the tube ends may be impaired, since less supporting material is available here than in the region between the tube ends. The length of the effective supportive area of the stent is therefore usually less than the absolute length of the stent itself.
In einer weiteren Ausgestaltung der Erfindung ist daher vorge¬ sehen, dass an den Röhrenenden zusätzlich zu den Aufnahmeele¬ menten endständige Federelemente circumferential angeordnet sind. Diese endständigen Federelemente können breiter sein als die bereits beschriebenen Federelemente im Bereich zwischen den Röhrenenden.In a further embodiment of the invention, it is therefore provided that terminal spring elements are arranged circumferentially at the tube ends in addition to the receiving elements. These terminal spring elements may be wider than the previously described spring elements in the region between the tube ends.
Bevorzugt ist dabei vorgesehen, dass die Aufnahmeelemente und die endständigen Federelemente miteinander alternierend cir¬ cumferential angeordnet sind.It is preferably provided that the receiving elements and the terminal spring elements are arranged cir¬ cumferentially alternately with each other.
Vorteil dieser Ausgestaltungsformen ist, dass die Röhrenenden des Stents im entfalteten Zustand eine bessere Abstützung auf die Gefäßwand ausüben, was zur Folge hat, dass die Wirkungs¬ länge des Stents, also der Bereich, in dem z.B. eine Resteno- sierung wirksam verhindert werden kann, bedeutend größer ist.The advantage of these embodiments is that the tube ends of the stent in the deployed state exert a better support on the vessel wall, with the result that the length of the effect of the stent, ie the region in which e.g. a restenosis can be effectively prevented is significantly greater.
Ganz besonders vorteilhaft sind diese Arten der Ausgestaltung bei Stenosen im Bereich von Gefässverzweigungen, z.B. bei Blutgefässen. Da die effektiv stützende Fläche eines solcher- maßen ausgestalteten Stents erst am tatsächlichen Röhrenende endet, ist gewährleistet, dass der Stent bis direkt an die Verzweigung herangeführt werden kann, ohne dass die Gefahr be¬ steht, dass verbreiterte Aufnahmeelemente in die Blutbahn des abzweigenden Gefäßes hineinragen und dort zu Turbulenzen der Blutströmung und damit zu Verklumpungen der Blutzellen führen.These types of embodiment are particularly advantageous in the case of stenoses in the region of vessel branches, for example in the case of blood vessels. Since the effectively supporting surface of such a stent designed ends only at the actual end of the tube, it is ensured that the stent can be brought up directly to the branch, without the danger be¬ that widened receiving elements in the bloodstream of the protrude branching vessel and there lead to turbulence of the blood flow and thus clumping of the blood cells.
In besonders bevorzugter Weise ist dabei vorgesehen, dass die endständigen Federeleinente und die Aufnahmeelemente so ausge¬ bildet und/oder angeordnet sind, dass die in Richtung der Röh¬ ren- bzw. Stentenden weisenden Enden der Elemente eine kreis¬ förmige, quer zur longitudinalen Achse angeordnete Umfangsli- nie beschreiben, also gleichsam bündig angeordnet sind. Diese Anordnung hat den besonderen Vorteil, dass beim Platzieren des Stents, d.h. beim Vorwärtsschieben mit Hilfe eines Katheters, der Druck gleichmäßiger auf die gesamte Endumfangsfläche des Stents verteilt wird. Das heißt beim Entlassen bzw. Vorwärts¬ schieben des Stents aus dem Katheter, wirken die dabei auftre- tenden Kräfte nicht nur auf die Röntgenmarker, sondern vor al¬ lem auch auf die endständigen, fingerartigen Federelemente, wodurch der auftretende Widerstand besser verteilt wird und die Markerelemente entlastet werden. Auf diese Weise wird die Gefahr, dass sich ein eingeschweisster Marker ablöst oder gar bricht, stark verringert. Dabei wird auch die Gefahr vermin¬ dert, dass sich einzelne endständige Elemente verbiegen und ggf. in die Gefäßwand einschneiden. Die endständigen Federele¬ mente sind vorzugsweise breiter, insbesonders mindestens dop¬ pelt so breit, ausgestaltet als die Wandsegmente.In a particularly preferred manner, it is provided that the terminal spring element and the receiving elements are designed and / or arranged such that the ends of the elements pointing in the direction of the tube or stent ends have a circular, transversely to the longitudinal axis Describe arranged circumferential line, so it is arranged flush as it were. This arrangement has the particular advantage that when placing the stent, i. when pushing forward with the help of a catheter, the pressure is distributed more evenly over the entire end peripheral surface of the stent. That is to say, when the stent is released or pushed forward out of the catheter, the forces which occur thereby act not only on the x-ray markers, but above all on the terminal, finger-like spring elements, as a result of which the resistance occurring is better distributed and the Marker elements are relieved. In this way, the risk that a sealed marker peels off or even breaks, greatly reduced. In this case, the risk is reduced that individual terminal elements bend and possibly cut into the vessel wall. The terminal spring elements are preferably wider, in particular at least twice as wide, configured as the wall segments.
Außerdem ist dadurch gewährleistet, dass ein solchermaßen aus¬ gestalteter Stent bis zum bündig abschließenden Röhrenende die volle Stützwirkung entfalten kann. Die zuvor geschilderten Vorteile kommen damit noch stärker zum Tragen.In addition, this ensures that a stent designed in such a way can unfold the full support effect up to the flush end of the tube. The advantages described above are even more significant.
In einer Weiterbildung der Erfindung bilden die Verbind¬ ungselemente und die Federelemente mindestens einen durchge¬ henden Längssteg, der sich in Längsrichtung des Stents er¬ streckt und der mindestens eine Komponente in Axialrichtung zur Aufnahme einer Druck- oder Zugspannung in Längsrichtung aufweist. Entsprechend dieser Ausgestaltung können auch mehre¬ re Längsstege ausgebildet sein. Auf diese Weise werden die Wandsegmente besonders wirkungsvoll zueinander positioniert, wobei gleichzeitig eine Längenänderung des Stents zuverlässig vermieden wird.In one development of the invention, the connecting elements and the spring elements form at least one continuous longitudinal web which extends in the longitudinal direction of the stent and the at least one component in the axial direction for receiving a compressive or tensile stress in the longitudinal direction. According to this embodiment also several longitudinal webs can be formed. In this way, the wall segments are particularly effectively positioned to each other, at the same time a change in length of the stent is reliably prevented.
Bevorzugt ist dabei vorgesehen, dass der Längssteg bzw. die Längsstege eine die Gitterwand schraubenlinienartig umlaufende Gestalt aufweist bzw. aufweisen. Diese Art der Ausgestaltung lässt sich mittels Schneiden, insbesonders Laser- und/oder Wasserstrahlschneiden, aus einem Hohlzylinder besonders ein¬ fach herstellen. Außerdem werden so Längenänderungen aufgrund von Druck- oder Zugspannungen oder durch ein Zusammendrücken des Stents im Rahmen der bei der bestimmungsgemäßen Verwendung auftretenden Kräfte zuverlässig vermieden.Preferably, it is provided that the longitudinal web or the longitudinal webs has a helical wall surrounding the lattice wall or have. This type of configuration can be produced particularly easily from a hollow cylinder by means of cutting, in particular laser and / or water jet cutting. In addition, length changes due to compressive or tensile stresses or by compression of the stent are avoided as part of the forces occurring in the intended use reliably.
In besonders bevorzugter Weise ist vorgesehen, dass die Ver¬ bindungselemente im Vergleich zu den Federelementen flächig verbreitert ausgebildet sind. Auch diese Art der Ausgestaltung lässt sich mittels Laserschneiden einfach herstellen. Im Zu¬ stand vor der Entfaltung des Stents sind die Verbindungsele¬ mente dann beispielsweise geringfügig S-förmig ausgebildet. Im entfalteten Zustand mit grosseren Durchmesser weisen die Ver- bindungselemente dann zumindest eine parallel zum Längssteg angeordnete Komponente auf und unterstützen diesen in der zu¬ vor beschriebenen Wirkung.In a particularly preferred manner it is provided that the Ver¬ connecting elements are formed widened area compared to the spring elements. This type of configuration can be easily produced by means of laser cutting. In Zu¬ before the deployment of the stent Verbindungsele¬ elements are then formed, for example, slightly S-shaped. In the unfolded state with a larger diameter, the connecting elements then have at least one component arranged parallel to the longitudinal web and support this in the effect described above.
Besonders bevorzugt ist vorgesehen, dass die Verbindungs- elemente die doppelte Breite der Federelemente aufweisen. Da¬ durch ergibt sich ein besonders einfaches Schnittmuster. Übli¬ cherweise, jedoch nicht notwendigerweise, sind die Verbin¬ dungselemente kürzer als die Federelemente und weisen zweckmä¬ ßigerweise eine Länge von maximal 3/4, vorzugsweise maximal 2/3 der Länge eine Federelements auf. Besonders bevorzugt sind Längen von 1/2 oder weniger der Länge eines Federelements.It is particularly preferred that the connecting elements have twice the width of the spring elements. This results in a particularly simple cutting pattern. Usually, but not necessarily, the connecting elements are shorter than the spring elements and expediently have a maximum length of 3/4, preferably a maximum 2/3 of the length of a spring element. Particularly preferred are lengths of 1/2 or less of the length of a spring element.
Grundsätzlich müssen alle in einem Stent verwendeten Materia- lien biokompatibel sein. Es stellen sich jedoch noch weitere spezifische Anforderungen an die verschiedenen, in dem erfin¬ dungsgemäßen Stent verwendeten Materialien.In principle, all materials used in a stent must be biocompatible. However, there are other specific requirements for the various materials used in the stent according to the invention.
Bevorzugt bestehen die röntgenopaken Markerelemente des erfin- dungsgemäßen Stents aus einem Material, das ausgewählt ist aus der Gruppe bestehend aus Gold, Platin, Silber, Tantal, mit Ba¬ riumsulfat dotiertem Kunststoff, mit Wismuttrioxid dotiertem Kunststoff. Es können jedoch ebensogut andere röntgenopake Ma¬ terialien verwendet werden.The radiopaque marker elements of the stent according to the invention preferably consist of a material which is selected from the group consisting of gold, platinum, silver, tantalum, plastic doped with barium sulfate and plastic doped with bismuth trioxide. However, other radiopaque materials may as well be used.
Die Feder-, Verbindungs- und/oder Aufnahmeelemente des erfin¬ dungsgemäßen Stents bestehen besonders bevorzugt aus einem Formgedächtnis-Material.The spring, connecting and / or receiving elements of the stent according to the invention particularly preferably consist of a shape memory material.
Besonders bevorzugt werden die zu verwendenden Formgedächtnis- Materialien aus der Gruppe bestehend aus Nickel-Titan- Legierungen und Kupfer-Zink-Aluminium-Legierungen ausgewählt. Als besonders geeignet hat sich die Nickel-Titan-Legierung Ni- tinol herausgestellt.More preferably, the shape memory materials to be used are selected from the group consisting of nickel-titanium alloys and copper-zinc-aluminum alloys. The nickel-titanium alloy nitinol has proven to be particularly suitable.
Aus einem aus solchen Material bestehenden Hohlzylinder kann, z.B. mittels einer Schneidetechnik, wie z. B. mittels Laser¬ oder Wasserstrahl, ein im wesentlichen aus Federelementen, Verbindungselementen und Aufnahmeelementen bestehender Stent herausgeschnitten werden, dem anschliessend auf für Formge¬ dächtnis-Materialien bekannte Weise die entfaltete, dem Durch¬ messer des zu therapierenden Hohlorgans entsprechende Form aufgeprägt werden kann. Wird der so erzeugte Stent an¬ schliessend in den Zustand mit kleinem Durchmesser komprimiert und beispielsweise mit Hilfe eines Katheters in ein steno- siertes Blutgefäss eingeführt, so kann der Stent an Ort und Stelle durch Erwärmen auf über die sogenannte Konversions¬ temperatur zurück in die zuvor eingeprägte Form gebracht wer- den. Gegebenenfalls kann dieser Entfaltungsvorgang durch Ver¬ wendung eines Ballonkatheters unterstützt oder auch ganz da¬ durch ersetzt werden.From a hollow cylinder made of such material can, for example by means of a cutting technique, such. B. by means of laser or water jet, a substantially consisting of spring elements, connecting elements and receiving elements existing stent are cut out, the subsequently unfolded, the Durch¬ diameter of the hollow organ to be treated corresponding shape can be impressed on known for Formge¬ memory materials. If the stent thus produced is subsequently compressed to the state of small diameter and, for example, introduced into a stenosed blood vessel with the aid of a catheter, the stent can be brought back into the previously impressed shape by heating to above the so-called conversion temperature. Optionally, this unfolding process can be assisted by use of a balloon catheter or completely replaced by it.
Die Feder-, Verbindungs- und/oder Aufnahmeelemente können je- doch auch aus Materialien bestehen, die ausgewählt sind aus der Gruppe bestehend aus Edelstahl, Kunststoff, oder selbst¬ auflösenden Materialien. Da diese Materialien keine Formge¬ dächtnis-Eigenschaften aufweisen, müssen die daraus herge¬ stellten Stents an Ort und Stelle mit Hilfe eines Ballonkathe- ters entfaltet werden. Insbesondere die selbstauflösenden Ma¬ terialien sind dann von Vorteil, wenn ein Stent nicht dauer¬ haft gelegt werden soll.However, the spring, connecting and / or receiving elements can also consist of materials which are selected from the group consisting of stainless steel, plastic, or self-dissolving materials. Since these materials have no shape memory properties, the stents made from them have to be unfolded in situ with the aid of a balloon catheter. In particular, the self-dissolving materials are advantageous if a stent is not to be permanently applied.
Besonders bevorzugt vorgesehen ist, dass die Oberfläche des erfindungsgemäßen Stents bearbeitet, insbesondere veredelt, geglättet, und/oder poliert ist. Auf diese Weise ergibt sich eine glatte Oberfläche, die insbesondere den Ansprüchen an die Biokompatibilität des Stents genügt.It is particularly preferred that the surface of the stent according to the invention is processed, in particular finished, smoothed, and / or polished. In this way, a smooth surface results, which in particular satisfies the requirements of the biocompatibility of the stent.
Weiterhin ist ein Verfahren zur Herstellung eines erfindungs¬ gemäßen Stents vorgesehen, bei dem die konischen, röntgenopa- ken Markerelemente von der der longitudinalen Achse abgewand¬ ten Seite des Stents aus in die Aufnahmeelemente eingesetzt werden und auf dieser Seite durch Setzen von Schweißpunkten an den Aufnahmeelementen befestigt werden.Furthermore, a method for producing a stent according to the invention is provided, in which the conical radiopaque marker elements are inserted from the side of the stent facing away from the longitudinal axis into the receiving elements and on this side by setting welding points on the receiving elements be attached.
In einer bevorzugten Ausführungsform dieses Verfahrens ist da¬ bei vorgesehen, dass zunächst aus einem Hohlzylinder bestehend aus einem Material, das ausgewählt ist aus der Gruppe beste- hend aus Edelstahl, Kunststoff, einem selbstauflösenden Mate¬ rial oder einem Formgedächtnis-Material ein röhrenförmiger Stent-Rohling herausgeschnitten wird. Besonders bevorzugt ist weiterhin vorgesehen, dass die Feder-, Verbindungs- und/oder Aufnahmeelemente der Wandsegmente mittels Laser- oder Wasser¬ strahlschneiden aus dem Stent-Rohling hergestellt werden.In a preferred embodiment of this method, it is provided that initially consists of a hollow cylinder consisting of a material which is selected from the group made of stainless steel, plastic, a self-dissolving Mate¬ material or a shape memory material, a tubular stent blank is cut out. Particularly preferably, it is further provided that the spring, connecting and / or receiving elements of the wall segments by means of laser or Wasser¬ jet cutting are made from the stent blank.
Im Folgenden wird ein Ausführungsbeispiel der Erfindung anhand von Zeichnungen näher erläutert. Es zeigen:In the following an embodiment of the invention will be explained in more detail with reference to drawings. Show it:
Fig. 1 eine schematische Darstellung eines erfindungsgemäßen Stents 10 in abgewickelter Darstellung,1 is a schematic representation of a stent 10 according to the invention in an unwound representation,
Fig. 2 eine vergrösserte Teildarstellung des Endbereichs des in Fig. 1 gezeigten Stents, undFIG. 2 is an enlarged fragmentary view of the end portion of the stent shown in FIG. 1; and FIG
Fig. 3 eine Aufsicht auf einen Schnitt entlang der Linie A - A in Fig. 2.3 is a plan view of a section along the line A - A in Fig. 2nd
Fig. 1 zeigt eine schematische Draufsicht eines noch nicht ex¬ pandierten erfindungsgemäßen Stents 10. Der Stent 10 wird mit¬ tels Laserstrahlung aus einem Röhrchen aus einem geeigneten Material, beispielsweise einem Formgedächtnis-Material, ausge¬ schnitten. Der Stent 10 weist eine longitudinale Achse 11 so- wie eine Gitterwand 12 auf, die aus den einzelnen Wandsegmen¬ ten 13 aufgebaut ist. Die Wandsegmente 13 bestehen im nicht expandierten Zustand aus parallel zueinander angeordneten Fe¬ derelementen 16, die über Verbindungselemente 14 mit Federele¬ menten 16 aus dem benachbarten Wandsegment 13 verbunden sind.FIG. 1 shows a schematic plan view of a stent 10 which is not yet expanded. The stent 10 is cut out of a tube made of a suitable material, for example a shape memory material, by means of laser radiation. The stent 10 has a longitudinal axis 11 and a grid wall 12, which is constructed from the individual wall segments 13. In the unexpanded state, the wall segments 13 consist of Fe¬ elements 16 arranged parallel to one another, which are connected via connecting elements 14 with spring elements 16 from the adjacent wall segment 13.
Weiterhin weist der Stent 10 am Röhrenende 15 angeordnete Auf¬ nahmeelemente 17 auf, die ösenförmig ausgebildet sind und Aus¬ nehmungen 18 aufweisen, in denen Markerelemente 19 aus einem röntgenopaken Material, wie z.B. Tantal, angeordnet sind. Die Ausnehmungen 18 und die Markerelemente 19 weisen einen ovalen Querschnitt auf. Der Stent weist weiterhin endständige, vor¬ zugsweise fingerartig ausgebildete Federelemente 20 auf, wobei diese und die Aufnahmeelemente 17 so ausgebildet und angeord- net sind, dass die in Richtung der Röhrenenden 15 weisenden Enden der Elemente 20, 19 bündig angeordnet sind und eine kreisförmige, quer zur longitudinalen Achse 11 des Stents 10 angeordnete Umfangslinie beschreiben.Furthermore, the stent 10 has receiving elements 17 arranged at the tube end 15, which are designed in the shape of an eye and have recesses 18 in which marker elements 19 of a radiopaque material, such as tantalum, are arranged. The Recesses 18 and the marker elements 19 have an oval cross-section. The stent also has terminal, preferably finger-like spring elements 20, wherein these and the receiving elements 17 are designed and arranged in such a way that the ends of the elements 20, 19 pointing in the direction of the tube ends 15 are flush and form a circular, Describe transverse to the longitudinal axis 11 of the stent 10 arranged circumferential line.
Vorteil dieser Ausgestaltungsform ist, dass die Röhrenenden 15 des Stents 10 im entfalteten Zustand eine bessere Abstützung auf die Gefäßwand ausüben, was zur Folge hat, dass die Wir¬ kungslänge des Stents, also der Bereich, in dem z.B. eine Restenosierung wirksam verhindert werden kann, bedeutend grö- ßer ist. Außerdem hat diese Ausgestaltung den Vorteil, dass beim Platzieren des Stents 10, d.h. beim Vorwärtsschieben mit Hilfe eines Katheters, der Druck gleichmäßiger auf die gesamte Endumfangsfläche des Stents 10 verteilt wird und so verhindert wird, dass sich einzelne endständige Elemente 17, 20 in die Gefäßwand einschneiden.The advantage of this embodiment is that the tube ends 15 of the stent 10 in the deployed state exert a better support on the vessel wall, with the result that the effective length of the stent, ie the region in which e.g. a restenosis can be effectively prevented, is significantly greater. In addition, this design has the advantage that when placing the stent 10, i. when pushing forward with the aid of a catheter, the pressure is distributed more uniformly over the entire end circumferential surface of the stent 10 and thus prevents individual terminal elements 17, 20 from cutting into the vessel wall.
Fig. 1 läßt außerdem die in etwa S-förmige Gestalt der Verbin¬ dungselemente 14 erkennen. Ebenfalls wird in der Figur deut¬ lich, dass einander benachbart angeordnete Wandsegmente 13 je- weils gegeneinander versetzt angeordnet sind, und zwar vor¬ zugsweise um die Breite zweier Federelemente 16.Fig. 1 also reveals the approximately S-shaped configuration of the connecting elements 14. It is also clear in the figure that wall segments 13 arranged adjacent to one another are each arranged offset from one another, preferably by the width of two spring elements 16.
Die Verbindungselemente 14 und Federelemente 16 bilden so ei¬ nen durchgehenden Längssteg, der eine Komponente in Axialrich- tung des Stents zur Aufnahme von Druck- oder Zugspannungen in Längsrichtung aufweist. Aufgrund des beschriebenen Versatzes weist der Längssteg eine die Gitterwand 12 des Stents 10 schraubenlinienartig umlaufende Gestalt auf. Nach dem Einschneiden des in Fig. 1 dargestellten Musters in einen röhrenförmigen Rohling aus Formgedächtnis-Material wird der so hergestellte Stent 10 in einen zweiten Zustand expan¬ diert, der einen grosseren Durchmesser hat als der erste Zu- stand. Dieser zweite Zustand wird dem Stent 10 dann auf be¬ kannte Weise aufgeprägt. Zur Implantation mittels eines Ka¬ theters wird der so vorbereitetete Stent 10 dann in einen Zu¬ stand mit geringem Durchmesser zusammengedrückt. Nach der ge¬ wünschten Positionierung kann der Stent 10 dann durch Erwärmen über die sogenannte Konversionstemperatur wieder in die einge¬ prägte Form des zweiten Zustands expandiert.The connecting elements 14 and spring elements 16 thus form a continuous longitudinal web which has a component in the axial direction of the stent for absorbing compressive or tensile stresses in the longitudinal direction. Due to the described offset, the longitudinal web on a grid wall 12 of the stent 10 helically encircling shape. After cutting the pattern shown in FIG. 1 into a tubular blank made of shape-memory material, the stent 10 produced in this way is expanded into a second state, which has a larger diameter than the first state. This second state is then impressed on the stent 10 in a known manner. For implantation by means of a catheter, the stent 10 thus prepared is then compressed into a state having a small diameter. After the desired positioning, the stent 10 can then be expanded again by heating above the so-called conversion temperature into the imprinted form of the second state.
Fig. 2 zeigt eine vergrösserte Teildarstellung des Endbereichs des in Fig. 1 gezeigten Stents 10 mit den Verbindungselementen 14, den Federelementen 16, den Ausnehmungen 18 der Aufnahme¬ elemente 17 und den darin angeordneten Markerelementen 19 so¬ wie den endständigen Federelementen 20. Die Markerelemente 19 sind mittels Schweißpunkten 21, auf der longitudinalen Achse abgewandten Seite des Stents in den Aufnahmeelementen 17 be- festigt.2 shows an enlarged partial view of the end region of the stent 10 shown in FIG. 1 with the connecting elements 14, the spring elements 16, the recesses 18 of the receiving elements 17 and the marker elements 19 arranged therein, as well as the terminal spring elements 20. The marker elements 19 are fastened in the receiving elements 17 by means of welding points 21 on the side of the stent facing away from the longitudinal axis.
Fig. 3 zeigt eine Aufsicht auf einen Schnitt durch einen er¬ findungsgemäßen Stent 10 entlang der Linie A - A in Fig. 2. Dargestellt ist ein Aufnahmeelement 17, eine Ausnehmung 18, ein in der Ausnehmung 18 angeordnetes Markerelement 19, zwei endständige Federelemente 20 sowie zwei Schweißpunkte 21.3 shows a plan view of a section through a stent 10 according to the invention along the line A-A in FIG. 2. Shown is a receiving element 17, a recess 18, a marker element 19 arranged in the recess 18, two terminal spring elements 20 as well as two welding points 21.
Das Aufnahmeelement 17 ist quer zu seiner Längsrichtung kreis¬ bogenförmig um die longitudinale Achse 11 des Stents 10 ge- krümmt. Die Ausnehmung 18 weist sich in Richtung der longitu¬ dinalen Achse 11 verjüngende Querschnittsflächen auf. Das röntgenopake Markerelement 19 ist konisch ausgebildet und ra¬ dial zur longitudinalen Achse 11 in der Ausnehmung 18 des Auf¬ nahmeelements 17 angeordnet. Das Markerelement 19 ist also ähnlich dem Schlussstein eines römischen Gewölbes in dem Auf¬ nahmeelement 17 angeordnet.The receiving element 17 is curved arcuately around the longitudinal axis 11 of the stent 10 transversely to its longitudinal direction. The recess 18 has tapered cross-sectional areas in the direction of the longitu¬ dinalen axis 11. The radiopaque marker element 19 has a conical design and is arranged radially to the longitudinal axis 11 in the recess 18 of the receiving element 17. The marker element 19 is thus similar to the capstone of a Roman vault in the receiving element 17 Auf¬ arranged.
Auf diese Weise ist gewährleistet, dass das Markerelement 19 sich nicht in Verjüngungsrichtung der Querschnittsflächen der Ausnehmung 18 bewegen kann, selbst wenn es bricht oder korro¬ diert. Es kann sich allenfalls entgegen der Verjüngungsrich¬ tung der Querschnittsflächen der Ausnehmung 18 ablösen, also in Richtung zur Wand des Hohlorgans, wo es keinen Schaden an- richtet.In this way, it is ensured that the marker element 19 can not move in the direction of tapering of the cross-sectional areas of the recess 18, even if it breaks or corrodes. At most, it can come off against the direction of the rejuvenation of the cross-sectional surfaces of the recess 18, that is to say in the direction of the wall of the hollow organ, where it causes no damage.
Es sei noch einmal betont, dass die Ausnehmung 18 und die Mar¬ kerelemente 19 runde oder im wesentlichen rechteckige Quer¬ schnitte aufweisen können, und dass die Markerelemente radial- konisch in Form von Kegelstümpfen oder konisch in Form von Py¬ ramidenstümpfen ausgebildet sein können.It should be emphasized once again that the recess 18 and the marker elements 19 can have round or substantially rectangular cross sections, and that the marker elements can be formed radially conically in the form of truncated cones or conically in the form of pyramidal stumps.
Unter dem Begriff „runde Querschnitte" sollen dabei kreisför¬ mige, ovale und elliptoide Querschnitte verstanden werden. Un- ter den Begriff „im Wesentlichen rechteckige Querschnitte" sollen dabei auch solche Querschnitte fallen, die auf Recht¬ ecke mit abgerundeten Ecken zurückführbar sind. The term "round cross-sections" should be understood to mean circular, oval and elliptoid cross-sections. The term "substantially rectangular cross-sections" should also include those cross-sections which can be traced back to corners with rounded corners.
STENT ZUR IMPLANTATION IN ODER UM EIN HOHLORGAN MIT MARKERELEMENTEN AUS EINEM RÖNTGENOPAKEN MATERIALSTENT FOR IMPLANTATION IN OR A HOLLOW ORGAN WITH MARKER ELEMENTS FROM AN X-RAY OPTICAL MATERIAL
BezugszeichenlisteLIST OF REFERENCE NUMBERS
10 Stent 11 longitudinale Achse10 stent 11 longitudinal axis
12 Gitterwand12 grid wall
13 Wandsegment13 wall segment
14 Verbindungselement14 connecting element
15 Röhrenende 16 Federelement15 tube end 16 spring element
17 Aufnahmeelement17 receiving element
18 Ausnehmung18 recess
19 Markerelement19 marker element
20 endständiges Federelement 21 Schweißpunkt 20 terminal spring element 21 welding point

Claims

STENT ZUR IMPLANTATION IN ODER UM EIN HOHLORGAN MIT MARKERELEMENTEN AUS EINEM RÖNTGENOPAKEN MATERIALPatentansprüche STENT FOR IMPLANTATION IN OR A HOLLOW ORGAN WITH MARKER ELEMENTS FROM AN X-RAY OPTICAL MATERIAL PATENT DESCRIBE
1. Stent (10) zur Implantation in oder um ein Hohlorgan, mit einer um eine longitudinale Achse (11) verlaufenden röhren¬ förmigen Gitterwand (12) aus elastischen Wandsegmenten (13), die circumferential entlang der longitudinalen Achse (11) hintereinander angeordnet und über Verbindungselemente (14) miteinander verbunden sind, mit an entgegengesetzten Achsenenden liegenden Röhrenenden (15) , wobei die Wandseg¬ mente (13) Federelemente (16) mit einer elastischen Struk¬ tur aufweisen, sowie mindestens ein Aufnahmeelement (17) , das mit den Federelementen (15) verbunden ist, und wobei das Aufnahmeelement (17) mindestens eine einen Querschnitt aufweisende Ausnehmung (18) aufweist, in der ein Markerele¬ ment (19) aus einem röntgenopaken Material angeordnet ist, dadurch gekennzeichnet, dass die Ausnehmung (18) eine sich in Richtung zur longitudinalen Achse (11) konisch ver¬ jüngenden Querschnitt aufweist, und das röntgenopake Mar- kerelement (19) konisch ausgebildet und radial zur longitu¬ dinalen Achse (11) in der Ausnehmung (18) der Aufnahmeele¬ mente (17) angeordnet ist.A stent (10) for implantation in or around a hollow organ, comprising a tubular wall (12) of elastic wall segments (13) extending around a longitudinal axis (11) arranged circumferentially along the longitudinal axis (11) one behind the other and are connected to one another via connecting elements (14), with tube ends (15) lying at opposite axial ends, the wall segments (13) having spring elements (16) with an elastic structure, and at least one receiving element (17) connected to the Spring element (15) is connected, and wherein the receiving element (17) has at least one cross-section recess (18) in which a Markerele¬ element (19) is arranged from a radiopaque material, characterized in that the recess (18) a conically tapering cross-section in the direction of the longitudinal axis (11), and the radiopaque marker element (19) has a conical shape and radial to longitu¬ dinalen axis (11) in the recess (18) of the Aufnahmeele¬ elements (17) is arranged.
2. Stent gemäß Anspruch 1, dadurch gekennzeichnet, dass die Ausnehmung und das Markerelement runde Querschnitte aufwei¬ sen, und das Markerelement radialkonisch in Form von Kegel¬ stümpfen ausgebildet ist.2. Stent according to claim 1, characterized in that the recess and the marker element have round cross-sections, and the marker element is designed to be radially conical in the form of conical truncated stumps.
3. Stent gemäß Anspruch 1, dadurch gekennzeichnet, dass die Ausnehmung und das Markerelement im Wesentlichen rechtecki¬ ge Querschnitte aufweisen, und die Markerelemente konisch in Form von Pyramidenstümpfen ausgebildet sind. 3. Stent according to claim 1, characterized in that the recess and the marker element have substantially rechtecki¬ ge cross-sections, and the marker elements are formed conically in the form of truncated pyramids.
4. Stent gemäß einem der Ansprüche 1 - 3, dadurch gekennzeich¬ net, dass die Markerelemente auf ihrer der longitudinalen Achse abgewandten Seite mit den Aufnahmeelementen ver- schweißt sind.4. Stent according to one of claims 1-3, characterized gekennzeich¬ net, that the marker elements are welded on its side facing away from the longitudinal axis side with the receiving elements.
5. Stent gemäß einem der vorherigen Ansprüche, dadurch gekenn¬ zeichnet, dass die Aufnahmeelemente an den Röhrenenden des Stents angeordnet sind.5. Stent according to one of the preceding claims, characterized gekenn¬ characterized in that the receiving elements are arranged at the tube ends of the stent.
6. Stent gemäß Anspruch 5, dadurch gekennzeichnet, dass die Aufnahmeelemente an den Röhrenenden des Stents circumferen- tial angeordnet sind.6. Stent according to claim 5, characterized in that the receiving elements are arranged on the tube ends of the stent.
7. Stent gemäß Anspruch 6, dadurch gekennzeichnet, dass an den Röhrenenden zusätzlich zu den Aufnahmeelementen endständige Federelemente (20) circumferential angeordnet sind.7. Stent according to claim 6, characterized in that at the tube ends in addition to the receiving elements terminal spring elements (20) are arranged circumferentially.
8. Stent gemäß Anspruch 7, dadurch gekennzeichnet, dass an den Röhrenenden die Aufnahmeelemente und die endständigen Fe¬ derelemente miteinander alternierend circumferential ange¬ ordnet sind.8. Stent according to claim 7, characterized in that at the tube ends the receiving elements and the terminal Fe¬ derelemente alternately circumferentially arranged ange¬ circumferentially.
9. Stent gemäß Anspruch 8, dadurch gekennzeichnet, dass die endständigen Federelemente und die Aufnahmeelemente so aus¬ gebildet und/oder angeordnet sind, dass die in Richtung der Röhrenenden weisenden Enden der endständigen Federelemente und der Aufnahmeelemente eine kreisförmige, quer zur longi¬ tudinalen Achse angeordnete Umfangslinie beschreiben.9. Stent according to claim 8, characterized in that the terminal spring elements and the receiving elements aus¬ formed and / or arranged so that the pointing in the direction of the tube ends ends of the terminal spring elements and the receiving elements a circular, transversely to the longi¬ tudinalen axis Describe arranged perimeter.
10. Stent gemäß einem der vorherigen Ansprüche, dadurch gekenn¬ zeichnet, dass Verbindungselemente und Federelemente min¬ destens einen durchgehenden Längssteg bilden, der sich in Längsrichtung des Stents erstreckt, und der mindestens eine Komponente in Axialrichtung zur Ausnehmung einer Druck- o- der Zugspannung in Längsrichtung aufweist. 10. Stent according to one of the preceding claims, characterized gekenn¬ characterized in that connecting elements and spring elements at least one continuous longitudinal ridge form, which extends in the longitudinal direction of the stent, and the at least one component in the axial direction to the recess of a pressure or tension in the longitudinal direction.
11. Stent gemäß Anspruch 10, dadurch gekennzeichnet, dass der Längssteg eine die Gitterwand schraubenlinienartig umlau¬ fende Gestalt aufweist.11. Stent according to claim 10, characterized in that the longitudinal web has a lattice wall in a helical umlau¬ fende shape.
12. Stent gemäß einem der vorherigen Ansprüche, dadurch gekenn¬ zeichnet, dass die Verbindungselemente im Vergleich zu den Federelementen flächig verbreitert ausgebildet sind.12. Stent according to one of the preceding claims, characterized gekenn¬ characterized in that the connecting elements are formed widened in area compared to the spring elements.
13. Stent gemäß Anspruch 12, dadurch gekennzeichnet, dass die Verbindungselemente die doppelte Breite der Federelemente aufweisen.13. Stent according to claim 12, characterized in that the connecting elements have twice the width of the spring elements.
14. Verfahren zur Herstellung eines Stents gemäß einem der vor¬ herigen Ansprüche, dadurch gekennzeichnet, dass die koni- sehen, röntgenopaken Markerelemente von der der longitudi- nalen Achse abgewandten Seite des Stents aus in die Aufnah¬ me elemente eingesetzt werden und auf dieser Seite durch Setzen von Schweißpunkten an den Aufnahmeelementen befes¬ tigt werden.14. A method for producing a stent according to one of the vor¬ herigene claims, characterized in that the conical see, radiopaque marker elements from the longitudinal axis of the opposite side of the stent are used in the Aufnah¬ me elements and on this page be set by setting welding points on the receiving elements.
15. Verfahren zur Herstellung eines Stents gemäß Anspruch 14, dadurch gekennzeichnet, dass die Feder-, Verbindungs- und/oder Aufnahmeelemente der Wandsegmente durch Schneiden aus dem Stent-Rohling hergestellt werden.15. A method for producing a stent according to claim 14, characterized in that the spring, connecting and / or receiving elements of the wall segments are produced by cutting from the stent blank.
16. Verfahren zur Herstellung eines Stents gemäß Anspruch 14 oder 15, dadurch gekennzeichnet, dass aus einem Hohlzylin- der bestehend aus einem Material, das ausgewählt ist aus der Gruppe bestehend aus Edelstahl, Kunststoff, einem selbstauflösenden Material, oder einem Formgedächtnis-16. A method for producing a stent according to claim 14 or 15, characterized in that consisting of a hollow cylinder consisting of a material which is selected from the group consisting of stainless steel, plastic, a self-dissolving material, or a shape memory
Material ein röhrenförmiger Stent-Rohling herausgeschnitten wird.Material a tubular stent blank is cut out.
*** ***
PCT/DE2005/001661 2004-09-22 2005-09-21 Stent to be implanted in or around a hollow organ, comprising marker elements made of an x-ray opaque material WO2006047977A1 (en)

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