EP1610723A1 - Stent - Google Patents

Stent

Info

Publication number
EP1610723A1
EP1610723A1 EP04725701A EP04725701A EP1610723A1 EP 1610723 A1 EP1610723 A1 EP 1610723A1 EP 04725701 A EP04725701 A EP 04725701A EP 04725701 A EP04725701 A EP 04725701A EP 1610723 A1 EP1610723 A1 EP 1610723A1
Authority
EP
European Patent Office
Prior art keywords
stent
support structure
metal
stent according
radio
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP04725701A
Other languages
German (de)
English (en)
Inventor
Carsten Momma
Bärbel BECHER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biotronik SE and Co KG
Original Assignee
Biotronik SE and 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 Biotronik SE and Co KG filed Critical Biotronik SE and Co KG
Publication of EP1610723A1 publication Critical patent/EP1610723A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • 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
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00Stock material or miscellaneous articles
    • Y10T428/24Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24802Discontinuous or differential coating, impregnation or bond [e.g., artwork, printing, retouched photograph, etc.]

Definitions

  • the invention relates to a stent with a metallic, relatively radio-lucent support structure and at least one marker element made of comparatively radio-opaque material.
  • Stents are endovascular prostheses that are used, among other things, to treat stenoses, i.e. vasoconstriction.
  • Stents usually have a tubular support structure which is open at both longitudinal ends of the tube and which is formed by webs and by openings enclosed by the webs.
  • Such stents can usually assume two states, namely a compressed state with a small diameter and an expanded state with a comparatively larger diameter. In the compressed state, such a stent can be inserted into a blood vessel, for example, by means of a catheter and positioned at a site to be treated. At the place of treatment
  • the stent is expanded or is allowed to expand itself.
  • Stents that do not self-expand are typically expanded using an inflatable balloon at a distal end of a catheter to insert the stent. Such stents are therefore referred to as balloon-expanded.
  • Other stents have the property of expanding themselves, for example due to inherent spring forces.
  • Such stents are referred to as self-expanding.
  • the self-expanding stents include, in particular, those which have a support structure made of a memory metal such as Nitinol, a known titanium-nickel compound.
  • Such memory metals have the property of maintaining a first shape below a certain crack temperature or of being plastically deformable, and of assuming a second shape when the crack temperature is exceeded.
  • memory metals are used in such a way that the first form corresponds to the compressed state of a stent and the second form corresponds to the expanded state of a stent.
  • a stent In the expanded state of a stent, it is used, for example, for the treatment of vasoconstrictions (stenoses) as a vascular support which keeps a blood vessel to be treated open at a narrowed point.
  • the expanded stent counteracts the vasoconstriction and supports the vascular wall in the area of the vasoconstriction. To do this, the stent must have sufficient radial strength or load capacity.
  • the support structure of the stent must also have sufficient surface coverage to adequately support the vasoconstriction.
  • the requirement to be able to expand the stent necessarily results in openings between the webs of the support structure of a stent. In the compressed state of the stent, these openings can be essentially closed.
  • the opening is definitely widened.
  • stents In addition to a sufficient load-bearing capacity, stents must also have sufficient flexibility with regard to their longitudinal axis in order to be able to follow vascular movements. There is also a desire to keep changes in the length of a stent as small as possible when expanding. Finally, the material of the stent or at least its surface should be as physically compatible as possible.
  • the stents of interest here have a tag structure made from a metal tube as the starting material. By cutting the metal tube, for example using a laser or by spark erosion, the webs are created as the remaining material. Such cut stents offer the great advantage over first-generation wire-formed stents that the geometry of the support structure can be optimized with regard to the diverse requirements.
  • the stent In addition to this multitude of requirements for stents, there is also the requirement that the stent should be positioned as precisely as possible. Positioning one. Stens is usually done with the help of imaging methods that work with X-rays, for example. In this context, it is generally disadvantageous that materials suitable for the support structure of a stent are often difficult to identify with the aid of the imaging methods used, since the material forming the support structure is relatively radio-lucent. It is therefore known to provide stents with so-called X-ray markers, which contain a relatively radio-opaque material which is easy to locate with the aid of the imaging methods mentioned. A known radio-opaque material is gold, for example.
  • the object of the present invention is to provide a stent which is X-ray-visible and, moreover, combines as many of the desirable properties as possible.
  • this object is achieved by a stent of the type mentioned, in which the marker element (22) is welded to the rest of the support structure (12, 16) after cutting and the radio-opaque material is completely enclosed by a cover layer made of a material other than the radio-opaque material , wherein the cover layer comprises metal or a metal compound. .
  • the invention is based on the basic idea of integrating radio-opaque material as an X-ray marker for a stent into the supporting structure of the stent in such a way that the outwardly acting surface of the stent in the region of the X-ray marker is not shaped by the radio-opaque material but by another metal or a metal connection.
  • the metal of the cover layer of the marker element advantageously allows the marker element to be welded to it after the remaining supporting structure has been cut out.
  • the surface of the X-ray marker acting outwards can be designed to be compatible with the body, for example by means of a silicon carbide coating.
  • the metal forming the cover layer is identical to the metal of the support structure and can therefore be easily connected to the rest of the support structure by welding without contact corrosion or the like occurring.
  • the latter property is particularly advantageous in connection with a stent with a self-expanding support structure, for example made of a memory metal such as Nitinol.
  • a stent with a self-expanding support structure for example made of a memory metal such as Nitinol.
  • the x-ray marker in the form of a hollow nitinol wire which is filled with gold on the inside and is easily welded to the rest of the stent's supporting structure. In this way, the X-ray marker can even be integrated into the supporting structure.
  • such a stent in particular such a self-expanding nitinol stent, is drug-coated.
  • Suitable drugs contain active substances with anti-inflammatory and anti-proliferative effects.
  • active ingredients are, for example, sartans or cyclospurin A, which are connected to the support structure of the stent with the aid of a polymeric carrier matrix. After implantation of the stent, the active substance or substances can elute into the body tissue and develop its desired anti-inflammatory or anti-proliferative effect. The active ingredients can thus help to prevent unwanted restenosis or inflammation.
  • Figure 1 is a schematic representation of a stent
  • FIG. 2 shows an example of a development of the support structure of a stent that forms a stent peripheral wall
  • FIG. 3 shows a cross section of a web section for stents forming an x-ray maker according to FIG. 1 or 2.
  • FIG. 4 shows an alternative embodiment to Figure 1
  • the stent 10 shown in FIG. 1 has the shape of a hollow body which is open on its end faces and whose peripheral wall is formed by a support structure with a partially folded web 12.
  • the webs 12 form support sections 14, which are each formed by a web that is closed in a ring shape in the circumferential direction, folded in a zigzag or meandering fashion.
  • the stent 10 is formed by a plurality of such support sections 14 which follow one another in the longitudinal direction.
  • the support sections or web rings 14 are connected to one another via connecting webs 16.
  • Two adjacent connecting webs in the circumferential direction and the partial sections of the web rings or support sections 14 lying opposite one another between these connecting webs 16 define a mesh 18 of the stent 10.
  • Such a mesh 18 represents an opening in the support structure or peripheral wall of the stent 10.
  • a corresponding mesh 18 is shown highlighted in FIG. 1.
  • the number of web rings or support sections 14 and their length I in relation to the total length L of the stent 10 depends on the purpose of the stent. Coronary stents usually have a smaller overall length L and a smaller number of support sections 14.
  • the support sections 14 arranged at the two longitudinal ends of the stent 10 form end sections 20 of the stent.
  • the annularly closed, zigzag-folded webs forming the end terminations 20 are provided with marker elements 22 in sections.
  • the webs 12 and 16 of the stent 10 are preferably made from a nitinol tube as the starting material by cutting out with the aid of a laser or by spark corrosion, the marker elements 22 are subsequently welded to the webs 12.
  • corresponding recesses are provided in the manufacture of the support structure by cutting out the webs 12 and 16 from a nitinol tube, into which the marker elements 22 are later welded.
  • the end sections 20 independently of the remaining support structure of the stent 10 and, for example, to prefabricate them entirely from a nitinol wire, for example one with a gold core.
  • the entire end sections 20 each form a continuous X-ray marker which, after the remaining supporting structure has been cut out of a nitinol tube, is connected to the outermost connecting webs 24 by welding.
  • This embodiment variant is not shown separately in FIG. 1, since the only difference from the illustration in FIG. 1 is that the entire end section 20 forms a continuous marker element 22.
  • one or more individual marker elements are welded to the support structure of a stent 10 shown in FIG. 1.
  • This embodiment variant is shown in FIG. 4. Accordingly, the entire support structure of the stent, including the end sections 20, is cut out of a nitinol tube and only the marker elements 22 'are subsequently welded to this support structure.
  • X-ray marker 22 or 22 ' this is formed by a wire 30 which contains a core 32 made of X-ray-opaque material such as gold in its interior. This core 32 is completely enclosed by support material 34.
  • the carrier material 34 corresponds to the metallic material from which the remaining stent 10 is made.
  • a preferred carrier material is Nitinol, a titanium-nickel alloy, which is also known as memory metal.
  • the advantage of such X-ray marker consists in that it can be easily connected to the rest of the support structure of a stent, for example by welding, without the known problems such as transition or contact corrosion. This is particularly important in the case of self-expanding stents made from a memory metal such as Nitinol.
  • Memory metals such as Nitinol are preferably used for self-expanding stents.
  • the peculiarity of such a memory metal is that it can assume two shape states and, when a transition temperature is exceeded, it changes from the first shape state to the second stable shape state.
  • the first shape state corresponds to the compressed state of the stent, in which it is inserted, for example, into a blood vessel or is applied to a stent delivery catheter.
  • the stent tends to assume its expanded state and develops corresponding expansion forces that have the desired vascular support effect. In this way, the stent may not need to be expanded with a balloon and plastically deformed.

Landscapes

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

Abstract

L'invention concerne un stent comportant une structure porteuse (12, 16) métallique relativement radiotransparente et au moins un élément de marquage (20) comprenant un matériau comparativement radio-opaque (22). L'invention se caractérise en ce que ledit matériau radio-opaque (22) est entouré complètement d'une couche de recouvrement (24) constituée d'un matériau autre que le matériau radio-opaque, ladite couche de recouvrement (24) comprenant du métal ou un composé métallique.
EP04725701A 2003-04-10 2004-04-05 Stent Withdrawn EP1610723A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10317241A DE10317241A1 (de) 2003-04-10 2003-04-10 Stent
PCT/EP2004/003630 WO2004089247A1 (fr) 2003-04-10 2004-04-05 Stent

Publications (1)

Publication Number Publication Date
EP1610723A1 true EP1610723A1 (fr) 2006-01-04

Family

ID=33039090

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04725701A Withdrawn EP1610723A1 (fr) 2003-04-10 2004-04-05 Stent

Country Status (4)

Country Link
US (1) US8728611B2 (fr)
EP (1) EP1610723A1 (fr)
DE (1) DE10317241A1 (fr)
WO (1) WO2004089247A1 (fr)

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US9468704B2 (en) 2004-09-07 2016-10-18 Biotronik Vi Patent Ag Implant made of a biodegradable magnesium alloy
EP2169090B3 (fr) 2008-09-30 2014-06-25 Biotronik VI Patent AG Implant fabriqué à partir d'un alliage de magnésium biodégradable
DE102006038232A1 (de) * 2006-08-07 2008-02-14 Biotronik Vi Patent Ag Endoprothese und Verfahren zur Herstellung einer solchen
DE102006038238A1 (de) * 2006-08-07 2008-02-14 Biotronik Vi Patent Ag Röntgenmarker für medizinische Implantate aus einem biokorrodierbaren metallischen Werkstoff
DE102007025921A1 (de) * 2007-06-02 2008-12-04 Biotronik Vi Patent Ag Medizinisches Implantat, insbesondere Stent
US8114149B2 (en) * 2009-10-20 2012-02-14 Svelte Medical Systems, Inc. Hybrid stent with helical connectors
EP2327380B1 (fr) 2009-11-30 2015-06-17 Biotronik VI Patent AG Stent doté d'éléments de fonction
EP2399619B1 (fr) * 2010-06-25 2015-08-05 Biotronik AG Implant et son procédé de fabrication
WO2013156861A2 (fr) 2012-04-17 2013-10-24 University College Dublin, National University Of Ireland, Dublin Méthodes et composés de traitement de troubles prolifératifs et d'infections virales
US9388127B2 (en) 2012-04-17 2016-07-12 University College Dublin, National University Of Ireland, Dublin Thromboxane receptor antagonists
US9233015B2 (en) 2012-06-15 2016-01-12 Trivascular, Inc. Endovascular delivery system with an improved radiopaque marker scheme
ES2858551T3 (es) 2015-06-16 2021-09-30 Atxa Therapeutics Ltd Antagonistas del receptor de tromboxano
GB201718299D0 (en) 2017-11-03 2017-12-20 Ab Wasstand Dev Stents

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Also Published As

Publication number Publication date
US20070168015A1 (en) 2007-07-19
DE10317241A1 (de) 2004-10-28
US8728611B2 (en) 2014-05-20
WO2004089247A1 (fr) 2004-10-21

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