DE10301026B4 - Device for anchoring and aligning heart valve prostheses - Google Patents
Device for anchoring and aligning heart valve prostheses Download PDFInfo
- Publication number
- DE10301026B4 DE10301026B4 DE10301026.2A DE10301026A DE10301026B4 DE 10301026 B4 DE10301026 B4 DE 10301026B4 DE 10301026 A DE10301026 A DE 10301026A DE 10301026 B4 DE10301026 B4 DE 10301026B4
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- DE
- Germany
- Prior art keywords
- heart valve
- stent
- valve
- struts
- catheter
- Prior art date
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- Expired - Lifetime
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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
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2230/0054—V-shaped
Abstract
Vorrichtung zur Behandlung einer erkrankten Aorten- oder Pulmonalklappe, wobei die Vorrichtung folgendes aufweist: – einen Herzklappen-Stent mit einem klappentragenden Segment und Streben, wobei in dem Herzklappen-Stent eine Herzklappenprothese eingebracht ist, wobei zur Positionierung Herzklappen-Stents die Streben in die Taschen der erkrankten Aorten- oder Pulmonalklappe einschiebbar sind; – einen Katheter zum Implantieren des Herzklappen-Stents, wobei sich der Herzklappen-Stent in einem zusammengefalteten Zustand in dem Katheter befindet; und – einen Führungsdraht, über den das distale Ende des Katheters bis in den linken bzw. rechten Ventrikel vorschiebbar ist.Device for the treatment of a diseased aortic or pulmonary valve, the device comprising the following: a heart valve stent with a valve-supporting segment and struts, a heart valve prosthesis being introduced into the heart valve stent, the struts in the pockets for positioning the heart valve stent the diseased aortic or pulmonary valve can be inserted; A catheter for implanting the heart valve stent, the heart valve stent being in a folded state in the catheter; and a guide wire, via which the distal end of the catheter can be advanced into the left or right ventricle.
Description
Gegenwärtiger Stand der Technik:Current state of the art:
Das derzeitige Standardverfahren zum Ersatz menschlicher Herzklappen verwendet gegenwärtig biologische oder mechanische Herzklappenprothesen, welche über eine operative Eröffnung des Brustkorbs nach Entfernung der kranken Herzklappe im Herzklappenbett festgenäht werden. Damit eine Herzklappe eingenäht werden kann, muss der Kreislauf des Patienten durch eine Herz-Lungen-Maschine getragen werden. Es wird ein Herzstillstand induziert und während des Herzstillstandes die Herzklappenprothese eingenäht. Es handelt sich folglich um einen sehr großen chirurgischen Eingriff mit entsprechenden Risiken für den Patienten und eine lange postoperative Behandlungsphase. Der Eingriff ist somit auf jüngere und möglichst gesunde Patienten beschränkt. Sehr alten Patienten und sehr herzschwachen Patienten kann dieser Eingriff nicht mehr zugemutet werden.The current standard human heart valve replacement method currently uses biological or mechanical heart valve prostheses which are sutured through an operative chest opening after removal of the diseased heart valve in the heart valve bed. For a heart valve to be sewn, the patient's circulation must be carried by a heart-lung machine. Cardiac arrest is induced and the heart valve prosthesis sewn during cardiac arrest. It is therefore a very large surgical procedure with corresponding risks for the patient and a long postoperative treatment phase. The procedure is therefore limited to younger and as healthy as possible patients. Very old patients and very weak patients, this procedure can no longer be expected.
Daher wurde in den letzten Jahren vermehrt nach Verfahren gesucht, welche die erkrankte Herzklappe mittels Katheter perkutan, transluminal ersetzen können. Zu diesem Verfahren, bei welchem eine Herzklappe mittels eines Stents durch einen Katheter am schlagenden Herzen minimal-invasiv implantiert werden kann, sind mehrere nationale und internationale Patente, Patentanmeldung und Gebrauchsmuster erteilt bzw. eingereicht, auf die an dieser Stelle verwiesen wird.Therefore, in recent years increasingly sought after methods that can replace the diseased heart valve by catheter percutaneously, transluminally. For this method, in which a cardiac valve can be minimally invasively implanted by means of a stent through a catheter to the beating heart, several national and international patents, patent application and utility model are granted or referred to, to which reference is made at this point.
Die Druckschrift
Die Druckschrift
Die Druckschrift
- – ein Stentkörperelement mit einer luminalen und einer abluminalen Oberfläche, einem proximalen Verankerungsabschnitt, einem distalen Verankerungsabschnitt, einem ringförmigen Zwischenabschnitt und einer zentralen ringförmigen Öffnung entlang einer Mittellängsachse des Stentkörperelements;
- – ein Transplantatelement, das zumindest einen Abschnitt von zumindest einer der luminalen und der abluminalen Oberfläche des Stentkörperelements bedeckt;
- – zumindest einen Vorspannarm, der von dem Stentkörperelement und in die zentrale ringförmige Öffnung des Stentkörperelements vorsteht, wobei der zumindest eine Vorspannarm zwischen dem ringförmigen Zwischenabschnitt und dem proximalen Verankerungsabschnitt angeordnet ist; und
- – zumindest ein Ventilklappenelement, das mit dem zumindest einen Vorspannarm und zumindest einem Abschnitt des Transplantatelements verbunden ist, wobei der Vorspannarm das zumindest eine Ventilklappenelement so vorspannt, dass es, wenn an dem Implantat eine Druckdifferenz von 0 vorliegt, eine Position einnimmt, in der es die zentrale ringförmige Öffnung des Stentkörperelements verschließt.
- A stent body member having a luminal and an abluminal surface, a proximal anchoring portion, a distal anchoring portion, an annular intermediate portion and a central annular opening along a central longitudinal axis of the stent body member;
- A graft member covering at least a portion of at least one of the luminal and abluminal surfaces of the stent body member;
- At least one biasing arm projecting from the stent body member and into the central annular opening of the stent body member, the at least one biasing arm being disposed between the annular intermediate portion and the proximal anchoring portion; and
- At least one valve flap member connected to the at least one biasing arm and at least a portion of the graft member, the biasing arm biasing the at least one valve flap member to assume a position where there is a pressure differential of 0 on the implant the central annular opening of the stent body member closes.
Die Druckschrift
Allen Verfahren des perkutanen, transluminalen Herzklappenersatzes gemeinsam ist das Vorbringen der zu implantierenden Herzklappenprothese mit einem Katheter, der über ein peripheres Gefäß minimal-invasiv, perkutan eingeführt wird. Die Klappenprothese ist in ein Träger-Stütz-System (Stent) eingebracht, welches aus einem Drahtgeflecht besteht und das bei der Implantation von selbst aufspringt (= selbstexpandierend) oder von einem Ballon aufgedehnt wird (= Ballon expandierbar). Unter Kontrolle von Röntgendurchleuchtung (Herzkatheterlabor = HKL) und Ultraschall (transösophageales Echokardiogramm = TEE) wird über einen Führungsdraht, der zuvor als Leitschiene platziert wurde, der Einführkatheter und die darin befindliche Herzklappen-Stent-Einheit zur Implantationsstelle vorgebracht, wo sich die erkrankte und zu ersetzende Klappe befindet. Hier wird der Stent freigegeben und durch die Stent-Expansion die neue Klappenprothese aufgespannt.The publication
Common to all methods of percutaneous transluminal heart valve replacement is the provision of the heart valve prosthesis to be implanted with a catheter that is minimally invasively introduced percutaneously via a peripheral vessel. The valve prosthesis is incorporated into a carrier-support system (stent), which consists of a wire mesh and which pops up during implantation by itself (= self-expanding) or by a balloon is expanded (= balloon expandable). Under the control of fluoroscopy (cardiac catheterization laboratory = HKL) and ultrasound (transesophageal echocardiogram = TEE) is placed over a guide wire, which was previously placed as a guide rail, the delivery catheter and the heart valve stent unit located therein to the implantation site, where the diseased and closed replacing flap is located. Here, the stent is released and stretched by the stent expansion, the new valve prosthesis.
Nachteile des derzeitigen Verfahrens:Disadvantages of the current procedure:
Als wesentliche Nachteile des derzeitigen Verfahrens sind zum einen Probleme bei der sicheren Positionierung des Stents zu sehen, die trotz hoher Auflösung im HKL und des TEE die Gefahr von Fehlimplantationen birgt. Eine Implantation des Herzklappen-Stents zu weit in der Herzkammer (Ventrikel) führt zur Undichtigkeit (Klappeninsuffizienz) und erheblichen Belastung des Ventrikels. Eine Fehlimplantation zu weit oberhalb der eigentlichen Klappenebene kann zum Verschluss der Abgänge der Herzkranzgefäße (Koronarien) und damit zu einer tödlichen Koronarischämie mit Herzinfarkt führen.One of the main disadvantages of the current method is the problem of the secure positioning of the stent, which despite high resolution in the HVAC and the TEE carries the risk of incorrect implantation. Implantation of the heart valve stent too far in the ventricle leads to leakage (valvular insufficiency) and considerable stress on the ventricle. A false implantation too far above the actual valve plane can lead to closure of the outflows of the coronary arteries (coronaries) and thus to a fatal coronary anemia with myocardial infarction.
Des Weiteren muss eine Aortenklappenprothese erhebliche Kräfte während der Diastole aushalten, die eine sichere Verankerung des Herzklappen-Stents voraussetzt, damit dieser nicht in den Ventrikel disloziert. Eine solche Verankerung bieten Widerhaken, welche sich in der Wand der Aorta abstützen, wie dies in dem deutschen Patent
Darstellung der Erfindung:Presentation of the invention:
Der vorliegenden Erfindung liegen die o. g. Probleme bei der transluminalen Herzklappenimplantation zugrunde, so dass Bedarf für die Weiterentwicklung dieses Verfahrens hinsichtlich einer sicheren Positionierung bei der Implantation und eine zusätzliche Abstützung des Herzklappen-Stents gegen eine ventrikelwärts gerichtete Dislokation besteht.The present invention are the o. Problems with the transluminal heart valve implantation so that there is a need for the further development of this method with regard to a secure positioning during implantation and an additional support of the heart valve stent against a ventricle-facing dislocation.
Dazu wurde eine Modifikation der derzeitig verfügbaren Stents hinsichtlich der Bauart und damit des Verhaltens bei Implantation und hinsichtlich der Verankerung vorgenommen. Diese Modifikation sieht Bügel/Streben bzw. Ausarbeitungen des Stents vor, welche bei der Implantation in die Taschen der alten Klappe hinein geschoben werden (
Die Bügel/Streben/Ausarbeitungen des Stents gewährleisten somit während der Implantation eine sichere Positionierung durch die anatomischen Strukturen der Taschen der alten Klappe, die neben der Kontrolle im HKL und mittels TEE die exakte Implantation des Herzklappen-Stents erlaubt. Außerdem gewährleistet dieses Konstruktionsmerkmal eine zusätzliche Abstützung in den Taschen und damit am Klappenring der alten Herzklappe, wodurch eine Dislokation des Herzklappen-Stents in. Richtung der linken Herzkammer verhindert wird.The stents / struts / elaborations of the stent thus ensure secure positioning during implantation through the anatomical structures of the pockets of the old flap, which, in addition to the control in the HKL and by means of TEE, permit the exact implantation of the heart valve stent. In addition, this design feature provides additional support in the pockets and thus the flap ring of the old heart valve, thereby preventing dislocation of the heart valve stent in the direction of the left ventricle.
Diese Konstruktionsmerkmale des Stents bieten die gleichen Vorzüge auch bei transluminalem Ersatz der Pulmonalklappe. Somit soll das o. g. Verfahren und die beschriebenen Konstruktionsmerkmale des Herzklappen-Stents in Analogie für den Einsatz an der rechten Herzkammer (rechter Ventrikel, Pulmonalklappe, Arteria pulmonalis) gelten.These design features of the stent provide the same benefits even with transluminal replacement of the pulmonary valve. Thus, the o. G. Procedures and the described design features of the heart valve stent in analogy for use in the right ventricle (right ventricle, pulmonary valve, pulmonary artery) apply.
Gegenüber den bisherigen Herzklappenprothesen für einen transluminalen Klappenersatz zeichnet sich die Erfindung dadurch aus:
- 1. Dass der Herzklappen-Stent um Bügel/Streben/Ausarbeitungen ergänzt wird.
- 2. Dass diese Bügel/Streben/Ausarbeitungen während der ersten Phase der Implantation aus dem Katheter im Bereich der Hauptschlagader (Aortenwurzel) bzw. im proximalen Anteil der Lungenschlagader (Arteria pulmonalis) freigegeben werden.
- 3. Dass diese Bügel/Streben/Ausarbeitungen während der Implantation in die Taschen der alten Herzklappe hinein geschoben werden.
- 4. Dass die Bügel/Streben/Ausarbeitungen eine exaktere Implantation des Herzklappen-Stents ermöglichen.
- 5. Dass durch diese Modifikation der Bauart des Herzklappen-Stents wird eine zusätzliche Verankerung des Systems gegen eine Dislokation ermöglicht.
- 6. Dass diese Modifikation der Bauart des Herzklappen-Stents beim transluminalen Ersatz der Aorten- wie auch der Pulmonalklappe Verwendung finden kann.
- 1. That the heart valve stent is supplemented by straps / struts / elaborations.
- 2. That these stirrups / struts / elaborations are released during the first phase of implantation from the catheter in the area of the main artery (aortic root) or in the proximal portion of the pulmonary artery (pulmonary artery).
- 3. That these straps / struts / elaborations are pushed into the pockets of the old heart valve during implantation.
- 4. That the straps / struts / elaborations allow a more accurate implantation of the heart valve stent.
- 5. That this modification of the design of the heart valve stent allows additional anchoring of the system against dislocation.
- 6. That this modification of the design of the heart valve stent can be used for the transluminal replacement of the aortic as well as the pulmonary valve.
Ausführungsbeispiele der Erfindung sind in den
Claims (5)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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DE10301026.2A DE10301026B4 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
DE20321838U DE20321838U1 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
Applications Claiming Priority (3)
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DE10237573 | 2002-08-13 | ||
DE10237573.9 | 2002-08-13 | ||
DE10301026.2A DE10301026B4 (en) | 2002-08-13 | 2003-01-14 | Device for anchoring and aligning heart valve prostheses |
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DE10301026A1 DE10301026A1 (en) | 2004-02-26 |
DE10301026B4 true DE10301026B4 (en) | 2014-10-30 |
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CN110314017A (en) * | 2019-07-11 | 2019-10-11 | 陈绍良 | The aorta petal bracket being implanted into through conduit |
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US11413139B2 (en) | 2011-11-23 | 2022-08-16 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US11497602B2 (en) | 2012-02-14 | 2022-11-15 | Neovasc Tiara Inc. | Methods and apparatus for engaging a valve prosthesis with tissue |
US11617650B2 (en) | 2012-05-30 | 2023-04-04 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
US11389294B2 (en) | 2012-05-30 | 2022-07-19 | Neovasc Tiara Inc. | Methods and apparatus for loading a prosthesis onto a delivery system |
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US11389291B2 (en) | 2013-04-04 | 2022-07-19 | Neovase Tiara Inc. | Methods and apparatus for delivering a prosthetic valve to a beating heart |
US11357622B2 (en) | 2016-01-29 | 2022-06-14 | Neovase Tiara Inc. | Prosthetic valve for avoiding obstruction of outflow |
US11464631B2 (en) | 2016-11-21 | 2022-10-11 | Neovasc Tiara Inc. | Methods and systems for rapid retraction of a transcatheter heart valve delivery system |
US10856984B2 (en) | 2017-08-25 | 2020-12-08 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
US11793640B2 (en) | 2017-08-25 | 2023-10-24 | Neovasc Tiara Inc. | Sequentially deployed transcatheter mitral valve prosthesis |
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US11602429B2 (en) | 2019-04-01 | 2023-03-14 | Neovasc Tiara Inc. | Controllably deployable prosthetic valve |
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US11779742B2 (en) | 2019-05-20 | 2023-10-10 | Neovasc Tiara Inc. | Introducer with hemostasis mechanism |
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US11931254B2 (en) | 2019-06-20 | 2024-03-19 | Neovasc Tiara Inc. | Low profile prosthetic mitral valve |
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