DE10223399B4 - Vascular support (STENT) and method of making such a vascular support - Google Patents

Vascular support (STENT) and method of making such a vascular support Download PDF

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DE10223399B4
DE10223399B4 DE10223399A DE10223399A DE10223399B4 DE 10223399 B4 DE10223399 B4 DE 10223399B4 DE 10223399 A DE10223399 A DE 10223399A DE 10223399 A DE10223399 A DE 10223399A DE 10223399 B4 DE10223399 B4 DE 10223399B4
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support
vascular
vascular support
support elements
making
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DE10223399A1 (en
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Hans Haindl
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time

Abstract

Gefäßstütze (STENT) zur Abstützung einer Gefäßwandung,
– mit in Achsrichtung nebeneinander angeordneten Stützelementen, die durch eine die Stützelemente umschließende Folie (12) aus resorbierbarem Material in Achsrichtung im Abstand zueinander gehalten sind,
dadurch gekennzeichnet, daß die Folie Durchbrechungen aufweist.Vascular support (STENT) for supporting a vessel wall,
With support elements arranged side by side in the axial direction, which are held in the axial direction at a distance from each other by a foil (12) enclosing the support elements made of resorbable material,
characterized in that the film has openings.

Figure 00000001
Figure 00000001

Description

Die Erfindung betrifft eine Gefäßstütze (STENT) der im Oberbegriff des Anspruchs 1 genannten Art zur Abstützung einer Gefäßwandung sowie ein Verfahren gemäß Anspruch 3 zur Herstellung einer solchen Gefäßstütze.The Invention relates to a stent (STENT) The type mentioned in the preamble of claim 1 for supporting a vessel wall and a method according to claim 3 for producing such a vascular support.

Gefäßstützen zur Abstützung einer Gefäßwandung sind allgemein bekannt. Es handelt sich dabei um im wesentlichen rohrförmige Gebilde, die in ein abzustützendes Gefäß eingebracht werden. Gefäßstützen einer bekannten Art bestehen aus plastischem Material und sind somit bleibend aufweitbar. Diese Gefäßstützen werden in der Regel auf einen Ballonkatheter aufgebracht und so in das abzustützende Gefäß eingebracht, wo sie dann am passenden Ort mittels des Ballons aufgeweitet werden. Der Ballon wird danach druckentlastet und aus dem Gefäß entfernt, so daß dort die aufgeweitete Gefäßstütze bleibt und somit einen gewünschten Querschnitt des Gefäßes sicherstellt.Vascular supports for support a vessel wall are well known. These are essentially tubular Formations to be supported in a Introduced vessel become. Vascular supports one known type are made of plastic material and are thus permanent expandable. These vascular supports will be usually applied to a balloon catheter and so in the be supported Vessel inserted, where they are then expanded at the appropriate place by means of the balloon. The balloon is then depressurized and removed from the vessel, so that there the expanded vascular support remains and thus a desired Cross section of the vessel ensures.

Durch WO 00/62708 A1 ist eine Gefäßstütze der im Oberbegriff des Anspruchs 1 genannten Art bekannt, bei der die Stützelemente durch einen kontinuierlichen Zylinder gehalten sind, der gespritzt oder aus einer Folie gebildet oder auch käfig- oder netzförmig sein kann. Eine Folie verhindert jedoch, daß das die Gefäßstütze durchströmende Blut mit der Innenwandung des Gefäßes in Kontakt steht. Andererseits verhindert ein netzartiger Zylinder nicht, daß atheromatöse Plaques, die bei der Aufdehnung von Gefäßverengungen (Stenosen) aufgebrochen oder aufgerissen werden, in das Innere des Gefäßes gelangen, wodurch es zu thrombotischen Gefäßverschlüssen und Herzinfarkt kommen kann.By WO 00/62708 A1 is a vascular support of in the preamble of claim 1 mentioned type, in which the support elements held by a continuous cylinder that is sprayed or be formed from a film or be cage or net shape can. However, a foil prevents the blood flowing through the vessel support in contact with the inner wall of the vessel stands. On the other hand, a reticulated cylinder does not prevent atheromatous plaques, in the dilation of vasoconstrictions (Stenoses) are broken or torn, in the interior of the Get to the vessel, causing thrombotic vascular occlusions and Heart attack can come.

Der Erfindung liegt die Aufgabe zugrunde, eine Gefäßstütze der im Oberbegriff des Anspruchs 1 genannten Art zu schaffen, bei der ein ausreichender Kontakt zwischen dem in dem Gefäß fließenden Blut und der Gefäßinnenwandung sichergestellt und gleichzeitig die Gefahr des Eindringens von atheromatösen Plaques in den Blutkreislauf und damit das Entstehen von thrombotischen Gefäßverschlüssen und folgendem Herzinfarkt verringert oder vermieden ist.Of the Invention is based on the object, a vascular support in the preamble of Claim 1 mentioned type, in which a sufficient contact between the blood flowing in the vessel and the vessel inner wall at the same time ensuring the risk of penetration of atheromatous plaques into the bloodstream and thus the emergence of thrombotic Vascular occlusions and reduced or avoided following myocardial infarction.

Die der Erfindung zugrundeliegende Aufgabe wird durch die in den Merkmalen des Anspruchs 1 angegebene Lehre gelöst.The The problem underlying the invention is characterized by in the features of claim 1 given teaching.

Der Grundgedanke der Erfindung besteht darin, die einzelnen Stützelemente grundsätzlich durch eine sie umschließende Folie aus resorbierbarem Material im Abstand zueinander zu halten, diese Folie jedoch mit Durchbrechungen zu versehen, die von einem Fachmann ohne weiteres so bemessen werden können, daß einerseits die beim Aufweiten freikommenden Teile der Plaques nicht in das Innere des Gefäßes gelangen können, gleichzeitig Blut aus dem Inneren des Gefäßes zu der Innenwandung des Gefäßes gelangen und dieses versorgen kann. Die Erfindung geht also von der Erkenntnis aus, daß die Teile der Plaques eine größere Abmessung haben als die Zellen des Blutes, so daß die Plaques zurückgehalten, die Blutzellen jedoch durchgelassen werden.Of the The basic idea of the invention is the individual support elements basically by an embracing one Keep foil of absorbable material at a distance from each other, However, this film to be provided with openings by a It will be readily appreciated by one skilled in the art that, on the one hand, the ones which are freed during expansion Parts of the plaques can not get inside the vessel, at the same time Blood from the inside of the vessel to the Pass inside wall of the vessel and can provide this. The invention thus proceeds from the knowledge from that parts the plaques a larger size have as the cells of the blood, so that the plaques retained, however, the blood cells are allowed to pass through.

Gemäß einer Ausführungsform der Erfindung besteht die Folie aus einem Vlies, bei dem die Zwischenräume zwischen den Fasern die Durchbrechungen bilden.According to one embodiment the invention, the film consists of a nonwoven, in which the spaces between the fibers form the openings.

Die Erfindung betrifft auch ein Verfahren zur Herstellung einer Gefäßstütze, bei der die Verbindungsmittel für die Stützelemente durch eine die Stützelemente umschließende, einen Schlauch bildende Folie umschlossen sind. Gemäß diesem Verfahren werden zunächst die Stützelemente mit einem Polymer beschichtet und dann auf einem Stab mit Abstand aufgereiht. Danach wird ein gelöstes Polymer die Stützelemente verbindend aufgebracht. Nach der Polymerisation des Polymers oder des Entweichens eines Lösungsmittels wird die so gefertigte Gefäßstütze von dem Stab abgezogen. Um dieses Abziehen zu erleichtern; wird gemäß einer Weiterbildung des erfindungsgemäßen Verfahrens für das Aufreihen der Stützelemente ein Stab aus elastisch oder plastisch streckbarem Material verwendet. Durch Strecken des Stabes verringert sich dessen Querschnitt, was das Abziehen der Gefäßstütze erleichtert. Dem gelösten Polymer werden vor dem Beschichten herauslösbare Partikel zugemischt und diese nach dem Entweichen des Lösungsmittels oder der Polymerisation herausgelöst, so daß eine poröse Struktur entsteht.The The invention also relates to a method for producing a vascular support, in the connecting means for the support elements by one of the support elements enclosing, a tube forming film are enclosed. According to this Procedures are first the support elements coated with a polymer and then on a rod at a distance lined up. After that, a solved Polymer the support elements binding applied. After the polymerization of the polymer or the escape of a solvent is the thus prepared vascular support of deducted from the staff. To facilitate this removal; is according to a Further development of the method according to the invention for stringing the support elements a rod of elastically or plastically stretchable material used. By Stretching the rod reduces its cross section, which is the Removal of the vascular support facilitates. The solved one Polymer be added before coating leachable particles and this after the solvent has escaped or the polymerization dissolved out, so that a porous structure is formed.

Anhand der Zeichnung soll die Erfindung näher erläutert werden.Based the drawing, the invention will be explained in more detail.

Die Zeichnung zeigt weitgehend schematisch und im Längsschnitt eine Gefäßstütze bestehend aus ringförmigen Stützelementen 2 aus plastischem Material, die durch eine einen Schlauch bildende Folie 4 aus resorbierbarem Material parallel im Abstand zueinander gehalten sind. Die Folie 4 hat eine poröse Struktur, so daß Plaquematerial nicht, Blutzellen jedoch hindurchtreten können.The drawing shows a largely schematic and in longitudinal section a vascular support consisting of annular support elements 2 made of plastic material passing through a film forming a tube 4 made of resorbable material are held parallel spaced from each other. The foil 4 has a porous structure so that plaque material can not pass, but blood cells can pass.

Claims (4)

Gefäßstütze (STENT) zur Abstützung einer Gefäßwandung, – mit in Achsrichtung nebeneinander angeordneten Stützelementen, die durch eine die Stützelemente umschließende Folie (12) aus resorbierbarem Material in Achsrichtung im Abstand zueinander gehalten sind, dadurch gekennzeichnet, daß die Folie Durchbrechungen aufweist.Vascular support (STENT) for supporting a vessel wall, - with support elements arranged side by side in the axial direction, which are supported by a foil enclosing the support elements (FIG. 12 ) are held in the axial direction at a distance from absorbable material, characterized in that the film has openings. Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, daß die Folie aus einem Vlies besteht.Vascular support after Claim 1, characterized in that the film consists of a nonwoven consists. Verfahren zum Herstellen einer Gefäßstütze nach Anspruch 1, dadurch gekennzeichnet, daß die Stützelemente mit einem Polymer beschichtet, auf einem Stab mit Abstand aufgereiht, mit einem gelösten oder einem Mehrkomponentenpolymer die Stützelemente verbindend beschichtet und nach der Trocknung oder Polymerisation die so gefertigte Gefäßstütze von dem Stab abgezogen wird, wobei dem Polymer vor dem Beschichten herauslösbare Partikel zugemischt und diese nach der Polymerisation herausgelöst werden.Method of making a vascular support Claim 1, characterized in that the support elements with a polymer coated, strung on a rod spaced, with a dissolved or a multi-component polymer, the support elements connecting coated and after drying or polymerization, the vascular support of is stripped off the rod, wherein the polymer admixed leachable particles before coating and these are dissolved out after the polymerization. Verfahren zur Herstellen einer Gefäßstütze nach Anspruch 3, dadurch gekennzeichnet, daß für das Aufreihen der Stützelemente ein Stab aus elastisch oder plastisch streckbarem Material verwendet wird.Method of making a vascular support Claim 3, characterized in that for the alignment of the support elements a rod of elastically or plastically stretchable material is used.
DE10223399A 2002-05-25 2002-05-25 Vascular support (STENT) and method of making such a vascular support Expired - Fee Related DE10223399B4 (en)

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US7985249B2 (en) 2002-05-08 2011-07-26 Abbott Laboratories Corporation Endoprosthesis having foot extensions
US8048146B2 (en) 2003-05-06 2011-11-01 Abbott Laboratories Endoprosthesis having foot extensions
WO2011151318A1 (en) 2010-06-02 2011-12-08 Nonwotecc Medical Gmbh Device for placement in a hollow organ, in particular for holding open said hollow organ and method for producing such device
US8075610B2 (en) 2002-05-06 2011-12-13 Abbott Laboratories Endoprosthesis for controlled contraction and expansion
US8109991B2 (en) 2003-05-06 2012-02-07 Abbot Laboratories Endoprosthesis having foot extensions
US8128682B2 (en) 2005-04-11 2012-03-06 Cook Medical Technologies Llc Medical device with tensionably attached remodelable material
US8382821B2 (en) 1998-12-03 2013-02-26 Medinol Ltd. Helical hybrid stent
US9039755B2 (en) 2003-06-27 2015-05-26 Medinol Ltd. Helical hybrid stent
US9155639B2 (en) 2009-04-22 2015-10-13 Medinol Ltd. Helical hybrid stent

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US9839537B2 (en) 2012-03-07 2017-12-12 Abbott Cardiovascular Systems Inc. Bioresorbable polymer scaffold treatment of coronary and peripheral artery disease in diabetic patients
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WO2000062708A1 (en) * 1999-04-15 2000-10-26 Mayo Foundation For Medical Education And Research Multi-section stent
DE19923133A1 (en) * 1999-05-19 2000-11-23 Malte Neus Support for blood or other vessels, which can radially expand or contract without decrease in length comprises flexibly linked zigzag form ring elements

Cited By (11)

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Publication number Priority date Publication date Assignee Title
US8382821B2 (en) 1998-12-03 2013-02-26 Medinol Ltd. Helical hybrid stent
US8075610B2 (en) 2002-05-06 2011-12-13 Abbott Laboratories Endoprosthesis for controlled contraction and expansion
US7985249B2 (en) 2002-05-08 2011-07-26 Abbott Laboratories Corporation Endoprosthesis having foot extensions
US8048146B2 (en) 2003-05-06 2011-11-01 Abbott Laboratories Endoprosthesis having foot extensions
US8109991B2 (en) 2003-05-06 2012-02-07 Abbot Laboratories Endoprosthesis having foot extensions
US8915954B2 (en) 2003-05-06 2014-12-23 Abbott Laboratories Endoprosthesis having foot extensions
US9039755B2 (en) 2003-06-27 2015-05-26 Medinol Ltd. Helical hybrid stent
US9456910B2 (en) 2003-06-27 2016-10-04 Medinol Ltd. Helical hybrid stent
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