DE19907646A1 - Ventileinrichtung zum Einsetzen in ein Hohlorgan - Google Patents
Ventileinrichtung zum Einsetzen in ein HohlorganInfo
- Publication number
- DE19907646A1 DE19907646A1 DE1999107646 DE19907646A DE19907646A1 DE 19907646 A1 DE19907646 A1 DE 19907646A1 DE 1999107646 DE1999107646 DE 1999107646 DE 19907646 A DE19907646 A DE 19907646A DE 19907646 A1 DE19907646 A1 DE 19907646A1
- Authority
- DE
- Germany
- Prior art keywords
- sail
- holder
- flap
- stent
- valve device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
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
- 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
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Abstract
Eine Ventileinrichtung dient zum Einsetzen in ein Hohlorgan, ein Gefäß oder dergleichen. Sie weist eine künstliche Gefäßklappe, insbesondere Taschenklappe, auf, die mehrere, im Umriß in Flachlage dreieckige Klappensegel (11) aufweist, die in Funktionsstellung in Umfangsrichtung aneinandergrenzen, wobei die Gefäßklappe aus mehreren separaten Klappensegeln zusammengesetzt ist. Als Halterung für die Klappensegel (11) ist wenigstens ein Stent (12) vorgesehen, der ein oder mehrere Halter (1) zum Anbringen von an den Klappensegeln befindlichen Gegenhaltern (4) aufweist.
Description
Die Erfindung bezieht sich auf eine Ventileinrichtung zum Einsetzen
in ein Hohlorgan, ein Gefäß oder dergleichen, mit einer künstlichen
Gefäßklappe, insbesondere Taschenklappe, die mehrere, im Umriß
in Flachlage dreieckige Klappensegel aufweist, die in Funktions
stellung in Umfangsrichtung aneinandergrenzen, wobei die
Gefäßklappe aus mehreren separaten Klappensegeln zusammengesetzt
ist.
Die exakte Fixierung einer solchen Ventileinrichtung beim Einsetzen
in ein Hohlorgan, ein Gefäß oder dergleichen, insbesondere zum
Ersetzen von Herzklappen ist problematisch.
Bisheriger Ansatz zur Problemlösung ergab sich aus der Patentanmel
dung DE 43 16 97 A1 und der DE 195 32 846 A1.
Aufgabe vorliegender Erfindung ist es, eine Ventileinrichtung zu
schaffen, die exakt dort positionierbar ist, wo sie in Aktion
treten soll. Außerdem soll eine Kathetervariation geschaffen
werden, die ein Einführen der Klappensegel für die Mitralklappe
ermöglicht. Ferner soll die Möglichkeit bestehen, die Implanation
der Klappensegel der Herzklappe in einem Arbeitsgang zu er
möglichen.
Zur Lösung dieser Aufgabe wird erfindungsgemäß vorgeschlagen, daß
als Halterung für die Klappensegel wenigstens ein Stent vorgesehen
ist, der ein oder mehrere Halter zum Anbringen von an den
Klappensegeln befindlichen Gegenhaltern aufweist.
Mit dem Stent steht eine gut positionierbare Halterung zur
Verfügung, an der sich die Ventileinrichtung befestigen läßt.
Zweckmäßigerweise weisen die am Stent angebrachten Halter sowie
die an den Klappensegeln befindlichen Gegenhalter in Längsrichtung
durchgehende Innenhöhlungen auf zum Durchtritt eines Führungs
fadens, Führungsdrahtes oder dergleichen.
Die am Stent angebrachten Halter weisen vorzugsweise jeweils eine
Hülse mit einem Verankerungsabschnitt für den Führungsdraht oder
dergleichen und einen sich daran anschließenden Befestigungs
abschnitt zum Anbringen des ein Klappensegel haltenden Gegenhalters
auf, wobei sich an den Befestigungsabschnitt vorzugsweise ein
trichterförmiger Zentrierabschnitt anschließt.
Der Befestigungsabschnitt kann ein Schraubengewinde enthalten und
mehrfach an der herzzugewandten Seite geschlitzt sein, um
krallenförmig den Führungsdraht oder -faden fixieren zu können
oder bei nur einfacher Schlitzung, das Fadenende des Führungs
drahtes aufzunehmen. Dieser hat dann am Ende einen Knoten, so
daß der Führungsdraht vorübergehend mit dem Hohlkörper, der an
den Stent angeschweißt ist, fixiert ist. Der Knoten verhindert
vorübergehend das ungewollte Herausziehen des Fadens. Auch kann
an der herzabgewandten Seite ein zweites Schraubengewinde
angebracht werden, mit dem der Führungsdraht vorübergehend fixiert
wird.
Das biologische Segel wird auf eine durch die Spannung des Drahtes
sich aufklappende Halterung aufgenäht oder geklebt. Das Aufklappen
kann auch durch Memory-Effekt geschehen. Diese Halterung hat an
der dem Herzen zugewandten Seite ebenfalls einen Trichter. Die
beiden Trichter werden über den Führungsfaden oder -draht
zusammengeführt. Hinter diesem Trichter läuft auf dem Führungsdraht
bzw. -faden eine Hohlschraube. Diese weist am Kopf einen Vierkant
auf. Diese Hohlschraube wird mit dem zweiten Trichter zusammen
vor Ort geschoben und die Trichter werden ineinander eingepaßt.
Zuvor wird das Segel mit dem Segelhalterungskatheter, der ebenfalls
über den Führungsfaden läuft, wandständig eingerichtet und dann
die Schraube endgültig festgezogen. Der Segelhalterungskatheter
wird zurückgezogen und das Segel kann sich öffnen und in Funktion
gehen. Beim Anziehen der Schraube wird mit den letzten Drehungen
die Kralle erweitert bzw. wird der Knoten aus der Schlitzung
gedrückt und der Führungsfaden bzw. -draht kann zurückgezogen
werden.
Zusätzlich zu dem mit Klappensegel-Haltern versehenen Stent kann
ein Abschlußstent zum Festlegen der dem Herz abgewandten Ränder
der Klappensegel vorgesehen ist.
Dieser wird nach den Einbringen auf der herzabgewandten Seite
auf dem überstehenden Teil des Segels geöffnet und es werden damit
auch paravalvuläre Leckagen verhindert.
Auch kann das Segel über eine Minihydraulik an den gewünschten
Platz gedrückt werden.
An der Segelhalterung können Segel aus biologischem oder
Kunststoffmaterialien befestigt werden.
Eine Weiterentwicklung dieser Einführungstechnik besteht darin,
daß drei Stents mit jeweils einer Segelhalterung eingeführt werden,
wobei dann ein Stent in den anderen hineingeschoben wird und
gedehnt wird. An jedem Stent befindet sich ein Hohlkörper wie
oben beschrieben. Nach Ausrichtung der Segel werden die Stents
gedehnt, wobei die Segel auf gleicher Ebene positioniert werden.
Die drei Stents befinden sich hintereinander in einer Einführungs
hülse und werden mit Hilfe eines Fadens bzw. Drahtes vor Ort
gebracht. Auch hier wird schließlich der oben beschriebene
Abschlußstent angebracht.
Auch können die oben beschriebenen Stents hintereinander
positioniert werden. Dann müssen die walzenförmigen Hohlkörper
die Träger der Segel sind entsprechend verlängert werden, so daß
die Endstellung der Segel auf gleicher Höhe ist.
Eine weitere Ausgestaltung der Erfindung besteht darin, daß die
Fixation des Segels über einen Klettverschluß durchgeführt wird.
Dazu ist vorgesehen, daß die am Stent angebrachten Halter jeweils
durch einen Klettverschluß-Abschnitt gebildet und die Klappensegel
mit einem Klettverschluß-Gegenabschnitt versehen sind und daß
vorzugsweise der Klettverschluß-Abschnitt durch die Maschenseite
und der Klettverschluß-Gegenabschnitt durch die Häkchenseite
gebildet ist.
Das Material des Klettverschlusses besteht vorzugsweise aus Polypin
o. ä. und ist damit resorbierbar. Die Maschenseite des Klettver
schlusses kleidet die Innenfläche des Stents aus und auf der
Rückseite des Segels wird die Häkchenseite des Klettverschlusses
geklebt. Dazwischen wird ein Katheter der sich flächig verbreitert
und deckungsgleich zur Rückwand des Segels ist, angebracht. Das
Segel wird in die exakte Funktionslage gebracht und anschließend
flächige Katheter entfernt, während gleichzeitig mit der Dehnung
des Ballons das Segel exakt positioniert wird. Auch hier wird
der oben beschriebene Abschlußstent angebracht.
Somit ist zum Positionieren eines Klappensegels am Stent ein
hülsenförmiger Katheter zur Aufnahme des zusammengerollten
Klappensegels während des Zuführens sowie eines im zusammengeroll
ten Klappensegel eingesetzten, aufweitbaren Ballons vorgesehen.
Eine weitere Ausgestaltung der Erfindung besteht darin, daß am
Stent eine Halterung angebracht wird, die eine Schienenfunktion
hat. Diese Schiene verläuft im Stent zunächst vertikal geht dann
am Ende des Stentes und nach seiner Dehnung in eine Spiralform
über. Diese schließt sich herzwärts kreisförmig und hat am Ende
eine Brems- bzw. Einrastvorrichtung. Die Schiene ist hohl zur
Aufnahme des Führungsdrahtes bzw. -fadens.
Die drei Segel der biologischen Klappe liegen nun nebeneinander.
Dies entsteht dadurch, daß der in vivo vorhandene Kreis bei der
Präparation so behandelt wird, daß zwischen den Kommissuren
durchtrennt wird und aus dem kreisförmigen Gebilde eine seitliche
Aneinanderreihung entsteht. An deren Rückwand werden kleine
durchlöcherte Kunststoffkugeln angeklebt. Durch diese Kugeln wird
der Führungsfaden gezogen und auf diesem Führungsfaden werden
die aneinandergereihten Segel zunächst vertikal zum Aortenquer
schnitt hochgezogen bzw. hochgedrückt. Die Segel gehen mit der
Schiene aus der Vertikalen spiralig in die Horizontale über und
am Ende befindet sich dann ein Blockierungs- bzw. Einrastmecha
nismus, an dem die Segel dann endgültig horizontal in ihrer
Endstellung angekommen sind und in Funktion gehen können. Zur
Leckageverhinderung wird dann herzwärts und herzabgewandt der
Ventileinrichtung auf die Überstände des biologischen Materials
ein Abschlußstent angebracht.
Dieses Vorgehen ermöglicht die Positionierung aller drei Segel
in einem einzigen Arbeitsgang.
Eine weitere Ausgestaltung der Erfindung besteht darin, daß am
Stent ein dornartiger Hohlkörper angeschweißt wird. Der Hohlraum
nimmt den Führungsdraht auf und dieser wird wie oben beschrieben
vorübergehend festgeschraubt. An der herzwärts befindlichen Seite
des Segels wird ein Rastmechanismus z. B. mit einer Feder an Segel
und einer Rille am Dorn angebracht, der das Segel auf dem Dorn
fixiert und der auch erlaubt, das Segel bei Bedarf herauszu
schrauben.
Um die Herzklappe mit ihren Segeln in den Bereich der Mitralklappe
zu bringen, bedarf es eines besonderen Katheters. Dieser besteht
aus einem Normalkatheter, an dem sich seitlich zusätzlich ein
kurzer abspreizbarer Schenkel befindet, der beim Einführen an
den Hauptkatheter gepreßt ist. Nach Einbringen in den Ventrikel
des Herzens wird dieser kleine Katheter abgespreizt. Dieser trägt
den Stent. Das Abspreizen geschieht mechanisch oder über einen
Memoryeffekt. Danach wird der Katheter etwas zurückgezogen, wobei
die abgespreizte Schenkelspitze in den Bereich der Mitralklappe
gebracht wird. Der Stent der sich über Memoryeffekt öffnet, krallt
sich dabei in den biologischen Halterungsring der Mitralklappe
ein.
Über Hydraulik oder auch mechanisch wird dann das Segel wie oben
beschrieben angedockt und kann in Funktion gehen.
Zusätzliche Ausgestaltung der Erfindung sind in den weiteren
Unteransprüchen aufgeführt. Nachstehend ist die Erfindung mit ihren
wesentlichen Einzelheiten anhand der Zeichnungen noch näher
erläutert. Es zeigt stärker schematisiert:
Fig. 1 eine schematische Längsschnitt-Ansicht der Andock
vorrichtung mit einzelnen Teilen,
Fig. 2 eine Seitenansicht des Andockmechanismus,
Fig. 3 eine Seitenansicht eines in Spreizlage befindlichen
Klappensegels in der Aorta mit Halterungsstent und
Abschlußstent,
Fig. 4 eine Seitenansicht beim Positionieren der Segel
in einem Arbeitsgang,
Fig. 5 eine Draufsicht beim Positionieren der Segel in
einem Arbeitsgang,
Fig. 6 eine Detailansicht der in Fig. 4 Segelhalterung,
Fig. 7 eine Schnittdarstellung eines hülsenförmigen
Katheters zur Aufnahme eines zusammengerollten
Klappensegels sowie eines aufweitbaren Ballons,
Fig. 8 einen Katheter zum Einbringen von Klappensegeln
in den Bereich der Mitralklappe,
Fig. 9 den in Fig. 8 gezeigten Katheter in Abgeklappter
Lage und
Fig. 10 einen Katheter zum gleichzeitigen Einbringen von
drei Klappensegeln.
In Fig. 1 sind die Einzelbestände eines Andockmechanismus
dargestellt. Er weist einen walzenförmigen Hohlkörper 1 mit einer
trichterförmigen Erweiterung 2 auf. Herzwärts befindet sich an
diesem Hohlkörper 1 ein Gewinde 3 für den Führungsdraht 7 (vergl.
Fig. 2). Der zweite Trichter 4 ist mit der Segelhalterung 6
verbunden. In diesen Trichter 4 mündet beim Andocken die
Hohlschraube 8, deren Gewinde über einen Vierkant 10 den zweiten
Trichter 4 in den ersten Trichter 2 schiebend in das Gewinde 5
des walzenförmigen Hohlkörpers 1 hineingedreht wird. Die Stellung
des Segels 11 wird mit Hilfe der Einführungshülse wandständig
gedreht und dann endgültig mit Hilfe eines am Vierkant 10
ansetzenden Schraubendrehers angedockt.
Anschließend wird der Führungsdraht 7 zurückgedreht und zurückgezo
gen und aus dem Körper entfernt. Das Segel 11 kann dann in
Funktion gehen, nachdem sich die Segelhalterung gespreizt hat
und die Schutz- und Einführungshülse in Form eines Katheters 19
(Fig. 7) zurückgezogen ist.
Beim Einsetzen der Ventileinrichtung wird zunächst der Halterungs
ring 12 (Stent nach Palmaz) mit einem Katheter in die beabsichtigte
Position am Ende der Aorta 13 (Fig. 3) eingebracht und mit dem
Ballon 20 (Fig. 7) gedehnt.
In Fig. 2 sind die ineinandergeschobenen Teile des Andockmecha
nismus schematisch dargestellt. Der Einführungsdraht 7 befindet
sich im Gewinde 3 des walzenförmigen Hohlkörpers 1, der herz
abgewendet den Trichter 2 aufweist. Die Hohlschraube 8 hat mit
ihrem Gewinde 9 den Trichter 4 der Segelhalterung 6 in den Trichter
2 des walzenförmigen Hohlkörpers 1 gedrückt.
Die Fig. 3 zeigt die Aorta 13, in der der Stent 12 aufgedehnt
ist. Die beiden Trichter 2 und 4 sind mit Hilfe der Hohlschraube
8 ineinandergeschoben und die Segelhalterung 6 ist gespreizt und
bringt das Segel 11 in Funktion. Zum Schluß wird der Abschlußstent
21 eingebracht.
Fig. 4 zeigt die Aorta 13, in der der Stent 12 aufgedehnt ist.
Randständig ist eine Schiene 14 angebracht, die im Stent zunächst
vertikal verläuft und dann in die Spiralform bei 15 übergeht und
sich kreisförmig bei 16 schließt, wobei sich am Ende ein Brems-
und Rastmechanismus 17 befindet.
An der Rückseite der Segel 11 befinden sich kleine Glas- oder
Kunststoffperlen 18, die perforiert sind und durch die der
schienende Faden 14 läuft (vergl. auch Fig. 6).
Fig. 5 zeigt dann einen Draufblick, nachdem die Segel 11 in die
Horizontale entlang der Spirale 15 geschoben worden sind.
Fig. 10 zeigt eine Anordnung, wo ein Katheter eine der Anzahl der
Klappensegel entsprechende Anzahl von voneinander unabhängig
betätigbare Ballons 20a, 20b, 20c aufweist. Diese sind in Reihe
hintereinander angeordnet und tragen jeweils ein Klappensegel 11.
Die Klappensegel 11 an benachbarten Ballons sind jeweils um 120°
versetzt zueinander angeordnet und damit entsprechend ihrer
späteren Lage vorpositioniert. Beim Einsetzen der Klappensegel
werden die entsprechenden Ballons über die Zuleitungen 24
nacheinander aufgeweitet und dabei die einzelnen Klappensegel
nebeneinander abgesetzt. Nur zur Verdeutlichung sind in Fig. 10
alle Ballons gleichzeitig aufgeweitet dargestellt.
Um die Herzklappe mit ihren Segeln in den Bereich der Mitralklappe
zu bringen, bedarf es eines besonderen Katheters 22, der in den
Fig. 8 und 9 gezeigt ist. Dieser besteht aus einem Normal
katheter, an dem sich seitlich zusätzlich ein kurzer abspreizbarer
Schenkel 23 befindet, der beim Einführen an den Hauptkatheter
gespreßt ist. Nach Einbringen in den Ventrikel des Herzens spreizt
sich dieser Schenkel 23 des Katheters, der den Stent 12 trägt
über einen Memory- oder mechanischen Mechanismus ab und kann dann
den Stent tragend in den Bereich der Ventilebene gebracht werden.
Nach Dehnung des Stent werden über einen Faden bzw. Draht die
Segel angedockt, indem der Katheter als Schubvorrichtung genutzt
wird. Das zweite Segel wird nach Lösung des ersten Segels ebenfalls
hochgeschoben.
Claims (20)
1. Ventileinrichtung zum Einsetzen in ein Hohlorgan, ein Gefäß
oder dergleichen, mit einer künstlichen Gefäßklappe,
insbesondere Taschenklappe, die mehrere, im Umriß in Flachlage
dreieckige Klappensegel aufweist, die in Funktionsstellung
in Umfangsrichtung aneinandergrenzen, wobei die Gefäßklappe
aus mehreren separaten Klappensegeln zusammengesetzt ist,
dadurch gekennzeichnet, daß als Halterung für die Klappensegel
(11) wenigstens ein Stent (12) vorgesehen ist, der ein oder
mehrere Halter (1) zum Anbringen von an den Klappensegeln
befindlichen Gegenhaltern (4) aufweist.
2. Ventileinrichtung nach Anspruch 1, dadurch gekennzeichnet,
daß die am Stent angebrachten Halter (1) sowie die an den
Klappensegeln befindlichen Gegenhalter (4) in Längsrichtung
durchgehende Innenhöhlungen aufweisen zum Durchtritt eines
Führungsfadens (7), Führungsdrahtes oder dergleichen.
3. Ventileinrichtung nach Anspruch 1 oder 2, dadurch gekenn
zeichnet, daß zum Fixieren der jeweils mit einem Klappensegel
(11) verbundenen Gegenhalter in Aufsteckrichtung am Halter
eine in Funktionsstellung eingreifende Rastverbindung
vorgesehen ist und daß zum Ausrichten in Drehlage am
Gegenhalter und am Halter beim Zusammenstecken aufeinander
treffende Schrägflächen vorgesehen sind.
4. Ventileinrichtung nach einem der Ansprüche 1 bis 3, dadurch
gekennzeichnet, daß mehrere Stents (12) mit jeweils einem
oder mehreren daran angebrachten Haltern (1) vorgesehen sind,
daß die Halter am jeweiligen Stent so angeordnet sind, und
daß sich dort aufgesteckte Klappensegel (11) bei in Reihe
hintereinander angeordneten Stents etwa im gleichen Umfangs
bereich beziehungsweise in gleicher Höhe befinden.
5. Ventileinrichtung nach einem der Ansprüche 1 bis 4, dadurch
gekennzeichnet, daß eine der Anzahl der vorgesehenen
Klappensegel entsprechende Anzahl von Stents (12) mit jeweils
einem Halter vorgesehen sind.
6. Ventileinrichtung nach einem der Ansprüche 1 bis 5, dadurch
gekennzeichnet, daß die Klappensegel (11) eine Segelhalterung
(6) mit einem Faltmechanismus zum Zusammenfalten der
Klappensegel für das Einbringen durch ein Gefäß an die
Einsatzstelle und dort zum Auffalten der Segel hat.
7. Ventileinrichtung nach Anspruch 6, dadurch gekennzeichnet,
daß die Segelhalterung (6) 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.
8. Ventileinrichtung nach Anspruch 6 oder 7, dadurch gekenn
zeichnet, daß zumindest die Verbindungsstelle der Spannbügel
der Segelhalterung (6) aus Memorymetall (Formerinnerungs
metall) besteht.
9. Ventileinrichtung nach einem der Ansprüche 1 bis 8, dadurch
gekennzeichnet, daß die Klappensegel (11) aus biologischem
Material, vorzugsweise aus Schweineklappen, gegebenenfalls
aus Kunststoff bestehen.
10. Ventileinrichtung nach einem der Ansprüche 1 bis 9, dadurch
gekennzeichnet, daß das Klappensegel mit Halterung in
zusammengefalteten Zustand im Querschnitt kleiner als 6 mm
ist.
11. Ventileinrichtung nach einem der Ansprüche 1 bis 10, dadurch
gekennzeichnet, daß zum Einführen der Klappensegel eine
Einführungshülse zur Aufnahme eines oder vorzugsweise aller
zu einer Ventileinrichtung gehörenden Klappensegel vorgesehen
ist und daß die Klappensegel in der Einführungshülse hinter
einander in Reihe angeordnet sind.
12. Ventileinrichtung nach einem der vorstehenden Ansprüche,
dadurch gekennzeichnet, daß die am Stent angebrachten Halter
jeweils eine Hülse mit einem Verankerungsabschnitt für den
Führungsdraht oder dergleichen und einen sich daran an
schließenden Befestigungsabschnitt zum Anbringen des ein
Klappensegel haltenden Gegenhalters (4) aufweisen und daß sich
an den Befestigungsabschnitt vorzugsweise ein trichterförmiger
Zentrierabschnitt anschließt.
13. Ventileinrichtung nach Anspruch 12, dadurch gekennzeichnet,
daß die Gegenhalter jeweils einen in den Zentrierabschnitt des
am Stent angebrachten Halters passenden Konusabschnitt mit
einem Durchgangskanal aufweisen und daß an dem Konusabschnitt
ein Haltebügel zum Aufspannen eines Klappensegels angebracht
ist.
14. Ventileinrichtung nach Anspruch 12 oder 13, dadurch gekenn
zeichnet, daß der am Stent angebrachte Halter mit diesem durch
eine Schweißverbindung verbunden, vorzugsweise angelasert ist.
15. Ventileinrichtung nach einem der Ansprüche 12 bis 14, dadurch
gekennzeichnet, daß die am Stent angebrachten Halter jeweils
durch einen Klettverschluß-Abschnitt gebildet und die Klappen
segel mit einem Klettverschluß-Gegenabschnitt versehen sind
und daß vorzugsweise der Klettverschluß-Abschnitt durch die
Maschenseite und der Klettverschluß-Gegenabschnitt durch die
Häkchenseite gebildet ist.
16. Ventileinrichtung nach einem der Ansprüche 1 bis 15, dadurch
gekennzeichnet, daß zusätzlich zu dem mit Klappensegel-Haltern
versehenen Stent (12) ein Abschlußstent (21) zum Festlegen der
dem Herz abgewandten Ränder der Klappensegel (11) vorgesehen
ist.
17. Katheter zum Einführen einer Ventileinrichtung nach einem der
Ansprüche 1 bis 16, dadurch gekennzeichnet, daß zum Positio
nieren eines Klappensegels (11) am Stent (12) ein hülsenförmi
ger Katheter (19) zur Aufnahme des zusammengerollten Klappen
segels (11) während des Zuführens sowie eines im zusammenge
rollten Klappensegel eingesetzten, aufweitbaren Ballons (20)
vorgesehen ist.
18. Katheter nach Anspruch 17, dadurch gekennzeichnet, daß
zwischen dem mit einem Klettverschluß-Abschnitt versehenen
Klappensegel und der Innenwand des hülsenförmigen Katheters
eine entfernbare Zwischenlage vorgesehen ist.
19. Katheter nach Anspruch 17 oder 18, dadurch gekennzeichnet, daß
er eine der Anzahl der Klappensegel (11) entsprechende Anzahl
von voneinander unabhängig betätigbaren Ballons (20a, 20b, 20c)
aufweist, die, in Reihe hintereinander angeordnet sind und
jeweils ein Klappensegel (11) tragen.
20. Katheter nach einem der Ansprüche 17 bis 19, dadurch gekenn
zeichnet, daß der Katheter (22) am proximalen Endbereich einen
kurzen, abspreizbaren Schenkel (23)aufweist.
Priority Applications (1)
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DE1999107646 DE19907646A1 (de) | 1999-02-23 | 1999-02-23 | Ventileinrichtung zum Einsetzen in ein Hohlorgan |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE1999107646 DE19907646A1 (de) | 1999-02-23 | 1999-02-23 | Ventileinrichtung zum Einsetzen in ein Hohlorgan |
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Publication Number | Publication Date |
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DE19907646A1 true DE19907646A1 (de) | 2000-08-24 |
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ID=7898482
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Application Number | Title | Priority Date | Filing Date |
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DE1999107646 Withdrawn DE19907646A1 (de) | 1999-02-23 | 1999-02-23 | Ventileinrichtung zum Einsetzen in ein Hohlorgan |
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