DE202008018458U1 - Herzklappenstent - Google Patents
Herzklappenstent Download PDFInfo
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- DE202008018458U1 DE202008018458U1 DE202008018458.4U DE202008018458U DE202008018458U1 DE 202008018458 U1 DE202008018458 U1 DE 202008018458U1 DE 202008018458 U DE202008018458 U DE 202008018458U DE 202008018458 U1 DE202008018458 U1 DE 202008018458U1
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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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- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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- A—HUMAN NECESSITIES
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- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
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- A—HUMAN NECESSITIES
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- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
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- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
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- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
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Abstract
Herzklappenstent (10) mit einem zur Aufnahme eines Herzklappenimplantats (30) eingerichteten Abschnitt und mit einer Mehrzahl von proximal angeordneten Verankerungselementen (20), mit einer Mehrzahl von Verankerungsfäden (40), die mit ihrem einen Ende am Stent (10) befestigt sind, und einem die Verankerungsfäden (40) mit ihrem anderen Ende an der distalen Herzkammerwandung unter Ausbildung einer Spannung zwischen der Herzkammerwandung und den proximal verankerten Verankerungselementen (20) befestigenden Widerlager (80), dadurch gekennzeichnet, dass das Widerlager (80) als Fadenlängenstellelement ausgebildet ist.
Description
- Die Erfindung betrifft einen Herzklappenstent mit einem zur Aufnahme eines Herzklappenimplantats eingerichteten Abschnitt und mit einer Mehrzahl von proximal angeordneten Verankerungselementen.
- Derartige Herzklappenstents sind in einer Vielzahl von Ausbildungen zum Ersatz fehlgebildeter oder krankhaft veränderter Herzklappen bekannt. Dabei wird die chirurgische Implantation von Herzklappenprothesen regelmäßig am kardioplegischen Herzen durchgeführt. Die alte, in ihrer Funktion beeinträchtigte Herzklappe wird herausgeschnitten und die zu implantierende Herzklappenprothese eingenäht.
- Bei Vorliegen von Erkrankungen der Mitralklappe hingegen wird versucht, die alte Klappe trotz aufgetretener Fehlfunktion weitestgehend zu erhalten, damit der gesamte dynamische Mitralklappenapparat nicht zerstört wird. Das liegt daran, dass z. B. die an der Mitralklappe ansetzenden Sehnenfäden (chordae tendineae) für die Ventrikelfunktion sehr wichtig sind und daher möglichst nicht von der alten Mitralklappe losgelöst werden sollten.
- Ideal ist es daher, die Mitralklappe (wenn sie nicht rekonstruiert werden kann) weitestgehend zur Seite zu drängen, um der Klappenprothese Platz zu machen. Der Platz spielt hier eine nicht so gravierende Rolle wie in dem Aortenannulus, bei dem eine Einengung viel leichter zu Stande kommt (z. B. beim Verdrängen der alten Aortenklappe bei rein perkutaner Implantation).
- Die Sehnenfäden {chordae tendineae) der Mitralklappe sollten dabei nach Möglichkeit in ihrer Struktur erhalten bleiben, um die Ventrikelgeometrie und damit eine bestmögliche Funktion der linken Kammer weitestgehend zu erhalten bzw. zu erreichen. Hierbei ist es von enormer Bedeutung, dass das vordere (anteriore) Mitralklappensegel nicht einfach in den freien Raum Richtung linken Ventrikel gedrückt wird, sondern an den Mitralklappenannulus angeheftet wird, damit ein Vorwärts-Drängen des vorderen Mitralklappensegels in den Ausflusstrakt des linken Ventrikels (Sam-Phänomen: Systolic Anterior Movement) verhindert wird. Dieses ist außerordentlich wichtig, da es sonst schnell zu einer Linksherz-Dekompensation (massives Fehlverhalten des linken Ventrikels) kommen kann.
- Chirurgisch wird also die alte Mitralklappe an den alten Annulus angeheftet, so dass ein ungehinderter Blutfluss durch die Klappe und durch die beiden anliegenden Herzkammern gegeben ist. Nach dem Zurückdrängen (dem Anheften der Klappe an den Annulus) wird die Herzklappenprothese chirurgisch in diesen Annulus durch Einnähen implantiert.
- Diese aufwendige Methode geschieht obligatorisch unter zur Hilfenahme der Herz-Lungen-Maschine und kommt für Hochrisikopatienten regelmäßig nicht in Frage, sodass nach minimal-invasiven oder perkutanen Methoden zur Implantation einer Herzklappe gesucht wird.
- So ist aus der
DE 195 46 692 C2 oder inEP 1 469 797 B1 eine selbstexpandierbare Herzklappenprothese zur Implantation im menschlichen Körper über ein Kathetersystem mit einer Herzklappe und mit einem mit der Herzklappe verbundenen zusammenfaltbaren und expandierbaren Stent bekannt. Eine solche selbstexpandierbare Herzklappenprothese kann mit Hilfe eines Kathetersystems durch eine Leistenarterie bis hin zum Implantationsort am Herzen geführt werden. Nach Erreichen des Implantationsortes kann dann ein solcher Stent, der in seiner Längsrichtung aus mehreren relativ zueinander abwinkelbaren selbstexpandierenden Segmenten zusammengesetzt ist, sukzessiv entfaltet werden. Nach der Entfaltung kann die Herzklappenprothese mit Unterstützung von Verankerungshaken zumindest im herznahen Bereich im jeweiligen Blutgefäss verankert werden. - Eine weitere Vorrichtung zur Befestigung und Verankerung von Herklappenprothesen ist in der
DE 100 10 074 A1 beschrieben, die im Wesentlichen aus drahtförmigen miteinander verbundenen Elementen gebildet wird. Verschieden ausgebildete Bügel werden hierbei eingesetzt, um eine sichere Befestigung und Abstützung einer Herzklappe zu erreichen. Bei diesen bekannten Lösungen besteht jedoch die Gefahr einer Fehlimplantation von Herklappen durch fehlerhafte Positionierung und der fehlerhafte angulare Ausrichtung der zu implantierenden Herzklappenprothese. - Eine bessere Positionierung und angulare Ausrichtung kann durch den aus der
EP 1 469 797 B1 bekannten Stent erreicht werden, bei dem sogenannte Stützbügel ausgebildet sind, die in die Aortentaschen einführbar sind und so eine definierte Entfernung zur Aortenklappe herstellen. Darüber hinaus besteht auch die Möglichkeit eine fehlgeschlagene Implantation einer Herzklappenprothese abzubrechen und den Klappenstent wieder in das Kathetersystem bzw. die sogenannte die Kartusche hineinzuziehen. Hierbei wird dann der gesamte Stent zusammengefaltet und in die Kartusche zurückgeführt. Dabei ist es möglich den Stent erneut heraus gleiten zu lassen, sodass eine gute Positionierung für den Klappenstent nach mehreren Positionierungsversuchen erreicht werden kann (”sliding technique”). - Ein weitaus größeres Problem für die optimale Platzierung der neuen Herzklappe im Stent (bzw. Klappenstent) besteht jedoch darin, dass die alte native Klappe in den meisten Fällen der zuvor beschriebenen Implantationstechnik nicht entfernt werden soll.
- Dies führt jedoch dazu, dass die neue Klappe, die in eine alte, deformierte Klappe hineingedrückt (teilweise hineingequetscht) wird, in ihrer ursprünglichen Stentform abgewandelt wird. Dies liegt daran, dass der Implantationsort für den Klappenstent durch die Anatomie, den Zustand und die Beschaffenheit der alten nativen Klappe bestimmt wird (z. B. bei Klappensklerose oder -Verkalkung der nativen Klappe).
- Daher bestimmt der alte Klappenannulus mit den dazugehörigen veränderten Klappen/Taschen inwieweit und wohin sich die neue Klappe entfalten und damit in ihrer Form entwickeln kann. Somit ist also nicht nur die Verankerung/Positionierung wichtig, um eine optimale Klappenfunktion, sowie Vorhof und Ventrikelfunktion zu erhalten, sondern auch das Einpassen des Klappenstents in den Neo-Annulus (alter Klappenannulus bildet diesen mit alter Klappe aus) und damit das Zurückdrängen der alten Klappe. Ausgehend von den bei den bekannten Herzklappenstents auftretenden Problemen, ist es daher Aufgabe der Erfindung einen Herzklappenstent, insbesondere einen Mitralklappenstent für die minimal-invasive Transplantation, zu schaffen, der eine möglichst natürliche Funktionsausübung des Herzens ermöglicht.
- Erfindungsgemäß wird die Aufgabe durch den Herzklappenstent mit den Merkmalen von Anspruch 1 gelöst. Die Unteransprüche geben vorteilhafte Ausgestaltungen der Erfindung wieder.
- Grundgedanke der Erfindung ist es, einen Herzklappenstent zu schaffen, der die anatomischen Voraussetzungen für eine natürliche Funktionsausübung, ähnlich einem gesunden Herz, schafft. Dabei ist mit dem erfindungsgemäßen Herzklappenstent in der selbstexpandierend faltbaren Ausgestaltung eine minimal-invasive Operation ermöglicht, die eine exakte Positionierung und sichere Fixierung des Klappenstents gewährleistet. Dabei wird, insbesondere bei Ausbildung des erfindungsgemäßen Herzklappenstents als Mitralklappenstent, eine Spannung zwischen Mitralklappe und Ventrikel ähnlich der natürlichen Sehnenfadenspannung (der chordae tendineae) erzeugt und gleichzeitig dafür gesorgt, dass die Klappenanteile der alten Mitralklappe (insbesondere das anteriore Mitralklappensegel) nicht mehr den Durchfluss des Blutes stören.
- Es ist also vorgesehen, dass der Klappenstent nach der Erfindung kathetergestützt durch eines der Herzkammern oder der angrenzenden, großen Gefäße des Herzens eingeführt wird, sich dann in einer der Herzkammern entfalten kann, wobei seine Verankerungselemente im Gewebe fixiert werden. Abschließend wird der Stent an der dem Stent gegenüberliegenden, subvalvulären Herzkammerwandung unter Ausbildung einer Spannung zwischen der Herzkammerwandung und den proximal, supravalvulär verankerten Verankerungselementen mit Verankerungsfäden (im Folgenden auch neo-chordae genannt) fixiert.
- Die Fixierung der Verankerungsfäden in der distalen Herzkammerwandung stellt also zu den proximalen Verankerungselementen ein Widerlager dar, das beispielsweise durch einen Knoten oder durch ein anderes als Widerlager wirkendes Element gebildet wird. Dieses Widerlager kann bevorzugt auch als Fädenlängenstellelement ausgebildet sein.
- Vorteile des erfindungsgemässen Herzklappenstents sind also genaue und einfache Fixierung des Herzklappenstents bei minimal-invasiver Operation und verbesserte Kontraktilität des Herzens gegenüber herkömmlichen Klappenstents.
- Bevorzugt sind die im Verhältnis zur Längsachse des erfindungsgemäßen Klappenstents axial ausgerichteten Verankerungsfäden mit ihrem einen Ende am Annulus des Herzklappenimplantats befestigt, sodass bei Ausbildung der Spannung zwischen Stent und Herzkammerwandung eine direkte Wirkung auf die Positionierung und angulare Ausrichtung der Klappe erreicht werden kann.
- Die Verankerungsfäden können jedoch auch am distalen Klappenstentumfang mit dem Stent verbunden sein. Die Verbindung zwischen Verankerungsfaden und Stent muss jedoch so vorgenommen sein, dass eine im Wesentlichen im Verhältnis zur Längsachse des Stents in axialer Richtung verlaufende Spannung zwischen proximalen Verankerungselementen und distalem Widerlager ausgebildet werden kann.
- Nach einer weiteren bevorzugten Ausgestaltung der Erfindung weisen die Verankerungsfäden (neo-chordae) Elemente zur Längenverstellung der Verankerungsfaden auf, mit den die Länge der Verankerungsfäden zum Einstellen einer bestimmten Spannung zwischen Herzklappenstent und Herzwandung eingestellt werden kann. Dabei kann beispielsweise ein Fädenlängenstellelement für je einen Faden oder beispielweise ein Fädenlängenstellelement für alle Fäden gemeinsam vorgesehen sein. Das Fädenlängenstellelement ist bevorzugt klein ausgebildet und kann beispielsweise derart eingerichtet sein, dass das Element durch Aufwickeln einer überschüssigen Fadenlänge den Faden auf die gewünschte Länge verkürzt.
- Bevorzugt ist auch die Ausgestaltung von in axialer Richtung elastischen Verankerungsfäden, diese auf Kontraktionsbewegungen des Herzens reagieren können, ohne dass eine zu große Fadenlänge vorliegt, die die Herzfunktion negativ beeinflussen könnte. Dabei ist die Fadenlänge so zu wählen, dass die Elastizität nicht vollständig auf Kosten der Spannung zwischen Verankerungselementen und Herzwandung geht. Ist das Widerlager als Fädenlängenstellelement ausgebildet, ergibt sich eine besonders vorteilhafte Ausgestaltung, da hiermit auch eine Nacheinstellung der Spannung zwischen Verankerungselementen und Widerlager, also ein Nachspannen der Verankerungsraden möglich ist, ohne dass das Herz geöffnet werden müsste.
- Besonders bevorzugt ist die Struktur des Mitralklappenstents in der Ebene des Mitralklappenannulus im Wesentlichen oval oder U-förmig ausgebildet, dass kein Druck auf den LVOT (Left Ventrikulär Outflow Tract; linksventrikulärer Ausflusstrakt) und/oder Aortenannulus ausgeübt wird und damit eine Beeinträchtigung der Herzfunktion unterbleibt (Ma L, Tozzi P. Huber CH, Taub S5 Gerelle G, von Segesser LK. Double-crowned valved Stents for off-pump mitral valve replacement. Eur J Cardiothorac Surg. 2005 Aug; 28(2): 194–8; discussion 198–9.). Auch bleibt der subvalvuläre Apparat in seiner natürlichen Anatomie dadurch vollkommen erhalten und wird nicht beeinträchtigt (Boudjemline Y, Agnoletti G, Bonnet D, Behr L, Borenstein N, Sidi D, Bonhoeffer P. Steps toward the percutaneous replacement of atrioventricular valves an experimental study. J Am Coli Cardiol. 2005 Jul 19, 46(2). – 360–5).
- Dieser Klappenstent erhält eine dem natürlichen Mitralklappen-Apparat vollkommen angepasste, äußerst anschmiegende Form, so dass sich dieser konisch-zulaufende (kranial-caudale Achse) nicht ganz zirkuläre (oval-ähnlich in der transversalen Achse) Klappenstent sehr stark an die natürliche Form der Mitralklappe anlegen und anlehnen kann. Im Bereich des anterioren Mitralklappenannulus ist der Klappenstent flach und führt zu fast keinem Druck und zu keiner Einengung auf den LVOT. Im Bereich des posterioren Mitralklappenannulus ist er oval und bildet die Form des posterioren Annulus nach. Dieser Klappenstent bildet eine dünne, in der Länge (cranial-caudal) begrenzte Struktur, die sich in seiner Form vollkommen an die Mitralklappe anschmiegt und damit aussieht wie ein Negativabdruck im Bereich des natürlichen Mitralklappenannulus. Der Klappenstent berührt zwar die alte Mitralklappe und deren Annulus, jedoch belässt er diese in ihrer Anatomie fast vollkommen unverändert.
- Die Erfindung wird im Folgenden anhand von in den beigefügten Zeichnungen abgebildeten besonders bevorzugten Ausführungsbeispielen näher erläutert. Es zeigen:
-
1 ein bevorzugtes Ausführungsbeispiel des erfindungsgemäßen Klappenstents in einer schematischen Seitenansicht; -
2 das in1 gezeigte Ausführungsbeispiel in Draufsicht von oben; -
3 eine Draufsicht auf mehrere besonders bevorzugt ausgebildete Klappenstents nach der Erfindung; -
4 eine Draufsicht auf ein Ausführungsbeispiel von unten; -
5 eine schematische Ansicht zur Verdeutlichung der minimal-invasiven Transplantation eines Mitralklappenstents nach der Erfindung in einer ersten Phase bei Einbringen des erfindungsgemäßen Mitralklappenstents an den Transplantationsort; -
6 eine schematische Ansicht zur Verdeutlichung der minimal-invasiven Transplantation eines Mitralklappenstents nach der Erfindung in einer zweiten Phase nach Positionierung der Mitralklappe; -
7 eine schematische Ansicht zur Verdeutlichung der minimal-invasiven Transplantation eines Mitralklappenstents nach der Erfindung nach Abschluss der Fixierung der Verankerungsfäden außerhalb des Apex der linkventrikulären Herzwandung; -
8 eine schematische Ansicht einer alternativen, intracardialen Fixierung der Verankerungsfäden im Bereich der Papillarmuskeln; -
9 eine schematische Ansicht eines im Aortenannulus fixierten Herzklappenstents nach der Erfindung; -
10 eine schematische Ansicht eines in der Pulmonalposition fixierten Herzklappenstents nach der Erfindung; -
11 eine schematische Ansicht eines in der Trikuspidalposition fixierten Herzklappenstents nach der Erfindung; -
12 ein besonders bevorzugtes Ausführungsbeispiel des erfindungsgemäßen Klappenstents in einer schematischen Seitenansicht ohne Herzklappe und Verankerungsfaden; und -
13 eine schematische, dorsale, intracardiale Ansicht eines in der Mitralposition fixierten Herzklappenstents nach der Erfindung. - Die
1 bis11 zeigen den erfindungsgemäßen Stent zur Implantation und Befestigung von Herzklappenprothesen in verschiedenen Ansichten zur Verdeutlichung des Aufbaus des Stents und der räumlichen Verhältnisse der einzelnen Stentabschnitte zueinander im entfalteten (1 –4 und6 –11 ) und im gefalteten Zustand (5 ). -
1 zeigt einen faltbaren Mitralklappenstent10 nach der Erfindung in einer perspektivischen Lateralansicht. Der Stent10 weist im Wesentlichen drei Abschnitte auf: Proximal (supravalvulär) sind am Stent10 kreisförmig eine Vielzahl von gezackt oder bogenförmigen (3 ) Verankerungselementen20 angeordnet, die den Klappenstent10 im implantierten Zustand supravalvulär (bzw. atrial) verankern. Distal benachbart angeordnet befindet sich der konisch und im Querschnitt ovalartig geformte, zum LVOT bevorzugt abgeflachte Stentkörper30 (vgl.2 ). - Der Stentkörper
30 bildet eine korb- oder trapezähnliche Figur, die sich an den Mitralklappenannulus anschmiegt und sich in Richtung des linken Ventrikels erstreckt. Gehalten wird dieser Stent10 im Atrium durch seine konisch zulaufende Form und durch die atrialen Verankerungselemente20 . In diesen Stentkörper30 kann eine zwei oder dreizipflige Klappe50 integriert sein. - An dem Stentkörper
30 befinden sich distal (zum linken Ventrikel hin) Verankerungsfäden40 , die distal von diesem Stentkörper30 zur Verankerung des gesamten Stents10 eingerichtet sind. Diese Verankerungsfäden40 sorgen für eine Verankerung in der gegenüberliegenden Ventrikelwand oder z. B. im Bereich des Papillarmuskels (proximale, medialer oder distaler Papillarmuskelanteil); vgl.7 und8 . Diese Verankerungsfäden40 können mittels eines adjustierbaren Fadenlängenstellelements70 positioniert und mit der optimalen Länge eingestellt werden, so dass der Herzklappenstent10 dann fixiert und verankert werden können. -
2 zeigt den Stent10 in einer Draufsicht. Dabei ist zu erkennen, dass der Stent10 einen Neo-Annulus, bzw. Stentkörper30 ausbildet, in den die Herzklappenprothese50 eingesetzt und an dem sie befestigt werden kann. Weiterhin ist zu erkennen, dass der erfindungsgemäße Stent10 in Bezug auf die Vielzahl von supravalvulären (atrialen) Stentbügel20 asymmetrisch ausgebildet sein kann. Dieses ist daran zu erkennen, dass der Stentkörper30 in dieser Abbildung ovalartig ausgebildet und an einer Seite abgeflacht, also im Wesentlichen U-förmig ausgebildet ist, so dass er an dieser abgeflachten Stelle in die Richtung des LVOTs eingesetzt werden kann. Diese Abflachung bewirkt, dass an dieser Stelle kein Druck auf den LVOT und die Aortenklappe durch den selbstexpandierbaren Stent ausgeübt werden kann, wenn der Stent10 z. B. in die Mitralposition eingesetzt wird. Weitere bevorzugte Ausgestaltungen des Stents10 nach der Erfindung sind in3 gezeigt. -
4 zeigt den erfindungsgemäßen Stent10 in einer Unteransicht. Hieraus wird deutlich, dass sich der Durchmesser von dem atrialen Anteil zum ventrikulären Anteil des Stentkörpers30 verringert, so dass dieser von lateral aussieht wie ein Kegelstumpf (vgl.1 ). Sowohl die Befestigungselemente20 als auch der Stentkörper30 können mit Stoff (z. B. Kunststoff, Perikard, PTFE oder Goretex, etc.) bezogen sein, um eine verbesserte Abdichtung zwischen der Herzklappenprothese50 , Stentkörper30 und der umgebenden Herzstruktur zu erreichen. Diese Abdichtungsmembran wird dann zwischen Herzklappenprothese50 und Stentkörper30 oder auf die atrialen Stentstreben20 ein-, bzw. aufgezogen, um eine optimale Abdichtung der Klappe zwischen den beiden Herzkammern zu erreichen. - In den
5 bis7 und8 wird die retrograde transapikale Implantation eines Klappenstents beschrieben. Der retrograde transaortale als auch der antegrade transatriale Zugangsweg kann alternativ durchgeführt werden. Die Platzierung des Klappenstents mit einem gefalteten Klappenstent über dem alten Mitralklappen-Annulus ist in5 gezeigt. Nach erfolgreicher Orientierung mittels Markierungen am Klappenstent10 (nicht gezeigt) kann langsam mit der Entfaltung (z. B. bevorzugt selbstexpandierend) der atrialen Verankerungselemente20 begonnen werden. Die Positionierung im linken Atrium sollte so geschehen, dass die abgeflachte Seite des Stentkörpers30 in die Richtung es LVOT (Aortenklappe) zu liegen kommt. Der Stent wird dann weiter expandiert. -
6 zeigt den expandierten Klappenstent10 in dem linksatrioventrikularen Einflusstrakt. Verankerungsfäden40 werden an, in oder außerhalb der Herzwand adjustiert und später – wie in7 dargestellt – mit Hilfe des bevorzugt als Fädenlängenstellelement ausgebildeten Widerlagers80 fixiert. Während des Adjustierens der Länge der Verankerungsfäden40 erfolgt u. a. auch eine Visualisierung des Mitralklappenapparates (z. B. Echo, CT oder NMR), sodass der Annulus mittels des neuen Stents10 optimal in Richtung Ventrikelwand gezogen werden kann, kein paravalvuläres Leck mehr besteht, der Stent10 gut fixiert ist und der Mitralklappenannulus und -apparat vorteilhaft die linksventrikuläre Funktion unterstützt. - Alternativ zu
7 können die Verankerungsfäden40 auch an den Papillarmuskeln befestigt werden (siehe8 ), so dass diese Fäden40 neo-chordae darstellen und die Funktion der ausser Funktion gesetzten chordae tendineae übernehmen können. Die Befestigung der Verankerungsfäden40 an der Herzwandung erfolgt jeweils mittels eines Widerlagers80 , das als Knoten oder auch als eigenständiges Element ausgebildet sein kann. Auch ist es möglich, dass die ventrikulären Verankerungsfäden40 nicht nur am Stentkörper30 , sondern auch an der integrierten Klappe selbst angebracht werden. Auch können diese kaudalen Verankerungsfäden40 an jedem anderen Punkt im Ventrikel fixiert werden. Die7 zeigt die vollendete Positionierung und Fixierung des Stents10 . Nach Längen und Lagebestimmung der einzelnen Verankerungsfäden40 werden diese mittels des adjustierbaren Fadenlängenstellelements70 z. B. in der links ventrikulären Wand fixiert. Das Fadenlängenstellelement70 dient der optimalen Einstellung der Länge und der Position des Klappenstents10 und damit der Klappenprothese50 . Unterschiedliche Fäden40 können unterschiedliche Längen und Befestigungspositionen im Ventrikel aufweisen. - Die
9 bis11 zeigen weitere Beispiele für den Einsatz des Herzklappenstents10 nach der Erfindung, wobei der Stent10 an die jeweilige Anatomie angepasst ist (für die Aorten- und Pulmonalklappenposition eine eher zirkuläre Form (vgl.3 ) und für die Tricuspidalposition eine eher ovale Form). -
12 zeigt ein besonders bevorzugt ausgestaltetes Ausführungsbeispiel des erfindungsgemäßen Klappenstents in einer schematischen Seitenansicht, der zur besseren Übersichtlichkeit ohne Herzklappe und Verankerungsfäden dargestellt ist. - Zur Verdeutlichung der Lage des Klappenstents aus
12 in situ zeigt13 eine schematische, dorsale, intracardiale Ansicht eines in der Mitralposition fixierten Herzklappenstents nach der Erfindung. Beachte das gute Anschmiegen des Klappenstents an die linksatriale Umgebung. Abstände zwischen der linksatrialen Wand/Mitralannulus und dem Klappenstent werden so vermieden. Herzklappe und Verankerungsfaden zur Ventrikelspitze sind zur Vereinfachung der Darstellung weggelassen worden. - ZITATE ENTHALTEN IN DER BESCHREIBUNG
- Diese Liste der vom Anmelder aufgeführten Dokumente wurde automatisiert erzeugt und ist ausschließlich zur besseren Information des Lesers aufgenommen. Die Liste ist nicht Bestandteil der deutschen Patent- bzw. Gebrauchsmusteranmeldung. Das DPMA übernimmt keinerlei Haftung für etwaige Fehler oder Auslassungen.
- Zitierte Patentliteratur
-
- DE 19546692 C2 [0008]
- EP 1469797 B1 [0008, 0010]
- DE 10010074 A1 [0009]
- Zitierte Nicht-Patentliteratur
-
- Ma L, Tozzi P. Huber CH, Taub S5 Gerelle G, von Segesser LK. Double-crowned valved Stents for off-pump mitral valve replacement. Eur J Cardiothorac Surg. 2005 Aug; 28(2): 194–8; discussion 198–9 [0023]
- Boudjemline Y, Agnoletti G, Bonnet D, Behr L, Borenstein N, Sidi D, Bonhoeffer P. Steps toward the percutaneous replacement of atrioventricular valves an experimental study. J Am Coli Cardiol. 2005 Jul 19, 46(2). – 360–5 [0023]
Claims (9)
- Herzklappenstent (
10 ) mit einem zur Aufnahme eines Herzklappenimplantats (30 ) eingerichteten Abschnitt und mit einer Mehrzahl von proximal angeordneten Verankerungselementen (20 ), mit einer Mehrzahl von Verankerungsfäden (40 ), die mit ihrem einen Ende am Stent (10 ) befestigt sind, und einem die Verankerungsfäden (40 ) mit ihrem anderen Ende an der distalen Herzkammerwandung unter Ausbildung einer Spannung zwischen der Herzkammerwandung und den proximal verankerten Verankerungselementen (20 ) befestigenden Widerlager (80 ), dadurch gekennzeichnet, dass das Widerlager (80 ) als Fadenlängenstellelement ausgebildet ist. - Herzklappenstent (
10 ) nach Anspruch 1, dadurch gekennzeichnet, dass die Verankerungsfäden (40 ) an dem den Verankerungselementen (20 ) gegenüberliegenden Ende des Stentkörpers (30 ) befestigt sind. - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, gekennzeichnet durch wenigstens ein zur Längeneinstellung wenigstens eines Verankerungsfadens (40 ) eingerichtetes Fadenlängenstellelement (70 ). - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass das Herzklappenimplantat (30 ) eine Mitralklappe ist. - Herzklappenstent (
10 ) nach Anspruch 4, dadurch gekennzeichnet, dass der Herzklappenstent (10 ) in der Ebene des Mitralklappenannulus im Wesentlichen oval oder U-förmig ausgebildet ist. - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass der Herzklappenstent (10 ) als Kegelstumpf ausgebildet ist. - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass zwischen dem Herzklappenimplantat (30 ) und dem Stent (10 ) eine Abdichtungsmembran angeordnet ist. - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass zwischen den Verankerungselementen (20 ) und dem Herzklappenimplantat (30 ) eine Abdichtungsmembran angeordnet ist. - Herzklappenstent (
10 ) nach einem der vorhergehenden Ansprüche, dadurch gekennzeichnet, dass wenigstens ein Verankerungselement (20 ) aus einer Formgedächtnislegierung besteht.
Priority Applications (1)
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DE202008018458.4U DE202008018458U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
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DE202008018458.4U DE202008018458U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
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DE102007043830A Withdrawn DE102007043830A1 (de) | 2007-09-13 | 2007-09-13 | Herzklappenstent |
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DE202008018459.2U Expired - Lifetime DE202008018459U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
DE202008018461.4U Expired - Lifetime DE202008018461U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
DE202008018470.3U Expired - Lifetime DE202008018470U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
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DE202008018459.2U Expired - Lifetime DE202008018459U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
DE202008018461.4U Expired - Lifetime DE202008018461U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
DE202008018470.3U Expired - Lifetime DE202008018470U1 (de) | 2007-09-13 | 2008-09-10 | Herzklappenstent |
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2007
- 2007-09-13 DE DE102007043830A patent/DE102007043830A1/de not_active Withdrawn
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2008
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- 2008-09-10 EP EP08801319.8A patent/EP2194925B1/de active Active
- 2008-09-10 WO PCT/DE2008/001515 patent/WO2009033469A1/de active Application Filing
- 2008-09-10 DE DE202008018458.4U patent/DE202008018458U1/de not_active Expired - Lifetime
- 2008-09-10 DE DE202008018459.2U patent/DE202008018459U1/de not_active Expired - Lifetime
- 2008-09-10 DE DE202008018461.4U patent/DE202008018461U1/de not_active Expired - Lifetime
- 2008-09-10 ES ES08801319.8T patent/ES2445589T3/es active Active
- 2008-09-10 DE DE202008018470.3U patent/DE202008018470U1/de not_active Expired - Lifetime
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2011
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2012
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2014
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2015
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US20200000583A1 (en) | 2020-01-02 |
US9730792B2 (en) | 2017-08-15 |
DE202008018470U1 (de) | 2014-02-27 |
DE102007043830A1 (de) | 2009-04-02 |
US11213387B2 (en) | 2022-01-04 |
US20120035703A1 (en) | 2012-02-09 |
ES2445589T3 (es) | 2014-03-04 |
US20160151155A1 (en) | 2016-06-02 |
US20120035713A1 (en) | 2012-02-09 |
US9254192B2 (en) | 2016-02-09 |
DE202008018459U1 (de) | 2014-02-07 |
US9095433B2 (en) | 2015-08-04 |
US9078749B2 (en) | 2015-07-14 |
EP2194925B1 (de) | 2013-11-06 |
US10456248B2 (en) | 2019-10-29 |
WO2009033469A1 (de) | 2009-03-19 |
US20150305868A1 (en) | 2015-10-29 |
EP2194925A1 (de) | 2010-06-16 |
US20220039947A1 (en) | 2022-02-10 |
US20110004296A1 (en) | 2011-01-06 |
US20170312076A1 (en) | 2017-11-02 |
DE202008018461U1 (de) | 2014-02-12 |
US20140364944A1 (en) | 2014-12-11 |
US20120283824A1 (en) | 2012-11-08 |
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