DE19628880A1 - Verfahren zum Behandeln von aufweitbaren medizinischen Gefäßstützen - Google Patents

Verfahren zum Behandeln von aufweitbaren medizinischen Gefäßstützen

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Publication number
DE19628880A1
DE19628880A1 DE19628880A DE19628880A DE19628880A1 DE 19628880 A1 DE19628880 A1 DE 19628880A1 DE 19628880 A DE19628880 A DE 19628880A DE 19628880 A DE19628880 A DE 19628880A DE 19628880 A1 DE19628880 A1 DE 19628880A1
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Germany
Prior art keywords
diameter
stent
stents
annealed
expandable medical
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Ceased
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DE19628880A
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English (en)
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Eckhard Dr Alt
Robert Alter
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Individual
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Individual
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Publication of DE19628880A1 publication Critical patent/DE19628880A1/de
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • 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
    • 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
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated 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
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated 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
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
    • A61F2250/0036—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 thickness
    • 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
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers 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
    • C—CHEMISTRY; METALLURGY
    • C21—METALLURGY OF IRON
    • C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
    • C21D1/00—General methods or devices for heat treatment, e.g. annealing, hardening, quenching or tempering
    • C21D1/74—Methods of treatment in inert gas, controlled atmosphere, vacuum or pulverulent material
    • C21D1/773—Methods of treatment in inert gas, controlled atmosphere, vacuum or pulverulent material under reduced pressure or vacuum
    • Y—GENERAL 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901—Method of manufacturing prosthetic device

Description

Medizinische Gefäßstützen haben die Aufgabe, die Gefäßwand optimal abzustützen. Nach Aufdehnung mit Hilfe eine Ballons wird ein bestimmtes Innenlumen der Gefäßstütze erzielt. Nach Ablassen des Ballons sollte diese Gefäßstütze möglichst dieses erzielte Innenlumen halten. Aufgrund der elastischen Rückstellkräfte der Wand, aber auch der elastischen Rückstellkräfte des Stents, ist das tatsächlich erzielte Ergebnis, sprich das tatsächlich erzielte Innenlumen jedoch different von dem maximalen Innendurchmesser des Stents, während Inflation des Ballons.
Mit Hilfe der sogenannten QCA (Quantitativen Koronarangiographie) lassen sich diese Rückstellkräfte, oder im englischen auch als "recoil" bezeichneten Meßwerte, genau erfassen. Das Recoil hängt zum. Einen von Charakteristiken der Gefäßwand ab, sprich Elastizität, Rückstellkraft der Gefäßwand, Verkalkungen, Härte, Dicke, Konstitution des umgebenden Gewebes usw., zum Zweiten aber auch von den Charakteristiken des Stents. Hier ist zum Einen einmal die mechanische Konfiguration, der prozentuale Anteil der Gefäßstütze an der gedeckten Fläche der abgestützten Gefäßwand zu nennen. Sie bewegt sich je nach Aufdehnungsgrad zwischen 10 und 30%, wobei dies vom Stent-Typ abhängt.
Aus verständlichen Gründen wird nun angestrebt, den Durchmesser des Stent möglichst gering zu machen, um möglichst wenig des erzielten Innenlumens durch den Stent zu bedecken, so daß ein relativ hohes Lumen für den Fluß des Blutes zu Verfügung steht. Ein dickerer metallischer Stent hat natürlicherweise eine größere Abstützkraft. Durch bestimmte Designänderungen, läßt sich eine entsprechende Stabilität erzielen. Es muß aber das Ziel einer jeden implantierbaren Gefäßstütze sein, ein möglichst dünnes, zylindrisch tupuläres Element in den Körper einzubringen, das eine maximale Abstützfunktion hat. Die Oberfläche sollte deswegen nicht so groß sein, um die Aktivierung der plasmatischen und zellulären Gerinnung durch das metallische Fremdkörpermaterial möglichst gering zu halten.
Es ist Aufgabe der vorliegenden Zusatzerfindung ein Verfahren zu beschreiben, bei dem ein minimaler Recoil im klinischen Betrieb durch die Implantation von Gefäßstützen erzielt werden kann.
Die Erfindung besteht darin, aus einem zylindrischen metallischen Körper geometrische Öffnungen herauszuschneiden, die ein Aufdehnen der zylindrischen Struktur im Körper des Menschen erlauben. Dabei unterliegt ein solches Gefäßimplantat einem Gestaltwandel bezüglich seines Innen- und Außendurchmessers. Die erste Gestalt hat es in Form eines Durchmessers eines massiven zylindrischen Röhrchens, aus dem die Gefäßstrukturen geschnitten werden. Die zweite Gestalt hat es in Form eines Diameters, wenn dieses Röhrchen auf einem Ballon mit Hilfe von Quetschkräften aufgebracht wird, so daß eine entsprechende Reibung entsteht zum Ballon, so daß dieser mit aufgekrimmten oder aufgebrachter Gefäßstütze an den Ort der Läsuren vorgeschoben werden. Als Referenz dient hierzu die Bedienungsanleitung des InFlow-Stents der in der Anlage beigefügt ist. Der Durchmesser eines Stents hängt von den Charakteristiken des verwandten Ballons ab, kann aber bei modernen Niedrigprofilballons durchaus bis auf 0.6 mm heruntergehen. Nach Einbringen in das Gefäß wird nun der Stent aufgedehnt und erzielt dort einen Durchmesser von 2.5-6.0 mm.
Es ist die Aufgabe der vorliegenden Erfindung die Rückstellkräfte dadurch zu minimieren, daß der Stent nach der Originalbearbeitung aus einem bestimmten Durchmesser habenden Röhrchen in der Regel 1.5-1.8 mm aufgedehnt wird auf einen Durchmesser, der über dem Originaldurchmesser des geschnittenen oder roh bearbeitenden Röhrchens liegt. Ein solcher intermediärer Durchmesser nähert sich dem endgültigen Durchmesser, den das Gefäßimplantat im Körper haben soll an und liegt zwischen 2.0 und 2.5 mm. Wird nun der Stent, zum Beispiel über eine Nadel aufgedehnt, behält er seine elastischen Rückstellkräfte. Das bedeutet, daß nach Aufdehnung der Stent versucht, wieder auf seinen Originaldurchmesser, der durch die Gitterstruktur des initial zylindrischen Hohlkörpers oder Röhrchens vorgegeben war, zurückzugehen.
Die vorliegende Erfindung beschreibt nun, daß durch Glühen in aufgedehntem Zustand die metallischen kristallinen Strukturen so verändert werden, daß keine elastischen Rückstellkräfte mehr bestehen, die den Stent auf seine initiale Durchmesserstruktur zurückziehen würden. Dadurch entsteht eine geringere elastische Rückstellkraft des Stents, was im klinischen Betrieb bedeutet, daß das Recoil nach Implantation im Gefäß minimal wird.
Die Erfahrungen mit mehr als 150 Gefäßstützen bei über 60 Patienten haben gezeigt, daß durch dieses Verfahren des Vakuumglühens in aufgedehntem Zustand ein klinisches Recoil von unter 5% erzielt werden kann. Dies ist im Vergleich zu allen anderen Gefäßstützen, die zwischen 10 und 15% liegen, ein extrem positives Ergebnis, insbesondere unter dem Aspekt, daß die benutzte Gefäßstütze mit 70 bis 80 µ Durchmesser eine geringere Wanddicke aufweist, als andere verwandte und vergleichbare Gefäßstützen. Der Patentanspruch gilt nun zur Verminderung der elastischen Rückstellkräfte einer implantierbaren Gefäßstütze. Wird diese Gefäßstütze mit Temperaturen zwischen 700 und 1050° vakuumgeglüht, um eine Änderung der kristallinen Strukturen des Stents in der Weise zu erzielen, daß die elastischen Rückstellkräfte in aufgedehntem Zustand vermindert werden, daß auch nach Implantation im Gefäß eine optimale Stützfunktion erzielt wird und der Stent trotzdem noch auf einem minimalen Diameter auf dem Ballon aufgekrimmt werden kann, spielen nach Diameterverringerung die elastischen Rückstellkräfte keine so wesentliche Rolle mehr.

Claims (5)

1. Verfahren zum Behandeln von aufdehnbaren medizinischen Gefaßstützen, dadurch gekennzeichnet, daß die Gefäßstütze im aufgedehnten Zustand geglüht wird.
2. Verfahren nach Anspruch 1, dadurch gekennzeichnet, daß die medizinische Gefäßstütze nach dem Glühen wieder in ihre Ausgangsform gebracht wird.
3. Verfahren nach Anspruch 1, dadurch gekennzeichnet, daß die Gefäßstütze bei einem Durchmesser geglüht wird, der geringfügig unterhalb des Durchmessers liegt, den die aufgedehnte Gefaßstütze im Körper einnimmt.
4. Verfahren nach Anspruch 1, dadurch gekennzeichnet, daß die Gefäßstütze bei einem Durchmesser geglüht wird, der zwischen dem kleinsten Durchmesser und dem Durchmesser liegt, den die aufgedehnte Gefaßstütze im Körper einnimmt.
5. Verfahren nach Anspruch 4, dadurch gekennzeichnet, daß der Durchmesser, bei dem die Gefäßstütze geglüht wird, in einem Bereich liegt, der zwischen einem Drittel und zwei Drittel zwischen den beiden Durchmessern liegt.
DE19628880A 1996-02-14 1996-07-17 Verfahren zum Behandeln von aufweitbaren medizinischen Gefäßstützen Ceased DE19628880A1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US08/599,880 US5843117A (en) 1996-02-14 1996-02-14 Implantable vascular and endoluminal stents and process of fabricating the same

Publications (1)

Publication Number Publication Date
DE19628880A1 true DE19628880A1 (de) 1997-08-21

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DE19628880A Ceased DE19628880A1 (de) 1996-02-14 1996-07-17 Verfahren zum Behandeln von aufweitbaren medizinischen Gefäßstützen
DE69632390T Expired - Lifetime DE69632390T2 (de) 1996-02-14 1996-07-17 Implantierbare vaskuläre und endoluminale Stents

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DE69632390T Expired - Lifetime DE69632390T2 (de) 1996-02-14 1996-07-17 Implantierbare vaskuläre und endoluminale Stents

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US (4) US5843117A (de)
EP (1) EP0790041B1 (de)
DE (2) DE19628880A1 (de)

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US5843117A (en) 1998-12-01
DE69632390D1 (de) 2004-06-09
EP0790041B1 (de) 2004-05-06
US7632301B2 (en) 2009-12-15
US6159237A (en) 2000-12-12
DE69632390T2 (de) 2005-08-11
EP0790041A2 (de) 1997-08-20
US7153322B2 (en) 2006-12-26
US20070010870A1 (en) 2007-01-11
EP0790041A3 (de) 1998-01-07

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