专利摘要:

公开号:WO1986003129A1
申请号:PCT/DE1985/000479
申请日:1985-11-15
公开日:1986-06-05
发明作者:Tassilo Bonzel
申请人:Tassilo Bonzel;
IPC主号:A61M25-00
专利说明:
[0001] Dilatationskatheter
[0002] Die Erfindung betrifft einen Dilatationskatheter mit einem Tubus, dessen patientenseitiges Ende in einen aufweitbaren Ballon mündet, und mit einem den Ballon durchquerenden Schlauchabschnitt, der mit dem distalen Ende des Ballons abgedichtet verbunden ist und durch den ein Führungsdraht hindurchführbar ist.
[0003] Ein derartiger Dilatationskatheter ist in The American Journal of Cardiology, Vol. 49, April 1, 1982, Seiten 1216 bis 1222, beschrieben und wird zur Aufweitung von Verengungen in Gefäßen und Körperhohlräumen, insbe¬ sondere von Koronararterien, verwendet. An der Spitze eines solchen Dilatationskatheters ist ein aufblasbarer Ballon angebracht, der über ein im Katheter befind¬ liches Innenlumen gefüllt oder entleert werden kann. -
[0004] Bei dem bekannten Dilatationskatheter ist ein Tubus vorgesehen, der am vorderen Ende in einen Ballon über¬ geht. Durch das Balloninnere und den Tubus erstreckt sich bei dem bekannten Dilatationskatheter ein Schlauch, der über das vordere Ende des Ballons vor¬ steht und mit dem vorderen Ende des Ballons abgedichtet verbunden ist. Durch das Innere des Schlauches ist ein Führungsdraht geführt, der während der Operation gegen¬ über dem Ballon verschoben werden kann, so daß der Dilatationskatheter entlang dem Führungsdraht vorge¬ schoben oder zurückgezogen werden kann. Beim Auswech- sein eines mit Hilfe eines Führungskatheters gelegten Dilatationskatheters ist es erforderlich, daß der Füh¬ rungsdraht um eine Länge aus dem Körper des Patienten herausragt, die größer ist als die Länge des Dilata¬ tionskatheters mit seinem Tubus. Aus diesem Grunde ist die Handhabung des bekannten Dilatationskatheters schwierig, zumal die Reibungskräfte zwischen dem Füh¬ rungsdraht und dem den Ballon und den Tubus ganz durch¬ setzenden Schlauch groß sind.
[0005] Ausgehend von diesem Stand der Technik liegt der Erfin¬ dung die Aufgabe zugrunde, ein Dilatationskatheter zu schaffen, das entlang einem Führungsdraht leicht ge¬ führt werden kann und leicht und einfach gegen ein anderes Dilatationskatheter ausgewechselt werden kann.
[0006] Diese Aufgabe wird erfindungsgemäß dadurch gelöst, daß das proximale Ende des Uni Ions ebenfalls dichtend am Schlauchabschnitt befestigt ist und der Tubus gegenüber dem Schlauchabschnitt seitlich versetzt in das Ballon- innere mündet.
[0007] Dadurch, daß der mit der Oberfläche des Führungsdrahtes in Berührung kommende Schlauchabschnitt lediglich etwa die Länge des Ballons aufweist und der Tubus nicht mehr den Führungsdraht und den diesen umgebenden Führungs¬ schlauch umgibt, erhöht sich die Handhabbarkeit des Dilatationskatheters. Die Steuerbarkeit ist wegen des Fehlens der Reibungskräfte in einem langen Führungs- schlauch erheblich verbessert. Außerdem braucht der Führungsdraht wegen des verhältnismäßig kurzen Schlauchabschnitts nicht mehr etwa um die gleiche Länge aus dem Körper des Patienten herausragen, wie die Länge des Dilatationskatheters beträgt.
[0008] Zweckmäßige Ausgestaltungen und Weiterbildungen der Erfindung sind in den Unteransprüchen gekennzeichnet. Die Erfindung wird nachstehend anhand des in der Zeich¬ nung dargestellten Ausführungsbeispiels erläutert. Es zeigen:
[0009] Fig. 1 den vorderen Teil des erfindungsgemäßen Dila¬ tationskatheters mit dem in den Ballon ein¬ mündenden Tubus,
[0010] Fig. 2 oinen QuorschnLtt durch den Dilatationskathe- ter im Bereich des neben dem Führungsdraht verlaufenden Tubus und
[0011] Fig. 3 einen Querschnitt durch den Dilatationskathe¬ ter im Bereich eines Goldmarkers im Ballon.
[0012] In Fig. 1 ist der vordere Teil eines Dilatationskathe¬ ters dargestellt, der mit Hilfe eines in der Zeichnung nicht dargestellten Führungskatheters mit einem Durch¬ messer von einigen Millimetern und einer Länge von etwa 1 m, beispielsweise von der rechten Leiste eines Pa¬ tienten über die gesamte Länge der Arterie bis zur Aorta und zu den Koronararterien vorgeführt wird. Durch den in der Zeichnung nicht dargestellten Führungskathe¬ ter wird zunächst ein Führungsdraht 1 in die entspre- chende Herzkranzarterie vorgeführt. Ein Abschnitt des etwa 1 m langen Führungsdrahtes 1 ist in Fig. 1 sicht¬ bar. Der Führungsdraht 1 dient als Instrumentierschiene zum Führen des Dilatationskatheters.
[0013] Der Dilatationskatheter verfügt über einen Ballon 2 und einen Tubus 3, der in Fig. 1 abgeschnitten dargestellt ist und ebenfalls eine Länge in der Größenordnung von 1 m hat. In Fig. 2 ist ein Schnitt durch den Führungsdraht 1 und den Tubus 3 dargestellt. Der Tubus 3 dient einerseits zur Übertragung von Schub- und Zugkräften zum Hin- und Herschieben sowie zum Drehen des Ballons 2 auf dem Füh- rungsdraht 1. Aus diesem Grunde ist es zweckmäßig, wenn der Tubus 3 durch einen Stabilisierungsdraht 4 in der in den Figuren 1 bis 3 dargestellten Weise verstärkt ist. Neben seiner Aufgabe zur Übertragung von Kräften dient der Tubus 3 zum Einspritzen von Flüssigkeiten in das Balloninnere 5 zum Aufweiten des Ballons 2 und zum Absaugen von Flüssigkeiten, wenn der Ballondurchmesser verringert werden soll.
[0014] Wie in Fig. 1 zu erkennen ist, besteht der Ballon aus einer Ballonhülle 6 und einem Schlauchabschnitt 7 , . so daß der Ballon 2 einen Ballondurchgang 8 aufweist, der gegenüber dem Balloninneren 5 abgedichtet ist. Die Ballondurchführung 8 gestattet es, den Ballon 2 auf den Führungsdraht 1 aufzuschieben und dadurch auf dem Füh- rungsdraht 1 zu führen.
[0015] In Fig. 3 erkennt man den im wesentlichen ringförmigen Querschnitt des Ballons 2 mit der Ballondurchführung 8, durch die sich der Führungsdraht 1 erstreckt. Um die auf den Tubus 3 ausgeübten Kräfte gut auf den Ballon 2 zu übertragen, reicht der Stabilisierungsdraht 4 bis in die Nähe des distalen Endes 9 des Ballons 2.
[0016] Wie man in Fig. 1 deutlich erkennt, ist am distalen Ende 9 des Ballons 2 die Ballonhülle 6 als Schlauchseg¬ ment 10 ausgebildet, das mit dem distalen Ende des Schlauchabschnittes 7 dicht verbunden ist. In ähnlicher Weise läuft die Ballonhülle 6 am proximalen Ende in ein Schlauchsegment 11 aus, das einerseits mit dem proxi¬ malen Ende des Schlauchabschnittes 7 abdichtend und andererseits mit dem Tubus 3 abdichtend verbunden ist.
[0017] Das in Fig. 1 nach rechts weisende patientenseitige Ende 12 des Tubus 3 läuft in eine Verjüngung 13 aus, die am Schlauchabschnitt 7 befestigt ist. Sowohl in der Verjüngung 13 als auch im übrigen Bereich des patien- tenseitigen Endes 12 sind im Tubus 3 radiale Öffnungen 14 vorgesehen, über die die in den Tubus 3 eingespritz¬ te Flüssigkeit vom Tubus 3 in das Balloninnere 5 des Ballons 2 gelangen kann.
[0018] In den Figuren 1 und 3 sind weiterhin Goldstreifen 15 und 16 dargestellt, die bei Röntgenaufnahmen zum Mar¬ kieren der Lage des Dilatationskatheters dienen.
[0019] In Fig. 3 erkennt man einen Querschnitt durch den Ballon 2 im Bereich des Goldstreifens 15. Der Tubus 3 mit seinem Innenlumen 17 sowie der Schlauchabschnitt 7 mit dem Ballondurchgang 8 sind in dem in Fig. 3 gezeig¬ ten Bereich einstückig ausgebildet, so daß der Gold¬ streifen 15 im wesentlichen eine Ovalform und nicht die Form einer Ziffer 8 hat.
[0020] Der Führungsdraht 1 kann ein in der Zeichnung nicht dargestelltes zentrales Lumen für die Druckmessung oder ein Kontrastmittel enthalten. Um den Reibungswiderstand zwischen dem Innern des Ballondurchgangs 8 und der Oberfläche des Führungsdrahtes 1 möglichst gering zu halten, kann die Innenseite des durch den Stabilisie¬ rungsdraht 4 versteiften Schlauchabschnitts 7 und/oder die Oberseite des Führungsdrahtes 1 mit einer Gleit¬ schicht versehen sein. Zur Dilatation von Herzkranzgefäßen wird durch den Füh¬ rungskatheter zunächst der Führungsdraht 1 in die ent¬ sprechende Herzkranzarterie vorgeführt. Der Führungs¬ draht 1 liegt hierbei frei im Führungskatheter und ist somit gut dreh- und steuerbar. Zur anatomischen Orien¬ tierung sind zusätzlich ausreichende Kontrastmittel gaben möglich. Wenn der Führungsdraht 1 die Einengung in der Herzkranzarterie passiert hat, verbleibt die Spitze des Führungsdrahtes 1 weiterhin jenseits der Stenose im Herzkranzgefäß. Erst jetzt wird der erfin¬ dungsgemäße Dilatationskatheter außerhalb des Körpers auf den Führungsdraht 1 geschoben und an der durch den Führungsdraht 1 gebildeten Schiene durch den Führungs¬ katheter in die Herzkranzarterie und über die Einengung vorgeschoben. Soll der Ballon 2 während der Operation gegen einen Ballon 2 mit größerer Ballonweite ausge¬ wechselt werden, ist es auf einfache Weise möglich, den erfindungsgemäßen Dilatationskatheter zurückzuziehen, wobei der Führungsdraht 1 mit seinem vorderen Ende im Koronargefäß verbleibt und ein sicheres Vorführen des ausgewechselten Ballons erlaubt, ohne daß hohe Rei¬ bungskräfte zu überwinden sind und die Stenose erneut gesucht werden muß. Bei Verdacht auf mangelnde Stabili¬ tät des Dilatationserfolges kann der Führungsdraht 1 sogar für mehrere Stunden liegen bleiben, um zu einem späteren Zeitpunkt eine erneute Dilatation vorzunehmen. Das distale Ende 9 des Dilatationskatheters ist zur besseren Einführbarkeit in Gefäßeinengungen in der oben beschriebenen Weise flacher gestaltet.
[0021] Die Erfindung gestattet es, Ballons unterschiedlicher Länge, Weite und Wanddicke zur Aufnahme variabler Drücke vorzusehen und einfach auszuwechseln. Je nach den medizinischen Erfordernissen sind die Dilatations¬ katheter mit Tuben 3 unterschiedlicher Stärke und Bieg¬ samkeit, die unterschiedliche Vorschübe gewährleisten, ausgerüstet. Für größere Dilatationskatheter ist ein in der Zeichnung nicht dargestelltes zusätzliches Innen¬ lumen vorgesehen, dessen vorderes Ende bis zum distalen Ende 9 des Ballons 2 reicht und mit dem Gefäßinnenraum des operierten Patienten in Verbindung steht. Hierdurch können Druckmessungen und Kontrastmittelinjektionen durchgeführt werden. Die Führungsdrähte 1 eines kom¬ pletten Instrumentariums weisen ebenfalls unterschied¬ liche Stärken und Biegsamkeiten auf. Die Führungsdrähte 1 verfügen über weiche flexible Spitzen, die kürzer oder länger sowie gerade oder gebogen sein können. Wenn im Ballon kein zusätzliches Innenlumen vorgesehen ist, kann in den Führungsdrähten ein bereits oben erwähntes zentrales Lumen für Druckmessungen und Kontrastmittel¬ injektionen vorgesehen sein.
权利要求:
ClaimsPATENTANSP ÜCHE
1. Dilatationskatheter mit einem Tubus, dessen pa- tientenseitiges Ende in einen aufweitbaren Ballon mündet, und mit einem den Ballon durchquerenden
Schlauchabschnitt, der mit dem distalen Ende des Ballons abgedichtet verbunden ist und durch den ein Führungsdraht hindurchführbar ist, da¬ durch gekennzeichnet , daß das proximale Ende des Ballons (11) ebenfalls dichtend am
Schlauchabschnitt (7) befestigt ist und der Tubus (3) gegenüber dem Schlauchabschnitt (7) seitlich versetzt in das Balloninnere (5) mündet.
2. Dilatationskatheter nach Anspruch 1, d ad urch gekennzeichnet , daß die Wandung des Tubus (3) an der Wandung des Schlauchabschnitts (7) an¬ geformt ist.
3. Dilatationskatheter nach Anspruch 1 oder 2, d a¬ durch gekennzeichnet , daß der Tubus (3) durch einen Stabilisierungsdraht (4) verstärkt ist.
4. Dilatationskatheter nach Anspruch 3, d ad urch gekennzeichnet , daß der Stabilisierungs¬ draht (4) sich im Innern des Ballons (2) entlang dem Mantel des Schlauchabschnittes (7) bis zum vorderen Ende (9) des Balloninnenraums (5) er- streckt.
5. Dilatationskatheter nach einem der vorstehenden Ansprüche, d ad urch gekennz eichnet , daß die Ballonhülle (6) an ihren Befestigungsenden in Schlauchsegmente (10, 11) ausläuft, die pa¬ rallel zum Schlauchabschnitt (7) auslaufen.
6. Dilatationskatheter nach einem der vorstehenden Ansprüche , d ad urch gekennzeichnet , daß der Tubus (3) im Balloninnern (5) mit seitli¬ chen Öffnungen (14) versehen ist.
5
7. Dilatationskatheter nach Anspruch 6, d ad urch gekennzeichnet , daß das distale Ende des Tubus (3) in eine Verjüngung (13) ausläuft.
10 8. Dilatationskatheter nach einem der vorstehenden
Ansprüche , d adurch gekennzeichnet , daß der Führungsdraht (1) ein zentrales Lumen für eine Druckmessung und/oder eine Kontrastmittelein¬ spritzung aufweist.
T5
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优先权:
申请号 | 申请日 | 专利标题
DEP3442736.8||1984-11-23||
DE19843442736|DE3442736C2|1984-11-23|1984-11-23||EP19850905779| EP0203945B2|1984-11-23|1985-11-15|Dilatationskatheter|
DE19853571935| DE3571935D1|1984-11-23|1985-11-15|Dilatation catheter|
AT85905779T| AT45098T|1984-11-23|1985-11-15|Dilatationskatheter.|
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