DE102006052564B3 - Mitral valve stent for surgical implantation and fixation of heart valve prosthesis to heart, has stent clips arranged distally, where one of stent clips forms section that is externally rolled in unfolded condition of stent - Google Patents
Mitral valve stent for surgical implantation and fixation of heart valve prosthesis to heart, has stent clips arranged distally, where one of stent clips forms section that is externally rolled in unfolded condition of stent Download PDFInfo
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- DE102006052564B3 DE102006052564B3 DE200610052564 DE102006052564A DE102006052564B3 DE 102006052564 B3 DE102006052564 B3 DE 102006052564B3 DE 200610052564 DE200610052564 DE 200610052564 DE 102006052564 A DE102006052564 A DE 102006052564A DE 102006052564 B3 DE102006052564 B3 DE 102006052564B3
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- stent
- mitral valve
- heart
- valve
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—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
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- 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
- A61F2230/005—Rosette-shaped, e.g. star-shaped
Abstract
Description
Die Erfindung betrifft einen faltbaren Mitralklappenstent mit einer Mehrzahl von distal angeordneten Stentbügeln und einer Mehrzahl von proximal angeordneten Verankerungselementen.The The invention relates to a foldable mitral valve stent with a A plurality of distally disposed stent bars and a plurality of proximally arranged anchoring elements.
Die chirurgische Implantation von Herzklappenprothesen wird am kardioplegischen (herzschlafenden) Herzen durchgeführt (Goldener Standard). Die alte, in ihrer Funktion beeinträchtigte Herzklappe wird üblicherweise herausgeschnitten und die zu implantierende Herzklappenprothese eingenäht.The Surgical implantation of heart valve prostheses is cardioplegic (heart-stopping) hearts performed (Golden Standard). The old, impaired in their function Heart valve is usually cut out and implanted heart valve prosthesis sewn.
Bei Vorliegen von Erkrankungen der Mitralklappe hingegen wird versucht, die alte Klappe trotz aufgetretener Fehlfunktion weitestgehend zu erhalten, damit der gesamte Mitralklappenapparat nicht zerstört wird. Das liegt daran, dass z.B. die Sehnenfäden, die an der Mitralklappe ansetzen, sehr wichtig für die Ventrikelfunktion sind und daher auch möglichst nicht von der alten Mitralklappe losgelöst werden sollten. Ideal ist es daher, die Mitralklappe weitestgehend zur Seite zu drängen, um der neuen Klappe Platz zu machen, wenn sie nicht rekonstruiert werden kann. 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).at Presence of diseases of the mitral valve, however, it is attempted the old flap as much as possible despite malfunction occurred so that the entire mitral valve apparatus is not destroyed. This is because, e.g. the tendon threads attached to the mitral valve take on, very important for the ventricular function are and therefore not possible from the old one Mitral valve detached should be. Ideal, therefore, the mitral valve as far as possible to push aside, to make way for the new flap if it is not reconstructed can be. The course plays a not so serious role here as in the aortic annulus, which is much easier to narrow Comes off (for example, when displacing the old aortic valve with purely percutaneous implantation).
Die Sehnenfäden (Chordae tendineae) der Mitralklappe sollten dabei nach Möglichkeit in ihrer Struktur erhalten bleiben, um die Ventrikelgeometrie weitestgehend zu erhalten und damit eine bestmögliche Funktion der linken Kammer zu erhalten und zu erreichen.The chordae (Chordae tendineae) of the mitral valve should if possible retained in their structure to the ventricular geometry as far as possible to obtain and thus the best possible To maintain and reach the function of the left ventricle.
Hierbei ist es wiederum sehr wichtig, dass das vordere (anteriore) Mitralklappesegel nicht einfach in den freien Raum Richtung linken Ventrikel gedrückt wird, sondern an den Mitralklappen-Armalus angeheftet wird, damit ein Vorwärts-Drängen des vorderen Mitralklappensegels in den Ausflusstrakt des linken Ventrikels (Sam-Phänomen: Systolic Anterior Movement) verhindert wird. Dieses ist sehr wichtig, da es sonst schnell zu einer Linksherz-Dekompensation (massives Fehlverhalten des linken Ventrikels) kommen kann.in this connection Again, it is very important that the anterior (anterior) mitral valve sails does not simply push in the free space towards the left ventricle, but attached to the mitral valve Armalus, so that one Forward-urging the front Mitral valve leaflet into the outflow tract of the left ventricle (Sam phenomenon: systolic Anterior Movement) is prevented. This is very important because otherwise it quickly leads to left heart decompensation (massive misconduct of the left ventricle).
Chirurgisch wird also die alte Mitralklappe an den alten Annulus geheftet, 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 implantiert.surgical so the old mitral valve is attached to the old annulus, so that unimpeded blood flow through the flap and through the is given to both adjoining chambers of the heart. After pushing back (the Attaching the flap to the annulus) becomes the prosthetic heart valve surgically implanted in this annulus.
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 wurde.These Complex method is obligatory under the help the heart-lung machine and comes for High-risk patients do not regularly in question, so after minimally invasive or percutaneous methods was sought for implantation of a heart valve.
So
ist aus der
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 auch mit Unterstützung von Verankerungshaken zumindest im herznahen Bereich im jeweiligen Blutgefäss verankert werden. Die eigentliche Herzklappenprothese befindet sich dabei im proximalen Anteil des Stents.A Such self-expanding heart valve prosthesis can with the help of a Catheter system through a groin artery up to the implantation site led by the heart become. After reaching the implantation site can then such Stent in its longitudinal direction from a plurality of self-expanding relatively bendable Segments is gradually unfolded. To The unfolding can also assist the heart valve prosthesis Anchoring hook anchored at least in the immediate vicinity of the respective blood vessel become. The actual heart valve prosthesis is here in the proximal portion of the stent.
Eine
weitere Vorrichtung zur Befestigung und Verankerung von Herklappenprothesen
ist in der
Bei diesen bekannten Lösungen besteht jedoch die Gefahr einer Fehlimplantation von Herklappen bei der exakten Positionierung und der angularen Ausrichtung der zu implantierenden Herzklappenprothesen.at these known solutions However, there is a risk of incorrect implantation of Herklappen in the exact positioning and the angular alignment of the heart valve prostheses to be implanted.
Eine
verbesserte Positionierung und angulare Ausrichtung zur Aortenklappe
kann durch den Stent der
Darüber hinaus besteht auch die Möglichkeit eine fehlgeschlagene Implantation einer Herzklappenprothese abzubrechen und den Klappenstent (in einen Stent integrierte Klappe) wieder in das Kathetersystem (genauer die Kartusche) hineinzuziehen. Hierbei wird dann der gesamte Stent wieder zusammengefaltet und in die Katheteröffnung (Kartusche) zurückgeführt. Dabei ist es möglich den Stent wieder heraus gleiten zu lassen, wenn eine gute Positionierung für den Klappenstent erreicht wird. So kann der Klappenstent heraus und wieder hereingeholt werden bis die optimale Positionierung erreicht wird („sliding technique").In addition, it is also possible to cancel a failed implantation of a heart valve prosthesis and pull the valve stent (flap integrated into a stent) back into the catheter system (more precisely, the cartridge). In this case, the entire stent is then folded back and returned to the catheter opening (cartridge). It is possible to let the stent slide out again, if a good positioning for the valve stent is achieved. Thus, the valve stent can be brought in and out until the optimal positioning is achieved ("sli ding technique ").
Zum Positionieren des Stents können Bowdenzüge für die Kartusche oder für einzelne Katheter-Anteile eingesetzt werden, damit eine Biegsamkeit in alle Richtungen für das Kathetersystem erreicht wird und der Klappenstent damit senkrecht zur Klappenebene und zentriert zur nativen Öffnung der Klappe positioniert werden kann.To the Positioning the stent can cables for the Cartridge or for single catheter portions are used, thus allowing flexibility in all directions for the catheter system is reached and the valve stent with it vertically positioned to the valve plane and centered to the native opening of the valve can be.
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.One much bigger problem for the optimal placement of the new heart valve in the stent (or valve stent) However, that is the old native flap in most make the implantation technique described above should not be removed.
Dies für allerdings 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 Morphologie, den Zustand und die Beschaffenheit der alten nativen Klappe bestimmt wird (z.B. bei Klappersklerose oder -verkalkung der nativen Klappe).This for though to that the new flap, which in an old, deformed flap pushed (partially squeezed in), in its original Stent form is modified. This is because the implantation site for the Flap stent by morphology, condition and texture the old native valve (e.g., rash sclerosis) or calcification of the native valve).
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 Klapperfunktion und 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.Therefore determines the old valve annulus with the associated modified flaps / pockets to what extent and where the new flap unfolds and thus in their shape can develop. Thus, not only the anchoring / positioning important to optimal rattle function and atrial and ventricular function but also fitting the valve stent in the Neo-annulus (old valve annulus forms this with old valve aus) and thus the pushing back of the old flap.
Ausgehend von den bei den bekannten Stens auftretenden Problemen ist es daher die Aufgabe der Erfindung, einen Stent zu schaffen, der die Anantomie des Herzens möglichst unbeeinflusst lässt. Insbesondere soll ein Stent zur Aufnahme einer Mitralldappenprothese geschaffen werden, bei dessen Implantation die Klappenanteile der alten Mitralklappe nicht mehr den Durchfluss des Blutes stören (insbesondere das anteriore Mitralklappensegel) und andererseits aber die Sehnenfadenspannung im Ventrikel erhalten bleibt.outgoing of the problems encountered with the known Stens, it is therefore the object of the invention to provide a stent, the anantomy the heart as possible unaffected. In particular, a stent for receiving a Mitralldappenprothese be created, at the implantation of the valve shares the old mitral valve no longer disturb the flow of blood (in particular the anterior mitral valve leaflet) and on the other hand the tendon thread tension preserved in the ventricle.
Erfindungsgemäß wird diese Aufgabe durch einen Mitralklappenstent mit den Merkmalen des Anspruchs 1 gelöst. Vorteilhafte Ausgestaltungsformen und Weiterbildungen der Erfindung werden mit den in den untergeordneten Ansprüchen bezeichneten Merkmalen erreicht.According to the invention this Task by a Mitralklappenstent with the features of the claim 1 solved. Advantageous embodiments and developments of the invention are provided with the features indicated in the subordinate claims reached.
Die Grundidee der Erfindung ist es, die Vorteile einer invasiven, chirurgischen Fixierung des anterioren Mitralklappensegels an den alten Annulus mit den Vorteilen der minimal-invasiven Operation durch Einbringen eines in einem Katheter geführten Stents dadurch zu vereinen, dass der erfindungsgemäße Stent das Einrollen des anterioren Mitralklappensegels bewirkt und damit zu ähnlich vorteilhaften Verhältnissen wie beim chirurgischen Anheften der Mitralklappe an den Annulus führt.The The basic idea of the invention is the advantages of an invasive, surgical Fixing the anterior mitral valve leaflet to the old annulus with the benefits of minimally invasive surgery by introducing a in a catheter guided stents to unite that the stent according to the invention, the curling of the Anterior Mitralklappensegels causes and thus to similarly advantageous conditions as in the surgical attachment of the mitral valve to the annulus leads.
Die Erfindung wird im Folgenden anhand eines in den beigefügten Zeichnungen abgebildeten besonders bevorzugten Ausführungsbeispiels näher erläutert. Es zeigen:The The invention will be described below with reference to the attached drawings illustrated particularly preferred embodiment explained in more detail. It demonstrate:
Die
Zur
Erreichung einer Elastizität
der Verankerungselemente
Zusätzlich oder
alternativ zu den als ösenartigen
Schlaufen ausgebildeten Federelementen
Im
Folgenden wird das Einbringen des erfindungsgemäßen Stents
Der
Stent
Die
im Stent
Zur
besseren Orientierung werden zunächst in
Die
Länge der
Kartusche
Dann
werden, wie in
Erst
hiernach würde
dann der weitere (mediale und distale Anteil) des Klappenstents
Wie
in
Gegenüber den
bekannten Lösungen
besteht hiermit also die Möglichkeit,
dass mindestens ein Segel verdrängt
wird und partiell oder komplett eingepackt/eingerollt wird. Dieses
erfolgt über
den wenigstens einen Stützbügel
Um
dieses Verdrängen
und Einklappen einzelner Klappensegel zu erreichen, kann es sein,
dass mehr als ein Stentbügel
Um
eine guten Durchfluss über
der neuen Mitralklappe und dem linksventrikulären Ausflusstrakt zu erhalten,
muss die alte Klappe mittels der sich proximalseitigen Stentbügel eingerollt
und darüber
hinaus an den Mitralklappenannulus herangehoben werden. Dies geschieht
dadurch, dass sich nach dem gesamten Ausfahren des Mitralklappenstents
Der Blutstrom aus dem linken Vorhof via linker Herzkammer in die Aorta ascendens ist so frei und ungehindert möglich.Of the Blood flow from the left atrium via the left ventricle into the aorta ascendens is so free and unhindered possible.
Zur besseren Fixation hat z.B. der Mitralklappenstent einen größeren Winkel als 90° zwischen den atrialen (supravalvulären, 30) und den medialen (in der Mitte liegenden, zwischen 20 und 30) Stentstreben. Diese Aufweitung der atrialen zu den annulären und ventrikulären 20 Stentanteilen fördert die Fixation des Klappenstents in dem Neo-Annulus und verhindert seine Migration.to better fixation has e.g. the mitral valve stent a larger angle as 90 ° between the atrial (supravalvular, 30) and the medial (in the middle, between 20 and 30) Stent struts. This dilation of the atrial to the annular and ventricular Promotes 20 stent shares the fixation of the valve stent in the neo-annulus and prevents his migration.
Claims (8)
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DE200610052564 DE102006052564B3 (en) | 2006-11-06 | 2006-11-06 | Mitral valve stent for surgical implantation and fixation of heart valve prosthesis to heart, has stent clips arranged distally, where one of stent clips forms section that is externally rolled in unfolded condition of stent |
Applications Claiming Priority (1)
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DE200610052564 DE102006052564B3 (en) | 2006-11-06 | 2006-11-06 | Mitral valve stent for surgical implantation and fixation of heart valve prosthesis to heart, has stent clips arranged distally, where one of stent clips forms section that is externally rolled in unfolded condition of stent |
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Publication Number | Publication Date |
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DE102006052564B3 true DE102006052564B3 (en) | 2007-12-13 |
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DE200610052564 Active DE102006052564B3 (en) | 2006-11-06 | 2006-11-06 | Mitral valve stent for surgical implantation and fixation of heart valve prosthesis to heart, has stent clips arranged distally, where one of stent clips forms section that is externally rolled in unfolded condition of stent |
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WO2012177942A2 (en) | 2011-06-21 | 2012-12-27 | Hanson Gifford, Iii | Prosthetic heart valve devices and associated systems and methods |
US8398708B2 (en) | 2010-03-05 | 2013-03-19 | Edwards Lifesciences Corporation | Retaining mechanisms for prosthetic valves |
US8449599B2 (en) | 2009-12-04 | 2013-05-28 | Edwards Lifesciences Corporation | Prosthetic valve for replacing mitral valve |
WO2014110023A1 (en) * | 2013-01-08 | 2014-07-17 | Medtronic Inc. | Valve prosthesis |
CN104684505A (en) * | 2012-05-20 | 2015-06-03 | 戴尔马修墨医学研究内结构和服务有限公司 | Prosthetic mitral valve |
US9078749B2 (en) | 2007-09-13 | 2015-07-14 | Georg Lutter | Truncated cone heart valve stent |
US9241790B2 (en) | 2010-05-05 | 2016-01-26 | Neovasc Tiara Inc. | Transcatheter mitral valve prosthesis |
US9289291B2 (en) | 2009-11-05 | 2016-03-22 | The Trustees Of The University Of Pennsylvania | Valve prosthesis |
US9295552B2 (en) | 2011-10-19 | 2016-03-29 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
US9301840B2 (en) | 2008-10-10 | 2016-04-05 | Edwards Lifesciences Corporation | Expandable introducer sheath |
US9308087B2 (en) | 2011-04-28 | 2016-04-12 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
USD755384S1 (en) | 2014-03-05 | 2016-05-03 | Edwards Lifesciences Cardiaq Llc | Stent |
US9333073B2 (en) | 2009-04-15 | 2016-05-10 | Edwards Lifesciences Cardiaq Llc | Vascular implant and delivery method |
US9345573B2 (en) | 2012-05-30 | 2016-05-24 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
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US9901443B2 (en) | 2011-10-19 | 2018-02-27 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
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US10010417B2 (en) | 2015-04-16 | 2018-07-03 | Edwards Lifesciences Corporation | Low-profile prosthetic heart valve for replacing a mitral valve |
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