DE19532846A1 - Valve for use in heart - Google Patents

Valve for use in heart

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Publication number
DE19532846A1
DE19532846A1 DE1995132846 DE19532846A DE19532846A1 DE 19532846 A1 DE19532846 A1 DE 19532846A1 DE 1995132846 DE1995132846 DE 1995132846 DE 19532846 A DE19532846 A DE 19532846A DE 19532846 A1 DE19532846 A1 DE 19532846A1
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DE
Germany
Prior art keywords
characterized
valve device
device according
valve
catheter
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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.)
Withdrawn
Application number
DE1995132846
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German (de)
Inventor
Georg Dr Berg
Original Assignee
Georg Dr Berg
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Priority to DE1995132846 priority Critical patent/DE19532846A1/en
Publication of DE19532846A1 publication Critical patent/DE19532846A1/en
Application status is Withdrawn legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Abstract

The replacement heart valve (100) has a vessel flap which contains three triangular valve flaps (4). In the working position the triangular valve flaps adjoin each other. The separate flaps have connection points on them for a jointed connection with the vessel wall at the point of insertion. The flaps have a holder, which has a folding mechanism which allows the device to be introduced into the vessel and moved to the required position.

Description

Die Erfindung bezieht sich auf eine Ventileinrichtung zum Einsetzen in ein Hohlorgan, ein Gefäß oder dergleichen, mit einer künstlichen Gefäßklappe, insbesondere einer Taschenklappe, die mehrere, im Umriß in Flachlage dreieckige Einzeltaschen oder Einzelsegel, die in Funktionsstellung in Umfangsrichtung aneinander grenzen, aufweist. The invention relates to a valve device for insertion into a hollow organ, a vessel or the like with an artificial vascular valve, in particular a pocket flap, the more in the flat position triangular individual bags or single sail, adjacent to each other in the functional position in the circumferential direction comprises in outline.

Eine solche Ventileinrichtung kann insbesondere zum Ersetzen einer Herzklappe mit Hilfe eines Kathetersystems dienen. Such valve means may be used in particular for replacing a heart valve by using a catheter system.

Die Segel der Herzklappen haben eine Ventilfunktion. The sails of the heart valves have a valve function. Kommt es zu krankhaften Veränderungen dieser Segelklappen, so ergeben sich Strömungsverhältnisse, die kurz- und langfristig Herzschädigungen verursachen mit entsprechend schweren Auswirkungen auf den Gesamtorganismus. If it comes to pathological changes of these atrioventricular valves, then flow conditions that cause short and long term heart damage with correspondingly serious impact on the whole organism arise.

Bisherige Lösungen des Problems der insuffizienten Klappe bestehen in einer medikamentellen Beeinflussung oder im chirurgischen Ersatz der Klappen mit Hilfe der Herz-Lungen-Maschine. Previous solutions to the problem of insufficient flap made in a pharmacologic agents influencing or surgical replacement of the valve with the aid of cardiopulmonary bypass.

Nicht-chirurgische Lösungsansätze für dieses Problem ergeben sich aus der PCT-WO 91/17720 und der PCT-W 93/01768. Non-surgical solutions to this problem arising from PCT WO 91/17720 and PCT W 93/01768.

Aufgabe der vorliegenden Erfindung ist es, eine Ventileinrichtung oder dergleichen zu schaffen, die mit Hilfe einer nicht-operativen Vorgehensweise das Einsetzen einer Ventileinrichtung beziehungs weise den Ersatz der Herzklappe ermöglicht. The object of the present invention is to provide a valve device or the like using a non-surgical procedure, the insertion of a valve device as relationship allows replacement of the heart valve.

Zur Lösung dieser Aufgabe wird erfindungsgemäß insbesondere vorgeschlagen, daß die Gefäßklappe aus mehreren, separaten Einzelsegeln zusammengesetzt ist, die jeweils Anschlußstellen zum gelenkigen Verbinden mit der Gefäßwand oder dergleichen an der Einsatzstelle aufweisen und daß die Einzelsegel eine Halterung mit einem Faltmechanismus zum Zusammenfalten der Einzelsegel für das Einbringen durch ein Gefäß an die Einsatzstelle und dort zum Auffalten der Segel hat. To achieve this object according to the invention in particular proposes that the vessel lid is composed of several separate individual sails, each of connecting points for the articulated connection with the vessel wall or the like at the site and that the individual sail a holder with a folding mechanism for folding the individual sails for the has introduction through a vessel to the deployment site and there to the folding of the sails.

Durch den Aufbau der Ventileinrichtung aus mehreren Einzelbau gruppen, insbesondere Einzelsegeln, ergeben sich für diese Einzelteile erheblich reduzierte Außenabmessungen, so daß sie einzeln wesentlich einfacher einführbar und auch einfacher an den Einsatzort transportierbar sind. By the construction of the valve means from a plurality of individual construction groups, in particular single sailing, are obtained for these items greatly reduced outer dimensions, so that they are much easier to be inserted and also easier be transported to the site individually.

Vorzugsweise sind die Anschlußstellen der Einzelsegel-Halterung zum gelenkigen Verbinden mit einem an der Einsatzstelle verankerten Stent ausgebildet, insbesondere zum Einhaken bei diesem Stent. Preferably, the connection points of the individual sails bracket for the articulated connection are formed with an anchored stent at the deployment site, in particular for hooking in this stent.

An der Einsatzstelle werden die Einzelsegel jeweils nach Positionierung und Verankerung aufgefaltet beziehungsweise aufgeweitet. the individual sails are unfolded, respectively after positioning and anchoring or expanded at the point of use. Es ist dabei vorgesehen, daß in einem ersten Arbeitsgang zunächst der entsprechend modifizierte Gefäßstent nach Palmaz als Verankerungsring eingeführt wird. It is provided that first the corresponding modified vessel stent according to Palmaz is introduced as an anchoring ring in a first operation. In einem zweiten Arbeitsgang wird dann die Ventileinrichtung, dh die einzelnen Segel der Herzklappe gesondert positioniert und am Stent verankert. then the valve device in a second operation, ie the individual leaflets of the heart valve is positioned separately and anchored on the stent.

Nach einer anderen Ausführungsform der Erfindung besteht auch die Möglichkeit, den Stent zusammen mit den einzelnen Klappense geln bzw. den Klappensegel-Halterungen auf einmal zur Einsatzstelle zu bringen. According to another embodiment of the invention is also possible, rules the stent along with each Klappense or to bring the leaflet holders at once to the operation site.

Dazu ist zum Einführen der Ventileinrichtung ein Katheter vorgesehen, der am proximalen Endbereich Befestigungsmittel zum Anbringen von in Umfangsrichtung und Längsrichtung verteilt angebrachten, also hintereinandergeschalteten Klappensegeln beziehungsweise Klappensegel-Halterungen aufweist, wobei am freien Ende des Katheters vorzugsweise ein Ballon zum Haltern des Stents vorgesehen ist. For this purpose, for insertion of the valve means, a catheter is provided which is mounted distributed on the proximal end portion of attachment means for attaching in the circumferential direction and the longitudinal direction, thus having series-connected valve leaflets or leaflet holders, being provided at the free end of the catheter is preferably a balloon for holding the stent.

Zweckmäßigerweise ist dabei am Katheter im Bereich der Be festigungsmittel für die Klappensegel-Halterungen eine über diese verschiebbare, äußere Hülle vorgesehen ist, die zum Freigeben und Verbinden der einzelnen Klappensegel-Halterungen mit dem Stent oder dergleichen in Richtung zum äußeren Ende des Katheters zurückziehbar ist und daß der Querschnitt des Katheters im Halterungsbereich für die Klappensegel-Halterungen kleiner ist als der lichte Durchtrittsquerschnitt des aufgeweiteten, verankerten Katheters. Conveniently, is on the catheter in the area of ​​Be fastening means for the valve leaflet supports a is provided above this movable outer sleeve which is retractable for releasing and connecting the individual leaflet holders with the stent or the like in the direction towards the outer end of the catheter and that the cross section of the catheter in mount area for the leaflet holders is smaller than the clear passage cross section of the widened anchored catheter.

Mit Hilfe dieses Katheters werden alle drei Klappensegel mit ihren Halterungen und dem Stent auf einmal eingeführt und an der Einsatzstelle wird dann zunächst der Stent verankert und anschließend werden nacheinander bei gleichzeitigem Zurückziehen der äußeren Schutzhülle die Klappensegel mit Halterung freigegeben bzw. soweit freigegeben, daß sie mit ihren Einfädelenden freiliegen und auf den Stent aufgeschoben werden können. Using this catheter all three leaflets to be introduced with their supports and the stent at once, and the stent is then first place of use, anchored, and then the valve leaflets are released with bracket or to the extent successively released with simultaneous retraction of outer protective sheath that it with exposed their Einfädelenden and can be pushed onto the stent. Die Schutzhülle wird dann immer weiter zurückgezogen bis auch das dritte Klappensegel mit Halterung freigegeben und auf den Stent aufgeschoben werden kann. The protective sleeve is then gradually pulling up and the third valve leaflets can be released with support and pushed onto the stent.

Eine bevorzugte Ausführungsform der Erfindung sieht vor, daß die Einzelsegel-Halterung an einem Ende miteinander verbundene Spannbügel aufweist, die entlang der beiden Längsseiten des jeweiligen Segels verlaufen und dort mit den Rändern des Segels verbunden sind und daß die beiden Spannbügel zwischen einer Zusammenfaltlage mit etwa parallel verlaufenden Spannbügeln und einer Aufspreizlage mit V-förmiger Stellung der Spannbügel verstellbar sind. A preferred embodiment of the invention provides that the individual sail holder having at one end interconnected clamping brackets which extend along the two longitudinal sides of the respective sail and connected there to the edges of the sail and that the two clamping bars between a Zusammenfaltlage with approximately parallel extending clamps and a Aufspreizlage V-shaped position of the clamping strap are adjustable.

In der Zusammenfaltlage ergeben sich nur vergleichsweise geringe Außenabmessungen, insbesondere ein kleiner Querschnitt, so daß die Einzelsegel mit Halterung mit Hilfe eines Katheters gut an die Herz-nahe Einsatzstelle gebracht werden können. In the Zusammenfaltlage only relatively small external dimensions, in particular a small cross section, so that the individual sails can be made with support by means of a catheter well to the heart-close operation site arise.

Zusätzliche Ausgestaltungen der Erfindung sind in den weiteren Unteransprüchen aufgeführt. Additional embodiments of the invention are given in the further subclaims. Nachstehend ist die Erfindung mit ihren wesentlichen Einzelheiten anhand der Zeichnungen näher erläutert. The invention with its essential details with reference to the drawings is explained in more detail. Es zeigt stärker schematisiert: It shows more schematically:

Fig. 1 eine schematische Querschnitts-Ansicht mit in der Aorta angeordneter Ventileinrichtung, Fig. 1 is a schematic cross-sectional view of the aorta disposed in valve means,

Fig. 2 eine Seitenansicht eines in komprimierter Lage gezeigten Klappen-Segels, und Fig. 2 is a side view of a compressed position shown in flap-sail, and

Fig. 3 eine Seitenansicht eines in Spreizlage befindlichen Klappen-Segels. Fig. 3 is a side view of a spread position situated in flap sail.

Die Ventileinrichtung 100 ( Fig. 1) weist drei Klappensegel 4 auf, die in Funktionsstellung in Umfangsrichtung aneinander grenzen. The valve device 100 (Fig. 1) has three cusps 4, which adjoin one another in the functional position in the circumferential direction. Die Klappensegel 4 bestehen aus einem klammerartigen Gebilde aus Metall oder Kunststoff. The valve leaflets, 4 consist of a clamp-like structures made of metal or plastic. An den äußeren Schenkeln 3 , 3 a sind Perforationen beziehungsweise Ösen angebracht, ebenfalls am unteren Bereich des Innenbügels 11 und mit deren Hilfe wird die biologische oder die Kunststoffklappe aufgenäht. At the outer legs 3, 3 a perforations or eyelets are mounted, also on the lower portion of the inner strap 11 and by means of which the biological or plastic flap is sewn. An der oberen Windung 5 sind federnde Aufrollungen vorgesehen, die die äußeren Streben der Klammer nach dem Entfernen aus der Schutzhülse auf eine gewünscht spezifische Weite auseinanderdrückt. Resilient recalculations are provided on the upper coil 5, which presses apart the outer struts of the staple after the removal of the protective sleeve to a desired specific length. Die Enden der Klammer sind spitz oder auch mit Widerhaken versehen und können mit Hilfe des Memory-Effektes sich nach außen drehend in die Gefäßwand eindringend eine zusätzliche Brems- und Fixierwirkung der Einrichtung erzeugen. The ends of the clip are pointed or provided with barbs and can produce penetrating rotationally outwardly into the vessel wall, an additional braking and fixing effect of the device with the aid of the memory effect.

Nach dem Herausstoßen aus der Schutzhülse werden die Außenschenkel der Klammer der Rundung der Aorta angepaßt, mit Hilfe eines inovasiven Spreizers oder auch mit Hilfe des Memory-Effektes geweitet. After pushing out from the protection sleeve, the outer legs of the clip of the rounding of the aorta are adapted widened by means of a spreader inova immersive or with the aid of the memory effect. Nach dieser Spreizung wird die einzelne Segelklappe funktionsfähig. After this spread, the individual sails flap is functional.

Beim Einsetzen der Ventileinrichtung wird zunächst der Halterungs ring 2 (Stent nach Palmaz) mit einem Katheter in die beabsichtigte Position am Ende der Aorta 1 eingebracht und mit einem Ballon gedehnt. Upon insertion of the valve means of the bracket, first ring 2 (A stent according to Palmaz) with a catheter in the intended position introduced at the end of the aorta 1 and expanded with a balloon.

Der Halterungsring 2 ist ein modifizierter Stent nach Palmaz, der am Ende mit Spitzen versehen ist, die sich beim Aufdehnen in die Schleimhaut einsenken und so eine Primärfixation bewirken. The retaining ring 2 is a modified stent according to Palmaz, which is provided at the end with tips sink down during expansion in the mucous membrane and thus cause a primary fixation. Außerdem weist dieser modifizierte Palmaz-Stent Aussparungen im Gitternetz auf, die als radiologische Orientierungshilfen beim Einbringen der Klappensegel dienen. Furthermore, this modified Palmaz stent recesses in the grid, which serve as radiological guidance during insertion of the valve leaflets.

In Fig. 2 ist die komprimierte Vorrichtung mit dem aufgenähten Klappensegel 4 dargestellt. In FIG. 2, the compressed device is illustrated with the stitched valve leaflets. 4 Die Vorrichtung beginnt links unten mit dem Verankerungsdorn 10 und setzt sich fort in zwei Spreizbügel 3 , 3 a, die über eine Zwischenwindung 5 miteinander verbunden sind. The apparatus begins the bottom left to the anchor mandrel 10, and continues in two spreader 3, 3 a, which are interconnected by a intermediate turn. 5 In diesen Spreizbügeln 3 , der Zwischenwindung 5 und dem oberen Teil des Innenbügels 11 befinden sich mehrere Verbindungsstellen 8 , die die Haltefäden 9 aufnehmen und das komprimierte Klappensegel fixieren. In these Spreizbügeln 3, the intermediate turn 5 and the upper part of the inner bracket 11 are a plurality of connecting points 8, which receive the retaining threads 9 and fix the compressed leaflets.

Über die Retraktionswindung 12 geht die Vorrichtung über in den Innenbügel 11 und das Einfädelende 6 und endet mit dem gegenseiti gen Verankerungsdorn 10 . About the Retraktionswindung 12, the device goes into the inner bracket 11 and the Einfädelende 6 and ends with the gegenseiti gen anchoring thorn 10th

In Fig. 3 ist die gespreizte Vorrichtung dargestellt, nachdem sie röntgenologisch positioniert und aus der Schutzhülse des Gefäßkatheters herausgeschoben wurde. In Fig. 3 the spread device is shown after it has been radiologically positioned and pushed out of the protective sleeve of the vascular catheter. Dabei wird der Innenbügel 11 mit Hilfe des Einfädelendes 6 hinter den Stent 2 geschoben und so auf dem Stent fixiert. The inner bar 11 is pushed by means of the Einfädelendes 6 behind the stent 2 and thus fixed on the stent. Auch die Zwischenwindung 5 kann zusätzlich zum Einrasten auf den Stent 2 benutzt werden. The intermediate turn 5 can be used for snapping onto the stent 2 addition. Der Spreiz- und Spannbügel 3 öffnet sich nach dem Entlassen aus der Schutzhülse des Katheters aufgrund der Federspannung der Zwischenwindung 5 und bringt das komprimierte Klappensegel 4 in seinen gespannten und geweiteten Funktionszustand, wobei sich die Längsseiten 7 der einzelnen Segel überlappen. The spreading and clamping bracket 3 open after release from the protective sleeve of the catheter due to the spring tension of the intermediate turn 5 and brings the compressed leaflets 4 in its stretched and expanded functional state, with the longitudinal sides 7 overlap of the individual sails. Nach dem Öffnen dringen die Verankerungsdorne 10 in die oberflächliche Aortenwand 1 ein und bewirken eine Zusatzfixation. After opening, the anchoring pins 10 penetrate into the superficial aorta wall 1 and cause an additional fixation. Wird eines der Klappense gel insuffizient, werden die Verankerungsdorne mit Hilfe einer endovasiven Gefäßzange komprimiert und an der Retraktionswindung 12 herausgezogen und aus dem Körper entfernt. If one of the Klappense insufficient gel, the anchoring pins are compressed by means of a endovasiven vessel forceps and pulled out at the Retraktionswindung 12 and removed from the body.

Anstatt die einzelnen Klappensegel 4 zusammen mit ihrer jeweiligen klammerartigen Halterung 13 nacheinander an die Einsatzstelle zu bringen, besteht auch noch die Möglichkeit, mit einem speziell ausgebildeten Katheter die Halterungen mit Klappensegeln in Umfangsrichtung um 120 Grad versetzt (bei drei Klappsegeln) und zusätzlich auch in Längsrichtung versetzt am Ende dieses Katheters anzubringen und diese Baugruppen zusammen auf einmal zur Einsatzstelle einzubringen. Instead, the individual valve leaflets 4 to bring together with their respective clip-like holder 13 in succession to the deployment site, there is also the possibility, the brackets with leaflets in circumferentially offset with a specially designed catheter 120 degrees (when three folding sailing) and additionally in the longitudinal direction added at the end of the catheter to attach and incorporate these components together at one time to the operation site.

Über die Anordnung der zueinander versetzten Klappensegel 4 mit ihren Halterungen 13 ist eine Sicherheitshülse geschoben, damit die Klappensegel mit ihren Halterungen beim Einführen des Katheters nicht verschoben werden. About the arrangement of the offset leaflets 4 with its supports 13 a safety sleeve is pushed so that the valve leaflets are not moved with their supports upon insertion of the catheter. Eine Vorfixierung am Ende des Katheters kann beispielsweise durch Magnetkraft erfolgen. A prefixing at the end of the catheter may be effected for example by magnetic force. Proximal zu den Befestigungsmitteln für die Halterungen 13 und die Klappensegel 4 befindet sich dann am freien Ende des Katheters ein Ballon, auf den der Stent aufgeschoben und gehalten ist. Proximal to the fastening means for the brackets 13 and the valve leaflets 4 is then located at the free end of the catheter, a balloon on which the stent is pushed and held.

Nach dem Einführen des Katheters mit allen drei Klappsegeln mit Halterungen und Stent, wird an der Einsatzstelle dann zunächst der Stent verankert und anschließend werden nacheinander bei gleichzeitigem Zurückziehen der äußeren Schutzhülle die Klappensegel mit Halterung freigegeben bzw. jeweils soweit freigegeben, daß sie mit ihren Einfädelenden 6 freiliegen und auf den Stent 2 aufgeschoben werden können. After insertion of the catheter with all three folding sailing with brackets and stent, the stent is at the deployment site then anchored at first and then to be released successively with a simultaneous withdrawal of the protective outer shell, the valve leaflets with mounting or in each case unless released, that they with their Einfädelenden 6 can be exposed and pushed onto the stent. 2 Die Schutzhülle wird dann immer weiter zurückgezogen bis auch das dritte Klappensegel mit Halterung freigegeben und auf den Stent aufgeschoben werden kann. The protective sleeve is then gradually pulling up and the third valve leaflets can be released with support and pushed onto the stent.

Nach dem Aufweiten des Stents mit dem Ballon ist das Lumen des Stents 2 so groß, daß die nachfolgenden Klappensegel-Halterungen, die außen an der Katheterhalterung angebracht sind, soweit vorgeschoben werden können, daß jeweils nacheinander die Klappensegel-Halterungen an dem Stent in Eingriff kommen. After expansion of the stent to the balloon, the lumen of the stent 2 is so large that the subsequent leaflet holders which are mounted externally on the catheter mount may be advanced to the extent that in each case one after the leaflet holders come to the stent in engagement , Durch die in Umfangsrichtung um 120 Grad versetzte Lage der Klappensegel-Halterungen (bei drei Klappensegeln) kommen diese beim Vorschieben automatisch in richtiger Position beim Stent in Eingriff und verbinden sich mit diesem. Due to the offset in the circumferential direction by 120 degrees position of the leaflet holders (with three leaflets) automatically come in the correct position during advancement when stent engage and connect to this. An dem Stent könnte randseitig auch jeweils um 120 Grad versetzt eine Einführhilfe und Zentrierhilfe vorgesehen sein, damit auch bei einer relativen Verdrehung des Katheters zum gesetzten Stent ein exaktes Positionieren der Klappensegel-Halterungen möglich ist. could also each edge of the stent 120 degrees offset be provided an insertion and centering, so that an exact positioning of the leaflet holders is possible even with a relative rotation of the catheter to set the stent.

Claims (18)

1. Ventileinrichtung zum Einsetzen in ein Hohlorgan, ein Gefäß oder dergleichen, mit einer künstliche Gefäßklappe, insbesondere Taschenklappe, die mehrere, im Umriß in Flachlage dreieckige Klappensegel, die in Funktionsstellung in Umfangsrichtung aneinandergrenzen, aufweist, dadurch gekennzeichnet, daß die Gefäßklappe aus mehreren separaten Klappensegeln ( 4 ) zusammengesetzt ist, die jeweils Anschluß stellen zum gelenkigen Verbinden mit der Gefäßwand oder dergleichen an der Einsatzstelle aufweisen und daß die Klappensegel ( 4 ) eine Halterung ( 13 ) mit einem Faltmecha nismus zum Zusammenfalten der Klappensegel für das Einbringen durch ein Gefäß an die Einsatzstelle und dort zum Auffalten der Segel hat. 1. Valve device for insertion into a hollow organ, a vessel or the like with an artificial vessel flap, in particular pocket flap which has a plurality of, in outline in flat position triangular valve leaflets, which adjoin one another in the functional position in the circumferential direction, characterized in that the vessel lid of a plurality of separate valve leaflets (4) is assembled, the respective connection points for the articulated connection with the vessel wall or the like at the site and that the valve flaps (4) on a support (13) having a Faltmecha mechanism for folding of the leaflets for introduction through a vessel the work site and there for unfolding the sail has.
2. Ventileinrichtung nach Anspruch 1, dadurch gekennzeichnet, daß sich die Anschlußstellen an der Klappensegel-Halterung ( 13 ) befinden. 2. Valve device according to claim 1, characterized in that there are the connecting points at the leaflet holder (13).
3. Ventileinrichtung nach Anspruch 1 oder 2, dadurch gekenn zeichnet, daß die Klappensegel-Halterung ( 13 ) an einem Ende miteinander verbundene Spannbügel ( 3 , 3 a) aufweist, die entlang der beiden Längsseiten des jeweiligen Segels ( 4 ) verlaufen und dort mit den Rändern des Segels verbunden sind und daß die beiden Spannbügel ( 3 , 3 a) zwischen einer Zusammenfaltlage mit etwa parallel verlaufenden Spannbügeln und einer Aufspreizlage mit V-förmiger Stellung der Spannbügel verstellbar sind. 3. Valve device according to claim 1 or 2, characterized in that the leaflet holder (13) at one end interconnected clamping bracket (3, 3a) which extend along the two longitudinal sides of the respective sail (4) and from there to are connected to the edges of the sail and that the two clamping brackets (3, 3 a) are adjustable between a Zusammenfaltlage approximately parallel clamps and a Aufspreizlage V-shaped position of the clamping bracket.
4. Ventileinrichtung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, daß die Klappensegel-Halterung ( 13 ) zumindest bereichsweise aus Runddraht besteht. 4. Valve device according to one of claims 1 to 3, characterized in that the leaflet holder (13) at least partially consists of round wire.
5. Ventileinrichtung nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß die Spann- und Spreizbügel ( 3 , 3 a) der Klappensegel-Halterung ( 13 ) vorzugsweise elastisch biegbar miteinander verbunden sind und daß in ihrem Verbindungs bereich wenigstens eine Zwischenwindung ( 5 ) vorgesehen ist. Are 5. Valve device according to one of claims 1 to 4, characterized in that the clamping and straddle bar (3, 3 a) of the leaflet holder (13) is preferably connected elastically bendable to one another, and that in their connecting region at least one intermediate turn (5 ) is provided.
6. Ventileinrichtung nach einem der Ansprüche 1 bis 5, dadurch gekennzeichnet, daß die Klappensegel-Halterung ( 13 ) mit ihren Spannbügeln ( 3 , 3 a) und der oder den Anschlußstellen zum Verbinden mit der Gefäßwand oder dergleichen aus einem Stück Draht gebogen ist. 6. Valve device according to one of claims 1 to 5, characterized in that the leaflet holder (13) with its clamps (3, 3 a) and the one or more ports for connecting with the vessel wall or the like bent from a piece of wire.
7. Ventileinrichtung nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß die Spannbügel ( 3 , 3 a) im Verlauf ihrer Längserstreckung Verbindungsstellen ( 8 ) für das Klappensegel ( 4 ) aufweisen, die insbesondere durch mehrere, zueinander beabstandete Löcher zum Durchfädeln von Haltefäden ( 9 ) gebildet sind und daß die Spannbügel ( 3 , 3 a) im Bereich der Verbindungsstellen vorzugsweise abgeplattet sind. 7. Valve device according to one of claims 1 to 6, characterized in that the clamping strap (3, 3 a) junctions in the course of their longitudinal extension (8) for the valve flaps (4), in particular by a plurality of spaced-apart holes for threading of holding threads (9) are formed and that the clamping strap (3, 3 a) are preferably flattened in the region of the joints.
8. Ventileinrichtung nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß zumindest einer der Spannbügel ( 3 a) an seinem freien Ende zur Bildung der Anschlußstelle als Haken oder Öse mit sich bei einer Einführöffnung überlappenden Schenkeln ausgebildet ist. 8. Valve device according to one of claims 1 to 7, characterized in that at least one of the clamping bracket (3 a) is formed at its free end to form the connection point as a hook or eyelet with overlapping with an insertion legs.
9. Ventileinrichtung nach einem der Ansprüche 1 bis 8, dadurch gekennzeichnet, daß einer der überlappenden Schenkel durch das freie Ende des Hakens oder der Öse und der andere Schenkel durch einen Teilbereich des zugehörigen Spannbügels gebildet ist. 9. Valve arrangement according to one of claims 1 to 8, characterized in that one of the overlapping legs being formed by the free end of the hook or the loop and the other limb through a partial area of ​​the associated clamp clip.
10. Ventileinrichtung nach einem der Ansprüche 1 bis 9, dadurch gekennzeichnet, daß der Haken oder die Öse ringbügelartig ausgebildet ist und sich über einen Großteil der Länge des Spannbügels erstreckt. 10. Valve device according to one of claims 1 to 9, characterized in that the hook or eyelet ring is formed in a bow shape and extending over a major part of the length of the tensioning bow.
11. Ventileinrichtung nach einem der Ansprüche 1 bis 10, dadurch gekennzeichnet, daß das zwischen den beiden Spannbügeln innenliegende Ende des ringbügelartigen Hakens als Ein fädelende ( 6 ) ausgebildet ist und einen gerundeten Verlauf, gegebenenfalls mit einer seitlichen Auslenkung aufweist. 11. Valve device according to one of claims 1 to 10, characterized in that the inside between the two clamps the end of the ring bow-shaped hook as a fädelende (6) and has a rounded course, optionally having a lateral deflection.
12. Ventileinrichtung nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, daß zumindest die Verbindungsstelle der Spannbügel der Klappensegel-Halterung ( 13 ), vorzugsweise die Zwischenwindung ( 5 ), aus Memorymetall (Formerinnerungs metall) besteht. 12. A valve device according to any one of claims 1 to 11, characterized in that at least the juncture of the clamping bracket of the leaflet holder (13), preferably the intermediate turn (5), made of memory metal (shape memory metal).
13. Ventileinrichtung nach einem der Ansprüche 1 bis 12, dadurch gekennzeichnet, daß die Anschlußstellen der Klappensegel- Halterung ( 13 ) zum gelenkigen Verbinden mit einem an der Einsatzstelle verankerten Stent ( 2 ) ausgebildet sind, insbesondere zum Einhaken bei diesem Stent. 13. Valve device according to one of claims 1 to 12, characterized in that the connection points of Klappensegel- holder (13) are designed for the articulated connection with an anchored at the site stent (2), in particular for hooking in this stent.
14. Ventileinrichtung nach einem der Ansprüche 1 bis 13, dadurch gekennzeichnet, daß die Klappensegel ( 4 ) aus biologischem Material, vorzugsweise aus Schweineklappen, gegebenenfalls aus Kunststoff bestehen. 14. Valve device according to one of claims 1 to 13, characterized in that the valve flaps (4) from biological material, preferably of porcine valves, optionally made of plastic.
15. Ventileinrichtung nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, daß das Klappensegel mit Halterung in zusammengefalteten Zustand im Querschnitt kleiner als 6 mm ist. 15. Valve device according to one of claims 1 to 14, characterized in that the valve leaflets with holder in the folded state in cross-section smaller than 6 mm.
16. Ventileinrichtung nach einem der Ansprüche 1 bis 15, dadurch gekennzeichnet, daß am freien Ende eines der Spannbügel ( 3 ) ein Verankerungsdorn ( 10 ), gegebenenfalls mit Widerhaken oder dergleichen zum Verankern in der Gefäßwand vorgesehen ist. 16. Valve device according to one of claims 1 to 15, characterized in that the free end of the clamping bracket (3) is an anchor mandrel (10), optionally with barbs or the like are provided for anchoring in the vessel wall.
17. Katheter zum Einführen einer Ventileinrichtung nach einem der Ansprüche 1 bis 16, dadurch gekennzeichnet, daß der Katheter am proximalen Endbereich Befestigungsmittel zum Anbringen von in Umfangsrichtung und Längsrichtung verteilt angebrachten Klappensegel-Halterungen ( 13 ) aufweist und daß am freien Ende des Katheters vorzugsweise ein Ballon zum Haltern eines Stents ( 2 ) vorgesehen ist. 17. A catheter for insertion of a valve device according to any one of claims 1 to 16, characterized in that the catheter at the proximal end portion of attachment means for attaching distributed in the circumferential direction and the longitudinal direction has attached leaflet holders (13) and that preferably at the free end of the catheter, a balloon is provided for holding a stent (2).
18. Katheter nach Anspruch 17, dadurch gekennzeichnet, daß am Katheter im Bereich der Befestigungsmittel für die Klappense gel-Halterungen eine über diese verschiebbare, äußere Hülle vorgesehen ist, die zum Freigeben und Verbinden der einzelnen Klappensegel-Halterungen mit dem Stent oder dergleichen in Richtung zum äußeren Ende des Katheters zurückziehbar ist und daß der Querschnitt des Katheters im Halterungsbereich für die Klappensegel-Halterungen kleiner ist als der lichte Durchtrittsquerschnitt des aufgeweiteten, verankerten Katheters. 18. A catheter according to claim 17, characterized in that a is provided above this movable outer sleeve on the catheter in the region of the fastening means for the Klappense gel-holders which for releasing and connecting the individual leaflet holders with the stent or the like in the direction is retractable to the outer end of the catheter and that the cross section of the catheter in mount area for the leaflet holders is smaller than the clear passage cross section of the widened anchored catheter.
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