DE19857887A1 - Anchoring support for a heart valve prosthesis comprises a single-piece component which is formed of rod shaped elements made of a memory metal, and has at least in part a lattice structure - Google Patents

Anchoring support for a heart valve prosthesis comprises a single-piece component which is formed of rod shaped elements made of a memory metal, and has at least in part a lattice structure

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Publication number
DE19857887A1
DE19857887A1 DE1998157887 DE19857887A DE19857887A1 DE 19857887 A1 DE19857887 A1 DE 19857887A1 DE 1998157887 DE1998157887 DE 1998157887 DE 19857887 A DE19857887 A DE 19857887A DE 19857887 A1 DE19857887 A1 DE 19857887A1
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DE
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Application
Patent type
Prior art keywords
characterized
anchoring support
anchoring
support according
heart valve
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.)
Granted
Application number
DE1998157887
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German (de)
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DE19857887B4 (en )
Inventor
Carsten Weber
Christoph Damm
Hans-Reiner Figulla
Markus Ferrari
Klaus Lang
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JENAVALVE TECHNOLOGY INC., WILMINGTON, DEL., US
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Fraunhofer Gesellschaft zur Forderung der Angewandten Forschung
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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

Anchoring support is a single-piece component which is formed of rod shaped elements (1, 3, 4, 5) and has at least in parts a lattice structure. An Independent claim is also included for a method for producing an anchoring support as above. The method involves production of a lattice structure of rod shaped elements made of a memory metal, bringing of the support into the required shape and size implantation, and its heat treatment with the jump temperature of the material taken into account

Description

Die Erfindung betrifft eine Verankerungsstütze (Stent) für eine Herzklappenprothese sowie ein Ver fahren zu deren Herstellung, bei dem ein Formgedächt nismetall, auch Memory-Metall genannt, verwendet wird, um eine Herzklappenprothese zu implantieren, ohne einen größeren operativen Eingriff, mit voll ständiger Öffnung des Thorax durchführen zu müssen. The invention relates to an anchoring support (stent) for a heart valve prosthesis and a Ver drive for their preparation, in which a Formgedächt nismetall, also called memory metal, is used to implant a prosthetic heart valve without major surgery, with more fully opening having to carry the chest.

So ist es neben anderem, beispielsweise aus der DE 195 46 692 A1 bekannt, eine selbstexpandierende Herz klappenprothese 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 Be reich der ursprünglichen Herzklappe zu positionieren und diese dort durch eine Selbstexpansion fest zu installieren. It is known, among other things, for example, from DE 195 46 692 A1, a self-expanding heart valve prosthesis with an anchoring support through a cardiac catheter system without opening the chest on introducing open aorta in the groin area of ​​a human being and when it reaches the desired location, near of the heart, preferably rich in position be the original heart valve and install it there by a fixed self-expansion.

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 konn te. 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 te. Eine solche Verankerungsstütze muß aber zusätz lich 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 must be zusätz Lich able to reach in a second state of a size and shape, is secured to the that the heart valve function can be backed up again over a sufficiently long period of time.

Als ebenfalls nicht praktikabel hat sich der DE 43 16 971 A1 entnehmbare Vorschlag erwiesen. As also not practical, the DE has proven 43 16 971 A1 removable proposal. Dort soll ein Memory-Material verwendet werden, das am Einsatzort aufrollbar bzw. aufweitbar sein soll. There, a memory material to be used, which is to be rolled up or expandable in the field. 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 Aorte ninnenwandung anlegen, wobei für die Verankerung zu sätzlich Verankerungsmittel am Verankerungsring nach außen ragend, vorhanden sind. The there described as heart valves anchoring ring carrier for an artificial heart valve should ninnenwandung bear against the aorte in the rolled up state, as mentioned above, led to the heart via a catheter, where upon heating due to the winding of the anchor ring, whereby to additionally for anchoring the anchoring means projecting at the anchor ring to the outside, 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 plaziert werden soll, äußerst exakt positioniert wer den, da die Öffnungen der Herzkranzgefäße in keiner Weise verschlossen werden dürfen. In addition, a corresponding device must if you want to place in the vicinity of the heart, very precisely positioned to who, 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 befriedigen den 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 not shown satisfy the 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 er forderliche Größe genügt jedoch den tatsächlich zur Verfügung stehenden räumlichen Verhältnissen in der Aorta nicht, und so ist es auch bisher nicht gelun gen, einen entsprechenden operativen Eingriff mit Erfolg durchführen zu können. The purpose it is not sufficient ford variable size to actually available spatial conditions in the aorta, and so it is not yet gen Gelun, to conduct an appropriate surgical procedure successfully.

Es ist daher Aufgabe der Erfindung, eine Veranke rungsstütze für eine Herzklappenprothese zur Verfü gung 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 insurance support for a heart valve prosthesis for Availability checked to make supply that is easy to produce and with which one is able to keep them together with a prosthetic heart valve through the aorta to the immediate vicinity of the heart and implant there with success.

Erfindungsgemäß wird diese Aufgabe mit den Merkmalen des Patentanspruchs 1 für die Verankerungsstütze an sich und in Merkmalen des Patentanspruchs 12 für ein Verfahren zur Herstellung einer entsprechenden Ver ankerungsstütze gelöst. According to the invention this object is achieved anchoring support with the features of claim 1 for the anchoring support per se and in the features of claim 12 for a method for producing a corresponding Ver. Vorteilhafte Ausgestaltungs formen und Weiterbildungen der Erfindung ergeben sich durch die in den untergeordneten Ansprüchen genannten Merkmale. Advantageous Ausgestaltungs embodiments and developments of the invention result from the mentioned in the subordinate claims.

Dabei geht die erfindungsgemäße Lösung von dem be kannten Gedanken, der Verwendung eines Memory-Materi- als 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 einge prägte Form und Größe einzunehmen, die einen sicheren Halt, Dichtheit der Herzklappenprothese, geringe Thrombosegefahr und die Beachtung der Freihaltung der Herzkranzgefäßöffnungen ermöglicht. The solution of the be familiar idea of ​​the invention, the use of a memory Materi- than goes out and it is proposed therefore to use an anchoring support from a shape memory metal that is capable of reaching a certain predetermined threshold temperature an embossed shape take and size that allows a secure fit, tightness of the prosthetic heart valve, low risk of thrombosis and the observance of the free attitude of coronary artery openings. Die erfindungs gemäße Verankerungsstütze für eine Herzklappenprothe se ist daher als einteiliger Körper ausgebildet, der aus einzelnen stabförmigen Elementen gebildet ist, die zumindest teilweise eine Gitterstruktur darstel len. Inventive proper anchoring support for a Herzklappenprothe se is therefore formed as an integral body which is formed from individual bar-shaped elements which at least in part a grid structure depicting len.

Dabei wird die Dicke der stabförmigen Elemente so klein, wie möglich gewählt, um einmal eine ausrei chende 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 suffi-reaching strength and stability, and on the other hand, however, to keep the risk of thrombosis correspondingly small. Demzufolge liegt die Stärke der stabförmi gen Elemente im Bereich zwischen 0,3 bis maximal 1 mm. Accordingly, the strength of the gene elements stabförmi is 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 zusammen gedrückt bzw. gefaltet werden kann und der bei der Positionierung des zusammengedrückten bzw. zusammen gefalteten Körpers durch die Aorta nicht zu über schreitende freie Querschnitt von ca. 7 mm mit Sicherheit eingehalten werden kann. Thereby it can be ensured that the from a semifinished product consisting of a shape memory metal, produced body may be very small pressed or together to the other folded and in the positioning of the compressed or folded body through the aorta is not to be exceeded free section of about 7 mm 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. ausge stanzt wird. According to the invention the anchoring support is prepared from a group consisting of a shape memory metal ores, in the cut out the actual structure of the rod-shaped elements in or out is punched. 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 klei nen 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 into the relatively klei NEN 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 Berück sichtigung 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 rohrför miges Halbzeug verwendet werden. As a semi-finished rohrför Miges semi-finished product, a correspondingly formed plate-shaped element, but preferably be used. Für den Fall, daß ein plattenförmiges Element verwendet wird, muß die ses für das Einprägen der gewünschten Form und Größe nicht nur aufgeweitet, sondern auch entsprechend, zu mindest annähernd in eine kreisrunde Form gebogen werden. In the event that a plate-shaped member is used, the SES must not only expanded for the impressing of the desired shape and size, but also correspondingly be to least approximately bent into a circular shape.

Nach dem Einprägen der Form und Größe der erfindungs gemäßen Verankerungsstütze kann an ihr die Herzklap penprothese befestigt werden. After impressing of the shape and size of modern fiction, the anchor post Herzklap can be attached penprothese her. Die Herzklappenprothese kann von außen von einer Seite auf die Verankerungs stütze übergestülpt und gegebenenfalls zusätzlich angenäht werden, wobei dieser Teil der Verankerungs stütze so geformt und dimensioniert ist, daß die Kommissuren einer biologischen Herzklappenprothese, die z. The heart valve prosthesis can be imposed and optionally additionally sewn on support from the outside of one side to the anchor, wherein this part of the anchoring support is shaped and dimensioned such that the commissure of a biological heart valve prosthesis, the z. B. von einem Schweineherz entnommen sein kann und in präparierter Form zur Verfügung gestellt wird, berücksichtigt wird. B. can be removed from a pig heart and is placed in-prepared form, is taken into account. 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 künst liche Herzklappenprothese aus hierfür geeigneten Ma terialien eingesetzt werden. Similarly, but also artificially Liche heart valve prosthesis suitable for this purpose Ma terialien can be used.

Als Formgedächtnismetall kann eine Nickel-Titanlegie rung, die z. As a shape memory metal, a nickel-Titanlegie tion, the z. B. unter der Bezeichnung "Nitinol" kom merziell erhältlich ist, verwendet werden. be as com under the name "Nitinol" is mercially available is used. Nach der Ausbildung der Struktur und dem Einprägen der ge wünschten Form und Größe im implantierten Zustand, kann die Verankerungsstütze mittels bekannter Ober flächenbehandlungsverfahren, wie z B. dem Elektropo lieren 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 ge desired shape and size in the implanted state, the anchor post may area cutting method by means of known Ober, such as lose the electropolished be refined on its surface and smoothed, 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 bil den, der sich als solcher im implantierten Zustand an der Aorteninnenwandung anlegen kann. In the inventive anchoring support a grating structure is formed, wherein the rod-shaped elements are formed in meandering fashion in part and in their orientation at least a support ring bil the one who can create as such in the implanted state at the Aorteninnenwandung. An dem einen aber auch an mehreren solcher mit den stabförmigen Elementen gebildeten Stützringen können verankerungs haken ausgebildet sein, die ebenfalls aus dem verwen deten Formgedächtnismetall bestehen. At the one but also of several such with the rod-shaped elements formed support rings may be formed, which is also made of the shape memory metal used does mooring hook. Diesen Veranke rungshaken wird beim Einprägen jedoch eine radial nach außen aufgerichtete Stellung eingestellt, so daß sie sich im implantierten Zustand in der Aorteninnen wandung verhaken und die Verankerungsstütze entspre chend sicher gehalten werden kann und die Verhakung zusätzlich zur Spannkraft der expandierten Veranke rungsstütze wirken kann. approximately hook this anchoring is, however, set a radially erected outward position during embossing, entangled so that they wall in the implanted state in the Aorteninnen and the anchoring support accordingly can be securely held and the entanglement may additionally approximately support act to the clamping force of the expanded anchoring.

Vorteilhaft ist es, wenn den verankerungshaken ver schiedene 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 Veran kerungsstütze erreicht werden kann. it when the anchoring hooks ver different Aufrichtrichtungen are embossed which are respectively in opposite directions with respect to the longitudinal axis of the anchor post at an angle other than 90 ° so that a secure anchoring in the two possible directions of movement of a Veran can be kerungsstütze achieved is advantageous. Die verankerungs haken sollten eine Länge von mindestens 1 und maximal 5 mm aufweisen, so daß eine vollständige Durchtren nung der Aortenwandung vermieden werden kann. The hook should mooring a length of at least 1 and at most 5 mm have, so that a complete drying of the Durchtren 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 Elemen te im implantierten Zustand an der Aorteninnenwand an. In this case, these arcuate elemene are to te in the implanted state of wall of the aorta. Mit den bogenförmigen Elementen kann im Gegensatz zu einem geschlossenen Ring eine höhere Elastizität bei der Selbstexpansion und gleichzeitig eine Anpas sung an die Form der Kommissuren einer Herzklappen prothese erreicht werden. With the arcuate elements as opposed to a closed ring a higher elasticity in the self-expansion and at the same time a solution ANPAS can be achieved prosthesis to the shape of the commissures of a heart valve.

Neben einer Röhrenform kann die erfindungsgemäße Ver ankerungsstütze auch in Form eines Vieleckes ausge bildet sein, wobei dieses aber mindestens über acht Ecken verfügen sollte. In addition to a tube shape, the invention can Ver anchoring support in the form of a polygon forms out to be, but where 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 kann ein erhöhter Formschluß für den sicheren Halt der Verankerungsstütze in der Aorta erreicht werden. Therefore, an increased positive engagement to securely hold the anchor post in the aorta can be achieved.

Nach der Befestigung der Herzklappenprothese an der erfindungsgemäßen Verankerungsstütze kann beides ge meinsam zusammengedrückt bzw. -gefaltet und in einer Tasche, die an einem Katheter befestigt ist, unterge bracht werden. After the attachment of the heart valve prosthesis to the inventive anchoring support both can ge compressed jointly or -gefaltet and be placed in a bag, which is attached to a catheter, underweight body. Dabei ist die Tasche mit einem Kühlsy stem verbunden, durch das entsprechend gekühlte Koch salzlösung geführt wird, so daß die Verankerungsstüt ze unterhalb der Sprungtemperatur gehalten wird. The bag is connected to a Kühlsy stem, is guided by the corresponding Refrigerated brine, so that the anchoring support alarm ze 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 bezüg lich der Herzkranzgefäßöffnungen kann die schützende Kappe entfernt oder zerstört werden und bei Erreichen der Sprungtemperatur stellt sich infolge von Selbst expansion 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 Lich bezüg coronary vascular openings, the protective cap to be removed or destroyed, and upon reaching the transition temperature is a result of self-expansion, the desired for implantation shape and size of the anchoring support, wherein at the same time the anchoring hooks upright 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:

Fig. 1 ein Beispiel einer erfindungsgemäßen Ver ankerungsstütze mit einer Herzklappenpro these in implantierter Form und Größe und Fig. 1 shows an example of an inventive Ver anchoring support with a synthesis Herzklappenpro implanted in shape and size, and

Fig. 2 eine Gitterstruktur eines Beispiels einer Verankerungsstütze in einer Abwicklung. Fig. 2 is a lattice structure of an example of an anchoring support in a processing.

Bei dem in Fig. 1 gezeigten Beispiel verfügt die Verankerungsstütze über zwei aus sägezahnförmig an einandergereihten stabförmigen Elementen 4 gebildete Stützringe 6 , die mit Verbindungsstegen 3 miteinander verbunden sind. In the example shown in Fig. 1, the anchoring support has two rows of saw-tooth at each rod-shaped elements 4 formed support rings 6, which are interconnected with connecting webs 3. Außerdem sind ein Dicht- und Befesti gungsring 1 für die Herzklappenprothese 2 , der hier eine Kreisringform aufweist sowie weitere stabförmige Elemente vorhanden sind, die die Verbindung zu den Stützringen 6 darstellen und die Form und Größe der Kommissuren von Herzklappenprothesen berücksichtigen. In addition, a sealing fixing arrangements and are supply ring 1 for the prosthetic heart valve 2, which here has a circular ring shape and other rod-shaped elements are present, which constitute the connection to the support rings 6 and take into account the size and shape of the commissures of the heart valve prostheses.

Außerdem sind an den Stützringen 6 zusätzlich Veran kerungshaken 5 vorhanden, die sich, wie im allgemei nen Teil der Beschreibung bereits erwähnt, bei Über schreiten der durch Prägung vorgegebenen Sprungtempe ratur radial nach außen aufrichten. Moreover Veran are attached to the support rings 6 in addition kerungshaken 5 present, which, as already mentioned, in the description by general questions, in the event of the predetermined temperature by embossing jump Tempe proceed radially outwardly upright.

Bei dem in Fig. 2 gezeigten Beispiel einer erfin dungsgemäßen Verankerungsstütze, wurde die Darstel lungsform einer Abwicklung gewählt, um die im Formge dächtnismetall ausgebildete Struktur deutlicher er kennen zu können. In the example shown in FIG. 2, an OF INVENTION to the invention anchor post that was depicting lung form of a settlement, elected to the dächtnismetall trained in Formge structure more he to know. Bei diesem Beispiel wurden wiederum zwei Stützringe 6 , durch sägezahnförmige Ausbildung von stabförmigen Elementen 4 , an denen wiederum Ver ankerungshaken 5 vorhanden sind, gewählt. In this example again, two support rings 6 have been, are available by sawtooth formation of rod-shaped elements 4 to which, in turn anchoring hook 5 Ver selected. Die beiden Stützringe 6 sind außerdem wieder mit Verbindungsste gen 3 verbunden, die für einen gegebenenfalls erfor derlichen Längenausgleich teilweise schlaufenartig abgebogen sind. The two support rings 6 are reconnected to Verbindungsste gen 3 also, which are bent partially looped an optionally erfor sary length compensation.

Im Bereich der Verankerungsstütze, an dem die Herz klappenprothese positioniert und fixiert werden soll, sind bei diesem Beispiel drei bogenförmige Elemente 7 ausgebildet, an denen die Herzklappenprothese anlie gen kann und befestigt wird. In the field of anchoring support, to which the heart valve prosthesis is to be positioned and fixed, three arcuate members 7 are formed, in this example, to which the heart valve prosthesis can anlie gene and is fixed. Die Form der bogenförmi gen Elemente 7 berücksichtigt die Form und Größe der Kommissuren einer biologischen Herzklappenprothese. The shape of the bogenförmi gen elements 7 takes into account the size and shape of the commissures of a biological heart valve prosthesis.

Claims (18)

  1. 1. Verankerungsstütze für eine Herzklappenprothese, die aus einem, bei einer vorgebbaren Temperatur eine vorbestimmte Form einnehmenden Formgedächt nismetall gebildet ist, dadurch gekennzeichnet , daß die Verankerungsstütze ein einteiliger Kör per ist, der aus stabförmigen Elementen ( 1 , 3 , 4 , 5 ), die zumindest teilweise eine Gitterstruk tur darstellen, gebildet ist. 1. anchoring support for a heart valve prosthesis consisting of a, at a predetermined temperature, a predetermined shape engaging Formgedächt formed nismetall, characterized in that the anchoring support is a one-piece Kör per consisting of rod-shaped elements (1, 3, 4, 5) is at least partially representing a structural lattice structure is formed.
  2. 2. Verankerungsstütze nach Anspruch 1, dadurch gekennzeichnet, daß die stabförmigen Elemente ( 4 ) sägezahnförmig ausgebildet sind und mindestens einen Stützring ( 6 ) bilden. 2. anchoring support according to claim 1, characterized in that the rod-shaped elements (4) are configured sawtooth-shaped and at least one support ring (6) form.
  3. 3. Verankerungsstütze nach Anspruch 1 oder 2, dadurch gekennzeichnet, daß Verankerungshaken ( 5 ), die sich bei Erreichen der Sprungtemperatur des Formgedächtnismetalls radial nach außen auf richten, am/an dem/den Stützring(en) ( 6 ) vorhan den sind. 3. anchoring support according to claim 1 or 2, characterized in that the anchoring hooks (5), the radially directed upon reaching the transition temperature of the shape memory metal to the outside on, on / to the / the support ring (s) (6) EXISTING the are.
  4. 4. Verankerungsstütze nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Verankerungsha ken ( 5 ) eine Länge von mindestens 1 mm aufwei sen. 4. sen anchoring support according to one of claims 1 to 3, characterized in that the Verankerungsha ken (5) has a length of at least 1 mm aufwei.
  5. 5. Verankerungsstütze nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß Verankerungs haken ( 5 ), die sich in Bezug zur Längsachse der Verankerungsstütze in entgegengesetzten Richtun gen in einem Winkel ungleich 90° radial nach außen aufrichten, vorhanden sind. 5. anchoring support according to one of claims 1 to 4, characterized in that the anchor hook (5), the gene with respect to the longitudinal axis of the anchor post in opposite Richtun unequal radial upright at an angle 90 ° to the outside, are provided.
  6. 6. Verankerungsstütze nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die Stütz ringe ( 6 ) mittels Verbindungsstegen ( 3 ) verbun den sind. 6. anchoring support according to one of claims 1 to 5, characterized in that the supporting rings (6) verbun by means of connecting webs (3) are the.
  7. 7. Verankerungsstütze nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß an der Seite, an der die Herzklappenprothese fixiert ist, drei bogenförmige Elemente ( 7 ) zur Fixierung der Herzklappenprothese ( 2 ) ausgebildet sind, die an der Aorteninnenwand anliegen. 7. anchoring support according to one of claims 1 to 6, characterized in that at the side at which the heart valve prosthesis is fixed, three arcuate members (7) for fixing the heart valve prosthesis (2) are formed which abut wall of the aorta.
  8. 8. Verankerungsstütze nach einem der Ansprüche l bis 7, dadurch gekennzeichnet, daß sämtliche Elemente ( 1 , 3 , 4 , 5 ) eine(n) Breite/Durchmesser von maximal 1 mm aufweisen. 8. anchoring support according to any one of claims l to 7, characterized in that all elements (1, 3, 4, 5) a (n) width / diameter of at most 1 mm.
  9. 9. Verankerungsstütze nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß die Gitter struktur, die Größe und Lage der Herzkranzgefäß öffnungen berücksichtigend, ausgebildet ist. 9. anchoring support according to one of claims 1 to 8, characterized in that the lattice structure, the size and location of openings of the coronary vessel into consideration, is formed.
  10. 10. Verankerungsstütze nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß die Veranke rungsstütze innerhalb einer gekühlten Tasche, an einem Katheter während der Positionierung durch die Aorta angeordnet ist/sind. 10. anchoring support according to one of claims 1 to 9, characterized in that the anchoring support approximately within a refrigerated bag, is disposed on a catheter during positioning through the aorta is / are.
  11. 11. Verankerungsstütze nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß der/die Stützring(e) ( 6 ) als Vieleck, mit mindestens acht Ecken ausgebildet ist. 11. anchoring support according to one of claims 1 to 10, characterized in that the / the support ring (e) (6) as a polygon, is formed with at least eight corners.
  12. 12. Verfahren zur Herstellung einer Verankerungs stütze nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, daß 12. A process for the preparation of a anchoring support according to one of claims 1 to 11, characterized in that
    • - eine Gitterstruktur mit stabförmigen Ele menten ( 1 , 3 , 4 , 5 ) in einem Halbzeug aus Formgedächtnismetall ausgebildet; - a grating structure with rod-shaped ele ments (1, 3, 4, 5) formed in a semifinished product made of shape-memory metal;
    • - die Verankerungsstütze in die gewünschte Form und Größe in implantierter Stellung gebracht und diese dem Formgedächtnismetall bei einer Wärmebehandlung, unter Berück sichtigung der Sprungtemperatur eingeprägt wird. - brought the anchor post in the shape and size desired in the implanted position and this is the shape memory metal stamped in a heat treatment, taking into account the critical temperature.
  13. 13. Verfahren nach Anspruch 12, dadurch gekennzeichnet, daß die Gitterstruktur durch ein Laserschneidverfahren ausgebildet wird. 13. The method according to claim 12, characterized in that the lattice structure is formed by a laser cutting method.
  14. 14. Verfahren nach Anspruch 12 oder 13, dadurch gekennzeichnet, daß ein rohrförmiges Halbzeug aus einem Formgedächtnismetall verwen det wird. 14. The method of claim 12 or 13, characterized in that a tubular semi-finished USAGE of a shape memory metal is det.
  15. 15. Verfahren nach einem der Ansprüche 12 bis 14, dadurch gekennzeichnet, daß ein Halbzeug, dessen Wandstärke die Dicke der stabförmigen Elemente ( 1 , 3 , 4 , 5 ) aufweist, verwendet wird. 15. The method according to any one of claims 12 to 14, characterized in that a semifinished product, the wall thickness of the thickness of the rod-shaped elements (1, 3, 4, 5), is used.
  16. 16. Verfahren nach einem der Ansprüche 12 bis 15, dadurch gekennzeichnet, daß das Einprägen der Form und Größe der Verankerungsstütze für eine Sprungtemperatur von ca. 37°C durchgeführt wird. 16. The method according to any one of claims 12 to 15, characterized in that the impressing of the shape and size of the anchoring support for a transition temperature of about 37 ° C is performed.
  17. 17. Verfahren nach einem der Ansprüche 12 bis 16, dadurch gekennzeichnet, daß eine Nickel-Titan- Legierung verwendet wird. 17. The method according to any one of claims 12 to 16, characterized in that a nickel-titanium alloy is used.
  18. 18. Verfahren nach einem der Ansprüche 12 bis 17, dadurch gekennzeichnet, daß die Verankerungs stütze mittels Elektropolieren einer Ober flächenbehandlung unterzogen wird. 18. The method according to any one of claims 12 to 17, characterized in that the anchoring support is subjected by means of electro-polishing a top surface treatment.
DE1998157887 1998-12-15 1998-12-15 Anchoring support for a heart valve prosthesis Active DE19857887B4 (en)

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