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 structureInfo
- 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
- Authority
- DE
- Germany
- Prior art keywords
- anchoring
- anchoring support
- support
- heart valve
- shaped elements
- 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.)
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Classifications
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- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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; Valves implantable in the body
- A61F2/2412—Heart 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; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Abstract
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 to their manufacture, in which a shape memory nismetall, also called memory metal, used to implant a prosthetic heart valve, without major surgery, with full constant opening of the thorax.
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.So it is among other things, for example from DE 195 46 692 A1 known to be a self-expanding heart flap prosthesis with an anchoring support Cardiac catheter system without opening the chest over the one open in the groin area of a person Introduce aorta and when the desired one is reached Place, near the heart, preferably in the Be position the original heart valve and there firmly through self-expansion to install.
Es hat sich jedoch gezeigt, daß das dort angedeutete Lösungsprinzip bisher nicht praktikabel umgesetzt werden konnte. 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. 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, it has been shown that what is indicated there So far, the solution principle has not been practically implemented could be. So far, no path has been shown with an anchoring support for a Heart valve prosthesis once in a condition so small could be folded up that together with a catheter through the aorta and here in particular through the aortic arch to the heart te. However, such anchoring support must be additional Lich able to be in a second state To achieve size and shape that is secured that the heart valve function is sufficient can be backed up for a long period of time.
Als ebenfalls nicht praktikabel hat sich der DE 43 16 971 A1 entnehmbare Vorschlag erwiesen. Dort soll ein Memory-Material verwendet werden, das am Einsatzort aufrollbar bzw. aufweitbar sein soll. 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.DE 43 16 971 A1 has likewise not been practical removable proposal proved. There should be one Memory material used on site should be able to be rolled up or expanded. The one there Heart valve anchor ring designated carriers for an artificial heart valve is said to be curled up Condition, as already mentioned, using a catheter led to the heart and there when heated as a result of The anchoring ring is wound onto the aortic Lay the inner wall, whereby for anchoring additional anchoring means on the anchoring ring protruding outside, are present.
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. 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.So far, this solution has not been practical either be implemented because of the spiral wound Body is still too large in diameter to be easily led to the heart through an aorta to be able to. In addition, a corresponding Establishment if you are close to the heart who is to be placed, positioned extremely precisely because the openings of the coronary arteries in none May be closed in a manner.
Problematisch dürfte sich zusätzlich auch die dort vorgeschlagene Lösung bezüglich der Erhöhung einer Thrombosegefahr erweisen.The one there is also likely to be problematic proposed solution regarding increasing a Show risk of thrombosis.
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. 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. 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.Also the use of balloon catheters for here intended application, has so far failed to satisfy the results and so could that in System described in WO 91/17720 A1 in practice not be used. One becomes several Metal wire composite and bent element used to which a heart valve prosthesis is attached can be and that with the existing on the catheter Balloon is mechanically clamped. The he for this however, the required size is actually sufficient Available spatial conditions in the Aorta not, and so far it has not been possible appropriate surgery with To be able to carry out success.
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 anchor support for a heart valve prosthesis supply that is easy to manufacture and with who are put in a position to share them with a prosthetic heart valve through the aorta up to to lead the immediate proximity of the heart and there to implant successfully.
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. Vorteilhafte Ausgestaltungs formen und Weiterbildungen der Erfindung ergeben sich durch die in den untergeordneten Ansprüchen genannten Merkmale. According to the invention, this object is achieved with the features of claim 1 for the anchoring support itself and in features of claim 12 for a Process for producing a corresponding ver anchor support released. Advantageous design Shapes and developments of the invention result by those mentioned in the subordinate claims Characteristics.
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. 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.The solution according to the invention is based on the known thoughts, the use of a memory material as from and it is therefore proposed to create a Anchoring support made of a shape memory metal use that is capable of reaching one a certain predeterminable jump temperature embossed shape and size to assure a safe Hold, tightness of the prosthetic heart valve, low Thrombosis and observance of the freedom of the Allow coronary artery openings. The fiction appropriate anchoring support for a heart valve prosthesis se is therefore designed as a one-piece body, the is formed from individual rod-shaped elements, which at least partially represent a lattice structure 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. Demzufolge liegt die Stärke der stabförmi gen Elemente im Bereich zwischen 0,3 bis maximal 1 mm.The thickness of the rod-shaped elements becomes like this Small, as possible, chosen to be enough adequate strength and stability and to others, however, the risk of thrombosis is correspondingly small to keep. Accordingly, the strength of the rod-shaped elements in the range between 0.3 to maximum 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.This can ensure that the one Semi-finished product, which consists of a shape memory metal, manufactured bodies to the other very small together can be pressed or folded and the at Positioning the compressed or together folded body through the aorta with a free cross section of approx. 7 mm Security can be maintained.
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. 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.According to the anchoring support from one semi-finished product consisting of a shape memory metal manufactured in which the actual structure with the cut out or cut out rod-shaped elements is punched. When cutting out has been special advantageously highlighted a laser cutting process, with which you are able to, 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 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 in the desired shape and Brought size for the implanted state and at the same time with a heat treatment, under consideration the jump temperature to be set, the should advantageously be in the range of approx. 37 ° C, embossed.
Als Halbzeug kann ein entsprechend ausgebildetes plattenförmiges Element, bevorzugt aber ein rohrför miges Halbzeug verwendet werden. 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.An appropriately designed semifinished product can be used plate-shaped element, but preferably a tubular semi-finished products can be used. In case that a plate-shaped element is used, the for embossing the desired shape and size not only expanded, but also accordingly bent at least approximately into a circular shape become.
Nach dem Einprägen der Form und Größe der erfindungs gemäßen Verankerungsstütze kann an ihr die Herzklap penprothese befestigt werden. 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. B. von einem Schweineherz entnommen sein kann und in präparierter Form zur Verfügung gestellt wird, berücksichtigt wird. Eine solche Herzklappenprothese kann aber auch durch die Verankerungsstütze geführt sein und von innen an der entsprechend ausgebildeten Gitterstruktur oder bogenförmigen Elementes befestigt werden. In ähnlicher Weise kann aber auch eine künst liche Herzklappenprothese aus hierfür geeigneten Ma terialien eingesetzt werden.After impressing the shape and size of the fiction according to the anchoring support, the heartbeat can be attached to it pen prosthesis. The heart valve prosthesis can be anchored to the outside from one side Support put on and if necessary additionally be sewn on, this part of the anchor Support is shaped and dimensioned so that the Commissures of a biological heart valve prosthesis, the z. B. can be taken from a pig heart and is provided in a prepared form, is taken into account. Such a heart valve prosthesis but can also be guided through the anchoring support be and from the inside on the appropriately trained Lattice structure or arcuate element attached become. In a similar way, however, an art Liche heart valve prosthesis from suitable Ma materials are used.
Als Formgedächtnismetall kann eine Nickel-Titanlegie rung, die z. B. unter der Bezeichnung "Nitinol" kom merziell erhältlich ist, verwendet werden. 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.A nickel-titanium alloy can be used as a shape memory metal tion, the z. B. under the name "Nitinol" com commercially available can be used. After Training the structure and memorizing the ge desired shape and size in the implanted state, can the anchor support using known upper surface treatment processes such as electropo greased and smoothed on their surface be, so that also the risk of thrombosis can 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. 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. 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.In the anchoring support according to the invention a lattice structure is formed in the rod-shaped Elements are partially meandering and in their alignment at least one support ring bil the one who looks at himself in the implanted state the inner wall of the aorta can create. On one but also on several such with the rod-shaped Elements formed support rings can be anchored be designed hooks, which also from the use the existing shape memory metal. That anchorage tion hook becomes a radial when embossed set upward position so that they are implanted in the aortic cavity hook the wall and correspond to the anchoring support can be kept safe and the entanglement in addition to the elasticity of the expanded anchor support can act.
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. 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.It is advantageous if the anchoring hook ver different erection directions are impressed that each in opposite directions with respect to Longitudinal axis of the anchoring support at an angle are not equal to 90 °, so that secure anchoring in both possible directions of movement of a veran core support can be achieved. The anchoring hooks should be at least 1 and maximum in length 5 mm so that a complete penetration of the aortic wall 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.Becomes an anchor post with more than one Support ring used, these support rings by means of Connecting bridges between side by side Meandering through the rod-shaped elements of the Support rings are formed can be achieved.
Die Herzklappenprothese kann an einem stirnseitig angeordneten geschlossenen Kreisring oder einem aus einem Vieleck gebildeten Ring anliegen.The prosthetic heart valve can be on one face arranged closed circular ring or one out a ring formed polygon.
Es besteht aber auch die Möglichkeit, an dieser Stirnseite der Verankerungsstütze drei bogenförmige Elemente für die Fixierung der Herzklappenprothese auszubilden. Dabei liegen diese bogenförmigen Elemen te im implantierten Zustand an der Aorteninnenwand an. 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.But there is also the possibility of this Front of the anchor support three arched Elements for the fixation of the heart valve prosthesis to train. These arc-shaped elements lie here te in the implanted state on the aortic inner wall on. With the arched elements, in contrast to a closed ring a higher elasticity self-expansion and adjustment at the same time solution to the shape of the commissures of a heart valve prosthesis can be achieved.
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. 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. Daher kann ein erhöhter Formschluß für den sicheren Halt der Verankerungsstütze in der Aorta erreicht werden.In addition to a tubular shape, the Ver anchor support also in the form of a polygon forms, but this is at least over eight Corners should have. The latter form has an increased self-locking effect because of the corner edges and that for the connection of several support rings used rod-shaped elements not parallel to Be aligned along the longitudinal axis of the anchoring support can. Therefore, an increased form fit for the the anchoring support is held securely 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. 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.After attaching the heart valve prosthesis to the Anchoring support according to the invention can both ge compressed or folded together and in one Bag attached to a catheter be brought. The bag comes with a cooling system stem connected by the appropriately cooled cook Saline solution is performed so that the anchorage ze 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. 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.The catheter can then be in a known form on a Wire through the aorta to close proximity of the heart. After reaching the desired position and review of the location the protective coronary artery openings Cap can be removed or destroyed and when reached the jump temperature arises as a result of self expansion the shape desired for the implantation and size of the anchoring support at the same time raise the anchor hook and in cling to the aortic inner wall.
Im Anschluß hieran können Führungsdraht und Katheter wieder entfernt werden und die Herzklappenprothese, die Funktion der natürlichen Herzklappe übernehmen. Following this, the guidewire and catheter can be used be removed and the prosthetic heart valve, take over the function of the natural heart valve.
Nachfolgend soll die Erfindung beispielhaft, anhand von Ausführungsbeispielen näher erläutert werden.In the following, the invention will be exemplified, based on are explained in more detail by exemplary embodiments.
Dabei zeigen: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 anchorage Ver invention with a prosthetic prosthesis in implanted 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. 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 the example shown in FIG. 1, the anchoring support has two support rings 6 which are formed from sawtooth-shaped rod-shaped elements 4 and which are connected to one another by connecting webs 3 . In addition, a sealing and fastening supply ring 1 for the heart valve prosthesis 2 , which here has a circular ring shape and further rod-shaped elements are present, which represent the connection to the support rings 6 and take into account the shape and size of the commissures of 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.In addition, Veran kerungshaken 5 are present on the support rings 6 , which, as already mentioned in the general part of the description, rise above the embossing temperature set by stamping radially outward.
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. Bei diesem Beispiel wurden wiederum zwei Stützringe 6, durch sägezahnförmige Ausbildung von stabförmigen Elementen 4, an denen wiederum Ver ankerungshaken 5 vorhanden sind, gewählt. Die beiden Stützringe 6 sind außerdem wieder mit Verbindungsste gen 3 verbunden, die für einen gegebenenfalls erfor derlichen Längenausgleich teilweise schlaufenartig abgebogen sind.In the example of an anchoring support according to the invention shown in FIG. 2, the representation form of a settlement was chosen in order to be able to know the structure formed in the shape metal more clearly. In this example, two support rings 6 were again selected by sawtooth-shaped formation of rod-shaped elements 4 , on which in turn anchor hooks 5 are present. The two support rings 6 are also again connected to Verbindungsste gene 3 , which are partially loop-like bent for a possibly necessary 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. Die Form der bogenförmi gen Elemente 7 berücksichtigt die Form und Größe der Kommissuren einer biologischen Herzklappenprothese.In the area of the anchoring support, on which the heart valve prosthesis is to be positioned and fixed, in this example three arcuate elements 7 are formed, to which the heart valve prosthesis can lie and be attached. The shape of the bow-shaped elements 7 takes into account the shape and size of the commissures of a biological heart valve prosthesis.
Claims (18)
- - eine Gitterstruktur mit stabförmigen Ele menten (1, 3, 4, 5) in einem Halbzeug aus Formgedächtnismetall ausgebildet;
- - 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.
- - A lattice structure with rod-shaped elements ( 1 , 3 , 4 , 5 ) formed in a semi-finished product made of shape memory metal;
- - The anchoring support is brought into the desired shape and size in the implanted position and this is impressed on the shape memory metal during heat treatment, taking into account the crack temperature.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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DE1998157887 DE19857887B4 (en) | 1998-12-15 | 1998-12-15 | Anchoring support for a heart valve prosthesis |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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DE1998157887 DE19857887B4 (en) | 1998-12-15 | 1998-12-15 | Anchoring support for a heart valve prosthesis |
Publications (2)
Publication Number | Publication Date |
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DE19857887A1 true DE19857887A1 (en) | 2000-07-06 |
DE19857887B4 DE19857887B4 (en) | 2005-05-04 |
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Application Number | Title | Priority Date | Filing Date |
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DE1998157887 Expired - Lifetime DE19857887B4 (en) | 1998-12-15 | 1998-12-15 | Anchoring support for a heart valve prosthesis |
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