DE19857887B4 - Anchoring support for a heart valve prosthesis - Google Patents

Anchoring support for a heart valve prosthesis

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Publication number
DE19857887B4
DE19857887B4 DE1998157887 DE19857887A DE19857887B4 DE 19857887 B4 DE19857887 B4 DE 19857887B4 DE 1998157887 DE1998157887 DE 1998157887 DE 19857887 A DE19857887 A DE 19857887A DE 19857887 B4 DE19857887 B4 DE 19857887B4
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Germany
Prior art keywords
anchoring
heart valve
characterized
anchoring support
support according
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Expired - Lifetime
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DE1998157887
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German (de)
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DE19857887A1 (en
Inventor
Christoph Dipl.-Ing. Damm
Markus Dr.med. Dr.disc.pol. Ferrari
Hans-Reiner Prof. Dr.med. Figulla
Klaus Dr.med. Lang
Carsten Dipl.-Ing. Weber
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JENAVALVE TECHNOLOGY INC., WILMINGTON, DEL., US
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Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung eV
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Priority to DE1998157887 priority Critical patent/DE19857887B4/en
Publication of DE19857887A1 publication Critical patent/DE19857887A1/en
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Publication of DE19857887B4 publication Critical patent/DE19857887B4/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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

Verankerungsstütze für eine Herzklappenprothese, die aus einem, bei einer vorgebbaren Temperatur eine vorbestimmte Form einnehmenden Formgedächtnismetall besteht und die als ein einteiliger Körper, der aus stabförmigen Elementen (1, 2, 3, 4, 5), die zumindest teilweise eine Gitterstruktur darstellen, gebildet ist, dadurch gekennzeichnet, daß die stabförmigen Elemente (4) sägezahnförmig aneinandergereiht sind und mindestens einen Stützring (6) bilden, der als Vieleck mit mindestens acht Ecken ausgebildet ist. Anchoring support for a heart valve prosthesis consisting of a, at a predetermined temperature, a predetermined shape engaging shape-memory metal and that as a one-piece body formed of rod-shaped elements (1, 2, 3, 4, 5) which at least partly represent a grating structure, is characterized in that the rod-shaped elements (4) are sawtooth-lined up and at least a support ring (6) form, which is designed as a polygon with at least eight corners.

Description

  • Die Erfindung betrifft eine Verankerungsstütze (Stent) für eine Herzklappenprothese, bei der ein Formgedächtnismetall, auch Memory-Metall genannt, verwendet wird, um eine Herzklappenprothese zu implantieren, ohne einen größeren operativen Eingriff, mit vollständiger Öffnung des Thorax durchführen zu müssen. is The invention relates to an anchoring support (stent) for a heart valve prosthesis in which is called a shape memory metal, also memory metal, used to implant a prosthetic heart valve to without having to perform major surgery, fully opening the thorax.
  • So ist es neben anderem, beispielsweise aus der So it is among other things, for example, from DE 195 46 692 A1 DE 195 46 692 A1 bekannt, eine selbstexpandierende Herzklappenprothese mit einer Verankerungsstütze über ein Herzkathetersystem ohne Öffnung des Brustkorbes über die in der Leistengegend eines Menschens geöffnete Aorta einzuführen und bei Erreichen des gewünschten Ortes, in der Nähe des Herzens, vorzugsweise im Bereich der ursprünglichen Herzklappe zu positionieren und diese dort durch eine Selbstexpansion fest zu installieren. known to introduce a self-expanding prosthetic heart valve with an anchoring support through a cardiac catheter system without opening the chest through the open in the groin area of ​​a human aorta and position upon reaching the desired location, near the heart, preferably in the range of the original heart valve and that there by to install a self-expansion fixed.
  • Es hat sich jedoch gezeigt, daß das dort angedeutete Lösungsprinzip bisher nicht praktikabel umgesetzt werden konnte. It has, however, shown that the solution indicated there principle previously could not be implemented practical. Es konnte bisher kein Weg aufgezeigt werden, mit dem eine Verankerungsstütze für eine Herzklappenprothese einmal in einem Zustand so klein zusammengefaltet werden konnte, daß sie gemeinsam mit einem Katheter durch die Aorta und hier insbesondere durch den Aortenbogen zum Herzen geführt werden konnte. It could be shown so far no way by which an anchoring support for a heart valve prosthesis was once folded up so small in a state that it could be done in conjunction with a catheter through the aorta and particularly through the aortic arch to the heart. Eine solche Verankerungsstütze muß aber zusätzlich in der Lage sein, in einem zweiten Zustand eine Größe und Form zu erreichen, mit der gesichert ist, daß die Herzklappenfunktion über einen ausreichend langen Zeitraum wieder gesichert werden kann. However, such an anchoring support should additionally be able to achieve in a second state of a size and shape with which it is ensured that the heart valve function can be backed up again over a sufficiently long period of time.
  • Als ebenfalls nicht praktikabel hat sich der As also not practical has the DE 43 16 971 A1 DE 43 16 971 A1 entnehmbare Vorschlag erwiesen. removable proposal proved. Dort soll ein Memory-Material verwendet werden, das am Einsatzort auf rollbar bzw. aufweitbar sein soll. There, a memory material to be used, which should be at the site to be rolled or widened. Der dort als Herzklappen-Verankerungsring bezeichnete Träger für eine künstliche Herzklappe soll im zusammengerollten Zustand, wie bereits erwähnt, mittels eines Katheters zum Herzen geführt und dort bei Erwärmung infolge der Aufwicklung des Verankerungsringes sich an die Aorteninnenwandung anlegen, wobei für die Verankerung zusätzlich Verankerungsmittel am Verankerungsring nach außen ragend, vorhanden sind. The there described as heart valves anchoring ring carrier for an artificial heart valve, is to performed in the rolled up state, as mentioned above via a catheter to the heart and create there upon heating due to the winding of the anchor ring to the Aorteninnenwandung, wherein for anchoring additionally anchoring means on the anchoring ring projecting outward are provided.
  • Auch diese Lösung konnte bisher nicht praktikabel umgesetzt werden, da der spiralförmig aufgewickelte Körper in seinem Durchmesser immer noch zu groß ist, um durch eine Aorta problemlos zum Herzen geführt werden zu können. Also this solution could not be implemented practicable date, as the spirally wound body in its diameter is still too large to be passed through an aorta easily to the heart to. Außerdem muß eine entsprechende Einrichtung, wenn Sie in der Nähe des Herzens planiert werden soll, äußerst exakt positioniert werden, da die Öffnungen der Herzkranzgefäße in keiner Weise verschlossen werden dürfen. In addition, a corresponding device must if you want to planes near the heart, be extremely accurately positioned since the openings of the coronary arteries may be closed in any way.
  • Problematisch dürfte sich zusätzlich auch die dort vorgeschlagene Lösung bezüglich der Erhöhung einer Thrombosegefahr erweisen. The problem the solution proposed therein concerning the increase of thrombosis risk is likely to additionally turn.
  • Auch die Verwendung von Ballonkathetern, für die hier bezweckte Applikation, hat bisher keine befriedigenden Ergebnisse gezeigt und so konnte auch das in WO 91/17720 A1 beschriebene System in der Praxis noch nicht eingesetzt werden. The use of balloon catheters for the intended application here, has so far shown no satisfactory results and so does the system described in WO 91/17720 A1 in practice has not yet been used. Dabei wird ein aus mehreren Metalldrähten zusammengesetztes und gebogenes Element verwendet, an dem eine Herzklappenprothese befestigt werden kann und das mit dem an dem Katheter vorhanden Ballon mechanisch aufgespannt wird. In this case, an image composed of a plurality of metal wires and bent member is used, to which a heart valve prosthesis can be attached and which is clamped mechanically to the present on the catheter balloon. Die hierfür erforderliche Größe genügt jedoch den tatsächlich zur Verfügung stehenden räumlichen Verhältnissen in der Aorta nicht, und so ist es auch bisher nicht gelungen, einen entsprechenden operativen Eingriff mit Erfolg durchführen zu können. However, this does not meet the required size actually available spatial conditions in the aorta, and so it is also so far failed to conduct an appropriate surgical procedure successfully.
  • Daneben ist in Besides, in DE 195 32 846 A1 DE 195 32 846 A1 eine dort sogenannte Ventileinrichtung beschrieben, die insbesondere als Ersatz für eine Herzklappe verwendet werden kann. described there a so-called valve means which can be used in particular as a substitute for a heart valve. Bei dieser Lösung werden Spann- und Spreizbügel verwendet, an denen ein Segel, das die Funktion einer Herzklappenprothese übernehmen soll, taschenartig angenäht ist. In this solution, clamping and spreader bar to be used where a sail that will take over the function of a heart valve prosthesis is sewn pocket-like.
  • Ein sogenannter "Stent", der für die Aufweitung von einfachen Blutgefäßen verwendet werden kann, ist in A so-called "stent" that can be used for the expansion of simple blood vessels in US 5,540,712 US 5,540,712 beschrieben. described. Dieser "Stent" wird durch eine drahtförmige Gitterstruktur, die aus einem Formgedächtnismetall besteht, gebildet, wobei nach Einführung dieses "Stents" und entsprechende Temperierung das Formgedächtnismetall eine Aufweitung dieses "Stents" bewirkt, so dass er an der Gefäßinnenwand anliegt. This "stent" is formed by a wire-shaped lattice structure consisting of a shape memory metal, wherein "stents" and corresponding temperature, the shape memory metal causes a widening of this "stents" by introducing this so that it abuts against the vessel inner wall. Für eine verbesserte Fixierung im Blutgefäß wird vorgeschlagen, Widerhaken auszubilden, die sich in der Gefäßwand verhaken oder eine Anpassung, durch entsprechende Einprägung unterschiedlicher Durchmesser an unterschiedliche Blutgefäßinnendurchmesser den Halt verbessern soll. For an improved fixing in the blood vessel is proposed to form barbs which snag in the vessel wall, or an adjustment to improve by a corresponding indentation of different diameters to different blood vessel inner diameter of the support.
  • Es ist daher Aufgabe der Erfindung, eine Verankerungsstütze für eine Herzklappenprothese zur Verfügung zu stellen, die einfach herstellbar ist und mit der man in die Lage versetzt wird, diese gemeinsam mit einer Herzklappenprothese durch die Aorta bis in die unmittelbare Nähe des Herzens zu führen und dort mit Erfolg zu implantieren. It is therefore an object of the invention to provide an anchoring support for a heart valve prosthesis are available which can be manufactured easily and with which one is able to guide them together with a prosthetic heart valve through the aorta into the immediate vicinity of the heart and there to implant successfully.
  • Erfindungsgemäß wird diese Aufgabe mit den Merkmalen des Patentanspruchs 1 für die Verankerungsstütze gelöst. According to the invention this object is achieved with the features of claim 1 for the anchoring support. Vorteilhafte Ausgestaltungsformen und Weiterbildungen der Erfindung ergeben sich durch die in den untergeordneten Ansprüchen genannten Merkmale. Advantageous embodiments and developments of the invention will be apparent by those mentioned in the subordinate claims.
  • Dabei geht die erfindungsgemäße Lösung von dem bekannten Gedanken, der Verwendung eines Memory-Materials aus und es wird demzufolge vorgeschlagen, eine Verankerungsstütze aus einem Formgedächtnismetall zu verwenden, das in der Lage ist, bei Erreichen einer bestimmten vorgebbaren Sprungtemperatur eine eingeprägte Form und Größe einzunehmen, die einen sicheren Halt, Dichtheit der Herzklappenprothese, geringe Thrombosegefahr und die Beachtung der Freihaltung der Herzkranzgefäßöffnungen ermöglicht. The inventive solution is based on the familiar idea of ​​using a memory material and it is therefore proposed to use an anchoring support from a shape memory metal that is able to assume a memorized shape and size when a certain predetermined critical temperature, which allows a secure grip, tightness of the prosthetic heart valve, low risk of thrombosis and the observance of the free attitude of coronary artery openings. Die erfindungsgemäße Verankerungsstütze für eine Herzklappenprothese ist daher als einteiliger Körper ausgebildet, der aus einzelnen stabförmigen Elementen gebildet ist, die zumindest teilweise eine Gitterstruktur darstellen. The anchoring bracket according to the invention for a heart valve prosthesis is therefore designed as a one-piece body which is formed from individual bar-shaped elements which at least partly represent a lattice structure.
  • Dabei wird die Dicke der stabförmigen Elemente so klein, wie möglich gewählt, um einmal eine ausreichende Festigkeit und Stabilität zu sichern und zum anderen jedoch die Thrombosegefahr entsprechend klein zu halten. The thickness of the rod-shaped elements is as small as possible, once chosen to ensure a sufficient strength and stability, and on the other hand, however, to keep the risk of thrombosis correspondingly small. Demzufolge liegt die Stärke der stabförmigen Elemente im Bereich zwischen 0,3 bis maximal 1 mm. Accordingly, the strength of the rod-shaped elements in the range between 0.3 to a maximum of 1 mm.
  • Dadurch kann gesichert werden, daß der aus einem Halbzeug, das aus einem Formgedächtnismetall besteht, hergestellte Körper zum anderen sehr klein zusammengedrückt bzw. gefaltet werden kann und der bei der Positionierung des zusammengedrückten bzw. zusammengefalteten Körpers durch die Aorta nicht zu überschreitende freie Querschnitt von ca. 7 mm mit Sicherheit eingehalten werden kann. Thereby it can be ensured that the body consists of a semi-finished product, consisting of a shape memory metal produced on the other compressed very small or can be folded and in the positioning of the compressed or folded body not to be exceeded by the aorta free cross section of ca . 7mm can be maintained with certainty.
  • Erfindungsgemäß wird die Verankerungsstütze aus einem aus einem Formgedächtnismetall bestehenden Halbzeug hergestellt, in dem die eigentliche Struktur mit den stabförmigen Elementen ausgeschnitten bzw. ausgestanzt wird. According to the invention the anchoring support from a group consisting of a shape memory metal semifinished product is prepared, in the cut out the actual structure of the rod-shaped elements, or die cut. Beim Ausschneiden hat sich besonders vorteilhaft ein Laserschneidverfahren herausgestellt, mit dem man in die Lage versetzt ist, sehr genau und exakt die gewünschten Strukturen in den relativ kleinen Wandstärken auszubilden. When cutting a laser cutting method has been found particularly advantageous, with which one is able to form very precisely and exactly the desired structures in the relatively small wall thicknesses.
  • Nachdem die gewünschte Struktur ausgebildet ist, wird die Verankerungsstütze in die gewünschte Form und Größe für den implantierten Zustand gebracht und gleichzeitig bei einer Wärmebehandlung, unter Berücksichtigung der einzustellenden Sprungtemperatur, die vorteilhaft im Bereich von ca. 37 °C liegen sollte, eingeprägt. After the desired structure is formed, the anchoring support is brought into the desired shape and size on the implanted state and at the same time in a heat treatment, taking into account the adjusted critical temperature, which should advantageously be in the range of about 37 ° C, stamped.
  • Als Halbzeug kann ein entsprechend ausgebildetes plattenförmiges Element, bevorzugt aber ein rohrförmiges Halbzeug verwendet werden. As a semi-finished product, a tubular semi-finished product, a correspondingly formed plate-shaped element, but preferably be used. Für den Fall, daß ein plattenförmiges Element verwendet wird, muß dieses für das Einprägen der gewünschten Form und Größe nicht nur aufgeweitet, sondern auch entsprechend, zumindest annähernd in eine kreisrunde Form gebogen werden. In the event that a plate-shaped member is used, it must not only expanded for the impressing of the desired shape and size, but also in accordance, at least approximately be bent into a circular shape.
  • Nach dem Einprägen der Form und Größe der erfindungsgemäßen Verankerungsstütze kann an ihr die Herzklappenprothese befestigt werden. After impressing the shape and size of the anchoring support according to the invention, the heart valve prosthesis can be attached to it. Die Herzklappenprothese kann von außen von einer Seite auf die Verankerungsstütze übergestülpt und gegebenenfalls zusätzlich angenäht werden, wobei dieser Teil der Verankerungsstütze so geformt und dimensioniert ist, daß die Kommissuren einer biologischen Herzklappenprothese, die zB von einem Schweineherz entnommen sein kann und in präparierter Form zur Verfügung gestellt wird, berücksichtigt wird. The heart valve prosthesis can be imposed from the outside of one side to the anchoring support and optionally additionally sewn, said part of the anchoring support is shaped and dimensioned such that the commissure of a biological heart valve prosthesis, for example, can be removed from a pig heart and in-prepared form available is taken into account is found. Eine solche Herzklappenprothese kann aber auch durch die Verankerungsstütze geführt sein und von innen an der entsprechend ausgebildeten Gitterstruktur oder bogenförmigen Elementes befestigt werden. However, such a heart valve prosthesis can also be guided by the anchoring support and be attached to the inside of the correspondingly shaped grating structure or sheet-shaped element. In ähnlicher Weise kann aber auch eine künstliche Herzklappenprothese aus hierfür geeigneten Materialien eingesetzt werden. Similarly, as well as an artificial heart valve prosthesis can be used for this purpose suitable materials.
  • Als Formgedächtnismetall kann eine Nickel-Titanlegierung, die zB unter der Bezeichnung "Nitinol" kommerziell erhältlich ist, verwendet werden. As a shape memory metal, a nickel-titanium alloy, for example, under the name "Nitinol" is commercially available, can be used. Nach der Ausbildung der Struktur und dem Einprägen der gewünschten Form und Größe im implantierten Zustand, kann die Verankerungsstütze mittels bekannter Oberflächenbehandlungsverfahren, wie zB dem Elektropolieren an ihrer Oberfläche veredelt und geglättet werden, so daß auch hierdurch der Thrombosegefahr entgegengewirkt werden kann. After formation of the structure and the impressing of the desired shape and size in the implanted state, the anchoring support as can be refined, for example, the electro-polishing on the surface and smoothed by means of a known surface treating method, so that thereby the risk of thrombosis may be counteracted.
  • Bei der erfindungsgemäßen Verankerungsstütze wird eine Gitterstruktur ausgebildet, bei der stabförmige Elemente zum Teil mäanderförmig ausgebildet sind und in ihrer Ausrichtung mindestens einen Stützring bilden, der sich als solcher im implantierten Zustand an der Aorteninnenwandung anlegen kann. In the inventive anchoring support a grating structure is formed, are formed in meandering fashion in the rod-shaped elements to form at least part and a support ring in their orientation that can bear against the Aorteninnenwandung as such in the implanted state. An dem einen aber auch an mehreren solcher mit den stabförmigen Elementen gebildeten Stützringen können Verankerungshaken ausgebildet sein, die ebenfalls aus dem verwendeten Formgedächtnismetall bestehen. Anchoring hooks may be formed on the one but also of several such with the rod-shaped elements formed support rings, which are also made of the shape memory metal used. Diesen Verankerungshaken wird beim Einprägen jedoch eine radial nach außen aufgerichtete Stellung eingestellt, so daß sie sich im implantierten Zustand in der Aorteninnenwandung verhaken und die Verankerungsstütze entsprechend sicher gehalten werden kann und die Verhakung zusätzlich zur Spannkraft der expandierten Veranke rungsstütze wirken kann. This anchoring hook is however set a radially erected outward position during embossing, so that they embed themselves within the implanted state in the Aorteninnenwandung and the anchoring support can be kept correspondingly safe and entanglement can approximately support act in addition to the clamping force of the expanded anchoring.
  • Vorteilhaft ist es, wenn den Verankerungshaken verschiedene Aufrichtrichtungen eingeprägt werden, die jeweils in entgegengesetzten Richtungen in bezug zur Längsachse der Verankerungsstütze in einem Winkel ungleich 90° liegen, so daß eine sichere Verankerung in beiden möglichen Bewegungsrichtungen einer Verankerungsstütze erreicht werden kann. it when the anchoring hooks different Aufrichtrichtungen are embossed which are respectively in opposite directions with respect to the longitudinal axis of the anchor post at an angle equal to 90 °, so that a reliable anchoring can be achieved in two possible directions of movement of an anchoring support is advantageous. Die Verankerungshaken sollten eine Länge von mindestens 1 und maximal 5 mm aufweisen, so daß eine vollständige Durchtrennung der Aortenwandung vermieden werden kann. The anchoring hooks should have a length of at least 1 and at most 5 mm, so that a complete cut through the Aortenwandung can be avoided.
  • Wird eine Verankerungsstütze mit mehr als einem Stützring verwendet, können diese Stützringe mittels Verbindungsstegen zwischen nebeneinander angeordneten Mäandern, die durch die stabförmigen Elemente der Stützringe gebildet sind, erreicht werden. Is an anchor post used with more than a support ring, these support rings can be achieved by means of connecting webs between adjacent meanders that are formed by the rod-shaped elements of the support rings.
  • Die Herzklappenprothese kann an einem stirnseitig angeordneten geschlossenen Kreisring oder einem aus einem Vieleck gebildeten Ring anliegen. The heart valve prosthesis can bear against a frontally arranged closed circular ring or a ring formed of a polygon.
  • Es besteht aber auch die Möglichkeit, an dieser Stirnseite der Verankerungsstütze drei bogenförmige Elemente für die Fixierung der Herzklappenprothese auszubilden. There is also the possibility of forming three arcuate elements for the fixation of the prosthetic heart valve at that end face of the anchor post. Dabei liegen diese bogenförmigen Elemente im implantierten Zustand an der Aorteninnenwand an. In this case, this arc-shaped elements in the implanted state of wall of the aorta are on. Mit den bogenförmigen Elementen kann im Gegensatz zu einem geschlossenen Ring eine höhere Elastizität bei der Selbstexpansion und gleichzeitig eine Anpassung an die Form der Kommissuren einer Herzklappenprothese erreicht werden. With the arcuate elements as opposed to a closed ring a higher elasticity in the self-expansion and at the same time to adapt to the shape of the commissures of the heart valve prosthesis can be achieved.
  • Neben einer Röhrenform kann die erfindungsgemäße Ver ankerungsstütze auch in Form eines Vieleckes ausgebildet sein, wobei dieses aber mindestens über acht Ecken verfügen sollte. In addition to a tubular form Ver the present invention can be formed anchoring support in the form of a polygon, but wherein this should have at least eight corners. Die letztgenannte Form hat einen erhöhten Selbstarretiereffekt, da die Eckkanten und die für die Verbindung von mehreren Stützringen verwendeten stabförmigen Elemente nicht parallel zur Längsachse der Verankerungsstütze ausgerichtet sein können. The latter form has an increased Selbstarretiereffekt, since the corner edges and the rod-shaped elements used for the connection of a plurality of support rings may not be aligned parallel to the longitudinal axis of the anchoring support. Daher kan ein erhöhter Formschluß für den sicheren Halt der Verankerungsstütze in der Aorta erreicht werden. Therefore kan increased positive engagement to securely hold the anchor post be achieved in the aorta.
  • Nach der Befestigung der Herzklappenprothese an der erfindungsgemäßen Verankerungsstütze kann beides gemeinsam zusammengedrückt bzw. -gefaltet und in einer Tasche, die an einem Katheter befestigt ist, untergebracht werden. After the attachment of the heart valve prosthesis to the inventive anchoring support both can be compressed together or -gefaltet and housed in a pocket that is attached to a catheter. Dabei ist die Tasche mit einem Kühlsystem verbunden, durch das entsprechend gekühlte Kochsalzlösung geführt wird, so daß die Verankerungsstütze unterhalb der Sprungtemperatur gehalten wird. The bag with a cooling system is connected, is guided by the corresponding cooled saline, so that the anchoring support is kept below the transition temperature.
  • Das Katheter kann dann in bekannter Form, an einem Draht durch die Aorta bis in die unmittelbare Nähe des Herzens geführt werden. The catheter can then be in a known form, are fed to a wire through the aorta into the immediate vicinity of the heart. Nach dem Erreichen der gewünschten Position und Überprüfung der Lage bezüglich der Herzkranzgefäßöffnungen kann die schützende Kappe entfernt oder zerstört werden und bei Erreichen der Sprungtemperatur stellt sich infolge von Selbstexpansion die für die Implantation gewünschte Form und Größe der Verankerungsstütze ein, wobei sich gleichzeitig die Verankerungshaken aufrichten und in der Aorteninnenwandung verklammern. After reaching the desired position, and checking the location with respect to the coronary openings, the protective cap can be removed or destroyed, and upon reaching the transition temperature arises as a result of self-expansion, the desired for implantation shape and size of the anchoring support, where at the same time raise the anchoring hooks and brace in the Aorteninnenwandung.
  • Im Anschluß hieran können Führungsdraht und Katheter wieder entfernt werden und die Herzklappenprothese, die Funktion der natürlichen Herzklappe übernehmen. Following this guide wire and catheter can be removed and take over the prosthetic heart valve, the function of the natural heart valve.
  • Nachfolgend soll die Erfindung beispielhaft, anhand von Ausführungsbeispielen näher erläutert werden. The invention will exemplarily be explained in more detail with reference to embodiments.
  • Dabei zeigen: They show:
  • 1 1 ein Beispiel einer erfindungsgemäßen Verankerungsstütze mit einer Herzklappenprothese in implantierter Form und Größe und an example of an anchoring support the invention with a prosthetic heart valve implanted in shape and size and
  • 2 2 eine Gitterstruktur eines Beispiels einer Verankerungsstütze in einer Abwicklung. a grating structure of one example of an anchoring support in a processing.
  • Bei dem in In the in 1 1 gezeigten Beispiel verfügt die Verankerungsstütze über zwei aus sägezahnförmig aneinandergereihten stabförmigen Elementen In the example shown the anchoring support has two out of a sawtooth juxtaposed rod-shaped elements 4 4 gebildete Stützringe Support rings formed 6 6 , die mit Verbindungsstegen That connecting webs 3 3 miteinander verbunden sind. are connected together. Außerdem sind ein Dicht- und Befestigungsring In addition, a sealing and fixing ring 1 1 für die Herzklappenprothese for the heart valve prosthesis 2 2 , der hier eine Kreisringform aufweist sowie weitere stabförmige Elemente vorhanden sind, die die Verbindung zu den Stützringen Having an annular form here and other rod-shaped elements are present, the connection to the support rings 6 6 darstellen und die Form und Größe der Kommissuren von Herzklappenprothesen berücksichtigen. represent and take into account the shape and size of the commissures of heart valves.
  • Außerdem sind an den Stützringen In addition to the support rings 6 6 zusätzlich Verankerungshaken additional anchoring hooks 5 5 vorhanden, die sich, wie im allgemeinen Teil der Beschreibung bereits erwähnt, bei Überschreiten der durch Prägung vorgegebenen Sprungtemperatur radial nach außen aufrichten. present which, as already mentioned, in the general part of the description, straighten radially on exceeding the predetermined transition temperature by embossing to the outside.
  • Bei dem in In the in 2 2 gezeigten Beispiel einer erfindungsgemäßen Verankerungsstütze, wurde die Darstellungsform einer Abwicklung gewählt, um die im Formgedächtnismetall ausgebildete Struktur deutlicher erkennen zu können. For an anchoring support the invention shown, the representation form of a settlement was chosen to recognize the educated in the shape memory metal structure clearer. Bei diesem Beispiel wurden wiederum zwei Stützringe In this example, again, two support rings were 6 6 , durch sägezahnförmige Ausbildung von stabförmigen Elementen By sawtooth formation of rod-shaped elements 4 4 , an denen wiederum Verankerungshaken Where turn anchoring hooks 5 5 vorhanden sind, gewählt. are present, is selected. Die beiden Stützringe The two support rings 6 6 sind außerdem wieder mit Verbindungsstegen are also back with connecting webs 3 3 verbunden, die für einen gegebenenfalls erforderlichen Längenausgleich teilweise schlaufenartig abgebogen sind. connected, which are bent partially looped an optionally necessary length compensation.
  • Im Bereich der Verankerungsstütze, an dem die Herzklappenprothese positioniert und fixiert werden soll, sind bei diesem Beispiel drei bogenförmige Elemente In the field of anchoring support, to which the heart valve prosthesis is to be positioned and fixed, in this example, three arcuate members 7 7 ausgebildet, an denen die Herzklappenprothese anliegen kann und befestigt wird. formed, on which can rest the heart valve prosthesis and is fixed. Die Form der bogenförmigen Elemente The shape of the arcuate members 7 7 berücksichtigt die Form und Größe der Kommissuren einer biologischen Herzklappenprothese. takes into account the size and shape of the commissures of a biological heart valve prosthesis.

Claims (8)

  1. Verankerungsstütze für eine Herzklappenprothese, die aus einem, bei einer vorgebbaren Temperatur eine vorbestimmte Form einnehmenden Formgedächtnismetall besteht und die als ein einteiliger Körper, der aus stabförmigen Elementen ( Anchoring support for a heart valve prosthesis consisting of a, at a predetermined temperature, a predetermined shape engaging shape-memory metal and that as a one-piece body (of rod-shaped elements 1 1 , . 2 2 , . 3 3 , . 4 4 , . 5 5 ), die zumindest teilweise eine Gitterstruktur darstellen, gebildet ist, dadurch gekennzeichnet , daß die stabförmigen Elemente ( ), Which at least partly represent a grating structure is formed, characterized in that the rod-shaped elements ( 4 4 ) sägezahnförmig aneinandergereiht sind und mindestens einen Stützring ( ) Are sawtooth-shaped juxtaposed and at least one support ring ( 6 6 ) bilden, der als Vieleck mit mindestens acht Ecken ausgebildet ist. ) Form, which is designed as a polygon with at least eight corners.
  2. Verankerungsstütze nach Anspruch 1, dadurch gekennzeichnet, daß Verankerungshaken ( Anchoring support according to claim 1, characterized in that the anchoring hooks ( 5 5 ), die sich bei Erreichen der Sprungtemperatur des Formgedächtnismetalls radial nach außen aufrichten, am/an dem/den Stützring(en) ( ) Which sit up upon reaching the transition temperature of the shape memory metal radially outwardly (at / near the / the support ring s) ( 6 6 ) vorhanden sind. ) available.
  3. Verankerungsstütze nach Anspruch 2, dadurch gekennzeichnet, daß die Verankerungshaken ( Anchoring support according to claim 2, characterized in that the anchoring hooks ( 5 5 ) eine Länge von mindestens 1 mm aufweisen. ) Have a length of at least 1 mm.
  4. Verankerungsstütze nach einem der Ansprüche 2 oder 3, dadurch gekennzeichnet, daß Verankerungshaken ( Anchoring support according to one of claims 2 or 3, characterized in that the anchoring hooks ( 5 5 ), die sich in Bezug zur Längsachse der Verankerungsstütze in entgegengesetzten Richtungen in einem Winkel ungleich 90° radial nach außen aufrichten, vorhanden sind. Are present), the unequal in opposite directions at an angle radially outwardly upright with respect to the longitudinal axis of the anchor post 90 °.
  5. Verankerungsstütze nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß die Stützringe ( Anchoring support according to one of claims 1 to 4, characterized in that the supporting rings ( 6 6 ) mittels Verbindungsstegen ( ) (By means of connecting webs 3 3 ) verbunden sind. ) are connected.
  6. Verankerungsstütze nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß an der Seite, an der die Herzklappenprothese fixiert ist, drei bogenförmige Elemente ( Anchoring support according to one of claims 1 to 5, characterized in that at the side at which the heart valve prosthesis is fixed, three arcuate members ( 7 7 ) zur Fixierung der Herzklappenprothese ( ) (For fixation of prosthetic heart valve 2 2 ) ausgebildet sind, die an der Aorteninnenwand anliegen. are formed) which bear against wall of the aorta.
  7. Verankerungsstütze nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß sämtliche stabförmigen Elemente ( Anchoring support according to one of claims 1 to 6, characterized in that all rod-shaped elements ( 1 1 , . 3 3 , . 4 4 , . 5 5 ) eine(n) Breite/Durchmesser von maximal 1 mm aufweisen. ) A (n) have width / diameter of at most 1 mm.
  8. Verankerungsstütze nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß die Gitterstruktur, die Größe und Lage der Herzkranzgefäßöffnungen berücksichtigend, ausgebildet sind. Anchoring support according to one of claims 1 to 7, characterized in that the lattice structure, the size and location of the coronary artery openings are taking into account, is formed.
DE1998157887 1998-12-15 1998-12-15 Anchoring support for a heart valve prosthesis Expired - Lifetime DE19857887B4 (en)

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