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
Authority
DE
Germany
Prior art keywords
flap
valve device
sail
catheter
valve
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Withdrawn
Application number
DE1995132846
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German (de)
Inventor
Georg Dr Berg
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Individual
Original Assignee
Individual
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Publication date
Application filed by Individual filed Critical Individual
Priority to DE1995132846 priority Critical patent/DE19532846A1/en
Publication of DE19532846A1 publication Critical patent/DE19532846A1/en
Withdrawn legal-status Critical Current

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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; Valves implantable in the body
    • 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; Valves implantable in the body 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 in a hollow organ, a vessel or the like, with a artificial vascular valve, especially a pocket valve, the several single pockets, triangular in outline, or Single sails that are in the functional position in the circumferential direction limit, has.

Eine solche Ventileinrichtung kann insbesondere zum Ersetzen einer Herzklappe mit Hilfe eines Kathetersystems dienen.Such a valve device can in particular be used to replace a Serve heart valve using a catheter system.

Die Segel der Herzklappen haben eine Ventilfunktion. Kommt es zu krankhaften Veränderungen dieser Segelklappen, so ergeben sich Strömungsverhältnisse, die kurz- und langfristig Herzschädigungen verursachen mit entsprechend schweren Auswirkungen auf den Gesamtorganismus.The heart valve sails have a valve function. It comes pathological changes in these sail flaps, so arise Flow conditions, the short and long term heart damage cause with correspondingly serious effects on the Whole organism.

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 the insufficient valve exist in medication or surgical replacement the valves using the heart-lung machine.

Nicht-chirurgische Lösungsansätze für dieses Problem ergeben sich aus der PCT-WO 91/17720 und der PCT-W 93/01768.Non-surgical approaches to this problem arise 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 a valve device or the like to create that with the help of a non-operative Procedure for inserting a valve device enables the 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 solve this problem, the invention in particular suggested that the vascular valve consist of several separate Single sail is composed, the respective connection points for articulated connection to the vessel wall or the like  have the site and that the individual sails a bracket with a folding mechanism for folding the individual sails for the introduction through a vessel to the site and there to unfold the sail.

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 constructing the valve device from several individual buildings Groups, especially individual sails, arise for them Items significantly reduced outer dimensions, so they individually much easier to insert and easier to use the place of use can be transported.

Vorzugsweise sind die Anschlußstellen der Einzelsegel-Halterung zum gelenkigen Verbinden mit einem an der Einsatzstelle verankerten Stent ausgebildet, insbesondere zum Einhaken bei diesem Stent.The connection points of the single sail holder are preferably for articulated connection with one at the place of use anchored stent, in particular for hooking into this Stent.

An der Einsatzstelle werden die Einzelsegel jeweils nach Positionierung und Verankerung aufgefaltet beziehungsweise aufgeweitet. Es ist dabei vorgesehen, daß in einem ersten Arbeitsgang zunächst der entsprechend modifizierte Gefäßstent nach Palmaz als Verankerungsring eingeführt wird. In einem zweiten Arbeitsgang wird dann die Ventileinrichtung, d. h. die einzelnen Segel der Herzklappe gesondert positioniert und am Stent verankert.At the point of use, the individual sails are Positioning and anchoring unfolded respectively expanded. It is provided that in a first The first step is the modified stent after Palmaz is introduced as an anchor ring. In a second Operation is then the valve device, d. H. the single ones The heart valve sail is positioned separately and on the stent anchored.

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 there is also the possibility of using the stent together with the individual Klappense or the flap sail brackets to the place of use at once bring to.

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, a catheter is used to insert the valve device provided that the fastening means at the proximal end region Attachment distributed in the circumferential and longitudinal directions attached, i.e. cascaded flap sails or flap sail mounts, with the free End of the catheter preferably a balloon for holding the stent is provided.

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.It is expedient for the catheter in the area of the loading fixings for the flap sail brackets one over this slidable outer sleeve is provided for releasing  and connecting the individual flap sail brackets to the stent or the like towards the outer end of the catheter is retractable and that the cross section of the catheter in Bracket area for the flap sail brackets is smaller than the clear passage cross section of the expanded 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. Die Schutzhülle wird dann immer weiter zurückgezogen bis auch das dritte Klappensegel mit Halterung freigegeben und auf den Stent aufgeschoben werden kann.With the help of this catheter, all three valve leaflets with their Mounts and the stent inserted all at once and on the The stent is then anchored first and then be successively with simultaneous withdrawal the outer protective cover released the flap sail with bracket or released so far that they with their threading ends exposed and can be pushed onto the stent. The The protective cover is then pulled back further and further until that too third valve leaflet with bracket released and onto the stent can be postponed.

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 Single sail holder connected at one end Has clamping bracket that along the two long sides of the of the respective sail and there with the edges of the sail are connected and that the two clamps between one Folding position with approximately parallel tensioning brackets and an expansion position with a V-shaped position of the clamps 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 collapsible position, there are only comparatively few External dimensions, in particular a small cross section, so that the individual sails with brackets with the help of a catheter that can be brought close to the heart.

Zusätzliche Ausgestaltungen der Erfindung sind in den weiteren Unteransprüchen aufgeführt. Nachstehend ist die Erfindung mit ihren wesentlichen Einzelheiten anhand der Zeichnungen näher erläutert. Es zeigt stärker schematisiert:Additional embodiments of the invention are in the others Subclaims listed. Below is the invention with their essential details with reference to the drawings explained. 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 flap sail shown in a compressed position, and

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

Die Ventileinrichtung 100 (Fig. 1) weist drei Klappensegel 4 auf, die in Funktionsstellung in Umfangsrichtung aneinander grenzen. Die Klappensegel 4 bestehen aus einem klammerartigen Gebilde aus Metall oder Kunststoff. An den äußeren Schenkeln 3, 3a sind Perforationen beziehungsweise Ösen angebracht, ebenfalls am unteren Bereich des Innenbügels 11 und mit deren Hilfe wird die biologische oder die Kunststoffklappe aufgenäht. 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. 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 valve device 100 ( FIG. 1) has three flap leaflets 4 which adjoin one another in the circumferential direction in the functional position. The flap 4 consist of a clamp-like structure made of metal or plastic. On the outer legs 3 , 3 a perforations or eyelets are attached, also on the lower region of the inner bracket 11 and with the help of which the biological or the plastic flap is sewn on. On the upper turn 5 resilient roll-ups are provided which, after removal from the protective sleeve, press the outer struts of the clip apart to a desired specific width. The ends of the clip are pointed or barbed and can, with the help of the memory effect, rotate outward and penetrate into the vessel wall to produce an additional braking and fixing effect of the device.

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. Nach dieser Spreizung wird die einzelne Segelklappe funktionsfähig.After pushing out of the protective sleeve, the outer legs the bracket of the rounding of the aorta adapted with the help of a inovasive spreader or with the help of the memory effect widened. After this spread, the single sail flap functioning.

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.When inserting the valve device, the holder ring 2 (stent according to Palmaz) is first introduced with a catheter into the intended position 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. Außerdem weist dieser modifizierte Palmaz-Stent Aussparungen im Gitternetz auf, die als radiologische Orientierungshilfen beim Einbringen der Klappensegel dienen.The retaining ring 2 is a modified stent according to Palmaz, which is provided at the end with tips that sink into the mucous membrane when expanded and thus cause primary fixation. In addition, this modified Palmaz stent has cutouts in the grid that serve as radiological guidance when inserting the valve leaflets.

In Fig. 2 ist die komprimierte Vorrichtung mit dem aufgenähten Klappensegel 4 dargestellt. Die Vorrichtung beginnt links unten mit dem Verankerungsdorn 10 und setzt sich fort in zwei Spreizbügel 3, 3a, die über eine Zwischenwindung 5 miteinander verbunden sind. 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 FIG. 2, the compressed device is illustrated with the stitched valve leaflets. 4 The device begins at the bottom left with the anchoring mandrel 10 and continues into two expansion brackets 3 , 3 a, which are connected to one another via an intermediate turn 5 . In these expansion brackets 3 , the intermediate turn 5 and the upper part of the inner bracket 11 there are a plurality of connection points 8 which receive the retaining threads 9 and fix the compressed flap sail.

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 retraction turn 12 , the device passes into the inner bracket 11 and the threading end 6 and ends with the mutual anchoring pin 10th

In Fig. 3 ist die gespreizte Vorrichtung dargestellt, nachdem sie röntgenologisch positioniert und aus der Schutzhülse des Gefäßkatheters herausgeschoben wurde. Dabei wird der Innenbügel 11 mit Hilfe des Einfädelendes 6 hinter den Stent 2 geschoben und so auf dem Stent fixiert. Auch die Zwischenwindung 5 kann zusätzlich zum Einrasten auf den Stent 2 benutzt werden. 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. Nach dem Öffnen dringen die Verankerungsdorne 10 in die oberflächliche Aortenwand 1 ein und bewirken eine Zusatzfixation. 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.In Fig. 3, the spread device is shown after it has been X-ray positioned and pushed out of the protective sleeve of the vascular catheter. The inner bracket 11 is pushed behind the stent 2 with the aid of the threading end 6 and is thus fixed on the stent. The intermediate turn 5 can also be used for snapping onto the stent 2 . The expanding and tensioning bracket 3 opens after being released from the protective sleeve of the catheter due to the spring tension of the intermediate turn 5 and brings the compressed valve leaflet 4 into its tensioned and expanded functional state, the longitudinal sides 7 of the individual sails overlapping. After opening, the anchoring pins 10 penetrate into the superficial aortic wall 1 and bring about an additional fixation. If one of the valve cores becomes insufficient, the anchoring mandrels are compressed with the aid of endovasive forceps and pulled out at the retraction turn 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 of bringing the individual flap sails 4 together with their respective bracket-like holder 13 to the place of use, there is also the possibility of using a specially designed catheter to offset the holders with flap sails by 120 degrees in the circumferential direction (with three folding sails) and also in the longitudinal direction to be installed offset at the end of this catheter and to bring these assemblies together to the site at once.

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. Eine Vorfixierung am Ende des Katheters kann beispielsweise durch Magnetkraft erfolgen. 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.A safety sleeve is pushed over the arrangement of the flap leaflets 4 offset from one another with their holders 13 , so that the flap leaflets with their holders are not displaced when the catheter is inserted. A pre-fixation at the end of the catheter can be done, for example, by magnetic force. Proximal to the fastening means for the holders 13 and the valve leaflets 4, there is a balloon at the free end of the catheter, onto 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. Die Schutzhülle wird dann immer weiter zurückgezogen bis auch das dritte Klappensegel mit Halterung freigegeben und auf den Stent aufgeschoben werden kann.After inserting the catheter with all three folding sails with brackets and stent, the stent is then anchored at the site of use and then the valve leaflets with holder are released one after the other while simultaneously pulling back the outer protective sheath, or respectively released so far that their threading ends 6 exposed and can be pushed onto the stent 2 . The protective cover is then pulled back further and further until the third valve leaflet with holder can also be released 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. 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. 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.After the stent has been expanded with the balloon, the lumen of the stent 2 is so large that the subsequent flap sail holders, which are attached to the outside of the catheter holder, can be advanced so far that the flap sail holders on the stent come into engagement one after the other . Due to the position of the valve leaflet brackets (with three valve leaflets) which is offset by 120 degrees in the circumferential direction, they automatically engage and connect to the stent when pushed forward. An insertion aid and centering aid could also be provided on the edge of the stent, offset by 120 degrees, so that the flap sail holders can be precisely positioned even when the catheter is rotated relative to the inserted 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 flap leaflets which are triangular in outline in flat position and which adjoin one another in the functional position in the circumferential direction, characterized in that the vessel flap consists of several separate ones Flap sails ( 4 ) is composed, each have connection for articulated connection to the vessel wall or the like at the point of use and that the flap sails ( 4 ) have a holder ( 13 ) with a folding mechanism for folding up the flap sails for insertion through a vessel the place of use and there to unfold the sails. 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 the connection points are located on the flap sail holder ( 13 ). 3. Ventileinrichtung nach Anspruch 1 oder 2, dadurch gekenn­ zeichnet, daß die Klappensegel-Halterung (13) an einem Ende miteinander verbundene Spannbügel (3, 3a) 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, 3a) 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 flap sail holder ( 13 ) at one end interconnected clamps ( 3 , 3 a) which run along the two long sides of the respective sail ( 4 ) and there with the edges of the sail are connected and that the two clamping brackets ( 3 , 3 a) are adjustable between a collapsible position with approximately parallel clamping brackets and an expansion position with a V-shaped position of the clamping brackets. 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 flap sail holder ( 13 ) consists at least in regions of round wire. 5. Ventileinrichtung nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, daß die Spann- und Spreizbügel (3, 3a) der Klappensegel-Halterung (13) vorzugsweise elastisch biegbar miteinander verbunden sind und daß in ihrem Verbindungs­ bereich wenigstens eine Zwischenwindung (5) vorgesehen ist.5. Valve device according to one of claims 1 to 4, characterized in that the tensioning and expanding brackets ( 3 , 3 a) of the flap sail holder ( 13 ) are preferably elastically bendable and that 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, 3a) 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 flap sail holder ( 13 ) with its clamping bracket ( 3 , 3 a) and the or the connection points for connecting to the vessel wall or the like is bent from a piece of wire. 7. Ventileinrichtung nach einem der Ansprüche 1 bis 6, dadurch gekennzeichnet, daß die Spannbügel (3, 3a) 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, 3a) im Bereich der Verbindungsstellen vorzugsweise abgeplattet sind.7. Valve device according to one of claims 1 to 6, characterized in that the clamping bracket ( 3 , 3 a) have in the course of their longitudinal extension connection points ( 8 ) for the valve flap ( 4 ), in particular through a plurality of spaced holes for threading through Retaining threads ( 9 ) are formed and that the clamping bracket ( 3 , 3 a) are preferably flattened in the area of the connection points. 8. Ventileinrichtung nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, daß zumindest einer der Spannbügel (3a) 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 eye with overlapping legs at an insertion opening. 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 device according to one of claims 1 to 8, characterized characterized in that one of the overlapping legs by the free end of the hook or eye and the other Leg through a portion of the associated clamp is formed. 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 characterized in that the hook or the eyelet ring-like is trained and over a large part of the length of the Stretching bracket extends.   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 inner end of the ring bracket-like hook between the two clamping brackets is designed as a threading end ( 6 ) and has a rounded course, optionally with 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. Valve device according to one of claims 1 to 11, characterized in that at least the connection point of the clamping bracket of the flap sail holder ( 13 ), preferably the intermediate turn ( 5 ), consists 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 the valve leaflet holder ( 13 ) are designed for articulated connection to a stent ( 2 ) anchored at the point of use, in particular for hooking into 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 flap sail ( 4 ) made of biological material, preferably of pig flaps, 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 characterized in that the flap sail with bracket in folded state in cross section less than 6 mm is. 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 an anchoring mandrel ( 10 ), optionally with barbs or the like is provided for anchoring in the vessel wall at the free end of one of the clamping bracket ( 3 ). 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. Catheter for inserting a valve device according to one of claims 1 to 16, characterized in that the catheter at the proximal end region has fastening means for attaching flap sail holders ( 13 ) distributed in the circumferential and longitudinal directions and that preferably at the free end of the catheter Balloon for holding a stent ( 2 ) is provided. 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. Catheter according to claim 17, characterized in that on Catheter in the area of the fasteners for the valve flap gel holders an outer shell that can be slid over this is provided for releasing and connecting the individual Flap sail mounts with the stent or the like in Is retractable towards the outer end of the catheter and that the cross section of the catheter in the mounting area for the flap sail brackets is smaller than the clear one Cross section of the widened, anchored Catheters.
DE1995132846 1995-09-06 1995-09-06 Valve for use in heart Withdrawn DE19532846A1 (en)

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